Long-term Medtronic device registry shows how implantable devices work in clinical practice


The first results from the Medtronic OMNI study were released on 14 May at Heart Rhythm 2009, the annual congress of the Heart Rhythm Society, in Boston, USA, revealing that one out of six patients with implantable cardioverter-defibrillator or cardiac resynchronization therapy-defibrillators to prevent sudden cardiac arrest, received potentially lifesaving medical therapy – either in the form of antitachycardia pacing 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 sudden cardiac arrest, 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; n=69, nonguideline group):

  • 66% of patients among the guideline group, and 71% among the nonguideline group received antitachycardia pacing therapy;
  • 34% of patients among the guideline group, and 29% among the nonguideline group received a shock.

While OMNI researchers recognise 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.

OMNI is expected to be complete in 2012.