Objective: To determine trends in real-world utilization and in-hospital adverse events from Watchman implantation since its approval by the Food and Drug Administration in 2015. Background: The risk of embolic stroke caused by atrial fibrillation is reduced by oral anticoagulants, but not all patients can tolerate long-term anticoagulation. Left atrial appendage occlusion with the Watchman device has emerged as an alternative therapy. Methods: This was a retrospective cohort study utilizing data from National Inpatient Sample for calendar years 2015-2017. The outcomes assessed in this study were associated complications, in-hospital mortality, and resource utilization trends after Watchman implantation. Trends analysis were performed using analysis of variance. Multivariable adjusted logistic regression analysis was performed to determine predictors of mortality. Results: A total of 17,700 patients underwent Watchman implantation during the study period. There was a significantly increased trend in the number of Watchman procedures performed over the study years (from 1,195 in 2015 to 11,165 devices in 2017, p < 0.01). A significant decline in the rate of complications (from 26.4% in 2015 to 7.9% in 2017, p < 0.01) and inpatient mortality (from 1.3% in 2015 to 0.1% in 2017, p < 0.01) were noted. Predictors of in-hospital mortality included a higher CHA₂DS₂-VASc score (OR 2.61 per 1-point increase, 95% CI 1.91-3.57), chronic blood loss anemia (OR 3.63, 95% CI 1.37-9.61) and coagulopathy (OR 4.90, 95% CI 2.32-10.35). Conclusion: In contemporary United States clinical practice, Watchman utilization has increased significantly since approval in 2015, while complications and in-patient mortality have declined.

Background: Representation trends of women, older adults, and ethnic/racial minorities in randomized controlled trials (RCTs) of atrial fibrillation (AF) are uncertain. Methods: We systematically reviewed 134 AF related RCTs (phase II and III) encompassing 149,162 participants using Medline and ClinicalTrials.gov through April 2019 to determine representation trends of women, older patients (≥ 75 years), and ethnic/racial minorities. Weighted data on the prevalence of AF from epidemiological studies were used to compare the representation of the studied groups of interest in AF RCTs to their expected burden of the disease. Results: Only 18.7% of the RCTs reported proportion of older patients, and 12.7% RCTs reported ethnic/racial minorities. In RCTs, proportions of women, Hispanics, Blacks, American Indian/Alaskan patients, Asians, native Hawaiian/Pacific Islanders and non-Whites were 35.2%, 11.9%, 1.2%, 0.2%, 14.2%, 0.05%, and 19.5%, respectively. The corresponding proportions in general population were 35.1%, 5.2%, 5.7%, 0.2%, 2.4%, 0.1%, and 22.5%, respectively. The weighted mean age (SD) across the trials was 65.3 (3.2) years which was less than the corresponding weighted mean age of 71.1 (4.5) years in the comparative epidemiological data. Conclusion: The reporting of older patients and ethnic/racial minorities was poor in RCTs of AF. The representation of women and American Indian/Alaskan natives matched their expected population share of disease burden. Hispanics and Asians were over-represented and Blacks, native Hawaiian/Pacific Islanders and non-Whites were under-represented in RCTs of AF. In nearly all studied RCTs, the reporting of racial demographics did not start until later part of last decade.

Background: End stage renal disease (ESRD) is a well-recognized risk factor for development of sudden cardiac arrest (SCA). There is limited data on baseline characteristics and outcomes after an in-hospital SCA event in ESRD patients. Methods: For the purpose of this study, data were obtained from National Inpatient Sample from January 2007 to December 2017. In-hospital SCA was identified using International Classification of Disease, 9th Revision, Clinical Modification and International Classification of Disease, 10th Revision, Clinical Modification codes of 99.60, 99.63 and 5A12012. ESRD patients were subsequently identified using codes of 585.6 and N18.6. Baseline characteristics and outcomes were compared among ESRD and non-ESRD patients in crude and propensity matched (PS) cohorts. Predictors of mortality in ESRD patients after an in-hospital SCA event were analyzed using a multivariate logistic regression model. Results: A total of 1,412,985 patients sustained in-hospital SCA during our study period. ESRD patients with in-hospital SCA were younger and had a higher burden of key co-morbidities. Mortality was similar in ESRD and non-ESRD patients in PS matched cohort (70.4% vs. 70.7%, p = 0.45) with an overall downward trend over our study years. Advanced age, Black race, diabetes, hypertension and peripheral vascular disease were independently associated with increased mortality in ESRD patients after an in-hospital SCA event. Conclusion: In the context of in-hospital SCA, mortality is similar in ESRD and non-ESRD patients in adjusted analysis. Adequate risk factor modification could further mitigate the risk of in-hospital SCA among ESRD patients.