Meta-analysis of three randomized, controlled trials (CHAMPION, GUIDE-HF and LAPTOP-HF) of the CardioMEMS HF System, presented at the Technology and Heart Failure Therapeutics (THT) Conference this month, found that monitoring patients remotely with hemodynamic pressure sensing technology can significantly improve survival in heart failure patients with reduced ejection fraction (HFrEF).
For the new analysis, data from the CHAMPION, GUIDE-HF and LAPTOP-HF trials were combined to assess the mortality and heart failure hospitalizations of 1,350 HFrEF patients. Among the three randomized trials, more than 650 patients were subjected to hemodynamic monitoring and 684 received the control. Heart failure hospitalizations were analyzed over a 12-month follow-up period and all-cause mortality was evaluated across 24 months.
The meta-analysis validated that hemodynamic monitoring can slow the progression of heart failure in HFrEF patients by providing an early warning against worsening heart failure, which significantly decreased heart failure-related hospitalizations and reduced mortality risk by 25% at two years.
“These new findings are encouraging news for physicians and the millions of people living with a progressive disease for which there is no cure,” said Philip B. Adamson, M.D., chief medical officer of Abbott’s heart failure business. “Heart Failure is a growing health crisis that demands innovative solutions and now we have a clinically proven life-extending option for this population.”
The CardioMEMS sensor is a paperclip-sized device that, once placed in the pulmonary artery during a minimally invasive procedure, monitors for pressure changes that indicate worsening heart failure. It wirelessly transmits daily readings to a patient’s clinical team.
“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 meta-analysis and professor of medicine at Vanderbilt University Medical Center in Nashville. “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.”