patterns of in-stent restenosis after placement of nir gold-coated …summitmd.com/pdf/syllabus/new...

Catheter Cardiovasc Interv 2002 Feb;55(2):157-62

Patterns of in-stent restenosis after placement of NIR gold-coated stents in

unselected patients.

Danzi GB, Capuano C, Sesana M, Di Blasi A, Predolini S, Antoniucci D.

The aim of this study was to assess the incidence and angiographic patterns of in-stent restenosis 6

months after the implantation of NIR gold-coated stents in an unselected patient population. One

hundred and sixteen consecutive patients were treated with the implantation of 149 NIR gold-coated

stents. The majority of the patients (52%) had unstable angina or acute myocardial infarction. The

baseline lesion morphology was complex in 78% of cases; the mean lesion length was 18 5 mm. The

procedural success rate was 97%. Subacute stent thrombosis occurred in three patients (2.6%).

During the 6-month follow-up, there were 2 deaths and 22 subjects (19.5%) underwent target vessel

revascularization. The 6-month event-free survival was 60%. The angiographic restenosis rate was

32%. In 83% of the cases, the morphology of the restenosis was proliferative; in the remaining 17%, it

presented as total occlusion. In conclusion, the restenosis rate after NIR gold-coated stent

implantation in high-risk patients is similar to that reported using other stent designs. However,

restenosis was always diffuse, involving the overall stent length and extending beyond the margins,

thus indicating a greater proliferative neointimal response to this device.


Angiographic outcome after intracoronary X-Sizer helical atherectomy and

thrombectomy: first use in humans.

Kwok OH, Prpic R, Gaspar J, Mathey DG, Escobar A, Goldar-Najafi A, Reifart N, Ischinger TA, Popma

JJ.

The objective of this study was to evaluate the early angiographic outcome in the first human

subjects who underwent intracoronary atherectomy and thrombectomy using the X-Sizer helical

cutting and aspiration system. Percutaneous coronary interventions in patients with thrombo-

occlusive disease or friable degenerative saphenous vein grafts are associated with considerable

periprocedural morbidity and mortality, predominantly related to microscopic distal embolization. X-

Sizer catheter system is a novel atherectomy and thrombectomy device that consists of a helix cutter

connected to a handheld motor drive unit and a vacuum collection chamber for aspiration of excised

atheroma, thrombus, and debris. Quantitative coronary angiography was obtained in 14 patients before

and after X-Sizer extraction atherectomy with adjunctive balloon angioplasty and stenting. Thirteen

native coronary arteries and one saphenous vein graft were treated. Mean preprocedural reference

vessel diameter was 3.06 0.66 mm. There were 71.4% AHA/ACC type B2 and C lesions.

Preprocedural thrombus was present in nine patients and total occlusion in 64% of cases. Minimal

luminal diameter was increased from 0.29 0.47 mm to 1.32 0.64 mm, a gain of 1.04 0.69 mm after

atherectomy. Final total gain was 1.47 0.61 mm. Mean diameter stenosis was reduced from 89.3% to

a final residual stenosis of 14.4%. Postatherectomy distal embolization occurred in one patient who

had heavy preprocedural thrombus burden. No episodes of perforation, distal coronary spasm, abrupt

closure, or slow/no-reflow occurred. The angiographic analysis of the first cohort of human subjects

suggests that X-Sizer helical atherectomy is a feasible method of removing occlusive tissue or

thrombus in coronary artery disease with a low angiographic complication rate. A large-scale

randomized phase II clinical trial is underway to determine the ultimate safety and efficacy of this

device in thrombo-occlusive native coronary arteries and saphenous vein grafts.

J Interv Cardiol 2002 Oct;15(5):371-9

New catheter-based technology for the treatment of restenosis.

Kataoka T, Honda Y, Bonneau HN, Yock PG, Fitzgerald PJ.

Catheter-based vascular interventions have been in development worldwide for several decades,

leading to remarkable progress in device technology. Mechanical interventional devices, such as

angioplasty balloons, atherectomy devices, and stents, were invented and have contributed greatly to

the treatment of atherosclerotic vascular stenosis. However, mechanical approaches do not

effectively prevent subsequent intimal growth. Recently, several biological approaches, including

radiation therapy and drug-eluting stents, have shown striking inhibition of intimal growth. These

significant results are likely to change the treatment strategy in the field of interventional cardiology.

Furthermore, additional catheter-based technologies for vascular interventions are presently being

evaluated. These latest technologies designed to prevent intimal proliferation include intravascular

sonotherapy, cryotherapy, photoangioplasty, and soft X ray. To date, intravascular sonotherapy has

proven its efficacy in animal studies and safety in human studies. Cryotherapy, the application of cold

thermal energy during angioplasty, enhances the acute effects of conventional dilation while

decreasing the likelihood of restenosis. Photoangioplasty has a unique property based on its selective

mechanism of action to treat atheromatous plaque. Soft X ray systems provide convenient device

handling and well-controlled radiation dose. Some of these technologies may play an important role in

vascular interventions in the near future.

Q J Nuc Med 2002 Dec 46(4):323-30 l ;

Nuclear medicine procedures in cardiovascular diseases. An evidence based

approach.

Acampa W, Petretta M, Cuocolo A.

The aim of evidence-based medicine is to integrate individual clinical expertise with the best

available external clinical evidence from systematic research. The aim of this article is to introduce

the concept of evidence based medicine and to review the evidence for applying cardiovascular

nuclear medicine in various clinical settings. A systematic review is defined as a scientific technique

to identify and summarize evidence on effectiveness of interventions and to allow the consistency of

research. Different clinical applications of nuclear medicine procedures in cardiology have been

reviewed. Radionuclide imaging techniques appear to be appropriate in risk assessment, prognosis

and evaluation of therapy in patients after acute myocardial infarction. In patients with unstable angina,

radionuclide testing is indicated in the identification of ischemia within the distribution of the "culprit"

lesion or in remote areas. Exercise and pharmacological cardiac perfusion imaging are appropriate

and useful in the diagnosis and prognosis of chronic coronary artery disease. Nuclear medicine

procedures are also useful in the assessment of myocardial viability in patients with left ventricular

dysfunction, in the assessment of interventions for the evaluation of patients after percutaneous

transluminal coronary angioplasty and coronary artery bypass grafting. There has been rapid

evolution in radionuclide imaging technologies and both the number and the complexity of choices for

the clinician have increased. Further progress in technology and clinical applications of nuclear

cardiology may be expected. The development of new instrumentation and of new agents will allow

consistent progress and improve the state-of-art of nuclear cardiology. Thus, guidelines for the use

of cardiac radionuclide imaging have been difficult to develop and apply. An evidence-based approach

may be useful for the best use of nuclear medicine procedures in cardiovascular diseases.

Heart 2002 Sep;88(3):289-92

A rapid and reproducible on line automated technique to determine endothelial

function.

Sidhu JS, Newey VR, Nassiri DK, Kaski JC.

OBJECTIVE: To evaluate clinically a new on line, automated technique to measure flow mediated

dilatation (FMD) as a marker of endothelial function. DESIGN: Prospective study. PATIENTS: 12

healthy volunteers and 12 patients with significant, angiographically documented coronary artery

disease. INTERVENTIONS: Brachial arteries were imaged using a standard vascular ultrasound

system with a 5-12 MHz linear transducer. Arterial diameter was measured on line (in real time) by

connecting the ultrasound system to a personal computer equipped with a frame grabber and artery

wall detection software (VIA) specially developed by the authors' group. By using this new technique,

FMD was measured following 4.5 minutes of ischaemia of the proximal forearm in all subjects on two

separate days. RESULTS: The mean (SD) day to day variability in FMD measurements was 0.90

(0.48)%,which compares very favourably with current methods. The FMD measurement was available

within seconds of completing the scan. CONCLUSIONS: Personal computer based automated

techniques to assess FMD involve image acquisition and recording after which a second (off line)

image interpretation session is required. The need for off line analysis makes current methods time

consuming and increases the variability of measurement. This on line, automated analysis technique

for FMD assessment reduces the variability and greatly increases the speed of measurement. Using

this system may mean that fewer patients will be required in clinical trials assessing the effects of

interventions on endothelial function. Adopting this method may also facilitate the screening of larger

numbers of subjects for endothelial dysfunction.

Heart 2002 May;87(5):455-60

Early experience with a helical coronary thrombectomy device in patients with acute

coronary thrombosis.

Constantinides S, Lo TS, Been M, Shiu MF.

OBJECTIVE: To report our experience with a new thrombectomy device (X-SIZER(TM)) in patients

with angiographically visible thrombus or total coronary occlusion in the setting of acute coronary

syndromes. DESIGN: A safety and feasibility study in the use of the X-SIZER during intervention in

patients with acute coronary syndromes. PATIENTS: 35 patients, age range 31 to 83 years (mean 60).

SETTING: University Hospitals of Coventry and Warwickshire NHS Trust (tertiary referral centre).

INTERVENTIONS: The indication for intervention was primary or salvage percutaneous coronary

intervention for acute myocardial infarction in 17 of the 35 patients; unstable angina or non-ST-

elevation myocardial infarction in 10; and unstable postinfarct angina in eight. Abciximab was given in

11 patients. MAIN OUTCOME MEASURES: Device success (successful deployment of the device at

the site of the lesion with resultant improvement in TIMI flow); clinical success (no residual stenosis

at the end of the procedure with no in-hospital major adverse coronary events). RESULTS:

Successful use of the device was achieved in 26 of the 35 cases. It failed to cross the lesion in five

and failed to improve TIMI flow despite crossing the lesion in four. Clinical success was achieved in

30 of the 35 cases. Device related complications occurred in two cases (vessel perforation) and there

was one intraprocedural death (acute myocardial infarction with cardiogenic shock). CONCLUSIONS:

Thrombectomy with the X-SIZER catheter system appears promising in percutaneous coronary

intervention where thrombus extraction is considered necessary before stent implantation.

BioDrugs 2002;16(1):75-6

FGF-4 gene therapy GENERX--Collateral Therapeutics.

Collateral Therapeutics and Schering AG in Germany are developing a gene therapy product,

GENERX for coronary artery disease. Based on the terms of the agreement, Schering or its affliates

will be responsible for conducting and financing phase II/III clinical trials which are currently

underway in the US and Europe. In particular, Berlex Labs (the US subsidiary of Schering AG), is

involved in developing the gene therapy in the US. GENERX is an angiogenic gene therapy which

triggers the production of a protein that stimulates new blood vessel growth providing an alternative

route for blood to bypass clogged and blocked arteries in the heart. GENERX involves a one-time,

non-surgical delivery of an adenovirus vector containing the human fibroblast growth factor-4 (FGF-

4) into coronary arteries via a standard catheter. The FGF-4 gene was licensed from New York

University. Collateral Therapeutics has been granted a US patent for "gene transfer-mediated

angiogenesis therapy" for the nonsurgical administration of angiogenic genes for coronary and

peripheral vascular disease. The patented technology has been licensed from the University of

California. Collateral and Berlex have initiated pivotal phase IIb/III trials with GENERX in the US and

Europe. The US-based study will evaluate the safety and efficacy of GENERX in patients with stable

exertional angina due to coronary artery disease. The European-based study will evaluate patients

with advanced coronary artery disease who are not considered candidates for interventions such as

angioplasty and bypass surgery and/or patients who are unlikely to have positive outcomes from such

interventions. Both studies, of a multicentre, randomised, double-blind and placebo-controlled design,

will evaluate 2 dose levels of GENERX which will be non-surgically administered to the heart via

intracoronary infusion through a standard cardiac catheter. Collateral also plans to develop a non-

surgical gene therapy product using the FGF-4 gene for the treatment of patients with heart failure.

In a blinded placebo-controlled study in a pig model of pacing-induced heart failure, intracoronary

delivery of human FGF-4 expressed in an adenovirus vector showed significant improvement in

regional cardiac function and a reduction in the size of the heart over a 3-week study period. If these

results translated favourably to humans, FGF-4 gene therapy may be a therapeutic option for patients

with dilated heart failure. Collateral Therapeutics has also announced a research collaboration with

Targeted Genetics on the use of viral vectors to deliver therapeutic genes in cardiovascular disease.

Under the terms of the agreement, Targeted Genetics and Collateral Therapeutics each have the

option to collaborate further to use Targeted Genetics' recombinant adeno-associated viral vector to

treat congestive heart failure. In such an event, Targeted Genetics would be responsible for

constructing and manufacturing the vector, and Collateral Therapeutics will fund the costs of future

collaboration. Either party may terminate this agreement at any time upon 30 days prior written notice.

Am J Cardiol 2002 Jan 1;89(1):44-9

Significant reduction of radiation exposure to operator and staff during cardiac

interventions by analysis of radiation leakage and improved lead shielding.

Kuon E, Schmitt M, Dahm JB.

The objectives of this study were to disclose and to reduce occupational radiation leakage in

invasive cardiology. Prospectively, we analyzed various dose parameters for 330 coronary

procedures. We used a Rando phantom to measure scatter entrance skin air kerma to the operator (S-

ESAK-O) during fluoroscopy for all standard tube angulations, and to plot isodose lines for 0 degrees

/0 degrees -posterior anterior angulation. The patient's measured dose area product due to diagnostic

catheterization and elective percutaneous transluminal coronary angioplasty was 6.2 and 10.4

Gycm(2), which represents 11% and 13% of currently typical values, respectively. With use of 0.5-

and 1.0-mm overcouch and undercouch shielding, it was possible to reduce the mean of 4,686

nSv/Gycm(2) to 677 and 277 nSv/Gycm(2), respectively. Closure of radiation leakage up to 897

microSv/hour at the operator's gonadal height (80 to 105 cm), not heretofore described, was achieved

by an additional 1.0-mm, lead-equivalent undercouch-top and overcouch-flap adjacent to the table,

down to a S-ESAK-O/dose area product level of 47.5 nSv/Gycm(2). With use of a 0.5-mm lead apron,

collar, glasses, foot-switch shield and 1.0-mm lead cover around the patient's thighs, the operator

received a mean S-ESAK-O of 8.5, while his forehead, eyes, thyroid, chest, gonads, and hands were

exposed to 68.2, 1.2, 1.2, 1.2, 0.8, and 58.2 nSv/Gycm(2), respectively. In conclusion, radiation-

attenuating intervention techniques and improved lead protection can effectively contribute to a new

state of the art in invasive cardiology, with reduction of operator radiation exposure to 0.8% of typical

S-ESAK-O levels in advanced catheterization laboratories.

Rev Esp Cardiol 2003 Mar;56(3):271-80

Angiographic results of thrombectomy performed with two new devices in lesions

with intracoronary thrombus.

Lopez-Palop R, Pinar E, Lozano I, Carrillo P, Saura D, Cortes R, Pico F, Valdes M.

Introduction and objective. The presence of intracoronary thrombus is associated with less favorable

results of percutaneous coronary interventions. In recent years, new devices have been designed to

improve the outcome of these procedures when an intracoronary thrombus is present. The results of

two new systems of thrombectomy used in a single center are analyzed.Methods. Prospective

observational registry of the use of two thrombectomy devices, X-SIZER (EndiCOR Medical Inc., San

Clemente, California, USA) and RESCUE (Boston Scientific Scimed, Inc., Maple Grove, Minnesota,

USA), between 1 June 2000 and 15 February 2002.Results. One hundred thirty-nine devices were

used in 137 patients (112 RESCUE and 27 X-SIZER). The main indication was primary angioplasty for

acute myocardial infarction (80%). In 7 patients (5%), unscheduled thrombectomy was performed for

unexpected complications that appeared during the procedure. In 75% of patients, IIb/IIIa inhibitors

were given. In 10 cases (7%) the device did not reach the lesion. Complications derived from the use

of the device were recorded in 3 cases (2.1%). TIMI flow improved from 1.28 1.1 before

thrombectomy to 2.31 1.2 after the procedure. Improvement in the thrombus image was observed in

86%. The intervention was successful in 86%.Conclusions. Thrombectomy with X-Sizer and Rescue

improved the angiographic thrombus image in most cases and was associated to a low complication

rate. Its efficacy compared to the conventional technique should be assessed in future trials.

IEEE Trans Med Imaging 2002 Oct;21(10):1254-63

A novel measurement technique to assess the effects of coronary brachytherapy in

clinical trials.

Koning G, Tuinenburg JC, Hekking E, Peelen J, van Weert AW, Bergkamp D, Goedhart B, Reiber JH.

This paper presents a novel measurement technique to assess the effects of coronary brachytherapy.

This new technique is based upon the conventional quantitative coronary analysis (QCA) technique,

which is accepted worldwide as an accurate and reliable analysis tool for clinical trials. This paper

provides the definitions and main issues important for correct brachytherapy analysis. Based on these

definitions, this novel technique is implemented as an extension of conventional QCA software, as a

multisegmental analysis tool. It allows to follow the influence of radiation on restenosis, and the

mutual relation between intervention devices. A pilot interobserver study was performed to assess

the reliability and reproducibility of the brachytherapy analysis tool, using 15 patient cases. The

validation results show that the segment lengths, minimum lumen diameter, and reference diameters

of the user-defined and derived (sub)segments can be assessed reproducible. However, these good

results can only be obtained, when strict and extensive image acquisition and image analysis

protocols are followed. From this pilot validation study presented in this paper and only based on a

small number of patients, we may conclude that the software can be applied to clinical trials.

Catheter Cardiovasc Interv 2002 Nov;57(3):332-9

Export aspiration catheter thrombosuction before actual angioplasty in primary

coronary intervention for acute myocardial infarction.

Wang HJ, Kao HL, Liau CS, Lee YT.

Primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) in lesions

with a large thrombus load increases the procedural complication rate. We describe a thrombus

reduction technique in this setting using the Export aspiration catheter (EAC) for primary

thrombosuction before actual angioplasty. The EAC is a component of the GuardWire Plus system

(PercuSurge, Sunnyvale, CA), which was originally developed for emboli containment in saphenous

vein graft and peripheral vessel interventions. Primary EAC thrombosuction was performed

successfully in 12 patients undergoing primary PCI, and gross thrombi were obtained from 9 patients

(75%). After definitive treatment with balloon angioplasty and/or stenting, TIMI 3 flow was restored in

all target vessels. There was no angiographic evidence of distal branch loss or vessel injury. No

major procedural or in-hospital complication occurred in any patients. This primary EAC

thrombosuction technique may offer a new, potentially effective method for thrombus burden

reduction in treating AMI patients.

Catheter Cardiovasc Interv 2003 Apr;58(4):419-27

Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic

lesions in native coronary arteries and saphenous vein grafts: Results from the

multicenter X-sizer for treatment of thrombus and atherosclerosis in coronary

applications trial (X-TRACT) study.

Stone GW, Cox DA, Low R, Cates CU, Satler L, Bailey SR, Kuntz RE, Lansky AJ.

Intervention in thrombotic lesions and diseased saphenous vein grafts frequently results in

thromboembolic complications, including no-reflow, distal branch occlusion, periprocedural MI, and

death. The utility of a novel thromboatherectomy device, the X-Sizer, was tested in 50 consecutive

patients at nine U.S. centers. A total of 61 lesions were treated in 31 vein grafts and 19 native

coronary arteries; thrombus was present in 78% of lesions, and TIMI 0-1 flow in 21%. TIMI 3 flow

improved from 57% at baseline to 94% postprocedure. No patient developed visible distal

thromboemboli, side-branch occlusion, or reduced antegrade flow. Thirty-day events included one

death (2.0%), Q- or non-Q-wave MI in 4.0%, TVR in 6.0%, and any MACE in 6.0%. We conclude that

the use of the X-Sizer prior to percutaneous intervention is safe in high-risk vein grafts and

thrombotic lesions and results in a low rate of adverse events compared to historical controls.

J Interv Cardiol 2002 Dec;15(6):491-7

Guiding catheter aspiration to prevent embolic events during saphenous vein graft

intervention.

Morales PA, Heuser RR.

Percutaneous coronary interventions (PCI) in saphenous vein graft (SVG) stenosis carries 10%-20%

risk of major adverse clinical events (MACE) or reduced antigrade flow (No-reflow Phenomena). The

PercuSurge device is not available at all United States hospitals and sometimes anatomically cannot

be placed (distal stenosis). We developed a simple technique for use in patients who could not have

the PercuSurge device placed during PCI of SVG. METHODS: The basic concept of this technique is

the use of guiding catheter aspiration during PCI. Over a two-year period, seven patients underwent

PCI in SVG, using this technique for symptomatic stenosis. They were all males, average SVG age

was 14 +/- 6 years, 43% were degenerated SVG's, four (57%) had new stents placed, and three

(43%) had percutaneous transluminal coronary angioplasty (PTCA) or cutting balloon therapy. All

patients were pretreated with aspirin and clopidogrel and had baseline preprocedure serum creatine

kinase (CK) and ECG. Following the procedure, patients had repeat serum CK and ECG eights hours

post-procedure. No patients received glycoprotein platelets inhibitors. RESULTS: Twenty to 60 mL of

blood with gross macroscopic material was recovered during aspiration. None of the patients

experienced no-reflow phenomena or had major elevated CKs during the procedure as defined as 5 x

normal baseline. Thirty-day MACE in all patients was zero. CONCLUSION: The pilot study suggests

that guiding catheter aspiration may be effective in reducing MACE is some patients undergoing PCA

in SVG.

J Am Coll Cardiol 2002 Nov 20;40(10):1882-8

Distal filter protection during saphenous vein graft stenting: technical and clinical

correlates of efficacy.

Stone GW, Rogers C, Ramee S, White C, Kuntz RE, Popma JJ, George J, Almany S, Bailey S.

OBJECTIVES: The aim of this study was to evaluate the clinical, angiographic, and technical factors

related to successful stenting of diseased saphenous vein grafts (SVGs) using a novel filter-based

distal protection device. BACKGROUND: Protection of the distal microvasculature with a balloon

occlusion and aspiration system has been shown to reduce atherothrombotic embolization and peri-

procedural myocardial infarction (MI) after percutaneous coronary intervention (PCI) in SVGs. The

safety, efficacy, and technical factors relating to procedural success with filter-based distal

protection devices are unknown. METHODS: Percutaneous coronary intervention was performed in 60

lesions in 48 patients undergoing SVG intervention with the FilterWire EX distal protection system in

a phase I experience at six sites. A larger phase II study was then performed in 248 lesions in 230

SVGs at 65 U.S. centers. RESULTS: Cumulative adverse events to 30 days occurred in 21.3% of

patients in phase I, including a 19.1% rate of MI. Numerous anatomic, device-specific, and operator-

related contributors to these adverse events were identified, resulting in significant changes to the

protocol and instructions for use. Subsequently, despite similar clinical and angiographic

characteristics to the phase I patients, the 30-day adverse event rate in phase II was reduced to

11.3% (p = 0.09), due primarily to a lower incidence of peri-procedural Q-wave and non-Q-wave MI.

CONCLUSIONS: Distal protection during SVG PCI with the FilterWire EX is associated with a low rate

of peri-procedural adverse events compared to historical controls. A unique set of anatomic, technical,

and operator-related issues exist with distal filters which, if ignored, may reduce their effectiveness.

Am J Cardiol 2003 Feb 6;91(3A):27A-33A

New frontiers and unresolved controversies in percutaneous coronary intervention.

Dzavik V.

Percutaneous coronary intervention (PCI) has become a key modality of therapy of patients with

coronary artery disease. However, with the exception of acute coronary syndromes, there is as yet

no conclusive evidence from randomized controlled trials that PCI improves survival and outcome

compared with optimal medical therapy. Randomized trials comparing PCI and coronary artery bypass

grafting in patients with stable coronary artery disease conducted before stenting showed superiority

of the surgical approach. Early results from stent trials continue to indicate better symptom relief and

less need for repeat intervention with the surgical approach, although myocardial infarction and

mortality are similar with the 2 revascularization modalities. In the setting of acute coronary

syndromes, however, recent trials suggest superiority of an aggressive approach, including PCI,

compared with a conservative strategy of medical therapy only. This benefit extends to patients with

acute ST-elevation myocardial infarction, including those with shock. In the latter setting, mortality

remains high and novel approaches to protect myocardial metabolism and improve perfusion will be

needed to further improve survival. The role of revascularization in patients with completed

myocardial infarction and persistently occluded arteries is much less clear. Although the late open

artery hypothesis is widely accepted and interventional cardiologists routinely open late infarct-

related coronary occlusions, the available evidence to justify this strategy is weak. New devices, such

as thrombectomy devices in thrombus-laden lesions and drug-eluting stents, offer promise, although

all lack the degree of proof of benefit and safety typically required of new pharmaceutical agents. As

new technologies and therapies with the potential to improve outcomes and decelerate the

atherosclerotic process are developed, it will be important for investigators and industry to

collaborate in incorporating these advances into ongoing and new trials testing the efficacy of PCI in

all settings.

Am J Cardiol 2002 Nov 15;90(10):1079-83

Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting

Balloon Global Randomized Trial.

Mauri L, Bonan R, Weiner BH, Legrand V, Bassand JP, Popma JJ, Niemyski P, Prpic R, Ho KK,

Chauhan MS, Cutlip DE, Bertrand OF, Kuntz RE.

The cutting balloon (CB) is a specialized device designed to create discrete longitudinal incisions in

the atherosclerotic target coronary segment during balloon inflation. Such controlled dilatation

theoretically reduces the force needed to dilate an obstructive lesion compared with standard

percutaneous transluminal coronary angioplasty (PTCA). We report a multicenter, randomized trial

comparing the incidence of restenosis after CB angioplasty versus conventional balloon angioplasty in

1,238 patients. Six hundred seventeen patients were randomized to CB treatment, and 621 to PTCA.

The mean reference vessel diameter was 2.86 +/- 0.49 mm, mean lesion length 8.9 +/- 4.3 mm, and

prevalence of diabetes mellitus in patients was 13%. The primary end point, the 6-month binary

angiographic restenosis rate, was 31.4% for CB and 30.4% for PTCA (p = 0.75). Acute procedural

success, defined as the attainment of <50% diameter stenosis without in-hospital major adverse

cardiac events, was 92.9% for CB and 94.7% for PTCA (p = 0.24). Freedom from target vessel

revascularization was slightly higher in the CB arm (88.5% vs 84.6%, log-rank p = 0.04). Five

coronary perforations occurred in the CB arm only (0.8% vs 0%, p = 0.03). At 270 days, rates of

myocardial infarction, death, and total major adverse cardiac events for CB and PTCA were 4.7%

versus 2.4% (p = 0.03), 1.3% versus 0.3% (p = 0.06), and 13.6% versus 15.1% (p = 0.34), respectively.

In summary, the proposed mechanism of controlled dilatation did not reduce the rate of angiographic

restenosis for the CB compared with conventional balloon angioplasty. CB angioplasty should be

reserved for difficult lesions in which controlled dilatation is believed to provide a better acute result

compared with balloon angioplasty alone.

J Invasive Cardiol 2002 Dec 14(12):720-4 ;

Safety and efficacy of cutting balloon angioplasty: the Mayo Clinic experience.

Orford JL, Fasseas P, Denktas AE, Hammes L, Garratt KN, Berger PB, Holmes DR, Barsness GW.

A number of evolving clinical indications for cutting balloon angioplasty (CBA) have been described

in the clinical literature, including angioplasty-resistant stenoses, in-stent restenosis, ostial lesions

and small vessel disease. METHODS: We analyzed the Mayo Clinic PTCA registry and report

procedural and in-hospital clinical outcomes in 100 patients (103 procedures, 114 lesions) undergoing

CBA. RESULTS: CBA was successfully completed in 109 lesions (96%). The majority of lesions (73%)

required additional treatment with either balloon angioplasty (39%) or stent implantation (34%).

Severe intimal dissection resulting in at least 50% luminal obstruction occurred in 13 lesions (11%). A

single incident of branch occlusion was documented, resulting in ST elevation myocardial infarction.

There were no incidents of vessel perforation, urgent percutaneous or surgical target vessel

revascularization, or in-hospital death. CONCLUSION: CBA is feasible and safe, with a low incidence

of procedural complications and in-hospital adverse cardiac events when used primarily for in-stent

restenosis.

NEW TECHNIQUES

1. Patterns of in-stent restenosis after placement of NIR gold-coated stents in unselected patients.

Danzi GB, Capuano C, Sesana M, Di Blasi A, Predolini S, Antoniucci D.


2. Angiographic outcome after intracoronary X-Sizer helical atherectomy and thrombectomy: first use

in humans.

Kwok OH, Prpic R, Gaspar J, Mathey DG, Escobar A, Goldar-Najafi A, Reifart N, Ischinger TA, Popma

JJ.


3. New catheter-based technology for the treatment of restenosis.

Kataoka T, Honda Y, Bonneau HN, Yock PG, Fitzgerald PJ.

J Interv Cardiol 2002 Oct;15(5):371-9

4. Nuclear medicine procedures in cardiovascular diseases. An evidence based approach.

Acampa W, Petretta M, Cuocolo A.

Q J Nucl Med 2002 Dec;46(4):323-30

5. A rapid and reproducible on line automated technique to determine endothelial function.

Sidhu JS, Newey VR, Nassiri DK, Kaski JC.

Heart 2002 Sep;88(3):289-92

6. Early experience with a helical coronary thrombectomy device in patients with acute coronary

thrombosis.

Constantinides S, Lo TS, Been M, Shiu MF.

Heart 2002 May;87(5):455-60

7. FGF-4 gene therapy GENERX--Collateral Therapeutics.

BioDrugs 2002;16(1):75-6

8. Significant reduction of radiation exposure to operator and staff during cardiac interventions by

analysis of radiation leakage and improved lead shielding.

Kuon E, Schmitt M, Dahm JB.

Am J Cardiol 2002 Jan 1;89(1):44-9

9. Angiographic results of thrombectomy performed with two new devices in lesions with

intracoronary thrombus.

Lopez-Palop R, Pinar E, Lozano I, Carrillo P, Saura D, Cortes R, Pico F, Valdes M.

Rev Esp Cardiol 2003 Mar;56(3):271-80

10. A novel measurement technique to assess the effects of coronary brachytherapy in clinical trials.

Koning G, Tuinenburg JC, Hekking E, Peelen J, van Weert AW, Bergkamp D, Goedhart B, Reiber JH.

IEEE Trans Med Imaging 2002 Oct;21(10):1254-63

11. Export aspiration catheter thrombosuction before actual angioplasty in primary coronary

intervention for acute myocardial infarction.

Wang HJ, Kao HL, Liau CS, Lee YT.

Catheter Cardiovasc Interv 2002 Nov;57(3):332-9

12. Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in

native coronary arteries and saphenous vein grafts: Results from the multicenter X-sizer for

treatment of thrombus and atherosclerosis in coronary applications trial (X-TRACT) study.

Stone GW, Cox DA, Low R, Cates CU, Satler L, Bailey SR, Kuntz RE, Lansky AJ.

Catheter Cardiovasc Interv 2003 Apr;58(4):419-27

13. Guiding catheter aspiration to prevent embolic events during saphenous vein graft intervention.

Morales PA, Heuser RR.

J Interv Cardiol 2002 Dec;15(6):491-7

14. Distal filter protection during saphenous vein graft stenting: technical and clinical correlates of

efficacy.

Stone GW, Rogers C, Ramee S, White C, Kuntz RE, Popma JJ, George J, Almany S, Bailey S.

J Am Coll Cardiol 2002 Nov 20;40(10):1882-8

15. New frontiers and unresolved controversies in percutaneous coronary intervention.

Dzavik V.

Am J Cardiol 2003 Feb 6;91(3A):27A-33A

16. Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global

Randomized Trial.

Mauri L, Bonan R, Weiner BH, Legrand V, Bassand JP, Popma JJ, Niemyski P, Prpic R, Ho KK,

Chauhan MS, Cutlip DE, Bertrand OF, Kuntz RE.

Am J Cardiol 2002 Nov 15;90(10):1079-83

17. Safety and efficacy of cutting balloon angioplasty: the Mayo Clinic experience.

Orford JL, Fasseas P, Denktas AE, Hammes L, Garratt KN, Berger PB, Holmes DR, Barsness GW.

J Invasive Cardiol 2002 Dec;14(12):720-4

J Am Coll Cardiol 2001 Jul;38(1):91-8

Myocardial viability assessment by endocardial electroanatomic mapping: comparison with metabolic imaging

and functional recovery after coronary revascularization.

Koch KC, vom Dahl J, Wenderdel M, Nowak B, Schaefer WM, Sasse A, Stellbrink C, Buell U, Hanrath P.

OBJECTIVES: The objective of this study was to compare electroanatomic mapping for the assessment of

myocardial viability with nuclear metabolic imaging using positron emission computed tomography (PET) and

with data on functional recovery after successful myocardial revascularization. BACKGROUND: Animal

experiments and first clinical studies suggested that electroanatomic endocardial mapping identifies the

presence and absence of myocardial viability. METHODS: Forty-six patients with prior (> or =2 weeks)

myocardial infarction underwent fluorine-18 fluorodeoxyglucose (FDG) PET and Tc-99m sestamibi single-

photon emission computed tomography (SPECT) before mapping and percutaneous coronary

revascularization. The left ventricular endocardium was mapped and divided into 12 regions, which were

assigned to corresponding nuclear regions. Functional recovery using the centerline method was assessed in 25

patients with a follow-up angiography. RESULTS: Regional unipolar electrogram amplitude was 11.0 mV +/-

3.6 mV in regions with normal perfusion, 9.0 mV +/- 2.8 mV in regions with reduced perfusion and preserved

FDG-uptake and 6.5 mV +/- 2.6 mV in scar regions (p < 0.001 for all comparisons). At a threshold amplitude of

7.5 mV, the sensitivity and specificity for detecting viable (by PET/SPECT) myocardium were 77% and 75%,

respectively. In infarct areas with electrogram amplitudes >7.5 mV, improvement of regional wall motion

(RWM) from -2.4 SD/chord +/- 1.0 SD/chord to -1.5 SD/chord +/- 1.1 SD/chord (p < 0.01) was observed, whereas,

in infarct areas with amplitudes <7.5 mV, RWM remained unchanged at follow-up (-2.3 SD/chord +/- 0.7

SD/chord to -2.4 SD/chord +/- 0.7 SD/chord). CONCLUSIONS: These data suggest that the regional unipolar

electrogram amplitude is a marker for myocardial viability and that electroanatomic mapping can be used for

viability assessment in the catheterization laboratory

Echocardiography 2001 Apr;18(3):213-7

Ultrasound as treatment for coronary artery disease.

Gunn J, Cumberland DC, Siegel RJ.

Therapeutic ultrasound is already established in the treatment of diverse surgical conditions, such as cataract,

liver cancer, and stones, without danger to healthy tissue. Clinical trials of catheter-delivered, high energy, low

frequency (kHz) ultrasound undertaken over the last decade have demonstrated the safety of ultrasound in the

treatment of peripheral and coronary artery disease, and have identified a number of indications in which it

may be particularly advantageous. The dispersal of thrombus, the recanalization of chronic total occlusions,

and the favorable modification of the distensibility of small, atherosclerotic vessels are three promising areas.

The authors review developments in these fields.


Therapeutic ultrasound for chronic total coronary artery occlusions.

Cannon LA, John J, LaLonde J.

This article focuses on the use of catheter-delivered ultrasound as a device for treatment of coronary arterial

total occlusion (CTO). The standard treatment of CTO is reviewed and serves as the basis for the need for new

treatment options, such as catheter-delivered ultrasound (SONICROSS). The results of FDA-approved Phase I

and Phase II clinical trials using SONICROSS for refractory CTO are described. The Phase II trials indicate that

the SONICROSS-facilitated guidewire passage in 71% of CTOs are otherwise refractory to guidewire passage.

However, at present, the SONICROSS catheter system is limited in its ability to be delivered reliably to the CTO

because of catheter size and trackability.


Catheter-delivered ultrasound therapy for native coronary arterial thrombosis and occluded saphenous vein

grafts.

Halkin A, Rosenschein U.

Acute coronary thrombosis, overlying ruptured atherosclerotic plaque, is the hallmark of myocardial infarction

and unstable angina. Despite use of modern therapeutic modalities, including glycoprotein IIb/IIIa antagonists

and stenting, intracoronary thrombus heralds an increased risk of serious complications following

percutaneous coronary interventions (PCI). Abundant in vitro and in vivo experimental data have proven that

ultrasound energy is capable of lysing intravascular thrombus without injuring the vessel wall. Expanding

experience and technological advancements now allow us to use this tool in clinical practice. In this article we

review the emergence of percutaneous ultrasonic thrombolysis as a safe and effective tool for treatment of

patients in various clinical settings associated with coronary thrombosis.


Ultrasound-enhanced thrombolysis.

Francis CW.

Problems with current thrombolytic therapy include slow and incomplete thrombolysis and frequent bleeding

complications. Increasing evidence from in vitro, animal, and initial patient studies indicates that application of

ultrasound as an adjunct to thrombolytic therapy offers unique potential to improve effectiveness and decrease

bleeding complications. Numerous studies in vitro demonstrate that low intensity ultrasound increases

enzymatic fibrinolysis through mechanisms that include improving drug transport, reversibly altering fibrin

structure, and increasing tPA binding to fibrin. These observations have been confirmed in animal models that

demonstrated that ultrasound delivered transcutaneously or with an endovascular catheter accelerates

thrombolysis in models of venous, arterial, and small vessel thrombosis. Ultrasound delivered at higher

intensities using either an endovascular vibrating wire or transcutaneously in conjunction with stabilized

microbubbles can cause mechanical fragmentation of thrombus without administration of plasminogen

activator. Recent studies indicate that ultrasound at lower frequencies in the range of 20-40 kHz has a greater

effect on thrombolysis with improved tissue penetration and less heating. These studies form the basis for

clinical trials investigating the potential of ultrasound as an adjunct to improve thrombolytic therapy.

Catheter Cardiovasc Interv 2002 Jan;55(1):43-9

Percutaneous transluminal therapeutic ultrasound for high-risk thrombus-containing lesions in native coronary

arteries.

Brosh D, Bartorelli AL, Cribier A, Mesa J, Calderon L, Martyn T, Amann F, Sampaolesi A, Desmet W, Fajadet J,

Rosenschein U; Acolysis Registry Study Group.

We assessed the short-term outcome of percutaneous coronary ultrasound thrombolysis (CUT) for high-risk

thrombus-containing lesions in native coronaries in the setting of acute coronary syndromes (ACS). Data were

prospectively collected in a multicenter (n = 32) registry of consecutive ACS patients. The study population (n =

126) had mostly (84%) totally occluded vessels. The mean age of clot was 5.7 +/- 9.5 days (range, 0-60 days).

CUT (41 kHz, 18 W) led to device success in 112 (89%) patients, with a residual stenosis of 69% +/- 20%. Adjunct

PTCA or stenting was used in 97% of the patients. Procedural success was achieved in 124 (98%) patients, with

a final residual stenosis of 6% +/- 10%. There were no major adverse clinical events during hospitalization.

Ultrasound thrombolysis is a feasible procedure that offers a safe and probably effective adjuvant device

solution for the treatment of high-risk, thrombus-containing lesions in the native coronary arteries.

J Am Coll Cardiol 2001 Apr;37(5):1284-8

Extensive development of vulnerable plaques as a pan-coronary process in patients with myocardial infarction:

an angioscopic study.

Asakura M, Ueda Y, Yamaguchi O, Adachi T, Hirayama A, Hori M, Kodama K.

OBJECTIVES: To test our hypothesis that the development of vulnerable plaques is not limited to the culprit

lesions, but is a pan-coronary process, we directly observed all three major coronary arteries by angioscopy and

evaluated the prevalence of yellow plaques in patients with myocardial infarction (MI). BACKGROUND:

Although pathologic studies have suggested that the disruption of atheromatous plaque plays a major role in

the development of acute MI, the prevalence of yellow plaques in the whole coronary arteries of patients with

MI has not been clarified. METHODS: Thirty-two patients undergoing follow-up catheterization one month

after the onset of MI were prospectively and consecutively enrolled in this study. The prevalence of yellow

plaques and thrombus in the major coronary arteries was successfully evaluated in 20 patients (58 coronary

arteries, 21 culprit lesions) by coronary angioscopy. The diameter stenosis (DS) of the culprit lesions and the

maximal diameter stenosis (maxDS) of nonculprit segments were angiographically measured for each coronary

artery. RESULTS: The DS of the culprit lesions and maxDS were 27 +/- 17% and 19 +/- 13%, respectively. Yellow

plaques and thrombus were detected in 19 (90%) and 17 (81%) of 21 culprit lesions, respectively. Yellow plaques

were equally prevalent in the infarct-related and non-infarct-related coronary arteries (3.7 +/- 1.6 vs. 3.4 +/- 1.8

plaques/artery). However, thrombus was only detected in the nonculprit segments of one (2%) coronary artery.

CONCLUSIONS: In patients with MI, all three major coronary arteries are widely diseased and have multiple

yellow though nondisrupted plaques. Acute MI may represent the pan-coronary process of vulnerable plaque

development.


Mechanical and structural characteristics of vulnerable plaques: analysis by coronary angioscopy and

intravascular ultrasound.

Takano M, Mizuno K, Okamatsu K, Yokoyama S, Ohba T, Sakai S.

OBJECTIVES: Mechanical and structural characteristics of vulnerable plaques were evaluated using coronary

angioscopy and intravascular ultrasound. BACKGROUND: Mechanical stress and composition of plaques play

an important role in plaque disruption. METHODS: Thirty-eight lesions in 38 patients were examined pre-

interventionally. The plaques were classified as either yellow or white using coronary angioscopy. Intravascular

ultrasound imaging was performed simultaneously with electrocardiographic and intracoronary pressure

recordings to calculate distensibility index and stiffness beta. Moreover, the type of remodeling was classified.

RESULTS: We identified 27 patients with yellow plaques and 11 patients with white plaques. Patients with

yellow plaques presented acute coronary syndromes more frequently than stable angina (85% vs. 36%, p < 0.01).

The distensibility index in yellow plaques was significantly greater than it was in white plaques (2.7 +/- 0.8 mm

Hg(-1) vs. 0.7 +/- 0.8 mm Hg(-1), p < 0.0001), while stiffness beta for white plaques was significantly greater

than it was for yellow plaques (34.9 +/- 16.3 vs. 8.7 +/- 2.7, p < 0.0001). Compensatory enlargement occurred

more frequently with yellow plaques than with white plaques (56% vs. 9%, p < 0.01), while paradoxical

shrinkage occurred more frequently with white plaques than it did with yellow plaques (64% vs. 4%, p < 0.001).

CONCLUSIONS: Yellow plaques with an increased distensibility and a compensatory enlargement may be

mechanically and structurally weak. As a result, mechanical ?atigue,?caused by repetitive stretching, may lead

to plaque disruption. Plaques with a high distensibility and a compensatory enlargement may be vulnerable.

J Am Coll Cardiol 2001 Dec;38(7):1916-22

The healing process of infarct-related plaques. Insights from 18 months of serial angioscopic follow-up.

Ueda Y, Asakura M, Yamaguchi O, Hirayama A, Hori M, Kodama K.

OBJECTIVES: To clarify the healing process of disrupted culprit plaques of acute myocardial infarction (MI),

we serially observed the culprit plaques for 18 months after the onset of acute MI by angioscopy.

BACKGROUND: Although it has been reported that disruption of the yellow plaque and subsequent

thrombosis cause acute MI and that the thrombogenicity of the plaque lasts for a month, the healing process of

the plaque after disruption has not been clarified. METHODS: Eighty-five patients with acute MI were

prospectively and consecutively enrolled. Angioscopic studies were performed immediately and at 1, 6 and 18

months after successful reperfusion. The prevalence of yellow plaques and thrombus was examined. The color

grade of the plaque was determined as 0 (white), 1 (light yellow), 2 (yellow) or 3 (bright yellow). RESULTS:

Although yellow plaque was present at the culprit lesion in most patients throughout follow-up, its color grade

was reduced from one to six months (1.9 +/- 0.6 vs. 1.1 +/- 0.7, p = 0.0003) after reperfusion, especially in the

patients without hyperlipidemia (HL). The incidence of thrombus was 92.5% immediately after reperfusion,

which was reduced significantly to 63.8%, 4.8% and 11.8% at 1, 6 and 18 months, respectively. The incidence of

thrombus (77.8% vs. 45.0%, p = 0.03) at one month was higher in the patients with diabetes mellitus (DM).

CONCLUSIONS: The healing process of yellow plaques at the culprit lesions of MI was detected by angioscopy

as reductions of color grade and thrombogenicity at six months and partially at one month after the onset of

acute MI. This healing process appears to deteriorate by complicating cases of DM or HL.

J Am Coll Cardiol 2001 Sep;38(3):672-9

Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational

atherectomy, additional stent implantation and balloon angioplasty.

Adamian M, Colombo A, Briguori C, Nishida T, Marsico F, Di Mario C, Albiero R, Moussa I, Moses JW.

OBJECTIVES: The purpose of the study was to determine whether cutting balloon angioplasty (CBA) has

advantages over other modalities in treatment of in-stent restenosis (ISR). BACKGROUND: Controversies exist

regarding optimal treatment for ISR. Recently, CBA emerged as a tool in management of ISR. METHODS: A

total of 648 lesions treated for ISR were divided into four groups according to the treatment strategy: CBA,

rotational atherectomy (ROTA), additional stenting (STENT), and percutaneous transluminal coronary

angioplasty (PTCA). Following the matching process, 258 lesions were entered into the analysis. RESULTS:

Baseline clinical and angiographic characteristics were similar among the groups (p = NS). Acute lumen gain

was significantly higher in the STENT group (2.12 +/- 0.7 mm), whereas in the CBA group the gain was similar

to one achieved following ROTA and following PTCA (1.70 +/- 0.6 vs. 1.79 +/- 0.5 mm and 1.56 +/- 0.7 mm,

respectively; p = NS). The lumen loss at follow-up was lower for the CBA versus ROTA and versus STENT (0.63

+/- 0.6 vs. 1.30 +/- 0.8 mm and 1.36 +/- 0.8 mm, respectively; p < 0.0001), yielding a lower recurrent restenosis

rate (20% vs. 35.9% and 41.4%, respectively; p < 0.05). By multivariate analysis, CBA (odds ratio [OR] = 0.17;

confidence interval [CI], 0.06 to 0.51; p = 0.001) and diffuse restenosis type at baseline (OR = 2.07; CI, 1.15 to

3.71; p = 0.02) were identified as predictors of target lesion revascularization. CONCLUSIONS: We conclude

that CBA is a safe and efficient technique for treatment of ISR, with immediate results similar to atheroablation

and better clinical and angiographic outcomes at follow-up. This approach might be implemented as a viable

option in management of focal ISR and to prepare diffuse ISR for brachytherapy treatment.

Am Heart J 2001 Nov;142(5):782-9

Final results of the CAPAS trial.

Izumi M, Tsuchikane E, Funamoto M, Kobayashi T, Sumitsuji S, Otsuji S, Sakurai M, Kobayashi T, Awata N.

BACKGROUND: The Cutting Balloon (Interventional Technologies Inc) is a new-concept balloon that

incorporates 3 to 4 blades to create sharp incisions on the luminal surface of the lesion during dilation without

causing severe tearing injury to the vessel wall. It may reduce restenosis and improve clinical outcome.

METHODS: Two hundred forty-eight lesions were randomly assigned to Cutting Balloon angioplasty (CBA,

120 lesions) or conventional balloon angioplasty (PTCA, 128 lesions). Inclusion criteria were type B/C lesions

(American College of Cardiology/American Heart Association classification) and reference diameter <3.0 mm

by visual image on angiogram. Quantitative coronary angiography was performed before and after

percutaneous coronary angioplasty and at 3-month follow-up. The primary end point was restenosis, defined

as >/=50% diameter stenosis at follow-up. Clinical event rates at 1 year were assessed. RESULTS: Baseline

characteristics were similar. Reference diameter was small in both groups (2.16 vs 2.18 mm, CBA vs PTCA).

Preprocedural percent diameter stenosis (%DS) was similar (69.8% vs 69.6%). However, postprocedural and

follow-up %DS were lower (26.2% vs 28.9%, P =.072; 40.8% vs 47.5%, P =.011) in the CBA group. Restenosis was

significantly lower (25.2% vs 41.5%, P =.009) in the CBA group. At 1 year, event-free survival was achieved in

72.8% of the CBA group and in 61.0% of the PTCA group (P =.047). CONCLUSION: These findings suggest that

CBA provides superior angiographic and clinical outcomes in comparison with PTCA in small coronary

arteries.

Catheter Cardiovasc Interv 2001 Dec;54(4):473-81

Cutting balloon angioplasty for treatment of calcified coronary lesions.

Karvouni E, Stankovic G, Albiero R, Takagi T, Corvaja N, Vaghetti M, Di Mario C, Colombo A.

The aim of the study was to evaluate the feasibility, safety, and efficacy of cutting balloon angioplasty in

treatment of angiographically moderate and severe calcified coronary lesions. Thirty-seven calcified coronary

lesions (29 patients) detected by angiography were dilated with cutting balloon. Predilatation with plain

balloon was performed in 27 (73.0%) lesions and stent was implanted in 23 (62.2%) lesions following cutting

balloon. Acute gain following cutting balloon in predilated lesions was compared to the acute gain following

plain balloon predilatation. For predilated lesions, acute gain after cutting balloon was significantly greater

compared with plain balloon predilatation (1.51 +/- 0.49 vs. 0.77 +/- 0.42; P = 0.01). This result was achieved with

larger size and lower pressure of cutting balloon compared with plain balloon (3.28 +/- 0.46 vs. 2.94 +/- 0.55, P =

0.01; 10.38 +/- 1.64 vs. 13.19 +/- 3.63, P = 0.001, respectively). The final gain following cutting balloon dilatation

was significantly higher than the expected gain obtained by using a plain balloon of the same size (1.51 +/- 0.49

vs. 0.93 +/- 0.48; P < 0.0001), which was inflated at significantly higher pressure compared with cutting balloon.

When we compared acute gain following cutting balloon in lesions with and without predilatation, we found

no significant difference (P = 0.31). Angiographic success was achieved in 36 (97.3%) lesions and procedural

success in 33 (89.1%) lesions. In-hospital major adverse cardiac event (MACE) occurred in three (10.3%)

patients. Follow-up MACE was reported from three (10.3%) patients. In conclusion, cutting balloon angioplasty

is feasible and safe in treatment of angiographically moderate and severe calcified lesions. Dilating efficiency of

cutting balloon seems to be greater compared with a plain balloon of the same size, which was inflated at

significantly higher pressure compared with cutting balloon. These results can be achieved with low in-hospital

MACE and are associated with a good long-term outcome.

J Invasive Cardiol 2001 May;13(5):401-5

?ireless?laser recanalization of chronic total coronary occlusions.

Perin EC, Sarmento-Leite R, Silva GV, Rogers MD, Topaz O.

Chronic total occlusions in particular, completely obstructed aorto-ostial lesions are among the most

challenging targets in interventional cardiology. Excimer laser is a debulking technology for revascularization

of complex lesions. Treatment of total occlusions with laser angioplasty can be applied providing that a

guidewire traverses the entire length of the occlusion prior to device activation. In many patients with total

occlusions, a guidewire is unable to penetrate the target stenosis. This communication presents a new

technique termed ?ireless?laser recanalization. This approach entails recanalization of a total occlusion with a

laser catheter without a leading guidewire.

Am J Cardiol 2001 Apr 1;87(7):849-55

Effectiveness of excimer laser coronary angioplasty in acute myocardial infarction or in unstable angina

pectoris.

Topaz O, Bernardo NL, Shah R, McQueen RH, Desai P, Janin Y, Lansky AJ, Carr ME.

This study was conducted to evaluate the feasibility, safety, and acute results of percutaneous excimer laser

coronary angioplasty (ELCA) in acute coronary syndromes. Fifty-nine patients were treated with ELCA (308

nm), including 33 patients with unstable angina pectoris (UAP) (35 vessels with 39 lesions) and 26 patients with

acute myocardial infarction (AMI) (26 vessels with 29 lesions). In each patient the target lesion had a complex

morphology. Overall, 71% of the patients had contraindications for pharmacologic thrombolytic agents or

glycoprotein IIb/IIIa receptor antagonists. All patients received adjunct balloon dilation followed by stent

implantation in 88% of patients with AMI versus 76% of patients with UAP (p = NS). Quantitative angiography

was performed at an independent core laboratory; 86% laser success and 100% procedural success was

achieved in the AMI group versus 87% laser success and 97% procedural success in the UAP group (p = NS). In

the AMI group, the minimal luminal diameter increased from 0.77 +/- 0.56 to 1.44 +/- 0.47 mm after lasing to a

final 2.65 +/- 0.47 mm versus 0.77 +/- 0.38 to 1.35 +/- 0.4 mm after lasing to 2.66 +/- 0.5 mm final in the UAP

group. A prelaser percent stenosis of 76 +/- 17% for the AMI group versus 70 +/- 16% for the UAP group (p =

NS) was decreased after lasing to 52 +/- 16% for the AMI group versus 51 +/- 14% for the UAP group (p = NS)

and to a final stenosis of 15 +/- 17% for the AMI group versus 12 +/- 15% for the UAP group (p = NS). A 96%

laser-induced reduction of thrombus burden area was achieved in the AMI group versus 97% in the UAP group

(p = NS). Preprocedure Thrombolysis In Myocardial Infarction flow of 1.3 +/- 0.9 in the AMI group versus 2.3

+/- 1.2 for the UAP group (p = 0.01) increased to a final flow of 3.0 +/- 0 for the AMI group versus 3.0 +/- 0 for

the UAP group (p = NS). There were no deaths, cerebrovascular accident, emergency bypass surgery, acute

closure, major perforation or major dissection, distal embolization, or bleeding complications in either group.

One patient with AMI had localized perforation (caused by guidewire) without sequelae and 1 patient with

UAP had an abnormal increase in creatine kinase levels. All 59 patients survived the laser procedure, improved

clinically, and were discharged. Thus, early experience in patients with acute coronary syndromes suggest that

percutaneous ELCA is feasible and safe.

Circulation 2001 May 29;103(21):2539-43

Percutaneous in situ coronary venous arterialization: report of the first human catheter-based coronary artery

bypass.

Oesterle SN, Reifart N, Hauptmann E, Hayase M, Yeung AC.

Diffuse coronary artery disease is frequently untreatable by coronary artery bypass or angioplasty. Many

such ?o-option?patients have been subjects for trials of angiogenesis using growth factor manipulation or laser

injury. We think these novel revascularization strategies are limited by insufficient inflow to putative areas of

new microvasculature and thus seek a more mechanical solution. We report the use of a catheter-based system

for arterializing the adjacent anterior cardiac vein in a patient with chronic total occlusion of the left anterior

descending coronary artery. A composite catheter system (phased-array ultrasound imaging system mounted

on a catheter with extendable nitinol needle) was used to deliver an exchange-length intracoronary guidewire

from the proximal left anterior descending coronary artery into the parallel anterior interventricular vein.

Using standard angioplasty techniques, a fistula was then constructed from the proximal artery to the coronary

vein using a self-expanding connector. The proximal vein was blocked with a novel self-

expanding ?locker,?thus precluding ?teal?through the coronary sinus and forcing retroperfusion of the anterior

wall. The procedure was completed without complication, and a follow-up angiogram at 3 months confirmed

continued patency of the arteriovenous connection. This patient, who had severe angina before the procedure,

has been asymptomatic for 12 months. Percutaneous in situ venous arterialization may be an effective therapy

for diffuse, ?ntreatable?coronary disease by supplying a robust inflow of arterialized blood via retroperfusion

to severely ischemic myocardium

Catheter Cardiovasc Interv 2001 Jun;53(2):235-40

Combined percutaneous biosense-guided laser myocardial revascularization and coronary intervention.

Laham RJ, Baim DS.

Laser myocardial revascularization is a promising new treatment strategy for patients with severe ischemic

heart disease who are not candidates for conventional percutaneous or surgical revascularization. The open

chest surgical approach to transmyocardial revascularization has been approved by the FDA for the treatment

of angina in inoperable patients, but has had limited use as a stand-alone procedure. More recently, use of

fiber-optic catheters has made it possible to use a holmium:yttrium aluminum garnet laser to perform

percutaneous catheter-based transmyocardial revascularization. To the extent that many patients have a

combination of ischemic sources, some amenable to conventional revascularization and some not, combination

or hybrid approaches have been considered. We report herein two patients with class IV angina who

underwent laser myocardial revascularization using the Biosense system and complex percutaneous coronary

intervention during the same procedure. Areas amenable to conventional percutaneous coronary intervention

(PCI) were so treated, and viable but ischemic areas were supplied by totally occluded native vessels and

bypass grafts underwent Biosense-guided laser myocardial revascularization (LMR). As the results of more

controlled and blinded studies of laser myocardial revascularization become available (if results continue to be

promising) and a better understanding of the mechanism of action of this treatment modality is achieved,

LMR-PTCA hybrid will be performed in increasing frequency. However, even after establishing LMR efficacy,

studies of LMR-PTCA hybrid should be conducted to determine the efficacy of this approach.

Catheter Cardiovasc Interv 2001 Oct;54(2):158-63

Direct coronary stenting without balloon or device pretreatment: acute success and long-term results.

Stys T, Lawson WE, Liuzzo JP, Hanif B, Bragg L, Cohn PF.

Improvements in coronary stents have made planned direct coronary stenting technically feasible, though

safety, acute success, cost-effectiveness, and long-term results remain to be determined. Sequential patients

eligible for direct stenting were prospectively characterized and treated with either direct or secondary stenting.

Major adverse cardiovascular events (MACE) such as cardiac death, myocardial infarction (MI), target vessel

ischemia, or revascularization (TVR) were followed for 6 months post-PCI. Enrollment included 128 direct (1.38

lesions/patient) and 69 secondary (1.39 lesions/patient) stented patients. Direct stenting was successful in 99%

(with 5% crossover to secondary stenting) without major procedural complications and with a similar rate of

vessel wall dissection or no-reflow phenomenon (2.3% vs. 2.1%; P > 0.05) as the secondary stenting group.

There was a trend toward less postprocedural CPK-MB elevation in the nonacute MI patients with direct vs.

secondary stenting (3% vs. 11%, respectively). At 6 months, there were no statistically significant differences in

overall MACE. Direct stenting has a high success rate, low complication rate, and durable long-term results.

Procedural cost and time savings, less contrast use and radiation exposure make direct stenting attractive in

properly selected patients. Copyright 2001 Wiley-Liss, Inc.

J Am Coll Cardiol 2001 Oct;38(4):1083-8

Repeated thermal therapy improves impaired vascular endothelial function in patients with coronary risk

factors.

Imamura M, Biro S, Kihara T, Yoshifuku S, Takasaki K, Otsuji Y, Minagoe S, Toyama Y, Tei C.

OBJECTIVES: We sought to determine whether sauna therapy, a thermal vasodilation therapy, improves

endothelial function in patients with coronary risk factors such as hypercholesterolemia, hypertension, diabetes

mellitus and smoking. BACKGROUND: Exposure to heat is widely used as a traditional therapy in many

different cultures. We have recently found that repeated sauna therapy improves endothelial and cardiac

function in patients with chronic heart failure. METHODS: Twenty-five men with at least one coronary risk

factor (risk group: 38 +/- 7 years) and 10 healthy men without coronary risk factors (control group: 35 +/- 8

years) were enrolled. Patients in the risk group were treated with a 60 degrees C far infrared-ray dry sauna

bath for 15 min and then kept in a bed covered with blankets for 30 min once a day for two weeks. To assess

endothelial function, brachial artery diameter was measured at rest, during reactive hyperemia (flow-mediated

endothelium-dependent dilation [%FMD]), again at rest and after sublingual nitroglycerin administration

(endothelium-independent vasodilation [%NTG]) using high-resolution ultrasound. RESULTS: The %FMD was

significantly impaired in the risk group compared with the control group (4.0 +/- 1.7% vs. 8.2 +/- 2.7%, p <

0.0001), while %NTG was similar (18.7 +/- 4.2% vs. 20.4 +/- 5.1%). Two weeks of sauna therapy significantly

improved %FMD in the risk group (4.0 +/- 1.7% to 5.8 +/- 1.3%, p < 0.001). In contrast, %NTG did not change

after two weeks of sauna therapy (18.7 +/- 4.2% to 18.1 +/- 4.1%). CONCLUSIONS: Repeated sauna treatment

improves impaired vascular endothelial function in the setting of coronary risk factors, suggesting a

therapeutic role for sauna treatment in patients with risk factors for atherosclerosis.

Circulation 2001 Sep 18;104(12 Suppl 1):I207-12

Cell transplantation for the treatment of acute myocardial infarction using vascular endothelial growth factor-

expressing skeletal myoblasts

Suzuki K, Murtuza B, Smolenski RT, Sammut IA, Suzuki N, Kaneda Y, Yacoub MH.

BACKGROUND: Vascular endothelial growth factor (VEGF) is a promising reagent for inducing myocardial

angiogenesis. Skeletal myoblast transplantation has been shown to improve cardiac function in chronic heart

failure models by regenerating muscle. We hypothesized that transplantation of VEGF-expressing myoblasts

could effectively treat acute myocardial infarction by providing VEGF-induced cardioprotection through

vasodilatation in the early phase, followed by angiogenesis effects in salvaging ischemic host myocardium

combined with the functional benefits of newly formed, skeletal myoblast-derived muscle in the later phase.

METHODS AND RESULTS: Primary rat skeletal myoblasts were transfected with the human VEGF(165) gene

using hemagglutinating virus of Japan-liposome with >95% transfection efficiency. Four million of these

myoblasts (VEGF group), control-transfected myoblasts (control group), or medium only (medium group) was

injected into syngeneic rat hearts 1 hour after left coronary artery occlusion. Myocardial VEGF-expression

increased for 2 weeks in the VEGF group, resulting in enhanced angiogenesis without the formation of tumors.

Grafted myoblasts had differentiated into multinucleated myotubes within host myocardium. Infarct size

(33.3+/-1.4%, 38.1+/-1.4%, and 43.7+/-1.6% for VEGF, control, and medium groups, respectively; P=0.0005) was

significantly reduced with VEGF treatment, and cardiac function improved in the VEGF group (maximum

dP/dt: 4072.0+/-93.6, 3772.5+/-101.1, and 3482.5+/-90.6 mm Hg/s in the 3 groups, respectively; P=0.0011;

minimum dP/dt: -504.2+/-68.5, -2311.3+/-57.0, and -2124.0+/-57.9 mm Hg/s, respectively; P=0.0008).

CONCLUSIONS: This combined strategy of cell transplantation with gene therapy could be of importance for

the treatment of acute myocardial infarction.

N Engl J Med 2001 Oct 25;345(17):1230-6

Blood transfusion in elderly patients with acute myocardial infarction.

Wu WC, Rathore SS, Wang Y, Radford MJ, Krumholz HM.

BACKGROUND: Anemia may have adverse effects in patients with coronary artery disease. However, the

benefit of blood transfusion in elderly patients with acute myocardial infarction and various degrees of anemia

is uncertain. METHODS: We conducted a retrospective study of data on 78,974 Medicare beneficiaries 65 years

old or older who were hospitalized with acute myocardial infarction. Patients were categorized according to

the hematocrit on admission (5.0 to 24.0 percent, 24.1 to 27.0 percent, 27.1 to 30.0 percent, 30.1 to 33.0 percent,

33.1 to 36.0 percent, 36.1 to 39.0 percent, or 39.1 to 48.0 percent), and data were evaluated to determine whether

there was an association between the use of transfusion and 30-day mortality. RESULTS: Patients with lower

hematocrit values on admission had higher 30-day mortality rates. Blood transfusion was associated with a

reduction in 30-day mortality among patients whose hematocrit on admission fell into the categories ranging

from 5.0 to 24.0 percent (adjusted odds ratio, 0.22; 95 percent confidence interval, 0.11 to 0.45) to 30.1 to 33.0

percent (adjusted odds ratio, 0.69; 95 percent confidence interval, 0.53 to 0.89). It was not associated with a

reduction in 30-day mortality among those whose hematocrit values fell in the higher ranges. In one of seven

subgroup analyses (among patients who survived at least two days), transfusion was not associated with a

reduction in mortality for patients with hematocrit values of 30.1 percent or higher. CONCLUSIONS: Blood

transfusion is associated with a lower short-term mortality rate among elderly patients with acute myocardial

infarction if the hematocrit on admission is 30.0 percent or lower and may be effective in patients with a

hematocrit as high as 33.0 percent on admission.

Circulation 2001 Nov 13;104(20):2436-41

Prevention of distal embolization during coronary angioplasty in saphenous vein grafts and native vessels

using porous filter protection.

Grube E, Gerckens U, Yeung AC, Rowold S, Kirchhof N, Sedgewick J, Yadav JS, Stertzer S.

BACKGROUND: Although distal embolization and the ?o-reflow?phenomenon are well described in

saphenous vein graft (SVG) interventions, the frequency, magnitude, and characterization of embolized debris

have not been evaluated in routine coronary interventions. A unique embolus protection device described

herein provides a means of containing and retrieving plaque material dislodged during percutaneous coronary

interventions. This report details the first clinical experience of the effectiveness and safety of an emboli

protection system in 11 SVG lesions and 15 native coronary artery lesions. METHODS AND RESULTS: The

AngioGuard Emboli Capture Guidewire (Cordis) consists of a PTCA wire with an expandable filter at the distal

tip. The porous membrane permits normal distal blood flow, while trapping potential emboli by filtration.

After crossing the lesion, the filter is expanded, and routine angioplasty is performed over the same wire.

Emboli retrieval is achieved by collapsing the filter and retracting the emboli capture wire (ECW). In 26

patients, standard angioplasty was performed over the ECW; 20 of these 26 patients received a stent. Collected

debris was sent for histopathological analysis. Plaque debris was retrieved after native coronary and SVG

interventions in all cases. The ECW was positioned and retrieved without complications. No major adverse

events occurred. Myocardial infarctions and no-reflow were not observed. CONCLUSIONS: The embolization

of plaque fragments frequently occurs during coronary and SVG intervention. Distal embolization leading to

microvascular obstruction and no-reflow could be successfully minimized by using the ECW.

Journal of the American College of Cardiology, 30:3:649-656

Recanalization of Chronic Total Coronary Occlusions Using a Laser Guide Wire: A Pilot Study

Jaap N. Hamburger, MD, Geert H. M. Gijsbers, PhD, Yukio Ozaki, MD, PhD, Peter N. Ruygrok, MD, Pim J. de

Feyter, MD, PhD, FESC, FACC, Patrick W. Serruys, MD, PhD, FESC, FACC

Objectives. This study sought to prospectively evaluate the performance of a laser guide wire in crossing

chronic total coronary occlusions in patients with a failed previous mechanical guide wire attempt.

Background. Despite continued refinement of mechanical hardware available for coronary angioplasty,

restoration and maintenance of blood flow through a chronically occluded coronary artery remains a true

challenge.

Methods. Fifty patients with a chronic total coronary occlusion and a previous failed attempt at recanalization

using mechanical guide wires were included. A mechanical attempt to cross the occlusion was repeated. In case

of failure, an additional attempt was made with the laser guide wire.

Results. The median age of occlusion was 22 weeks (range 5 to 200), and the occlusion length was 23 ± 11 mm

(mean ± SD). A repeat mechanical attempt was successful in six cases (12%). Dissection occurred in five other

cases, and device crossover was not attempted. Thus, in 39 patients an attempt was made with the laser guide

wire, with successful recanalization in 23 (59%). Thereby the overall success rate increased from 12% to 58% (29

of 50 patients). The amount of contrast medium used was 515 ± 154 ml, fluoroscopy time was 99 ± 43 min,

and total procedure time was 2 h 48 min (±55 min). Procedural success was achieved in 26 cases and clinical

success (procedural success without in hospital events) in 24. In-hospital events were two non-Q wave

myocardial infarctions related to subacute reocclusion. In one patient, a balloon dilation after laser guide wire

perforation resulted in tamponade requiring pericardiocentesis. After a successful procedure, the angina class

decreased from 2.9 ± 0.2 to 1.4 ± 0.7 at 3 months of clinical follow-up. Six-month angiographic follow-up

was completed in all 24 eligible patients and showed vessel patency in 20 (80%).

Conclusions. The use of the laser guide wire for recanalization of chronic total coronary occlusions refractory to

treatment with mechanical guide wires is feasible and relatively safe and was successful in 59% of cases. This

device must thus be considered a valuable addition to the interventional armamentarium and accordingly will

be evaluated in a randomized clinical trial.

Cathet. Cardiovasc. Diagn. 40:297-300, 1997.

New device for compression of the radial artery after diagnostic and interventional cardiac procedures

Pascal Chatelain, Adalberto Arceo, Emmanuel Rombaut, Vitalin Verin, Philip Urban

Recently the transradial route has emerged as a valuable alternative to the femoral approach for coronary

angiography and angioplasty. However, sheath and catheter size and their immediate removal after the

procedure, combined with aggressive antiplatelet and anticoagulant therapies, have favored mechanical

compression of the radial artery to achieve satisfactory hemostasis. We report on our initial clinical experience

with a new device specially designed for prolonged controlled mechanical compression of the radial artery (the

RadiStopTM radial compression system, RADI Medical Systems AB, Uppsala, Sweden). A total of 159

consecutive patients (mean age 60 ± 11 yr, 130 males) who required either coronary angiography (group 1,

103 patients) or ad hoc or elective coronary angioplasty (group 2, 56 patients) via the right radial route had

local hemostasis with the RadiStopTM system. In group 1, 4F and 5F sheaths and catheters were used, whereas

in group 2, 6F systems were inserted in the radial artery. Hemostasis was achieved with the device in all

patients but was considered difficult to obtain in 4 patients (2.5%). Twenty-eight patients (18%) considered the

device uncomfortable or painful, but no release of pressure was necessary. The mean compression time was 151

± 82 min (114 ± 64 min in group 1, and 223 ± 64 min in group 2; P = 0.0001). There were 23 local

complications (15%). In 7 patients (4.4%), the radial pulse was absent after compression and at discharge,

without major clinical consequences. In one patient, recurrent bleeding occurred 2 hr after compression,

requiring a new compression session. In 15 patients, a small local hematoma was observed. Neither heparin

dosage nor the use of a 6F sheath affected the rate of radial artery patency in this survey. We conclude that the

use of this device for mechanical compression of the radial artery after coronary angiography and angioplasty

is efficient, and that its use is related to an acceptable rate of local complications.

The American Journal of Cardiology, 1997;80:11:1424-1428

Treatment of In-Stent Coronary Restenosis by Excimer Laser Angioplasty

Ralf Koster, MD, Christian W. Hamm, MD, Wolfram Terres, MD, Dietmar H. Koschyk, MD, Jacobus Reimers,

MD, Jan Kahler, MD, Thomas Meinertz, MD

We evaluated the efficacy and safety of excimer laser angioplasty (ELCA) with adjunctive balloon angioplasty

in patients with restenotic or occluded coronary stents. ELCA was performed in 70 patients (60 ± 9 years),

who had previously been treated with Micro Stents (n = 65), Palmaz-Schatz (n = 38), Wiktor, NIR, Freedom, and

Multi-Link stents (n = 1 each). Restenosis (≥50% diameter stenosis) was documented in 90 stents, another 17

stents were occluded. Laser energy was delivered to the lesions with catheters 1.4, 1.7 (eccentric), and 2.0 mm in

diameter. Procedural success was controlled by intravascular ultrasound in a subgroup. Laser catheters crossed

all restenotic or occluded stents and decreased diameter stenosis from 80 ± 13% to 44 ± 11% (p <0.001).

Adjunctive balloon angioplasty further reduced diameter stenosis to 13 ± 13% (p <0.001). In 13 patients with

21 stents, serial intravascular ultrasound imaging revealed a reduction of plaque area within the stent by 34 ±

22% (from 4.2 ± 1.8 mm2 to 2.7 ± 1.1 mm2) after ELCA and a reduction by 65 ± 16% (to 1.5 ± 0.7 mm2)

after balloon angioplasty (p <0.01). There were 4 patients with an increase of creatine kinase levels, 8 patients

with major dissections (in 7 patients they were related to adjunctive balloon angioplasty), 1 patient with distal

embolization, 2 with minor perforations, and 1 patient with stent dislocation. Reintervention during

hospitalization was necessary in 3 patients. ELCA is an efficient and safe technique to debulk tissue in

restenotic lesions and total occlusions within stents. The incidence of procedure related complications was low.


Percutaneous Coronary Angioscopic Comparison of Thrombus Formation During Percutaneous Coronary

Angioplasty With Ionic and Nonionic Low Osmolality Contrast Media in Unstable Angina

Najmi R. Qureshi, MRCP, Peter den Heijer, PhD, Harry J.G.M. Crijns, PhD

Patients with unstable coronary syndromes are more likely to have a lesion containing thrombus and have a

higher procedural complication and restenosis rate. The aim of this study was to evaluate the effect of an ionic

(ioxaglate) and a nonionic (iohexol) low osmolality contrast media on thrombus generation using percutaneous

intracoronary angioscopy in patients with unstable angina undergoing percutaneous transluminal coronary

angioplasty (PTCA). Thirty patients with unstable angina pectoris randomized to either ioxaglate or iohexol (15

patients in each group), underwent percutaneous intracoronary angioscopy before and after PTCA and 15

minutes after PTCA. Angioscopically visible thrombus was defined using the Ermenonville classification and

the lesion divided into 3 zones-proximal, mid, and distal. Angiographic filling defects were seen in 3 patients

before PTCA, and in 10 after PTCA. Angioscopically visible thrombus was seen in 10 patients before PTCA in

the ioxaglate group and 8 in the iohexol group. After PTCA 5 patients (33.3%) in the ioxaglate and 11 (73.6%) in

the iohexol group developed new thrombus, p = 0.028. Total thrombi before PTCA were 16 versus 13, after

PTCA 25 versus 27, and at 15 minutes after PTCA 23 versus 25, ioxaglate versus iohexol respectively, p = NS.

There was no correlation between type or extent of intimal dissection and angioscopically visible new

thrombus formation. Angiography underestimated the incidence of intracoronary thrombus before and after

PTCA. Nonionic low osmolality contrast medium was associated with significantly more patients developing

angioscopically visible new thrombus. This has clinical implications in the choice of contrast medium used in

PTCA, particularly in the setting of unstable angina.

Circulation 1997;96: 91-98

Randomized Comparison of Angioplasty of Complex Coronary Lesions at a Single Center : Excimer Laser,

Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study

Nicolaus Reifart, Michel Vandormael, Mladen Krajcar, Stefan Gohring, Wolfgang Preusler, Franz Schwarz,

Hans Storger, Manfred Hofmann, Johann Klopper, Stefan Muller, and Jurgen Haase

Background. The purpose of this study was to test whether coronary revascularization with ablation of either

excimer laser or rotational atherectomy can improve the initial angiographic and clinical outcomes compared

with dilatation (balloon angioplasty) alone.

Methods and Results. At a single center, a total of 685 patients with symptomatic coronary disease warranting

elective percutaneous revascularization for a complex lesion were randomly assigned to balloon angioplasty

(n=222), excimer laser angioplasty (n=232), or rotational atherectomy (n=231). The primary end point was

procedural success (diameter stenosis <50%, absence of death, Q-wave myocardial infarction, or coronary

artery bypass surgery). The patients who underwent rotational atherectomy had a higher rate of procedural

success than those who underwent excimer laser angioplasty or conventional balloon angioplasty (89% versus

77% and 80%, P=.0019), but no difference was observed in major in-hospital complications (3.2% versus 4.3%

versus 3.1%, P=.71). At the 6-month follow-up, revascularization of the original target lesion was performed

more frequently in the rotational atherectomy group (42.4%) and the excimer laser group (46.0%) than in the

angioplasty group (31.9%, P=.013).

Conclusions. Procedural success of rotational atherectomy is superior to laser angioplasty and balloon

angioplasty; however, it does not result in better late outcomes. The role of plaque debulking before balloon

dilatation in percutaneous coronary revascularization remains to be fully defined.

Circulation 1997;96: 2183-2189

Treatment of In-Stent Restenosis With Excimer Laser Coronary Angioplasty : Mechanisms and Results

Compared With PTCA Alone

Roxana Mehran, Gary S. Mintz, Lowell F. Satler, Augusto D. Pichard, Kenneth M. Kent, Theresa A. Bucher,

Jeffery J. Popma, and Martin B. Leon

Background. This study determined the clinical safety, mechanisms, and 6-month results of excimer laser

angioplasty (ELCA)+adjunct PTCA for the treatment of in-stent restenosis and (via lesion matching) compared

the results of ELCA+PTCA to PTCA alone.

Methods and Results. Using quantitative angiography (QCA) and intravascular ultrasound (IVUS), we studied

107 restenotic previously stented lesions in 98 patients before and after intervention. QCA measurements

included minimum lumen diameter (MLD) and diameter stenosis (DS). IVUS measurements included stent,

lumen, and intimal hyperplasia (IH=stent-lumen) cross-sectional areas (CSA) and volumes. In the 54 lesions

treated with ELCA+PTCA, the MLD increased from 0.73±0.38 mm before ELCA to 2.10±0.47 mm after

ELCA+PTCA (P<.0001); the DS decreased from 70±14% to 25±12% (P<.0001). By IVUS, the minimum lumen

CSA increased from 1.58±0.78 mm2 before ELCA to 6.34±1.75 mm2 after ELCA+PTCA (P<.0001) as a result of

an increase in minimum stent CSA from 7.70±2.41 to 9.10±2.60 mm2 (P<.0001) and a decrease in IH CSA from

5.25±2.84 to 2.63±1.41 mm2 (P<.0001). Volumetric analysis showed that tissue ablation (during ELCA)

contributed 29±15%, tissue extrusion (during adjunct PTCA) contributed 31±14%, and additional stent

expansion (during adjunct PTCA) contributed 40±16% to the overall lumen gain. There were no ELCA-related

complications. Matched to lesions treated with PTCA alone, ELCA+PTCA resulted in greater lumen gain, more

IH ablation/extrusion, larger final lumen CSA (IVUS), and a tendency for less frequent need for subsequent

target vessel revascularization (TVR, 21% versus 38%, P=.0823).

Conclusions. ELCA safely and effectively ablates in-stent neointimal tissue. Adjunct PTCA extrudes neointimal

tissue out of the stent and also further expands the stent. Compared with PTCA alone, ELCA+PTCA achieves

better short-term and, potentially, better long-term results.


Percutaneous Transluminal Septal Myocardial Ablation in Hypertrophic Obstructive Cardiomyopathy: Acute

Results and 3-Month Follow-Up in 25 Patients

Hubert Seggewiss, MD, Ulrich Gleichmann, MD, Lothar Faber, MD, Dieter Fassbender, MD, Henning K.

Schmidt, MD, Stefan Strick, MD

Objectives. We report the acute results and midterm clinical course after percutaneous transluminal septal

myocardial ablation (PTSMA) in symptomatic patients with hypertrophic obstructive cardiomyopathy

(HOCM).

Background. In the treatment of HOCM, surgical myectomy and DDD pacemaker therapy are considered the

standard procedural extensions to drug therapy with negatively inotropic drugs. As an alternative nonsurgical

procedure for reducing the left ventricular outflow tract (LVOT) gradient, PTSMA by alcohol-induced septal

branch occlusion was introduced. However, clinical follow-up has not been sufficiently described.

Methods. In 25 patients (13 women, 12 men; mean [±SD] age 54.7 ± 15.0 years) who were symptomatic

despite sufficient drug therapy, 1.4 ± 0.6 septal branches were occluded with an injection of 4.1 ± 2.6 ml of

alcohol (96%) to ablate the hypertrophied interventricular septum. After 3-months, follow-up results of LVOT

gradients and clinical course were determined.

Results. The invasively determined LVOT gradients could be reduced in 22 patients (88%), with a mean

reduction from 61.8 ± 29.8 mm Hg (range 4 to 152) to 19.4 ± 20.8 mm Hg (range 0 to 74) at rest (p < 0.0001)

and from 141.4 ± 45.3 mm Hg (range 76 to 240) to 61.1 ± 40.1 mm Hg (range 0 to 135) after extrasystole. All

patients had angina pectoris for 24 h. The maximal creatine kinase increase was 780 ± 436 U/liter (range 305 to

1,810) after 11.1 ± 6.0 h (range 4 to 24). Thirteen patients (52%) developed a trifascicular block for 5 min to 8

days requiring temporary (n = 8 [32%]) or permanent (DDD) pacemaker implantation (n = 5 [20%]). An 86-year

old woman died 8 days after successful intervention of uncontrollable ventricular fibrillation in conjunction

with beta-sympathomimetics in chronically obstructive pulmonary disease. The remaining patients were

discharged after 11.3 ± 5.4 days (range 5 to 24), after an uncomplicated hospital course. Clinical and

echocardiographic follow-up was achieved in all 24 surviving patients after 3 months. No cardiac

complications occurred. Twenty-one patients (88%) showed clinical improvement, with a New York Heart

Association functional class of 1.4 ± 1.1. A further reduction in LVOT gradient was shown in 14 patients (58%).

Conclusions. PTSMA of HOCM is a promising nonsurgical technique for septal myocardial reduction, with a

consecutive reduction in LVOT gradient. Possible complications are trifascicular blocks, requiring permanent

pacemaker implantation, and tachycardiac rhythm disturbances. Clinical long-term observations of larger

patient series and a comparison with conventional forms of therapy are necessary to determine the conclusive

therapeutic significance.

Circulation 1998; 98: 2415-2421

Percutaneous Transluminal Septal Myocardial Ablation in Hypertrophic Obstructive Cardiomyopathy : Results

With Respect to Intraprocedural Myocardial Contrast Echocardiography

Lothar Faber, Hubert Seggewiss, and Ulrich Gleichmann

Background-Percutaneous transluminal septal myocardial ablation (PTSMA) has been introduced as an

alternative procedure for reducing the left ventricular outflow tract gradient (LVOTG) in hypertrophic

obstructive cardiomyopathy. We report on the acute and mid-term results in 91 symptomatic patients with

respect to intraprocedural myocardial contrast echocardiography (MCE).

Methods and Results-PTSMA was intended for 46 women and 45 men (54.1±15.5 years). In 2 patients, the

intervention could not be completed. In the first 30 patients the target vessel was determined by probatory

balloon occlusion alone and in the remainder by additional intraprocedural MCE. Resting LVOTG was reduced

from 73.8±35.4 to 16.6±18.1 and nostextrasystolic LVOTG from 149.3±42.5 to 61.9±43.0 mm Hg (P<0.0001

each). In 10 (11%) patients, permanent DDD pacemaker implantation was necessary. Two (2%) patients died, 1

from ventricular fibrillation associated with treatment for chronic obstructive pulmonary disease after 9 days

and 1 from fulminant pulmonary embolism after 2 days. After 3 months, mean New York Heart Association

class was reduced from 2.8±0.6 to 1.1±1.0 (P<0.0001). The LVOTG remained reduced to 14.6±25.5 mm Hg at

rest and 49.1±48.7 mm Hg (P<0.0001 each). Four patients underwent successful repeat PTSMA. Determination

of the target vessel by MCE was associated with a higher rate of acute (92% vs 70%; P<0.01) and mid-term (94%

vs 64%; P<0.01) success.

Conclusions-PTSMA is a promising nonsurgical technique for reduction of symptoms and LVOTG in

hypertrophic obstructive cardiomyopathy. MCE has been shown to be a useful addition to probatory balloon

occlusion for target vessel selection. Prospective, long-term observations of larger populations and a

comparison with the established forms of therapy are necessary to determine the definitive significance of

PTSMA.

Circulation 1998;98: 1837-1841

Comparison Between Left Ventricular Electromechanical Mapping and Radionuclide Perfusion Imaging for

Detection of Myocardial Viability

Ran Kornowski, Mun K. Hong, and Martin B. Leon

Background-A novel 3-dimensional left ventricular (LV) mapping system uses low-intensity magnetic field

energy to determine the location of sensor-tipped electrode catheters within the LV. Using this system, we

sought to distinguish between infarcted, ischemic, and normal myocardium by comparing LV

electromechanical mapping data with myocardial perfusion imaging studies.

Methods and Results-Unipolar voltage potentials and local endocardial shortening (LS) were measured in 18

patients (mean age, 58±12 years) with symptomatic chronic angina having reversible and/or fixed myocardial

perfusion defects on single photon emission computed tomography imaging studies using 201Tl at rest and

99mTc-sestamibi after adenosine stress. Overall, a significant difference in voltage potentials and LS values was

found between groups (P<0.001 for each comparison by ANOVA). The average voltage potentials (14.0±2.0

mV) and LS values (12.5±2.8%) were highest when measured in myocardial segments (n=56) with normal

perfusion and lowest (7.5±3.4 mV and 3.4±3.4%) when measured in myocardial segments with fixed perfusion

defects (n=20) (P<0.0001). Myocardial segments with reversible perfusion defects (n=66) had intermediate

voltage amplitudes (12.0±2.8 mV, P=0.048 versus normal and P=0.005 versus fixed segments) and LS values

(10.3±3.7%, P=0.067 versus normal and P=0.001 versus fixed segments).

Conclusions-In patients with myocardial ischemia, LV mapping, compared with myocardial perfusion imaging,

shows (1) mild reduction of endocardial voltage potentials and LS in segments with reversible perfusion

defects and (2) profound electromechanical impairment in segments with fixed perfusion defects. Thus, such

an LV mapping procedure may allow the detection on-line of myocardial viability in the catheterization

laboratory.

Circulation 1998 ;98: 1116-1124

Preliminary Animal and Clinical Experiences Using an Electromechanical Endocardial Mapping Procedure to

Distinguish Infarcted From Healthy Myocardium

Ran Kornowski, Mun K. Hong, Lior Gepstein, Steven Goldstein, Samer Ellahham, Shlomo A. Ben-Haim, and

Martin B. Leon

Background-A catheter-based left ventricular (LV) endocardial mapping procedure using electromagnetic field

energy for positioning of the catheter tip was designed to acquire simultaneous measurements of endocardial

voltage potentials and myocardial contractility. We investigated such a mapping system to distinguish between

infarcted and normal myocardium in an animal infarction model and in patients with coronary artery disease.

Methods and Results-Measurements of LV endocardial unipolar (UP) and bipolar (BP) voltages and local

endocardial shortening were derived from dogs at baseline (n=12), at 24 hours (n=6), and at 3 weeks (n=6) after

occlusion of the left anterior descending coronary artery. Also, 12 patients with prior myocardial infarction (MI)

and 12 control patients underwent the LV endocardial mapping study for assessment of electromechanical

function in infarcted versus healthy myocardial regions. In the canine model, a significant decrease in voltage

potentials was noted in the MI zone at 24 hours (UP, 42.8±9.6 to 29.1±12.2 mV, P=0.007; BP, 11.6±2.3 to 4.9±1.2

mV, P<0.0001) and at 3 weeks (UP, 41.0±8.9 to 13.9±3.9 mV, P<0.0001; BP, 11.2±2.8 to 2.4±0.4 mV, P<0.0001). No

change in voltage was noted in zones remote from MI. In patients with prior MI, the average voltage was 7.2±

2.7 mV (UP)/1.4±0.7 mV (BP) in MI regions, 17.8±4.6 mV (UP)/4.5±1.1 mV (BP) in healthy zones remote from

MI, and 19.7±4.4 mV (UP)/5.8±1.0 mV (BP) in control patients without prior MI (P<0.001 for MI values versus

remote zones or control patients). In the canine model and patients, local endocardial shortening was

significantly impaired in MI zones compared with controls.

Conclusions-These preliminary data suggest that infarcted myocardium could be accurately diagnosed and

distinguished from healthy myocardium by a reduction in both electrical voltage and mechanical activity. Such

a diagnostic electromechanical mapping study might be clinically useful for accurate assessment of myocardial

function and viability.

Journal of the American College of Cardiology, 1998;31:3:558-566

Balloon Angioplasty Versus New Device Intervention: Clinical Outcomes : A Comparison of the NHLBI PTCA

and NACI Registries

Spencer B. King, III, MD, FACC, Wanlin Yeh, MS, Richard Holubkov, PhD, Donald S. Baim, MD, FACC, George

Sopko, MD, MPH, Patrice Desvigne-Nickens, MD, David R. Holmes, Jr., MD, FACC, Michael J. Cowley, MD,

FACC, Martial G. Bourassa, MD, FACC, James Margolis, MD, FACC, Katherine M. Detre, MD, DrPH, FACC for

the NHLBI PTCA and NACI Registry Investigators

Objectives. We sought to compare outcomes of patients treated in the National Heart, Lung, and Blood Institute

(NHLBI) Percutaneous Transluminal Coronary Angioplasty (PTCA) and New Approaches to Coronary

Intervention (NACI) registries.

Background. Coronary angioplasty has numerous shortcomings. New devices for performing coronary

interventions have been introduced in an effort to improve clinical outcomes.

Methods. Under the sponsorship of the NHLBI, a registry of consecutive patients treated with PTCA during

1985 to 1986 was established. In 1990, the NHLBI funded a second registry, the NACI. The two registries used

the same data coordinating center to collect detailed baseline and follow-up information.

Results. Patients enrolled in the NACI registry were older, had undergone more previous bypass surgery

procedures and had more stenoses located in bypass grafts than patients in the NHLBI PTCA registry.

Procedural success was achieved in 72.1% and 82.6% of patients in the PTCA and NACI registries, respectively;

however, in-hospital and 1-year mortality rates were 1.0% versus 1.8% and 3.1% versus 5.9% for the PTCA

versus NACI registries, respectively. After risk adjustment, there was no difference in 1-year mortality. Rates of

target lesion revascularization (TLR) were 21.5% for the PTCA registry and 24.2% for the NACI registry. NACI

registry patients had a higher risk for TLR and the composite end point of death, myocardial infarction or

revascularization (relative risk 1.28 and 1.23, respectively). However, the NACI registry patients who received

stents tended to have a lower adjusted TLR rate.

Conclusions. This comparative study found no overall superiority of these newer devices in terms of patient

survival or freedom from TLR after adjustment for baseline risk profiles. Although technologic improvements

(especially improved stenting) continue, these observations highlight the importance of careful assessment of

clinical results in the broad population of patients in whom interventions are used.


Intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent suppresses the restenotic

changes of the coronary artery in pigs in vivo

Tohru Yamawaki, Hiroaki Shimokawa, Toshiyuki Kozai, Kenji Miyata, Taiki Higo, Eriko Tanaka, Kensuke

Egashira, Tadayoshi Shiraishi, Hideo Tamai, Keiji Igaki, Akira Takeshita

Objectives. This study was designed to examine whether or not intramural delivery of ST638 (a specific

tyrosine kinase inhibitor) with biodegradable stent can suppress the restenotic changes of the coronary artery

in vivo.

Background. Clinical and animal studies demonstrated that restenosis after coronary intervention results from

a combined effect of neointimal formation and geometric remodeling (decrease in total cross-sectional area).

Thus, the most effective strategy to prevent the restenosis appears to inhibit both the neointimal formation and

geometric remodeling by antiproliferative agent and stent, respectively. We have previously shown that ST638

markedly suppresses the restenotic changes of the porcine coronary artery when applied from the adventitial

site.

Methods. A poly-L-lactic acid biodegradable stent was coated with either ST638 (0.8 mg) or equimolar of its

inactive metabolite, ST494. A pair of these stents were implanted alternatively in the left anterior descending or

circumflex coronary artery in pigs (n = 6). Three weeks after the procedure, coronary stenosis was assessed by

angiography followed by histological examination.

Results. Coronary stenosis was significantly less at the ST638 stent site than at the ST494 stent site (47 ± 5% vs.

25 ± 4%, p < 0.01). Histological examination also showed that the extent of neointimal formation and that of

geometric remodeling were significantly less at the ST638 stent site than at the ST494 stent site (p < 0.05).

Conclusions. These results indicate that intramural delivery of a specific tyrosine kinase inhibitor with

biodegradable stent overcomes the proliferative stimuli caused by balloon injury, the stent itself, and the drug

coating on the stent, resulting in the suppression of the restenotic changes of the coronary artery in vivo. This

strategy might also be useful in the clinical setting in humans.


Usefulness of collagen plugging with VasoSeal짋after PTCA as compared to manual compression with

identical sheath dwell times

Sigmund Silber, Aina Bjorvik, Holger Muhling, Andreas Rosch

This study investigated the usefulness of collagen plugging with VasoSeal(r) in patients after PTCA compared

to a control group having identical sheath dwell times and therefore comparable levels of anticoagulation. A

total of 150 patients were enrolled in this prospective and randomized study. Sheaths were pulled at exactly 5 h

after arterial puncture. Time to hemostasis and local complications were determined. There were no statistical

differences in baseline characteristics. The mean time to hemostasis in the collagen group was significantly

shorter (3 ± 3 min) than that of the control group (17.4 ± 7 min). At 24 h, 23% of the collagen group patients

had a small, 1% a medium and 4% a large hematoma. In the control group, 32% had a small, 4% a medium

sized, but no patient a large hematoma. After collagen, one patient developed a pseudoaneurysm needing

vascular surgery. In the control group, no major complication occurred.

Compared to patients with manual compression at an identical sheath dwell time and an identical level of

anticoagulation, there was a significant reduction in time to hemostasis but no statistical difference regarding

local complications. Although the incidence of medium or large hematoma was low, the trend towards a

decreased risk of smaller hematomas seemed to be counterbalanced by an increased risk of larger hematomas.


Short-Term Results and Intermediate-Term Follow-Up of Laser Wire Recanalization of Chronic Coronary

Artery Occlusions: A Single-Center Experience

Joachim Schofer, MD, Thomas Rau, MD, Michael Schluter, PhD, Detlef G. Mathey, MD, FACC

Objectives. This study sought to elucidate the short-term efficacy and intermediate-term outcome of excimer

laser recanalization of chronic coronary artery occlusions in patients in whom attempts at mechanical

revascularization had failed.

Background. Recanalization of chronic coronary occlusions with the use of a mechanical guide wire fails in 30%

to 50% of cases, mostly because of inability to pass the wire through the lesion. The value of using excimer laser

energy in this setting has not yet been determined.

Methods. The study group comprised 66 consecutive patients with 68 chronic coronary occlusions. Patients

were eligible for inclusion in the study if a previous attempt at mechanical revascularization had failed and if

their angiographic status was such that 1) the vessel segment distal to the occlusion could be visualized by way

of collateral vessels, 2) the entry point of the occlusion was clearly outlined, and 3) not more than one anatomic

bend was expected within the occlusion. Excimer laser energy was applied to the lesion through a 0.018-in.

(0.046 cm) fiber-optic guide wire. Adjunctive balloon angioplasty and stenting were performed in all

successfully treated patients but one.

Results. Thirty-four occlusions (50%) in 32 patients (48%) could be crossed with the laser wire. Location and

age of the occlusion had no adverse influence on the outcome of laser wire recanalization, nor did the presence

of bridging collateral vessels, a major side branch at the site of the lesion or a blunt stump of the occlusion. An

inverse relation was found between the success rate and the length of the occlusion, such that a 19% reduction

of the success rate accompanied each 10-mm increment of the mean occlusion length. Thus, the success rate

was 68% for lesions 10 mm but only 25% for lesions >30 to ≤40 mm. The presence of a bend in the lesion

exceeding 60° was strongly related to procedural failure. During a median angiographic follow-up period of 18

weeks, restenosis >50% (n = 6) or reocclusion (n = 4) was found in 10 of the 32 successfully treated patients, for

an intermediate-term success rate of 33% (22 of 66). Clinical follow-up revealed improved anginal status in 21

patients (66%) after a median of 24 weeks. Major complications (death, myocardial infarction, emergency

operation) were not encountered.

Conclusions. Successful recanalization of a chronic coronary occlusion by using currently available laser wires

can be expected in 50% of selected patients in whom attempts at mechanical revascularization fail. Restenosis

or reocclusion accounts for an overall 6-month success rate of 35%.

Circulation 1999 99: 26-29.

Percutaneous Transluminal Therapy of Occluded Saphenous Vein Grafts : Can the Challenge Be Met With

Ultrasound Thrombolysis?

Uri Rosenschein, Georg Gaul, Raimund Erbel, Franz Amann, Diego Velasguez, H. Stoerger, Ruediger Simon,

German Gomez, Joerg Troster, Antonio Bartorelli, Michael Pieper, Zenon Kyriakides, Shlomo Laniado, Hylton I.

Miller, Alain Cribier, and Jean Fajadet

Background-Percutaneous transluminal treatment of a thrombotic vein graft yields poor results. We have

previously reported our experience with transluminal percutaneous coronary ultrasound thrombolysis (CUT)

in the setting of acute myocardial infarction (AMI). This report describes the first experience with ultrasound

thrombolysis in thrombus-rich lesions in saphenous vein grafts (SVGs), most of which were occluded.

Methods and Results-The patients (n=20) were mostly male (85%), aged 64±4 years old. The presenting

symptom was AMI in 2 patients (10%) and unstable angina in the rest. Fifteen patients (75%) had totally

occluded SVGs. The median age of clots was 6 days (range, 0 to 100 days). The ultrasound thrombolysis device

has a 1.6-mm-long tip and fits into a 7F guiding catheter over a 0.014-in guidewire in a “rapid-exchange”

system. CUT (41 kHz, 18 W, 6 minutes) led to device success in 14 (70%) of the patients and residual stenosis of

65±28%. Procedural success was obtained in 13 (65%) of the patients, with a final residual stenosis of 5±8%.

There was a low rate of device-related adverse events: 1 patient (5%) had a non-Q-wave myocardial infarction,

and distal embolization was noted in 1 patient (5%). Adjunct PTCA or stenting was used in all patients. There

were no serious adverse events during hospitalization.

Conclusions-Ultrasound thrombolysis in thrombus-rich lesions in SVGs offers a very promising therapeutic

option.

Circulation 1999;100: II-128-II-133

Intermediate-Term Clinical Outcome Following Transmyocardial Laser Revascularization in Patients With

Refractory Angina Pectoris

Carolyn K. Landolfo, Kevin P. Landolfo, G. Chad Hughes, Edward R. Coleman, Robin B. Coleman, and James E.

Lowe

Background-This study was conducted to examine the intermediate-term clinical outcomes in patients with

refractory angina pectoris treated with transmyocardial laser revascularization (TMR) at our institution. TMR is

an alternative surgical technique for the treatment of myocardial ischemia and angina pectoris not amenable to

conventional percutaneous or surgical revascularization. Limited data exist evaluating the natural history and

duration of clinical improvement in angina pectoris following TMR.

Methods and Results-Thirty-four patients with severe coronary artery disease unsuitable for treatment with

standard revascularization techniques underwent TMR in myocardial regions determined to be ischemic by

preoperative SPECT 201Tl perfusion imaging following dipyridamole stress. Patients were assessed

postoperatively at 3, 6, and 12 months for clinical outcomes including death, myocardial infarction, functional

class of angina pectoris, and hospitalizations for unstable angina. Myocardial perfusion imaging by 201Tl

scintigraphy was also assessed at these temporal end points. Overall mortality at 1 year was 14.7% (n=5).

Nonfatal myocardial infarction occurred in 3 patients (8.8%). Among the patients with complete 12-month

follow-up (n =27), mean anginal class improved from 3.5±0.5 pre-TMR to 2.8±0.7 and 2.5±0.7 at 3 and 6

months, respectively, and 2.8±0.9 at 12 months. Overall improvement in angina pectoris was sustained at 1

year by at least one functional class in 50% of patients. Mean hospitalizations per year for unstable angina

declined from 2.4±1.6 pre-TMR to 1.7±2.0 post-TMR (P=0.01). There was no significant improvement in

perfusion by SPECT 201Tl imaging at any temporal end point post-TMR.

Conclusions-Despite the lack of demonstrable improvement in perfusion by SPECT 201Tl imaging, TMR

improved the functional class of angina pectoris in patients with end stage coronary artery disease to a modest

degree. Although the maximal benefit in symptoms occurred at 6 months post-TMR, mild sustained clinical

improvement above baseline was evident in 50% of patients at 1 year.

The American Journal of Cardiology, 83:8:1170-1174

Tissue proliferation within and surrounding Palmaz-Schatz stents is dependent on the aggressiveness of stent

implantation technique

Rainer Hoffmann, Gary S. Mintz, Roxana Mehran, Kenneth M. Kent, Augusto D. Pichard, Lowell F. Satler,

Martin B. Leon

In-stent restenosis is entirely due to intimal hyperplasia. Histologic studies have indicated that intimal

hyperplasia is related to the arterial injury induced during stent implantation. We used intravascular

ultrasound (IVUS) imaging to study whether tissue proliferation inside and surrounding stents is related to the

aggressiveness of the implantation technique. After intervention and follow-up (mean 5.6 ± 3.7 months), serial

IVUS imaging was performed in 102 native artery stented stenoses in 91 patients. Measurements at 5

predetermined segments within each stented lesion included external elastic membrane, stent, and lumen

cross-sectional areas (CSAs). Calculations included mean plaque CSA growth outside of the stent (external

elastic membrane-stent) and mean neointimal hyperplasia CSA and thickness within the stent (stent-lumen).

Stenoses were categorized depending on the aggressiveness of stent placement (group 1, adjunct percutaneous

transluminal coronary angioplasty pressure <16 atm and/or balloon/artery ratio <1.1; group 2, adjunct

percutaneous transluminal coronary angioplasty pressure ≥16 atm and balloon/artery ratio ≥1.1). An

aggressiveness score was calculated as balloon/artery ratio ∙ inflation pressure. Mean intimal hyperplasia CSA

(2.9 ± 1.5 vs 2.2 ± 1.6 mm2, p = 0.028), mean intimal hyperplasia thickness (0.34 ± 0.19 vs 0.25 ± 0.19 mm,

p = 0.012), and mean peristent tissue growth CSA (2.5 ± 1.0 vs 1.1 ± 1.4 mm2, p = 0.003) were significantly

greater in group 2 stenoses. In addition, intimal hyperplasia CSA and thickness correlated significantly with

balloon/artery ratio ∙ inflation pressures: r = 0.305, p = 0.002 and r = 0.329, p = 0.0007, respectively, as did

peristent tissue proliferation CSA (r = 0.466, p = 0.001). Tissue proliferation inside and surrounding stents may

be related to aggressiveness of the stent implantation technique.


Laser angioplasty of restenosed coronary stents: results of a multicenter surveillance trial

Ralf Koster, Christian W. Hamm, Ricardo Seabra-Gomes, Gunhild Herrmann, Horst Sievert, Carlos Macaya,

Eckart Fleck, Klaus Fischer, Johannes J.R.M. Bonnier, Jean Fajadet, Jurgen Waigand, Karl-Heinz Kuck, Michel

Henry, Marie Claude Morice, Luciano Pizzulli, Michael M. Webb-Peploe, Arnd B. Buchwald, Lars Ekstrom,

Eberhard Grube, Saad Al Kasab, Antonio Colombo, Archimedes Sanati, Sjef M.P.G. Ernst, Michael Haude,

Martin B. Leon, Charles Ilsley, Rafael Beyar, Yvo Taeymans, Uwe Gladbach, Karl Wegscheider, Patrick W.

Serruys for the Laser Angioplasty of Restenosed Stents (LARS) Investigators

OBJECTIVES This study evaluated safety and efficacy of excimer laser angioplasty for treatment of restenosed

or occluded coronary stents.

BACKGROUND Balloon angioplasty of in-stent restenosis is limited by a high recurrence rate. Debulking by

laser angioplasty is a novel concept to treat in-stent restenosis.

METHODS A total of 440 patients with restenoses or occlusions in 527 stents were enrolled for treatment with

concentric or eccentric laser catheters and adjunctive balloon angioplasty.

RESULTS Laser angioplasty success (50% diameter stenosis after laser treatment or successful passage with a

2.0-mm or 1.7-mm eccentric laser catheter) was achieved in 92% of patients. Adjunctive balloon angioplasty

was performed in 99%. Procedural success (laser angioplasty success followed by 30% stenosis with or without

balloon angioplasty) was 91%. There was neither a significant difference in success with respect to lesion length,

nor were there differences between small and large vessels or native vessels and vein grafts. Success was higher

and residual stenosis lower using large or eccentric catheters. Serious adverse events included death (1.6%, not

directly laser catheter related), Q-wave myocardial infarction (0.5%), non-Q-wave infarction (2.7%), cardiac

tamponade (0.5%) and stent damage (0.5%). Perforations after laser treatment occurred in 0.9% of patients and

after balloon angioplasty in 0.2%. Dissections were visible in 4.8% of patients after laser treatment and in 9.3%

after balloon angioplasty. Reinterventions during hospitalization were necessary in 0.9% of patients; bypass

surgery was performed in 0.2%.

CONCLUSIONS Excimer laser angioplasty with adjunctive balloon angioplasty is a safe and efficient

technology to treat in-stent restenoses. These data justify a randomized comparison with balloon angioplasty.


A novel vascular sealing device for closure of percutaneous arterial access sites

Sigmund Silber, Gary Gershony, Brigitte Schon, Norbert Schon, Todd Jensen, Wolfgang Schramm

The purpose of this study was to investigate the safety and efficacy of a novel vascular sealing device that

incorporates a unique low-profile balloon-positioning catheter and a procoagulant delivered after diagnostic

cardiac catheterization and percutaneous transluminal coronary angioplasty (PTCA) procedures. Current

management of the vascular access site after percutaneous interventions is associated with patient discomfort

and complications. Based on previously reported successful results in canine models, we proceeded with this

first human feasibility and safety study. Immediately after an invasive procedure, the sealing device was

successfully deployed at the femoral arterial access site in 24 of 24 procedures (diagnostic 19, PTCA 5). All

patients were followed up at 1 month with clinical assessment, ankle-brachial index measurement, and

Doppler ultrasound. Successful hemostasis was achieved in all patients. The activated clotting time before

sealing device deployment was 125.5 ± 22.2 and 267.8 ± 60.0 seconds for diagnostic and PTCA patients,

respectively. The time to hemostasis was 2.5 ± 0.9 minutes for diagnostic and 6.0 ± 2.2 minutes for PTCA

patients. No major complications were observed. Coagulation markers (fibrinogen, D-dimer, thrombin-

antithrombin-3 complex, and prothrombin fragment 1 and 2) measured before and after sealing device

deployment did not reveal excessive intravascular thrombin generation or other coagulopathy. This novel

vascular sealing device successfully achieves safe and effective vascular access site hemostasis immediately

after cardiac catheterization and PTCA. These promising first human results will need to be confirmed by a

multicenter randomized trial.

Circulation 1999;99: 1054-1061.

High-Resolution Intravascular Magnetic Resonance Imaging : Monitoring of Plaque Formation in Heritable

Hyperlipidemic Rabbits

Gesine G. Zimmermann-Paul, Harald H. Quick, Peter Vogt, Gustav K. von Schulthess, Dorothee Kling, and Jorg

F. Debatin

Background-The individual makeup of atherosclerotic plaque has been identified as a dominant prognostic

factor. With the use of an intravascular magnetic resonance (MR) catheter coil, we evaluated the effectiveness of

high-resolution MR in the study of the development of atherosclerotic lesions in heritable hyperlipidemic

rabbits.

Methods and Results-Sixteen hyperlipidemic rabbits were investigated at the ages of 6, 12, 24, and 36 months.

The aorta was studied with digital subtraction angiography and high-resolution MR with the use of a surface

coil and an intravascular coil that consisted of a single-loop copper wire integrated in a 5F balloon catheter.

Images were correlated with histological sections regarding wall thickness, plaque area, and plaque

components. Digital subtraction angiography revealed no abnormalities in the 6- and 12-month-old rabbits and

only mild stenoses in the 24- and 36-month-old rabbits. High-resolution imaging with surface coils resulted in

an in-plane resolution of 234x468 μm. Delineation of the vessel wall was not possible in younger rabbits and

correlated only poorly with microscopic measurements in the 36-month-old rabbits. Intravascular images

achieved an in-plane resolution of 117x156 μm. Increasing thickness of the aortic wall and plaque area was

observed with increasing age. In the 24- and 36-month-old animals, calcification could be differentiated from

fibrous and fatty tissue on the basis of the T2-fast spin echo images, as confirmed by histological correlation.

Conclusions-Atherosclerotic evolution of hyperlipidemic rabbits can be monitored with high-resolution

intravascular MR imaging. Image quality is sufficient to determine wall thickness and plaque area and to

differentiate plaque components.

Circulation 1999 Jun 29;99(25):3221-3

Prevention of distal embolization during saphenous vein graft lesion angioplasty. Experience with a new

temporary occlusion and aspiration system.

Carlino M, De Gregorio J, Di Mario C, Anzuini A, Airoldi F, Albiero R, Briguori C, Dharmadhikari A, Sheiban I,

Colombo A

BACKGROUND: Repeat coronary artery bypass graft surgery (CABG) is associated with a high morbidity and

mortality, rendering percutaneous treatment of saphenous vein graft (SVG) lesions an attractive alternative.

However, percutaneous interventions of degenerated SVGs carries high risk of distal embolization. METHODS

AND RESULTS: This study reports our initial experience with the PercuSurge GuardWire, a new device

developed to prevent embolization during treatment of degenerated SVG. This device consists of a 190-cm-long,

hollow 0.014-in guidewire with a central lumen connected to a distal occlusion balloon. A dedicated inflation

device (the MicroSeal Adapter) was used to inflate the distal balloon and maintain complete lumen occlusion

during balloon dilatation and stent implantation. A monorail aspiration catheter, connected to a vacuum

syringe, was used to evacuate atherosclerotic and thrombotic debris. Angioplasty with stent implantation was

performed in 15 degenerated SVGs (18 lesions). Procedural success was achieved in all patients with normal

postprocedure flow (Thrombolysis in Myocardial Infarction grade 3). No distal embolization was observed.

There were no major in-hospital adverse clinical events, including Q-wave or non-Q-wave myocardial

infarction, emergency CABG, or death. All patients were asymptomatic at discharge. CONCLUSIONS: This

preliminary series supports the feasible use of the PercuSurge GuardWire for retrieval of plaque debris and

prevention of embolization in degenerated SVGs. The good tolerance of temporary occlusions without

angiographic or clinical evidence of distal embolization represents encouraging early findings.

Summary

1. Procedural success: 100%

2. No distal embolization

3. No in-hospital MACE. All patients were asymptomatic at discharge.

Am J Cardiol 1999 Apr 1;83(7):994-9

Thrombectomy with AngioJet catheter in native coronary arteries for patients with acute or recent myocardial

infarction.

Nakagawa Y, Matsuo S, Kimura T, Yokoi H, Tamura T, Hamasaki N, Nosaka H, Nobuyoshi M

The AngioJet thrombectomy catheter removes thrombi by rheolytic fragmentation and suction. The purpose of

this study was to identify the efficacy and safety of this new device. Myocardial infarction (MI) is associated

with intracoronary thrombus. Intracoronary thrombus has been identified as a risk factor of unfavorable

outcome after percutaneous transluminal coronary angioplasty. To what extent the AngioJet is applicable or

effective for acute or recent MI in native coronary artery is not clear. Thrombectomy with the AngioJet was

attempted in 31 patients with 31 native coronary arteries selected from 304 patients with acute or recent MI.

Follow-up angiography was performed at 3 to 6 months. Procedure success was achieved in 29 patients (94%).

Adjunctive balloon angioplasty was performed after AngioJet thrombectomy in 30 patients (97%), and in only 1

patient (3%) AngioJet thrombectomy was the sole procedure. Subsequent stenting after balloon angioplasty

was attempted successfully in 12 patients (40%) without thrombotic complications. Thrombolysis In

Myocardial Infarction trial flow grading increased from 0.70 +/- 0.97 before to 2.61 +/- 0.88 after AngioJet

thrombectomy (p <0.0001), to 2.84 +/- 0.64 after adjunctive procedures (p = 0.070). At follow-up angiography

restenosis rate was 21% but Thrombolysis In Myocardial Infarction flow 3 was present in all patients. The

restenosis rate of stented patients was 8%. There were no major events during in-hospital and follow-up. The

AngioJet can be used safely and successfully to remove thrombus from the native coronary artery of patients

with MI. Thrombus removal makes subsequent stenting safe and uncomplicated. The restenosis rate was

considered to be acceptable.

Summary

1. Procedure success: 94%

2. TIMI flow: before - 0.70 +/- 0.97, after - 2.61 +/- 0.88 (p <0.0001)

3. Restenosis rate: 21%

4. There were no major events during in-hospital and follow-up.

Am Heart J 1999 Feb;137(2):227-33

Is all unstable angina the same? insights from the Coronary Angioplasty Versus Excisional Atherectomy Trial

(CAVEAT-I). The CAVEAT-Investigators.

Harrington RA, Califf RM, Holmes DR Jr, Pieper KS, Lincoff AM, Berdan LG, Thompson TD, Topol EJ

BACKGROUND: Certain characteristics of unstable angina have been associated with worse clinical outcomes

after percutaneous revascularization procedures. METHODS AND RESULTS: We compared outcomes of

patients with (n = 690) and those without (n = 320) unstable angina in the Coronary Angioplasty Versus

Excisional Atherectomy Trial (CAVEAT-I) by unstable angina subgroup: rest chest pain, postinfarction chest

pain, chest pain with ischemic electrocardiographic changes, chest pain with recent acceleration, and no chest

pain. Regression models were constructed to predict in-hospital and 6-month composite end point death,

infarction, bypass surgery, percutaneous revascularization, and abrupt closure (in-hospital) or restenosis (6

months) for each subgroup. Only chest pain with electrocardiographic changes predicted the composite in-

hospital outcome (24% vs 17% with no chest pain, P =.0374.) This subgroup also had a greater acute gain, more

late loss, and more restenosis than patients in the other subgroups. Rest chest pain carried a higher incidence of

the composite 6-month outcome (39.9% vs 29% with no chest pain, P =.0472). For all unstable angina categories,

atherectomy was associated with worse overall outcomes than angioplasty. CONCLUSIONS: Patients with

unstable angina have more complications of percutaneous revascularization than patients without unstable

angina, but event rates vary by anginal subgroup. The clinical presentation may help to identify unstable

angina patients at particularly high risk for adverse outcomes.

Summary

Circulation 2000;102: 1120-1125

Short- and Intermediate-Term Clinical Outcomes From Direct Myocardial Laser Revascularization Guided by

Biosense Left Ventricular Electromechanical Mapping

Ran Kornowski, Donald S. Baim, Jeffrey W. Moses, Mun K. Hong, Roger J. Laham, Shmuel Fuchs, Robert C.

Hendel, Deborah Wallace, David J. Cohen, Robert O. Bonow, Richard E. Kuntz, and Martin B. Leon

Background-Direct myocardial revascularization (DMR) has been examined as an alternative treatment for

patients with chronic refractory myocardial ischemic syndromes who are not candidates for conventional

coronary revascularization.

Methods and Results-We used left ventricular electromagnetic guidance in 77 patients with chronic refractory

angina (56 men, mean age 61±11 years, ejection fraction 0.48±0.11) to perform percutaneous DMR with an

Ho:YAG laser at 2 J/pulse. Procedural success (laser channels placed in prespecified target zones) was achieved

in 76 of 77 patients with an average of 26±10 channels (range 11 to 50 channels). The rate of major in-hospital

cardiac adverse events was 2.6%, with no deaths or emergency operations, 1 patient with postprocedural

pericardiocentesis, and 1 patient with minor embolic stroke. The rate of out-of-hospital adverse cardiac events

(up to 6 months) was 2.6%, with 1 patient with myocardial infarction and 1 patient with stroke. Exercise

duration after DMR increased from 387±179 to 454±166 seconds at 1 month and to 479±161 seconds at 6

months (P=0.0001). The time to onset of angina increased from 293±167 to 377±176 seconds at 1 month and to

414±169 seconds at 6 months (P=0.0001). Importantly, the time to ST-segment depression (1 mm) also increased

from 327±178 to 400±172 seconds at 1 month and to 436±175 seconds at 6 months (P=0.001). Angina

(Canadian Cardiovascular Society classification) improved from 3.3±0.5 to 2.0±1.2 at 6 months (P<0.001).

Nuclear perfusion imaging studies with a dual-isotope technique, however, showed no significant

improvements at 1 or 6 months.

Conclusions-Percutaneous DMR guided by left ventricular mapping is feasible and safe and reveals improved

angina and prolonged exercise duration for up to a 6-month follow-up.

Circulation 2000;102: 1755-1760

Randomized Secondary Prevention Trial of Azithromycin in Patients With Coronary Artery Disease : Primary

Clinical Results of the ACADEMIC Study

Joseph B. Muhlestein, Jeffrey L. Anderson, John F. Carlquist, Kirti Salunkhe, Benjamin D. Horne, Robert R.

Pearson, T. Jared Bunch, Ann Allen, Sanjeev Trehan, and Cindy Nielson

Background-Chlamydia pneumoniae is associated with coronary artery disease (CAD), although its causal role

is uncertain. A small preliminary study reported a >50% reduction in ischemic events by azithromycin, an

antibiotic effective against C pneumoniae, in seropositive CAD patients. We tested this prospectively in a larger,

randomized, double-blind study.

Methods and Results-CAD patients (n=302) seropositive to C pneumoniae (IgG titers ≥1:16) were randomized

to placebo or azithromycin 500 mg/d for 3 days and then 500 mg/wk for 3 months. The primary clinical end

point included cardiovascular death, resuscitated cardiac arrest, nonfatal myocardial infarction (MI), stroke,

unstable angina, and unplanned coronary revascularization at 2 years. Treatment groups were balanced, and

azithromycin was generally well tolerated. During the trial, 47 first primary events occurred (cardiovascular

death, 9; resuscitated cardiac arrest, 1; MI, 11; stroke, 3; unstable angina, 4; and unplanned coronary

revascularization, 19), with 22 events in the azithromycin group and 25 in the placebo group. There was no

significant difference in the 1 primary end point between the 2 groups (hazard ratio for azithromycin, 0.89; 95%

CI, 0.51 to 1.61; P=0.74). Events included 9 versus 7 occurring within 6 months and 13 versus 18 between 6 and

24 months in the azithromycin and placebo groups, respectively.

Conclusions-This study suggests that antibiotic therapy with azithromycin is not associated with marked early

reductions (50%) in ischemic events as suggested by an initial published report. However, a clinically

worthwhile benefit (ie, 20% to 30%) is still possible, although it may be delayed. Larger (several thousand

patient), longer-term (3 to 5 years) antibiotic studies are therefore indicated.

Cathet. Cardiovasc. Intervent. 51:107-109, 2000.

Coronary angioplasty using 5 French guiding catheters:

preliminary experience Francois Gobeil, MD, Thierry Lefevre, MD *, Yves Louvard, MD, Jean-Francois

Piechaud, MD, Marie-Claude Morice, MD

In a retrospective study of 40 patients, we evaluated the effectiveness of the new 5 Fr 0.058? lumen diameter

guiding catheter in routine PTCA. A total of 54 balloon angioplasties were performed. The mean age was

62.1 ?12.8 years, with 71% men. The artery dilated was the LAD in 50%, the RCA in 37%, and the circumflex in

13%. Sixty percent of the lesions dilated were proximal lesions, with only 25% defined as distal lesions.

Significant calcifications were present in 20% of the lesions. Stents were implanted in 96%, and mean stent

length was 14.0 mm, ranging from 8 to 24 mm. Mean balloon diameter was 2.7 mm, ranging from 2.0 to 3.5 mm.

The procedure was a success in 95%, with only two failures. No other complications occurred. We concluded

that the 0.058? 5 Fr guiding catheter could be suitable in the majority of noncomplex, selected PTCA cases.

However, limitations and advantages over the standard 6 Fr technique are yet to be defined.

Procedural Data

Summary

Coronary angioplasty using 5 French guiding catheters:

Cathet. Cardiovasc. Intervent. 51:112-119, 2000

Experimental evaluation of a short transitional edge protection balloon for intracoronary stent deployment

Andrew J. Carter, David P. Lee, MD, Takeshi Suzuki, MD, Lynn Bailey, Alexandra Lansky, MD, Russ Jones,

Renu Virmani, MD

The purpose of this study was to determine if balloon injury to the adjacent arterial wall during intracoronary

stent deployment influences late in-stent neointimal formation. Stent design and deployment techniques are

considered important factors in determining acute and long-term success with intracoronary stenting.

Experimental and clinical studies support that the extent of neointimal formation and the probability for

restenosis are influenced by the magnitude of arterial trauma induced with stenting. Nineteen 18-mm-long

balloon-expandable stainless steel stents (MULTI-LINK Duet) were implanted at a 1:1 stent-to-artery ratio in

the coronary arteries of swine with a conventional noncompliant balloon (n = 10) or a novel noncompliant

balloon with short tapered shoulders to prevent edge dissection (n = 9). Quantitative coronary angiography and

histology were used to evaluate balloon and artery interactions and the chronic vascular responses to the stents.

Nineteen stents were implanted in the coronary arteries of seven swines at an inflation pressure of 14 atm using

a standard noncompliant (n = 10) or a unique short transitional edge protection (n = 9) balloon. Histologic

analysis at 28 days demonstrated balloon-associated barotrauma in 13 of 20 (65%) of adjacent nonstented

arterial segments with the conventional balloon and only 3 of 18 (17%) of the adjacent nonstented arterial

segments with the short transition edge protection balloon (P = 0.022). In-stent neointimal area and % stenosis

correlated with the severity of peristent arterial injury (r = 0.43, P = 0.01). In-stent vessel injury scores were

similar for stents with peristent injury (1.0 ( 0.3) versus stents without peristent injury (1.0 ( 0.03, P = 0.73). In-

stent neointimal area and % stenosis were greater for stents with peristent injury (2.36 ( 0.74 mm2, 32% ( 9%) as

compared to stents without peristent injury (1.39 ( 0.70 mm2, 20% ( 10%, P = 0.01). Arterial wall injury adjacent

to a stent after high-pressure deployment contributes to late in-stent neointimal hyperplasia in this model.

These experimental data suggest that further study is warranted to refine stent implantation techniques and

that modifications of balloon shape or material may be useful to optimize stent deployment and reduce arterial

trauma.

Summary

Experimental evaluation of a short transitional edge protection balloon for intracoronary stent deployment

Cathet Cardiovasc Intervent 2001;52:173-176.

Early and mid-term angiographic and clinical results after intracoronary Duet stent placement

Kean-Wah Lau, Zee-Pin Ding, Veronica Kwok, Ulrich Sigwar

The Duet stent (Guidant/Advanced Cardiovascular Systems) is a new stent with a corrugated ring design and

very limited data on its short- and mid-term performance. Accordingly, in this study we sought to determine

the early and mid-term clinical and angiographic outcomes in a moderate-sized series of 86 consecutive

patients who underwent placement of 108 premounted Duet stents in 98 coronary lesions. Procedural success,

accomplished in all patients, was accompanied by a significant reduction in lesion severity from 89% ( 11%

before to 5% ( 3% diameter stenosis after the procedure (P = 0.0001) and a 0.9% incidence of subacute stent

thrombosis. Angiographic restudy at 5.7 months in 89% of eligible patients revealed a binary in-stent restenosis

rate of 26%. Coronary stenting with the new Duet stent confers a low risk of stent thrombosis and a favorable

mid-term clinical and angiographic outcome despite the presence of a large proportion of patients at high risk

of in-stent restenosis.

Summary

Early and mid-term angiographic and clinical results after intracoronary duet stent placement

Cathet. Cardiovasc. Intervent. 51:407-413,2000

Rotational atherectomy or balloon angioplasty in the treatment of intra-stent restenosis: BARASTER

Multicenter Registry

The BARASTER registry was formed to evaluate the initial success and long-term results of rotational

atherectomy in the management of in-stent restenosis. Rotational atherectomy was used in 197 cases of in-stent

restenosis: 46 with stand-alone rotational atherectomy or at most 1 atmosphere of balloon inflation (Rota

strategy), and 151 with rotational atherectomy and adjunctive balloon angioplasty <1 atmosphere

(Combination strategy). These were compared with 107 episodes of in-stent restenosis treated with balloon

angioplasty alone. In this observational study, the use of Combination therapy was associated with a slightly

higher initial success rate (95% vs. 87% with the Rota strategy and 89% with Balloons, P = 0.08). There was a

reduction in one year clinical outcomes (death, myocardial infarction or target lesion revascularization) in the

combination group (38% vs. 60% with Rota and 52% with balloons, P = 0.02). These data support a benefit of

the strategy of debulking with rotational atherectomy followed by adjunctive balloon angioplasty, in the

management of in-stent restenosis.

Summary

Rotational atherectomy or balloon angioplasty in the treatment of intra-stent restenosis: BARASTER


Outcome of therapy of in-stent restenosis

*p<0.05 compared to the other two groups


Beta-radiation for coronary in-stent restenosis

Donald R. Latchem, MBBS, Philip Urban, MD *, Jean-Jacques Goy, MD, Edoardo De Benedetti, MD, Alessia

Pica, MD, Philippe Coucke, MD, Eric Eeckhout, MD, PhD

To determine the feasibility and safety of an intracoronary beta-radiation device in preventing the recurrence of

in-stent restenosis (ISR) after successful angioplasty, we studied 37 patients treated with beta-radiation (30-mm

strontium-90 source) after angioplasty. The mean reference diameter was 2.9 ±0.5 mm, and 62% of lesions

were diffuse, including four total occlusions. Beta-radiation was successfully delivered in 36 of 37 (97%) cases.

Over the course of 7.1 ±4.5 mo follow-up, there were no myocardial infarctions and three deaths: one from

preexisting malignancy, one from progressive cardiac failure, and one from sudden cardiac death. Target vessel

revascularization (TVR) was performed in seven of 36 (19%) patients. Thirty patients underwent angiography

at 6 mo; three (10%) experienced restenosis (diameter stenosis > 50%) at the target site, four (13%) had edge

stenoses, and two (7%) had late (> 1 mo) thrombotic occlusions. Beta-radiation for ISR is associated with

encouragingly low rates of target lesion restenosis and TVR. Further improvements are needed to solve the

limitations of the edge effect and late occlusion.

Immediate outcomes and follow-up

Summary

Beta-radiation for coronary in-stent restenosis


Angiographic and clinical outcome of a new self-expanding intracoronary stent (RADIUS): Results from

multicenter experience in Japan

Atsushi Hirayama, MD, Kazuhisa Kodama, MD*, Takayoshi Adachi, MD, Shinsuke Nanto, MD, Tomoki Ohara,

MD, Hideo Tamai, MD, Eisyo Kyo, MD, Takaaki Isshiki, MD, Masahiko Ochiai, MD

The RADIUS coronary stent featuring a multisegmented slotted tube design and self-expanding nitinol

delivery system has a high radial force and flexibility, uniform expansion, and contours to the shape of the

vessel. Successful stent deployment was achieved in 104 stable angina patients (106 lesions; 44% LAD, 19%

circumflex, and 37% RCA). Mean minimal lumen diameter (MLD) increased from 0.77 ±0.46 mm to 2.88 ±

0.61 mm and mean percent diameter stenosis (% DS) decreased from 73 ±14% to 6 ±13% immediately after

the procedure. At 6-month follow-up, two patients (2%) underwent urgent target revascularization, and

cerebral bleeding occurred in one patient (1%). Angiographic follow-up was performed in 94 lesions (89%) and

mean MLD and mean % DS were 2.08 ±0.92 mm and 30% ±24%, respectively. Stent restenosis (>50% diameter

stenosis at follow-up) was observed in 16 (17%) of all lesions. The high success rate for stent deployment, low

incidence of major adverse cardiac event, and lower restenosis rate after stent implantation indicate that the

RADIUS stent is useful for coronary intervention.

Summary

Angiographic and clinical outcome of a new self-expanding intracoronary stent (RADIUS): Results from


Cathet. Cardiovasc Intervent. 49:369-375, 2000.

Physiologically guided angioplasty in support to a provisional stenting strategy: Immediate and six-month

outcome

Patrick Dupouy, MD*, Gabriel Pelle, PhD, Philippe Garot, MD, Morton J. Kern, MD, G. Kane, MD, Javier

Woscoboinick, MD, Eduardo Aptecar, MD, Abdel Belarbi, MD, Jean Marie Pernes, MD, Jean Luc Dubois Rande,

MD, PhD, Emmanuel Teiger, MD, PhD

The results of an observational multicenter angioplasty study suggested that stenting decisions may be

facilitated by physiologic data. The purpose of this study was to evaluate the early and long-term clinical and

angiographic outcome of prospective physiologically guided provisional stenting. Coronary angioplasty using

a Doppler-tipped angioplasty guidewire was performed in 68 patients. The provisional stent strategy dictated

that balloon angioplasty was to be continued until a coronary flow reserve was 2.2 with a residual diameter

stenosis by quantitative coronary angiography < 35%. Repeat coronary angiography was obtained at 6 months.

Based on the study criteria, 32/68 patients (47%) received a stent. Compared to the stent group, the angioplasty

alone group had higher postprocedural stenosis (23%±13% vs. 13%±10%; P < 0.05) and lower coronary

vasodilatory reserve (2.3±0.4 vs. 2.6±0.7; P < 0.05). At follow-up (6.0±1.5 months), the angiographic restenosis

rate was 39% in the angioplasty group and 35% in the stent groups (P = NS). Adverse cardiac events (unstable

angina, target lesion revascularization, myocardial infarction, death) occurred in 19% and 18% (P = NS) of the

angioplasty and stent patients, respectively. A prospective application of a physiologically guided provisional

stent strategy for coronary angioplasty indicated that stent implantation may be required in approximately 50%

of patients, an approach that produces similar clinical and angiographic long-term outcomes for stenting and

guided angioplasty. These data support a role of coronary physiology as an adjunct in conducting an

angioplasty procedure without obligatory stenting.

Journal of the American College of Cardiology 35(5):1170-77,2000

Transmyocardial revascularization with CO2 laser in patients with refractory angina pectoris: Clinical results

from The Norwegian Randomized Trial

Lars Aaberge Kenneth Nordstrand, Morten Dragsund, Kjell Saatvedt, Knut Endresen, Svein Golf, Odd Geiran,

Michel Abdelnoor and Kolbjorn Forfang

OBJECTIVES The purpose of the study was to evaluate clinical effects, exercise performance and effect on

maximal oxygen consumption (MVO2) of transmyocardial revascularization with CO2-laser (TMR) in patients

with refractory angina pectoris.

BACKGROUND Transmyocardial laser revascularization is a new method to treat patients with refractory

angina pectoris not eligible for conventional revascularization. Few randomized studies comparing TMR with

conventional treatment have been published.

METHODS One hundred patients with refractory angina not eligible for conventional revascularization were

block-randomized in a 1:1 ratio to receive continued optimal medical treatment (MT) or TMR in addition to MT.

The patients were evaluated at baseline and at three and 12 months with end points to symptoms, exercise

capacity and MVO2.

RESULTS Transmyocardial laser revascularization resulted in significant relief in angina symptoms after three

and 12 months compared to baseline. Time to chest pain during exercise increased from baseline by 78 s after

three months (p = NS) and 66 s (p < 0.01) after 12 months in the TMR group, whereas total exercise time and

MVO2 were unchanged. No significant changes were observed in the MT group. Perioperative mortality was

4%. One year mortality was 12% in the TMR group and 8% in the MT group (p = NS.)

CONCLUSIONS Transmyocardial laser revascularization was performed with low perioperative mortality and

caused significant symptomatic improvement, but no improvement in exercise capacity.

Circulation. 103(1):14-17, January 2/9, 2001.

Radioactive Stents Delay but Do Not Prevent In-Stent Neointimal Hyperplasia

Kay, I. Patrick MBChB; Wardeh, Alexander J. MD; Kozuma, Ken MD; Foley, David P. MBBCh, PhD; Knook, A.H.

Marco MD; Thury, Attila MD; Sianos, George MD; van der Giessen, Willem J. MD, PhD; Levendag, Peter C. MD,

PhD; Serruys, Patrick W. MD, PhD

Background-: Restenosis after conventional stenting is almost exclusively caused by neointimal hyperplasia.

[beta]-Particle-emitting radioactive stents decrease in-stent neointimal hyperplasia at 6-month follow-up. The

purpose of this study was to evaluate the 1-year outcome of 32P radioactive stents with an initial activity of 6 to

12 [mu]Ci using serial quantitative coronary angiography and volumetric ECG-gated 3D intravascular

ultrasound (IVUS)Methods and Results-: Of 40 patients undergoing initial stent implantation, 26 were event-

free after the 6-month follow-up period and 22 underwent repeat catheterization and IVUS at 1 year; they

comprised half of the study population. Significant luminal deterioration was observed within the stents

between 6 months and 1 year, as evidenced by a decrease in the angiographic minimum lumen diameter (-

0.43+/-0.56 mm;P =0.028) and in the mean lumen diameter in the stent (-0.55+/-0.63 mm;P =0.001); a significant

increase in in-stent neointimal hyperplasia by IVUS (18.16+/-12.59 mm3 at 6 months to 27.75+/-11.99 mm3 at 1

year;P =0.001) was also observed. Target vessel revascularization was performed in 5 patients (23%). No patient

experienced late occlusion, myocardial infarction, or death. By 1 year, 21 of the initial 40 patients (65%)

remained event-free. Conclusions-: Neointimal proliferation is delayed rather than prevented by radioactive

stent implantation. Clinical outcome 1 year after the implantation of stents with an initial activity of 6 to 12

[mu]Ci is not favorable when compared with conventional stenting.

Summary

Table 2. Subsegmental Quantitative Coronary Angiography Analysis*P<0.05,†P=0.0041,‡P=0.025,§

P=0.028,[//]P=0.001 by ANOVA.

Figure 1. Mean neointimal area in stent at 6 months ([black small square]) and 1 year ([black up pointing small

triangle]) using IVUS.

American Journal of Cardiology. 86(10):1073-1079, November 15, 2000.

The PARAGON Stent Study: A Randomized Trial of a New Martensitic Nitinol Stent Versus the Palmaz-Schatz

Stent for Treatment of Complex Native Coronary Arterial Lesions

Holmes, David R. Jr. MD; Lansky, Alexandra MD; Kuntz, Richard MD; Bell, Malcolm R. MBBS; Buchbinder,

Maurice MD; Fortuna, Richard MD; O’Shaughnessy, Charles D. MD; Popma, Jeffrey MD; for the PARAGON

Investigators

A new martensitic nitinol stent with improved flexibility and radiopacity was tested to evaluate whether these

differences improve initial or long-term outcome. Patients who underwent percutaneous revascularization of a

discrete native coronary lesion were randomly assigned to the new stent (PARAGON, n = 349) or to the first-

generation Palmaz-Schatz (PS) stent (n = 339). The primary end point was target vessel failure at 6 months (a

composite of cardiac or noncardiac death, any infarction in the distribution of the treated vessel, or clinically

indicated target vessel revascularization). Secondary end points were, among others, device and procedural

success and angiographic restenosis. Mean age was 62 years; diabetes was present in 21% of patients, prior

bypass surgery in 6%, and recent infarction in 22% (p = NS for comparison between the 2 randomized arms).

The PARAGON stent group had smaller reference vessels (2.97 vs 3.05 mm, p = 0.05), more prior restenosis

(8.0% vs 4.5%, p = 0.07), and a longer average stent length (21.3 vs 19.4 mm, p <0.05). Device success was

significantly higher in the PARAGON arm (99.1% vs 94.3%, p <0.05). Death and infarction at 6-month follow-up

were infrequent in both groups. There was no significant difference in death (2.0% vs 1.2%, p = 0.546), but a

higher rate of infarction for the PARAGON cohort (9.2% vs 4.7%, p = 0.025). Although target vessel failure

(20.3% vs 12.4%, p = 0.005) and target lesion revascularization (12.0% vs 5.9%, p = 0.005) were higher in the

PARAGON group, there was no significant difference in 6-month follow-up in in-stent minimal lumen

diameter or in the rate of binary angiographic restenosis. Both PARAGON and PS stents are safe and associated

with infrequent adverse events. The PARAGON stent can be delivered more frequently than the first-

generation PS stent. Although there was no significant difference in in-stent minimal lumen diameter or the

frequency of angiographic restenosis, clinical restenosis was more frequent in the PARAGON group.

TABLE 5 Adjudicated 6-Month Outcome

TABLE 6 Results of Follow-up Angiography

Circulation. 102(14):1657-1663, October 3, 2000.

Feasibility of a Novel Blood Noise Reduction Algorithm to Enhance Reproducibility of Ultra-High-Frequency

Intravascular Ultrasound Images

Hibi, Kiyoshi MD; Takagi, Atsushi MD; Zhang, Xiangmin PhD; Teo, Tat-Jin PhD; Bonneau, Heidi N. RN, MS;

Yock, Paul G. MD; Fitzgerald, Peter J. MD, PhD

Background: Ultra-high-frequency (40- to 50-MHz) intravascular ultrasound (IVUS) improves image quality

compared with conventional 20- to 30-MHz IVUS. However, as the frequency of IVUS increases, high-intensity

backscatter from blood components may cause visual difficulties in discrimination between the lumen and

arterial wall structure. The purpose of this study was to evaluate the effect of a novel blood noise reduction

algorithm (BNR) on quantitative coronary ultrasound measurements Methods and Results: IVUS studies using

a 40-MHz transducer were performed in 35 patients with coronary artery disease. A total of 620 gray-scale

images (310 pairs) were processed with and without the BNR, and lumen cross-sectional area (CSA) was

determined by 2 independent observers. With the BNR, the intraobserver and interobserver correlation

coefficients for lumen CSA were significantly improved (0.85 to 0.99 and 0.80 to 0.98, respectively). In the 270

images (135 pairs) in which vessel wall measurements were possible, the BNR significantly improved the

intraobserver and interobserver correlation coefficients for plaque plus media CSA (0.83 to 0.99 and 0.76 to 0.97,

respectively), whereas no influence was observed for external elastic membrane CSA (1.00 to 1.00 and 0.99 to

0.99, respectively). Conclusions: This study demonstrates the feasibility of this novel algorithm to reduce blood

noise, thereby enabling accurate lumen border delineation and providing reproducible measurements of both

the lumen and plaque plus media CSAs. Incorporating a digital BNR may serve as an important adjunct to

ultra-high-frequency IVUS imaging for improving accurate quantitative evaluation of vessel dimensions.

Summary

Circulation. 102(9):951-958, August 29, 2000.

Inhibition of Restenosis With [beta]-Emitting Radiotherapy: Report of the Proliferation Reduction With

Vascular Energy Trial (PREVENT).

Raizner, Albert E. MD; Oesterle, Stephen N. MD; Waksman,

Ron MD; Serruys, Patrick W. MD, PhD; Colombo, Antonio MD; Lim, Yean-Leng MD; Yeung, Alan C. MD; van

der Giessen, Wim J. MD, PhD; Vandertie, Lynn MS; Chiu, Joseph K. MD; White, Larry R. PhD; Fitzgerald, Peter

J. MD, PhD; Kaluza, Grzegorz L. MD, PhD; Ali, Nadir M. MD

Background: Intracoronary [gamma]- and [beta]-radiation have reduced restenosis in animal models. In the

clinical setting, the effectiveness of [beta]-emitters has not been studied in a broad spectrum of patients,

particularly those receiving stents. Methods and Results: A prospective, randomized, sham-controlled study of

intracoronary radiotherapy with the [beta]-emitting 32P source wire, using a centering catheter and automated

source delivery unit, was conducted. A total of 105 patients with de novo (70%) or restenotic (30%) lesions who

were treated by stenting (61%) or balloon angioplasty (39%) received 0 (control), 16, 20, or 24 Gy to a depth of 1

mm in the artery wall. Angiography at 6 months showed a target site late loss index of 11+/-36% in

radiotherapy patients versus 55+/-30% in controls (P <0.0001). A low late loss index was seen in stented and

balloon-treated patients and was similar across the 16, 20, and 24 Gy radiotherapy groups. Restenosis (>=50%)

rates were significantly lower in radiotherapy patients at the target site (8% versus 39%;P =0.012) and at target

site plus adjacent segments (22% versus 50%;P =0.018). Target lesion revascularization was needed in 5

radiotherapy patients (6%) and 6 controls (24%;P <0.05). Stenosis adjacent to the target site and late thrombotic

events reduced the overall clinical benefit of radiotherapy. Conclusions: [beta]-radiotherapy with a centered

32P source is safe and highly effective in inhibiting restenosis at the target site after stent or balloon angioplasty.

However, minimizing edge narrowing and late thrombotic events must be accomplished to maximize the

clinical benefit of this modality.

Summary

American Journal of Cardiology. 85(8):957-961, April 15, 2000.

Balloon Optimization Versus Stent Study (BOSS): Provisional Stenting and Early Recoil After Balloon

Angioplasty.

Dangas, George MD, PhD; Ambrose, John A. MD; Rehmann, Diane RN; Marmur, Jonathan D. MD; Sharma,

Samin K. MD; Hemdal-Monsen, Craig MD; Sanborn, Timothy A. MD; Fischman, David L. MD

“Optimal” percutaneous transluminal coronary angioplasty (PTCA) may have a late restenosis rate similar to

stenting. We sought to assess short- and long-term results of a provisional stenting/optimal PTCA approach

compared with elective stenting in a prospective, randomized study. A total of 97 patients with discrete, de

novo lesions in native coronary arteries >=3 mm in diameter were randomized 2:1 in PTCA with prolonged

perfusion balloon inflation (n = 66) versus elective stenting (n = 31). Recoil after PTCA was assessed by routine

delayed angiograms (5 and 20 minutes). Cross over to stent was allowed for an inadequate result; there was no

on-line quantitative angiography. An independent core angiographic laboratory assessed all results and

evaluated the adequacy of the subjective interpretation. Within the PTCA arm, there were 24 (36%) crossovers

to stenting (5 of 24 [21%] due to recoil), whereas 2 stents could not be delivered to the lesion and crossed over

to PTCA. As assessed by quantitative angiography, baseline reference vessel diameters were similar between

the PTCA and stent groups. The immediate lumen diameter achieved with PTCA was smaller than that

achieved with stenting (2.18 +/- 0.49 vs 2.44 +/- 0.38 mm, respectively, p = 0.01). There were no differences in

angiographic results between elective and crossover stenting and there were no in-hospital complications in

any patient. Target lesion revascularization at 8 months was 19% (n = 6) in the elective stent arm versus 21% (n

= 14) in the PTCA arm, p = NS; respective rates in PTCA alone and crossed over-to-stent subsets were 23% (n =

10) versus 17% (n = 4), p = NS. Angiographic restenosis was 47% after elective stenting versus 38% after PTCA

(intention to treat), p = NS. By received treatment, it was 41% (11 of 27) in the group treated with the PTCA

versus 33% (5 of 15) in the crossover-to-stent arm (p = NS). Thus, provisional stenting can be safely performed

in the treatment of discrete, native de novo lesions. Early recoil after PTCA cannot be reliably assessed without

quantitative angiography.

Summary

TABLE I Quantitative Angiographic Results: Intention-to-Treat Analysis

TABLE II Quantitative Angiographic Results: Treatment-Received Analysis

TABLE 5 Adjudicated 6-Month Outcome

TABLE 6 Results of Follow-up Angiography


Feasibility of a Novel Blood Noise Reduction Algorithm to Enhance Reproducibility of Ultra-High-Frequency

Intravascular Ultrasound Images

Hibi, Kiyoshi MD; Takagi, Atsushi MD; Zhang, Xiangmin PhD; Teo, Tat-Jin PhD; Bonneau, Heidi N. RN, MS;

Yock, Paul G. MD; Fitzgerald, Peter J. MD, PhD

Background: Ultra-high-frequency (40- to 50-MHz) intravascular ultrasound (IVUS) improves image quality

compared with conventional 20- to 30-MHz IVUS. However, as the frequency of IVUS increases, high-intensity

backscatter from blood components may cause visual difficulties in discrimination between the lumen and

arterial wall structure. The purpose of this study was to evaluate the effect of a novel blood noise reduction

algorithm (BNR) on quantitative coronary ultrasound measurements Methods and Results: IVUS studies using

a 40-MHz transducer were performed in 35 patients with coronary artery disease. A total of 620 gray-scale

images (310 pairs) were processed with and without the BNR, and lumen cross-sectional area (CSA) was

determined by 2 independent observers. With the BNR, the intraobserver and interobserver correlation

coefficients for lumen CSA were significantly improved (0.85 to 0.99 and 0.80 to 0.98, respectively). In the 270

images (135 pairs) in which vessel wall measurements were possible, the BNR significantly improved the

intraobserver and interobserver correlation coefficients for plaque plus media CSA (0.83 to 0.99 and 0.76 to 0.97,

respectively), whereas no influence was observed for external elastic membrane CSA (1.00 to 1.00 and 0.99 to

0.99, respectively). Conclusions: This study demonstrates the feasibility of this novel algorithm to reduce blood

noise, thereby enabling accurate lumen border delineation and providing reproducible measurements of both

the lumen and plaque plus media CSAs. Incorporating a digital BNR may serve as an important adjunct to

ultra-high-frequency IVUS imaging for improving accurate quantitative evaluation of vessel dimensions.

Summary


Inhibition of Restenosis With [beta]-Emitting Radiotherapy: Report of the Proliferation Reduction With


Raizner, Albert E. MD; Oesterle, Stephen N. MD; Waksman, Ron MD; Serruys, Patrick W. MD, PhD; Colombo,

Antonio MD; Lim, Yean-Leng MD; Yeung, Alan C. MD; van der Giessen, Wim J. MD, PhD; Vandertie, Lynn MS;

Chiu, Joseph K. MD; White, Larry R. PhD; Fitzgerald, Peter J. MD, PhD; Kaluza, Grzegorz L. MD, PhD; Ali,

Nadir M. MD

Background: Intracoronary [gamma]- and [beta]-radiation have reduced restenosis in animal models. In the

clinical setting, the effectiveness of [beta]-emitters has not been studied in a broad spectrum of patients,

particularly those receiving stents. Methods and Results: A prospective, randomized, sham-controlled study of

intracoronary radiotherapy with the [beta]-emitting 32P source wire, using a centering catheter and automated

source delivery unit, was conducted. A total of 105 patients with de novo (70%) or restenotic (30%) lesions who

were treated by stenting (61%) or balloon angioplasty (39%) received 0 (control), 16, 20, or 24 Gy to a depth of 1

mm in the artery wall. Angiography at 6 months showed a target site late loss index of 11+/-36% in

radiotherapy patients versus 55+/-30% in controls (P <0.0001). A low late loss index was seen in stented and

balloon-treated patients and was similar across the 16, 20, and 24 Gy radiotherapy groups. Restenosis (>=50%)

rates were significantly lower in radiotherapy patients at the target site (8% versus 39%;P =0.012) and at target

site plus adjacent segments (22% versus 50%;P =0.018). Target lesion revascularization was needed in 5

radiotherapy patients (6%) and 6 controls (24%;P <0.05). Stenosis adjacent to the target site and late thrombotic

events reduced the overall clinical benefit of radiotherapy. Conclusions: [beta]-radiotherapy with a centered

32P source is safe and highly effective in inhibiting restenosis at the target site after stent or balloon angioplasty.

However, minimizing edge narrowing and late thrombotic events must be accomplished to maximize the

clinical benefit of this modality.

Summary


Balloon Optimization Versus Stent Study (BOSS): Provisional Stenting and Early Recoil After Balloon

Angioplasty.

Dangas, George MD, PhD; Ambrose, John A. MD; Rehmann, Diane RN; Marmur, Jonathan D. MD; Sharma,

Samin K. MD; Hemdal-Monsen, Craig MD; Sanborn, Timothy A. MD; Fischman, David L. MD

“Optimal” percutaneous transluminal coronary angioplasty (PTCA) may have a late restenosis rate similar to

stenting. We sought to assess short- and long-term results of a provisional stenting/optimal PTCA approach

compared with elective stenting in a prospective, randomized study. A total of 97 patients with discrete, de

novo lesions in native coronary arteries >=3 mm in diameter were randomized 2:1 in PTCA with prolonged

perfusion balloon inflation (n = 66) versus elective stenting (n = 31). Recoil after PTCA was assessed by routine

delayed angiograms (5 and 20 minutes). Cross over to stent was allowed for an inadequate result; there was no

on-line quantitative angiography. An independent core angiographic laboratory assessed all results and

evaluated the adequacy of the subjective interpretation. Within the PTCA arm, there were 24 (36%) crossovers

to stenting (5 of 24 [21%] due to recoil), whereas 2 stents could not be delivered to the lesion and crossed over

to PTCA. As assessed by quantitative angiography, baseline reference vessel diameters were similar between

the PTCA and stent groups. The immediate lumen diameter achieved with PTCA was smaller than that

achieved with stenting (2.18 +/- 0.49 vs 2.44 +/- 0.38 mm, respectively, p = 0.01). There were no differences in

angiographic results between elective and crossover stenting and there were no in-hospital complications in

any patient. Target lesion revascularization at 8 months was 19% (n = 6) in the elective stent arm versus 21% (n

= 14) in the PTCA arm, p = NS; respective rates in PTCA alone and crossed over-to-stent subsets were 23% (n =

10) versus 17% (n = 4), p = NS. Angiographic restenosis was 47% after elective stenting versus 38% after PTCA

(intention to treat), p = NS. By received treatment, it was 41% (11 of 27) in the group treated with the PTCA

versus 33% (5 of 15) in the crossover-to-stent arm (p = NS). Thus, provisional stenting can be safely performed

in the treatment of discrete, native de novo lesions. Early recoil after PTCA cannot be reliably assessed without

quantitative angiography.

Summary

TABLE I Quantitative Angiographic Results: Intention-to-Treat Analysis

TABLE II Quantitative Angiographic Results: Treatment-Received Analysis

New techniques in coronary interventions

1. Myocardial viability assessment by endocardial electroanatomic mapping: comparison with metabolic

imaging and functional recovery after coronary revascularization.

Koch KC, vom Dahl J, Wenderdel M, Nowak B, Schaefer WM, Sasse A, Stellbrink C, Buell U, Hanrath

P.


2. Ultrasound as treatment for coronary artery disease.

Gunn J, Cumberland DC, Siegel RJ.


3. Therapeutic ultrasound for chronic total coronary artery occlusions.

Cannon LA, John J, LaLonde J.


4. Catheter-delivered ultrasound therapy for native coronary arterial thrombosis and occluded saphenous vein

grafts.

Halkin A, Rosenschein U.


5. Ultrasound-enhanced thrombolysis.

Francis CW.


6. Percutaneous transluminal therapeutic ultrasound for high-risk thrombus-containing lesions in native

coronary arteries.

Brosh D, Bartorelli AL, Cribier A, Mesa J, Calderon L, Martyn T, Amann F, Sampaolesi A, Desmet W,

Fajadet J, Rosenschein U; Acolysis Registry Study Group.

Catheter Cardiovasc Interv 2002 Jan;55(1):43-9

7. Extensive development of vulnerable plaques as a pan-coronary process in patients with myocardial

infarction: an angioscopic study.

Asakura M, Ueda Y, Yamaguchi O, Adachi T, Hirayama A, Hori M, Kodama K.

J Am Coll Cardiol 2001 Apr;37(5):1284-8

8. Mechanical and structural characteristics of vulnerable plaques: analysis by coronary angioscopy and

intravascular ultrasound.

Takano M, Mizuno K, Okamatsu K, Yokoyama S, Ohba T, Sakai S.


9. The healing process of infarct-related plaques. Insights from 18 months of serial angioscopic follow-up.

Ueda Y, Asakura M, Yamaguchi O, Hirayama A, Hori M, Kodama K.

J Am Coll Cardiol 2001 Dec;38(7):1916-22

10. Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational

atherectomy, additional stent implantation and balloon angioplasty.

Adamian M, Colombo A, Briguori C, Nishida T, Marsico F, Di Mario C, Albiero R, Moussa I, Moses JW.

J Am Coll Cardiol 2001 Sep;38(3):672-9

11. Final results of the CAPAS trial.

Izumi M, Tsuchikane E, Funamoto M, Kobayashi T, Sumitsuji S, Otsuji S, Sakurai M, Kobayashi T,

Awata N.

Am Heart J 2001 Nov;142(5):782-9

12. Cutting balloon angioplasty for treatment of calcified coronary lesions.

Karvouni E, Stankovic G, Albiero R, Takagi T, Corvaja N, Vaghetti M, Di Mario C, Colombo A.

Catheter Cardiovasc Interv 2001 Dec;54(4):473-81

13. ?ireless?laser recanalization of chronic total coronary occlusions.

Perin EC, Sarmento-Leite R, Silva GV, Rogers MD, Topaz O.

J Invasive Cardiol 2001 May;13(5):401-5

14. Effectiveness of excimer laser coronary angioplasty in acute myocardial infarction or in unstable angina

pectoris.

Topaz O, Bernardo NL, Shah R, McQueen RH, Desai P, Janin Y, Lansky AJ, Carr ME.

Am J Cardiol 2001 Apr 1;87(7):849-55

15. Percutaneous in situ coronary venous arterialization: report of the first human catheter-based coronary

artery bypass.

Oesterle SN, Reifart N, Hauptmann E, Hayase M, Yeung AC.

Circulation 2001 May 29;103(21):2539-43

16. Combined percutaneous biosense-guided laser myocardial revascularization and coronary intervention.

Laham RJ, Baim DS.

Catheter Cardiovasc Interv 2001 Jun;53(2):235-40

17. Direct coronary stenting without balloon or device pretreatment: acute success and long-term results.

Stys T, Lawson WE, Liuzzo JP, Hanif B, Bragg L, Cohn PF.

Catheter Cardiovasc Interv 2001 Oct;54(2):158-63

18. Repeated thermal therapy improves impaired vascular endothelial function in patients with coronary risk

factors.

Imamura M, Biro S, Kihara T, Yoshifuku S, Takasaki K, Otsuji Y, Minagoe S, Toyama Y, Tei C.

J Am Coll Cardiol 2001 Oct;38(4):1083-8

19. Cell transplantation for the treatment of acute myocardial infarction using vascular endothelial growth

factor-expressing skeletal myoblasts

Suzuki K, Murtuza B, Smolenski RT, Sammut IA, Suzuki N, Kaneda Y, Yacoub MH.

Circulation 2001 Sep 18;104(12 Suppl 1):I207-12

20. Blood transfusion in elderly patients with acute myocardial infarction.

Wu WC, Rathore SS, Wang Y, Radford MJ, Krumholz HM.

N Engl J Med 2001 Oct 25;345(17):1230-6

21. Prevention of distal embolization during coronary angioplasty in saphenous vein grafts and native vessels

using porous filter protection.

Grube E, Gerckens U, Yeung AC, Rowold S, Kirchhof N, Sedgewick J, Yadav JS, Stertzer S.

Circulation 2001 Nov 13;104(20):2436-41

22. Recanalization of Chronic Total Coronary Occlusions Using a Laser Guide Wire: A Pilot Study

Jaap N. Hamburger, MD, Geert H. M. Gijsbers, PhD, Yukio Ozaki, MD, PhD, Peter N. Ruygrok, MD,

Pim J. de Feyter, MD, PhD, FESC, FACC, Patrick W. Serruys, MD, PhD, FESC, FACC


23. New device for compression of the radial artery after diagnostic and interventional cardiac procedures

Pascal Chatelain, Adalberto Arceo, Emmanuel Rombaut, Vitalin Verin, Philip Urban


24. Treatment of In-Stent Coronary Restenosis by Excimer Laser Angioplasty

Ralf Koster, MD, Christian W. Hamm, MD, Wolfram Terres, MD, Dietmar H. Koschyk, MD, Jacobus

Reimers, MD, Jan Kahler, MD, Thomas Meinertz, MD


25. Percutaneous Coronary Angioscopic Comparison of Thrombus Formation During Percutaneous Coronary

Angioplasty With Ionic and Nonionic Low Osmolality Contrast Media in Unstable Angina

Najmi R. Qureshi, MRCP, Peter den Heijer, PhD, Harry J.G.M. Crijns, PhD


26. Randomized Comparison of Angioplasty of Complex Coronary Lesions at a Single Center : Excimer Laser,

Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study

Nicolaus Reifart, Michel Vandormael, Mladen Krajcar, Stefan Gohring, Wolfgang Preusler, Franz

Schwarz, Hans Storger, Manfred Hofmann, Johann Klopper, Stefan Muller, and Jurgen

Haase


27. Treatment of In-Stent Restenosis With Excimer Laser Coronary Angioplasty : Mechanisms and Results

Compared With PTCA Alone

Roxana Mehran, Gary S. Mintz, Lowell F. Satler, Augusto D. Pichard, Kenneth M. Kent, Theresa A.

Bucher, Jeffery J. Popma, and Martin B. Leon

Circulation 1997 96: 2183-2189.

28. Percutaneous Transluminal Septal Myocardial Ablation in Hypertrophic Obstructive Cardiomyopathy:

Acute Results and 3-Month Follow-Up in 25 Patients

Hubert Seggewiss, MD, Ulrich Gleichmann, MD, Lothar Faber, MD, Dieter Fassbender, MD, Henning

K. Schmidt, MD, Stefan Strick, MD


29. Percutaneous Transluminal Septal Myocardial Ablation in Hypertrophic Obstructive Cardiomyopathy :

Results With Respect to Intraprocedural Myocardial Contrast Echocardiography

Lothar Faber, Hubert Seggewiss, and Ulrich Gleichmann

Circulation 1998 98: 2415-2421.

30. Comparison Between Left Ventricular Electromechanical Mapping and Radionuclide Perfusion Imaging for

Detection of Myocardial Viability

Ran Kornowski, Mun K. Hong, and Martin B. Leon

Circulation 1998 98: 1837-1841

31. Preliminary Animal and Clinical Experiences Using an Electromechanical Endocardial Mapping Procedure

to Distinguish Infarcted From Healthy Myocardium

Ran Kornowski, Mun K. Hong, Lior Gepstein, Steven Goldstein, Samer Ellahham, Shlomo A. Ben-

Haim, and Martin B. Leon

Circulation 1998 98: 1116-1124.

32. Balloon Angioplasty Versus New Device Intervention: Clinical Outcomes : A Comparison of the NHLBI

PTCA and NACI Registries

Spencer B. King, III, MD, FACC, Wanlin Yeh, MS, Richard Holubkov, PhD, Donald S. Baim, MD,

FACC, George Sopko, MD, MPH, Patrice Desvigne-Nickens, MD, David R. Holmes, Jr., MD, FACC,

Michael J. Cowley, MD, FACC, Martial G. Bourassa, MD, FACC, James Margolis, MD, FACC,

Katherine M. Detre, MD, DrPH, FACC for the NHLBI PTCA and NACI Registry Investigators

Journal of the American College of Cardiology, 1998;31:3:558-566

33. Intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent suppresses the restenotic

changes of the coronary artery in pigs in vivo

Tohru Yamawaki, Hiroaki Shimokawa, Toshiyuki Kozai, Kenji Miyata, Taiki Higo, Eriko Tanaka,

Kensuke Egashira, Tadayoshi Shiraishi, Hideo Tamai, Keiji Igaki, Akira Takeshita

Objectives. This study was designed to examine whether or not intramural delivery of ST638 (a

specific tyrosine kinase inhibitor) with biodegradable stent can suppress the

restenotic changes of the coronary artery in vivo.


34. Usefulness of collagen plugging with VasoSeal(r) after PTCA as compared to manual compression with

identical sheath dwell times

Sigmund Silber, Aina Bjorvik, Holger Muhling, Andreas Rosch


35. Short-Term Results and Intermediate-Term Follow-Up of Laser Wire Recanalization of Chronic Coronary

Artery Occlusions: A Single-Center Experience

Joachim Schofer, MD, Thomas Rau, MD, Michael Schluter, PhD, Detlef G. Mathey, MD, FACC


36. Percutaneous Transluminal Therapy of Occluded Saphenous Vein Grafts : Can the Challenge Be Met With

Ultrasound Thrombolysis?

Uri Rosenschein, Georg Gaul, Raimund Erbel, Franz Amann, Diego Velasguez, H. Stoerger, Ruediger

Simon, German Gomez, Joerg Troster, Antonio Bartorelli, Michael Pieper, Zenon

Kyriakides, Shlomo Laniado, Hylton I. Miller, Alain Cribier, and Jean Fajadet


37. Intermediate-Term Clinical Outcome Following Transmyocardial Laser Revascularization in Patients With

Refractory Angina Pectoris

Carolyn K. Landolfo, Kevin P. Landolfo, G. Chad Hughes, Edward R. Coleman, Robin B. Coleman,

and James E. Lowe

Circulation 1999 100: II-128-II-133.

38. Tissue proliferation within and surrounding Palmaz-Schatz stents is dependent on the aggressiveness of

stent implantation technique

Rainer Hoffmann, Gary S. Mintz, Roxana Mehran, Kenneth M. Kent, Augusto D. Pichard, Lowell F.

Satler, Martin B. Leon


39. Laser angioplasty of restenosed coronary stents: results of a multicenter surveillance trial

Ralf Koster, Christian W. Hamm, Ricardo Seabra-Gomes, Gunhild Herrmann, Horst Sievert, Carlos

Macaya, Eckart Fleck, Klaus Fischer, Johannes J.R.M. Bonnier, Jean Fajadet, Jurgen

Waigand, Karl-Heinz Kuck, Michel Henry, Marie Claude Morice, Luciano Pizzulli, Michael M.

Webb-Peploe, Arnd B. Buchwald, Lars Ekstrom, Eberhard Grube, Saad Al Kasab, Antonio Colombo,

Archimedes Sanati, Sjef M.P.G. Ernst, Michael Haude, Martin B. Leon, Charles Ilsley,

Rafael Beyar, Yvo Taeymans, Uwe Gladbach, Karl Wegscheider, Patrick W. Serruys for the Laser

Angioplasty of Restenosed Stents (LARS) Investigators


40. A novel vascular sealing device for closure of percutaneous arterial access sites

Sigmund Silber, Gary Gershony, Brigitte Schon, Norbert Schon, Todd Jensen, Wolfgang Schramm


41. High-Resolution Intravascular Magnetic Resonance Imaging : Monitoring of Plaque Formation in Heritable

Hyperlipidemic Rabbits

Gesine G. Zimmermann-Paul, Harald H. Quick, Peter Vogt, Gustav K. von Schulthess, Dorothee Kling,

and Jorg F. Debatin

Circulation 1999 99: 1054-1061.

42. Prevention of distal embolization during saphenous vein graft lesion angioplasty. Experience with a new

temporary occlusion and aspiration system.

Carlino M, De Gregorio J, Di Mario C, Anzuini A, Airoldi F, Albiero R, Briguori C, Dharmadhikari A,

Sheiban I, Colombo A

Circulation 1999 Jun 29;99(25):3221-3

43. Thrombectomy with AngioJet catheter in native coronary arteries for patients with acute or recent

myocardial infarction.

Nakagawa Y, Matsuo S, Kimura T, Yokoi H, Tamura T, Hamasaki N, Nosaka H, Nobuyoshi M

Am J Cardiol 1999 Apr 1;83(7):994-9

44. Is all unstable angina the same? insights from the Coronary Angioplasty Versus Excisional Atherectomy

Trial (CAVEAT-I). The CAVEAT- Investigators.

Harrington RA, Califf RM, Holmes DR Jr, Pieper KS, Lincoff AM, Berdan LG, Thompson TD, Topol EJ

Am Heart J 1999 Feb;137(2):227-33

45. Short- and Intermediate-Term Clinical Outcomes From Direct Myocardial Laser Revascularization Guided

by Biosense Left Ventricular Electromechanical Mapping

Ran Kornowski, Donald S. Baim, Jeffrey W. Moses, Mun K. Hong, Roger J. Laham, Shmuel Fuchs,

Robert C. Hendel, Deborah Wallace, David J. Cohen, Robert O. Bonow, Richard E. Kuntz, and

Martin B. Leon

Circulation 2000 102: 1120-1125.

46. Randomized Secondary Prevention Trial of Azithromycin in Patients With Coronary Artery Disease :

Primary Clinical Results of the ACADEMIC Study

Joseph B. Muhlestein, Jeffrey L. Anderson, John F. Carlquist, Kirti Salunkhe, Benjamin D. Horne,

Robert R. Pearson, T. Jared Bunch, Ann Allen, Sanjeev Trehan, and Cindy Nielson

Circulation 2000 102: 1755-1760.

47. Coronary angioplasty using 5 French guiding catheters:

preliminary experience Francois Gobeil, MD, Thierry Lefevre, MD *, Yves Louvard, MD, Jean-Francois

Piechaud, MD, Marie-Claude Morice, MD


48. Experimental evaluation of a short transitional edge protection balloon for intracoronary stent deployment

Andrew J. Carter, David P. Lee, MD, Takeshi Suzuki, MD, Lynn Bailey, Alexandra Lansky, MD, Russ

Jones, Renu Virmani, MD

Cathet. Cardiovasc. Intervent. 51:112-119, 2000

49. Early and mid-term angiographic and clinical results after intracoronary duet stent placement

Kean-Wah Lau, Zee-Pin Ding, Veronica Kwok, Ulrich Sigwar

Cathet Cardiovasc Intervent 2001;52:173-176.

50. Rotational atherectomy or balloon angioplasty in the treatment of intra-stent restenosis: BARASTER


Cathet. Cardiovasc. Intervent. 51:407-413,2000

51. Beta-radiation for coronary in-stent restenosis

Donald R. Latchem, MBBS, Philip Urban, MD *, Jean-Jacques Goy, MD, Edoardo De Benedetti, MD,

Alessia Pica, MD, Philippe Coucke, MD, Eric Eeckhout, MD, PhD


52. Angiographic and clinical outcome of a new self-expanding intracoronary stent (RADIUS): Results from


Atsushi Hirayama, MD, Kazuhisa Kodama, MD*, Takayoshi Adachi, MD, Shinsuke Nanto, MD,

Tomoki Ohara, MD, Hideo Tamai, MD, Eisyo Kyo, MD, Takaaki Isshiki, MD, Masahiko

Ochiai, MD


53. Physiologically guided angioplasty in support to a provisional stenting strategy: Immediate and six-month

outcome

Patrick Dupouy, MD*, Gabriel Pelle, PhD, Philippe Garot, MD, Morton J. Kern, MD, G. Kane, MD,

Javier Woscoboinick, MD, Eduardo Aptecar, MD, Abdel Belarbi, MD, Jean Marie

Pernes, MD, Jean Luc Dubois Rande, MD, PhD, Emmanuel Teiger, MD, PhD

Cathet. Cardiovasc Intervent. 49:369-375, 2000.

54. Transmyocardial revascularization with CO2 laser in patients with refractory angina pectoris: Clinical

results from The Norwegian Randomized Trial

Lars Aaberge Kenneth Nordstrand, Morten Dragsund, Kjell Saatvedt, Knut Endresen, Svein Golf, Odd

Geiran, Michel Abdelnoor and Kolbjorn Forfang

Journal of the American College of Cardiology 35(5):1170-77,2000

55. Radioactive Stents Delay but Do Not Prevent In-Stent Neointimal Hyperplasia

Kay, I. Patrick MBChB; Wardeh, Alexander J. MD; Kozuma, Ken MD; Foley, David P. MBBCh, PhD;

Knook, A.H. Marco MD; Thury, Attila MD; Sianos, George MD; van der Giessen, Willem J. MD,

PhD; Levendag, Peter C. MD, PhD; Serruys, Patrick W. MD, PhD

Circulation. 103(1):14-17, January 2/9, 2001.

56. The PARAGON Stent Study: A Randomized Trial of a New Martensitic Nitinol Stent Versus the Palmaz-

Schatz Stent for Treatment of Complex Native Coronary Arterial Lesions

Holmes, David R. Jr. MD; Lansky, Alexandra MD; Kuntz, Richard MD; Bell, Malcolm R. MBBS;

Buchbinder, Maurice MD; Fortuna, Richard MD; O’Shaughnessy, Charles D. MD; Popma, Jeffrey

MD; for the PARAGON Investigators

American Journal of Cardiology. 86(10):1073-1079, November 15, 2000.

57. Feasibility of a Novel Blood Noise Reduction Algorithm to Enhance Reproducibility of Ultra-High-

Frequency Intravascular Ultrasound Images

Hibi, Kiyoshi MD; Takagi, Atsushi MD; Zhang, Xiangmin PhD; Teo, Tat-Jin PhD; Bonneau, Heidi N.

RN, MS; Yock, Paul G. MD; Fitzgerald, Peter J. MD, PhD


58. Inhibition of Restenosis With [beta]-Emitting Radiotherapy: Report of the Proliferation Reduction With


Raizner, Albert E. MD; Oesterle, Stephen N. MD; Waksman, Ron MD; Serruys, Patrick W. MD, PhD;

Colombo, Antonio MD; Lim, Yean-Leng MD; Yeung, Alan C. MD; van der Giessen, Wim J. MD,

PhD; Vandertie, Lynn MS; Chiu, Joseph K. MD; White, Larry R. PhD; Fitzgerald, Peter J. MD, PhD; Kaluza,

Grzegorz L. MD, PhD; Ali, Nadir M. MD


59. Balloon Optimization Versus Stent Study (BOSS): Provisional Stenting and Early Recoil After Balloon

Angioplasty.

Dangas, George MD, PhD; Ambrose, John A. MD; Rehmann, Diane RN; Marmur, Jonathan D. MD;

Sharma, Samin K. MD; Hemdal-Monsen, Craig MD; Sanborn, Timothy A. MD; Fischman, David L.

MD


patterns of in-stent restenosis after placement of nir gold-coated …summitmd.com/pdf/syllabus/new...

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