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Updated: Mar 12, 2026
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Post-Approval U.S. Experience With Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation
Vivek Y Reddy1, Douglas N Gibson2, Saibal Kar3
1Icahn School of Medicine at Mount Sinai, New York, New York.
Insights
Left atrial appendage closure (LAAC) offers stroke prevention for atrial fibrillation patients. Real-world data show high success and low complication rates, even with new operators, post-FDA approval.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Left atrial appendage closure (LAAC) is an FDA-approved stroke prevention alternative for nonvalvular atrial fibrillation.
- LAAC balances reduced bleeding risk against upfront procedural complications.
- Real-world adoption of LAAC is expanding beyond clinical trials.
Purpose of the Study:
- To evaluate the acute procedural performance of LAAC in the United States.
- To assess complication rates for all LAAC cases post-FDA approval.
Main Methods:
- Utilized procedural data from all US LAAC implantations since FDA approval (March 2015).
- Collected data via standardized forms with manufacturer specialist presence for each procedure.
- Included 3,822 consecutive cases performed by 382 physicians, including many new operators.
Main Results:
- High implantation success rate of 95.6% (3,653/3,822 cases).
- Median procedure time was 50 minutes.
- Low complication rates: 1.02% pericardial tamponade, 0.078% stroke, 0.24% device embolization, and 0.078% procedure-related death.
Conclusions:
- LAAC demonstrates high procedural success in real-world practice.
- Complication rates remain low despite a significant proportion of inexperienced operators.
- LAAC is a safe and effective stroke prevention strategy in post-market surveillance.
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.
