title: Thoracoscopic Ablation With Appendage Ligation Versus Medical Therapy for Stroke Prevention: A Proof-of-Concept Randomized Trial.
abstract: OBJECTIVE
  Atrial fibrillation (AF) has a demonstrable effect on quality of life (QOL). Recurrent stroke occurs in 10% of patients with AF. The objective of this study was to demonstrate proof of concept that thoracoscopic pulmonary vein isolation and atrial appendage ligation (TPVIAL) could prevent recurrent stroke and could potentially improve QOL in patients with AF with a previous stroke.
  
  
  METHODS
  The study was a National Institutes of Health-funded single-center proof-of-concept design that randomized 23 patients with AF-related stroke to TPVIAL (n = 12) or to medical management (n = 11). Quality of life was the primary outcome variable; secondary end points included restoration of rhythm, recurrent stroke, and surgical morbidity.
  
  
  RESULTS
  Quality-of-life subscores at 3 and 6 months revealed improvements in energy and decreases in fatigue in the TPVIAL arm [baseline, 33 (19.8); 3 months, 49.5 (20.6), P = 0.01; 6 months, 55.5 (14.4), P = 0.03]. At 12-month follow-up, there were no recurrent strokes in the TPVIAL group. In the medically treated arm, two patients at 6 months (P = 0.22) and three total patients at 12 months (P = 0.09) had recurrent ischemic stroke. There was one death in the medical management arm. In the TPVIAL arm, no AF recurrence occurred in patients with paroxysmal AF, and one patient had recurrence of persistent and long-standing AF. Seven patients in the TPVIAL arm discontinued warfarin therapy for secondary stroke prevention.
  
  
  CONCLUSIONS
  This small proof-of-concept study showed that TPVIAL improved QOL on two subscores and restored normal sinus rhythm in all but one patient, and it showed the potential to prevent secondary stroke. A larger study will be needed.
authors.affiliation: From the *Division of Thoracic and Cardiovascular Surgery, †Department of Neurology, ‡Division of Cardiology, Department of Medicine, and §Department of Clinical and Health Psychology, University of Florida, Gainesville, FL USA; and ∥Department of Radiology, NF/SG Veterans Administration and University of Florida, Gainesville, FL USA.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Beaver
authors.forename: Vishnumurthy Shushrutha
authors.initials: VS
authors.lastname: Hedna
authors.forename: Anna Y
authors.initials: AY
authors.lastname: Khanna
authors.forename: William M
authors.initials: WM
authors.lastname: Miles
authors.forename: Catherine C
authors.initials: CC
authors.lastname: Price
authors.forename: Ilona M
authors.initials: IM
authors.lastname: Schmalfuss
authors.forename: Seyed Hossein
authors.initials: SH
authors.lastname: Aalaei-Andabili
authors.forename: Michael F
authors.initials: MF
authors.lastname: Waters
mesh_terms: D055011:Ablation Techniques / Q000379:methods*; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage*; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000628:therapy*; D000069604:Dabigatran / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery; D011788:Quality of Life; D020521:Stroke / Q000517:prevention & control*; D013906:Thoracoscopy; D016896:Treatment Outcome; D014859:Warfarin / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin; D000069604:Dabigatran