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RAJ CHAHAL 31/01/2012. ASSERT Healey et al NEJM 2012;366(2):120. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1105575. Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial (ASSERT).
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RAJ CHAHAL 31/01/2012 ASSERTHealey et alNEJM 2012;366(2):120 http://www.nejm.org/doi/pdf/10.1056/NEJMoa1105575
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial (ASSERT)
Assessment of subclinical AF on the risk of stroke and systemic embolism • Detected on PPM/ICD check at 3 month post-implant of St Jude Medical dual chamber or ICD • In hypertensives over 65 with no prev AF • Excluded – prev AF/Flutter >5 mins, or need for warfarin Inc/exc
Prospective study • 2004 to 2009 • 2580 patients enroled • 23 countries • Atrial tachy >190 as surrogate for AF • Episodes longer than 6 mins • Mean f/u 2.5 years for outcomes design
Primary outcome • Stroke or systemic embolisation • Secondary outcomes • Vascular death • MI • All cause stroke • Atrial tachy on surface ECG outcomes
Study population had similar demographics and risks of age / sex / BMI / prior CVA/TIA / HF / CHADS2 / Medication • Slight inc in subclinical AF group of DM / prior MI population
Subclinical AF in 261 (10.1%) • Inc risk of clinical AF with subclinical AF (5.56 HR) • 11/261 (4.2%) (1.69% /yr) had 1º outcome compared to 40/2319 (1.7%) (0.69% /yr) • Inc risk of 1º outcome in subclinical AF (2.49 HR) • HR of 2.41 even when clinical AF patients censored results
Insignificant trend of inc risk of 1º outcome with inc duration of AF episodes and incfreq of AF episodes (underpowered however) • No significance in 2º outcomes • Of the 51 total 1º outcomes 11 had subclinical AF (13%) results
population attributable risk of ischemic stroke or systemic embolism associated with subclinical atrial tachyarrhythmias before 3 months was 13%, • which is similar to the attributable risk of stroke associated with clinical atrial fibrillation reported by the Framingham investigators