20 Sep Low Adverse Event Rates Related to the CardioMEMS Heart Failure System
MedicalResearch.com Interview with:
Dr. Vaduganathan
Muthiah Vaduganathan, MD, MPH
Brigham and Women’s Hospital Heart &
Vascular Center and Harvard Medical School
Boston, Massachusetts
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The CardioMEMS™ HF System (Abbott, Sylmar, CA) is a commercially-available, wireless hemodynamic monitor that can be permanently implanted in the pulmonary artery (PA) to permit real-time, remote monitoring of PA pressures to enhance clinical decision-making in patients with heart failure (HF). Based on a favorable safety profile and the results of the CHAMPION trial, the US Food and Drug Administration (FDA) approved the device in May 2014. Since FDA approval, the device is being implanted in older patients with greater comorbidities compared with those enrolled in CHAMPION. Limited safety data are available after market introduction in this higher-risk pool.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: We used data from the publicly-available Manufacturer and User Facility Device Experience (MAUDE) database to identify CardioMEMS-related adverse events within the first 3 years of FDA approval. Overall, estimated rates of adverse events (~2 to 3%) were low and comparable between the MAUDE passive surveillance system and the CHAMPION trial. We did identify several cases of PA injury, which were mostly clustered early after device introduction and appeared to stabilize over time.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The MAUDE reporting system is subject to a number of limitations, and thus these safety signals will need to be contextualized alongside other, parallel post-marketing surveillance efforts. Indeed, preliminary findings from the first 300 enrolled patients in the CardioMEMS HF System Post Approval Study were also presented at this meeting.
Disclosures: I am supported by the NHLBI T32 postdoctoral training grant (T32HL007604).
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Last Updated on September 20, 2017 by Marie Benz MD FAAD