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

IF 1.1 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Annals of Noninvasive Electrocardiology Pub Date : 2023-07-28 DOI:10.1111/anec.13073
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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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.

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高危LVAD患者术中预防性室性心律失常消融(PIVATAL)试验的设计与特点
背景在过去的二十年中,左心室辅助装置(LVAD)在难治性晚期心力衰竭患者中的应用稳步发展。数据显示,LVAD疗效降低,临床结果更差,出现明显室性心动过速(VTA)的患者死亡率更高。我们假设,在LVAD植入时,一种新的预防性术中VTA消融方案可能会减少复发的VTA和植入后的不良事件。方法我们设计了一项前瞻性、多中心、开放标签、随机对照的临床试验,纳入了100例LVAD候选患者,这些患者在过去5年内有VTA病史。入选的患者将以1:1的比例随机分为术中VTA消融组(n = 50)和植入LVAD的传统医疗管理组(n = 50)。心律失常结果数据将由植入式心律转复除颤器(ICD)捕获,以监测VTA事件,并采用统一的ICD编程协议。患者将在LVAD植入后平均随访18个月(至少9个月),以评估复发性VTA、不良事件和手术结果。次要终点包括右心功能/血流动力学、医疗保健利用和生活质量。这项首次随机试验的主要目的是评估LVAD手术期间术中消融在减少VTA复发和改善有VTA病史患者临床预后方面的疗效。
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来源期刊
CiteScore
3.40
自引率
0.00%
发文量
88
审稿时长
6-12 weeks
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.
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