Key result
Trifecta valve linked to ~216% higher reintervention risk versus Perimount valve in SAVR.
Why the study?
Recent studies suggested higher rates of early structural valve degeneration or reintervention for the Trifecta valve compared to other valves in patients undergoing SAVR.
Does the Trifecta bioprosthetic valve increase the rate of reintervention or all-cause mortality compared to the Perimount valve in patients undergoing surgical aortic valve replacement?
Meta-Analysis (n=11,135)
Does the Trifecta bioprosthetic valve increase the rate of reintervention or all-cause mortality compared to the Perimount valve in patients undergoing surgical aortic valve replacement?
Effect estimate: HR 3.16 (95% CI 1.83-5.46)
p-value: p=<0.0001
In patients undergoing surgical aortic valve replacement, the Trifecta bioprosthetic valve is associated with a more than threefold higher risk of reintervention compared to the Perimount valve, with no significant difference in all-cause mortality.
Trifecta valves warrant caution in SAVR to minimize reintervention; meta-analysis extends observational durability concerns without mortality signals.
Objective Recent studies suggested higher rates of early structural valve degeneration or reintervention for the Trifecta valve compared to other valves. Thus, we conducted a systematic review and meta-analysis comparing the outcomes of the Trifecta valve and the Perimount valves in patients who underwent a surgical aortic valve replacement (SAVR). Methods All randomized control trials and observational studies which investigated the outcomes of the Trifecta valve and Perimount valves were identified with PubMed and EMBASE. The endpoints were the rates of reintervention and all-cause mortality. Hazard ratios (HRs) for reintervention and all-cause mortality were combined with the random-effects model. Results Our search identified 6 eligible observational studies which enrolled a total of 11,135 patients who underwent SAVR with either the Trifecta valve (n = 4932) or Perimount (n = 6203). Pooled analyses demonstrated that the reintervention rates were significantly higher with the Trifecta valve compared with Perimount valves (HR [95% confidence interval {CI}] = 3.16 [1.83–5.46]; p < .0001; I2 = 40%). In contrast, all-cause mortality was not significantly different between the two groups (HR [95% CI] = 1.09 [0.75–1.58]; p = .32, I2 = 12%). Conclusion Our analysis showed that AVR with the Trifecta valve was associated with higher rates of reintervention compared for that with the Perimount valve. Although further long-term randomized trials are warranted, surgeons need to be cautious when choosing a bioprosthetic valve for patients undergoing SAVR.
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Yokoyama et al. (2021) conducted a meta-analysis in Surgical aortic valve replacement (n=11,135). Trifecta valve vs. Perimount valve was evaluated on Reintervention (HR 3.16, 95% CI 1.83-5.46, p=<0.0001). Surgical aortic valve replacement with the Trifecta valve was associated with significantly higher rates of reintervention compared to the Perimount valve (HR 3.16; 95% CI 1.83-5.46; p<0.0001).
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