15-Year Comparison of Supra-Annular Porcine and PERIMOUNT Aortic Bioprostheses

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1 ORIGINAL CONTRIBUTION 15-Year Comparison of Supra-Annular Porcine and PERIMOUNT Aortic Bioprostheses WR Eric Jamieson, MD, Eva Germann, MSc, Michel R Aupart, MD 1, Paul H Neville, MD 1, Michel A Marchand, MD 1, Guy J Fradet, MD Division of Cardiovascular Surgery Department of Surgery University of British Columbia Vancouver, Canada 1 Cardiac Surgery Service Hopital Trousseau Francois-Rabelais University Tours, France ABSTRACT The second-generation Carpentier-Edwards bioprostheses, the supra-annular porcine valve and the PERIMOUNT pericardial valve, have been evaluated longitudinally for several years. This study compared clinical performance over 15 years. Aortic valve replacement was performed with a supra-annular porcine valve in 1,823 patients (group 1) aged years (mean, 68.9 ± 1.9 years) and with a PERIMOUNT pericardial bioprosthesis in 1,43 patients (group 2) aged 16 9 years (mean, 69.5 ± 1.4 years). The groups were similar except for concomitant coronary artery bypass in 43% of group 1 and 18% of group 2 ( p <.1). survival at 15 years was 29.3% ± 1.5% for group 1 and 35.2% ± 3.1% for group 2 ( p =.9). The actual freedom from valve-related mortality was 88.5% ±.9% for group 1 and 84.9% ± 1.7% for group 2. The actual freedom from structural valve deterioration at 15 years was similar overall, and for patients aged > 6 years, between the groups, but was dissimilar (group 2 > group 1) for age 6 years. The predictors of structural valve deterioration were valve type (group 1 > group 2), sex (male > female), age, and concomitant coronary artery bypass. Both bioprostheses provided satisfactory clinical performance at 15 years after aortic valve replacement. (Asian Cardiovasc Thorac Ann 26;14:2 5) INTRODUCTION The Carpentier-Edwards supra-annular porcine valve () and the Carpentier-Edwards PERIMOUNT () pericardial bioprosthesis (Edwards Lifesciences, Irvine, CA, USA) have been evaluated longitudinally for several years. 1 8 Implantation of the at the University of British Columbia commenced in 1981, and implantation of the at Francois-Rabelais University started in The major publications on these two prostheses have come from these two centers. 2,3,7,8 Clinical performance has been excellent with both prostheses in the aortic position, but there has been no formal comparison of the two valves. They are both formulated with an Elgiloy wire stent. The is a non-composite porcine valve preserved with glutaraldehyde at less than 2 mm Hg pressure. The has 3 individual computer-generated leaflets preserved with glutaraldehyde by zero-pressure fixation. The is a supra-annular bioprosthesis with no intra-annular component, designed to improve hemodynamics over the first generation intra-annular bioprostheses. The has a supra-annular sewing ring and an intra-annular component. The purpose of this study was to compare the clinical performance of For reprint information contact: WR Eric Jamieson, MD Tel: Fax: wrej@interchange.ubc.ca 486 Burrard Building, St. Paul s Hospital, 181 Burrard Street, Vancouver, BC V6Z 1Y6, Canada. ASIAN CARDIOVASCULAR & THORACIC ANNALS 2 26, VOL. 14, NO. 3

2 Jamieson AVR Comparison of Bioprostheses to 15 years Table 1. Profile of Patients Undergoing Aortic Valve Replacement with Each Bioprosthesis Variable p-value Male sex 1,259 (69%) 995 (7%).75 Prior CAB 53 (3%) 8 (1%) <.1 Prior valve surgery 17 (6%) 69 (5%).19 Concomitant CAB 788 (43%) 264 (18%).1 Valve size 19/21 mm 428 (23%) 673 (47%) 23 mm 59 (32%) 42 (29%) 25 mm 471 (26%) 296 (21%) 27/29/31 mm 4 (18%) 41 (3%).1 Sinus rhythm 2 (11%) 17 (12%).41 CAB = coronary artery bypass, = Carpentier-Edwards PERIMOUNT, = Carpentier-Edwards supra-annular valve. Table 2. Predictors of Structural Valve Deterioration Male Female Variable HR p-value HR p-value HR p-value HR p-value HR p-value Valve type ( > ) >.5 Age (continuous).96 <.1.96 < < Age ( 65, > 65 years) 3.5 < < Sex (M > F) >.5 Heart rhythm Prior CAB Prior valve surgery 1.4 >.5 >.5 >.5 >.5 >.5 Concomitant CAB > >.5 Valve size >.5 >.5 >.5 >.5 CAB = coronary artery bypass, = Carpentier-Edwards PERIMOUNT, = Carpentier-Edwards supra-annular valve, HR = hazard ratio. these bioprostheses over 15 years, specifically with regard to long-term durability and freedom from valve-related composites of complications, mortality, and re-operation. PATIENTS AND METHODS The was implanted in 1,825 patients between 1981 and 1999 in Vancouver, Canada. The was implanted in 1,43 patients between 1984 and 21 in Tours, France. The mean age at implantation was 68.9 ± 1.9 years (range, years) in the group, and 69.5 ± 1.4 years (range, 16 9 years) in the group ( p =.83). The total follow-up was 14,392.3 patient-years for the group and 7,722.8 patient-years for the group; mean follow-up durations were 7.89 ± 4.86 years and 5.4 ± 3.96 years, respectively ( p <.1). The patient profiles in each group are detailed in Table 1. The groups differed significantly in the number of patients who had previous coronary artery bypass (CAB) and the number who had concomitant CAB. The end-points compared were: structural valve deterioration (SVD), valve-related mortality, and valve-related re-operation. The Guidelines for Reporting Morbidity and Mortality after Cardiac Valvular Operations were used to define the complications. 9 Actuarial analysis was performed by the Kaplan-Meier method and is presented with standard error of the estimate. Actuarial freedoms were compared using the log-rank statistical test where p-values less than.5 were considered significant. The actual/cumulative incidence analysis promoted by Grunkemeier was used to assess the clinical performance of the two bioprostheses It should be noted that actual freedoms were not compared statistically. The likelihood ratio test was used to compare linearized rates with p-values <.5 considered significant. Multivariate proportional hazard regression analysis was used 26, VOL. 14, NO ASIAN CARDIOVASCULAR & THORACIC ANNALS

3 AVR Comparison of Bioprostheses to 15 years Jamieson Yrs >7 Yrs Yrs >7 Yrs Yrs >7 Yrs Yrs >7 Yrs Yrs >7 Yrs p =.6351 (NS) Figure 1. Freedom from structural valve deterioration (actuarial) for the Carpentier-Edwards supra-annular valve. to assess risk factors: age (continuous and age categories 65 and < 65 years), sex, valve type, valve size, previous valve surgery, previous CAB, and concomitant CAB, as independent predictors of SVD, valve-related mortality, and valve-related re-operation. The composites of valve-related complications are inclusive of SVD, non-structural dysfunction, thromboembolism, hemorrhage, and prosthetic valve endocarditis. RESULTS Early mortality was 5.% (91 patients) in the group and 2.8% (4 patients) in the group ( p <.1). At the latest follow-up, 51.2% (9 patients) in the group and 25.7% (368 patients) in the group had died ( p <.1). The late mortality rate was 6.48% per patient-year in the group and 4.76% per patient year in the group. Survival at 15 years was 29.3% ± 1.5% in the group and 35.2% ± 3.1% in the group ( p =.9). Survival in the subgroup of patients < 65 years was 51.% ± 2.9% for the valve vs. 61.2% ± 4.7% for the valve ( p =.165). For those 65 years, it was 19.6% ± 1.6% for vs. 17.6% ± 4.2% for ( p =.14). For the subgroup of patients aged years, survival was 39.6% ± 5.3% with the valve vs. 58.8% ± 6.8% with the valve ( p =.7). Survival was not different in the 66 7-year-old subgroup (3.3% ± 3.1% with the valve vs. 25.9% ± 12.% with the valve). The predictors of SVD are detailed in Table 2. Significant predictors of SVD overall by multivariate analysis were valve type, age (continuous or categorical), sex, and concomitant CAB. A previous valve procedure was predictive when age subgroups ( 65 and > 65 years) were assessed, but not when age was evaluated as a continuous variable for both male and female sex. Valve type and concomitant CAB were 61-7 Yrs >7 Yrs p =.1 Figure 2. Freedom from structural valve deterioration (actuarial) for the Carpentier-Edwards PERIMOUNT valve. Table 3. Predictors of Valve-related Re-operation Variable HR p-value Valve type Age (continuous).95 <.1 Age ( 65, > 65) 4.7 <.1 Sex (M > F) Heart rhythm Prior CAB Prior valve surgery 2.3 <.1 Concomitant CAB 1.7. Valve size CAB = coronary artery bypass, HR = hazard ratio. only predictive of SVD in males. Only age was predictive of SVD with the, whereas age, sex, and concomitant CAB were predictive of SVD with the. The linearized occurrence rate of valve-related re-operation was 1.9% per patient-year for vs..63% per patient-year for ( p =.5). The predictors of valve-related re-operation (age, sex, previous valve surgery, and concomitant CAB) are detailed in Table 3. The linearized rate of valve-related mortality was similar for both types of prosthesis: 1.14% per patient-year for vs. 1.28% per patient-year for ( p =.3572). Age subgroup ( 65 years vs. > 65 years) was predictive with a hazard ratio of 4.7 ( p <.1). The actuarial freedom from SVD for these prostheses is shown in Figures 1 and 2. For the most common age subgroup (> 7 years), actuarial freedom from SVD at 15 years was 94.5% ± 2.3% for the ASIAN CARDIOVASCULAR & THORACIC ANNALS 22 26, VOL. 14, NO. 3

4 Jamieson AVR Comparison of Bioprostheses to 15 years Yrs >7 Yrs Yrs >7 Yrs Yrs >7 Yrs Yrs >7 Yrs Yrs >7 Yrs Yrs >7 Yrs Figure 3. Freedom from structural valve deterioration (actual) for Carpentier-Edwards supra-annular valve. Figure 4. Freedom from structural valve deterioration (actual) for Carpentier-Edwards PERIMOUNT valve pns Age Groups 41-5, 51-6, >7 pns 4 (P > SAV) p = (SAV > P) p =.26 Figure 5. freedom from valve-related re-operation (actuarial). = Carpentier-Edwards PERIMOUNT, = Carpentier-Edwards supra-annular valve. and 99.4% ±.6% for the. The actual freedom from SVD is shown in Table 4, Figures 3 and 4. For the age subgroup years, the actual freedom from SVD at 15 years was 92.3% ± 2.8% for the and 86.6% ± 4.5% for the. For the age subgroup 66 7 years, the actual freedom from SVD at 15 years was reversed: 93.1% ± 1.8% for the and 99.1% ±.9% for the. The actuarial and actual freedom from valve-related re-operation is presented in Figures 5 and 6. The actuarial freedom at 15 years was 73.7% ± 2.3% for the and 81.9% ± 3.8% for the (not significantly different). The actual freedom from valve-related re-operation at 15 years was 87.8% ± 1.% for the and 9.2% ± 1.7% for the Figure 6. freedom from valve-related re-operation (actual). = Carpentier-Edwards PERIMOUNT, = Carpentier-Edwards supra-annular valve. Table 4. Freedom from Structural Valve Deterioration (actual at 15 years) Subgroup 89.% ± 1.% 93.5% ± 1.5% 4 years 48.4% ± 7.5% 72.6% ± 14.6% 41 5 years 63.1% ± 6.4% 85.8% ± 6.6% 51 6 years 75.4% ± 3.6% 84.8% ± 5.6% 61 7 years 93.% ± 1.5% 92.7% ± 2.5% > 7 years 98.2% ±.6% 99.6% ±.4% = Carpentier-Edwards PERIMOUNT, = Carpentier-Edwards supra-annular valve. The actuarial and actual freedom from valve-related mortality is illustrated in Figures 7 and 8. The overall actuarial freedom at 15 years was 82.% ± 1.6% for and 79.3% ± 2.8% for (not significantly 26, VOL. 14, NO ASIAN CARDIOVASCULAR & THORACIC ANNALS

5 AVR Comparison of Bioprostheses to 15 years Jamieson pns Age Groups 4, 41-5, 51-6, 61-7, >7 pns 61-65, 66-7, <65, 65 pns 176 Figure 7. freedom from valve-related mortality (actuarial). = Carpentier-Edwards PERIMOUNT, = Carpentier-Edwards supra-annular valve. different). The actual freedom from valve-related mortality at 15 years was 88.5% ±.9% for and 84.9% ± 1.7% for. DISCUSSION The and bioprostheses are the most long-standing of the current second and third generations. Both were introduced in the early 198s with advanced tissue preservation and calcium mitigation therapy to reduce the incidence of SVD. The use of a bioprosthesis for aortic valve replacement has been extended worldwide in the past 5 years, predominantly with stented bioprostheses. The trend away from mechanical valves was based on the anticipation of enhanced durability and optimization of hemodynamics with modern bioprostheses. This trend has also been fostered by the fact that advanced age protects against structural valve deterioration, in parallel with the advancing age of the population with degenerative aortic valve disease. 11 Early and late mortality and overall survival differentiate the populations in this study and favor the over the. This is related to the preponderance of concomitant CAB in the population. These second-generation bioprostheses have been evaluated periodically since their initial use in the two centers. 2,3,7,8 This comparative study revealed that the actual freedom from SVD did not differentiate the populations; but in the age groups 6 years, the was superior to the. Valve type was predictive of SVD but did not contribute to valve-related re-operation or mortality. The type and mode of presentation of SVD differed between the two prostheses. The predominant mode of failure of the was calcified stenosis, presenting with a mean gradient > 4 mm Hg or insufficiency grade III or IV with or without symptoms. The presentation of failure was predominantly deterioration of Figure 8. freedom from valve-related re-operation (actual). = Carpentier-Edwards PERIMOUNT, = Carpentier-Edwards supra-annular valve. functional class with symptomatic insufficiency, with or without echocardiographic documentation of calcification accompanying leaflet tears, or stenotic dystrophic calcification. 8 The mode of failure of the was 25% calcified stenosis and 75% insufficiency with or without calcification. Structural failure of the was confirmed at re-operation in 92% of cases, whereas only 83% of failures were confirmed at re-operation. The different modes of failure of these prostheses and their presentation and diagnostic criteria at the two evaluating centers may be important in the comparative analysis. The most recent report evaluated performance to 18 years. 8 The actual freedom from SVD was 98% (actuarial, 95%) for patients > 7 years of age and 91% (actuarial, 78%) for patients aged 61 7 years. The diagnosis of SVD was made at re-operation, autopsy, or echocardiographically in patients with reducing functional class. The has been extensively implanted Frater and colleagues 1 reported the regulatory trial of 267 patients in 1998 and found actuarial freedom from SVD re-operation at 14 years of 76% for patients 65 years and 96% for patients > 65 years. Banbury and colleagues 4 reported on the same patient cohort in 21, identifying an overall freedom from explant for SVD at 15 years of 77%. They reported < 1% chance of explant for SVD by 15 years, considering actual freedom from SVD, for patients 65 years. The freedom from SVD of the was reported by Aupart and colleagues 2,3 as 96% and 94% at 1 and 12 years, respectively. Dellgren and colleagues 5 found an overall actuarial freedom from SVD at 12 years of 86%. In 1998, Poirier and colleagues 6 determined 93% and 8% actuarial freedom from SVD at 1 and 14 years, respectively, for aortic valve replacement. The currently marketed second and third generations of aortic bioprosthesis have been used for shorter durations The main aim of this study was to compare the durability of the and. However, the groups differed in the proportion undergoing concomitant CAB which ASIAN CARDIOVASCULAR & THORACIC ANNALS 24 26, VOL. 14, NO. 3

6 Jamieson influences survival. Concomitant CAB likely decreased the incidence of SVD in the group because of the reduced survival. The groups also differed in the sizes of prostheses implanted, a small size of was used more often on the assumption that it provided superior hemodynamic performance, which was subsequently shown not to differ from the bioprosthesis. 18 A further limitation of this study was the shorter mean follow-up in the group because of its later commencement of use. Nevertheless, it was concluded that both bioprostheses have excellent and comparable durability at 15 years. Although the modes of presentation of valve failure differ, both require long-term echocardiographic surveillance. This may be more important for the because of its predominant mode of failure. Both bioprostheses provide excellent clinical performance for aortic valve replacement, especially in patients over 6 years of age. Presented at the Biennial Meeting of the Society for Heart Valve Disease, Paris, France, June 29 July 1, 23. REFERENCES 1. Frater RW, Furlong P, Cosgrove DM, Okies JE, Colburn LQ, Katz AS, et al. Long-term durability and patient functional status of the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis in the aortic position. J Heart Valve Dis 1998;7: Aupart MR, Sirinelli AL, Diemont FF, Meurisse YA, Dreyfus XB, Marchand MA. The last generation of pericardial valves in the aortic position: ten-year follow-up in 589 patients. Ann Thorac Surg 1996;61: 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 Banbury MK, Cosgrove DM 3rd, White JA, Blackstone EH, Frater RW, Okies JE. Age and valve size effect on the longterm durability of the Carpentier-Edwards aortic pericardial bioprosthesis. Ann Thorac Surg 21;72: Dellgren G, David TE, Raanani E, Armstrong S, Ivanov J, Rakowski H. Late hemodynamic and clinical outcomes of aortic valve replacement with the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. J Thorac Cardiovasc Surg 22;124: AVR Comparison of Bioprostheses to 15 years 6. Poirier NC, Pelletier LC, Pellerin M, Carrier M. 15-year experience with the Carpentier-Edwards pericardial bioprosthesis. Ann Thorac Surg 1998;66(6 Suppl):S Jamieson WR, Janusz MT, Burr LH, Ling H, Miyagishima RT, Germann E. Carpentier-Edwards supra-annular porcine bioprosthesis: second-generation prosthesis in aortic valve replacement. Ann Thorac Surg 21;71(5 Suppl):S Jamieson WR, Burr LH, Miyagishima RT, Germann E, MacNab JS, Stanford E, et al. Carpentier-Edwards supra-annular aortic porcine bioprosthesis: clinical performance over 2 years. J Thorac Cardiovasc Surg 25;13: Edmunds LH Jr, Clark RE, Cohn LH, Grunkemeier GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. The American Association for Thoracic Surgery, Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Ann Thorac Surg 1996;62: Grunkemeier GL, Jamieson WR, Miller DC, Starr A. Actuarial versus actual risk of porcine structural valve deterioration. J Thorac Cardiovasc Surg 1994;18: Jamieson WR, Burr LH, Miyagishima RT, Germann E, Anderson WN. Actuarial versus actual freedom from structural valve deterioration with the Carpentier-Edwards porcine bioprostheses. Can J Cardiol 1999;15: Jamieson WR, Miyagishima RT, Burr LH, Lichtenstein SV, Fradet GJ, Janusz MT. Carpentier-Edwards porcine bioprostheses: clinical performance assessed by actual analysis. J Heart Valve Dis 2;9: David TE, Ivanov J, Armstrong S, Feindel CM, Cohen G. Late results of heart valve replacement with the Hancock II bioprosthesis. J Thorac Cardiovasc Surg 21;121: Rizzoli G, Bottio T, Thiene G, Toscano G, Casarotto D. Longterm durability of the Hancock II porcine bioprosthesis. J Thorac Cardiovasc Surg 23;126: Jamieson WR, Fradet GJ, MacNab JS, Burr LH, Stanford EA, Janusz MT, et al. Medtronic mosaic porcine bioprosthesis: investigational center experience to six years. J Heart Valve Dis 25;14: Myken P, Bech-Hanssen O, Phipps B, Caidahl K. Fifteen years follow up with the St. Jude Medical Biocor porcine bioprosthesis. J Heart Valve Dis 2;9: Jamieson WR, David TE, Feindel CM, Miyagishima RT, Germann E. Performance of the Carpentier-Edwards SAV and Hancock-II porcine bioprostheses in aortic valve replacement. J Heart Valve Dis 22;11: Jamieson WR, Janusz MT, MacNab J, Henderson C. Hemodynamic comparison of second- and third-generation stented bioprostheses in aortic valve replacement. Ann Thorac Surg 21;71(5 Suppl):S , VOL. 14, NO ASIAN CARDIOVASCULAR & THORACIC ANNALS