Analysis of Adverse Events Related to Impella® Usage (From the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases).
Impella® devices are increasingly utilized for hemodynamic support in high risk percutaneous coronary intervention or cardiogenic shock despite a lack of randomized clinical trial data showing clinical benefit and newer observational data suggesting harm. In this retrospective analysis, our aim was to determine the most common adverse events associated with Impella® usage reported annually to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and to estimate via the National Inpatient Sample (NIS) database the number of percutaneous ventricular assist devices (pVAD) utilized and associated with inpatient mortality since introduction of the Impella®. Among the 885 complete reports submitted to the MAUDE database between 2008 and 2019 related to Impella® usage, there were 1206 complications coded; 88.2% of reports occurred between 2016 and 2019. Among patients with adverse events reported, bleeding (32.8%), device deployment or retrieval issues (18.2%), vascular complications (15.8%), and death (12.4%) were the most common, and 7.9% of all complications were attributable to operator decision-making or technique. Between 2007 and 2017 there was a >100-fold increase in pVAD use with an increase and plateau in in-hospital mortality to 31% between 2012-2016 based on NIS data. In conclusion, Impella® use has increased substantially over the last decade but remains associated with high inpatient mortality and serious complications based on data from the NIS and MAUDE databases. These findings emphasize the need for high quality randomized controlled trials to determine the clinical utility of Impella® in high risk percutaneous coronary intervention and cardiogenic shock.