Post-Approval U.S. Experience With Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation
Key result
In a real-world post-FDA approval cohort of 3,822 cases, left atrial appendage closure achieved a 95.6% successful implantation rate with low complication rates, including 1.02% pericardial tamponade.
Why the study?
LAAC causes upfront implantation complications, tempering enthusiasm as it moves beyond clinical trials into real-world practice, prompting evaluation of post-FDA approval procedural performance.
What are the acute procedural success and complication rates of left atrial appendage closure (LAAC) in real-world U.S. practice post-FDA approval?
Key Points
- This study aimed to evaluate the acute procedural performance and complication rates of left atrial appendage closure (LAAC) in the U.S. post-approval.
- Analyzed procedural data from 3,822 LAAC cases performed since FDA approval in March 2015.
- Data included periprocedural complications and procedural parameters collected with a standardized process.
- Involved 382 implantation physicians, with a significant portion being new, nonclinical trial implanters.
- Implantation was successful in 3,653 of 3,822 cases (95.6%) with a median procedure time of 50 minutes.
- Complication rates included 39 pericardial tamponades (1.02%), 3 procedure-related strokes (0.078%), and 9 device embolizations (0.24%).
- The study noted 3 procedure-related deaths (0.078%), indicating low overall complication rates despite many inexperienced operators.
Study Design
Type
Observational (n=3,822)
Multicenter
Yes
Structured PICO
What are the acute procedural success and complication rates of left atrial appendage closure (LAAC) in real-world U.S. practice post-FDA approval?
P
Population
3,822 consecutive patients with nonvalvular atrial fibrillation undergoing left atrial appendage closure (LAAC) in the United States since FDA approval.
I
Intervention
Left atrial appendage closure (LAAC)
O
Outcome
Acute procedural performance (implantation success) and periprocedural complication ratessafety
In real-world U.S. practice post-FDA approval, LAAC demonstrated high procedural success (95.6%) and low complication rates despite a large proportion of inexperienced operators.
Limitations
- Absence of a formal national clinical registry, relying on manufacturer clinical specialist forms for data collection.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“In terms of efficacy, LAA closure was non-inferior to anticoagulation when you combine those three endpoints of stroke, cardiovascular death and systemic embolism. And the p-value was statistically significant, being less than 0.01. From a safety standpoint, LAA closure was superior to anticoagulant therapy in terms of bleeding.”
“Our data suggest that the left atrial appendage closure device used in this trial is a potential and reasonable alternative to medication—even among patients who are suitable for long-term blood thinners—and may be discussed as part of a shared decision-making process.”
“The message for the clinician is clear: left atrial appendage closure failed to fulfill its theoretical promise to become an alternative treatment to best medical therapy — at least for older patients such as those enrolled in the trial. Best individualized medical therapy should remain standard treatment for older patients.”
Implication
Supports real-world LAAC safety post-approval; leaves open long-term outcome confirmation in randomized cohorts.
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.
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Cite This Study
Reddy et al. (2016) conducted an observational in Nonvalvular atrial fibrillation (n=3,822). Left atrial appendage closure (LAAC) was evaluated on Successful implantation. In a real-world post-FDA approval cohort of 3,822 cases, left atrial appendage closure achieved a 95.6% successful implantation rate with low complication rates, including 1.02% pericardial tamponade.