Author + information
- Received March 16, 2009
- Revision received May 4, 2009
- Accepted May 7, 2009
- Published online July 1, 2009.
- Peter C. Block, MD⁎,⁎ (, )
- Steven Burstein, MD†,
- Paul N. Casale, MD‡,
- Paul H. Kramer, MD§,
- Paul Teirstein, MD∥,
- David O. Williams, MD¶ and
- Mark Reisman, MD#
- ↵⁎Reprint requests and correspondence:
Dr. Peter C. Block, Emory University Hospital, 1364 Clifton Road Northeast, Suite F606, Atlanta, Georgia 30322
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.
This research was supported by ev3, Inc., Plymouth, Minnesota.
- Received March 16, 2009.
- Revision received May 4, 2009.
- Accepted May 7, 2009.
- American College of Cardiology Foundation