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J Am Coll Cardiol, 2005; 46:9-14, doi:10.1016/j.jacc.2005.03.042
© 2005 by the American College of Cardiology Foundation
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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{dagger}, Paul H. Kramer, MD, FACC{ddagger}, Ray V. Matthews, MD, FACC§, William A. Gray, MD, FACC{dagger}, 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{dagger}{dagger}, Paul N. Casale, MD, FACC{ddagger}{ddagger}, 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{dagger}{dagger}{dagger}, Toshiko Nakai, MD{dagger}{dagger}{dagger}, Yves Bayard*, Kai Billinger, MD*, Thomas Trepels, MD*, Ulrike Krumsdorf, MD* and Horst Sievert, MD, FACC*,*

* CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany
{dagger} Swedish Cardiovascular Research Institute, Seattle, Washington
{ddagger} 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
{dagger}{dagger} Electrophysiology and Arrhythmology Unit, San Raffaele Hospital, Milan, Italy
{ddagger}{ddagger} 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
{dagger}{dagger}{dagger} 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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