Comparison of bleeding and thrombotic outcomes in veno-venous extracorporeal membrane oxygenation: Heparin versus bivalirudin.

OBJECTIVES: We aimed to evaluate thrombotic and hemorrhagic complications with heparin versus bivalirudin use in veno-venous extracorporeal membrane oxygenation (V-V ECMO). METHODS: We performed a retrospective cohort study of adult patients placed on V-V ECMO with intravenous anticoagulation with either heparin or bivalirudin. Time to thrombotic event and major bleed were analyzed in addition to related outcomes. RESULTS: We identified 95 patients placed on V-V ECMO: 61 receiving heparin, 34 bivalirudin. The bivalirudin group had a higher rate of severe COVID-19, higher BMI, and longer ECMO duration. Despite this, bivalirudin was associated with reduced risk of thrombotic event (HR 0.14, 95% CI 0.06-0.32, p < .001) and increased average lifespan of the circuit membrane lung (16 vs. 10 days, p = 0.004). While there was no difference in major bleeding, the bivalirudin group required fewer transfusions of packed red blood cells and platelets per 100 ECMO days (means of 13 vs. 39, p = 0.004; 5 vs. 19, p = .014, respectively). Lastly, the bivalirudin group had improved survival to ECMO decannulation in univariate analysis (median OS 53 vs. 26 days, p = .015). CONCLUSIONS: In this real-world analysis of bivalirudin versus heparin, bivalirudin is a viable option for V-V ECMO and associated with lower risk of thrombotic complications and fewer transfusion requirements.

Predictors of thrombosis during VV ECMO: an analysis of 9809 patients from the ELSO registry.

Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a life-saving therapy for critically ill patients, but it carries an increased risk of thrombosis due to blood interacting with non-physiological surfaces. While the relationship between clinical variables and thrombosis remains unclear, our study aimed to identify which factors are most predictive of thrombosis. The Extracorporeal Life Support Organization Registry was queried to obtain a cohort of VV-ECMO patients aged 18 years and older from 2015 to 2019. Patients who were over 80-years-old, at the extremes of weight, who received less than 24 h of ECMO, multiple rounds of ECMO, or had missing data were excluded. Multivariate logistic regression modeling was used to assess predictors of thrombosis and mortality. A total of 9809 patients were included in the analysis, with a mean age of 47.1 ± 15.1 years and an average ECMO run time of 305 ± 353 h. Thrombosis occurred in 19.9% of the cohort, with circuit thrombosis (8.6%) and membrane lung failure (6.1%) being the most common. Multivariate analysis showed that ECMO runs over 14 days (OR: 2.62, P < 0.001) and pregnancy-related complications (OR: 1.79, P = 0.004) were associated with an increased risk of thrombosis. Risk factors for circuit thrombosis included incremental unit increases in the pump flow rate at 24 h (OR: 1.07 [1.00-1.14], P = 0.044) and specific cannulation sites. Increased body weight (OR: 1.02 [1.00-1.04], P = 0.026) and increased duration on ECMO (OR: 3.82 [3.12-4.71], P < 0.001) were predictive of membrane lung failure. Additionally, patients with thrombosis were at increased likelihood of in-hospital mortality (OR: 1.52, P < 0.001). This study identified multiple thrombotic risk factors in VV-ECMO, suggesting that future studies investigating the impact of pregnancy associated complications and ECMO flow rate on hemostasis would be illuminating.

Epidemiology and Clinical Outcomes of Fusobacterium Infections: A Six-Year Retrospective Study.

Background and Objectives: Anaerobic bacteria like Fusobacterium can lead to severe and life-threatening infections. The inherent complexities in the isolation of these bacteria may result in diagnostic and therapeutic delays, thereby escalating both morbidity and mortality rates. We aimed to examine data from patients with infections due to Fusobacterium to gain insights into the epidemiology and clinical outcomes of patients with these infections. Methods and Results: We conducted a retrospective analysis of clinical data from a cohort of patients with cultures positive for Fusobacterium species at a tertiary care medical center in the United States. Between 2009 and 2015, we identified 96 patients with cultures positive for Fusobacterium. Patients could be categorized into three groups based on the site of primary infection. Patients with head and neck infections constituted 37% (n 36). Patients with infections of other soft tissue sites accounted for 38.5% (n 37). Patients with anaerobic bacteremia due to Fusobacterium formed 24% (n 23) of the cohort. Surgical intervention coupled with antibiotic therapy emerged as cornerstones of management for patients with head and neck or other soft tissue infections, who generally exhibited more favorable outcomes. Patients with bacteremia were older, more likely to have malignancy, and had a high mortality rate. When speciation was available, Fusobacterium necrophorum was the most frequently isolated species. Conclusions: Our retrospective analysis of epidemiology and clinical outcomes of Fusobacterium infections revealed three distinct cohorts. Patients with head, neck, or soft tissue infections had better outcomes than those with bacteremia. Our findings highlight the importance of employing management strategies based on infection site and underlying comorbidities in patients with Fusobacterium infections. Further research is needed to investigate the optimal therapeutic strategies and identify prognostic indicators to improve clinical outcomes for these complex infections.

Novel method for left ventricular unloading utilizing percutaneous pulmonary artery drainage in cardiorespiratory failure due to COVID-19 infection.

Left ventricular (LV) unloading is an important concept in patients undergoing peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO). We present a case of a 32-year-old male in acute cardiorespiratory collapse due to coronavirus disease (COVID-19) who underwent VA-ECMO cannulation in the setting of cardiogenic shock and acute respiratory distress syndrome. Due to inability to utilize percutaneous LV assist device (pLVAD) for LV unloading due to small end diastolic dimension, alternative strategies were explored. A traditionally utilized right ventricular support device, the ProTek Duo (TandemLife, Pittsburgh, PA), was utilized to drain the pulmonary artery, leading to improvement in parameters for cardiogenic shock. To our knowledge, this is the first case in which a ProTek Duo has been utilized in conjunction with VA-ECMO to provide LV unloading in support of a patient in cardiogenic shock. This method can be employed in future challenging situations where pLVAD is not feasible.

Trends in Preoperative Imaging Prior to Elective Carotid Endarterectomy in the Southern California Vascular Outcomes Improvement Collaborative.

BACKGROUND: Duplex ultrasound (DUS) has been an important imaging modality for carotid bifurcation disease due to its low cost and noninvasive nature. Over the past decade, computed tomography angiography (CTA) has replaced conventional angiography (CA) due to safety and availability. There are significant differences in cost and patient exposures between CTA and DUS. The objective of this study is to analyze the trends in preoperative imaging modalities in the Southern California region for elective carotid endarterectomies (CEA). METHODS: A retrospective review of the Southern California Vascular Outcomes Improvement Collaborative (SoCal VOICe) was performed. All elective CEA procedures were identified from January 2011 through May 2020. Data included all preoperative imaging modalities used. An analysis was performed of the types and numbers of studies obtained. The trends in the usage of single and multiple preoperative studies and the trends in use of DUS versus CTA were analyzed. RESULTS: From January 2011 to May 2020, 2,519 elective CEAs were entered into the regional database. Of the 2,336 eligible cases (183 excluded due to incomplete data), 38% were for symptomatic (Sx) and 62% for asymptomatic (ASx) carotid disease. Preoperative imaging studies ordered included 56% DUS, 28% CTA, 6% magnetic resonance angiography, and 10% CA. Single imaging studies were used in 56.3% of cases, 2 studies in 40.4%, and >2 studies in 3.3%. A majority of both Sx and ASx patients undergoing elective CEA had only a single preoperative imaging study. ASx patients were more likely to have a single study than Sx patients (P = 0.0054). DUS was the most frequent single study ordered in both Sx and ASx patients, 37.4% and 41.4%, respectively. The trend over time shows a decreasing use of DUS and an increasing use of CTA for both Sx and ASx patients. In 2020, CTA overtook duplex as the most frequently ordered study for Sx patients. The average number of imaging studies per procedure per year for both Sx and ASx patients has not changed substantially at approximately 1.5 studies. In addition, the overall trend shows that although a single preoperative study was more common than 2 or more studies for elective CEA, single studies were more common for ASx patients, whereas the use of 2 or more studies was more common for Sx patients. The overall trend among three different time periods, 2011-2013, 2014-2016, and 2017-2020 shows that for both Sx and ASx patients, the use of single DUS studies has decreased over time (P < 0.001), whereas the use of single CTA studies has increased over time (P < 0.001). The use of CTA varied widely by a study center ranging from 12-53% for Sx and 10.5-75% for ASx patients. CONCLUSIONS: Over the past decade, most patients undergoing elective CEA in the SoCal VOICe had only a single preoperative imaging study with DUS as the most frequent sole study in both Sx and ASx patients. However, as a single study, CTA is becoming more frequently used than DUS. Further investigation into the variation in practice may help standardize imaging prior to CEA and control healthcare costs.

Human factors in ECLS - A keystone for safety and quality - A narrative review for ECLS providers.

INTRODUCTION: Although the technology used for extracorporeal life support (ECLS) has improved greatly in recent years, the application of these devices to the patient is quite complex and requires extensive training of team members both individually and together. Human factors is an area that addresses the activities, contexts, environments, and tools which interact with human behavior in determining overall system performance. HYPOTHESIS: Analyses of the cognitive behavior of ECLS teams and individual members of these teams with respect to the occurrence of human errors may identify additional opportunities to enhance safety in delivery of ECLS. RESULTS: The aim of this article is to support health-care practitioners who perform ECLS, or who are starting an ECLS program, by establishing standards for the safe and efficient use of ECLS with a focus on human factor issues. Other key concepts include the importance of ECLS team leadership and management, as well as controlling the environment and the system to optimize patient care. CONCLUSION: Expertise from other industries is extrapolated to improve patient safety through the application of simulation training to reduce error propagation and improve outcomes.

A Flat Inferior Vena Cava on Computed Tomography Is Associated With Worse Outcomes in Emergency General Surgery.

BACKGROUND: Several trauma studies have shown that a "flat" inferior vena cava (IVC) is associated with poor clinical outcomes, including hypovolemic shock, major bleeding, transfusions and mortality. These studies utilize IVC measurements on computed tomography (CT) scans, and rarely include emergency general surgery patients. We examine the association between IVC flatness and clinical outcomes in a series of patients with perforated viscus. MATERIALS AND METHODS: Medical records at an academic hospital were reviewed of adults with perforated viscus. Patients who underwent laparotomy or laparoscopy were included if they underwent CT within 12 h prior to incision time. Perforated appendicitis was excluded. A ratio was calculated of the transverse to anterior-posterior diameter of the IVC at 3 locations, then averaged. Clinical outcomes were analyzed by the average IVC ratio. RESULTS: A total of 83 patients were included. Using binomial regression, the average IVC ratio significantly correlated with ICU admission (OR 3.6, 95% CI 1.2 to 11) and acute kidney injury (OR 2.3, 95% CI 1.0 to 5.3), but not postoperative shock (OR 1.2, 95% CI 0.56 to 2.6). CONCLUSIONS: A flat IVC on CT prior to an operation for perforated viscus was associated with worse outcomes, including increased rate of ICU admission and acute kidney injury. More outcomes research is needed to assess the potential role of IVC assessment in preoperative resuscitation.

Choosing the Optimal Wound Dressing for Bathing After Total Knee Arthroplasty.

BACKGROUND: Many surgical dressings claim to be waterproof and safe for bathing postoperatively. The purpose of this study is to evaluate and compare the effectiveness of commonly used dressings' ability to prevent water penetration while bathing. Additionally, a survey was used to determine satisfaction and cost analysis performed. METHODS: Four different dressings were applied to 17 subjects' knees: Aquacel, Opsite, Acticoat, and Tegaderm. A folded Medline Gauze Sponge was weighed and placed under each dressing before and after showering and bathing (submergence under water) in order to measure water penetration (change in weight of sponge in grams). A failure was defined as any dressing that allowed a sponge weight change greater than 1 standard deviation, or 3.9 g. All participants were additionally asked to complete a short survey after testing about the dressings. RESULTS: Tegaderm was found to have significantly less water penetration than all other dressings except Aquacel and demonstrated no failures with showering, significantly less than all other dressings. Tegaderm was also found to have significantly less water penetration than all other dressings except Acticoat with bathing and had significantly less failures than all other dressings. Furthermore, Tegaderm was found to be the most comfortable and lowest cost per dressing. CONCLUSION: Tegaderm was overall the most effective at preventing water penetration, most comfortable, and most cost-effective. Aquacel was found to be equally as effective at preventing water penetration while showering but overall had more water penetration, had more failures, caused more discomfort, and was more expensive.

Position Paper on Global Extracorporeal Membrane Oxygenation Education and Educational Agenda for the Future: A Statement From the Extracorporeal Life Support Organization ECMOed Taskforce.

OBJECTIVES: The purpose of this position paper is two-fold: first, to describe the state of extracorporeal membrane oxygenation education worldwide, noting current limitations and challenges; and second, to put forth an educational agenda regarding opportunities for an international collaborative approach toward standardization. DESIGN: Relevant medical literature was reviewed through literature search, and materials from national organizations were accessed through the Internet. Taskforce members generated a consensus statement using an iterative consensus process through teleconferences and electronic communication. SETTING: In 2018, the Extracorporeal Life Support Organization convened the ECMOed Taskforce at two structured, face-to-face meetings of 40 healthcare practitioners and educators with expertise in caring for the extracorporeal membrane oxygenation patient and in extracorporeal membrane oxygenation education. PATIENTS: None. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The ECMOed Taskforce identified seven educational domains that would benefit from international collaborative efforts. Of primary importance, the Taskforce outlined actionable items regarding 1) the creation of a standardized extracorporeal membrane oxygenation curriculum; 2) defining criteria for an extracorporeal membrane oxygenation course as a vehicle for delivering the curriculum; 3) outlining a mechanism for evaluating the quality of educational offerings; 4) utilizing validated assessment tools in the development of extracorporeal membrane oxygenation practitioner certification; and 5) promoting high-quality educational research to guide ongoing educational and competency assessment development. CONCLUSIONS: Significant variability and limitations in global extracorporeal membrane oxygenation education exist. In this position paper, we outline a road map for standardizing international extracorporeal membrane oxygenation education and practitioner certification. Ongoing high-quality educational research is needed to evaluate the impact of these initiatives.

The Southern California Lupus Registry: I. Baseline characteristics of lupus patients in uncharted territory.

OBJECTIVE: This study aimed to determine the baseline characteristics of a multi-ethnic systemic lupus erythematosus (SLE) cohort in Southern California established with the intent of addressing regional health inequity. METHODS: Patients ≥18 years of age with SLE per the Systemic Lupus International Collaborating Clinics (SLICC) criteria were recruited into the Southern California Lupus Registry (SCOLR) if they resided in San Bernardino and Riverside counties in California. Individuals were categorized according to their stated ethnicity as non-Hispanic White, Hispanic, Black, or Asian. Descriptive statistics were utilized for analysis. Predictors of renal disease were assessed by binomial regression. RESULTS: The SCOLR cohort comprised 162 patients: 57 non-Hispanic White, 58 Hispanic, 17 Asian, and 30 Black. A difference in the rate of renal involvement and SLE duration was found among the four ethnic groups. Renal involvement was significantly higher in Hispanics compared with non-Hispanic Whites. CONCLUSION: In line with other cohorts, this study shows greater renal involvement in Hispanics than non-Hispanic Whites, demonstrating a need for more aggressive screening and early intervention to improve long-term outcomes. As a multi-ethnic SLE cohort, the SCOLR serves as a foundation for longitudinal studies addressing health inequity in this region.

Evaluation and Management of Intermediate and High-Risk Pulmonary Embolism.

OBJECTIVE. The evidence regarding pulmonary embolism treatment has greatly advanced over the past 10 years, particularly in patients with right ventricular dysfunction or hemodynamic instability. Treatment options include systemic anticoagulation, systemic thrombolysis, catheter-assisted thrombus removal (mechanical with or without catheter-directed thrombolysis), and surgical embolectomy. CONCLUSION. This article will review the data available for treatment options and summarize the evidence-based guidelines on treatment of intermediate- or high-risk pulmonary embolism.

Sedation Requirements in Patients on Venovenous or Venoarterial Extracorporeal Membrane Oxygenation.

Background:There is a paucity of data evaluating optimal dosing strategies of commonly utilized opioids and sedatives for patients on extracorporeal membrane oxygenation (ECMO) support where pharmacokinetic and pharmacodynamic variables of these administered agents are altered. Objective: To assess the daily dosing requirement of sedatives and analgesics for patients on venovenous (VV) and venoarterial (VA) ECMO after the initial ECMO cannulation period. Methods: We performed a retrospective, observational study of adult patients receiving sedation and analgesia while receiving ECMO support for at least 24 hours. Patients cannulated at an outside hospital more than 24 hours before transfer, those with a history of intravenous drug use or acute alcohol withdrawal, or those who died within 48 hours of ECMO initiation were excluded. Results: We evaluated 26 patients on ECMO, including 13 on VV and 13 on VA ECMO. The median dose of fentanyl was 140 µg/h, with the VV group requiring a higher dose compared with the VA group (167 vs 106 µg/h, P < 0.001). The median doses of dexmedetomidine and propofol were 0.7 µg/kg/h and 26 µg/kg/min, respectively, with no significant differences between groups (P = 0.38 and P = 0.24, respectively). The median daily doses of fentanyl, dexmedetomidine, and propofol did not significantly increase throughout the time on ECMO support. Conclusions and Relevance: We found that the overall opioid daily dosing requirements were lower than previously reported in the literature. Additionally, light sedation strategies with a target RASS of -1 to 0 are feasible in this patient population.

Extracorporeal membrane oxygenation and V/Q ratios: an ex vivo analysis of CO2 clearance within the Maquet Quadrox-iD oxygenator.

While hypercapnia is typically well treated with modern membrane oxygenators, there are cases where respiratory acidosis persists despite maximal extracorporeal membrane oxygenation support. To better understand the physiology of gas exchange within the membrane oxygenator, CO2 clearance within an adult Maquet Quadrox-iD oxygenator was evaluated at varying blood CO2 tensions and V/Q ratios in an ex vivo extracorporeal membrane oxygenation circuit. A closed blood-primed circuit incorporating two Maquet Quadrox-iD oxygenators in series was attached to a Maquet PLS Rotaflow pump. A varying blend of CO2 and air was connected to the first oxygenator to provide different levels of pre-oxygenator blood CO2 levels (PvCO2) to the second oxygenator. Varying sweep gas flows of 100% O2 were connected to the second oxygenator to provide different V/Q ratios. Exhaust CO2 was directly measured, and then VCO2 and oxygenator dead space fraction (VD/VT) were calculated. VCO2 increased with increasing gas flow rates with plateauing at V/Q ratios greater than 4.0. Exhaust CO2 increased with PvCO2 in a linear fashion with the slope of the line decreasing at high V/Q ratios. Oxygenator dead space fraction varied with V/Q ratio-at lower ratios, dead space fraction was 0.3-0.4 and rose to 0.8-0.9 at ratios greater than 4.0. Within the Maquet Quadrox-iD oxygenator, CO2 clearance is limited at high V/Q ratios and correlated with elevated oxygenator dead space fraction. These findings have important implications for patients requiring high levels of extracorporeal membrane oxygenation support.

Evaluating Vasopressor Discontinuation Strategies in Patients With Septic Shock on Concomitant Norepinephrine and Vasopressin Infusions.

BACKGROUND: There is little data guiding clinicians on how to discontinue vasopressors among septic shock patients on concomitant norepinephrine (NE) and vasopressin (VP). OBJECTIVE: To determine the incidence of hypotension within 24 hours of discontinuing NE (NE DC first) versus VP (VP DC first) first in septic shock patients. METHODS: This retrospective study evaluated septic shock patients admitted to the medical intensive care unit (MICU) and surgical ICU (SICU) receiving concomitant NE and VP. Receipt of additional vasopressors, mixed shock states, expired or care withdrawn, and NE and VP discontinued simultaneously were exclusion criteria. The primary outcome was incidence of hypotension within 24 hours of first vasopressor discontinuation. Secondary outcomes included time to hypotension, hospital length of stay (LOS), ICU LOS, and ICU mortality. RESULTS: A total of 80 patients were included (NE DC first [n = 35]; VP DC first [n = 45]), with a median age of 73 years and median modified Acute Physiology and Chronic Health Evaluation II and Sequential Organ Failure Assessment scores of 21 and 7, respectively. More patients in the NE DC first group were in the SICU (42.9% vs 20.0%; P = 0.048) with more intra-abdominal infections (40.0% vs 15.6%; P = 0.021) and fewer appropriate empirical antibiotics (62.9% vs 86.7%; P = 0.018). Hypotension within 24 hours of first agent discontinuation was higher in the VP DC first group (28.6% vs 62.2%; P = 0.004), with similar hospital LOS and ICU mortality. Multivariate analysis identified VP DC first as an independent predictor of hypotension (odds ratio = 7.2; CI = 2.3-22.7). CONCLUSION: Among septic shock patients on concomitant NE and VP, discontinuation of VP first was associated with an increased incidence of hypotension; future prospective control trials are warranted.

The Utility of High-Fidelity Simulation for Training Critical Care Fellows in the Management of Extracorporeal Membrane Oxygenation Emergencies: A Randomized Controlled Trial.

OBJECTIVE: Although extracorporeal membrane oxygenation volume has increased, proficiency in the technology requires extensive training. We compared traditional water-drill-based extracorporeal membrane oxygenation training with simulation-based extracorporeal membrane oxygenation training with the hypothesis that simulation-based training is superior. DESIGN: Randomized controlled trial. SETTING: Academic medical center. SUBJECTS: Pulmonary/critical care fellows. INTERVENTIONS: Participants had a preintervention simulated extracorporeal membrane oxygenation emergency (Sim1-recirculation) then randomized into simulation and traditional groups. Each group participated in three teaching scenarios, via high-fidelity simulation or via water-drills. After 6 weeks and after 1 year, participants returned for two simulated extracorporeal membrane oxygenation emergencies (Sim2-pump failure and Sim3-access insufficiency). Sim2 was a case encountered during teaching, whereas Sim3 was novel. A critical action, necessary for resolution of each scenario, was preidentified for timing. MEASUREMENTS AND MAIN RESULTS: Primary outcome was time required to perform critical actions. Twenty-one fellows participated in the study (simulation, 10; traditional, 11). Groups had similar scenario scores (p = 0.4) and times to critical action (p = 0.8) on Sim1. At 6 weeks, both groups had similar scenario scores on Sim2 (p = 0.5), but the simulation group scored higher on Sim3 (p = 0.03). Times to critical actions were shorter in the simulation group during Sim2 (127 vs 174 s, p = 0.004) and Sim3 (159 vs 300 s; p = 0.04). These findings persisted at 1 year. CONCLUSIONS: In novice critical care fellows, simulation-based extracorporeal membrane oxygenation training is superior to traditional training. Benefits transfer to novel scenarios and are maintained over the long term. Further studies evaluating the utility of simulation in other learner groups and for maintenance of proficiency are required.