Evaluating The Trends In The Reported Adverse Events Related To Impella: Insights From The US FDA MAUDE Database

Abstract

Background

In recent years, there has been an increasing demand for left ventricular mechanical assist devices, and one of the commonly used such devices includes Impella. This study evaluates the trends associated with Impella based on the data reported from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE).

Methods

The MAUDE database was queried using the identifier code "OZD" from January 2020 to December 2023 to identify adverse events associated with Impella. The entries were then analyzed for Gender, Access site, type of Impella, indication, and type of complication. The percentages of Device types, Gender, Access site, Indications and Complications across various Impella models were then calculated.

Results

In our cohort of 5100 reported events, 4543 were included for analysis after excluding reports with duplicates and insufficient information. Among those, the highest reported were Impella CP (54.37%) and Impella 5.5 (36.10%) across device types, Male (58.82%) across gender, Acute Myocardial infarction/High-Risk Coronary PCI (36.94%) across indications, Femoral (15.14%) across access site and Bleeding/Hematoma (22.98%) across complications with a nonnegligible contribution from unspecified information in some. Further trends, including complications under each impella device, are in Table 1, Table 2, and Figure 1.

Conclusion

These findings highlight the need for continued surveillance and comparative analyses of different Impella models to optimize patient outcomes. Further studies into complications associated with these devices may bring about the need for specific mitigation strategies to prevent them in the future. At the same time, certain limitations exist in using such databases, such as the inability to calculate the incidences, underreporting of events and furthermore .