Late outcomes of transcatheter aortic valve implantation in bicuspid versus tricuspid valves: Meta-analysis of reconstructed time-to-event data

Based on previous meta-analyses including immediate/1-year results, individuals with bicuspid aortic valve (BAV) stenosis can undergo TAVI with similar outcomes as those with tricuspid aortic valve (TAV), but with higher rates of periprocedural complications. The widespread belief is that BAV patients would have poor results in comparison with TAV patients after TAVI over time. Therefore, we performed a systematic review with meta-analysis with reconstructed time-to-event data of studies published by January 2022 to compare late outcomes of patients with BAV versus TAV who underwent TAVI. This approach reconstructs individual patient data (IPD) based on the published Kaplan-Meier graphs. Ten studies met our eligibility criteria, including 9,071 patients with BAV and 171,070 patients with TAV. Patients with BAV had a significantly lower risk of mortality (HR 0.70, 95%CI 0.65-0.77, P<0.001), however, this result was driven by populations in which the risk score was statistically significantly lower in the BAV group (HR 0.69, 95%CI 0.63-0.76, P<0.001) and by populations in which the BAV group was statistically significantly younger (HR 0.72, 95%CI 0.64-0.81, P<0.001). In patients with selected BAV anatomy deemed favorable for TAVI, we did not find worse survival over time in comparison with patients with TAV; however, the follow-up beyond 1 year remains limited in the studies and we need more investigation for specific bicuspid anatomies with longer follow-up. Most importantly, randomized controlled trials including exclusively BAV patients treated with TAVI versus SAVR are warranted.