Aims To report the incidence, the predictors and clinical impact of device-related complications (DRCs) in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry. Impella is percutaneous left ventricular assist devices, which provides mechanical circulatory support both in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT registry is a multicentre registry evaluating the trends in use and clinical outcomes of Impella in Italy. Methods and results A total of 406 patients have been included in this registry: 56.4% in the setting of CS, while 43.6% patients in the setting of HR-PCI. DRCs were defined as a composite endpoint of access-site bleeding, limb ischaemia, vascular complication requiring treatment, haemolysis, aortic injury, and left ventricular perforation. DRC incidence in the overall population was 25.6%, with significantly higher rate in the CS (37.1%) than in the HR-PCI (10.7%) group. The most frequent complication was haemolysis (11.8%), which occurred almost exclusively in CS population. Access-site bleeding was observed in 9.6% of the overall population, with no significant difference between the two groups. Limb ischaemia was observed in 8.3% of the overall population, with significantly higher rate in the CS group. CS and right ventricular dysfunction appear as the strongest independent predictors of DRC. One-year mortality in patients with DRC appears higher than in patients with no DRC. However, DRC was not confirmed as an independent predictor of 1-year mortality at multivariate analysis. Conclusion In the IMP-IT registry, the rate of DRC was 25.6%, with CS being the strongest independent predictor. DRC was not found as an independent predictor of 1-year mortality.

中文翻译：

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Impella 机械循环支持植入后的设备相关并发症：一项 IMP-IT 观察性多中心注册子研究

目的 报告 IMP-IT（意大利 IMPella 机械循环支持装置）注册中装置相关并发症 (DRC) 的发生率、预测因子和临床影响。Impella 是经皮左心室辅助装置，可在心源性休克（ CS ）和高危经皮冠状动脉介入治疗（ HR-PCI ）中提供机械循环支持。IMP-IT 登记处是一个多中心登记处，评估 Impella 在意大利的使用趋势和临床结果。方法和结果 该登记系统共纳入 406 名患者：56.4% 在 CS 环境中，而 43.6% 患者在 HR-PCI 环境中。DRC 被定义为穿孔出血、肢体缺血、需要治疗的血管并发症、溶血、主动脉损伤和左心室穿孔的复合终点。总体人群中的 DRC 发生率为 25.6%，CS 组 (37.1%) 的发生率显着高于 HR-PCI (10.7%) 组。最常见的并发症是溶血 (11.8%)，几乎只发生在 CS 人群中。在总人口的 9.6% 中观察到穿刺点出血，两组之间无显着差异。在总人群中观察到肢体缺血的发生率为 8.3%，CS 组的发生率明显更高。CS 和右心室功能障碍似乎是 DRC 最强的独立预测因子。患有 DRC 的患者的一年死亡率似乎高于没有 DRC 的患者。然而，在多变量分析中，DRC 未被确认为 1 年死亡率的独立预测因子。结论 在 IMP-IT 注册中，DRC 率为 25.6%，CS 是最强的独立预测因子。未发现 DRC 是 1 年死亡率的独立预测因子。