Short and long-term complications of transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract Background Transcatheter aortic valve replacement (TAVR) is superior or non-inferior to surgical aortic valve replacement (SAVR) across all surgical risk groups in patients with severe aortic stenosis (1-3). TAVR-related complications remain a significant concern, with their incidence varying based on the type of prosthesis used, such as self-expanding valves (SEVs) and balloon-expandable valves (BEVs). Purpose To identify the cumulative incidences of short and long-term complications among different transcatheter heart valve (THV) prostheses used in TAVR. Methods We conducted a systematic review and meta-analysis according to PRISMA and PROSPERO statements from 2002 to April 2024. We included patients with severe aortic stenosis treated with transfemoral TAVR who reported short or long-term complications. The studies included in the analysis explicitly specified the type of valve used. We calculated the cumulative incidence of each complication according to each type of valve using the random-effects model. Results We included 242 papers with 181,187 patients. Patients received the THV prosthesis via transfemoral access (97.1%), with most being BEVs (54.2%) and SEVs (43.5%). The most common short-term complications across all models were permanent pacemaker implantation (PPI) (12.6%), major or life-threatening bleeding (5.1%), acute kidney injury (4.7%), major vascular complications (3.4%) and stroke (2.5%). Long-term complications in the first year were valve dysfunction (1.2%), endocarditis (0.9%), and valve thrombosis (0.2%). The earliest models had the highest cumulative incidence of complications, showing significant improvement with newer generations. The third-generation BEV 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); PPI is the most frequent complication, with third-generation BEVs and a third-generation SEV showing fewer cumulative incidence (7.7, 95% CI: 5.82-10.11). The safety profile of TAVR has improved significantly, with reductions in major vascular complications with third-generation SEVs and BEVs (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). Conclusion PVL were more common among SEVs. PPI is the most frequent complication, with some THV prostheses showing a better safety profile. Stroke remained consistent among the new generation of THVs. Annular rupture, coronary artery obstruction, and valve embolization are rare complications (1%). Longer follow-ups in registries are necessary to provide cumulative data on long-term complications and valve durability.