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Percutaneous Left Atrial Appendage Occlusion for Patients in Atrial Fibrillation Suboptimal for Warfarin Therapy

5-Year Results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Study

Peter C. Block, MD^_*,_*, Steven Burstein, MD, Paul N. Casale, MD, Paul H. Kramer, MD, Paul Teirstein, MD^||, David O. Williams, MD^¶, Mark Reisman, MD^#

^_* Emory University, Atlanta, Georgia
Los Angeles Cardiology Associates, Los Angeles, California
The Heart Group, Lancaster, Pennsylvania
Shawnee Mission Medical Center, Shawnee, Kansas
^|| Scripps Memorial Hospital, San Diego, California
^¶ The Rhode Island Hospital, Providence, Rhode Island
^# Swedish Medical Center, Seattle, Washington

^_* Reprint requests and correspondence: Dr. Peter C. Block, Emory University Hospital, 1364 Clifton Road Northeast, Suite F606, Atlanta, Georgia 30322 (Email: pblock{at}emory.edu).

Objectives: The aim of this study was to determine 5-year clinical status for patients treated with percutaneous left atrial appendage transcatheter occlusion with the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) system.

Background: Anticoagulation reduces thromboembolism among patients with nonvalvular atrial fibrillation (AF). However, warfarin is a challenging medication due to risks of inadequate anticoagulation and bleeding. Thus, PLAATO was evaluated as a treatment strategy for nonwarfarin candidate patients with AF at high risk for stroke.

Methods: Sixty-four patients with permanent or paroxysmal AF participated in this observational, multicenter prospective study. Primary end points were: new major or minor stroke, cardiac or neurological death, myocardial infarction, or requirement for cardiovascular surgery related to the procedure within 1 month of the index procedure. Patients were followed for up to 5 years.

Results: Thirty-day freedom from major adverse events rate was 98.4% (95% confidence interval: 90.89% to >99.99%). One patient, who did not receive a PLAATO implant, experienced 2 events within 30 days (cardiovascular surgery, death). Treatment success was 100% 1 month after device implantation. At 5-year follow-up, there were 7 deaths, 5 major strokes, 3 minor strokes, 1 cardiac tamponade requiring surgery, 1 probable cerebral hemorrhage/death, and 1 myocardial infarction. Only 1 event (cardiac tamponade) was adjudicated as related to the implant procedure. After up to 5 years of follow-up, the annualized stroke/transient ischemic attack (TIA) rate was 3.8%. The anticipated stroke/TIA rate (with the CHADS₂ scoring method) was 6.6%/year.

Conclusions: The PLAATO system is safe and effective. At 5-year follow-up the annualized stroke/TIA rate in our patients was 3.8%/year, less than predicted by the CHADS₂ scoring system.

Key Words: atrial fibrillation • left atrial appendage • PLAATO • stroke • transcatheter

Abbreviations and Acronyms   AF = atrial fibrillation   INR = international normalized ratio   LAA = left atrial appendage   MAE = major adverse event   NIHSS = National Institutes of Health Stroke Scale   SAE = serious adverse event   TEE = transesophageal echocardiography   TIA = transient ischemic attack

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