Importance:Conduction system pacing (CSP) is a promising and potentially cost-effective alternative to biventricular pacing (BiVP) in patients with heart failure with reduced ejection fraction (HFrEF) and left bundle-branch block (LBBB), but its impact on heart failure (HF) outcomes remains uncertain. Objective:To compare CSP vs BiVP on an HF-related outcome in patients with HFrEF and LBBB. Design, Setting, and Participants:PhysioSync-HF (Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure) was an investigator-initiated, multicenter, noninferiority randomized clinical trial enrolling participants from November 2022 to December 2023 with 12 months of follow-up at 14 hospitals across all regions of Brazil. Adults with symptomatic HFrEF (New York Heart Association NYHA] classes II through III), left ventricular ejection fraction (LVEF) of 35% or less, and LBBB (QRS duration ≥130 milliseconds) were eligible for inclusion. Data were analyzed from May to August 2025. Intervention:Patients were randomized 1:1 to either CSP (preferentially left bundle-branch area pacing) or BiVP. Main Outcomes and Measures:The primary outcome was a hierarchical composite of death, HF hospitalizations, urgent HF visits, and change in LVEF at 12 months. The prespecified noninferiority margin for the odds ratio (OR) was 1.2. Results:A total of 173 patients (median [IQR] age, 62 years [56-68]; 86 female patients [49.7%]; 115 (66.5%) with dilated cardiomyopathy; median [IQR] LVEF, 26% [22%-31%]; median [IQR] QRS, 180 milliseconds [170-200]) were included. At 12 months, CSP failed to meet noninferiority and was inferior to BiVP for the primary end point (OR, 2.36; 95% CI, 1.37-4.06; P = .99 for noninferiority; P = .002 for between-group difference). The time-to-event composite of death, HF hospitalizations, or urgent HF visits was higher in CSP (hazard ratio, 2.35; 95% CI, 0.99-5.61). Mean (SD) LVEF increased to 35% (12%) with CSP and 39% (12%) with BiVP (mean difference, 3.8%; 95% CI, 0.3%-7.3%). Relative to baseline, both groups had comparable improvements in QRS duration, Kansas City Cardiomyopathy Questionnaire Overall Summary Score, NYHA class, and natriuretic peptide levels. Total direct medical cost related to the procedure and heart failure care was the equivalent of $7090 (95% CI, $5779-$8648) lower in patients randomized to CSP at 12 months. Conclusions and Relevance:In patients with HFrEF and LBBB, CSP was inferior to BiVP for a composite of death, HF hospitalizations, urgent HF visits, and change in LVEF at 12 months. These findings do not support the routine use of CSP as the first-line resynchronization strategy in this population. Trial Registration:ClinicalTrials.gov Identifier: NCT05572736.
Background In low- and middle-income countries, reimbursement decisions often rely on projected incremental budget impact (IBI) analyses. We assessed whether drug incorporations into the Brazilian public health system (SUS) between 2012 and 2024 were consistent with affordability considerations within the health technology assessment (HTA) framework. Methods A retrospective documentary analysis was conducted using technical recommendation reports issued by the Brazilian National Committee for Health Technology Incorporation (Conitec). The primary variable was the total projected IBI of incorporated drugs. Subgroup analyses were performed by year of incorporation, health condition, and budget impact output. The proportion of total projected IBI relative to the Specialized Component of Pharmaceutical Care (CEAF) budget was assessed. Findings A total of 199 incorporated drugs were analyzed, 64 of which were projected to be cost-saving (Int$ 6·67 billion). These savings exceeded the total positive projected IBI generated by the remaining drugs (Int$ 4·05 billion). When COVID-19 vaccines were excluded, the cumulative projected IBI became positive, totaling Int$ 2·80 billion over the period analyzed, with sensitivity analyses yield estimates ranging from Int$ 2·36 billion to Int$ 2·88 billion. Preventable diseases exhibited the lowest median per capita IBI (Int$ 28; IQR Int$ 15; IQR Int$ 132), and oncological diseases the highest (Int$ 23,550; IQR Int$ 6789; IQR Int$ 57,154). Among drugs reimbursed exclusively by the Ministry of Health, the cumulative projected IBI represented 29% of the CEAF budget in 2024, exceeding 45% from 2019 to 2022. Interpretation The findings suggest that Conitec's decisions were consistent with HTA principles related to affordability. This interpretation is based on the evidence available at the time of the HTA decision rather than on observed real-world data following incorporation into the SUS. Funding None.
BACKGROUND:Whether the anatomical complexity of percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) influences the effects of antiplatelet therapy remains unknown. AIMS:We aimed to evaluate the impact of coronary anatomical complexity on clinical outcomes in patients receiving potent P2Y12 inhibitor monotherapy or dual antiplatelet therapy (DAPT). METHODS:In the NEO-MINDSET trial, patients with ACS were randomised after successful PCI to 12-month ticagrelor- or prasugrel-based monotherapy or DAPT, initiated within the first 4 days of hospitalisation. The co-primary endpoints were (i) a composite of death, myocardial infarction, urgent target vessel revascularisation, or stroke; and (ii) Bleeding Academic Research Consortium (BARC) Type 2, 3, or 5 bleeding. Complex PCI was defined by one or more of the following criteria: three-vessel PCI, ≥3 treated lesions, ≥3 stents implanted, total stent length >60 mm, two-stent bifurcation, or stenting in the left main coronary artery, in a bypass graft, or in a chronic total occlusion lesion. RESULTS:Of the 3,408 randomised patients with available procedural data, 791 (23.2%) underwent complex PCI. Compared with the non-complex PCI group, patients in the complex PCI group were older (mean age 60.63±10.52 years vs 59.33±10.83 years; p=0.005) and had a higher prevalence of hypertension (67.9% vs 62.9%; p=0.010). Among patients undergoing complex PCI, 1, 2, or ≥3 complexity criteria were present in 45.5% (n=360), 22.5% (n=178), and 32.0% (n=253), respectively. PCI complexity did not significantly modify the treatment effects of monotherapy versus DAPT on the ischaemic co-primary endpoint (p-interaction=0.68). Likewise, PCI complexity did not have an effect on the comparative risk of BARC Type 2, 3, or 5 bleeding between monotherapy versus DAPT. CONCLUSIONS:In this post hoc analysis of the NEO-MINDSET trial, PCI complexity did not significantly modify the treatment effects of potent P2Y12 inhibitor monotherapy versus DAPT on the co-primary ischaemic or bleeding outcomes. CLINICALTRIALS:gov: NCT04360720.
ABSTRACT Cardiac sarcoidosis (CS) is a potentially severe manifestation of systemic sarcoidosis, associated with advanced atrioventricular block, ventricular arrhythmias, heart failure, and sudden death. Diagnosis remains challenging due to phenotypic variability and the limitations of conventional diagnostic methods. Advances in imaging techniques, especially the combination of positron emission tomography/computed tomography (PET/CT) using 18F-FDG and cardiac magnetic resonance imaging (CMR), have revolutionized the diagnostic approach and therapeutic monitoring of CS. This article reviews current concepts of CS and its diagnosis, with a focus on the role of PET/CT, the importance of appropriate patient preparation, and integration with CMR.
Importance Bridging the low-density lipoprotein cholesterol (LDL-C) care gap in patients with established atherosclerotic cardiovascular disease (ASCVD) is challenging. Few quality improvement (QI) interventions have successfully improved patient care. Objective To evaluate the impact of a digitally enabled, multifaceted, QI intervention on the control of LDL-C concentration in patients with ASCVD. Design, Setting and Participants This was a pragmatic, 2-arm, cluster randomized clinical trial. A total of 28 clusters (public or private outpatient clinics) in Brazil were randomized to receive a digitally enabled QI intervention or routine practice (control). Adult patients (≥18 years) with established ASCVD were enrolled between November 2023 and December 2024 and followed up for 6 months. Intervention The intervention comprised a structured, digitally enabled QI strategy integrating previsit screening, electronic clinical decision support algorithms, audit and feedback mechanisms, and targeted clinician and patient engagement tools embedded within routine workflows to support lipid monitoring, treatment intensification, and adherence. Main Outcomes and Measures The primary outcome was mean LDL-C level at 6 months. Secondary outcomes included relative LDL-C change, achievement of LDL-C targets (<50 mg/dL and ≥50% reduction; to convert to millimoles per liter, multiply by 0.0259), and prescription of lipid-lowering therapies. All analyses were performed following the intention-to-treat principle and accounted for the cluster design by using a generalized estimating equations model. Results Among 1465 enrolled patients (mean [SD] age, 62.3 [10.1] years; 894 male [61.0%]; 714 intervention; 751 control), mean (SD) LDL-C concentration at 6 months was 76.3 (37.5) mg/dL in the intervention group and 85.6 (37.1) mg/dL in the control group. The adjusted mean difference was −6.62 mg/dL (95% CI, −11.11 to −2.13 mg/dL; P = .004). Patients in the intervention group were more likely to achieve an LDL-C concentration less than 50 mg/dL (23.5% vs 13.4%; odds ratio, 1.86; 95% CI, 1.30-2.65) and a 50% or greater reduction in LDL-C concentration (18.6% vs 13.4%; odds ratio, 1.76; 95% CI, 1.27-2.43). Prescription of intensive and combination lipid-lowering therapy was significantly higher in the intervention group. No significant differences in major cardiovascular events were observed. Conclusions and Relevance In this pragmatic cluster randomized clinical trial, a digitally enabled, multifaceted strategy produced modest LDL-C reduction and increased treatment intensification among patients with ASCVD. However, a proportion of patients had LDL-C levels that remained above recommended LDL-C targets, underscoring that the strategy tested was only partially effective in eliminating the residual care gap. Trial Registration ClinicalTrials.gov Identifier: NCT05622929
