Circulation, Volume 148, Issue Suppl_1, Page A12701-A12701, November 6, 2023. Background:The initiation of blood pressure lowering pharmacologic agents during an acute myocardial infarction (AMI) can be challenging. The PARADISE MI trial randomised AMI patients with LV dysfunction and/or pulmonary congestion to either sacubitril/valsartan or ramipril within 7 days of presentation. At the physician’s discretion, drug initiation occurred in the inpatient (IP), day of discharge (DD), or outpatient (OP) setting.Objectives:To explore the safety and tolerability of sacubitril/valsartan versus ramipril when initiated in AMI in the IP, DD or OP care setting.Methods:Efficacy (cardiovascular death or incident heart failure), safety and tolerability were compared across initiation settings, and by randomization to either sacubitril/valsartan or ramipril.Results:Compared to IP, both DD and OP groups had fewer poor prognostic characteristics. Furthermore, serious adverse events were less frequent in the DD and OP compared to IP cohorts. The efficacy of sacubitril/valsartan on the primary outcome did not vary. Although overall adverse event rates were similar within initiation setting cohorts, systolic BP was lower with sacubitril/valsartan, regardless of initiation setting. The increased relative risk of hypotension with sacubitril/valsartan was similar across initiation settings.Conclusion:In this analysis of the PARADISE-MI trial based on drug initiation setting, sacubitril/valsartan reduced BP compared to ramipril. However, the clinical setting of drug commencement did not impact adverse event or tolerability signals between sacubitril/valsartan and ramipril.
Risultati per: Artrite psoriasica e altre comorbilità in pazienti con psoriasi nel setting della medicina generale
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Abstract 17846: Successful Treatment of Recurrent Pericarditis With Rilonacept in the Setting Of ATRA/ATO Use in Acute Promyelocytic Leukemia
Circulation, Volume 148, Issue Suppl_1, Page A17846-A17846, November 6, 2023. Case Presentation:A 40-year-old female was admitted for a 4-day history of recurrent left-sided pleuritic chest pain. Physical examination was pertinent for tachycardia and presence of a pericardial friction rub. Past medical history included recently diagnosed Acute Promyelocytic Leukemia undergoing active chemotherapy. Complete blood count showed leukopenia. Brain natriuretic peptide was slightly elevated at 241 pg/mL. Electrocardiogram demonstrated sinus tachycardia with diffuse ST-segment elevation and PR-segment depression (Figure 1. A). Echocardiogram showed normal biventricular function with a small posterior and lateral pericardial effusion and small pericardial effusion adjacent to the right ventricle (Figure 1. B). Cardiac magnetic resonance (CMR) imaging showed a moderate circumferential pericardial effusion and increased pericardial signal on T2 STIR imaging and late gadolinium enhancement (LGE) (Figure 1. C, D). Given the constellation of symptoms and findings, the patient was diagnosed with acute pericarditis secondary to differentiation syndrome (DS) suspected to be due to her underlying malignancy and anti-cancer treatments. She was started on aspirin and colchicine. Steroids and rilonacept were later added for incomplete treatment response. On follow-up, she was doing well. Repeat CMR demonstrated mild to moderate pericardial delayed enhancement with no edema and no pericardial effusion (Figure 1. E,F).Discussion:The presentation of DS can vary, and consensus diagnostic criteria are lacking. Cases of myopericarditis with concurrent pericardial effusions have been reported in the setting of patients undergoing chemotherapeutic treatment with differentiating agents. Management is complicated and requires multi-disciplinary care. Our case illustrates that rilonacept may be considered as an alternative to corticosteroids in the treatment of recurrent pericarditis in a patient with a hematologic malignancy.
Abstract 16644: Unusual Manifestation of Acute Pericarditis in the Setting of Primary Biliary Cirrhosis
Circulation, Volume 148, Issue Suppl_1, Page A16644-A16644, November 6, 2023. Introduction:Primary biliary cirrhosis (PBC) is an immune-mediated liver disease leading to destruction of intrahepatic bile ducts and cirrhosis. However, its association with pericarditis has not been investigated. Here, we describe a case of a female with PBC who presented with severe pericardial disease.Clinical Case:A 57-year-old female with past medical history of primary biliary cirrhosis, thrombocytosis and type 2 diabetes who presented with sudden onset sharp chest pain, worse with movement or breathing. Workup was notable for elevated D-dimer, CT chest with no evidence of pulmonary embolism but did reveal a moderate pericardial effusion, further confirmed on echocardiogram. Nuclear stress test was unremarkable. CRP 13 mg/dL and ESR 82 mm/hr. Given concern for pericarditis, she was started on colchicine and ibuprofen. On further evaluation in clinic, cardiac MRI showed severe LGE and edema consistent with active pericarditis (figure 1) with mild constrictive physiology and worsening inflammatory markers (ESR 95 mm/hr, us-CRP 118mg/L). Therefore, decision was made to start triple therapy with the addition of prednisone. Repeat cardiac MRI 6 months later showed resolution of LGE and pericardial edema (figure 2). Given clinical improvement, patient was tapered off steroids, started anakinra and weaned off ibuprofen and colchicine. She remained on anakinra for two years after which she was transitioned to single therapy with colchicine with no episodes of recurrence.Discussion:PBC commonly exists with liver autoimmune disorders, but its association with pericardial disease has not been investigated. NSAIDs are often used as first-line therapy for pericarditis, but can be detrimental in advanced liver failure, often seen in patients with PBC. Steroid use is not only advantageous in pericardial disease but also in PBC. As a result, it is critical to identify the link between pericardial disease and PBC to determine appropriate therapeutic management.
Abstract 12361: Predictors and Utilization of Ultrasound Enhancing Agents for Echocardiography in the Outpatient Setting
Circulation, Volume 148, Issue Suppl_1, Page A12361-A12361, November 6, 2023. Background:The national utilization of ultrasound enhancing agents (UEAs) for transthoracic (TTE) or stress (SE) echocardiography in the outpatient setting and their association with downstream utilization of care remains uncertain.Methods:In a set of large, all-payer claims databases (ACTICS Open and Closed Claims) encompassing 90% of the US population, we evaluated rates, predictors of use, and association of UEAs with downstream utilization using linear mixed effects models amongst adult outpatients receiving TTE or SE, 2019-2022. Amongst those with recent hospitalization for AMI, we evaluated the association of UEA receipt and downstream healthcare utilization.Results:A total of 11,270,268 individuals receiving TTE and 744,175 adults receiving SE across 2,407 sites were included (mean age 63, 54.8% female), of which 6.8% receiving TTE and 21.0% receiving SE received UEAs. Patients receiving UEAs were more frequently older, male, and had a greater number of comorbidities. Sites performing UEAs were more frequently large, rural, nonprofits, and teaching facilities. Use varied widely by state (Figure;19.7% in Minnesota vs. 1.1% in Delaware) and was not explained by patient or site characteristics (median odds ratios = 4.35). Amongst those receiving TTE after AMI, UEA use was associated with a reduction in cardiac non-stress imaging (adjusted RR 0.77, 95% CI 0.64-0.92, p = 0.004), but no substantial differences in cost, days alive at home, readmission rates, cardiac catheterization, or stress imaging (p > 0.05 for all).Conclusions:In this large, nationally representative cohort study, UEAs were used in 6.8% of TTEs and 21.0% of SEs performed in the outpatient setting but use varied widely across sites, unexplained by patient or site characteristics. Amongst outpatients, UEA receipt after AMI was associated with a reduction in cardiac stress imaging, but not other outcomes.
Abstract 17182: A Case of Purulent Pericarditis in the Setting of Streptococcal Pneumonia
Circulation, Volume 148, Issue Suppl_1, Page A17182-A17182, November 6, 2023. Introduction:Purulent pericarditis was a prevalent complication of streptococcal pneumonia prior to antibiotic era, but uncommon in the modern age. Purulent pericarditis is characterized by gross pus or microscopic purulence localized in the pericardial space.Case Presentation:A case of a 68-year-old male presenting with dyspnea, chest pain, left knee pain and edema. Medical history was significant for hypertension, diabetes, hypothyroidism. He developed respiratory failure due to pneumonia and was treated in intensive care unit. S. pneumoniae bacteremia and septic arthritis with isolation of the same pathogen from synovial fluid were diagnosed. Initial ECG showed diffuse ST elevations suggestive of pericarditis, so TTE was obtained. It showed a small, free flowing pericardial effusion along RV free wall with no evidence of hemodynamic compromise. Serial TTEs were done showing increasing size of pericardial effusion. On day 7 of hospitalization patient had several episodes of atrial fibrillation with RVR complicated by hypotension. A subsequent TTE showed a large, free-flowing pericardial effusion with signs of early tamponade. Patient underwent urgent pericardiocentesis with drainage of one liter of purulent fluid and placement of pericardial drain. Fluid analysis confirmed purulent pericarditis, gram stain and cultures were negative. Repeat TTE showed a trivial pericardial effusion and a 2.7mm mass suspicious for vegetation on the mitral valve with moderate MR, confirmed by TEE. CT surgery recommended 6 weeks of antibiotics with no surgical intervention. Patient was discharged to a skilled nursing facility for a prolonged IV antibiotic course with a follow up with cardiology.Conclusion:This case shows purulent pericarditis in the setting of pneumonia complicated by bacteremia, infective endocarditis, and septic arthritis. Although rare, purulent pericarditis is a life-threatening disease, so timely diagnosis and treatment are of essence.
Abstract 19090: Top Patient Initiated Uses of the Chronic Care Management Phone Line in a Rural Setting Reported Through Patient Survey
Circulation, Volume 148, Issue Suppl_1, Page A19090-A19090, November 6, 2023. Introduction:Patients can utilize Medicare’s Chronic Care Management [CCM] in different ways depending on their specific needs and conditions. It is important to have an understanding of patient utilization of this service in order to better tailor the program to their needs. Patient access to a CCM program has previously been found to reduce health expenditures, and improve engagement between the patient and the medical facility.Research Question:How do patients utilize the CCM phone line when it comes to their medical needs?Goal:The goal was to determine the top patient-initiated uses of the CCM phone line.Methods:An anonymized survey was sent out via email to patients enrolled in the CCM program of our rural clinic. Patients were asked to indicate how they have used the CCM phone line in the last 6 months. Patients also responded to their experiences with CCM as it relates to callback time and perception of access to providers. Finally, patients were asked if they would benefit from receiving a quarterly newsletter on current innovation in healthcare as part of CCM. Percentages were calculated based on patient responses.Results:Patients responded to some or all questions of the survey (N = 477). When asked, 94.78% of patients reported receiving a response within 24 hours after calling in regards to their specific request. In addition, 95.35% of patients affirmed that CCM provides an easier and more efficient access for patients to clinical providers when a need or concern arises than traditional clinical care. When asked about receiving a healthcare innovations newsletter as part of CCM, 63.48% of patients thought it would be beneficial.Conclusion:Patients utilized the Chronic Care Management Phone Line to accomplish various tasks. In conclusion, the majority of patients used the service to schedule appointments, request medication refills, and seek medical advice while agreeing that medical education (newsletter) could be a potentially beneficial aspect of CCM.
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Detecting transthyretin amyloid cardiomyopathy (ATTR-CM) using machine learning: an evaluation of the performance of an algorithm in a UK setting
Objective
The aim of this study was to evaluate the potential real-world application of a machine learning (ML) algorithm, developed and trained on heart failure (HF) cohorts in the USA, to detect patients with undiagnosed wild type cardiac amyloidosis (ATTRwt) in the UK.
Design
In this retrospective observational study, anonymised, linked primary and secondary care data (Clinical Practice Research Datalink GOLD and Hospital Episode Statistics, respectively, were used to identify patients diagnosed with HF between 2009 and 2018 in the UK. International Classification of Diseases (ICD)-10 clinical modification codes were matched to equivalent Read (primary care) and ICD-10 WHO (secondary care) diagnosis codes used in the UK. In the absence of specific Read or ICD-10 WHO codes for ATTRwt, two proxy case definitions (definitive and possible cases) based on the degree of confidence that the contributing codes defined true ATTRwt cases were created using ML.
Primary outcome measure
Algorithm performance was evaluated primarily using the area under the receiver operating curve (AUROC) by comparing the actual versus algorithm predicted case definitions at varying sensitivities and specificities.
Results
The algorithm demonstrated strongest predictive ability when a combination of primary care and secondary care data were used (AUROC: 0.84 in definitive cohort and 0.86 in possible cohort). For primary care or secondary care data alone, performance ranged from 0.68 to 0.78.
Conclusion
The ML algorithm, despite being developed in a US population, was effective at identifying patients that may have ATTRwt in a UK setting. Its potential use in research and clinical care to aid identification of patients with undiagnosed ATTRwt, possibly enabling earlier diagnosis in the disease pathway, should be investigated.
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High versus low positive end-expiratory pressure setting in patients receiving veno-venous extracorporeal membrane oxygenation support for severe acute respiratory distress syndrome: study protocol for the multicentre, randomised ExPress SAVER Trial
Introduction
While limiting the tidal volume to 6 mL/kg during veno-venous extracorporeal membrane oxygenation (V-V ECMO) to ameliorate lung injury in patients with acute respiratory distress syndrome (ARDS) is widely accepted, the best setting for positive end-expiratory pressure (PEEP) is still controversial. This study is being conducted to investigate whether a higher PEEP setting (15 cmH2O) during V-V ECMO can decrease the duration of ECMO support needed in patients with severe ARDS, as compared with a lower PEEP setting.
Methods and analysis
The study is an investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial conducted with the participation of 20 intensive care units (ICUs) at academic as well as non-academic hospitals in Japan. The subjects of the study are patients with severe ARDS who require V-V ECMO support. Eligible patients will be randomised equally to the high PEEP group or low PEEP group. Recruitment to the study will continue until a total of 210 patients with ARDS requiring V-V ECMO support have been randomised. In the high PEEP group, PEEP will be set at 15 cmH2O from the start of V-V ECMO until the trials for liberation from V-V ECMO (or until day 28 after the allocation), while in the low PEEP group, the PEEP will be set at 5 cmH2O. Other treatments will be the same in the two groups. The primary endpoint of the study is the number of ECMO-free days until day 28, defined as the length of time (in days) from successful libration from V-V ECMO to day 28. The secondary endpoints are mortality on day 28, in-hospital mortality on day 60, ventilator-free days during the first 60 days and length of ICU stay.
Ethics and dissemination
Ethics approval for the trial at all the participating hospitals was obtained on 27 September 2022, by central ethics approval (IRB at Hiroshima University Hospital, C2022-0006). The results of this study will be presented at domestic and international medical congresses, and also published in scientific journals.
Trial registration number
The Japan Registry of Clinical Trials jRCT1062220062. Registered on 28 September 2022.
Protocol version
28 March 2023, version 4.0.
Effects of education and age on the experience of youth violence in a very low-resource setting: a fixed-effects analysis in rural Burkina Faso
Objective
The study aimed to investigate the effects of education and age on the experience of youth violence in low-income and middle-income country settings.
Design
Using a standardised questionnaire, our study collected two waves of longitudinal data on sociodemographics, health practices, health outcomes and risk factors. The panel fixed-effects ordinary least squares regression models were used for the analysis.
Settings
The study was conducted in 59 villages and the town of Nouna with a population of about 100 000 individuals, 1 hospital and 13 primary health centres in Burkina Faso.
Participants
We interviewed 1644 adolescents in 2017 and 1291 respondents in 2018 who participated in both rounds.
Outcome and exposure measures
We examined the experience of physical attacks in the past 12 months and bullying in the past 30 days. Our exposures were completed years of age and educational attainment.
Results
A substantial minority of respondents experienced violence in both waves (24.1% bullying and 12.2% physical attack), with males experiencing more violence. Bullying was positively associated with more education (β=0.12; 95% CI 0.02 to 0.22) and non-significantly with older age. Both effects were stronger in males than females, although the gender differences were not significant. Physical attacks fell with increasing age (β=–0.18; 95% CI –0.31 to –0.05) and this association was again stronger in males than females; education and physical attacks were not substantively associated.
Conclusions
Bullying and physical attacks are common for rural adolescent Burkinabe. The age patterns found suggest that, particularly for males, there is a need to target violence prevention at younger ages and bullying prevention at slightly older ones, particularly for those remaining in school. Nevertheless, a fuller understanding of the mechanisms behind our findings is needed to design effective interventions to protect youth in low-income settings from violence.
Brain connectivity-guided, Optimised theta burst transcranial magnetic stimulation to improve Central Pain Modulation in knee Osteoarthritis Pain (BoostCPM): protocol of a pilot randomised clinical trial in a secondary care setting in the UK
Introduction
Chronic pain is a common health problem that is not efficiently managed by standard analgesic treatments. There is evidence that treatment resistance may result from maladaptive brain changes in areas that are fundamental to the perception of pain. Knee osteoarthritis is one of the most prevalent causes of chronic pain and commonly associated with negative affect. Chronic knee osteoarthritis pain is also associated with altered right anterior insula functional connectivity. We posit that reversal of these brain circuit alterations may be critical to alleviate chronic pain and associated negative affect, and that this can be achieved through non-invasive neuromodulation techniques. Despite growing interest in non-invasive neuromodulation for pain relief and proven efficacy in depression, results in chronic pain are mixed with limited high-quality evidence for clinical and mechanistic efficacy. Limitations include patient heterogeneity, imprecision of target selection, uncertain blinding and protocols that may deliver pulses at subclinical efficacy.
Methods and analysis
We hence developed an optimised treatment protocol of connectivity-guided intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex with accelerated delivery on four consecutive days (allowing 4 days within the same week as protocol variation) with five daily treatment sessions that will be piloted in a sham-controlled design in 45 participants with chronic knee pain. This pilot study protocol will assess feasibility, tolerability and explore mechanistic efficacy through serial functional/structural magnetic resonance imaging (MRI) and quantitative sensory testing.
Ethics and dissemination
This pilot trial has been approved by the Ethics Committee Cornwall and Plymouth.
Results of the pilot trial will be submitted to peer-reviewed journals, presented at research conferences and may be shared with participants and PPI/E advisors.
Trial registration number
ISRCTN15404076.