Abstract Body (Do not enter title and authors here): Background: Cardiac contractility modulation (CCM) is a device-based heart failure therapy that augments cardiac contractility. One CCM device – the Optimizer Smart Mini System [Impulse Dynamics, Marlton, NJ] – is approved by the Food and Drug Administration (FDA) for clinical use.
Research Question: What are real-world and long-term outcomes of the Optimizer Smart Mini CCM system?
Objective: We reviewed the United States FDA Manufacturer and User Facility Device Experience (MAUDE) database for adverse events and outcomes associated with the Optimizer Smart Mini System CCM.
Methods: On June 3rd, 2024, we performed a MAUDE database search for all reports of CCM devices from January 2019 - when the first pre-market implantation was noted - to the present. Duplicates were removed, and outcomes were noted.
Results: A total of 34 total reports were found. The majority of events were reported since 2023. 58.8% (n=20) of events were classified as device malfunctions. This occurred most often due to a computer software problem (35.3%, n=12), failure to charge (14.7%, n=5), and an adverse event without an identified problem (14.7%, n=5). Commonly, error code A09 - a charging error due to incorrect interpretation of a high current during a routine safety self-check - occurred in 38.2% (n=13) of all cases, even in patients without a reported software problem, and was solved by resetting the device in 47.1% (n=16) of cases. This is a known problem. Injury occurred in 35.3% (n=12) of cases due to implant failure (52.9%, n=18) as the most common patient problem. There was a 5.9% (n=2) rate of mortality.
Conclusions: Real-world CCM implantation appears to have low device-related adverse risks but suffers from computer software issues that may be solved by resetting the device. Continued monitoring and accurate adverse event reporting are needed with increased use to assess long-term risks.