Peripheral Vascular Complications Research Articles

VA-ECMO-related complications seem not causally related to mortality in patients with acute myocardial infarction complicated by cardiogenic shock

Abstract Background Recently published randomized controlled trials and an individual patient data meta-analysis showed that the routine use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) did not reduce mortality compared to medical therapy alone in patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS). Purpose The aim of this study was to investigate as to whether possible VA-ECMO-related medical complications might be associated with an increased mortality risk, which might explain the observed equipoise among mortality outcomes between VA-ECMO and usual care in patients with AMI-CS. Methods Using data from the randomized ECLS-SHOCK trial (Extracorporeal Life Support in Infarct-Related Cardiogenic Shock), which compared routine VA-ECMO use versus medical therapy alone. Causal mediation analyses (primary analysis; VA-ECMO-related complications used as a mediator), logistic regression and causes of death analyses (secondary analyses) were utilised to test potential effects of possible VA-ECMO-related complications on 30-day mortality. Analyses were adjusted for risk factors of bleeding and vascular complications. Results In total, 417 patients were included in this analysis. Moderate and severe bleeding as well as peripheral vascular complications requiring intervention were identified as possible VA-ECMO-related complications. A total of 88 patients (21.1%) developed possible VA-ECMO-related complications, which mostly occurred within five days after randomisation and more frequently in the VA-ECMO group than in the control group: 49 (23.4%) vs. 20 (9.6%) patients, p<0.001 for bleeding and 23 (11.0%) vs. 8 (3.8%) patients, p=0.01 for peripheral vascular complications, respectively. Causal mediation analyses revealed no significant mediation effect of possible VA-ECMO-related complications on 30-day mortality (p=n.s.; Figure). Logistic regression and causes of death analyses of possible VA-ECMO-related complications confirmed no significant associations between the incidence of VA-ECMO-related complications and mortality (p=n.s.). Conclusion VA-ECMO use in patients with AMI-CS was associated with increased incidences of moderate to severe bleeding as well as vascular complications warranting intervention. In this causal mediation analysis, VA-ECMO-related complications do not appear to mediate an increased mortality risk.

Identifying prognostic factors in patients with cardiogenic shock undergoing VA-ECMO treatment: insights from ECLS-SHOCK using machine learning

Abstract Background/Introduction Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has not been shown to reduce short-term mortality in patients with acute myocardial infarction complicated by cardiogenic shock. However, whether some patients might benefit from VA-ECMO remains to be cleared. Purpose To identify the impact of VA-ECMO therapy on outcomes by leveraging the potential of machine learning. Methods The ECLS-SHOCK trial is a randomized controlled trial where patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early VA-ECMO plus usual medical treatment or usual medical treatment alone. The primary outcome was death from any cause at 30 days. Extreme gradient boosting (XGBoost) was used to develop a model for the prediction of 30-day all-cause mortality and to assess the influence of VA-ECMO on outcomes. Results Overall, 209 patients were randomized to the VA-ECMO and 208 to control. Baseline characteristics between groups were well balanced (median age 63 years, 81% male, 67% presenting with ST-segment elevation myocardial infarction). At 30-days 100 patients in the VA-ECMO and 102 in the control group were dead. The final XGBoost model contained 27 variables and the 10 most influential variables are shown in Fig. 1. On derivation the model predicted mortality with an AUC of 1.00 and on validation with an AUC of 0.80 (95% CI 0.71 to 0.89), with a sensitivity of 95% (95% CI 88% to 100%) and a specificity of 55% (40% to 69%), resulting in a positive predictive value of 65% and a negative predictive value of 92% at a Youden-derived cut-off. Importantly, neither the VA-ECMO therapy nor its complications were among the most influential factors of the model with a relative importance of 1.1% for VA-ECMO therapy and 0.25% for peripheral vascular complications and bleeding complications even being discarded by the model. Conclusion In patients with acute myocardial infarction complicated by cardiogenic shock the influence of VA-ECMO therapy on 30-day mortality, even when investigated with complex machine learning models, is negligibly low.

Do DanGer-SHOCK-like patients benefit from VA-ECMO treatment in infarct-related cardiogenic shock? results of an individual patient data meta-analysis.

In a recent meta-analysis of randomized controlled trials, routine use of veno-arterial ECMO (VA-ECMO) did not improve outcomes in patients with acute myocardial infarction-related cardiogenic shock (AMI-CS), while a microaxial flow pump reduced mortality in a selected group of patients with AMI-CS in the DanGer-Shock trial. Individual patient data of patients included in four randomized clinical trials investigating the routine use of VA-ECMO in AMI-CS were centrally analysed. For the purpose of this sub-analysis, DanGer-Shock-like patients were analysed (STEMI only, presumed low likelihood of brain injury). The primary endpoint was 180-day all-cause mortality. A total of 202 patients (106 randomized to VA-ECMO and 96 to control) were included. There were no differences in baseline characteristics, angiographic and interventional features between the two groups. Mortality after 6 months was numerically lower with VA-ECMO between the groups [45% in VA-ECMO group vs. 51% in control group; hazard ratio, 0.84; 95% confidence interval (CI), 0.56-1.26], while major bleeding (OR, 2.24; 95% CI, 1.08-4.64) and peripheral vascular complications (OR, 3.65; 95% CI, 1.15-11.56) were increased with the use of VA-ECMO. In this exploratory subgroup analysis in patients with CS, STEMI, and a low likelihood of brain injury, there was no mortality benefit with the routine use of VA-ECMO. However, as indicated by the large confidence intervals, the statistical power was limited to draw definite conclusions.

Association of chronic kidney disease and end-stage renal disease with procedural complications and inpatient outcomes of leadless pacemaker implantations across the United States

Leadless pacemakers have emerged as a promising alternative to transvenous pacemakers in patients with kidney disease. However, studies investigating leadless pacemaker outcomes and complications based on kidney dysfunction are limited. The objective of this study was to evaluate the association of chronic kidney disease (CKD) and end-stage renal disease (ESRD) with inpatient complications and outcomes of leadless pacemaker implantations. National Inpatient Sample and International Classification of Diseases, Tenth Revision codes were used to identify patients with CKD and ESRD who underwent leadless pacemaker implantations in the United States from 2016 to 2020. Study end points assessed included inpatient complications, outcomes, and resource utilization of leadless pacemaker implantations. A total of 29,005 leadless pacemaker placements were identified. Patients with CKD (n = 5245 [18.1%]) and ESRD (n=3790 [13.1%]) were younger than patients without CKD and had higher prevalence of important comorbidities. In crude analysis, ESRD was associated with higher prevalence of major complications, peripheral vascular complications, and inpatient mortality. After multivariable adjustment, CKD and ESRD were associated with inpatient mortality (CKD: adjusted odds ratio [aOR], 1.62 [95% CI, 1.40-1.86]; ESRD: aOR, 1.38 [95% CI, 1.18-1.63]) and prolonged length of stay (CKD: aOR, 1.55 [95%CI, 1.46-1.66]; ESRD: aOR, 1.81 [95% CI 1.67-1.96]). ESRD was also associated with higher hospitalization costs (aOR, 1.63; 95% CI, 1.50-1.77) and major complications (aOR, 1.33; 95% CI, 1.13-1.57) after leadless pacemaker implantation. Approximately one-third of patients undergoing leadless pacemaker implantation had CKD or ESRD. CKD and ESRD were associated with greater length and cost of stay and inpatient mortality.

Association of circulating inflammatory proteins with type 2 diabetes mellitus and its complications: a bidirectional Mendelian randomization study.

Increasing evidence indicates that immune response underlies the pathology of type 2 diabetes (T2D). Nevertheless, the specific inflammatory regulators involved in this pathogenesis remain unclear. We systematically explored circulating inflammatory proteins that are causally associated with T2D via a bidirectional Mendelian randomization (MR) study and further investigated them in prevalent complications of T2D. Genetic instruments for 91 circulating inflammatory proteins were derived from a genome-wide association study (GWAS) that enrolled 14,824 predominantly European participants. Regarding the summary-level GWASs of type 2 diabetes, we adopted the largest meta-analysis of European population (74,124 cases vs. 824,006 controls) and a prospective nested case-cohort study in Europe (9,978 cases vs. 12,348 controls). Summary statistics for five complications of T2D were acquired from the FinnGen R9 repository. The inverse variance-weighted method was applied as the primary method for causal inference. MR-Egger, weighted median and maximum likelihood methods were employed as supplementary analyses. Results from the two T2D studies were combined in a meta-analysis. Sensitivity analyses and phenotype-wide association studies (PheWAS) were performed to detect heterogeneity and potential horizontal pleiotropy in the study. Genetic evidence indicated that elevated levels of TGF-α (OR = 1.16, 95% CI = 1.15-1.17) and CX3CL1 (OR = 1.30, 95% CI = 1.04-1.63) promoted the occurrence of T2D, and increased concentrations of FGF-21 (OR = 0.87, 95% CI = 0.81-0.93) and hGDNF (OR = 0.96, 95% CI = 0.95-0.98) mitigated the risk of developing T2D, while type 2 diabetes did not exert a significant influence on said proteins. Elevated levels of TGF-α were associated with an increased risk of ketoacidosis, neurological complications, and ocular complications in patients with T2D, and increased concentrations of FGF-21 were potentially correlated with a diminished risk of T2D with neurological complications. Higher levels of hGDNF were associated with an increased risk of T2D with peripheral vascular complications, while CX3CL1 did not demonstrate a significant association with T2D complications. Sensitivity analyses and PheWAS further ensure the robustness of our findings. This study determined four circulating inflammatory proteins that affected the occurrence of T2D, providing opportunities for the early prevention and innovative therapy of type 2 diabetes and its complications.

Complications from peripheral cardiopulmonary bypass in minimally invasive mitral valve surgery

Background: To determine the incidence of peripheral complications associated with peripheral cardiopulmonary bypass (CPB) and to detail cases of severe complications necessitating surgical intervention during peripheral CPB at the HCMC University of Medicine and Pharmacy Hospital. Material and Methods: A cross-sectional, retrospective study on patients who underwent minimally invasive mitral valve surgery with the establishment of peripheral CPB between January 2017 and January 2022. Results: Of the 199 patients who underwent the surgery, 24 cases (12%) experienced peripheral complications. The incidence rates were as follows: femoral artery stenosis from thrombosis at 1.5%, femoral vein occlusion from thrombosis at 0.5%, lower limb compartment compression at 0.5%, and inguinal incision bleeding at 1%. There were no recorded cases of incisional infections in the groin area. Five patients had serious peripheral vascular complications that necessitated urgent surgical intervention. However, no life-threatening complications or deaths during hospitalization were reported. Conclusion: The occurrence of peripheral complications from the initiation of peripheral CPB is relatively low. These complications are manageable and do not diminish the efficacy of peripheral CPB in minimally invasive mitral valve procedures. Key words: peripheral cardiopulmonary bypass, vascular complications, cardiac surgery, minimally invasive surgery, mitral valve surgery.

Gender Predicts Differences in Acute Ischemic Cardioembolic Stroke Profile: Emphasis on Woman-Specific Clinical Data and Early Outcome-The Experience of Sagrat Cor Hospital of Barcelona Stroke Registry.

Background and Objectives: Acute ischemic cardioembolic stroke (CS) is a clinical condition with a high risk of death, and can lead to dependence, recurrence, and dementia. Materials and Methods: In this study, we evaluated gender differences and female-specific clinical data and early outcomes in 602 women diagnosed with CS from a total of 4600 consecutive acute stroke patients in a single-center hospital stroke registry over 24 years. A comparative analysis was performed in women and men in terms of demographics, cerebrovascular risk factors, clinical data, and early outcomes. Results: In a multivariate analysis, age, hypertension, valvular heart disease, obesity, and internal capsule location were independent variables associated with CS in women. The overall in-hospital mortality rate was similar, but the group of women had a greater presence of neurological deficits and a higher percentage of severe limitation at hospital discharge. After the multivariate analysis, age, altered consciousness, limb weakness, and neurological, respiratory, gastrointestinal, renal, cardiac and peripheral vascular complications were independent predictors related to early mortality in women. Conclusions: Women with CS showed a differential demographic and clinical profile and worse early outcomes than men. Advanced age, impaired consciousness, and medical complications were predictors of stroke severity in women with CS.

Digital Ulcers and Ventricular Arrhythmias as Red Flags to Predict Replacement Myocardial Fibrosis in Systemic Sclerosis.

Cardiac involvement in systemic sclerosis (SSc) affects the prognosis of the disease. Echocardiography is the first line imaging tool to detect cardiac involvement, but it is not able to routinely detect myocardial fibrosis. Late gadolinium enhancement (LGE) cardiovascular magnetic resonance (CMR) is the gold standard for replacement myocardial fibrosis assessment, but its availability is currently limited. We aimed to assess the clinical and instrumental parameters that would be useful for predicting the presence of LGE-CMR, to achieve a better selection of patients with SSc that could benefit from third-level CMR imaging. 344 SSc patients underwent a comprehensive echocardiogram and LGE-CMR on the same day; for 189 patients, a 24 h ECG Holter monitoring was available. CMR showed non-junctional replacement myocardial fibrosis via LGE in 25.1% patients. A history of digital ulcers (OR 2.188; 95% C.I. 1.069-4.481) and ventricular arrhythmias at ECG Holter monitoring (OR 3.086; 95% C.I. 1.191-7.998) were independent predictors of replacement myocardial fibrosis. CMR can detect patterns of clinical and subclinical cardiac involvement, which are frequent in SSc. A history of digital ulcers and evidence of ventricular arrhythmias at ECG Holter monitoring are red flags for the presence of replacement myocardial fibrosis in CMR. The association between digital ulcers and myocardial fibrosis suggests that a similar pathological substrate of abnormal vascular function may underlie peripheral vascular and cardiac complications.

Abstract 13389: Outcomes of Transcatheter Aortic Valve Replacement in Patients With Prior Mediastinal Radiation in the United States

Introduction: Although prior mediastinal radiation is associated with significantly worse clinical outcomes after SAVR, it is unknown if the same holds true for patients undergoing transcatheter aortic valve replacement (TAVR). Hypothesis: We hypothesized that the presence of prior mediastinal radiation may affect the outcomes of patients undergoing TAVR and tested this hypothesis using data from a nationally representative sample of the US population. Methods: The National Readmissions Database was analyzed from 2016-2019 to identify patients ≥ 18 years old undergoing TAVR. Patients with prior mediastinal radiation were then identified by using ICD-10 CM codes. Propensity score matching was used to adjust for confounders. Results: Our cohort included 173,743 patients undergoing TAVR, of which 2,780 (1.6%) had prior mediastinal radiation. Patients with prior mediastinal radiation undergoing TAVR were younger, had a higher proportion of females, and had a lower burden of comorbidities including hypertension, diabetes, and renal failure. Crude percentages are reported in Figure 1. On propensity score-matched analysis, the presence of prior mediastinal radiation was associated with similar odds of in-hospital mortality and peri-procedural complications including cardiovascular complications, peripheral vascular complications, pulmonary complications, neurological complications, major bleeding, and new pacemaker implantation along with similar odds of 30-day and 180-day all-cause, stroke-related, bleeding-related, and heart failure-related readmissions compared to those without prior mediastinal radiation. Conclusion: In conclusion, our data suggest that patients with prior mediastinal radiation undergoing TAVR have similar outcomes compared to those who have no history of mediastinal radiation.

Quantifying association and disparities between diabetes complications and COVID-19 outcomes: A retrospective study using electronic health records.

Despite established relationships between diabetic status and an increased risk for COVID-19 severe outcomes, there is a limited number of studies examining the relationships between diabetes complications and COVID-19-related risks. We use the Adapted Diabetes Complications Severity Index to define seven diabetes complications. We aim to understand the risk for COVID-19 infection, hospitalization, mortality, and longer length of stay of diabetes patients with complications. We perform a retrospective case-control study using Electronic Health Records (EHRs) to measure differences in the risks for COVID-19 severe outcomes amongst those with diabetes complications. Using multiple logistic regression, we calculate adjusted odds ratios (OR) for COVID-19 infection, hospitalization, and in-hospital mortality of the case group (patients with diabetes complications) compared to a control group (patients without diabetes). We also calculate adjusted mean difference in length of stay between the case and control groups using multiple linear regression. Adjusting demographics and comorbidities, diabetes patients with renal complications have the highest odds for COVID-19 infection (OR = 1.85, 95% CI = [1.71, 1.99]) while those with metabolic complications have the highest odds for COVID-19 hospitalization (OR = 5.58, 95% CI = [3.54, 8.77]) and in-hospital mortality (OR = 2.41, 95% CI = [1.35, 4.31]). The adjusted mean difference (MD) of hospital length-of-stay for diabetes patients, especially those with cardiovascular (MD = 0.94, 95% CI = [0.17, 1.71]) or peripheral vascular (MD = 1.72, 95% CI = [0.84, 2.60]) complications, is significantly higher than non-diabetes patients. African American patients have higher odds for COVID-19 infection (OR = 1.79, 95% CI = [1.66, 1.92]) and hospitalization (OR = 1.62, 95% CI = [1.39, 1.90]) than White patients in the general diabetes population. However, White diabetes patients have higher odds for COVID-19 in-hospital mortality. Hispanic patients have higher odds for COVID-19 infection (OR = 2.86, 95% CI = [2.42, 3.38]) and shorter mean length of hospital stay than non-Hispanic patients in the general diabetes population. Although there is no significant difference in the odds for COVID-19 hospitalization and in-hospital mortality between Hispanic and non-Hispanic patients in the general diabetes population, Hispanic patients have higher odds for COVID-19 hospitalization (OR = 1.83, 95% CI = [1.16, 2.89]) and in-hospital mortality (OR = 3.69, 95% CI = [1.18, 11.50]) in the diabetes population with no complications. The presence of diabetes complications increases the risks of COVID-19 infection, hospitalization, and worse health outcomes with respect to in-hospital mortality and longer hospital length of stay. We show the presence of health disparities in COVID-19 outcomes across demographic groups in our diabetes population. One such disparity is that African American and Hispanic diabetes patients have higher odds of COVID-19 infection than White and Non-Hispanic diabetes patients, respectively. Furthermore, Hispanic patients might have less access to the hospital care compared to non-Hispanic patients when longer hospitalizations are needed due to their diabetes complications. Finally, diabetes complications, which are generally associated with worse COVID-19 outcomes, might be predominantly determining the COVID-19 severity in those infected patients resulting in less demographic differences in COVID-19 hospitalization and in-hospital mortality.

Venoarterial extracorporeal membrane oxygenation in patients with infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used in patients with cardiogenic shock despite the lack of evidence from adequately powered randomised clinical trials. Three trials reported so far were underpowered to detect a survival benefit; we therefore conducted an individual patient-based meta-analysis to assess the effect of VA-ECMO on 30-day death rate. Randomised clinical trials comparing early routine use of VA-ECMO versus optimal medical therapy alone in patients presenting with infarct-related cardiogenic shock were identified by searching MEDLINE, Cochrane Central Register of Controlled Trials, Embase, and trial registries until June 12, 2023. Trials were included if at least all-cause death rate 30 days after in-hospital randomisation was reported and trial investigators agreed to collaborate (ie, providing individual patient data). Odds ratios (ORs) as primary outcome measure were pooled using logistic regression models. This study is registered with PROSPERO (CRD42023431258). Four trials (n=567 patients; 284 VA-ECMO, 283 control) were identified and included. Overall, there was no significant reduction of 30-day death rate with the early use of VA-ECMO (OR 0·93; 95% CI 0·66-1·29). Complication rates were higher with VA-ECMO for major bleeding (OR 2·44; 95% CI 1·55-3·84) and peripheral ischaemic vascular complications (OR 3·53; 95% CI 1·70-7·34). Prespecified subgroup analyses were consistent and did not show any benefit for VA-ECMO (pinteraction ≥0·079). VA-ECMO did not reduce 30-day death rate compared with medical therapy alone in patients with infarct-related cardiogenic shock, and an increase in major bleeding and vascular complications was observed. A careful review of the indication for VA-ECMO in this setting is warranted. Foundation Institut für Herzinfarktforschung.

Extracorporeal Life Support in Infarct-Related Cardiogenic Shock

BackgroundExtracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality.MethodsIn this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy.ResultsA total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P=0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25).ConclusionsIn patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.)

Prognostic benefits of early vascular surgical intervention in patients with major peripheral vascular complications following transcatheter aortic valve implantation

ObjectivesThis study aimed to analyze the incidence, surgical management of major vascular complications, and outcomes in patients undergoing transfemoral (TF) transcatheter aortic valve replacement (TAVR) at our center after strict selection of the access route, carefully considering all known major predictors. MethodsData of 494 consecutive patients with pre-interventional multi-slice computed tomography (CT) of the aorta who had undergone TF TAVR from 2009 to 2019 were analyzed. ResultsIn total, 23/494 (4.7%) patients had major vascular and access-related complications of peripheral vessels and/or infrarenal aorta. These included hematomas that met the Valve Academic Research Consortium 3-criteria of major vascular complications (7/494, 1.4%), arterial dissections (3/494, 0.6%), pseudoaneurysm (6/494, 1.2%), thrombus of the external iliac artery leading to acute limb ischemia (1/494, 0.2%), fistula (1/494, 0.2%), and perforation (5/494, 1.0%). In total, 17/23 (73.9%) major vascular complications required immediate endovascular and/or open surgery. In 16/17 (94%) cases, only 1 surgical procedure was performed.The long-term survival of patients with and without major vascular complications of the peripheral vessels was determined after 2 years. ConclusionsEarly vascular surgery intervention reversed the mortality disadvantage in patients with major complications of the peripheral vessels after TAVR. This underscores the importance of immediate vascular surgery stand-by as an indispensable requirement.

Impact of a VA-ECMO in Combination with an Extracorporeal Cytokine Hemadsorption System in Critically Ill Patients with Cardiogenic Shock-Design and Rationale of the ECMOsorb Trial.

Cardiogenic shock and arrest present as critical, life-threatening emergencies characterized by severely compromised tissue perfusion and inadequate oxygen supply. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) serves as a mechanical support system for patients suffering shock refractory to conventional resuscitation. Despite the utilization of VA-ECMO, clinical deterioration due to systemic inflammatory response syndrome (SIRS) resulting from the underlying shock and exposure of blood cells to the artificial surfaces of the ECMO circuit may occur. To address this issue, cytokine adsorbers offer a valuable solution by eliminating blood proteins, thereby controlling SIRS and potentially improving hemodynamics. Consequently, a prospective, randomized, blinded clinical trial will be carried out with ECMOsorb. ECMOsorb is a single-center, controlled, randomized, triple-blinded trial that will compare the hemodynamic effects of treatment with a VA-ECMO in combination with a cytokine adsorber (CytoSorb®, intervention) to treatment with VA-ECMO only (control) in patients with cardiogenic shock (with or without prior cardiopulmonary resuscitation (CPR)) requiring extracorporeal, hemodynamic support. Fifty-four patients will be randomized in a 1:1 fashion to the intervention or control group over a 36-month period. The primary endpoint of ECMOsorb is the improvement of the Inotropic Score (IS) 72 h after the intervention. Prognostic indicators, including mortality rates, hemodynamic parameters, laboratory findings, echocardiographic assessments, quality of life measurements, and clinical parameters, will serve as secondary outcome measures. The safety evaluation encompasses endpoints such as air embolisms, allergic reactions, peripheral ischemic complications, vascular complications, bleeding incidents, and stroke occurrences. The ECMOsorb trial seeks to assess the efficacy of a cytokine adsorber (CytoSorb®; CytoSorbents Europe GmbH, Berlin, Germany) in reducing SIRS and improving hemodynamics in patients with cardiogenic shock who are receiving VA-ECMO. We hypothesize that a reduction in cytokine levels can lead to faster weaning from inotropic and mechanical circulatory support, and ultimately to improved recovery.

Embolization of Renal Pseudoaneurysm Following Partial Nephrectomy of Localized Tumour and Preserving Renal Function: Clinical Case and Review of Literature

Surgical procedures in highly vascularized renal parenchyma sometimes can cause iatrogenic vascular complications. Although incidence renal pseudoaneurysms after partial nephrectomy is low, around 1%, clinical presentation of these patients can be quite severe – hematuria, lumbar pain, dizziness, weakness. Prompt and precise diagnostics and treatment are essential. Ultrasound and Computed Tomography are two most common diagnostic approaches for the assessment of pseudoaneurysms or arteriovenous fistulas following partial nephrectomy. Endovascular selective microcoil embolization is a safe and effective kidney-preserving procedure for treating iatrogenic vascular complications. Although when embolizing renal arteries some of renal parenchyma loses perfusion and becomes fibrotic, no significant decrease in renal function in early post-embolization period was noted. Comparing open surgery to endovascular treatment of pseudoaneurysms, latter one allows shorter average hospital stay and less frequent cardiac and peripheral vascular complications. The article discusses a case of a patient that had developed renal pseudoaneurysm after partial nephrectomy. During a routine check-up of a middle-aged woman a presumable renal cyst was found. On more throughout examination the cyst was ruled as a tumour and partial nephrectomy was performed. After 12 days from surgery patient was admitted to hospital complaining macrohematuria, lower abdomen pain, episodic right-side ache. Urgent contrast enhanced computed tomography was performed, which confirmed that patient was bleeding from the operated kidney. Patient was admitted to interventional radiology departament and perform embolization of bleeding vessel. After embolization of pseudoaneurysm, bleeding was controlled and patient was completely treated.

Abstract 15384: Regional Trends in Watchman Device Placement in United States, Insight From National Inpatient Sample

Introduction: Watchman Implant is a minimally invasive procedure designed to reduce the risk of strokes that originate in the left atrial appendage in patients who cannot receive anticoagulation. Recently, the device is widely adopted in United States(US). Hypothesis: Significant variability exists in watchman device implantation across US. Methods: National Inpatient sample was used from year 2015-2019. ICD9 & ICD-10 codes were used for data extraction. US population was divided into four regions. Northeast, Midwest, South and West. Mortality and major complications were adjusted for age, sex, race and standard comorbid conditions using logistic regression analysis. Major complication was composite of cardiac arrest, ischemic stroke, hemorrhagic stroke, TIA, arterial embolism, myocardial infarction, major bleeding, pericardial effusion requiring intervention and peripheral vascular complications. Results: Total of 62,980 patients were identified (Figure1). There has been gradual increase trend in watchman implants over the years. Median age was 77(71-82) yrs. Mortality was lowest in Midwest (Figure 2), while Major complications were lowest West region (Figure 3). Conclusions: Significant variability exists in outcomes across different regions of US. Further studies are needed to determine the significance of these findings.

Imaging of COVID-19 vasculopathy from head to toe: Egyptian collective experience after 2 years of the pandemic

BackgroundCOVID-19 vasculopathy is a critical condition that impacts the disease prognosis including vasculitis and thromboembolic complications. This study aimed to provide the Egyptian experience about the COVID-19 vasculopathy during the past two years of the pandemic and to collectively include the different modalities and imaging techniques for the diagnosis of cerebrovascular, pulmonary, gastrointestinal, and peripheral arterial vascular complications.ResultsThis is a multi-center retrospective analysis of 3500 PCR-proved COVID-19 infection between March 2020 and December 2021. A cohort of 282 consecutive patients with COVID-19 vasculopathy was considered for inclusion. They included 204 males and 78 females (72:28%). The mean age was 68 years, and age ranged from 48 to 90 years. Five radiologists evaluated the different imaging examinations in consensus including computed tomography (CT), CT-angiography (CTA), CT-perfusion (CTP), magnetic resonance imaging (MRI), MR-arteriography (MRA), and MR-venography (MRV). 244/282 (86.5%) patients suffered from non-hemorrhagic cerebral ischemic infarctions. 13/282 (4.6%) patients suffered from hemorrhagic cerebral infarctions. 5/282 (1.8%) patients suffered from cerebral vasculitis. Pulmonary vascular angiopathy was detected in 10/282 (3.5%) patients, including pulmonary embolism in 10/10 patients, pulmonary infarctions in 8/10 patients, pulmonary vascular enlargement in 5/10 patients, and vascular "tree-in-bud" sign in 2/10 patients. Intestinal ischemia and small bowel obstruction were detected in 3/282 patients (1%) while GIT bleeding was encountered in 4/282 patients (1.4%). Lower limb arterial ischemia was found in 3/282 patients (1%). Additionally; 39/282 (13.8%) patients developed peripheral deep venous thrombosis (DVT) due to prolonged ICU recumbence while 28/282 (10%) patients developed jugular vein thrombosis sequel to prolonged catheterization. A p value (0.002) and (r) = 0.8 statistically proved strong significant relation between COVID-19 vasculopathy and D-dimer levels.ConclusionsMulti-system vasculopathy was a serious complication of COVID-19 which impacted the patients' morbidity and mortality. An Egyptian experience about the COVID-19 vasculopathy during the past two years of the pandemic was provided. It encountered the different modalities and imaging techniques for the diagnosis of cerebrovascular, pulmonary, gastrointestinal, and peripheral arterial COVID-19 vascular complications.

Comparison of Sandbag, Close Pad, and Cold Application Combined with Sandbag in Preventing Peripheral Vascular Complications After Cardiac Catheterisation

Objective: This study was conducted to compare the effectiveness of sandbag method, close pad application, and cold application plus sandbag in preventing peripheral vascular complications after coronary procedure. 
 Methods: 120 patients were included in this experimental study. Three different methods were used following coronary procedure within the scope of the planned study. Only sandbag was used for 40 patients, only close pad for 40 patients and cold application plus sandbag for 40 patients. In all groups, the presence of hematoma, haemorrhage, ecchymosis, and pain was evaluated at the 15th minute, 4th hour, on 1st, and 2nd days after removal of the catheter. The data were collected using the Personal Information Form, the Individual Observation Form and the Visual Analogue Scale.
 Results: In the second day follow-up after coronary intervention, it was found that ecchymosis was higher for the close pad method, but it was similar in the sandbag group and sandbag plus cold application group (p = 0.047). At the 4th hour follow-up after coronary intervention, the pain in the sandbag plus cold application method was less than the close pad and sandbag methods (p = 0.04).
 Conclusions: It was concluded that the methods applied in the present study were effective in preventing peripheral vascular complications, but close pad application was less effective in preventing ecchymosis compared to the other methods and sandbag plus cold application method was more effective in pain control. In this context, it was thought that the present study may guide the more comprehensive randomised controlled studies to be planned in the future.

Occupations associated with diabetes complications: A nationwide-multicenter hospital-based case-control study

AimInvestigating the risks of diabetes complications among inpatients with diabetes associated with longest-held and current occupations. MethodUsing a Japanese nationwide, multicenter, hospital inpatient dataset (2005–2015), a matched case-control study with 39,550 inpatients with diabetes was conducted. We considered both the longest-held and current occupations of the study subjects. ResultDiabetes complications such as retinopathy, nephropathy, neuropathy, and peripheral vascular complications occur more often in managers, sales workers, service workers, transportation workers, construction and mining workers and carrying, cleaning and packing workers. Among these occupations, particularly the service workers indicated consistently significant increased risks (OR = 1.36 (1.23–1.51)) in developing all the considered subtypes of diabetes complications, and the performed sensitivity analysis confirmed this conclusion. Moreover, among service workers, cooks, waiters, building service staff and other service workers were identified as having the highest risks in developing diabetes complications (ORs = 1.30 (1.12–1.51), 1.63 (1.36–1.95), 1.79 (1.21–2.67), and 2.05 (1.30–3.22), respectively). ConclusionsOur study’s potential translational impact should lead to subsequent investigations on the causes connected to certain occupations of various diabetes complications and particularly to more carefully dealing with patients with diabetes who work in the identified occupational areas and their health risks.

Prediction of Micro Vascular and Macro Vascular Complications in Type-2 Diabetic Patients using Machine Learning Techniques

A collection of metabolic conditions known as diabetes mellitus are defined by hyperglycemia brought on by deficiencies in insulin secretion, action, or both. In terms of mortality rate, type-2 diabetes is 20 times higher when compared with type-1. Based on the earlier research, there is still scope to identify different risk levels of type-2 diabetes complications. To achieve this, we have proposed a T2DC machine learning-based prediction system using a decision tree as a base estimator with random forest to identify the severity of T2-DM complications at an early stage. Our proposed model achieved accuracies of 95.43%, 94.62%, 96.25%, 97.55%, and 97.83% for Nephropathy, Neuropathy, Retinopathy, Cardiovascularand Peripheral Vascu-lar complications in T2-DM patients. The proposed model has the potential to improve clinical outcomes by promoting the delivery of early and personalized care to T2-DM patients.