CardioMEMS Sensor Reliable, Safe; Hospitalizations Reduced by More Than Half
Patients who received a CardioMEMS heart failure (HF) sensor had a 58 percent reduction in HF-related hospitalizations in the year after it was placed, according to the results of a Late-Breaking Clinical Trial presented March 17 at ACC.19 in New Orleans, LA.
The prospective, open-label trial of 1,200 patients at 104 sites in the U.S. was initiated as a post-approval study to evaluate the efficacy and safety of the CardioMEMS sensor in clinical practice per U.S. Food and Drug Administration (FDA) mandates. The device was approved by the FDA in May 2014 for use in patients who have NYHA Class III HF and who have been hospitalized for HF in the previous year.
Among study participants, 38 percent were women, 17 percent were nonwhite, 30 percent had HF with preserved ejection fraction (HFpEF) and 52 percent had HF with reduced ejection fraction (HFrEF). Their average age was 69 years. The study's primary efficacy endpoint was the rate of HF hospitalizations in the year after the sensor was placed vs. the year before.
Results showed a significant difference in the rate of HF-related hospitalizations within the year after the device was placed compared with the year before (0.52 vs. 1.24, respectively). Patients with more than two hospitalizations in the year before receiving the sensor experienced a similar decrease. Hospitalizations decreased regardless of the patient's level of ejection fraction.
In addition, women experienced a 61 percent decrease in HF hospitalizations, while black patients experienced a 53 percent decrease. Patients with the sensor also had a 28 percent reduction in all-cause hospitalizations for conditions like pneumonia, chronic obstructive pulmonary disease or arrhythmias.
The safety endpoint assessed device- or system-related complications or failure one year after its placement. After one year, four patients experienced complications, and only one sensor failed.
"This 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," said lead author David Shavelle, MD, FACC. "Our findings further validate the concept that remote monitoring of pulmonary artery pressures … 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."
Keywords: ACC19, ACC Annual Scientific Session, Pulmonary Artery, Heart Failure, Blood Pressure Monitoring, Ambulatory
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