PROPHYLACTIC CARDICA SYMPATHETIC DENERVATION FOR PREVENTION OF VENTRICULAR TACHYARRHYTHMIAS (PREVENT VT)

摘要 室性心动过速（VT/VF）是结构性心脏病患者死亡的常见原因， 导致植入ICD以降低心源性猝死的风险。超过150，000个ICD被植入， 美国每年。虽然是一种挽救生命的治疗，但许多患者经历了反复的ICD电击， 最佳的药物治疗，导致生活质量下降和发病率增加。此外，经常 随着时间的推移，VT和ICD电击与死亡率增加相关。因此，室性心动过速的导管消融术 成为反复休克患者的标准治疗。然而，高达30 - 50%的患者会出现复发 尽管进行了药物和抗心律失常治疗，但在手术后12个月内发生VT/VF和电击， 在多次尝试消融、重复住院和转诊心室辅助装置放置或 心脏移植 已知交感神经系统在脑缺血的发生和维持中起关键作用。 VT/VF和神经轴调制代表了治疗这些心律失常的一种新的路线改变途径 结构性心脏病的患者。靶向交感神经系统的药物，包括β- 肾上腺素能受体阻滞剂，已被证明可以降低心源性猝死的风险， 心力衰竭患者的结局。双侧心脏交感神经去神经（CSD），通过中断 交感神经传出和传入纤维，可以有类似的潜在影响，并已报告， 在结构性心脏病患者的回顾性观察性研究中， 心脏病和VT。然而，这种潜在的重要疗法的价值是未知的，需要 以随机的方式进行测试。我们建议对40例随机接受CSD+的患者进行临床初步研究 常规护理或单独常规护理。这项试点研究的目标是获得重要的可行性，有效性， 安全性数据，以允许设计一项大规模的多中心试验，然后可以确定是否双侧 与常规相比，CSD可延长ICD电击/VT/VF的时间，并减少ICD电击的负担 独自照顾。拟议的试点研究将提供有关患者招募、把握度和 与手术相关的副作用和并发症。双边可持续发展委员会是一种有可能 考虑到导管消融手术所需的高昂成本和资源， 心室辅助装置植入和心脏移植。这项试点研究的结果将使 设计一个适当的随机试验来测试这种可能挽救生命的疗法的价值。

ABSTRACT Ventricular tacharrhythmias (VT/VF) are a common cause of mortality in patients with structural heart disease, resulting in implantation of ICDs to reduce risk of sudden cardiac death. Over 150,000 ICDs are implanted in the U.S. each year. Although a life-saving therapy, many patients experience recurrent ICD shocks despite optimal medical therapy, resulting in decreased quality of life and increased morbidity. Furthermore, recurrent VT and ICD shocks are associated with increased mortality over time. Therefore, catheter ablation of VT has become standard-of-care for patients with recurrent shocks. Yet, up to 30-50% of patients experience recurrent VT/VF and shocks within 12 months of their procedure, despite medical and anti-arrhythmic therapy, resulting in multiple attempts at ablation, repeat hospitalizations, and referral for ventricular assist device placement or heart transplantation. The sympathetic nervous system is known to play a critical role in the genesis and maintenance of VT/VF, and neuraxial modulation represents a new course-altering avenue for treatment of these arrhythmias in patients with structural heart disease. Medications that target the sympathetic nervous system, including β- adrenergic receptor blockers, have been shown to reduce the risk of sudden cardiac death and improve outcomes of heart failure patients. Bilateral cardiac sympathetic denervation (CSD), by interrupting sympathetic efferent and afferent fibers, can have a similar potential impact, and has been reported to significantly reduce the burden of ICD shocks in retrospective observational studies of patients with structural heart disease and VT. However, the value of this potentially important therapy is unknown and needs to be tested in a randomized fashion. We propose a clinical pilot study of 40 patients randomized to CSD plus routine care or routine care alone. The goal of this pilot study is to obtain important feasibility, efficacy, and safety data to allow for the design of a large-scale multi-center trial that can then determine whether bilateral CSD can increase the time to ICD shock/VT/VF and decrease burden of ICD shocks as compared to routine care alone. The proposed pilot study will provide essential data on patient recruitment, power, and analysis of side-effects and complications related to the procedure. Bilateral CSD is an approach that has the potential for a global impact, given the prohibitive high cost and resources needed for catheter ablation procedures, ventricular assist device implantation, and heart transplantion. The results of this pilot study will allow for the design of a proper randomized trial to test the value of this potentially life-saving therapy.