title: Early structural valve deterioration of Mitroflow aortic bioprosthesis: mode, incidence, and impact on outcome in a large cohort of patients.
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.
  
  
  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.affiliation: 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.).
authors.forename: Thomas
authors.initials: T
authors.lastname: Sénage
authors.affiliation: 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.).
authors.forename: Thierry
authors.initials: T
authors.lastname: Le Tourneau
authors.affiliation: 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.).
authors.forename: Yohann
authors.initials: Y
authors.lastname: Foucher
authors.affiliation: 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.).
authors.forename: Sabine
authors.initials: S
authors.lastname: Pattier
authors.affiliation: 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.).
authors.forename: Caroline
authors.initials: C
authors.lastname: Cueff
authors.affiliation: 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.).
authors.forename: Magali
authors.initials: M
authors.lastname: Michel
authors.affiliation: 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.).
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Serfaty
authors.affiliation: 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.).
authors.forename: Antoine
authors.initials: A
authors.lastname: Mugniot
authors.affiliation: 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.).
authors.forename: Christian
authors.initials: C
authors.lastname: Périgaud
authors.affiliation: 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.).
authors.forename: Hubert François
authors.initials: HF
authors.lastname: Carton
authors.affiliation: 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.).
authors.forename: Ousama
authors.initials: O
authors.lastname: Al Habash
authors.affiliation: 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.).
authors.forename: Olivier
authors.initials: O
authors.lastname: Baron
authors.affiliation: 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.
authors.forename: Jean Christian
authors.initials: JC
authors.lastname: Roussel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001024:Aortic Valve Stenosis / Q000401:mortality* / Q000601:surgery*; D001705:Bioprosthesis / Q000009:adverse effects / Q000706:statistics & numerical data*; D002417:Cattle; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality*; D006801:Humans; D015994:Incidence; D007362:Intensive Care Units / Q000706:statistics & numerical data; D053208:Kaplan-Meier Estimate; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D009369:Neoplasms / Q000401:mortality; D016016:Proportional Hazards Models; D012086:Reoperation / Q000401:mortality; D012770:Shock, Cardiogenic / Q000209:etiology / Q000401:mortality
keywords: aortic stenosis; bioprosthesis; cardiac valves; echocardiography; survival analysis