Why the study?
Recent reports suggested an increased rate of early structural valve degeneration in the Trifecta bioprosthesis, prompting a comparison of intermediate-term outcomes between Magna and Trifecta valves.
Does the Trifecta bioprosthesis increase the risk of valve failure compared to the Magna bioprosthesis in patients undergoing surgical aortic valve replacement?
Does the Trifecta bioprosthesis increase the risk of valve failure compared to the Magna bioprosthesis in patients undergoing surgical aortic valve replacement?
The Trifecta bioprosthesis is associated with a significantly higher risk of intermediate-term structural valve degeneration and failure compared to the Magna bioprosthesis.
Trifecta valves were associated with higher failure risk; leaves open whether this reflects causation or residual confounding in observational data.
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.
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Yount et al. (2022) studied this question.
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