Patients with mild to moderate heart failure benefited from an implanted Medtronic Inc device that combines a pacemaker to coordinate pumping with a defibrillator that shocks the heart if needed, according to new data that support use of the therapy earlier in treatment.
The data reinforce results seen in prior studies of the devices, known as Cardiac Resynchronization Therapy Defibrillators, or CRT-Ds, which pace the heart's pumping through electrical pulses and include an implantable cardioverter defibrillator, or ICD, to shock a racing heart back into normal rhythm.
The study, sponsored by Medtronic, was released Sunday at the American Heart Association's annual meeting here.
"It is evident, very clearly, that ICD with CRT works, and works well, in patients with mild to moderate heart failure," Clyde Yancy, medical director at Baylor Heart and Vascular Institute, said at the meeting.
Medtronic CRT devices currently are not approved for mildly symptomatic heart failure patients. The data will support the company's application with the U.S. Food and Drug Administration to market the products for use in this patient group.
"Earlier intervention with CRT-D will help physicians to address the needs of this growing patient population. Medtronic is seeking FDA approval for the use of CRT-D in this new patient population," said Marshall Stanton, Medtronic's vice president of clinical research for the Cardiac Rhythm Disease Management business.
Yancy of Baylor predicted the data will help influence a change in clinical practice, compelling physicians to use the therapy in a wider population of heart failure patients.
The study, dubbed RAFT, showed patients on the combined ICD/CRT treatment were 25 percent less likely to die or be hospitalized for heart failure, compared with patients who didn't receive CRT.
Patients on the combined treatment also were 25 percent less likely to die of any cause.
"This study conclusively demonstrates that this particular therapy, in addition to an ICD, will save lives," said Anthony Tang, the study's lead author and an electrophysiologist at Royal Jubilee Hospital in Victoria, British Columbia.
The Raft study suggests CRT-D appears to have particular benefits in three subsets of heart failure patients: women, patients with an abnormality known as left bundle branch block in which contraction of the left ventricle is delayed, and those with a form of rapid heartbeat known as wide QRS complex, the researchers said.
The data with be examined in conjunction with earlier studies to determine which thresholds should trigger expanded indications, they said.
In September, Boston Scientific Corpwon U.S. regulatory approval to promote three of its CRT-D devices for broader use among patients with heart failure, based on the results of its MADIT-CRT study, which showed patients fared better with a CRT-D than an ICD alone.
More than 22 million people worldwide have heart failure, in which the heart struggles to pump blood around the body, and early-stage patients make up about 70 percent of the total.
The CRT-D devices cost about $25,000 to $35,000, or as much as $8,000 more than a standard ICD. Heart failure is also the most costly cardiovascular disease in the United States.
J.P. Morgan analyst Michael Weinstein said the study should accelerate the shift to CRT-Ds from ICDs in earlier-stage heart failure patients.
"With an incremental $6,000 to $8,000 in revenue per implant, this should help provide a modest boost to an otherwise stagnant US high power market," Weinstein said in a note to clients after the data were released.
Study author Tang said more study data looking at whether spending the money upfront on a CRT-D is more cost effective will be available in coming months. (Reporting by Susan Kelly, editing by Martin Golan and Marguerita Choy)
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