Ten-Year Trend of Oral Anticoagulation Use in Postoperative and Nonpostoperative Atrial Fibrillation in Routine Clinical Practice.

BACKGROUND: The study aimed to describe the patterns and trends of initiation, discontinuation, and adherence of oral anticoagulation (OAC) in patients with new-onset postoperative atrial fibrillation (POAF), and compare with patients newly diagnosed with non-POAF. METHODS AND RESULTS: This retrospective cohort study identified patients newly diagnosed with atrial fibrillation or flutter between 2012 and 2021 using administrative claims data from OptumLabs Data Warehouse. The POAF cohort included 118 366 patients newly diagnosed with atrial fibrillation or flutter within 30 days after surgery. The non-POAF cohort included the remaining 315 832 patients who were newly diagnosed with atrial fibrillation or flutter but not within 30 days after a surgery. OAC initiation increased from 28.9% to 44.0% from 2012 to 2021 in POAF, and 37.8% to 59.9% in non-POAF; 12-month medication adherence increased from 47.0% to 61.8% in POAF, and 59.7% to 70.4% in non-POAF. The median time to OAC discontinuation was 177 days for POAF, and 242 days for non-POAF. Patients who saw a cardiologist within 90 days of the first atrial fibrillation or flutter diagnosis, regardless of POAF or non-POAF, were more likely to initiate OAC (odds ratio, 2.92 [95% CI, 2.87-2.98]; P <0.0001), adhere to OAC (odds ratio, 1.08 [95% CI, 1.04-1.13]; P <0.0001), and less likely to discontinue (odds ratio, 0.83 [95% CI, 0.82-0.85]; P <0.0001) than patients who saw a surgeon or other specialties. CONCLUSIONS: The use of and adherence to OAC were higher in non-POAF patients than in POAF patients, but they increased over time in both groups. Patients managed by cardiologists were more likely to use and adhere to OAC, regardless of POAF or non-POAF.

Enrollment in High-Deductible Health Plans and Incident Diabetes Complications.

Importance: Preventing diabetes complications requires monitoring and control of hyperglycemia and cardiovascular risk factors. Switching to high-deductible health plans (HDHPs) has been shown to hinder aspects of diabetes care; however, the association of HDHP enrollment with microvascular and macrovascular diabetes complications is unknown. Objective: To examine the association between an employer-required switch to an HDHP and incident complications of diabetes. Design, Setting, and Participants: This retrospective cohort study used deidentified administrative claims data for US adults with diabetes enrolled in employer-sponsored health plans between January 1, 2010, and December 31, 2019. Data analysis was performed from May 26, 2022, to January 2, 2024. Exposures: Adults with a baseline year of non-HDHP enrollment who had to switch to an HDHP because their employer offered no non-HDHP alternative in that year were compared with adults who were continuously enrolled in a non-HDHP. Main Outcomes and Measures: Mixed-effects logistic regression models examined the association between switching to an HDHP and, individually, the odds of myocardial infarction, stroke, hospitalization for heart failure, lower-extremity complication, end-stage kidney disease, proliferative retinopathy, treatment for retinopathy, and blindness. Models were adjusted for demographics, comorbidities, and medications, with inverse propensity score weighting used to account for potential selection bias. Results: The study included 42 326 adults who switched to an HDHP (mean [SD] age, 52 [10] years; 19 752 [46.7%] female) and 202 729 adults who did not switch (mean [SD] age, 53 [10] years; 89 828 [44.3%] female). Those who switched to an HDHP had greater odds of experiencing all diabetes complications (odds ratio [OR], 1.11; 95% CI, 1.06-1.16 for myocardial infarction; OR, 1.15; 95% CI, 1.09-1.21 for stroke; OR, 1.35; 95% CI, 1.30-1.41 for hospitalization for heart failure; OR, 2.53; 95% CI, 2.38-2.70 for end-stage kidney disease; OR, 2.23; 95% CI, 2.17-2.29 for lower-extremity complication; OR, 1.17; 95% CI, 1.13-1.21 for proliferative retinopathy; OR, 2.35; 95% CI, 2.18-2.54 for blindness; and OR, 2.28; 95% CI, 2.15-2.41 for retinopathy treatment). Conclusions and Relevance: This study found that an employer-driven switch to an HDHP was associated with increased odds of experiencing all diabetes complications. These findings reinforce the potential harm associated with HDHPs for people with diabetes and the importance of affordable and accessible chronic disease management, which is hindered by high out-of-pocket costs incurred by HDHPs.

Daylight Saving Time Practice and the Rate of Adverse Cardiovascular Events in the United States: A Probabilistic Assessment in a Large Nationwide Study.

We investigated the association of daylight saving time (DST) transitions with the rates of adverse cardiovascular events in a large, US-based nationwide study. The study cohort included 36,116,951 unique individuals from deidentified administrative claims data of the OptumLabs Data Warehouse. There were 74,722 total adverse cardiovascular events during DST transition and the control weeks (2 weeks before and after) in spring and autumn of 2015-2019. We used Bayesian hierarchical Poisson regression models to estimate event rate ratios representing the ratio of composite adverse cardiovascular event rates between DST transition and control weeks. There was an average increase of 3% (95% uncertainty interval, -3% to -10%) and 4% (95% uncertainty interval, -2% to -12%) in adverse cardiovascular event rates during Monday and Friday of the spring DST transition, respectively. The probability of this being associated with a moderate-to-large increase in the event rates (estimate event rate ratio, >1.10) was estimated to be less than 6% for Monday and Friday, and less than 1% for the remaining days. During autumn DST transition, the probability of any decrease in adverse cardiovascular event rates was estimated to be less than 46% and a moderate-to-large decrease in the event rates to be less than 4% across all days. Results were similar when adjusted by age. In conclusion, spring DST transition had a suggestive association with a minor increase in adverse cardiovascular event rates but with a very low estimated probability to be of clinical importance. Our findings suggest that DST transitions are unlikely to meaningfully impact the rate of cardiovascular events.

Mortality and Morbidity of Heart Failure Hospitalization in Adult Patients With Congenital Heart Disease.

BACKGROUND: Little is known about outcomes following heart failure (HF) hospitalization among adults with congenital heart disease (CHD) in the United States. We aim to compare the outcomes of HF versus non-HF hospitalizations in adults with CHD. METHODS AND RESULTS: Using a national deidentified administrative claims data set, patients with adult congenital heart disease (ACHD) hospitalized with and without HF (ACHDHF+, ACHDHF-) were characterized to determine the predictors of 90-day and 1-year mortality and quantify the risk of mortality, major adverse cardiac and cerebrovascular events, and health resource use. Cox proportional hazard regression was used to compare ACHDHF+ versus ACHDHF- for risk of events and health resource use. Of 26 454 unique ACHD admissions between January 1, 2010 and December 31, 2020, 5826 (22%) were ACHDHF+ and 20 628 (78%) were ACHDHF-. The ACHD HF+ hospitalizations increased from 6.6% to 14.0% (P<0.0001). Over a mean follow-up period of 2.23 ± 2.19 years, patients with ACHDHF+ had a higher risk of mortality (hazard ratio [HR], 1.86 [95% CI, 1.67-2.07], P<0.001), major adverse cardiac and cerebrovascular events (HR, 1.73 [95% CI, 1.63-1.83], P<0.001) and health resource use including rehospitalization (HR, 1.09 [95% CI, 1.05-1.14], P<0.001) and increased postacute care service use (HR, 1.56 [95% CI, 1.32-1.85], P<0.001). Cardiology clinic visits within 30 days of hospital admission were associated with lower 90-day and 1-year all-cause mortality (odds ratio [OR], 0.62 [95% CI, 0.49-0.78], P<0.001; OR, 0.69 [95% CI, 0.58-0.83], P<0.001, respectively). CONCLUSIONS: HF hospitalization is associated with increased risk of mortality and morbidity with high health resource use in patients with ACHD. Recent cardiology clinic attendance appears to mitigate these risks.

Physicians' perspectives on percutaneous left atrial appendage occlusion for patients with atrial fibrillation.

BACKGROUND: There has been an increasing uptake of transcatheter left atrial appendage occlusion (LAAO) for stroke reduction in atrial fibrillation. OBJECTIVES: To investigate the perceptions and approaches among a nationally representative sample of physicians. METHODS: Using the American Medical Association Physician Masterfile, we selected a random sample of 500 physicians from each of the specialties: general cardiologists, interventional cardiologists, electrophysiologists, and vascular neurologists. The participants received the survey by mail up to three times from November 9, 2021 to January 14, 2022. In addition to the questions about experiences, perceptions, and approaches, physicians were randomly assigned to 1 of the 4 versions of a patient vignette: white man, white woman, black man, and black woman, to investigate potential bias in decision-making. RESULTS: The top three reasons for considering LAAO were: a history of intracranial bleeding (94.3%), a history of major extracranial bleeding (91.8%), and gastrointestinal lesions (59.0%), whereas the top three reasons for withholding LAAO were: other indications for long-term oral anticoagulation (87.7%), a low bleeding risk (77.0%), and a low stroke risk (65.6%). For the reasons limiting recommendations for LAAO, 59.8% mentioned procedural risks, 42.6% mentioned "limiting efficacy data comparing LAAO to NOAC" and 32.8% mentioned "limited safety data comparing LAAO to NOAC." There was no difference in physicians' decision-making by patients' race, gender, or the concordance between patients' and physicians' race or gender. CONCLUSIONS: In the first U.S. national physician survey of LAAO, individual physicians' perspectives varied greatly, which provided information that will help customize future educational activities for different audiences. CONDENSED ABSTRACT: Although diverse practice patterns of LAAO have been documented, little is known about the reasoning or perceptions that drive these variations. Unlike prior surveys that were directed to Centers that performed LAAO, the current survey obtained insights from individual physicians, not only those who perform the procedures (interventional cardiologists and electrophysiologists) but also those who are closely involved in the decision-making and referral process (general cardiologists and vascular neurologists). The findings identify key evidence gaps and help prioritize future studies to establish a consistent and evidence-based best practice for AF stroke prevention.

Advanced Heart Failure Characteristics and Outcomes in Commercially Insured U.S. Adults.

BACKGROUND: The characteristics and outcomes of patients with advanced heart failure (HF) have been poorly defined due to challenges in applying the complex advanced HF definition broadly to populations. OBJECTIVES: In this study, the authors sought to apply a validated advanced HF algorithm to a large U.S. administrative claims database and describe the population and use of advanced HF therapies. METHODS: This study included adults with advanced HF identified in the OptumLabs Data Warehouse from 2009 to 2019. The algorithm for advanced HF required 2 hospitalizations for HF plus 1 additional sign of advanced HF in a 12-month period. The association of baseline characteristics with mortality was examined with the use of Cox proportional hazards models. Associations of patient characteristics with advanced therapies were estimated with the use of cause-specific Cox proportional hazard models. RESULTS: In 60,197 patients identified with advanced HF, the mean age was 73 years, 51.5% were men, and 64.3% were non-Hispanic White, 1.9% Asian, 21.2% Black, and 8.2% Hispanic. The median survival with advanced HF was 2.0 years (IQR: 0.4-5.5 years). Differences in mortality and use of advanced therapies by age, sex, and race/ethnicity were observed. Adjusted mortality was higher in patients who were older, male, non-Hispanic White, and from rural areas (P < 0.05 for all). Advanced therapies were used less in older patients and women (P < 0.05 for both). Black patients were more likely to be treated with a left ventricular assist device (P = 0.010) but less likely to receive a heart transplant compared with White patients (P = 0.034). CONCLUSIONS: In U.S. adults with advanced HF, variation in outcomes and use of advanced therapies exist by age, sex, and race/ethnicity.

Effectiveness of Transcatheter Closure of Patent Foramen Ovale in Clinical Practice.

Background Transcatheter closure of patent foramen ovale (PFO) has reduced the risk of recurrent stroke in patients with cryptogenic strokes in randomized clinical trials. Whether PFO closure in clinical practice is associated with similar benefit remains unknown. Methods and Results We identified patients with PFO and a history of ischemic stroke or transient ischemic attack who were treated with PFO closure or medical therapy in the OptumLabs database. The primary end point was recurrent ischemic stroke or systemic embolization. Secondary outcomes included mortality, all stroke, transient ischemic attack, and major bleeding. A total of 6668 propensity-matched patients were included (PFO closure n=4111; medical therapy n=2557). The incidence of stroke or systemic embolization per 100 person-years was 2.38 after PFO cohort and 2.99 with medical therapy (hazard ratio [HR], 0.85 [95% CI, 0.68-1.05], P=0.13). Mortality was lower in the PFO closure cohort (1.78 versus 2.59 per 100 person-years: HR, 0.69 [95% CI, 0.55-0.87], P=0.002). Falsification end points showed that this difference is unlikely to be completely explained by residual confounders. There were no significant differences between the groups in secondary end points including intracranial hemorrhage and major bleeding except for an increase in nonintracranial hemorrhage bleeding among patients treated with oral anticoagulation (1.42 versus 2.16 per 100 person-years: HR, 0.69 [95% CI, 0.48-0.99], P=0.043). The main end point was consistent in subanalyses including patients <60 years of age, patients with prior stroke, and those treated after the publication of the positive PFO trials in 2017. Conclusions In contemporary US practice, PFO closure is not associated with lower rates of recurrent ischemic stroke or systemic embolization compared with medical therapy. Potential reasons for this discrepancy warrant further investigation.

Contemporary trends and barriers to oral anticoagulation therapy in Non-valvular atrial fibrillation during DOAC predominant era.

There is a need to reassess contemporary oral anticoagulation (OAC) trends and barriers against guideline directed therapy in the United States. Most previous studies were performed before major guideline changes recommended direct oral anticoagulant (DOAC) use over warfarin or have otherwise lacked patient level data. Data on overuse of OAC in low-risk group is also limited. To address these knowledge gaps, we performed a nationwide analysis to analyze current trends. This is a retrospective cohort study assessing non-valvular AF identified using a large United States de-identified administrative claims database, including commercial and Medicare Advantage enrollees. Prescription fills were assessed within a 90-day follow-up from the patient's index AF encounter between January 1, 2016, and December 31, 2020. Among the 339,197 AF patients, 4.4%, 8.0%, and 87.6% were in the low-, moderate-, and high-risk groups (according to CHA2DS2-VASc score). An over (29.6%) and under (52.2%) utilization of OAC was reported in low- and high-risk AF patients. A considerably high frequency for warfarin use was also noted among high-risk group patients taking OAC (33.1%). The results suggest that anticoagulation use for stroke prevention in the United States is still comparable to the pre-DOAC era studies. About half of newly diagnosed high-risk non-valvular AF patients remain unprotected against stroke risk. Several predictors of OAC and DOAC use were also identified. Our findings may identify a population at risk of complications due to under- or over-treatment and highlight the need for future quality improvement efforts.

Outcomes of Early Rhythm Control Therapy in Patients With Atrial Fibrillation and a High Comorbidity Burden in Large Real-World Cohorts.

BACKGROUND: A recent subanalysis of the EAST-AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial) suggests a stronger benefit of early rhythm control (ERC) in patients with atrial fibrillation and a high comorbidity burden when compared to patients with a lower comorbidity burden. METHODS: We identified 109 739 patients with newly diagnosed atrial fibrillation in a large United States deidentified administrative claims database (OptumLabs) and 11 625 patients in the population-based UKB (UK Biobank). ERC was defined as atrial fibrillation ablation or antiarrhythmic drug therapy within the first year after atrial fibrillation diagnosis. Patients were classified as (1) ERC and high comorbidity burden (CHA2DS2-VASc score ≥4); (2) ERC and lower comorbidity burden (CHA2DS2-VASc score 2-3); (3) no ERC and high comorbidity burden; and (4) no ERC and lower comorbidity burden. Patients without an elevated comorbidity burden (CHA2DS2-VASc score 0-1) were excluded. Propensity score overlap weighting and cox proportional hazards regression were used to balance patients and compare groups for the primary composite outcome of all-cause mortality, stroke, or hospitalization with the diagnoses heart failure or myocardial infarction as well as for a primary composite safety outcome of death, stroke, and serious adverse events related to ERC. RESULTS: In both cohorts, ERC was associated with a reduced risk for the primary composite outcome in patients with a high comorbidity burden (OptumLabs: hazard ratio, 0.83 [95% CI 0.72-0.95]; P=0.006; UKB: hazard ratio, 0.77 [95% CI, 0.63-0.94]; P=0.009). In patients with a lower comorbidity burden, the difference in outcomes was not significant (OptumLabs: hazard ratio, 0.92 [95% CI, 0.54-1.57]; P=0.767; UKB: hazard ratio, 0.94 [95% CI, 0.83-1.06]; P=0.310). The comorbidity burden interacted with ERC in the UKB (interaction- P=0.027) but not in OptumLabs (interaction-P=0.720). ERC was not associated with an increased risk for the primary safety outcome. CONCLUSIONS: ERC is safe and may be more favorable in a population-based sample of patients with high a comorbidity burden (CHA2DS2-VASc score ≥4).

Cardiovascular Events Among Survivors of Sepsis Hospitalization: A Retrospective Cohort Analysis.

Background Sepsis is associated with an elevated risk of late cardiovascular events among hospital survivors. Methods and Results We included OptumLabs Data Warehouse patients from 2009 to 2019 who survived a medical/nonsurgical hospitalization lasting at least 2 nights. The association between sepsis during hospitalization, based on explicit and implicit discharge International Classification of Diseases, Ninth Revision (ICD-9)/Tenth Revision (ICD-10) diagnosis codes, with subsequent death and rehospitalization was analyzed using Kaplan-Meier survival analysis and multivariable Cox proportional-hazards models. The study population included 2 258 464 survivors of nonsurgical hospitalization (5 396 051 total patient-years of follow-up). A total of 808 673 (35.8%) patients had a sepsis hospitalization, including implicit sepsis only in 448 644, explicit sepsis only in 124 841, and both in 235 188. Patients with sepsis during hospitalization had an elevated risk of all-cause mortality (adjusted hazard ratio [HR], 1.27 [95% CI, 1.25-1.28]; P<0.001), all-cause rehospitalization (adjusted HR, 1.38 [95% CI, 1.37-1.39]; P<0.001), and cardiovascular hospitalization (adjusted HR, 1.43 [95% CI, 1.41-1.44]; P<0.001), especially heart failure hospitalization (adjusted HR, 1.51 [95% CI, 1.49-1.53]). Patients with implicit sepsis had higher risk than those with explicit sepsis. A sensitivity analysis using the first hospitalization yielded concordant results for cardiovascular hospitalization (adjusted HR, 1.78 [95% CI, 1.76-1.78]; P<0.001), as did a propensity-weighted analysis (adjusted HR, 1.52 [95% CI, 1.50-1.54]; P<0.001). Conclusions Survivors of sepsis hospitalization are at elevated risk of early and late post-discharge death as well as cardiovascular and non-cardiovascular rehospitalization. This hazard spans the spectrum of cardiovascular events and may suggest that sepsis is an important cardiovascular risk factor.

Evaluation of High-Deductible Health Plans and Acute Glycemic Complications Among Adults With Diabetes.

Importance: Optimal diabetes care requires regular monitoring and care to maintain glycemic control. How high-deductible health plans (HDHPs), which reduce overall spending but may impede care by increasing out-of-pocket expenses, are associated with risks of severe hypoglycemia and hyperglycemia is unknown. Objective: To examine the association between an employer-forced switch to HDHP and severe hypoglycemia and hyperglycemia. Design, Setting, and Participants: This retrospective cohort study used deidentified administrative claims data for privately insured adults with diabetes from a single insurance carrier with multiple plans across the US between January 1, 2010, and December 31, 2018. Analyses were conducted between May 15, 2020, and November 3, 2022. Exposures: Patients with 1 baseline year of enrollment in a non-HDHP whose employers subsequently forced a switch to an HDHP were compared with patients who did not switch. Main Outcomes and Measures: Mixed-effects logistic regression models were used to examine the association between switching to an HDHP and the odds of severe hypoglycemia and hyperglycemia (ascertained using diagnosis codes in emergency department [ED] visits and hospitalizations), adjusting for patient age, sex, race and ethnicity, region, income, comorbidities, glucose-lowering medications, baseline ED and hospital visits for hypoglycemia and hyperglycemia, and baseline deductible amount, and applying inverse propensity score weighting to account for potential treatment selection bias. Results: The study population was composed of 42 326 patients who switched to an HDHP (mean [SD] age: 52 [10] years, 19 752 [46.7%] women, 7375 [17.4%] Black, 5740 [13.6%] Hispanic, 26 572 [62.8%] non-Hispanic White) and 202 729 patients who did not switch (mean [SD] age, 53 [10] years, 89 828 [44.3%] women, 29 551 [14.6%] Black, 26 689 [13.2%] Hispanic, 130 843 [64.5%] non-Hispanic White). When comparing all study years, switching to an HDHP was not associated with increased odds of experiencing at least 1 hypoglycemia-related ED visit or hospitalization (OR, 1.01 [95% CI, 0.95-1.06]; P = .85), but each year of HDHP enrollment did increase these odds by 2% (OR, 1.02 [95% CI, 1.00-1.04]; P = .04). In contrast, switching to an HDHP did significantly increase the odds of experiencing at least 1 hyperglycemia-related ED visit or hospitalization (OR, 1.25 [95% CI, 1.11-1.42]; P < .001), with each year of HDHP enrollment increasing the odds by 5% (OR, 1.05 [95% CI, 1.01-1.09]; P = .02). Conclusions and Relevance: In this cohort study, employer-forced switching to an HDHP was associated with increased odds of potentially preventable acute diabetes complications, potentially because of delayed or deferred care. These findings suggest that employers should be more judicious in their health plan offerings, and health plans and policy makers should consider allowing preventive and high-value services to be exempt from deductible requirements.

Out-of-Pocket Cost Burden Associated With Contemporary Management of Advanced Prostate Cancer Among Commercially Insured Patients.

PURPOSE: Out-of-pocket costs represent an important component of financial toxicity and may impact patients' receipt of care. Herein, we evaluated patient-level factors associated with out-of-pocket costs for contemporary advanced prostate cancer treatment options. MATERIALS AND METHODS: We identified all commercially insured men receiving treatment for advanced prostate cancer between 2007 and 2019 within the OptumLabs Data Warehouse®. Patients were categorized into 3 treatment groups: androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy. The primary outcome was out-of-pocket costs in the first year of treatment. The associations of treatment and patient variables with out-of-pocket costs were assessed using multivariable regression models. All costs were adjusted to reflect 2019 U.S. dollars using the Consumer Price Index. RESULTS: In a cohort of 13,409 men 81% (n = 10,926) received androgen deprivation monotherapy, 6% (n = 832) novel hormonal therapy, and 12% (n = 1,651) nonandrogen systemic therapy. Mean treatment-related out-of-pocket costs in the first year were $165, $4,236, and $994 for androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy, respectively. The adjusted difference in annual treatment-related out-of-pocket costs for novel hormonal therapy and nonandrogen systemic therapy were $2,581 (95% CI: $1,923-$3,240) and $752 (95% CI: $600-$903) higher than androgen deprivation monotherapy, respectively. Patient characteristics associated (P < .05) with higher treatment-related out-of-pocket costs included older age (65-74 years), Black race, lower comorbidity scores, and lower household income. CONCLUSIONS: Patients receiving novel hormonal therapy for advanced prostate cancer had substantially higher treatment-related out-of-pocket costs. In addition to raising awareness among prescribers, these data support the inclusion of treatment associated financial toxicity in shared decision making for advanced prostate cancer and call attention to subgroups of patients particularly vulnerable to financial toxicity.

Percutaneous Left Atrial Appendage Occlusion in Comparison to Non-Vitamin K Antagonist Oral Anticoagulant Among Patients With Atrial Fibrillation.

Background This study aimed to compare percutaneous left atrial appendage occlusion (LAAO) with non-vitamin K antagonist oral anticoagulants among patients with atrial fibrillation. Methods and Results Using a US administrative database, 562 850 patients with atrial fibrillation were identified, among whom 8397 were treated with LAAO and 554 453 were treated with non-vitamin K antagonist oral anticoagulants between March 13, 2015 and December 31, 2018. Propensity score overlap weighting was used to balance baseline characteristics. The primary outcome was a composite end point of ischemic stroke or systemic embolism, major bleeding, and all-cause mortality. The mean age was 76.4±7.6 years; 280 097 (49.8%) were female. Mean follow-up was 1.5±1.0 years. LAAO was associated with no significant difference in the risk of the primary composite end point (hazard ratio [HR], 0.93 [0.84-1.03]), or the secondary outcomes including ischemic stroke/systemic embolism (HR, 1.07 [0.81-1.41]), and intracranial bleeding (HR, 1.08 [0.72-1.61]). LAAO was associated with a higher risk of major bleeding (HR, 1.22 [1.05-1.42], P=0.01) and a lower risk of mortality (HR, 0.73 [0.64-0.84], P<0.001). The lower risk of mortality associated with LAAO was most pronounced in patients with a prior history of intracranial bleeding. Conclusions In comparison to non-vitamin K antagonist oral anticoagulants, LAAO was associated with no significant difference in the risk of the composite outcome and a lower risk of mortality, which suggests LAAO might be a reasonable option in select patients with atrial fibrillation. The observation of higher bleeding risk associated with LAAO highlights the need to optimize postprocedural antithrombotic regimens as well as systematic efforts to assess and address bleeding predispositions.

Longitudinal Cost of Septal Myectomy Versus Alcohol Septal Ablation for Hypertrophic Cardiomyopathy.

OBJECTIVE: To compare the postprocedural health care utilization and cost of septal myectomy (SM) and alcohol septal ablation (ASA). PATIENTS AND METHODS: Using the OptumLabs Data Warehouse, we analyzed de-identified claims data of adult patients undergoing SM and ASA for obstructive hypertrophic cardiomyopathy from January 1, 2006, through December 31, 2018. We used propensity score weighting to compare the 2-year incidence rates of emergency department visits and rehospitalizations after SM and ASA. RESULTS: We identified 953 patients in total: 660 underwent SM and 293 underwent ASA. There was no difference in the risk (odds ratio, 1.1; 95% CI, 0.6 to 1.8) or frequency (incidence rate ratio, 1.1; 95% CI, 0.8 to 1.5) of emergency department visits, but the annual risk of hospital readmission was 10.8% after SM and 25.9% after ASA during the second postoperative year (P=.004). In those who were ever readmitted, the average length of hospital stay within the first 2 years after ASA was 1.6 times as long as that after SM (incidence rate ratio, 1.6; 95% CI, 1.0 to 2.4). Overall, the 2-year cumulative postprocedural cost was significantly higher after ASA (P<.001). CONCLUSION: Compared with ASA, SM is associated with fewer hospital readmissions and lower 2-year postprocedural health care cost.

Shared Decision-Making for Patients Hospitalized with Acute Myocardial Infarction: A Randomized Trial.

Objective: Adherence to guideline-recommended medications after acute myocardial infarction (AMI) is suboptimal. Patient fidelity to treatment regimens may be related to their knowledge of the risk of death following AMI, the pros and cons of medications, and to their involvement in treatment decisions. Shared decision-making may improve both patients' knowledge and involvement in treatment decisions. Methods: In a pilot trial, patients hospitalized with AMI were randomized to the use of the AMI Choice conversation tool or to usual care. AMI Choice includes a pictogram of the patient's estimated risk of mortality at 6 months with and without guideline-recommended medications, ie, aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors. Primary outcomes were patient knowledge and conflict with the decision made assessed via post-encounter surveys. Secondary outcomes were patient involvement in the decision-making process (observer-based OPTION12 scale) and 6-month medication adherence. Results: Patient knowledge of the expected survival benefit from taking medications was significantly higher (62% vs 16%, p<0.0001) in the AMI Choice group (n = 53) compared to the usual care group (n = 53). Both groups reported similarly low levels of conflict with the decision to start the medications (13 (SD 24.2) vs 16 (SD 22) out of 100; p=0.16). The extent to which clinicians in the AMI Choice group involved their patients in the decision-making process was high (OPTION12 score 53 out of 100, SD 12). Medication adherence at 6-months was relatively high in both groups and not different between groups. Conclusion: The AMI Choice conversation tool improved patients' knowledge of their estimated risk of short-term mortality after an AMI and the pros and cons of treatments to reduce this risk. The effect on patient fidelity to recommended medications of using this SDM tool and of SDM in general should be tested in larger trials enrolling patients at high risk for nonadherence. Trial Registration Number: NCT00888537.

Generalizability of the EAST-AFNET 4 Trial: Assessing Outcomes of Early Rhythm-Control Therapy in Patients With Atrial Fibrillation.

Background EAST-AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial) demonstrated clinical benefit of early rhythm-control therapy (ERC) in patients with new-onset atrial fibrillation (AF) and concomitant cardiovascular conditions compared with current guideline-based practice. This study aimed to evaluate the generalizability of EAST-AFNET 4 in routine practice. Methods and Results Using a US administrative database, we identified 109 739 patients with newly diagnosed AF during the enrollment period of EAST-AFNET 4. Patients were classified as either receiving ERC, using AF ablation or antiarrhythmic drug therapy, within the first year after AF diagnosis (n=27 106) or not receiving ERC (control group, n=82 633). After propensity score overlap weighting, Cox proportional hazards regression was used to compare groups for the primary composite outcome of all-cause mortality, stroke, or hospitalization with the diagnoses heart failure or myocardial infarction. Most patients (79 948 of 109 739; 72.9%) met the inclusion criteria for EAST-AFNET 4. ERC was associated with a reduced risk for the primary composite outcome (hazard ratio [HR], 0.85; 95% CI, 0.75-0.97 [P=0.02]) with largely consistent results between eligible (HR, 0.89; 95% CI, 0.76-1.04 [P=0.14]) or ineligible (HR, 0.77; 95% CI, 0.60-0.98 [P=0.04]) patients for EAST-AFNET 4 trial inclusion. ERC was associated with lower risk of stroke in the overall cohort and in trial-eligible patients. Conclusions This analysis replicates the clinical benefit of ERC seen in EAST-AFNET 4. The results support adoption of ERC as part of the management of recently diagnosed AF in the United States.

Speech Pathology Utilization and Stroboscopy Before and After Adult Medialization Laryngoplasty.

OBJECTIVES: Evaluation of trends and utilization of speech-language-pathology (SLP) services, including stroboscopy, before and after medialization laryngoplasty (ML) over 11 years. METHODS: Retrospective national US database study conducted using OptumLabs Data Warehouse. Study cohort included patients (age ≥18 years) who underwent ML between January 2007 and December 2016. Primary outcomes were rates of SLP visits in the 12 months before and 12 months after ML. Linear regression analysis was performed assessing for trends utilization across years. Secondary outcomes were predictors of utilization After-ML using multivariable logistic regression. RESULTS: 1114 patients met criteria. Services, including stroboscopy, were utilized by 774 (69%) Before-ML and 697 (63%) After-ML. SLP services, excluding stroboscopy, were utilized by 512 (46%) Before-ML and 478 (43%) After-ML. Vocal cord paralysis was the most common diagnosis, 945 (84.8%) patients. Other service billed were stroboscopy, [Before-ML 676 (60.7%); After-ML 567 (50.9%)], voice evaluation [Before-ML 431(38.7%); After-ML 366 (32.9%)], voice therapy [Before-ML 309 (27.7%); After-ML 339 (30.4%)], laryngeal function studies, [Before-ML 175 (15.7%); After-ML 164 (14.7%)], swallow evaluations [Before-ML 150 (13.5%); After-ML 90 (8.1%)], and swallow therapy [Before-ML 53 (4.8%); After-ML 47 (4.2%)]. SLP utilization Before-ML predicted SLP utilization After-ML [Odds Ratio (95% Confidence Interval): 9.31 (6.78, 12.77)]. Nearly half (49%) of visits occurred in the 6 months around ML. Of those who had voice therapy, the majority (73.7%) had a total of 1 to 5 sessions. CONCLUSION: Based on this retrospective US national database study, SLP services and stroboscopy are a complementary component of assessment and treatment of patients who undergo ML with the majority of services occurring in the 3 months before and after ML. Future work would benefit from outcome data.

Trends in the Incidence and Treatment of Distal Radius Fractures in the United States in Privately Insured and Medicare Advantage Enrollees.

Background: This study aims to determine the trends in the treatment of distal radius fractures (DRFs) in patients aged 18 years and older. Methods: An administrative claims database of more than 100 million patients was used to identify patients aged 18 years and older with a DRF between 2005 and 2014. A total of 137 130 DRFs were identified in 135 128 patients. Results: The proportion and rate of fractures were more predominant in those aged 55 years and older compared with a decreasing incidence in patients younger than 55 years. Age-adjusted rates of surgical treatment have significantly increased in both women and men by 15.9% (absolute change, 4.8%) and 5.0% (absolute change, 1.7%) change over time, respectively. Conversely, age-adjusted rates of nonsurgical treatment have significantly decreased overtime in both women and men by 6.9% and 2.6%, respectively. Conclusions: These data provide better understanding of the epidemiology of DRF, which is important to develop preventive strategies targeting high-risk populations and to develop effective treatment strategies.

Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention.

PURPOSE: To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making. METHODS: In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives. RESULTS: We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them. CONCLUSIONS: Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov: NCT01502891.