Design and characteristics of the prophylactic intra‐operative ventricular arrhythmia ablation in high‐risk LVAD candidates (PIVATAL) trial

• Type of Material: Article
• Authors: David T. Huang, University of Rochester Medical Center; Igor Gosev, University of Rochester Medical Center; Katherine L. Wood, University of Rochester Medical Center; hima Vidula, University of Pennsylvania Medical Center; William Stevenson, Vanderbilt University Medical Center; Frank Marchlinski, University of Pennsylvania Medical Center; Gregory Supple, University of Pennsylvania Medical Center; Sandip K. Zalawadiya, Vanderbilt University Medical Center; J. Peter Weiss, Banner University Medical Center; Roderick Tung, The University of Arizona College of Medicine-Phoenix; Wendy S. Tzou, University of Colorado Anschutz Medical Campus; Joshua D. Moss, University of California-San Francisco; Krishna Kancharla, University of Pittsburgh; Sunit-Preet Chaudhry, Ascension St. Vincent Cardiovascular Research Institute; Parin J. Patel, Ascension St. Vincent Cardiovascular Research Institute; Arfaat M. Khan, Henry Ford Hospital; Claudio Schuger, Henry Ford Hospital; Guy Rozen, Tufts Medical Center; Michael S. Kiernan, Tufts Medical Center; Gregory S. Couper, Tufts Medical Center; Marzia Leacche, Spectrum Health; Ezequiel J. Molina, Piedmont Heart Institute; Anand D. Shah, Emory University; Michael S Lloyd, Emory University; Jakub Sroubek, Cleveland Clinic; Edward Soltesz, Cleveland Clinic; Kalyanam Shivkumar, University of California, Los Angeles; Casey White, University of Rochester Medical Center; Sinan Tankut, University of Rochester Medical Center; Brent A. Johnson, University of Rochester; Scott McNitt, University of Rochester Medical Center; Valentina Kutyifa, University of Rochester Medical Center; Wojciech Zareba, University of Rochester Medical Center; Ilan Goldenberg, University of Rochester Medical Center
• Language: English
• Date: 2023-07-28
• Publisher: Wiley Periodicals LLC
• Publication Version: Final Published Version
• Copyright Statement: © 2023 The Authors. Annals of Noninvasive Electrocardiology published by Wiley Periodicals LLC.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): https://doi.org/10.1111%2Fanec.13073
• Title of Journal or Parent Work: Annals of Noninvasive Electrocardiology
• Volume: 28
• Issue: 5
• Start Page: e13073
• Grant/Funding Information: This study is supported by the National Institutes of Health NIH Grant R01HL159401.
• Keywords: ablation; left ventricular assist device; ventricular tachycardia
• Research Categories: Health Sciences, General

Abstract

Background The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra‐operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. Methods We designed a prospective, multicenter, open‐label, randomized‐controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra‐operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. Conclusion The primary aim of this first‐ever randomized trial is to assess the efficacy of intra‐operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.