Johns Hopkins University School of Medicine, Baltimore, Maryland.
Yale School of Medicine, New Haven, Connecticut.
Am J Cardiol. 2021 Sep 15;155:64-71. doi: 10.1016/j.amjcard.2021.06.020. Epub 2021 Jul 25.
Primary prevention implantable cardioverter-defibrillators (ICDs) in patients with recent myocardial infarction or coronary revascularization and those with newly diagnosed or severe heart failure (HF) are considered non-evidence-based, as defined by pivotal randomized clinical trials. Although non-evidence-based ICDs have been associated previously with greater risk of in-hospital adverse events, longitudinal outcomes are not known. We used Medicare-linked data from the National Cardiovascular Data Registry's ICD Registry to identify patients discharged alive following first-time primary prevention ICD implantations performed between 2010 and 2013. We compared longitudinal outcomes, including all-cause mortality and all-cause hospital readmission among patients receiving non-evidence-based versus evidence-based ICDs, up to 4.75 years after implantation, using multivariable time-to-event analyses. Of 71,666 ICD implantations, 9,609 (13.4%) were classified as non-evidence-based. Compared to patients receiving evidence-based ICDs, non-evidence-based ICD recipients had greater mortality risk at 90 days (HR = 1.44, CI: 1.37 - 1.52, p <0.0001) and at 1 year (HR = 1.19, CI: 1.15 - 1.24, p <0.0001), but similar mortality risk at 3 years (HR = 1.03, CI: 0.98 - 1.08, p = 0.2630). Risk of all-cause hospitalization was higher in patients with non-evidence-based ICDs at 90 days (HR = 1.17, CI: 1.14 - 1.20, p <0.0001), but the difference diminished at 1 year (HR = 1.04, CI 1.00 - 1.07, p = 0.0272) and at 3 years (HR = 0.94, CI: 0.90 - 0.99, p = 0.0105). In conclusion, among patients undergoing primary prevention ICD implantations between 2010 and 2013, those with non-evidence-based ICDs were at increased risk of mortality and readmission during longitudinal follow-up. Differences in the risk of mortality and hospitalization were highest in the first year following device implantation.
在 2010 年至 2013 年间接受初次预防植入式心脏复律除颤器 (ICD) 的患者中，根据关键随机临床试验的定义，最近心肌梗死或冠状动脉血运重建患者和新诊断或严重心力衰竭 (HF) 患者的 ICD 植入属于非循证治疗。尽管之前已经证明非循证 ICD 与住院期间不良事件风险增加有关，但纵向结局尚不清楚。我们使用医疗保险相关数据，从国家心血管数据注册的 ICD 注册库中确定了 2010 年至 2013 年间首次进行初次预防 ICD 植入后存活出院的患者。我们使用多变量时间事件分析比较了接受非循证 ICD 和循证 ICD 治疗的患者的纵向结局，包括植入后长达 4.75 年的全因死亡率和全因再入院率。在 71666 例 ICD 植入中，有 9609 例 (13.4%)被归类为非循证。与接受循证 ICD 的患者相比，非循证 ICD 接受者在 90 天 (HR=1.44，95%CI：1.37-1.52，p<0.0001) 和 1 年 (HR=1.19，95%CI：1.15-1.24，p<0.0001) 时的死亡率风险更高，但在 3 年时的死亡率风险相似 (HR=1.03，95%CI：0.98-1.08，p=0.2630)。非循证 ICD 患者在 90 天时有更高的全因住院风险 (HR=1.17，95%CI：1.14-1.20，p<0.0001)，但在 1 年时风险降低 (HR=1.04，95%CI 1.00-1.07，p=0.0272)，在 3 年时风险进一步降低 (HR=0.94，95%CI：0.90-0.99，p=0.0105)。总之，在 2010 年至 2013 年间接受初次预防 ICD 植入的患者中，非循证 ICD 患者在纵向随访期间死亡率和再入院率更高。在器械植入后的第一年，死亡率和住院风险的差异最大。
