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Charles A. Yankah
Miralem Pasic
Michele Musci
Roland Hetzer
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J Thorac Cardiovasc Surg 2008;136:688-696
© 2008 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease

Aortic valve replacement with the Mitroflow pericardial bioprosthesis: Durability results up to 21 years

Charles A. Yankah, MD, PhD*, Miralem Pasic, MD, PhD, Michele Musci, MD, Julia Stein, MSc, Christine Detschades, SRN, Henryk Siniawski, MD, PhD, Roland Hetzer, MD, PhD

Deutsches Herzzentrum Berlin, Berlin, Germany

Received for publication November 12, 2007; revisions received March 28, 2008; accepted for publication May 13, 2008.

* Address for reprints: A. Charles Yankah, MD, PhD, Professor of Surgery, Humboldt, Charité Medical University, German Heart Institute Berlin, Augustenburger Platz 1, D-13353 Berlin, Germany. (Email: yankah{at}dhzb.de).

Objective: The study aim was to analyze the performance profile of a large series of Mitroflow pericardial valves (Sorin Group Canada Inc. Mitroflow Division) in the very long term.

Methods: Data from 1513 patients with isolated aortic valve replacement who received pericardial bioprostheses between 1986 and 2007 were analyzed. Cumulative duration of follow-up was 6164 patient-years with a maximum duration of 21 years. Actuarial rates of valve-related events were calculated by the Kaplan–Meier method and the Cox multivariate analysis to identify independent determinants of outcome.

Results: Hospital mortality for elective surgery was 2.5%. Late death was 40.6%. Reoperation was required in 86 (5.7%) patients and was valve related in 83: structural valve deterioration in 64 (4.2%) patients, prosthetic valve endocarditis in 17 patients (1.1%), valve thrombosis in 1, and periprosthetic leak in 1. Rates of 20-year actuarial freedom from valve-related morbidity were as follows: structural valve deterioration 84.8% (actual 96.6%) in patients 70 years of age or older; thromboembolism 94.1%; and prosthetic valve endocarditis 96.8%. Twenty-year actual risk of reoperation for structural valve deterioration was 11.4% in all patients and 3.4%, in patients 70 years or age or older. Advanced age, renal insufficiency, pulmonary disease, and low body mass index were independent risk factors for late outcome (P < .001).

Conclusions: After 2 decades of follow-up, the Mitroflow pericardial aortic valve continues to be a valve of choice with a predictable low rate of valve-related events, particularly for patients over the age of 65 to 70 years and others with comorbidities.

Abbreviations and Acronyms NYHA = New York Heart Association; CI = confidence interval; CL = confidence limits; OR = odds ratio; PVE = prosthetic valve endocarditis; SVD = structural valve deterioration; TE = thromboembolism






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