Associations Between Social Vulnerability Indicators and Pediatric Tonsillectomy Outcomes.

OBJECTIVE: To investigate the impact of neighborhood-level social vulnerability on pediatric tonsillectomy outcomes. METHODS: This single-center retrospective cohort study included tonsillectomies performed on children aged 1 to 18 between August 2019 and August 2020. Geographic information systems were used to geocode addresses, and spatial overlays were used to assign census-tract level social vulnerability index (SVI) scores to each patient. For categorical variables, two-sided Pearson chi-square tests were used, whereas for continuous variables, paired t-tests, means, and standard deviations were calculated. SVI and its four subthemes were investigated using binomial logistic regressions to determine their impact on post-T&A complications and readmissions. RESULTS: The study included 397 patients, with 52 having complications (13.1%) and 33 (8.3%) requiring readmissions due to their complications. Controlling for age, gender, race, insurance status, surgical indication, comorbidities, obesity, and obstructive sleep apnea, postoperative complications were associated with high overall SVI (odds ratio [OR] 5.086, 95% confidence interval [CI] 1.128-22.938), high socioeconomic vulnerability (SVI theme 1, OR 6.003, 95% CI 1.270-28.385), and high house composition vulnerability (SVI theme 2, OR 6.340, 95% CI 1.275-31.525). Readmissions were also associated with high overall SVI (10.149, 95% CI 1.293-79.647) and high housing/transportation vulnerability (SVI theme 4, OR 5.657, 95% CI 1.089-29.396). CONCLUSION: Social vulnerability at the neighborhood level is linked to poorer surgical outcomes in otherwise healthy children, suggesting a target for community-based interventions. Because of the increased risk, it may have implications for preoperative decision-making, treatment plans, and clinic follow-ups. LEVEL OF EVIDENCE: 3: Laryngoscope, 134:954-962, 2024.

Association Between Claims-Defined Frailty and Outcomes Following 30 Versus 12 Months of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: Findings From the EXTEND-DAPT Study.

Background Frailty is rarely assessed in clinical trials of patients who receive dual antiplatelet therapy (DAPT) after percutaneous coronary intervention. This study investigated whether frailty defined using claims data is associated with outcomes following percutaneous coronary intervention, and if there is a differential association in patients receiving standard versus extended duration DAPT. Methods and Results Patients ≥65 years of age in the DAPT (Dual Antiplatelet Therapy) Study, a randomized trial comparing 30 versus 12 months of DAPT following percutaneous coronary intervention, had data linked to Medicare claims (n=1326), and a previously validated claims-based index was used to define frailty. Net adverse clinical events, a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding, were compared between frail and nonfrail patients. Patients defined as frail using claims data (12.0% of the cohort) had higher incidence of net adverse clinical events (23.1%) compared with nonfrail patients (10.7%; P<0.001) at 18-month follow-up and increased risk after multivariable adjustment (adjusted hazard ratio [HR], 2.24 [95% CI, 1.38-3.63]). There were no differences in effects of extended duration DAPT on net adverse clinical events for frail (HR, 1.42 [95% CI, 0.73-2.75]) and nonfrail patients (HR, 1.18 [95% CI, 0.83-1.68]; interaction P=0.61), although analyses were underpowered. Bleeding was highest among frail patients who received extended duration DAPT. Conclusions Among older patients in the DAPT Study, claims-defined frailty was associated with higher net adverse clinical events. Effects of extended duration DAPT were not different for frail patients, although comparisons were underpowered. Further investigation of how frailty influences ischemic and bleeding risks with DAPT are warranted. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00977938.

Identifying Patients for Intensive Blood Pressure Treatment Based on Cognitive Benefit: A Secondary Analysis of the SPRINT Randomized Clinical Trial.

Importance: Intensive vs standard treatment to lower systolic blood pressure (SBP) reduces risk of mild cognitive impairment (MCI) or dementia; however, the magnitude of cognitive benefit likely varies among patients. Objective: To estimate the magnitude of cognitive benefit of intensive vs standard systolic BP (SBP) treatment. Design, Setting, and Participants: In this ad hoc secondary analysis of the Systolic Blood Pressure Intervention Trial (SPRINT), 9361 randomized clinical trial participants 50 years or older with high cardiovascular risk but without a history of diabetes, stroke, or dementia were followed up. The SPRINT trial was conducted between November 1, 2010, and August 31, 2016, and the present analysis was completed on October 31, 2022. Intervention: Systolic blood pressure treatment to an intensive (<120 mm Hg) vs standard (<140 mm Hg) target. Main Outcomes and Measures: The primary outcome was a composite of adjudicated probable dementia or amnestic MCI. Results: A total of 7918 SPRINT participants were included in the analysis; 3989 were in the intensive treatment group (mean [SD] age, 67.9 [9.2] years; 2570 [64.4%] men; 1212 [30.4%] non-Hispanic Black) and 3929 were in the standard treatment group (mean [SD] age, 67.9 [9.4] years; 2570 [65.4%] men; 1249 [31.8%] non-Hispanic Black). Over a median follow-up of 4.13 (IQR, 3.50-5.88) years, there were 765 and 828 primary outcome events in the intensive treatment group and standard treatment group, respectively. Older age (hazard ratio [HR] per 1 SD, 1.87 [95% CI, 1.78-1.96]), Medicare enrollment (HR per 1 SD, 1.42 [95% CI, 1.35-1.49]), and higher baseline serum creatinine level (HR per 1 SD, 1.24 [95% CI, 1.19-1.29]) were associated with higher risk of the primary outcome, while better baseline cognitive functioning (HR per 1 SD, 0.43 [95% CI, 0.41-0.44]) and active employment status (HR per 1 SD, 0.44 [95% CI, 0.42-0.46]) were associated with lower risk of the primary outcome. Risk of the primary outcome by treatment goal was estimated accurately based on similar projected and observed absolute risk differences (C statistic = 0.79). Higher baseline risk for the primary outcome was associated with greater benefit (ie, larger absolute reduction of probable dementia or amnestic MCI) of intensive vs standard treatment across the full range of estimated baseline risk. Conclusions and Relevance: In this secondary analysis of the SPRINT trial, participants with higher baseline projected risk of probable dementia or amnestic MCI gained greater absolute cognitive benefit from intensive vs standard SBP treatment in a monotonic fashion. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.

Reliability of stored river water as an alternative for consumption in Ekpoma, Nigeria: a human health risk assessment.

With looming global water-related issues, the monitoring of water quality for household and industrial consumption has become more pertinent. Rivers in nearby towns serve as primary water sources for Ekpoma town. 123 samples of stored river water were collected from 41 sampling locations and physical properties - pH, electrical conductivity (EC), salinity, temperature, and total dissolved solids (TDS) - were measured in situ using the Hanna edge® Multiparameter EC/TDS/Salinity Meter-HI2030. Atomic absorption spectrophotometry (AAS) was used to detect and measure the concentration of potentially toxic metals (PTMs): Al, Cr, Cu, Fe, Mn, Ni, Pb, and Zn. The measured concentrations were compared to the WHO, US EPA, and NSDWQ regulatory standards, and a spatiotemporal health risk analysis was performed using HERisk software. Twenty-five percent of the tested samples contained PTM concentrations within the allowable regulatory limits. Spatiotemporal health risk analysis showed that 98.8% of the cumulative carcinogenic risks (CRcum) were entirely from Pb contamination via oral ingestion. PTM concentrations in the samples suggest the degradation of river water quality due to agricultural activities, crude oil exploration activities, and soil composition in the region. Best management practices (BMPs) and treatment processes for the removal of detected contaminants are recommended to improve water quality.

Mohs Surgeons Dominate Cutaneous Reconstructions in Cosmetically and Functionally Sensitive Sites: Medicare Trends From 2013 to 2019.

BACKGROUND: Although dermatologists perform more cutaneous reconstructions than any other specialists for the Medicare population, the perception of dermatologists as surgeons may not be as fully recognized. Mohs surgeons are trained in complex reconstructions of cosmetically and functionally sensitive (CFS) sites, although the proportion they account for is unknown. OBJECTIVE: To quantify the proportion of cutaneous reconstructions in CFS sites performed by Mohs surgeons compared with other specialists, and to identify trends from 2013 to 2019. METHODS: A cross-sectional analysis was performed using the Medicare Public Use Files for 2013 to 2019. Data were stratified by physician specialty, with dermatologists further subdivided into Mohs surgeons and non-Mohs dermatologists. RESULTS: Mohs surgeons performed 75.3% of all reconstructions in 2019, a significant increase from 2013 ( p < .0001). Mohs surgeons dominated nearly every type of CFS cutaneous reconstruction, with significant increases in proportion ( p < .0001) from 2013 to 2019 for every category except interpolation flaps. Complex repairs were the most commonly performed cutaneous reconstruction type. CONCLUSION: Mohs surgeons perform far more cutaneous reconstructive surgeries in CFS sites than any other specialty for the Medicare population, with significant increases in their lead over the study period.

Holistic Wellness Coaching for Older Adults: Preliminary Evidence for a Novel Wellness Intervention in Senior Living Communities.

Although resident wellness is increasingly a priority in senior living communities, there are few programs that promote holistic wellness in later life. A total of 79 residents (ages 71 to 97; M = 84.27, SD = 6.46) from eight senior living communities completed a pilot study of a novel, staff-led wellness coaching program consisting of resident-driven goals and individual and group coaching sessions. Participants completed surveys at three time points (pre-program, post-program, and 1-month follow-up). Repeated measures ANOVAs revealed positive changes in resident health satisfaction, physical quality of life (QOL), psychological QOL, loneliness, relatedness, competence, and sense of purpose. Some of these results (i.e., psychological QOL, loneliness) persisted at follow-up. Residents reported high satisfaction with the program. These findings have implications for the application of holistic wellness frameworks in later life, as well as the development and implementation of wellness coaching programs with older adults.

Comparison of patient demographics, utilization trends, and costs of total ankle arthroplasty and ankle fusion in the United States from 2010 to 2019.

INTRODUCTION: Contemporary studies evaluating utilization and trends of total ankle arthroplasty (TAA) and ankle fusion (AF) for tibiotalar osteoarthritis are sparse. Therefore, the purpose of this study was to utilize a nationwide administrative claims database from 2010 to 2019 to compare: (1) baseline demographics; (2) utilization, (3) in-hospital length of stay (LOS), and (4) costs of care. METHODS: Using the PearlDiver database, a retrospective query from January 1st, 2010 to December 31st, 2019 was performed for all patients who underwent TAA and AF for tibiotalar osteoarthritis. Baseline demographics, comorbidities, and geographic utilization were compared using Pearson Chi-square analyses. Linear regression was used to compare differences in procedure utilization and in-hospital LOS during the study interval. Reimbursements between the two cohorts during the study interval were compared. A p value less than 0.05 was statistically significant. RESULTS: In total, 14,248 patients underwent primary TAA (n = 5544) or AF (n = 8704). Patients undergoing AF were generally younger (< 60) with greater comorbidity burden driven by hypertension, diabetes mellitus, obesity, and tobacco use compared to TAA patients (p < 0.0001). Over the study interval, TAA utilization remained constant (912 vs 909 procedures; p = 0.807), whereas AF utilization decreased by 42.5% (1737 vs 998 procedures; p = 0.0001). Mean in-hospital LOS for patients undergoing TAA decreased (2.5 days vs. 2.0 days, p = 0.0004), while AF LOS increased (2.6 days vs. 3.5 days, p = 0.0003). Reimbursements for both procedures significantly declined over the study interval (TAA: $4559-$2156, AF: $4729-$1721; p < 0.013). CONCLUSION: TAA utilization remained constant, while AF utilization declined by 42.5% from 2010 to 2019. There was divergence in the LOS for TAA versus AF patients. Both procedures significantly declined by over 50% in reimbursements over the study interval.

Comparative performance of distinct frailty measures among patients undergoing percutaneous left atrial appendage closure.

AIMS: Frailty is associated with increased morbidity and mortality in patients undergoing left atrial appendage closure (LAAC). This study aimed to compare the performance of two claims-based frailty measures in predicting adverse outcomes following LAAC. METHODS: We identified patients 66 years and older who underwent LAAC between October 1, 2016, and December 31, 2019, in Medicare fee-for-service claims. Frailty was assessed using the previously validated Hospital Frailty Risk Score (HFRS) and Kim Claims-based Frailty Index (CFI). Patients were identified as frail based on HFRS ≥5 and CFI ≥0.25. RESULTS: Of the 21,787 patients who underwent LAAC, frailty was identified in 45.6% by HFRS and 15.4% by CFI. There was modest agreement between the two frailty measures (kappa 0.25, Pearson's correlation 0.62). After adjusting for age, sex, and comorbidities, frailty was associated with higher risk of 30-day mortality, 1-year mortality, 30-day readmission, long hospital stay, and reduced days at home (p < .01 for all) regardless of the frailty measure used. The addition of frailty to standard comorbidities significantly improved model performance to predict 1-year mortality, long hospital stay, and reduced days at home (Delong p-value < .001). CONCLUSION: Despite significant variation in frailty detection and modest agreement between the two frailty measures, frailty status remained highly predictive of mortality, readmissions, long hospital stay, and reduced days at home among patients undergoing LAAC. Measuring frailty in clinical practice, regardless of the method used, may provide prognostic information useful for patients being considered for LAAC, and may inform shared decision-making in this population.

Counting the cost of premature mortality with progressively worse aortic stenosis in Australia: a clinical cohort study.

BACKGROUND: Aortic stenosis is the most common cardiac valve disorder requiring clinical management. However, there is little evidence on the societal cost of progressive aortic stenosis. We sought to quantify the societal burden of premature mortality associated with progressively worse aortic stenosis. METHODS: In this observational clinical cohort study, we examined echocardiograms on native aortic valves of 98 565 men and 99 357 women aged 65 years or older across 23 sites in Australia, from Jan 1, 2003, to Dec 31, 2017. Individuals were grouped according to their peak aortic valve velocity in 0·50 m/s increments up to 4·00 m/s or more (severe aortic stenosis), using 1·00-1·99 m/s (no aortic stenosis) as the reference group. Sex-specific premature mortality and years of life lost during a 5-year follow-up were calculated, along with willingness-to-pay to regain quality-adjusted life years (QALYs). FINDINGS: Overall, 20 701 (21·0%) men and 18 576 (18·7%) women had evidence of mild-to-severe aortic stenosis. The actual 5-year mortality in men with normal aortic valves was 32·1% and in women was 26·1%, increasing to 40·9% (mild aortic stenosis) and 52·2% (severe aortic stenosis) in men and to 35·9% (mild aortic stenosis) and 55·3% (severe aortic stenosis) in women. Overall, the estimated societal cost of premature mortality associated with aortic stenosis was AU$629 million in men and $735 million in women. Per 1000 men and women investigated, aortic stenosis was associated with eight more premature deaths in men resulting in 32·5 more QALYs lost (societal cost of $1·40 million) and 12 more premature deaths in women resulting in 57·5 more QALYs lost (societal cost of $2·48 million) when compared with those without aortic stenosis. INTERPRETATION: Any degree of aortic stenosis in older individuals is associated with premature mortality and QALYs. In this context, there is a crucial need for cost-effective strategies to promptly detect and optimally manage this common condition within our ageing populations. FUNDING: Edwards LifeSciences, National Health and Medical Research Council of Australia, and the National Heart, Lung, and Blood Institute.

Mitral Regurgitation and Mortality Risk in Medicare Beneficiaries With Heart Failure and Preserved Ejection Fraction.

The association of mitral regurgitation (MR) severity and mortality in heart failure with preserved ejection fraction (HFpEF) is uncertain. We sought to evaluate the relation between MR severity on transthoracic echocardiography (TTE) and subsequent all-cause mortality in Medicare beneficiaries with HFpEF. We linked 57,608 patients referred for TTE at Beth Israel Deaconess Medical Center to Medicare inpatient claims from 2003 to 2017. In those with a history of HF and a physician-reported left ventricular ejection fraction ≥50%, we evaluated the relation of MR severity and time to the primary end point of all-cause mortality using Kaplan-Meier methods. A total of 7,778 individuals (14.5%) met inclusion criteria (mean age 75.5 years ± 11.9, 55.9% female). Over a median follow-up of 8.1 years, 2,016 (25.9%) died at a median (interquartile range) of 1.7 (0.3 to 4.1) years. At 1 year, 15.8% with 3 to 4+ MR had died versus 10.5% with 0 to 2+ MR (hazard ratio 1.54, 95% confidence interval 1.22 to 1.95, p <0.001). After multivariable adjustment, 3 to 4+ MR continued to be associated with increased all-cause mortality (hazard ratio 1.48, 95% confidence interval 1.14 to 1.94, p = 0.004) except in the subset with atrial fibrillation (interaction p = 0.03) or recent (<3 months) HF hospitalization (p = 0.54). In conclusion, in this large, single-institution retrospective study of Medicare beneficiaries with HFpEF who underwent TTE, moderate-to-severe and severe MR were significantly associated with an increased risk of all-cause mortality after multivariable adjustment, except in those with atrial fibrillation or recent HF. Prospective studies are needed to assess the role of MR reduction in mitigating this risk.

Characterizing the Accuracy of International Classification of Diseases, Tenth Revision Administrative Claims for Aortic Valve Disease.

BACKGROUND: Administrative claims for aortic stenosis (AS) regurgitation may be useful, but their accuracy and ability to identify individuals at risk for valve-related outcomes have not been well characterized. METHODS: Using echocardiographic (transthoracic echocardiogram [TTE]) reports linked to US Medicare claims, 2017 to 2018, the performance of candidate International Classification of Diseases, Tenth Revision claims to ascertain AS/aortic regurgitation was evaluated. The optimal performing algorithm was tested against outcomes at 1-year after TTE in a separate 100% sample of US Medicare claims, 2017 to 2019. RESULTS: Of those included in the derivation (N=5497, mean age 74.4±11.0 years, 49.7% female), any AS or aortic regurgitation was present in 24% and 38.8%, respectively. The sensitivity and specificity of International Classification of Diseases, Tenth Revision code I35.0 for identification of any AS was 53.1% and 94.8%, respectively. Among those with an I35.0 code, 40.3% had severe AS. Claims were unable to distinguish disease severity (ie, severe versus nonsevere) or subtype (eg, bicuspid or rheumatic AS), and were insensitive and nonspecific for aortic regurgitation of any severity. Among all beneficiaries who received a TTE (N=4 033 844), adjusting for age, sex, and 27 comorbidities, those with an I35.0 code had a higher adjusted risk of all-cause mortality (adjusted hazard ratio, 1.33 [95% CI, 1.31-1.34]), heart failure hospitalization (adjusted hazard ratio, 1.37 [95% CI, 1.34-1.41]), and aortic valve replacement (adjusted hazard ratio, 34.96 [95% CI, 33.74-36.22]). CONCLUSIONS: Among US Medicare beneficiaries receiving a TTE, International Classification of Diseases, Tenth Revision claims, though identifying a population at significant greater risk of valve-related outcomes, failed to identify nearly half of individuals with AS and were unable to distinguish disease severity or subtype. These results argue against the widespread use of International Classification of Diseases, Tenth Revision claims to screen for patients with AS and suggests the need for improved coding algorithms and alternative systems to extract TTE data for quality improvement and hospital benchmarking.

Unsupervised pattern-recognition and radiological risk assessment applied to the evaluation of behavior of rare earth elements, Th, and U in monazite sand.

The Brazilian coast is rich in monazite which is found in beach sand deposits. In this study, the composition of the monazite sands from beaches of State of Espírito Santo, Brazil, was investigated. The concentrations of rare earth elements (REEs), Th, and U were determined by inductively coupled plasma mass spectrometry (ICP-MS). In the studied region, the mean concentration of investigated elements increased in the following order: Tm < Yb < Ho < Lu < Eu < Er < Tb < Dy < U < Y < Th < Gd < Sm < Pr < Nd < La < Ce. The sampling sites were classified into three clusters and discriminated by the concentrations of REEs, Th, and U found. In general, the radiological risk indices were higher than the established limits, and the risk of developing cancer was estimated to be higher than the world average.

Cost-Effectiveness of Masked Hypertension Screening and Treatment in US Adults With Suspected Masked Hypertension: A Simulation Study.

BACKGROUND: Recent US blood pressure (BP) guidelines recommend using ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) to screen adults for masked hypertension. However, limited evidence exists of the expected long-term effects of screening for and treating masked hypertension. METHODS: We estimated the lifetime health and economic outcomes of screening for and treating masked hypertension using the Cardiovascular Disease (CVD) Policy Model, a validated microsimulation model. We simulated a cohort of 100,000 US adults aged ≥20 years with suspected masked hypertension (i.e., office BP 120-129/<80 mm Hg, not taking antihypertensive medications, without CVD history). We compared usual care only (i.e., no screening), usual care plus ABPM, and usual care plus HBPM. We projected total direct healthcare costs (2021 USD), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Future costs and QALYs were discounted 3% annually. Secondary outcomes included CVD events and serious adverse events. RESULTS: Relative to usual care, adding masked hypertension screening and treatment with ABPM and HBPM was projected to prevent 14.3 and 20.5 CVD events per 100,000 person-years, increase the proportion experiencing any treatment-related serious adverse events by 2.7 and 5.1 percentage points, and increase mean total costs by $1,076 and $1,046, respectively. Compared with usual care, adding ABPM was estimated to cost $85,164/QALY gained. HBPM resulted in lower QALYs than usual care due to increased treatment-related adverse events and pill-taking disutility. CONCLUSIONS: The results from our simulation study suggest screening with ABPM and treating masked hypertension is cost-effective in US adults with suspected masked hypertension.

The Differential Impact of Medicaid Expansion on Disparities in Outcomes Following Peripheral Vascular Intervention.

BACKGROUND: Peripheral artery disease (PAD) disproportionately affects nonwhite, Hispanic/Latino, and low socioeconomic status patients, who are less likely to have insurance and routine healthcare visits. Medicaid expansion (ME) has improved insurance rates and access to care, potentially benefitting these patients. We sought to assess the impact of ME on disparities in outcomes after peripheral vascular intervention (PVI) for PAD. METHODS: A retrospective analysis of prospectively-collected Vascular Quality Initiative PVI procedures between 2011 and 2019 was conducted. The sample was restricted to first-record procedures in adults under the age 65 in states that expanded Medicaid on January 1, 2014 (ME group) or had not expanded before January 1, 2019 (non-expansion [NE] group). ME and NE groups were compared between pre-expansion (2011-2013) and post-expansion (2014- 2019) time periods to assess baseline demographic and operative differences. We used difference-in-differences multivariable logistic regression adjusted for patient factors and clinical center and year fixed effects. Our primary outcome was 1-year major amputation. Secondary outcomes included trends in presentation, 30-day mortality, 1-year mortality, and 1-year primary and secondary patency. Outcomes were stratified by race and ethnicity. RESULTS: We examined 34,313 PVI procedures, including 20,378 with follow-up data. Rates of Medicaid insurance increased post-expansion in ME and NE states (ME 16.7% to 23.0%, P < 0.001; NE 10.0% to 11.9%, P = 0.013) while rates of self-pay decreased in ME states only (ME 4.6% to 1.8%, P < 0.001; NE 8.1% to 8.4%, P = 0.620). Adjusted difference-in-differences analysis revealed lower odds of urgent/emergent PVI among all patients and all nonwhite patients in ME states post-expansion compared to NE states (all: odds ratio [OR] 0.53 [95% confidence interval 0.33-0.87], P = 0.011; nonwhite: OR 0.41 [0.19-0.88], P = 0.023). No differences were observed for 1-year major amputation (OR 0.70 [0.43-1.14], P = 0.152), primary patency (OR 0.93 [0.63-1.38], P = 0.726), or secondary patency (OR 1.29 [0.69-2.41], P = 0.431). Odds of 1-year mortality were higher in ME states post-expansion compared to NE states (OR 2.50 [1.07-5.87], P = 0.035), although 30-day mortality was not different (OR 2.04 [0.60-6.90], P = 0.253). Notably, odds of 1-year major amputation among Hispanic/Latino patients decreased in ME states post-expansion compared to NE states (OR 0.11 [0.01-0.86], P = 0.036). CONCLUSIONS: ME was associated with lower odds of 1-year major amputation among Hispanic/Latino patients who underwent PVI for PAD. ME was also associated with lower odds of urgent/emergent procedures among patients overall and nonwhite patients specifically. However, 1-year mortality increased in the overall cohort. Further study is needed to corroborate our findings that ME may have benefits for certain underserved populations with PAD.

Cost-effectiveness of Icosapent Ethyl for High-risk Patients With Hypertriglyceridemia Despite Statin Treatment.

Importance: The Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated the efficacy of icosapent ethyl (IPE) for high-risk patients with hypertriglyceridemia and known cardiovascular disease or diabetes and at least 1 other risk factor who were treated with statins. Objective: To estimate the cost-effectiveness of IPE compared with standard care for high-risk patients with hypertriglyceridemia despite statin treatment. Design, Setting, and Participants: An in-trial cost-effectiveness analysis was performed using patient-level study data from REDUCE-IT, and a lifetime analysis was performed using a microsimulation model and data from published literature. The study included 8179 patients with hypertriglyceridemia despite stable statin therapy recruited between November 21, 2011, and May 31, 2018. Analyses were performed from a US health care sector perspective. Statistical analysis was performed from March 1, 2018, to October 31, 2021. Interventions: Patients were randomly assigned to IPE, 4 g/d, or placebo and were followed up for a median of 4.9 years (IQR, 3.5-5.3 years). The cost of IPE was $4.16 per day after rebates using SSR Health net cost (SSR cost) and $9.28 per day with wholesale acquisition cost (WAC). Main Outcomes and Measures: Main outcomes were incremental quality-adjusted life-years (QALYs), total direct health care costs (2019 US dollars), and cost-effectiveness. Results: A total of 4089 patients (2927 men [71.6%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive IPE, and 4090 patients (2895 men [70.8%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive standard care. Treatment with IPE yielded more QALYs than standard care both in trial (3.34 vs 3.27; mean difference, 0.07 [95% CI, 0.01-0.12]) and over a lifetime projection (10.59 vs 10.35; mean difference, 0.24 [95% CI, 0.15-0.33]). In-trial, total health care costs were higher with IPE using either SSR cost ($18 786) or WAC ($24 544) than with standard care ($17 273; mean difference from SSR cost, $1513 [95% CI, $155-$2870]; mean difference from WAC, $7271 [95% CI, $5911-$8630]). Icosapent ethyl cost $22 311 per QALY gained using SSR cost and $107 218 per QALY gained using WAC. Over a lifetime, IPE was projected to be cost saving when using SSR cost ($195 276) compared with standard care ($197 064; mean difference, -$1788 [95% CI, -$9735 to $6159]) but to have higher costs when using WAC ($202 830) compared with standard care (mean difference, $5766 [95% CI, $1094-$10 438]). Compared with standard care, IPE had a 58.4% lifetime probability of costing less and being more effective when using SSR cost and an 89.4% probability of costing less than $50 000 per QALY gained when using SSR cost and a 72.5% probability of costing less than $50 000 per QALY gained when using WAC. Conclusions and Relevance: This study suggests that, both in-trial and over the lifetime, IPE offers better cardiovascular outcomes than standard care in REDUCE-IT participants at common willingness-to-pay thresholds.

Outcomes of stroke events during transcatheter aortic valve implantation.

BACKGROUND: Despite improvements in the safety of transcatheter aortic valve implantation (TAVI), ~4% of patients experience a procedure-related stroke. Understanding long-term health and healthcare implications of these events may motivate the development and adoption of preventative strategies.  Aims: We aimed to assess the association of TAVI-related ischaemic stroke with subsequent clinical outcomes and healthcare utilisation. METHODS: We used Medicare fee-for-service claims to identify patients who underwent their first TAVI between January 2012 and December 2017. Previously used ICD-9-CM and ICD-10-CM codes were used to identify TAVI-related ischaemic stroke. Among those with and without TAVI-related ischaemic stroke, we compared the risk of a composite endpoint that included all-cause mortality, acute myocardial infarction, and subsequent stroke using inverse probability treatment weighted Cox regression. We also performed a difference-in-difference analysis to compare 1-year Medicare expenditures and days spent at home during the first year after TAVI. RESULTS:  Among 129,628 primary TAVI patients, 5,549 (4.3%) had a procedure-related stroke. These patients were more likely to be female and have had prior stroke, peripheral vascular disease, ischaemic heart disease, or renal failure. After adjustment, TAVI-related ischaemic stroke was associated with a higher risk of the 1-year composite outcome (HR 1.67, 95% CI: 1.56-1.78), higher 1-year Medicare expenditures (difference $9,245 [standard error 790], p<0.001), and fewer days at home during the first year (difference 16 days [standard error 1], p<0.001). CONCLUSIONS: Among Medicare beneficiaries undergoing TAVI, procedure-related ischaemic stroke was associated with worse outcomes, increased Medicare expenditures, and less time spent at home. Procedure-related ischaemic stroke during TAVI remains a critically important and potentially preventable source of patient mortality, morbidity and healthcare utilisation.

Frailty in patients undergoing percutaneous left atrial appendage closure.

BACKGROUND: Frailty is associated with significant morbidity and mortality in older adults. Whether frailty predicts adverse outcomes after percutaneous left atrial appendage closure (LAAC) remains uncertain. OBJECTIVE: The purpose of this study was to examine the association between frailty and clinical outcomes after percutaneous LAAC. METHODS: We identified patients 65 years and older in Medicare fee-for-service claims who underwent LAAC between October 1, 2016, and December 31, 2019. Patients were identified as frail on the basis of the Hospital Frailty Risk Score (HFRS), a validated frailty measure centered on health resource utilization, with the cohort stratified into low (<5), intermediate (5-15), and high (>15) risk groups. RESULTS: Of the 21,787 patients who underwent LAAC, 10,740 (49.3%) were considered frail (HFRS >5), including 3441 (15.8%) in the high-risk group. The mortality rate (up to 1095 days) were 16.1% in the low-risk group, 26.7% in the intermediate-risk group, and 41.1% in the high-risk group (P < .001). After adjusting for age, sex, and comorbidities, HFRS >15 (compared with HFRS <5) was associated with a higher risk of long hospital stay (odds ratio [OR] 8.29; 95% confidence interval [CI] 5.94-11.57), 30-day readmission (OR 1.80, 95% CI 1.58-2.05), 30-day mortality (OR 5.68, 95% CI 3.40-9.40), and 1-year mortality (OR 2.83, 95% CI 2.39-3.35). In restricted cubic spline models, the adjusted OR for all outcomes monotonically increased with increasing HFRS. CONCLUSION: Frailty is common in patients undergoing LAAC and is associated with increased risks of long hospital stay, readmissions, and short-term mortality.