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: 10432087
• 负责人: David T Huang
• 金额: $ 74.02万
• 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/10432087
• 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; right ventricular failure

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.

抽象的 左心室辅助装置（LVAD）在晚期心力衰竭患者中的​​应用持续不断 逐年增加。当前一代 LVAD 显着改善了生存率 部分原因是设备耐用性和机械性能的进步。然而，几个重要因素仍在继续 限制 LVAD 支持的益处和 LVAD 植入后的室性快速心律失常 (VTA) 建议与随后的重复住院和死亡率增加有关。我们的回顾展 罗切斯特大学的数据显示，LVAD 植入后发生 VTA 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 的有力预测因素是 LVAD 之前任何时间的 VTA 病史。多次消融 试验表明，在选定的缺血性心脏高危患者群体中，复发性 VTA 会减少 疾病, 死亡率.这些发现表明，在 LVAD 期间进行 VTA 消融的早期干预是有效的 高危患者（特别是有 VTA 病史的患者）的植入可能会减少 VTA 复发， 改善临床结果。由于没有前瞻性，该策略的利用因中心而异。 有关该管理的有效性和安全性的数据。因此，我们提出了一项前瞻性、随机、 多中心临床试验将评估高危 LVAD 受者的预防性术中 VTA 消融 关于临床结果。研究队列将由 100 名有 VTA 病史的 LVAD 候选患者组成 缺血性心肌病随机接受术中预防性 VTA 消融与传统治疗 1：1的医疗管理。八家拥有 VTA 消融经验的大容量 LVAD 植入中心 会参加。 主要具体目的是评估术中预防性 VTA 消融的效果 考虑死亡竞争风险后，LVAD 植入对植入后总复发性 VTA 事件的影响。 次要的具体目标是： 1) 评估包含内部管理策略的效果 LVAD 植入时进行手术性 VT 消融对 LVAD 后不良临床结果的影响 植入； 2) 收集与拟议小说相关的围手术期结果的前瞻性数据 术中预防性 VT 消融的方法。我们还将探讨与以下相关的机制：a) LVAD 植入后复发性 VTA 的电生理学研究和 b) 复发性 VTA 对 LVAD 植入后右心室血流动力学与超声心动图斜坡研究和右心 导管插入术。