Abstract 159: Long-Term Survival and Neurological Follow-Up of Cardiac Arrest Survivors: Results From the French Multicentric Prospective Cohort the DESAC Study

Circulation, Volume 148, Issue Suppl_1, Page A159-A159, November 6, 2023. Background:While short-term prognosis of cardiac arrest (CA) patients has been extensively studied, less is known regarding the mid- and long-term outcome of survivors.Aims:The aim of the DESAC study was to describe mid- and long-term survival and neurological status of CA survivors, and to assess the influence of pre- and intra-hospital therapeutic strategies on these outcomes.Methods:Between Jul 2015 and Oct 2018, patients over 18 years who were discharged alive from intensive care units in Paris and suburbs (France) after a non-traumatic CA were included and interviewed every 6 months during at least 24 months and up to 48 months in this multicentric study. Factors associated with Cerebral Performance Category (CPC) scale at 24 months were assessed with logistic regression, with CPC 1 or 2 level considered as a favorable neurological outcome. Trajectories of CPC were derived by mixed linear model in survivors with at least 3 evaluations.Results:Out of 593 survivors, 525 had a 24 months follow-up (mean age 57.6 +/-15.3, 79% men). CA occurred in public location in 251/525, with an initial shockable rhythm in 392/525. Prognostic factors independently associated with a favorable neurological outcome at 24 months were initial shockable rhythm (OR= 3.53 (1.65; 7.58)) and previous practice of sport (OR= 3.12 (1.20 ; 8.11)), whereas older age (OR per 10 years= 0.52 (0.40; 0.68)) and previous ischemic cardiomyopathy (OR= 0.34 (0.15 ; 0.77)) were poor prognostic factors. Therapeutic hypothermia or coronary procedures were not related to prognosis. Five trajectories of CPC could be derived among the 514 patients. Overall, 64% remained in CPC1, 13% in CPC2, 11% improved from CPC2 to CPC 12% died either early or lately (Figure 1).Conclusions:In this multicentric and prospective study, practice of sport and shockable rhythm were strongly associated with a favorable neurological recovery at 24 months. Furthermore, two thirds of the survivors remained in CPC 1 over time.

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Novembre 2023

Abstract 141: Automated Head-Up Cardiopulmonary Resuscitation Increased End Tidal Co2 in Patients With Out-of-Hospital Cardiac Arrest Compared With Conventional CPR: A Prospective Before-After Interventional Study

Circulation, Volume 148, Issue Suppl_1, Page A141-A141, November 6, 2023. Background:Little is known in humans about the physiological effects of the combination of automated Head-Up cardiopulmonary resuscitation CPR, active compression-decompression CPR and an impedance threshold device (ITD). This new approach, termed AHUP-CPR, improves perfusion of vital organs and lowers intracranial pressure compared with conventional (C)CPR in animal models of cardiac arrest. This study tested the hypothesis that AHUP-CPR treatment would increase end tidal CO2 (ETCO2), a circulation surrogate, more than C-CPR in out-of-hospital cardiac arrest (OHCA) patients.Method:Prospective before-after interventional study of witnessed OHCA patients. C-CPR and AHUP-CPR were performed by firefighters who measured ETCO2. AHUP-CPR was delivered using a LUCAS AD (5 cm of compression and 3 cm active decompression) (Stryker Medical, USA), an EleGARD Patient Positioning System (AdvancedCPR Solutions, USA), and an ITD (ResQPOD-16, Zoll, USA). The study was performed in the greater Grenoble France region in four different fire stations. The primary endpoint was the measurement of maximum EtCO2 during CPR. Results are presented as mean ± standard deviation.Results:Baseline characteristics (age, sex, arrest location, initial rhythm, bystander CPR, witnessed) were not statistically different between groups.EtCO2 was higher for patients treated with AHUP-CPR (n=63) compared to the C-CPR (n=59) (41±18 vs. 30.2 mmHg, p

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Novembre 2023

Abstract 11932: Discharge Dichotomy: Lack of Appropriate Discharge Follow Up in ST-segment Elevation Myocardial Infarction With Non-Obstructive Coronary Arteries (STE-MINOCA) Patients

Circulation, Volume 148, Issue Suppl_1, Page A11932-A11932, November 6, 2023. Introduction:Readmission after acute myocardial Infarction is a challenge in health care. Guidelines recommend early follow-up as those who do not have established follow-up are 10 times more likely to be re-hospitalized. This allows for close review of cardiac symptoms and medications. While there is substantive data about early follow up in the obstructive ST-Segment Elevation Myocardial Infarction (STE-Obstructive) populations improving readmission rates, there are minimal guidelines regarding follow up for STE-MINOCA patients.Hypothesis:Does time to post-discharge outpatient care impact rate of readmission between STE-Obstructive and STE-MINOCA patients?Methods:A single center, retrospective cohort study analyzed demographics and discharge pathways of patients meeting STEMI criteria who underwent coronary angiography. Discharge medications, follow up appointment, and readmissions were examined. Simple and multiple logistic regression analyses were used to explore the association between discharge pathways and clinical factors in two STEMI populations.Results:377 of 433 patients survived discharge with a median age of 59. Of those who survived, 63.9% were male, 44.3% Black, 30.2% Hispanic, and 82.7% had government-issued insurance. STE-Obstructive patients had significantly higher rates of follow up (p=0.0006) and earlier than STE-MINOCA patients (p=0.052) (Table 1). Despite differences in follow up, readmissions for cardiovascular issues were not significantly different between the STE-MINOCA and STE-Obstructive patients. Of note 64% of STE-MINOCA patients who were readmitted did not have follow up prior to readmission.Conclusions:STE-MINOCA patients had longer time to follow up and less follow up than STE-Obstructive patients. Readmission rates between the two groups were similar. Further studies are required to explore the role of earlier follow up in STE-MINOCA clinical trajectory.

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Novembre 2023

Abstract 15589: Impact of Preprocedural Anemia on In-Hospital and Follow-Up Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention

Circulation, Volume 148, Issue Suppl_1, Page A15589-A15589, November 6, 2023. Background:The impact of preprocedural anemia on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study.Methods:We examined the clinical and angiographic characteristics and procedural outcomes of 8,633 CTO PCIs performed at 39 US and non-US centers between 2012 and 2023. Anemia was defined as a hemoglobin level of

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Novembre 2023

Abstract 321: Manual vs Automated Ventilation During Automated Head-Up Cardiopulmonary Resuscitation in a Porcine Model

Circulation, Volume 148, Issue Suppl_1, Page A321-A321, November 6, 2023. Background:The efficacy of mechanical ventilation during CPR with the combination of active compression-decompression, an impedance threshold device, and head-up positioning, collectively termed automated head-up (AHUP)-CPR, is unknown.Hypothesis:Hemodynamic and ventilatory parameters will be similar with manual bag ventilation (MBV) versus automated bag ventilation (ABV) during AHUP-CPR in a porcine model of cardiac arrest.Aim:Assess the proof-of-concept that ABV is safe and effective during AHUP-CPR.Methods:Nine male and female swine (~40 kg) were anesthetized and ventilated. VF was induced and left untreated for 8 min. AHUP-CPR was performed at 105 compressions/min for 7 min using MBV, followed by 6 min using an automated mechanical bag compressor to deliver 10ml/kg of tidal volume (TV) over 1 sec at 10 breaths/min. Pigs were randomized during ABV to a synchronized (Sync) breath delivered at the start of decompression or an asynchronous (Async) breath. Cerebral perfusion pressure, coronary perfusion pressure, end-tidal CO2, intracranial pressure, esophageal intrathoracic pressure, peak airway pressure (PAP), inspiratory and expiratory TVs as well as arterial blood gases were continuously measured. Values (mean ± SD) were compared by paired and unpaired student’s t-tests with a Bonferroni correction.Results:Parameters during the last minute of MBV and ABV are summarized in the table. No significant differences were observed in hemodynamic and ventilatory parameters, except for PAP and pO2 values which were significantly lower with MBV. No significant differences were also observed between the Sync and Async ABV modes.Conclusion:Manual and mechanical ventilation resulted in overall similar physiological effects. The clinical relevance of the observed significant differences in PAP and pO2 is unclear. Additional studies are warranted to further assess the safety and effectiveness of mechanical ventilation during AHUP-CPR.

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Novembre 2023

Protocol of the Berlin Long-term Observation of Vascular Events (BeLOVE): a prospective cohort study with deep phenotyping and long-term follow up of cardiovascular high-risk patients

Introduction
The Berlin Long-term Observation of Vascular Events is a prospective cohort study that aims to improve prediction and disease-overarching mechanistic understanding of cardiovascular (CV) disease progression by comprehensively investigating a high-risk patient population with different organ manifestations.

Methods and analysis
A total of 8000 adult patients will be recruited who have either suffered an acute CV event (CVE) requiring hospitalisation or who have not experienced a recent acute CVE but are at high CV risk. An initial study examination is performed during the acute treatment phase of the index CVE or after inclusion into the chronic high risk arm. Deep phenotyping is then performed after ~90 days and includes assessments of the patient’s medical history, health status and behaviour, cardiovascular, nutritional, metabolic, and anthropometric parameters, and patient-related outcome measures. Biospecimens are collected for analyses including ‘OMICs’ technologies (e.g., genomics, metabolomics, proteomics). Subcohorts undergo MRI of the brain, heart, lung and kidney, as well as more comprehensive metabolic, neurological and CV examinations. All participants are followed up for up to 10 years to assess clinical outcomes, primarily major adverse CVEs and patient-reported (value-based) outcomes. State-of-the-art clinical research methods, as well as emerging techniques from systems medicine and artificial intelligence, will be used to identify associations between patient characteristics, longitudinal changes and outcomes.

Ethics and dissemination
The study was approved by the Charité—Universitätsmedizin Berlin ethics committee (EA1/066/17). The results of the study will be disseminated through international peer-reviewed publications and congress presentations.

Study registration
First study phase: Approved WHO primary register: German Clinical Trials Register: https://drks.de/search/de/trial/DRKS00016852; WHO International Clinical Registry Platform: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00016852. Recruitment started on July 18, 2017.
Second study phase: Approved WHO primary register: German Clinical Trials Register DRKS00023323, date of registration: November 4, 2020, URL: http://www.drks.de/ DRKS00023323. Recruitment started on January 1, 2021.

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Ottobre 2023

Scaling up a school-based intervention to increase physical activity and reduce sedentary behaviour in children: protocol for the TransformUs hybrid effectiveness-implementation trial

Introduction
Efficacious programmes require implementation at scale to maximise their public health impact. TransformUs is an efficacious behavioural and environmental intervention for increasing primary (elementary) school children’s (5–12 years) physical activity and reducing their sedentary behaviour within school and home settings. This paper describes the study protocol of a 5-year effectiveness–implementation trial to assess the scalability and effectiveness of the TransformUs programme.

Methods and analysis
A type II hybrid implementation–effectiveness trial, TransformUs is being disseminated to all primary schools in the state of Victoria, Australia (n=1786). Data are being collected using mixed methods at the system (state government, partner organisations), organisation (school) and individual (teacher, parent and child) levels. Evaluation is based on programme Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. RE-AIM domains are being measured using a quasi-experimental, pre/post, non-equivalent group design, at baseline, 12 and 24 months. Effectiveness will be determined in a subsample of 20 intervention schools (in Victoria) and 20 control schools (in New South Wales (NSW), Australia), at baseline, 12 and 24 months. Primary outcomes include TransformUs Reach, Adoption, Implementation and organisational Maintenance (implementation trial), and children’s physical activity and sedentary time assessed using accelerometers (effectiveness trial). Secondary outcomes include average sedentary time and moderate to vigorous-intensity physical activity on weekdays and during school hours, body mass index z-scores and waist circumference (effectiveness trial). Linear mixed-effects models will be fitted to compare outcomes between intervention and control participants accounting for clustering of children within schools, confounding and random effects.

Ethics and dissemination
The trial was approved by the Deakin University Human Research Ethics Committee (HEAG-H 28_2017), Victorian Department of Education, the NSW Department of Education, Australian Catholic University (2017-145R), Melbourne Archdiocese Catholic Schools and Catholic Schools NSW. Partners, schools/teachers and parents will provide an informed signed consent form prior to participating. Parents will provide consent for their child to participate in the effectiveness trial. Findings will be disseminated via peer-reviewed publications, scientific conferences, summary reports to schools and our partner organisations, and will inform education policy and practice on effective and sustainable ways to promote physical activity and reduce sedentary behaviours population-wide.

Trial registration number
Australian Clinical Trials Registration Registry (ACTRN12617000204347).

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Ottobre 2023

Socio-demographic and clinical characteristics associated with retention in care among adults living with HIV and severe mental illness and reasons for loss to follow-up in Uganda: a mixed-methods study

Objective
This study aimed to determine the socio-demographic and clinical characteristics associated with retention in care and reasons for loss to follow-up (LTFU) among people living with HIV (PLWH) with a known diagnosis of severe mental illness (SMI).

Design
We conducted a parallel convergent mixed-methods study. The quantitative study was used to determine the proportion and factors associated with retention in care among PLWH and SMI. The qualitative study explored reasons for LTFU.

Setting
This study was conducted at two the HIV clinics of two tertiary hospitals in Uganda.

Participants
We reviewed records of 608 PLWH who started antiretroviral therapy (ART) and included participants who had a documented diagnosis of SMI.

Outcomes
The primary outcome was retention in care. Age, gender, religion, tuberculosis (TB) status, WHO clinical stage, functional status, cluster of differentiation 4 (CD4) cell count, viral load and SMI diagnosis were among the predictor variables.

Results
We collected data from 328 participants. Retention at 6 months was 43.3% compared with 35.7% at 12 months. Having an unsuppressed viral load (≥1000 copies/mL) (adjusted incidence risk ratio (IRR)=1.54, 95% CI: 1.17 to 2.03), being 36 years and below (adjusted IRR=0.94, 95% CI: 0.94 to 0.95), initial presentation at outpatient department (adjusted IRR=0.74, 95% CI: 0.57 to 0.96), having TB signs and symptoms (adjusted IRR=0.98 95% CI: 0.97 to 0.99) and being in lower WHO stages (I and II) (adjusted IRR=1.08, 95% CI: 1.02 to 1.14) at ART initiation were significantly associated with retention in care at 6 and 12 months. Inadequate social support, long waiting hours at the clinic, perceived stigma and discrimination, competing life activities, low socioeconomic status and poor adherence to psychiatric medication were barriers to retention in care.

Conclusion
Twelve-month retention in care remains low at 35.7% far below the 90% WHO target. There is a need to design and implement targeted interventions to address barriers to retention in care among PLWH and SMI.

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Ottobre 2023

Scale-up of the Australian Fans in Training (Aussie-FIT) mens health behaviour change program: a protocol for a randomised controlled hybrid effectiveness-implementation trial

Introduction
Improving physical activity (PA) and healthy eating is critical for primary and secondary prevention of cardiovascular disease (CVD). Behaviour change programmes delivered in sporting clubs can engage men in health behaviour change, but are rarely sustained or scaled-up post trial. Following the success of pilot studies of the Australian Fans in Training (Aussie-FIT) programme, a hybrid effectiveness–implementation trial protocol was developed. This protocol outlines methods to: (1) establish if Aussie-FIT is effective at supporting men with or at risk of CVD to sustain improvements in moderate-to-vigorous PA (primary outcome), diet and physical and psychological health and (2) examine the feasibility and utility of implementation strategies to support programme adoption, implementation and sustainment.

Methods and analysis
A pragmatic multistate/territory hybrid type 2 effectiveness–implementation parallel group randomised controlled trial with a 6-month wait list control arm in Australia. 320 men aged 35–75 years with or at risk of CVD will be recruited. Aussie-FIT involves 12 weekly face-to-face sessions including coach-led interactive education workshops and PA delivered in Australian Football League (Western Australia, Northern Territory) and rugby (Queensland) sports club settings. Follow-up measures will be at 3 and 6 months (both groups) and at 12 months to assess maintenance (intervention group only). Implementation outcomes will be reported using the Reach, Effectiveness, Adoption, Implementation, Maintenance framework.

Ethics and dissemination
This multisite study has been approved by the lead ethics committees in the lead site’s jurisdiction, the South Metropolitan Health Service Human Research Ethics Committee (Reference RGS4254) and the West Australian Aboriginal Health Ethics Committee (HREC1221). Findings will be disseminated at academic conferences, peer-reviewed journals and via presentations and reports to stakeholders, including consumers. Findings will inform a blueprint to support the sustainment and scale-up of Aussie-FIT across diverse Australian settings and populations to benefit men’s health.

Trial registration number
This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000437662).

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Ottobre 2023

Patient-led home-based follow-up after surgery for colorectal cancer: the protocol of the prospective, multicentre FUTURE-primary implementation study

Introduction
Colorectal cancer (CRC) is the third most common type of cancer in the Netherlands. Approximately 90% of patients can be treated with surgery, which is considered potentially curative. Postoperative surveillance during the first 5 years after surgery pursues to detect metastases in an early, asymptomatic and treatable stage. Multiple large randomised controlled trials have failed to show any (cancer-specific) survival benefit of intensive postoperative surveillance compared with a minimalistic approach in patients with CRC. This raises the question whether an (intensive) in-hospital postoperative surveillance strategy is still warranted from both a patient well-being and societal perspective. A more modern, home-based surveillance strategy could be beneficial in terms of patients’ quality of life and healthcare costs.

Methods and analysis
The multicentre, prospective FUTURE-primary study implements a patient-led home-based surveillance after curative CRC treatment. Here, patients are involved in the choice regarding three fundamental aspects of their postoperative surveillance. First regarding frequency, patients can opt for additional follow-up moments to the minimal requirement as outlined by the current Dutch national guidelines. Second regarding the setting, both in-hospital or predominantly home-based options are available. And third, concerning patient–doctor communication choices ranging from in-person to video chat, and even silent check-ups. The aim of the FUTURE-primary study is to evaluate if such a patient-led home-based follow-up approach is successful in terms of quality of life, satisfaction and anxiety compared with historic data. A successful implementation of the patient-led aspect will be assessed by the degree in which the additional, optional follow-up moments are actually utilised. Secondary objectives are to evaluate quality of life, anxiety, fear of cancer recurrence and cost-effectiveness.

Ethics and dissemination
Ethical approval was given by the Medical Ethics Review Committee of Erasmus Medical Centre, The Netherlands (2021-0499). Results will be presented in peer-reviewed journals.

Trial registration number
NCT05656326.

Leggi
Ottobre 2023