Short summary

Based on this an internal review at Aarhus University Hospital Skejby and an analysis of survival and need for reoperation among 1,293 patients treated with bioprostheses in Vestern Denmark has raised a concern that the durability and survival of patients implanted with a Mitroflow heart valve prosthesis possibly is lesser than other bioprostheses. Current study is undertaken to assess the magnitude of the problem and to assess the effect of a tailored follow-up program for early detection of SVD.

Rationale

Annually more than 200,000 patients are treated with surgical aortic valve replacement (SAVR) for aortic valve stenosis (AS) or aortic valve regurgitation (AR). In younger patients (age<65 years) a mechanical prosthesis is usually chosen due to durability whereas biological prostheses are preferred in elderly and frail patients. The advantage of bioprostheses are mainly related to freedom from warfarin therapy, the major weakness of biological prostheses is the occurrence of structural valve deterioration (SVD) with premature degeneration of the valve due to cusp tears and thickening, calcification, pannus formation and thrombus. The rate of SVD differs among ages; valves implanted in younger patients degenerate faster. For patients over age 65, the 10-year freedom from SVD in new pericardial valves is typically over 90%. Among bovine pericardial prostheses, the Mitroflow (Sorin Group Inc) valve, has been available since 1982, and has been implanted in more than 100,000 patients worldwide. Concern has been raised regarding the durability of this heart valve.

Description of the cohort

The study comprises a cross-sectional study based on all patients alive in Western Denmark that have undergone a SAVR with a Mitroflow prosthesis, and a prospective study based on follow-up of all patients included in the cross sectional study at Odense University Hospital.

Data and biological material

Data will be retrieved from hospital charts and relevant registries. In all patients evaluated at the surgical center, self-reported symptoms will be recorded together with a functional assessment according to the NYHA classification and CCS classification by experienced cardiologist who performs echocardiography. Co morbidity, past medical history, demographics, concomitant medication will be recorded from hospital charts. Surgical details including valve size will be recorded from operating notes. Height, body weight, heart rate and blood pressure will be recorded at echocardiographic evaluation.

Collaborating researchers and departments

Department of Cardiology, Odense University Hospital

• PhD-student Issa F. Issa
• Professor Hans Mickley, MD, DMSc

Department of Cardiology, Aarhus University Hospital

• Associate professor Steen Hvitfeldt Poulsen, MD, PhD, DMSc
• Registrar Farhad Waziri, MD

Department of Cardiology, Aalborg University Hospital

• Professor Christian Torp Pedersen, MD, DMSc
• Professor Peter Søgaard, MD, DMSc

Department of Cardiothoracic Surgery, Odense University Hospital

• Senior registrar Lars Riber, MD, PhD
• Consultant Gert Lerbjerg, MD

Department of Cardiothoracic Surgery, Aarhus University Hospital , Per Hostrup, MD, DMSc, Department of Cardiothoracic Surgery, Aalborg University Hospital

• Professor Jan Jesper Andreasen, MD, PhD