Mitroflow aortic bioprosthesis 5-year follow-up: North American prospective multicenter study

Federico M. Asch, David Heimansohn, Daniel Doyle, Walter Dembitsky, Francis D. Ferdinand, Jeffrey Swanson, Joseph A. Dearani, Neil J. Weissman

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

Abstract

Background: The Mitroflow valve (Sorin Group, Milan, Italy) has been in use since 1982 and has shown long-term durability in large studies from European centers but has not been studied for long-term hemodynamics in large standardized multicenter trials. This study sought to assess the hemodynamics of the Mitroflow valve by extending the duration of follow-up in an ongoing prospective multicenter trial conducted in North America. Methods: Six sites participated in this midterm study requiring annual follow-up and echocardiographic evaluation using a standardized transthoracic echocardiography acquisition protocol. Results: There were 276 patients enrolled (age 74 ± 8 years) and 54% were in New York Heart Association (NYHA) functional class III-IV. Follow-up from the time of valve implantation had a mean of 4.0 ± 1.7 years with a cumulative follow-up of 1,102 patient-years. At 5 years of follow-up, 99% of patients were free of moderate or severe aortic regurgitation and 94% were in NYHA functional class I or II. Between baseline and 5 years, mean gradients increased an average of 0.4 to 4.3 mm Hg. The change in effective orifice area was appreciably small (-0.1 to -0.3 cm2) after 5 years. There were 57 deaths (4 early and 53 late) and 9 valve explants. Conclusions: The Mitroflow valve implanted in the aortic position has shown to be hemodynamically stable over a 5-year follow-up in an elderly population with a high prevalence of comorbid conditions.

Original languageEnglish (US)
Pages (from-to)1198-1203
Number of pages6
JournalAnnals of Thoracic Surgery
Volume94
Issue number4
DOIs
StatePublished - Oct 2012

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of 'Mitroflow aortic bioprosthesis 5-year follow-up: North American prospective multicenter study'. Together they form a unique fingerprint.

Cite this