Racial and Ethnic Disparities in the Use and Outcomes With WATCHMAN FLX: A SURPASS Analysis of the NCDR Left Atrial Appendage Occlusion Registry
Key result
Black patients undergoing left atrial appendage occlusion had a significantly higher adjusted risk of 1-year mortality (HR 1.26) and major bleeding (HR 1.36) compared with White patients.
Figures
Why the study?
Left atrial appendage occlusion is increasingly used for stroke prevention in select patients with atrial fibrillation, but data on outcomes in racial and ethnic minority individuals are limited.
Are there racial and ethnic disparities in the use and outcomes of WATCHMAN FLX left atrial appendage occlusion in patients with atrial fibrillation?
Key Points
- This analysis aims to evaluate the differences in the use and outcomes of left atrial appendage occlusion based on race and ethnicity.
- Retrospective analysis of the NCDR LAAO registry data through September 2022
- Included all patients with attempted WATCHMAN FLX implantation and known race and ethnicity
- Compared baseline characteristics and 1-year event rates among racial and ethnic groups
- A total of 97,185 patients analyzed; 90% White, 3.9% Black, 2.9% Hispanic
- Black and Hispanic patients had higher incidence of prior stroke and significant bleeding compared to White patients
- Black patients experienced higher 1-year death and bleeding rates compared to White and Hispanic patients
Study Design
Type
Observational (n=97,185)
Multicenter
Yes
Structured PICO
Are there racial and ethnic disparities in the use and outcomes of WATCHMAN FLX left atrial appendage occlusion in patients with atrial fibrillation?
P
Population
97,185 patients with nonvalvular atrial fibrillation who underwent WATCHMAN FLX implantation across 772 US sites, followed for 1 year to evaluate racial and ethnic disparities in clinical outcomes.
E
Exposure
Left atrial appendage occlusion (LAAO) with WATCHMAN FLX
C
Comparator
Comparison across racial and ethnic groups (White, Black, Hispanic)
O
Outcome
Procedural success and 1-year event rates (death and bleeding)hard clinical
Main Result
Hazard Ratio: 1.26 (95% CI 1.06–1.5)
Absolute Event Rate: 11.2% vs 8%
Racial and ethnic minority patients are disproportionately underrepresented in LAAO procedures, and while procedural success is similar, Black patients experience higher 1-year mortality and bleeding rates.
Limitations
- Unmeasured or residual confounders
- Race and ethnicity are social constructs defined by the subject
- Canceled procedures are not included in the data
- Hospital location or region are not known
- Patient zip code and insurance status were not available
- Dialysis status is unknown
- No control group to determine if disparities are inherent to differences in efficacy versus baseline risk
- Limited to 1 year follow-up
- Relies on site-reported data
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“patients treated in routine clinical practice are achieving [comparable] short-term outcomes as those observed in the pivotal PINNACLE FLX approval study”
MAMohamad AlkhouliInterventional cardiologist, Mayo Clinic Rochester
“These safety data are great and tell us how much engineering refinements and technology improvement have lowered the complication rate. But they still don't address the fact that we only have three randomized trials done several years ago, and of modest size, addressing the efficacy of the approach.”
“Among patients undergoing left atrial appendage occlusion (LAAO), rates of procedural success were similar across racial and ethnic groups, but Black patients had higher rates of death and bleeding at one year... Black and Hispanic patients who underwent the procedure were younger and had significantly higher comorbidities when compared with White patients. They also made up a disproportionately small fraction of all patients who undergo LAAO relative to their proportion of the U.S. population.”
Implication
Similar procedural success across groups supports equitable delivery; leaves open disparities in LAAO access and utilization among minorities.
Abstract
BACKGROUND: Left atrial appendage occlusion (LAAO) is increasingly used as an alternative to oral anticoagulation for stroke prevention in select patients with atrial fibrillation. Data on outcomes in racial and ethnic minority individuals are limited. This analysis assessed differences in the use and outcomes of LAAO by race and ethnicity in a large national registry. METHODS AND RESULTS: This analysis acquired data on patients who underwent WATCHMAN FLX implantation from the retrospective NCDR (National Cardiovascular Data Registry) LAAO registry through September 2022. All patients with an attempted WATCHMAN FLX implantation and known race and ethnicity were included. Baseline characteristics and 1-year event rates were compared. A total of 97 185 patients were analyzed; 87 339 were White individuals (90%), 3750 Black individuals (3.9%), and 2866 Hispanic individuals (Hispanic/Latinx), 2.9%). Black and Hispanic patients were younger, with a higher incidence of prior stroke and significant bleeding compared with White patients. Black and Hispanic patients were treated with LAAO in smaller numbers relative to their proportion of the US population. Rates of procedural success were similar between groups. Though direct oral anticoagulants were prescribed in most patients across the groups, dual and single antiplatelet therapy were prescribed more often in Black patients. Black patients had significantly higher rates of 1-year death and bleeding compared with White and Hispanic patients. CONCLUSIONS: Patients from racial and ethnic minority groups comprise a disproportionately small fraction of all patients who undergo LAAO. Black and Hispanic patients were younger but had significantly higher comorbidities compared with White patients. Procedural success was similar among the groups, but Black patients experienced higher rates of death and bleeding at 1 year.
Discussion
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Cite This Study
Alli et al. (2024) conducted an observational in Nonvalvular atrial fibrillation (n=97,185). Black race vs. White race was evaluated on 1-year all-cause death (HR 1.26, 95% CI 1.06-1.50). Black patients undergoing left atrial appendage occlusion had a significantly higher adjusted risk of 1-year mortality (HR 1.26) and major bleeding (HR 1.36) compared with White patients.