Post-Approval U.S. Experience With Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation.
Reddy VY, Gibson DN, Kar S, O'Neill W, Doshi SK, Horton RP, Buchbinder M, Gordon NT, Holmes DR. Post-FDA Approval, Initial US clinical experience with watchman left atrial appendage closure for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2017 ;69(3):253-261.
Journal of the American College of Cardiology
BACKGROUND: Left atrial appendage closure (LAAC) was approved by the U.S. Food and Drug Administration (FDA) as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation. However, clinical decision-making is confounded by the fact that although LAAC attenuates the anticoagulant-related lifetime risk of bleeding, implantation is associated with upfront complications. Thus, enthusiasm for LAAC as a treatment option has been appropriately tempered, particularly as the therapy is introduced beyond the clinical trial sites into general clinical practice.
OBJECTIVES: This study evaluated the acute procedural performance and complication rates for all cases performed in the United States since FDA approval.
METHODS: In the absence of a formal national clinical registry since regulatory approval in March 2015, we obtained procedural data on implantation procedures. Every LAAC procedure requires the presence of a manufacturer clinical specialist and for procedural parameter and periprocedural complication data to be collected using a standardized process and forms.
RESULTS: In 3,822 consecutive cases, implantation was successful in 3,653 (95.6%), with a median procedure time of 50 min (range 10 to 210 min). Implanting physicians performing these procedures (n = 382) included 71% new, nonclinical trial implanters, who performed 50% of the procedures. Procedural complication rates included 39 pericardial tamponades (1.02%) (24 treated percutaneously, 12 surgically, and 3 fatal); 3 procedure-related strokes (0.078%); 9 device embolizations (0.24%) (6 requiring surgical removal); and 3 procedure-related deaths (0.078%).
CONCLUSIONS: Despite a large fraction of previously inexperienced operators, in the real-world post-FDA approval experience of LAAC, procedural success was high and complication rates were low.
Medical Subject Headings
Atrial Appendage; Atrial Fibrillation; Equipment and Supplies; Humans; Postoperative Complications; Stroke; Treatment Outcome; United States