Incidence and Predictors of Complications After Transcatheter Aortic Valve Implantation According to VARC‐3 Criteria: A Systematic Review and Meta‐Analysis

Abstract

BACKGROUND: Despite continuous advancements in devices and techniques, transcatheter aortic valve implantation remains associated with complications impacting outcomes. In 2021, the Valve Academic Research Consortium (VARC) introduced the VARC-3 criteria to better classify procedural complications. METHODS: We conducted a systematic review and meta-analysis of studies reporting transcatheter aortic valve implantation-related complications using VARC-3 definitions between 2021 and 2025. The primary end point was all-cause mortality at latest follow-up. Secondary end points included major VARC-3 complications and predictors of adverse events. RESULTS: A total of 57 studies with 73 588 patients were included. The cohort had a mean age of 81.7 years, 51.7% were women, and most had preserved ejection fraction (55.5%) and low-to-moderate surgical risk (Society of Thoracic Surgeons [STS] predicted risk of mortality [PROM] 4.1%). Technical and 30-day device success rates were 95% and 90%, respectively; early safety rate at 30 days was 66%. At average 12 months follow-up, all-cause mortality was 10.2%. The most common complication was permanent pacemaker implantation (13%), followed by type 2 or greater bleeding (9.7%), acute kidney injury stage 3-4 (4.7%), major vascular events (4.3%), and stroke (3.0%). Moderate/severe paravalvular regurgitation and patient-prosthesis mismatch occurred in 4% and 8%, respectively. Study-level pooled predictor analyses showed that acute kidney injury, type 2 or greater bleeding, paravalvular regurgitation, non-structural valve dysfunction, and higher STS score were associated with higher mortality, while eccentric/severe aortic valve calcification was associated with significant paravalvular regurgitation. CONCLUSIONS: Transcatheter aortic valve implantation shows high procedural success but non-negligible complication rates under VARC-3 criteria. acute kidney injury, type 2 or greater bleeding, NSVD, periprocedural stroke and myocardial infarction after transcatheter aortic valve implantation were associated with higher mortality.