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.

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.

Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation.

BACKGROUND/AIMS: The Pediatric Research Equity Act and Best Pharmaceuticals for Children Act are intended to promote the conduct of clinical trials that generate pediatric-specific evidence about drug safety and efficacy. This study assesses the quality of evidence generated through Pediatric Research Equity Act-mandated and Best Pharmaceuticals for Children Act-incentivized clinical trials of hematology/oncology drugs and characterizes subsequent changes in pediatric drug utilization rates. METHODS: Trial characteristics (blinding, randomization, and comparator group) were determined for clinical trials that supported pediatric label changes. Using data from OptumLabs® Data Warehouse, a de-identified administrative claims database, we calculated pediatric utilization rates for each drug. We calculated monthly utilization rates from January 2003 (or from the first month in which data were available) to December 2018. RESULTS: We identified 11 hematology/oncology drugs that underwent pediatric label changes under the Pediatric Research Equity Act Pediatric Research Equity Act and/or Best Pharmaceuticals for Children Act, and we identified 15 trials supporting these changes. Of these trials, 36% (5/14) were randomized, 31% (4/13) were blinded, and 36% (5/14) used a comparator group. A median of 49 children (interquartile range 29.5) received the drug under investigation across these trials. Pediatric label changes were not associated with subsequent changes in pediatric drug utilization. Although some drugs saw increased pediatric use after gaining new pediatric indications, this pattern was not consistently observed. In addition, there was no evidence to suggest that drugs were utilized less frequently after they failed to receive pediatric indications. CONCLUSIONS: Clinical trials of hematology/oncology drugs conducted under the Pediatric Research Equity Act Pediatric Research Equity Act and Best Pharmaceuticals for Children Act generally have low methodological rigor, and the resulting label changes are not consistently associated with changes in pediatric utilization. Alternative regulatory strategies and study designs may be necessary to maximize the impact of newly generated knowledge on drug utilization.

Healthcare Cost and Utilization in Nonalcoholic Fatty Liver Disease: Real-World Data From a Large U.S. Claims Database.

The prevalence of nonalcoholic fatty liver disease (NAFLD) is increasing. The health care burden resulting from the multidisciplinary management of this complex disease is unknown. We assessed the total health care cost and resource utilization associated with a new NAFLD diagnosis, compared with controls with similar comorbidities. We used OptumLabs Data Warehouse, a large national administrative claims database with longitudinal health data of over 100 million individuals enrolled in private and Medicare Advantage health plans. We identified 152,064 adults with a first claim for NAFLD between 2010 and 2014, of which 108,420 were matched 1:1 by age, sex, metabolic comorbidities, length of follow-up, year of diagnosis, race, geographic region, and insurance type to non-NAFLD contemporary controls from the OptumLabs Data Warehouse database. Median follow-up time was 2.6 (range 1-6.5) years. The final study cohort consisted of 216,840 people with median age 55 (range 18-86) years, 53% female, 78% white. The total annual cost of care per NAFLD patient with private insurance was $7,804 (interquartile range [IQR] $3,068-$18,688) for a new diagnosis and $3,789 (IQR $1,176-$10,539) for long-term management. These costs are significantly higher than the total annual costs of $2,298 (IQR $681-$6,580) per matched control with similar metabolic comorbidities but without NAFLD. The largest increases in health care utilization that may account for the increased costs in NAFLD compared with controls are represented by liver biopsies (relative risk [RR] = 55.00, 95% confidence interval [CI] 24.48-123.59), imaging (RR = 3.95, 95% CI 3.77-4.15), and hospitalizations (RR = 1.87, 95% CI 1.73-2.02). Conclusion: The costs associated with the care for NAFLD independent of its metabolic comorbidities are very high, especially at first diagnosis. Research efforts shouldfocus on identification of underlying determinants of use, sources of excess cost, and development of cost-effective diagnostic tests.

Ten-Year Trends in Antiemetic Prescribing in Patients Receiving Highly Emetogenic Chemotherapy.

Purpose: Prevention of chemotherapy-induced nausea and vomiting is essential to preserve quality of life in patients with cancer receiving highly emetogenic chemotherapy (HEC). Recently, new drugs (eg, fosaprepitant, and the newer neurokinin-1 receptor antagonists [NK1RAs] rolapitant and netupitant) and updated antiemetic guidelines have emerged. However, trends in real-world antiemetic use are understudied. Methods: We identified patients treated with an initial dose of HEC (either cisplatin or doxorubicin/cyclophosphamide) from January 2006 to June 2016 using administrative claims data from a US commercial insurance database (OptumLabs). Antiemetic use was determined by identifying intravenous/oral/transdermal administration within ±1 day of the chemotherapy dose and/or prescription fill from 14 days before to 7 days after chemotherapy. We used descriptive statistics to present patient demographics, chemotherapy drugs administered, presence/absence of a central intravenous access device, and antiemetics used. Results: A total of 23,030 patients (67.3%) received doxorubicin/cyclophosphamide and 11,206 (32.7%) received cisplatin. Dexamethasone and 5-hydroxytryptamine 3 receptor antagonists (5-HT3RAs) were consistently used by 85% to 95% of patients, consistent with guideline recommendations. NK1RAs were underused early on, but use increased to approximately 80% in the most recently evaluated year. Fosaprepitant use increased precipitously starting in 2009, preceding a sharp decrease in aprepitant use beginning in 2011. Receipt of olanzapine, rolapitant, and netupitant was minimal throughout the study period. Conclusions: Dexamethasone and 5-HT3RAs were used by most patients receiving HEC, in accordance with guideline recommendations. NK1RA use was less adherent with guidelines.

National trends in emergency department visits and hospitalizations for food-induced anaphylaxis in US children.

BACKGROUND: Food is the leading cause of anaphylaxis in children seen in emergency departments in the United States, yet data on emergency department visits and hospitalizations related to food-induced anaphylaxis are limited. The objective of our study was to examine national time trends of pediatric food-induced anaphylaxis-related emergency department visits and hospitalizations. METHODS: We conducted an observational study using a national administrative claims database from 2005 through 2014. Participants were younger than 18 years with an emergency department visit or hospitalization for food-induced anaphylaxis. Outcome measures of our study included time trends of pediatric food-induced anaphylaxis-related emergency department visits and hospitalizations, including observations (in an emergency department or a hospital unit), inpatient admissions, and intensive care unit admissions. RESULTS: During the study period, participants had 7310 food-induced anaphylaxis-related emergency department visits. Emergency department visits for food-induced anaphylaxis increased by 214% (P < .001); the highest rates were in infants and toddlers (age 0-2 years). Rates of emergency department visits significantly increased in all age-groups, with the highest increase in adolescents (age 13-17 years: 413%; P < .001). Peanuts accounted for the highest rates (5.85 per 100 000 in 2014) followed by tree nuts/seeds (4.62 per 100 000 in 2014). The greatest increase in rates of emergency department visits for food-induced anaphylaxis occurred with tree nuts/seeds (373.0% increase during the study period). CONCLUSIONS: The incidence of food-induced anaphylaxis has significantly increased over time in children of all ages. Food-induced anaphylaxis in children is an important national public health concern.

Risk factors for recurrent anaphylaxis-related emergency department visits in the United States.

BACKGROUND: Anaphylaxis is a potentially life-threatening allergic reaction with a strong risk of recurrence. OBJECTIVE: To assess risk factors associated with recurrent anaphylaxis-related emergency department (ED) visits within 1 year of an ED visit for anaphylaxis in a large observational cohort study. METHODS: We used an administrative claims database to identify patients seen from 2008 through 2012 in the ED for anaphylaxis based on an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code algorithm. Patients with at least 2 years of continuous enrollment in a health plan were included. Multivariable logistic regression analysis was used to determine associations with recurrence of anaphylaxis within 1 year. RESULTS: During the 5-year study period, 7,367 patients (median age, 42 years; <18 years old, 23.3%) met the inclusion criteria. The most common anaphylaxis trigger was unspecified (56.2%), followed by food (25.3%), medication (14.6%), and venom (3.9%). Overall, 3.0% of patients had an additional anaphylaxis-related ED visit within 1 year (3.61 episodes per 100 patient-years). On multivariable analysis, risk factors associated with anaphylaxis recurrence were food trigger (odds ratio [OR], 2.31; 95% confidence interval [CI], 1.34-3.99), history of asthma (OR, 1.30; 95% CI, 1.13-1.51), and intensive care unit admission at the index anaphylaxis event (OR, 1.95; 95% CI, 1.41-2.69). CONCLUSION: In this contemporary cohort study, history of asthma, food trigger, and greater index anaphylaxis severity, as measured by intensive care unit admission, were associated with a higher likelihood of a recurrent anaphylaxis-related ED visit within 1 year.

Impact of treatment regimen on acute care use during and after adjuvant chemotherapy for early-stage breast cancer.

PURPOSE: The Oncology Care Model was developed, in part, to reduce acute care use during the 6 months after chemotherapy initiation. However, little is known about the impact of chemotherapy regimen on acute care needs, or about later acute care. We sought to assess acute care use over 2 years in patients receiving four contemporary adjuvant chemotherapy regimens for breast cancer. METHODS: Administrative claims data from a large U.S. commercial insurance database (OptumLabs Data Warehouse) were used to retrospectively identify women with early-stage breast cancer who received adjuvant doxorubicin-cyclophosphamide (AC), AC followed or preceded by docetaxel or paclitaxel (AC-T), AC concurrent with docetaxel or paclitaxel (TAC), or docetaxel-cyclophosphamide (TC) between 2008 and 2014. Rates of hospitalizations and emergency department (ED) visits that did not lead to hospitalizations were compared during four sequential 6-month periods among recipients of these four regimens using negative binomial regression (TC = reference). RESULTS: We identified 8621 eligible patients, 87.2% younger than 65. Over 6 months, 11.9% were hospitalized and 17.1% had ED visits. Over 24 months, 17.9% were hospitalized and 28.3% visited the ED. Adjusted rates of hospitalizations/100 patients were significantly higher in AC-T and TAC compared to TC recipients in the first 6 months (14.9, 21.9, and 11.3, respectively, p < 0.001). There were no hospitalization rate differences among regimens later. ED visit rates did not differ significantly by regimen during any 6-month period. CONCLUSION: Higher rates of hospitalizations in recipients of AC-T and TAC were restricted to the chemotherapy administration period, and did not persist afterwards.

Contralateral Prophylactic Mastectomy with Immediate Breast Reconstruction Increases Healthcare Utilization and Cost.

BACKGROUND: The rates of contralateral prophylactic mastectomy (CPM) in women with unilateral breast cancer continue to rise, especially in women undergoing immediate breast reconstruction (IBR). METHODS: We utilized administrative claims data from a large US commercial insurance database (OptumLabs) to identify women age 18-64 years who underwent IBR between January 2004 and December 2013. We compared 2-year unadjusted utilization rates and total costs of care between unilateral mastectomy (UM) and bilateral mastectomy (BM) for implant-based and autologous reconstruction. Comparisons were tested using t-test and differences in cost were estimated using the Wilcoxon rank-sum test. RESULTS: Overall, 11,235 women undergoing mastectomy with IBR were identified; 7319 with implant reconstruction [1923 UM (26%) and 5396 BM (74%)] and 3916 with autologous reconstruction [1687 UM (43%) and 2229 BM (57%)]. The overall rate of office visits (2386 vs. 2391 per 100 women, p = 0.42) and hospital readmission rate (29.1 per 100 women vs. 27.4, p = 0.06) were similar between BM + IBR and UM + IBR. Women undergoing BM + IBR had a higher emergency room (ER) visit rate (34.1 per 100 women vs. 29.8, p < 0.0001). The total 2-year cost of care was higher for BM + IBR than UM + IBR for implant reconstruction ($106,711 vs. $97,218, p < 0.0001) and for autologous reconstruction ($114,725 vs. $87,874, p < 0.0001). CONCLUSIONS: BM + IBR (autologous or implant) was associated with increased ER visits and higher total cost of care over 2 years compared with UM + IBR. Patients considering CPM should be counseled on the additional risks and costs associated with BM + IBR.

Trajectories of Glycemic Change in a National Cohort of Adults With Previously Controlled Type 2 Diabetes.

BACKGROUND: Individualized diabetes management would benefit from prospectively identifying well-controlled patients at risk of losing glycemic control. OBJECTIVES: To identify patterns of hemoglobin A1c (HbA1c) change among patients with stable controlled diabetes. RESEARCH DESIGN: Cohort study using OptumLabs Data Warehouse, 2001-2013. We develop and apply a machine learning framework that uses a Bayesian estimation of the mixture of generalized linear mixed effect models to discover glycemic trajectories, and a random forest feature contribution method to identify patient characteristics predictive of their future glycemic trajectories. SUBJECTS: The study cohort consisted of 27,005 US adults with type 2 diabetes, age 18 years and older, and stable index HbA1c <7.0%. MEASURES: HbA1c values during 24 months of observation. RESULTS: We compared models with k=1, 2, 3, 4, 5 trajectories and baseline variables including patient age, sex, race/ethnicity, comorbidities, medications, and HbA1c. The k=3 model had the best fit, reflecting 3 distinct trajectories of glycemic change: (T1) rapidly deteriorating HbA1c among 302 (1.1%) youngest (mean, 55.2 y) patients with lowest mean baseline HbA1c, 6.05%; (T2) gradually deteriorating HbA1c among 902 (3.3%) patients (mean, 56.5 y) with highest mean baseline HbA1c, 6.53%; and (T3) stable glycemic control among 25,800 (95.5%) oldest (mean, 58.5 y) patients with mean baseline HbA1c 6.21%. After 24 months, HbA1c rose to 8.75% in T1 and 8.40% in T2, but remained stable at 6.56% in T3. CONCLUSIONS: Patients with controlled type 2 diabetes follow 3 distinct trajectories of glycemic control. This novel application of advanced analytic methods can facilitate individualized and population diabetes care by proactively identifying high risk patients.

Predictors of epinephrine dispensing and allergy follow-up after emergency department visit for anaphylaxis.

BACKGROUND: National guidelines recommend that patients with anaphylaxis be prescribed an epinephrine auto-injector (EAI) and referred to an allergy/immunology (A/I) specialist. OBJECTIVE: To evaluate guideline concordance and identify predictors of EAI dispensing and A/I follow-up in patients with anaphylaxis treated in the emergency department (ED). METHODS: We identified patients seen in the ED for anaphylaxis from 2010 through 2014 from an administrative claims database using an expanded International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code algorithm. RESULTS: Of 7,790 patients identified, 46.5% had an EAI dispensed and 28.8% had A/I follow-up within 1 year after discharge. On multivariable analysis, those 65 years or older (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.30-0.41) and with a medication trigger (OR 0.24, 95% CI 0.21-0.28) had a lower likelihood of EAI dispensing. Those younger than 5 years (OR 2.67, 95% CI 2.15-3.32) and with food (OR 1.40, 95% CI 1.24-1.59) or venom (OR 4.48, 95% CI 3.51-5.72) triggers had a higher likelihood of EAI dispensing. Similarly, for A/I follow-up, the likelihood was lower for age 65 years or older (OR 0.46, 95% CI 0.39-0.54) and medication trigger (OR 0.66, 95% CI 0.56-0.78) and higher for age younger than 5 years (OR 3.15, 95% CI 2.63-3.77) and food trigger (OR 1.39, 95% CI 1.22-1.58). CONCLUSION: Overall, 46.5% of patients with anaphylaxis in the ED had EAI dispensing and 28.8% had A/I follow-up. Patient age and triggers were associated with likelihood of EAI dispensing and A/I follow-up. Post-ED visit anaphylaxis management can be improved, with the potential to decrease future morbidity and mortality risk.

Risk factors for severe anaphylaxis in the United States.

BACKGROUND: Anaphylaxis is an acute systemic allergic reaction and may be life-threatening. OBJECTIVE: To assess risk factors associated with severe and near-fatal anaphylaxis in a large observational cohort study. METHODS: We analyzed administrative claims data from Medicare Advantage and privately insured enrollees in the United States from 2005 to 2014. Severe anaphylaxis was defined as anaphylaxis resulting in hospital or intensive care unit (ICU) admission, requiring endotracheal intubation, or meeting criteria for near-fatal anaphylaxis. RESULTS: Of 38,695 patients seen in the emergency department for anaphylaxis during the study period, 4,431 (11.5%) required hospitalization, 2,057 (5.3%) were admitted to the ICU, 567 (1.5%) required endotracheal intubation, and 174 (0.45%) were classified as having a near-fatal episode. Multivariable analysis revealed that medication-related anaphylaxis (odds ratio [OR], 1.50; 95% confidence interval [CI], 1.38-1.63; P < .001), age of 65 years or older (OR, 3.15; 95% CI, 2.88-3.44; P < .001), and the presence of cardiac disease (OR, 1.56; 95% CI, 1.50-1.63; P < .001) or lung disease (OR, 1.23; 95% CI, 1.16-1.30; P < .001) were associated with increased odds of severe anaphylaxis requiring any hospital admission, ICU admission, or intubation or being a near-fatal reaction. CONCLUSION: In this large contemporary cohort study, 11.6% of patients had severe anaphylaxis. Age of 65 years or older, medication as a trigger, and presence of comorbid conditions (specifically cardiac and lung disease) were associated with significantly higher odds of severe anaphylaxis. Additional studies examining risk factors for severe anaphylaxis are needed to define risk assessment strategies and establish a framework for management.

Trends in Utilization and Outcomes of Hip Arthroscopy in the United States Between 2005 and 2013.

BACKGROUND: The utilization of hip arthroscopy continues to increase in the United States. The purpose of this study was to examine trends in hip arthroscopy procedures and outcomes. METHODS: We performed a retrospective cohort study using Optum Labs Data Warehouse administrative claims data. The cohort comprised 10,042 privately insured enrollees aged 18-64 years who underwent a hip arthroscopy procedure between 2005 and 2013. Utilization trends were examined using age-specific, sex-specific, and calendar-year-specific hip arthroscopy rates. Outcomes were examined using the survival analysis methods and included subsequent hip arthroscopy and total hip arthroplasty (THA). RESULTS: Hip arthroscopy rates increased significantly over time from 3.6 per 100,000 in 2005 to 16.7 per 100,000 in 2013. The overall 2-year cumulative incidence of subsequent hip arthroscopy and THA was 11% and 10%, respectively. In the subset of patients in whom laterality of the subsequent procedure could be determined, about half of the subsequent hip arthroscopy procedures (46%) and almost all of the THA procedures (94%) were on the same side. Decreasing age was significantly associated with the risk of subsequent arthroscopy (P < .01), whereas increasing age was significantly associated with the subsequent risk of THA (P < .01). The 5-year cumulative incidence of THA reached as high as 35% among individuals aged 55-64 years. CONCLUSION: The utilization of hip arthroscopy procedures increased dramatically over the last decade in the 18-64-year-old privately insured population, with the largest increase in younger age-groups. Future studies are warranted to understand the determinants of the large increase in utilization of hip arthroscopy and outcomes.

Association of physician specialty and medical therapy for benign prostatic hyperplasia.

BACKGROUND: Despite little available evidence to determine whether recently introduced selective α-1 blockers and 5-α reductase inhibitors (5-ARIs) are superior to the existing agents in treating benign prostatic hyperplasia (BPH), they are being increasingly prescribed. OBJECTIVE: To describe the prescribing patterns of new and existing agents among patients with incident BPH after the introduction of several new agents and determine whether these varied by physician specialty. RESEARCH DESIGN: We analyzed a retrospective cohort from an administrative claims database from January 2004 through December 2010. SUBJECTS: Patients diagnosed with incident BPH aged 40 years and above and those who received medical management. MEASURES: Receipt of medical therapy for incident BPH (ie, selective α-1 blockers [prazosin (released 1976), terazosin (1987), doxazosin (1990), tamsulosin (1997), alfuzosin (2003), silodosin (2009)] and 5-ARIs [finasteride (1992) and dutasteride (2002)]). RESULTS: A total of 42,769 men with incident BPH received any selective α-1 blocker or 5-ARI. Tamsulosin and dutasteride were the most widely prescribed agents of their respective drug classes. Predicted probabilities showed that urologists were more likely to prescribe alfuzosin (24.0% vs. 7.8%; P<0.001) and silodosin (2.3% vs. 0.4%; P<0.001) when compared with primary care providers (PCPs) at 6 months after diagnosis. Urologists were more likely to prescribe 5-ARIs but less likely to prescribe older α-1 blockers (terazosin, prazosin, and doxazosin) than PCPs at 6 months postdiagnosis. CONCLUSIONS: Among insured patients diagnosed with BPH, our study suggests that the overall use of new agents is rising. In particular, urologists were more likely to prescribe newer selective α-1 blockers compared with PCPs.

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.

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.

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.

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.

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.