A post-FDA approval study of Abbott’s CardioMEMS heart failure sensor found the device reduced HF-related hospitalizations by 58 percent in a trial group of 1,200 patients, researchers reported at this year’s American College of Cardiology symposium in New Orleans.
The study, led by David Shavelle, MD, an associate professor at the Keck School of Medicine of USC, evaluated the safety and efficacy of the CardioMEMS device, which was first approved by the FDA in 2014 for use in patients with New York Heart Association Class III heart failure. The size of a small paperclip, CardioMEMS is implanted directly into a patient’s pulmonary artery to detect rising pressures, which can be an early red flag for congestive heart failure.
Shavelle et al. launched the current study as a mandated FDA follow-up and enrolled 1,200 patients across 104 clinical sites in the U.S. Participants were 38 percent women and 17 percent non-white, and 30 percent presented with preserved ejection fraction (HFpEF). Another 53 percent had reduced ejection fraction.
The researchers considered a primary efficacy endpoint of patients’ HF hospitalization rates in the year after their CardioMEMS was implanted compared to the year before. They found patients’ average 1.24 HF hospitalizations in the year before their implant slid to 0.52 hospitalizations in the year after, translating to a 58 percent reduction in HF-related hospitalizations.
“Having the device cut the risk of hospitalizations by more than half,” Shavelle said in a release. “The benefits of lower hospitalizations were seen across all subgroups of patients, and we also validated that this treatment can decrease hospitalizations in patients with HFpEF.”
Women and black patients saw the greatest benefits, he said, including a 61 percent reduction in HF hospitalizations for women and a 53 percent reduction in hospitalizations for blacks.
“The study was done in a large number of patients with substantial representation of women and minorities and showed the device to be not only safe but markedly effective in keeping people out of the hospital,” Shavelle said. “Our findings further validate the concept that remote monitoring of pulmonary artery pressures, which is a surrogate to a patient’s volume status, allows adjustment of medical therapy in a timely manner to prevent future heart failure hospitalizations. This represents an important advance in heart failure management, as these patients are at very high risk of hospitalizations and complications.”
According to Shavelle, the CardioMEMS sensor also met its safety endpoint, with study participants achieving 99.7 percent freedom from device/system-related complications and 99.9 percent freedom from sensor failure at one year post-implant.