Early safety and efficacy of percutaneous left atrial appendage suture ligation

Results from the U.S. Transcatheter LAA ligation consortium

Matthew J. Price, Douglas N. Gibson, Steven J. Yakubov, Jason C. Schultz, Luigi Di Biase, Andrea Natale, J. David Burkhardt, Ashish Pershad, Timothy J. Byrne, Brett Gidney, Joseph R. Aragon, Jeffrey Goldstein, Kriegh Moulton, Taral Patel, Bradley Knight, Albert C. Lin, Miguel Valderrábano

Research output: Contribution to journalArticle

125 Citations (Scopus)

Abstract

Background Transcatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation. Objectives 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 CHADS 2 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.

Original languageEnglish (US)
Pages (from-to)565-572
Number of pages8
JournalJournal of the American College of Cardiology
Volume64
Issue number6
DOIs
StatePublished - Aug 12 2014
Externally publishedYes

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Atrial Appendage
Sutures
Ligation
Safety
Stroke
Equipment and Supplies
Transesophageal Echocardiography
Hemorrhage
Atrial Fibrillation
Myocardial Infarction
Pericardial Effusion
Thromboembolism
Transient Ischemic Attack
Thoracic Surgery
Multicenter Studies
Diabetes Mellitus
Thrombosis
Heart Failure
Retrospective Studies
Hypertension

Keywords

  • atrial fibrillation
  • Lariat
  • left atrial appendage
  • stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Early safety and efficacy of percutaneous left atrial appendage suture ligation : Results from the U.S. Transcatheter LAA ligation consortium. / Price, Matthew J.; Gibson, Douglas N.; Yakubov, Steven J.; Schultz, Jason C.; Di Biase, Luigi; Natale, Andrea; Burkhardt, J. David; Pershad, Ashish; Byrne, Timothy J.; Gidney, Brett; Aragon, Joseph R.; Goldstein, Jeffrey; Moulton, Kriegh; Patel, Taral; Knight, Bradley; Lin, Albert C.; Valderrábano, Miguel.

In: Journal of the American College of Cardiology, Vol. 64, No. 6, 12.08.2014, p. 565-572.

Research output: Contribution to journalArticle

Price, MJ, Gibson, DN, Yakubov, SJ, Schultz, JC, Di Biase, L, Natale, A, Burkhardt, JD, Pershad, A, Byrne, TJ, Gidney, B, Aragon, JR, Goldstein, J, Moulton, K, Patel, T, Knight, B, Lin, AC & Valderrábano, M 2014, 'Early safety and efficacy of percutaneous left atrial appendage suture ligation: Results from the U.S. Transcatheter LAA ligation consortium', Journal of the American College of Cardiology, vol. 64, no. 6, pp. 565-572. https://doi.org/10.1016/j.jacc.2014.03.057
Price, Matthew J. ; Gibson, Douglas N. ; Yakubov, Steven J. ; Schultz, Jason C. ; Di Biase, Luigi ; Natale, Andrea ; Burkhardt, J. David ; Pershad, Ashish ; Byrne, Timothy J. ; Gidney, Brett ; Aragon, Joseph R. ; Goldstein, Jeffrey ; Moulton, Kriegh ; Patel, Taral ; Knight, Bradley ; Lin, Albert C. ; Valderrábano, Miguel. / Early safety and efficacy of percutaneous left atrial appendage suture ligation : Results from the U.S. Transcatheter LAA ligation consortium. In: Journal of the American College of Cardiology. 2014 ; Vol. 64, No. 6. pp. 565-572.
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abstract = "Background Transcatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation. Objectives 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 CHADS 2 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.",
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T2 - Results from the U.S. Transcatheter LAA ligation consortium

AU - Price, Matthew J.

AU - Gibson, Douglas N.

AU - Yakubov, Steven J.

AU - Schultz, Jason C.

AU - Di Biase, Luigi

AU - Natale, Andrea

AU - Burkhardt, J. David

AU - Pershad, Ashish

AU - Byrne, Timothy J.

AU - Gidney, Brett

AU - Aragon, Joseph R.

AU - Goldstein, Jeffrey

AU - Moulton, Kriegh

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N2 - Background Transcatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation. Objectives 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 CHADS 2 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.

AB - Background Transcatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation. Objectives 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 CHADS 2 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.

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