Prospective Investigation of Palliative and End-of-Life ExpeRiences with ICDs (PIPER-ICD) Study

摘要X 植入式心律转复除颤器(ICD)指南借鉴了对少数老年患者进行的试验，但约有50,000例ICD 每年在65岁的≥患者身上植入。一半的老年ICD接受者要么已经死亡，要么参加了 植入后5年内接受临终关怀，几乎没有证据支持关键的长期决策，包括(1) 是否在电池电量下降时更换ICD，或(2)ICD停用的时间，以避免在以下时间发生痛苦的电击 地老天荒。因此，迫切需要关于患者健康状况和临床的纵向数据 ICD植入后多年的经验，支持以患者为中心的决策。来扩展我们先前的工作 并进一步改善对ICD生死患者的护理，我们现在提出 ICD的缓解期和临终体验研究(Piper-ICD)，一项严格的、多学科的研究 中心队列，目标是定义老年ICD患者的以患者为中心的体验&>5年后 植入。我们将前瞻性地收集1200名患者的老年状况和生活质量数据，地点为 5个地点，丰富了关于心律失常和体力活动的远程监测数据，以评估临床和 功能轨迹(目标1)。该队列将支持半竞争风险方法的新应用，以 个性化死亡和ICD休克的个体化结局描述(目标2)。最后，我们将应用混合 方法对死亡队列(N~200)在生命末期量化ICD电击并确定潜在靶点 进行干预以改善他们的护理(目标3)。这项提议是由有专业知识的心脏电生理学家领导的 在老年病学、结果研究和生物伦理学方面，由经验丰富、有良好记录的研究团队提供支持 合作的力量。影响：作为第一项针对老年ICD患者的全面、前瞻性研究，重点是长期和长期的 Piper-ICD将生成以患者为中心的个性化数据，满足以下需求 以循证为基础的指导，服务于弱势群体。Piper-ICD因此将成为一个丰富的资源 为数百万考虑更换或停用ICD的患者提供决策支持。

Summary X Implantable cardioverter-defibrillator (ICD) guidelines draw on trials with few older patients, yet ~50,000 ICDs are implanted annually in patients ≥65 years old. Half of older ICD recipients will either be dead or enrolled in hospice within 5 years of implantation, and little evidence supports critical long-term decisions including (1) whether to replace ICDs when the battery declines, or (2) timing of ICD deactivation to avoid painful shocks at the end of life. There is therefore a pressing need for longitudinal data on patient health status and clinical experiences in the years after ICD implantation to support patient-centered decisions. To extend our prior work and further improve the care of patients living and dying with ICDs, we now propose the Prospective Investigation of Palliative and End-of-Life ExpeRiences with ICDs (PIPER-ICD) Study, a rigorous, multi- center cohort with the goal of defining patient-centered experiences of older ICD patients >5 years post implantation. We will prospectively collect data on geriatric conditions and quality of life from 1200 patients at 5 sites, enriched with remote monitoring data on arrhythmias and physical activity, to evaluate clinical and functional trajectories (Aim 1). This cohort will support novel application of a semi-competing risks approach to personalizing individualized outcome profiles for death and ICD shocks (Aim 2). Lastly, we will apply mixed methods to the decedent cohort (N~200) to quantify ICD shocks at the end of life and identify potential targets for interventions to improve their care (Aim 3). This proposal is led by cardiac electrophysiologist with expertise in geriatrics, outcomes research, and bioethics, supported by an experienced research team with a strong record of collaboration. IMPACT: As the first comprehensive, prospective study of older ICD patients focused on long- term and end-of-life experiences, PIPER-ICD will generate patient-centered and personalized data essential for evidence-based guidance to serve a vulnerable population. PIPER-ICD will thus serve as a rich resource to support decision-making for millions of patients considering replacement or deactivation of their ICDs.