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OBJECTIVE: To compare transcatheter aortic valve replacement (TAVR) outcomes during the period when public health emergency (PHE) flexibilities were in place with outcomes during a period before they were introduced. METHODS: Patients who received a native TAVR with either a SAPIEN 3 or SAPIEN 3 Ultra valve from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry between June 22, 2019, and August 30, 2022, were placed into one of two cohorts: (1) pre-PHE cohort, and (2) peri-PHE cohort. Outcomes included in-hospital events and events occurring 30 days post-TAVR. Patients were matched 1:1 on their propensity of receiving a TAVR during the pre- or peri-PHE periods. After matching, relative risk was calculated for each in-hospital outcome and HRs for outcomes 30 days post-TAVR. RESULTS: In this study, 173,434 patients met inclusion criteria; after 1:1 matching, there were 37,063 patients in each cohort. There was no difference between cohorts in in-hospital outcomes, including all-cause mortality, stroke, composite of mortality and stroke, pacemaker, or major vascular complications. Similarly, there was no statistically significant difference in 30-day outcomes between the cohorts. CONCLUSION: In this large-scale retrospective study of 74,126 patients undergoing TAVR procedures from 2019 to 2022, no significant differences existed in TAVR outcomes during the PHE period.
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Background: Hospital admissions for cardiogenic shock have increased in the United States. Temporary mechanical circulatory support (tMCS) can be used to acutely stabilize patients. We sought to evaluate the presence of racial, ethnic, and socioeconomic inequities in access to MCS in the United States among patients with cardiogenic shock. Methods: Medicare data were used to identify patients with cardiogenic shock admitted to hospitals with advanced tMCS (microaxial left ventricular assist device [mLVAD] or extracorporeal membranous oxygenation [ECMO]) capabilities within the 25 largest core-based statistical areas, all major metropolitan areas. We modeled the association between patient race, ethnicity, and socioeconomic status and use of mLVAD or ECMO. Results: After adjusting for age and clinical comorbidities, dual eligibility for Medicaid was associated with a 19.9% (95% CI, 11.5%-27.4%) decrease in odds of receiving mLVAD in a patient with cardiogenic shock (P < .001). After adjusting for age, clinical comorbidities, and dual eligibility for Medicaid, Black race was associated with 36.7% (95% CI, 28.4%-44.2%) lower odds of receiving mLVAD in a patient with cardiogenic shock. Dual eligibility for Medicaid was associated with a 62.0% (95% CI, 60.8%-63.1%) decrease in odds of receiving ECMO in a patient with cardiogenic shock (P < .001). Black race was associated with 36.0% (95% CI, 16.6%-50.9%) lower odds of receiving ECMO in a patient with cardiogenic shock, after adjusting for Medicaid eligibility. Conclusions: We identified large and significant racial, ethnic, and socioeconomic inequities in access to mLVAD and ECMO among patients presenting with cardiogenic shock to metropolitan hospitals with active advanced tMCS programs. These findings highlight systematic inequities in access to potentially lifesaving therapies.
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Background: Catheter-directed thrombolysis (CDT) and large-bore mechanical thrombectomy (MT) are the leading percutaneous-based therapies for the management of intermediate-risk pulmonary embolism (PE). While previous studies have demonstrated their procedural safety and efficacy, the cost implications of these interventions remain unclear. This study aims to conduct a cost-benefit analysis to evaluate the economic advantages associated with CDT and MT from the perspective of the treating hospital. Methods: A total of 372 consecutive patients with intermediate-risk acute PE who underwent either MT or CDT at 3 academic centers between 2013 and 2021 were included in this analysis. The costs of care incurred during the index hospitalization for the 2 treatment groups were collected and compared using an adjusted cost model. Results: This study compared the hospital costs of 226 patients who underwent CDT and 146 patients who underwent MT. In the unadjusted overall cohort, the use of CDT was associated with a numerical but nonsignificant increase in costs amounting to $5120 relative to MT (P = .062). This cost difference was primarily driven by the longer length of stay in the intensive care unit and hospital for CDT patients, particularly earlier in the studied timeframe. However, when accounting for confounders including variations between the treating institutions and the timing of treatment during the study period, the adjusted cost differential between CDT and MT narrowed to $1351 (P = .71). Conclusions: This multicenter cost analysis does not reveal a clear cost advantage of 1 treatment over the other for intermediate-risk PE. The observed cost differences were influenced by variations in practice patterns across the study period and among the 3 participating institutions. Future efforts should also focus on strategies to reduce the length of stay, improve efficiency, and minimize the overall cost of care for intermediate-risk PE patients.
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BACKGROUND: The extent and consequences of ischemia in patients with chronic limb-threatening ischemia (CLTI) may change rapidly, and delays from diagnosis to revascularization may worsen outcomes. We sought to describe the association between time from diagnosis to endovascular lower extremity revascularization (diagnosis-to-limb revascularization [D2L] time) and clinical outcomes in outpatients with CLTI. METHODS AND RESULTS: In the CLIPPER cohort, comprising patients between 66 and 86 years old diagnosed with CLTI betweeen 2010 and 2019, we used Medicare claims data to identify patients who underwent outpatient endovascular revascularization within 180 days of diagnosis. We described the risk-adjusted association between D2L time and clinical outcomes. Among 1 130 065 patients aged between 66 and 86 years with CLTI, 99 221 (8.8%) underwent outpatient endovascular lower extremity revascularization within 180 days of their CLTI diagnosis. Among patients with D2L time <30 days, there was no association between D2L time and all-cause death or major lower extremity amputation. However, among patients with D2L time >30 days, each additional 10-day increase in D2L time was associated with a 2.5% greater risk of major amputation (hazard ratio, 1.025 [95% CI, 1.014-1.036]). There was no association between D2L time and all-cause death. CONCLUSIONS: A delay of >30 days from CLTI diagnosis to lower extremity endovascular revascularization was associated with an increased risk of major lower extremity amputation among patients undergoing outpatient endovascular revascularization. Improving systems of care to reduce D2L time could reduce amputations.
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Amputación Quirúrgica , Isquemia Crónica que Amenaza las Extremidades , Procedimientos Endovasculares , Tiempo de Tratamiento , Humanos , Anciano , Masculino , Femenino , Anciano de 80 o más Años , Procedimientos Endovasculares/efectos adversos , Isquemia Crónica que Amenaza las Extremidades/cirugía , Isquemia Crónica que Amenaza las Extremidades/complicaciones , Estados Unidos/epidemiología , Amputación Quirúrgica/estadística & datos numéricos , Factores de Tiempo , Resultado del Tratamiento , Recuperación del Miembro , Estudios Retrospectivos , Medicare , Extremidad Inferior/irrigación sanguínea , Factores de Riesgo , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/complicaciones , Pacientes Ambulatorios , Medición de Riesgo , Isquemia/cirugía , Isquemia/diagnósticoRESUMEN
BACKGROUND: Studies comparing transcatheter and surgical aortic valve replacement (TAVR and SAVR) for patients with trileaflet aortic stenosis (AS) have found similar or larger effective orifice area (EOA) for TAVR prostheses. To our knowledge, no studies have compared EOA in patients undergoing TAVR versus SAVR for bicuspid AS. METHODS: We retrospectively compared prosthetic valvular sizing and predicted EOA for patients with bicuspid AS undergoing TAVR or SAVR at our institution between January 1, 2016, and December 31, 2021. We excluded patients undergoing procedures for indications other than AS and those without a pre-procedural gated Chest CT. Comparisons included demographics, comorbidities, annular size, prosthetic valve size, predicted EOA and prosthesis-patient mismatch (PPM) for TAVR (N = 78) and SAVR (N = 74) cohorts. RESULTS: TAVR patients had smaller pre-procedural annular area (501.7 mm2 vs. 571.8 mm2, p < 0.05) and annular perimeter (80.6 mm vs. 86.5 mm, p < 0.05), but larger mean implanted prosthetic valve size (26.4 mm vs 24.2 mm, p < 0.001) compared to SAVR patients. No differences were observed in predicted EOA, predicted EOA indexed to patient body surface area (EOAi), or predicted PPM grade between TAVR and SAVR groups, including in cohorts sorted by pre-procedural annular size. CONCLUSIONS: For bicuspid AS patients undergoing aortic valve replacement, TAVR achieves similar predicted EOA to SAVR. These data support the use of TAVR in selected patients with bicuspid AS and can inform heart team discussions.
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Estenosis de la Válvula Aórtica , Válvula Aórtica , Enfermedad de la Válvula Aórtica Bicúspide , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Válvula Aórtica/anomalías , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estudios Retrospectivos , Femenino , Enfermedad de la Válvula Aórtica Bicúspide/cirugía , Enfermedad de la Válvula Aórtica Bicúspide/diagnóstico por imagen , Enfermedad de la Válvula Aórtica Bicúspide/fisiopatología , Masculino , Resultado del Tratamiento , Anciano , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Anciano de 80 o más Años , Factores de Riesgo , Enfermedades de las Válvulas Cardíacas/cirugía , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Enfermedades de las Válvulas Cardíacas/fisiopatología , Hemodinámica , Recuperación de la Función , Persona de Mediana Edad , Factores de TiempoRESUMEN
Adults with lower socioeconomic status have a disproportionately higher burden of cardiovascular disease. Medicaid expansion under the Affordable Care Act, which went into effect January 1, 2014, in adopting states, led to an expansion of health insurance coverage for low-income adults. To understand whether Medicaid expansion was associated with increased access to outpatient cardiovascular care in expansion states, we examined Medicaid Analytic eXtract administrative claims data for nonelderly adult beneficiaries from the period 2012-15 for two states that expanded Medicaid eligibility (New Jersey and Minnesota) and two states that did not (Georgia and Tennessee) and calculated population-level rates of cardiovascular care use. There was a 38.1 percent greater increase in expansion states in the rate of beneficiaries with outpatient visits for cardiovascular disease management associated with Medicaid expansion relative to nonexpansion states. This was accompanied by a 42.9 percent greater increase in the prescription rate for cardiovascular disease management agents. These results suggest that expansion of Medicaid eligibility was associated with an increase in cardiovascular care use among low-income nonelderly adults in expansion states.
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Enfermedades Cardiovasculares , Medicaid , Estados Unidos , Adulto , Humanos , Seguro de Salud , Patient Protection and Affordable Care Act , Pacientes Ambulatorios , Accesibilidad a los Servicios de Salud , Cobertura del SeguroRESUMEN
BACKGROUND: Climate change is causing an increase in extreme heat. Individuals with cardiovascular disease are at high risk of heat-related adverse health effects. How the burden of extreme heat-associated cardiovascular deaths in the United States will change with the projected rise in extreme heat is unknown. METHODS: We obtained data on cardiovascular deaths among adults and the number of extreme heat days (maximum heat index ≥90â °F [32.2â °C]) in each county in the contiguous United States from 2008 to 2019. Based on representative concentration pathway trajectories that model greenhouse gas emissions and shared socioeconomic pathways (SSP) that model future socioeconomic scenarios and demographic projections, we obtained county-level projected numbers of extreme heat days and populations under 2 scenarios for the midcentury period 2036 to 2065: SSP2-4.5 (representing demographic projections from a "middle-of-the-road" socioeconomic scenario and an intermediate increase in emissions) and SSP5-8.5 (demographic projections in an economy based on "fossil-fueled development" and a large increase in emissions). The association of cardiovascular mortality with extreme heat was estimated with a Poisson fixed-effects model. Using estimates from this model, the projected number of excess cardiovascular deaths associated with extreme heat was calculated. RESULTS: Extreme heat was associated with 1651 (95% CI, 921-2381) excess cardiovascular deaths per year from 2008 to 2019. By midcentury, extreme heat is projected to be associated with 4320 (95% CI, 2369-6272) excess deaths annually, which is an increase of 162% (95% CI, 142-182) under SSP2-4.5, and 5491 (95% CI, 3011-7972) annual excess deaths, which is an increase of 233% (95% CI, 206-259) under SSP5-8.5. Elderly adults are projected to have a 3.5 (95% CI, 3.2-3.8) times greater increase in deaths in the SSP2-4.5 scenario compared with nonelderly adults. Non-Hispanic Black adults are projected to have a 4.6 (95% CI, 2.8-6.4) times greater increase compared with non-Hispanic White adults. The projected change in deaths was not statistically significantly different for other race and ethnicity groups or between men and women. CONCLUSIONS: By midcentury, extreme heat is projected to be associated with a significantly greater burden of excess cardiovascular deaths in the contiguous United States.
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Enfermedades Cardiovasculares , Calor Extremo , Masculino , Adulto , Humanos , Estados Unidos/epidemiología , Femenino , Anciano , Calor Extremo/efectos adversos , Calor , PredicciónRESUMEN
Importance: American Indian and Alaska Native persons face significant health disparities; however, data regarding the burden of cardiovascular disease in the current era is limited. Objective: To determine the incidence and prevalence of cardiovascular disease, the burden of comorbid conditions, including cardiovascular disease risk factors, and associated mortality among American Indian and Alaska Native patients with Medicare insurance. Design, Setting, and Participants: This was a population-based cohort study conducted from January 2015 to December 2019 using Medicare administrative data. Participants included American Indian and Alaska Native Medicare beneficiaries 65 years and older enrolled in both Medicare part A and B fee-for-service Medicare. Statistical analyses were performed from November 2022 to April 2023. Main Outcomes and Measures: The annual incidence, prevalence, and mortality associated with coronary artery disease (CAD), heart failure (HF), atrial fibrillation/flutter (AF), and cerebrovascular disease (stroke or transient ischemic attack [TIA]). Results: Among 220â¯598 American Indian and Alaska Native Medicare beneficiaries, the median (IQR) age was 72.5 (68.5-79.0) years, 127â¯402 were female (57.8%), 78â¯438 (38.8%) came from communities in the most economically distressed quintile in the Distressed Communities Index. In the cohort, 44.8% of patients (98â¯833) were diagnosed with diabetes, 61.3% (135â¯124) were diagnosed with hyperlipidemia, and 72.2% (159â¯365) were diagnosed with hypertension during the study period. The prevalence of CAD was 38.6% (61â¯125 patients) in 2015 and 36.7% (68â¯130 patients) in 2019 (P < .001). The incidence of acute myocardial infarction increased from 6.9 per 1000 person-years in 2015 to 7.7 per 1000 patient-years in 2019 (percentage change, 4.79%; P < .001). The prevalence of HF was 22.9% (36â¯288 patients) in 2015 and 21.4% (39â¯857 patients) in 2019 (P < .001). The incidence of HF increased from 26.1 per 1000 person-years in 2015 to 27.0 per 1000 person-years in 2019 (percentage change, 4.08%; P < .001). AF had a stable prevalence of 9% during the study period (2015: 9.4% [14â¯899 patients] vs 2019: 9.3% [25â¯175 patients]). The incidence of stroke or TIA decreased slightly throughout the study period (12.7 per 1000 person-years in 2015 and 12.1 per 1000 person-years in 2019; percentage change, 5.08; P = .004). Fifty percent of patients (110â¯244) had at least 1 severe cardiovascular condition (CAD, HF, AF, or cerebrovascular disease), and the overall mortality rate for the cohort was 19.8% (43â¯589 patients). Conclusions and Relevance: In this large cohort study of American Indian and Alaska Native patients with Medicare insurance in the US, results suggest a significant burden of cardiovascular disease and cardiometabolic risk factors. These results highlight the critical need for future efforts to prioritize the cardiovascular health of this population.
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Indio Americano o Nativo de Alaska , Enfermedades Cardiovasculares , Medicare , Pobreza , Determinantes Sociales de la Salud , Anciano , Femenino , Humanos , Masculino , Indio Americano o Nativo de Alaska/estadística & datos numéricos , Aleteo Atrial , Enfermedades Cardiovasculares/economía , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etnología , Enfermedades Cardiovasculares/mortalidad , Estudios de Cohortes , Enfermedad de la Arteria Coronaria , Insuficiencia Cardíaca , Ataque Isquémico Transitorio , Medicare/economía , Medicare/estadística & datos numéricos , Accidente Cerebrovascular , Estados Unidos/epidemiología , Beneficios del Seguro/economía , Beneficios del Seguro/estadística & datos numéricos , Costo de Enfermedad , Incidencia , Prevalencia , Comorbilidad , Factores de Riesgo , Factores de Riesgo Cardiometabólico , Determinantes Sociales de la Salud/economía , Determinantes Sociales de la Salud/etnología , Determinantes Sociales de la Salud/estadística & datos numéricos , Pobreza/economía , Pobreza/etnología , Pobreza/estadística & datos numéricosRESUMEN
Importance: Inadequate representation of older patients, women, and racial minority individuals in cardiovascular clinical trials limits both the generalizability of trial findings and inclusivity in access to novel therapies and therapeutic strategies. Objective: To report on temporal trends in the representation of older patients, women, and racial and ethnic minority individuals in clinical trials studying treatments for valvular heart disease. Evidence Review: All published clinical trials enrolling more than 100 adults with any valvular heart disease published between 2005 and 2020 were included after searches with PubMed and ClinicalTrials.gov. Data on age, sex, race, and ethnicity reported in the included studies were collected. Trials were assigned to 4 time periods based on the publication date, and temporal trends were analyzed in the representation of older patients, women, and racial and ethnic minority individuals. Findings: A total of 139 clinical trials with 51â¯527 participants were identified. Of these trials, 103 (74%) investigated aortic valve disease and the remainder mitral valve disease. Overall, 63 trials (45.3%) enrolled patients only in Europe, 24 (17.3%) only in North America, and 19 (13.7%) in multiple geographical regions. The weighted mean (SD) age of enrolled patients was 68.4 (11.4) years, increasing nonsignificantly from 61.9 (5.9) years in 2005-2008 to 72.8 (9.6) years in 2017-2020 (P = .09 for trend). The overall proportion of women enrolled in valvular heart disease trials was 41.1%, with no significant changes over time. Data on race and ethnicity of trial participants were reported in 13 trials (9.4%), in which trial-level representation of American Indian/Alaska Native, Asian, Black/African American, Hispanic, and Native Hawaiian/Pacific Islander patients ranged from 0.27% to 43.9%. There were no significant temporal trends noted in the enrollment of racial and ethnic minority populations. The representation of women in clinical trials was positively associated with enrollment rates of older patients and underrepresented racial and ethnic groups. Conclusions and Relevance: This review found that over the past 2 decades, women and racial and ethnic minority individuals have remained underrepresented in North American valvular heart disease clinical trials. Further work is needed to improve the reporting of race and ethnicity data and address barriers to trial enrollment for older patients, women, and racial and ethnic minority individuals.
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Etnicidad , Enfermedades de las Válvulas Cardíacas , Adulto , Humanos , Femenino , Anciano , Grupos Minoritarios , Minorías Étnicas y Raciales , Hispánicos o LatinosRESUMEN
BACKGROUND: Racial residential segregation is associated with racial health inequities, but it is unclear if segregation may exacerbate Black-White disparities in cardiovascular disease (CVD) mortality. This study aimed to assess associations between Black-White residential segregation, CVD mortality rates among non-Hispanic (NH) Black and NH White populations, and Black-White disparities in CVD mortality. METHODS: This cross-sectional study analyzed Black-White residential segregation, as measured by county-level interaction index, of US counties, county-level CVD mortality among NH White and NH black adults aged 25 years and older, and county-level Black-White disparities in CVD mortality in years 2014 to 2017. Age-adjusted, county-level NH Black CVD mortality rates and NH White cardiovascular disease mortality rates, as well as group-level relative risk ratios for Black-White cardiovascular disease mortality, were calculated. Sequential generalized linear models adjusted for county-level socioeconomic and neighborhood factors were used to estimate associations between residential segregation and cardiovascular mortality rates among NH Black and NH White populations. Relative risk ratio tests were used to compare Black-White disparities in the most segregated counties to disparities in the least segregated counties. RESULTS: We included 1,286 counties with ≥5% Black populations in the main analysis. Among adults aged ≥25 years, there were 2,611,560 and 408,429 CVD deaths among NH White and NH Black individuals, respectively. In the unadjusted model, counties in the highest tertile of segregation had 9% higher (95% CI, 1%-20% higher, P = .04) rates of NH Black CVD mortality than counties in the lowest tertile of segregation. In the multivariable adjusted model, the most segregated counties had 15% higher (95% CI, 0.5% to 38% higher, P = .04) rates of NH Black CVD mortality than the least segregated counties. In the most segregated counties, NH Black individuals were 33% more likely to die of CVD than NH White individuals (RR 1.33, 95% CI 1.32 to 1.33, P < .001). CONCLUSIONS: Counties with increased Black-White residential segregation have higher rates of NH Black CVD mortality and larger Black-White disparities in CVD mortality. Identifying the causal mechanisms through which racial residential segregation widens disparities in CVD mortality requires further study.
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Negro o Afroamericano , Enfermedades Cardiovasculares , Disparidades en el Estado de Salud , Segregación Residencial , Blanco , Adulto , Humanos , Enfermedades Cardiovasculares/etnología , Enfermedades Cardiovasculares/mortalidad , Estudios Transversales , Segregación Residencial/estadística & datos numéricos , Estados Unidos/epidemiología , Blanco/estadística & datos numéricos , Población Blanca , Negro o Afroamericano/estadística & datos numéricosRESUMEN
BACKGROUND: We assess the rates of device use and outcomes by race among patients undergoing lower extremity peripheral arterial intervention using the American College of Cardiology National Cardiovascular Data Registry-Peripheral Vascular Intervention (PVI) registry. METHODS: Patients who underwent PVI between April 2014 and March 2019 were included. Socioeconomic status was evaluated using the Distressed Community Index score for patients' zip codes. Multivariable logistic regression was used to assess factors associated with utilization of drug-eluting technologies, intravascular imaging, and atherectomy. Among patients with Centers for Medicare and Medicaid Services data, we compared 1-year mortality, rates of amputation, and repeat revascularizations. RESULTS: Of 63 150 study cases, 55 719 (88.2%) were performed in White patients and 7431 (11.8%) in Black patients. Black patients were younger (67.9 versus 70.0 years), had higher rates of hypertension (94.4% versus 89.5%), diabetes (63.0% versus 46.2%), less likely to be able to walk 200 m (29.1% versus 24.8%), and higher Distressed Community Index scores (65.1 versus 50.6). Black patients were provided drug-eluting technologies at a higher rate (adjusted odds ratio, 1.14 [95% CI, 1.06-1.23]) with no difference in atherectomy (adjusted odds ratio, 0.98 [95% CI, 0.91-1.05]) or intravascular imaging (adjusted odds ratio, 1.03 [95% CI, 0.88-1.22]) use. Black patients experienced a lower rate of acute kidney injury (adjusted odds ratio, 0.79 [95% CI, 0.72-0.88]). In Centers for Medicare and Medicaid Services-linked analyses of 7429 cases (11.8%), Black patients were significantly less likely to have surgical (adjusted hazard ratio, 0.40 [95% CI, 0.17-0.96]) or repeat PVI revascularization (adjusted hazard ratio, 0.42 [95% CI, 0.30-0.59]) at 1 year compared with White patients. There was no difference in mortality (adjusted hazard ratio [0.8-1.4]) or major amputation (adjusted hazard ratio, 2.5 [95% CI, 0.8-7.6]) between Black and White patients. CONCLUSIONS: Black patients presenting for PVI were younger, had higher prevalence of comorbidities and lower socioeconomic status. After adjustment, Black patients were less likely to have surgical or repeat PVI revascularization after the index PVI procedure.
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Enfermedad Arterial Periférica , Humanos , Anciano , Estados Unidos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Factores de Riesgo , Factores Raciales , Resultado del Tratamiento , Medicare , Sistema de Registros , Estudios RetrospectivosRESUMEN
Background Inequitable access to high-technology therapeutics may perpetuate inequities in care. We examined the characteristics of US hospitals that did and did not establish left atrial appendage occlusion (LAAO) programs, the patient populations those hospitals served, and the associations between zip code-level racial, ethnic, and socioeconomic composition and rates of LAAO among Medicare beneficiaries living within large metropolitan areas with LAAO programs. Methods and Results We conducted cross-sectional analyses of Medicare fee-for-service claims for beneficiaries aged 66 years or older between 2016 and 2019. We identified hospitals establishing LAAO programs during the study period. We used generalized linear mixed models to measure the association between zip code-level racial, ethnic, and socioeconomic composition and age-adjusted rates of LAAO in the most populous 25 metropolitan areas with LAAO sites. During the study period, 507 candidate hospitals started LAAO programs, and 745 candidate hospitals did not. Most new LAAO programs opened in metropolitan areas (97.4%). Compared with non-LAAO centers, LAAO centers treated patients with higher median household incomes (difference of $913 [95% CI, $197-$1629], P=0.01). Zip code-level rates of LAAO procedures per 100 000 Medicare beneficiaries in large metropolitan areas were 0.34% (95% CI, 0.33%-0.35%) lower for each $1000 zip code-level decrease in median household income. After adjustment for socioeconomic markers, age, and clinical comorbidities, LAAO rates were lower in zip codes with higher proportions of Black or Hispanic patients. Conclusions Growth in LAAO programs in the United States had been concentrated in metropolitan areas. LAAO centers treated wealthier patient populations in hospitals without LAAO programs. Within major metropolitan areas with LAAO programs, zip codes with higher proportions of Black and Hispanic patients and more patients experiencing socioeconomic disadvantage had lower age-adjusted rates of LAAO. Thus, geographic proximity alone may not ensure equitable access to LAAO. Unequal access to LAAO may reflect disparities in referral patterns, rates of diagnosis, and preferences for using novel therapies experienced by racial and ethnic minority groups and patients experiencing socioeconomic disadvantage.
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Apéndice Atrial , Medicare , Humanos , Anciano , Estados Unidos/epidemiología , Etnicidad , Apéndice Atrial/cirugía , Estudios Transversales , Grupos Minoritarios , RentaRESUMEN
Importance: Racial and ethnic minority and socioeconomically disadvantaged patients have been underrepresented in randomized clinical trials. Efforts have focused on enhancing inclusion of minority groups at sites participating at clinical trials; however, there may be differences in the patient populations of the sites that participate in clinical trials. Objective: To identify any differences in the racial, ethnic, and socioeconomic composition of patient populations among candidate sites in the US that did vs did not participate in trials for novel transcatheter therapies. Design, Setting, and Participants: This cross-sectional analysis used Medicare Provider Claims from 2019 for patients admitted to hospitals in the US. All clinical trials for transcatheter mitral and tricuspid valve therapies and the hospitals participating in each of the trials were identified using ClinicalTrials.gov. Hospitals with active cardiac surgical programs that did not participate in the trials were also identified. Data analysis was performed between July 2021 and July 2022. Exposures: Multivariable linear regression models were used to identify differences in racial, ethnic, and socioeconomic characteristics among patients undergoing cardiac surgery or transcatheter aortic valve replacement at trial vs nontrial hospitals. Main Outcome and Measures: The main outcome of the study was participation in a clinical trial for novel transcatheter mitral or tricuspid valve therapies. Results: A total of 1050 hospitals with cardiac surgery programs were identified, of which 121 (11.5%) participated in trials for transcatheter mitral or tricuspid therapies. Patients treated in trial hospitals had a higher median zip code-based household income (difference of $5261; 95% CI, $2986-$7537), a lower Distressed Communities Index score (difference of 5.37; 95% CI, 2.59-8.15), and no significant difference in the proportion of patients dual eligible for Medicaid (difference of 0.86; 95% CI, -2.38 to 0.66). After adjusting for each of the socioeconomic indicators separately, there was less than 1% difference in the proportion of Black and Hispanic patients cared for at hospitals participating vs not participating in clinical trials. Conclusions and Relevance: In this cohort study among candidate hospitals for clinical trials for transcatheter mitral or tricuspid valve therapies, trial hospitals took care of a more socioeconomically advantaged population than nontrial hospitals, with a similar proportion of Black and Hispanic patients. These data suggest that site selection efforts may improve enrollment of socioeconomically disadvantaged patients but may not improve the enrollment of Black and Hispanic patients.
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Enfermedades de las Válvulas Cardíacas , Válvula Tricúspide , Anciano , Humanos , Estados Unidos/epidemiología , Válvula Tricúspide/cirugía , Estudios de Cohortes , Etnicidad , Estudios Transversales , Medicare , Grupos Minoritarios , Enfermedades de las Válvulas Cardíacas/cirugíaRESUMEN
This Viewpoint discusses the structural barriers to care that exist for patients of racial and ethnic minoritized and socioeconomically disadvantaged groups and proposes solutions to address the inequities in health care delivery.
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Atención a la Salud , Etnicidad , HumanosRESUMEN
Background: Chronic limb-threatening ischemia (CLTI) is a common condition with high rates of morbidity and mortality. Despite extensive literature documenting poor outcomes in patients with CLTI, as well as racial, ethnic, socioeconomic, and geographic disparities in these outcomes, process measures for high-quality CLTI care have not been developed. We developed the Chronic Limb threatening Ischemia Process PERformace (CLIPPER) cohort to develop and test the validity of CLTI care quality measures. Methods: Using inpatient and outpatient claims data from patients with fee-for-service Medicare from 2010 to 2019, we created a coding algorithm to identify patients with CLTI. To qualify for a CLTI diagnosis, patients had to have either diagnostic codes for peripheral artery disease and for ulceration, infection, or gangrene on the same inpatient or outpatient claim or a CLTI-specific diagnostic code. Patients were also required to have a procedural code indicating arterial vascular testing within 6 months before or after the earliest qualifying CLTI diagnostic code(s). We describe baseline characteristics and long-term outcomes of this cohort. Results: The final cohort comprised 1,130,065 patients diagnosed with CLTI between 2010 and 2019. Mean (±SD) age of the cohort was 75 ± 5.8 years; 48.4% were women, and 14.6% were Black. Within 30 days of CLTI diagnosis, 20.4% of patients underwent either percutaneous or surgical revascularization. Within 6 months, 3.3% of patients underwent major amputation; 16.7% of patients died within 1 year and 50.3% within 5 years. Conclusions: We described the development of a cohort of fee-for-service Medicare patients with CLTI using inpatient and outpatient Medicare claims data. CLIPPER will be a resource for developing a set of process measures that can be captured from administrative claims data, with plans to describe their association with limb outcomes and corresponding racial, ethnic, socioeconomic, sex-based, and geographic variability.