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

摘要 左心室辅助装置（LVAD）在晚期心力衰竭患者中的应用持续， 逐年增加。目前这一代LVAD的生存率显著提高， 部分原因是器械耐用性和机械性能的进步。然而，几个重要因素继续 限制LVAD支持和LVAD植入后室性快速性心律失常（VTA）的受益， 提示与随后的重复住院和死亡率增加有关。我们的回顾 来自罗切斯特大学的数据表明，在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， LVAD植入后VTA的有力预测因素是LVAD植入前任何时间的VTA病史。多次消融 临床试验已经证明，在选定的缺血性心脏病高危患者组中， 疾病死亡率这些结果表明，LVAD周围VTA消融的有效早期干预 在高危患者中植入，特别是那些有VTA病史的患者，可以减少VTA复发， 改善临床结果。该策略的使用在各中心之间存在差异，因为没有前瞻性 关于这种管理的有效性和安全性的数据。因此，我们提出了一个前瞻性的，随机的， 一项多中心临床试验，将评价高风险LVAD接受者的预防性术中VTA消融 临床结果。研究队列将包括100例有VTA既往史的LVAD候选患者 缺血性心肌病随机分为预防性术中VTA消融组和常规消融组 1：1的医疗管理模式。8家具有VTA消融经验的高容量LVAD植入中心 将参与。 主要的具体目的是评价预防性术中VTA消融术在以下时间的效果： 考虑竞争性死亡风险后，LVAD植入对植入后总复发VTA事件的影响。 第二个具体目标是：（1）评价管理战略的效果，包括内部， LVAD植入时手术室性心动过速消融对LVAD后不良临床结局的影响 2）收集与所提出的新型植入相关的围手术期结局的前瞻性数据 预防性术中室性心动过速消融方法。我们还将探讨与以下方面相关的机制： LVAD植入后复发VTA的电生理学研究和B）复发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 漂浮导管

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.