David T. Huang MD, Igor Gosev MD, PhD, Katherine L. Wood MD, Hima Vidula MD, William Stevenson MD, Frank Marchlinski MD, Gregory Supple MD, Sandip K. Zalawadiya MD, J. Peter Weiss MD, Roderick Tung MD, Wendy S. Tzou MD, Joshua D. Moss MD, Krishna Kancharla MD, Sunit-Preet Chaudhry MD, Parin J. Patel MD, Arfaat M. Khan MD, Claudio Schuger MD, Guy Rozen MD, Michael S. Kiernan MD, Gregory S. Couper MD, Marzia Leacche MD, Ezequiel J. Molina MD, Anand D. Shah MD, Michael Lloyd MD, Jakub Sroubek MD, PhD, Edward Soltesz MD, Kalyanam Shivkumar MD, PhD, Casey White MD, Sinan Tankut MD, Brent A. Johnson PhD, Scott McNitt MS, Valentina Kutyifa MD, PhD, Wojciech Zareba MD, PhD, Ilan Goldenberg MD
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引用次数: 0
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.
期刊介绍:
The ANNALS OF NONINVASIVE ELECTROCARDIOLOGY (A.N.E) is an online only journal that incorporates ongoing advances in the clinical application and technology of traditional and new ECG-based techniques in the diagnosis and treatment of cardiac patients.
ANE is the first journal in an evolving subspecialty that incorporates ongoing advances in the clinical application and technology of traditional and new ECG-based techniques in the diagnosis and treatment of cardiac patients. The publication includes topics related to 12-lead, exercise and high-resolution electrocardiography, arrhythmias, ischemia, repolarization phenomena, heart rate variability, circadian rhythms, bioengineering technology, signal-averaged ECGs, T-wave alternans and automatic external defibrillation.
ANE publishes peer-reviewed articles of interest to clinicians and researchers in the field of noninvasive electrocardiology. Original research, clinical studies, state-of-the-art reviews, case reports, technical notes, and letters to the editors will be published to meet future demands in this field.