ORLANDO -- The clinical benefits observed with using a monitoring device for lung congestion were maintained in the longer run, according to results from the IMPEDANCE-HF trial.
Over follow-up, lung impedance-guided therapy was associated with a decrease in heart failure hospitalization (HR 0.63, 95% CI 0.53-0.75), , of Hillel Yaffe Medical Center in Israel here at the Heart Failure Society of America annual scientific meeting.
All-cause mortality rates favored this group (8% versus 14% per patient-year, HR 0.52, 95% CI 0.35-0.78), as did the rates of heart failure-related deaths (3% versus 8%, HR 0.30, 95% CI 0.15-0.58).
The analysis adds an extra year's worth of data to what was previously reported in the Journal of Cardiac Failure and at the American College of Cardiology's annual meeting earlier this year.
"Not only is the effect maintained over longer follow-up, but it is greater than previously seen," Shochat told ѻý. The present analysis includes 4.5-year data.
At the end of the day, however, "we shouldn't base treatment on clinical signals," he said.
The non-invasive monitor is one example of the technology that may change the treatment paradigm of heart failure patients. "Today we treat them at the hospital -- with this technology, preventative treatment may significantly reduce signs of heart failure before clinical signals emerge," he said.
The vest-style device has electrodes that detect electromagnetic energy passing through the chest.
That appears to be a trend with device developers: a similar vest-like monitor ( from Sensible Medical) is undergoing investigation; meanwhile, an invasive option, the CardioMems, is still the only FDA-approved heart failure monitoring system.
IMPEDANCE-HF was a single-blind trial that randomized 256 patients from two centers to heart failure treatment guided by either standard clinical assessment alone or with additional lung impedance monitoring.
Participants were in New York Heart Association class II to IV and had left ventricular ejection fraction under 35%. Baseline characteristics were similar between the groups.
Disclosures
Shochat reported co-founding the RSMM Company, which manufactured the devices used in the trial and supplied the devices for the study.
Primary Source
HFSA
Shochat MK, et al "One year follow up after termination non-invasive lung IMPEDANCE-guided preemptive treatment in chronic heart failure patients: A randomized controlled trial (IMPEDANCE-HF trial)" HFSA 2016.