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Comparison of Outcomes in High-Risk Patients >70 Years of Age With Aortic Valvuloplasty and Percutaneous Coronary Intervention Versus Aortic Valvuloplasty Alone Wes R. Pedersen, MD a,b, *, Paul J. Klaassen, MD a , Christopher W. Pedersen a , Jessica A. Wilson a , Kevin M. Harris, MD a , Irvin F. Goldenberg, MD b , Anil K. Poulose, MD a , Michael R. Mooney, MD a , Timothy D. Henry, MD a , and Robert S. Schwartz, MD a 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 high risk, older (>70 years) population with both aortic stenosis (AS) and coronary artery disease (CAD). The medical records, coronary angiograms, and procedural reports of 100 consecutive patients who underwent BAV and coronary angiography at our institution from July 2003 to November 2006 were reviewed. Seventeen patients (mean age 86.2 ؎ 6.4 years) 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 before BAV and 4 after BAV. All 17 patients were successfully treated with this combined strategy. T h e incidence of periprocedural mortality, myocardial infarction, and stroke was zero. An additional 25 patients (mean age 85.9 ؎ 6.9) with CAD were identified who 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 complexity or a perceived low probability of symptomatic benefit. There was 1 procedural death, no myocardial infarction, and 1 postprocedural stroke in these 25 patients. The procedural duration and hospital length of stay for the combined BAV and PCI group was 98.8 ؎ 17.6 minutes and 4.1 ؎ 2.8 days, respectively, and for the BAV only group was 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 of elderly, high-risk patients with severe AS and CAD. © 2008 Elsevier Inc. All rights reserved. (Am J Cardiol 2008;101:1309 –1314) As percutaneous aortic valve implantation evolves, the fea- sibility and safety of combined percutaneous aortic valve and coronary intervention will require clinical evaluation. We report patient and procedural characteristics and in- hospital outcomes in a consecutive series of patients who underwent combined (i.e., performed as a single procedure) balloon aortic valvuloplasty (BAV) and percutaneous cor- onary intervention (PCI) at our institution and compared them with those who also had aortic stenosis (AS) and coronary artery disease (CAD) but underwent BAV only. Methods We reviewed the cases of 100 consecutive patients who underwent BAV and coronary angiography at our institution from July 2003 to November 2006, examining in detail those with both severe AS and CAD. All patients had co-morbidities placing them at increased surgical risk for aortic valve replacement and coronary artery bypass graft- ing or were Ն90 years of age. All patients had symptoms of New York Heart Association functional classes II to IV. Data were derived from both retrospective and prospec- tive databases designed for evaluating patient characteris- tics, procedural techniques, and outcomes in those under- going BAV at our institution. An online calculator was used to quantitate the Society of Thoracic Surgery risk scores 1 for estimates of operative mortality. Left ventricular ejection fraction was obtained from pre- operation echocardiography performed within 30 days of the BAV procedure. All reported pre- and post-BAV aortic valve gradients and valve areas were obtained from the cardiac catheterization-derived hemodynamics at the time of valvuloplasty. Patients with documented CAD, defined as Ն70% diameter narrowing were divided into 2 groups. One group included patients treated with combined (nonstaged) BAV and PCI, and the other group underwent BAV but no PCI. Coronary lesions in both groups were categorized by previously established A, B1, B2, C criteria. 2 Bilateral cardiac catheterization was performed from the transfemoral approach. Aortic valve mean gradients were determined by simultaneous, ascending aortic, and left ven- tricular pressure recordings using double lumen pigtail cath- eters. Cardiac outputs were determined by standard ther- a Minneapolis Heart Institute Foundation at Abbott Northwestern Hos- pital; b Twin Cities Heart Foundation, Minneapolis, Minnesota. Manuscript received August 9, 2007; revised manuscript received and accepted De- cember 19, 2007. *Corresponding author: Tel: 612-863-7372; fax: 612-863-2490. E-mail address: Wesley.Pedersen@allina.com (W.R. Pedersen). 0002-9149/08/$ – see front matter © 2008 Elsevier Inc. All rights reserved. www.AJConline.org doi:10.1016/j.amjcard.2007.12.033 modilution technique and aortic valve area calculated by using the Gorlin formula. Coronary angiography is rou- tinely carried out on our patients with BAV unless contra- indicated. BAV was performed by standard retrograde technique in 16 of the 17 patients who underwent combined BAV and PCI and by antegrade technique in the remaining patient. 3,4 Retrograde BAV was performed in 20 of 25 patients who underwent BAV alone and antegradely in the remaining 5 patients. In those who underwent retrograde BAV, single balloon inflations were carried out using commercially available cylindrical balloons ranging from 20 to 26 mm in diameter. Generally, between 2 and 3 balloon inflations were carried out with each balloon size used. Aortic valve gradients and thermodilution cardiac outputs were repeated before determining the need for upsizing to a larger balloon diameter. A 50% to 100% improvement in aortic valve area was the procedural goal. Successful BAV was defined as a Ն30% increase in aortic valve area. Twelve or 14 French sheaths were used in all patients for valvuloplasty balloon access. Simultaneous transvenous rapid right ventricular pacing was carried out at 200 to 220 ppm during balloon inflations in all but the initial 2 patients to limit transaortic flow and thus assist in securing balloon position. A 26 mm Inoue balloon was used for antegrade BAV. PCI was carried out on “significant” stenosis defined as Ն70% diameter narrowing by visual estimate and, in the opinion of the operator, would likely contribute to residual angina or anginal equivalent symptoms after BAV alone. Whether BAV or PCI was carried out initially was left to the discretion of the operator. Standard 6 to 8 French coronary guide catheters were used for PCI. All lesions were treated with either bare metal or drug eluting stents. Balloon predi- latation was performed in coronary lesions believed poorly suited for primary stenting. Severe calcification requiring rotational atherectomy was not seen in this patient series. Intravascular ultrasound guidance was not used. Periopera- tive myocardial infarction was defined as a postoperative creatine kinase-MB elevation Ն3 times normal. Postopera- tive renal insufficiency was defined as an increase in creat- inine Ͼ0.5 mg/dl. Patients were treated with 325 mg of aspirin preopera- tively; 70 to 90 U/kg of heparin were administered to achieve an activated clotting time of 200 to 250 seconds after obtaining femoral arterial and venous access in the retrograde patients and after transseptal puncture in ante- grade patients. A 300 to 600 mg clopidogrel oral load was given when the decision was made to proceed with PCI. Glycoprotein IIb/IIIa inhibitors were not used in any pa- tients. All patients were maintained postoperatively on 81 to 325 mg of aspirin. Those who underwent PCI were also maintained on 75 mg of clopidogrel. The femoral arterial sheath was removed when the activated clotting time fell to Ͻ140 seconds. Arteriotomy compression was carried out for 30 to 40 minutes, followed by 8 hours of bed rest. Suture or other percutaneous closure devices were not used. Comparisons of patient clinical data and coronary lesion characteristics are listed in Table 1. Categorical (nominal) data items were analyzed using Pearson’s chi-square test; interval data was examined by Student’s t test with 2-sided p values. Comparisons of numbers of lesions in each group used Wilcoxon’s signed-rank test; Pearson’s chi-square or t tests gave qualitatively identical results. Full disclosure data for each patient in the BAV and PCI group and BAV only group are provided in Tables 2 and 3, respectively. Results Of 100 consecutive BAV procedures, 42 (42%) were found to have angiographically significant CAD. Of these 42 pa- tients, 17 (40%) underwent combined BAV and PCI. None of the 42 patients with CAD who were scheduled for BAV and possible PCI had either procedural component aborted as a result of a complication. The mean maximal (final) balloon diameter used for retrograde BAV in these patients was 23.7 Ϯ 1.7 mm (range 20 to 26 mm). The average number of balloon inflations per case was 3.0 (range 1 to 8). Both BAV and PCI were carried out successfully in all Table 1 Comparison of clinical and coronary lesion characteristics in patients who underwent combined balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) versus BAV only Variable BAV ϩ PCI (n ϭ 17) BAV Only (n ϭ 25) p Value Age (yrs) 86.2 Ϯ 6.4 85.9 Ϯ 7.0 0.88 Women:Men 10:7 10:15 0.35 Left ventricular ejection fraction (%) 44 Ϯ 13.6 41 Ϯ 16.3 0.62 Creatinine (mg/dl) 1.2 Ϯ 0.4 1.2 (Ϯ0.4) 0.75 Previous coronary bypass 3 of 17 (17.6%) 10 of 25 (40.0%) 0.18 Number of diseased coronary vessels 1.9 Ϯ 0.9 2.3 Ϯ 0.8 0.16 Coronary lesion classification A) Treated (n ϭ 24) B) Untreated (n ϭ 11) C) All Untreated (n ϭ 45) A vs C A 17 1 4 Ͻ0.0001 B1 6 2 11 0.45 B2 1 1 13 0.008 C 0 7 17 0.0002 Reference diameter Ͻ2.5 mm 3 (12.5%) 6 (54.5%) 16 (35.6%) 0.005 BAV ϭ balloon aortic valvuloplasty; PCI ϭ percutaneous coronary intervention. 1310 The American Journal of Cardiology (www.AJConline.org) Table 2 Combined balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) group Pt. Age Gender Hx CAB Pre Cr (mg/dl) DM EF Pre (%) 1/2/3/vcad Lesions Stented Vessels A or R BAV Pre p-p gr (mm Hg) Pre mn gr (mm Hg) Pre AVA (cm 2 ) Post p-p gr (mm Hg) Post mn gr (mm Hg) Post AVA (cm 2 ) Procedure Time (min) LOS (days) 1 99 F Y 1 N 58 3VCAD A * B 1 1 R 64 62 0.43 32 33 0.7 73 7 2 95 F N 2.2 N 40 1VCAD A* 1 R 77 63 0.38 20 29 0.76 100 2 3 93 F N 1.1 N 55 3VCAD A* B 1 C 1 A 59 49 0.71 18 17 1.1 129 11 4 90 F N 0.7 N 60 1VCAD B 1 * 1 R 73 64 0.28 20 26 0.71 85 3 5 89 F N 0.8 TYPE II 37 1VCAD A* 1 R 70 62 0.3 27 26 0.66 114 4 6 88 F N 1.6 N 60 1VCAD A* 1 R 61 62 0.58 29 30 1.06 75 4 7 88 F N 1.2 N 45 1VCAD A* 1 R 20 22 0.62 9 11 0.95 63 2 8 88 M N 1.1 N 58 1VCAD A* 1 R 48 53 0.55 27 29 1.27 94 5 9 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* B 1 * B 1 * 3 R 58 58 0.64 32 35 0.94 104 4 11 85 M Y 1 N 45 3VCAD B 2 * C C C 1 R 59 53 0.45 22 26 0.75 89 3 12 84 M N 1.2 N 38 2VCAD A* A* C 2 R 61 48 0.43 33 32 0.66 104 2 13 84 M N 1.5 N 20 3VCAD A B 1 * B 2 C 1 R 63 64 0.4 22 27 1.26 104 2 14 81 F N 0.9 N 55 1VCAD B 1 * 1 R 79 67 0.37 23 23 0.72 94 2 15 81 M N 1.3 N 22 2VCAD A* A* 2 R 30 29 0.77 19 19 1.19 95 4 16 78 M N 1.3 TYPE II 20 3VCAD A* A* B 1 * C 2 R 43 36 0.65 18 17 1.1 124 10 17 72 F N 1.2 N 45 1VCAD A* 1 R 25 26 0.47 14 18 0.79 115 3 Mean 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 4.1 SD Ϯ 6.4 Ϯ 0.4 Ϯ 13.6 Ϯ 0.9 Ϯ 0.6 Ϯ 17.3 Ϯ 14.6 Ϯ 0.14 Ϯ 6.6 Ϯ 6.6 Ϯ 0.22 Ϯ 17.6 Ϯ 2.8 Pt ϭ patient; HxCAB ϭ history of coronary artery bypass; Precr ϭ preoperative creatinine; DMϭ diabetes mellitus; EF Pre ϭ ejection fraction preoperatively; 1/2/3vcad ϭ 1, 2, or 3 vessel coronary artery disease; A or R BAV ϭ antigrade or retrograde balloon aortic valvuloplasty; Pre p-p gr ϭ preoperative peak to peak aortic valve gradient; Pre mn gr ϭ preoperative mean aortic valve gradient; Pre AVA ϭ preoperative aortic valve area; Post p-pgr ϭ postoperative peak to peak gradient; Post mn gr ϭ postoperative mean aortic valve gradient; Post AVA ϭ postoperative aortic valve area; LOS ϭ length of stay. * Lesions treated with PCI. 1 3 1 1 H e a r t F a i l u r e / C o m b i n e d A o r t i c V a l v u l o p l a s t y a n d C o r o n a r y S t e n t i n g Table 3 Balloon aortic valvuloplasty (BAV) without stenting Pt. Age Gender Hx CAB Pre Cr (mg/dl) DM EF Pre (%) 1/2/3vcad Lesions A or R BAV Pre p-p gr (mm Hg) Pre mn gr (mm Hg) Pre AVA (cm 2 ) Post p-p gr. (mm Hg) Post mn gr. (mm Hg) Post AVA (cm 2 ) Procedure Time (min) LOS (days) 1 100 F N 1.1 N 45 1VCAD A R 71 72 0.45 33 37 0.8 67 5 2 98 F N 1.1 N 55 3VCAD B 1 B 2 C R 37 42 NA 17 19 NA 114 2 3 93 M N 1 N 52 3VCAD C C C R 35 35 0.65 12 14 1.06 49 5 4 92 M Y 0.9 N 63 3VCAD B 2 A 38 39 0.78 19 21 1.02 123 2 5 91 M Y 1.1 N 40 3VCAD B 1 C A 48 42 0.53 21 21 0.91 88 4 6 90 M Y 1.6 N 20 3VCAD C R 39 41 0.43 11 17 0.73 93 4 7 90 F N 0.8 N 40 3VCAD B 1 B 2 C R 34 37 0.51 18 20 0.86 87 7 8 89 M N 0.9 N 50 1VCAD B 1 R 72 74 0.46 39 43 0.7 106 1 9 88 F N 1 N 20 3VCAD B 1 B 2 B 2 R 81 68 0.32 21 31 NA 165 0 10 88 M N 1.7 N 30 2VCAD B 1 C R 30 30 0.54 11 16 0.89 58 2 11 88 M Y 1.2 TYPE II 30 2VCAD B 1 R 45 42 0.4 32 34 0.73 75 2 12 86 F N 1 N 60 2VCAD B 2 B 2 R 65 50 0.67 33 27 0.93 91 4 13 86 F N 1.1 TYPE II 30 1VCAD B 1 A 51 56 0.47 11 18 0.8 100 4 14 85 M N 0.9 N 30 1VCAD C R 28 35 0.8 10 15 1.06 104 7 15 85 M Y 1.9 N 60 3VCAD C R 54 48 0.73 28 28 0.94 73 1 16 84 F Y 1.1 N 45 3VCAD B 2 R 28 28 0.63 18 20 0.75 65 4 17 84 F N 1.1 TYPE II 15 2VCAD B 1 B 2 C R 47 38 0.44 17 20 1.06 63 5 18 84 M N 1.1 N 20 1VCAD C R 50 41 0.81 18 20 1.6 67 1 19 84 M Y 2.3 N 60 3VCAD B 2 C R 34 34 0.7 16 22 NA 34 1 20 84 F N 1.8 N 55 2VCAD A B 1 R 39 42 0.46 14 17 1.04 88 5 21 82 M N 1.3 TYPE II 25 3VCAD B 1 B 2 C R 31 32 0.78 16 18 0.98 63 3 22 79 F N 1.2 N 70 1VCAD A A 38 47 0.63 30 26 0.94 96 1 23 78 M Y 1.1 N 25 3VCAD C C R 30 29 1.03 8 14 1.7 95 7 24 70 M Y 1.6 TYPE II 60 3VCAD A B 2 R 59 51 0.6 44 44 0.83 114 4 25 70 M Y 1.8 TYPE II 40 2VCAD B 2 C A 34 34 0.72 20 25 0.9 77 2 Mean 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 3.3 SD Ϯ 6.97 Ϯ 0.4 Ϯ 16.3 Ϯ 0.8 Ϯ 14.9 Ϯ 12.6 nϮ 0.17 Ϯ 9.6 Ϯ 8.5 Ϯ 0.25 Ϯ 27.2 Ϯ 2.1 Abbreviations as in Table 2. 1 3 1 2 T h e A m e r i c a n J o u r n a l o f C a r d i o l o g y ( w w w . A J C o n l i n e . o r g ) 17 patients in the combined group. Pre- and post-BAV mean gradients were 50.7 Ϯ 14.6 mm Hg and 24.7 Ϯ 6.6 mm Hg respectively. Pre- and post-BAV aortic valve areas were 0.50 Ϯ 0.14 cm 2 and 0.92 Ϯ 0.22 cm 2 , respectively. PCI was carried out before BAV in 13 of 17 cases; 3 of the 4 BAV-first cases underwent valve dilatation before PCI be- cause of an at rest systolic arterial pressure Ͻ90 mm Hg on arrival to the cardiac catheterization laboratory. The fourth patient underwent antegrade BAV first to avoid hepariniza- tion before the transseptal puncture. Single vessel PCI was carried out in 12 patients, 2-vessel PCI in 4, and 3-vessel PCI in 1. Complete revascularization was achieved in 13 of 17 patients. There were 24 lesions treated within 23 target vessels. All lesions were treated with intracoronary stents, 15 of which were predilated before stent delivery. An av- erage of 1.1 stents per lesion was deployed; 5 of 17 patients received bare metal stents only, 11 patients received drug- eluting stents only, and 1 patient received both. Table 1 lists coronary lesion characteristics of both treated and untreated lesions. Two of the 3 saphenous vein graft lesions in these pa- tients were treated with distal filter wire embolic protection; 1 patient had brief transient slow flow in the treated saphe- nous vein graft with degenerative disease despite distal embolic protection. The peak creatine kinase-MB was 7.0 mg/dl on the morning after the procedure, i.e., Ͻ3 times upper limit of normal. There were no strokes, myocardial infarctions, procedural or in-hospital mortalities in this combined patient group; 1 patient had transient nonoliguric renal insufficiency postprocedure and 1 had transient AV block requiring temporary pacing Ͻ24 hours. There were no percutaneous entry site bleeds requiring blood transfusion or surgical repair. Mean procedural duration was 98.8 Ϯ 17.6 minutes, and mean length of hospitalization after BAV was 4.1 Ϯ 2.8 days (range 2 to 11). BAV was successful in 24 of the 25 patients undergoing BAV alone; 1 patient died intraprocedurally secondary to aortic root dissection. There were no myocardial infarctions, 1 postprocedural stroke, and 1 additional in-hospital mor- tality in this group secondary to pneumonia and sepsis unrelated to any procedural complication. Two minor com- plications included 1 patient requiring transfusion for vas- cular entry site bleed and 1 with transient, nonoliguric renal insufficiency. Twenty BAVs were carried out retrogradely with a mean maximal balloon diameter of 23.8 Ϯ 1.5 mm (range 22 to 25). Pre- and post-BAV mean gradients were 43.5 Ϯ 12.6 mm Hg and 24 Ϯ 8.5 mm Hg, respectively. Pre- and post-BAV aortic valve areas were 0.61 Ϯ0.17 cm 2 and 0.97 Ϯ 0.25 cm 2 , respectively. Mean procedure dura- tion was 86.2 Ϯ 27.2 minutes and mean length of hospital- ization after BAV was 3.3 Ϯ 2.1 days (range 1 to 7). Discussion Appropriate strategies for the percutaneous treatment of poor surgical risk patients with both severe symptomatic AS and CAD have not been defined. Very small case series have been published previously, reporting on the feasibility of combined BAV and balloon coronary angioplasty with- out significant complications. 5–9 These small case series generally included patients with mean ages in the late 70s, a decade younger than our series. In addition, they have included patients who underwent BAV and PCI days to weeks apart. With an expanding population of elderly high- risk patients who mostly go untreated, PCI and percutane- ous aortic valve implantation offers the potential for more durable treatment than coronary angioplasty and BAV alone. Although we did not have a comparison group who underwent BAV and PCI days to weeks apart, we believed the risk of a combined procedure would be equivalent and possibly lower, as well as more convenient, than 2 separate interventions. In hopes of limiting critical myocardial ischemia second- ary to hypotension during valve dilation, 13 of the 17 patients underwent PCI before BAV; 3 of the 4 patients who underwent BAV first arrived in the catheterization labora- tory hypotensive secondary to critical AS and thus under- went BAV before PCI. With percutaneous valve implanta- tion on the horizon, PCI would ideally be carried out before device deployment in the aortic root given its small poten- tial for limiting coronary access. Based on our small series, this approach is worthy of further investigation. A decision to proceed with PCI at the time of BAV was based primarily on operator bias that the untreated coronary stenosis would contribute to inadequate symptomatic im- provement. This in turn reflected myocardial viability and size of territory subtended. In addition, complex lesions with low likelihood of success or increased probability of complications were avoided as reflected in the lesion ana- tomic score. Useful discriminators between those undergo- ing PCI at the time of BAV and patients undergoing BAV only included coronary lesion classification (A, B1, B2, C), reference vessel diameter, and vessels subtending myocar- dial infarction zones. These discriminators were valid when comparing treated coronary lesions with those left untreated in both groups. A higher percentage of treated lesions were type A and untreated lesions were type C. The high PCI success rate and low complication rate was therefore in part related to our ability to correctly identify and target more favorable lesion morphologies. Strategically, this translated into a desire to avoid treating lesions with low success rates as well as those unlikely to result in symptomatic benefit. Clinical discriminators in Table 1 were not significantly different between groups. This study is limited by its small size and retrospective nature; therefore, the combined approach of BAV and PCI should not be generalized to all patients with AS and CAD. Patients were not randomized to either BAV or PCI alone, making it difficult to evaluate the relative merits of each compared with the combined strategy. This population is likely typical of poor-surgical-risk elderly patients with symptomatic AS and severe CAD who could be considered candidates for BAV and PCI. In this small series of high-surgical-risk elderly patients with symptomatic AS and CAD, combined BAV and PCI was accomplished with low procedural morbidity and in- hospital mortality when appropriately selected. 1. STS risk calculator, http://66.89.112.110/STSwebriskcalc/de.aspx. 2. 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