Circulation, Volume 150, Issue Suppl_1, Page A4141352-A4141352, November 12, 2024. Background:Major adverse cardiovascular events (MACE), including myocardial infarction, acute coronary syndrome, ischemic heart disease requiring revascularization, stroke, and heart failure, have been documented as significant contributors to mortality in cancer survivors. Coronary artery calcium (CAC) can predict MACE in non-cancer populations, while calcium in the aorta (CA) has not been evaluated as a prognostic marker. Every patient diagnosed with cancer undergoes a standard-of-care Positron Emission Tomography-Computed Tomography (PET-CT) or a chest CT before the initiation of chemotherapy.Hypothesis:To determine whether the CAC or CA of patients with Hodgkin’s or non-Hodgkin’s lymphoma, derived from standard-of-care PET-CT/chest CT, can predict the incidence of MACE.Methods:Patients treated with anthracycline-based chemotherapy, diagnosed and followed from January 1, 2013, through June 30, 2023, were included. Patients who did not undergo a PET-CT or CT, and/or developed MACE before treatment initiation were excluded. Univariate and multivariate adjusted Cox regression models were employed to assess whether the presence of CAC, CA, or CAC-CA was associated with the development of MACE. Calcium was retrospectively quantified using TeraRecon software (Durham NC) and categorized as: 0, 1-99, and >100. Outcome analyses was estimated using the Kaplan-Meier method.Results:326 patients were included, mean age of 55 years (range: 52-60), predominantly male 201 (61%) and white 314 (96%), CAC was found in 89 patients and CA in 140. In the univariate regression model, a statistically significant association was found with values >100 for CA, CAC and CAC-CA with the risk of MACE. (Fig 1a/b/c). CAC equal to 0 demonstrated a significant protective effect against MACE. (Fig 1a). In the multivariable analysis, these associations persisted even after adjusting for comorbidities. (Table 1).Conclusion:CAC, CA and CAC/CA >100 in the standard-of-care CT/PET CT are predictors of MACE in lymphoma patients undergoing anthracycline treatment, a CAC equal to 0 has protective effect, these relationships remained statistically significant after adjusting for comorbidities.
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Abstract 4141704: An Innovative, Non-invasive, Credit-Card Sized Device for Ambulatory 12 Lead ECG Recording: First-In-Human Experience Compared to Standard 12 Lead ECG
Circulation, Volume 150, Issue Suppl_1, Page A4141704-A4141704, November 12, 2024. Background:The multiple electrodes needed to generate a 12-lead electrocardiogram (12L ECG) limits its use to traditional health care settings. An innovative credit-card sized unit (HeartBeam, Santa Clara, CA, USA) when placed on the chest without cables captures a vectorcardiogram (VCG). A personalized transformation matrix (PTM) then converts the signals into a 12L ECG.Objective:This is the first quantitative (standard intervals and amplitudes) and qualitative (rhythm diagnosis) accuracy assessment of a synthesized 12L ECG (Syn 12L) compared to a simultaneously recorded standard 12L ECG (Std 12L) on patients in sinus rhythm (SR) or in a non-life-threatening arrhythmia.Methods:The 80 patients, who were enrolled at a single center (Dedinje Cardiovascular Research Institute, Belgrade, Serbia), first underwent recording of a Std 12L and VCG to create a unique PTM, which was used to create the Syn 12L from the VCG. Then a simultaneous Std 12L and VCG were recorded. The quantitative endpoint was the calculated difference (mean and standard deviation [SD]) between the Syn 12L and Std 12L in a series of intervals (RR, PQ, QJ, and QT) and amplitudes (P wave, R wave, and T wave). For the qualitative endpoint, 2 blinded electrophysiology physicians (EP) classified the Syn 12L and Std 12L arrhythmia status.Results:Of the 80 patients, 41 were in SR and 39 in another rhythm (3:SR with PACs, 5:SR with PVCs, 1:SR with pre-excitation, 16:atrial fibrillation, 3:atrial flutter, 2:atrial pacing, and 9:ventricular pacing). The interval and amplitude differences are listed in the table. Rhythm classification by the blinded EPs demonstrated a sensitivity of 94.9% (95% CI: 82.7-99.4%) and specificity of 100% (95% CI: 91.4-100%) compared to Std 12L.Conclusion:In this first study comparing the performance of a 12L ECG created from a credit card sized VCG recorder, the 12L Syn demonstrated clinically equivalent interval and amplitude accuracy and excellent agreement in arrhythmia classification when compared to a simultaneously recorded 12L Std. This approach holds significant promise, potentially permitting patients to obtain a 12L ECG outside of a health care setting with a compact, easy to use device.
Abstract 4120131: Absence of standard modifiable risk factors (SMuRF-less) among 5002 Middle Eastern patients with atherosclerotic cardiovascular disease: (Interim analysis from the Jo-SMuRF Study)
Circulation, Volume 150, Issue Suppl_1, Page A4120131-A4120131, November 12, 2024. Introduction:A growing number of patients develop atherosclerotic cardiovascular disease (ASCVD) despite the absence of standard modifiable risk factors i.e. hypertension (HTN), type 2 diabetes (T2D), dyslipidemia (DSL), and cigarette smoking (SMuRF-less). There is scarcity of studies on prevalence and clinical profiles of SMuRF-less patients in the Middle Ease (ME).Aim:To study the prevalence and clinical features of ME patients with ASCVD who are SMuRF-less vs. those with ≥ 1 SMuRFs, presence of other risk factors and utilization of secondary preventive medications in the 2 groups, and one year survival.Methods:Clinical details of adult patients with ASCVD who participated in 5 previous registries were analyzed according to the absence or presence of ≥ 1 SMuRFs.Results:Of the 5002 patients included in the analysis, 676 (13.5%) were SMuRF-less and 4326 (86.5%) had ≥ 1 SMuRFs. Prevalence of the 4 SMuRFs in the whole cohort was 53.5% HTN, 47.8% T2D, 40.2% smoking, and 37.5% DSL, and the SMuRF group was 61.9%, 55.2%, 46.5%, and 43.4%, respectively. Compared with the SMuRFs group, patients in the SMuRFless group were younger (mean age 52±11.4 years vs. 56.3±11.5 years, respectively, p
Abstract 4136889: Impact of hypercholesterolemia definitions on prevalence and prognosis of patients without standard modifiable cardiovascular risk factors and ST-segment elevation myocardial infarction.
Circulation, Volume 150, Issue Suppl_1, Page A4136889-A4136889, November 12, 2024. Background:In patients with acute myocardial infarction (AMI), recent studies have intriguingly reported that up to a quarter of AMI patients have none of the 4 main standard modifiable cardiovascular (CV) risk factors (SMuRFs) (i.e. hypertension (HTN), diabetes mellitus (DM), hypercholesterolemia (HC), and smoking) and have worse mortality.Hypothesis:We tested the hypothesis that the prevalence and prognosis of SMuRF-less patients varies with the definition of risk factors.Aim:Using a French nationwide MI cohort, we aimed to compare SMuRF-less ST-segment elevation MI (STEMI) patients according to 2 HC definitions, given the possibility of using several HC criteria.Methods:The French Cohort of Myocardial Infarction Evaluation (FRENCHIE) is a large ongoing AMI cohort, collecting data from all patients hospitalized for AMI < 48 h of symptom onset in 21 French centers. STEMI patients without prior CAD admitted in 2019 to 2022 were studied. DM was defined as prior DM diagnosis, HbA1c >7% or anti-diabetic medications, ongoing or at discharge, HTN was defined as treated or previous HTN diagnosis and smoking was defined as current smoking within the past month. Restrictive HC (RHC) was defined as either a previous diagnosis of HC or statin therapy. Permissive HC (PHC) was defined as previous diagnosis of HC or lipid-lowering therapy, or LDL-C > 135 mg/dL or total Cholesterol > 213 mg/dL.Results:Among 8008 patients (mean age 61.5± 12.9y, 22.6% women), 41.4% were smokers, 17.4% had diabetes, and 38.5% HTN. According to HC definitions, the prevalence of HC almost doubled, ranging from 30.3% for RHC to 61.0% for PHC. Consequently, the prevalence of SMuRF-less was divided by ≈ two (21.1% vs 11.3%, respectively), depending on the definition of HC used. Age and sex-adjusted logistic regression analysis showed that PHC, but not RHC, was associated with lower odds of in-hospital death (figure). Moreover, having multiple SMuRFs was associated with higher risk of mortality than no SMuRF when using RHC, but not with PHC definition.Conclusion:The prevalence and impact on acute mortality of being SMURFless varies largely with the definition of HC. More research is needed, using HC standardized definitions to explore these patients.Frenchie:was supported in part by the RHU iVASC grant ANR-16-RHUS-00010 from the French National Research Agency (ANR) as part of the Investissements d’Avenir program. The FRENCHIE cohort is registered with ClinicalTrials.gov, NCT04050956.
Abstract 4125157: Efficacy of Adding Sodium-Glucose Co-Transporter 2 Inhibitor versus Standard Therapy Alone in Post-Percutaneous Coronary Intervention Patients: A Systematic Review and Meta-Analysis
Circulation, Volume 150, Issue Suppl_1, Page A4125157-A4125157, November 12, 2024. Background:Recent evidence suggests that sodium-glucose cotransporter-2 inhibitors (SGLT2-i) may improve outcomes in patients with coronary artery disease (CAD) through various physiological pathways. However, their impact on patients who have undergone percutaneous coronary intervention (PCI) is not well established. This meta-analysis aims to evaluate the effectiveness of additive SGLT2 inhibitors versus standard therapy alone in patients with CAD after PCI.Methods:A systematic search was conducted across the Medline, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) and observational studies that compared the addition of SGLT2 inhibitors to standard therapy versus standard therapy alone in patients post-PCI. The outcomes analyzed were Major Adverse Cardiovascular Events (MACE), all-cause death, cardiovascular death, recurrent acute myocardial infarction (AMI), nonfatal stroke, revascularization, and hospitalization for heart failure (HF).Results:A total of 7 studies met the inclusion criteria, encompassing a total of 11,800 individuals (5,004 on SGLT2-i and 6,796 non-SGLT2-i; mean age of 62.7 years; 28% women; 95% diabetic patients). SGLT2 inhibitors significantly reduced the risk of all-cause mortality (RR 0.6, 95% CI: 0.5-0.72, p
Abstract 4138167: Comparative Efficacy Of Minimally Invasive Versus Standard Treatments For Intracerebral Hemorrhage: A Meta-Analysis and Systemic Review
Circulation, Volume 150, Issue Suppl_1, Page A4138167-A4138167, November 12, 2024. Background:Intracerebral hemorrhage (ICH) has high morbidity and mortality. Traditional craniotomy causes significant trauma and lacks proven benefits. Minimally invasive techniques (MIT) like CT-guided thrombolysis, endoscopic, and neuronavigation surgeries show promise in reducing secondary neurotoxicity. Our meta-analysis compares MIT with standard treatments for supratentorial spontaneous intracerebral hematomas (SSICHs) to evaluate their effectiveness in improving clinical outcomes.Methods:We comprehensively searched PubMed, EMBASE, and Cochrane Library for studies published before June 1, 2024, comparing MIT versus standard treatment for ICH. Data were analyzed using R (v.4.3). Pooled proportions with 95% confidence intervals (CIs) were calculated using a random effects model. Odds ratios (ORs) and mean differences (MDs) with 95% CIs were used for dichotomous and continuous variables. Outcomes included overall survival, functional neurological outcome, hospitalization length, recurrent bleeding, volume reduction, and Glasgow Coma Scale (GCS) score at discharge.Results:We identified six studies, including 1,117 patients. There were 463 patients who underwent MIT and 654 patients who received standard treatment. The MIT group exhibited statistically significant increased odds of survival (OR: 1.98 [1.25, 3.15]; I2=26%; p=0.004) and functional neurological outcome (OR: 1.94 [1.27, 2.96]; I2=25%; p=0.002) compared to the standard treatment group. The MIT group demonstrated statistically significant lower length of hospitalization (MD: -2.89 [-4.49, -1.30]; I2=47%; p=0.0004) and better GCS score at discharge (MD: 1.50 [1.00, 2.00]; I2=0%; p
Abstract 4147960: Intensive treatment compared to Standard for hypertension in elderly patients, is it safe and effective? A Systematic Review and Meta-Analysis
Circulation, Volume 150, Issue Suppl_1, Page A4147960-A4147960, November 12, 2024. Introduction:Blood pressure targets for the elderly are still controversial, there is a lack of certainty about the benefit and safety of targeting ≤ 130mmHg systolic blood pressure. Evaluate the benefit in important cardiovascular outcomes and safety in elderly patients of a blood pressure control ≤ 130mmHg compared to standard of care.Methods:The research was performed in PubMed, EMBASE, Scielo, LILACS, and Cochrane Central Register of Controlled Trials (CENTRAL) from January 1st, 2013 to May 1st, 2023. Randomized controlled trials that were published between January 1st, 2013 and May 1st, 2023 that included hypertensive patients over 60 years old which reported major adverse cardiovascular outcomes (MACE) or all-cause mortality, cardiovascular mortality and safety outcomes were selected. The data extraction was performed independently by two investigators following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). A meta-analysis was performed using a fixed-effect model. The results were reported as the pooled results using risk ratio (RR) and a confidence interval (CI) of 95%.Results:The 4 trials included a number of 16,834 patients, the mean age was over 65 years, there was a good balance between genders, 13.3% of patients had cardiovascular disease, 10.9% diabetes, and 15.5% chronic kidney disease. The mean achieved blood pressure was roughly under 130mmHg, only one study was over (135mmHg) and the mean follow-up time was over 32 months. The intensive therapy decreased the outcomes for mortality (RR = 0.75, 95% CI 0.64 – 0.87, p
Abstract 4137708: Implementation of a Standard Hydration Protocol Improves Compliance of Pre-procedural Hydration, Reducing the Incidence of Contrast-Induced Acute Kidney Injury (CI-AKI) After Percutaneous Coronary Intervention (PCI)
Circulation, Volume 150, Issue Suppl_1, Page A4137708-A4137708, November 12, 2024. Introduction:Intravenous hydration and contrast media volume reduction are the most important preventive factors against CI-AKI after PCI. Multiple studies have demonstrated the effectiveness of intravenous hydration before PCI, however, varied hydration protocols have rather complicated standardization. Doctors’ preferences and local institutional factors further hinder protocol implementation, resulting in reduced compliance.Hypothesis:Standardizing hydration protocol increases the compliance rate of preprocedural hydration orders and administration, reducing the incidence of CI-AKI.Methods:A team at Memorial Hermann The Woodlands Medical Center, comprising a cardiovascular nurse coordinator, catheterization laboratory director, pharmacist, information technologist, and hospital administrators, was formed to improve PCI outcomes through a multi-faceted approach. This involved a standardized hydration protocol with direct education, continuous monitoring, and repeated internal feedback, reviewed monthly. The new protocol included normal saline pre- and post-procedure maintenance fluids, with a 250 ml normal saline bolus pre-operatively. Maintenance fluids were set at 75 ml/hr, and 20 ml/hr for patients with congestive heart failure and an ejection fraction ≤ 40%. The team reviewed 233 patients under the old protocol and 281 under the new protocol. Compliance rates of pre-procedural intravenous hydration were compared and CI-AKI incidence, defined as a >50% increase or a 0.3 mg/dL increase in creatinine levels within 5 days post-procedure, was assessed. Chi square tests and t-tests were used to compare cohorts on 12 parameters and CI-AKI incidence assessment, with a p-value of 0.05.Results:Compliance with pre-procedural hydration significantly increased under the new protocol (86.1% vs 55.4%, p
Abstract 4141224: Prognostic Value of Serum Glycated Albumin in Acute Coronary Syndrome Patients Without Standard Modifiable Cardiovascular Risk Factors
Circulation, Volume 150, Issue Suppl_1, Page A4141224-A4141224, November 12, 2024. Background:Glycated albumin (GA) has been demonstrated to be associated with adverse outcomes in patients with acute coronary syndrome (ACS). However, as a specific subgroup of ACS, a significant proportion of patients with ACS without standard modifiable cardiovascular risk factors (SMuRFs) are currently being identified. The prognostic value of serum GA for adverse events in such patients remains unexplored.Aims:This study aims to evaluate the prognostic value of GA in predicting adverse outcomes in patients with ACS without SMuRFs.Methods:This study involved 1,140 consecutive patients who were diagnosed with ACS without SMuRFs at the Beijing Anzhen Hospital between May 2018 and December 2020 and underwent coronary angiography. Each patient was followed up for a period of 35–66 months after discharge. The primary endpoint of this study was major adverse cardiovascular and cerebrovascular events (MACCEs) that included all-cause mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, and ischemia-driven revascularization.Results:The average age of the study participants was 59.55 ± 10.98 years, and men accounted for 61.8%. The average GA level was 14.37 ± 2.42. The median follow-up duration was 48.3 months, during which 220 cases (19.3%) experienced MACCEs. In the fully adjusted model, with GA as a continuous variable, the hazard ratio (HR) for MACCEs in the high GA group was 1.069 (95% confidence interval (CI): 1.008, 1.133), the HR for ischemia-driven revascularization was 1.095 (95% CI: 1.021, 1.175), and the HR for all-cause mortality was 1.155 (95% CI: 1.021, 1.306), all with P values less than 0.05. Similarly, when GA was considered as a categorical variable, in the fully adjusted model, GA was associated with MACCEs, ischemia-driven revascularization, and all-cause mortality, with P values all less than 0.05. The restricted cubic spline curve showed that the relationship between GA and MACCEs was linear (p for non-linear = 0.079; p for overall association = 0.026). Furthermore, GA levels were correlated with poor prognosis in the subgroups of patients.Conclusion:Serum GA might be an independent predictor of all-cause death, ischemia-driven revascularization, and MACCEs in patients with ACS without SMuRFs.
Abstract 4146606: Complication Rate of Fractional Flow Reserve-guided Angiography in Comparison to Standard Angiography: A Systematic Review and Meta-Analysis
Circulation, Volume 150, Issue Suppl_1, Page A4146606-A4146606, November 12, 2024. Background:Intracoronary measurement of fractional flow reserve (FFR) has demonstrated higher sensitivity and better negative predicative value in evaluation of coronary artery disease than visual/angiographic only evaluation. Nonetheless, there is profound lack of evidence in the available literature that discusses the rate of complications when utilizing FFR versus standard angiography.Research Question:Does FFR carry higher or lower risk of procedural complications when compared with standard angiography?Aim:Compare the risk of complications encountered in FFR guidance in comparison to angiography only.Methods:The following databases were searched; PubMed, SCOPUS, CENTRAL, Web of Science. The following keywords were used; ((Fractional flow reserve OR FFR) AND (Adverse effect OR Complication)). The studies were included if they compared Angiography-guided Percutaneous Coronary Intervention (PCI) and Fractional Flow Reserve (FFR)-guided PCI in terms of mortality or Major Adverse Cardiac Events (MACE). Case reports and series, animal studies, reviews and non-English articles were excluded from this study. The exposure of interest was FFR-guided PCI whereas the outcomes of interest were MACE and mortality.Results:A total of 1,822 articles were identified. After removing duplicates, initial screening, and secondary screening, 15 articles were included and the total number of included patients was 421,291. The percentage of patients who underwent FFR guidance was 3.5% whereas the rest underwent angiography only. Male predominance was noted in both, FFR and angiography. The mean age of the patients who underwent FFR and angiography was 64.9 ± 9.1 and 65.2 ± 9.3 years, respectively. The model that compared between angiography only and FFR in MACE (14 studies) showed that FFR was significantly associated with lower risk of MACE compared to angiography (RR=0.62, 95%CI:0.48-0.81); this model also showed significant heterogeneity (P-value
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Addition of prophylactic compression garments to standard care to prevent irreversible lower limb lymphoedema after gynaeco-oncological therapy (Gynolymph): protocol for a randomised controlled trial embedded within an observation cohort study
Introduction
In female patients diagnosed with gynaecological cancer, the main priority is treating cancer itself. However, a significant number of these patients develop lower limb lymphoedema (LLL), with its incidence strongly influenced by the diagnostic cut-off (a difference in leg circumference between both legs of 5% or 10%). LLL significantly impacts patients’ quality of life (QoL) due to functional impairment, the daily time investment required for treatment, financial costs and affected body image. Additionally, it increases the risk of cellulitis, often leading to hospitalisation for intravenous antibiotics. Timely recognition and acknowledgement of symptoms are crucial first steps in improving the QoL for these women. LLL is a common and irreversible complication following treatment for gynaecological cancer. Despite its clinical significance, there are limited prospective studies investigating LLL incidence, risk factors, early detection and clinical course in this patient population. Therefore, the objective of this observational cohort study is to investigate the incidence rate of stage 0–1 or stage 2–3 LLL based on the International Society of Lymphology criteria in the first 2 years after gynaecological cancer treatment. The embedded randomised control study (RCT) examines the added value of prophylactic compression garments (class II) to standard care in preventing irreversible lymphoedema after gynaeco-oncological therapy.
Methods and analysis
In June 2022, two university hospitals in Belgium initiated a multicentre observational cohort study, which also includes an embedded RCT. The study aims to enrol 400 patients before they begin cancer treatment or within 14 days of starting chemotherapy, radiotherapy or surgery. This cohort will be followed for up to 2 years. The embedded RCT will focus on patients who develop clinical lymphoedema stage 0–1 within the first 12 months following their initial cancer treatment. A total of 196 patients will be randomised into two groups: the intervention group (98 patients), receiving usual care plus prophylactic compression garments (compression class 2 (CCL2): 23–32 mm Hg), and the control group (98 patients), receiving only usual care. The RCT aims to assess the impact of adding prophylactic compression garments to standard care on further deterioration. Assessments will be conducted at baseline, and at 3, 12 and 24 months after initial cancer treatment. An additional assessment (T-visit) will be provided if there is a transition to LLL stage 0–1 or from stage 0–1 to stage 2–3 LLL, based on follow-up findings or patient initiative, using the predictive value of a validated self-report lower extremity questionnaire. This questionnaire is part of a lymph diary app provided to all patients. The primary outcome of the observational study is to determine the incidence rate of stage 0–1 or stage 2–3 LLL in the first 2 years after gynaecological cancer treatment. The primary outcome of the RCT is to evaluate the effect of wearing CCL2 preventive garments to avoid progression to higher-stage lymphoedema in patients who develop LLL within 1 year of treatment. Key secondary outcomes of the observational study include the timing of the development of LLL, risk factors for developing LLL and the impact of LLL on QoL and sexuality, as well as the evaluation of screening and diagnostic tools. The secondary outcomes of the RCT include tolerance and compliance with wearing the preventive compressive garments, the impact of the garments on limb volume and the patient’s time and financial investment.
Ethics and dissemination
The study was approved by the Ethics Committee of the two academic hospitals: the University Hospital of Ghent in September 2021 and the University Hospital of Leuven in December 2021. Approval has been granted for the study protocol, informed consent forms and other related documents by the main Ethics Committee of Ghent (BC-09915) and the local Ethics Committee of Leuven (S65724). All patients will provide written informed consent before participating in the trial. The results will be shared through peer-reviewed journals and presentations.
Trial registration number
NCT05469945.