As the most prevalent cardiac arrhythmia, atrial fibrillation has given rise to a multitude of interventions with variable effectiveness. While drug-based interventions have certainly seen success, as of late, ablation procedures have received significant interest among organizations looking to grow their cardiac service lines through the addition of new services. However, organizations seeking to develop AF ablation programs are likely to encounter a number of barriers along the way.
Effective data collection a top priority for new AF ablation programs
Last year, the Roundtable reported on the results of CardioMEMS Inc.’s CHAMPION trial, but despite seemingly favorable data, the FDA’s Circulatory System Devices panel this week recommended the FDA not approve the device based upon issues noticed with the trial design that may have impacted results. In particular, the FDA’s panel took issue with an apparent violation of approved pre-market approval (PMA) protocols. Following the FDA clinical-site inspections, it was discovered that vendor-provided emails on suggested treatments occurred in as much as 10 percent of study subjects within the treatment group. With many FDA panelists explaining there was no way to determine whether the device or the care protocols were responsible for results, the decision fell 3-7 against device effectiveness.
Pre-market approval (PMA) protocols outlined specific actions to be taken by physicians when readings suggested the need for intervention. However, CardioMEMS nurses apparently sent emails directly to physicians, influencing treatment decisions and ultimately confounding results.
Remote-monitoring technology receives FDA scrutiny over confounded clinical trial
Eric Bushlow, Cardiovascular Roundtable
Cardiovascular programs continue to search for innovative solutions to improve longitudinal care delivery and ensure patients are managed in the most appropriate post-acute settings. Remote monitoring for patients receiving pacemakers has long been suggested as an opportunity to improve the quality—and cost—of care along the continuum. Given the relative nascence of the technology, however, the impact of remote monitoring compared to other more established post-acute management strategies remains not well understood. However, a recent study published in the European Heart Journal examines the potential for remote-monitoring of pacemaker recipients to curb costs and improve quality of care.
COMPAS trial results support safety efficacy of Pacemaker remote monitoring