Sérgio Renato da Rosa Decker

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.

OBJECTIVE: Identifying social and economic factors associated with initiation of semaglutide or tirzepatide may inform strategies to support equitable uptake. RESEARCH DESIGN AND METHODS: A cross-sectional study was conducted using 100% of Medicare claims of patients ≥65 years with type 2 diabetes mellitus (T2DM). The outcome was initiation of semaglutide or tirzepatide. We calculated adjusted odds ratios (aORs) for each exposure (self-reported race and ethnicity, dual enrollment in Medicare and Medicaid, rurality, and social vulnerability index), accounting for demographic and clinical characteristics. RESULTS: Among 13,922,387 patients with T2DM, 673,776 (4.8%) initiated semaglutide or tirzepatide in 2023. Minoritized racial and ethnic identity (e.g., non-Hispanic Black compared with White; aOR 0.72; 95% CI 0.71–0.72), dual enrollment (aOR 0.90; 0.89–0.91), and residence in the most versus least vulnerable socially vulnerable neighborhoods (aOR 0.93; 0.92–0.93) were associated with lower initiation. CONCLUSIONS: Minoritized racial and ethnic identity and adverse socioeconomic factors were associated with lower odds of initiation among Medicare beneficiaries with T2DM.

Conduction system pacing (CSP) has emerged as an alternative to biventricular pacing (BVP) for cardiac resynchronization therapy (CRT), with potential clinical benefits and lower costs. PhysioSync-HF is a multicenter, randomized trial comparing these strategies from both clinical and economic perspectives in patients with heart failure with reduced ejection fraction (HFrEF). To describe the rationale and design of the trial-based economic evaluation embedded within the PhysioSync-HF trial. The PhysioSync-HF trial enrolled 179 patients with 1-year follow-up. Procedural cost data will be collected using a time-driven activity-based costing approach. Costs associated with the device, adverse clinical events, and ambulatory care during follow-up will be estimated using resource-based accounting methods. Appropriate methods will address missing data, and statistical analyses will account for the skewed distribution of cost variables. The primary economic outcome is the between-group difference in total direct medical costs per patient over the 1-year follow-up (CSP vs BVP). Secondary outcomes include component-level cost breakdowns of direct medical expenses and a budget impact analysis estimating the annual effect on Brazil's health care system if all eligible patients received CSP instead of BVP. By leveraging a multicenter cardiovascular trial to measure costs of CSP versus BVP, this economic evaluation aims to identify cost-saving opportunities that could expand equitable access to CRT for individuals with HFrEF in Brazil, while providing insights relevant to other health care settings worldwide. NCT05572736.

The lingering effects of COVID‐19 may impair survivors' long‐term health‐related quality of life (HRQoL). However, multicentre studies focusing on the Omicron variant, particularly in middle‐ and low‐income settings, are scarce. We conducted a prospective cohort study across 24 Brazilian hospitals between December 2021 and March 2024, when Omicron was the predominant variant. Adult COVID‐19 survivors were followed for 12 months via telephone interviews. The primary outcome was HRQoL at 12 months, assessed using the EuroQol five‐dimension three‐level questionnaire (EQ‐5D‐3L; range −0.17 to 1.0). All‐cause mortality was a secondary outcome. Among 649 participants (47.9% women; median age 71 years), the median EQ‐5D‐3L utility score at 12 months was 0.69 (IQR 0.41–0.80), and survival was 86.6%. Factors associated with lower HRQoL included female sex, age ≥ 60 years, Charlson comorbidity index ≥ 1, and need for respiratory support. Mortality was associated with age ≥ 60 years (HR 2.81), CCI ≥ 2 (HR 2.17), need for low‐flow oxygen therapy (HR 2.03), and BMI ≥ 25 kg/m² (HR 0.58). One year after hospitalization, Omicron survivors in Brazil showed impaired HRQoL and high mortality. Older age, comorbidities, and need for oxygen therapy were linked to worse outcomes. Long‐term support strategies are needed for these vulnerable populations.

INTRODUCTION Historically, relying on observational data to evaluate causal effects has been considered a sin, with journals often advising authors to remove causal language from their results, whereas randomized clinical trials remain the gold standard for assessing the comparative effectiveness and safety of treatments.() However, clinical trials are often impractical, unethical, or untimely.() In addition, […] INTRODUCTION Historically, relying on observational data to evaluate causal effects has been considered a sin, with journals often advising authors to remove causal language from their results, whereas randomized clinical trials remain the gold standard for assessing the comparative effectiveness and safety of treatments.() However, clinical trials are often impractical, unethical, or untimely.() In addition, […]

The novel coronavirus (SARS-CoV-2) has caused a significant impact in Brazil, with over 37 million cases and 690,000 deaths. Survivors often experience prolonged symptoms, termed post-COVID-19 condition or long COVID, affecting various aspects of life. Data on post-COVID-19 in Brazil, particularly amid the Omicron variant, are limited. This study aims to address this gap by assessing the incidence, associated factors, and impact of post-COVID-19 in adults infected during the Omicron phase, using the World Health Organization case definition. This Brazilian cohort study involves virtual recruitment and a nested case-control design. Participants from all regions will be recruited through electronic announcements. Inclusion criteria comprise age ≥ 18, Brazilian residency, and confirmed symptomatic SARS-CoV-2 infection. A nested case-control study will compare cognitive domains in post-COVID-19 cognitive dysfunction cases and controls. Data collection will utilize standardized instruments, including the EQ-5D-3L, Lawton & Brody Scale, Barthel Index, and others. Statistical analyses will employ adjusted models for primary and secondary outcomes. The study follows ethical guidelines, with an informed consent process tailored to participant preferences. Confidentiality measures include restricted access and secure electronic data storage. Results will be disseminated in academic forums, peer-reviewed journals, and directly communicated to participants. Authorship criteria align with international standards, and data sharing requests will be evaluated by the steering committee. The study is currently recruiting participants.

Background: Acute respiratory viral infections (ARVI) contribute to hospitalizations, morbidity, and mortality. While rhinoviruses are considered less virulent, respiratory syncytial virus (RSV) shows higher virulence. Limited studies compare in-hospital outcomes of rhinovirus and RSV infections in adults, especially during the COVID-19 Omicron era. Our aim is to compare these outcomes among hospitalized adults. Methods: This retrospective cohort study evaluated ARVI severity caused by RSV and rhinovirus in adult inpatients at Moinhos de Vento Hospital, Brazil, from April 2022 to July 2023, during the SARS-CoV-2 Omicron period. The primary outcome was a composite of in-hospital death, mechanical ventilation, and ICU admission, with secondary outcomes including individual components, hospital length of stay (LOS), and days alive and out of the hospital (DAOH) over 30 days. Results: 3,329 tests were conducted, yielding 329 positive results for either rhinovirus (n = 216) or RSV (n = 113). RSV cohort was older than the rhinovirus cohort (69.72 vs. 64.10 years, p = 0.03). No significant differences were found between the groups in gender or comorbidity burden. In the rhinovirus cohort, 33.80% experienced the primary composite outcome, similar to the RSV cohort (37.17%, p = 0.94). Secondary outcomes were also similar, with mean DAOH at 20.20 days for rhinovirus and 20.10 days for RSV (p = 0.12). Conclusion: Our study revealed high rates of adverse in-hospital outcomes among adults with rhinovirus and RSV, with over a quarter experiencing death, mechanical ventilation, or ICU admission. Notably, rhinovirus outcomes were similar to those of RSV, challenging the view of rhinovirus as a milder pathogen.

Background Conduction system pacing (CSP) has emerged as an alternative to biventricular pacing (BVP) for cardiac resynchronization therapy (CRT), with potential clinical benefits and lower costs. PhysioSync-HF is a multicenter, randomized trial comparing these strategies from both clinical and economic perspectives in patients with heart failure with reduced ejection fraction (HFrEF). Objective To describe the rationale and design of the trial-based economic evaluation embedded within the PhysioSync-HF trial. Methods The PhysioSync-HF trial enrolled 179 patients with 1-year follow-up. Procedural cost data will be collected using a time-driven activity-based costing approach. Costs associated with the device, adverse clinical events, and ambulatory care during follow-up will be estimated using resource-based accounting methods. Appropriate methods will address missing data, and statistical analyses will account for the skewed distribution of cost variables. Results The primary economic outcome is the between-group difference in total direct medical costs per patient over the 1-year follow-up (CSP vs BVP). Secondary outcomes include component-level cost breakdowns of direct medical expenses and a budget impact analysis estimating the annual effect on Brazil’s health care system if all eligible patients received CSP instead of BVP. Conclusion By leveraging a multicenter cardiovascular trial to measure costs of CSP versus BVP, this economic evaluation aims to identify cost-saving opportunities that could expand equitable access to CRT for individuals with HFrEF in Brazil, while providing insights relevant to other health care settings worldwide. Trial Registration NCT05572736.