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

预防性贲门交感神经去神经术预防室性快速心律失常（预防室性心动过速）

• 批准号: 10043765
• 负责人: David Elashoff
• 金额: $ 24.03万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-10 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10043765
• 关键词: Ablation; Acute; Adverse event; Affect; Amiodarone; Angiotensin-Converting Enzyme Inhibitors; Anti-Arrhythmia Agents; Arrhythmia; Bilateral; Cardiac; Cardiac ablation; Cardiomyopathies; Case Series; Cause of Death; Cessation of life; Chronic; Clinical; Data; Defibrillators; Dose; EFRAC; Enrollment; Fiber; Goals; Heart; Heart Diseases; Heart Transplantation; Heart failure; Hospitalization; Implant; Interruption; Left; Life; Maintenance; Medical; Morbidity - disease rate; Multicenter Trials; Myocardium; Neurons; Observational Study; Operative Surgical Procedures; Participant; Pathologic; Patient Care; Patient Recruitments; Patients; Pharmaceutical Preparations; Pharmacotherapy; Pilot Projects; Play; Prevention; Procedures; Quality of life; Randomized; Randomized Clinical Trials; Recurrence; Refractory; Reporting; Resources; Retrospective Studies; Risk; Role; Safety; Savings; Shock; Structure; Sudden Death; Sympathectomy; Sympathetic Ganglia; Sympathetic Nervous System; Tachyarrhythmias; Testing; Therapeutic; Time; Ventricular; Ventricular Arrhythmia; Ventricular Fibrillation; Ventricular Tachycardia; adverse event risk; arm; beta-adrenergic receptor; cost; design; experience; hospital readmission; implantation; improved outcome; mortality; myocardial injury; novel strategies; power analysis; primary endpoint; prophylactic; randomized trial; routine care; side effect; standard of care; structural heart disease; sudden cardiac death; treatment arm; treatment strategy; ventricular assist device

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.

抽象的 心室心律失常（VT/VF）是结构性心脏病患者死亡率的常见原因， 导致ICD植入以降低心脏猝死的风险。超过150,000个ICD被植入 美国每年。尽管一种挽救生命的疗法，许多患者经历了经常性的ICD冲击目的地 最佳医疗疗法，导致生活质量降低和发病率提高。此外，经常性 VT和ICD冲击与随着时间的流逝增加死亡率有关。因此，VT的导管消融具有 成为反复休克患者的护理标准。然而，多达30-50％的患者经历了经常性 VT/VF以及手术后的12个月内的冲击，目的地医疗和抗心律失常疗法，由此产生 多次尝试进行消融，重复住院和转介室辅助设备放置或 心脏移植。 众所周知，交感神经系统在起源和维持中起着至关重要的作用 VT/VF和神经氧化调制代表了一种改变这些心律失常的新课程途径 在结构性心脏病的患者中。针对交感神经系统的药物，包括β- 肾上腺素受体阻滞剂已被证明可降低心脏猝死的风险并改善 心力衰竭患者的结果。双侧心脏交感神经神经（CSD），通过中断 有效的交感神经和传入的纤维，可能具有相似的潜在影响，并已报告为 在结构性患者的回顾性观察研究中，显着降低了ICD冲击的伯嫩 心脏病和VT。但是，这种潜在重要疗法的价值尚不清楚，需要是 以随机方式进行测试。我们建议对40名随机与CSD Plus的患者进行一项临床试验研究 仅例行护理或例行护理。这项试验研究的目的是获得重要的可行性，效率和 安全数据允许设计大型多中心试验，然后可以确定双边 与常规相比 一个人关心。拟议的试点研究将提供有关患者招聘，权力和分析的重要数据 与该过程有关的副作用和并发症。双边CSD是一种具有潜力的方法 考虑到导管消融程序所需的高成本和资源，全球影响 心室辅助装置植入和心脏翻译。这项试验研究的结果将允许 设计适当的随机试验，以测试这种潜在的挽救生命疗法的价值。