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Comparison of Long-Term Performance of Bioprosthetic Aortic Valves in Sweden
Quick Takes
- In a population-based, nationwide cohort study using the SWEDEHEART registry, the cumulative incidence of reintervention was lowest in the Perimount valve model group and highest in the Mitroflow/Crown and Soprano valve model groups.
- Survival was highest in the Perimount, Mosaic/Hancock, and Biocor/Epic groups; and lowest in the Mitroflow/Crown group.
- The incidence of heart failure hospitalization also was lowest in the Perimount group and highest in the Mitroflow/Crown group.
Study Questions:
What are the long-term rates of reintervention, all-cause mortality, and heart failure hospitalization associated with commonly used bioprosthetic aortic valves? Are there valve model groups with deviation in clinical performance?
Methods:
Using the SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry, adult patients who underwent surgical aortic valve replacement with or without concomitant coronary artery bypass surgery or ascending aortic surgery in Sweden between January 2003–December 2018 were identified and included in this population-based, nationwide cohort study. Exclusions included patients with concomitant valve surgery, previous cardiac surgery, previous transcatheter valve replacement, the use of deep hypothermia and circulatory arrest, or the use of stentless or rapid deployment valves. Evaluated valve model groups were Perimount, Mosaic/Hancock, Biocor/Epic, Mitroflow/Crown, Soprano, and Trifecta. The primary outcome was cumulative incidence of reintervention, defined as subsequent aortic valve operation or transcatheter valve replacement. Secondary outcomes were all-cause mortality and heart failure hospitalization. Follow-up was complete for all participants. Mean follow-up time was 7.1 years, and maximum follow-up time was 16.0 years. Regression standardization and flexible parametric survival models were used to account for intergroup differences.
Results:
A total of 16,983 patients (mean age 72.6 ± 8.5 years; 10,685 [62.9%] men) were included in the analysis. A Perimount valve was implanted in 11,269 (66.4%), Mosaic/Hancock in 1,235 (7.3%), Biocorc/Epic in 1,670 (9.8%), Mitroflow/Crown in 1,643 (9.7%), Soprano in 974 (5.7%), and Trifecta in 192 (1.1%). The cumulative incidence of reintervention was lowest in the Perimount valve model group (cumulative incidence of reintervention at 10 years, 3.6%; 95% confidence interval [CI], 3.1-4.2%), and highest in the Mitroflow/Crown (reintervention at 10 years, 12.2%; 95% confidence interval [CI], 9.8-15.1%) and Soprano valve model groups (reintervention at 10 years, 11.7%; 95% CI, 9.2-14.8%), with a significant difference compared to the Perimount group throughout the study period. After regression standardization, survival was highest in the Perimount (cumulative incidence of all-cause mortality at 10 years, 44%; 95% CI, 43-45%), Mosaic/Hancock, and Biocor/Epic groups; and lowest in the Mitroflow/Crown group (10-year all-cause mortality, 54%; 95% CI, 52-57%). The estimated cumulative incidence of heart failure hospitalization also was lowest in the Perimount group (10-year cumulative incidence, 12.9%; 95% CI, 12.0-13.8%) and highest in the Mitroflow/Crown group (10-year incidence, 19.9%; 95% CI, 17.6-22.5%).
Conclusions:
The Perimount valve was the most commonly used and had the lowest incidence of reintervention, all-cause mortality, and heart failure hospitalization; whereas the Mitroflow/Crown valve had the highest rates of reintervention, all-cause mortality, and heart failure hospitalization. The authors concluded that the findings highlight the need for clinical vigilance in patients who receive either a Soprano or Mitroflow/Crown aortic bioprosthesis.
Perspective:
Surgical aortic valve replacement most commonly is performed using a bioprosthesis. Multiple different models exist, with differences in both materials and construction. Although clinical decisions and guideline statements typically consider the choice between a tissue and a mechanical valve replacement, findings from this study highlight important outcome differences between specific valve model groups within the bioprosthetic valve designation. Although the study is limited by small numbers for some bioprostheses with analysis by valve model group rather than by specific valve model, and by the exclusion of stentless and rapid deployment valves, the study nonetheless emphasizes important outcome differences between bioprosthesis groups. This should not only help to guide the follow-up of patients after bioprosthetic aortic valve replacement with a ‘higher risk’ valve, but also could be used to help inform decisions regarding future aortic valve replacement valve choice.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease
Keywords: Bioprosthesis, Cardiac Surgical Procedures, Cardiology Interventions, Coronary Artery Bypass, Evidence-Based Medicine, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Transcatheter Aortic Valve Replacement
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