Abbott, Ancora Heart score study wins with heart failure devices

Heart failure is notoriously difficult to diagnose and track. Though treatment options are increasing, the mortality rate within the first few years of diagnosis remains high—meaning there’s plenty of room for improvement in the realm of devices specifically targeting the condition.

Taking advantage of that gap are Abbott and Ancora Heart. Both companies have developed implanted devices that are designed to improve outcomes for heart failure patients—though they take vastly different approaches to do so.

Despite their differences, both devices are well on their way to achieving that goal. In separate studies presented at the annual Technology and Heart Failure Therapeutics conference in Boston this week, each of the companies showed that use of their respective device resulted in improvements in heart failure patients’ lives within the first year or two of implantation.

Abbott’s presentation revolved around its CardioMEMS remote monitoring system. The paper-clip-sized implant is placed within the pulmonary artery, where it watches for changes in blood pressure that could indicate worsening heart failure. Abbott acquired the device in its 2017 buyout of St. Jude Medical. The device was originally FDA-approved in 2014 and earned an expanded indication last year.

A meta-analysis of three clinical trials of the device showed that using the system’s wirelessly transmitted readings to track a patient’s condition could help doctors proactively adjust treatments and, ideally, keep patients out of the hospital, according to Abbott's press release, since heart failure patients’ mortality risk rises significantly with every hospitalization.

The analysis focused specifically on 1,350 heart failure patients with reduced ejection fraction (HFrEF), about half of whom were implanted with the CardioMEMS device across the three trials. The study found that those who’d undergone the remote monitoring not only experienced significantly fewer hospitalizations than the control group but also saw their mortality risk drop by about 25% at the two-year point, per Abbott.

“The incidence of heart failure is a growing epidemic that affects more than 6.2 million Americans, and nearly half of those hospitalized for heart failure die within a year of their first admission,” said JoAnn Lindenfeld, M.D., investigator for the study and a professor of medicine at Vanderbilt University Medical Center, in the press release. “This analysis confirms that remote pressure monitoring is a life-extending option that reduces hospitalizations and should be considered for those with this type of weak heart.”

Ancora’s study, meanwhile, concerned its AccuCinch technology. The flexible implant is meant to help reduce the size of the left ventricle to improve blood flow in HFrEF patients. The device comprises a cablelike system that wraps around the inside of the ventricle, then is cinched to reshape and support the heart chamber.

The AccuCinch system—which was given the FDA’s breakthrough-device designation last summer—is specifically aimed at heart failure patients whose symptoms can’t be effectively treated by a pacemaker or drug therapies but who haven’t yet reached the stage of needing a full-blown heart transplant or left ventricular assist device.

The study followed 51 symptomatic HFrEF patients treated with the AccuCinch device. According to Ancora's press release, one year after implantation, 94% of the participants had either improved or remained steady on the New York Heart Association classification, which rates the severity of heart failure. The patients also saw their left ventricular end diastolic volume improve by an average of 33.6 mL and their ejection fraction improve by about three percentage points during that time.

Additionally, the patients saw improvements in their functional capacity, as measured by the standard six-minute walk test, in which they were able to add an average of nearly 46 meters to their baseline distances. Quality-of-life scores also shot up, climbing about 16 points on the 100-point Kansas City Cardiomyopathy Questionnaire.