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|Study Shows CRT-D Devices with Medtronic AdaptivCRT(TM) Associated with Reduction of Costs of Atrial Fibrillation|
Study Supplements Earlier Data Showing Reduction in Hospital Readmissions for Heart Failure Patients with AdaptivCRT Technology
MINNEAPOLIS, USA and NICE, FRANCE - June 18, 2014 - New data from the Medtronic, Inc. (NYSE: MDT) Adaptive CRT trial show a 61 percent (p=0.01) lower risk of atrial fibrillation (AF)-related problems in patients who receive a cardiac resynchronization therapy-defibrillator (CRT-D) with the Medtronic-exclusive AdaptivCRT(TM) algorithm compared to conventional biventricular pacing therapy. Presented today at CARDIOSTIM / EHRA EUROPACE 2014, World Congress in Electrophysiology and Cardiac Techniques, the data also indicate a 55 percent relative reduction in healthcare utilizations (HCUs, including hospitalizations, emergency department or clinic visits) when patients have devices with AdaptivCRT.
Patients with heart failure, which is a progressive disease, are more likely than the general population to develop AF. AF is associated with worsening heart failure symptoms and higher mortality, along with patients' increased use of healthcare resources. Previous data from this trial showed patients with heart failure who received the AdaptivCRT technology were at a 46 percent lower risk of spending 48 consecutive hours or more in AF compared to conventional CRT patients1.
According to the analysis of 476 patients, potential use of healthcare resources because of AF are reduced with the AdaptivCRT technology; specific data was presented for the healthcare systems in the United States and Germany, which showed AF-related provider cost savings of $630 USD per patient and €130 over 24 months, respectively. Nearly all of these cost savings (92 percent in the U.S., 93 percent in Germany) were from a reduction in hospitalizations.
"The study results are clear in showing that CRT devices with adaptive algorithms reduce the risk of atrial fibrillation adverse events and related costs," said Prof. Dr. Med. Bernd Lemke, head of the Department of Cardiology at Lüdenscheid Hospital, Germany. "On an individual level, the algorithm's personalized therapy helps keep more patients out of the hospital. On a system-level, this results in savings and less use of healthcare resources."
Recent data presented at Heart Rhythm 2014 from the Adaptive CRT trial also showed that the AdaptivCRT feature reduced 30-day readmissions for heart failure by nearly half2, and 30-day readmissions for all-cause hospitalizations by more than 40 percent2, which are both noteworthy since readmissions within 30 days of discharge may result in reduced or no payment under many payment settings. Heart failure leads to more than 1 million hospitalizations in the United States yearly3, and U.S. patients are readmitted on average 1.23 times the first year after initial heart failure diagnosis4. As a consequence, heart failure is currently the fourth-leading cause of 30-day hospital readmissions5 and the leading cause of readmission of Medicare patients6. More than 60 percent of patients indicated for any type of CRT therapy do not receive it7.
Because of the favorable evidence showing reduction in AF incidence and all-cause hospitalizations among patients with the AdaptivCRT technology, Medtronic plans to conduct a global study of 3,000 patients to evaluate the superiority of CRT with AdaptivCRT therapy in reducing heart failure events and mortality, compared to conventional bi-ventricular pacing.
The AdaptivCRT feature, found on market-released Medtronic Viva® CRT-D and Viva® CRT-P devices, works by preserving normal heart rhythms and automatically adjusting to the patient's needs every minute, creating a customized therapy for each patient8. The research presented today builds on previous findings from the Adaptive CRT trial that showed the benefits of the AdaptivCRT algorithm, including:
"As today's healthcare environment evolves and more focus is placed on curbing readmission rates, hospital administrators and payers must increasingly focus on both the health benefits and quality of life of individual patients and the long-term cost savings of effective treatments," said Sheri Dodd, vice president of Clinical Research, Healthcare Economics and Policy for the Cardiac Rhythm Disease Management business at Medtronic. "Hospital administrators must increasingly look to new solutions for tackling heart failure and associated costs, and this is made easier with this data showing the benefit of implanting devices that have the adaptive algorithm."
About the Adaptive CRT Trial
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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1 Martin D, et al. Can Adaptive Cardiac Resynchronization Therapy Reduce Atrial Fibrillation Risk? Circulation. 2013;128(22S):A17740.