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LEFT ATRIAL APPENDAGE OCCLUSION TO PREVENT STROKE IN SUB- OPTIMAL WARFARIN CANDIDATES: INTERIM RESULTS OF THE EUROPEAN MULTICENTER REGISTRY TRIAL Horst Sievert 1, Yves Bayard1; Heyder Omran2; Leif Thuesen,3; Maximilian Pichler4; Edward Rowland 5, Antonio Bartorelli6; Pedro Brugada7, P. W. Serruys 8; Werner Budts9; Angelo Ramondo10; Alec Vahanian11; Peter Probst12; Gilles Montalescot13; Jean-François Piéchaud14; Karl-Heinz Kuck15; Witold Ruzyllo 16, Jean Marco17, Thomas Wichter18, Eulogio Garcia19, Eustaquio Onorato20, Evelyn Fischer1, Michaela Leetz1, Stefan Ostermayer1, Franziska Büscheck1, Hildegard Lißmann-Jensen1, Klaus Lang1 1CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany, 2 St. Marien Krankenhaus Bonn, Bonn, Germany, 3 Skejby Sygehus, Aarhus, Denmar, 4 Landeskrankenhaus Salzburg, Salzburg, Austria, 5 St Georges Hospital, London, United Kingdom, 6 Centro Cardiologico S.p.A., Milan, Italy, 7 O.L. Vrouwziekenhuis, Aalst, Belgium, 8 Hartcentrum Rotterdam, Rotterdam, Netherlands, 9 UZ Gasthuisberg, Leuven, Belgium, 10Azienda Ospedaliera di Padova, Padova, Italy, 11Groupe Hospitalier Bichat, Paris, France, 12Allgemeines Krankenhaus Vienna, Vienna, Austria, 13Groupe Hospitalier Pitié- Salpêtrière, Paris, France, 14Institut Cardiovasculaire Paris Sud, Massy, France, 15Allgemeines, Krankenhaus St. Georg, Hamburg, Germany, 16Institute of Cardiology, Warsaw, Poland, 17 Clinique Pasteur, Toulouse, France, 18Universitätsklinikum Münster, Münster, Germany, 19Hospital General Universitario, Madrid, Spain, 20Humanitas Gavazzeni, Bergamo, Italy

Background: The PLAATO™ (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Feasibility Study finished in January 2003 proved the safety and feasibility of left atrial appendage occlusion by catheter techniue. The European PLAATO registry trial with a main focus on stroke risk reduction is still ongoing. Methods: 172 patients will be enrolled in the study. Inclusion criteria are atrial fibrillation (AF) with inability to take warfarin, prior cerebral ischemia and at least one clinical risk factor for stroke. Patients with an existing thrombus in the left atrial appendage or with significant carotid disease are excluded. After implantation of the occluder, the patients are followed with X-ray, TEE and NIH stroke scale after one, six, twelve and 24 months. The stroke risk reduction was calculated with the CHADS2 Score. Results: 110 patients (67% male) with a mean age of 70±9 years were implanted so far. Implantation of the PLAATO occluder was successful in all patients. The mean procedure time was 76± 36 minutes. In one a patient, the device size chosen did not meet the oversizing criteria of at least 20% and embolized into the aorta after its release. It was snared and removed without sequalae for the patient. Another device was successfully implanted in the same procedure. In three patients, a thrombus on the occluder was found prior to hospital discharge (2) and one month after the procedure (1). All thrombi were resolved without complications. During a follow up time of 67 implant years, one patient died of a bronchial carcinoma diagnosed 9 months after the procedure. One patient sustained a stroke six months after implantation. The incidence of stroke was 1.9%. According to the CHADS2 score, the mean expected annual risk of stroke for the patients enrolled was 4.2%. Therefore, the estimated risk reduction by PLAATO was 55%.Conclusion: Catheter closure of the left atrial appendage with the PLAATO device continues to be a safe procedure. In comparison to the CHADS2 study control group, the incidence of stroke in high risk patients unable to take warfarin seems to be reduced during short term follow-up.