Real-world Experience Of Adverse Events And Modes Of Failure Related To The New Impella 5.5 - A Retrospective Analysis From Manufacturer And User Facility Device Experience Database

• Published in: Journal of cardiac failure Vol. 30; no. 1; p. 133
• Main Authors: Rajak, Kripa, Halder, Anupam, Amirian, Aslan, Khanal, Resha, Atrash, Anas, Ramesh, Navitha, Goswami, Rohan
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01-01-2024
• ISSN: 1071-9164; 1532-8414
• DOI: 10.1016/j.cardfail.2023.10.040

Impella 5.5 with Smart Assist is the newest heart pump that has received U.S. Food and Drug Administration (FDA) pre-market approval in 2019 for safety and efficacy in the therapy of cardiogenic shock for up to 14 days at limited centers in the United States. Impella consists of several different models that vary in caliber, insertion technique, and maximum hemodynamic support capabilities. Impella 5.5 is minimally invasive, implanted via the axillary artery or the anterior aorta eliminating the need for a sternotomy or coring of the left ventricle unlike older versions. There are multiple publications on complications of older versions of impella approved before 2019 but there is no published post-approval surveillance data on the most reported complications and failure modes associated with the newest Impella 5.5.
In this retrospective study, our aim was to analyze the US FDA Manufacturer and User Facility Device Experience (MAUDE) database to report the real-world adverse events and modes of failures for Impella 5.5.
We quarried the database from September 2019 to March 2023 for Impella 5.5 devices. Based on the severity, events were classified into three categories: death, injury, and malfunction.
A total of 260 medical device reports were obtained. After excluding the Impella CP, heartmate and other devices, 226 reports were included in the final analysis. The temporal trends for annual reporting of the adverse events related to Impella 5.5 devices were 3 in 2019 followed by 29 in 2020, 67 in 2021, and 104 in 2023 which has exponentially gone up with the increased usage of the device. 49.11% (n=111) were reported as injury followed by 46.01% (n=104) as malfunction and the remaining 4.86% (n=11) as death. Of the total malfunctions reported, the most common failure mode was pump stoppage (67%) followed by fluid leak (9.60%) and crack/fracture (4.80%). Some of the least reported device issues were unexpected shutdown, device detachment/expulsion, failure of alarm function. The most common injuries reported were hemolysis 25.2% (n=28) followed by ischemic stroke 24.3%(n=27), cardiac perforation 20.72% (n=23), and hemorrhage 18.9% (n=21). The least reported injuries were vascular dissection, bacterial infection, and valvular insufficiency.
In conclusion, Impella 5.5 use has substantially increased over the last few years as it provides a significant level of hemodynamic support but also remains associated with serious complications based on data from MAUDE databases. Physicians should be aware of the common device failure modes like pump stopping to work or the consequences on the patients like stroke or cardiac perforation. Appropriate patient selection, device education and operator experience can help mitigate the complications related to device malfunction. These data emphasize the need for high quality randomized controlled trials to determine the temporal relationship of device failure and patient outcome.