Carpentier-Edwards Supra-annular Porcine Bioprosthesis Research Articles

Carpentier-Edwards supra-annular aortic porcine bioprosthesis: Clinical performance over 20 years

Experience with the Carpentier-Edwards supra-annular porcine bioprosthesis (Edwards Lifesciences, Irvine, Calif) has been evaluated longitudinally over 20 years. Clinical performance was evaluated by actuarial and actual analysis. Hemodynamic performance was evaluated by echocardiographic/Doppler assessment. Morphology of structural failure was evaluated from pathologic examinations. From 1981 through 1999, 1823 patients (mean age, 68.9 +/- 10.9 years; range, 19-89 years) underwent 1847 procedures. Concomitant coronary artery bypass was performed in 788 (42.7%) patients. Previous valve procedures were performed in 107 (5.8%) patients, and other cardiac procedures were performed in 87 (4.7%) patients. The overall valve-related complication rate was 4.36% per patient-year (630 patients), with a fatality rate of 0.96% per patient-year (139 patients). Patient survival at 18 years was 15.8% +/- 1.6%. Overall late mortality rate was 6.3% per patient-year. Overall actual cumulative freedom at 18 years from reoperation was 85.0% +/- 1.2%, valve-related mortality was 88.7% +/- 1.1%, and valve-related residual morbidity was 96.3% +/- 5.0%. Actual freedom from structural valve deterioration at 18 years was 86.4% +/- 1.2% overall, 90.5% +/- 1.8% for age 61 to 70 years, and 98.2% +/- 0.6% for age greater than 70 years. Structural valve deterioration presented with pathologic evidence consistent with stenosis in 27.6% and insufficiency in 72.4%. Hemodynamic performance at 1 year revealed normal effective orifice area indexes for sizes 23 to 27 mm and mild-to-moderate reduction for size 21 mm. The Carpentier-Edwards supra-annular aortic porcine bioprosthesis continues to provide excellent freedom from structural valve deterioration and overall freedom from valve-related residual morbidity, mortality, and reoperation up to 18 years. Hemodynamic performance is satisfactory. The prosthesis remains recommended for patients older than 70 years and for patients 61 to 70 years of age, especially when comorbid risk factors are not anticipated to provide extended survival.

Stent fracture in a Carpentier-Edwards supra-annular porcine bioprosthesis implanted in the mitral position

J Thorac Cardiovasc Surg 1999;118:197-9

Carpentier-Edwards supraannular porcine bioprosthesis evaluation over 15 years

Background. The Carpentier-Edwards supraannular porcine bioprosthesis experience during 15 years has been evaluated to determine the incidence of structural valve deterioration by valve position in various age groupings. Methods. From 1981 to 1995, 2,943 patients older than 20 years had the prosthesis implanted in 3,024 procedures. The mean age of the population was 65.5 ± 11.9 years (range, 21 to 89 years). Aortic valve replacement was performed in 1,657 patients (54.8%); mitral valve replacement, 1,092 (36.1%); multiple valve replacement, 253 (8.3%); pulmonary valve replacement, 2 (0.1%); and tricuspid valve replacement, 20 (0.7%). Concomitant procedures were performed in 1,332 patients (45.3%), and 352 (12.0%) had previous procedures. Results. The early mortality was 8.9% (270), only 0.4% (11) valve-related. The total follow-up was 17,471 years (mean, 5.9 ± 4.1 years). The late mortality was 5.2%/patient-year (901) with the valve-related component 1.0%/patient-year (171). The reoperation rate was 2.1%/patient-year (369) with 4.3% mortality (16). The linearized rate of structural valve deterioration was 2.0%/patient-year (341), and overall complications, 5.9%/patient-year (1,019). The overall survival, at 15 years, was 31.1% ± 2.8% ( p < 0.05; aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration for aortic valve replacement was, at 12 years, for patients older than 70 years, 95.3% ± 2.7%; 61 to 70 years, 92.9% ± 2.1%; 51 to 60 years, 70.1% ± 5.3%; 41 to 50 years, 60.0% ± 8.8%; and 21 to 40 years, 75.7% ± 7.3%. The freedom from structural valve deterioration for mitral valve replacement was, at 12 years, for patients older than 70 years, 66.1% ± 9.7%; 61 to 70 years, 53.1% ± 4.7%; 51 to 60 years, 52.6% ± 5.5%; 41 to 50 years, 39.3% ± 6.9%; and 21 to 40 years, 42.1% ± 9.4%. Conclusions. The prosthesis is recommended for aortic valve replacement for patients older than 70 years and for patients 61 to 70 years (when extended longevity is not anticipated) and for mitral valve replacement for patients older than 70 years (when extended longevity is not anticipated).

Carpentier-Edwards Bioprosthesis: Structural Deterioration by Age Groups

The Carpentier-Edwards supra-annular porcine bioprosthesis (second generation prosthesis) was implanted in 2438 patients in 2482 operations between 1982 and 1992. The mean age of the population was 64 years with a range from 21 years to 89 years. There were 1334 aortic and 934 mitral valve replacements. The population was divided into five groups: 21 to 40 years (n = 132); 41 to 50 years (n = 189); 51 to 60 years (n = 454); 61 to 70 years (n = 849); and over 70 years (n = 858). There was no difference in sunival by valve position for age groups 21 to 40 years and 41 to 50 years. Sunival within the age groups 51 to 60 years, 61 to 70 years, and over 70 years was greater for patients with aortic compared with mitral and multiple valve replacements. The freedom from structural valve deterioration at 10 years for all age groups was highest for valves in the aortic position. Patients with valves in the mitral position had a higher freedom from structural valve deterioration at 10 years than those who had multiple valve replacement, although not all the differences were significant. There was a lower incidence of structural valve deterioration in the older age groups. We concluded that the use of the Carpentier-Edwards supra-annular porcine bioprosthesis for aortic valve replacement can be extended to patients over 60 years of age, while its use for mitral valve replacement can be extended to those above 70 years of age.

Carpentier-Edwards supraannular porcine bioprosthesis: Clinical performance to twelve years

The Carpentier-Edwards supraannular porcine bioprosthesis, a second-generation biologic prosthesis, has had clinical performance assessment to 12 years. This bioprosthesis was used in 2,489 operations in 2,444 patients between 1982 and 1992, inclusive (mean age 64.1 years, age range 6 to 89 years). There were 1,335 aortic valve replacements (AVR), 938 mitral valve replacements (MVR), and 200 multiple valve replacements (MR). Concomitant procedures were performed in 1,017 cases (40.9%). The age group distribution was: 35 years or younger, 83 patients; 36 to 50 years, 245; 51 to 64 years, 728; 65 to 69 years, 458; and 70 years and older, 975. The total follow-up was 12,785 patient-years (mean, 5.1 years) and was 96% complete. The early mortality rate was 7.4% (185 patients), and the late mortality was 4.9%/patient year (623). Concomitant procedures influenced both early and late mortality (p < 0.05). The overall patient survival at 12 years was 44% +/- 3% (p < 0.05, AVR > MVR, MR). The freedom from thromboembolism was not different by valve position. The freedom from major thromboembolism at 12 years was 82% +/- 4% (p = not significant by valve position). The overall freedom from antithromboembolic hemorrhage was 96% +/- 1% at 12 years (p < 0.05, AVR > MVR > MR). The overall freedom from valve-related reoperation at 12 years was 58% +/- 5% (p < 0.05, AVR > MVR, MR), and from valve-related mortality 89% +/- 2% (p < 0.05, AVR > MVR > MR). The freedom from residual morbidity (permanent impairment) at 12 years was 87% +/- 4% (p = not significant by valve position).(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical performance of biological and mechanical prostheses

Prosthetic valve replacement remains the most viable alternative for the treatment of severely diseased heart valves. The cumulative experience of mechanical protheses and bioprostheses was evaluated for a 10-year performance comparison: Carpentier-Edwards standard porcine bioprosthesis (CE-S), 1,214 operations; Carpentier-Edwards supraannular porcine bioprosthesis (CE-SAV), 2,489; and mechanical prostheses, 1,364 operations (St. Jude Medical, Carbomedics, Duromedics, and Björk-Shiley Monostrut). The freedom from thromboembolism and hemorrhage at 10 years was 82% for CE-S, 78% for CE-SAV, and 65% for mechanical prostheses (p < 0.05). The relationship existed for major thromboembolism and hemorrhage, 91% (CE-S), 87% (CE-SAV), and 88% (mechanical) (p < 0.05), without clinical relevance. The freedom from structural valve deterioration and valve-related reoperation favored mechanical prostheses (p < 0.05) at 10 years (structural failure: 78% for CE-S, 81% for CE-SAV, and 99% for the mechanical group; reoperation: 74% for CE-S, 76% for CE-SAV, and 88% for mechanical prostheses). The freedom from fatal reoperation was not clinically different: 96% for CE-S, 99% for CE-SAV, and 99% for mechanical prostheses (p < 0.05) at 10 years. The freedom from valve-related mortality was not different (p = not significant) at 10 years: 87% for CE-S; 92% for CE-SAV; and 91% for mechanical. The freedom from permanent impairment or residual morbidity, primarily from thromboembolism, was 95% for CE-S, 92% for CE-SAV, and 95% for mechanical group (p < 0.05) but not clinically relevant.(ABSTRACT TRUNCATED AT 250 WORDS)

Randomised, prospective evaluation of a new pericardial heart valve: outcome after seven years

Between 2 February 1987 and 20 March 1990, 170 patients were randomly allocated to receive a new pericardial heart valve (the Bioflo) or the Carpentier-Edwards supra-annular porcine bioprosthesis. Eighty-five patients (mean age 61 years, range 38-77) received 93 Bioflo valves, 46 having aortic valve replacement (AVR), 31 mitral valve replacement (MVR) and 8 aortic and mitral valve replacement (A+MVR); 85 patients (mean age 62.1 years, range 41-77) received 99 Carpentier-Edwards porcine valves (48 AVR, 23 MVR and 14 A+MVR). Cumulative follow-up totals 926 patient-years (mean 5.45 +/- 1.93, median 6.03, maximum 7.47 years). The overall operative mortality rate for the Bioflo group was 2.4%, and 5.9% for the Carpentier-Edwards group. At 7 years, there was no statistically significant difference in survival or in any prosthesis-related complication between the pericardial and porcine valve recipients overall, or when the data were analysed according to valve implant position. The actuarial survival rate at 7 years for the Bioflo group was 80.1 +/- 5.1% and 72.3 +/- 5.9% for the Carpentier-Edwards group. Freedom from structural valve deterioration (SVD) at 7 years for Bioflo patients was 98.5 +/- 1.5% and for Carpentier-Edwards patients 91.2 +/- 4.1%. No patient in the Bioflo group has required reoperation for SVD. The randomised prospective trial has proven practical and effective and has shown the pericardial valve to perform at least as well as the porcine valve up to 7 years when all of the standard outcome measures of valve performance are assessed.

The Carpentier-Edwards Supra-Annular Porcine Bioprosthesis: Clinical Performance to 8 Years of a New Generation Porcine Bioprosthesis

The Carpentier-Edwards supra-annular porcine bioprosthesis has been utilized at the University of British Columbia since its introduction in 1982. The prosthesis was designed to improve hemodynamics with the supra-annular configuration and to reduce tissue failure with low-pressure glutaraldehyde preservation of the porcine aortic tissue. The prosthesis was inserted in 1,956 patients with 2,129 prostheses between 1982 and 1989. The mean age of the patient population was 62.7 years (range 13 to 87 years). The mean follow-up was 3.7 years per patient. The freedom from thromboembolism and antithromboembolic therapy-related hemorrhage at 8 years was 92% for aortic valve replacement (AVR), 83% for mitral valve replacement (MVR), and 92% for multiple valve replacement (MR) (p less than 0.05, AVR greater than MR greater than MVR). The freedom from structural valve deterioration was 86% for AVR, 73% for MVR, and 96% for MR at 8 years (p less than 0.05, AVR greater than MR greater than MVR). The freedom from nonstructural valve dysfunction and prosthetic valve endocarditis was not different between positions (p = NS). The freedom from valve-related mortality at 8 years was 98% for AVR, 94% for MVR, and 98% for MR (p less than 0.05, AVR greater than MR greater than MVR). The freedom from residual morbidity was not different at 8 years (p = NS). The freedom from treatment failure (valve-related mortality and residual morbidity) was 96% for AVR, 89% for MVR, and 94% for MR (p less than 0.05, AVR greater than MVR greater than MR).(ABSTRACT TRUNCATED AT 250 WORDS)

The Carpentier-Edwards Supra-Annular Porcine Bioprosthesis: New Generation Low Pressure Glutaraldehyde Fixed Prosthesis

The Carpentier-Edwards supra-annular porcine bioprosthesis was implanted in 1,576 operations (1,536 patients with 1,704 valves) between 1981 and 1987. The mean age of the patients was 61.9 years (range 13 to 87 years). During the years 1981 and 1987, approximately 90% of the total valvular surgery population received the prosthesis. The early mortality was 7.0% (included patients with concomitant procedures including coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 4.0% per patient-year. The total cumulative follow-up was 4,237 years. Thromboembolism (TE) was 2.4% per patient-year (fatal 0.4% per patient-year) (minor 1.2%; major 1.3%); antithromboembolic therapy-related hemorrhage (ATH) 0.5% (fatal 0.07%); prosthetic valve endocarditis (PVE) 0.5% (fatal 0.2%); periprosthetic leak (PPL) 0.3% (fatal 0%); clinical valve dysfunction (CVD) 0.3% (fatal 0.02%); and structural valve deterioration/primary tissue failure (SVD) 0.2%/patient-year (fatal 0%). Thromboembolism and structural valve deterioration were the significant complications, SVD occurring primarily between the fourth and fifth year of evaluation. The overall patient survival was 77.1% +/- 1.4% at five years. The patients were classified as 89.6% NYHA functional Class III and IV preoperatively and 96.1% Class I and II postoperatively. The freedom at five years from TE was 90.6% +/- 1.0%; SVD 98.9% +/- 0.5%; and reoperation 95.9% +/- 0.9%. Freedom from all valve-related complications at five years was 84.1% +/- 1.3%; valve-related mortality 96.8% +/- 0.7%; mortality and reoperation (valve failure) 92.9% +/- 1.1%; mortality and residual morbidity (treatment failure) 93.7% +/- 0.9%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 90.0% +/- 1.2%. There were 28 valve-related deaths of a total 280 deaths (early 4, late 24) (TE 17; ATH 3; CVD 1; PVE 7; PPL 0; and SVD 0). Valve-related reoperations were performed in 32 patients (TE 2; CVD 4; PVE 7; PPL 11; and SVD 8). The supra-annular Carpentier-Edwards porcine bioprosthesis has provided very satisfactory clinical performance and afforded patients an excellent quality of life. The long-term durability of this low pressure glutaraldehyde fixed prosthesis will be determined by observation over the next five to seven years.

The Carpentier-Edwards supraannular porcine bioprosthesis: A new generation tissue valve with excellent intermediate clinical performance

The Carpentier-Edwards supraannular porcine bioprosthesis, an investigational valve, was implanted in 1167 patients (1174 operations, 1274 valves) between November 1981 and December 1985 (age range 13 to 85 years, mean 61 years). The early mortality rate was 7.2% (with concomitant procedures 10.9%, without 4.8%; with previous operation 10.5%, without 6.6%). The late mortality rate was 4.5% per patient-year (aortic valve replacement, 4.0%; mitral valve replacement, 4.8%; multiple valve replacement, 5.6%). Total cumulative follow-up was 2272.3 years. The prevalence of thromboembolism was 2.6% per patient-year (fatal 0.4% per patient-year, major 1.4%, minor 1.2%); hemorrhage related to antithromboembolic therapy, 0.7% (fatal 0.1%); prosthetic valve endocarditis, 0.4% (fatal 0.2%); periprosthetic leak, 0.4% (fatal 0%); structural valve deterioration (primary tissue failure/structural failure), 0.1% per patient-year; and clinical valve dysfunction, 0.4%. The reoperation rate was 0.8% per patient-year (thromboembolism, 0.1%; clinical valve dysfunction, 0.1%; prosthetic valve endocarditis, 0.1%; periprosthetic leak, 0.4%; structural valve deterioration, 0.1%). Thromboembolism occurred throughout the observation period but with decreasing frequency, hemorrhage throughout the period in no predictable fashion, prosthetic valve endocarditis within 2 years, periprosthetic leak within 2 years, and structural valve deterioration occurred during the fourth year of assessment. The overall survival rate was 79.8% +/- 1.7% (4 years). Freedom (at 4 years) from thromboembolism was 92.2% +/- 1.2%; from structural valve deterioration, 98.8% +/- 0.8%; and from reoperation, 95.8% +/- 1.3%. Freedom from all complications (4 years) was 85.9% +/- 1.7%; from complication mortality, 98.4% +/- 0.4%; and from valve failure (mortality and reoperation), 94.3% +/- 1.3%. This investigational Carpentier-Edwards supraannular porcine bioprosthetic valve has provided excellent clinical performance and remains our overall prosthesis of choice.