title: Safety and effectiveness of compassionate use of LARIAT® device for epicardial ligation of anatomically complex left atrial appendages.
abstract: BACKGROUND
  Percutaneous left atrial appendage (LAA) ligation using an epicardial suture system (LARIAT®, SentreHEART, Palo Alto, CA) has been used in patients with nonvalvular atrial fibrillation (AF) and contraindication to oral anticoagulation. However, complex LAA anatomy may preclude its use. We report the safety and effectiveness of compassionate use of first-generation LARIAT® device for epicardial ligation of large, complex left atrial appendages.
  
  
  METHODS
  Between January 2010 and March 2013, 93 patients with AF, high CHADS2 score, and contraindication(s) for oral anticoagulation therapy were evaluated for LAA ligation. Complex anatomy detected by 3D cardiac computed tomography CT angiography led to preclusion of 25 patients (27%). Of these, nine patients who opted for epicardial LAA ligation on compassionate grounds were studied.
  
  
  RESULTS
  Mean age was 68.1 ± 8.2 years, four females, all with large LAA width (>40 mm, 45-58 mm) and additional anatomic complexities such as bilobed (two), long C-shaped-like (two), goose neck-like (one), multilobed cauliflower-like (two), cactus-like (one), and chicken wing-like (one) LAA. LAA ligation with LARIAT® was successfully performed with surgical standby in all patients. Seven patients (78%) were safely treated percutaneously and only two patients required minimally invasive thoracotomy (one due to inability to release the epicardial snare from long C-shaped LAA and other due to preexisting adhesions precluding pericardial entry). There were no major complications. Repeat trans-esophageal echocardiography at 3 months showed no remnant flow and none had stroke off Coumadin at 19.3 ± 8.2 months of follow-up.
  
  
  CONCLUSIONS
  Despite a high preclusion rate, percutaneous LAA ligation may be safely and effectively performed on compassionate grounds using the first-generation LARIAT® device with surgical standby in patients with large and complex LAA.
authors.affiliation: Texas Heart Institute/Baylor CHI St. Luke Health System, 6770 Bertner Street, MC 2-255, Houston, TX, 77030, USA.
authors.forename: Mehul B
authors.initials: MB
authors.lastname: Patel
authors.forename: Abdi
authors.initials: A
authors.lastname: Rasekh
authors.forename: Mossaab
authors.initials: M
authors.lastname: Shuraih
authors.forename: Mihail G
authors.initials: MG
authors.lastname: Chelu
authors.forename: Tracy
authors.initials: T
authors.lastname: Bartlett
authors.forename: Nilesh
authors.initials: N
authors.lastname: Mathuria
authors.forename: Payam
authors.initials: P
authors.lastname: Naeini
authors.forename: James
authors.initials: J
authors.lastname: Strickland
authors.forename: Ali
authors.initials: A
authors.lastname: Massumi
authors.forename: Mehdi
authors.initials: M
authors.lastname: Razavi
authors.forename: Jie
authors.initials: J
authors.lastname: Cheng
mesh_terms: D000368:Aged; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000601:surgery*; D057176:Compassionate Use Trials / Q000295:instrumentation*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D005260:Female; D006329:Heart Conduction System / Q000601:surgery*; D006801:Humans; D008026:Ligation / Q000295:instrumentation; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation; D010496:Pericardium / Q000601:surgery*; D013536:Suture Techniques / Q000295:instrumentation*; D016896:Treatment Outcome