Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of severe aortic stenosis, compared with more invasive surgical aortic valve replacement (SAVR). Outcomes after device advancements and the landmark 2018 update to TAVI clinical guidelines were analyzed in a 10-year cohort study conducted by a Brazilian health maintenance organization.

The study analyzed TAVI procedures performed from July 2013 to December 2023 in a Brazilian health maintenance organization. Patients were grouped into two cohorts: those treated before January 2019 and those treated after January 2019, aligning with the implementation of the updated guidelines. Data on patient demographics, procedural details, and clinical outcomes were collected from institutional databases. Primary outcomes included rates of mortality and major complications, while secondary outcomes encompassed rates of procedural success and device-related complications. Statistical comparisons were conducted using chi-square and t-tests, with significance set at p<0.05.

The study included 325 patients, with 56 treated before and 269 after the guideline update. There was no difference in median age (84 years) between the two cohorts, and 58 percent were female. After guideline implementation, a shift to self-expanding valves resulted in reduced rates of pacemaker implantation (28.6 to 18.2%; p=0.03) and stroke (8.9 to 5.6%; p=0.2). The one-year mortality rate decreased from 25 to 14.9 percent, reflecting significant improvements in clinical outcomes. Procedural success rates exceeded 98 percent in both cohorts, demonstrating the reliability of TAVI in routine practice.

The implementation of updated procedural protocols in 2018 led to significant improvements in TAVI outcomes for patients with similar risk profiles. These findings underscore the importance of evidence-based practice and continuous technological advancements in optimizing patient care for severe aortic stenosis. Future studies should focus on long-term outcomes and durability of TAVI devices.

The United States Food and Drug administration (FDA) Accelerated Approval (AA) pathway facilitates early access to therapies for severe conditions based on surrogate endpoints, requiring confirmatory trials to validate benefits. This study compared FDA AA outcomes with Brazilian regulatory decisions, highlighting alignment and discrepancies, and their implications for patient safety and healthcare systems, focusing on post-market surveillance and evidence-based decision-making.

Data on drugs on the FDA AA pathway were retrieved from the FDA’s publicly available repository as of 7 November 2024. Each drug was categorized by approval status: ongoing, verified clinical benefit, withdrawn, and other. Drugs were further analyzed for approval, coverage, and reimbursement decisions in Brazil using data from the Brazilian Health Regulatory Agency (ANVISA), the National Committee for Health Technology Incorporation (CONITEC), and the National Supplementary Health Agency (ANS). The analysis focused on discrepancies between FDA and ANVISA decisions and the implications for Brazilian healthcare systems.

A total of 336 drugs were analyzed: 53 percent achieved confirmed clinical benefit, 12.8 percent were withdrawn due to safety or efficacy concerns, and 30.7 percent are still undergoing confirmatory trials. The average time from AA to withdrawal was 7.35 years, highlighting extended patient exposure to unverified therapies. Of the 43 drugs withdrawn by the FDA, 12 retained active label indications by ANVISA. This regulatory lag impacts the Brazilian National and Supplementary Health Systems through potential inefficiencies in resource allocation.

Discrepancies between FDA and ANVISA decisions underscore the need for stronger international collaboration on post-market surveillance and harmonized criteria for drug approvals. For Brazil, addressing these gaps could enhance patient safety, optimize healthcare resources, and align regulatory practices to ensure timely, evidence-based decision-making.

Severe scoliosis affects three percent of the population, with 0.3 percent requiring surgery that often results in significant blood loss. The cell saver technique collects and reinfuses lost blood, potentially reducing the need for transfusions. This study evaluated its clinical outcomes and feasibility in scoliosis surgeries performed between January 2022 and March 2024 in a Brazilian Health Maintenance Organization.

A non-concurrent cohort study analyzed the use of cell savers in scoliosis surgeries performed between January 2022 and March 2024 within a non-profit health assistance organization in Brazil. Patients were divided into two groups: those who underwent intraoperative use of the cell saver technique and those who did not. Data on patient demographics, procedural details, and clinical outcomes were collected from institutional databases. Primary outcomes included the length of hospital stay, the need for blood transfusion, and rates of major complications. Statistical comparisons were performed using chi-square tests and t-tests (statistical significance set at p<0.05).

Among 311 patients, nine received the cell saver technique. The mean age was 14.8 years, with 66 percent being younger than 19 years. In the non-cell saver group (302 patients), 36 percent required blood transfusions (average two units/patient) and the mean hospital stay was 7.52 days. In the cell saver group, 44 percent required transfusions (average 1.25 units/patient), and the mean hospital stay was 6.89 days. The results suggested trends toward reduced transfusion needs, use of fewer blood units, and shorter hospital stays in the cell saver group, although the sample size was limited.

This study identified potential benefits of intraoperative cell saver use in scoliosis surgeries, including reduced transfusion needs, use of fewer blood units, and shorter hospital stays. However, the findings require validation in larger, more diverse samples to establish clinical significance and cost effectiveness in routine practice.

To evaluate clinical outcomes in patients with uncomplicated β-hemolytic Streptococcus spp. bloodstream infections (BSI) transitioned to oral antimicrobial therapy (OAT) compared with those that remain on intravenous antimicrobial therapy.

Retrospective cohort study.

Tertiary academic hospital.

This retrospective cohort study included adult patients hospitalized between 1/1/2013 and 12/31/2019 diagnosed with uBSI due to β-hemolytic streptococci. Patients were excluded if BSI was due to endovascular, central nervous system, or bone/joint infection or patient was immunosuppressed or died within 72 hours of identification of BSI. We compared outcomes including: 30-day mortality, antimicrobial therapy, BSI relapse, 30-day rehospitalization, adverse drug events, and reversion to IV therapy. Fisher’s exact test was used for categorical variables; Mann – Whitney test and Independent T-test for continuous variables.

232 BSIs were included. OAT was used in 152 (65%). Cohort demographics were similar. Mortality was also similar between cohorts (2% vs 6% P = .13). Hospital length of stay was shorter in the OAT cohort with a median of 5 days (interquartile range 4.00, 8.00) versus 8 (5.00, 16.00) in the IV group (P < .0001). Patients transitioned to OAT were more likely to finish antibiotics outpatient (93% vs 62% P < .001).

For β-hemolytic Streptococcus uBSI, OAT was associated with decreased length of stay without adverse clinical outcomes. Opportunities exist to modify clinical management of uBSI.

We introduced a urinary tract infection (UTI) panel requiring symptom documentation and identification of special populations linked to reflex urine culturing and evaluated its impact on catheter-associated UTI (CAUTI) including during the COVID-19 pandemic.

Quasi-experimental encompassing 3 periods: pre-panel (January 2014–March 2015), post-panel (April 2015–March 2020), and post-panel COVID (April 2020–June 2022).

Tertiary care center inpatients.

Poisson regression and interrupted time series (ITS) analysis evaluated changes in catheter days (CD), urine cultures (UC), and CAUTI measured by 1,000 CD and patient days (PD). National Health Safety Network standardized infection ratio (SIR) and standardized utilization ratio (SUR) data were analyzed.

UC per 1,000 PD decreased after implementation (pre-panel 36.9 vs 16.6 post-panel vs 14.4 post-panel COVID, all P < .001). CD declined pre-panel versus post-panel (RR 0.37, P < .001) but not from post-panel to post-panel COVID (RR 0.94, P = .88). UTI panel implementation was associated with a 40% decrease in CAUTI rates per 1,000 CD (P < .001). During the COVID-19 pandemic (post-panel COVID), a nonsignificant increase of 13% (P = .61) in CAUTI was noted but remained 32% lower than pre-panel (P = .02). The slope of change using ITS changed from negative to positive but was nonsignificant (P = .26). CAUTI rates per 1,000 PD demonstrated greater reductions (pre- vs post-panel (RR 0.37; 95% CI, 0.29–0.47) and pre- vs post-panel COVID (RR 0.35; 95% CI, 0.26–0.46)). SIRs were unavailable before 2016, but median SIRs post-panel compared to post-panel COVID were similar (1.05 vs 1.56, respectively, P = .067).

Implementation of the UTI panel was associated with a reduction in both UC and CAUTI with the impact maintained despite the COVID-19 pandemic.

Brazil’s public health system serves most of the population, but 25 percent of citizens rely on private health insurance. The National Regulatory Agency for Private Health Insurance and Plans (ANS) regulates private medicine reimbursements, which diverge from the public sector threshold. In 2022, the National Committee for Health Technology Incorporation (CONITEC) set a willingness-to-pay benchmark of BRL40,000 (USD8,215) per quality-adjusted life-year. The ANS has no such benchmark, highlighting a pivotal gap in economic evaluations for private health care.

This quantitative study investigated the Incremental cost-effectiveness ratios (ICER) for reimbursed medicines in Brazil’s private health sector, comparing them with CONITEC’s benchmarks and international thresholds. Data were extracted from industry reimbursement submissions to the ANS and analyzed for statistical disparity and policy implications.

Preliminary findings found an ICER peak of BRL619,900 (USD127,220) per quality-adjusted life-year for talazoparib, which is used to treat certain advanced breast cancers. This contrasted sharply with CONITEC’s established threshold, indicating a critical need to evaluate ANS policies.

Early results indicate that the ICERs for some medicines surpass CONITEC’s willingness-to-pay limit, suggesting that the ANS should consider establishing a defined cost-effectiveness threshold. This is imperative to harmonize with global standards and maintain sustainable health financing.

Despite medical advancements, endocarditis still results in high mortality rates. Surgery, while often essential, elevates the risk of hyperinflammation, sepsis, and cytokine release. The use of a cytokine filter to prevent this remains controversial. This study reviewed existing literature to assess the efficacy of cytokine filters and to support its integration into supplementary health services.

An exhaustive search of the MEDLINE, Cochrane Library, Embase, LILACS, and CytoSorbents Corporation databases was conducted to identify relevant meta-analyses and systematic reviews. The study focused on randomized controlled trials and case series studies assessing the efficacy of cytokine filtration. Key variables considered were the duration of antibiotic treatment, severity of endocarditis, and surgical treatment rationale. These factors were crucial for evaluating clinical outcomes and patient survival after surgery.

The systematic reviews yielded mixed outcomes. Two found no benefits for hemoadsorption, while one found that it reduced mortality rates and intensive care unit stays based on observational studies. Randomized controlled trials, however, showed no significant impact for cytokine filters on mortality rates or postoperative hemodynamic parameters. In contrast, case series studies reported potential benefits, but these results were confounded by biases in patient allocation and failure to account for critical variables like antibiotic treatment duration, case severity, and surgical rationale. These discrepancies highlight the complexity of evaluating the effectiveness of cytokine filtration in surgical settings.

Randomized and non-randomized controlled trials on the role of cytokine filters in cardiac surgery for endocarditis reported contradictory findings. Only case series studies suggested benefits from cytokine filters, necessitating further high quality research before recommending their widespread use. Understanding the implications of these results is essential, underscoring the need for more rigorous studies to resolve these inconsistencies.

Informed healthcare policies in Brazil rely on robust health technology assessment (HTA), especially for conditions like non-small cell lung cancer (NSCLC). We present an efficiency frontier analysis to evaluate NSCLC treatments that correlates annual treatment costs with clinical outcomes, offering a systematic approach to enhance decision-making in the Brazilian healthcare context.

This quantitative study analyzed NSCLC drug costs within the Brazilian healthcare system and the clinical efficacy data of pivotal studies. The data were analyzed using Python and R software. The dataset comprised drug costs and hazard ratios for overall survival. After data preparation, which involved normalization and outlier management, we constructed an efficiency frontier by ranking drugs based on cost and effectiveness. A linear regression model was then developed to extrapolate this frontier, deriving a formula that predicts treatment costs for specified improvements in overall survival.

The analysis delineated an efficiency frontier and revealed cost-effective NSCLC treatments in Brazil. The following linear regression equation was derived: overall survival = (1.033551 − 0.000003) × treatment cost (USD). This allows for the estimation of appropriate treatment costs for new therapies based on their expected clinical outcomes. This initial model provides a foundation for estimating the economic impact of new treatments.

This preliminary efficiency frontier analysis offers a novel perspective for evaluating NSCLC treatment strategies in Brazil to support sustainable healthcare policy decisions. The model is subject to limitations due to the absence of a systematic literature review. However, it represents an initial step towards a more comprehensive HTA framework. Further research should refine the model by including systematic data collection and analysis.

In Brazil, equitable access to medications is critical. There are significant pricing disparities between the National Health System and private health care, which are influenced by the National Committee for Health Technology Incorporation (CONITEC) and Law 14.307. This study investigated these disparities, with aim of proposing strategies for equitable access and sustainability in health care.

This analysis compared prices between the public and private sectors for trastuzumab and adalimumab. Public sector prices were obtained from the Health Prices Database (HPD) and private sector prices were obtained from the Unimed National Table of Materials and Medications (TNUMM), as of May 2023. The study evaluated the extent of pricing discrepancies, considering Drug Market Regulation Chamber ceiling prices and industry discounts.

The cost of the trastuzumab biosimilar, KANJINTI® (Amgen Inc.), was BRL15.79 (USD3.24) per mg in the private sector, compared with BRL4.50 (USD0.92) per mg in the public sector (a 250% difference). The original version of adalimumab, HUMIRA® (AbbVie), was priced at BRL5,450.38 (USD1,120.53) in the TNUMM versus BRL2,445.46 (USD502.33) in the HPD (a 123% difference). The adalimumab biosimilar, HYRIMOZ® (Sandoz Inc.), was priced at BRL7,723.99 (USD1,586.87) in the TNUMM compared with BRL2,449.19 (USD503.05) in the HPD (a 215% price discrepancy).

The study highlights significant disparities in drug pricing between Brazil’s public and private healthcare sectors. These disparities affect the financial sustainability of private health entities and elevate costs for consumers, potentially increasing reliance on the National Health System. Policy revisions, price parity strategies, and further studies are vital for a sustainable healthcare system.

There is a lack of standardised psychometric data in electronic health record (EHR)-based research. Proxy measures of symptom severity based on patients' clinical records may be useful surrogates in mental health EHR research.

This study aimed to validate proxy tools for the short versions of the Positive and Negative Syndrome Scale (PANSS-6), Young Mania Rating Scale (YMRS-6) and Montgomery–Åsberg Depression Rating Scale (MADRS-6).

A cross-sectional, multicentre study was conducted in a sample of 116 patients with first-episode psychosis from 12 public hospitals in Spain. Concordance between PANSS-6, YMRS-6 and MADRS-6 scores and their respective proxies was evaluated based on information from EHR clinical notes, using a variety of statistical procedures, including multivariate tests to adjust for potential confounders. Bootstrapping techniques were used for internal validation, and an independent cohort from the Treatment and Early Intervention in Psychosis Program (TIPP-Lausanne, Switzerland) for external validation.

The proxy versions correlated strongly with their respective standardised scales (partial correlations ranged from 0.75 to 0.84) and had good accuracy and discriminatory power in distinguishing between patients in and not in remission (percentage of patients correctly classified ranged from 83.9 to 91.4% and bootstrapped optimism-corrected area under the receiver operating characteristic curve ranged from 0.76 to 0.89), with high interrater reliability (intraclass correlation coefficient of 0.81). The findings remained robust in the external validation data-set.

The proxy instruments proposed for assessing psychotic and affective symptoms by reviewing EHR provide a feasible and reliable alternative to traditional structured psychometric procedures, and a promising methodology for real-world practice settings.

Pulmonary regurgitation is the most common complication in repaired tetralogy of Fallot patients. Severe chronic pulmonary regurgitation can be tolerated for decades, but if not treated, it can progress to symptomatic, irreversible right ventricular dilatation and dysfunction. We investigated clinical associations with pulmonary valve replacement among patients with significative pulmonary regurgitation and how interventional developments can change their management.

All adult patients with repaired tetralogy of Fallot who were followed at an adult CHD Clinic at a single centre from 1980 to 2022 were included on their first outpatient visit. Follow-up was estimated from the time of correction surgery until one of the following events occurred first: pulmonary valve replacement, death, loss to follow-up or conclusion of the study.

We included 221 patients (116 males) with a median age of 19 (18–25). At a median age of 33 (10) years old, 114 (51%) patients presented significant pulmonary regurgitation. Among patients with significant pulmonary regurgitation, pulmonary valve replacement was associated with male gender, older age at surgical repair, and longer QRS duration in adulthood. Pulmonary valve replacement was performed in 50 patients, including four transcatheter pulmonary valve implantations, at a median age of 34 (14) years.

Pulmonary regurgitation affects a large percentage of tetralogy of Fallot adult patients, requiring a long-term clinical and imaging follow-up. Sex, age at surgical repair and longer QRS are associated with the need of PVR among patients with significative pulmonary regurgitation. Clinical practice and current literature support TPVI as the future gold standard intervention.

This brief report aims to describe and determine the association of family functioning (e.g., cohesion and expressiveness) with psychosocial needs among Spanish Latinx patients coping with advanced cancers.

Descriptive and correlation analyses were performed on data from 103 patients coping with advanced cancer (Stages III and IV). The measures used were the Family Relationships Index, the Hospital Anxiety and Depression Scale, and the Functional Assessment of Cancer Therapy: General.

Results indicated that most of the participants had low family function (65%). Participants with higher family functioning (35%) had high levels of quality of life [r(103) .318, p < .002]. A higher level of quality of life was also strongly associated with lower levels of anxiety [r(95) −.653, p < .000], lower levels of depression [r(95) −.733, p < .000], and lower levels of hopelessness [r(95) −.585, p = .000]. A total of 22.3% of Latinx advanced cancer patients reported poor cohesiveness; those with low cohesiveness also had higher levels of depression [r(103) −.28, p = .004] and anxiety [r(103) −.27, p = .005]. Correlations between expressiveness and hopelessness were significant; namely, those with higher expressiveness had lower hopelessness [r(103) −.274, p = .005].

Findings present a high correlation between family functioning and psychosocial symptoms.