[Review] Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension

The CONSORT-iNeurostim extension will promote increased transparency, clarity, and completeness of trial reports of implantable neurostimulation devices. It will assist journal editors, peer-reviewers, and readers to better interpret the appropriateness and generalisability of the methods used and reported outcomes.

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Novembre 2024

Pilot study protocol evaluating the impact of telerobotics interactions with autistic children during a Denver intervention on communication skills using single-case experimental design

Introduction
For several years, studies have been conducted on the contribution of social robots as an intervention tool for children with autism spectrum disorder (ASD). One of the early intervention models recommended by the French National Authority for Health is the Early Start Denver Model, an individualised, intensive programme based on play activities chosen by the child. While studies published in recent years suggest that robots provide benefits for autistic children in learning social interactions within a clinical setting, there is no scientific consensus on the widespread contribution and maintenance of their effects over time. On the other hand, a robotic solution controlled directly by a practitioner (ie, on-site telepresence system) enables greater adaptability to children’s responses and choices during interventions. We believe that such a solution would enable better assessment of progress in the fundamental skills of expressive communication and imitation as well as greater engagement during interventions.

Methods and analysis
This is a prospective, monocentric, descriptive and evaluative pilot study based on single-case experimental design (SCED) methodology. The study will recruit eight children diagnosed with ASD aged between 2 and 5 years. The intervention will take place 15 min after the usual weekly care. The SCED methodology is constructed in three stages: (A) 4 weekly sessions at baseline without the robot, (B) 9 weekly sessions with intervention modification using a social robot as cotherapist and (C) 4 weekly sessions without the robot for follow-up.

Ethics and dissemination
Ethical approval was obtained from the South East IV Ethics Committee (CPP Sud-Est IV) (number: 2023-A00895-40) in France. Explicit consent is required from all legal representatives (parents) of children participating in this study. We aim to disseminate the results of this study through national and international conferences, international peer-reviewed journals and social media.

Trial registration number
NCT05991791.

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Novembre 2024

Burden and determinants of scabies in a pastoralist community: a case-control study from Southwest Ethiopia

Background
Scabies is a skin infestation caused by the human itch mite, affecting people globally across all demographics. However, it is more prevalent among children, individuals with poor hygiene, those in overcrowded or slum areas and people affected by drought and war. There is limited research on scabies in Ethiopia and none specifically focused on marginalised communities. This study aimed to assess the burden of scabies and its contributing factors among pastoralist communities in Ethiopia.

Methods
A community-based, unmatched case–control study (1:2 ratio) was conducted in Meinit Goldiya District to assess risk factors for scabies. The researchers collected line-listed data on scabies and conducted face-to-face interviews from January to February 2023, with a sample of 156 cases and 312 controls. Data were gathered using a structured questionnaire and analysed with SPSS V.22. OR, p values and 95% CI were calculated to identify associated factors. Independent factors were determined using a p value of

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Novembre 2024

Prevalence of comorbidities among patients with rheumatoid arthritis in the UAE: a case-control study

Objectives
Data on the rate of comorbidities in Arab patients with rheumatoid arthritis (RA) are limited, and extrapolating the prevalence of comorbidities from international studies is challenging. This study aimed to investigate the prevalence of comorbidities in patients with RA, compare it with that in non-RA controls and explore the association between the body mass index of patients with RA and comorbidities.

Design
This is a retrospective, case–control study.

Setting
This study included patients receiving secondary care at the Rheumatology Department of a public hospital in the Emirate of Dubai. The controls were recruited from patients receiving primary and secondary care at the Dubai Academic Health Corporation in the fourth quarter of 2022.

Participants
This study included all consecutive UAE national patients with RA who visited the rheumatology clinic. The study included 1756 participants in an age-matched and sex-matched control group and 439 patients with RA. Of these, 88.6% were female, and the median age was 55 years. Each RA case was randomly matched with four controls of the same age and sex. All relevant information, including case and control demographics and comorbidities, was retrieved from the electronic medical record.

Primary and secondary outcome measures
The relative risk of comorbidities was compared between patients with RA and age-matched controls. The relationship between obesity in RA and the frequency of comorbidities was determined.

Results
This study revealed that 188 (42.8%) patients with RA had at least one comorbidity, whereas only 636 (36.2%) individuals in the control group had at least one comorbidity (OR 1.3; 95% CI 1.1 to 1.6, p

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Novembre 2024

Abstract 4143264: A Case of Spike-on-T Phenomenon and Polymorphic Ventricular Tachycardia

Circulation, Volume 150, Issue Suppl_1, Page A4143264-A4143264, November 12, 2024. Background:R-on-T phenomenon occurs when an electrical stimulus is delivered at a critical point during ventricular repolarization. This can initiate ventricular arrhythmias like polymorphic ventricular tachycardia (PMVT). We describe a case of ventricular pacemaker spikes delivered on the T wave causing PMVT.Case:A 53-year-old female with CAD s/p stent, postpartum cardiomyopathy s/p Bi-V CRT-D (Boston Scientific G124), and paroxysmal atrial fibrillation presented for elective endoscopy and colonoscopy to evaluate her dysphagia and abdominal pain. Her CRT-D was reprogrammed from DDD pacing with lower rate limit (LRL) 50 bpm to an asynchronous Bi-V DOO mode at 50 bpm (‘electrocautery mode’) for the procedure (tachy therapy disabled). Her LV-RV offset was 40 msec. Prior to receiving sedation or medications, she was found unresponsive. Telemetry showed Spike-on-T phenomenon which initiated PMVT. She was externally defibrillated with 200J and received magnesium and an IV amiodarone bolus. She returned to sinus rhythm, but one minute later had another Spike-on-T event initiating PMVT. She was successfully defibrillated with 360J. Post-shock EKG showed an asynchronous Bi-V paced rhythm at 50 bpm.Decision Making:The patient was admitted to the CCU for post-resuscitation care. Her electrolytes and cardiac enzymes were unremarkable. Her CRT-D was reprogrammed to DDD 80-140 bpm. Transthoracic echocardiogram showed normal biventricular systolic function. Cardiac catheterization did not show obstructive CAD. After reprogramming of her device, she had no further events. After initial treatment with IV amiodarone load, she was discharged home on oral magnesium gluconate.Discussion:The only intervention prior to her procedure was device reprogramming (DDD 50 bpm to DOO 50 bpm). Telemetry showed pacer spikes initiating PMVT. Given the LV-RV offset of 40 msec, she would have received these two tightly coupled pacemaker spikes in an asynchronous mode, in this unfortunate instance during her T wave. While her bowel preparation may have led to electrolytes abnormalities, post-resuscitation electrolytes were normal. Fortunately, she received prompt therapy and was reprogrammed with increased LRL.Conclusion:We described a case of Spike-on-T PMVT prior to colonoscopy without obvious provocation other than asynchronous pacemaker spikes. Reprogramming devices in DOO mode with increased LRL may prevent PVCs and asynchronous pacemaker spikes from triggering PMVT.

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Novembre 2024

Abstract 4145899: The Danger of Moderator Band Ectopy: A Case of Premature Ventricular Contraction induced Recurrent Ventricular Fibrillation

Circulation, Volume 150, Issue Suppl_1, Page A4145899-A4145899, November 12, 2024. Introduction:Premature Ventricular Contractions (PVCs) are often a benign arrhythmia. However, those originating from the Purkinje system can result in fatal arrhythmias. One example is PVCs originating from the moderator band (MB) within the right ventricle (RV) of the heart. We present a case of PVCs originating from the MB triggering idiopathic ventricular fibrillation (VF) and electrical storm.Case:A previously healthy 49-year-old woman was admitted following a witnessed VF cardiac arrest. She had recurrent episodes of VF, initially treated with Amiodarone and Procainamide which failed to suppress the recurrent VF. She received 54 external defibrillations before a transvenous pacer (TVP) was placed to override the PVCs at a pacing rate of 110 bpm. Post-resuscitation ECGs revealed frequent PVCs originating from the RV free wall, potentially from the lateral part of MB (Figure 1). Quinidine was added to suppress the PVCs ultimately allowing removal of the TVP. Transthoracic Echocardiogram revealed normal cardiac function and a prominent MB. A cardiac MRI was performed showing no infiltrative disease or any other abnormalities. The patient underwent sympathectomy and defibrillator placement. Despite recurrent cardiac arrest, she had excellent neurologic recovery and was subsequently discharged on Quinidine.Discussion:MB extends from the septal wall to the base of the anterior papillary muscle in the RV, carrying Purkinje fibers(PF) from the right bundle branch as it exits the septum. Purkinje fibers have been shown to initiate arrhythmias by several mechanisms including enhanced automaticity, triggered activity and re-entry. In the genesis of PVCs, triggered activity is the likely mechanism. This can degenerate into VF in a structurally normal heart, hence the term “idiopathic VF”. Familiarity with this entity and ECG features of MB ectopy leads to timely management and may potentially prevent lethal arrhythmias in symptomatic patients with such PVCs. Further studies are required to fully understand the arrhythmogenic mechanisms and the optimal management approach for MB ectopy.

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Novembre 2024

Abstract 4148074: Radial Artery Pseudoaneurysm Following Transradial Cardiac Catheterization: A Systematic Review and Case Report

Circulation, Volume 150, Issue Suppl_1, Page A4148074-A4148074, November 12, 2024. Introduction/Background:Transradial cardiac catheterization (TRC) is recommended for patients with acute coronary syndrome over femoral artery catheterization. Randomized controlled trials show TRC has significantly lower rates of bleeding, vascular complications, and mortality in high-risk acute coronary syndrome patients. However, vascular complications like radial artery spasm, occlusion, arteriovenous fistula, perforation, and pseudoaneurysm (PSA) can still occur. Despite TRC’s widespread adoption, recent data summarizing radial artery pseudoaneurysm post-TRC is lacking.Research Question/HypothesisThis review aims to identify at-risk patients, present a case of catheterization-related radial artery pseudoaneurysm, and provide diagnostic and management insights. We hypothesize that older patients with hypertension are at higher risk and that early detection and management are associated with low complication rates.Methods/Approach:Systematic searches were conducted in PubMed, Web of Science, EMBASE, and CINAHL databases. Two researchers independently selected articles, extracted data, and evaluated study quality on RA PSA post-TRC (2003–2023). A third reviewer resolved conflicts. The Joanna Briggs Institute (JBI) tool was used to evaluate bias risk. Additionally, a case report is presented.Results:From 3,262 records, 43 studies were selected, involving 67 patients (58.8% female, median age 73.5 years). Hypertension (39.5%) and atrial fibrillation (27.9%) were the most common comorbidities. Percutaneous interventions like stenting and angioplasty caused 58.1% of cases; diagnostic catheterizations accounted for 37.2%. Ultrasonography diagnosed 83.7% of cases. Symptoms appeared a few hours to four months post-TRC, with pulsatile mass (21.4%) and swelling (14.3%) being the most common, and pain and ecchymosis at 2.4% each. More than half of the patients (51.2%) required surgical intervention, but 66.7% recovered without deficits. Severe complications were rare, affecting fewer than 5%.Conclusions:A literature review of 43 articles with 67 patients suggests older female patients with hypertension may be more prone to radial artery pseudoaneurysm post-TRC. It typically presents as a pulsatile, painful swelling detectable by ultrasound. This complication precludes the use of the radial artery as a conduit for coronary artery bypass grafting. The review highlights the importance of vigilant post-catheterization monitoring to enable early detection and treatment.

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Novembre 2024

Abstract 4139198: A Systematic Approach to Prompting Large Language Models for Automated Feature Extraction from Cardiovascular Imaging Reports

Circulation, Volume 150, Issue Suppl_1, Page A4139198-A4139198, November 12, 2024. Introduction:Cardiovascular radiology reports contain valuable diagnostic information linked to images, but the unstructured text format makes feature extraction difficult on a large scale. Large language models (LLMs) allow for feature extraction where string parsing alone is insufficient, but require careful prompting for accurate results.Hypothesis:We hypothesize that a systematic prompting approach using LLMs can expedite the extraction of features from unstructured text in transesophageal echocardiography (TEE) reports.Methods:The data consisted of 7106 intraoperative TEE reports, 600 of which were manually reviewed to obtain pre- and post-intervention ground truth values for left ventricular ejection fraction (LVEF), right ventricular systolic function (RVSF), and tricuspid regurgitation (TR). Reports are paired with an imaging study consisting of 50-200 clips. For each feature considered, 100 of the 600 labeled reports were used to engineer a prompt in Llama-2 that maximized feature extraction accuracy.Results:We found that using multiple, shorter prompts yielded higher accuracy than did fewer, longer prompts. Additionally, when imposing semantic information onto a numerical scale, prompt engineering in combination with string parsing (Figure 1) gave the best results. When evaluated on the 500 labeled reports withheld for testing, the finalized prompts had accuracies of 94.1%, 94.8%, and 91.3% for LVEF, RVSF, and TR, respectively. Using this strategy, 5000 intraoperative TEE reports were analyzed and used to train and evaluate a regression model for LVEF estimation from TEE clips (Figure 2).Conclusion:We have shown that performing prompt engineering on Llama-2 can be used to extract features from unstructured TEE reports in an accurate manner. As an extension of these methods, automated feature prediction from echocardiograms can be used to create rapid, low-cost, and accessible cardiac assessments.

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Novembre 2024

Abstract 4144526: A Case Presentation of Severe Left Ventricular Dysfunction from Focal Myocarditis due to Immune Checkpoint Inhibitor

Circulation, Volume 150, Issue Suppl_1, Page A4144526-A4144526, November 12, 2024. Introduction:Immune checkpoint inhibitors (ICI), such as pembrolizumab, are an effective immunotherapy for several malignancies, however, have been associated with adverse events including myocarditis and accelerated atherosclerosis. ICI myocarditis is associated with a mortality rate of up to 33%. This case reports a patient on pembrolizumab with an atypical presentation.Case presentation:A 75-year-old female with a past medical history significant for lung cancer on pembrolizumab and myasthenia gravis presented to the hospital with dyspnea and mild, intermittent exertional chest discomfort. She denied nausea, radiation of pain, diplopia, weakness in extremities, or dysphagia. Workup revealed a leucocyte count of 13,500 cells/uL, pro-brain natriuretic peptide of 13,458 pg/mL, troponin of 26 ng/L, and a normal erythrocyte sedimentation rate and C reactive protein. A chest computed tomography was performed that showed mild bilateral pleural effusion and no pulmonary embolism. A nuclear stress test showed no evidence of ischemia but showed a severely reduced left ventricular ejection fraction (LVEF) at 29%. An echocardiogram confirmed that the ejection fraction was reduced at 23% (baseline LVEF was 60% from 1 year ago). Cardiac MRI revealed a mildly increased regional T2 signal in the anterolateral wall, mildly elevated extracellular volume fraction, and no late gadolinium enhancement. With ongoing clinical suspicion despite equivocal findings on cardiac MRI, an endomyocardial biopsy was done that revealed a single small aggregate of lymphocytes present in 1 of 6 tissue samples. Ultimately, with the single site of aggregated lymphocytes on biopsy, a diagnosis of ICI myocarditis was determined, and the patient was started on high-dose intravenous glucocorticoids as well as bisoprolol, empagliflozin, spironolactone, and Entresto for heart failure management as she was able to tolerate.Discussion:Myocarditis due to pembrolizumab is a rare, but potentially lethal adverse effect. Patients typically have abnormal electrocardiograms and elevated cardiac biomarkers. Cardiac MRIs have sensitivity and specificity of 68% and 91% respectively for diagnosis, and the gold standard is endomyocardial biopsy however, it is limited due to sampling error. Our patient had an unusual presentation, but with both imaging and biopsy, we found a case of focal myocarditis with severe left ventricular dysfunction, which typically is seen with fulminant myocarditis.

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Novembre 2024

Abstract 4145267: An Unusual Case of Listeria LVAD Infection Complicated by Intracranial Catastrophe

Circulation, Volume 150, Issue Suppl_1, Page A4145267-A4145267, November 12, 2024. Description of Case:A 56-year-old male with ischemic cardiomyopathy, HeartMate 3 LVAD implantation presented with fatigue and diarrhea after eating expired cheese a week prior. Hypovolemia, AKI, an unremarkable LVAD interrogation and an INR of 3.4 were noted. Blood cultures and infectious work-up including imaging were obtained. Imaging was unremarkable. Over the first 2 hospital days, he was fluid resuscitated. Hemodynamics showed low biventricular filling pressures and adequate cardiac index. On hospital day 3, blood cultures revealedListeria monocytogenesprompting initiation of IV ampicillin. AKI worsened, associated with altered mentation requiring endotracheal intubation and renal replacement therapy.On hospital day 8, bronchoscopy was performed to address worsening respiratory secretions. An hour after procedural sedation, he never regained consciousness and anisocoria was noted. Emergent cranial imaging revealed multicompartment hemorrhage with midline shift. Neurosurgical intervention was not recommended due to the catastrophic nature of the bleeding. Supportive pharmacologic measures were futile; brain death was declared 48 hours later.Discussion:Listeria monocytogenesis a gram-positive rod which causes gastrointestinal illness in immunocompetent adults. Cases of Listeria bacteremia in patients with indwelling cardiac hardware are rare but have been previously described in the literature. A case ofListeriabacteremia and leukocytoclastic vasculitis in an LVAD patient resulting in AKI has been reported. To our knowledge, this is the first published case ofListeriabacteremia in an LVAD patient complicated by acute intracranial hemorrhage.While the exact mechanism of the brain bleed was not confirmed, it is postulated that the altered mental status and AKI were the products of septic embolization to the brain and kidneys, with ultimate hemorrhagic conversion noted in the setting of therapeutic anticoagulation. A transesophageal echocardiogram had been planned prior to the stroke but not performed due to medical futility.Clinicians should be aware of the more unusual complications ofListeriainfection in the setting of indwelling cardiac hardware.

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Novembre 2024

Abstract 4147050: Genetic Insights into Arrhythmogenic Mitral Valve Prolapse – A Case-Control Study from UK Biobank and NIH All of Us

Circulation, Volume 150, Issue Suppl_1, Page A4147050-A4147050, November 12, 2024. Background:Mitral valve prolapse (MVP) is a common valvular abnormality. Observational studies demonstrate an association between MVP and increased risk of sudden cardiac death from ventricular arrhythmias, coined arrhythmogenic MVP. A genetic component has been postulated but remains under-investigated.Hypothesis:Predicted deleterious variants in Mendelian cardiomyopathy and arrhythmia genes are more frequent in arrhythmogenic MVP (aMVP) compared to non-arrhythmogenic MVP.Aims:To comprehensively phenotype and genotype a single-centeraMVPcohort and compare tonon-aMVPfrom two large population-based cohorts and investigate their clinical outcomes.Methods:TheaMVPcohort included 46 prospectively enrolled patients from a regional referral center for inherited cardiovascular disease and had undergone multi-modality imaging and clinical gene panel testing.Thenon-aMVPcomparator cohorts included 453 participants from the UK Biobank (UKBB), a prospective cohort of 500,000 UK residents, and 1,418 participants from the National Institutes of Health (NIH) All of Us (AoU), a prospective cohort of 450,000 USA participants. Gene variants were annotated in ANNOVAR. Participants with and without pathogenic/likely pathogenic (P/LP) variants reported on ClinVar with ≥2-star level of evidence were considered genotype positive (G+) and negative (G-) respectively.Results:The demographics foraMVP(age 61.2 ± 12.8 years, 56.5% female) andnon-aMVP(UKBB: age 59.8 ± 7.3 years, 50.7% female and AoU: age 65.3 ± 13.4 years, 76.2% female) were comparable.G+ participants were more prevalent in theaMVPcohort 10/46 (21.7%) versusnon-aMVPin the UKBB 8/453 (1.8%) and in the AoU 21/1418 (1.5%); p

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Novembre 2024