Abstract
BACKGROUND:
Left atrial appendage occlusion using a Watchman device has shown promise in reducing stroke risk in selected atrial fibrillation patients. Limited data exist on differences in characteristics and in-hospital outcomes of Watchman recipients in the United States based on race/ethnicity.
METHODS:
Data were extracted from the National Inpatient Sample database for calendar years 2015 to 2018. The study sample was stratified into 4 groups (White, Black, Hispanic, and other races). Baseline characteristics, procedural complications, and key in-hospital outcomes were then assessed. We also analyzed the independent association of race/ethnicity with key in-hospital outcomes including major complications, prolonged hospital stay, and increased hospitalization cost.
RESULTS:
A total of 34 960 Watchman recipients were included in the final analysis. Black and Hispanic patients had higher prevalence of heart failure, hypertension, obesity, and renal failure when compared with White patients. The crude rate of overall procedural complications was also higher in Blacks, Hispanics, and patients of other race when compared with White patients (15.2%, 12.4%, and 14.1% versus 9.9%; P<0.01). After multivariable adjustment, compared with White patients, Blacks, Hispanics, and patients of other race experienced a higher likelihood of a major complication from the procedure (adjusted odds ratio, 1.223 [95% CI, 0.986–1.517], 1.296 [95% CI, 1.075–1.561], and 1.924 [95% CI, 1.569–2.360], respectively) and prolonged length of stay >1 day (adjusted odds ratio, 1.631 [95% CI, 1.431–1.859], 1.239 [95% CI, 1.110–1.383], and 1.619 [95% CI, 1.403–1.869], respectively).
CONCLUSIONS:
Non-White patients undergoing Watchman implantation had higher prevalence of key comorbidities and also experienced increased Watchman-related adverse events including procedural complications and prolonged length of stay, even after adjustment for potential confounders. Further research is needed to identify etiologies behind differential outcomes among non-White patients after Watchman implantation.
Keywords: atrial fibrillation, comorbidity, continental population groups, obesity, prevalence
Graphical Abstract
Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice. With advancing age of the US population, its prevalence is projected to increase to >12 million by year 2030.1 AF is associated with increased risk of ischemic stroke, congestive heart failure (CHF), and mortality.2–4 Earlier studies have shown significant racial/ethnic differences with respect to AF-related outcomes. For example, the risk of ischemic stroke is higher among Black and Hispanic patients with AF on oral anticoagulation compared with White patients.5 Additionally, Black patients are 90% more likely to die during AF index hospitalization when compared with White patients.6 Similarly, such racial/ethnic disparities with respect to outcomes are also noted after certain cardiovascular invasive procedures such as percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery.7–9
Left atrial appendage occlusion using a Watchman device has emerged as a viable therapeutic modality in mitigating stroke risk in certain AF patients since its approval by the Food and Drug Administration in early 2015.10 To date, there are little data on how racial/ethnic demographics differ with respect to Watchman utilization in the United States. Additionally, little data exist regarding differential adverse events associated with Watchman implantation based on race/ethnicity. In this article, we sought to determine these parameters from a large, nationally representative sample of the US population.
METHODS
Data from the National Inpatient Sample (NIS) were used for the purpose of our current study. We analyzed the NIS database from years 2015 to 2018 for Watchman device implantations. 2015 was taken as a start year for our study since the Watchman device was approved by the Food and Drug Administration in March of 2015. The NIS is made possible by a Federal State Industry partnership sponsored by the Agency for Healthcare Research and Quality. The NIS is derived from nonfederal hospitals in all states and can be used for computing national estimates of health care utilization, costs, and outcomes.11 The NIS provides discharge weights that are used for estimation of disease and procedure trends nationally. Due to the deidentified nature of the NIS dataset, the need for informed consent and institutional review board approval is waived.
We stratified patients undergoing Watchman implantation using the International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification codes of 37.90 and 02L73DK, respectively. Patients <18 years of age were excluded. The study sample was further stratified on the basis of racial/ethnic subgroups (White, Black, Hispanics, and other races) based on previous cardiovascular studies on racial disparities.5,8 Baseline characteristics, key procedural complications, and in-hospital outcomes were compared in Watchman recipients based on race/ethnicity. For computing hospitalization costs, the cost-to-charge ratio files supplied by the Healthcare Cost and Utilization Project were applied to the total hospital charges and adjusted for inflation to December 2018. Independent associations of race/ethnicity with major complications (defined as composite of pericardial effusion requiring intervention, cardiac arrest, ischemic stroke/transient ischemic attack, hemorrhagic stroke, systemic embolism, myocardial infarction, major bleeding, and peripheral vascular complications that included arteriovenous fistula, pseudoaneurysm, access site hematoma, retroperitoneal bleeding, and venous thromboembolism), prolonged hospital stay (length of stay, >1 day), and increased hospitalization cost (median hospitalization cost, >$24 573) were analyzed. We also assessed AF admissions and number of Watchman implantations stratified on the basis of race/ethnicity over our study years.
Descriptive statistics are presented as frequencies with percentages for categorical variables and as median with interquartile range for continuous variables. Baseline characteristics were compared using a Pearson χ2 test and Fisher exact test for categorical variables and Mann-Whitney U test for continuous variables. For comparison of key procedural complications and in-hospital outcomes among different races/ethnicities, the Kruskal-Wallis H test was utilized. For assessment of independent association of race/ethnicity with key outcomes including major complications, length of stay >1 day, and median hospitalization cost >$24 573, a single-step multivariable logistic regression model was utilized. Age, sex, CHA2DS2-VASc score, median income, and 29 Elixhauser comorbidities (heart failure, valvular disease, pulmonary circulation disease, peripheral vascular disease, paralysis, neurological disorders, chronic pulmonary disease, diabetes without complications, diabetes with chronic complications, hypothyroidism, hypertension, renal failure, liver disease, peptic ulcer, AIDS, lymphoma, metastatic cancer, solid tumor without metastasis, collagen vascular disease, coagulopathy, obesity, weight loss, fluid and electrolyte disorders, chronic blood loss anemia, deficiency anemia, alcohol abuse, drug abuse, psychoses, and depression) were used for adjustment. A type I error rate of <0.05 was considered statistically significant. All statistical analyses were performed using SPSS, version 26 (IBM Corp), and R, version 3.6. Because of the complex survey design of NIS, sample weights, strata, and clusters were applied to the raw data to generate national estimates. Of note, the data that support the findings of this study are available from the corresponding author upon reasonable request.
RESULTS
A total of 34 960 patients underwent Watchman implantation from 2015 to 2018. Of these patients, 30 075 (86%) Watchman recipients were White, 1480 (4.2%) patients were Black, 2090 (5.9%) patients were Hispanics, and 1315 (3.7%) patients were of other races. Baseline characteristics of the study population stratified by race/ethnicity are shown in Table 1. Black patients who underwent Watchman implantation were younger compared with White and Hispanic patients (median age, 72 versus 77 and 77 years; P<0.01). Black women were more commonly implanted with the Watchman device compared with other races/ethnicities (40.8% women among Whites, 53.7% among Blacks, 43.5% among Hispanics, and 40.7% among other races). Black and Hispanic Watchman recipients had higher prevalence of key comorbidities when compared with White Watchman recipients, including CHF(48% and 34.9% versus 32.6%; P<0.01), hypertension (93.9% and 89.7% versus 85.1%, P<0.01), liver disease (3% and 4.8% versus 2.3%; P<0.01), obesity (22.6% and 17% versus 15.9%; P<0.01), and renal failure (43.2% and 23.4% versus 23%; P<0.01).
Table 1.
Baseline Characteristics of Watchman Recipients Stratified on the Basis of Race/Ethnicity
| Variable, n (%) | White (n=30 075) | Black (n=1480) | Hispanics (n=2090) | Other races (n=1315) | P value |
|---|---|---|---|---|---|
| Age, y; median (IQR) | 77 (72–82) | 72 (66–78) | 77 (70–82) | 75 (67–82) | |
| Women | 12 270 (40.8) | 795 (53.7) | 910 (43.5) | 535 (40.7) | <0.01 |
| Age, y | <0.01 | ||||
| <65 | 1865 (6.2) | 320 (21.6) | 275 (13.2) | 200 (15.2) | |
| 65–74 | 9630 (32.0) | 545 (36.8) | 595 (28.5) | 455 (34.6) | |
| ≥75 | 18 580 (61.8) | 615 (41.6) | 1220 (58.4) | 660 (50.2) | |
| CHA2DS2-VASc Score | <0.01 | ||||
| 0 | 100 (0.3) | 10 (0.7) | <11 (<0.5) | <11 (<0.8) | |
| 1 | 905 (3) | 45 (3) | 105 (5) | 70 (5.3) | |
| 2 | 4245 (14.1) | 245 (16.6) | 245 (11.7) | 245 (18.6) | |
| 3 | 9345 (31.1) | 395 (26.7) | 625 (29.9) | 390 (29.7) | |
| 4 | 9280 (30.9) | 465 (31.4) | 640 (30.6) | 310 (23.6) | |
| 5 | 4515 (15) | 190 (12.8) | 315 (15.1) | 205 (15.6) | |
| ≥6 | 1685 (5) | 130 (8.7) | 150 (7.1) | 85 (6.5) | |
| Median score | 4 (3–4) | 4 (3–4) | 4 (3–4) | 3 (2–4) | <0.01 |
| Comorbidities | |||||
| Deficiency anemia | 1035 (3.4) | 60 (4.1) | 45 (2.2) | 15 (1.1) | <0.01 |
| CHF | 9810 (32.6) | 710 (48.0) | 730 (34.9) | 420 (31.9) | <0.01 |
| Chronic pulmonary disease | 6575 (21.9) | 460 (31.1) | 420 (20.1) | 210 (16.0) | <0.01 |
| Coagulopathy | 1240 (4.1) | 90 (6.1) | 70 (3.3) | 45 (3.4) | <0.01 |
| Coronary artery disease | 14 840 (49.3) | 635 (42.9) | 1005 (48.1) | 590 (44.9) | <0.01 |
| Diabetes | 5620 (18.7) | 260 (17.6) | 515 (24.6) | 300 (22.8) | <0.01 |
| Hypertension | 25 595 (85.1) | 1390 (93.9) | 1875 (89.7) | 1120 (85.2) | <0.01 |
| Liver disease | 700 (2.3) | 45 (3.0) | 100 (4.8) | 55 (4.2) | <0.01 |
| Obesity | 4790 (15.9) | 335 (22.6) | 355 (17.0) | 130 (9.9) | <0.01 |
| Peripheral vascular disorders | 3120 (10.4) | 145 (9.8) | 145 (6.9) | 105 (8.0) | <0.01 |
| Renal failure | 6920 (23.0) | 640 (43.2) | 490 (23.4) | 310 (23.6) | <0.01 |
| Weight loss | 125 (0.4) | <11 (<0.3) | 20 (1.0) | <11 (<0.8) | 0.003 |
| Hospital location | <0.01 | ||||
| Rural | 595 (2.0) | 0 | 0 | 0 | |
| Urban nonteaching | 2700 (9.0) | 90 (6.1) | 185 (8.9) | 75 (5.7) | |
| Urban teaching | 26 780 (89.0) | 1390 (93.9) | 1905 (91.1) | 1240 (94.3) | |
| Bed size of the hospital | <0.01 | ||||
| Small | 3015 (10.0) | 115 (7.8) | 325 (15.6) | 175 (13.3) | |
| Medium | 6530 (21.7) | 320 (21.6) | 425 (20.3) | 265 (20.2) | |
| Large | 20 530 (68.3) | 1045 (70.6) | 1340 (64.1) | 875 (66.5) | |
| Census divisions | <0.01 | ||||
| New England | 935 (3.1) | 30 (2.0) | <11 (<0.5) | 15 (1.1) | |
| Mid-Atlantic | 4015 (13.3) | 205 (13.9) | 210 (10.0) | 200 (15.2) | |
| East North Central | 4580 (15.2) | 235 (15.9) | 110 (5.3) | 105 (8.0) | |
| West North Central | 2120 (7.0) | 65 (4.4) | 15 (0.7) | 30 (2.3) | |
| South Atlantic | 6605 (22.0) | 580 (39.2) | 185 (8.9) | 110 (8.4) | |
| East South Central | 1750 (5.8) | 90 (6.1) | <11 (<0.5) | <11 (<0.8) | |
| West South Central | 3165 (10.5) | 135 (9.1) | 715 (34.2) | 305 (23.2) | |
| Mountain | 2985 (9.9) | 60 (4.1) | 315 (15.1) | 80 (6.1) | |
| Pacific | 3920 (13.0) | 80 (5.4) | 525 (25.1) | 460 (35.0) | |
| Payee | <0.01 | ||||
| Medicare | 26 905 (89.7) | 1190 (80.4) | 1720 (82.3) | 1075 (81.7) | |
| Medicaid | 200 (0.7) | 75 (5.1) | 80 (3.8) | 50 (3.8) | |
| Private insurance | 2415 (8.0) | 155 (10.5) | 230 (11.0) | 150 (11.4) | |
| Self-pay | 145 (0.5) | <11 (<0.3) | 15 (0.7) | <11 (<0.8) | |
| Other | 20 (0.1) | <11 (<0.3) | <11 (<0.5) | <11 (<0.8) | |
| Median income | <0.01 | ||||
| 0–25 | 5570 (18.8) | 705 (48.0) | 600 (29.4) | 195 (15.0) | |
| 25–50 | 7810 (26.4) | 295 (20.1) | 480 (23.5) | 235 (18.1) | |
| 50–75 | 8375 (28.3) | 285 (19.4) | 570 (27.9) | 365 (28.1) | |
| 75–100 | 7880 (26.6) | 185 (12.6) | 390 (19.1) | 505 (38.8) | |
For n <11, the absolute numbers are not reported as per the Healthcare Cost and Utilization Project recommendations. CHF indicates congestive heart failure; and IQR, interquartile range.
Watchman procedure-related complications stratified by race/ethnicity are shown in Table 2. The overall prevalence of complications was higher in Blacks, Hispanics, and patients of other race when compared with White patients (15.2%, 12.4, and 14.1% versus 9.9%; P<0.01). The prevalence of major complications was also higher in Blacks, Hispanics, and patients of other race versus White patients (7.1%, 6.5%, and 8.7% versus 5%; P<0.01). Other key hospital outcomes after Watchman implantation stratified by race/ethnicity are shown in Table 3. The median length of stay was uniform across various races/ethnicities. The prevalence of nonhome discharges was higher among Blacks, Hispanics, and patients of other race compared with White patients after the implantation of the Watchman device (12.8%, 9.8%, and 9.5% versus 8.1%; P<0.01). Blacks and patients of other race also had higher costs of Watchman-related hospitalization when compared with White patients ($25 737 and $26 315 versus $24 542; P<0.01). There was a total of 70 (0.2%) in-hospital deaths in the cohort, all of which occurred in White patients. Blacks and patients of other race have a lower rate of Watchman implantations when stratified on the basis of AF admissions (Table I in the Data Supplement).
Table 2.
Watchman Procedure-Related Complications Stratified by Race/Ethnic Groups
| Variables, n (%) | White (n=30 075) | Black (n=1480) | Hispanics (n=2090) | Other races (n=1315) | P value |
|---|---|---|---|---|---|
| Overall complications | 2975 (9.9) | 225 (15.2) | 260 (12.4) | 185 (14.1) | <0.01 |
| Major complications* | 1495 (5) | 105 (7.1) | 135 (6.5) | 115 (8.7) | <0.01 |
| Any cardiovascular complication† | 1790 (6) | 105 (7) | 120 (5.6) | 90 (7) | 0.02 |
| Any systemic complication‡ | 55 (0.2) | 0 | 0 | 0 | 0.03 |
| Any peripheral vascular complication§ | 390 (1.3) | 40 (2.7) | 40 (1.8) | 20 (1.6) | <0.01 |
| Any neurological complication∥ | 260 (0.9) | <11 (<0.3) | <11 (<0.2) | <11 (<0.4) | 0.25 |
| Any bleeding complication¶ | 1245 (4.2) | 100 (6.8) | 135 (6.4) | 75 (5.7) | <0.01 |
| Any pulmonary complication# | 805 (2.6) | 50 (3.3) | 60 (2.8) | 25 (2) | <0.01 |
For n <11, the absolute numbers are not reported as per the Healthcare Cost and Utilization Project recommendations. PCI indicates percutaneous coronary intervention.
Defined as a composite of pericardial effusion requiring intervention, cardiac arrest, ischemic stroke/transient ischemic attack, hemorrhagic stroke, systemic embolism, myocardial infarction, major bleeding, and peripheral vascular complications (arteriovenous fistula, pseudoaneurysm, access site hematoma, retroperitoneal bleeding, and venous thromboembolism).
Any cardiovascular complication constitutes cardiac arrest, heart block, ST and non–ST-segment–elevation myocardial infarction, PCI, pericardial effusion requiring intervention, cardiac tamponade, pericarditis, and cardiogenic shock.
Any systemic complication constitutes anaphylaxis, arterial thrombosis, and septic shock.
Any peripheral vascular complication constitutes arteriovenous fistula, pseudoaneurysm, hematoma, retroperitoneal bleeding, and venous thromboembolism.
Any neurological complication constitutes transient ischemic attack, ischemic, and hemorrhagic stroke.
Any bleeding complication constitutes gastrointestinal bleeding and need for blood transfusion.
Any pulmonary complication constitutes respiratory failure, pneumothorax, pleural effusion, pneumonia, and prolonged ventilator support (>36 h).
Table 3.
Hospital Outcomes in Watchman Recipients Stratified by Race/Ethnic Groups
| Variables, n (%) | White (n=30 075) | Black (n=1480) | Hispanics (n=2090) | Other races (n=1315) | P value |
|---|---|---|---|---|---|
| Died at discharge | 70 (0.2) | 0 | 0 | 0 | 0.01 |
| Discharge disposition | <0.01 | ||||
| Home/routine/self-care | 27 625 (91.9) | 1290 (87.2) | 1885 (90.2) | 1190 (90.5) | |
| Nonhome discharges | 2425 (8.1) | 190 (12.8) | 205 (9.8) | 125 (9.5) | |
| Resource utilization, median (IQR) | <0.01 | ||||
| Length of stay, d | 1 (1–1) | 1 (1–2) | 1 (1–1) | 1 (1–1) | |
| Cost of hospitalization, $ | 24 542 (18 580–30 734) | 25 737 (19 257–30 244) | 24 270 (19 947–31 643) | 26 315 (20 247–31 678) | <0.01 |
For n <11, the absolute numbers are not reported as per the Healthcare Cost and Utilization Project recommendations. IQR indicates interquartile range.
Multivariable analyses adjusted for potential confounders were performed to assess the independent association of race/ethnicity with in-hospital adverse events (Figure). After multivariable adjusted analyses, Blacks, Hispanics, and patients of other race experienced a higher likelihood of a major complication from the procedure (adjusted odds ratio [OR], 1.223 [95% CI, 0.986–1.517], 1.296 [95% CI, 1.075–1.561], and 1.924 [95% CI, 1.569–2.360], respectively) and a prolonged length of stay >1 day (adjusted OR, 1.631 [95% CI, 1.431–1.859], 1.239 [95% CI, 1.110–1.383], and 1.619 [95% CI, 1.403–1.869], respectively) when compared with White patients. Similarly, Black patients and patients of other race experienced increased hospitalization costs (median cost, >$24 573) when compared with White patients after the Watchman implantation (adjusted OR, 1.206 [95% CI, 1.082–1.345] and 1.379 [95% CI, 1.231–1.545], respectively).
Figure. Unadjusted and adjusted association of race/ethnicity with outcomes including major complications (A), hospital length of stay >1 d (B), and median hospitalization cost >$24 573 (C).
OR indicates odds ratio.
DISCUSSION
In this large and nationally representative sample of patients with AF implanted with a Watchman device, we report several key findings. (1) White patients were the largest proportion of patients implanted with Watchman at 86% of all patients, and Black and Hispanic patients had higher burden of key cardiovascular comorbidities when compared with White patients. (2) The likelihood of overall and major procedural complications and a prolonged hospital stay was higher in Blacks, Hispanics, and patients of other race compared with White patients, including after multivariable adjustment for potential confounders. (3) Blacks, Hispanics, and patients of other race had higher prevalence of nonhome discharges after Watchman implantation when compared with White patients, with an increased cost of hospitalization in these racial/ethnic groups.
Earlier studies have shown disparate utilization and outcomes in patients of different races/ethnicities undergoing other invasive cardiovascular procedures such as PCI, implantable cardioverter-defibrillator (ICD) implantation, and transcatheter aortic valve replacement. Peterson et al evaluated data of >33 000 male veterans admitted after an episode of acute myocardial infarction. They found that Black male veterans were 33% less likely to undergo cardiac catheterization and 42% less likely to receive coronary angioplasty than White male veterans within 90 days of index hospitalization.12 In another study of >4000 veterans admitted with acute myocardial infarction, Maynard et al also showed lower utilization of PCI in Black patients as compared with White patients (32% versus 40%; P<0.0001).13 In a study of 769 502 hospitalizations for multivessel PCI, Desai et al7 showed a higher rate of cardiac complications and inpatient mortality among Black and Hispanic patients. Both Hispanic male (OR, 1.234 [95% CI, 1.150–1.325]) and female (OR, 1.224 [95% CI, 1.128–1.328]) patients had higher odds of mortality after multivessel PCI in their cohort. In a single-center study of >200 CHF patients eligible for primary prevention ICD implantation, Mezu et al14 showed that Black patients were 72% less likely to receive an ICD compared with White patients even after adjusting for potential confounding variables (OR, 0.28 [95% CI, 0.13–0.59]). Similarly, in another larger study from Get With The Guidelines-Heart Failure Program, Hess et al15 demonstrated that Black and Hispanic patients were less likely to receive counseling for primary prevention ICD implantation than White patients (OR, 0.69 [95% CI, 0.63–0.76] and 0.62 [95% CI, 0.55–0.70]). Even among patients who are counseled for ICD therapy, the implantation rate was lower among Black and Hispanic patients when compared with White patients (OR, 0.70 [95% CI, 0.56–0.88] and 0.68 [95% CI, 0.46–1.01], respectively). In a study of >70 000 transcatheter aortic valve replacement recipients from the Transcatheter Valve Therapy registry, Alkhouli et al16 showed that Black and Hispanic patients had frequent CHF hospitalizations compared with White patients during 1 year of post-transcatheter aortic valve replacement follow-up after adjustment for potential confounders (hazard ratio, 1.39 [95% CI, 1.16–1.67] and 1.37 [95% CI, 1.13–1.66]). More recently, Vincent et al17 analyzed 16 830 hospitalizations for Watchman implantations from 2015 to 2017 and found that the device was utilized in only 4.1% of Black patients. They also showed increased postprocedural complications of stroke, acute kidney injury, and significant bleeding in Black patients undergoing Watchman implantation as compared with White patients. Our more contemporary cohort of 34 960 Watchman implantations showed persistence of such disparities in non-White patients as of all patients implanted with the Watchman device, only 4.2% were Blacks, 5.9% were Hispanics, and 3.7% were patients of other race. Additionally, non-White Watchman recipients continued to experience increased postprocedural major complications and resource utilization when compared with White patients. These findings merit further confirmation from a large real-world registry setting such as the NCDR left atrial appendage occlusion registry with the goal of improving these racial/ethnic disparities.
Due to continued persistence of racial/ethnic differences in the delivery of invasive cardiovascular care, it is imperative to assess etiologies behind such disparate care so necessary steps can be taken for mitigating such differences. Several earlier studies have shown that such racial/ethnic disparities are likely related to patient, provider, and health care delivery institutional factors. For example, on the patient side, the increased prevalence of key comorbidities driving worse procedure-related outcomes may be one of the potential factors. In a study of 581 789 patients undergoing isolated coronary artery bypass graft procedure, Bridges et al9 analyzed operative mortality based on race/ethnicity. They found increased risk of operative mortality among Black patients especially in those with concomitant diabetes, hypertension, and CHF. In our cohort of AF patients undergoing Watchman implantation, the prevalence of these key comorbidities was higher among Black and Hispanic patients when compared with White patients thus perhaps contributing to worse outcomes after a Watchman left atrial appendage occlusion device implantation. Additionally, studies have shown that Black patients may be less informed about symptoms and treatment options for various cardiovascular disorders and thus may deny more advanced therapeutic strategies.18 On the provider side, these disparities may be due to unconscious attitudes or stereotypes directed toward specific racial/ethnic groups that affect their decision-making capacity in delivering health care therapies. Earlier studies have depicted prevalence of such unconscious behavior, commonly referred to as implicit bias among members of health care community. Green et al19 conducted a study on 287 internal and emergency medicine residents to assess implicit bias by utilizing implicit association test and further studied its impact on delivery of care for patients presenting with acute coronary syndrome. The implicit association test score revealed significant stereotyping of Black patients by the treating physicians depicting them less likely to be cooperative with the medical procedures. Moreover, there was increased utilization of thrombolytic therapy by physicians for White patients compared with Black patients due to implicit bias against Black patients. Similarly, another study involving about 2900 patients and 134 physicians showed that the greater the degree of implicit bias shown by physicians against their Black patients, the lower was the patient satisfaction rating regarding the care they received from the provider.20 On the health care delivery institution side, it is possible that minority patients are largely receiving care at hospitals that are not strongly adherent to established treatment guidelines, which are shown to greatly improve outcomes specifically for cardiovascular diseases. In a study of >100 000 patients presenting with ST-segment–elevation myocardial infarction from the National Registry of Myocardial Infarction, Bradley et al21 showed significantly longer door-to-drug and door-to-balloon times for Black and Hispanic patients and further depicted that delay in treatment in these specific patient groups was largely due to the hospital factors to which they presented. Unfortunately, granularity of our dataset is limited in assessing whether similar core etiologies were also responsible for disparate care among Watchman recipients but should be the focus of future research studies.
Strategies on reducing racial/ethnic disparities in cardiovascular care should focus on broad interventions that encompass patients, providers, and health care institutions. For example, diversifying health care force will improve compliance among minority patients, which will reduce the burden of comorbidities and also make them more receptive of advanced cardiovascular therapies.18 Studies have shown that physicians’ self-awareness of implicit bias results in similar clinical decision-making for White and non-White patients, which ultimately leads to improved outcomes in minority patients.22 Health care institutions should be encouraged to adhere to specific guidelines for management of various cardiovascular diseases, which will improve quality of care across all racial/ethnic groups.23 These measures can result in widespread dissemination of Watchman left atrial appendage occlusion device in patients belonging to minority communities. Widespread acceptance of Watchman device will also result in improved outcomes as Black AF patients are shown to have heightened stroke risk when compared with White patients and in some instances cannot be safely prescribed oral anticoagulation long term.5,24
Our study also showed increased prevalence of nonhome discharges and prolonged length of stay >1 day in Blacks, Hispanics, and patients of other race Watchman left atrial appendage occlusion recipients. This is likely related to increased prevalence of major Watchman-related procedural complications in these racial/ethnic groups, which often make it difficult to discharge patients early after the procedure and usually result in an institutional discharge such as to a nursing home for rehabilitation purposes.
Limitations
The results of our study should be interpreted in the context of following limitations, most of which are related to administrative nature of the NIS dataset. First, the NIS uses the International Classification of Diseases codes for identification of disease processes and comorbidities that may be subjected to error. The hard-clinical end points, however, are less prone to error and Agency for Healthcare Research and Quality quality control measures are routinely instituted that guarantees data integrity.11 Second, the NIS is a representative sample of the US population; however, ascertainment bias resulting in uneven sampling of racial groups cannot be ruled out with certainty. Nonetheless, our study is the first one to compare characteristics and outcomes of Watchman recipients between various racial/ethnic groups currently represented in the United States, when these groups are able to be identified. Third, the NIS collects information on hospital admissions only and censors data at discharge; therefore, long-term outcomes such as device-related thrombus and device leaks cannot be analyzed from this dataset. Fourth, the International Classification of Diseases, Ninth Revision, codes utilized in our study to identify Watchman implantations are not specific and can be used for any left atrial appendage occlusion (LAAO) device. However, due to the limited clinical application of other LAAO devices and Food and Drug Administration approval of only the Watchman device during the study period, we believe that this code was mostly able to characterize the Watchman implants in our study.
Conclusions
In this large and nationally representative sample of the US population, we demonstrated that significant differences exist in characteristics and outcomes of Watchman recipients based on race/ethnicity. Black and Hispanic patients undergoing Watchman implantation have a greater burden of comorbidities and worse clinical inpatient outcomes compared with White patients.
Supplementary Material
WHAT IS KNOWN?
Left atrial appendage occlusion using a Watchman device has witnessed an exponential increase in utilization since its approval by Food and Drug Administration in 2015.
Early studies have shown disparate utilization and outcomes in patients of racial/ethnic minorities with respect to delivery of invasive cardiovascular care.
WHAT THE STUDY ADDS?
In a nationwide contemporary cohort of Watchman implantations from years 2015 to 2018, the predominant recipients were Whites (86%) as only 4.2% Blacks, 5.9% Hispanics, and 3.7% patients of other race were implanted with this device.
Blacks, Hispanics, and patients of other race experienced a higher adjusted odds of major complications and prolonged length of stay after the Watchman implantation when compared with White patients.
Acknowledgments
Sources of Funding
None.
Disclosures
Dr Hsu reports receiving honoraria from Medtronic, Abbott, Boston Scientific, Biotronik, Janssen Pharmaceuticals, Pfizer, Bristol-Myers Squibb, Altathera Pharmaceuticals, Zoll Medical, and Biosense Webster; research grants from Biotronik and Biosense Webster; and has equity interest in Acutus Medical and Vektor Medical. The other authors report no conflicts.
Nonstandard Abbreviations and Acronyms
- AF
atrial fibrillation
- CHF
congestive heart failure
- ICD
implantable cardioverter-defibrillator
- LAAO
left atrial appendage occlusion
- NIS
National Inpatient Sample
- OR
odds ratio
- PCI
percutaneous coronary intervention
Footnotes
The Data Supplement is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCEP.120.009691.
Supplemental Materials
Contributor Information
Muhammad Zia Khan, Division of Cardiovascular Medicine, West Virginia University Heart and Vascular Institute, Morgantown.
Muhammad Bilal Munir, Section of Electrophysiology, Division of Cardiology, University of California San Diego, La Jolla.
Douglas Darden, Section of Electrophysiology, Division of Cardiology, University of California San Diego, La Jolla.
Deepak Kumar Pasupula, Division of Cardiology, MercyOne North Iowa Medical Center, Mason City.
Sudarshan Balla, Division of Cardiovascular Medicine, West Virginia University Heart and Vascular Institute, Morgantown.
Frederick T. Han, Section of Electrophysiology, Division of Cardiology, University of California San Diego, La Jolla.
Ryan Reeves, Section of Electrophysiology, Division of Cardiology, University of California San Diego, La Jolla.
Jonathan C. Hsu, Section of Electrophysiology, Division of Cardiology, University of California San Diego, La Jolla.
REFERENCES
- 1.Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013;112:1142–1147. doi: 10.1016/j.amjcard.2013.05.063 [DOI] [PubMed] [Google Scholar]
- 2.Meschia JF, Merrill P, Soliman EZ, Howard VJ, Barrett KM, Zakai NA, Kleindorfer D, Safford M, Howard G. Racial disparities in awareness and treatment of atrial fibrillation: the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study. Stroke. 2010;41:581–587. doi: 10.1161/STROKEAHA.109.573907 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D’Agostino RB, Massaro JM, Beiser A, Wolf PA, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110:1042–1046. doi: 10.1161/01.CIR.0000140263.20897.42 [DOI] [PubMed] [Google Scholar]
- 4.Wattigney WA, Mensah GA, Croft JB. Increased atrial fibrillation mortality: United States, 1980–1998. Am J Epidemiol. 2002;155:819–826. doi: 10.1093/aje/155.9.819 [DOI] [PubMed] [Google Scholar]
- 5.Shen AY, Yao JF, Brar SS, Jorgensen MB, Wang X, Chen W. Racial/Ethnic differences in ischemic stroke rates and the efficacy of warfarin among patients with atrial fibrillation. Stroke. 2008;39:2736–2743. doi: 10.1161/STROKEAHA.107.508580 [DOI] [PubMed] [Google Scholar]
- 6.Naderi S, Rodriguez F, Wang Y, Foody JM. Racial disparities in hospitalizations, procedural treatments and mortality of patients hospitalized with atrial fibrillation. Ethn Dis. 2014;24:144–149. [PubMed] [Google Scholar]
- 7.Desai R, Singh S, Fong HK, Goyal H, Gupta S, Zalavadia D, Doshi R, Savani S, Pancholy S, Sachdeva R, et al. Racial and sex disparities in resource utilization and outcomes of multi-vessel percutaneous coronary interventions (a 5-year nationwide evaluation in the United States). Cardiovasc Diagn Ther. 2019;9:18–29. doi: 10.21037/cdt.2018.09.02 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Becker ER, Rahimi A. Disparities in race/ethnicity and gender in in-hospital mortality rates for coronary artery bypass surgery patients. J Natl Med Assoc. 2006;98:1729–1739. [PMC free article] [PubMed] [Google Scholar]
- 9.Bridges CR, Edwards FH, Peterson ED, Coombs LP. The effect of race on coronary bypass operative mortality. J Am Coll Cardiol. 2000;36:1870–1876. doi: 10.1016/s0735-1097(00)00956-6 [DOI] [PubMed] [Google Scholar]
- 10.Holmes DR Jr, Alkhouli M, Reddy V. Left atrial appendage occlusion for the unmet clinical needs of stroke prevention in nonvalvular atrial fibrillation. Mayo Clin Proc. 2019;94:864–874. doi: 10.1016/j.mayocp.2018.09.025 [DOI] [PubMed] [Google Scholar]
- 11.Agency for Healthcare Research and Quality. Overview of the National Inpatient Sample (NIS). Rockville: AHRQ. Accessed January 15, 2021. https://www.hcup-us.ahrq.gov/nisoverview.jsp [Google Scholar]
- 12.Peterson ED, Wright SM, Daley J, Thibault GE. Racial variation in cardiac procedure use and survival following acute myocardial infarction in the Department of Veterans Affairs. JAMA. 1994;271:1175–1180. [PubMed] [Google Scholar]
- 13.Maynard C, Sun H, Lowy E, Sales AE, Fihn SD. The use of percutaneous coronary intervention in black and white veterans with acute myocardial infarction. BMC Health Serv Res. 2006;6:107. doi: 10.1186/1472-6963-6-107 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Mezu U, Ch I, Halder I, London B, Saba S. Women and minorities are less likely to receive an implantable cardioverter defibrillator for primary prevention of sudden cardiac death. Europace. 2012;14:341–344. doi: 10.1093/europace/eur360 [DOI] [PubMed] [Google Scholar]
- 15.Hess PL, Hernandez AF, Bhatt DL, Hellkamp AS, Yancy CW, Schwamm LH, Peterson ED, Schulte PJ, Fonarow GC, Al-Khatib SM. Sex and race/ethnicity differences in implantable cardioverter-defibrillator counseling and use among patients hospitalized with heart failure: findings from the get with the guidelines-heart failure program. Circulation. 2016;134:517–526. doi: 10.1161/CIRCULATIONAHA.115.021048 [DOI] [PubMed] [Google Scholar]
- 16.Alkhouli M, Holmes DR Jr, Carroll JD, Li Z, Inohara T, Kosinski AS, Szerlip M, Thourani VH, Mack MJ, Vemulapalli S. Racial disparities in the utilization and outcomes of TAVR: TVT Registry Report. JACC Cardiovasc Interv. 2019;12:936–948. doi: 10.1016/j.jcin.2019.03.007 [DOI] [PubMed] [Google Scholar]
- 17.Vincent L, Grant J, Ebner B, Potchileev I, Maning J, Olorunfemi O, Olarte N, Colombo R, de Marchena E. Racial disparities in the utilization and in-hospital outcomes of percutaneous left atrial appendage closure among patients with atrial fibrillation [published online February 12, 2021]. Heart Rhythm. doi: 10.1016/j.hrthm.2021.02.008. https://www.sciencedirect.com/science/article/pii/S1547527121001302?via%3Dihub. [DOI] [PubMed]
- 18.Capers Q, Sharalaya Z. Racial disparities in cardiovascular care: a review of culprits and potential solutions. J Racial Ethnic Health Disparities. 2014;1:171–180. [Google Scholar]
- 19.Green AR, Carney DR, Pallin DJ, Ngo LH, Raymond KL, Iezzoni LI, Banaji MR. Implicit bias among physicians and its prediction of thrombolysis decisions for black and white patients. J Gen Intern Med. 2007;22:1231–1238. doi: 10.1007/s11606-007-0258-5 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Blair IV, Steiner JF, Fairclough DL, Hanratty R, Price DW, Hirsh HK, Wright LA, Bronsert M, Karimkhani E, Magid DJ, et al. Clinicians’ implicit ethnic/racial bias and perceptions of care among Black and Latino patients. Ann Fam Med. 2013;11:43–52. doi: 10.1370/afm.1442 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Bradley EH, Herrin J, Wang Y, McNamara RL, Webster TR, Magid DJ, Blaney M, Peterson ED, Canto JG, Pollack CV Jr, et al. Racial and ethnic differences in time to acute reperfusion therapy for patients hospitalized with myocardial infarction. JAMA. 2004;292:1563–1572. doi: 10.1001/jama.292.13.1563 [DOI] [PubMed] [Google Scholar]
- 22.Devine PG, Forscher PS, Austin AJ, Cox WT. Long-term reduction in implicit race bias: a prejudice habit-breaking intervention. J Exp Soc Psychol. 2012;48:1267–1278. doi: 10.1016/j.jesp.2012.06.003 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, et al. ; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37:2893–2962. doi: 10.1093/eurheartj/ehw210 [DOI] [PubMed] [Google Scholar]
- 24.Kabra R, Girotra S, Vaughan Sarrazin M. Refining stroke prediction in atrial fibrillation patients by addition of African-American Ethnicity to CHA2DS2-VASc score. J Am Coll Cardiol. 2016;68:461–470. doi: 10.1016/j.jacc.2016.05.044 [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.