Reducing Vulnerability to ICD Shock Treated Ventricular Arrhythmias

描述（由申请人提供）：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装置。虽然ICD可以挽救生命，但随着ICD冲击频率的增加，可能会出现重大的调整问题和生活质量（QOL）下降。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中，我们已经确定了急性情绪压力的经历和反应是发生心律失常的特定脆弱性，需要电击终止。因此，我们确定了一个潜在的干预目标-精神/情绪压力-以减少ICD患者对心律失常需要休克的易感性。减压治疗已被证明可以减少对情绪引发的缺血的易感性，并提高ACS后的无事件生存率。因此，本研究的具体目的是通过一项随机临床试验，在新的ICD患者中测试减压干预（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电生理（EP）变化，以及3)生活质量。在收到ICD时，总共招募了304名住院患者，并随机分配到常规治疗组或12周的认知行为应激减轻治疗组（SRT）。主要终点包括2年以上经休克治疗的心律失常无事件生存率、实验室精神压力下诱发心律失常的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改变、住院、死亡和愤怒的心理测量。相关性：关于SRT治疗益处的假设的证实可能会改变ICD患者的护理。接受这些装置的患者可以预防性地提供SRT，以降低需要休克终止的心律失常的风险。此外，如果SRT对那些容易愤怒的患者的效果特别大，则可以前瞻性地识别出因愤怒而存在风险的ICD患者，并且SRT特别针对他们。

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.