Search Results for: Circulation

Introduction
Out-of-hospital cardiac arrest is a public health concern with a high mortality rate. Hypoxic ischaemic brain injury is the primary cause of death in patients admitted to the intensive care unit (ICU) after return of spontaneous circulation (ROSC). Several systemic factors, such as hypotension, can exacerbate brain injuries. International guidelines recommend targeting a mean arterial pressure (MAP) of at least 65 mm Hg. Several observational studies suggest that a higher MAP may be associated with better outcomes, but no randomised trials have shown an effect of higher MAP. The ongoing METAPHORE (mean arterial pressure after out-of-hospital cardiac arrest) trial aims to compare a standard MAP threshold (MAP ≥65 mm Hg) with a high MAP threshold (MAP ≥90 mm Hg) to evaluate whether implementing a higher MAP threshold can improve neurological outcomes in patients admitted to ICU after cardiac arrest.

Methods and analysis
METAPHORE is a randomised, controlled, multicentre, open-label trial with a blinded primary outcome assessor, comparing two parallel groups of patients 18 years of age or older, receiving invasive mechanical ventilation for coma defined by a Glasgow Coma Score ≤8/15 after out-of-hospital cardiac arrest and sustained ROSC. Eligible patients are randomly assigned in a 1:1 ratio to either a MAP target threshold of 65 mm Hg or higher throughout the ICU stay (control group) or a MAP target threshold of 90 mm Hg or higher during the first 24 hours after randomisation, followed by 65 mm Hg or higher for the remainder of the ICU stay (intervention group). Both groups receive the same general care concerning post-cardiac arrest syndrome management according to international guidelines. The primary endpoint is the proportion of patients with a favourable neurological outcome as defined by a modified Rankin scale (mRS) of 0 to 3 measured on day 180 after inclusion by a psychologist blinded to the allocation of the intervention. Secondary outcomes are the proportion of patients alive at ICU and hospital discharge, at day 28 and day 180; proportion of patients alive at ICU discharge with a mRS of 0 to 3; the EuroQOL-5D-5L at day 180; the Clinical Frailty Scale at day 180; the number of ICU-free days, ventilator-free days, catecholamine-free days and renal replacement therapy-free days at day 28; the proportion of patients with acute kidney injury stage 3 and need for renal replacement therapy within ICU stay and proportion of patients with persistent need for renal replacement therapy at ICU discharge; and safety outcomes (cardiovascular, neurological, cutaneous, digestive and haemorrhagic complications within 7 days after inclusion). Subgroup analyses are planned according to initial cardiac arrest rhythm (shockable or non-shockable), chronic hypertension and Cardiac Arrest Hospital Prognosis score. Outcomes will be analysed on an intention-to-treat basis. Recruitment started in October 2024 in 27 French ICUs, and a sample of 1380 patients is expected by October 2027.

Ethics and dissemination
The study received approval from the national ethics review board on 8 February 2024 (Comité de Protection des Personnes Sud-Est V – 2023-A00257-38). Patients are included after informed consent has been obtained either from a proxy or through an emergency procedure. Results will be submitted for publication in peer-reviewed journals.

Trial registration number
ClinicalTrials.gov: NCT05486884.

Circulation, Ahead of Print. Background: The PRAETORIAN trial investigated the efficacy and safety of the subcutaneous implantable cardioverter-defibrillator (S-ICD) compared with transvenous ICD (TV-ICD) and showed non-inferiority of the S-ICD with regard to the composite endpoint of device-related complications and inappropriate shocks (IAS) after 49.1 months. Complications associated with transvenous leads are expected to occur after longer follow-up. The PRAETORIAN-XL trial aims to investigate whether the S-ICD is superior to the TV-ICD with respect to device-related complications at 8-year follow-up.Methods: The PRAETORIAN trial randomized patients with a class I or IIa indication for ICD therapy without the need for pacing to either S-ICD or TV-ICD among 39 centers in the US and Europe between March 2011 and January 2017. The follow-up was extended after 49.1 months with an additional four years, for the PRAETORIAN-XL trial. The primary endpoint was the composite of all device-related complications. Complications could be related or unrelated to the lead, and minor or major, with major complications being those requiring an invasive intervention. Endpoints were analyzed according to the modified intention-to-treat principle using a Fine-Gray subdistribution hazards model to account for competing risks. An as-treated analysis was performed using a Cox proportional hazards model with device type as time-dependent variable.Results: Patients were randomized to S-ICD (N=426) and TV-ICD (N=423). Twenty-one percent of the S-ICD group versus 18% of the TV-ICD group was female. The median age at implantation was 63 (IQR 54-69) years for the S-ICD and 64 (IQR 56-69) years for the TV-ICD. After a median follow-up of 87.5 months, all device-related complications (major and minor combined) were not significantly different in the modified intention-to-treat analysis (sHR 0.73 (95%CI 0.48-1.12); P=0.15). However, TV-ICD patients more often had a major complication or lead-related complication (P=0.03 and P

Circulation, Ahead of Print. Background: There is sparse high-quality safety and effectiveness data for pulsed field ablation (PFA) of persistent atrial fibrillation (PerAF), where lesions beyond pulmonary vein isolation (PVI) are often placed. Additionally, no large trials have used insertable cardiac monitors (ICMs) for continuous rhythm monitoring post-ablation in PerAF patients, or after PFA inanyAF population. InADVANTAGE AF-Phase 2, PerAF patients underwent PFA for PVI and posterior wall ablation (PWA), and in a sub-cohort, cavotricuspid isthmus (CTI) ablation for typical atrial flutter.Methods: PerAF pts underwent PVI and PWA with the pentaspline PFA catheter, and CTI with a novel focal-linear PFA catheter after IV NTG prophylaxis. Patients were followed for 1 year with continuous rhythm monitoring after ablation with ICMs to 1) emulate traditional intermittent monitoring for the primary efficacy endpoint, and 2) examine atrial arrhythmia (AA) burden and episode duration.Results: This 255-patient cohort (age 66.7±9.3, female 29%, CHA2DS2-VASc 2.4±1.4, BMI 30.9±5.3, left atrium diameter 4.3±0.6 cm) underwent PVI plus PWA (99.6%/100% acute success); a subpopulation (n=141; 55.3%) also received CTI PFA, with 98.6% achieving bidirectional block without complications (ST changes, ventricular fibrillation). CTI ablation took 8±13 minutes, using 18±6 PF applications and 4±2 mg IV NTG. The total procedure and atrial dwell times were 105±36 and 59±24 minutes, respectively. Mimicking traditional monitoring, freedom from AA was 73.4% with adverse events in 2.4%, both meeting prespecified endpoint criteria. Freedom from recurrent atrial flutter was 97.2%. Detailed analysis of the full ICM data revealed freedom from AA ≥30 seconds in 52.0%, and no episode exceeded 24 hours in 94.0% of this PerAF cohort. An AA burden >0.1% or longest episode duration >1 hour were both predictive of increased healthcare utilization. One-year procedural effectiveness was 71.6% and 70.0% using these ≤0.1% burden and

Introduction
Dengue fever is a major global public health challenge caused by the Arbovirus and transmitted by Aedes mosquitoes. The increasing incidence of dengue, particularly in the Southeast Asia (SEA) region, including Malaysia, highlights the urgent need for a comprehensive understanding of dengue molecular epidemiology. This study aims to systematically review various aspects of dengue molecular epidemiology to gain insights into the disease’s dynamics, transmission and circulation. Providing evidence-based insights is crucial for the prevention and control of dengue.

Methods and analysis
A systematic review and meta-analysis will be conducted following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. Eligible studies will include observational designs from the inception of time to 31 December 2024, in the SEA region. The review will encompass various molecular epidemiology domains as the exposures and assess the outcomes, such as confirmed dengue cases and severity. Descriptive and meta-analytical methods will determine prevalence, genetic changes and associations. Grading of Recommendations Assessment, Development, and Evaluation methodology will evaluate the quality of evidence, and reporting biases will be addressed. This review aims to bridge the gap in dengue molecular epidemiology in the SEA region by providing comprehensive insights crucial for effective dengue prevention and control.

Ethics and dissemination
No primary data will be collected; thus, the ethical exemption was obtained from Medical Research Ethics Committee with reference number 23-03212-AE6 and ethics approval from the IMU University Joint Committee. The results will be disseminated through a peer-reviewed publication and conference presentation.

PROSPERO registration number
CRD42023480417.

Circulation, Ahead of Print. BACKGROUND:Patients with an autoimmune or inflammatory disease (AIID) are at increased cardiovascular risk and may benefit more from statin therapy. In the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor evolocumab lowered low-density lipoprotein cholesterol levels, but not hsCRP (high-sensitivity C-reactive protein) levels, and reduced the risk of cardiovascular events.METHODS:FOURIER was a randomized trial of evolocumab versus placebo in 27 564 patients with stable atherosclerosis who were taking statins. This analysis focused on the effect of evolocumab in patients with or without an AIID, defined as any autoimmune or chronic inflammatory condition. The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, unstable angina, or coronary revascularization.RESULTS:At baseline, 889 patients (3.2%) had an AIID, most commonly rheumatoid arthritis (33.7%) or psoriasis (15.6%). Median (interquartile range) low-density lipoprotein cholesterol levels were 90.0 mg/dL (79.5–105.5) and 91.5 mg/dL (79.5–108.5) in patients with or without an AIID, respectively (P=0.025), and the placebo-adjusted percent reduction with evolocumab was consistent (60.2% versus 59.0%;P=0.57). Baseline hsCRP was higher in patients with an AIID (median 2.1 versus 1.7 mg/L;P

Circulation, Ahead of Print. BACKGROUND:High-volume physical activity (PA) is associated with a higher prevalence of subclinical coronary artery disease (CAD). However, the clinical significance of subclinical CAD among high-volume exercisers remains incompletely understood, and the dose–response relationship between high-volume PA and clinical CAD events remains uncertain.METHODS:Individual participant data from the Cooper Center Longitudinal Study (1987–2018) were linked to Medicare claims files. PA volume was determined by self-report and categorized as

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Circulation, Ahead of Print. Cardiovascular disease remains a leading cause of morbidity and mortality in adults despite recent scientific advancements. Although people are living longer lives, there may be an adverse impact on quality of life, necessitating a greater need for palliative care services and support. Palliative care for adults with advanced cardiovascular disease has the potential to significantly improve quality of life for individuals living with cardiovascular disease and their informal care partners. Effective communication, shared decision-making, age-friendly care principles, and advance care planning are vital components of palliative care and support comprehensive and holistic care throughout the advanced cardiovascular disease trajectory and across care settings. Current evidence highlights the benefits of palliative care in managing symptoms, reducing psychological distress, and supporting both people with cardiovascular disease and their care partners. However, significant gaps exist in palliative care research related to non–heart failure populations, care partner outcomes, and palliative care implementation in diverse populations. This scientific statement (1) discusses the application of effective communication, shared decision-making, age-friendly care, and advance care planning in advanced cardiovascular disease palliative care; (2) provides a summary of recent evidence related to palliative care and symptom management, quality of life, spiritual and psychological support, and bereavement support in individuals with advanced cardiovascular disease and their care partners; (3) discusses issues involving diversity, equity, and inclusion in cardiovascular disease palliative care; (4) highlights the ethical and legal concerns surrounding palliative care and implanted cardiac devices; and (5) provides strategies for palliative care engagement in adults with advanced cardiovascular disease for the care team.