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on April 8, 2002

Circulation. 2002
Published online before print April 8, 2002, doi: 10.1161/01.CIR.0000015698.54752.6D
A more recent version of this article appeared on April 23, 2002
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Submitted on January 28, 2002
Revised on March 4, 2002
Accepted on March 4, 2002

Percutaneous Left Atrial Appendage Transcatheter Occlusion to Prevent Stroke in High-Risk Patients With Atrial Fibrillation. Early Clinical Experience

Horst Sievert MD*, Michael D. Lesh MD, Thomas Trepels , Heyder Omran MD, Antonio Bartorelli MD, Paola Della Bella MD, Toshiko Nakai MD, Mark Reisman MD, Carlo DiMario MD, Peter Block MD, Paul Kramer MD, Dirk Fleschenberg , Ulrike Krumsdorf , and Detlef Scherer MD

From the Cardiovascular Center Bethanien (H.S., T.T., D.F., U.K., D.S.), Frankfurt; Germany; University of California (M.D.L., T.N.), San Francisco; Appriva Medical (M.D., T.N.), Sunnyvale, Calif; the Department of Cardiology (H.O.), University Hospital Bonn, Bonn, Germany; Centro Cardiologico Monzino Istituto di Ricerca e Cura a Carattere Scientifico (A.B., P.D.B.), Milano, Italy; Swedish Medical Center (M.R.), Seattle, Wash; Hospital S Raffaele (C.D.), Milano, Italy; Emory University Hospital (P.B.), Atlanta, Ga; and St Luke's Hospital (P.K.), Kansas City, Mo.

* To whom correspondence should be addressed. E-mail: horst.sievert{at}dgn.de.

Background—Thromboembolism due to atrial fibrillation (AF) is a frequent cause of stroke. More than 90% of thrombi in AF form in the left atrial appendage (LAA). Obliteration of the appendage may prevent embolic complications.

Methods and Results—We evaluated the feasibility and safety of implanting a novel device for percutaneous left atrial appendage transcatheter occlusion (PLAATO). LAA occlusion using the PLAATO system was attempted in 15 patients with chronic AF at high risk for stroke, who are poor candidates for long-term warfarin therapy. The implant consists of a self-expanding nitinol cage covered with a polymeric membrane (ePTFE). The LAA was successfully occluded in 15/15 patients (100%). Angiography and transesophageal echocardiography (TEE) during the procedure showed that the device was well-seated in all patients and that there was no evidence of perforation, device embolization, or interference with surrounding structures. In 1 patient, the first procedure was complicated by a hemopericardium, which occurred during LAA access. A second attempt 30 days later was successful with no untoward sequela. No other complications occurred. At 1-month follow-up, chest fluoroscopy and TEE revealed continued stable implant position with smooth atrial-facing surface and no evidence of thrombus.

Conclusions—Thus, transcatheter closure of the LAA is feasible in humans. This novel implant technology may be appropriate for patients with AF who are not suitable candidates for anticoagulation therapy. Further trials are needed to show the long-term safety and its efficacy in reducing stroke.


Key words: atrial flutter • embolism • stroke • thrombus • atrium




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