Longitudinal outcomes following peripheral vascular intervention among older persons living with HIV.

BACKGROUND: Persons living with human immunodeficiency virus (HIV, PLWH) have an increased risk of peripheral artery disease (PAD) in comparison to the general population. However, a gap remains in understanding optimal management for this condition. This study assesses longitudinal outcomes associated with peripheral endovascular intervention (PVI) for PAD among PLWH. METHODS: All Medicare fee-for-service patients undergoing femoropopliteal artery PVI between April 1, 2015 and December 31, 2018 were identified and stratified by HIV serostatus. The primary outcome was major adverse limb events (MALE), defined as major amputation or arterial embolism/thrombosis following an index procedure. The subdistribution hazard was used to evaluate the association between HIV serostatus and MALE, accounting for the competing risk of death. Results were adjusted for sociodemographics and major comorbidities. RESULTS: Of 168,553 patients who underwent PVI, 357 (0.21%) were PLWH. The average age was 77.0 ± 7.6 years; 80.3% had hypertension, 70.3% had hyperlipidemia, and 24.6% had tobacco use disorder. Compared to those without HIV, PLWH were younger and had a higher burden of cardiovascular risk factors. MALE were substantially more frequent among PLWH, with a cumulative incidence of 24.6%, compared to 14.5% among those without HIV. The adjusted subdistribution hazard ratio was 1.26 (95% CI 1.00-1.58, p = 0.05). The use of guideline-directed statin therapy was low in both groups in the 90 days following revascularization (57.9% in PLWH vs 58.1% in those without HIV, p = 0.95). CONCLUSION: Among US Medicare beneficiaries, PLWH had poorer long-term outcomes following PVI. Greater attention to the management of symptomatic PAD is warranted for the HIV population, particularly following revascularization.

Long term risk of death and readmission after hospital admission with covid-19 among older adults: retrospective cohort study.

OBJECTIVES: To characterize the long term risk of death and hospital readmission after an index admission with covid-19 among Medicare fee-for-service beneficiaries, and to compare these outcomes with historical control patients admitted to hospital with influenza. DESIGN: Retrospective cohort study. SETTING: United States. PARTICIPANTS: 883 394 Medicare fee-for-service beneficiaries age ≥65 years discharged alive after an index hospital admission with covid-19 between 1 March 2020 and 31 August 2022, compared with 56 409 historical controls discharged alive after a hospital admission with influenza between 1 March 2018 and 31 August 2019. Weighting methods were used to account for differences in observed characteristics. MAIN OUTCOME MEASURES: All cause death within 180 days of discharge. Secondary outcomes included first all cause readmission and a composite of death or readmission within 180 days. RESULTS: The covid-19 cohort compared with the influenza cohort was younger (77.9 v 78.9 years, standardized mean difference -0.12) and had a lower proportion of women (51.7% v 57.3%, -0.11). Both groups had a similar proportion of black beneficiaries (10.3% v 8.1%, 0.07) and beneficiaries with dual Medicaid-Medicare eligibility status (20.1% v 19.2%; 0.02). The covid-19 cohort had a lower comorbidity burden, including atrial fibrillation (24.3% v 29.5%, -0.12), heart failure (43.4% v 49.9%, -0.13), and chronic obstructive pulmonary disease (39.2% v 52.9%, -0.27). After weighting, the covid-19 cohort had a higher risk (ie, cumulative incidence) of all cause death at 30 days (10.9% v 3.9%; standardized risk difference 7.0%, 95% confidence interval 6.8% to 7.2%), 90 days (15.5% v 7.1%; 8.4%, 8.2% to 8.7%), and 180 days (19.1% v 10.5%; 8.6%, 8.3% to 8.9%) compared with the influenza cohort. The covid-19 cohort also experienced a higher risk of hospital readmission at 30 days (16.0% v 11.2%; 4.9%, 4.6% to 5.1%) and 90 days (24.1% v 21.3%; 2.8%, 2.5% to 3.2%) but a similar risk at 180 days (30.6% v 30.6%;-0.1%, -0.5% to 0.3%). Over the study period, the 30 day risk of death for patients discharged after a covid-19 admission decreased from 17.9% to 7.2%. CONCLUSIONS: Medicare beneficiaries who were discharged alive after a covid-19 hospital admission had a higher post-discharge risk of death compared with historical influenza controls; this difference, however, was concentrated in the early post-discharge period. The risk of death for patients discharged after a covid-19 related hospital admission substantially declined over the course of the pandemic.

Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study.

BACKGROUND: Concerns have been raised about the long-term performance of aortic stent grafts for the treatment of abdominal aortic aneurysms, in particular, unibody stent grafts (eg, Endologix AFX AAA stent grafts). Only limited data sets are available to evaluate the long-term risks related to these devices. The SAFE-AAA Study (Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries Study) was designed with the Food and Drug Administration to provide a longitudinal assessment of the safety of unibody aortic stent grafts among Medicare beneficiaries. METHODS: The SAFE-AAA Study was a prespecified, retrospective cohort study evaluating whether unibody aortic stent grafts are noninferior to non-unibody aortic stent grafts with respect to the composite primary outcome of aortic reintervention, rupture, and mortality. Procedures were evaluated from August 1, 2011, through December 31, 2017. The primary end point was evaluated through December 31, 2019. Inverse probability weighting was used to account for imbalances in observed characteristics. Sensitivity analyses were used to evaluate the effect of unmeasured confounding, including assessment of the falsification end points heart failure, stroke, and pneumonia. A prespecified subgroup included patients treated from February 22, 2016, through December 31, 2017, corresponding to the market release of the most contemporary unibody aortic stent grafts (Endologix AFX2 AAA stent graft). RESULTS: Of 87 163 patients who underwent aortic stent grafting at 2146 US hospitals, 11 903 (13.7%) received a unibody device. The average age of the total cohort was 77.0±6.7 years, 21.1% were female, 93.5% were White, 90.8% had hypertension, and 35.8% used tobacco. The primary end point occurred in 73.4% of unibody device-treated patients versus 65.0% of non-unibody device-treated patients (hazard ratio, 1.19 [95% CI, 1.15-1.22]; noninferior P value of 1.00; median follow-up, 3.4 years). Falsification end points were negligibly different between groups. In the subgroup treated with contemporary unibody aortic stent grafts, the cumulative incidence of the primary end point occurred in 37.5% of unibody device-treated patients and 32.7% of non-unibody device-treated patients (hazard ratio, 1.06 [95% CI, 0.98-1.14]). CONCLUSIONS: In the SAFE-AAA Study, unibody aortic stent grafts failed to meet noninferiority compared with non-unibody aortic stent grafts with respect to aortic reintervention, rupture, and mortality. These data support the urgency of instituting a prospective longitudinal surveillance program for monitoring safety events related to aortic stent grafts.

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.

Enriching the American Heart Association COVID-19 Cardiovascular Disease Registry Through Linkage With External Data Sources: Rationale and Design.

Background The AHA Registry (American Heart Association COVID-19 Cardiovascular Disease Registry) captures detailed information on hospitalized patients with COVID-19. The registry, however, does not capture information on social determinants of health or long-term outcomes. Here we describe the linkage of the AHA Registry with external data sources, including fee-for-service (FFS) Medicare claims, to fill these gaps and assess the representativeness of linked registry patients to the broader Medicare FFS population hospitalized with COVID-19. Methods and Results We linked AHA Registry records of adults ≥65 years from March 2020 to September 2021 with Medicare FFS claims using a deterministic linkage algorithm and with the American Hospital Association Annual Survey, Rural Urban Commuting Area codes, and the Social Vulnerability Index using hospital and geographic identifiers. We compared linked individuals with unlinked FFS beneficiaries hospitalized with COVID-19 to assess the representativeness of the AHA Registry. A total of 10 010 (47.0%) records in the AHA Registry were successfully linked to FFS Medicare claims. Linked and unlinked FFS beneficiaries were similar with respect to mean age (78.1 versus 77.9, absolute standardized difference [ASD] 0.03); female sex (48.3% versus 50.2%, ASD 0.04); Black race (15.1% versus 12.0%, ASD 0.09); dual-eligibility status (26.1% versus 23.2%, ASD 0.07); and comorbidity burden. Linked patients were more likely to live in the northeastern United States (35.7% versus 18.2%, ASD 0.40) and urban/metropolitan areas (83.9% versus 76.8%, ASD 0.18). There were also differences in hospital-level characteristics between cohorts. However, in-hospital outcomes were similar (mortality, 23.3% versus 20.1%, ASD 0.08; home discharge, 45.5% versus 50.7%, ASD 0.10; skilled nursing facility discharge, 24.4% versus 22.2%, ASD 0.05). Conclusions Linkage of the AHA Registry with external data sources such as Medicare FFS claims creates a unique and generalizable resource to evaluate long-term health outcomes after COVID-19 hospitalization.

Association Between Medicare Program Type and Health Care Access, Acute Care Utilization, and Affordability Among Adults With Cardiovascular Disease.

BACKGROUND: Medicare Advantage plans now provide health insurance coverage to >24 million older adults in the United States, and enrollment is increasing among individuals with cardiovascular disease (CVD). Whether Medicare Advantage enrollment is associated with similar health care access, acute care utilization, and financial strain for adults with CVD compared with traditional Medicare is unknown. METHODS: We performed a cross-sectional study of Medicare beneficiaries 65 years or older with CVD using the 2019 National Health Interview Survey. We fit multivariable logistic regression models to examine the association of Medicare program type (Medicare Advantage versus traditional Medicare) with measures of health care access, acute care utilization, and affordability. RESULTS: The weighted population included 11 013 437 Medicare beneficiaries, of whom 3 922 104 (35.6%) were enrolled in Medicare Advantage, and 7 091 334 (64.4%) were enrolled in traditional Medicare. Medicare Advantage and traditional Medicare enrollees were similar with respect to age, sex, racial/ethnic distribution, and household income; however, Medicare Advantage beneficiaries were more likely to live in an urban setting (82.7% versus 76.0%; P=0.01) and to be college educated (24.2% versus 19.0%; P=0.01). Medicare Advantage beneficiaries were more likely to have a usual source of care (93.5% versus 88.9%; OR, 1.99 [95% CI, 1.33-2.98)]; however, there were no other differences in health care access or utilization. Medicare Advantage beneficiaries were more likely to have problems paying medical bills (16.5% versus 11.6%; OR, 1.68 [1.17-2.40]) and to worry about paying medical bills (40.1% versus 33.8%; OR, 1.37 [1.07-1.76]) compared with those enrolled in traditional Medicare. CONCLUSIONS: Adults with CVD in Medicare Advantage were more likely to experience financial strain related to their medical bills compared with those in traditional Medicare. As enrollment in Medicare Advantage grows, policy efforts should focus on ensuring care is affordable for patients with CVD.

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.

Health Care Access and Management of Cardiovascular Risk Factors Among Working-Age Adults With Low Income by State Medicaid Expansion Status.

Importance: Medicaid expansion led to gains in insurance coverage among working-age adults with low income. To date, the extent to which disparities in access and cardiovascular care persist for this population in Medicaid nonexpansion and expansion states is unknown. Objective: To compare insurance coverage, health care access, and cardiovascular risk factor management between working-age adults (age 18-64 years) with low income in Medicaid nonexpansion and expansion states and between uninsured and insured adults in these states. Design, Setting, and Participants: This cross-sectional study analyzed data on adults aged 18 to 64 years with low income from the Behavioral Risk Factor Surveillance System from January 1 to December 31, 2019. Exposures: State Medicaid expansion and insurance status. Main Outcomes and Measures: The main outcomes were health care access and monitoring and treatment of cardiovascular risk factors. The estimated adjusted risk difference (RD) in outcomes was estimated to compare adults in Medicaid nonexpansion and expansion states and uninsured and insured individuals in nonexpansion and expansion states. Results: The weighted study population consisted of 28 028 451 working-age adults with low income, including 10 094 994 (36.0%) in Medicaid nonexpansion states (63.4% female) and 17 933 457 (64.0%) in expansion states (59.2% female). Adults in nonexpansion states had higher uninsurance rates (42.4% [95% CI, 40.2%-44.7%] vs 23.8% [95% CI, 22.8%-24.8%]), were less likely to have a usual source of care (55.4% [95% CI, 53.1%-57.6%] vs 65.4% [95% CI, 64.3%-66.5%]; adjusted RD, -11.4% [95% CI, -13.9% to -8.8%]) or a recent examination (78.9% [95% CI, 77.0%-80.9%] vs 84.4% [95% CI, 83.5%-85.2%]; RD, -6.2% [95% CI, -8.4% to -4.0%]), and were more likely to have deferred care owing to cost (36.1% [95% CI, 34.0%-38.2%] vs 21.8% [95% CI, 20.9%-22.8%]; RD, 14.2% [95% CI, 11.9%-16.6%]) than were those in expansion states. There were no significant differences in cardiovascular risk factor management between these groups. In nonexpansion states, uninsured adults had significantly worse access to care across these measures and were less likely to receive indicated monitoring of cholesterol (72.6% [95% CI, 67.7%-77.4%] vs 93.7%; [95% CI, 92.4%-95.0%]; RD, -17.2% [95% CI, -21.8% to -12.6%]) and hemoglobin A1c (55.2% [95% CI, 40.0%-72.5%] vs 88.5% [95% CI, 79.2%-97.9%]; RD, -25.8% [95% CI, -47.6% to -4.1%]) levels or to receive treatment for hypertension (49.4% [95% CI, 43.3%-55.6%] vs 74.7% [95% CI, 71.5%-78.0%]; RD, -16.3% [95% CI, -23.2% to -9.4%]) and hyperlipidemia (30.2% [95% CI, 23.5%-36.8%] vs 58.7% [95% CI, 53.9%-63.5%]; RD, -19.3% [95% CI, -27.9% to -10.7%]) compared with insured adults. These patterns were similar for uninsured and insured adults in expansion states. Conclusions and Relevance: In this study, working-age adults with low income in Medicaid nonexpansion states experienced higher uninsurance rates and worse access to care than did those in expansion states; however, cardiovascular risk factor management was similar and treatment rates were low. In nonexpansion states, uninsured adults were less likely to receive appropriate cardiovascular risk factor management compared with insured adults.

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.

Early buprenorphine-naloxone initiation for opioid use disorder reduces opioid overdose, emergency room visits, and healthcare cost compared to late initiation.

Background: Although the effectiveness of buprenorphine-naloxone (BUP-NX) has been established, real-world evidence on the benefits of early treatment initiation is limited.Objective: To evaluate the association between early BUP-NX initiation and health-related outcomes among insured adults with opioid use disorder (OUD).Methods: We conducted a cross-sectional analysis using the Optum's de-identified Clinformatics® Data Mart Database from 2010 to 2018. Patients who initiated BUP-NX within 30 days of OUD diagnosis were classified as early initiators. Patients who initiated BUP-NX later, but within the one-year follow-up, were defined as late initiators. Outcomes included opioid overdose, opioid overdose-related emergency department (ED) visits, and all-cause healthcare cost during the year after OUD diagnosis. We employed generalized linear models to compare outcomes between early and late initiators, adjusting for baseline covariates and accounting for missing information for covariates using multiple imputation.Results: A total of 8,388 patients with OUD were identified; mean age was 39.9 years; 36% were female; and 67.6% were early initiators. Early initiators had an estimated 42% lower rate of opioid overdose (adjusted rate ratio (aRR) = 0.58; 95% confidence interval (CI): 0.52, 0.64); 51% lower rate of opioid overdose-related ED visits (aRR = 0.49; 95% CI: 0.44, 0.55); and 31% lower total healthcare cost (adjusted cost ratio = 0.69; 95% CI: 0.66, 0.72), compared to late initiators.Conclusion: Compared to late BUP-NX initiation, early initiation was associated with a lower risk of opioid overdose and opioid overdose-related ED visits, and reduced total healthcare cost among insured adult patients with OUD.