American heart journal最新文献

Background: Electrical storm (ES) is a clinical syndrome characterized by densely clustered ventricular arrhythmias, associated with substantial morbidity and mortality. Autonomic dysfunction is thought to play key role in the pathophysiology of ES, with sympathetic blockade considered a therapeutic target. However, robust data supporting this treatment strategy remains limited. The objective of the SEDATE trial is to evaluate the effectiveness and safety of dexmedetomidine in the acute management of ES.

Methods and design: SEDATE is a multi-center, double-blinded, randomized trial comparing dexmedetomidine to placebo in the acute treatment of patients with ES. A total of 192 participants admitted to an intensive care unit with ES will be randomized in a 1:1 fashion to receive either dexmedetomidine or placebo. Participants will undergo a study drug titration phase, followed by a 48-hour maintenance period and a subsequent study drug weaning phase. The primary outcome is a composite of all-cause in-hospital mortality and/or recurrent ventricular arrhythmia prompting intervention. All participants will be followed for the duration of their hospitalization.

Implication: The SEDATE clinical trial aims to determine whether early use of dexmedetomidine improves in-hospital outcomes in patients with ES.

Trial registration: clinicaltrials.gov NCT06281977.

Introduction: Atrial fibrillation (AF) is the most common arrhythmia in older people, with an increasing prevalence of various geriatric conditions, such as multimorbidity and frailty. A contemporary integrated approach is effective in reducing the risk of clinical adverse events, particularly when streamlined through the application of the Atrial Fibrillation Better Care (ABC) pathway, as proven in two non-European trials.

Methods: The AFFIRMO trial, a European multicentre, open-label, cluster-randomised study, will examine whether a mobile-health integrated care approach based on the ABC pathway combined with a multidimensional Comprehensive Geriatric Assessment (CGA) can reduce the 12-month risk of unplanned all-cause hospitalisations in patients with AF ≥65 years with ≥1 concomitant chronic condition(s).

Results: The AFFIRMO trial enrolled 1,260 patients with AF (mean age 74 (SD 6) years; 44.4% female) across six European countries (Bulgaria, Denmark, Italy, Romania, Serbia, and Spain). At baseline, the median [IQR] CHA₂DS₂-VASc score was 4 [3-5], and the median [IQR] HAS-BLED score was 1 [1-2]. Hypertension was reported in 992 (78.7%) patients, and diabetes mellitus in 369 (29.3%) patients. Among the enrolled patients, 507 (40.5%) were pre-frail, and 171 (13.7%) were frail. OACs were prescribed for 1,225 (97.2%) patients, with 1,149 (91.2%) patients receiving NOACs. Follow-up is ongoing and planned to be completed in January 2026.

Conclusions: The AFFIRMO trial will provide evidence on the efficacy of the ABC pathway in conjunction with the CGA approach in reducing the risk of unplanned all-cause hospitalisations and other clinical adverse events in older, multimorbid patients with AF.

Registration: ClinicalTrials.gov NCT06775028.

Background: Transcatheter tricuspid valve interventions have expanded with the recent FDA approval of both replacement (TTVR) and edge-to-edge repair (T-TEER) devices. However, the volume and outcomes of commercial, off-label TTVR and T-TEER procedures are unknown. Herein, we describe institutional volume and patient characteristics for commercial, off-label TTVR and T-TEER procedures in the STS/ACC Transcatheter Valve Therapies (TVT) registry, and assess 30-day and 1-year outcomes, including quality of life.

Methods: Patients undergoing isolated TTVR or T-TEER for tricuspid regurgitation (TR) without stenosis were identified. The primary outcomes were residual TR severity and change in KCCQ-OS at 30 days. Secondary outcomes included 30-day mortality, vascular/bleeding complications, heart failure readmission, tricuspid reintervention, and 1-year Kaplan-Meier estimated mortality.

Results: A total of 995 tricuspid procedures were performed at 142 sites from 01/2021 to 12/2023, including 238 TTVR (primarily valve-in-valve or valve-in-ring) and 757 T-TEER. 72% of sites performed 5 or fewer procedures, while 4 high-volume centers performed 49, 81, 94, and 120 procedures, respectively. Among TTVR patients (median age 60), 97% had ≤ moderate residual TR at 30 days; 61% had substantial improvement and 14% had moderate improvement in KCCQ-OS. 30-day and 1-year estimated mortality were 3.9% and 19% respectively. Among T-TEER patients (median age 78), 74% had ≤ moderate residual TR; 54% had substantial improvement and 17% moderate improvement in KCCQ-OS. 30-day and 1-year estimated mortality were 3.0% and 18%, respectively.

Conclusions: Off-label use of transcatheter tricuspid valve interventions was highly variable across institutions, with the majority of institutions performing <5 procedures, while others performed >100. Both T-TEER and TTVR reduced residual TR to ≤ moderate in the majority of cases and were associated with substantial improvements in quality of life.

Background: Complete revascularization (CR) has been shown to reduce the risk of adverse cardiovascular events compared with culprit-only revascularization (COR) in acute ST-segment elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD). However, the optimal timing of staged complete revascularization (SCR) after primary percutaneous coronary intervention (PCI) remains unclear.

Trial design: The STAGED trial is an investigator-initiated, multicenter, randomized study involving 37 sites, aiming to include 1,586 acute STEMI patients with MVD undergoing successful primary PCI of the culprit lesion followed by SCR. Eligible patients will be assigned to two groups based on the timing of SCR: early-staged PCI and delayed-staged PCI. The primary endpoint is major adverse cardiac event (MACE), including cardiovascular death, myocardial infarction, or ischemia-driven revascularization for both culprit and non-culprit vessels at 12 months since the randomization. The secondary endpoint is individual components of primary endpoint, all-cause death, heart failure-related rehospitalization, stroke, contrast-induced nephropathy, and radiation exposure dose . Follow-up will be conducted through clinic visits or telephone interviews at 1, 3, and 12 months after the index procedure.

Conclusion: The STAGED trial is the first randomized controlled study specifically designed to evaluate the clinical efficacy and safety of different timing strategies for SCR in acute STEMI patients with MVD.

Trial registration: clinicaltrials.gov, NCT04918030.

An accurate interpretation of hemodynamics measured by right heart catheterization (RHC) is crucial for guiding the management of heart failure and pulmonary hypertension. We evaluated the concordance and variability between site-reported and core laboratory-adjudicated interpretations of invasive hemodynamic measurements.

Artificial intelligence (AI) is becoming increasingly prevalent in medical practice and has demonstrated sufficient clinical acumen to pass several licensing examinations. We tested the ability of three popular large-language models, ChatGPT-4.0 (OpenAI), Gemini (Google), and Bing AI (Microsoft), to pass a cardiovascular medicine board-style exam. Of these AI platforms, only ChatGPT-4.0 was able to achieve a score similar to human participants.