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Publications

Journal Article Ahead of print 1 citation

PubMed: 42808440 DOI: 10.1161/JAHA.125.045455

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

J Am Heart Assoc

Authors: 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

Affiliations

  • Division of Cardiology, Cardiovascular and Thoracic Department Città della Salute e della Scienza Turin Italy.
  • Division of Cardiology, Department of Medical Sciences University of Turin Italy.
  • Royal Brompton and Harefield Hospitals Trust and Imperial College London UK.
  • Cardiology Clinic, Department of Cardiac, Thoracic, and Vascular Sciences and Public Health Padova University of Padua Italy.
  • Division of Cardiac Surgery, Cardiovascular and Thoracic Department Città della Salute e della Scienza Turin Italy.
  • Department of Cardiology Kerckhoff Heart and Thorax Center Bad Nauheim Germany.
  • Interventional Cardiology Unit, Cardiovascular Department Fondazione Poliambulanza Brescia Italy.
  • Department of internal medicine St. Johannes hospital Dortmund Dortmund Germany.
  • Department of cardiology University Oldenburg Oldenburg Germany.
  • Department of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf Medical Faculty of the Heinrich Heine University Düsseldorf Düsseldorf Germany.
  • Cardiovascular Research Institute Düsseldorf (CARID) Düsseldorf Germany.
  • IRCCS Centro Cardiologico Monzino Valvular and Structural Invasive Cardiology Unit Milan Italy.
  • Medizinische Klinik und Poliklinik I LMU Klinikum München Munich Germany.
  • Division of Cardiac Surgery IRCCS Azienda Ospedaliero-Universitaria di Bologna Italy.
  • Technical University of Munich, TUM School of Medicine and Health, Department of Cardiovascular Surgery TUM University Hospital German Heart Center Munich Germany.
  • Department of Cardiology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) Southern Medical University Guangzhou China.
  • Universitätsklinikum St. Pölten Karl Landsteiner Privatuniversität für Gesundheitswissenschaften Dunant-Platz St. Pölten Austria.
  • Cardiovascular Research and Advanced Education, MedStar Heart and Vascular Institute MedStar Washington Hospital Center Washington DC USA.
  • Interventional Cardiology Unit, Sheba Medical Center, Ramat Gan Tel Aviv University Israel.
  • Division of Cardiology, Mount Sinai Medical Center Icahn School of Medicine at Mount Sinai New York NY USA.
  • Collegium Medicum - Faculty of Medicine WSB University Dabrowa Gornicza Poland.
  • St. Paul's Hospital University of British Columbia Vancouver Canada.
  • Department of Cardiology, Division of Minimal Invasive Treatment Center IMS Tokyo Katsushika General Hospital Katsushika City Tokyo Japan.
  • Morriston Regional Heart Centre Swansea University Medical School Swansea UK.
  • IRCCS Humanitas Research Hospital Rozzano, Milan Italy.
  • Cardiology Unit, Cardiothoracic and Vascular Department (DICATOV) IRCCS Ospedale Policlinico San Martino Genoa Italy.
  • TUM University Hospital German Heart Center Technical University of Munich Germany.
  • German Center for Cardiovascular Research (DZHK) Berlin Germany.
  • Heart Center Lucerne, Luzerner Kantonsspital Lucerne Switzerland.
  • Faculty of Medicine and University Hospital Cologne, Clinic III for Internal Medicine University of Cologne Cologne Germany.
  • National Taiwan University Hospital Taipei Taiwan.
  • Herzzentrum Dresden, University Clinic, Department of Internal Medicine and Cardiology Technische Universitaet Dresden Dresden Germany.
  • Quebec Heart & Lung Institute Laval University Quebec City Quebec Canada.
  • Department of Cardiology The Alfred Melbourne Australia.
  • Monash Alfred Baker Centre for Cardiovascular Research, School of Translational Medicine Monash University Melbourne Australia.
  • Heart Failure Research Group Baker Institute Melbourne Australia.
  • Department of Cardiology, School of Medicine University of Galway Ireland.
  • Department of Cardiology Clinique Saint Hilaire Rouen France.
  • Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center Albert Einstein College of Medicine Bronx NY USA.

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.

MeSH

Mortality, Heart Diseases, Hemorrhage, Stroke, Incidence, Kidney, Drug-Related Side Effects And Adverse Reactions, Aortic Valve, Transcatheter Aortic Valve Replacement, Acute Kidney Injury