Background

Cardiac resynchronization therapy (CRT) reduces mortality and improves outcomes in appropriately selected patients with heart failure (HF); however, response may vary.

Objective

We sought to correlate 6-month CRT response assessed by clinical composite score (CCS) and left ventricular end-systolic volume index (LVESVi) with longer-term mortality and HF-related hospitalizations.

Methods

Individual patient data from 5 prospective CRT studies—Multicenter InSync Randomized Clinical Evaluation (MIRACLE), Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD), InSync III Marquis, predictors of response to cardiac resynchronization therapy (PROSPECT), and Adaptive CRT—were pooled. Classification of CRT response status using CCS and LVESVi were made at 6 months. Kaplan-Meier analyses were used to assess time to mortality. Cox proportional hazards regression models were used to compute hazard ratios (HRs) for the 3 levels of CRT response: improved, stabilized, and worsened. Adjusted models controlled for baseline factors known to influence both CRT response and mortality. HF-related hospitalization was compared between CRT response categories using incidence rate ratios.

Results

Among a total of 1603 patients, 1426 and 1165 were evaluated in the CCS and LVESVi outcome assessments, respectively. Mortality was significantly lower for patients in the improved (CCS: HR 0.22; 95% confidence interval [CI] 0.15–0.31; LVESVi: HR 0.40; 95% CI 0.27–0.60) and stabilized (CCS: HR 0.38; 95% CI 0.24–0.61; LVESVi: HR 0.41; 95% CI 0.25–0.68) groups than in the worsened group for both measures after adjusting for potential confounders.

Conclusion

Patients with a worsened CRT response status have a high mortality rate and HF-related hospitalizations. Stabilized patients have a more favorable prognosis than do worsened patients and thus should not be considered CRT nonresponders.

中文翻译：

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心脏再同步化治疗后早期评估对重新定义反应的重要性：来自 5 项前瞻性研究的汇总个体患者分析

背景

Cardiac resynchronization therapy (CRT) reduces mortality and improves outcomes in appropriately selected patients with heart failure (HF); 但是，反应可能会有所不同。

客观的

我们试图将通过临床综合评分 (CCS) 和左心室收缩末期容积指数 (LVESVi) 评估的 6 个月 CRT 反应与长期死亡率和 HF 相关住院率相关联。

方法

来自 5 项前瞻性 CRT 研究的个体患者数据——多中心 InSync 随机临床评估 (MIRACLE)、多中心 InSync ICD 随机临床评估 (MIRACLE ICD)、InSync III Marquis、对心脏再同步治疗反应的预测因子 (PROSPECT) 和自适应 CRT——被汇总. 在 6 个月时使用 CCS 和 LVESVi 对 CRT 反应状态进行分类。Kaplan-Meier 分析用于评估死亡时间。Cox 比例风险回归模型用于计算 3 个 CRT 反应水平的风险比 (HR)：改善、稳定和恶化。调整后的模型控制了已知会影响 CRT 反应和死亡率的基线因素。使用发生率比率比较 CRT 反应类别之间与 HF 相关的住院情况。

结果

在总共 1603 名患者中，分别有 1426 名和 1165 名接受了 CCS 和 LVESVi 结果评估。改善（CCS：HR 0.22；95% 置信区间 [CI] 0.15–0.31；LVESVi：HR 0.40；95% CI 0.27–0.60）和稳定（CCS：HR 0.38；95% CI 0.24）患者的死亡率显着降低–0.61；LVESVi：HR 0.41；95% CI 0.25–0.68) 组在调整潜在混杂因素后的两项指标均优于恶化组。

结论

CRT 反应状态恶化的患者死亡率和 HF 相关住院率较高。稳定的患者比恶化的患者预后更好，因此不应被视为 CRT 无反应者。