A study intended to establish that patients with mild heart failure may benefit from cardiac resynchronization therapy (CRT) in much the same way that those with moderate or severe heart failure do failed to meet its primary endpoint, but trial researchers and the company sponsoring the trial, Medtronic (Minneapolis), saw enough evidence that the therapy is worth pursuing.

Data from the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) clinical trial, were presented as part of the late breaking sessions at the annual meeting of the American College of Cardiology (Washington) this week.

Despite not meeting statistical significance for the pre-specified analysis of its primary endpoint of a heart failure Clinical Composite Score at 12 months, more patients in the trial improved with CRT.

Additionally, in a secondary endpoint, the trial showed that CRT leads to improvement in cardiac structure and function as measured by echocardiography meaning that the heart size is reduced and therefore acts as a more-efficient pump.

"CRT in combination with optimal medical therapy improved left ventricular function in this population of heart failure patients," principle investigator Cecilia Linde, MD, of Karolinska University Hospital (Stockholm, Sweden) told Medical Device Daily.

Additionally, Linde said she saw "significant reverse modeling and improvement in ejection fraction and that CRT in these mildly symptomatic patients delayed the time to first heart failure hospitalization. There was an improvement in cardiac structure and function as measured by echocardiography, meaning the heart size is reduced and therefore acts as a more-efficient pump.

"We are convinced that we have a significant result with future bearing for candidates for CRT," she said, adding that another method of slicing the data, which diverged from the original study protocol, was more favorable to the CRT devices.

Currently, CRT is only indicated for the more advanced forms of heart failure, Class III and IV New York Heart Association (NYHA) patients.

"CRT is intended to complement standard drug therapy, and dietary and lifestyle modifications," Tracy McNulty, a spokeswoman for Medtronic told MDD. "Cost of these devices ranges from approximately $25,000 to $35,000."

Medtronic originally believed that the number of patients who could benefit from CRT with and without defibrillator backup could dramatically increase (Medical Device Daily, July 8, 2004).

Heart failure is responsible for 1 million hospitalizations a year in the U.S. and about 22 million people worldwide.

Trial investigators implanted Medtronic's InSync family CRT pacemakers or CRT defibrillators in patients at 100 centers in Europe, the U.S. and Canada.

Despite the less-than-significant data, the company is not backing away from the application.

"Medtronic remains committed to this patient population," McNulty said. "In the U.S. the company is entering discussions with FDA about the path forward to best serve the patients who could benefit from cardiac resynchronization therapy."

Rick Wise, an analyst at Bear Stearns (New York), issued a note saying, "Conventional analysis and other studies [heart class, EF, LVESVi, time to hospitalization] did show a benefit to lower risk patients. One expert expects a change in overall practice patterns with a shift towards CRT-D implants, and more focus on Class II HF patients.

"We view this positively as CRT-D's carry higher average sales prices than conventional ICDs, and the Class II HF patient population remains under-penetrated."

Orqis Medical (Lake Forest, California) also reported the results of a trial that failed to meet its primary endpoint, but also with investigators finding positives in the study data.

resented during the Late Breaking clinical Trials results at the meeting, Orqis issued data on its MOMENTUM Trial evaluating its percutaneous Cancion System for treating patients hospitalized with heart failure. The system works by continuously augmenting blood flow in the descending aorta throughout the cardiac cycle.

Barry Greenberg, MD, director of the Advanced Heart Failure Treatment Program at the University of California San Diego Medical Center, and national principal investigator of the trial, presented, "Efficacy and Safety of Continuous Aortic Flow Augmentation in Patients Hospitalized with Acute Decompensated Heart Failure: Results of the MOMENTUM Trial."

"While the MOMENTUM Trial did not meet its primary composite efficacy endpoint, MOMENTUM is a landmark study demonstrating that the Cancion System, in combination with conventional medical (drug) treatment, statistically significantly improved cardiac performance compared with drug treatment alone," Greenberg said. "There has been very little progress in identifying effective new approaches for treating patients with decompensated heart failure and the Cancion System provides physicians with a needed new treatment option."

Ken Charhut, president/CEO of Orqis, said, "MOMENTUM proved that the Cancion System significantly improves cardiac performance. Orqis' unique aortic flow therapy bridges the gap between medical management and more invasive procedures without ever touching the heart."

The Cancion System is currently available in markets outside the U.S.