Thomas Sénage1, Thierry Le Tourneau1, Yohann Foucher1, Sabine Pattier1, Caroline Cueff1, Magali Michel1, Jean-Michel Serfaty1, Antoine Mugniot1, Christian Périgaud1, Hubert François Carton1, Ousama Al Habash1, Olivier Baron1, Jean Christian Roussel2. 1. From the Department of Thoracic and Cardiovascular Surgery (T.S., S.P., M.M., A.M., C.P., H.F.C., O.A.H., O.B., J.C.R.), Institut du Thorax (T.S., T.L.T., S.P., C.C., M.M., A.M., C.P., H.F.C., O.A.H., O.B., J.C.R.), Department of Cardiology (T.L.T., C.C.), and Department of Radiology (J.S.), University Hospital, Nantes, France; Member of Translink European Network (dedicated to structural valve deterioration) (T.S., T.L.T., C.C., J.C.R.); INSERM UMR1087, Nantes, France (T.L.T.); and EA 4275 SPHERE (BioStatistics, Pharmacoepidemiology & Human SciEnces REsearch), University of Nantes, Nantes, France (T.S., Y.F.). 2. From the Department of Thoracic and Cardiovascular Surgery (T.S., S.P., M.M., A.M., C.P., H.F.C., O.A.H., O.B., J.C.R.), Institut du Thorax (T.S., T.L.T., S.P., C.C., M.M., A.M., C.P., H.F.C., O.A.H., O.B., J.C.R.), Department of Cardiology (T.L.T., C.C.), and Department of Radiology (J.S.), University Hospital, Nantes, France; Member of Translink European Network (dedicated to structural valve deterioration) (T.S., T.L.T., C.C., J.C.R.); INSERM UMR1087, Nantes, France (T.L.T.); and EA 4275 SPHERE (BioStatistics, Pharmacoepidemiology & Human SciEnces REsearch), University of Nantes, Nantes, France (T.S., Y.F.). jeanchristian.roussel@chu-nantes.fr.
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 seventeen consecutive 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 valve-related 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.
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 seventeen consecutive 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 valve-related 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.
Authors: Paul Werner; Jasmin Gritsch; Sabine Scherzer; Christoph Gross; Marco Russo; Iuliana Coti; Alfred Kocher; Guenther Laufer; Martin Andreas Journal: Interact Cardiovasc Thorac Surg Date: 2021-01-01