Key result
MitraClip-associated reported fatal events drop ~78% between 2014 and 2021.
Why the study?
To evaluate safety trends in fatal complications associated with MitraClip implantation over the last decade using post-marketing surveillance data.
Observational (n=8,941)
Yes
Absolute Event Rate: 3.5% vs 15.9%
p-value: p=<0.0001
Analysis of the FDA MAUDE database over 10 years shows a significant decline in reported fatal events associated with MitraClip implantation, likely reflecting increasing operator experience and device iterations.
Supports greater MitraClip safety in contemporary practice; leaves open need for prospective mortality studies.
Background The MitraClip device (Abbott), an FDA-approved transcatheter apparatus, is employed for the management of mitral regurgitation (MR) among patients deemed at high risk for surgical interventions. We analyzed reports in the FDA MAUDE database to evaluate the safety trend in fatal complications associated with MitraClip implantation in the last decade. Methods We searched the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) database for reports of deaths and injuries associated with MitraClip implantation from October 2013 to September 2023. Duplicate reports were excluded. The Cochran-Armitage test was used to analyze the trend in proportion of fatal events. Results In the 10 year period after FDA approval, a total of 927 death reports and 9211 injury reports were recorded by the MAUDE database. 592 death reports were included for analysis after excluding duplicates and reports from other sources. The most frequently reported complications were MR (26.69%), tissue damage (24.16%) and hypotension (22.13% ). The most common device-related problems were incomplete coaptation (14.70%), difficult to remove (6.42%), and failure to adhere or bond/positioning failure(4.90%). Most deaths (76.94%) occurred within one year of implantation. The proportion of reported fatal events showed a significant declining trend from 15.9% in 2014-2015 to 3.5% in 2020-2021 (p<0.0001). Conclusions Analysis of the MAUDE database suggests a decline in reported fatal events associated with MitraClip implantation over time, which may reflect increasing experience with the device. However, passive reporting has limitations including underreporting and incomplete data. Further studies are needed to better characterize the safety profile and complication rates of MitraClip implantation in real-world practice.
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Sun et al. (2024) conducted an observational in Mitral regurgitation (n=8,941). MitraClip was evaluated on Trend in proportion of reported fatal events among all casualty events (p=<0.0001). The proportion of reported fatal events associated with MitraClip implantation significantly declined from 15.9% in 2014-2015 to 3.5% in 2020-2021.
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