Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.
Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.
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DOI：
10.1111/anec.13073
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发表时间：
2023-09
影响因子：
1.9
通讯作者：
Goldenberg, Ilan
中科院分区：
文献类型：
--
作者：
Huang, David T.;Gosev, Igor;Wood, Katherine L.;Vidula, Hima;Stevenson, William;Marchlinski, Frank;Supple, Gregory;Zalawadiya, Sandip K.;Weiss, J. Peter;Tung, Roderick;Tzou, Wendy S.;Moss, Joshua D.;Kancharla, Krishna;Chaudhry, Sunit-Preet;Patel, Parin J.;Khan, Arfaat M.;Schuger, Claudio;Rozen, Guy;Kiernan, Michael S.;Couper, Gregory S.;Leacche, Marzia;Molina, Ezequiel J.;Shah, Anand D.;Lloyd, Michael;Sroubek, Jakub;Soltesz, Edward;Shivkumar, Kalyanam;White, Casey;Tankut, Sinan;Johnson, Brent A.;McNitt, Scott;Kutyifa, Valentina;Zareba, Wojciech;Goldenberg, Ilan
在过去的二十年中，左心室辅助装置（LVAD）在最佳医疗管理难治性晚期心力衰竭患者中的应用取得了稳步进展。数据表明，发生严重室性快速性心律失常（VTA）的患者LVAD疗效降低，临床结局较差，死亡率较高。我们假设在LVAD植入时采用一种新的预防性术中VTA消融方案可能会减少VTA复发和植入后不良事件。我们设计了一项前瞻性、多中心、开放标签、随机对照临床试验，招募了100例在过去5年内有VTA病史的LVAD候选患者。入组的患者将以1：1的比例随机分配至术中VTA消融（n = 50）与LVAD植入物的传统医疗管理（n = 50）。心律失常结局数据将由植入式心律转复除颤器（ICD）采集，以监测VTA事件，并采用统一的ICD程控方案。将在LVAD植入后对患者进行平均18个月（至少9个月）的前瞻性随访，以评价复发性VTA、不良事件和手术结局。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病史患者临床结局方面的有效性。在过去的二十年中，左心室辅助装置（LVAD）在最佳医疗管理难治性晚期心力衰竭患者中的应用取得了稳步进展。数据表明，发生严重室性快速性心律失常（VTA）的患者LVAD疗效降低，临床结局较差，死亡率较高。我们假设在LVAD植入时采用一种新的预防性术中VTA消融方案可能会减少VTA复发和植入后不良事件。我们设计了一项前瞻性、多中心、开放标签、随机对照临床试验，招募了100例在过去5年内有VTA病史的LVAD候选患者。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病史患者临床结局方面的有效性。
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. 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. 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. 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. 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. 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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