Left Atrial Appendage Occlusion Versus Oral Anticoagulation in Atrial Fibrillation : A Decision Analysis.

Abstract

Background

Left atrial appendage occlusion (LAAO) is a potential alternative to oral anticoagulants in selected patients with atrial fibrillation (AF). Compared with anticoagulants, LAAO decreases major bleeding risk, but there is uncertainty regarding the risk for ischemic stroke compared with anticoagulation.

Objective

To determine the optimal strategy for stroke prevention conditional on a patient's individual risks for ischemic stroke and bleeding.

Design

Decision analysis with a Markov model.

Data sources

Evidence from the published literature informed model inputs.

Target population

Women and men with nonvalvular AF and without prior stroke.

Time horizon

Lifetime.

Perspective

Clinical.

Intervention

LAAO versus warfarin or direct oral anticoagulants (DOACs).

Outcome measures

The primary end point was clinical benefit measured in quality-adjusted life-years.

Results of base-case analysis

The baseline risks for stroke and bleeding determined whether LAAO was preferred over anticoagulants in patients with AF. The combined risks favored LAAO for higher bleeding risk, but that benefit became less certain at higher stroke risks. For example, at a HAS-BLED score of 5, LAAO was favored in more than 80% of model simulations for CHA2DS2-VASc scores between 2 and 5. The probability of LAAO benefit in QALYs (>80%) at lower bleeding risks (HAS-BLED score of 0 to 1) was limited to patients with lower stroke risks (CHA2DS2-VASc score of 2). Because DOACs carry lower bleeding risks than warfarin, the net benefit of LAAO is less certain than that of DOACs.

Results of sensitivity analysis

Results were consistent using the ORBIT bleeding score instead of the HAS-BLED score, as well as alternative sources for LAAO clinical effectiveness data.

Limitation

Clinical effectiveness data were drawn primarily from studies on the Watchman device.

Conclusion

Although LAAO could be an alternative to anticoagulants for stroke prevention in patients with AF and high bleeding risk, the overall benefit from LAAO depends on the combination of stroke and bleeding risks in individual patients. These results suggest the need for a sufficiently low stroke risk for LAAO to be beneficial. The authors believe that these results could improve shared decision making when selecting patients for LAAO.

Primary funding source

None.

Department

Description

Provenance

Subjects

Citation

Published Version (Please cite this version)

10.7326/m21-4653

Publication Info

Chew, Derek S, Ke Zhou, Sean D Pokorney, David B Matchar, Sreekanth Vemulapalli, Larry A Allen, Kevin P Jackson, Zainab Samad, et al. (2022). Left Atrial Appendage Occlusion Versus Oral Anticoagulation in Atrial Fibrillation : A Decision Analysis. Annals of internal medicine, 175(9). pp. 1230–1239. 10.7326/m21-4653 Retrieved from https://hdl.handle.net/10161/26014.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Pokorney

Sean Pokorney

Assistant Professor of Medicine
Vemulapalli

Sreekanth Vemulapalli

Associate Professor of Medicine
Jackson

Kevin Patrick Jackson

Associate Professor of Medicine

Research interests include:
- optimization of device timing for Cardiac Resynchronzation Therapy (CRT)
- novel cardiac imaging technologies for CRT
- catheter ablation versus anti-arrhythmic drug for treatment of atrial fibrillation.

Samad

Zainab Samad

Adjunct Associate Professor in the Department of Medicine

Dr. Zainab Samad is chairwoman of the Department of Medicine at Aga Khan University (AKU) in Pakistan and currently serves as an Adjunct Associate Professor of Medicine at Duke University. 

She attended Medical School at the Aga Khan University Medical College in Karachi, Pakistan and thereafter completed her residency training in Internal Medicine and fellowship in Cardiology at Duke University Medical Center in Durham, North Carolina. Additionally, she completed advanced training in cardiovascular imaging, specifically in clinical echocardiography, cardiac MRI and SPECT-myocardial perfusion imaging. She is also trained in quantitative methods with a Master of Health Sciences in Clinical Research degree from the National Institutes of Health- Duke Clinical Research Training Program. She served on faculty in the Division of Cardiology, Department of Medicine for nine years before accepting the position at AKU in 2018. She resides full-time in Karachi.


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