Author + information
- Received March 1, 2012
- Revision received May 25, 2012
- Accepted June 12, 2012
- Published online July 9, 2013.
- Krzysztof Bartus, MD, PhD⁎,
- Frederick T. Han, MD†,
- Jacek Bednarek, MD, PhD‡,
- Jacek Myc, MD, PhD⁎,
- Boguslaw Kapelak, MD, PhD⁎,
- Jerzy Sadowski, MD, PhD⁎,
- Jacek Lelakowski, MD, PhD‡,
- Stanislaw Bartus, MD, PhD⁎,
- Steven J. Yakubov, MD§ and
- Randall J. Lee, MD, PhD†∥,¶,⁎ ()
- ⁎Department of Cardiovascular Surgery and Transplantology, Jagiellonian University, John Paul II Hospital in Krakow, Krakow, Poland
- †Department of Medicine, University of California San Francisco, San Francisco, California
- ‡Department of Electrocardiology, Jagiellonian University, John Paul II Hospital in Krakow, Krakow, Poland
- §Riverside Methodist Hospital, Columbus, Ohio
- ∥Cardiovascular Research Institute, University of California San Francisco, San Francisco, California
- ¶Institute for Regeneration Medicine, University of California San Francisco, San Francisco, California
- ↵⁎Reprint requests and correspondence:
Dr. Randall J. Lee, University of California–San Francisco, Box 1354, San Francisco, California 94143
Objectives The purpose of the study was to determine the efficacy and safety of left atrial appendage (LAA) closure via a percutaneous LAA ligation approach.
Background Embolic stroke is the most devastating consequence of atrial fibrillation. Exclusion of the LAA is believed to decrease the risk of embolic stroke.
Methods Eighty-nine patients with atrial fibrillation were enrolled to undergo percutaneous ligation of the LAA with the LARIAT device. The catheter-based LARIAT device consists of a snare with a pre-tied suture that is guided epicardially over the LAA. LAA closure was confirmed with transesophageal echocardiography (TEE) and contrast fluoroscopy immediately, then with TEE at 1 day, 30 days, 90 days, and 1 year post-LAA ligation.
Results Eighty-five (96%) of 89 patients underwent successful LAA ligation. Eighty-one of 85 patients had complete closure immediately. Three of 85 patients had a ≤2-mm residual LAA leak by TEE color Doppler evaluation. One of 85 patients had a ≤3-mm jet by TEE. There were no complications due to the device. There were 3 access-related complications (during pericardial access, n = 2; and transseptal catheterization, n = 1). Adverse events included severe pericarditis post-operatively (n = 2), late pericardial effusion (n = 1), unexplained sudden death (n = 2), and late strokes thought to be non-embolic (n = 2). At 1 month (81 of 85) and 3 months (77 of 81) post-ligation, 95% of the patients had complete LAA closure by TEE. Of the patients undergoing 1-year TEE (n = 65), there was 98% complete LAA closure, including the patients with previous leaks.
Conclusions LAA closure with the LARIAT device can be performed effectively with acceptably low access complications and periprocedural adverse events in this observational study.
Drs. Yakubov and Lee are consultants to SentreHEART, Inc., with equity in the company. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Bartus and Han contributed equally to the preparation of the manuscript.
- Received March 1, 2012.
- Revision received May 25, 2012.
- Accepted June 12, 2012.
- 2012 American College of Cardiology Foundation