Medtronic Device Registry First To Show How Implantable Heart Devices Work In Real-World

The first results from the Medtronic Inc., OMNI Study were released at Heart Rhythm 2009, the annual congress of the Heart Rhythm Society, revealing that one out of six patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillators (CRT-Ds) to prevent sudden cardiac arrest (SCA), received potentially life-saving medical therapy – either in the form of anti-tachycardia pacing (ATP) or a shock for dangerously fast heart rhythms – within a period of two years following their implant. Further, the study showed that patients received therapy at similar rates, regardless of whether they meet current medical society guidelines.

The OMNI Study is the first large-scale, longitudinal registry to follow nearly 3,000 real-world device patients. This analysis includes 1,620 patients who received devices for primary prevention of SCA, 993 of whom meet current guidelines, and 389 patients that do not. Patients among both groups received therapy at roughly the same rate. And among those who received therapy (n=172, guideline group; 69, non-guideline group):

– Sixty-six percent of patients among the guideline group, and 71 percent among the non-guideline group received ATP therapy
– Thirty-four percent of patients among the guideline group, and 29 percent among the non-guideline group received a shock

While OMNI researchers recognize that physicians may interpret the medical guidelines differently to drive individual treatment decisions for their patients, OMNI was not designed to assess why patients who meet or do not meet guidelines received devices from their doctors.

“We are pleased to be able to share the first wave of results from the five-year, post-market observational study, which provide a better sense of how Medtronic devices may save lives in real-world clinical settings,” said David Steinhaus, M.D., vice president and medical director of Cardiac Rhythm Disease Management at Medtronic.

“This study and these insights are a direct result of Medtronic’s commitment to scientific research and clinical outcomes, and specifically, who will benefit most from our therapies,” Dr. Steinhaus continued.

About the OMNI Study

– The purpose of OMNI is to determine how ICDs/CRTs and device-based diagnostics are used to treat and monitor life-threatening arrhythmias in real-world primary and secondary prevention patients.

– OMNI began in 2005, the same year in which Medtronic committed two million dollars to support a separate, federally-mandated registry of defibrillator patients that was developed to gather additional evidence to support Coverage with Evidence Development (CED) questions posed by Centers for Medicare and Medicaid Services (CMS) regarding a particular subgroup of patients. Additional analysis from OMNI addresses these questions, showing no significant difference between the rate at which CED and non-CED patients received therapy. Insights into which of these patients with a heart condition called non-ischemic dilated cardiomyopathy received device therapy were observed and warrant further analysis.

– OMNI is expected to be complete in 2012; Medtronic will release additional interim results upon availability.

Source: Medtronic

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