Quantification of device-related event reports associated with the CardioMEMS Heart Failure System
Authors: Lin A.L , Hu G.H , Dhruva S.D , Kinard M.T , Redberg R.R 
Published: October 2021

Abstract

Introduction
The CardioMEMS (Abbott) is an implantable pulmonary artery pressure monitor for heart failure patients approved by the United States Food and Drug Administration (FDA) based on the CHAMPION trial reporting a reduction in the composite outcome of heart failure hospitalizations (HFH) and all-cause mortality. The result was driven by reduction in HFH; there was no benefit on mortality. While CardioMEMS was approved by the FDA in May 2014 and received Conformitè Europënne (CE) Mark approval in December 2014, the FDA review found preferential attention towards patients in the treatment arm that may have biased results. The FDA-mandated industry-sponsored post-marketing study identified 5 device-related complications in a 1,200-patient cohort from September 2014 to October 2017. A separate review of adverse events reported to the FDA during a similar timeframe from May 2014 to May 2017 identified 155 instances of injury or death. As worldwide implantation rates of CardioMEMS have increased since 2017 to roughly 20,000, we updated device-related events reported to the FDA to aid in understanding its current real-world safety profile.

Methods
The FDA mandates reporting of all medical device-related events to the Manufacturer and User Facility Device Experience (MAUDE) database, a passive surveillance system. We queried all available reports from May 28, 2014 to November 28, 2020 using the unique product code for CardioMEMS (“MOM”). Almost all reports (96%) contained a narrative description, which was used to enumerate adverse events.

Results
A total of 2,861 MAUDE reports have been filed for CardioMEMS in the reporting period, increasing from an average of 38 reports per 6-month period from May 2014 to May 2017 to an average of 149 reports per 6-month period afterwards (Figure 1). The majority reported inaccurate measurements, which required replacement of the external unit, repeat non-invasive testing, or repeat catheterization to resolve (Table). There were 169 (5.9%) patient deaths reported; most commonly reported non-fatal safety events included hemoptysis, heart failure exacerbation, and significant bleeding at the groin site (Table 1).

Conclusion
We found an increased number of adverse events associated with CardioMEMS in the last 3 years compared to the first 3 years, partially coinciding with increased use. Safety of CardioMEMS should be considered along with the lack of evidence of benefit on all-cause mortality from clinical trials. MAUDE has the known limitation of incomplete adverse event reporting, thus actual adverse event rates are certainly higher. Another limitation is lack of an exact denominator as number of implantations annually is not publicly available. Our analysis demonstrates risks associated with CardioMEMS implantation that are increasing in number. These data can more accurately inform discussions regarding risks and benefits between patients, physicians, and policymakers when considering CardioMEMS.

Funding Acknowledgement
Type of funding sources: None. FigureTable