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
Matchar

David Bruce Matchar

Professor of Medicine

My research relates to clinical practice improvement - from the development of clinical policies to their implementation in real world clinical settings. Most recently my major content focus has been cerebrovascular disease. Other major clinical areas in which I work include the range of disabling neurological conditions, cardiovascular disease, and cancer prevention.
Notable features of my work are: (1) reliance on analytic strategies such as meta-analysis, simulation, decision analysis and cost-effectiveness analysis; (2) a balancing of methodological rigor the needs of medical professionals; and (3) dependence on interdisciplinary groups of experts.
This approach is best illustrated by the Stroke Prevention Patient Outcome Research Team (PORT), for which I served as principal investigator. Funded by the AHCPR, the PORT involved 35 investigators at 13 institutions. The Stroke PORT has been highly productive and has led to a stroke prevention project funded as a public/private partnership by the AHCPR and DuPont Pharma, the Managing Anticoagulation Services Trial (MAST). MAST is a practice improvement trial in 6 managed care organizations, focussing on optimizing anticoagulation for individuals with atrial fibrillation.
I serve as consultant in the general area of analytic strategies for clinical policy development, as well as for specific projects related to stroke (e.g., acute stroke treatment, management of atrial fibrillation, and use of carotid endarterectomy.) I have worked with AHCPR (now AHRQ), ACP, AHA, AAN, Robert Wood Johnson Foundation, NSA, WHO, and several pharmaceutical companies.
Key Words: clinical policy, disease management, stroke, decision analysis, clinical guidelines

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.

Patel

Manesh Raman Patel

Richard Sean Stack, M.D. Distinguished Professor

Manesh Patel is the Chief of the Division of Cardiology and the Division of Clinical Pharmacology.  His clinical interests include diagnostic and interventional coronary angiography, peripheral angiography and endovascular intervention.  His is involved in several clinical trials involving patients with cardiovascular disease and in cardiac imaging.  He is also the Chair of the American College of Cardiology Task Force for Appropriate Use Criteria for Cardiovascular Procedures and is Chair of the American Heart Association Diagnostic and Interventional Cath Committee.

Patel's interest in cardiac imaging, quality of care, cardiac devices is also evident in his research.  His integration of these efforts into his roles at Duke was recognized in 2010 when he received the prestigious Duke Cardiology Fellowship Mentor Award.   In 2011, Dr. Patel was named the endowed John Bush Simpson Assistant Professor of Cardiology.  In 2013, Dr. Patel received the Robert M. Califf Faculty clinical research Award.

Currently, Dr. Patel is leading an effort to redesign the delivery of care to patients undergoing invasive catheterization procedures in the health system with a specific aim of measure and providing individualized, patient centered, innovative, and efficient care.

Piccini

Jonathan Paul Piccini

Professor of Medicine

Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS is a clinical cardiac electrophysiologist and Professor of Medicine at Duke University Medical Center and the Duke Clinical Research Institute. He is the Director of the Cardiac Electrophysiology section at the Duke Heart Center. His focus is on the care of patients with atrial fibrillation and complex arrhythmias, with particular emphasis on catheter ablation and lead extraction. His research interests include the development and evaluation of innovative cardiovascular interventions for the treatment heart rhythm disorders. He has served as the chairman for several national and international clinical trials and registries, including the American Heart Association-Get with the Guidelines Atrial Fibrillation program. He is an Associate Editor at JACC: Clinical Electrophysiology and is an elected member of the American Society for Clinical Investigation. Dr. Piccini has more than 550 publications in the field of heart rhythm medicine and has been the recipient of several teaching and mentorship awards.


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