Publications

BACKGROUND: Vaccine hesitancy persists alongside concerns about the safety of coronavirus disease 2019 (COVID-19) vaccines. We aimed to examine the effect of COVID-19 vaccination on risk of death among US veterans.

METHODS: We conducted a target trial emulation to estimate and compare risk of death up to 60 days under two COVID-19 vaccination strategies: vaccination within 7 days of enrollment versus no vaccination through follow-up. The study cohort included individuals aged ≥18 years enrolled in the Veterans Health Administration system and eligible to receive a COVID-19 vaccination according to guideline recommendations from 1 March 2021 through 1 July 2021. The outcomes of interest included deaths from any cause and excluding a COVID-19 diagnosis. Observations were cloned to both treatment strategies, censored, and weighted to estimate per-protocol effects.

RESULTS: We included 3 158 507 veterans. Under the vaccination strategy, 364 993 received vaccine within 7 days. At 60 days, there were 156 deaths per 100 000 veterans under the vaccination strategy versus 185 deaths under the no vaccination strategy, corresponding to an absolute risk difference of -25.9 (95% confidence limit [CL], -59.5 to 2.7) and relative risk of 0.86 (95% CL, .7 to 1.0). When those with a COVID-19 infection in the first 60 days were censored, the absolute risk difference was -20.6 (95% CL, -53.4 to 16.0) with a relative risk of 0.88 (95% CL, .7 to 1.1).

CONCLUSIONS: Vaccination against COVID-19 was associated with a lower but not statistically significantly different risk of death in the first 60 days. These results agree with prior scientific knowledge suggesting vaccination is safe with the potential for substantial health benefits.

BACKGROUND: Recent advances in heart failure (HF) care have sought to shift management from inpatient to outpatient and observation settings. We evaluated the association among HF treatment in the (1) inpatient; (2) observation; (3) emergency department (ED); and (4) outpatient settings with 30-day mortality, hospitalizations and cost.

METHODS: Using 100% Medicare inpatient, outpatient and Part B files from 2011-2018, 1,534,708 unique patient encounters in which intravenous (IV) diuretics were received for a primary diagnosis of HF were identified. Encounters were sorted into mutually exclusive settings: (1) inpatient; (2) observation; (3) ED; or (4) outpatient IV diuretic clinic. The primary outcome was 30-day all-cause mortality. Secondary outcomes included 30-day hospitalization and total 30-day costs. Multivariable logistic and linear regression were used to examine the association between treatment location and the primary and secondary outcomes.

RESULTS: Patients treated in observation and outpatient settings had lower 30-day mortality rates (observation OR 0.67, 95% CI 0.66-0.69; P < 0.001; outpatient OR 0.53, 95% CI 0.51-0.55; P < 0.001) compared to those treated in inpatient settings. Observation and outpatient treatment were also associated with decreased 30-day total cost compared to inpatient treatment. Observation relative cost -$5528.77, 95% CI -$5613.63 to -$5443.92; outpatient relative cost -$7005.95; 95% CI -$7103.94 to -$6907.96). Patients treated in the emergency department and discharged had increased mortality rates (OR 1.15, 95% CI 1.13-1.17; P < 0.001) and increased rates of hospitalization (OR 1.72, 95% CI 1.70-1.73; P < 0.001) compared to patients treated as inpatients.

CONCLUSIONS: Medicare beneficiaries who received IV diuresis for acute HF in the outpatient and observation settings had lower mortality rates and decreased costs of care compared to patients treated as inpatients. Outpatient and observation management of acute decompensated HF, when available, is a safe and cost-effective strategy in certain populations of patients with HF.

BACKGROUND AND AIMS: Declines in cardiovascular mortality have stagnated in the USA since 2011. There is growing concern that these patterns reflect worsening cardiovascular health in younger adults. However, little is known about how the burden of acute cardiovascular hospitalizations and mortality has changed in this population. Changes in cardiovascular hospitalizations and mortality among adults aged 25-64 years were evaluated, overall and by community-level income.

METHODS: Using the National Inpatient Sample, age-standardized annual hospitalization and in-hospital mortality rates for acute myocardial infarction (AMI), heart failure, and ischaemic stroke were determined among adults aged 25-64 years. Quasi-Poisson and quasi-binominal regression models were fitted to compare outcomes between individuals residing in low- and higher-income communities.

RESULTS: Between 2008 and 2019, age-standardized hospitalization rates for AMI increased among younger adults from 155.0 (95% confidence interval: 154.6, 155.4) per 100 000 to 160.7 (160.3, 161.1) per 100 000 (absolute change +5.7 [5.0, 6.3], P < .001). Heart failure hospitalizations also increased (165.3 [164.8, 165.7] to 225.3 [224.8, 225.8], absolute change +60.0 (59.3, 60.6), P < .001), as ischaemic stroke hospitalizations (76.3 [76.1, 76.7] to 108.1 [107.8, 108.5], absolute change +31.7 (31.2, 32.2), P < .001). Across all conditions, hospitalizations rates were significantly higher among younger adults residing in low-income compared with higher-income communities, and disparities did not narrow between groups. In-hospital mortality decreased for all conditions over the study period.

CONCLUSIONS: There was an alarming increase in cardiovascular hospitalizations among younger adults in the USA from 2008 to 2019, and disparities between those residing in low- and higher-income communities did not narrow.

BACKGROUND: Lower-limb amputation rates in patients with chronic limb-threatening ischemia vary across the United States, with marked disparities in amputation rates by gender, race, and income status. We evaluated the association of patient, hospital, and geographic characteristics with the intensity of vascular care received the year before a major lower-limb amputation and how intensity of care associates with outcomes after amputation.

METHODS: Using Medicare claims data (2016-2019), beneficiaries diagnosed with chronic limb-threatening ischemia who underwent a major lower-limb amputation were identified. We examined patient, hospital, and geographic characteristics associated with the intensity of vascular care received the year before amputation. Secondary objectives evaluated all-cause mortality and adverse events following amputation.

RESULTS: Of 33 036 total Medicare beneficiaries undergoing major amputation, 7885 (23.9%) were due to chronic limb-threatening ischemia; of these, 4988 (63.3%) received low-intensity and 2897 (36.7%) received high-intensity vascular care. Mean age, 76.6 years; women, 38.9%; Black adults, 24.5%; and of low income, 35.2%. After multivariable adjustment, those of low income (odds ratio, 0.65 [95% CI, 0.58-0.72]; P<0.001), and to a lesser extent, men (odds ratio, 0.89 [95% CI, 0.81-0.98]; P=0.019), and those who received care at a safety-net hospital (odds ratio, 0.87 [95% CI, 0.78-0.97]; P=0.012) were most likely to receive low intensity of care before amputation. High-intensity care was associated with a lower risk of all-cause mortality 2 years following amputation (hazard ratio, 0.79 [95% CI, 0.74-0.85]; P<0.001).

CONCLUSIONS: Patients who were of low-income status, and to a lesser extent, men, or those cared for at safety-net hospitals were most likely to receive low-intensity vascular care. Low-intensity care was associated with worse long-term event-free survival. These data emphasize the continued disparities that exist in contemporary vascular practice.

IMPORTANCE: The Centers for Medicare & Medicaid Services (CMS) Bundled Payments for Care Improvement (BPCI) program was launched in 2013 with a goal to improve care quality while lowering costs to Medicare.

OBJECTIVE: To compare changes in the quality and outcomes of care for patients hospitalized with heart failure according to hospital participation in the BPCI program.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used a difference-in-difference approach to evaluate the BPCI program in 18 BPCI hospitals vs 211 same-state non-BPCI hospitals for various process-of-care measures and outcomes using American Heart Association Get With The Guidelines-Heart Failure registry and CMS Medicare claims data from November 1, 2008, to August 31, 2018. Data were analyzed from May 2022 to May 2023.

EXPOSURES: Hospital participation in CMS BPCI Model 2 Heart Failure, which paid hospitals in a fee-for-service process and then shared savings or required reimbursement depending on how the total cost of an episode of care compared with a target price.

MAIN OUTCOMES AND MEASURES: Primary end points included 7 quality-of-care measures. Secondary end points included 9 outcome measures, including in-hospital mortality and hospital-level risk-adjusted 30-day and 90-day all-cause readmission rate and mortality rate.

RESULTS: During the study period, 8721 patients were hospitalized in the 23 BPCI hospitals and 94 530 patients were hospitalized in the 224 same-state non-BPCI hospitals. Less than a third of patients (30 723 patients, 29.8%) were 75 years or younger; 54 629 (52.9%) were female, and 48 622 (47.1%) were male. Hospital participation in BPCI Model 2 was not associated with significant differential changes in the odds of various process-of-care measures, except for a decreased odds of evidence-based β-blocker at discharge (adjusted odds ratio [aOR], 0.63; 95% CI, 0.41-0.98; P = .04). Participation in the BPCI was not associated with a significant differential change in the odds of receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitors at discharge, receiving an aldosterone antagonist at discharge, having a cardiac resynchronization therapy (CRT)-defibrillator or CRT pacemaker placed or prescribed at discharge, having implantable cardioverter-defibrillator (ICD) counseling or an ICD placed or prescribed at discharge, heart failure education being provided among eligible patients, or having a follow-up visit within 7 days or less. Participation in the BPCI was associated with a significant decrease in odds of in-hospital mortality (aOR, 0.67; 95% CI, 0.51-0.86; P = .002). Participation was not associated with a significant differential change in hospital-level risk-adjusted 30-day or 90-day all-cause readmission rate and 30-day or 90-day all-cause mortality rate.

CONCLUSION AND RELEVANCE: In this study, hospital participation in the BPCI Model 2 Heart Failure program was not associated with improvement in process-of-care quality measures or 30-day or 90-day risk-adjusted all-cause mortality and readmission rates.

The care of Black adults is highly concentrated at a limited set of US hospitals that often have limited resources. In 2011, the Medicare Hospital Value-Based Purchasing (VBP) Program began financially penalizing or rewarding hospitals based on thirty-day mortality rates for target conditions (myocardial infarction, heart failure, and pneumonia). Because the VBP Program has disproportionately penalized resource-constrained hospitals caring for high proportions of Black adults since its implementation in 2011, clinicians, health system leaders, and policy makers have worried that the program may unintentionally be widening racial disparities in health outcomes. Using Medicare claims for beneficiaries ages sixty-five and older who were hospitalized for three target conditions at 2,908 US hospitals participating in the VBP Program, we found that thirty-day mortality rates were consistently higher for two of three conditions at hospitals with high proportions of Black adults compared with other hospitals. There was no evidence of a differential change in thirty-day mortality among all Medicare beneficiaries with targeted conditions at high-proportion Black hospitals versus other hospitals seven years after the implementation of the VBP Program. However, gaps in mortality between these sites did widen in the subgroup of Black adults with pneumonia. These findings highlight that important concerns remain about the regressive nature and equity implications of national pay-for-performance programs.