title: Early safety and efficacy of percutaneous left atrial appendage suture ligation: results from the U.S. transcatheter LAA ligation consortium.
abstract: BACKGROUND
  Transcatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation.
  
  
  OBJECTIVE
  This study sought to assess the early safety and efficacy of transcatheter ligation of the LAA for stroke prevention in atrial fibrillation.
  
  
  METHODS
  This was a retrospective, multicenter study of consecutive patients undergoing LAA ligation with the Lariat device at 8 U.S. sites. The primary endpoint was procedural success, defined as device success (suture deployment and <5 mm leak by post-procedure transesophageal echocardiography), and no major complication at discharge (death, myocardial infarction, stroke, Bleeding Academic Research Consortium bleeding type 3 or greater, or cardiac surgery). Post-discharge management was per operator discretion.
  
  
  RESULTS
  A total of 154 patients were enrolled. Median CHADS2 score (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism [doubled]) was 3 (interquartile range: 2 to 4). Device success was 94%, and procedural success was 86%. A major complication occurred in 15 patients (9.7%). There were 14 major bleeds (9.1%), driven by the need for transfusion (4.5%). Significant pericardial effusion occurred in 16 patients (10.4%). Follow-up was available in 134 patients at a median of 112 days (interquartile range: 50 to 270 days): Death, myocardial infarction, or stroke occurred in 4 patients (2.9%). Among 63 patients with acute closure and transesophageal echocardiography follow-up, there were 3 thrombi (4.8%) and 13 (20%) with residual leak.
  
  
  CONCLUSIONS
  In this initial multicenter experience of LAA ligation with the Lariat device, the rate of acute closure was high, but procedural success was limited by bleeding. A prospective randomized trial is required to adequately define clinical efficacy, optimal post-procedure medical therapy, and the effect of operator experience on procedural safety.
authors.affiliation: Scripps Clinic, La Jolla, California. Electronic address: price.matthew@scrippshealth.org.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Price
authors.affiliation: Scripps Clinic, La Jolla, California.
authors.forename: Douglas N
authors.initials: DN
authors.lastname: Gibson
authors.affiliation: OhioHealth Research Foundation, Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Scripps Clinic, La Jolla, California.
authors.forename: Jason C
authors.initials: JC
authors.lastname: Schultz
authors.affiliation: St. David's Medical Center, Austin, Texas.
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Biase
authors.affiliation: St. David's Medical Center, Austin, Texas.
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.affiliation: St. David's Medical Center, Austin, Texas.
authors.forename: J David
authors.initials: JD
authors.lastname: Burkhardt
authors.affiliation: Banner Good Samaritan Medical Center, Phoenix, Arizona.
authors.forename: Ashish
authors.initials: A
authors.lastname: Pershad
authors.affiliation: Banner Good Samaritan Medical Center, Phoenix, Arizona.
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Byrne
authors.affiliation: Heart Rhythm Center, Santa Barbara, California.
authors.forename: Brett
authors.initials: B
authors.lastname: Gidney
authors.affiliation: Samsun Clinic, Santa Barbara, California.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Aragon
authors.affiliation: Prairie Heart, Springfield, Illinois.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Goldstein
authors.affiliation: Prairie Heart, Springfield, Illinois.
authors.forename: Kriegh
authors.initials: K
authors.lastname: Moulton
authors.affiliation: Northwestern University, Chicago, Illinois.
authors.forename: Taral
authors.initials: T
authors.lastname: Patel
authors.affiliation: Northwestern University, Chicago, Illinois.
authors.forename: Bradley
authors.initials: B
authors.lastname: Knight
authors.affiliation: Northwestern University, Chicago, Illinois.
authors.forename: Albert C
authors.initials: AC
authors.lastname: Lin
authors.affiliation: Houston Methodist Hospital, Houston, Texas.
authors.forename: Miguel
authors.initials: M
authors.lastname: Valderrábano
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000453:epidemiology* / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008026:Ligation; D008297:Male; D008875:Middle Aged; D012042:Registries; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: Lariat; atrial fibrillation; left atrial appendage; stroke
references.citation: J Am Coll Cardiol. 2011 Mar 15;57(11):e101-98
references.pmid: 21392637
references.citation: J Am Coll Cardiol. 2011 Jan 11;57(2):173-80
references.pmid: 21111555
references.citation: Catheter Cardiovasc Interv. 2015 Jul;86(1):121-7
references.pmid: 23765504
references.citation: Circulation. 2013 Feb 12;127(6):720-9
references.pmid: 23325525
references.citation: Catheter Cardiovasc Interv. 2014 Mar 1;83(4):664-9
references.pmid: 24214652
references.citation: Circulation. 2011 Feb 1;123(4):417-24
references.pmid: 21242484
references.citation: Heart Rhythm. 2014 Aug;11(8):1489
references.pmid: 24211315
references.citation: Chest. 2010 Feb;137(2):263-72
references.pmid: 19762550
references.citation: J Am Coll Cardiol. 2008 Sep 9;52(11):924-9
references.pmid: 18772063
references.citation: N Engl J Med. 2009 Sep 17;361(12):1139-51
references.pmid: 19717844
references.citation: Catheter Cardiovasc Interv. 2014 Mar 1;83(4):661-3
references.pmid: 24115231
references.citation: J Am Coll Cardiol. 2012 Mar 6;59(10):923-9
references.pmid: 22381428
references.citation: J Am Coll Cardiol. 2011 Jan 11;57(2):223-42
references.pmid: 21177058
references.citation: Heart Rhythm. 2014 Sep;11(9):1600-1
references.pmid: 24184785
references.citation: JACC Cardiovasc Interv. 2013 Jun;6(6):606-13
references.pmid: 23787233
references.citation: N Engl J Med. 2011 Mar 3;364(9):806-17
references.pmid: 21309657
references.citation: Heart Rhythm. 2013 Dec;10(12):1810-1
references.pmid: 23911428
references.citation: Ann Thorac Surg. 1996 Feb;61(2):755-9
references.pmid: 8572814
references.citation: Lancet. 2009 Aug 15;374(9689):534-42
references.pmid: 19683639
references.citation: N Engl J Med. 2011 Sep 15;365(11):981-92
references.pmid: 21870978
references.citation: Eur Heart J. 2012 Aug;33(16):1998
references.pmid: 22334585
references.citation: J Am Coll Cardiol. 2013 Jul 9;62(2):108-118
references.pmid: 23062528
references.citation: N Engl J Med. 2013 Nov 28;369(22):2093-104
references.pmid: 24251359
references.citation: N Engl J Med. 2011 Sep 8;365(10):883-91
references.pmid: 21830957
references.citation: J Thorac Cardiovasc Surg. 2011 Nov;142(5):1002-9, 1009.e1
references.pmid: 21906756
references.citation: Circulation. 2011 Jun 14;123(23):2736-47
references.pmid: 21670242