Medtronic device registry shows how implantable heart devices work
in clinical practice
28 May 2009
The first results from the Medtronic Inc., (NYSE: MDT) OMNI Study
were released today 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):
- 66% of patients among the guideline group, and 71 percent among
the non-guideline group received ATP therapy; and
- 34% 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.
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