Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases).

ABSTRACT: 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 utilized and associated with inpatient mortality since introduction of the Impella. Among the 885 complete reports submitted to the MAUDE database from 2008 to 2019 related to Impella usag

SUBMITTER: Philipson DJ 

PROVIDER: S-EPMC7796940 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature