Abbott touts lowered hospitalizations for HF in CardioMems study
Abbott (NYSE:ABT) yesterday released data from a trial of its CardioMems heart failure sensor, touting a 58% reduction in heart failure hospitalizations.
Results from the trial were presented at the American College of Cardiology 68th Annual Scientific Sessions in New Orleans, Chicago-based Abbott said.
“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. Our findings further validate the concept that remote monitoring of pulmonary artery pressures, which is a surrogate to a patients’ 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,” study lead author Dr. David Shavelle of USC’s Keck School of Medicine said in a prepared release.
Study investigators in the prospective, open-label post-approval study looked to analyze the safety and efficacy of the CardioMems sensor in clinical practice. A total of 1,200 subjects were enrolled in the trial at 104 clinical sites in the U.S. Average participant age was 69 and included 38% women, 17% non-white, 30% with preserved ejection fraction and 53% with reduced ejection fraction.
The primary efficacy endpoint in the trial was heart failure hospitalization in the year post-implant as compared to the prior year.
Results from the trial indicated that while patients had an average of 1.24 heart failure hospitalizations in the year prior to implant, after receiving the CardioMems device the hospitalization rate fell to 0.52 per year, a 58% reduction.
Hospitalization was prevented regardless of the patient’s ejection fraction, preserved ejection fraction, reduced ejection fraction or mid-range ejection fraction, study authors said. Rates were also low for patients with or without implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, and those with an ischemic or non-ischemic cardiomyopathy.
The device was reported to have reduced all-cause hospitalizations for conditions including pneumonia, chronic obstructive pulmonary disease or arrhythmias by 28%. Study authors said that other analyses showed a combined rate of heart failure-related hospitalizations or death dropped by 44% after sensor placement.
“Having the device cut the risk of hospitalizations by more than half. 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,” Shavelle said in a press release.
Study investigators said that the CardioMems also met its primary safety endpoint of freedom from device or system-related complications or sensor failure at one year.
Only four patients had device or system related complications, and only one sensor was reported to fail, giving patients a 99.7% freedom from device or system-related complications and a 99.9% freedom from sensor failure.
Researchers said that an ongoing clinical trial is evaluating the CardioMems in patients with other classes of heart failure and for patients at risk but without prior heart failure hospitalizations.
“If you can maintain more normal cardiac filling pressures and less heart stress, you are less likely to be seriously affected and need hospitalization for other conditions such as lung disease or liver disease, which are affected by heart function. We believe that having the sensor monitored by their care team also encourages patients to follow their medication plan and gives them a sense of security that is particularly important for those living far away from a hospital,” Shavelle said in prepared remarks.