Durability of the Mitroflow Pericardial Prosthesis: Influence of Patient–Prosthesis Mismatch and New Anticalcification Treatment

Abstract

Background The Mitroflow pericardial bioprosthesis (MPB) has been recently associated with a high incidence of early structural failures, questioning its validity as cardiac valve substitute. We have therefore reviewed our experience with this device.

Materials and Methods A total of 398 patients with a mean age of 75 ± 7 years (58% above the age of 75 years) had aortic valve replacement with a Mitroflow prosthesis (2005–2015). Most patients had calcific aortic stenosis (86%) and were in sinus rhythm (89%). Mean EuroSCORE II was 5.5 ± 6.2. Mean follow-up was 4 ± 2 years (range: 4 months to 10 years), which was 100% complete.

Results Hospital mortality was 6.5%; at discharge, 25% of patients had a moderate patient–prosthesis mismatch and none had a severe mismatch. Cumulative incidence of structural valve deterioration in the entire series was 2% (95% confidence interval [CI]: 1–4) at 5 years and 7% (95% CI: 4–14) at 8 years. Significant factors influencing MPB durability were age ≤ 65 years (p < 0.001) and the presence of patient–prosthesis mismatch (p = 0.01). No cases of structural valve deterioration were observed in patients with the new prosthetic model incorporating an anticalcification treatment the first 4 years of follow-up.

Conclusions The Mitroflow prosthesis has shown satisfactory results in the first decade of use. Durability appears adversely influenced by patient age and patient–prosthesis mismatch. Thus, a careful valve size selection and implantation in patients >65 years of age appears to be associated with excellent valve durability in the aortic position. Whether the new anticalcification treatment will provide a more durable prosthesis must be verified at a longer follow-up.

Keywords

aortic valve - aortic valve replacement - bioprosthesis

• References

• 1 Conte J, Weissman N, Dearani JA. , et al. A North American, prospective, multicenter assessment of the Mitroflow aortic pericardial prosthesis. Ann Thorac Surg 2010; 90 (01) 144-152.e1 , 3
• 2 Minami K, Zittermann A, Schulte-Eistrup S, Koertke H, Körfer R. Mitroflow synergy prostheses for aortic valve replacement: 19 years experience with 1,516 patients. Ann Thorac Surg 2005; 80 (05) 1699-1705
• 3 Yankah CA, Pasic M, Musci M. , et al. Aortic valve replacement with the Mitroflow pericardial bioprosthesis: durability results up to 21 years. J Thorac Cardiovasc Surg 2008; 136 (03) 688-696
• 4 ISTHMUS Investigators. The Italian study on the Mitroflow postoperative results (ISTHMUS): a 20-year, multicentre evaluation of Mitroflow pericardial bioprosthesis. Eur J Cardiothorac Surg 2011; 39 (01) 18-26 , discussion 26
• 5 Alvarez JR, Sierra J, Vega M. , et al. Early calcification of the aortic Mitroflow pericardial bioprosthesis in the elderly. Interact Cardiovasc Thorac Surg 2009; 9 (05) 842-846
• 6 Joshi V, Prosser K, Richens D. Early prosthetic valve degeneration with Mitroflow aortic valves: determination of incidence and risk factors. Interact Cardiovasc Thorac Surg 2014; 19 (01) 36-40
• 7 Sénage T, Le Tourneau T, Foucher Y. , et al. Early structural valve deterioration of Mitroflow aortic bioprosthesis: mode, incidence, and impact on outcome in a large cohort of patients. Circulation 2014; 130 (23) 2012-2020
• 8 Akins CW, Miller DC, Turina MI. , et al; Councils of the American Association for Thoracic Surgery; Society of Thoracic Surgeons; European Assoication for Cardio-Thoracic Surgery; Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg 2008; 135 (04) 732-738
• 9 Pibarot P, Dumesnil JG. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Heart 2006; 92 (08) 1022-1029
• 10 Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. Somerset, NJ: Wiley & Sons Inc.; 1980
• 11 Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1988; 16: 1141-1154
• 12 Gabbay S, Bortolotti U, Wasserman F, Factor S, Strom J, Frater RWM. Fatigue-induced failure of the Ionescu-Shiley pericardial xenograft in the mitral position. In vivo and in vitro correlation and a proposed classification. J Thorac Cardiovasc Surg 1984; 87 (06) 836-844
• 13 Bortolotti U, Milano A, Thiene G. , et al. Early mechanical failures of the Hancock pericardial xenograft. J Thorac Cardiovasc Surg 1987; 94 (02) 200-207
• 14 Bortolotti U, Milano A, Mazzucco A. , et al. The Hancock pericardial xenograft: incidence of early mechanical failures at a medium-term follow-up. Eur J Cardiothorac Surg 1988; 2 (06) 458-464
• 15 Thiene G, Bortolotti U, Valente M. , et al. Mode of failure of the Hancock pericardial valve xenograft. Am J Cardiol 1989; 63 (01) 129-133
• 16 Saleeb SF, Newburger JW, Geva T. , et al. Accelerated degeneration of a bovine pericardial bioprosthetic aortic valve in children and young adults. Circulation 2014; 130 (01) 51-60
• 17 Leandri J, Bertrand P, Mazzucotelli JP, Loisance D. Mode of failure of the Mitroflow pericardial valve. J Heart Valve Dis 1992; 1 (02) 225-231
• 18 Mosquera VX, Bouzas-Mosquera A, Velasco-García C. , et al. Long-term outcomes and durability of the Mitroflow aortic bioprosthesis. J Card Surg 2016; 31 (05) 264-273
• 19 Ius F, Schulz J, Roumieh M. , et al. Long-term results of the Mitroflow aortic pericardial bioprosthesis in over 800 patients: limited durability and mechanisms of dysfunction. Eur J Cardiothorac Surg 2017; 52 (02) 264-271
• 20 Flameng W, Herregods MC, Vercalsteren M, Herijgers P, Bogaerts K, Meuris B. Prosthesis-patient mismatch predicts structural valve degeneration in bioprosthetic heart valves. Circulation 2010; 121 (19) 2123-2129
• 21 Lootens L, Verbeke J, Martens T. , et al. Ten-year results of aortic valve replacement with first-generation Mitroflow bioprosthesis: is early degeneration a structural or a technical issue?. Eur J Cardiothorac Surg 2017; 52 (02) 272-278
• 22 Luk A, Cusimano RJ, Butany J. Pathologic evaluation of 28 Mitroflow pericardial valves: a 12-year experience. Ann Thorac Surg 2015; 99 (01) 48-54
• 23 Milano A, Bortolotti U, Talenti E. , et al. Calcific degeneration as the main cause of porcine bioprosthetic valve failure. Am J Cardiol 1984; 53 (08) 1066-1070