Prophylactic Intra-Operative VT Ablation in High-Risk LVAD Candidates

高风险 LVAD 候选者的预防性术中 VT 消融

• 批准号: 10278030
• 负责人: David T Huang
• 金额: $ 75.81万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10278030
• 关键词: Ablation; Accounting; Adverse event; Arrhythmia; Cardiac Catheterization Procedures; Cessation of life; Cicatrix; Clinical; Cohort Studies; Control Groups; Data; Devices; Disease; Early Intervention; Electrophysiology (science); Enrollment; Event; Exercise; Failure; Freedom; Generations; Goals; Heart; Heart failure; Heart-Assist Devices; Hospitalization; Implant; Life; Measures; Mechanics; Medical; Medical center; Monitor; Multi-Institutional Clinical Trial; Myocardial Ischemia; Outcome; Patients; Postoperative Period; Procedures; Protocols documentation; Publishing; Ramp; Randomized; Randomized Clinical Trials; Recording of previous events; Records; Recurrence; Risk; Safety; Safety Management; Stress; Stroke; Tachyarrhythmias; Testing; Time; Translating; Universities; Ventricular; Ventricular Tachycardia; adverse outcome; effective therapy; experience; follow-up; heart rhythm; hemodynamics; high risk; high risk population; hospital readmission; implantable device; implantation; improved; innovation; ischemic cardiomyopathy; left ventricular assist device; mortality; mortality risk; novel strategies; preservation; prophylactic; prospective

ABSTRACT The use of left ventricular assist device (LVAD) for patients with advanced heart failure has continued to increase over the years. The significant improvement in survival with the current generation of LVADs is in large part due to the advances in device durability, and mechanics. However, several important factors continue to limit the benefit of LVAD support and ventricular tachyarrhythmias (VTA) following LVAD implantation has been suggested to be associated with subsequent repeat hospitalization and increased mortality. Our retrospective data from the University of Rochester have shown that patients who developed VTA following LVAD implant experienced a 7-fold increase in subsequent mortality risk. Importantly, we have also shown that the most powerful predictor of VTA post LVAD implant is a history of VTA at any time prior to the LVAD. Several ablation trials have demonstrated reduction of recurrent VTA and, in selected at-risk patient groups with ischemic heart disease, mortality. These findings suggest an effective early intervention with VTA ablation peri-LVAD implantation in high-risk patients, specifically those with a history of VTA, may reduce VTA recurrence and improve clinical outcomes. Utilization of this strategy has varied amongst centers as there are no prospective data on the efficacy and safety of this management. Accordingly, we propose a prospective, randomized, multicenter clinical trial that will evaluate prophylactic intra-operative VTA ablation in high-risk LVAD recipients on clinical outcomes. The study cohort will consist of 100 LVAD candidate patients with a prior history of VTA and ischemic cardiomyopathy randomized to either prophylactic intra-operative VTA ablation vs. conventional medical management in a 1:1 fashion. Eight high-volume LVAD implant centers with experience in VTA ablation will participate. The primary specific aim is to evaluate the effect of prophylactic intra-operative VTA ablation at the time of LVAD implantation on post-implant total recurrent VTA events after accounting for the competing risk of death. Secondary specific aims are: 1) To evaluate the effects of a management strategy that incorporates intra- operative VT ablation at the time of LVAD implantation on adverse clinical outcomes following LVAD implantation; 2) To collect prospective data on peri-procedural outcomes associated with the proposed novel approach of prophylactic intra-operative VT ablation. We will also explore the mechanisms associated with: a) recurrent VTA post LVAD implant with electrophysiology studies and b) the ramifications of recurrent VTA on right ventricular hemodynamics post LVAD implant with echocardiographic ramp studies and right heart catheterization.

摘要 左心辅助装置(LVAD)在晚期心力衰竭患者中的应用 随着时间的推移而增加。与当前一代的LVAD相比，存活率的显著改善是巨大的 部分原因是设备耐用性和机械方面的进步。然而，几个重要因素继续 限制LVAD支持和LVAD植入术后室性快速性心律失常(VTA)的益处 建议与随后的重复住院和死亡率增加有关。我们的回顾展 来自罗切斯特大学的数据显示，左冠状动脉左前降支植入术后出现室上性心动过速的患者 随后的死亡风险增加了7倍。重要的是，我们还表明，最 LVAD植入后VTA的强大预测指标是在LVAD之前的任何时间VTA的病史。几次烧蚀 试验表明，在特定的心脏病高危人群中，VTA复发率和 疾病，死亡。这些发现提示对室上性心动过速消融进行有效的早期干预。 植入高危患者，特别是那些有VTA病史的患者，可能会减少VTA的复发和 改善临床结果。这一策略的使用在不同的中心有所不同，因为没有预期的 关于这种管理的有效性和安全性的数据。因此，我们提出了一种前瞻性的、随机的、 多中心临床试验将评估术中预防性VTA消融对高危LVAD接受者的影响 对临床结果的影响。研究队列将包括100名有室上性心动过速病史的LVAD候选患者 和缺血性心肌病随机分为术中预防性VTA消融组和常规消融组 以1：1方式进行医疗管理。8个具有VTA消融经验的大容量LVAD植入中心 都会参与其中。 主要的具体目的是评估术中预防性消融VTA的效果。 在考虑了死亡的竞争风险后，LVAD植入后总的VTA复发事件。 次要的具体目标是：1)评估结合了内部和外部因素的管理战略的效果 LVAD植入时的手术VT消融对LVAD术后不良临床结局的影响 植入；2)收集与拟议的新型手术相关的围术期结果的预期数据 术中预防性消融VT的方法探讨我们还将探讨与以下内容相关的机制：a) LVAD植入术后复发的室上性心动过速与电生理学研究及b)复发的室上性心动过速对心脏功能的影响 超声心动图检测LVAD植入术后右室血流动力学及右心 导尿术。