title: Percutaneous left atrial appendage closure with an epicardial suture ligation approach: a prospective randomized pre-clinical feasibility study.
abstract: BACKGROUND
  Percutaneous approaches to left atrial appendage (LAA) closure are being developed for stroke prophylaxis in atrial fibrillation (AF) patients as an alternative to warfarin. A pericardial suture ligation approach has the advantage of ultimately leaving no permanent implant within the blood pool, but the potential disadvantage of inadequate placement, thereby not excluding the entire LAA from the circulation.
  
  
  OBJECTIVE
  This study sought to investigate the ability of a novel percutaneous pericardial snare and suture ligation device to achieve complete LAA exclusion.
  
  
  METHODS
  Ten animals underwent LAA exclusion with a pericardial snare and suture ligation in this prospective randomized feasibility study. Animals were randomized to concomitant use of a transseptally placed endoluminal balloon within the LAA to aid in proximal positioning and stabilization of the pericardial snare and suture. The level of LAA appendage exclusion was determined at necropsy.
  
  
  RESULTS
  Nine animals completed the study, 5 with and 4 without the use of the endoluminal LAA balloon. In all animals, LAA closure was complete without a leak. The level of LAA closure was at the base without a proximal residual LAA remnant in 5 of 5 (100%) animals when the endoluminal balloon was used, but in only 1 of 4 (25%) of animals when it was not used. No acute procedural complications occurred.
  
  
  CONCLUSIONS
  Percutaneous epicardial suture ligation of the LAA is feasible with this novel device. The concomitant use of an endoluminal balloon catheter placed in the LAA significantly increases the likelihood of excluding the entire LAA from the circulation.
authors.affiliation: Cardiac Arrhythmia Service, The Mount Sinai School of Medicine, New York, New York, USA.
authors.forename: Sheldon M
authors.initials: SM
authors.lastname: Singh
authors.forename: Srinivas R
authors.initials: SR
authors.lastname: Dukkipati
authors.forename: Andre
authors.initials: A
authors.lastname: d'Avila
authors.forename: Shephal K
authors.initials: SK
authors.lastname: Doshi
authors.forename: Vivek Y
authors.initials: VY
authors.lastname: Reddy
mesh_terms: D000818:Animals; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000150:complications / Q000601:surgery*; D004195:Disease Models, Animal; D005240:Feasibility Studies; D006325:Heart Atria / Q000601:surgery; D011446:Prospective Studies; D011897:Random Allocation; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013536:Suture Techniques; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control