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CirculationReview

06 May 2025

Evidence Generation and Implementation of Transcatheter Interventions for Atrioventricular Valvular Heart Disease in Heart Failure: Current Status and Future Directions.

Abstract

Mitral regurgitation and tricuspid regurgitation are the most common valvular heart diseases in patients with heart failure and have independent prognostic value.

Transcatheter interventions are now available for the treatment of valvular heart disease, and their efficacy and safety have been tested in randomized controlled trials.

However, evidence is still limited and sometimes inconclusive because several aspects of these trials limit their interpretation or consistency.

These include heterogeneity in the pathogenesis and clinical characteristics of patients, the dynamic nature of secondary atrioventricular valve disease severity, the role of heart failure medications and devices, dependency on procedural results and operators' skills, smaller number of patients enrolled and the power to detect differences in trials, and limitations to use patients' reported outcomes with unblinded study protocols.

These specific aspects of trials in patients with atrioventricular valve disease are reviewed in this article with a focus on possible solutions to generate further evidence for the efficacy and safety for transcatheter treatments of atrioventricular valve disease in patients with heart failure.

COI Statement

Dr Metra reports personal consulting honoraria of minimal amount from Abbott Structural, AstraZeneca, Bayer, Boehringer Ingelheim, Edwards LifeSciences, Pharmacosmos, Roche Diagnostics, and NovoNordisk for participation in advisory board meetings and executive committees of clinical trials, outside the submitted work. Dr Tomasoni reports speaker fees and honoraria from Alnylam Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, and Pfizer, outside the submitted work. Dr Adamo reports speaker fees from Abbott Vascular and Medtronic, outside the submitted work. Dr Anker reports grants and personal fees from Vifor and Abbott Vascular and personal fees for consultancies, trial committee work, and/or lectures from Actimed, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bioventrix, Brahms, Cardiac Dimensions, Cardior, Cordio, CVRx, Cytokinetics, Edwards, Farraday Pharmaceuticals, GSK, HeartKinetics, Impulse Dynamics, Novartis, Occlutech, Pfizer, Repairon, Sensible Medical, Servier, Vectorious, and V-Wave. Dr Anker was named coinventor of 2 patent applications regarding MR-proANP (DE 102007010834 and DE 102007022367), but he does not benefit personally from the related issued patents. Dr Bayes-Genis has received speaker honoraria and/or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Roche Diagnostics, and Vifor. Dr von Bardeleben is principal investigator or on the steering committee of trials with IIT (University of Göttingen, Germany) Abbott Structural, Edwards Lifesciences, Jenscare, Medtronic, and NeoChord; he declares consultancy fees from Abbott, Edwards Lifesciences, Jenscare, Medtronic, NeoChord, Philips Medical Systems, and Siemens Healthineers. Dr Böhm is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project 322900939) and reports personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, ReCor Medical, Servier, and Vifor. Dr Donal reports no conflicts. Dr Filippatos reports grants from the European Commission; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Bayer and Boehringer Ingelheim; participation on a data safety monitoring board or advisory board from Bayer and Boehringer Ingelheim; leadership or fiduciary role in the Heart Failure Association; and other financial or nonfinancial interests as a committee member for Medtronic, Vifor Pharma, Amgen, Servier, and Novartis. Dr Maisano declares grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, Terumo, and Venus; consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, CardioValve, Occlufit, Simulands, Mtex, Venus, and Squadra; royalty income/IP rights Edwards Lifesciences; and shareholder (including share options) of Cardiogard, CardioValve, Magenta, SwissVortex, Transseptalsolutions, 4Tech, and Perifect. Dr Ponikowski reports participation in clinical trials for and grants and personal fees from Vifor Pharma during the conduct of the study; participation in clinical trials for and personal fees from Amgen, Bayer, Novartis, Abbott Vascular, Boehringer Ingelheim, Pfizer, Servier, AstraZeneca, Cibiem, BMS, and Impulse Dynamics, outside the submitted work; participation in clinical trials for Cardiac Dimensions, outside the submitted work; and personal fees from Berlin Chemie, outside the submitted work. Dr Savarese reports grants and personal fees from Vifor, Boehringer Ingelheim, AstraZeneca, Novartis, Cytokinetics, and Pharmacosmos; personal fees from Medtronic, Servier, TEVA, Edwards Lifescience, and INTAS; and grants from Boston Scientific, Merck, Bayer, outside the submitted work. Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, Medira, Polares Medical, and Siemens Healthineers. Dr Butler reports support from Abbott, American Regent, Amgen, Applied Therapeutic, AskBio, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardiac Dimension, Cardiocell, Cardior, CSL Bearing, CVRx, Cytokinetics, Daxor, Edwards, Element Science, Faraday, Foundry, G3P, Innolife, Impulse Dynamics, Imbria, Inventiva, Ionis, Lexicon, Lilly, LivaNova, Janssen, Medtronics, Merck, Occlutech, Owkin, Novartis, Novo Nordisk, Pharmacosmos, Pharmain, Pfizer, Prolaio, Regeneron, Renibus, Roche, Salamandra, Sanofi, SC Pharma, Secretome, Sequana, SQ Innovation, Tenex, Tricog, Ultromics, Vifor, and Zoll, outside the submitted work.

Article info

Journal issue:

  • Volume: 151
  • Issue: 18

Doi:

10.1161/CIRCULATIONAHA.124.070411

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