心脏再同步治疗及其在 2 型糖尿病患者中的效果——自动与超声引导方法优化比较。来自 DIA-OPTA 研究者的数据。
Cardiac resynchronization therapy and its effects in patients with type 2 DIAbetes mellitus OPTimized in automatic vs. echo guided approach. Data from the DIA-OPTA investigators.
机构信息
Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia 2, 80131, Naples, Italy.
Unit of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine-DIMES, University of Bologna, Bologna, Italy.
出版信息
Cardiovasc Diabetol. 2020 Nov 28;19(1):202. doi: 10.1186/s12933-020-01180-8.
OBJECTIVES
To evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiography-guided approach.
BACKGROUND
The suboptimal atrio-ventricular (AV) and inter-ventricular (VV) delays optimization reduces CRTd response. Therefore, we hypothesized that automatic CRTd optimization might improve clinical outcomes in T2DM patients.
METHODS
We designed a prospective, multicenter study to recruit, from October 2016 to June 2019, 191 consecutive failing heart patients with T2DM, and candidate to receive a CRTd. Study outcomes were CRTd responders rate, hospitalizations for heart failure (HF) worsening, cardiac deaths and all cause of deaths in T2DM patients treated with CRTd and randomly optimized via automatic (n 93) vs. echocardiography-guided (n 98) approach at 12 months of follow-up.
RESULTS
We had a significant difference in the rate of CRTd responders (68 (73.1%) vs. 58 (59.2%), p 0.038), and hospitalizations for HF worsening (12 (16.1%) vs. 22 (22.4%), p 0.030) in automatic vs. echocardiography-guided group of patients. At multivariate Cox regression analysis, the automatic guided approach (3.636 [1.271-10.399], CI 95%, p 0.016) and baseline highest values of atrium pressure (automatic SonR values, 2.863 [1.537-6.231], CI 95%, p 0.006) predicted rate of CRTd responders. In automatic group, we had significant difference in SonR values comparing the rate of CRTd responders vs. non responders (1.24 ± 0.72 g vs. 0.58 ± 0.46 g (follow-up), p 0.001), the rate of hospitalizations for HF worsening events (0.48 ± 0.29 g vs. 1.18 ± 0.43 g, p 0.001), and the rate of cardiac deaths ( 1.13 ± 0.72 g vs. 0.65 ± 0.69 g, p 0.047).
CONCLUSIONS
Automatic optimization increased CRTd responders rate, and reduced hospitalizations for HF worsening. Intriguingly, automatic CRTd and highest baseline values of SonR could be predictive of CRTd responders. Notably, there was a significant difference in SonR values for CRTd responders vs. non responders, and about hospitalizations for HF worsening and cardiac deaths. Clinical trial ClinicalTrials.gov Identifier NCT04547244.
目的
评估通过自动与超声心动图引导方法优化的心脏再同步治疗（CRTd）对 2 型糖尿病（T2DM）患者的影响。
背景
房室（AV）和室间（VV）延迟的优化不足会降低 CRTd 的反应。因此，我们假设自动 CRTd 优化可能会改善 T2DM 患者的临床结局。
方法
我们设计了一项前瞻性、多中心研究，招募了 191 名患有 T2DM 且需要接受 CRTd 的心力衰竭患者。研究结果是在 12 个月的随访中，通过自动（n=93）与超声心动图引导（n=98）方法随机优化的 CRTd 治疗的 T2DM 患者中 CRTd 反应者的比例、因心力衰竭恶化而住院的情况、心脏死亡和所有原因死亡。
结果
我们发现，在自动组和超声心动图引导组中，CRTd 反应者的比例（68（73.1％）与 58（59.2％），p=0.038）和因心力衰竭恶化而住院的比例（12（16.1％）与 22（22.4％），p=0.030）有显著差异。多变量 Cox 回归分析表明，自动引导方法（3.636 [1.271-10.399]，95％CI，p=0.016）和心房压力的基线最高值（自动 SonR 值，2.863 [1.537-6.231]，95％CI，p=0.006）预测 CRTd 反应者的比例。在自动组中，我们发现 SonR 值在 CRTd 反应者与非反应者之间有显著差异（1.24±0.72 g 与 0.58±0.46 g（随访），p=0.001），因心力衰竭恶化事件而住院的比例（0.48±0.29 g 与 1.18±0.43 g，p=0.001）和心脏死亡的比例（1.13±0.72 g 与 0.65±0.69 g，p=0.047）。
结论
自动优化增加了 CRTd 反应者的比例，减少了心力衰竭恶化的住院率。有趣的是，自动 CRTd 和最高的基线 SonR 值可以预测 CRTd 反应者。值得注意的是，CRTd 反应者与非反应者之间的 SonR 值以及心力衰竭恶化和心脏死亡的发生率有显著差异。临床试验 ClinicalTrials.gov 标识符 NCT04547244。
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