Short summary

Surgical aortic valve replacement with biological prosthesis is gold standard in treating patients over 65 years of age with severe aortic stenosis or regurgitation. AS is the most frequent valve disease requiring intervention in Europe and North America. We conducted this register based retrospective single centre cohort study to investigate long-term clinical outcomes of Carpentier-Edwards Perimount and Mitroflow valves.

Rationale

Surgical aortic valve replacement (SAVR) with biological prosthesis is gold standard in treating patients over 65 years of age with severe aortic stenosis (AS) or regurgitation. AS is the most frequent valve disease requiring intervention in Europe and North America, with frequency of is 4-5% in those aged over 65.

Carpentier-Edwards Perimount (CE-P) (Edwards Lifesciences, Irvine, CA, USA) valve was introduced in Denmark 1999 and is a reliable valve with satisfying durability for AVR in terms of long-term survival, risk of reoperation and freedom from structural valve deterioration (SVD). Mitroflow bioprosthetic valve (Sorine Group Inc., Milan, Italy) has been in the European market since 1982, with the fourth-generation valve being introduced in 2011 by the promotion of beneficial for patients with small aortic annulus (size 19 and 21mm). Several studies however reported that the Mitroflow valve in the aortic position had notable as well as early development of SVD which is associated with adverse left ventricle remodelling and increased risk of death or reintervention. A recent study even recommends that patients with Mitroflow bioprosthetic should be systematically and routinely followed with echocardiography in order to consider reoperation due to early detection of SVD.

Larger studies on long-term comparison of CE-P and Mitroflow in solitary AVR procedure is still limited. This includes data on expected cases of reoperation due to AVR with Mitroflow. We therefore conducted this register based retrospective single centre cohort study to investigate the long-term survival with all-cause mortality, risk of re-operation, and clinical outcomes in all patients treated for AS or regurgitation who underwent a solitary AVR procedure with ether CE-P or Mitroflow bioprosthetic valve between 1999 and 2014 at OUH, Odense University Hospital.

Description of the cohort

A population-based single-centre retrospective cohort study analysis including all patients who underwent solitary AVR with CE-P valve or Mitroflow in Department of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark.

We excluded patients operated with other valve types of AVR or had concomitant surgery.

Data and biological material

Data from 1999 to 2014. The data was obtained July 2020 from the Western Danish Heart Registry (WDHR), The National Danish Patient Registry and the Program of clinical quality development of the Danish Regions.

Collaborating researchers and departments

Department of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark