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Comparison of Outcomes in High-Risk Patients >70 Years of AgeWith Aortic Valvuloplasty and Percutaneous Coronary

Intervention Versus Aortic Valvuloplasty Alone

Wes R. Pedersen, MDa,b,*, Paul J. Klaassen, MDa, Christopher W. Pedersena, Jessica A. Wilsona,Kevin M. Harris, MDa, Irvin F. Goldenberg, MDb, Anil K. Poulose, MDa, Michael R. Mooney, MDa,

Timothy D. Henry, MDa, and Robert S. Schwartz, MDa

The goal of this study was to compare outcomes of combined balloon aortic valvuloplasty(BAV) plus percutaneous coronary intervention (PCI) with BAV alone in a surgically highrisk, older (>70 years) population with both aortic stenosis (AS) and coronary arterydisease (CAD). The medical records, coronary angiograms, and procedural reports of 100consecutive patients who underwent BAV and coronary angiography at our institutionfrom July 2003 to November 2006 were reviewed. Seventeen patients (mean age 86.2 � 6.4years) underwent combined (nonstaged) BAV and PCI with a calculated Society of Tho-racic Surgery risk score of 13.5% � 6.7; 13 of these underwent coronary stenting beforeBAV and 4 after BAV. All 17 patients were successfully treated with this combinedstrategy. T h e incidence of periprocedural mortality, myocardial infarction, and strokewas zero. An additional 25 patients (mean age 85.9 � 6.9) with CAD were identifiedwho underwent BAV alone with a Society of Thoracic Surgery risk score of 12.6 �5.7%. PCI in these patients was avoided primarily because of greater lesion complexityor a perceived low probability of symptomatic benefit. There was 1 procedural death,no myocardial infarction, and 1 postprocedural stroke in these 25 patients. Theprocedural duration and hospital length of stay for the combined BAV and PCI groupwas 98.8 � 17.6 minutes and 4.1 � 2.8 days, respectively, and for the BAV only groupwas 86.2 � 27.3 minutes and 3.3 � 2.1 days, respectively. In conclusion, with appro-priate selection, BAV plus PCI was safely performed in this retrospective series ofelderly, high-risk patients with severe AS and CAD. © 2008 Elsevier Inc. All rights

reserved. (Am J Cardiol 2008;101:1309 –1314)

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s percutaneous aortic valve implantation evolves, the fea-ibility and safety of combined percutaneous aortic valvend coronary intervention will require clinical evaluation.e report patient and procedural characteristics and in-

ospital outcomes in a consecutive series of patients whonderwent combined (i.e., performed as a single procedure)alloon aortic valvuloplasty (BAV) and percutaneous cor-nary intervention (PCI) at our institution and comparedhem with those who also had aortic stenosis (AS) andoronary artery disease (CAD) but underwent BAV only.

ethods

e reviewed the cases of 100 consecutive patients whonderwent BAV and coronary angiography at our institutionrom July 2003 to November 2006, examining in detailhose with both severe AS and CAD. All patients hado-morbidities placing them at increased surgical risk for

aMinneapolis Heart Institute Foundation at Abbott Northwestern Hos-ital; bTwin Cities Heart Foundation, Minneapolis, Minnesota. Manuscripteceived August 9, 2007; revised manuscript received and accepted De-ember 19, 2007.

*Corresponding author: Tel: 612-863-7372; fax: 612-863-2490.

eE-mail address: Wesley.Pedersen@allina.com (W.R. Pedersen).

002-9149/08/$ – see front matter © 2008 Elsevier Inc. All rights reserved.oi:10.1016/j.amjcard.2007.12.033

ortic valve replacement and coronary artery bypass graft-ng or were �90 years of age. All patients had symptoms ofew York Heart Association functional classes II to IV.Data were derived from both retrospective and prospec-

ive databases designed for evaluating patient characteris-ics, procedural techniques, and outcomes in those under-oing BAV at our institution. An online calculator was usedo quantitate the Society of Thoracic Surgery risk scores1

or estimates of operative mortality.Left ventricular ejection fraction was obtained from pre-

peration echocardiography performed within 30 days ofhe BAV procedure. All reported pre- and post-BAV aorticalve gradients and valve areas were obtained from theardiac catheterization-derived hemodynamics at the timef valvuloplasty. Patients with documented CAD, defined as70% diameter narrowing were divided into 2 groups. One

roup included patients treated with combined (nonstaged)AV and PCI, and the other group underwent BAV but noCI. Coronary lesions in both groups were categorized byreviously established A, B1, B2, C criteria.2

Bilateral cardiac catheterization was performed from theransfemoral approach. Aortic valve mean gradients wereetermined by simultaneous, ascending aortic, and left ven-ricular pressure recordings using double lumen pigtail cath-

ters. Cardiac outputs were determined by standard ther-

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odilution technique and aortic valve area calculated bysing the Gorlin formula. Coronary angiography is rou-inely carried out on our patients with BAV unless contra-ndicated.

BAV was performed by standard retrograde technique in6 of the 17 patients who underwent combined BAV andCI and by antegrade technique in the remaining patient.3,4

etrograde BAV was performed in 20 of 25 patients whonderwent BAV alone and antegradely in the remaining 5atients. In those who underwent retrograde BAV, singlealloon inflations were carried out using commerciallyvailable cylindrical balloons ranging from 20 to 26 mm iniameter. Generally, between 2 and 3 balloon inflationsere carried out with each balloon size used. Aortic valveradients and thermodilution cardiac outputs were repeatedefore determining the need for upsizing to a larger ballooniameter. A 50% to 100% improvement in aortic valve areaas the procedural goal. Successful BAV was defined as a30% increase in aortic valve area. Twelve or 14 French

heaths were used in all patients for valvuloplasty balloonccess. Simultaneous transvenous rapid right ventricularacing was carried out at 200 to 220 ppm during balloonnflations in all but the initial 2 patients to limit transaorticow and thus assist in securing balloon position. A 26 mmnoue balloon was used for antegrade BAV.

PCI was carried out on “significant” stenosis defined as70% diameter narrowing by visual estimate and, in the

pinion of the operator, would likely contribute to residualngina or anginal equivalent symptoms after BAV alone.

hether BAV or PCI was carried out initially was left to theiscretion of the operator. Standard 6 to 8 French coronaryuide catheters were used for PCI. All lesions were treatedith either bare metal or drug eluting stents. Balloon predi-

atation was performed in coronary lesions believed poorlyuited for primary stenting. Severe calcification requiringotational atherectomy was not seen in this patient series.ntravascular ultrasound guidance was not used. Periopera-ive myocardial infarction was defined as a postoperative

able 1omparison of clinical and coronary lesion characteristics in patients whooronary intervention (PCI) versus BAV only

ariable BAV �(n �

ge (yrs) 86.2 �omen:Men 10

eft ventricular ejection fraction (%) 44 �reatinine (mg/dl) 1.2 �revious coronary bypass 3 of 17 (umber of diseased coronary vessels 1.9 �

oronary lesion classification A) Treated(n � 24)

171 62 1

0eference diameter �2.5 mm 3 (12.5%)

BAV � balloon aortic valvuloplasty; PCI � percutaneous coronary int

reatine kinase-MB elevation �3 times normal. Postopera-

ive renal insufficiency was defined as an increase in creat-nine �0.5 mg/dl.

Patients were treated with 325 mg of aspirin preopera-ively; 70 to 90 U/kg of heparin were administered tochieve an activated clotting time of 200 to 250 secondsfter obtaining femoral arterial and venous access in theetrograde patients and after transseptal puncture in ante-rade patients. A 300 to 600 mg clopidogrel oral load wasiven when the decision was made to proceed with PCI.lycoprotein IIb/IIIa inhibitors were not used in any pa-

ients. All patients were maintained postoperatively on 81 to25 mg of aspirin. Those who underwent PCI were alsoaintained on 75 mg of clopidogrel. The femoral arterial

heath was removed when the activated clotting time fell to140 seconds. Arteriotomy compression was carried out

or 30 to 40 minutes, followed by 8 hours of bed rest. Suturer other percutaneous closure devices were not used.

Comparisons of patient clinical data and coronary lesionharacteristics are listed in Table 1. Categorical (nominal)ata items were analyzed using Pearson’s chi-square test;nterval data was examined by Student’s t test with 2-sided

values. Comparisons of numbers of lesions in each groupsed Wilcoxon’s signed-rank test; Pearson’s chi-square or tests gave qualitatively identical results. Full disclosure dataor each patient in the BAV and PCI group and BAV onlyroup are provided in Tables 2 and 3, respectively.

esults

f 100 consecutive BAV procedures, 42 (42%) were foundo have angiographically significant CAD. Of these 42 pa-ients, 17 (40%) underwent combined BAV and PCI. Nonef the 42 patients with CAD who were scheduled for BAVnd possible PCI had either procedural component aborteds a result of a complication. The mean maximal (final)alloon diameter used for retrograde BAV in these patientsas 23.7 � 1.7 mm (range 20 to 26 mm). The averageumber of balloon inflations per case was 3.0 (range 1 to 8).

ent combined balloon aortic valvuloplasty (BAV) and percutaneous

BAV Only(n � 25)

p Value

85.9 � 7.0 0.8810:15 0.35

41 � 16.3 0.621.2 (�0.4) 0.75

10 of 25 (40.0%) 0.182.3 � 0.8 0.16

ntreated� 11)

C) All Untreated(n � 45)

A vs C

1 4 �0.00012 11 0.451 13 0.0087 17 0.0002

54.5%) 16 (35.6%) 0.005

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Both BAV and PCI were carried out successfully in all

Table 2Combined balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) group

Pt. Age Gender HxCAB

Pre Cr(mg/dl)

DM EF Pre(%)

1/2/3/vcad Lesions StentedVessels

A or RBAV

Pre p-pgr

(mm Hg)

Pre mngr

(mm Hg)

PreAVA(cm2)

Post p-pgr

(mm Hg)

Post mngr

(mm Hg)

PostAVA(cm2)

ProcedureTime(min)

LOS(days)

1 99 F Y 1 N 58 3VCAD A * B1 1 R 64 62 0.43 32 33 0.7 73 72 95 F N 2.2 N 40 1VCAD A* 1 R 77 63 0.38 20 29 0.76 100 23 93 F N 1.1 N 55 3VCAD A* B1 C 1 A 59 49 0.71 18 17 1.1 129 114 90 F N 0.7 N 60 1VCAD B1* 1 R 73 64 0.28 20 26 0.71 85 35 89 F N 0.8 TYPE II 37 1VCAD A* 1 R 70 62 0.3 27 26 0.66 114 46 88 F N 1.6 N 60 1VCAD A* 1 R 61 62 0.58 29 30 1.06 75 47 88 F N 1.2 N 45 1VCAD A* 1 R 20 22 0.62 9 11 0.95 63 28 88 M N 1.1 N 58 1VCAD A* 1 R 48 53 0.55 27 29 1.27 94 59 86 F N 0.9 N 50 2VCAD A* A* 2 R 55 44 0.51 22 22 1.07 100 2

10 85 M Y 1.9 N 40 3VCAD A* B1* B1* 3 R 58 58 0.64 32 35 0.94 104 411 85 M Y 1 N 45 3VCAD B2* C C C 1 R 59 53 0.45 22 26 0.75 89 312 84 M N 1.2 N 38 2VCAD A* A* C 2 R 61 48 0.43 33 32 0.66 104 213 84 M N 1.5 N 20 3VCAD A B1* B2 C 1 R 63 64 0.4 22 27 1.26 104 214 81 F N 0.9 N 55 1VCAD B1* 1 R 79 67 0.37 23 23 0.72 94 215 81 M N 1.3 N 22 2VCAD A* A* 2 R 30 29 0.77 19 19 1.19 95 416 78 M N 1.3 TYPE II 20 3VCAD A* A* B1* C 2 R 43 36 0.65 18 17 1.1 124 1017 72 F N 1.2 N 45 1VCAD A* 1 R 25 26 0.47 14 18 0.79 115 3Mean 86.2 NA NA 1.3 NA 44 1.9 NA 1.4 NA 55.6 50.7 0.5 22.8 24.7 0.92 98.8 4.1SD � 6.4 � 0.4 � 13.6 � 0.9 � 0.6 � 17.3 � 14.6 � 0.14 � 6.6 � 6.6 � 0.22 � 17.6 � 2.8

Pt � patient; HxCAB � history of coronary artery bypass; Precr � preoperative creatinine; DM � diabetes mellitus; EF Pre � ejection fraction preoperatively; 1/2/3vcad � 1, 2, or 3 vessel coronary arterydisease; A or R BAV � antigrade or retrograde balloon aortic valvuloplasty; Pre p-p gr � preoperative peak to peak aortic valve gradient; Pre mn gr � preoperative mean aortic valve gradient; Pre AVA� preoperative aortic valve area; Post p-pgr � postoperative peak to peak gradient; Post mn gr � postoperative mean aortic valve gradient; Post AVA � postoperative aortic valve area; LOS � length ofstay.

* Lesions treated with PCI.

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Table 3Balloon aortic valvuloplasty (BAV) without stenting

Pt. Age Gender HxCAB

Pre Cr(mg/dl)

DM EF Pre(%)

1/2/3vcad Lesions A or RBAV

Pre p-p gr(mm Hg)

Pre mn gr(mm Hg)

PreAVA(cm2)

Post p-p gr.(mm Hg)

Post mn gr.(mm Hg)

PostAVA(cm2)

ProcedureTime(min)

LOS(days)

1 100 F N 1.1 N 45 1VCAD A R 71 72 0.45 33 37 0.8 67 52 98 F N 1.1 N 55 3VCAD B1 B2 C R 37 42 NA 17 19 NA 114 23 93 M N 1 N 52 3VCAD C C C R 35 35 0.65 12 14 1.06 49 54 92 M Y 0.9 N 63 3VCAD B2 A 38 39 0.78 19 21 1.02 123 25 91 M Y 1.1 N 40 3VCAD B1 C A 48 42 0.53 21 21 0.91 88 46 90 M Y 1.6 N 20 3VCAD C R 39 41 0.43 11 17 0.73 93 47 90 F N 0.8 N 40 3VCAD B1 B2 C R 34 37 0.51 18 20 0.86 87 78 89 M N 0.9 N 50 1VCAD B1 R 72 74 0.46 39 43 0.7 106 19 88 F N 1 N 20 3VCAD B1 B2 B2 R 81 68 0.32 21 31 NA 165 0

10 88 M N 1.7 N 30 2VCAD B1 C R 30 30 0.54 11 16 0.89 58 211 88 M Y 1.2 TYPE II 30 2VCAD B1 R 45 42 0.4 32 34 0.73 75 212 86 F N 1 N 60 2VCAD B2 B2 R 65 50 0.67 33 27 0.93 91 413 86 F N 1.1 TYPE II 30 1VCAD B1 A 51 56 0.47 11 18 0.8 100 414 85 M N 0.9 N 30 1VCAD C R 28 35 0.8 10 15 1.06 104 715 85 M Y 1.9 N 60 3VCAD C R 54 48 0.73 28 28 0.94 73 116 84 F Y 1.1 N 45 3VCAD B2 R 28 28 0.63 18 20 0.75 65 417 84 F N 1.1 TYPE II 15 2VCAD B1 B2 C R 47 38 0.44 17 20 1.06 63 518 84 M N 1.1 N 20 1VCAD C R 50 41 0.81 18 20 1.6 67 119 84 M Y 2.3 N 60 3VCAD B2 C R 34 34 0.7 16 22 NA 34 120 84 F N 1.8 N 55 2VCAD A B1 R 39 42 0.46 14 17 1.04 88 521 82 M N 1.3 TYPE II 25 3VCAD B1 B2 C R 31 32 0.78 16 18 0.98 63 322 79 F N 1.2 N 70 1VCAD A A 38 47 0.63 30 26 0.94 96 123 78 M Y 1.1 N 25 3VCAD C C R 30 29 1.03 8 14 1.7 95 724 70 M Y 1.6 TYPE II 60 3VCAD A B2 R 59 51 0.6 44 44 0.83 114 425 70 M Y 1.8 TYPE II 40 2VCAD B2 C A 34 34 0.72 20 25 0.9 77 2Mean 85.92 NA NA 1.3 NA 41.6 2.3 NA NA 44.7 43.5 0.61 20.7 24 0.97 86.2 3.3SD � 6.97 � 0.4 � 16.3 � 0.8 � 14.9 � 12.6 n� 0.17 � 9.6 � 8.5 � 0.25 � 27.2 � 2.1

Abbreviations as in Table 2.

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1313Heart Failure/Combined Aortic Valvuloplasty and Coronary Stenting

7 patients in the combined group. Pre- and post-BAV meanradients were 50.7 � 14.6 mm Hg and 24.7 � 6.6 mm Hgespectively. Pre- and post-BAV aortic valve areas were.50 � 0.14 cm2 and 0.92 � 0.22 cm2, respectively. PCIas carried out before BAV in 13 of 17 cases; 3 of the 4AV-first cases underwent valve dilatation before PCI be-ause of an at rest systolic arterial pressure �90 mm Hg onrrival to the cardiac catheterization laboratory. The fourthatient underwent antegrade BAV first to avoid hepariniza-ion before the transseptal puncture. Single vessel PCI wasarried out in 12 patients, 2-vessel PCI in 4, and 3-vesselCI in 1. Complete revascularization was achieved in 13 of7 patients. There were 24 lesions treated within 23 targetessels. All lesions were treated with intracoronary stents,5 of which were predilated before stent delivery. An av-rage of 1.1 stents per lesion was deployed; 5 of 17 patientseceived bare metal stents only, 11 patients received drug-luting stents only, and 1 patient received both. Table 1 listsoronary lesion characteristics of both treated and untreatedesions.

Two of the 3 saphenous vein graft lesions in these pa-ients were treated with distal filter wire embolic protection;

patient had brief transient slow flow in the treated saphe-ous vein graft with degenerative disease despite distalmbolic protection. The peak creatine kinase-MB was 7.0g/dl on the morning after the procedure, i.e., �3 times

pper limit of normal. There were no strokes, myocardialnfarctions, procedural or in-hospital mortalities in thisombined patient group; 1 patient had transient nonoliguricenal insufficiency postprocedure and 1 had transient AVlock requiring temporary pacing �24 hours. There were noercutaneous entry site bleeds requiring blood transfusionr surgical repair. Mean procedural duration was 98.8 �7.6 minutes, and mean length of hospitalization after BAVas 4.1 � 2.8 days (range 2 to 11).BAV was successful in 24 of the 25 patients undergoing

AV alone; 1 patient died intraprocedurally secondary toortic root dissection. There were no myocardial infarctions,postprocedural stroke, and 1 additional in-hospital mor-

ality in this group secondary to pneumonia and sepsisnrelated to any procedural complication. Two minor com-lications included 1 patient requiring transfusion for vas-ular entry site bleed and 1 with transient, nonoliguric renalnsufficiency. Twenty BAVs were carried out retrogradelyith a mean maximal balloon diameter of 23.8 � 1.5 mm

range 22 to 25). Pre- and post-BAV mean gradients were3.5 � 12.6 mm Hg and 24 � 8.5 mm Hg, respectively.re- and post-BAV aortic valve areas were 0.61 � 0.17 cm2

nd 0.97 � 0.25 cm2, respectively. Mean procedure dura-ion was 86.2 � 27.2 minutes and mean length of hospital-zation after BAV was 3.3 � 2.1 days (range 1 to 7).

iscussion

ppropriate strategies for the percutaneous treatment ofoor surgical risk patients with both severe symptomatic ASnd CAD have not been defined. Very small case seriesave been published previously, reporting on the feasibilityf combined BAV and balloon coronary angioplasty with-ut significant complications.5–9 These small case series

enerally included patients with mean ages in the late 70s,

decade younger than our series. In addition, they havencluded patients who underwent BAV and PCI days toeeks apart. With an expanding population of elderly high-

isk patients who mostly go untreated, PCI and percutane-us aortic valve implantation offers the potential for moreurable treatment than coronary angioplasty and BAVlone. Although we did not have a comparison group whonderwent BAV and PCI days to weeks apart, we believedhe risk of a combined procedure would be equivalent andossibly lower, as well as more convenient, than 2 separatenterventions.

In hopes of limiting critical myocardial ischemia second-ry to hypotension during valve dilation, 13 of the 17atients underwent PCI before BAV; 3 of the 4 patients whonderwent BAV first arrived in the catheterization labora-ory hypotensive secondary to critical AS and thus under-ent BAV before PCI. With percutaneous valve implanta-

ion on the horizon, PCI would ideally be carried out beforeevice deployment in the aortic root given its small poten-ial for limiting coronary access. Based on our small series,his approach is worthy of further investigation.

A decision to proceed with PCI at the time of BAV wasased primarily on operator bias that the untreated coronarytenosis would contribute to inadequate symptomatic im-rovement. This in turn reflected myocardial viability andize of territory subtended. In addition, complex lesionsith low likelihood of success or increased probability of

omplications were avoided as reflected in the lesion ana-omic score. Useful discriminators between those undergo-ng PCI at the time of BAV and patients undergoing BAVnly included coronary lesion classification (A, B1, B2, C),eference vessel diameter, and vessels subtending myocar-ial infarction zones. These discriminators were valid whenomparing treated coronary lesions with those left untreatedn both groups. A higher percentage of treated lesions wereype A and untreated lesions were type C. The high PCIuccess rate and low complication rate was therefore in partelated to our ability to correctly identify and target moreavorable lesion morphologies. Strategically, this translatednto a desire to avoid treating lesions with low success ratess well as those unlikely to result in symptomatic benefit.linical discriminators in Table 1 were not significantlyifferent between groups.

This study is limited by its small size and retrospectiveature; therefore, the combined approach of BAV and PCIhould not be generalized to all patients with AS and CAD.atients were not randomized to either BAV or PCI alone,aking it difficult to evaluate the relative merits of each

ompared with the combined strategy. This population isikely typical of poor-surgical-risk elderly patients withymptomatic AS and severe CAD who could be consideredandidates for BAV and PCI.

In this small series of high-surgical-risk elderly patientsith symptomatic AS and CAD, combined BAV and PCIas accomplished with low procedural morbidity and in-ospital mortality when appropriately selected.

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