Dhruv S. Kazi

BACKGROUND: COVID-19 hospitalization in the pre-Omicron era was associated with an increased risk of major adverse cardiovascular events, but data from the Omicron era are sparse. We examined the risk of death and major adverse cardiovascular events among older adults hospitalized with COVID-19 during the Omicron era compared with the pre-Omicron era and a historical influenza cohort. METHODS: Retrospective cohort study of Medicare beneficiaries aged ≥65 years hospitalized for COVID-19 in the Omicron era (November 2021–September2022), COVID-19 in the pre-Omicron era (March 2020–November 2021), and influenza (October 2017–September 2018). The primary outcome was a composite of all-cause death and hospitalization for myocardial infarction, ischemic stroke, transient ischemic attack, pulmonary embolism, deep vein thrombosis, heart failure, and cardiac arrest within 1 year of the index admission. We standardized the cohorts using inverse probability weighting. RESULTS: We included 1 184 182 patients (mean age 79 years; 51% women):361 382 in the Omicron cohort, 731 455 in the pre-Omicron cohort, and 91 345 in the influenza cohort. The risk of the primary outcome in the Omicron cohort was lower than in the pre-Omicron cohort (48.8% versus 49.3%; standardized risk difference, −0.6% [95% CI, −0.8% to −0.3%]) but higher than in the influenza cohort (48.8% versus 33.4%; risk difference, 15.4% [15.1%–15.6%]). Compared with the pre-Omicron cohort, the Omicron cohort had a significantly lower risk of death (34.2% versus 39.7%; risk difference, −5.5% [−5.7% to −5.3%]) but a higher risk of myocardial infarction, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis, and heart failure. CONCLUSIONS: Among older adults hospitalized with COVID-19, the risk of death within 1 year was lower, and the risk of major adverse cardiovascular event was higher in the Omicron era than the pre-Omicron era; however, the risk of either outcome was higher than after influenza hospitalization. These findings underscore the need for effective cardiovascular prevention strategies after a COVID-19 hospitalization.

BACKGROUND: Sodium-glucose co-transporter 2 (SGLT2) inhibitors and angiotensin receptor-neprilysin inhibitors (ARNI) are heart failure (HF) therapies selected for price negotiations under the Inflation Reduction Act. This study aimed to summarize the cost-effectiveness of SGLT2 inhibitors and ARNIs for HF, examine how cost-effectiveness varies by ejection fraction (EF) and drug price, and estimate the effect of negotiated prices on cost-effectiveness. METHODS: A systematic literature search identified cost-effectiveness analyses of SGLT2 inhibitors and ARNIs versus standard of care for the treatment of HF from a US perspective, published through 2025. Analyses were stratified by HF with reduced EF (<40%, HFrEF), moderately reduced EF (40% to 49%, HFmrEF), and preserved EF (≥50%, HFpEF). Incremental cost-effectiveness ratios were estimated at negotiated drug prices from base-case, threshold, and sensitivity analyses of drug pricing. Key drivers of cost-effectiveness were identified from the top 3 variables in 1-way sensitivity analyses. RESULTS: Of 821 studies identified, 16 were included: 11 HFrEF, 2 HFrEF/HFmrEF/HFpEF, and 3 HFmrEF/HFpEF. Across all EF categories, incremental cost-effectiveness ratios (2024 US dollars) versus standard of care ranged from $59 600 to $187 100/quality-adjusted life year (QALY) gained with SGLT2 inhibitors, $24 400 to $92 300 with ARNIs, and $69 300 to $91 500 with SGLT2 inhibitors + ARNIs. Incremental cost-effectiveness ratios in studies of HFrEF were <$120 000/QALY gained and all but 1 were ≥$120 000/QALY gained in studies of HFmrEF/HFpEF. At negotiated drug prices across all EF categories, the incremental cost-effectiveness ratio was estimated to be $47 800/QALY gained with SGLT2 inhibitors, $39 900/QALY gained with ARNIs, and $44 400/QALY gained with SGLT2 inhibitors+ARNIs. The key drivers of cost-effectiveness included drug price (17 studies), cardiovascular death risk with SGLT2 inhibitors and ARNIs (15 studies), and duration of intervention effectiveness (5 studies). CONCLUSIONS: At negotiated prices resulting from the Inflation Reduction Act, SGLT2 inhibitors and ARNIs seem cost-effective in HFrEF, with projected cost-effectiveness in HFmrEF/HFpEF dependent on price reductions and less certain treatment-effect estimates.

The United States is facing a growing health care affordability crisis. In 2024, national health expenditures totalled $5.3 trillion, or $15 474 per person, accounting for 18.0% of the U.S. economy. Spending on health care continues to rise, propelled by high prices for services, drugs, and devices; growing administrative complexity; chronic underinvestment in prevention, primary care, and public health; and the mounting burden of chronic conditions such as cardiovascular disease. Patients, even those with insurance, frequently face financial hardship, delayed or foregone care, and medical debt because of gaps in coverage and inadequate consumer protections. Addressing this crisis will require coordinated action across the health care system, guided by evidence and a commitment to shared responsibility among key stakeholders. This Presidential Advisory from the American Heart Association draws on interviews and listening sessions with patients, clinicians, payers, employers, health system leaders, and public health experts to examine the many dimensions of affordability and offer a practical framework for action. The Advisory presents 5 core principles to guide efforts to address the affordability crisis: ensuring access to high-quality care without financial hardship; minimizing cost sharing for high-value services; creating shared accountability across the health care system; investing in the workforce, infrastructure, and data systems needed to support progress; and addressing the social and structural factors that make care less affordable for many communities. The evidence, tools, and expertise to combat the health care affordability crisis already exist. What is needed now is the collective will to act.

It has long been accepted that observational analyses have an important role in evaluating use patterns and assessing the safety of different treatments, including cardiovascular devices, in clinical practice. With the proliferation of large electronic databases, there has been increasing interest in using observational analyses to also examine the comparative effectiveness of devices. However, these analyses are often met with skepticism because of concerns about whether they can generate credible evidence about causal effects. This is in part a result of the difficulty in meeting the assumptions necessary to interpret observational associations as causal effects and of the wide variability in analytic rigor. In this review, we outline frameworks and review methods for using observational analyses to answer questions about the effectiveness and safety of cardiovascular devices. We highlight the target trial framework as a practical tool for guiding observational comparative effectiveness analyses. We illustrate how the framework allows investigators planning and conducting observational analyses to organize their activities as responses to 3 prompting questions. First, what is the research question of the study (ie, “What do we want?”)? Second, what are the resources—including background knowledge, research concepts, principles and methods, and available data—that can be brought to bear on the research question (ie, “What do we have?”)? And third, what specific steps should be taken to use the available resources to answer the research question (ie, “What do we do?”)? We focus our exposition on the evaluation of cardiovascular devices, for which randomized trial data are often limited and there is a strong need for real-world evidence. In this setting, real-world evidence is usually derived from observational comparisons of the treatment of interest with relevant comparator groups using data captured during routine care. A principled approach to the planning and conduct of observational analyses can improve the quality of real-world evidence generation and ensure that the results of observational studies on medical devices can support meaningful conclusions about the risks and benefits of new devices.

OBJECTIVE: Use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for diabetes or weight management may affect pregnancy outcomes. We sought to estimate the number of U.S. women of reproductive age eligible for GLP-1 RA therapy. RESEARCH DESIGN AND METHODS: Using 2017–2023 nationally representative survey data, we identified nonpregnant U.S. women aged 18–44 years who met trial-based eligibility criteria for diabetes, weight management, or secondary cardiovascular prevention. RESULTS: Among 3,218 participants, 1,447 were eligible for GLP-1 RAs, representing 24.6 million U.S. women. Among GLP-1 RA–eligible women, mean BMI was 34.8 kg/m2, 8.3% had diabetes, and 1.9% had prior cardiovascular disease. Eligibility was primarily for weight management (24.1 million), followed by diabetes (2.0 million) and cardiovascular prevention (0.34 million). CONCLUSIONS: Nearly half of U.S. reproductive-age women are eligible for GLP-1 RAs. Given limited pregnancy safety data and rising cardiometabolic burden in reproductive-age women, research is needed to guide counseling and coverage of preconception GLP-1 RA use.