Williams Jeffrey L, Harley Bertha, Williams Gabriella
Lakeland Regional Health System, Lakeland, FL, USA.
University of Notre Dame, Notre Dame, IN, USA.
J Innov Card Rhythm Manag. 2020 Dec 15;11(12):4325-4332. doi: 10.19102/icrm.2020.111203. eCollection 2020 Dec.
The occurrence of patient longevity exceeding implantable cardioverter-defibrillator (ICD) service life has important implications for patient outcomes and the cost of care. Battery capacity as measured in ampere-hours (Ah) is a strong predictor of survival to an elective replacement indicator (ERI) point and 2.1 Ah is the largest-capacity ICD battery in use at our facility. This was a long-term study of ICDs out of service (OOS) in patients with heart failure with reduced ejection fraction who received a 2.1-Ah cardiac resynchronization therapy defibrillator (CRT-D). All 2.1-Ah CRT-D systems implanted (n = 418) from August 1, 2008 through August 31, 2016 were included in this retrospective chart review. The primary endpoint was device OOS due to the battery reaching an ERI point, patient death, infection/erosion, advisory/recall, heart transplant, or unspecified. The maximum follow-up period was 10.3 years, with a mean follow-up length of 4.7 years. The most common reason for device OOS was patient death (65.6%), with only 5.7% of devices reaching the ERI point during the study. There was a period of OOS acceleration driven numerically by patient death in the sixth to ninth years of follow-up. Male sex, ischemic cardiomyopathy, elevated creatinine level, advanced age, and reduced ejection fraction were associated with OOS (p < 0.05). To our knowledge, this is the first study to report ICD battery life exceeding patient survival in a chronic heart failure cohort. During an accelerated time of CRT-D OOS (when it is expected that ~98% of 1.0-Ah and 1.4-Ah CRT-D systems reach an ERI point), patient death resulted in substantially more device OOS than battery replacement and avoided costs of complications and generator changes. These results help to explain the elevated risks of CRT-D generator changes in shorter-longevity devices.
患者寿命超过植入式心脏复律除颤器(ICD)使用寿命这一情况,对患者的治疗结果及护理成本具有重要影响。以安培小时(Ah)衡量的电池容量,是预测达到择期更换指标(ERI)时间的有力指标,且2.1 Ah是我们机构目前使用的最大容量ICD电池。这是一项针对射血分数降低的心力衰竭患者中已停用(OOS)的ICD进行的长期研究,这些患者接受了2.1 Ah的心脏再同步治疗除颤器(CRT-D)。2008年8月1日至2016年8月31日期间植入的所有2.1 Ah CRT-D系统(n = 418)均纳入了此次回顾性病历审查。主要终点是由于电池达到ERI点、患者死亡、感染/侵蚀、咨询/召回、心脏移植或未明确原因导致的设备停用。最长随访期为10.3年,平均随访时长为4.7年。设备停用的最常见原因是患者死亡(65.6%),在研究期间只有5.7%的设备达到ERI点。在随访的第六至第九年,受患者死亡数字驱动,出现了一段设备停用加速期。男性、缺血性心肌病、肌酐水平升高、高龄和射血分数降低与设备停用相关(p < 0.05)。据我们所知,这是第一项报告慢性心力衰竭队列中ICD电池寿命超过患者生存期的研究。在CRT-D停用加速期(预计1.0 Ah和1.4 Ah的CRT-D系统约98%会达到ERI点),患者死亡导致的设备停用比电池更换多得多,且避免了并发症和发生器更换的成本。这些结果有助于解释寿命较短的设备中CRT-D发生器更换风险较高的原因。