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. 2017 Jan 24;69(3):253-261.
doi: 10.1016/j.jacc.2016.10.010. Epub 2016 Nov 2.

Post-Approval U.S. Experience With Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

Vivek Y Reddy  1 , Douglas N Gibson  2 , Saibal Kar  3 , William O'Neill  4 , Shephal K Doshi  5 , Rodney P Horton  6 , Maurice Buchbinder  7 , Nicole T Gordon  8 , David R Holmes  9
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Free article

Post-Approval U.S. Experience With Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

Vivek Y Reddy et al. J Am Coll Cardiol. .
Free article

Abstract

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.

Keywords: Watchman; atrial fibrillation; complications; left atrial appendage closure; stroke.

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