Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, Essen, Germany.
Stiftung Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg, Ludwigshafen, Germany.
ESC Heart Fail. 2020 Jun;7(3):984-995. doi: 10.1002/ehf2.12613. Epub 2020 Feb 18.
Diabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation.
Within the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post-procedural clinical outcome, including a composite clinical endpoint of all-cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow-up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non-DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non-DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non-DM patients. Unadjusted and adjusted analyses revealed similar all-over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan-Meier survival analysis showed higher all-cause mortality after 1 year (9.0% vs 6.3%; log-rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non-DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89-1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68-2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9-5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42-1.28)].
The overall risk of periprocedural complications and short-term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT-D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT-D implantation.
糖尿病（DM）对心力衰竭（HF）患者的预后有负面影响。DM 在植入式心脏复律除颤器（ICD）或心脏再同步治疗（CRT）装置的 HF 患者中的作用影响可能不同，目前仍不清楚。我们的研究目的是探讨 DM 对接受 ICD 或 CRT 植入的 HF 患者围手术期并发症和临床结局的影响。
在德国设备注册处，收集了 2007 年 1 月至 2014 年 2 月期间来自 50 个德国中心的数据。对接受 ICD 植入的 5329 名患者进行了回顾性分析。分析了患者的特征、手术数据、围手术期并发症以及术后临床结局，包括全因死亡率、卒中和心肌梗死（MACCE）的复合临床终点。对 ICD 和 CRT 植入进行了亚组分析。DM 和非 DM 患者的中位随访时间分别为 15.7（12.9；20.0）和 16.2（12.8；21.2）个月。在 5329 名入组患者中，有 1448 名（27.2%）患有 DM。在该队列中，94%的 DM 和 90%的非 DM 患者患有 HF。与非 DM 患者相比，DM 患者年龄更大，体重指数更高，心血管合并症的发生率也更高。未调整和调整后的分析显示，两组的整体院内围手术期并发症发生率相似（4.1%比 3.9%）。未调整的 Kaplan-Meier 生存分析显示，DM 组患者 1 年后全因死亡率较高（9.0%比 6.3%；log-rank P = 0.001），MACCE 发生率也较高（10.0%比 7.3%；P < 0.001）。在对相关协变量进行多变量调整后，DM 与 MACCE 的关联消失[HR 1.11（0.89-1.38）]。由于慢性肾脏病（CKD）在多变量调整后与 1 年 MACCE 明显相关[比值比（OR）2.11（1.68-2.64）]，因此进行了亚组分析，结果显示 CKD 患者 DM 患者围手术期并发症的风险呈明显增加趋势[OR 2.16（0.9-5.21）]，而在无 CKD 的患者中未观察到 DM 的影响[OR 0.73（0.42-1.28）]。
DM 合并 HF 患者接受 ICD 或 CRT 除颤器（CRT-D）植入术时，围手术期并发症和短期（1 年）临床结局的总体风险并未增加。相反，CKD 与 HF 患者接受 ICD/CRT-D 植入术后 1 年 MACCE 风险增加相关。
