Outcomes in patients undergoing high-risk PCI using Impella circulatory support: 10-year experience

Objectives: The Impella® percutaneous systems (Abiomed, Danvers, USA) are temporary ventricular assist devices, approved for use in high-risk percutaneous coronary intervention (PCI). Impella use in the United Kingdom (UK) is limited by cost, reimbursement, lack of operator experience and paucity of long-term outcome data. We investigated 10-year outcomes of Impella circulatory support in a large quaternary UK hospital. Methods: Consecutive patients undergoing Impella-assisted PCI between 2008 and 2018 were retrospectively identified and outcome data collected. Results: Eighty patients underwent Impella-assisted PCI and were predominantly male (73.8%) with a mean age of 71.2 + 13.7 years. Fifty-three (66.3%) presented with non-ST segment elevation myocardial infarction (MI) and 7.5% with ST-segment elevation MI. The majority of patients had severe left ventricular systolic dysfunction (58.8%), multivessel disease (83.8%) and unprotected left main stem disease (52.5%). Ten (12.5%) patients had pre-procedural cardiogenic shock. In-hospital major adverse cardiac and cerebrovascular events (MACCE) and all-cause mortality occurred in 21.3% and 18.8% respectively. Post-procedure stroke and bleeding occurred in 2.5% and 13.8% of patients respectively, with one vascular complication (conservatively managed pseudoaneurysm). Median time to first follow-up visit was 105 (64.5; 282.0) days, at which point MACCE occurred in 18.8% of patients. Pre-procedural cardiogenic shock was a significant predictor of in-hospital MACCE (OR 9.0, C.I. 2.1-37.6, p=0.003). Conclusion: When used to support high-risk PCI, Impella has an excellent safety profile. These data support the practice of Impella use in this cohort; however a randomised controlled trial is required to determine the efficacy of Impella against unsupported PCI.