Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial

Introduction
In critically ill patients, individualised strategies for red blood cell transfusion (RBCT) are lacking. The objective of this study is to demonstrate the potential advantages of employing an individualised transfusion strategy compared with a restrictive approach, in unselected intensive care unit (ICU) patients.

Methods
This will be a randomised, multicentre, international trial. Two open-label parallel groups will be compared with an allocation ratio of 1:1. The trial is designed to investigate the superiority of the individualised intervention group compared with the standard intervention group. The study will be performed in three mixed, academic ICUs located in two different countries. In the individualised group, prescription of RCBT is restricted to patients who present haemoglobin (Hb) ≤9.0 g/dL and oxygen extraction ratio (O2ER) ≥ 30%, for a minimum Hb value of ≤6.0 g/dL. In the control group, prescription of RBCT is guided by thresholds proposed by recent guidelines, regardless of O2ER values.

Ethics and dissemination
This trial is approved by the Comitato Etico Area Vasta Centro della Regione Emilia-Romagna (protocol number 350/2023/Sper/AOUFe/PRBCT, date of approval 18/05/2023) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals.

Trial registration number
Clinicaltrials.gov NCT06102590

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Novembre 2024

Abstract 4140139: Cardio-ankle vascular index (CAVI) in prediction of chronic coronary artery disease: risk, coronary artery lesions, and cardiovascular disease events

Circulation, Volume 150, Issue Suppl_1, Page A4140139-A4140139, November 12, 2024. Introduction:The cardio-ankle vascular index (CAVI) is a significant metric for evaluating arterial function. The test measures the stiffness of the arteries from the beginning of the aorta to the ankle, and the algorithm used is not influenced by blood pressure. Recent statistics indicate that a high CAVI score has the potential to predict future cardiovascular disease (CVD) occurrences. However, no research has been conducted in Vietnam to investigate this matter.Methods:A prospective study was conducted on 222 patients. Out of these, 162 patients had chronic coronary artery disease (CAD), while the remaining 62 patients were free of CAD. The study took place between October 2019 and December 2022. Participants who fulfilled the criteria were evaluated using the CAVI baseline measurement and clinical and paraclinical parameters. A total of 162 patients with chronic coronary artery disease (CAD) were monitored for cardiovascular disease (CVD) events over a period of 2 years.Results:CAVI in chronic CAD patients (9.21±0.79) was significantly higher compared to those in free-CAD patients (8.48 ± 0.62) with p

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Novembre 2024

Abstract 4144542: In-Hospital Outcomes of Open Mitral Valve Repair or Replacement versus Percutaneous Mitral Valve Repair or Replacement in patients with Prior Mediastinal Radiation: Insight from The National Inpatient Database (2015-2020)

Circulation, Volume 150, Issue Suppl_1, Page A4144542-A4144542, November 12, 2024. Background:Radiation associated heart disease has a wide spectrum of manifestations including pericardial disease, coronary artery disease, and valvular heart disease. Mitral valve regurgitation is the second most common valvular dysfunction in patients with prior mediastinal radiation.Research Question:What are the outcomes of percutaneous or transcatheter mitral valve replacement/repair (T-MVR) versus surgical mitral valve replacement/repair (S-MVR) in patients with prior mediastinal radiation.Methods:The National Inpatient Sample (NIS) was analyzed from 2015-2020 to identify patients with mediastinal tumors and prior exposure to radiation therapy undergoing mitral valve repair/replacement. We subclassified the data into hospitalizations for S-MVR and T-MVR. Baseline characteristics were compared between the two groups and multivariate logistic regression was used to analyze hospitalization outcomes.Results:A total of 1725 patients with prior mediastinal radiation were hospitalized for MVR; 1110 (64.3%) patients underwent S-MVR and 615 (35.6%) patients underwent T-MVR. On a multivariable analysis, the odds of MACCE [aOR: 2.21; 95 % CI: (1.87-4.01); p

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Novembre 2024

Abstract 4144560: Phase 2 Open-label, Single-arm, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Camostat Mesylate in Patients with Protein-losing Enteropathy after Fontan Operation-Preliminary Outcome

Circulation, Volume 150, Issue Suppl_1, Page A4144560-A4144560, November 12, 2024. Introduction:Protein-losing enteropathy (PLE) is a multifaceted condition that profoundly affects the systemic health and quality of life of Fontan patients. Despite medical progress, the treatment of PLE remains a significant challenge. This study investigates the efficacy and safety of Camostat Mesylate for managing PLE patients who have undergone the Fontan operation.Hypothesis:We hypothesize that Camostat Mesylate will enhance the gut environment, resulting in increase of serum albumin levels and decrease of stool alpha-1 antitrypsin levels in PLE patients following Fontan operation.Methods:This phase 2, multicenter, open-label, single-arm trial included patients over 4 years old diagnosed with PLE following Fontan operation. Camostat Mesylate was added to conventional treatments, with follow-up assessments at 1, 3, and 6 months, and a final evaluation one month after discontinuation. Efficacy was measured by changes in serum albumin, stool alpha-1 antitrypsin levels, and PLE symptoms such as diarrhea, edema, weight changes, and ascites.Results:Nineteen patients were enrolled in the study, of whom fifteen patients completed follow-up as per protocol. The median age was 15 years (interquartile range, 12.0-21.3). The median time between the Fontan operation and PLE diagnosis was 2.4 years. Serum albumin levels increased from 2.5 to 2.6 g/dL (p=0.504), and stool alpha-1 antitrypsin levels decreased significantly from 280.0 to 172.1 mg/dL (p=0.033). Notably, patients with diarrhea at baseline showed substantial improvement in both parameters, with increased serum albumin levels from 1.8 to 2.2 g/dL and decreased stool alpha-1 antitrypsin levels from 220.3 to 80.2 mg/dL. No serious adverse events were reported during study period.Conclusions:Camostat Mesylate demonstrated safety and efficacy, reducing stool alpha-1 antitrypsin in PLE patients after Fontan operation, especially those with diarrhea at baseline. Therefore, Camostat Mesylate could be considered as an additional treatment option for patients with PLE following Fontan operation.Key words:Camostat mesylate; protein-losing enteropathy; Fontan operationSource of Funding:This research was funded by SNUH Lee Kun-hee Child Cancer&Rare Disease Project, Republic of Korea.

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Novembre 2024

Abstract 4145037: Effects of Empagliflozin on cardio-renal interaction in heart failure: Results from the CINNAMON-study and in-vivo experiments

Circulation, Volume 150, Issue Suppl_1, Page A4145037-A4145037, November 12, 2024. Background and Purpose:Heart failure is associated with renal dysfunction suggesting a pathophysiological link between heart and kidney. Empagliflozin, a SGLT2 inhibitor, showed beneficial effects on both cardiovascular and renal endpoints. However, mechanistically, it is unclear if empagliflozin-dependent kidney protection is mediated via inhibition of tubular SGLT2 or more indirectly via improved cardiac function.We hypothesized that Empagliflozin treatment improves left ventricular ejection fraction (LVEF) and thereby renal function in patients and mice independent of renal SGLT2 inhibition.Methods:We evaluated LVEF and GFR in our patients with HF with reduced (n=32) and preserved ejection fraction (n=59) after 30 and 180 days (prospective, single-arm CINNAMON-study, DRKS00031101). Furthermore, we conducted transverse aortic constriction (TAC) in C57BL/6J (wildtype, WT) and SGLT2 deficient mice (SGLT2-KO). Animals received either Empagliflozin (10 mg/kg bw) or vehicle. Cardiac function was evaluated by echocardiography and kidney function by FITC-Sinistrin measurement (GFR).Results:Empagliflozin treatment improved LVEF in patients with reduced LVEF whereas in patients with preserved LVEF (Fig. A, B) there was no change in LVEF (Fig. C). Interestingly, only in patients with LVEF < 40% there was a parallel improvement in GFR (Fig. D, E), whereas in patients with LVEF > 40% we only observed the well-known transient drop of GFR (Fig. F).In mice after 10 weeks, echocardiography confirmed TAC induced pressure-overload, leading to reduced LVEF, which was attenuated by EMPA (Fig. G). Interestingly, at 10 weeks, TAC also reduced GFR, which was prevented by EMPA (Fig. H). To test if direct inhibition of SGLT2 is mechanistically involved, TAC surgery was repeated in SGLT2-deficient mice (SGLT2-KO). In fact, exposure to TAC resulted in comparable reduction of LVEF in SGLT2-KO and EMPA prevented this deterioration similar to WT mice (Fig. G vs. I). Surprisingly, EMPA also prevented GFR deterioration 10 weeks after TAC in SGLT2-KO mice with comparable magnitude as in WT mice (Fig. J), suggesting that the reno-protective effect of Empagliflozin was independent from SGLT2 inhibition.Conclusion and Outlook:This is the first study investigating the role of SGLT2 in Empagliflozin-dependent kidney protection in patients and of mice with heart failure. Importantly, Empagliflozin treatment prevented deterioration of LVEF and GFR independent of the presence of SGLT2.

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Novembre 2024

Abstract 4137441: Online Cognitive Behavioral Therapy Targeting Psychological Distress Following Open Heart Surgery: An Uncontrolled Pilot Study

Circulation, Volume 150, Issue Suppl_1, Page A4137441-A4137441, November 12, 2024. Background:Cardiac surgery is a significant procedure that reduces mortality and alleviates symptom burden in individuals with cardiovascular diseases. However, many patients develop depression and cardiac-related anxiety postoperatively, which negatively affects long-term prognosis and rehabilitation. There is a clinical need to develop scalable psychological treatments to mitigate these negative health effects.Objective:To investigate the feasibility and potential efficacy of a brief internet-delivered cognitive behavioral therapy (internet-CBT) intervention to reduce psychological distress in patients following cardiac surgery.Methods:The pilot study included 32 cardiac surgery patients (i.e., CABG, heart valve repair/replacement, aortic repair, or combined CABG and valve repair/replacement) with endorsed postoperative psychological distress and/or interference with daily life who underwent surgery from eight weeks to nine months prior to enrollment. Exclusion criteria included prior cardiac surgery with a ventricular assist device or heart transplant and severe medical or psychiatric illness. The internet-CBT targeted cardiac anxiety and depressive inactivity, lasted for five weeks, and was guided by clinical psychologists via text-based interactive online treatment modules. It included interoceptive exposure, in-vivo exposure, and behavioral activation. Self-assessments were completed at pre-treatment, post-treatment, and at 6-month follow-up.Results:Preliminary analyses post-treatment showed substantial pre-post improvements across multiple domains. Notable findings included significant reductions in depressive symptoms (Cohen’s d = 0.70; p = 0.04), cardiac anxiety (Cohen’s d = 1.53; p < 0.001), and perceived severity of post-operative symptoms (Cohen’s d = 1.06; p = 0.006). Participants demonstrated high adherence to the treatment, with the large majority of participants completing all five treatment modules (83.3%). Satisfaction with the treatment was also high (25.5 points out of 32), as measured by the Client Satisfaction Questionnaire, and no adverse events were reported.Conclusion:This novel internet-CBT intervention post-cardiac surgery appears to be feasible, acceptable, and clinically promising in reducing postoperative psychological distress. It could be used as a viable adjunct treatment to enhance recovery post-cardiac surgery. These preliminary findings warrant further testing in a randomized controlled trial.

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Novembre 2024

Abstract 4142895: Artificial Intelligence for Clinical Risk Stratification: Expert Based Risk Scores versus Online Open Source Generative Pre-Trained Transformers

Circulation, Volume 150, Issue Suppl_1, Page A4142895-A4142895, November 12, 2024. Background:We explored the potential of cutting-edge open-label artificial intelligence, particularly the unique cognitive capabilities it offers, in modern clinical practice. Our study evaluated the efficacy of online open-source generative pre-trained transformers (ChatGPT) in predicting cardiovascular risk in patients with heart failure and preserved ejection fraction, comparing its performance with expert-based clinical stratification.Methods:Retrospectively, we included 772 patients presenting with heart failure symptoms (mean age: 69±6 years, 56% female, mean ejection fraction: 61±5%, all >50%). They were followed for a median of 3.9 years for occurrences of death and hospitalization due to heart failure (HF). A script incorporating 12 variables (see Figure 1) was generated and submitted to the ChatGPT website, utilizing the returned score. Additionally, the H2FPEF score was computed as per guidelines. We then compared the predictive capabilities of both models for outcomes.Results:During follow-up, 17 patients died, 52 were hospitalized, and 67 experienced the combined outcome. The average ChatGPT score stood at 6.1±1.7, whereas the mean H2FPEF score was 3.1±1.5, exhibiting a modest correlation (r=0.51, p

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Novembre 2024

Abstract 4113573: Long Noncoding RNAs to Predict COVID-19 Neuro-Cardio-Vascular Outcomes

Circulation, Volume 150, Issue Suppl_1, Page A4113573-A4113573, November 12, 2024. Introduction/Background:Cardiovascular and neurological diseases develop in a significant proportion of COVID-19 patients. Minimally invasive tools to predict outcome after SARS-CoV-2 infection would enable personalized healthcare, potentially easing the disease burden. We showed that blood levels of the long noncoding RNA lymphoid enhancer-binding factor-1 antisense 1 (LEF1-AS1) predict COVID-19 in-hospital mortality.Hypothesis:LEF1-AS1 is associated with long-term clinical outcomes of COVID-19.Aim:Test the capacity of LEF1-AS1 to predict neuro-cardio-vascular outcomes post-SARS-CoV-2 infection.Methods/Approach:We enrolled 104 primo-infected COVID-19 patients aged 18+ recruited from April to December 2020 in the PrediCOVID national cohort for which 12-month follow-up data were available (Ethics Committee approvals 202003/07 and 202310/02-SU-202003/07). Whole blood samples were collected at baseline and expression levels of LEF1-AS1 were assessed by quantitative PCR.Results/Data:Of the 104 patients, 35 had at least one neurological symptom and one cardiovascular symptom at month 12. Levels of LEF1-AS1 at baseline were lower (p=0.019) in patients who developed neurological and cardiovascular symptoms as compared to patients who did not. Lower LEF1-AS1 was associated with symptoms development with an odds ratio of 0.48 (95% CI 0.28-0.83) from logistic regression model adjusted for age, sex, comorbidities and disease severity at baseline. Addition of LEF1-AS1 to a clinical model including age, sex, comorbidities and baseline severity yielded an incremental predictive value as attested by an increased AUC from 0.79 to 0.83 (likelihood ratio test p=0.005), a net reclassification index of 0.54 (p=0.007) and an integrated discrimination improvement of 0.08 (p=0.009).Conclusion:Blood levels of LEF1-AS1 predict 12-month neurological and cardiovascular outcomes of COVID-19 patients. This needs to be validated in larger populations.

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Novembre 2024

Abstract 4141401: Direct and Indirect Effects of Historic Residential Redlining on Prevalence of Cardiometabolic Diseases via Food Access

Circulation, Volume 150, Issue Suppl_1, Page A4141401-A4141401, November 12, 2024. Background:Given the importance of access to healthy food for adults at risk of cardiometabolic diseases, this study focused on investigating food access as a possible pathway between structural racism and prevalence of disease.Methods:Census tract level data were combined to create a final analytic dataset of 11,457 census tracts across 201 counties, within 38 states. Structural racism was defined as historic residential redlining using Home Owners’ Loan Corporation (HOLC) residential security maps from the Mapping Inequality project (score between 1=best to 4=redlined). Food access was defined using the modified retail food environment index (mRFEI) calculated as the number of healthy food retailers divided by the number of healthy and less healthy food retailers per census tract. Prevalence of disease in each census tract was based on CDC PLACES data and included prevalence of diabetes (DM), high blood pressure (HBP), coronary heart disease (CHD), and obesity. Direct and indirect relationships between redlining and each cardiometabolic disease via food access was investigated using structural equation modeling run in Stata v17, controlling for population of each census tract.Results:Mean prevalence of DM was 11.8%, HBP 31.9%, CHD 6.0%, and obesity 31.8%. Redlining (0.22, p

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Novembre 2024

Abstract 4139419: US National Trends in left atrial appendage occlusion volume and open payments to operators

Circulation, Volume 150, Issue Suppl_1, Page A4139419-A4139419, November 12, 2024. Background:Left atrial appendage occlusion (LAAO) was first performed among Medicare beneficiaries in 2017 and has grown rapidly in popularity. Payments from device manufacturers to physicians have been shown to correlate with other procedures, which are now publicly available. We report trends of LAAO in Medicare patients, and the relationship between procedure volume and manufacturer payment.Methods:We linked Medicare procedural data with Open Payments data via NPI number and identified physicians performing ≥ 1 LAAO between 2017 and 2021. Baseline physician information, including sex, operating location, and specialty, was extracted from CMS registries. Payment data were highly skewed, and winsorized at the 95thpercentile and compared to procedural volume.Results:The number of LAAO procedures increased from 6069 procedures in 2017 to 29083 in 2021 and 15.695 to 79.994 per 100,000 beneficiaries nationally. Across states, the median rate of implants 46.151 (IQR 33.765 – 62.271) per 100,000 beneficiaries, with Nebraska having the highest rate at 255.269 per 100,000 beneficiaries(Figure 1).The number of operators implanting LAAO devices increased from 286 (97.6% male) to 1003 (96.6% male). Roughly 49% of operators are licensed as electrophysiologists and 47% as interventional cardiologists. Total payments to physicians varied widely (median $ 3179.12, IQR 1703.16 – 9000.42) with >99% of operators receiving compensation from the LAAO device company; there is no clear relationship between compensation from the manufacturer and LAAO volume (r2=0.132) (Figure 2).Conclusions:LAAO has seen dramatic growth in volume of procedures and operators nationally, with substantial regional variation. While almost all LAAO operators received compensation from the primary LAAO device company, there is no correlation between payment amount and procedural volume.

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Novembre 2024

Abstract 4138107: Ventricular Tachycardia Mortality Trends in Oncology: Where Are We Now?

Circulation, Volume 150, Issue Suppl_1, Page A4138107-A4138107, November 12, 2024. Background:Advancements in chemotherapeutic modalities lead to improved cancer survival rates. While the cardiotoxicity related to the therapies is increasingly recognized, real-world data on ventricular tachycardia (VT) mortality among them is limited.Objective:This study sought to determine the longitudinal cardiovascular mortality trends related to ventricular tachycardia in the cancer population.Methods:We queried the CDC WONDER database among patients ≥ 25 years old from 1999 to 2020. Cardiovascular disease was listed as the main cause of death, while VT and cancer were listed as contributing causes of death. We calculated age-adjusted mortality rates (AAMR) per 1,000,000 individuals. We determined the trends over time by estimating the annual percent change (APC) using the Joinpoint regression program.Results:In the study period, there were 3,483 cardiovascular mortalities related to ventricular tachycardia in patients with comorbid cancer. The overall AAMR decreased significantly from 1.28 (95% CI, 1.11-1.44) in 1999 to 0.67 (95% CI, 0.57- 0.77) in 2020, with an average APC of -2.91 (95% CI, -3.95, -1.86). Overall, males had higher AAMR than females (1.25 [95% CI, 1.20 – 1.30] vs. (0.36 [95% CI, 0.34 – 0.39]). African Americans and White patients have comparable AAMR of 0.78 (95% CI, 0.69-0.86) and 0.77 (95% CI, 0.74-0.80), respectively, which were higher than Asians (0.34 [95% CI, 0.25-0.44]) and Hispanics (0.33 [95% CI, 0.27-0.40]). The AAMR was higher in the rural region than in the urban region (0.72 [95% CI, 0.69 – 0.75] vs. 0.76 [95% CI, 0.70 – 0.81]). The West region had the highest AAMR (0.79 [95% CI, 0.74 – 0.85]).Conclusion:Cardiovascular mortality related to VT in patients with comorbid cancer dropped significantly throughout the years. Further targeted approaches are needed to address the disparities in sex, race, and region.

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Novembre 2024

Abstract 4146264: A Meta-analysis of the Right Ventricle Changes in Cancer Therapy-Induced Cardiotoxicity – The Forgotten Ventricle in Cardio-Oncology

Circulation, Volume 150, Issue Suppl_1, Page A4146264-A4146264, November 12, 2024. Introduction:Cancer therapy-induced cardiotoxicity (CTRCD) is one of the most significant adverse effects of oncologic treatment, responsible for considerable morbidity and mortality. Heart failure stands out due to its higher frequency and severity with the focus of most studies being left ventricular dysfunction and remodeling. The right ventricle (RV) may also be damaged by CTRCD, however the effects on RV function have not been elucidated.Research Question:What are the echocardiographic changes in RV due chemotherapy treatment?Objective:To conduct a systematic review and meta-analysis evaluating the RV echocardiographic parameters in patients undergoing chemotherapy treatment.Methods:Pubmed, Embase and Cochrane were systematically searched for studies that assessed RV echocardiographic changes in patients due to chemotherapy treatment. Statistical analysis was performed using the R statistical environment, with a summary estimate using Mean Differences (MD), adopting a random-effects model to account for variability among studies and a two-tailed significance level of 5%. A correlation coefficient of 0.5 was assumed for the paired measurements. Heterogeneity was assessed using the I2 statistic.Results:We included 641 patients from 11 studies, 75.5% of whom were women and with a mean age of 50.2±6.1 years. RV function was significantly lower after cancer treatment, with reduction in the fractional area change (MD -3.53%; CI -5.25, -1.41; p

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Novembre 2024

Abstract 4141052: Rare Combo: An Unusual Case of a 54-year-old Filipino with Coronary Artery Fistula from Left Anterior Descending Artery to Main Pulmonary Artery and Acute Cerebellar Infarct: A Cardio – Cerebral Infarction Syndrome – Case Report

Circulation, Volume 150, Issue Suppl_1, Page A4141052-A4141052, November 12, 2024. Introduction:Cardio-cerebral infarction, a rare clinical presentation involving simultaneous acute ischemic stroke and acute myocardial infarction, poses significant therapeutic challenges. The incidence of this dual infarction is currently unknown due to its rarity. Delaying intervention for one condition to address the other can lead to permanent morbidity, disability, or even death. Coronary artery fistulas are uncommon with estimated incidence of 0.3%. Among these, a fistula between the left anterior descending artery and the pulmonary artery is the rarest variant, comprising about 17% of all coronary artery fistula cases.Case:A 54-year-old male, with a known history of atrial fibrillation and hypertension, presented to our emergency department with non-rotatory dizziness. Physical examination was unremarkable, but neurological examination revealed medial rectus palsy and left facial asymmetry. A cranial MRI indicated a hyperacute infarction in the left cerebellum. Laboratory tests showed markedly elevated troponin I levels ( >50 ng/ml) and atrial fibrillation, along with inferior wall ST elevation on the electrocardiogram. Due to the high risk of hemorrhagic conversion, the loading of antiplatelets was deferred. Instead, the patient was treated with Aspirin 80 mg once daily, Clopidogrel 75 mg once daily, and Enoxaparin 0.4 ml subcutaneously once daily. A 2D echocardiogram revealed an ejection fraction of 43%, hypokinesia of the anterior and intraventricular septum from base to apex, and severe mitral stenosis. Cardiac catheterization identified a coronary artery fistula from the left anterior descending coronary artery to the main pulmonary artery. Treatment for acute coronary syndrome and acute cerebellar infarct continued. An open-heart surgery was considered. However, during his hospital stay, the patient experienced hemorrhagic conversion and altered sensorium. His condition further deteriorated, necessitating a tracheostomy and long-term care.Conclusion:Cardio-cerebral infarction is an extremely rare and poorly studied syndrome that presents significant treatment challenges and carries a grave prognosis if not addressed immediately. The medical conundrum of deciding which condition to treat first underscores the need for further research. Both interventional cardiologists and interventional neuroradiologists play crucial roles in the effective management of this emergency condition.

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Novembre 2024

Abstract 4142044: The prognostic value of criteria for diagnosis of Immune Checkpoint Inhibitor Related Myocarditis: a comparison of the Bonaca et.al. criteria and European Society of Cardiology (ESC)-International Cardio-Oncology Society (ICOS) guidelines

Circulation, Volume 150, Issue Suppl_1, Page A4142044-A4142044, November 12, 2024. Background:Myocarditis is a dreaded complication of immune-checkpoint inhibitor (ICI) therapy but challenging to diagnose. There are no published data comparing the two leading diagnostic criteria for ICI myocarditis and their association with cardiovascular events.Methods:Patients treated with ICI and cardiac Troponin (cTnT) measurements thereafter at a tertiary institution from 2011 to 2022 were identified. Charts were reviewed for ICI-related myocarditis according to the Bonaca et. al criteria and the ESC-ICOS guideline criteria. A propensity matched control group was identified of patients treated with ICI but without developing myocarditis. Medical records were reviewed for baseline characteristics and long-term outcomes, including cardiac death, MACE (myocardial infarction, TIA/stroke, new heart failure diagnosis), and arrhythmias (V-tach, A-fib, complete heart block).Results:A total of 59 patients were identified as having a diagnosis of ICI-related myocarditis per Bonaca criteria (16 having definite, 13 probable and 30 possible myocarditis), and 47 met the ESC-ICOS guideline criteria. Mean age was 73.1±10.2 years, 60.1% were male, median follow-up was 2.5 years. ICI-related myocarditis as diagnosed by both diagnostic criteria had prognostic value for cardiac death (HR 13.94, 95%CI 1.84-105.64, p=0.011 per Bonaca, HR 6.22, 95%CI 1.77-21.88, p=0.004 per ESC-ICOS), MACE, (HR 3.17, 95%CI 1.34-7.47, p=0.008 per Bonaca, HR 2.97, 95%CI 1.37-6.45, p=0.006 per ESC-ICOS), and arrhythmias (HR 1.93, 95%CI 1.10-3.38, p=0.022 per Bonaca, HR 2.09, 95%CI 1.21-3.60, p

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Novembre 2024

Abstract 4117085: Frequency and Patterns of Paroxysmal Supraventricular Tachycardia Episodes Among Patients Opting For Acute Drug Treatment: Analysis of the NODE-303 Open-Label Etripamil Trial

Circulation, Volume 150, Issue Suppl_1, Page A4117085-A4117085, November 12, 2024. Background:Etripamil nasal spray (NS) is a fast acting, self-administered calcium channel blocker in development for the termination of AV-nodal-dependent supraventricular tachycardia (SVT). Prior randomized, placebo-controlled and open-label studies have demonstrated favorable safety and efficacy of etripamil in converting paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm (SR) self-administered without direct medical supervision.Research Question/Hypothesis:To assess patterns and annualized PSVT episode frequency among patients opting to self-administer acute treatment with etripamil.Methods:NODE-303 was an event-driven, multi-center, open-label Phase 3 study, conducted in North and South America to evaluate the safety and efficacy of etripamil in patients with documented PSVT over multiple episodes. Test dosing was not performed prior to at-home use. Enrolled patients, upon perceiving symptoms of PSVT: applied an ambulatory ECG monitor, performed a previously trained vagal maneuver and, if symptoms persisted, self-administered etripamil NS 70 mg. During the study, the protocol was amended to allow a repeat dose (70 mg) if symptoms persisted 10 min after the first dose. Each patient could self-treat up to 4 episodes.Results:Of 1,116 enrolled patients, 503 (45.1%) treated ≥1 perceived PSVT episode (safety population). Etripamil achieved conversion to SR in 60% of patients by 30 minutes and 70% by 60 minutes. A total of 220, 118, 62, and 103 patients completed the study with 1, 2, 3, and 4 etripamil-treated perceived episodes of PSVT, respectively, with an average time on study of 440 days. Among these patients, the average number of annualized etripamil-treated PSVT episodes was 3.2 (standard deviation 3.8). Annualized use: etripamil was self-administered for 0-2 PSVT episodes per year, 2-6 episodes, 6-12 episodes, and >12 episodes, in 54%, 32%, 10%, and 4% of patients, respectively(Figure).Conclusions:This analysis aimed to assess the annualized use of etripamil NS in a real-world setting, by analyzing how often patients would self-administer the drug for PSVT episodes. Of patients that self-administered etripamil (n=503), the majority treated >1 episode and the annualized frequency of episodes treated with etripamil was 3.2 episodes/yr.

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Novembre 2024

Abstract 4147019: Role of Fractional Excretion of Uric Acid as a Predictor of Cardio-renal Syndrome in Acute Decompensated Heart Failure Patients: An Observational Study

Circulation, Volume 150, Issue Suppl_1, Page A4147019-A4147019, November 12, 2024. Cardio-renal syndrome (CRS) is a growing health, economical, and societal problem.The diagnosis and treatment of patients with acute decompensated heart failure (ADHF) especially complicated with CRS are challenging and hence, we aimed to determine the prevalence of CRS in ADHF patients and also determine the role of fractional excretion of uric acid (FeUa) in prediction of CRS in patients with ADHF.Methods:In this hospital-based, observational study, a total of sixty-five patients with ADHF and who met the inclusion criteria were recruited and their demographic details were recorded. Blood samples were collected, and various laboratory parameters were measured at day-1, day-3, and day-7. The fractional excretion of sodium (FeNa) and FeUa were calculated.Results:The mean age of participants was 52.32 ± 14.04 years, and 67.69 % were males. The prevalence of CRS in ADHF patients was noted to be 18.46 %. At baseline, the B-type natriuretic peptide (BNP) level for the enrolled patients was observed to be 8690.06 ± 6181.32 pg/ml. The serum creatinine and serum uric acid elevated as the day of hospitalization increased, and the maximum was observed at day-7 i.e., 1.35 ± 0.54 mg/ml and 11.08 ± 15.83 mg/ml, respectively. Declining trend in the FeNa (%) was noted, and the values at day-1, at day-3, and at day-7 were 1.25 ± 1.18, 1.01 ± 1.08, and 0.80 ± 0.79, respectively. The FeUa (%) value increased at day-3 from 5.60 ± 7.47 to 6.95 ± 7.43. However, decrease FeUa value was observed at day-7 (5.78 ± 5.63 %). On receiver operative curve analysis, FeUa served to be a negative predictor of CRS in ADHF patients with an area under the curve of 0.489.Conclusion:The FeUa seems to be a negative predictor of CRS in patients hospitalized with ADHF. However, multi-parametric techniques and biomarkers which are available for investigating cardiovascular diseases and kidney diseases may offer opportunities for the evaluation of CRS.

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Novembre 2024