Medtronic (NYSE:MDT) announced today that a study showed longer lives for patients treated with cardiac resynchronization therapy (CRT).
Fridley, Minn.-based Medtronic’s Reverse (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) clinical trial for those with mild heart failure (HF) found that patients whose HF stabilizes with CRT live longer, similar to those whose condition improves with CRT, according to a news release.
Results for the trial were recently published in the Journal of American College of Cardiology: Clinical Electrophysiology.
The trial was the first large-scale global, randomized, double-blind study to evaluate CRT benefits for those with mild HF. It included 73 sites globally, including ones in the U.S., Western Europe and Canada, Medtronic said.
Using clinical composite score (CCS) to categorize patient outcomes as improved, unchanged (stabilized) or worsened, Medtronic observed that, of 406 patients, more than half (56%) with mild HF improved at one year. In contrast, 30% remained unchanged or stabilized and 14% worsened. Five-year mortality for improved or stabilized patients was 10%, compared to 21% for those whose condition worsened.
Another observation method, left ventricular end systolic volume index (LVESVi), assesses the amount of blood remaining in the left ventricle after contracting to determine the heart’s effectiveness related to pumping enough blood to meet the body’s needs. Using the LVESVi method in a population of 353 patients, Medtronic observed a 73% decrease in the risk of dying at five years for CRT patients who stabilized or improved, compared to those who worsened.
Additionally, five-year mortality for improved or stabilized patients was 8%, compared to 30% for those whose condition worsened. Overall, Medtronic observed a greater percentage of patients with mild HF benefitting from CRT therapy compared to current classifications.
“As we look for innovative solutions to reduce the burden of heart failure, the Reverse analysis underscores that our CRT devices provide benefits for a larger number of patients than we previously understood,” chief medical officer of Medtronic’s cardiac rhythm management business Dr. Rob Kowal said in the release. “Reverse reinforces the strong clinical evidence supporting CRT, and the value of CRT as an option to slow the progression of this debilitating disease. Time and again, the landmark CRT trials have demonstrated a range of patient stabilization or improvement with the application of cardiac resynchronization therapy.”