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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Antithrombotic Therapy After Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation
James V Freeman1, Angela Y Higgins2, Yongfei Wang1
1Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA; Center for Outcomes Research and Evaluation, Yale New Haven Health Services Corporation, New Haven, Connecticut, USA.
Insights
Most patients receiving the Watchman device for left atrial appendage occlusion (LAAO) did not follow trial protocols. Discharging on warfarin or direct oral anticoagulant alone, without aspirin, reduced adverse events.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Practice
Background:
- Pivotal trials for percutaneous left atrial appendage occlusion (LAAO) established specific postprocedure treatment protocols.
- Real-world adherence to these protocols after Watchman device implantation is not well-characterized.
Purpose of the Study:
- To evaluate postprocedure care patterns for Watchman device LAAO in clinical practice.
- To compare the risk of adverse events associated with different discharge antithrombotic strategies.
Main Methods:
- Analysis of 31,994 patients from the LAAO Registry (National Cardiovascular Data Registry) who underwent Watchman LAAO (2016-2018).
- Assessment of adherence to pivotal trial protocols, including follow-up, imaging, and antithrombotics.
- Comparison of adverse event rates at 45 days and 6 months using multivariable COX frailty regression for common antithrombotic strategies.
Main Results:
- Only 12.2% of patients received the full postprocedure trial protocol; deviations were common in discharge antithrombotic medications.
- Most frequent discharge strategies: warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin alone (13.5%), DOAC alone (12.3%).
- Discharge on warfarin alone or DOAC alone was associated with significantly lower adjusted risk of adverse events at 45 days compared to warfarin and aspirin. Warfarin alone maintained lower risk at 6 months.
Conclusions:
- Contemporary U.S. practice rarely adheres to full FDA-approved postprocedure protocols for Watchman LAAO.
- Discharging patients on warfarin or DOAC monotherapy, without aspirin, is linked to a reduced risk of adverse outcomes.
Background:
Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols.
Objectives:
This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies.
Methods:
We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression.
Results:
Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up.
Conclusions:
In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.
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