Thoracoscopic Pulmonary Vein Isolation and Atrial Appendage Ligation (TPVIAL) versus Medical Management in Atrial Fibrillation Patients with Prior Stroke (P1.126)

OBJECTIVE: We conducted a prospective, randomized, single-center pilot trial comparing therapeutic efficacy of thorascopic pulmonary vein isolation and atrial appendage ligation (TPVIAL) versus medical management; hypothesizing superiority of TPVIAL for secondary stroke prevention in patients with atrial fibrillation (AF). BACKGROUND: AF is the most common cardiac arrhythmia affecting over 2.5 million Americans and costing over 7 billion dollars annually. AF causes about 15% of ischemic strokes. AF patients with stroke have a 10% risk for recurrent stroke. DESIGN/METHODS: Between April 2011 and April 2013, twenty-three patients with a history of AF and prior stroke assessed as cardioembolic in origin were enrolled and randomized within one month after event to TPVIAL (n=12) vs. medical therapy (n=11). TPVIAL was performed with thoracoscopic bipolar radiofrequency energy clamp of the pulmonary hila and placement of a clip at the base of the atrial appendage. All outcome analyses were performed according to intention-to-treat and Fisher’s exact test was used to determine stroke rate between the two arms at 6 and 12 months. RESULTS: Demographics were similar between groups. TPVIAL was technically successful in eleven of twelve patients. All patients had 6-month follow-up and eight medical arm and nine surgical arm patients had 12-month follow-up. No TPVIAL patients had recurrent stroke. Two medically managed patients had recurrent ischemic stroke at 6 months (p=0.22) and 3 medically managed patients had recurrent stroke at 12 months (p=0.08) including one death from ischemic stroke. In the TPVIAL arm: five patients with paroxysmal AF had no recurrance at 6 months, of seven patients with persistent AF five were in NSR, one had recurrence, and one patient withdrew after randomization. Seven patients from the TPVIAL arm successfully discontinued warfarin with aspirin monotherapy for secondary stroke prevention. CONCLUSIONS: TPVIAL may become an important therapeutic tool for reducing recurrent stroke in AF patients. Disclosure: Dr. Waters has nothing to disclose. Dr. Hedna has nothing to disclose. Dr. Khanna has nothing to disclose. Dr. Miles has nothing to disclose. Dr. Price has nothing to disclose. Dr. Schmalfuss has nothing to disclose. Dr. Robertson has nothing to disclose. Dr. Karimi has nothing to disclose. Dr. Beaver has nothing to disclose.