equipment & technology medical management · ing from pressure ulcers (bedsores) by invest-ing...

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THE MAGAZINE FOR HEALTHCARE DECISION MAKERS Weekly news updates on www.ihe-online.com HOSPITAL International Equipment & Technology Medical Management Volume 37 September 2011 Mitral valve repair techniques Closed chest hybrid coronary revascularisation Virtual histology of plaque: the V-HEART study Personalised antiplatelet therapy after PCI CTCA in risk stratification Cardiology Special PET/CT imaging management software Page 30 12-channel electrocardiograph Page 33 Advanced ECG system with touchscreen technology Page 32 Also in this issue

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Page 1: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

The Magazine for healThcare decision Makers

Weekly news updates on www.ihe-online.com

hospitalinternational

Equipment & Technology Medical ManagementVolume 37

September 2011

Mitral valve repair techniques

Closed chest hybrid coronary revascularisation

Virtual histology of plaque: the V-HEART study

Personalised antiplatelet therapy after PCI

CTCA in risk stratification

cardiology special

PeT/cT imaging management software

Page 30

12-channel electrocardiograph

Page 33

advanced ecg system with touchscreen technology

Page 32

also in this issue

Page 2: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

For more information, please visit www.samsungmedison.com

If imaging is your arena

See more in life

Samsung Medison is one of the world’s leading researchers, developers and manufacturers of ultrasound and other medical imaging products. Founded in 1985, Samsung Medison was acquired by Samsung Electronics in February 2011. Throughout its history, the company has achieved a series of technological breakthroughs, such as introducing the world’s first commercially available 3D and 4D diagnostic ultrasound scanners. Driven by an investment of 12 percent of revenues into R&D, its range of machines now covers everything from the lightest and most portable of scanners, to the very latest and most sophisticated in ultrasound technology.

www.ihe-online.com & search 45880

Page 3: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

One of the inevita-ble consequences of the upsurge in the ever increasing use of the internet as a medium of communication,

at least as far as medico-scientific subjects are concerned, is the steady decline in the scientific validity of the message being communicated. Nowadays just about every blog-ger worth his salt seems obliged to transmit a personal opinion on the latest “scientific report” concerning a whole gamut of subjects whose only common feature seems to be their anecdotal nature and lack of any semblance of statistical significance. Even so-called quality mainstream newspapers seem affected by the trend, including as they do popular medicine columns whose scientific merit is rarely greater than the same paper’s horoscope columns. As with horoscopes, the typical pseudo-sci-entific reports could be considered relatively harmless pieces of interest-ing fun, if it were not for the danger that readers might actually take them seriously. There is however another danger of the banalisation of main-stream medico-scientific report-ing, namely that whenever a really robust, statistically significant report is published it may be taken with the same lack of seriousness that the usual anecdotal tosh deserves. One such solid, significant report appeared mid August with the pub-lication in the Lancet of the results of a huge study carried out by a Tai-wanese group of researchers on the effect of physical activity on mor-tality reduction and extension of life expectancy (Lancet 16th August 2011). With more than 400 000 sub-jects participating in a standard med-ical screening programme and with an average follow-up of 8 years, no-one can quibble about the anecdotal nature of this report. Starting from the accepted premise that leisure-time physical activity is in general beneficial to overall health, the par-ticular objective of the study was to determine whether even less exercise than the recommended 150 minutes per week could also have positive effects. To do this, the population

being studied was categorised on the basis of a self-administered ques-tionnaire into five categories of exer-cise amount, namely inactive, low, medium, high or very high physi-cal activity. The mortality risks and life expectancy were measured for each category. Gratifyingly enough the results were astonishingly clear-cut: compared to individuals in the inactive group, even those subjects

in the low activity exercise group, who exercised for an average of 92 min per week (!) had a 14% reduced risk of all-cause mortality and had a 3 year longer life expectancy. Every additional 15 minutes of daily exer-cise beyond the minimum amount of 15 min a day further reduced mortality by 4% While the end-point of the Taiwanese study was mortal-ity from all causes, the surmise is that the benefits of even minimal exercise were principally modulated by improvements in cardio-vascular

risk. Of course the impact on per-sonal well-being is the huge, positive message of the study but, in addition, given that the economic cost of car-diovascular disease in Europe alone has been estimated to be a staggering 200 billion per year, it would seem that even minimal exercise could presumably reduce this amount sig-nificantly. Just the ticket for reducing the current European debt crisis.

www.ihe-online.com & search 45858

Editor’s LEttEr 3 – September 2011

taking the message to heart

Page 4: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

ContentsFRONT COVER PRODUCTS

[30] PEt/Ct imaging management software

[32] Advanced ECG system with touchs-creen technology

[33] 12-channel electro-cardiograph

FEATURES[8 - 23] CARDIOlOgy SPECIAl

[8] Scientific literature review- cardiology

[10 - 12] CT coronary angiography for risk

stratification in the emergency

department

[13 - 16] Virtual histology of plaque:

the V-HEART study

[17 - 20] Personalised antiplatelet therapy after coronary intervention

[20] Book review: Cardiovascular imaging

[22 - 23] Company spotlight

[24 - 27] ADVANCES IN SURgERy

[24 - 25] Closed chest hybrid coronary revascularisation

[26 - 27] Mitral valve repair techniques

REgUlARS

[3] Editor’s letter

[6 - 7] News in brief

[29] scientific literature review - digital X-ray systems

[30 - 33] Product News

[34] industry news

Healthcare professionals are entitled to receive international Hospital’s digital edition for the next 12 months completely free of charge. to begin a new subscription or to continue your existing free subscription go to

www.ihe-online.comClick on Free subscription and follow instructions

free subscription for healthcare professionals

For submission of editorial material, contact Alan Barclay at [email protected]

For advertising information, go online to www.ihe-online.com, simply click on ‘Magazine’ and ‘Media information’ or contact Astrid Wydouw at [email protected]

rue royale 326 1030 Brussels, Belgiumtel. +32-2-240 26 11 Fax: +32-2-240 26 18 www.ihe-online.com

Managing EditorsAlan Barclay, Ph.d.

[email protected] Bushrod, Ph.d.

Editorial & Advertising CoordinatorAnna Hyrkäs, M.sc.

Circulation ManagerArthur Léger

Publisher/Editor in ChiefBernard Léger, M.d.

Advertising Sales ManagerAstrid Wydouw

[email protected]

WebmasterJennifer Christopher

©2011 by PanGlobal Media bvba-sprl. Production & Lay-out by studiopress Communication, Brussels.

Circulation Controlled by Business of Performing Audits, shelton, Ct, UsA.

the publisher assumes no responsibility for opinions or state-ments expressed in advertisements or product news items. the opinions expressed in by-lined articles are those of the author and do not necessarily reflect those of the publisher. No conclusion can be drawn from the use of trade marks in this publication as to whether they are registered or not.

hospitalinternational

CoMiNG UP iN JUNE 2011Cardiology specialPediatricsUltrasound

issN 0306-7904

CoMiNG UP iN oCt 2011intensive care specialPneumologyNeonatology

Page 5: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

Better mattresses cut hospital costs

Hospitals could reduce healthcare costs aris-ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs), according to new research from the University of Toronto. Elderly patients in EDs are at high risk for pressure ulcers in part because they spend hours lying on hard surfaces. The researchers found that while the average cost of upgrading from standard to pressure-redistribution mattresses would be 30 cent per patient, the corresponding reduction in pressure-ulcer incidence would produce savings of $32 per patient.The researchers performed a cost-effective-ness analysis based on data drawn primarily from Ontario, Canada. They compared the projected incidence of pressure ulcers based on current practices in EDs with projected incidence after introduction of better mat-tresses, and found that early prevention was likely to be cost-effective 81% of the time. As part of their study, they also conducted a small survey of Ontario EDs and found that only 12% of stretchers and beds have pres-sure-reduction mattresses. In Ontario about 240,000 elderly patients are admitted to EDs annually; the researchers’ model suggested that providing better mattresses for these patients would prevent 1,005 pressure ulcers and save $7.2 million in health care costs.In other studies, the researchers have found potential for cost reduction through pres-sure-redistribution mattresses in operating rooms, long-term care homes and other facilities. Through the Toronto Health Economics and Technology Assessment Collaborative, they are working towards implementing a province-wide strategy on pressure-reduction mattresses with the Ontario Health Technology Advisory Com-mittee (OHTAC) and the Medical Advisory Secretariat at Health Quality Ontario.http://theta.utoronto.ca/static/?id=18

Venous thromboembolism risk predictorA new risk prediction tool can identify patients at high risk of serious blood clots who might need preventative treatment.The tool is based on simple variables which the patient is likely to know and could be easily

integrated into GP computer systems to risk assess patients prior to hospital admission, long haul flights or starting medications that carry an increased risk of venous throm-boembolism, a common potentially lethal disease which can be prevented. In England alone, it claims more than 25,000 lives each year and, of those who survive, almost a third experience long-term effects.In 2010, the UK National Institute for Health and Clinical Excellence (NICE) issued guid-ance to encourage the identification of high-risk patients and effective use of preventa-tive measures. Yet there are no validated risk prevention algorithms suitable for use in primary care. Researchers at the Univer-sity of Nottingham set out to develop and validate a new clinical risk prediction algo-rithm (QThrombosis), designed to predict a person’s risk of developing a potentially fatal clot. Using data from 563 general practices in England and Wales, they studied more than 3.5 million patients aged 25 to 84 years with no previous history of blood clots. First cases of venous thromboembolism — either deep vein thrombosis or pulmonary embolism — were identified from a patient’s medical records or death certificate, at one year and five years. The rate of venous thromboembo-lism was around 15 cases per 10,000 person years of observations.The data show that the risk of venous throm-boembolism in both men and women increased with increasing age, body mass index and quantity of cigarettes smoked each day. Risks were also elevated among those with varicose veins, congestive heart failure, chronic kidney disease, chronic lung disease, inflammatory bowel disease and any cancer. Admission to hospital in the last six months also conferred a greater risk, as did taking antipsychotic drugs, oral contraceptives, HRT or tamoxifen. A new risk prediction model, based on simple clinical variables, was developed and validated from the study that identifies patients at high risk of venous thromboembolism. Further research is needed to assess how best to use the algorithm and whether, upon implementation, it has any impact on health outcomes.

http://tinyurl.com/4yrpq28

Sniffer dogs could be used to detect lung cancerAccording to a study from researchers at Schillerhoehe Hospital in Germany, and published in the European Respiratory Journal, sniffer dogs could be used for the early detection of lung cancer. The study is the first to find that sniffer dogs can reliably detect lung cancer.

Lung cancer is not strongly associated with any symptoms and early detection is often by chance. Current methods of detection are unreliable and scientists have been working on using exhaled breath specimens from patients for future screening tests. This method relies on identifying volatile organic compounds (VOCs) that are linked to the presence of cancer. Although many different techno-logical applications have been developed, this method is still difficult to apply in a clinical setting and no lung cancer-specific VOCs have yet been identified.This new study assessed whether sniffer dogs could be used to identify a VOC in the breath of patients. The researchers worked with 220 volunteers, including lung cancer patients, chronic obstructive pulmonary disease (COPD) patients and healthy volunteers. They used dogs that had been specifically trained. A number of tests were carried out to see if the dogs were able to reliably identify lung cancer compared with healthy volunteers, volun-teers with COPD and whether the results were still found with the presence of tobacco. The dogs successfully identified 71 samples with lung cancer out of a possible 100. They also correctly detected 372 sam-ples that did not have lung cancer out of a possible 400. The dogs could also detect lung cancer independently from COPD and tobacco smoke. These results confirm the presence of a stable marker for lung cancer that is independent of COPD and also detectable in the presence of tobacco smoke, food odours and drugs. Now the compounds detected in the exhaled breath of patients should be precisely identified. http://www.european-lung-foundation.org/16599-.htm

5 – September 2011NEWs iN BriEF

Page 6: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

Minimal scar techniques for live kidney donations

Kidney transplants from living donors result in increased organ survival and help solve cadaver organ shortages. In 2010, according to the Spanish National Trans-plant Organisation, 240 living donor kid-ney transplants were carried out in Spain, which represented 11% of the total num-ber of kidney transplants. This year this number is expected to increase to about 300, which would be around 13-15% of the total. Research has been carried out at the IDIBAPS Hospital Clínic of Barcelona on new surgical technologies for the improve-ment of transplantation procedures.Dr Antonio Alcaraz, IDIBAPS investigator and head of the department of urology and his team have now confirmed the feasibil-ity of surgical techniques with minimal scars (10 and 5 mm) for the extraction of a kidney applied to transplantation. In an application of the NOTES (Natural Orifice Transluminal Endoscopy Surgery) tech-nique, the team successfully used modified transvaginal and transumbilical extraction techniques to extract kidneys for transplan-tation. The application of the technique in female donors involves two pathways (vagina and abdomen), and two minimal scars of 5 and 10 millimeters. In the case of male donors the pathway is restricted to the navel (which is a scar with a very little vascularisation). These minimally invasive surgical techniques for removal of living donor kidneys have many advantages: bet-ter quality of life for the donor, minimal scarring, a shorter hospital stay and less pain. According to Dr Alcaraz the surgical technique is completely reproducible and can be considered a good alternative pro-cedure that could increase the rate of living donors among women.http://tinyurl.com/minimal-scar-kidney

Hormone reduces risk of heart failure from chemotherapyRecent studies have shown that the heart contains cardiac stem cells that can con-tribute to regeneration and healing dur-ing disease and ageing. However, little is known about the molecules and pathways

that regulate these cells. Now, a new study utilising a heart failure model is providing insight into one way of coaxing the cardiac stem cells into repairing the damaged heart. The research finds that low doses of eryth-ropoietin (EPO), the hormone best known for controlling the production of red blood cells, might reduce the risk of heart failure associated with some anticancer therapies.Chemotherapy with doxorubicin (DOX) has been used effectively to treat a broad range of cancers but is limited because of severe side effects, most notably heart fail-ure. Likewise, blocking STAT3, an impor-tant factor that drives tumour growth has been associated with heart failure. To learn more about the activity of cardiac stem cells under these conditions Dr Den-ise Hilfiker-Kleiner and colleagues from the Hanover Medical School in Germany studied cardiac stem cells in mice that were lacking the STAT3 gene in their hearts or were treated with DOX.

The researchers observed that in both groups of mice cardiac stem cells displayed an impaired ability to form new blood ves-sels which are essential for oxygen delivery to the heart muscle. Both sets of mice produced less EPO in their heart muscle than untreated controls. The researchers went on to demon-strate that EPO binds to cardiac stem cells and is required to maintain the signalling molecules necessary for production of new blood vessels. Importantly, when the mice were given a synthetic EPO derivative at a low dose which did not affect red blood cell production, stem cell differentiation to blood vessel cells was restored and cardiac function preserved. Short-term EPO administration at low doses is thus an attractive avenue to pur-sue for protecting the heart during chemo-therapy and could have broader applications in cardiac regeneration.http://tinyurl.com/hormone-reduction-HF

Artificial lung device pioneeredSurgeons working at the University of Kentucky, USA announced that they were among the first to use artificial-lung tech-nology to demonstrate the feasibility of a lung transplant, using a device invented by

two university faculty members, Dr Joseph Zwischenberger and Dr Dongfang Wang. The device helps oxygenate blood by trans-porting it to a gas exchanger that removes carbon dioxide and oxygenates the blood before returning it to the heart, bypass-ing the lungs of the patient. The system is intended for patients who are too ill to be maintained on a ventilator, and is designed as temporary treatment for severe respira-tory failure. Normally, a patient is sedated while using an extracorporeal membrane oxygenation (ECMO); consequently, the patient is bedridden. The bi-caval dou-ble lumen catheter device is an advanced form of ECMO. Zwischenberger’s goal, now realised, was to allow patients to do normal things, even exercise, while using the device, rather than have their condition continuing to deteriorate as they waited for a lung transplant. The artificial lung tech-nology allows physicians to be certain that the patient potentially receiving the organ transplantation is physically well enough to undergo surgery and the recovery process.http://tinyurl.com/artificial-lung

Agent to both image and treat brain tumoursA single compound with dual function – delivering a diagnostic and therapeutic agent – may one day be used to enhance the diagnosis, imaging and treatment of brain tumours.

Glioblastomas are the most common and aggressive brain tumours in humans, with a high rate of relapse. The tumour cells often extend beyond the well-defined tumour margins making it extremely dif-ficult for clinicians and radiologists to vis-ualise using current imaging techniques.

6 NEWs iN BriEF – September 2011

Page 7: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

7 – September 2011NEWs iN BriEF

Researchers have been investigating enhanced methods of attack-ing these cells in order to possibly delay or prevent brain tumour relapse. A research team led by Dr Panos Fatouros, a former pro-fessor and chair of the Division of Radiation Physics and Biology in the Virginia Commonwealth University School of Medicine, USA, demonstrated that a nanoparticle containing an MRI diag-nostic agent can effectively be imaged within the brain tumour and provide radiation therapy in an animal model.The nanopar-ticle filled with gadolinium, the sensitive MRI contrast agent for imaging, coupled with radioactive lutetium 177 to deliver brachy-therapy, is thus a theranostic agent – a single compound capable of delivering simultaneously effective treatment and imaging. The lutetium 177 is attached to the outside of the carbon cage of the nanoparticle.The researchers believe that the clustering properties of this nano-platform prolong its retention within the tumour, thereby allow-ing a higher radiation dose to be delivered locally. The theranos-tic agent could potentially provide critical data about tumour response to therapy by means of longitudinal imaging without further contrast agent administration. Although the work was caarried out in a limited animal study, it shows great promise and hopefully this platform will be extended to humans.http://tinyurl.com/brain-theranostics

Abnormal liver tests associated with increased death rates in people over 75One in six people over 75 are likely to have at least one abnormal liver test and those that have two or more are twice as likely to die from cancer and 17 times more likely to die from liver disease, according to a recent study.UK researchers led by Dr Kate Fleming from the University of Nottingham studied 13,276 patients who were registered with 53 primary care physicians and agreed to an in-depth health assess-ment. Patients were drawn at random from the general popula-tion; those who were terminally ill or living in nursing homes were excluded. The aim of the study was to see how prevalent abnormal liver tests were in a random sample of people aged 75 plus and examine the association between positive results and deaths from all causes and specific causes. The study covered liver tests for abnormal levels of asparate transaminase (AST), alkaline phos-phatase (ALP) and bilirubin, with patients being followed up for an average of just over seven years. The elderly patients with the abnormal liver tests were compared with patients with normal liver tests. Key findings of the study included:16.1% of the patients had at least one abnormal liver test, 1.5% had two abnormal tests and just 0.07% has three abnormal tests. 9.2% of the total sample had abnormal levels of ALP, 5.4% had abnor-mal bilirubin and 3.3% had abnormal AST. Diabetes and dementia were associated with increased AST and ALP and a history of heart attacks with raised ALP. Abnormal AST was associated with a sevenfold increased risk of death from liver disease and a 56% increase in cancer risk. However, only 1.8% of the subjects with an abnormal AST died from liver disease during the follow-up period. Abnormal ALP was associated with nearly a six-fold increased risk of death from liver disease. It also raised the risk of death from a number of other illnesses: heart disease (34%), cancer (61%) and respiratory disease (58%). Only 1% of the patients with an abnormal ALP died from liver disease during the follow-up period.Abnormal bilirubin was associated with a small 15% increase in death risk, following adjustment for factors such as age, gender, other health issues, smoking status, alcohol intake and waist-hip ratio. http://tinyurl.com/liver-tests

Messe Düsseldorf GmbH Postfach 1010 0640001 DüsseldorfGermanyTel. +49(0)211/45 60-01Fax +49(0)211/45 60-6 68www.messe-duesseldorf.de

16 – 19 Nov 2011Düsseldorf • Germany

www.medica.de

Be part of it!

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Page 8: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

Bleeding in acute coronary syn-dromes and percutaneous coronary interventions: position paper by the Working Group on Thrombosis of the European Society of Cardiology.Steg PG et al. Eur Heart J. 2011 Aug;32:1854. Bleeding has recently emerged as an important outcome in the management of acute coronary syndromes (ACS). Relatively frequent compared to ischae-mic outcomes, bleeding has important implications in terms of prognosis, out-comes and costs. In particular, there is evidence that patients experiencing major bleeding in the acute phase are at higher risk of death in the following months, although the causal nature of this relation is still debated. This position paper aims to summarise current knowledge regard-ing the epidemiology of bleeding in ACS and percutaneous coronary intervention, including measurement and definitions of bleeding, with emphasis on the recent consensus Bleeding Academic Research Consortium (BARC) definitions. It also provides a European perspective on management strategies to minimise the rate, extent and consequences of bleed-ing. Finally, the research implications of bleeding (measuring and reporting bleed-ing in trials, the importance of bleed-ing as an outcome measure, and bleed-ing as a subject for future research) are also discussed.

The diagnostic value of intracoro-nary optical coherence tomography.Regar E et al. Herz 2011 Aug;36 :417Optical coherence tomography (OCT) is a novel light-based imaging modality that has applications in the analysis of coronary circulation. Compared to conventional

intravascular ultrasound, OCT has a ten-fold higher image resolution. This advan-tage has seen OCT successfully applied in the assessment of atherosclerotic plaque, stent apposition and tissue cover-age, heralding a new era in intravascular coronary imaging. This article discusses the diagnostic value of OCT, both in car-diovascular research as well as in potential clinical applications.

Advances in percutaneous therapy for upper extremity arterial disease.Capers Q 4th, Phillips J. Cardiol Clin. 2011 Aug;29(3):351-61.Upper extremity arteries are affected by occlusive diseases from diverse causes, with atherosclerosis being the most com-mon. Although the overriding principle in managing patients with upper extremity arterial occlusive disease should be cardio-vascular risk reduction by noninvasive and pharmacologic means, when target organ ischaemia produces symptoms or threat-ens the patient’s well-being, revascularisa-tion is necessary. Given their minimally invasive nature and successful outcomes, percutaneous catheter-based therapies are preferred to surgical approaches for this. The fact that expertise in these techniques resides in not one but several disciplines (vascular surgery, radiology, cardiology, vascular medicine) makes this an area ripe for multidisciplinary collaboration to the benefit of patients.

Beating heart valve surgery with lung perfusion/ventilation during cardiopulmonary bypass: do we need to break the limits?Gologorsky E, Macedo FI, Salerno TA. Expert Rev Cardiovasc Ther. 2011 Jul;9:927.Myocardial and pulmonary ischemia dur-ing cardiopulmonary bypass is associated with cardiac and pulmonary dysfunction that may result in poor outcomes after car-diac surgery. Beating heart valve surgery, utilising continuous coronary perfusion with warm oxygenated blood, together with continuous pulmonary artery perfu-sion and alveolar ventilation during cardio-pulmonary bypass, represents an emerging and exciting novel strategy for myocardial and pulmonary protection. This article presents preliminary clinical results, as well as basic and clinical evidence, indica-tions, contraindications and limitations of these new evolving techniques.

CT coronary angiography for risk stratification in the ED

Page 10

Observing Atherothrombosis:

the Liverpool V-HEART Study

Page 13

Personalised antiplatelet therapy after coronary

intervention - do all patients benefit

from a tailored pharmacotherapy?

Page 17

Book review Cardiovascular imaging

Page 20

Company spotlight: Fysicon

Page 22

September 2011

hospitalinternational

Cardiologyspecial

Cardiology Special selection of peer-reviewed literature on cardiology

The number of peer-reviewed papers covering the vast field of cardiology is huge, to such an extent that it is frequently difficult for healthcare professionals to keep up with the literature. As a special service to our readers, IHE presents a few key literature abstracts from the clinical and scientific literature chosen by our editorial board as being particularly worthy of attention.

Page 9: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

Vivid i

Vivid E9

Vivid 7

Vivid S6

GE Healthcare

GE imagination at work

© 2011 General Electric Company; GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, a subsidiary of General Electric Company, doing business as GE Healthcare.

Continuous improvement of ultrasound technology and our annual breakthrough philosophy allows us to offer a cardiovascular series that exceeds all expectations. GE’s Vivid ultrasound systems are tailor-made for entire access to the secret the human heart tries to keep. Imagine the heart as an open book which can be read by physicians with ease – Vivid ultrasound systems make it possible.

www.gehealthcare.com

GE Ultraschall Deutschland GmbHBeethovenstr. 239, D-42655 SolingenT 49 212-28 02-0, F 49 212-28 02-28

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Page 10: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

10 CArdioLoGY

Each year a substantial number of patients presenting to the Emergency Department show symptoms suggestive of an acute coronary syndrome (ACS). The fear of missing this diagnosis and further com-plications, and the need to discharge these patients safely often result in exten-sive testing in these patients. This can be problematic, as 75-85% of these patients are ultimately determined not to have ACS [1]. This extensive testing can lead to prolonged evaluations, unnecessary

admissions and emergency department crowding. Therefore current research has focused on finding cost effective and timely ways to identify the low risk patients who can safely be discharged from the Emergency Department. Com-puted Tomography (CT) coronary angi-ography is the latest technology that is being utilised in the risk stratification of chest pain patients in the acute setting.

The first CT scan was performed in 1971 in England. At that time, image acquisi-tion and processing took hours but with modern 64-slice scanners, acquisition and processing take seconds to minutes. Improved technology has also allowed for thinner slices, clearer images, and features such as 3D reconstruction. CT coronary angiography uses these technological fea-tures to capture images of the heart and more specifically, the coronary arteries. In electrocardiogram (ECG) analysis, the CT scanner is gated, acquiring images between each heartbeat. With these detailed images of the blood supply to the heart, physi-cians can determine if there are block-ages or narrowing in the blood vessels, which could be causing ischaemia and myocardial cell death.

Risk stratification of patients with chest painMost patients that present to an Emer-gency Department with chest pain and possible myocardial ischaemia receive a standard initial set of tests, including the taking of a history and having a physical exam, ECG analysis and laboratory analy-sis, such as the determination of serial cardiac troponins levels. It was previ-ously thought that certain characteristics of the patient’s pain made it more or less likely that the pain was of cardiac origin.

However, factors such as pain quality and reproducibility have since been shown to be poor predictors of cardiac versus non-cardiac origin of pain [6]. Multiple studies have also shown that history and physical examination do not perform well in iden-tifying patients with an MI. ECG is a good test to determine which patients are hav-ing an ST Elevation MI (STEMI) or other evidence of ischaemia, but is less useful for those patients who have a normal or non-diagnostic ECG. A 1997 paper by Singer et al showed that a normal ECG, or even multiple ECGs taken over 12 hours, only have a negative predictive value of 93-94% [9]. Although laboratory tests, such as tro-ponins, are also becoming more sensitive earlier in the presentation, they still miss some MIs. Clinical decision making tools such as TIMI risk score take a lot of these factors into account, but nevertheless still miss some MIs as well [1].

Cardiac imagingImaging modalities such as echocardiogra-phy and nuclear medicine studies have also been used in risk stratification. The ability to perform these tests in a timely manner suitable for the acute evaluation of chest pain patients is however limited by available resources and local expertise. Echocardiog-raphy in the acute chest pain setting is used to look for cardiac wall motion abnormal-ity. With this method, however, old infarcts appear the same as new infarcts, creating many false positives. Echocardiography may also miss non-Q wave MIs, as these are usually due to small infarcts. Several studies have estimated the sensitivity of echocardi-ography for acute MI at 93%. With similar sensitivities and NPVs of clinical criteria alone, echocardiography adds little to the evaluation of acute chest pain [8].

Myocardial Perfusion Imaging (MPI) uses radioisotopes such as technetium-99m ses-tamibi or tetrofosmin to get a “snapshot” of the bloodflow to the heart. Images are taken at rest, while the patient is having symptoms, or being stressed. MPI has the advantage of being able to simultaneously assess myocardial perfusion, wall motion, wall thickening and ejection fraction. A 1997 study by Tatum et al showed the MPI to have a sensitivity of 100% (64-100). Of the 338 patients that had a normal MPI

Ct coronary angiography for risk stratification in the emergency departmentComputed tomography coronary angiography is being increasingly uti-lised in the Emergency department for risk stratification of low- to intermedi-ate-risk chest pain patients. the test characteristics of Ct angiography allow emergency physicians to safely discharge patients that have a normal study, taking less time and money than other methods. this article addresses the role that Ct coronary angiography can play in decision making in the Emergency department.

by dr Joshua radke and dr deborah B. diercks

– September 2011

Table 1. Protocol for CT Coronary Angiography.

Ct Coronary Angiography Protocol

inclusion Criteria · Chest pain or discomfort · tiMi score 0-2 · ECG with no evidence of

myocardial ischemia · Normal initial troponin · Patient would otherwise be

admitted to rule out ACs

Exclusion Criteria · Atrial fibrillation · Known CAd (≥ 30%,

or history of stents or CABG) · Creatinine > 1.5 mg/dL · Contraindication to

beta-blocker · iodine allergy

image Acquisition · Patients with Hr > 65 given

beta-blocker - Metoprolol 5-20 mg iV

until Hr < 65 - Unless sBP < 100 or

other contraindications · Patients given 0.4 mg

sublingual nitro · image acquisition during

a single breath hold

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11

scan in this study, none had a cardiac death, and none had an MI within one year of the study, though seven of these patients required coronary revascularisation [10].

The ERASE trial (Emergency Room Assess-ment of Sestamibi for Evaluation of Chest Pain) in 2002 by Kapetaponoulos et al, was a randomised control trial that compared the usual ED evaluation to the usual ED evaluation plus acute resting MPI [11]. The study used 2475 patients who presented to the ED with chest pain and normal or non-diagnostic ECGs. They found that the sensitivity for MI and acute ischaemia was not significantly different between the two groups. [11]. A cost analysis of MPI had previously been carried out in 1997 and it found that the addition of MPI to the clinical decision-making process saved an average of $1000 per patient [7].

Both echocardiography and myocardial perfusion imaging requires skilled opera-tors and clinicians for interpretation. The availability of these imaging modalities is dependent on healthcare resources and availability of personnel to interpret and perform the exams. This can be a limitation when using these diagnostic modalities in the emergency department setting.

CT Coronary Angiography in the emergency departmentCT coronary angiography (CTA) has prom-ise as a novel imaging modality in the acute setting because it is readily available, rapid and requires minimal additional exper-tise to perform the imaging. In the Emer-gency Department setting, studies have been limited to those patients who have no evidence of myocardial necrosis or injury based on initial testing. Table 1 shows a list of inclusion and exclusion criteria often used in many of the studies. Early stud-ies of CTA compared the sensitivity and

specificity with that of cardiac catheterisa-tion in patients already undergoing cathe-terisation for suspected myocardial ischae-mia. All studies found high sensitivities, 95-96%, with varying specificities, 85-98%. Studies since then have shown that because of the high sensitivity and NPV of coronary CT angiography, it best used for determin-ing which patients have no or non-critical disease, and are therefore low risk and can be safely discharged home [Figure 1 and 2]. The ROMICAT Trial (Rule Out Myo-cardial Infarction using Computer Assisted Tomography) in 2009 looked at the useful-ness of CTA in patients with acute chest pain in the Emergency Department who had a normal initial troponin and non-ischaemic ECG. The trial showed that 50% of the patients who were thought to have low to intermediate likelihood of ACS were found to be free of CAD, and could be dis-charged immediately from the Emergency Department. This would save the patient a costly admission for observation, including serial cardiac markers, ECGs and possible stress testing [4].

A 2007 study by Goldstein et al looked specifically at cost and efficiency in com-parison to MPI [3]. The study compared standard of care, including ECG, serial

– September 2011

www.ihe-online.com & search 45813

Figure 1. Normal coronary angiogram.Courtesy of Harold Litt, MD. PhD., Univ of Penn.

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12 CArdioLoGY

troponins, and MPI to CTA while in the ED. It was found that CTA was both cheaper and faster than MPI. This same study also showed that CTA reduced the need for re-evaluation of chest pain. If the same chest pain occurred in patients who had had CTA, physicians were less likely to order further diagnostic studies [3]. CTA also has similar sensitivity and specificity to MPI [2]. More important than cost and efficiency, CT angiography has also been found to be safe when used in the deci-sion to discharge patients from the Emer-gency Department. Hollander et al found that in patients with a TIMI score <2, those with less than 50% stenosis were safe to discharge [5]. In this study, there were no adverse cardiac events in the 30 days after 365 patients in this study were sent home immediately after angiography. An added benefit of CTA is that it also helps exclude other intra-thoracic pathology, such as pericardial disease, aortic dissection and pulmonary embolism [5].

In some institutions coronary artery calcium scoring is a component of the CTA protocol. Utilisation of coronary artery calcium scor-ing may identify a patient at high risk of hav-ing coronary artery disease and identify a patient in whom the CTA may have reduced diagnostic accuracy [12]. A recent meta-analysis confirmed that there is a drop in the specificity of CTA in patients with increased coronary calcification. Although the appro-priate upper limit of the coronary artery calcium score that should preclude perfor-mance of a CTA has not been prospectively defined, a score of greater than 400 or 600 has been associated with an increased risk of false positive scans [12].

Limitations As more data are presented on the long term risks of radiation from CT scans, there is a push towards using fewer stud-ies that employ radiation. Although most CTAs are being performed in an older

population, the risk is still present. CTA also requires the use of contrast, which has its own set of risks and complications. Sometimes the result of CTA is indeter-minate, as well, often requiring invasive angiography and another dose of radiation and contrast. Another drawback is that the study is anatomical and not physiological. Angiography can show an area of stenosis, but without seeing how this stenosis affects blood flow, one cannot see whether this stenotic area is actually producing ischae-mia and causing the patient’s chest pain. This is one reason for the number of false positives associated with CTA.

ContraindicationsThere are also several contraindications which would limit the use of CTA in every patient. These include inability to hold a breath, renal insufficiency or car-diac arrythmias that may make ECG gat-ing impossible. A recent study created a clinical predication model to identify those patients at greatest risk of having an indeterminate scan. Variables in the model include age, history of chronic obstructive pulmonary disease, history of atrial fibril-lation, and diabetes as well as a few others [13]. Beta-blockers are given to patients undergoing CTA to bring the heart rate down so as to allow gating. If a patient has a contraindication to beta-blockade, such as asthma, they will not be eligible for the study. An allergy to iodine would also exclude the patient from use of CTA. Pro-posed inclusion and exclusion criteria, as well as a protocol for image acquisition can be seen in Table 1 [4,5]. Many facilities also lack the personnel and equipment to per-form these studies. The studies need to be interpreted by a cardiac radiologist, which is a highly specialised field.

ConclusionCT coronary angiography is being increas-ingly utilised in the Emergency Depart-ment for risk stratification of patients with chest pain. CTA has been shown to be a safe and efficient way to determine which patients have no significant CAD. CTA is a valuable asset to clinical decision-making in that it allows for the discharge of many patients who would otherwise be admitted for further observation and testing. CTA is not without its limitations, but as technol-ogy improves, so will the detail of images, which will improve the diagnostic capabili-ties of the modality.

References1. Chase M et al. Prospective validation of the

thrombolysis in MI Risk Score in the ED

chest pain population. Ann Emer Med 2006; 48: 252.

2. Gallagher M et al. The diagnostic accuracy of 64-slice CT coronary angiography compared with stress nuclear imaging in emergency department low-risk chest pain patients. Ann Emer Med 2007; 49: 125.

3. Goldstein JA et al. A randomized controlled trial of multi-slice coronary CT for evalua-tion of acute chest pain. J A Coll Card 2007; 49: 863.

4. Hoffmann U et al. J A Coll Card 2009; 53: 1642.

5. Hollander JE et al. One-year outcomes follow-ing coronary CT angiography for evaluation of ED patients with potential acute coronary syndrome. Ann of Emerg Med 2009; 53: 295.

6. Lee T et al. Acute chest pain in the emergency room. Identification and examination of low-risk patients. Arch Intern Med 1985; 145: 65.

7. Radensky PW et al. Potential cost effective-ness of initial myocardial perfusion imaging for assessment of emergency department patients with chest pain. Amer J Card 1997; 79: 595.

8. Sabia P et al. Importance of two-dimensional echocardiographic assessment of left ventric-ular systolic function in patients presenting to the emergency room with cardiac-related symptoms. Circulation 1991; 84: 1615.

9. Singer A et al. Effect of duration from symptom onset on the negative predic-tive value of a normal ECG for exclusion of acute myocardial infarction. J Ann Emer Med 1997; 29: 575.

10. Tatum J et al. Comprehensive strategy for the evaluation and triage of the chest pain patient. Ann of Emer Med 1997; 29: 116.

11. Kapetanopoulos A et al. Acute resting myo-cardial perfusion imaging in patients with diabetes mellitus: results from the Emer-gency Room Assessment of Sestamibi for Evaluation of Chest Pain (ERASE Chest Pain) trial. ACC Curr J Rev 2003; 12: 49.

12. Abdulla J et al. Influence of coronary cal-cification on the diagnostic accuracy of 64-slice computed tomography coronary angiography: a systematic review and meta-analysis. Int J of Card Imaging 2011; [Epub ahead of print]:

13. Vanhecke TE et al. Development and vali-dation of a predictive screening tool for uninterpretable coronary CT angiography results. Circ Card Imaging 2011; [Epub ahead of print]

The authorsJoshua Radke, MDDeborah B. Diercks, MD, MScDepartment of Emergency MedicineUniversity of CaliforniaDavis Medical CenterSacramento, CA, USA

– September 2011

Figure 2: Left anterior coronary artery with 80% stenosis.

Courtesy of Harold Litt, MD. PhD., Univ of Penn.

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From the days of Virchow and the analysis of post-mortem coronary specimens, an enormous amount of knowledge has built up about coronary pathophysiology. In the 1950s the dream of in vivo coronary imag-ing became a reality with the invention of coronary arteriography under the guid-ance of Mason Sones. As we fast forward 60 years, it has become clear that angiogra-phy has helped us focus on areas of steno-sis and flow limitation, but atherosclerosis is much more complex than can appear on this luminal silhouette. The finding of “normal coronary arteries” or a quotation of “percentage stenosis” following angiog-raphy is fundamentally flawed and does not take into account the positively remod-elled, eccentric disease lurking within the vessel wall or the physiological impact of diffuse disease or serial stenoses.

Coronary luminal narrowing is initially prevented by a vascular mechanism known as positive remodelling. This is an outwards expansion of the blood vessel

to accommodate the build up of plaque within the artery [Figure 1]. This phenom-enon appears within diseased segments of coronary arteries and the build up of these plaques is dependent on multiple well known factors from genetics and lifestyle, through to coronary anatomy, shear stress and endothelial function. Contemporary coronary investigation can now focus on the vessel wall and identify high risk, posi-tively remodelled plaques and their con-tents. There is a strong feeling amongst key opinion leaders around the world that we must now consider a paradigm shift in our investigational strategy away from reliance on the angiogram.

The status quoCurrently, coronary investigation (in the UK and Europe) is based on a paradigm of clinical haemodynamics. This is only use-ful when a large coronary plaque causes significant luminal obstruction, symp-toms and hypoperfusion of the myocar-dium. This has been the cornerstone of

our therapeutic approaches to chronic stable angina, acute coronary syndromes and acute myocardial infarction for the last 40 years. Unfortunately, in the major-ity of cases, this diagnosis comes after a plaque has become significant, caused recurrent ischaemia or ruptured. The patient has then been exposed to the maximum potential risk and ultimately, in some cases, an inferior outcome. If we aim to try and “catch” coronary disease before the plaque “pops” we clearly need more information.

Evolving investigational strategiesTo improve cardiovascular risk prediction, outcomes and prevention we can change our investigational strategy. We already know that disruption of a non-obstructive atherosclerotic plaque is the culprit event in at least two-thirds of acute coronary events. The histopathology of these rup-tured plaques demonstrates a large, posi-tively remodelled plaque with a necrotic core covered by a thin fibrous cap (Thin Cap Fibro-Atheroma - TCFA). Therefore, while severe anatomic stenoses can lead to symptoms of ischaemia, the plaque com-position of non-obstructive lesions may identify lesions “at-risk” for future cardio-vascular events. We can now visualise these plaques with Intravascular Ultrasound derived Virtual Histology (IVUS-VH).

Anatomical assessment of atherosclerosisIntravascular Ultrasound (IVUS)IVUS is performed at the time of coronary angiography and involves a tiny ultrasound probe that emits high frequency signals

observing atherothrombosisit is now appreciated that a detailed analysis of atherosclerotic plaque could be a vital factor in the prediction of cardiovascular risk and could result in improvement in both prevention and outcomes. the technique of intravascular ultrasound imaging - virtual histology (iVUs-VH) in which the composition of plaque can be determined from the analysis of back scat-tered ultrasound - has high potential in this respect. this paper describes the objectives and current status of a major clinical investigation — the Liverpool V-HEArt study: Virtual Histology Evaluation of Acute Coronary syndromes requiring treatment — designed to evaluate iVUs - VH.

by dr scott Murray

– September 2011CArdioLoGY

Figure 1. The comparison of angiographic and IVUS images showing large discrepancies between visual assessment of the disease severity.

Figure 2. The principle of IVUS-VH. The reflected ultrasound signal being converted to its corresponding tissue type.

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14 – September 2011

(20-40mhz). This wire based probe can be placed over a coronary guidewire into the artery and withdrawn at a set rate (0.5mm/sec) to provide segmental tomographic images of the vessel. IVUS has demon-strated discrepancies between the extent of atherosclerosis seen by coronary angiogra-phy and the actual extent of atherosclerotic disease. Quantitative assessment of the vessel and plaque within a lesion was made possible with the introduction of greyscale IVUS analysis and the further analysis of individual plaque components is now possible with Virtual Histology (VH).

As the majority of acute coronary events are triggered by plaque rupture, defining the anatomic features that lead to plaque rupture should be of central importance to lesion imaging. Post-mortem analyses have shown that TCFA is probably the main precursor lesion for plaque rupture. According to histological studies, the size of the necrotic core and the thickness of the fibrous cap have a critical influence on plaque stability. Therefore, these exact measurements and elements of plaque composition are all visualised by IVUS and IVUS-VH, but not by traditional angiography.

IVUS-VHIVUS-VH uses advanced radiofre-quency analysis of ultrasound backscat-ter signals to overcome the limitations of grayscale IVUS by providing a more

detailed analysis of plaque morphology.

In addition, IVUS-VH has the potential to provide in vivo patient-specific plaque analysis to determine the range of char-acteristics in relation to clinical factors and risk, rather than making assumptions about living plaque from a highly selected autopsy population.

There are many different cell and tissue types commonly found in atherosclerotic plaques. To simplify image interpreta-tion and because of the fundamental resolution limitations of the underlying ultrasound signal, plaque components are grouped into four basic tissue types during IVUS-VH imaging. These com-ponents are displayed on the image as different colour pixels. This technique is based on advanced radiofrequency analy-sis of reflected ultrasound signals in a fre-quency domain analysis and displays the reconstructed colour-coded tissue map of plaque composition superimposed on cross-sectional images of the grayscale IVUS {Figure 2].

Tissue types 1. FibrousFibrous tissue is represented by dark green pixels. Histologically, this tissue is collagenous with no lipid. On grayscale IVUS, these tissues tend to be medium-bright regions.

2. Fibrofatty Fibrofatty tissue is denoted in VH by light green pixels. This tissue is loosely packed collagen, but it can have a cellular qual-ity with potential for foam cells to start invading. There is usually no necrotic core and even cholesterol products are rare. If thrombus or plaque rupture are included as plaque during analysis, then they are displayed as fibrofatty plaque. 3. Necrotic coreIn VH the necrotic core is seen as red. This tissue is a mixture of soft, lipid-like dead cells, foam cells and trapped blood cells. Most of any real structure is lost and, with some areas producing micro-calcification as a by-product (from the dead cells), this leads to a recipe for gross instability and rupture with friable areas next to sharp calcification.

4. Dense calciumWhite pixels represent dense calcium. These calcified regions can be lost during histology processing but on plain gray-scale IVUS, they act as extremely strong reflectors of signal and appear as bright white. Plaque risk assessmentIn vivo plaque classification with VH-IVUS is based on a histopathological classification system. Coronary lesions can be classified as adaptive intimal thickening, pathologic intimal thick-ening, fibroatheroma, fibrocalcific and TCFA plaques.

The Liverpool V-HEART observational studyOur study is specifically focussed on four main areas of VH analysis in 125 patients attending for percutaneous coronary intervention (PCI) :

1. Measurement variability: We have now determined the magniture of intra and inter individual measurement vari-ability and the impact this has on the vol-umetric output of VH for serial studies of plaque components.

2. Plaque morphology: A direct com-parison of plaque morphology between

The Art of Diagnostics

CARDIOVIT MS-2015

Headquar te rs : SCHILLER AG, A l tgasse 68 , CH-6341 Baar, Sw i t ze r land Tel. +41 41 766 42 42, Fax +41 41 761 08 80, sales@schil ler.ch, www.schiller.ch

The new MS-2015 Touchscreen ECG system with 15-inch color display for resting ECG and Spirometry!

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27 - 31 August 2011, Booth C400

MS-2015 European Hospital 210x297.indd 1 21.07.2011 14:25:10

CArdioLoGY

Figure 3. Fibrous plaque (A) and Fibrofatty plaque (B).

A B

Figure 4. Necrotic core in a TCFA lesion (A) and dense calcium in fibro-calcific disease (B)

A B

“...elements of plaque composition are all visualised by IVUS and IVUS-VH, but not by traditional angiography...”

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The Art of Diagnostics

CARDIOVIT MS-2015

Headquar te rs : SCHILLER AG, A l tgasse 68 , CH-6341 Baar, Sw i t ze r land Tel. +41 41 766 42 42, Fax +41 41 761 08 80, sales@schil ler.ch, www.schiller.ch

The new MS-2015 Touchscreen ECG system with 15-inch color display for resting ECG and Spirometry!

Visit us at the ESC in Paris,

27 - 31 August 2011, Booth C400

MS-2015 European Hospital 210x297.indd 1 21.07.2011 14:25:10

www.ihe-online.com & search 45757

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ACS culprit (stented lesions) pre-PCI with non-culprit (bystander disease) and clinically stable culprit lesions (stented for stable angina).

3. Plaque position and commonly observed patterns of disease: Examina-tion of site specific plaque morphologies in each presentation on the spectrum of coronary disease. Is there a difference in necrotic core position in relation to the minimum lumen area (MLA)? Does the

remodelling index differ between these areas? Is there a common histological appearance of culprit plaques in ACS com-pared to other forms of disease? Are there any new VH features that may highlight a vulnerable plaque [Figure 6 ]?

4. The impact of angiographically guided percutaeous coronary intervention on the treatment of ACS plaques: Do we spread plaque out? Do we often “miss” disease and leave uncovered residual

unstable plaque behind? Do we land stent edges into necrotic core? Does this impact on 6-12 month outcomes?

We are currently at a stage where wide-spread dissemination of our final results via publication is our aim in the next year. We have already published and pre-sented our interim findings at Euro PCR 2010, BCS 2010, TCT 2010 and received a runner-up award in the best oral abstract competition at the ESC conference last year.

We hope in the next year to provide new theories in this novel field and expand our understanding of the pathology and treat-ment of atherothrombosis.

ReferencesThe above article has been written unreferenced by the Primary Investigator of the V-HEART study as it contains significant elements of his previous review publications in this area.

1. Murray SW, Stables RH, Palmer ND. Virtual Histology Imaging in Acute Coronary Syn-dromes: Useful or just a research tool? J Invas Cardiol 2010; 22: 84-91.

2. Murray SW, Rathore S, Stables RH, Palmer ND. From Patient to Plaque: Contemporary Coronary Imaging Part 1: IVUS derived Vir-tual Histology. Br J Cardiol 2010; 17:129-32.

The interim findings of the V-HEART study are available in the following references:

1. SW Murray, RH Stables, G Hart, RA Perry, ND Palmer. J Am Coll Cardiol 2010; 56: B82

2. SW Murray, RH Stables, G Hart, RA Perry, ND Palmer. J Am Coll Cardiol 2010; 56: B15-B16

3. SW Murray, RH Stables, G Hart, RA Perry, ND Palmer. European Heart Journal Aug 2010; 31: 797.

4. SW Murray, RH Stables, G Hart, RA Perry, ND Palmer. European Heart Journal Aug 2010; (31): 613-614.

5. SW Murray, RH Stables, G Hart, RA Perry, ND Palmer. Heart June 2010; 96 (11) supp 1: A62.

6. SW Murray, RH Stables, G Hart, RA Perry, ND Palmer. Eurointervention May 2010; 8(6): H55.

7. Murray SW, Palmer ND. Heart 2009; 95:1494.

The authorDr Scott W Murray MBChB, BSc, MRCPSpecialist Registrar in Interventional CardiologyLiverpool Heart and Chest HospitalLiverpoolUK

– September 2011 CArdioLoGY

Figure 5. IMT – intimal medial thickening; PIT – pathological intimal thickening;FT – fibrous plaque; FC – fibrocalcific; FA-fibroatheroma; Ca FA – Calcified fibroatheroma; TCFA –

Thin cap fibroatheroma.

Figure 6. The proportion of necrotic core within a plaque and the development of calcification appears to have an impact on stability at the luminal surface. Stable angina patients have larger

arcs of confluent calcium which theoretically may provide protection against biomechanical plaque rupture. We have called the DC/NC ratio – The Plaque Calcification Equipoise (PCE). We are also reporting on the reciprocal NC/DC ratio –Plaque Vulnerability Index (PVI), as we try to establish a

reliable VH marker for plaque vulnerability.

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Dual antiplatelet therapy with aspirin and an ADP-receptor blocker is currently the standard medication after percutane-ous coronary intervention (PCI) or in patients with acute coronary syndrome (ACS). Dual antiplatelet medication administered with optimal dosing and timing has significantly lowered the risk of recurrent ischaemic events in patients with cardiovascular disease and is rec-ommended in current guidelines [1]. However such proven enhanced anti-ischaemic effects come at the expense of increased bleeding complications. Addi-tionally, there is a high variability in indi-vidual response to antiplatelet treatment in as many as 40% of treated patients [4]. There are several factors that can lead to such poor response; these include drug interactions, polymorphisms of the cyto-chrome P450 isoform CYP 2C19 and clinical factors such as diabetes mel-litus, renal insufficiency, reduced left ventricular function, acute coronary syndrome and the degree of inflamma-tion. Other factors are lack of patient compliance and older age.

Since on-treatment platelet reactivity under dual antiplatelet therapy has been shown to predict recurrent ischaemic events after PCI, it is of great clinical importance to identify patients with high residual plate-let activity to adjust the antiplatelet medi-cation. For this reason, an individual risk assessment is vital for the establishment of a sufficient and cost-effective treatment.

This paper reviews the possibilities of a personalised antiplatelet therapy after individual risk assessment in the light of recent developments, such as the use of the new ADP-receptor blockers prasugrel and ticagrelor. Assessment of variability in platelet responsiveness The second generation thienopyridine, clopidogrel is a selective, irreversible inhibitor of the ADP-P2Y12 receptor on

platelets. Several distinct clinical, genetic and lab testing factors contribute to the phenomenon of variability of response to the drug [Figure 1].

Platelet function tests Several such tests have been developed to measure the efficacy of platelet inhibition but they are still not recommended for routine use because of the lack of adequate standardisation of the methods. While the laboratory definition of low response to clopidogrel is based on the results of tests of platelet reactivity, there is still no unique definition of inadequate platelet response described in the literature.

There are several platelet function tests using different principles. The most com-mon are agonist-induced assays in which the inhibition of a certain platelet activat-ing pathway by the substance being ana-lysed is measured (e.g. ADP-induced plate-let aggregation). Measurement by light transmission of ADP-induced aggregation can be considered as the gold standard, but even this is operator-dependent and not standardised. Newer near-patient tests

Personalised antiplatelet therapy after coronary intervention - do all patients benefit from a tailored pharmacotherapy?several mechanisms including clinical and genetic factors can lead to high on-treatment platelet reactivity under dual antiplatelet therapy with aspi-rin and clopidogrel. to improve patient care, high risk patients with low response to antiplatelet therapy should be identified by an individual risk assessment including platelet function tests; these and clinical features should be taken into account when any therapy changes are being considered.

this review focuses on the options of a personalised antiplatelet therapy after risk stratification and describes recent developments including the application of new AdP-receptor blockers such as prasugrel and ticagrelor.

by dr Karin Anne Lydia Mueller and dr tobias Geisler

– September 2011CArdioLoGY

Figure 1. Assessment of the factors contributing to variable platelet response that could influence personalised pharmacotherapy.

Diverse genetic and clinical risk factors and pharmacological interactions contribute to the phenom-enon of a variable response to clopidogrel. Individualised therapies might overcome this clinical

problem in future.

Genetic risk analysis

Polymorphisms of CYP2C19 Polymorphic variant of Paraoxonase-1

Platelet functioning test

Monitoring of response variability

Clinical risk assessment

PREDICT-Score high risk of increased RPA and

stent thrombosis

Patient related risk

assessment

Compliance Individual absorption and

metabolism

Comedication analysis

Possible drug-drug interactions (PPI, Statins, Ca-channel-blockers,

fungizids, antibiotics)

Options of a personalized pharmacotherapy and current strategies

• Intensified antiplatelet therapy (higher clopidgrel dosing)

• Alternative therapy: More effective and rapid acting ADP-receptor Antagonists Prasugrel, Ticagrelor, Cangrelor, Elinogrel

• Additional antithrombotic treatment GPIIb-IIIa-Inhibitors, Bivalirudin

Planned therapy

Medical treatment Percutaneous intervention

Surgery

Figure 1

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18 CArdioLoGY

such as the multiple platelet analyser (Mul-tiplate) and VerifyNow have been shown to provide reproducible data and predict recurrent ischaemic events after PCI. Limitations of platelet function tests are that cut-off points are not well defined and empirical values are chosen to divide patients into groups of “clopidogrel-responders” versus “low-responders”. For this reason, comparison of laboratory results of different studies or different assays remains difficult.

The GRAVITAS trial (Gauging Respon-siveness With A VerifyNow Assay– Impact on Thrombosis and Safety) enrolled 2,214 patients with high residual platelet reactiv-ity, as assessed by the VerifyNow P2Y12 Test measured 12 to 24 hours after the proce-dure. Patients in the trial were randomised to either high dose clopidogrel (additional loading dose, 150 mg daily thereafter) or standard-dose clopidogrel (no addi-tional loading dose, 75 mg daily there-after). Results showed that there was no

difference between the cohorts at 30 days and 6 months periods when the primary endpoint (cardiovascular (CV) death, non fatal myocardial infarction, or stent throm-bosis) was observed. Although GRAVITAS did thus not meet the primary hypothesis that high dose clopidogrel would lead to improved cardiovascular outcome in CAD patients using platelet function testing for patient pre-selection [2], this does not nec-essarily mean that there is an end to the discussion about personalised antiplatelet strategy using platelet function testing as risk criterion. On the contrary we believe that further research should be carried out to better define ideal cut-off values and patient subgroups who are at high risk of cardiovascular events and might benefit from individualised pharmacotherapy.

Assessment of clinical risk factorsClinical risk factors such as patient com-pliance, bleeding complications and co-morbidities should be taken into account when assessing individual risk. Figure 1 shows the PREDICT-SCORE model,

which involves ascribing weights to the factors and was developed in a large study of 1092 consecutive patients undergoing PCI. The aim of the study was to identify risk factors that could predict persistent high residual platelet activity under anti-platelet therapy after PCI. The factors included patient age >65 years, type 2 diabetes, decreased left ventricular ejec-tion fraction, renal insufficiency and pres-ence of acute coronary syndrome. The PREDICT-Score is a generally available tool to estimate residual platelet activity and the likelihood of the occurrence of a cardiovascular event after PCI [3, 4].

Additionally, we recently showed a link between the degree of inflammation and the response to antiplatelet therapy. In a study of a consecutive cohort of 157 patients with symptomatic coronary artery disease undergoing PCI, it was found that low responders to clopidogrel had signifi-cantly higher serum levels of Interleukin-6 and C-Reactive Protein (CRP). We also found in a study [5] of a consecutive cohort of 903 patients with symptomatic coro-nary artery disease undergoing PCI that the combination of high CRP levels and high residual platelet function is indicative of a higher risk of subsequent CV events, including stent thrombosis after PCI [Figure 3 A and B].

Assessment of genetic risk factorsPolymorphisms of genes encoding for hepatic cytochrome P450 isoenzymes have been associated with the variability of individual clopidogrel response, in par-ticular the isoform CYP2C19: the loss of function variant CYP2C19*2 is associated

– September 2011

Figure 3. Kaplan–Meier curves show cumulative rates of combined major adverse events (A) and stent thrombosis (B) defined according to ARC criteria within one year after PCI stratified according to baseline CRP and Residual Platelet Aggregation (RPA) levels. Significantly higher adverse event rates were

found in patients with RPA and CRP > median, indicating the stronger prognostic effect of high CRP and RPA.

350 300 250 200 150 100 50 0

Follow-up (days)

0.12

0.10

0.08

0.06

0.04

0.02

0

Cum

ulat

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inci

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e of

AR

C-d

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Stratum IV: RPA + CRP > median

Stratum III: RPA ≤ median + CRP > median

Stratum II: RPA > median + CRP ≤ median

Stratum I: RPA + CRP < median

Log rank: stratum IV vs. I: 0.002, vs. II: <0.001, vs. III: 0.04

stratum III vs. I + II: ns

stratum I vs. II: ns

Figure 3 B

Figure 2. The PREDICT score involved evaluation of easily available clinical risk factors to estimate the residual platelet activity after a clopidogrel loading dose. Higher score levels are associated with occurrence of recurrent cardiovascular events. Adapted from Geisler et al. J Thromb Haemost 2008;

6: 54 and from Zuern et al. Thrombosis and Haemostasis 2010 Mar; 103: 496.

PREDICT-Score Variables Diabetes mellitus (WF 2)

ACS (WF 1)

Reduced LV-function (WF 3)

Age > 65 years (WF 1)

Renal failure (WF 2)

(WF= weighting factor)

PREDICT-Score

Levels

1 2 3 4 5 6

1 - 3

4 - 6

7 - 9

Odds Ratio + 95% confidence interval for elevated residual platelet aggregation

Figure 2

350 300 250 200 150 100 50 0

Follow-up (days)

0.25

0.20

0.15

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Stratum IV: RPA + CRP > median

Stratum III: RPA ≤ median + CRP > median

Stratum II: RPA > median + CRP ≤ median

Stratum I: RPA + CRP < median

Log rank: stratum IV vs. I: <0.001, vs. II: <0.001, vs. III: 0.06

stratum III vs. I: 0.01, vs. II: ns

stratum I vs. II: ns

Figure 3 A

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with reduced responsiveness to clopidog-rel. To assess the effect of this on clinical outcomes after ACS, a study on 2209 con-secutive patients was carried out. The study showed that at one year follow-up there were significantly more recurrent cardio-vascular events in patients carrying two CYP2C19 loss-of-function alleles.

However, it is currently still unclear which subgroups of clopidogrel-treated patients really show the clinical effects of CYP2C19*2 genotype. Recently, it was suggested that patients undergoing PCI in particular are jeopardised by the loss-of-function genotype [6]. On the other hand, the gain-of-function genotype CYP2C19*17 has been correlated with increased risk of bleeding [7]. Recent evidence for the impact of polymorphic variant of Paraoxonase-1 (PON1) on clopidogrel bioactivation and efficacy has resulted in a controversial debate; its role in determining the clinical progno-sis of patients receiving dual antiplatelet therapy remains unclear [8, 9].

Antiplatelet therapy in patients with ACS and patients undergoing PCICurrent guidelines recommend dual ther-apy with aspirin and clopidogrel for up to 12 months as well as a sufficient pre-treatment with clopidogrel (600 mg LD, 75 mg daily MD) for all patients under-going PCI in order to prevent recurrent

cardiovascular events. The recommenda-tion depends on stent type (drug eluting stent or bare metal stent), the presence of acute coronary syndrome, co-morbidities, bleeding risk, complexity of procedure and other planned interventions. Large stud-ies showed that premature discontinua-tion of treatment was associated with the occurrence of stent thrombosis, especially early stent thrombosis. According to ESC guidelines, Clopidogrel use for at least 12 months is a Class I, Level of Evidence B indication. Novel ADP-receptor blockers such as prasugrel and ticagrelor are recom-mended as beneficial alternative after acute coronary syndrome, as both achieve their antiplatelet effect faster and to a greater extent than clopidogrel. The net clinical benefit of these novel substances are great-est in certain risk groups. Thus, improved outcome has been especially observed in patients with STEMI, those at high risk of stent thrombosis, and diabetics by the use of these novel platelet inhbitors [Figure 4].

How do new P2Y12 receptor inhibitors influence current antiplatelet therapy?Increased clopidogrel loading dose and/or maintenance doses can be considered to overcome an inadequate clopidogrel response, but improvement of clinical out-come has not yet been demonstrated — the GRAVITAS trial did not show a significant reduction of the primary endpoints.

Ticagrelor and prasugrel are two novel antiplatelet compounds which inhibit the P2Y12 receptor and have different phar-macokinetic characteristics compared to clopidogrel. The new drugs have a simpler metabolism, leading to greater bioavail-ability; in addition their efficacy seems to be less affected by genetic factors. It should be noted, however that interactions with other drugs have been described, espe-cially for Ticagrelor. Since Ticagrelor is an inhibitor of P-glycoprotein, increased plasma levels of substrates like digoxin or cyclosporin can be observed. Inhibitors of CYP 3A4, e.g. ketoconazole, interfere with the metabolism of Ticagrelor and can lead to increased plasma levels of ticagrelor being associated with bleeding complica-tions. Drugs such as simvastatin that are metabolised by CYP3A4 show increased plasma levels and more side effects if com-bined with ticagrelor. On the other hand inductors of CYP3A4 such as rifampicin can reduce the efficacy of Ticagrelor. For these reasons co-medications must be considered carefully for all patients undergoing antiplatelet therapy.

Both prasugrel and ticagrelor have a big-ger antiplatelet effect and achieve it faster than clopidogrel; these differences explain the improved efficacy and safety profile observed in clinical trials.

PrasugrelPrasugrel, a 3rd generation thienopyridine, needs biotransformation to produce its active compound and irreversibly inhibits the P2Y12 receptor. The effectiveness of the drug was evaluated in the TRITON-TIMI 38 trial involving 13,608 patients with ACS and

– September 2011

[email protected]

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Figure 4. Current ESC guidelines advocate a dual antiplatelet therapy for up to 12 months after coronary intervention and after acute coronary syndrome. Novel ADP-receptor blockers such as

prasugrel and ticagrelor are recommended as favourable alternative after acute coronary syndrome along with clopidogrel, as both have a greater and faster antiplatelet effect than clopidogrel; for this reason they are especially recommended in high risk patients. An intense 2-week clopidogrel

treatment is also an option.

Acute coronary syndrome

STEMI NSTEMI UAP

PCI conservative PCI conservative PCI conservative

Prasugrel: IB -  after stent thrombosis under clopidogrel -  diabetics -  < 75 years -  > 60 kg - loading dose: 60 mg -  maintenance dose: 10 mg daily 12 months Ticagrelor: IB -  loading dose: 180 mg -  maintenance dose: 90 mg twice a day 12 months

Clopidogrel: IC -  loading dose: 600 mg -  maintenance dose: 75 mg twice a day for 2 weeks - afterwards 75 mg daily for 12 months

ASS 100 mg 1xdaily permanently

+

+

+

+

+

high risk (diabetics)

low risk

+

+

+

+

+ low risk

+

+

+

+

Figure 4

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20 CArdioLoGY

undergoing PCI. The trial design involved randomising patients to a prasugrel arm (60 mg LD, 10 mg daily MD) or a clopidogrel arm (300 mg LD, 75 mg daily MD) for a median duration of 14.5 months. The primary end point of the study was the occurrence of CV death, non- fatal myocardial infarction, and stroke. It was found that there was a signifi-cant reduction of these in the prasugrel arm of the trial (9.9% vs. 12.1%, p<0.001). Major non-CABG associated bleeding complica-tions and fatal bleedings were observed sig-nificantly more often in the prasugrel group than the clopidogrel group (1.4% vs. 0.9%, p=0.001; 0.4% vs. 0.1%, p=0.002 respectively). This was especially true in the subgroup of patients with previous cerebrovascular events, age over 75 years, and body weight of less than 60 kg. Therefore prasugrel is not recom-mended for patients with previous bleeding complications or bleeding risks.

Data from subgroup analysis showed that diabetics with ACS had a greater benefit from treatment with prasugrel (12.2% vs. 17%, p=0.001) than non-diabetics, so pras-ugrel is highly recommended for diabetics with ACS.

One limitation of the TRITON-TIMI 38 is the relative underdosing of the clopidog-rel loading dose of 300 mg and the timing of the clopidogrel loading dose, as 72% of patients received first study medication only during PCI, not any time prior to PCI.

Genetic polymorphisms of cytochrome P450 do not seem to influence the efficacy

of prasugrel, which is another explana-tion of the low response variability in prasugrel-treated patients [10].

TicagrelorTicagrelor is a cyclopentyl-triazolo-pyrim-idine that reversibly inhibits the P2Y12 receptor and reaches plasma peak levels after 1.5 to 3 hours. The ONSET/OFFSET trial showed that there was a faster onset and higher maximum level of platelet inhi-bition after ticagrelor loading compared to clopidogrel [12].

The PLATO trial included 18,624 patients with ACS who were randomised to ticagre-lor (180 mg LD, 90 mg twice a day MD) or clopidogrel (300 mg or 600 mg LD, 75 mg daily MD) for a duration of 12 months. In the ticagrelor arm there was a significant reduction in the number of CV deaths, non- fatal myocardial infarctions, and/or strokes after 12 months compared to the clopidogrel arm (9.8 % vs. 11.7%).

There was no significant difference in the occurrence of major bleedings in the two groups, although more non-CABG asso-ciated and intracerebral bleedings were reported in the ticagrelor arm [12].

ConclusionsStandard dual antiplatelet therapy with aspirin and clopidogrel shows insufficient platelet inhibition in a significant number of patients undergoing coronary interven-tion. The response to antiplatelet therapy varies from patient to patient but can be

characterised by an individual risk assess-ment involving clinical factors, platelet function assays and genetic tests. This risk assessment is reasonable for certain high risk patients but can still not be recom-mended for daily routine. However, multi-factorial risk models including near patient platelet function testing, clinical risk factor analysis and genetic testing could be an approach in future. Novel P2Y12-inhib-itors such as prasugrel and ticagrelor can be helpful to overcome response variability, but the increased risk of bleeding needs to be considered. For reasons of cost-effec-tiveness and safety, the general use of novel antiplatelet substances can not be recom-mended. However, the pharmacokinetic advantages of prasugrel and ticagrelor can allow clinicians to optimise patient man-agement by selecting the best drug for each patient individually. The clinical effects of optimised personalised antiplatelet therapy need to be further addressed in large-scale clinical trials in future. First attempts using the results of platelet function as randomi-sation criterion for alternative antiplatelet regimens did improve clinical endpoints. In future, it will be necessary to better characterise individual patients on multi-modal bases so that candidates for alterna-tive or intensified treatment regimens can be chosen.

References1. King SB 3rd et al. J Am Coll Cardiol 2008; 51:

172.2. Price MJ et al. JAMA 2011; 305: 1097.3. Geisler T et al. J Thromb Haemost 2008; 6: 54.4. Zürn CS et al. Thrombosis and Haemostasis

2010; 103: 496.5. Müller K et al. Atherosclerosis 2010; 213: 256. 6. Paré G et al. N Engl J Med 2010; 363: 1704.7. Sibbing D et al. Circulation 2010; 121(4):512.8. Bouman HJ et al. Nat Med 2011; 17: 110.9. Trenk D et al. Circ Cardiovasc Genet 2011

Jun 17.10. European Association for Percutaneous Car-

diovascular Interventions, ESC Committee for Practice Guidelines, EACTS Clinical Guide-lines Committee. Eur Heart J 2010; 31: 2501.

11. Wiviott SD et al. N Engl J Med 2007; 357: 2001.12. Gurbel PA et al. Circulation 2009; 120: 2577.13. Wallentin L et al. N Engl J Med 2009; 361: 1045.

The authorsDr. med. Karin A. L. Müller, M.D.* &Tobias Geisler, M.D.Medizinische Klinik IIIEberhard-Karls-Universität TübingenOtfried-Müller-Straße 1072076 Tübingen, Germany*Corresponding author:e-mail: [email protected]

– September 2011

Cardiovascular ImagingEdited by Paul LeesonPublished by Oxford University Press 2011, 330 pp, 34,90 £

A range of cardiac imaging techniques is available, each with a unique approach. Most existing imaging books are predomi-nantly modality focused; however today’s clinical cardiologist needs to learn how to apply and integrate information from the different modalities to aid clinical decision-making. Based on the latest guidelines as published by the European Society of Cardiology, and in full colour throughout, ‘Cardiovascular Imaging’ provides a comparative overview of the different techniques and how they can be applied in different pathologies as well as providing key background information that sup-ports more in-depth modality-focused handbooks. An essential resource for all clinical trainees, it provides practical hands-on advice for cardiology, medical, radi-ology and technical personnel who need easily accessible, detailed information on how to use the full range of imaging modalities to investigate cardiac disease. OxfOrd UniverSity PreSSOxford, UK www.ihe-online.com & search 45872

BooK rEViEW

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the detection and analysis of ECG P-waves can provide vital information for the detection of pathologies such as arrhythmia. in practice however, because of their low frequency, weak ampli-tude and multi-morphology, P-waves are frequently difficult to analyse in detail.

to overcome this difficulty and to minimise the possibility of misdi-agnosis, EdAN instruments has introduced a new method using a Quadratic spline Wavelet transform algorithm which is a new way of detecting P-waves and improves the accuracy of arrhythmia diagnosis.

the new fully-automatic algorithm for the analysis of the raw data is based on the following steps:

(1) the Qrs complex is first detected and the onset of the Q-wave established.

(2) this enables the data prior to the Qrs complex, i.e. the P wave, to be processed using a proprietary quadratic spline wavelet algorithm based on the well-established curve-fitting procedure.

(3) if the raw data include extrema then the application of the quadratic spline wavelet algo-rithm will produce pairs of modu-lus maxima (i.e. independent of whether negative or positive). these depend on the degree of the polynomial used. it has been established that the use of a 4th degree polynomial spline function gives an optimal signal-to-noise ratio, which enables reliable iden-tification of such modulus maxima occurring prior to the Q onset of the Qrs complex.

(4) depending on the position of these modulus maxima, the raw data can then be analysed to identify the positive maximum which corresponds to the peak of the P wave.

(5) the precise position of P-onset and P-offset can then be identified using standard inflec-tion point detection procedures.

the above procedure has been rigorously validated using the Common standards of Elec-trocardiography (CsE) Mo1

database. it was found that the use of the Quadratic spline Wavelet algorithm for P-wave detection described above gave a much more accurate and reliable identification of P-wave abnormalities than con-ventional methods of P-wave analysis.

the new Quadratic spline Wavelet transform method is now implemented in all ECG systems from the EdAN com-pany and can thus be routinely used for the automatic inter-pretation of data generated by these systems.

AN iNNoVAtiVE MEtHod iN tHE diAGNosis oF ArrHYtHMiAs: the use of a Quadratic spline Wavelet transform algorithm in the analysis of ECG P-waves

www.ihe-online.com & search 45753

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Q. first of all for any of our readers who may not yet be familiar with fysicon, can you, as CeO, give us a brief overview of what your com-pany does and what are the products and services you provide?

A. Yes, we are a small privately owned Dutch company with fewer than 50 employ-ees, which was founded in 1995 and is based in the city of Oss, in the southern part of The Netherlands, from where we serve all major markets. Although we’re still young and rel-atively small, we are very proud that we are recognised as a market leader when it comes to developing sophisticated e-portal soft-ware, for the user-friendly capture, archive and transmission of medical images; we also develop advanced monitoring systems. Our products are found throughout the world, not just in hospitals but also in institutions such as clinical research facilities. Thus, our products are used by a whole range of medical professionals from clinicians and consultants, through researchers, nurses and technicians, this is why we are the first choice for all leading institutions. We are also proud that both the software and hardware lines of our products have been developed in-house and are maintained and supported by us. Perhaps because we’re still quite small we actively cultivate and main-tain close contact and co-operation with end-users to ensure that our products con-tinue to be user-friendly and at the forefront of technology.

The greater than 85% share that we have of the Dutch market for medical imaging and e-report exchange management means that we have a solid basis from which to service

other markets throughout the world. Even in today’s turbulent economy, our company Fysicon continues to thrive.

One key to our significant and continu-ing development in Europe is the growing number of hospitals and medical institu-tions participating in our award-winning EVOCS system, the web-based applica-tion designed to deliver complex DICOM images in a simple, fast and encrypted man-ner. The expansion of the use of EVOCS allows us to achieve true interoperability for all DICOM Imaging and e-Reporting. In fact, as users of the system will soon find out, we have just recently released a new addition to EVOCS, namely an even faster XDS web-based product with a new user interface and the inclusion of sophisticated

A fast-growing player in the image handling, monitoring and information systems fieldthe small privately owned dutch company, Fysicon, is currently the focus of a lot of attention in the market because of its leading user-friendly soft-ware and sophisticated e-portals that are designed to capture, archive and transmit medical images. in addition to this, the company also develops advanced monitoring systems. We wanted to find out more about what‘s behind the company’s success so we spoke not only to Bert Elberse, CEo of the company but also directly to a hospital using their systems to find out how in practice the company’s systems are appreciated.

– September 2011 CoMPANY sPotLiGHt

Mr Bert Elberse, CEO of Fysicon

Q. first of all please tell us a bit about your hospital, where you are and what patient population you serve.

Our hospital, ZGT, was actually created in 1998 from a merger between the Twenteborg Hospital in Almelo and the Central Regional Hospital Twente in Hengelo. These towns are situated in the region of Twente which lies about 150 km east of Amsterdam, not too far from the German border. Overall we are a general hospital with 3,500 staff and a catch-ment area of 300,000 inhabitants. At both our sites in Almelo and Hengelo, we deliver high quality specialist medical diagnostics and treatments, with both hospitals working closely with general practitioners, primary care providers, home care and nursing homes in the area.Each hospital can leverage the other’s par-ticular knowledge and skills, so the group provides a comprehensive range of facilities for our patients.

Q. now tell us about your cath lab please. How big is your catheter lab?

The cath lab is, of course called on by both radi-ologists and cardiologists and to handle these requests our lab personnel includes five cardiolo-gists and six cath lab technologists, of which five have an intensive care/ critical care experience.

The cath lab provides cardiology support six days a week, with typical procedures being diagnostic coronary angiography and insertion of pacemakers. Our new QynetiQ system is mostly used for monitoring these cardiology patients .

Q. What about the hardware equipment in the lab?

We have a Toshiba X-ray generator, an Enter-prise PACS,/Jivex PACS for cardiology and a Rogan PACS for radiology.

Q. When did you acquire a QynetiQ system and what were the main reasons behind the choice of this system?

Naturally enough, we looked at possible prod-ucts from a number of potential suppliers but the first step, even before this, was to set up a special project group within our hospital to make sure that we had a clear understand-ing of the essential features of the system we would need. In the end having compared the various offers against our requirements list, we opted for a Toshiba/Fysicon system which we finally purchased in late 2010. One factor in the choice of new system, but not the only one, was the fact that we had already been very satisfied with a previous haemodynamic monitoring system from Fysicon. Anyway we use the new QynetiQ Enterprise as

improving catheter lab performance: installing a new monitoring systemWe accepted Fysicon’s invitation to speak directly to users of their systems. the twente Hospital Group (ZGt) in the Netherlands has recently purchased a new monitoring system, the QynetiQ Enterprise, for its cath lab. iHE spoke to lab personnel at ZGt to see how this system was facilitating their work.

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image review tools designed for use by all radiologists.

Q. you mentioned that, in addition to the image and video exchange systems we’ve just been talking about, you also produce monitoring systems. tell us about these.

A. Yes we have a range of systems that go under the QynetiQ brand and which are designed for use in cardiac, vascular and interventional cath labs and adjacent recovery areas. Recently we installed a QynetiQ system in the cath lab of the ZGT Hospital in Hengelo in The Netherlands — but please speak directly to the people in Hengelo to get their first-hand impres-sion of the new system [see Box below]. In the near future we will also be updat-ing six cath labs in the university hospital in Maastricht.

QynetiQ Enterprise is a haemodynamic monitoring system with full relational

database, storage, query and statistic func-tionalities, extensive reporting capabilities, charting of used material and full haemo-dynamic analysis. QynetiQ Advanced + is a low profile monitoring system for the cardiac catheterisation lab, which supports patient administration, and provides sim-plified haemodynamic calculations and reporting templates (MS Word based) in the local language. Other patient moni-toring systems in the range are QynetiQ Advanced and QynetiQ Care.

Q. Haven’t you also recently expanded into the field of cardiovascular information systems?

A. Yes, our QynetiQ CVIS, part of a com-plete QynetiQ product range, is a next generation, multilingual cardiovascular information system which we developed to support cardiac and peripheral catheterisa-tion procedures. The system provides a sin-gle access point for all patient information, and so helps to improve the clinical and

financial performance of the department, for example, by providing a scheduling solution for managing patient and modal-ity resources.

Q. Out of all these technical features, what is the particular impact of the new systems on improved patient care?

A. It’s true that we shouldn’t forget that the point of all this technology is ultimately improved patient care. Apart from reliability and increased accessibil-ity the fact that the new system offers a global overview of all patient files and a complete management of all documents (text and images) related to the clini-cal follow-up of patients means that in practice the specialist ends up with much more time to see the patient and address clinical needs. Q. What about the impact of the

new systems on the running of the departments?

A. Here we know that because the system can make a complete recording of proceed-ings, it enables fast, extensive and efficient reporting of the overall management and, just as importantly, the financial perfor-mance of departments is significantly improved.

Q. So, overall, how do you see the future?

A. In short, with confidence — the on-going development of the QynetiQ product line will ensure that global sales continue to grow, and in parallel with this our dis-tribution network will expand to meet the market expectations. However even with this expected global growth we will still make it our number one priority to ensure that we meet the local medical needs.

In the much closer future, Fysicon will be demonstrating the QynetiQ CVIS at the ESC Congress in Paris at the booth of our partner Toshiba (booth E400 in hall 6).All IHE readers welcome! We’d be happy to tell you more about us and our products.

Fysicon Hoogheuvelstraat 1145349 BA Oss The NetherlandsTel. +31 412 653333E-mail: [email protected] www.ihe-online.com & search 45878

– September 2011

a fully integrated haemo-dynamic and monitoring system and for carrying out analysis & calcula-tions needed in cardiac and peripheral catheteri-sation procedures.

Q. So what impact has the new system had on the work of the cath lab?

Well, you must realise that since the system has only been installed relatively recently it’s still a bit early to come to firm, detailed conclusions about its per-formance. What we can say so far is that the sys-tem definitely facilitates coronary angiography and pacemaker insertions.

Q. What about the effect of the system on the lab’s performance in terms of diag-nostic quality, increased throughput and costs?

Again, since the system was only introduced recently we haven’t really had sufficient time to get a full, comprehensive picture of its over-all performance. We have a diagnostic centre and use some of the possibilities that QynetiQ offers, but we would like to clarify and inves-tigate in more detail some applications, such as the detection of certain arrhythmias and pressure curves. One thing that we can see already is that sys-tem reliability and quality are high. Likewise customer service is given high priority from Fysicon. They continuously monitor our sys-tem and will implement any improvements that seem useful at very short notice.

Q. Any additional benefits of the system which were you didn’t anticipate prior to purchase and installation?

Yes, one benefit that we didn’t fully expect or appreciate was the usefulness of the statistics that can be easily generated. The QynetiQ system incorporates angio query and activity report for reporting and data basing, including charting of used material and query & statis-tics for the department. Reports can be gener-ated for procedures and necessary follow-up.

Q. Are there any additional features/mod-ules that you would like to see added to or made available on the system?

So far no, but again it’s really too early to say anything meaningful about this. What is reas-suring however is that we know that if we do come to the conclusion that some additional functions would be advantageous or beneficial then Fysicon will for sure do their utmost to implement them rapidly.

The catheter lab at ZGT.

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Hybrid coronary revascularisation pro-cedures [1,2] combine coronary bypass surgery and percutaneous coronary inter-vention (PCI) and are alternative to mul-tivessel PCI or multivessel coronary artery bypass grafting (CABG). The underlying principle of hybrid procedures is the place-ment of the internal thoracic artery (ITA) graft to the left anterior descending coro-nary artery (LAD) together with PCI of a non-LAD target vessel [1,2]. The ration-ale for performing hybrid interventions on the coronary artery system is based on the premise that an ITA graft to the LAD provides the best long-term outcome for revascularisation of the anterior wall and the septum of the heart, and PCI with drug-eluting stents offers equally good long-term results compared to saphenous vein and radial artery grafts in non-LAD targets [1]. This concept combines the most effective treatment strategies of both cardiac surgery and interventional cardiol-ogy. More complex hybrid interventions include this standard procedure together with a combination of additional surgical grafts or PCIs. During recent years mini-mally invasive techniques, including totally endoscopic coronary artery bypass grafting (TECAB) have become feasible and repro-ducible. The development process spans a stepwise progression from single-vessel procedures to complex endoscopic multi-vessel revascularisation [3,4]. TECAB now represents a useful tool in the hybrid coro-nary revascularisation armamentarium,

providing a closed chest approach to surgical coronary revascularisation.

Patient selectionHybrid revascularisation can generally be offered to selected patients who meet the classical indications for coronary surgery or PCI. In these patients the LAD and non-LAD target vessels with high SYNTAX score (the angiographic-based system for the grading the complexity of coronary artery disease) lesions, which are not suitable for PCI, are grafted using one or both ITAs. Additional PCI is performed in non-LAD targets with low SYNTAX score lesions [2]. Contraindi-cations currently include the necessity for concomitant cardiac surgical intervention, haemodynamic instability, severe lung dis-ease and a high atherosclerotic burden [5, 6]. Reduced renal function is a relative contrain-dication for prolonged catheter-based inter-ventions, in which large amounts of contrast agents are likely to be used [7]. Additional exclusion criteria for TECAB include a his-tory of pleuritis, radiation and inflammatory thoracic disease. [Table 1]

Surgical procedureHybrid coronary revascularisation can be performed with a variety of approaches; some teams use conventional sternotomy for surgical access to the heart, but a mini-mally invasive approach is the more com-monly accepted method. Minimally inva-sive direct coronary artery bypass grafting (MIDCAB) can be carried out through a

minithoracotomy on the anterolateral chest wall with long instruments, or be augmented with robotic assistance (endoscopically assisted coronary artery bypass graft, Endo-ACAB) to harvest the internal mammary artery (IMA), providing improved length [4], and to locate the target vessel. Certain specialised centres used robotic technol-ogy to perform coronary artery bypass in a totally endoscopic fashion. Robotic tech-nology allows the surgeon to control the camera and the surgical instruments from a console with 3D high-definition vision, and suture the coronary anastomoses using standard techniques [1]. Placement of the ITA grafts can be performed either on the arrested or the beating heart. Groups which use the beating heart approach suggest that there are advantages for elderly and high risk patient populations [1,8,9,10]. Advan-tages of a totally endoscopic approach can be seen in improved physical health for the patient, shorter hospital stay and a more rapid return to daily activities [11]. Patients with significant risk factors for deep ster-nal wound infection, such as diabetes, severe chronic obstructive pulmonary dis-ease and obesity benefit significantly from sternal-preserving procedures [1].

Catheter-based interventionPCI is undertaken in non-LAD target ves-sels with low SYNTAX score lesions and is performed with different types of stents according to standard indications. Gener-ally, a drug eluting stent is indicated for a target vessel with a diameter less than 2.5 mm, whereas vessels with diameters larger than 3 mm fare better with bare-metal-stents [2,12]. Dual anti-platelet therapy (clopidogrel or pasrugrel and acetylsali-cylic acid) is recommended for 12 months after drug-eluting-stent implantation.

One important consideration in hybrid coronary revascularisation is that a com-plex left main disease can be converted into a relatively simple PCI target by protecting the LAD with an ITA graft.

Staged or simultaneous? An important question concerns the sequence of surgical and catheter-based intervention. Three modes are established: 1) PCI prior to TECAB 2) Concomitant TECAB and PCI 3) TECAB prior to PCI.

“PCI first” is commonly used for patients undergoing emergency PCI of non-LAD

Closed-chest hybrid coronary revascularisationHybrid coronary revascularisation, combining robotic technology and percu-taneous coronary intervention, allows closed chest treatement of multivessel coronary artery disease. Advanced procedures, including multivessel totally endoscopic coronary artery bypass grafting and multivessel percutaneous coronary interventions are feasible. the patient benefits from excellent long-term patency rates without the use of conventional sternotomy.

by dr F. Weidinger, dr t. schachner, dr E.J. Lehr, dr J.o. Bonatti and dr N. Bonaros

– September 2011

Table 1. Indications and contraindications for totally endoscopic hybrid coronary intervention.

Indications Contraindications• Adult patients with 2- or 3- vessel CAD• High SYNTAX score lesion of the LAD - Chronic total occlusion - Left main related lesion - Heavy calcification - Complex tortuosity• Low SYNTAX score lesion of non-LAD target

• Concomitant cardiac surgical intervention• Hemodynamic instability• Severe lung disease• Severe atherosclerosis• Renal dysfunction (relative CI)• History of: - Pleuritis - Radiation - Inflammatory thoracic disease

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target vessels. “TECAB prior to PCI” is an option for patients with stenoses of question-able significance in non-LAD vessels (the so-called “wait and see” concept) and has the advantage of performing surgery without aggressive platelet inhibition. TECAB and PCI in one session is indicated for patients with critical stenosis of a large non-LAD ves-sel, for which waiting would pose a significant risk of myocardial ischaemia until the PCI. Advantages of the simultaneous approach are the possibility of immediate conver-sion to sternotomy, the option of switching between PCI and surgery and the comfort of one single procedure instead of two [2].

In hybrid coronary intervention there is currently a debate regarding the risk of surgical bleeding in patients under dual antiplatelet therapy. A CABG first staged approach allows both the cardiologist and the surgeon to follow their standard pro-tocols regarding platelet inhibition and anticoagulation [13]. However this strat-egy is not always feasible. By avoiding sternotomy and reduced surgical trauma, minimal invasive surgery, especially total endoscopic procedures can minimise the risk of perioperative bleeding associated with antiplatelet therapy [1].

Two-centre experienceIn 2010 we reported the midterm results of 130 patients, after closed-chest hybrid coro-nary intervention had been carried out, at two centres (University Clinic of Cardiac

Surgery, Innsbruck Medical University and University of Maryland, Department of Surgery, Division of Cardiac Surgery) [2] using the da Vinci (Standard, S, and Si) sur-gical telemanipulation systems (Intuitive Inc., Sunnyvale, CA, USA). Single, double and triple-vessel TECAB procedures were performed with a perioperative mortality of only 0.7 %. Two patients required revi-sion for bleeding, and conversion to a larger thoracic incision was necessary in 10%. On-table revision of the LITA graft was neces-sary in four patients due to angiographic findings. Overall survival, freedom from angina and freedom from major adverse cardiac and cerebral events (MACCE) were 99%, 90% and 75% respectively. New PCI was required in 8%, but no re-interventions were necessary on ITA grafts. [2]

ConclusionHybrid procedures using robotic technol-ogy and PCI allow closed chest treatment of multivessel coronary artery disease using the best treatment modalities offered by cardiology and cardiac surgery. Single, double and even triple bypass grafts are feasible and simultaneous interventions can be performed. The overall safety of the procedure seems to be adequate, and perioperative clinical results are satisfac-tory. Intermediate term survival and free-dom from angina are equivalent or exceed results for traditional treatment strategies. With the advent of double ITA grafting using minimally invasive techniques, more complex and advanced hybrid coronary revascularisations can be carried out.

References1. Bonatti J, Lehr E, Vesely MR, Friedrich G, Bona-

ros N, Zimrin D. Curr Opin Cardiol. 2010 Nov;25(6):568-74. Review.

2. Bonaros N, Schachner T, Wiedemann D, Wei-dinger F, Lehr E, Zimrin D, Friedrich G, Bonatti J. Eur J Cardiothorac Surg. 2011 Apr 1.

3. Bonatti J, Schachner T, Bonaros N, et al. Am J Cardiol. 2009 Dec 15;104(12):1684-8.

4. J. Bonatti MD FETCS, T. Schachner MD, N. Bona-ros MD, E. Rützler MD, F. Weidinger, R. Schistek MD, G. Feuchtner MD, G. Friedrich MD FESC, O. Pachinger MD FESC, G. Laufer MD. Robotic tech-nology – probably a safe tool for development of completely endoscopic coronary revascularization procedures. Presented at he 10th Annual ISMICS Meeting in Rome 2007

5. Bonatti J, Schachner T, Bonaros N, Jonetzko P, Ohlinger A, Ruetzler E, Kolbitsch C, Feuchtner G, Laufer G, Pachinger O, Friedrich G. Cardiology 2008;110:92—5.

6. Schachner T, Bonaros N, Laufer G, Bonatti J. Heart Surg Forum 2004;7(6):E632—5.

7. Vassiliades TA Jr, Douglas JS, Morris DC, et al. J Thorac Cardiovasc Surg 2006; 131:956–962.

8. Hulusi M, Basaran M, Yilmaz M, et al. Texas Heart Inst J 2006; 33:458–462.

9. Angelini GD, Wilde P, Salerno TA, et al. ILancet 1996; 16:757–758.

10. Holzhey D, Jacobs S, Mochalski M, et al. Ann Thorac Surg 2008; 86:1856–1860.

11. Bonaros N, Schachner T, Wiedemann D, Oeh-linger A, Ruetzler E, Feuchtner G, Kolbitsch C, Velik-Salchner C, Friedrich G, Pachinger O, Laufer G, Bonatti J. Cardiology. 2009;114(1):56-8.

12. Friedrich GJ, Bonatti J. Heart Surg Forum 2007;10:E292—6. Review.

13. Zimrin D, Bonatti J, Vesely MR, Lehr EJ. Heart Surg Forum. 2010 Dec 1;13(6):E405-8. Review.

The authorsFelix Weidinger, MD1*, Thomas Schachner, MD1, Eric J. Lehr, MD2, Johannes O. Bon-atti, MD2 & Nikolaos Bonaros, MD, PhD1

1 Innsbruck Medical University, Department of Cardiac Surgery, Austria2 University of Maryland Medical Center, Division of Cardiac Surgery Eric J. Lehr, MD, PhD; Johannes Bonatti, MD;

*Corresponding author:Felix Weidinger, MD.University Clinic of Cardiac SurgeryInnsbruck Medical UniversityAnichstrasse 35, 6020 Innsbruck, AustriaTel. +43 (0)5125040e-mail: [email protected]

– September 2011

Figure 1. Angiographic result after hybrid coronary intervention. (a) Coronary angiogram of a patient with severe left main disease undergoing staged hybrid coronary intervention. (LM= left main coronary artery, LAD= left anterior descending artery, CX=circumflex artery) (b) A left internal thoracic artery

(LITA) to LAD graft was placed in totally endoscopic fashion, is perfectly patent. (c) Percutaneous coronary intervention (PCI) to the circumflex artery is carried out under protection of the LAD with a LITA graft. (d) Final result after staged PCI

LAD

CX

LM (a) (b)

LAD

LITA (c) PCI CX

(d)

CX post PCI

Figure 1: Angiographic result after hybrid coronary intervention

(a)  Coronary angiogram of a patient with severe left main disease undergoing staged hybrid coronary intervention. (LM= left main coronary artery,

LAD= left anterior descending artery, CX=circumflex artery) (b) A left internal thoracic artery (LITA) to LAD graft was placed in totally endoscopic fashion, is perfectly patent. (c) Percutaneous coronary intervention (PCI) to the circumflex artery is carried out under protection of the LAD with a LITA graft. (d) Final result after staged PCI

Figure 2. Third postoperative day after totally endoscopic multivessel revascularisation.

Figure 2: Third postoperative day after totally endoscopic multivessel revascularization

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26 sUrGErY

Valvular heart disease has always been one of the major challenges for cardiac surgeons. Before the introduction of car-diopulmonary bypass (CPB) valve repair was limited to the treatment of stenotic valves by dilatation of the stenotic valve, which was carried out by introducing either a finger or instruments through the valve of the beating heart.

The advent of reliable CPB made it pos-sible to visiualise valves being replaced or repaired directly using precise tech-niques. Major refinements of surgical techniques have made valve repair and replacement highly reproducible treat-ment methods with excellent short- and long-term results.

The usual approach to valve surgery now includes a midline sternotomy, full CPB and an arrested heart protected by cardi-oplegia. The valve has been approached using direct vision, with alternative visu-alisation (mainly ultrasound) only used as a method for quality assurance verifi-cation of the completed procedure.

The development of less invasive meth-ods has come relatively slowly to cardiac surgery, but the development of off-pump coronary bypass and the rapid expansion of minimally invasive interventions in other medical specialties has stimulated innovation and the development of less invasive procedures for treating valvu-lar pathology. Transcatheter aortic valve implantation (TAVI) is rapidly becom-ing clinically important in subgroups of patients with aortic stenosis. Sophis-ticated imaging techniques and micro-instrumentation mean that less invasive therapy on the mitral valve tis becoming a realistic alternative.

In this article we summarise a variety of approaches for the treatment of mitral valve pathology.

Surgery: robotic and thoracoscopic mitral valve operationAlthough the vast majority of mitral operations are still carried out using traditional surgical methods, it is now well documented that less invasive sur-gery can give excellent clinical results [1]. Most of these approaches involve CPB and an arrested heart. CPB may be accomplished through peripheral vessels. Alternativel, it may be performed thora-coscopically with central cannulation and aortic occlusion using the “Heart-port” balloon [2] method, or through thoracoscopic cannulation and clamping of the aorta. The valve procedure itself is accomplished using a small thoracotomy or ports for endoscopic surgery. The DaVinci surgical manipulator has made accurate repair and replacement of the valve possible, with mortality and com-plication rates similar to open surgery, but with markedly reduced postopera-tive pain and recovery time [3].

Catheter-based approachesJust as occurred with therapeutic approaches to coronary artery disease, catheter-based methods are becoming more common in mitral valve repair.

Results are however still less reliable than surgical methods and, except for bal-loon dilation of mitral stenosis, there is no catheter-based method that can give the excellent results produced by experi-enced mitral valve surgeons

Indirect methodsa) Coronary sinus instrumentation

and ventricular reshapingThe coronary sinus is anatomically close to the posterior mitral annulus, and shortening of the coronary sinus may therefore shrink the mitral annulus as well, thereby reducing regurgitation from a dilated mitral valve [4]. Anchor-ing mechanisms which are placed proxi-mal and distal in the coronary sinus have been designed to shorten the course of the coronary sinus, thereby creating a mitral annuloplasty. An alternative method is the attempted reshaping of the left ventricle by anterior and posterior patches on the left ventricle that are used to decrease the anterio-posterior diam-eter of the ventricle [5].These methods have still not gained wide popularity, and results are so far considered unreliable.

b) Fusion of the anterior and posterior mitral leaflets

Mitral regurgitation may be reduced by the so-called “Alfieri” technique [6], whereby portions of the prolapsing leaf-let’s free edge are sutured to each other. This can reduce mitral regurgitation by supporting the prolapsing leaflet with the non-prolapsing leaflet. A doublet inlet mitral valve is then created. This was initially an open surgical technique, which has now been converted to a cath-eter-based method, using the Mitraclip

A review of mitral valve repair techniquesMitral valve repair can be a highly effective therapy with predictable short- and long-term results. the invasiveness of surgery can be reduced with the use of small incisions, indirect vison and robotics. still less inva-sive procedures such as catheter-based and hybrid approaches are being developed. this article outlines a variety of approaches for the treatment of mitral valve pathology.

by dr Jacob Bergsland, dr Emir Mujanovic, dr Emir Kabil and dr Erik Fosse

– September 2011

Figure 1. Left Panel Mitraclip device in its open position. Right Panels Evalve delivery system

Page 27: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

27

(E-valve, Inc. USA) [7]. The method has been shown to reduce, but usually not eliminate, mitral regurgitation.

c) Implantation of artificial chordae.An important method of reducing mitral regurgitation of a prolapsing valve is the insertion of artificial chordae to replace or reinforce the natural chordae that have ruptured or become elongated due to degenerative changes. The procedure is per-formed surgically, usually in combination with an annuloplasty; instruments have been designed to implant artificial chordae using a transapical approach [8, 9], together with a very small thoracotomy. The method, which is currently undergoing early clinical trials, may be considered as a hybrid approach, com-bining minimally invasive off-pump surgical and catheter-based methodologies.

Surgery: mitral valve replacementReplacement of the mitral valve still remains the responsibil-ity of cardiac surgeons and is carried out under their auspices. However techniques similar to the ones used in TAVI are under development and aortic valve devices have already been used in previously operated patients using the apical valve-in-valve approach [10, 11]. Further developments are anticipated so that mitral valves may in the future be replaced routinely using catheter-based techniques.

SummaryMitral valve repair in the hands of experienced surgeons is a highly effective therapy with predictable short- and long-term results. Efforts to reduce the invasiveness of the surgery via the use of small incisions, indirect vison and robotics have made it possible to perform repairs with significantly reduced invasiveness.

The increasing age of the population and the desire of patients for still less invasive procedures have made catheter-based and hybrid methods attractive. However, the present time such methods cannot provide reproducible surgical results. This sit-uation is likely to change significantly in the near future, given the current intense research and development activity being carried out by both industry and academia.

References1. Galloway AC, Schwartz CF, Ribakove GH, Crooke GA, Gogoladze

G, Ursomanno P, et al. A decade of minimally invasive mitral repair: long-term outcomes. The Annals of Thoracic Surgery 2009; 88(4):1180-4.

2. Vanermen H, Farhat F, Wellens F, De Geest R, Degrieck I, Van Praet F, et al. Minimally invasive video-assisted mitral valve surgery: from Port-Access towards a totally endoscopic procedure. Journal of Car-diac Surgery 2000; 15(1):51-60.

3. Modi P, Rodriguez E, Chitwood WR, Jr. Robot-assisted cardiac surgery. Interactive Cardiovascular and Thoracic Surgery 2009; 9(3):500-5.

4. Fukamachi K. Percutaneous and off-pump treatments for functional mitral regurgitation. J Artif Organs 2008; 11(1):12-8.

5. Fukamachi K, Inoue M, Popovic ZB, Doi K, Schenk S, Nemeh H, et al. Off-pump mitral valve repair using the Coapsys device: a pilot study in a pacing-induced mitral regurgitation model. The Annals of Thoracic Surgery 2004; 77(2):688-92; discussion 92-3.

6. Alfieri O, Maisano F, Colombo A. Future of transcatheter repair of the mitral valve. The American Journal of Cardiology 2005 Dec 19;96(12A):71L-5L.

7. Block PC. Percutaneous mitral valve repair for mitral regurgitation. Journal of Interventional Cardiology 2003; 16(1):93-6.

8. Bajona P, Katz WE, Daly RC, Zehr KJ, Speziali G. Beating-heart, off-pump mitral valve repair by implantation of artificial chordae tendineae: an acute in vivo animal study. The Journal of Thoracic and Cardiovascular Surgery 2009; 137(1):188-93.

9. Seeburger J, Leontjev S, Neumuth M, Noack T, Hobartner M, Misfeld M, et al. Trans-apical beating-heart implantation of neo-chordae to mitral valve leaflets: results of an acute animal study. Eur J Cardio-thorac Surg 2011 May 17.

10. van Garsse LA, Gelsomino S, van Ommen V, Luca F, Maessen J. Emergency Transthoracic Transapical Mitral Valve-in-Valve Implantation. Journal of interventional cardiology 2011 Mar 17.

11. Nunez-Gil IJ, Goncalves A, Rodriguez E, Cobiella J, Marcos-Alberca P, Maroto L, et al. Transapical mitral valve-in-valve implantation: a novel approach guided by three-dimensional transoesophageal echocardiography. Eur J Echocardiogr 2011; 12(4):335-7.

The authorsJacob Bergsland, MD, PhD1,2

Emir Mujanovic, MD, PhD2

Emir Kabil, MD,PhD2

Erik Fosse, MD, PhD1

1Intervention Centre Oslo University Hospital University of Oslo Norway

2 BH Heart Centre,Tuzla, Bosnia and Herzegovina

– September 2011

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Less paper for a sustainable worldYour IHE digital edition has arrived!

Do you feel concerned about the environmental impact of the huge amounts of paper still being used in the vast majority of businesses, not least the publishing industry?

Now there’s something you can do: switch your IHE subscription from print to digital. Have a peek at IHE’s digital edition on www.ihe-online.com. It’s easy to use and you can make instant inquiries while browsing through the digital edition of your favourite hospital magazine.

Ready to switch? Click on Free subscription and Renew and make sure you select Digital at the top of the registration form. Your next issue of IHE will come automatically into your inbox. And that’s another plus… no more postal delays!

1. Post a comment online You can now post comments or ask questions regarding feature articles published in IHE on www.ihe-online.com using the link provided in the Comments box appearing below each article.

2. Get in touch directly with suppliers Go to www.ihe-online.com and enter in the search box the number appearing below each advertisement or product news published and submit the contact form at the bottom of the next screen.

THE MAGAzINE FoR HEALTHCARE DECIsIoN MAkERs

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29 – September 2011

Effect of transition to digital mam-mography on clinical outcomes.Glynn CG et al. Radiology. 2011 Jul 25. This study attempted to determine the effect of transition to digital screening mammog-raphy on clinical outcome measures, includ-ing recall rate, cancer detection rate and positive predictive value (PPV). Practice audit data were obtained for three breast imaging radiologists from 2004 to 2009. These data were sorted by time period into the following groups: baseline (2004-2005), digital year 1 (2007), digital year 2 (2008) and digital year 3 (2009). χ2 and Fisher exact tests were used to assess differences in pro-portions among and between years. Clini-cal outcomes based on lesion type from 2004 to 2008 were also compared. Com-puter-aided detection was used. The three radiologists interpreted 32 600 screen-film mammograms and 33 879 digital mammo-grams. Recall rates increased from 6.0% at baseline to 7.1% in digital year 1 and con-tinued to increase in subsequent years to 8.5%. The cancer detection rate increased from 3.3 at baseline to 5.3 in digital year 1, and it remained higher than that at baseline in subsequent years. PPV after screening mammogaphy (PPV(1)) increased from 5.6% at baseline to 7.5% in digital year 1 and returned to baseline levels in digital year 3. In contrast, PPV after biopsy (PPV(3)) decreased from 44.5% at baseline to 30.3% in digital year 3. From 2004 to 2008, 3444 patients with 3493 lesions were recalled. The percentage of recalls for calcifica-tions increased from 13.8% at baseline to a

peak of 23.9% in digital year 1 and 17.9% in digital year 2. Both PPV(1) and PPV(3) decreased for calcifications after the digital transition. Recall rate and cancer detection rate increase for at least 2 years after the transition to digital screening mammog-raphy. PPV(3) is significantly reduced after digital transition, primarily in patients with microcalcifications.

Radiation exposure monitoring: a new IHE profileO’Donnell K. Pediatr Radiol. 2011 May;41(5):588-91.This article describes a method for gath-ering and distributing radiation exposure data from X-ray-based imaging proce-dures such as CT, angiography, fluoroscopy, mammography and digital X-ray systems with integrated generators. The data are recorded in a standard format as a DICOM dose object and are managed in a similar fashion to the DICOM images produced by the procedure. The Integrating the Health-care Enterprise (IHE) process for stand-ardising such methods is presented and applications of such data for activities, such as dose QA and national dose repositories are also discussed.

Super-resolution variable-dose imaging in digital radiography: quality and dose reduction with a fluoroscopic flat-panel detector.Berliner L, Buffa A. Int J Comput Assist Radiol Surg. 2011 Sep;6(5):663-73. Super-resolution (SR) image processing pro-duces a high-resolution image from a series of low-resolution images. The aim of the study described in this paper was to evaluate SR-images based on fluoroscopic flat-detec-tor (FD) acquisition at different frame rates.Fluoroscopic FD-sequences with 20 frames were obtained with varying pulse frequencies of (1) a line pair resolution phantom; (2) a low-contrast resolution phantom, and (3) a human knee speci-men. Super-resolution digital radiographs (SR-Radiographs) were generated from each sequence. Variable-dose images were simulated by constructing SR-Radiographs using 6 and 12 frames from the corre-sponding fluoroscopic sequence. “Single Shot” and Computed Radiography (CR) images were obtained for comparison based on dynamic range and sharpness of bone detail structures. Patient-derived SR-Radiographic images were constructed to demonstrate clinical examples.The phantom testing images and simula-tion results demonstrated that diagnostic quality SR-radiographic images of skeletal extremities can be synthesised using a flat-panel detector system designed primarily

for angiography. SR-images obtained with substantially reduced radiation dose are feasible, and this technology may improve digital radiography for paediatric, neonatal radiography or mammography applications. Further testing is needed to validate super-resolution techniques in other body regions and for different flat-detector systems.

Comparison of full field digital (FFD) and computed radiography (CR) mammography systems.Kalathaki M et al. Radiat Prot Dosimetry. 2011 Aug 4. The study desccribed in this paper evalu-ated and compared the performance of 52 full field digital (FFD) and computed radiography (CR) mammography systems checked by the Greek Atomic Energy Com-mission with respect to dose and image quality. Entrance surface air kerma (ESAK) was measured and average glandular dose (AGD) was calculated according to the European protocol on dosimetry in mam-mography. The exposures were performed using the clinical protocol of each labora-tory. The image quality was assessed by the total score of resolved phantom structures incorporated in an American College of Radiology accreditation phantom. The mean ESAK values for FFD and CR systems were 4.59±1.93 and 5.0±1.78 mGy, respectively, whereas the AGD yielded a mean value of 1.06±0.36 mGy for the FFD and 1.04±0.35 mGy for the CR systems. Considering image quality, FFD systems indicated a mean total score of 13.04±0.89, whereas CR systems indicated a mean total score of 11.54±1.06.

Our path to a filmless futureAdair L 2nd, Ledermann E. J Digit Imaging. 2011 Jul 12. Film-based radiographs are still being used to teach in a conference format, which pre-sents several viewing challenges amongst other problems. In order to address the issue of digitising the film-based radio-graph libraries in a radiology department, this study looked at several options. The option chosen, based on price, resolu-tion, shades of gray, built-in transparency function and physical attributes, was a consumer-grade scanner. The goal was to digitise the film-based radiograph teaching files so they could be stored in a digital file locker such as Google Picassa for organisa-tion and quick access later. The file would be constantly updated. This method would allow even the smallest radiology depart-ment to benefit from the use of modern technology to gain access to valuable infor-mation stored in film-based radiographs and give every resident the opportunity to benefit from it.

diGitAL X-rAY: sCiENtiFiC LitErAtUrE

the many disadvantages of process-ing, managing and storing films have resulted in radiology depart-ments increasingly adopting dr instead. the scientific literature on this topic is burgeoning, and iHE’s editorial board chose several scien-tific papers which were thought to be particularly worthy of attention.

Page 30: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

ProdUCt NEWs30 – September 2011

Large load capacity patient liftWith a massive 386kg safe working load (SWL), the Oxford Calibre bariatric lift has one of the greatest load capacities available on the market today. Specially developed for the safe lifting of heavy or bari-atric patients, this ergonomically designed and electronically operated

hoist encompasses the very latest in medical device innovation and technol-ogy. The lift is able to handle a variety of different patient transfer requirements. In addition to its exceptional SWL, the lift has fitted as standard a large 6-point open cradle providing greater patient comfort and a Class III rated low-profile digital weigh-scale with intuitive easy-to-use controls ideal for patient monitoring.

Other notable features include a powered base to allow the lift’s legs to be opened and closed with minimal effort, eliminating the need to twist or bend when navigating around common obstacles such as armchairs, wheelchairs and bedside tables. The lift also comes with a stretcher attachment option making it an exceptionally versatile transfer device.

JOernS HeAltHCAre ltdPershore, Worcester, UK www.ihe-online.com & search 45877

Prone position breast tableThe advantages of the prone position over the traditional supine position for treating the breast are

clear. Studies demonstrate that more than 90% of women can benefit from being treated in the prone position. With proper equipment and increased patient comfort, there is really no reason why this technique should not be used as standard in all radiotherapy facilities. Offer-ing a number of advantages over other commercially available prone position tables, the unique ClearVue open design provides visual and treatment access to the breast, allowing the physician to plan and treat from multiple angles. The newly released Laser Alignment System provides an additional point of reference to better re-position the breast and increase targeting accuracy. The all carbon fibre prone position table addresses current and future requirements to deliver this emerging therapy technique. Placing the patient in the prone position reduces target motion, increases the separation between the target anatomy and critical structures such as lung and heart, and allows for better localisation of the treatment area.

OrbitAl tHerAPy llCbedford, MA, USA www.ihe-online.com & search 45876

Display system for breast tomosynthesis Breast tomosynthesis provides radi-ologists with three-dimensional images of the breast for better lesion visibility. These multi-frame images give rise to a need for solutions to optimise reading and interpretation. The Mammo Tomosynthesis 5MP display system for digital breast imag-

ing includes some groundbreaking technologies specifically devel-oped for multi-modality mammography. Its unique technologies for brighter and faster tomosynthesis visualisation enable detection of the smallest details, providing radiologists with a new degree of diagnos-tic confidence and performance. High-quality, multi-modality images are displayed more efficiently and more clearly so the radiologist can make the most effective diagnosis. The proprietary RapidFrame

Dual-modality PET/CT imaging management software Dual-modality PET/CT scans combine the low-resolution func-tional PET imagery with the precise localisation possible with a CT scan, helping specialists to identify conditions such as cancers more quickly and accurately, and to assess the progress of treat-ment. This type of imaging has become the “gold standard” in oncology. New software is available for Telemis’ medical image-management system, which provides a full-featured dual-modal-ity PET/CT viewer on any PC across any hospital using Telemis software. Upgrade is provided free with a standard software maintenance contract, and will enable healthcare institutions to reduce patient waiting times, speed up diagnosis and enhance treatment. The software greatly increases accessibility by allow-ing dual-modality viewing on any PC or laptop running it. Image fusion is performed locally, allowing oncologists to adjust the images independently for optimal viewing. Traditionally, dual modality images are inspected using an advanced visualisation workstation in specialised locations such as a nuclear medicine department. The typical practice, after a PET/CT scan, is for the radiologist to compile a report for the specialist commissioning the scan; typically an oncologist working with a cancer patient. To discuss the images in depth, the oncologist must meet with the radiologist in the laboratory where a dual-modality work-station is available. The laboratory usually has few workstations, and these are in frequent use, which can introduce delays and difficulties. The new software now allows any PC or laptop to provide sophisticated visualisation capabilities. Specialist teams can convene anywhere to discuss results and assess treatment. The physician can visualise the axial, coronal and sagittal axes in PET, CT and merged PET/CT at the same time. The viewer is highly controllable, allowing adjustment of the transparency level to ensure optimised images when inspecting various parts of the body, such as the lung, pelvis or abdomen. The embedded tools also allow the user to inspect the Maximal Intensity Projec-tion (MIP) and rotational MIP, and to adjust the dimension of the 3D sphere on which the SUV is calculated. Users can also access and manipulate SPECT/CT images in the same way.

teleMiSlouvain-la-neuve, belgium www.ihe-online.com & search 45875

Page 31: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

ProdUCt NEWs 31 – September 2011

technology speeds pixel refresh when reviewing multi-frame image sequences such as tomosynthesis or breast MRI, eliminating blurring or ghosting. Combined with Per Pixel Uniformity (PPU) to remove disturbing screen noise, the display renders mammograms with the best image quality, helping radiologists make accurate diagnoses while speeding up their workflow. Equipped with the powerful Dura-Light Nova backlight, the display system offers twice the calibrated brightness (1,000 cd/m²) of conventional displays, while more than doubling the lamp lifetime (50,000 hours). This luminance enables radiologists to see fine details in dense breast tissue and renders near skin-line details more clearly. The display also provides an I-Luminate ‘hot light’ button for extra brightness, which can reveal subtle details, even in dark areas. The adjustable dual-head stand allows users to angle the displays to their preferred position for optimum viewing. Additionally, the display can be viewed from a wide angle, without sacrificing contrast or black level. Images can now be read from any seat at the reading station, allowing radiologists to discuss the images with colleagues in the room or use them for educational purposes. The display system’s intrinsic brightness reduces eye fatigue and enables reading in a more pleasant ambient room light, preserving visibility of low-contrast details. It also includes the integrated I-Guard sensor which automatically checks contrast and luminance. This provides radiologists with an optimal work environment, boosting diagnostic performance and productivity. To ensure long-lasting image quality and high-grade Quality Assurance, the display system is bundled with MediCal QAWeb, an innovative web-based tool for automated and worry-free calibration. Together with I-Guard, the system guarantees consistent DICOM accuracy and uptime of all displays throughout the facility to ensure a consistent diagnostic outcome.

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Operating table for precision surgery in orthopaedics, traumatology and neurosurgerySpecifically developed to enable all surgical procedures to the upper and lower parts of the skeleton to be carried out on just a single operating table and with the very highest degree of precision, the Yuno OTN mobile operating table is also suitable for neurosurgery. Quality and cost-conscious clinics can have an efficient solution that optimises ergonomic conditions and workflows in orthopaedics, traumatology and neurosurgery. This state-of-the-art operating table was developed in collaboration with surgeons from these spe-cialist fields. It can be precisely adjusted for the type of surgery being carried out. With an adjustable height range of 600 mm, the table

allows the surgeon to work ergonomically during operations in a seated or standing position. With its nar-row – and yet very stable – column, the table ensures excellent accessibility of the sur-gical field. The operat-

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Low environmental impact tracheostomy maskIntersurgical has announced the launch of another product in its Eco range of low environmental impact products: the Adult Eco tracheostomy mask has 82% less impact on the environment compared to its PVC equivalent. The quick release elastic sys-tem ensures that the mask can be removed and refitted easily,

facilitating hygienic procedures. A soft “seal” provides an improved level of comfort whilst a fully rotational 22mm connector ensures optimum orientation for the attachment of humidifier tubing, venturi valves and nebulisers. In its aim to reduce the environmental impact of its products and processes, the company has searched for alterna-tive materials to PVC to address environmental concerns. Being PVC free, this mask is also phthalate free.

interSUrGiCAl Wokingham, berks, UK www.ihe-online.com & search 45862

Act on Heart Failure - a new consulting approachThe complexity of the disease pattern heart failure, the various diagnostic pro-cedures and the multitude of therapeutic approaches impose many requirements on the framework of clinical care. With Act on Heart Failure, Siemens Healthcare has created a new consulting approach specifically focusing on process improve-ment in the clinical management of heart failure. Based on a systematic model,

encompassing clinical guidelines, the latest scientific results and clinical best practice expertise, Act on Heart Failure rates the maturity level of complex clinical processes on a scale of 1 to 5.

Derived from this analysis, Act on Heart Failure offers specific optimization opportunities, focused on continuous improve-ments in heart failure-associated workflows in the hospital. The evaluation and optimization of processes requires in-depth knowledge and experience. Act on Heart Failure integrates the analyses of best-practice processes, the experience of world-lead-ing clinics, guidelines from medical societies, the results of the latest clinical studies and scientific developments as well as the knowledge about state of the art medical technologies. These ele-ments are brought together in an innovative data model, which serves as the basis for the evaluation and optimisation.

SieMenS HeAltHCAreGermany

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ProdUCt NEWs32 – September 2011

Robust C-Arm imaging table

The ergonomic C-Arm imaging table from Biodex has a lower profile base, a propri-etary control top designed in-house as well as a memory base system. The table incorporates a closed system, with all the electrical parts enclosed in bellows, so it is designed to keep out dust and dirt, extend-ing its life. The closed system design lets nothing in, not even water. When the prod-uct was extensively tested before going to market one table, sent out for trial testing, got lost and was later found on a shipping dock a thousand miles away. During this period there was record rainfall, and the box in which the table was packed all but disappeared. On arrival home, however,

the table was found to be in perfect work-ing condition.

biOdex MediCAl SySteMS, inC.Shirley, ny, USA www.ihe-online.com & search 45879

Tabletop dry laser imager

Laser imagers are widely used to print radi-ology images from digital X-ray systems for diagnostic, referral and archival purposes. Designed to meet the specialised radiol-ogy needs of clinics, imaging centres and other medical imaging services providers, the DRYVIEW 5700 laser imager delivers affordable, tabletop output of CR, DR, MRI and CT exams onto medical film. Its com-pact size, high quality and reliability com-bined with low operating costs make it an attractive solution for healthcare providers of all sizes. The laser imager also features Automatic Image Quality Control, which contributes to the system’s ease of opera-tion by ensuring superior quality images with no operator intervention. An intuitive user interface speeds operation and elimi-nates the need for detailed user training.

CAreStreAM HeAltHrochester, ny, USA www.ihe-online.com & search 45863

Anaesthesia delivery management system

The Aisys Car-estation anaes-thesia deliv-ery system, a modular and u p g r a d e a b l e solution built on GE Health-care‘s culture of innovations in anaesthesia

delivery and patient monitoring technologies, is now available with End Tidal (Et) Control. This optional gas delivery mode provides tar-geted control of the volatile agent and patient oxygen as well as an intelligent hypoxic guard, and ensures that the minimum amount of oxygen is delivered. Regardless of changes in the patient’s haemodynamic and metabolic

status, anaesthetic agent and oxygen levels are automatically adjusted to targeted end-tidal levels. Digital settings are monitored and adjusted through simplified menus. Et Control has also been shown to reduce anaesthetic agent consumption significantly, reducing costs and venting of greenhouse gases into the environment, while maintain-ing clinical performance.

Ge HeAltHCArebuc, france www.ihe-online.com & search 45864

System for safe transportation of blood culture vials

Designed for the safe transportation of blood culture vials in pneumatic tube sys-tems, and for the safe transportation of positive blood cultures from satellite sites to a central laboratory, the BD BACTEC Safe-Pod is an enclosed system that can accom-modate up to two BACTEC bottles. Fitting all pneumatic tube transport systems, blood culture vials can be safely conveyed from the point of collection to the point of analysis. An absorbent insert, capable of absorbing 100mL of liquid which is more than suffi-cient for the contents of two bottles, sepa-rates the blood culture vials to cushion them during high-speed transportation. Manu-factured from clear plastic for easy inspec-tion prior to opening, the system is sterilisa-ble for re-use. The BACTEC SafePod is fully compliant with all UN 3373 transportation requirements for diagnostic blood speci-mens – both inside and outside the hospital. The BACTEC blood culture bottles are fully compliant as the primary receptables, and the BACTEC SafePod is fully compliant as the secondary receptacle. Further packaging into either a pneumatic tube for transporta-tion within the hospital, or a rigid box for transportation within sites is possible.

bd diAGnOStiCSerembodegem, belgium www.ihe-online.com & search 45868

Telemedicine platformA pioneering telemedicine platform, the CSC eMEDlink enables clinicians in pri-mary and secondary care to conduct secure,

Advanced ECG system with touchscreen technology

A touch pad for electrocardiography and spirometry, the new MS-2015 provides complete integration of all available prac-tice information systems. Whether it is used as an integrated solution in the prac-tice or as handy device for home calls, the touch pad represents a milestone on the way towards the paperless practice. Based on the high-end touchscreen technology of the MS-2010, the new touch pad offers an even larger 15-inch high-resolution col-our display. It allows users to record, select and print 12 lead ECGs and exports them in XML, or PDF and DICOM fromat over the SCHILLER Communication Server, ena-bling transmission of recordings to any sys-tem that supports these industry standards.

SCHiller AGbaar, Switzerland www.ihe-online.com & search 45865

Page 33: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

ProdUCt NEWs 33 – September 2011

remote audio/visual consultations, empow-ering patients to take control of their per-sonal care. The platform allows patients with long-term conditions and chronic diseases to be treated at home, receiving the same care and treatment as if they had been admitted into hospital. By following patients closely, with virtual ward rounds and ad hoc con-sultations, it helps reduce waiting times and costs associated with unplanned admissions, outpatient clinics and patient transport. Vir-tual monitoring also reduces the precedence of readmission following hospital discharge. The platform can support patients with the following conditions: COPD, asthma, diabe-tes, hypertension, impaired mental health, obesity palliative care, post-operative care, pregnancy and stroke. Patients using the platform at home are provided with a user-friendly modified wireless netbook that connects with different types of devices to monitor vital signs such as blood pressure

or lung function. This allows them to take their own readings, which are then com-municated to clinicians for review and monitoring of their patients’ conditions. The intelligent system creates alerts for any read-ings that exceed pre-determined thresholds, so that clinicians can take the appropriate action. Patient access to speciality services is increased without the restrictions of physi-cal distance. The reduced needs to arrange transport and visit the hospital allow for increased independence and quality of life, as patients can set and achieve goals centred around self-care, increasing proactive per-sonal management of their condition and improving health outcomes. Patient confi-dentiality is also protected through secure storage of information (including video consultations).

CSC HeAltHCAre eMeAAldershot, Hants, UK www.ihe-online.com & search 45869

Efficient, safe castersA unique single-button, triple function caster, the Medic features a multi-purpose cam, which permits one easy-to-engage foot pedal to control three caster functions

– free swivel, swivel lock and total lock. The result is a caster that is easier to start, roll and swivel, allowing optimal mobility. The aesthetically pleasing design incorporates a colour-coded window that indicates the caster position: green for free swivel, yellow for swivel lock, red for total lock. Neoprene wheels, which are much softer than stand-ard medical casters, are both quiet and able to clear obstacles and reject debris without difficulty. Improved braking allows a typical cart with four casters easily to hold a weight of 30 kilos on a ten-degree incline. Hard-ened ball races prevent excessive wear and premature failure.

dArCOr toronto, Canada www.ihe-online.com & search 45871

Performance analyser and tester of electrosurgical devices

The speed and ease of electri-cal safety test-ing of electro-surgical devices is significantly improved with the 377 high p er for manc e analyser from Rigel Medical.The analyser features a range

of easy-to-use custom settings, including a variety of test sequences and power dis-tribution curves which make testing faster, easier and more accurate. The analyser can check the correct and safe performance of electrosurgical devices during routine, type and production line testing to within high degrees of accuracy. A large array of internal resistors, ranging from 10 - 5100Ω in 10Ω steps, provide extremely accurate and detailed power curves. Remote elec-trode monitoring capability is carried out using a rotary encoder, which also controls the potentiometer, scaling up and down in manual or automatic mode to capture the alarm using the on-screen dedicated fast

key. Data can be stored onboard for future traceability. A built-in memory, compre-hensive data management facilities and the widest range of in-built resistors, are pro-vided, while a large full colour screen dis-plays easy-to-follow, step-by-step instruc-tions to ensure the correct connection to the device under test. Bluetooth-enabled technology allows wireless connectivity to PCs and other equipment for the fast and convenient downloading of test data and the uploading of the electrosurgical device’s power curves and the manufac-turer’s test specific programmes. Output waveforms can be examined through a built-in scope output which allows for easy confirmation of the desired wave-form shape. Clear, easy-to-understand in-built graphics display connection dia-grams, programme settings, power curves, alarm settings, data management and data analyses.

riGel MediCAl Peterlee, County durham, UK www.ihe-online.com & search 45870

12-channel electrocardiograph

EDAN’s 12-channel ECG SE-1201 is designed to offer comprehensive solutions with practical features that meet the needs of hospitals, clinics, office-based practices and clinical trials. This compact and port-able ECG enables accurate age and gender specific interpretation supporting clinical decisions. Only minimal training is required, due to the one-button operation and intui-tive workflow, allowing health practitioners to focus on patients. The electrocardiograph records ECG reports or automatically trans-mits them to an appropriate system via LAN or WIFI. The worklist function also allows bi-directional transmission. PDF, SCP, FDA-XML and DICOM standard ECG format export allows open communications with hospital information systems.

edAn inStrUMentSShenzhen, China www.ihe-online.com & search 45866

Page 34: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

34 – September 2011 iNdUstrY NEWs

Samsung Medison aiming to be a world-class medical device companyMedison and Samsung Electronics have come together and announced a new corporate identity for Samsung’s healthcare business – Samsung Medison. The combined company, built from Korea’s leading diagnostic ultra-sound equipment and one of the world’s larg-est and most technologically-advanced elec-tronics and consumer goods companies, has now set out its vision of transforming itself into a world-leading medical device company.Samsung Medison’s CEO, Bang Sang-Won, has set out the new corporate vision of ‘New Vision into Life’, and has announced the com-pany’s goal of becoming one of the world’s top four ultrasound diagnostics firms. In part through synergies with Samsung Electronics, the company aims to become a top tier medi-cal equipment manufacturer by 2020. Mr. Bang said that in line with Samsung’s global image, the very best in quality and service would be provided. The company would dramatically increase its investment in research and devel-opment, and would do its utmost to promote human health and happiness by securing the best in scientific and human resources in the medical device industry.Samsung Medison will combine Samsung’s resources, digital technology and experience of growth worldwide with Medison’s techno-logical prowess and established market pres-ence. The company will continue to invest more than 10% of its annual sales in R&D, and will expand investment in marketing strate-gies such as through the holding of global academic conferences and seminars. Samsung plans to have more than 10,000 employees in its medical equipment business by 2020.www.samsungmedison.com

Philips agrees with Masimo to bring rainbow SET technology to monitoring productsIn an effort to advance quality of care and patient safety, Philips has established an agree-ment with Masimo, the California-based global medical technology company that develops and manufactures innovative noninvasive patient monitoring technologies. Philips will incorpo-rate Masimo’s rainbow SET technology into many of its patient monitoring devices dur-ing the next few years. This technology analy-ses multiple wavelengths of light to accurately measure total haemoglobin (SpHb), oxygen content (SpOC), carboxyhaemoglobin (SpCO), methaemoglobin (SpMet) and Pleth Variability Index (PVI) noninvasively and continuously. Deborah DiSanzo, executive vice president of Patient Care and Clinical Informatics for Philips Healthcare said that the integration of rainbow SET technology represented a great

benefit for Philips’ customers. The partnership with Masimo furthered the company’s Patient Care and Clinical Informatics strategy to sim-plify workflow by giving clinicians the meas-urement they needed at the bedside, measure-ments which would help improve and save lives.www.healthcare.philips.com

Socomec UPS strengthens its position in the Middle EastThe absolute necessity for a reliable power supply for healthcare buildings is now coupled with the need to improve the energy efficiency of buildings in order to achieve sustainable management of installations. One of the lead-ing companies supplying critical applications especially in the business continuity sector (including healthcare), Socomec UPS is now strengthening its hold in the Middle East with the opening of its new subsidiary in Dubai. There are numerous objectives involved: strengthening the company’s position in the Middle Eastern market, directly monitoring the progress of large-scale projects in the area, offering local distributors constant support and dedicating even more time and effort to the pre-and post-sales services provided. The team will be led by Stefano Costa, Socomec UPS Middle East & Africa Sales Director, who said that the Middle East was an important reference market for Socomec and one that was constantly changing. There were cur-rently three segments experiencing significant development in the area: infrastructure, hos-pital facilities and data centres with Socomec’s solutions being ideal for all those applications. A very high level of technological innovation was required in these areas, and Sococmec had all the right qualities to successfully tackle the challenges presented by the market.www.socomec.com

China International Medical Equipment Fair (CMEF) Spring 2011Asia’s most established and largest event for the medical equipment sector, the 64th CMEF was held recently in the Shenzen Con-vention and Exhibition Centre in Guang-dong province, China. The exhibition cov-ered 110,000 square metres, providing space for 5,400 booths. More than 2,400 exhibitors from over 20 countries flocked to the event, and there was a record breaking number of 24 national pavilions. Around 120 thou-sand visitors from more than 100 countries attended the show. The event offered a very diverse range of products under one roof, and clearly demarcated sectors facilitated the visi-tors’ scrutiny of many products whose quality is comparable with those offered by the Euro-pean market. www.cmef.com.cn

CALENdAr oF EVENtsSeptember 14-16, 2011

Medical Fair Thailand 2011

Bangkok, Thailand

Tel. +65 6332 9620

Fax +65 6332 9655

e-mail:

[email protected]

www.medicalfair-thailand.com

Sept 18-22, 2011

21st World Congress on

Ultrasound in Obstetrics and

Gynecology

Los Angeles, CA, USA

Tel. +44 (0) 20 7471 9955

e-mail: [email protected]

www.isuog.org/

WorldCongress/2011/

September 24-28, 2011

ERS Annual Congress

Amsterdam, The Netherlands

Tel. +49 30 246 032 20

Fax +49 30 246 033 99

e-mail: ers2011registration@

kit-group.org

www.erscongress2011.org

Sept 29 – Oct 2,2011

WORLDCON 2011 — XVIth

World Congress of Cardiology,

Echocardiography & Allied Imag-

ing Techniques

New Delhi, India

Tel. + 91 124 456300

e-mail: [email protected]

www.worldcon2011.org

October 1-5, 2011

ESICM LIVES 2011 24th Annual

Congress

ICC-Berlin, Germany

Tel. +32 2 559 03 71

Fax +32 2 559 03 79

e-mail: [email protected]

www.esicm.org

Oct 31 - Nov 3, 2011

CMEF Autumn 2011

Fuzhou, China

Tel. +86 10 84556695

http://en.cmef.com.cn/

November 16-19, 2011

MEDICA

Düsseldorf, Germany

e-mail: [email protected]

www.medica.de

November 17-18, 2011

Healthcare Supply Chain Officer

Summit 2011 (HSCO2011)

Shanghai, China

Tel. +86 21 3639 7572 - 805

http://healthcare.sco-summit.

com/2011

November 22-24, 2011

9th Doppler-Echocardiography

Course

Brussels, Belgium

Tel. +32 2 555 36 31

Fax +32 2 555 45 55

e-mail: [email protected]

www.intensive.org

November 27 – December

2, 2011

RSNA 2011

Chicago, IL, USA

Tel. +1 630 571 2670

www.rsna.org

December 6-8, 2011

17th Postgraduate Refresher

Course: Cardiovascular and

Respiratory Physiology Applied to

Intensive Care Medicine

Brussels, Belgium

Tel. +32 2 555 36 31

Fax +32 2 555 45 55

e-mail: [email protected]

www.intensive.org

December 11-14, 2011

Update on Neuromonitoring

Rome, Italy

Tel. +32 2 555 36 31

Fax +32 2 555 45 55

e-mail: [email protected]

www.intensive.org

January 23-26, 2012

Arab Health 2012

Dubai, UAE

Tel. +971 4 336 5161

www.arabhealthonline.com

February 2-5, 2012

Up Close and Personalized,

International Congress on Person-

alized Medicine (UPCP 2012)

Florence, Italy

Tel. +41 22 5330 948

www.upcp.org

March 1-5, 2012

ECR 2012

Vienna, Austria

Tel. +43 1 533 40 64 - 0

Fax +43 1 533 40 64 - 448

e-mail: [email protected]

www.myesr.org

March 20-23, 2012

32nd ISICEM

Brussels, Belgium

Tel. +32 2 555 36 31

Fax +32 2 555 45 55

e-mail: [email protected]

www.intensive.org

dates and descriptions of future events have been obtained from usually reliable official industrial sources. iHE cannot be held

responsible for errors, changes or cancellations.

For more events see www.ihe-online.com/events/

Page 35: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

Abstract Submission Scientifi c Papers: July 5 – September 18, 2011 Poster Abstract Submission for EPOSTM: all year long!

Online Registration: starts September 2011

Page 36: Equipment & Technology Medical Management · ing from pressure ulcers (bedsores) by invest-ing in pressure-reduction mattresses for elderly patients in emergency departments (EDs),

Cardiovascular care is in motion. On the one hand, healthcare systems hold increasing economical challenges. On the other hand, you want to safeguard your position as a leading cardiovascular care provider, both today and in the years to come. How to solve this issue?

With a partnership that lasts. At Siemens, we accompany you. We provide solutions that are sustainable and affordable, again and again. This is the long-run. And to navigate it, we provide you with technology that can support your ability to make sounder decisions, perform safer procedures, operate with better efficiency, and invest resources wisely. In short, we help you establish a sound basis for the future – so you are perfectly prepared for the long-run.

Answers for life.

www.siemens.com/cardiology

Are you ready for the long-run?Sustainable Cardiovascular Care

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www.ihe-online.com & search 45721