Department of Cardiac Surgery, Cedars-Sinai Medica Center, Los Angeles, CA, USA.
Department of Cardiology, Cedars-Sinai Medica Center, Los Angeles, CA, USA.
Eur J Cardiothorac Surg. 2023 Jun 1;63(6). doi: 10.1093/ejcts/ezad116.
The Impella 5.0 and 5.5 have largely superseded non-ambulatory temporary mechanical support devices; yet, clinical outcomes are predominantly limited to small series: this study presents the experience of a high-volume centre.
An institutional clinical registry was used to identify all patients with cardiogenic shock who underwent Impella 5.0 or 5.5 implantation from January 2014 to March 2022. The primary outcome was survival to device explantation.
The study cohort comprised 221 patients, including 146 (66.1%) Impella 5.0 and 75 (33.9%) Impella 5.5 patients. The primary aetiology was non-ischaemic cardiomyopathy (50.7%, n = 112), ischaemic cardiomyopathy (23.1%, n = 51) and acute myocardial infarction (26.2%, n = 58). Patients were prospectively classified according to strategy as bridge to transplant (47.5%, n = 105), bridge to durable device (13.6%, n = 30) or bridge to recovery (38.9%, n = 86). Patients were predominantly Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2 (95.0%, n = 210). The median bridging duration was 14 (range 0-137) days. Device exchange, Ischaemic stroke and ipsilateral arm ischaemia occurred in 8.1% (n = 18), 2.7% (n = 6) and 1.8% (n = 4) of patients, respectively. Compared to the 75 most recent Impella 5.0 patients, Impella 5.5 patients (n = 75) had lower rates of device exchange (4.0%, n = 3 vs 13.3%, n = 10, P = 0.04). Overall, 70.1% (n = 155) of patients survived to Impella explantation.
The Impella 5.0 and 5.5 provide safe and effective temporary mechanical support in appropriately selected patients with cardiogenic shock. The newer device generation may have a lower requirement for device exchange as compared to its predecessor.
Impella 5.0 和 5.5 在很大程度上已经取代了非卧床临时机械辅助设备；然而，临床结果主要限于小系列：本研究介绍了一个大容量中心的经验。
使用机构临床登记处确定 2014 年 1 月至 2022 年 3 月期间接受 Impella 5.0 或 5.5 植入的所有心源性休克患者。主要结局是设备取出的存活率。
研究队列包括 221 例患者，其中 146 例（66.1%）为 Impella 5.0 患者，75 例（33.9%）为 Impella 5.5 患者。主要病因是非缺血性心肌病（50.7%，n=112）、缺血性心肌病（23.1%，n=51）和急性心肌梗死（26.2%，n=58）。根据策略，患者前瞻性分为桥接移植（47.5%，n=105）、桥接耐用设备（13.6%，n=30）或桥接恢复（38.9%，n=86）。患者主要为 Interagency Registry for Mechanically Assisted Circulatory Support 1 或 2 级（95.0%，n=210）。中位桥接持续时间为 14 天（0-137 天）。8.1%（n=18）、2.7%（n=6）和 1.8%（n=4）的患者分别发生设备更换、缺血性中风和同侧手臂缺血。与最近的 75 例 Impella 5.0 患者相比，Impella 5.5 患者（n=75）的设备更换率较低（4.0%，n=3 与 13.3%，n=10，P=0.04）。总体而言，70.1%（n=155）的患者存活至 Impella 取出。
Impella 5.0 和 5.5 在适当选择的心源性休克患者中提供安全有效的临时机械支持。与前代产品相比，新一代设备的设备更换需求可能较低。
