Carpentier-Edwards Pericardial Valve in the Aortic Position: 25-Years Experience

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1 SURGERY: The Annals of Thoracic Surgery CME Program is located online at home. To take the CME activity related to this article, you must have either an STS member or an individual non-member subscription to the journal. Carpentier-Edwards Pericardial Valve in the Aortic Position: 25-Years Experience Jessica Forcillo, MD, MS, Michel Pellerin, MD, Louis P. Perrault, MD, PhD, Raymond Cartier, MD, Denis Bouchard, MD, MS, Philippe Demers, MD, MS, and Michel Carrier, MD, MBA Department of Cardiac Surgery, Montreal Heart Institute and Universite de Montreal, Montreal, Quebec, Canada Background. The Carpentier-Edwards pericardial valve was designed to minimize structural valve deterioration. Excellent durability and low incidence of valve-related complications have been reported. The objective of the present study was to analyze clinical results after 25 years of experience with this valve implanted in the aortic position. The effect of patient age at the time of surgery was also evaluated. Methods. This is a retrospective cohort study of 2,405 patients from November 1981 to March Primary outcomes of interest were survival and freedom from major adverse effects such as thromboembolic, endocarditis, and reoperation. Results. Sixty percent were male, with a mean age of 71 ± 9 years old. Actuarial survival rates including early deaths averaged 78% ± 2%, 55% ± 2%, and 16 % ± 2% after 5, 10, and 20 years of follow-up, respectively. The freedom rate of valve reoperation for prosthesis dysfunction and all other causes averaged 98 % ± 0.2%, 96% ± 1%, and 67% ± 4% at 5, 10, and 20 years. Patients younger than 60 years of age had a 15-year survival averaging 54% ± 5% compared with patients aged between 60 and 70 years of age averaging 46% ± 3% and with patients older than 70 years of age averaging 28% ± 3% (p [ 0.001). Survival at 5, 10, and 20 years for patients who had concomitant CABG [coronary artery bypass grafting] were 78% ± 1%, 55% ± 2%, and 9% ± 3% compared with no concomitant CABG (84% ± 1%, 62% ± 2%, and 22% ± 3% (p < 0.001)). Conclusions. Carpentier-Edwards pericardial valve implantation in the aortic position is secure and durable. The effects of age influence reoperation rate and survival as well as a concomitant coronary artery bypass procedure. (Ann Thorac Surg 2013;96:486 93) Ó 2013 by The Society of Thoracic Surgeons Biologic valves from porcine or glutaraldehyde-treated bovine pericardium procure good hemodynamic profile similar to native valves. Biologic valves are a popular choice for implantation in patients older than 65 years of age [1, 2]. The Carpentier-Edwards (CE) pericardial valve (Edwards Lifesciences, Irvine, CA) has been in clinical use since 1980 in Canada. It is a second-generation pericardial valve and was designed to minimize structural valve deterioration [3]. Several studies have published clinical results with this pericardial valve to up to 17 years. Excellent durability, especially in the aortic position has been reported in elderly patients. Moreover, a low incidence of valverelated complications at 17 years of follow-up was also shown [4 8]. The objective of the present study is to analyze clinical results after 25 years of experience with this valve Accepted for publication March 18, Address correspondence to Dr Carrier, Department of Cardiac Surgery, Montreal Heart Institute, 5000 Belanger St, Montreal, Quebec, Canada, H1T 1C8; michel.carrier@icm-mhi.org. implanted in aortic position. The effect of patient age at the time of surgery was also evaluated because of the current trend of implanting these valves in younger patients. Patients and Methods This retrospective cohort study reviewed 2,405 patients who underwent aortic valve replacement (AVR) with CE pericardial valves from November 1981 to March Patients with associated procedures such as aortoplasty and coronary artery bypass grafts (CABG) were included in this cohort. Patients who underwent repair or replacement of another valve concomitantly or a Bentall procedure were excluded from the present analysis (23%). Data were prospectively recorded. Patients were followed at the Montreal Heart Institute Valve Clinic every year. If the patient was unable to attend the clinic, mailed questionnaires were sent or telephone interviews were made. The rate of patients lost to follow-up was 7% (173 of 2,405) and the mean follow-up period averaged 6 9 years. Data collection and the present study were Ó 2013 by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc

2 Ann Thorac Surg FORCILLO ET AL 2013;96: CE AORTIC VALVE: 25 YEARS EXPERIENCE 487 approved by the Ethical Committee at the Montreal Heart Institute. Valves were implanted according to standard surgical techniques. Biologic valves usually implanted in patients older than 65 years of age, but patient preference was the primary determinant of valve selection. Primary outcomes of interest were recorded as defined in Guidelines recently published (Guidelines for reporting morbidity and mortality after cardiac valvular operations) [9]. Causes of death were obtained from hospital records or autopsy when available. Early mortality and complications were defined as those occurring during the hospital stay or within 30 days of valve implantation. Statistical Analysis Continuous data are presented as the mean SD. Categoric data are presented as percentages. Survival, freedom from reoperation, thromboembolic events, and combined endpoint curves were obtained with the Kaplan-Meier method (NCSS 2007, Kaysville, UT). Differences between groups of patients were analyzed using the log-rank tests. Preoperative Parameters Aortic valve replacements were performed in 2,405 patients during the study period. Sixty percent (1,450 of 2,405) were male and 40% (955 of 2,405) were female, with a mean age of 71 9 years (ranging from 18 to 90 years). Preoperative left ventricular ejection fraction averaged Most patients (853 of 2,405 and 1,316 of 2,405) were in the New York Heart Association (NYHA) functional class 2 and 3 at the time of surgery. The majority of patients (2,278 of 2,405, 95%) did not have a previous cardiac surgery. Eighty-five percent of patients (2,044 of 2,405) underwent aortic valve replacement for aortic stenosis with a preoperative aortic peak transvalvular gradient averaging mm Hg. Twelve percent of patients (294 of 2,405) were operated for aortic regurgitation, 2% (37 of 2,405) for prosthetic valve dysfunction, and 1% (30 of 2,405) for acute bacterial endocarditis. During the AVR procedure, 42% (1,005 of 2,405) of patients had concomitant coronary artery bypass grafts (CABG) and 6% (134 of 2,405) had enlargement of the aortic annulus. Aortic cross-clamp time and cardiopulmonary bypass time averaged and minutes, respectively (Table 1). Fifteen percent of patients had a valve size 19 implanted, 38% a size 21, 31% a size 23, 13% a size 25, 2% a size 27, and 1% a size 29. Results Survival and Functional Status One hundred seventeen (117 of 2,405, 4.9%) patients died during the first 30 days after surgery. Cardiac failure and noncardiac problems were the main causes of early death. Postoperative complications included bleeding and tamponade and atrioventricular block as the 2 most frequent events (Table 2). Percentage of late death was 28% and total death including early deaths at 30 years was 33%. Causes of death were principally Table 1. Preoperative Parameters Variable Carpentier-Edwards (n ¼ 2,405) Age (years) 71 9 Sex (Male) 1,450 (60%) Pre-op LVEF (%) Pre-op peak gradient (mm Hg) Surgical indication Stenosis 2,044 (85%) Regurgitation 294 (12%) Prosthesis dysfunction 37 (2%) Active endocarditis 30 (1%) CPB (minutes) Cross-clamp (minutes) NYHA functional classes I 101 (4%) II 853 (35%) III 1,316 (55%) IV 113 (5%) Unknown 22 (1%) Previous cardiac surgery 127 (5%) CABG 77 (61%) AVR 37 (29%) MVR 9 (7%) TVR 1 (1%) Multiple valve repairs 3 (2%) Other 5 (4%) None 2,278 (95%) Concomitant procedures CABG 1,005 (42%) Aortoplasty enlargement 134 (6%) AVR ¼ aortic valve replacement; CABG ¼ coronary artery bypass surgery; CPB ¼ cardiopulmonary bypass; LVEF ¼ left ventricular ejection fraction; MVR ¼ mitral valve replacement; NYHA ¼ New York Heart Association; TVR ¼ tricuspid valve replacement. unknown (40%) followed by cardiac insufficiency (21%) and myocardial infarction (10%). Major complications included combined endpoints (hemorrhage, cardiac insufficiency, myocardial infarction, endocarditis, and thromboembolic events) 9%, prosthesis dysfunction 4%, explant 4%, thromboembolic events 3%, and endocarditis 2% (Table 3). Actuarial survival rates including early deaths averaged 78% 2%, 55% 2%, 34% 2%, and 16% 2% after 5, 10, 15, and 20 years of follow-up, respectively (Fig 1). Seventy-five percent (1,808 of 2,405) of patients were in NYHA functional class 1 or 2 at the last follow-up averaging 6 9 years after surgery (Table 3). Valve-Related Complications and Reoperation Thromboembolic events represented 3% (80 of 2,405) of late complications and included 33 cases of fatal thromboembolic events (1%). Seventy-five percent of patients were not anticoagulated at the time of the event. The 5, 10, and 20-year freedom rate from thromboembolism averaged 97% 0.4%, 94% 1%, and 79% 6%, respectively. The freedom rate from prosthetic valve endocarditis

3 488 FORCILLO ET AL Ann Thorac Surg CE AORTIC VALVE: 25 YEARS EXPERIENCE 2013;96: Table 2. Early Mortality and Complications Table 3. Late and Overall Mortality and Complications Variable Carpentier-Edwards (n ¼ 2,405) Variable Carpentier-Edwards (n ¼ 2,405) Mortality <30 days 117 (5%) Causes of early death Cardiac failure 23 (20%) Myocardial infarction 10 (10%) Hemorrhage 12 (10%) Malignant arrhythmia 15 (13%) Infection 9 (8%) Thromboembolic 7 (6%) Low output syndrome 1 (1%) Noncardiac cause 30 (26%) Early complications Reexploration for bleeding 120 (5%) Atrioventricular block 89 (4%) Low output syndrome 36 (2%) Stroke 28 (1%) Myocardial infarction 17 (1%) Low output syndrome: cardiac insufficiency and hypotension; Stroke: with or without sequelae; reexploration for bleeding: hemorrhage and tamponade. averaged 98% 0.3%, 98% 0.5%, and 95% 2% at 5, 10, and 20 years after surgery (Fig 2). Ninety-one (91 of 2,405, 4%) patients showed evidence of prosthesis valve dysfunction necessitating explantation and replacement of the valve in 89 patients. Two patients refused redo surgery. Calcified stenotic prostheses and infection were the 2 most common causes of prosthetic dysfunction (Table 4). Reoperations for explantation and replacement of the prosthesis were performed 6 4 years after the initial surgery in all patients, including those with a preoperative diagnosis of endocarditis. Patients with a diagnosis of structural valve deterioration without evidence of endocarditis (63 of 89) underwent reoperation 11 5 years after the initial valve replacement. The overall freedom rate of valve reoperation for prosthesis valve dysfunction averaged 98% 0.2%, 96% 1%, and 67% 4% at 5, 10, and 20 years after initial surgery (Fig 3). Effect of Age on Survival and Reoperation Patients younger than 60 years of age at implantation had a 15-year survival averaging 54% 5% compared with patients between 60 and 70 years of age averaging 46% 3% and with patients older than 70 years of age averaging 28% 3% (p ¼ 0.001) (Fig 4). The freedom rate from reoperation for prosthesis valve dysfunction averaged 98% 1%, 90% 3%, 60% 6%, and 30% 8% at 5, 10, 15, and 20 years after surgery in patients younger than 60 years of age compared with 99% 0.3%, 95% 1%, 90% 3% at 5, 10, and 15 years after surgery in patients aged between 60 and 70 years old, and 100%, 99% 0.5% at 5 and 10 years after surgery in patients older than 70 years of age (p ¼ 0.001) (Fig 5). Mortality >30 days 677 (28%) Total mortality 794 (33%) Causes of late death Cardiac failure 145 (21%) Myocardial infarction 70 (10%) Sudden death unknown cause 40 (6%) Thromboembolic 33 (5%) Infection 32 (5%) Hemorrhage 20 (3%) Reoperation 22 (3%) Endocarditis 9 (1%) Malignant arrhythmia 3 (0.4%) Valve thrombosis 1 (0.1%) Noncardiac cause 28 (4%) Unknown 274 (40%) Complications Combined endpoints 216 (9%) Prosthesis dysfunction 91 (4%) Explant 89 (4%) Thromboembolic events 80 (3%) Endocarditis 43 (2%) NYHA classes post I 1,007 (42%) II 801 (33%) III 131 (5%) IV 7 (0.3%) Unknown 459 (19%) Combined endpoints: Hemorrhage, cardiac insufficiency, myocardial infarct, endocarditis, thromboembolic events. NYHA ¼ New York Heart Association. Reoperation from all causes including endocarditis was performed on average at 12 4 years after the initial valve implantation for patients less than 60 years of age, at 10 5 years for the 60 to 70 year old group, and at years for patients older than 70 years. There were 54 prostheses explanted (54 of 89, 61%) in patients younger than 60 years of age, 28 (28 of 89, 32%) prostheses explanted in patients aged between 60 to70 years old, and 7 (7 of 89, 8%) explants in patients older than 70 years of age (Table 4). After surgery for prosthesis explant and replacement, 39 out of the 89 (44%) patients died. Average time to postoperative mortality in that population was years. Effect of Concomitant CABG Procedure A total of 1,005 patients had concomitant CABG with the AVR procedure. Survival at 5, 10, 15, and 20 years for patients who had concomitant CABG were 78% 1%, 55% 2%, 27% 3 %, and 9% 3%, respectively, compared with 84% 1%, 62% 2%, 44% 2%, and 22% 3% in patients undergoing isolated AVR (p < 0.001) (Fig 6).

4 Ann Thorac Surg FORCILLO ET AL 2013;96: CE AORTIC VALVE: 25 YEARS EXPERIENCE 489 Fig 1. Overall patient survival at 25 years; mean standard error. ( ¼ aortic valve replacement, Carpentier-Edwards [AVR CE]). Echocardiographic Follow-Up Seven hundred eighty-five patients had an echocardiographic follow-up at 6 9 years after surgery. Transaortic mean gradient averaged 17 8 mm Hg and maximal gradient averaged mm Hg for the total population. Comment The present study showed that the freedom rate from reoperation for structural valve deterioration (SVD) averaged 99% in patients older than 70 years of age at implantation throughout the 30-year period of the study. Rates of reoperation increased significantly in the Fig 2. Overall freedom from endocarditis at 25 years; mean standard error. ( ¼ aortic valve replacement, Carpentier- Edwards [AVR CE]).

5 490 FORCILLO ET AL Ann Thorac Surg CE AORTIC VALVE: 25 YEARS EXPERIENCE 2013;96: Table 4. Causes for Surgical Explantation of the Prosthesis by Age Group Aortic Valve Replacement Carpentier-Edwards (n ¼ 89) Causes Under 60 years (n ¼ 54) years (n ¼ 28) Over 70 years (n ¼ 7) Prosthetic dehiscence 1 (2%) 1 (4%) 0 Infection 13 (24%) 9 (32%) 4 (57%) Stenosis and calcification 28 (52%) 12 (43%) 2 (29%) Leaflet tear 10 (19%) 6 (21%) 1 (14%) Thrombosis 1 (2%) 0 0 Other 1 (2%) 0 0 younger groups of patients. Moreover, prosthetic valve endocarditis remains the first cause of valve reoperation in elderly patients and the second cause after SVD in younger patients. Studies examining the experience with the CE pericardial valves in the aortic position had shown beneficial effects on durability and hemodynamic results compared with other bioprostheses [4 8]. This improvement in durability is due to decreased stress-induced structural deterioration through infrastent tissue mounting, better tissue orientation combined with improved tissue preservation techniques, and to flexible and distensible struts [10]. Early and late mortality and complications after bioprosthetic aortic valve replacement were similar to other studies when compared with the present analysis [4, 6, 8]. Long-term survival after surgery remains highly dependent on age groups at the time of implantation. Patients younger than 60 years have better 15-year survival than the other age groups, but the patients 70 and older have a higher rate of freedom from reoperation for SVD. However, even if patients 60 years and less experienced more reoperations, the low mortality risk of reoperation versus the increase risk of hemorrhage secondary to the anticoagulation, makes the option to use the bioprosthetic valve a good one for the younger patients [11, 12]. Moreover, patients may benefit later from percutaneous valve inserted in the old bioprosthetic valve, an approach that is not possible through a mechanical valve [13, 14]. Reoperation in the elderly patients was performed at a mean of 7 years after the initial implantation, at 10 years for the 60 to 70 years of age and at 12 years for patients less than 60 years. Age and valve position are the 2 most determinants of longevity of the bioprosthesis, with increasing durability in the elderly in the aortic position [4]. In our study the rate of reoperation among patients greater than 70 years was low, possibly secondary to reduced life expectancy, a blunted immune response, and reduced hemodynamic stress on the bioprosthesis [15]. Patients younger than 60 years were at highest risk for prosthesis explantation due to structural valve Fig 3. Freedom rate from reoperation for explantation of the prosthesis at 25 years for all related causes, including prosthesis valve dysfunction and endocarditis; mean standard error. ( ¼ aortic valve replacement, Carpentier-Edwards [AVR CE]).

6 Ann Thorac Surg FORCILLO ET AL 2013;96: CE AORTIC VALVE: 25 YEARS EXPERIENCE 491 Fig 4. Patient survival by age groups (logrank: p ¼ 0.001); mean standard error. (- ¼ Carpentier-Edwards [CE] aortic valve replacement [AVR] < 60 years old [y.o.]; : ¼ CE AVR 60 to 70 y.o.; ¼ CE AVR > 70 y.o.) deterioration characterized by valve restenosis and calcification of the prosthesis followed by infection and tearing of a leaflet. Indeed, tissue degeneration after 15 years of biologic valve longevity certainly changes the strength of the leaflets. Influence of gender could also be a cause of SVD because women have a higher prevalence of didronate treatment use which could promote early valve Ca þþ. Comparison of structural valve deterioration with other Fig 5. Freedom rate from reexploration for prosthesis valve dysfunction by age groups (excluding endocarditis) (log-rank: p ¼ 0.001); mean standard error. (- ¼ Carpentier-Edwards [CE] aortic valve replacement [AVR] < 60 years old [y.o.]; : ¼ CE AVR 60 to 70 y.o.; ¼ CE AVR > 70 y.o.)

7 492 FORCILLO ET AL Ann Thorac Surg CE AORTIC VALVE: 25 YEARS EXPERIENCE 2013;96: Fig 6. Patient survival after aortic valve replacement (AVR) with or without concomitant coronary artery bypass grafting (CABG) at 25 years (log-rank: p ¼ 0.001); mean standard error. ( ¼ AVR with CABG; - ¼ AVR without CABG.) tissue valves is difficult because there are not enough comparative studies and many factors could differ in different studies about the long-term experience of these valves. The low incidence of leaflet tear with the CE is the result of design improvement. David and colleagues [16] demonstrated that the Hancock II valve has an overall 8 years freedom from SVD of 93%. The Biocor porcine bioprosthesis (St. Jude Medical, St. Paul, MN) had a 10- year freedom from SVD of 78% [17]. Jamieson and colleagues [7] reported in 1995 their 17-year experience with the CE standard porcine valve and freedom from SVD was inferior to the pericardial valve at 15 years with 58% freedom with the porcine versus 80% with the pericardial. Aside from SVD and reoperation for any other causes, thromboembolism remains a concern with an overall rate of 3% in this study with 1% being fatal thromboembolism, which is comparable to what is published in the literature (0.8%) [7]. The effect of concomitant CABG procedures affected the overall survival, probably related to the long-term progression of the coronary artery disease. Patients with concomitant CABG had a lower long-term survival, as expected. Study Limitations This is a retrospective study with a long period of observation extending to 30 years. Underestimation of complications could be possible as recall bias during the telephone interviews. Surgical techniques and patient selection may have changed during the study period. Nevertheless, we use biologic valves in a greater number of patients and in younger patients at the present time. Thus, results of the present study give an accurate perspective to the result that patients could expect in our current clinical practice. Because of a long follow-up period and different standards of practice according to the anticoagulation regimen, that data for the entire cohort could not be included in this paper due to too many missing data. We included only data for patients who had thromboembolism. Conclusions Carpentier-Edwards pericardial valve implantation in the aortic position is secure and durable. Patient age at the time of surgery influences the rate of reoperation and survival after implantation of the prosthesis. Patients younger than 60 years old have a better survival at long-term follow-up but concerns still remain regarding the constant rate of reoperation for structural valve deterioration in that population. Patients under age 60 would benefit by having a closer follow-up approaching 10 years post implantation of the prosthesis. References 1. Rahimtoola SH. Choice of prosthetic heart valve in adults an update. J Am Coll Cardiol 2010;55: Bonow RO, Carabello BA, Chatterjee K, et al focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2008;52: e1 142.

8 Ann Thorac Surg FORCILLO ET AL 2013;96: CE AORTIC VALVE: 25 YEARS EXPERIENCE Trowbridge EA, Lawford PV, Crofts CE, Roberts KM. Pericardial heterografts: why do these valves fail? J Thorac Cardiovasc Surg 1988;95: Poirer NC, Pelletier LC, Pellerin M, Carrier M. 15-year experience with the Carpentier-Edwards pericardial bioprosthesis. Ann Thorac Surg 1998;66(6 Suppl):S Welke KF, Wu Y, Grunkemeier GL, Ahmad A, Starr A. Longterm results after Carpentier-Edwards pericardial aortic valve implantation, with attention to the impact of age. Heart Surg Forum 2011;14:E McClure RS, Narayanasamy N, Wiegerinck E, et al. Late outcomes for aortic valve replacement with the Carpentier- Edwards pericardial bioprosthesis: up to 17-year follow-up in 1,000 patients. Ann Thorac Surg 2010;89: Jamieson WR, Munro AI, Miyagishima RT, Allen P, Burr LH, Tyers GF. Carpentier-Edwards standard porcine bioprosthesis: clinical performance to seventeen years. Ann Thorac Surg 1995;60: Neville PH, Aupart MR, Diemont FF, Sirinelli AL, Lemoine EM, Marchand MA. Carpentier-Edwards pericardial bioprosthesis in aortic or mitral position: A 12-year experience. Ann Thorac Surg 1998;66(6 Suppl):S Edmunds LH Jr, Clark RE, Cohn LH, Grunkemeier GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ad hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity of The American Association for Thoracic Surgery and The Society of Thoracic Surgeons. J Thorac Cardiovasc Surg 1996;112: Pellerin M, Mihaileanu S, Couëtil JP, et al. Carpentier- Edwards pericardial bioprosthesis in aortic position: long-term follow-up 1980 to Ann Thorac Surg 1995;60(2 Suppl):S Potter DD, Sundt TM III, Zehr KJ, et al. Operative risk of reoperative aortic valve replacement. J Thorac Cardiovasc Surg 2005;129: LaPar DJ, Yang Z, Stukenborg GJ, et al. Outcomes of reoperative aortic valve replacement after previous sternotomy. J Thorac Cardiovasc Surg 2010;139: Walther T, Falk V, Borger MA, et al. Transapical aortic valve implantation in patients requiring redo surgery. Eur J Cardiothorac Surg 2009;36: Walther T, Falk V, Dewey T, et al. Valve-in-a-valve concept for transcatheter minimally invasive repeat xenograft implantation. J Am Coll Cardiol 2007;50: Cohn LH, Narayanasamy N. Aortic valve replacement in elderly patients: what are the limits? Curr Opin Cardiol 2007;22: David TE, Armstrong S, Sun Z. Clinical and hemodynamic assessment of the Hancock II bioprosthesis. Ann Thorac Surg 1992;54: Myken PS, Caidahl K, Larsson S, Berggren HE. 10-year experience with the Biocor porcine bioprosthesis in the aortic position. J Heart Valve Dis 1994;3: