Early structural valve deterioration of mitroflow aortic bioprosthesis: Mode, incidence, and impact on outcome in a large cohort of patients

Thomas Sénage, Thierry Le Tourneau, Yohann Foucher, Sabine Pattier, Caroline Cueff, Magali Michel, Jean Michel Serfaty, Antoine Mugniot, Christian Périgaud, Hubert François Carton, Ousama Al Habash, Olivier Baron, Jean Christian Roussel

Research output: Contribution to journalArticlepeer-review

Abstract

Background-Structural valve deterioration (SVD) is a major flaw of bioprostheses. Early SVD has been suspected in the last models of Mitroflow bioprosthesis. We sought to assess the incidence, mode, and impact of SVD on outcome in a large series of Mitroflow aortic valve replacement.

Methods and Results-Six hundred seventeenconsecutive patients (aged 76.1±6.3 years) underwent aortic valve replacement with a Mitroflow prosthesis (models 12A/LX) between 2002 and 2007. By echocardiography, 39 patients developed early SVD (1.66% per patient-year), with stenosis as the main mode (n=36). Mean delay to SVD was only 3.8±1.4 years, and 5-year SVD-free survival was 91.6% (95% confidence interval [CI], 88.7-94.7) for the whole cohort and 79.8% (95% CI, 71.2-89.4) and 94.0% (95% CI, 90.3-97.8) for 19- and 21-mm sizes, respectively. Among the 39 patients with SVD, 13 patients (33%) had an accelerated SVD once the mean gradient exceeded 30 mm Hg. Valve-related death was 46.2% in this SVD subgroup. Five-year overall survival was 69.6% (95% CI, 65.7-73.9). In multivariable analysis, SVD was the strongest correlate of overall mortality (hazard ratio=7.7; 95% CI, 4.4-13.6).

Conclusions-Early SVD is frequent in Mitroflow bioprosthesis (models 12A/LX), especially for small sizes (19 and 21 mm), and reduces overall survival. An unpredictable accelerated pattern of SVD constitutes a life-threatening condition. In view of the large number of Mitroflow valves implanted worldwide, one can expect an epidemic of SVD and valverelated deaths, which represents a major public health issue, especially in the elderly. Hence, a close follow-up with yearly echocardiography after Mitroflow implantation is advisable. An urgent reoperation should be discussed in patients with severe SVD even though they are still asymptomatic.

Original languageEnglish (US)
Pages (from-to)2012-2020
Number of pages9
JournalCirculation
Volume130
Issue number23
DOIs
StatePublished - Dec 2 2014
Externally publishedYes

Keywords

  • Aortic stenosis
  • Bioprosthesis
  • Cardiac valves
  • Echocardiography
  • Survival analysis

ASJC Scopus subject areas

  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

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