A new study reveals that when cardiac resynchronization (CRT) is added to a defibrillator, the risk for mildly symptomatic heart failure patients of death or being admitted to hospital is considerably lower, compared to using just a normal defibrillator and medical therapy. The results of the trial, called RAFT (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial) also showed a significant reduction in combined mortality and heart failure hospitalizations.

Anthony Tang, M.D., RAFT principal investigator, professor of medicine at the University of British Columbia and adjunct professor of medicine at the University of Ottawa Heart Institute in Ottawa, Canada, said:

    “These landmark findings demonstrate that earlier intervention with CRT‐D, in addition to guideline‐recommended medical and ICD therapy, saves lives in this patient population. Even for patients without major restrictions from their heart failure, CRT has been shown to slow the progression of their disease and reduce heart failure hospitalizations.”

The RAFT trial results have been published in NEJM (New England Journal of Medicine) and were also presented at the American Heart Association Annual Congress, Chicago.

The cardiac resynchronization therapy‐defibrillator (CRT‐D) was made and created by Medtronic Inc, Minneapolis, a leading medical technology company.

Heart failure is a serious condition in which the patient’s heart does not pump blood around the body efficiently enough. This can affect the left, right and sometimes both sides of the body. Symptoms depend on which side(s) of the body is affected and how severe the heart failure is. In some cases, symptoms may be severe. According to Medtronic, over 22 million people around the world suffer from heart failure, including over 6 million Americans and half-a-million Canadians. Even though the death rate for cardiovascular disease has fallen over the last thirty years, it has risen for heart failure.

Heart failure is estimated to cost the US economy approximately $40 billion annually, by far the most costly cardiovascular disease.

Some heart failure patients respond well to cardiac resynchronization therapy, with a reduction in symptoms, hospitalizations and risk of death.

The RAFT trial set out to determine how cardiac resynchronization therapy combined with ICD (implantable cardioverter‐defibrillator) and medical therapy might help individuals with mild/moderate heart failure. The trial revealed a 25% lower risk of combined mortality and heart failure hospitalization risk – mortality alone was also 25% lower.

Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic, said:

    This Medtronic‐supported research is the first to show the significant lifesaving value of CRT‐D for mildly symptomatic heart failure patients and builds upon the growing body of evidence calling for guideline changes. Our goal is to ensure heart failure patients who could benefit from our therapies are able to receive them.”

RAFT was a randomized, double-blinded controlled trial involving 1,798 individuals with mild to moderate heart failure. The study was led by the University of Ottawa Heart Institute, Canada, and carried out at 34 centers in Canada, Turkey, Australia and Europe. Trial participants were carefully monitored for 18 months and had an average follow-up of 40 months. Medtronic ICDs and CRT-Ds were used.

The main aim of the trial (primary outcome) was a combination of total mortality and heart failure hospitalization. The secondary aims (secondary outcomes) included death by any cause, death from a cardiovascular cause, and heart failure hospitalizations.

“Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure”
Anthony S.L. Tang, M.D., George A. Wells, Ph.D., Mario Talajic, M.D., Malcolm O. Arnold, M.D., Robert Sheldon, M.D., Stuart Connolly, M.D., Stefan H. Hohnloser, M.D., Graham Nichol, M.D., David H. Birnie, M.D., John L. Sapp, M.D., Raymond Yee, M.D., Jeffrey S. Healey, M.D., and Jean L. Rouleau, M.D.
NEJM November 14, 2010 (10.1056/NEJMoa1009540)

Written by Christian Nordqvist