Percutaneous left atrial appendage occlusion and risk of stroke, hospitalized bleeding and death in Medicare beneficiaries.

PURPOSE: Among patients with atrial fibrillation (AF), a nonpharmacologic option (e.g., percutaneous left atrial appendage occlusion [LAAO]) is needed for patients with oral anticoagulant (OAC) contraindications. Among beneficiaries in the Medicare fee-for-service coverage 20% sample databases (2015-18) who had AF and an elevated CHA2DS2-VASc score, we assessed the association between percutaneous LAAO versus OAC use and risk of stroke, hospitalized bleeding, and death. METHODS: Patients undergoing percutaneous LAAO were matched to up to five OAC users by sex, age, date of enrollment, index date, CHA2DS2-VASc score, and HAS-BLED score. Overall, 17 156 patients with AF (2905 with percutaneous LAAO) were matched (average ± SD 78 ± 6 years, 44% female). Cox proportional hazards model were used. RESULTS: Median follow-up was 10.3 months. After multivariable adjustments, no significant difference for risk of stroke or death was noted when patients with percutaneous LAAO were compared with OAC users (HRs [95% CIs]: 1.14 [0.86-1.52], 0.98 [0.86-1.10]). There was a 2.94-fold (95% CI: 2.50-3.45) increased risk for hospitalized bleeding for percutaneous LAAO compared with OAC use. Among patients 65 to <78 years old, those undergoing percutaneous LAAO had higher risk of stroke compared with OAC users. No association was present in those ≥78 years. CONCLUSION: In this analysis of real-world AF patients, percutaneous LAAO versus OAC use was associated with similar risk of death, nonsignificantly elevated risk of stroke, and an elevated risk of bleeding in the post-procedural period. Overall, these results support results of randomized trials that percutaneous LAAO may be an alternative to OAC use for patients with contraindications.

Diagnosed Gonorrhea Among Privately Insured Women: Analysis of United States Claims Data.

Background: Gonorrhea incidence in the United States has risen by nearly 50% in the last decade, while screening rates have increased. Gonorrhea sequelae rates could indicate whether increased gonorrhea incidence is due to better screening. We estimated the association of gonorrhea diagnosis with pelvic inflammatory disease (PID), ectopic pregnancy (EP), and tubal factor infertility (TFI) in women and detected changes in associations over time. Materials and Methods: This retrospective cohort study included 5,553,506 women aged 18-49 tested for gonorrhea in the IBM MarketScan claims administrative database from 2013-2018 in the United States. We estimated incidence rates and hazard ratios (HRs) of gonorrhea diagnosis for each outcome, adjusting for potential confounders using Cox proportional hazards models. We tested the interaction between gonorrhea diagnosis and the initial gonorrhea test year to identify changes in associations over time. Results: We identified 32,729 women with a gonorrhea diagnosis (mean follow-up time in years: PID = 1.73, EP = 1.75, TFI = 1.76). A total of 131,500 women were diagnosed with PID, 64,225 had EP, and 41,507 had TFI. Women with gonorrhea diagnoses had greater incidence per 1000 person-years for all outcomes (PID = 33.5, EP = 9.4, TFI = 5.3) compared to women without gonorrhea diagnoses (PID = 13.9, EP = 6.7, TFI = 4.3). After adjustment, HRs were higher in women with a gonorrhea diagnosis vs. those without [PID = 2.29 (95% confidence interval, CI: 2.15-2.44), EP = 1.57, (95% CI: 1.41-1.76), TFI = 1.70 (95% CI: 1.47-1.97)]. The interaction of gonorrhea diagnosis and test year was not significant, indicating no change in relationship by initial test year. Conclusion: The relationship between gonorrhea and reproductive outcomes has persisted, suggesting a higher disease burden.

Direct Oral Anticoagulants and Warfarin for Atrial Fibrillation Treatment: Rural and Urban Trends in Medicare Beneficiaries.

BACKGROUND: Data are needed on the use of oral anticoagulation in patients with atrial fibrillation (AF) in rural versus urban areas, including the initiation of direct oral anticoagulants (DOACs). OBJECTIVE: We used Medicare data to examine rural/urban differences in anticoagulation use in patients with AF. METHODS: We identified incident AF in a 20% sample of fee-for-service Medicare beneficiaries (aged ≥ 65 years) from 2011 to 2016 and collected ZIP code and covariates at the time of AF. We identified the first anticoagulant prescription filled, if any, following AF diagnosis. We categorized beneficiaries into four rural/urban areas using rural-urban commuting area codes and used Poisson regression models to compare anticoagulant use. RESULTS: We included 447,252 patients with AF (mean age 79 ± 8 years), of which 82% were urban, 9% large rural, 5% small rural, and 4% isolated. The percentage who initiated an anticoagulant rose from 34% in 2011 to 53% in 2016, paralleling the uptake of DOACs. In a multivariable-adjusted analysis, those in rural areas (vs. urban) were more likely to initiate an anticoagulant. However, rural beneficiaries (vs. urban) were less likely to initiate a DOAC; those in isolated areas were 17% less likely (95% confidence interval [CI] 13-20), those in small rural areas were 12% less likely (95% CI 9-15), and those in large rural areas were 10% less likely (95% CI 8-12). CONCLUSION: Among Medicare beneficiaries with AF, anticoagulation use was low but increased over time with the introduction of DOACs. Rural beneficiaries were less likely to receive a DOAC.

Sex differences in treatment strategy and adverse outcomes among patients 75 and older with atrial fibrillation in the MarketScan database.

BACKGROUND: Women with atrial fibrillation (AF) experience greater symptomatology, worse quality of life, and have a higher risk of stroke as compared to men, but are less likely to receive rhythm control treatment. Whether these differences exist in elderly patients with AF, and whether sex modifies the effectiveness of rhythm versus rate control therapy has not been assessed. METHODS: We studied 135,850 men and 139,767 women aged ≥ 75 years diagnosed with AF in the MarketScan Medicare database between 2007 and 2015. Anticoagulant use was defined as use of warfarin or a direct oral anticoagulant. Rate control was defined as use of rate control medication or atrioventricular node ablation. Rhythm control was defined by use of anti-arrhythmic medication, catheter ablation or cardioversion. We used multivariable Poisson and Cox regression models to estimate the association of sex with treatment strategy and to determine whether the association of treatment strategy with adverse outcomes (bleeding, heart failure and stroke) differed by sex. RESULTS: At the time of AF, women were on average (SD) 83.8 (5.6) years old and men 82.5 (5.2) years, respectively. Compared to men, women were less likely to receive an anticoagulant or rhythm control treatment. Rhythm control (vs. rate) was associated with a greater risk for heart failure with a significantly stronger association in women (HR women = 1.41, 95% CI 1.34-1.49; HR men = 1.21, 95% CI 1.15-1.28, p < 0.0001 for interaction). No sex differences were observed for the association of treatment strategy with the risk of bleeding or stroke. CONCLUSION: Sex differences exist in the treatment of AF among patients aged 75 years and older. Women are less likely to receive an anticoagulant and rhythm control treatment. Women were also at a greater risk of experiencing heart failure as compared to men, when treated with rhythm control strategies for AF. Efforts are needed to enhance use AF therapies among women. Future studies will need to delve into the mechanisms underlying these differences.

Association between excessive daytime sleepiness and measures of supraventricular arrhythmia burden: evidence from the Atherosclerosis Risk in Communities (ARIC) study.

PURPOSE: Excessive daytime sleepiness is a common sleep complaint among older adults. Assessment of excessive daytime sleepiness is used to screen for obstructive sleep apnea, which may be linked to atrial fibrillation (AF) and other sustained arrhythmias. Using data from the Atherosclerosis Risk in Communities (ARIC) Study cohort, we examined the association of excessive daytime sleepiness with measures of arrhythmia burden derived from a continuous ECG recording device in a community-based sample of older adults. METHODS: Participating older adults (N = 2306, mean age: 78.9 ± 4.5 years, 57.8% female) wore a Zio® XT Patch for 14 days. Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. Measures of AF and supraventricular arrhythmia burden were derived from the Zio® XT Patch. Multiple adjusted logistic, multinomial, and linear regression models were used to assess associations of excessive daytime sleepiness with AF, AF burden, and supraventricular arrhythmia burden. RESULTS: Approximately 18% of the sample had excessive daytime sleepiness, and 8.5% had AF. After adjustment, excessive daytime sleepiness was not significantly associated with AF (odds ratio (OR), 1.20; Confidence Interval (CI), 0.81-1.75), continuous AF burden (OR, 1.36; CI, 0.85-2.16), or measures of supraventricular arrhythmia burden (SVE burden: ß 0.01; 95% CI, -0.09-0.11; SVT burden: ß 0.02; 95% CI, -0.04-0.08). CONCLUSION: In this community-based sample of older adults, excessive daytime sleepiness was not associated with measures of arrhythmia burden. Future studies with objective measures of sleep are needed to further examine the role of sleep in the development and progression of arrhythmia burden.

Lifetime Risk of Atrial Fibrillation by Race and Socioeconomic Status: ARIC Study (Atherosclerosis Risk in Communities).

BACKGROUND: Limited information exists on the lifetime risk of atrial fibrillation (AF) in African Americans and by socioeconomic status. METHODS: We studied 15 343 participants without AF at baseline from the ARIC (Atherosclerosis Risk in Communities) cohort recruited in 1987 to 1989 from 4 communities in the United States when they were 45 to 64 years of age. Participants have been followed through 2014. Incidence rates of AF were calculated dividing the number of new cases by person-years of follow-up. Lifetime risk of AF was estimated by a modified Kaplan-Meier method considering death as a competing risk. Participants' family income and education were obtained at baseline. RESULTS: We identified 2760 AF cases during a mean follow-up of 21 years. Lifetime risk of AF was 36% (95% confidence interval, 32%-38%) in white men, 30% (95% confidence interval, 26%-32%) in white women, 21% (95% confidence interval, 13%-24%) in African American men, and 22% (95% confidence interval, 16%-25%) in African American women. Regardless of race and sex, incidence rates of AF decreased from the lowest to the highest categories of income and education. In contrast, lifetime risk of AF increased in individuals with higher income and education in most sex-race groups. Cumulative incidence of AF was lower in those with higher income and education compared with their low socioeconomic status counterparts through earlier life but was reversed after age 80. CONCLUSIONS: Lifetime risk of AF in the ARIC cohort was ≈1 in 3 among whites and 1 in 5 among African Americans. Socioeconomic status was inversely associated with cumulative incidence of AF before the last decades of life.