Short-Term Complications of Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis (PROLONG-TAVR).

Abstract

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%).