Heart Rhythm
Volume 7, Issue 3 , Pages 370-376, March 2010

Percutaneous left atrial appendage closure with an epicardial suture ligation approach: A prospective randomized pre-clinical feasibility study

  • Sheldon M. Singh, MD

      Affiliations

    • Cardiac Arrhythmia Service, The Mount Sinai School of Medicine, New York, New York
  • ,
  • Srinivas R. Dukkipati, MD

      Affiliations

    • Cardiac Arrhythmia Service, The Mount Sinai School of Medicine, New York, New York
  • ,
  • Andre d'Avila, MD, PhD

      Affiliations

    • Cardiac Arrhythmia Service, The Mount Sinai School of Medicine, New York, New York
  • ,
  • Shephal K. Doshi, MD

      Affiliations

    • St. Johns Health Center and Pacific Heart Institute, Santa Monica, California
  • ,
  • Vivek Y. Reddy, MD

      Affiliations

    • Cardiac Arrhythmia Service, The Mount Sinai School of Medicine, New York, New York
    • Corresponding Author InformationAddress reprint requests and correspondence: Dr. Vivek Y. Reddy, Mount Sinai School of Medicine, Zena and Michael A. Weiner Cardiovascular Institute, One Gustave L. Levy Place, Box 1030, New York, New York 10029

Received 31 October 2009; accepted 9 November 2009. published online 16 November 2009.

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.

Conclusion

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.

Keywords: Atrial fibrillation, Left atrial appendage, Thromboembolism, Epicardial, Suture ligation

Abbreviations: AF, atrial fibrillation, ICE, intracardiac echocardiography, LA, left atrium, LAA, left atrial appendage, RA, right atrium

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 Dr. Reddy received grant support from SentreHeart that directly supported this experimental animal study. Dr. D'Avila has received a research grant from SentreHeart. Dr. Doshi has received a consulting grant from SentreHeart. Drs. Reddy and Doshi were Principal Investigators in PROTECT-AF - a clinical trial that studied another left atrial appendage closure device (Watchman, Atritech, Inc).

PII: S1547-5271(09)01272-7

doi:10.1016/j.hrthm.2009.11.010

Heart Rhythm
Volume 7, Issue 3 , Pages 370-376, March 2010