What is the clinical evidence from this study?

Study design: Cohort. Population: Mitral valve disease requiring replacement (n=194). Intervention: Carpentier-Edwards standard bioprosthesis (stCE). Primary outcome: Freedom from structural valve failure at 10 years (MVR group).

What question did this study set out to answer?

To evaluate the long-term clinical performance and durability of the Carpentier-Edwards standard bioprosthesis in the mitral position over more than a decade of follow-up.

January 1, 1995European Journal of Cardio-Thoracic Surgery

Mitral valve replacement with the Carpentier-Edwards standard bioprosthesis: performance into the second decade

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Key result

The Carpentier-Edwards standard bioprosthesis demonstrated unsatisfactory long-term performance, with 10-year freedom from structural valve failure of 70.8% for isolated MVR and 59.6% for AVR/MVR.

Key Points

To evaluate the long-term clinical performance and durability of the Carpentier-Edwards standard bioprosthesis in the mitral position over more than a decade of follow-up.
Followed 194 patients who received 196 Carpentier-Edwards standard bioprostheses (154 isolated mitral valve replacements [MVR] and 42 combined aortic and mitral valve replacements [AVR/MVR]) implanted starting in March 1978.
Tracked patients over a mean follow-up of 7.05 years (range 0–15.2) for MVR and 7.15 years (range 0–13.8) for AVR/MVR to evaluate structural failure, thromboembolism, and survival.
Freedom from structural valve failure at 10 years was 70.8% ± 4.9% for MVR and 59.6% ± 11.1% for AVR/MVR, with failure rates accelerating sharply beyond 7 years.
Freedom from thromboembolism at 10 years reached 83.0% ± 3.8% (MVR) and 89.0% ± 6.0% (AVR/MVR), with thromboembolic events primarily linked to unanticoagulated atrial fibrillation.
Ten-year event-free survival was 43.6% ± 4.6% for MVR and 33.3% ± 8.6% for AVR/MVR, with prosthetic valve endocarditis exceeding 60% mortality.

Study Design

Type

Cohort (n=194)

Structured PICO

Population

194 patients who received Carpentier-Edwards standard bioprostheses for isolated mitral or combined aortic and mitral valve replacement, followed for a mean of approximately 7 years.

Exposure

Mitral valve replacement with the Carpentier-Edwards standard bioprosthesis

Outcome

Freedom from structural valve failure, thromboembolism, prosthetic endocarditis, and event-free survival at 10 yearshard clinical

The Carpentier-Edwards standard bioprosthesis in the mitral position demonstrates a low rate of thromboembolism but unsatisfactory long-term performance due to a high rate of structural valve failure after 7 years.

Discussion

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Implication

May caution against Carpentier-Edwards standard bioprosthesis for MVR; leaves open durability benchmarks versus contemporary valves in observational cohorts.

Cite This Study

VANDOORN et al. (1995) conducted a cohort in Mitral valve disease requiring replacement (n=194). Carpentier-Edwards standard bioprosthesis (stCE) was evaluated on Freedom from structural valve failure at 10 years (MVR group). The Carpentier-Edwards standard bioprosthesis demonstrated unsatisfactory long-term performance, with 10-year freedom from structural valve failure of 70.8% for isolated MVR and 59.6% for AVR/MVR.

synapsesocial.com/papers/6a9e705e8f37065ff4e98273 https://doi.org/10.1016/s1010-7940(05)80159-9

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Implication

May caution against Carpentier-Edwards standard bioprosthesis for MVR; leaves open durability benchmarks versus contemporary valves in observational cohorts.

Mitral valve replacement with the Carpentier-Edwards standard bioprosthesis: performance into the second decade

Key Points

Study Design

Structured PICO

Discussion

Implication

Cite This Study

Mitral valve replacement with the Carpentier-Edwards standard bioprosthesis: performance into the second decade

Key Points

Study Design

Structured PICO

Discussion

Implication

Cite This Study

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