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Cardiovascular disease (CVD) and heart failure (HF) are major causes of mortality in low-income populations and differ by sex. Risk assessment that incorporates cardiac biomarkers is common. However, research evaluating the utility of biomarkers rarely includes controlled substances, which may influence biomarker levels and thus influence CVD risk assessment.We identified the effects of multiple substances on soluble "suppression of tumorigenicity 2" (sST2), a biomarker of adverse cardiac remodelling, in 245 low-income women. Adjusting for CVD risk factors, we examined associations between substance use and sST2 over six monthly visits.Median age was 53 years and 74% of participants were ethnic minority women. An sST2 level35 ng/mL (suggesting cardiac remodelling) during ≥1 study visit was observed in 44% of participants. In adjusted analysis, higher sST2 levels were significantly and positively associated with the presence of cocaine (Adjusted Linear Effect [ALE]:1.10; 95% CI:1.03-1.19), alcohol (ALE:1.10; 95% CI:1.04-1.17), heroin (ALE:1.25; 95% CI:1.10-1.43), and the interaction between heroin and fentanyl use.Results suggest that the use of multiple substances influences the level of sST2, a biomarker often used to evaluate cardiovascular risk. Incorporating substance use alongside cardiac biomarkers may improve CVD risk assessment in vulnerable women.

Days at home (DAH) quantifies time spent at home after a medical event but has not been fully evaluated for TAVR. We sought to compare 1- and 5-year DAH (DAHWe linked data from the U.S. CoreValve High Risk Trial to Medicare Fee-for-Service claims in 456 patients with 450 (234 TAVR/216 SAVR) and 427 (222 TAVR/205 SAVR) analyzed at 1 and 5 years. DAH was calculated as the number of days alive and spent outside of a hospital, skilled nursing facility, rehabilitation, long-term acute care hospital, emergency department, or observation stay.Mean DAHIn the U.S. CoreValve High Risk Trial linked to Medicare, high-risk patients undergoing TAVR spend an average of 27 additional DAH compared with SAVR in the first year after the procedure due to a shorter index LOS and the additive effect of fewer but nonsignificantly different mortality and total facility days after discharge from the index hospitalization compared with SAVR. After the first year, both groups spend a similar number of DAH. These results describe the postprocedural course of high-risk patients from a patient-centered perspective, which may guide expectations regarding longitudinal health care needs and inform shared decision-making.

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.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. 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], p0.001), and fewer days at home during the first year (difference 16 days [standard error 1], p0.001).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.

We evaluated the prevalence, awareness, treatment, and control of hypertension (defined as a systolic blood pressure [BP]) ≥140 mm Hg, diastolic BP ≥90 mm Hg, or a self-reported use of an antihypertensive agent) among US adults, stratified by race/ethnicity. This analysis included 16 531 nonpregnant US adults (≥18 years) in the three National Health and Nutrition Examination Survey cycles between 2013 and 2018. Race/ethnicity was defined by self-report as White, Black, Hispanic, Asian, or other Americans. Among 76 910 050 (74 449 985–79 370 115) US adults with hypertension, 48.6% (47.3%–49.8%, unadjusted) have controlled BP. When compared with BP control rates for White adults (49.0% [46.8%–51.2%], age-adjusted), BP control rates are lower in Black (39.2%, adjusted odds ratio [aOR], 0.71 [95% CI, 0.59–0.85], P P =0.003), and Asian (37.8%, aOR, 0.68 [95% CI, 0.55–0.84], P =0.001) Americans. Black adults have higher hypertension prevalence (45.3% versus 31.4%, aOR, 2.24 [95% CI, 1.97–2.56], P P =0.005) and treatment rates (60.5% versus 67.3%, aOR, 0.78 [95% CI, 0.66–0.94], P =0.010) than White adults. Asian adults have similar hypertension prevalence, lower awareness (72.5% versus 79.1%, aOR, 0.75 [95% CI, 0.58–0.97], P =0.038) but similar treatment rates. Black, Hispanic, and Asian Americans have different vulnerabilities in the hypertension control cascade of prevalence, awareness, treatment, and control. These differences can inform targeted public health efforts to promote health equity and reduce the burden of hypertension in the United States.

Background: The impact of the COVID-19 pandemic on participation in and availability of cardiac rehabilitation (CR) is unknown. Methods: Among eligible Medicare fee-for-service beneficiaries, we evaluated, by month, the number of CR sessions attended per 100 000 beneficiaries, individuals eligible to initiate CR, and centers offering in-person CR between January 2019 and December 2021. We compared these outcomes between 2 periods: December 1, 2019 through February 28, 2020 (period 1, before declaration of the pandemic-related national emergency) and October 1, 2021 through December 31, 2021 (period 2, the latest period for which data are currently available). Results: In period 1, Medicare beneficiaries participated in (mean±SD) 895±84 CR sessions per 100 000 beneficiaries each month. After the national emergency was declared, CR participation sharply declined to 56 CR sessions per 100 000 beneficiaries in April 2020. CR participation recovered gradually through December 2021 but remained lower than prepandemic levels (period 2: 698±29 CR sessions per month per 100 000 beneficiaries, P =0.02). Declines in CR participation were most marked among dual Medicare and Medicaid enrollees and patients residing in rural areas or socially vulnerable communities. There was no statistically significant change in CR eligibility between the 2 periods. Compared with 2618±5 CR centers in period 1, there were 2464±7 in period 2 ( P Conclusions: The COVID-19 pandemic was associated with a persistent decline in CR participation and the closure of CR centers, which disproportionately affected rural and low-income patients and the most socially vulnerable communities. Innovation in CR financing and delivery is urgently needed to equitably enhance CR participation among Medicare beneficiaries.

Aims Prediction of mitral (MR) and tricuspid (TR) regurgitation progression on transthoracic echocardiography (TTE) is needed to personalize valvular surveillance intervals and prognostication. Methods and results Structured TTE report data at Beth Israel Deaconess Medical Center, 26 January 2000–31 December 2017, were used to determine time to progression (≥1+ increase in severity). TTE predictors of progression were used to create a progression score, externally validated at Massachusetts General Hospital, 1 January 2002–31 December 2019. In the derivation sample (MR, N = 34 933; TR, N = 27 526), only 5379 (15.4%) individuals with MR and 3630 (13.2%) with TR had progression during a median interquartile range) 9.0 (4.1–13.4) years of follow-up. Despite wide inter-individual variability in progression rates, a score based solely on demographics and TTE variables identified individuals with a five- to six-fold higher rate of MR/TR progression over 10 years (high- vs. low-score tertile, rate of progression; MR 20.1% vs. 3.3%; TR 21.2% vs. 4.4%). Compared to those in the lowest score tertile, those in the highest tertile of progression had a four-fold increased risk of mortality. On external validation, the score demonstrated similar performance to other algorithms commonly in use. Conclusion Four-fifths of individuals had no progression of MR or TR over two decades. Despite wide interindividual variability in progression rates, a score, based solely on TTE parameters, identified individuals with a five- to six-fold higher rate of MR/TR progression. Compared to the lowest tertile, individuals in the highest score tertile had a four-fold increased risk of mortality. Prediction of long-term MR/TR progression is not only feasible but prognostically important.

Objectives The aim of this study was to examine the applicability of pivotal transcatheter aortic valve replacement (TAVR) trials to the real-world population of Medicare patients undergoing TAVR. Background It is unclear whether randomized controlled trial results of novel cardiovascular devices apply to patients encountered in clinical practice. Methods Characteristics of patients enrolled in the U.S. CoreValve pivotal trials were compared with those of the population of Medicare beneficiaries who underwent TAVR in U.S. clinical practice between November 2, 2011, and December 31, 2017. Inverse probability weighting was used to reweight the trial cohort on the basis of Medicare patient characteristics, and a "real-world" treatment effect was estimated. Results A total of 2,026 patients underwent TAVR in the U.S. CoreValve pivotal trials, and 135,112 patients underwent TAVR in the Medicare cohort. Trial patients were mostly similar to real-world patients at baseline, though trial patients were more likely to have hypertension (50% vs 39%) and coagulopathy (25% vs 17%), whereas real-world patients were more likely to have congestive heart failure (75% vs 68%) and frailty. The estimated real-world treatment effect of TAVR was an 11.4% absolute reduction in death or stroke (95% CI: 7.50%-14.92%) and an 8.7% absolute reduction in death (95% CI: 5.20%-12.32%) at 1 year with TAVR compared with conventional therapy (surgical aortic valve replacement for intermediate- and high-risk patients and medical therapy for extreme-risk patients). Conclusions The trial and real-world populations were mostly similar, with some notable differences. Nevertheless, the extrapolated real-world treatment effect was at least as high as the observed trial treatment effect, suggesting that the absolute benefit of TAVR in clinical trials is similar to the benefit of TAVR in the U.S. real-world setting.

Introduction: The 2017 ACC/AHA guidelines lowered blood pressure (BP) thresholds for hypertension diagnosis and treatment compared to the 2003 JNC7. We compared cost-effectiveness of treating to ACC/AHA and JNC7 over 10 years in untreated hypertensive adults 35-84 years of age. Methods: The Cardiovascular Disease (CVD) Policy Model simulates CVD events, deaths, and costs in US adults. Inputs are estimated from national datasets, cohort studies, and literature. We simulated three treatment strategies: (1) no pharmacological treatment; (2) full JNC7; or (3) full ACC/AHA. Base-case analyses targeted all treatment-eligible adults. Secondary analyses stratified treatment by baseline BP (130-139/80-89 vs. ≥140/90 mmHg) and indicators of high CVD risk (diabetes, CKD, CVD, or 10-yr risk ≥10%). Results: Twenty-four million untreated adults could be treated under JNC7 and 29 million under ACC/AHA, preventing 1.2 million and 1.5 million CVD events at 10 years, respectively. Treating to JNC7 compared to no treatment and ACC/AHA compared to JNC7 was cost-effective ($150,000 per QALY gained for treating lower risk adults. Conclusion: Treating according to either JNC7 or ACC/AHA guidelines is a cost-effective way to prevent CVD. At ten years, regardless of guideline, treating high-risk hypertensive patients is either cost-saving or cost-effective; treating lower-risk patients is relatively low value.

Introduction: The 2017 ACC/AHA guidelines lowered the diagnostic blood pressure (BP) threshold, resulting in a new hypertension diagnosis for millions of younger, lower-risk U.S adults. Clinicians are encouraged to counsel these patients on health behavior modification. However, the potential population-level benefits from these non-pharmacologic interventions have not been assessed. Methods: We used the Cardiovascular Disease (CVD) Policy Model to simulate CVD events, mortality, and healthcare costs between 2018 and 2027. Simulations targeted US adults aged 35-64 years with untreated systolic BP 130-139 mmHg. Based on 2015-2018 NHANES estimates, we defined individuals as lower-risk based on not having diabetes, chronic kidney disease, or CVD and a predicted Results: Of the estimated 8.7 million U.S. adults (50.6% women) aged 35-64 with lower-risk stage 1 hypertension, 5.5 million (61%) had regular healthcare access. Controlling BP to Conclusion: Substantial health and economic benefits could result from widespread adoption of non-pharmacologic interventions in lower-risk U.S. adults with Stage 1 hypertension.

Perfect adherence to anticoagulant medications is an important aspect of care for patients with atrial fibrillation undergoing cardiac electrophysiology procedures to minimize the risk of stroke. Despite this, adherence remains imperfect as is associated with added cost of additional procedures (e.g., transesophageal echocardiography) and administrative burden. We sought to identify characteristics of such patients and predictors of medication errors at Beth Israel Deaconess Medical Center. Cardiol Res. 2021;12(4):265-268 doi: https://doi.org/10.14740/cr1266

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Agboola, McKenna, and Pearson are employed by ICER. Lin and Kazi received funding from ICER for work on this report.

Supplemental Digital Content is available in the text., Background: Cardiovascular deaths increased during the early phase of the COVID-19 pandemic in the United States. However, it is unclear whether diverse racial/ethnic populations have experienced a disproportionate rise in heart disease and cerebrovascular disease deaths. Methods: We used the National Center for Health Statistics to identify heart disease and cerebrovascular disease deaths for non-Hispanic White, non-Hispanic Black, non-Hispanic Asian, and Hispanic individuals from March to August 2020 (pandemic period), as well as for the corresponding months in 2019 (historical control). We determined the age- and sex-standardized deaths per million by race/ethnicity for each year. We then fit a modified Poisson model with robust SEs to compare change in deaths by race/ethnicity for each condition in 2020 versus 2019. Results: There were a total of 339 076 heart disease and 76 767 cerebrovascular disease deaths from March through August 2020, compared with 321 218 and 72 190 deaths during the same months in 2019. Heart disease deaths increased during the pandemic in 2020, compared with the corresponding period in 2019, for non-Hispanic White (age–sex standardized deaths per million, 1234.2 versus 1208.7; risk ratio for death [RR], 1.02 [95% CI, 1.02–1.03]), non-Hispanic Black (1783.7 versus 1503.8; RR, 1.19 [95% CI, 1.17–1.20]), non-Hispanic Asian (685.7 versus 577.4; RR, 1.19 [95% CI, 1.15–1.22]), and Hispanic (968.5 versus 820.4; RR, 1.18 [95% CI, 1.16–1.20]) populations. Cerebrovascular disease deaths also increased for non-Hispanic White (268.7 versus 258.2; RR, 1.04 [95% CI, 1.03–1.05]), non-Hispanic Black (430.7 versus 379.7; RR, 1.13 [95% CI, 1.10–1.17]), non-Hispanic Asian (236.5 versus 207.4; RR, 1.15 [95% CI, 1.09–1.21]), and Hispanic (264.4 versus 235.9; RR, 1.12 [95% CI, 1.08–1.16]) populations. For both heart disease and cerebrovascular disease deaths, Black, Asian, and Hispanic populations experienced a larger relative increase in deaths than the non-Hispanic White population (interaction term, P

Background: The COVID-19 pandemic has disproportionately affected low-income and racial/ethnic minority populations in the United States. However, it is unknown whether hospitalized patients with COVID-19 from socially vulnerable communities experience higher rates of death and/or major adverse cardiovascular events (MACEs). Thus, we evaluated the association between county-level social vulnerability and in-hospital mortality and MACE in a national cohort of hospitalized COVID-19 patients. Methods: Our study population included patients with COVID-19 in the American Heart Association COVID-19 Cardiovascular Disease Registry across 107 US hospitals between January 14, 2020 to November 30, 2020. The Social Vulnerability Index (SVI), a composite measure of community vulnerability developed by Centers for Disease Control and Prevention, was used to classify the county-level social vulnerability of patients’ place of residence. We fit a hierarchical logistic regression model with hospital-level random intercepts to evaluate the association of SVI with in-hospital mortality and MACE. Results: Among 16 939 hospitalized COVID-19 patients in the registry, 5065 (29.9%) resided in the most vulnerable communities (highest national quartile of SVI). Compared with those in the lowest quartile of SVI, patients in the highest quartile were younger (age 60.2 versus 62.3 years) and more likely to be Black adults (36.7% versus 12.2%) and Medicaid-insured (31.1% versus 23.0%). After adjustment for demographics (age, sex, race/ethnicity) and insurance status, the highest quartile of SVI (compared with the lowest) was associated with higher likelihood of in-hospital mortality (OR, 1.25 [1.03–1.53]; P =0.03) and MACE (OR, 1.26 [95% CI, 1.05–1.50]; P =0.01). These findings were not attenuated after accounting for clinical comorbidities and acuity of illness on admission. Conclusions: Patients hospitalized with COVID-19 residing in more socially vulnerable communities experienced higher rates of in-hospital mortality and MACE, independent of race, ethnicity, and several clinical factors. Clinical and health system strategies are needed to improve health outcomes for socially vulnerable patients.

Background: Cancer and cardiovascular disease (CVD) are independently associated with adverse outcomes in patients with COVID-19. However, outcomes in patients with COVID-19 with both cancer and comorbid CVD are unknown. Methods: This retrospective study included 2,476 patients who tested positive for SARS-CoV-2 at 4 Massachusetts hospitals between March 11 and May 21, 2020. Patients were stratified by a history of either cancer (n=195) or CVD (n=414) and subsequently by the presence of both cancer and CVD (n=82). We compared outcomes between patients with and without cancer and patients with both cancer and CVD compared with patients with either condition alone. The primary endpoint was COVID-19–associated severe disease, defined as a composite of the need for mechanical ventilation, shock, or death. Secondary endpoints included death, shock, need for mechanical ventilation, need for supplemental oxygen, arrhythmia, venous thromboembolism, encephalopathy, abnormal troponin level, and length of stay. Results: Multivariable analysis identified cancer as an independent predictor of COVID-19–associated severe disease among all infected patients. Patients with cancer were more likely to develop COVID-19–associated severe disease than were those without cancer (hazard ratio [HR], 2.02; 95% CI, 1.53–2.68; PP=.02) or CVD (HR, 1.79; 95% CI, 1.21–2.66; P=.004) alone. Patients died more frequently if they had both cancer and CVD compared with either cancer (35% vs 17%; P=.004) or CVD (35% vs 21%; P=.009) alone. Arrhythmias and encephalopathy were also more frequent in patients with both cancer and CVD compared with those with cancer alone. Conclusions: Patients with a history of both cancer and CVD are at significantly higher risk of experiencing COVID-19–associated adverse outcomes. Aggressive public health measures are needed to mitigate the risks of COVID-19 infection in this vulnerable patient population.

ImportanceAdding a sodium-glucose cotransporter-2 inhibitor (SGLT2-I) to standard-of-care treatment in patients with heart failure with preserved ejection fraction (HFpEF) reduces the risk of a composite outcome of worsening heart failure or cardiovascular mortality, but the cost-effectiveness in US patients with HFpEF is uncertain.ObjectiveTo evaluate the lifetime cost-effectiveness of standard therapy plus an SGLT2-I compared with standard therapy in individuals with HFpEF.Design, Setting, and ParticipantsIn this economic evaluation conducted from September 8, 2021, to December 12, 2022, a state-transition Markov model simulated monthly health outcomes and direct medical costs. Input parameters including hospitalization rates, mortality rates, costs, and utilities were extracted from HFpEF trials, published literature, and publicly available data sets. The base-case annual cost of SGLT2-I was $4506. A simulated cohort with similar characteristics as participants of the Empagliflozin in Heart Failure With a Preserved Ejection Fraction (EMPEROR-Preserved) and Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction (DELIVER) trials was used.ExposuresStandard of care plus SGLT2-I vs standard of care.Main Outcomes and MeasuresThe model simulated hospitalizations, urgent care visits, and cardiovascular and noncardiovascular death. Future medical costs and benefits were discounted by 3% per year. Main outcomes were quality-adjusted life-years (QALYs), direct medical costs (2022 US dollars), and incremental cost-effectiveness ratio (ICER) of SGLT2-I therapy from a US health care sector perspective. The ICER of SGLT2-I therapy was evaluated according to the American College of Cardiology/American Heart Association value framework (high value: ResultsThe simulated cohort had a mean (SD) age of 71.7 (9.5) years and 6828 of 12 251 participants (55.7%) were male. Standard of care plus SGLT2-I increased quality-adjusted survival by 0.19 QALYs at an increased cost of $26 300 compared with standard of care. The resulting ICER was $141 200 per QALY gained, with 59.1% of 1000 probabilistic iterations indicating intermediate value and 40.9% indicating low value. The ICER was most sensitive to SGLT2-I costs and effect of SGLT2-I therapy on cardiovascular death (eg, increasing to $373 400 per QALY gained if SGLT2-I therapy was assumed to have no effect on mortality).Conclusions and RelevanceResults of this economic evaluation suggest that at 2022 drug prices, adding an SGLT2-I to standard of care was of intermediate or low economic value compared with standard of care in US adults with HFpEF. Efforts to expand access to SGLT2-I for individuals with HFpEF should be coupled with efforts to lower the cost of SGLT2-I therapy.

There is growing concern about the health of older US adults who live in rural areas, but little is known about how mortality has changed over time for low-income Medicare beneficiaries residing in...

Racial/ethnic minority populations in the United States have increased rates of diabetes compared with White populations. The 2021 guidelines from the U.S. Preventive Services Task Force recommend diabetes screening for adults aged 35 to 70 years with a body mass index (BMI) of 25 kg/mTo determine the BMI threshold for diabetes screening in major racial/ethnic minority populations with benefits and harms equivalent to those of the current diabetes screening threshold in White adults.Cross-sectional study.NHANES (National Health and Nutrition Examination Survey), 2011 to 2018.Nonpregnant U.S. adults aged 18 to 70 years (A logistic regression model was used to estimate diabetes prevalence at various BMIs for White, Asian, Black, and Hispanic Americans. For each racial/ethnic minority group, the equivalent BMI threshold was defined as the BMI at which the prevalence of diabetes in 35-year-old persons in that group is equal to that in 35-year-old White adults at a BMI of 25 kg/mAmong adults aged 35 years with a BMI of 25 kg/mSample size limitations precluded assessment of heterogeneity within racial/ethnic groups.Among U.S. adults aged 35 years or older, offering diabetes screening to Black Americans and Hispanic Americans with a BMI of 18.5 kg/mRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology.

Background: Dietary intake of fruit and vegetables (FV) in the US falls well below recommended guidelines with only 12.2% of adults consuming at least 1.5-2 cup equivalents of fruit and 9.3% consuming at least 2-3 cup equivalents of vegetables each day. The Dietary Approaches to Stop Hypertension (DASH) trial demonstrated that consuming a “Mediterranean diet” with increased average daily FV intake resulted in reductions of systolic blood pressure of 0.8mmHg in those without hypertension and 7.2mmHg in those with hypertension. We used simulation modeling to estimate the impact of increasing FV intake in the population who currently are low FV consumers on subsequent incident cardiovascular disease (CVD) and death. Methods: We used the CVD Policy Model, a dynamic state-transition model of CVD risk factors, events, and outcomes to simulate the impact of increasing FV intake by one cup equivalent per day in US adults aged 35-94 years with no prior CVD who consume less than cup equivalent of FV per day; based on the National Health and Nutrition Examination Survey (NHANES) years 2015-2018. We used estimates of FV intake on blood pressure reductions based on DASH and ran 10 year simulations, focusing on the population with uncontrolled hypertension (baseline systolic BP ≥140mmHg). Results: Based on NHANES, 40.5M US adults age 35-94 years without a history of CVD consume less than 1 cup equivalent of FV per day. Increasing FV intake by cup equivalents per day in this population is estimated to prevent 98,000 incident CVD and 16,000 CVD deaths over 10 years, of which 82,000 (84%) and 13,000 (81%) respectively occur in 8.9M of this population with uncontrolled hypertension. Women would be expected to realize the greatest population improvements with increase in FV consumption. Conclusion: Increasing fruit and vegetable consumption among US adults could yield considerable population health benefits in prevention of cardiovascular disease and death, particularly for those with existing hypertension.

Background: Hypertension is a leading preventable cause of CHD, stroke, and heart failure (HF). WHO hypertension guidelines recommend initiating first dose medication in hypertensive adults with access to healthcare, yet many US adults with a usual source of care are not receiving treatment. We estimate the population impact of initiating hypertensive therapy in untreated US adults with uncontrolled blood pressure (BP) and access to usual healthcare on incident CVD. Methods: We used the CVD Policy Model, a dynamic state-transition model of CVD risk factors, events, and outcomes to simulate the impact over 10 years of treating uncontrolled BP in our target population of US adults 35-94 years of age with no prior CVD, baseline systolic BP ≥140mmHg, and no current hypertensive medication use, estimated from National Health and Nutrition Examination Survey years 2015-2018. We initiated first dose medication in the target population reporting access to a usual source of healthcare and at least two visits per year. We used the Law, Morris and Wald equation to estimate the systolic BP effect size for a standard first dose of medication. Results: Initiating hypertension medications in those with currently untreated but with regular healthcare access would prevent 214,000 incident CVD events in the US, a quarter of which (52,000) are incident heart failure (Table 1). First dose treatment (and maintenance) would be expected to reduce incident CHD by 9.1%, HF by 6.1%, ischemic stroke by 8.1%, and hemorrhagic stroke by 11.3% over the decade, compared to no treatment. Treatment of hypertension would have the greatest relative benefit in the prevention on incident CVD events in those younger than 65, compared with those over 65 years of age. Conclusion: In the US population with regular access to healthcare, initiating first dose medications for hypertension in those with elevated blood pressure but currently untreated would reduce incident CVD in both sexes and all age groups, with particular benefit for prevention in those less than 65 years of age.

Low-dose rivaroxaban reduced major adverse cardiac and limb events among patients with stable atherosclerotic vascular disease (ASCVD) in the COMPASS trial. The objective of our study was to evaluate the eligibility and budgetary impact of the COMPASS trial in a real-world population. The VA administrative and clinical databases were utilized to conduct a cross-sectional study to identify patients eligible for low-dose rivaroxaban receiving care at all 141 facilities between October 1, 2014 and September 30, 2015. Proportion of patients with stable ASCVD eligible for low-dose rivaroxaban and prevalence of multiple risk enrichment criteria among eligible patients. Pharmaceutical budgetary impact using VA pharmacy pricing. Chi-squared and Student’s t tests were used to compare patients eligible versus ineligible patients. From an initial cohort of 1,248,214 patients with ASCVD, 488,495 patients (39.1%) met trial eligibility criteria. Eligible patients were older (74.2 vs 64.5 years) with higher proportion of hypertension (84.1% vs 82.1%) and diabetes (46.2% vs 32.9) compared with ineligible patients (p

Background: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. Methods: We linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement [TAVR] versus surgical aortic valve replacement [SAVR]) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI). Results: Among 600 linked HiR participants (linkage rate, 80.0%), the rate of the trial’s primary end point of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1 year by using both trial data (hazard ratio, 0.84 [95% CI, 0.65–1.09]; P =0.33) and claims data (hazard ratio, 0.86 [95% CI, 0.66–1.11]; P =0.34; interaction P value=0.80). Noninferiority of TAVR relative to SAVR was seen by using both trial- and claims-based outcomes ( P noninferiority P =0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (hazard ratio, 1.02 [95% CI, 0.73–1.41]; P =0.58; interaction P value=0.89). TAVR was noninferior to SAVR when compared using both trial and claims ( P non inferiority Conclusions: In the HiR and SURTAVI trials, ascertainment of trial primary end points using claims reproduced both the magnitude and direction of treatment effect in comparison with adjudicated event data, but nonfatal and nonprocedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes but may be less suitable for other end points.

BACKGROUND: Individuals experiencing homelessness have higher hospitalization and mortality rates compared with the housed. Whether they also experience higher readmission rates, and if readmissions vary by region or cause of hospitalization is unknown. OBJECTIVE: Evaluate the association of homelessness with readmission rates across multiple US states. DESIGN: Retrospective analysis of administrative claims PATIENTS: All inpatient hospitalizations in Florida, Massachusetts, and New York from January 2010 to October 2015 MAIN MEASURES: Thirty- and 90-day readmission rates KEY RESULTS: Out of a total of 23,103,125 index hospitalizations, 515,737 were for patients who were identified as homeless at the time of discharge. After adjusting for cause of index hospitalization, state, demographics, and clinical comorbidities, 30-day and 90-day readmission rates were higher for index hospitalizations in the homeless compared with those in the housed group. The difference in 30-day readmission rates between homeless and housed groups was the largest in Florida (30.4% vs. 19.3%; p < 0.001), followed by Massachusetts (23.5% vs. 15.2%; p < 0.001) and New York (15.7% vs. 13.4%; p < 0.001) (combined 17.3% vs. 14.0%; p < 0.001). Among the most common causes of hospitalization, 30-day readmission rates were 4.1 percentage points higher for the homeless group for mental illness, 4.9 percentage points higher for diseases of the circulatory system, and 2.4 percentage points higher for diseases of the digestive system. CONCLUSIONS: After adjusting for demographic and clinical characteristics, homelessness is associated with significantly higher 30- and 90-day readmission rates, with a significant variation across the three states. Interventions to reduce the burden of readmissions among individuals experiencing homelessness are urgently needed. Differences across states point to the potential of certain public policies to impact health outcomes for individuals experiencing homelessness. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-020-05946-4) contains supplementary material, which is available to authorized users.

Background: In patients with transthyretin amyloid cardiomyopathy, tafamidis reduces all-cause mortality and cardiovascular hospitalizations and slows decline in quality of life compared with placebo. In May 2019, tafamidis received expedited approval from the US Food and Drug Administration as a breakthrough drug for a rare disease. However, at $225 000 per year, it is the most expensive cardiovascular drug ever launched in the United States, and its long-term cost-effectiveness and budget impact are uncertain. We therefore aimed to estimate the cost-effectiveness of tafamidis and its potential effect on US health care spending. Methods: We developed a Markov model of patients with wild-type or variant transthyretin amyloid cardiomyopathy and heart failure (mean age, 74.5 years) using inputs from the ATTR-ACT trial (Transthyretin Amyloidosis Cardiomyopathy Clinical Trial), published literature, US Food and Drug Administration review documents, healthcare claims, and national survey data. We compared no disease–specific treatment (“usual care”) with tafamidis therapy. The model reproduced 30-month survival, quality of life, and cardiovascular hospitalization rates observed in ATTR-ACT; future projections used a parametric survival model in the control arm, with constant hazards reduction in the tafamidis arm. We discounted future costs and quality-adjusted life-years by 3% annually and examined key parameter uncertainty using deterministic and probabilistic sensitivity analyses. The main outcomes were lifetime incremental cost-effectiveness ratio and annual budget impact, assessed from the US healthcare sector perspective. This study was independent of the ATTR-ACT trial sponsor. Results: Compared with usual care, tafamidis was projected to add 1.29 (95% uncertainty interval, 0.47–1.75) quality-adjusted life-years at an incremental cost of $1 135 000 (872 000–1 377 000), resulting in an incremental cost-effectiveness ratio of $880 000 (697 000–1 564 000) per quality-adjusted life-year gained. Assuming a threshold of $100 000 per quality-adjusted life-year gained and current drug price, tafamidis was cost-effective in 0% of 10 000 probabilistic simulations. A 92.6% price reduction from $225 000 to $16 563 would be necessary to make tafamidis cost-effective at $100 000/quality-adjusted life-year. Results were sensitive to assumptions related to long-term effectiveness of tafamidis. Treating all eligible patients with transthyretin amyloid cardiomyopathy in the United States with tafamidis (n=120 000) was estimated to increase annual healthcare spending by $32.3 billion. Conclusions: Treatment with tafamidis is projected to produce substantial clinical benefit but would greatly exceed conventional cost-effectiveness thresholds at the current US list price. On the basis of recent US experience with high-cost cardiovascular medications, access to and uptake of this effective therapy may be limited unless there is a large reduction in drug costs.

Background: Use of an antibiotic-eluting envelope (AEE) during cardiac implantable electronic device procedures reduces infection risk but increases procedural costs. We aim to estimate the cost-effectiveness of AEE use during cardiac implantable electronic device procedures among patients with heart failure. Methods: A state-transition cohort model of heart failure patients undergoing cardiac implantable electronic device implantation or generator replacement was developed with input parameters estimated from randomized trials, registries, surveys, and claims data. Effectiveness was estimated from the World-Wide Randomized Antibiotic Envelope Infection Prevention Trial. AEE was assumed to cost $953 per unit. The model projected mortality, quality-adjusted life-years, costs, and the incremental cost-effectiveness ratio of AEE use compared with usual care from a US healthcare sector perspective over a lifetime horizon. We assumed a cost-effectiveness threshold of $100 000 per quality-adjusted life-year gained. Results: Compared with usual care, AEE use in initial implantations produced an incremental cost-effectiveness ratio of $112 000 per quality-adjusted life-year gained (39% probability of being cost-effective). In generator replacement procedures, AEE use produced an incremental cost-effectiveness ratio of $54 000 per quality-adjusted life-year gained (84% probability of being cost-effective). Results were sensitive to the underlying rate of infection, cost of the AEE, and durability of AEE effectiveness. Conclusions: Universal AEE use for cardiac implantable electronic device procedures in patients with heart failure with reduced ejection fraction is unlikely to be cost-effective, reinforcing the need for individualized risk assessment to guide uptake of the AEE in clinical practice. Selective use in patients at increased risk of infection, such as those undergoing generator replacement procedures, is more likely to meet health system value benchmarks.

Background: Aspirin is recommended in patients with atherosclerotic cardiovascular disease for secondary prevention. In patients without atherosclerotic cardiovascular disease and not at high 10-year risk, there is no evidence aspirin reduces adverse cardiovascular events and it could increase bleeding. The 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease state that aspirin may be considered for primary prevention (class IIb) in patients 40 to 70 years that are at higher risk of atherosclerotic cardiovascular disease and that routine use of aspirin should be avoided (class III:Harm) for patients >70 years. We examined the frequency of patients on aspirin for primary prevention that would have been considered unindicated or potentially harmful per the recent guideline where aspirin discontinuation may be beneficial. Methods: To assess the potential impact, within the National Cardiovascular Disease Registry Practice Innovation and Clinical Excellence Registry, we assessed 855 366 patients from 400 practices with encounters between January 1, 2018 and March 31, 2019, that were receiving aspirin for primary prevention. We defined inappropriate use as the use of aspirin in patients 70 years and use without a recommended indication as use of aspirin in patients 40 to 70 years with low, borderline, or intermediate 10-year atherosclerotic cardiovascular disease risk. Frequency of inappropriate use and use without a recommended indication were calculated and practice-level variation was evaluated using the median rate ratio. Results: Inappropriate use occurred in 27.6% (193 674/701 975) and use without a recommended indication in 26.0% (31 810/122 507) with significant practice-level variation in inappropriate use (predicted median practice-level rate 33.5%, interquartile range, 24.1% to 40.8%; median rate ratio, 1.71 [95% CI, 1.67–1.76]). Conclusions: Immediately before the 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease, over one-fourth of patients in this national registry were receiving aspirin for primary prevention inappropriately or without a recommended indication with significant practice-level variation. These findings help to determine the potential impact of guideline recommendations on contemporary use of aspirin for primary prevention.

Background People who have been incarcerated have high rates of cardiovascular risk factors, such as hypertension and smoking, and cardiovascular disease (CVD) is a leading cause of hospitalizations and mortality in this population. Despite this, little is known regarding what pathways mediate the association between incarceration exposure and increased rates of CVD morbidity and especially what incarceration specific factors are associated with this risk. The objective of this study is to better understand CVD risk in people exposed to incarceration and the pathways by which accumulate cardiovascular risk over time. Methods and Analysis The Justice-Involved Individuals Cardiovascular Disease Epidemiology (JUSTICE) study is a prospective cohort study of individuals released from incarceration with known cardiovascular risk factors. We are recruiting 500 individuals within three months after release from jail/prison. At baseline we are assessing traditional risk factors for CVD, including diet, exercise, and smoking, and exposure to incarceration-related policies, psychosocial stress, and self-efficacy. Cardiovascular risk factors are measured at baseline through point of care testing. We are following these individuals for the 12 months following the index release from incarceration with re-evaluation of psychosocial factors and clinical risk factors every 6 months. Using these data, we will estimate the direct and indirect latent effects of incarceration on cardiovascular risk factors and the paths via which these effects are mediated. We will also model the anticipated 10-year burden of CVD incidence, health care use, and mortality associated with incarceration. Discussion Our study will identify factors associated with CVD risk factor control among people released from incarceration. Our measurement of incarceration-related exposures, psychosocial factors, and clinical measures of cardiovascular risk will allow for identification of unique targets for intervention to modify CVD risk in this vulnerable population.

Introduction: The COVID-19 pandemic has disproportionately affected low-income and racial/ethnic minority populations in the US. However, it remains unclear whether hospitalized COVID-19 patients who live in socially vulnerable neighborhoods are more likely to experience major adverse cardiovascular events and/or death. We evaluated the association between neighborhood social vulnerability and in-hospital outcomes in a national cohort of hospitalized COVID-19 patients. Hypothesis: Among patients hospitalized with COVID-19, residence in socially vulnerable neighborhoods is associated with worse in-hospital outcomes. Methods: The American Heart Association COVID-19 Cardiovascular Disease Registry includes patients hospitalized with COVID-19 across 107 hospitals in the US between January 14, 2020 to November 30, 2020. The Social Vulnerability Index (SVI), a composite measure of community vulnerability developed by Center for Disease Control was used to classify the social vulnerability of patients’ place of residence defined by zip codes. We fit multivariable logistic regression models to evaluate the association between patient’s SVI and in-hospital death or major adverse cardiovascular events (MACE, defined as composite of all-cause death, MI, stroke, new onset heart failure, or cardiogenic shock). Results: Among 20,925 hospitalized COVID-19 patients in the registry, 6083 (29.1%) resided in the most vulnerable communities (highest national quartile of SVI). Compared with those in lowest quartile of SVI, patients in the highest quartile were younger (mean age 59.8±17.7 versus 62.0±17.9), more likely to be women (47.1% vs. 43.2%), Black patients (36.1% vs. 13.3%), and less likely to have private insurance (29.0% vs. 39.1%). After adjusting for demographics (age, sex, race/ethnicity), insurance status, and comorbidities, the highest quartile of SVI (compared to lowest) was associated with higher likelihood of in-hospital MACE (OR [95% CI] 1.28 [1.12, 1.46], p Conclusion: Hospitalized patients with COVID-19 who reside in more socially vulnerable neighborhoods experience higher rates of in-hospital MACE and death, independent of race and ethnicity.

Introduction: Non-statin therapies may improve long-term outcomes in patients with atherosclerotic cardiovascular disease (ASCVD) who experience statin-associated side effects (SASE). Objective: To examine the cost-effectiveness of a newly approved combination of bempedoic acid and ezetimibe (BAEze) in patients with ASCVD from a U.S. healthcare sector perspective. Methods: State-transition Markov model of US adults with ASCVD and low-density lipoprotein cholesterol (LDL-C) ≥70mg/dL on maximally tolerated statin and ezetimibe. The study cohort was stratified by concurrent statin use: high-intensity (group1), moderate-/low-intensity (group 2), or no statin due to severe SASE (group 3). The intervention group received BAEze (annual cost $2,447) instead of ezetimibe. We estimated baseline LDL-C from NHANES; relative LDL-C lowering and rate of adverse events from randomized trials; and the relationship between LDL-C lowering and cardiovascular events from meta-analyses of statin trials. The main outcome was lifetime incremental cost-effectiveness ratio (ICER), with a threshold of $100,000 per quality-adjusted-life-year (QALY) gained. Results: BAEze had an ICER of $188,000/QALY in group 1 (95% UI: 141,500-284,600; cost-effective in 0% of 10,000 probabilistic simulations) and $175,600/QALY (132,700-264,700; cost-effective in 0% simulations) in group 2. In group 3, BAEze produced 0.28 incremental QALYs at a lifetime cost of $25,600, yielding an ICER of $92,600/QALY (66,000-152,100; cost-effective in 59% simulations). Conclusions: Among US adults with ASCVD, cost-effectiveness of BAEze varies substantially by concurrent statin use, and only meets conventional cost-effectiveness thresholds among patients unable to take a statin due to severe SASE. Our findings argue for the selective use of BAEze among patients with ASCVD and severe SASE but should be updated when more data on long-term effectiveness and safety become available.

Purpose of Review The launch of new effective and safe cardiovascular drugs has produced large gains in health outcomes for several cardiovascular conditions. But this innovation comes at the cost of rapidly increasing pharmaceutical spending and high out-of-pocket costs. Recent Findings In the USA, manufacturers are able to set prices according to what the market will bear rather than value to patients or society, with a complicated system of discounts and rebates obscuring the final price borne by payors. Some of these costs are passed on to patients in the form of co-payments or co-insurance, making these effective but high-cost medications unaffordable for many patients. Orphan drugs developed to treat rare diseases—for which manufactures are presented substantial financial and regulatory benefits—are particularly problematic, as they typically enter the market at very high prices compared with drugs for other indications. Summary Systematic cost-effectiveness analyses from the healthcare sector or societal perspectives can help identify the value-based price of a medication at market entry as well as later in the lifecycle of the drug when more data on effectiveness and safety becomes available. Despite bipartisan support, legislative progress on drug pricing has been slow. Clinicians should know the cost of the drugs they prescribe frequently, use generics where feasible, and regularly discuss out-of-pocket costs with patients to pre-empt cost-related non-adherence.