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Randomized, prospective assessment of bioprosthetic valve durability. Hancock versus Carpentier-Edwards valves
G E Sarris1, R C Robbins, D C Miller
1Department of Cardiovascular and Thoracic Surgery, Stanford University School of Medicine, Calif 94305-5247.
Insights
This study found no significant difference in the durability of Carpentier-Edwards (C-E) and Medtronic Hancock I (H) porcine valves after 10 years. Patient age, not valve type, was the key factor influencing structural valve deterioration.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Trials
Background:
- Porcine bioprosthetic valves have limited durability, a key clinical concern.
- No prior controlled studies compared the durability of the Carpentier-Edwards (C-E) and Medtronic Hancock I (H) valves.
Purpose of the Study:
- To compare the long-term durability of C-E and H porcine bioprosthetic valves in aortic and mitral positions.
- To identify predictors of structural valve deterioration (SVD).
Main Methods:
- A randomized controlled trial involving 174 patients undergoing aortic or mitral valve replacement.
- Patients received either a C-E or H valve, with follow-up up to 12 years.
- Structural valve deterioration (SVD) was assessed using AATS/STS guidelines.
Main Results:
- Younger patient age was the only significant independent predictor of SVD (P = .024).
- No statistically significant differences in SVD rates were observed between C-E and H valves at 10 years for either aortic or mitral positions.
- Actuarial rates free of SVD at 10 years were 71% for C-E and 59% for H in aortic replacements, and 60% for C-E and 72% for H in mitral replacements.
Conclusions:
- Durability did not differ significantly between C-E and H porcine valves after a decade.
- Valve choice should prioritize factors like implantation ease, hemodynamics, and cost over durability concerns.
Background:
Although the major limitation of porcine valves is their finite durability, no controlled clinical data exist regarding the relative durability of the two porcine bioprostheses implanted most commonly today, the Carpentier-Edwards (C-E) and Medtronic Hancock I (H) valves.
Methods And Results:
To assess this question, 174 patients undergoing aortic (AVR) or mitral (MVR) valve replacement with a bioprosthesis between March 1980 and March 1982 were randomized to receive either a C-E or a H valve. There were 102 AVRs (54 C-E and 48 H) and 74 MVRs (39 C-E and 35 H). For both the AVR and MVR cohorts, the average patient age was 58 +/- 14 years (+/- SD). The male/female ratio was 2.2:1 for AVR and 0.57:1 for MVR. Clinical follow-up was undertaken periodically; the most recent follow-up closing interval was July through October 1992, and current follow-up was 96% complete. Cumulative follow-up totaled 1369 patient-years (mean, 7.7 +/- 3.6 years; median, 9.1 years; maximum, 12.0 years). The main focus of this analysis was bioprosthetic durability, using the AATS/STS guidelines defining "Structural Valve Deterioration" (SVD). Multivariate analysis revealed that (younger) age was the only significant (P = .024) independent predictor of SVD. Valve manufacturer (C-E versus H) and valve site (aortic versus mitral) did not emerge as significant independent risk factors for SVD. Actuarial rates (Cutler-Ederer) expressed as percent free of SVD (+/- SEM) at 10 years (n = number of patients remaining at risk) were 71 +/- 7% and 59 +/- 9% for the C-E (n = 26) and H (n = 17) groups, respectively, for the AVR cohort; for the MVR cohort, these estimates were 60 +/- 10% (n = 12) and 72 +/- 10% (n = 11), respectively, but these differences were not statistically significant (P = NS, Lee-Desu).
Conclusions:
After 10 years, there was no statistically significant difference in durability or other valve-related complications between the H and C-E aortic or mitral valves. Based on current information, the choice of a porcine bioprosthesis should be based on factors other than durability, including ease of implantation, hemodynamic performance, and cost.