Key result
Newer-generation THVs reduce TAVR complications, with SAPIEN 3 showing ~1% moderate-to-severe paravalvular leak.
Why the study?
The cumulative incidence of short-term complications across different transcatheter heart valve prostheses used for TAVR was not well established.
What is the incidence of short-term complications associated with different transcatheter heart valve prostheses in patients undergoing TAVR?
Meta-Analysis (n=181,187)
Yes
What is the incidence of short-term complications associated with different transcatheter heart valve prostheses in patients undergoing TAVR?
Newer-generation THV prostheses exhibit lower short-term complications, with specific complication profiles varying by valve type, aiding prosthesis selection in TAVR.
Newer-generation TAVR valves may lower short-term complications; leaves open need for randomized head-to-head comparisons.
To estimate the cumulative incidence of short-term complications across different transcatheter heart valve (THV) prostheses used for transcatheter aortic valve replacement (TAVR). We performed a systematic review and meta-analysis in accordance with PRISMA and a prospectively registered PROSPERO protocol. Observational studies published from 2002 through May 2024 that included patients with severe aortic stenosis undergoing predominantly transfemoral TAVR and reported prosthesis-specific complications were eligible. Although the original protocol intended to evaluate both short- and long-term complications, long-term outcomes were too sparse and inconsistently reported for robust pooled analyses; therefore, the present analysis focuses on short-term complications. Pooled cumulative incidences were calculated using random-effects models. We included 242 studies comprising 181,187 patients. SAPIEN 3 had the lowest incidence of moderate-to-severe paravalvular leak (PVL) (1.04%, 95% CI 0.69-1.55) and stroke (1.87%, 95% CI 1.64-2.14), whereas ACURATE neo2 had the lowest incidence of permanent pacemaker implantation (PPI) (7.7%, 95% CI 5.82-10.11). Evolut PRO and SAPIEN 3 showed among the lowest rates of major vascular complications (3.56%, 95% CI 2.77-4.57 and 3.87%, 95% CI 3.22-4.66, respectively) and major or life-threatening bleeding (2.96%, 95% CI 2.09-4.17 and 4.8%, 95% CI 4.04-5.69, respectively). Short-term complications have decreased with newer-generation THV prostheses. PVL remains more frequent with self-expanding valves, whereas PPI is the most frequent complication and is generally less frequent with balloon-expandable valves and ACURATE neo2. Stroke rates have changed little across newer generations, and annular rupture, coronary artery obstruction, and valve embolization remain rare (< 1%).
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Castillo-Perez et al. (2026) conducted a meta-analysis in Severe aortic stenosis (n=181,187). Transcatheter heart valve (THV) prostheses vs. Different THV prostheses was evaluated on Cumulative incidence of short-term prosthesis-specific complications. Newer-generation THV prostheses for TAVR have decreased short-term complications, with SAPIEN 3 showing the lowest incidence of moderate-to-severe paravalvular leak (1.04%) and stroke (1.87%).
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