DOI: 10.1161/jaha.125.045455 ISSN: 2047-9980

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

Federico Giacobbe, Francesco Bruno, Marco Brero, Pierre Meynet, Andrea Solano, Sergio Capoccia, Riccardo Pilia, Fabrizio D’Ascenzo, Federico Conrotto, Giuseppe Tarantini, Michele la Torre, Won‐Keun Kim, Andrea Buono, Johannes Blumenstein, Amin Polzin, Marco Gennari, Jonas M. D. Gmeiner, Antonio Piperata, Hendrik Ruge, Jie Li, Julia Mascherbauer, Ron Waksman, Israel Barbash, Gilbert Tang, Tomasz Gasior, John Webb, Hirofumi Hioki, Daniel Obaid, Antonio Mangieri, Gabriele Crimi, Michael Joner, Stefan Toggweiler, Victor Mauri, Mao‐Shin Lin, Stephan Haussig, Marisa Avvedimento, Shane Nanayakkara, Patrick W. Serruys, Quentin Landolff, Azeem Latib, Josep Rodes‐Cabau, Gaetano Maria De Ferrari, Ovidio de Filippo
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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.

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