CRT-D cost-effective treatment for mildly symptomatic heart failure patients

Medtronic, Inc. (NYSE: MDT) today announced findings from an economic analysis of the landmark RAFT (Resynchronization / Defibrillation in Ambulatory Heart Failure Trial) trial demonstrating that cardiac resynchronization therapy with defibrillation (CRT-D) is a cost-effective treatment for mildly symptomatic heart failure patients. The findings showed a $33,025 (USD) cost per Quality Adjusted Life Year (QALY) gained using Medtronic CRT-Ds in a mild, New York Heart Association (NYHA)-designated Class II-III heart failure patient population, substantially lower than the benchmark for therapy cost effectiveness of other serious chronic conditions that cost at least $50,000 per QALY gained. QALY is a measure of the quantity and quality of life.

Presented today at Heart Rhythm 2012, the Heart Rhythm Society's 33rd Annual Scientific Sessions, the RAFT economic analysis is the only study to demonstrate cost-effectiveness in conjunction with the significant mortality benefit of CRT-D in mildly symptomatic heart failure patients. It complements the expansive body of clinical evidence for CRT-D illustrating the benefits of the Medtronic CRT-D portfolio of devices, as shown previously in the Medtronic-sponsored REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial.

In the RAFT economic analysis, patients who received CRT-D were estimated to gain more than one quality-adjusted life year (1.07) at an additional cost of $35,308 (USD) over a lifetime horizon, the typical time period commonly cited by health economists.

"The large-scale RAFT trial has provided us with a wealth of clinical insight into the overall benefits of CRT-D in treating mild heart failure, proving that this advanced therapy significantly decreases mortality and reduces heart failure hospitalization rates with an economic value to the healthcare system as a whole," said George Wells, Ph.D., University of Ottawa Heart Institute, Ottawa, Canada.

Approximately 6 million people in the United States suffer from heart failure, and the estimated cost for treating the life-threatening condition is almost $40 billion per year. In line with numerous clinical trials showing that CRT-D is a cost-effective treatment approach in treating moderate-to-severe disease, this new data confirms it is also associated with a cost-effectiveness benefit per QALY gained in mild heart failure patients.

Last month, the U.S. Food & Drug Administration (FDA) approval expanded the indication for Medtronic's CRT-D devices to treat NYHA Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than or equal to 130 milliseconds. The expanded indication fulfills a serious unmet need by enabling treatment with CRT-D in indicated patients in the earlier stages of heart failure, before their symptoms start impacting their quality of life.

"The recent FDA approval expanding the indication of our CRT-D devices - coupled with this strong economic data - showcases our commitment to treating heart failure and enhancing patient outcomes at every stage of care with our innovative portfolio of CRT-D therapies," said David Steinhaus, M.D., Vice President and General Manager, Heart Failure, and Medical Director for the Cardiac Rhythm Disease Management business, Medtronic. "With the rising cost of healthcare significantly impacting our global economy, it is critically important to provide high-value, safe, effective therapies like CRT-D, that provide significant improvements at cost thresholds deemed acceptable to health care decision makers, as this analysis demonstrated."