CLINICAL RESEARCH: CLINICAL TRIAL
Percutaneous Left Atrial Appendage Transcatheter Occlusion (PLAATO System) to Prevent Stroke in High-Risk Patients With Non-Rheumatic Atrial Fibrillation
Results From the International Multi-Center Feasibility Trials
Stefan H. Ostermayer, MD*,
Mark Reisman, MD, FACC ,
Paul H. Kramer, MD, FACC ,
Ray V. Matthews, MD, FACC ,
William A. Gray, MD, FACC,
Peter C. Block, MD, FACC||,
Heyder Omran, MD¶,
Antonio L. Bartorelli, MD, FACC#,
Paolo Della Bella, MD#,
Carlo Di Mario, MD, FACC**,
Carlo Pappone, MD,
Paul N. Casale, MD, FACC,
Jeffrey W. Moses, MD, FACC,
Athena Poppas, MD, FACC||||,
David O. Williams, MD, FACC||||,
Bernhard Meier, MD, FACC¶¶,
Allan Skanes, MD##,
Paul S. Teirstein, MD, FACC***,
Michael D. Lesh, MD,
Toshiko Nakai, MD,
Yves Bayard*,
Kai Billinger, MD*,
Thomas Trepels, MD*,
Ulrike Krumsdorf, MD* and
Horst Sievert, MD, FACC*,*
* CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany
Swedish Cardiovascular Research Institute, Seattle, Washington
Shawnee Mission Medical Center, Shawnee Mission, Kansas
Good Samaritan Hospital, Los Angeles, California
|| Emory University Hospital, Atlanta, Georgia
¶ Sankt Marien Hospital, Academic Center of the University of Bonn, Bonn, Germany
# Centro Cardiologico Monzino Istituto di Ricerca e Cura a Carattere Scientifico, Milan, Italy
** Royal Brompton Hospital and Imperial College, London, United Kingdom
Electrophysiology and Arrhythmology Unit, San Raffaele Hospital, Milan, Italy
Lancaster General Hospital, Lancaster, Pennsylvania
Columbia University, New York, New York
|||| Rhode Island Hospital, Providence, Rhode Island
¶¶ Swiss Cardiovascular Center Bern, University Hospital, Bern, Switzerland
## London Health Sciences Center, London, Ontario, Canada
*** Scripps Clinic Medical Group, La Jolla, California
University of California, San Francisco, California
Manuscript received October 5, 2004;
revised manuscript received March 11, 2005,
accepted March 15, 2005.
* Reprint requests and correspondence: Dr. Horst Sievert, CardioVascular Center Frankfurt, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany (Email: horstsievertmd{at}aol.com).
OBJECTIVES: These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota).
BACKGROUND: Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients.
METHODS: Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 ± 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month.
RESULTS: Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation.
CONCLUSIONS: Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.
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Abbreviations and Acronyms
| | AF = atrial fibrillation | | CI = confidence interval | | LAA = left atrial appendage | | LVEF = left ventricular ejection fraction | | MAE = major adverse event | | SAE = serious adverse event | | TEE = transesophageal echocardiogram | | TIA = transient ischemic attack |
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