Reducing Vulnerability to ICD Shock Treated Ventricular Arrhythmias

描述(申请人提供)：在美国，每年有超过40万人经历心脏骤停，植入式心律转复除颤器(ICD)已经改变了这些潜在致命心律失常的风险患者的护理。最近的临床试验结果扩大了ICD治疗的适应症，估计每年将有超过50万名患者接受这些设备。虽然ICD可以挽救生命，但作为ICD电击频率的函数，可能会出现重大的调整问题和生活质量(QOL)受损。此外，调整问题增加了心律失常需要休克终止的可能性。在实验室和自然环境下的工作中，我们已经确定了对急性情绪应激的体验和反应是发生心律失常的特定脆弱性，需要休克才能终止。因此，我们确定了一个潜在的干预目标--精神/情绪压力--以降低ICD患者对需要休克的心律失常的易感性。减压治疗已被证明可以降低对情绪触发的缺血的易感性，并提高急性冠脉综合征后的无事件生存率。因此，这项研究的具体目的是在一项针对新的ICD患者的随机临床试验中，测试减压干预(SRT)对以下方面的影响：1)休克治疗的心律失常；2)实验室急性应激期间致心律失常的电生理变化；以及3)生活质量。在接受ICD治疗时，共有304名患者将在住院期间被招募，并被随机分配到常规护理或为期12周的小组认知行为压力减轻治疗(SRT)中。主要终点包括经休克治疗的心律失常患者2年以上的无事件生存、实验室精神应激期间易发生心律失常的EP变化、24小时心率变异性和生活质量。次要终点包括抗心律失常药物的更换、住院、死亡和愤怒的心理指标。相关性：证实有关SRT治疗益处的假设可能会改变ICD患者的护理。接受这些装置的患者可以预防性地接受SRT，以降低需要休克终止的心律失常的风险。此外，如果SRT对那些容易生气的患者的影响特别大，可以前瞻性地识别因愤怒而有风险的ICD患者，并特别针对他们进行SRT。

DESCRIPTION (provided by applicant): Upwards of 400,000 people in the US experience cardiac arrest annually, and the implantable cardioverter- defibrillator (ICD) has transformed the care of patients at risk for these potentially fatal arrhythmias. The results of recent clinical trials have led to an expansion of the indications for ICD therapy, and it is estimated that over 500,000 patients will receive these devices annually. While ICDs can be life saving, significant adjustment problems and impaired quality of life (QOL) can arise as a function of ICD shock frequency. Further, adjustment problems increase the likelihood of arrhythmias requiring shock for termination. Working in the laboratory and in the natural setting, we have identified the experience and response to acute emotional stress as specific vulnerabilities to the occurrence of arrhythmias that require shock for termination. We have therefore identified a potential target for intervention - mental/emotional stress - to reduce vulnerability to arrhythmia requiring shock in patients with ICD. Stress reduction treatments have been shown to reduce vulnerability to emotion-triggered ischemia, and improve event free survival after ACS. Therefore, the Specific Aims of the proposed study are to test, in a randomized clinical trial with new ICD patients, the effects of a stress reduction intervention (SRT) on, 1) shock-treated arrhythmia, 2) arrhythmogenic electrophysiological (EP) changes during acute stress in the laboratory, and, 3) Quality of Life. A total of 304 patients will recruited while in hospital at the time of ICD receipt and be randomized to usual care or a 12-week, group based, cognitive behavioral stress reduction treatment (SRT). Primary endpoints include shock treated arrhythmia event-free survival over 2 years, pro-arrhythmic EP changes during laboratory mental stress, 24-hour heart rate variability, and quality of life. Secondary endpoints include anti-arrhythmic medication changes, hospitalizations, deaths, and psychological measures of anger. RELEVANCE: Confirmation of hypotheses concerning the benefits of SRT treatment could transform the care of ICD patients. Patients receiving these devices could be offered SRT prophylactically to reduce the risk of arrhythmia requiring shock for termination. In addition, should the effect of SRT be particularly greater for those patients prone to anger, ICD patients at risk due to anger could be identified prospectively, and SRT particularly targeted to them.