Cardiac Electrophysiology Section, Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
Center for Outcomes Research and Evaluation, Yale School of Medicine, Yale-New Haven Hospital, New Haven, Connecticut.
Heart Rhythm. 2020 Nov;17(11):1878-1886. doi: 10.1016/j.hrthm.2020.05.032. Epub 2020 Jun 1.
Randomized trials evaluating cardiac resynchronization therapy (CRT) have excluded patients with a pre-existing implantable cardioverter-defibrillator (ICD). The association of CRT upgrade with clinical outcomes in patients with a pre-existing ICD is unclear.
The purpose of this study was to examine a CRT-eligible population to evaluate clinical outcomes associated with CRT upgrade compared to patients who did not undergo CRT.
Using the National Cardiovascular Data Registry (NCDR) ICD Registry between April 2010 and December 2014, we created a hierarchical logistic regression model to identify predictors of CRT upgrade in a CRT-eligible ICD population. In the subpopulation of patients with Medicare-linked claims data, differential outcomes were determined with censoring at 3 years. The primary endpoint of this study was all-cause mortality, with secondary endpoints of rates of hospitalization and procedural complications.
CRT upgrade was performed in 75.5% of CRT-eligible patients with pre-existing ICD (n = 15,803). Presence of left bundle branch block conduction was the strongest predictor of CRT upgrade (odds ratio [OR] 4.56; 95% confidence interval [CI] 4.08-5.11; P <.0001). In both unadjusted and adjusted analyses, CRT upgrade was associated with a reduction in mortality at 3 years (unadjusted hazard ratio [HR] 0.80; 95% CI 0.70-0.92; P = .001; adjusted HR 0.84; 95% CI 0.72-0.98; P = .02, respectively). Compared to patients with ICD generator replacement only, patients who underwent CRT upgrade experienced no different 3-year rates of hospitalization (adjusted HR 1.01; 95% CI 0.91-1.12; P = .81) or 1-year periprocedural complication rates (adjusted HR 1.07; 95% CI 0.79-1.45; P = .66).
In a national registry of CRT-eligible patients with pre-existing ICD, upgrade to CRT was associated with lower rates of mortality than continued medical management.
评估心脏再同步治疗（CRT）的随机试验排除了存在植入式心脏复律除颤器（ICD）的患者。在存在预先存在的 ICD 的患者中，CRT 升级与临床结果的关联尚不清楚。
本研究的目的是检查 CRT 合格人群，以评估与未行 CRT 的患者相比，CRT 升级相关的临床结果。
使用国家心血管数据注册中心（NCDR）ICD 注册中心 2010 年 4 月至 2014 年 12 月期间的数据，我们创建了一个分层逻辑回归模型，以确定 CRT 合格的 ICD 人群中 CRT 升级的预测因素。在具有医疗保险相关索赔数据的亚组患者中，以 3 年为截止点确定差异结果。本研究的主要终点是全因死亡率，次要终点是住院率和程序并发症发生率。
在存在预先存在的 ICD 的 CRT 合格患者中，75.5%（n = 15803）进行了 CRT 升级。左束支传导阻滞的存在是 CRT 升级的最强预测因素（优势比[OR] 4.56；95%置信区间[CI] 4.08-5.11；P<.0001）。在未调整和调整分析中，CRT 升级与 3 年死亡率降低相关（未调整的危险比[HR] 0.80；95%CI 0.70-0.92；P =.001；调整的 HR 0.84；95%CI 0.72-0.98；P =.02）。与仅行 ICD 发生器更换的患者相比，行 CRT 升级的患者 3 年的住院率（调整的 HR 1.01；95%CI 0.91-1.12；P =.81）或 1 年围手术期并发症发生率（调整的 HR 1.07；95%CI 0.79-1.45；P =.66）没有差异。
在预先存在 ICD 的 CRT 合格患者的全国性注册研究中，与继续药物治疗相比，升级至 CRT 与死亡率降低相关。
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