Related Experiment Video
Updated: Dec 11, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Clinical Outcomes following Left Atrial Appendage Occlusion: A Single-Center Experience
Demilade Adedinsewo1, Najiyah Salwa2, Susie Sennhauser2
1Division of Cardiovascular Medicine, Mayo Clinic, Jacksonville, Florida, USA, Adedinsewo.Demilade@mayo.edu.
Insights
Watchman® device implantation for atrial fibrillation shows no difference in bleeding risk with antithrombotic choice. Smaller device sizes correlate with thromboembolic events, and peridevice leaks often persist.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Percutaneous left atrial appendage closure (LAAC) with the Watchman® device is an alternative to anticoagulation for stroke prevention in nonvalvular atrial fibrillation (NVAF).
- Current guidelines lack clarity on optimal antithrombotic therapy, anticoagulation cessation timing, and follow-up imaging post-Watchman® device deployment.
- Evaluating clinical outcomes after LAAC is crucial for refining patient management strategies.
Purpose of the Study:
- To assess clinical outcomes in patients who underwent Watchman® device implantation for NVAF.
- To investigate the impact of antithrombotic strategies on bleeding events.
- To determine the association between device size and thromboembolic risk, and to evaluate the natural history of peridevice leak (PDL).
Main Methods:
- Retrospective review of 231 patients who received a Watchman® device between January 2010 and December 2018.
- Cox-proportional hazard models were used to analyze the effect of variables on clinical outcomes.
- Analysis included bleeding events, thromboembolic events, and peridevice leak (PDL) progression.
Main Results:
- No significant difference in bleeding risk was observed based on the initial antithrombotic choice.
- Patients with a history of gastrointestinal bleeding had a higher risk of bleeding within 6 weeks post-implantation (HR 9.40).
- Smaller Watchman® device sizes (21 mm) were associated with an increased risk of thromboembolic events compared to larger sizes (24-27 mm) (HR 0.15).
- Peridevice leak (PDL) size generally remained stable or increased on follow-up imaging.
Conclusions:
- Initial antithrombotic choice does not significantly impact bleeding risk following Watchman® implantation.
- Smaller device sizes are linked to higher rates of thromboembolic events.
- Longitudinal assessment of PDL indicates that these leaks often do not resolve spontaneously.
- Larger prospective studies are warranted to confirm these findings and inform clinical practice.
Introduction:
Percutaneous left atrial appendage closure is an established alternative to anticoagulation therapy for stroke prophylaxis among patients with nonvalvular atrial fibrillation. There are currently no guidelines on the choice of antithrombotic therapy following placement of the Watchman® device, the optimal time to discontinue anticoagulation or the duration of follow-up imaging after device deployment. Our main objective was to evaluate clinical outcomes among these patients.
Methods:
We conducted a retrospective review of patients who received a Watchman® device at Mayo Clinic sites between January 2010 and December 2018. We constructed Cox-proportional hazard models to evaluate the effect of specific variables on clinical outcomes.
Results:
231 patients were identified (33% female), median age was 77 years, CHA2DS2-VASc score was 5 and HASBLED score was 4. We found no difference in clinically significant bleeding based on initial antithrombotic choice. However, patients with prior gastrointestinal bleeding were more likely to have a bleeding event in the first 6 weeks following Watchman® implantation (HR 9.40, 95% CI 2.15-41.09). Device sizes of 24-27 mm were significantly associated with a decreased risk of thromboembolic events (HR 0.15, 95% CI 0.04-0.55) compared to 21-mm devices. Peridevice leak (PDL) sizes appeared to either remain the same or increase on follow-up imaging.
Discussion/Conclusions:
This observational study showed no statistically significant difference in bleeding risk related to initial antithrombotic choice. Smaller device sizes were associated with thromboembolic events, and longitudinal PDL assessment using transesophageal echocardiography showed these frequently do not decrease in size. Larger studies are needed.
