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

Thorac Cardiovasc Surg. 2020 Mar;68(2):131-140. doi: 10.1055/s-0038-1667201. Epub 2018 Jul 30.

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.

MeSH terms

  • Age Factors
  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / pathology*
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery*
  • Bioprosthesis*
  • Calcinosis / diagnostic imaging
  • Calcinosis / physiopathology
  • Calcinosis / surgery*
  • Female
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis*
  • Hemodynamics
  • Hospital Mortality
  • Humans
  • Male
  • Middle Aged
  • Pericardium / transplantation*
  • Prosthesis Design
  • Recovery of Function
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome

Supplementary concepts

  • Aortic Valve, Calcification of