Patient-Centered Outcomes of Implantable Defibrillator Therapy in Older Patients

描述（由申请人提供）：每年有超过50,000台植入式心律转复除颤器（icd）被放置在bb0 - 65岁的患者中。人口趋势和相关的心脏病负担将使数百万老年心脏病患者在未来几年有资格使用这些设备。这些患者在ICD植入后的临床病程和医疗保健需求方面面临着重要的不确定性，必须与不植入ICD的猝死风险进行权衡。对于老年患者来说，两种最具挑战性和最昂贵的医疗保健过渡包括疗养院（NH）和临终关怀住院。ICD接收者最终需要NH或临终关怀，以及何时需要，完全未知。此外，他们更广泛的临终经历并没有得到很好的描述。本建议使用两种互补方法解决与老年ICD患者的临床过程、卫生保健需求和临终经历相关的知识差距。首先，从2005年到2010年，国家心血管数据登记处- ICD登记处的数据将与最小数据集和医疗保险数据相关联，以检查ICD植入后需要NH和临终关怀的老年ICD患者的使用模式和结果。其次，将从Beth Israel Deaconess Medical Center的ICD患者bbb65中收集主要数据，以检查次要数据集中不可用的关键临终预后。具体目的是：1：描述发生率并确定基线风险因素(a)长期NH护理和(b) ICD植入后3年内~ 300,000 ICD受者的临终关怀入院；2：描述和比较ICD受者的结果，包括：a)接受和未接受NHs的患者植入后的生存，以及(b) i.生命最后90天内的繁重过渡（住院或入院）；接受和未接受安宁疗护的死者死亡地点（N~ 90,000）；3：在75名ICD门诊患者中开展一项为期2年的前瞻性试验研究，以确定以下内容：预先护理计划（例如，医疗保健的正式授权书；预先指示；与提供者的讨论）；护理的主要目标（如延长生命vs.舒适）；保健服务的使用（如住院、临终关怀、新保健）；和临终结局（地点、ICD冲击/失活、干预措施、临终关怀使用）和临终关怀质量（工具包）在死者（N~20）中。影响：这项研究将产生关于老年icd患者的临床过程、卫生保健需求和临终经历的新数据。目的1和2将利用国家数据库来检查老年ICD患者在植入后需要长期NH和临终关怀的发生率和结果。目标3将确定对老年ICD患者进行前瞻性研究的可行性，并获得有关其临终经历的初步数据。这项工作是朝着更好地为老年患者使用icd的临床和政策决策提供信息的关键步骤。

DESCRIPTION (provided by applicant): More than 50,000 implantable cardioverter-defibrillators (ICDs) are placed annually in patients aged > 65. Demographic trends and the associated burden of heart disease will make millions more older cardiac patients eligible for these devices in the coming years. These patients face important uncertainties regarding their clinical course and health care needs after ICD implantation, which must be weighed against the risk of sudden death without the device. Two of the most challenging and costly health care transitions for older patients include nursing home (NH) and hospice admission. Which ICD recipients ultimately require NH or hospice care, and when, is entirely unknown. Additionally, their broader end-of-life experiences have not been well- characterized. This proposal addresses knowledge gaps related to the clinical course, health care needs, and end-of-life experiences of older ICD patients using 2 complementary approaches. First, data in the National Cardiovascular Data Registry - ICD Registry from 2005 to 2010 will be linked to Minimum Data Set and Medicare data to examine the utilization patterns and outcomes of older ICD patients needing NH and hospice care following ICD implantation. Second, primary data will be collected from ICD patients > 65 at the Beth Israel Deaconess Medical Center to examine key end-of-life outcomes unavailable in the secondary dataset. The Specific Aims are: 1: To describe the incidence and identify baseline risk factors for (a) long-term NH care and (b) hospice admission among ~ 300,000 ICD recipients > 65 up to 3 years after ICD implantation; 2: To describe and compare outcomes among ICD recipients, including: a) survival following implantation for those who were and were not admitted to NHs, and (b) i. burdensome transitions (hospitalization or NH admission) in last 90-days of life and ii. site of death for decedents (N~ 90,000) who were and were not admitted to hospice; and 3: To conduct a 2-year pilot prospective study among 75 ambulatory ICD patients > 65 to ascertain the following: advance care planning (e.g. formal power of attorney for health care; advance directives; discussions with providers); main goal of care (e.g. life prolongation vs. comfort); health service use (e.g. hospitalizations, hospice, NH); and end-of-life outcomes (site, ICD shocks/deactivation, interventions, hospice use) and quality of end-of-life care (Toolkit After-death Bereaved Family Interview) among those who die (N~20). IMPACT: This research will yield novel data about the clinical course, health care needs and end- of-life experiences of older patients with ICDs. Aims 1 and 2 will leverage national databases to examine the incidence and outcomes of older ICD patients needing long-term NH and hospice care post-implantation. Aim 3 will establish the feasibility of conducting a prospective study of older ICD patients and yield preliminary data regarding their end-of-life experiences. This work represents key steps towards better informing clinical and policy decisions regarding the use of ICDs among older patients.