Aortic valve biologic protheses: A cohort comparison of premature valve failure

Abstract

Background Recent reports suggest an increased rate of early structural valve degeneration (SVD) in the Trifecta bioprosthesis (Abbott Cardiovascular). We sought to compare the intermediate‐term outcomes of the Magna (Edwards Life Sciences) and Trifecta valves. Methods All surgical aortic valve replacements (SAVRs) with Trifecta or Magna/Magna Ease bioprostheses at an academic medical center were extracted from an institutional database. Patients who survived until after discharge (2011–2019) were included. The primary outcome was valve failure for any reason requiring reintervention or contributing to death, identified by reintervention or review of cause of death. Time to failure was estimated with Kaplan–Meier analysis and Cox Proportional Hazards Modeling. Results Out of 1444 patients, 521 (36%) underwent Trifecta and 923 (64%) underwent Magna implantation with a median follow‐up of 27.6 months. Trifecta patients had larger median valve size (25 vs. 23 mm, p < .001) and lower median gradient (8.0 vs. 10.9 mmHg, p < .001). Trifecta patients had higher 48‐month estimated failure rates (20.2 ± 7.6% vs. 2.6 ± 0.7%, p < .0001), with failure rates of 21.4 versus 9.2 failures per 1000 person‐years (p < .001). After risk‐adjustment, Trifecta patients had a 5.3 times hazard of failure (95% confidence interval: 2.78–12.34, p < .001) compared to Magna patients. Only Trifecta valves failed due to sudden aortic regurgitation, 8 out of 521 (1.5%). Conclusion Despite lower postoperative mean gradients, the Trifecta bioprosthesis may have an increased risk of intermediate‐term SVD. Further research is warranted to confirm the potential for sudden valve failure.

Eight‐year outcomes of aortic valve replacement with the Carpentier‐Edwards PERIMOUNT Magna Ease valve

“…However, comparing SVD rates from different studies is challenging because of differing SVD definitions and cohort ages. Freedom from SVD with the Trifecta valve was reported to be 98.7% and 93.3% at 5 and 8 years, respectively, 13 although a recent study demonstrated an increased risk of valve failure in the Trifecta valve compared with the Magna Ease valve at 48 months 16 …”

“…Freedom from SVD with the Trifecta valve was reported to be 98.7% and 93.3% at 5 and 8 years, respectively, 13 although a recent study demonstrated an increased risk of valve failure in the Trifecta valve compared with the Magna Ease valve at 48 months. 16 Freedom from reintervention due to SVD was 99.1% (95% CI: 97.9, 100.0) at 5 years and 93.6% (95% CI: 89.3, 97.8) at 8 years.…”

8-year outcomes of aortic valve replacement with the Carpentier-Edwards PERIMOUNT Magna Ease valve

“…Freedom from SVD with the Trifecta valve was reported to be 98.7% and 93.3% at 5 and 8 years, respectively, [15] although a recent study demonstrated increased risk of valve failure in the Trifecta valve compared with the Magna Ease valve at 48 months. [18] Freedom from reintervention due to SVD was 99.1% (95% CI 97.9, 100.0) at 5 years and 93.6% (95% CI 89.3, 97.8) at 8 years. Rates reported for the Trifecta valve were 97.3% (95% CI 94.7, 98.6) at 6 years.…”

“…[14][15][16] The Freestyle valve (Medtronic, Dublin, Ireland) showed similar rates of 10-year survival to Magna Ease in a retrospective cohort analysis. [17,18] In another multivariable retrospective analysis, the Mitroflow valve (LivaNova, London, UK) was associated with a higher risk of mortality compared with the Magna Ease valve at 5 years (hazard ratio 1.57 [95% CI 1.17, 2.11], p<0.01). [19] Thromboembolic events, bleeding, and endocarditis…”

Valve deterioration: A victim of construct over time?

“…In this issue of the journal, Yount et al consider two bioprosthetic aortic valves: the Trifecta valve (Abbott Cardiovascular) and the Magna/Magna Ease valve (Edwards Life Sciences). 13 They use retrospective institutional data to compare the rates of valve failure for these commercially available bioprosthetic heart valves. The study is clinically relevant as it aims to build on recent evidence suggesting Trifecta valves may be susceptible to early failure.…”