Date of Award

January 2020

Document Type

Thesis

Degree Name

Master of Public Health (MPH)

Department

School of Public Health

First Advisor

Judith Lichtman

Second Advisor

Jeptha Curtis

Abstract

Background/Purpose: Left atrial appendage occlusion (LAAO) is a procedure recommended for individuals with non-valvular atrial fibrillation (NVAF) who have contraindications for long-term anticoagulation. The WATCHMAN is the only FDA approved LAAO device and has been commercially available since 2015. To date, there have been no studies evaluating sex-based differences in safety and outcomes of LAAO with the WATCHMAN device. In this study we sought to determine if there were differences in baseline characteristics, medical history, and periprocedural outcomes of WATCHMAN implantation between women and men.

Methods: Using data from the National Cardiovascular Disease Registry (NCDR) - Left Atrial Appendage Occlusion Registry, 32,473 patients who underwent WATCHMAN implantation were analyzed. We compared baselines characteristics, intra-procedural sedation and anticoagulation strategies, and differences in marginal residual leak between men and women using chi-squared and student t-tests. Our primary outcomes included myocardial infarction, heart failure (HF), air embolism, left atrial thrombus, pericardial effusion (PE), AV fistula, ischemic stroke, hemorrhagic stroke, undetermined stroke, all stroke, transient ischemic attack (TIA), device thrombus, device systemic embolization, device explant, device migration, and major bleeding that occurred between the start of the procedure and hospital discharge. The associations between sex and our primary study outcomes were determined using multivariate logistic regression.

Results: Indications for LAAO with the WATCHMAN device varied by gender. At baseline, women were more likely to be at increased fall risk while men more likely to have a history of coronary artery disease, congestive heart failure, cardiomyopathy, left ventricular (LV) dysfunction, sleep apnea, and atrial flutter. After adjusting for differences in pre-implant characteristics, women were at increased risk of heart failure (OR = 1.76, 95% CI = 1.08 – 2.86), pericardial effusion (OR = 1.64, 95% CI = 1.39 – 1.92), and major bleeding (OR = 2.41, 95% CI = 1.73 – 3.37). Women were also more likely to die during the procedure (p = 0.004).

Conclusions: Men and women who undergo implantation vary in terms of baselines characteristics, medical history, and AF classification. Overall, women tend to have worse periprocedural outcomes of LAAO with WATCHMAN compared to men. These results warrant further research on potential mechanisms of the observed sex disparities and should be considered in patient-centered decision-making processes.

Comments

This thesis is restricted to Yale network users only. It will be made publicly available on 05/27/2021

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