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Publications

Journal Article Epublish

PubMed: 42701683 DOI: 10.1016/j.shj.2026.101101

Impact of Early Nonfatal Complications After Transcatheter Aortic Valve Implantation on 1-Year Mortality and Quality of Life: Insights From the LANDMARK Trial.

Struct Heart 10(9):101101

Authors: Akihiro Tobe, Yoshinobu Onuma, Niels van Royen, Ignacio J Amat-Santos, Martin Hudec, Matjaz Bunc, Ben J L van den Branden, Peep Laanmets, Daniel Unic, Bela Merkely, Renicus S Hermanides, Vlasis Ninios, Marcin Protasiewicz, Benno J W M Rensing, Pedro L Martin, Fausto Feres, Manuel de Sousa Almeida, Eric Van Belle, Axel Linke, Alfonso Ielasi, Matteo Montorfano, Mark Webster, Konstantinos Toutouzas, Emmanuel Teiger, Francesco Bedogni, Michiel Voskuil, Manuel Pan, Oskar Angerås, Won-Keun Kim, Jürgen Rothe, Mohamed Abdel-Wahab, Ivica Kristić, Vicente Peral, Scot Garg, Ashokkumar Thakkar, Udita Chandra, Pieter C Smits, Marie-Claude Morice, Andreas Baumbach, Patick W Serruys

Affiliations

  • CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.
  • Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
  • Centro de Investigación Biomédica en Red - Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.
  • Department of Cardiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
  • Department of Acute Cardiology, Middle-Slovak Institute of Cardiovascular Diseases, Banska Bystrica, Slovakia.
  • Department of Cardiology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
  • Department of Cardiology, Amphia Hospital, Breda, the Netherlands.
  • Department of Invasive Cardiology, North Estonia Medical Centre, Tallinn, Estonia.
  • Department of Cardiac and Transplant Surgery, University Hospital Dubrava, Zagreb, Croatia.
  • Heart and Vascular Center, Semmelweis University, Budapest, Hungary.
  • Department of Cardiology, Isala Hospital, Zwolle, the Netherlands.
  • Department of Cardiology, European Interbalkan Medical Center, Thessaloniki, Greece.
  • Department of Cardiology, Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.
  • Faculty of Medicine, Department of Non-Procedural Clinical Sciences, Wroclaw University of Science and Technology, Wroclaw, Poland.
  • Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands.
  • Department of Interventional Cardiology, University Hospital of Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain.
  • Department of Invasive Cardiology, Instituto Dante Pazzanese, São Paulo, Brazil.
  • CHRC, NOVA Medical School, NOVA University Lisbon, Lisbon, Portugal.
  • Department of Interventional Cardiology, Lille University Hospital, Lille, France.
  • Department of Internal Medicine and Cardiology, Heart Center Dresden, University of Technology Dresden, Dresden, Germany.
  • Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy.
  • School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.
  • Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Department of Cardiology, Auckland City Hospital, Auckland, New Zealand.
  • Department of Cardiology, Hippokration Hospital, Athens, Greece.
  • Department of Cardiology, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Créteil, France.
  • Department of Clinical Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Italy.
  • Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands.
  • Department of Cardiology, University Hospital Reina Sofía, University of Córdoba, IMIBIC, CIBERCV, Córdoba, Spain.
  • Department of Thoracic Surgery and Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
  • Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
  • Department of Cardiology & Angiology, University of Giessen and Marburg, Gießen, Germany.
  • Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
  • Department of Cardiology and Angiology, Campus Bad Krozingen, University Heart Center-University of Freiburg, Bad Krozingen, Germany.
  • Faculty of Medicine, University of Freiburg, Freiburg, Germany.
  • Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at Leipzig University, Leipzig, Germany.
  • Department of Cardiology, University Hospital of Split, Split, Croatia.
  • Department of Cardiology University Hospital Son Espases, Health Research Institute of the Balearic Islands, Palma de Mallorca, Spain.
  • Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.
  • School of Medicine, University of Central Lancashire, Preston, UK.
  • Department of Clinical Research, Meril Life Sciences Pvt. Ltd. Vapi, India.
  • Cardiovascular European Research Center (CERC), Massy, France.
  • ICPS, Hôpital Privé Jacques Cartier, Massy, France.
  • Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, UK.
  • Cleveland Clinic, London, UK.

Abstract

BACKGROUND

The impact of early nonfatal complications on subsequent mortality and quality of life (QOL) after contemporary transcatheter aortic valve implantation (TAVI) remains unclear.

METHODS

This post-hoc substudy of the LANDMARK trial included patients with severe aortic stenosis randomized to the Myval transcatheter heart valve (THV) series or to contemporary THV (Sapien or Evolut) series. Early nonfatal complications were defined as events occurring within 30 days after TAVI in patients surviving the first 30 days and included stroke, type 3 bleeding, major vascular complications, acute kidney injury stages 2-4, moderate or severe aortic regurgitation, new permanent pacemaker implantation, or reintervention according to the VARC-3 early safety endpoint. The primary endpoint was all-cause mortality from 30 to 365 days. QOL was assessed using the Short Form-12 at baseline, 30 days, and 1 year.

RESULTS

Of the 768 randomized patients, 742 were alive at 30 days. Of these, 177 (23.9%) experienced at least 1 early nonfatal complication, whereas 565 (76.1%) did not. Age (80 ± 5 years vs. 80 ± 6 years, p = 0.67) and Society of Thoracic Surgeons score (median 2.6 [interquartile range: 1.6-3.9] vs. 2.6 [1.7-3.9], p = 0.76) were similar between groups. Patients with early nonfatal complications had higher mortality between 30 and 365 days (8.0% vs. 3.9%, p = 0.03). Early nonfatal complications were independently associated with increased 1-year mortality (hazard ratio = 2.14; 95% CI, 1.07-4.27; p = 0.03). One-year QOL did not differ between groups.

CONCLUSIONS

In this post-hoc, hypothesis-generating analysis, early nonfatal complications after TAVI were associated with increased 1-year mortality, whereas 1-year QOL was comparable among survivors; findings should be interpreted with caution due to potential survivor bias.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov, NCT04275726.

MeSH

Quality Of Life, Mortality, Aortic Valve, Transcatheter Aortic Valve Replacement