Data from ASSERT implantable device monitoring study published in New England Journal of Medicine


St Jude Medical announced the publication of results from the ASSERT cohort study in the New England Journal of Medicine (NEJM). The ASSERT (Asymptomatic atrial fibrillation and stroke evaluation in pacemaker patients and the atrial fibrillation reduction atrial pacing) trial, was designed to determine whether the detection of arrhythmias using pacemaker-based diagnostics predicts an increased risk of stroke in elderly, hypertensive patients without any history of atrial fibrillation.

The study results, previously presented at an American Heart Association Scientific Sessions meeting, found that pacemaker patients who have no history of atrial tachycardia or atrial fibrillation, but do have device-detected arrhythmias, are approximately 2.5 times more likely to have a stroke than patients who do not have device-detected arrhythmias. The trial was sponsored by St Jude Medical and was conducted by the Population Health Research Institute of McMaster University and Hamilton Health Sciences in Hamilton, Canada.

“Approximately 85% of atrial arrhythmias documented in the study were picked up only by the pacemaker, proving the device plays a very significant role in identifying patients with a higher risk of stroke,” said Jeff S Healey, principal investigator for the arrhythmias programme at the Population Health Research Institute. “This monitoring technology is a built-in diagnostic tool and a huge value-add to further assist physicians in properly treating their patients.”

The study included 2,580 pacemaker and ICD patients over the age of 65 with hypertension and no history of atrial fibrillation. Subclinical (non-symptomatic) atrial tachyarrhythmias detected by implanted devices occurred in over 10% of patients at three months. The risk of systemic embolism (or stroke) associated with non-symptomatic atrial tachyarrhythmias was 13%.