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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.

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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