Cardiac Resynchronization Therapy Off-Label Use High

Almost a quarter of patients receiving CRT devices do not meet consensus guidelines

TUESDAY, Aug. 24 (HealthDay News) -- Nearly 25 percent of individuals who receive cardiac resynchronization therapy (CRT) devices do not meet consensus guidelines for CRT device use, according to a study in the Aug. 31 issue of the Journal of the American College of Cardiology.

Adam S. Fein, M.D., of Harvard Medical School in Boston, and colleagues used the National Cardiovascular Data Registry's Implantable Cardiac-Defibrillator Registry to define a cohort of 45,392 CRT-defibrillator (CRT-D) implants between January 2006 and June 2008 with a primary prevention indication. The researchers defined implants used "off-label" as those in which the ejection fraction was greater than 35 percent, the New York Heart Association functional class was less than III, or the QRS interval duration was under 120 ms without any documented need for ventricular pacing.

The investigators found that 23.7 percent of implants were placed without meeting all three guideline criteria, most frequently because the New York Heart Association functional class was below III (13.1 percent of implants) or the QRS interval duration was under 120 ms (12.0 percent). Factors associated with increased odds of off-label use included the presence of atrial fibrillation or flutter, previous percutaneous coronary intervention, and electrophysiology study performance prior to implantation. However, diabetes mellitus, increasing age, and female gender were linked to a decreased odds of off-label use.

"Given the evolving evidence base supporting the use of CRT, these practices require careful scrutiny," the authors write.

One author disclosed financial ties to Medtronic, while another author disclosed ties to Boston Scientific.

Abstract
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