Failure of Hancock Xenograft Valve: Importance of Valve Position (4- to 9-Year Follow-up)

doi:10.1016/S0003-4975(10)60124-5

The Annals of Thoracic Surgery

Volume 36, Issue 3, September 1983, Pages 246-252

https://doi.org/10.1016/S0003-4975(10)60124-5 Get rights and content

Abstract

To evaluate long-term durability of Hancock valves, we reviewed our results in 107 hospital survivors (120 valves) who were operated on during 1974 through mid-1979. Mitral valve replacement was done in 63 patients, aortic valve replacement in 20, and mitral valve replacement combined with other procedures in 24. The 7-year survival was 84 ± 4% (standard error of the mean) for 91 patients and 97 valves. During a follow-up of 590 patient-years, 15 (12 mitral and 3 aortic) of 120 valves at risk (87 mitral, 32 aortic, 1 tricuspid) were removed from 14 patients. Six valves (3 mitral and 3 aortic) were removed because of bacterial endocarditis. One mitral valve was removed because of thromboembolism. Eight mitral valves were removed because of valve structural failure, which occurred at a mean follow-up of 42 months. These valves showed extensive calcification, leaflet perforation, or cusp tear. Structural failure was unrelated to valve size, year of implantation, or valve shelf-life. Structural failure was not seen after aortic valve replacement.

Results show that structural failure of the Hancock xenograft valve in the mitral position is related primarily to valve position. After aortic valve replacement, valve failure is predominantly due to endocarditis. Although medium-term (mean, 6-year) durability of this xenograft valve compares satisfactorily with prosthetic valves, its high failure rate in the mitral position indicates the necessity for improvement in valve mounting, design, and preservation.

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Carpentier-Edwards pericardial bioprosthesis in aortic or mitral position: A 12-year experience
1998, Annals of Thoracic Surgery
Background. The first generation of pericardial valves was withdrawn from the market for a high rate of premature failure. With an original design, Carpentier-Edwards pericardial valves promised improved results.
Methods. Seven hundred eighty-seven patients who underwent isolated aortic valve replacement and 182 patients who underwent isolated mitral valve replacement between July 1984 and December 1995 with Carpentier-Edwards pericardial bioprostheses in our institution were followed up. The patients’ mean age was 68.3 (aortic valve replacement, AVR) and 63.9 (mitral valve replacement, MVR) years. All but five AVR patients were followed up for an average of 4.7 years after operation, with a total follow-up of 3,624 patient-years. All patients with MVR were followed up for an average of 5.3 years after operation, with a total follow-up of 969 patient-years.
Results. After 12 years, actuarial survival rate is 53% for AVR and 54% for MVR. Freedom from valve-related complications for aortic versus mitral valve replacement is, respectively, 68% and 55%, freedom from valve-related death is 84% and 85%, freedom from thromboembolism 87% and 94%, and freedom from endocarditis 97% and 94%. The behavior of the aortic valve is better than that of the mitral valve: freedom from reoperation is 92% and 76%, respectively; freedom from valve failure is 94% and 78%. Age is an important factor, especially in the mitral position: freedom from valve failure is 52% in patients younger than 60 years and 100% in patients older than 60 years.
Conclusions. With a low rate of valve-related events at 12 years and a low rate of structural deterioration, this prosthesis is a reliable choice for AVR and in patients over 60 years for MVR. A more durable mitral bioprosthesis is needed for patients younger than 60 years.
Echocardiographic assessment of prosthetic heart valves
1992, Current Problems in Cardiology
Use of the Carpentier-Edwards porcine bioprosthesis: Assessment of a patient selection policy
1992, Journal of Thoracic and Cardiovascular Surgery
The Carpentier-Edwards bioprosthesis was implanted in 369 patients (414 valves) between May 1977 and December 1987 (age 67.2 ± 0.5 years); 242 had aortic valve replacement, 80 had mitral valve replacement, 44 had multiple valve replacement, of which 41 were aortic and mitral valve replacement, 2 had isolated tricuspid valve replacement, and 1 had a pulmonary valve replacement. The selection criteria were the following: shorter life expectancy (253 patients) or contraindications to anticoagulants for organic (113 patients) or psychologic (38 patients) reasons, or both. The early mortality rate was 11.1% (aortic valve replacement, 9.1%; mitral valve replacement, 12.4%; aortic and mitral valve replacement, 23.1%). Total cumulative follow-up was 1456 pt-yr (mean 4.4 years, range 1 to 148 months), and the patient evaluation was 99.5% complete. Late mortality was 4.9%/pt-yr. Five-year survival was 70.4% ± 2.7% overall, 74.3% ± 3.2% after aortic valve replacement, 60.9% ± 6.2% after mitral valve replacement (p < 0.03), and 60.7% ± 8.1% after aortic and mitral valve replacement. Eight patients were reoperated on for primary tissue failure, and freedom from reoperation for structural valve deterioration was 97.5% ± 1.2% at 5 years and 95.6% ± 1.8% at 8 years. Failing aortic bioprostheses were explanted in four patients (0.4%/pt-yr) and mitral bioprostheses in seven (1.6% /pt-yr). No patient whose valve was inserted after the age of 70 had to be reoperated on for structural valve dysfunction. The probability of freedom from thromboembolism after 5 and 8 years of follow-up was 93.1% ± 1.6% and 92.2% ± 1.8%, respectively. The prevalence of anticoagulant-related hemorrhage was 0.8% /pt-yr (major 0.6%, minor 0.2%). Anticoagulants had to be maintained in 16.3% of the patients: 5.9% after aortic valve replacement, 35.7% after mitral valve replacement, and 45.8% after aortic and mitral valve replacement, while 80.0% were on a regimen of antiplatelet drug therapy. Prosthetic valve endocarditis happened in five patients (0.3%/pt-yr). Freedom from all valve-related morbidity and mortality, including hospital deaths, was 71.0% ± 2.7% at 5 years and 58.6% ± 4.6% at 8 years and was significantly better in the aortic valve replacement group (61.3% ± 6.6% at 8 years) compared with the mitral valve replacement group (54.4% ± 7.7% at 8 years; p = 0.04). This study confirms the satisfactory performance of the Carpentier-Edwards valve after aortic valve replacement in elderly patients. In mitral position, however, clinical performance is lower than in the aortic position, and the advantages of the biologic valve are often nullified by the necessity for long-term anticoagulation. (J Thorac Cardiovasc Surg 1992;104:1013-24)
The Carpentier-Edwards standard porcine bioprosthesis. A first-generation tissue valve with excellent long-term clinical performance
1990, Journal of Thoracic and Cardiovascular Surgery
The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1190 patients (1201 operations, 1303 valves) between January 1975 and June 1986; most implants were before 1982. The mean age of the patients was 57.2 years (range 8 to 85 years). The early mortality was 7.6% (aortic valve replacement 5.1%, mitral valve replacement 8.8%, and multiple valve replacement 15.3%). Late mortality was 3.9% per patient-year (aortic valve replacement 3.6%, mitral valve replacement 4.2%, and multiple valve replacement 3.8%). The total cumulative follow-up period was 6737 years. Thromboembolism was 1.5% per patient-year (fatal 0.4% per patient-year) (minor 0.6%, major 0.9%); antithromboembolic therapy-related hemorrhage was 0.5% (fatal 0.1%); prosthetic valve endocarditis was 0.6% (fatal 0.2%); nonstructural dysfunction was 0.5% (fatal 0.2%); and structural valve deterioration and/or primary tissue failure was 1.5% per patient-year (fatal, 0.2% per patient-year). Thromboembolism and structural valve deterioration were the significant complications, structural valve deterioration occurring primarily between the sixth and 10th year of evaluation. The overall patient survival was 65.0% for aortic valve replacement and 54.8% for mitral valve replacement (p < 0.05) at 10 years. The patients were classified as 92.9% New York Heart Association functional classes III and IV preoperatively and 92.3% classes I and II postoperatively. Freedom at 10 years from thromboembolism was 84.3% for aortic valve replacement and 76.5% for mitral valve replacement (p = 0.05); structural valve deterioration was 78.6% for aortic valve replacement and 71.6% for mitral valve replacement (p < 0.05); reoperation was 74.4% for aortic valve replacement and 67.1% for mitral valve replacement (p < 0.05). Freedom from all valve-related complications at 10 years was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p < 0.05); valve-related mortality was 89.5% for aortic valve replacement and 82.6% for mitral valve replacement (p = not significant); mortality and reoperation was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p < 0.05); mortality and residual morbidity (treatment failure) was 87.2% for aortic valve replacement and 75.1% for mitral valve replacement (p = not significant); mortality, residual morbidity, and reoperation were 66.3% for aortic valve replacement and 54.9% for mitral valve replacement (p < 0.05). The standard Carpentier-Edwards porcine bioprosthesis has provided satisfactory clinical performance and has afforded patients excellent quality of life.
The Carpentier-Edwards supraannular porcine bioprosthesis: A new generation tissue valve with excellent intermediate clinical performance
1988, Journal of Thoracic and Cardiovascular Surgery
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 antithrom-boembolic 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.
Intrinsic Failure of Hancock Mitral Bioprostheses: 10- to 15-Year Experience
1987, Annals of Thoracic Surgery
Hancock porcine bioprostheses have been implanted in the mitral position at the National Institutes of Health since July, 1970. Eight models (330, 330A, 330B, 330C, 332, 340, 341, and 342) were used during a 54-month period ending December, 1974, and 100 consecutive surviving patients were evaluated for subsequent bioprosthetic valve failure and prosthesis-related complications by annual clinic examinations and serial hemodynamic studies. Actuarial patient survival was 76 ± 4%, 51 ± 5%, and 30 ± 6% after 5, 10, and 15 years, respectively. Intrinsic valve failure, defined as structural degeneration of bioprosthetic tissue or stent geometry alteration or both, in the absence of prior infection, occurred in 23 patients. The linear occurrence rate of bioprosthetic valve failure was 0.2%, 5%, and 15% per patient-year, and it affected 1 patient, 14 patients, and 8 patients at sequential 5-year milestones. The actuarial freedom from valve failure was 99 ± 1%, 75 ± 6%, 58 ± 8%, and 40 ± 12% after 5, 10, 12, and 14 years, respectively. The valve durability of early Hancock bioprostheses (models 330 through 341; N = 39) was not appreciably different from that of the current model 342 valves (N = 61). However, an increased incidence of intrinsic valve failure was observed for the first polypropylene-stented valve type (model 330) compared with the currently available model 342 valve (8/16, 50%, versus 12/61, 20%; p = 0.034). The yearly occurrence rate of prosthesis-related complications remained constant, but the rate of intrinsic valve failure increased in a progressive, nonlinear fashion. The high intrinsic failure rate of the Hancock porcine bioprosthesis after 10 to 12 years has moderated our initial enthusiasm for this valve in the mitral position, and has resulted in more frequent implantations of mechanical valve substitutes at this institution.

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Presented at the Twenty-ninth Annual Meeting of the Southern Thoracic Surgical Association, Hilton Head Island, SC, Nov 4-6, 1982.

The authors acknowledge the contributions of Mrs. Stana Novak, Mr. Joel Kellner, and Richard Essner, B.A., in the preparation of these data and the patient follow-up.

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Failure of Hancock Xenograft Valve: Importance of Valve Position (4- to 9-Year Follow-up)

Abstract

Am J Cardiol

Ann Thorac Surg

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J Thorac Cardiovasc Surg

Clinical and hemodynamic evaluation of the Hancock valve bioprosthesis