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.

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.

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.

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.

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.

Development and evaluation of a patient-centered quality indicator for the appropriateness of type 2 diabetes management.

INTRODUCTION: Current diabetes quality measures are agnostic to patient clinical complexity and type of treatment required to achieve it. Our objective was to introduce a patient-centered indicator of appropriate diabetes therapy indicator (ADTI), designed for patients with type 2 diabetes, which is based on hemoglobin A1c (HbA1c) but is also contextualized by patient complexity and treatment intensity. RESEARCH DESIGN AND METHODS: A draft indicator was iteratively refined by a multidisciplinary Delphi panel using existing quality measures, guidelines, and published literature. ADTI performance was then assessed using OptumLabs Data Warehouse data for 2015. Included adults (n=206 279) with type 2 diabetes were categorized as clinically complex based on comorbidities, then categorized as treated appropriately, overtreated, or undertreated based on a matrix of clinical complexity, HbA1c level, and medications used. Associations between ADTI and emergency department/hospital visits for hypoglycemia and hyperglycemia were assessed by calculating event rates for each treatment intensity subset. RESULTS: Overall, 7.4% of patients with type 2 diabetes were overtreated and 21.1% were undertreated. Patients with high complexity were more likely to be overtreated (OR 5.60, 95% CI 5.37 to 5.83) and less likely to be undertreated (OR 0.65, 95% CI 0.62 to 0.68) than patients with low complexity. Overtreated patients had higher rates of hypoglycemia than appropriately treated patients (22.0 vs 6.2 per 1000 people/year), whereas undertreated patients had higher rates of hyperglycemia (8.4 vs 1.9 per 1000 people/year). CONCLUSIONS: The ADTI may facilitate timely, patient-centered treatment intensification/deintensification with the goal of achieving safer evidence-based care.

Health plan utilization and costs of specialty drugs within 4 chronic conditions.

BACKGROUND: Drugs are most typically defined as specialty because they are expensive; however, other criteria used to define a drug as specialty include biologic drugs, the need to inject or infuse the drug, the requirement for special handling, or drug availability only via a limited distribution network. Specialty drugs play an increasingly important role in the treatment of chronic conditions such as multiple sclerosis (MS), rheumatoid arthritis (RA), psoriasis, and inflammatory bowel disease (IBD), yet little is known regarding the comprehensive medical and pharmacy benefit utilization and cost trends for these conditions. OBJECTIVE: To describe MS, RA, psoriasis, and IBD trends for condition prevalence, treatment with specialty drugs, specialty costs, nonspecialty costs, and total direct costs of care within the medical and pharmacy benefits. METHODS: This was a descriptive analysis of a commercially insured population made up of 1 million members, using integrated medical and pharmacy administrative claims data from 2008 to 2010. Analyses were limited to continuously enrolled commercially insured individuals less than 65 years of age. Condition-specific cohorts for MS, RA, psoriasis, and IBD were defined using standardized criteria. Trends in condition prevalence, specialty drug use for the conditions, and direct total cost of care were analyzed. The direct costs were subcategorized into the following: medical benefit specialty drug costs, medical benefit all other costs, pharmacy benefit specialty drug costs, and pharmacy benefit all other costs. Trends and compound annual growth rates were calculated for the total cost of care and subcategory costs from 2008 through 2010. RESULTS: Condition prevalence ranged from a low of 1,720 per million members for MS to a high of 4,489 per million members for RA. Psoriasis and MS condition prevalence rates were unchanged over the 3 years; however, IBD prevalence increased 7.0%, and RA prevalence increased 9.7%. The rate of specialty drug use was lowest for IBD (13.7%) and highest for MS (71.8%). The lowest total annual cost of care was for psoriasis ($14,815), and the highest total annual cost was for MS ($36,901). The most commonly used specialty drugs for each of the conditions were as follows: glatiramer (MS), etanercept (RA and psoriasis), and infliximab (IBD). The total annual costs were more than double for the specialty drug users for psoriasis compared with all the psoriasis members ($29,565 vs. $14,815). The total costs were only somewhat higher among MS members using specialty drugs ($41,760 vs. $36,901). Among specialty drug users for each of the cohorts, the annual costs of specialty drugs accounted for 50% or more of the total annual costs. The annual spending growth rate for specialty drugs ranged from 4.4% to 18.0%. CONCLUSIONS: Although specialty drug utilization varied widely across the 4 chronic conditions analyzed, when specialty drugs were used they accounted for the majority of the annual total direct cost of care. Because specialty drugs are accounting for a growing portion of chronic disease total cost of care, health insurers will need to become more vigilant regarding specialty drug use and focus on 4 cost saving management opportunities: drug distribution channel, utilization management, contracting activities, and care coordination.