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.

Goals of care are rarely discussed prior to potentially futile trauma transfer: Is it okay to say "No"?

BACKGROUND: It is unknown how often the physician-to-physician trauma transfer conversation includes a discussion of patient goals of care (GOC). We hypothesized that physicians would rarely discuss GOC on transfer calls when faced with patients with catastrophic injuries. METHODS: We completed a retrospective case series of trauma patients transferred to an ACS-verified Level I trauma center between 2018 and 2022 who died or were discharged to hospice without surgical intervention within 48 hours. Transfer call recordings were analyzed for GOC conversations. RESULTS: A total of 5,562 patients were accepted as transfers and 82 (1.5%) met inclusion criteria. Eighty of the 82 patients had recorded transfer calls and were analyzed. The most common transfer reason was traumatic brain injury (TBI) and need for neurosurgical capabilities (53%) followed by complex multisystem trauma (23%). There was explicit discussion of code status prior to transfer in 20% and a more in depth GOC conversation for 10% of patients. Appropriateness of transfer was discussed in 21% and at least one physician expressed explicit concerns of futility for 14%, though all were subsequently transferred. Code status was changed immediately upon arrival for 15% for patients and 19% of patients transferred for neurosurgical expertise were deemed to have non-survivable injuries based on imaging and examination that were unchanged from the referring hospital. CONCLUSION: Among a group of profoundly injured trauma patients at high risk of death, an explicit discussion of GOC occurred in just 10%. This suggests that even when the catastrophic nature of patient injury is understood, transfers still occur, and patients and their families are subjected to an expensive, disruptive, and displacing experience with little to no anticipated benefit. A discussion of GOC and therapeutic objectives should be considered in all severely injured trauma patients prior to transfer. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Targeting the Contact Pathway of Coagulation for the Prevention and Management of Medical Device-Associated Thrombosis.

Hemorrhage remains a major complication of anticoagulants, with bleeding leading to serious and even life-threatening outcomes in rare settings. Currently available anticoagulants target either multiple coagulation factors or specifically coagulation factor (F) Xa or thrombin; however, inhibiting these pathways universally impairs hemostasis. Bleeding complications are especially salient in the medically complex population who benefit from medical devices. Extracorporeal devices-such as extracorporeal membrane oxygenation, hemodialysis, and cardiac bypass-require anticoagulation for optimal use. Nonetheless, bleeding complications are common, and with certain devices, highly morbid. Likewise, pharmacologic prophylaxis to prevent thrombosis is not commonly used with many medical devices like central venous catheters due to high rates of bleeding. The contact pathway members FXI, FXII, and prekallikrein serve as a nexus, connecting biomaterial surface-mediated thrombin generation and inflammation, and may represent safe, druggable targets to improve medical device hemocompatibility and thrombogenicity. Recent in vivo and clinical data suggest that selectively targeting the contact pathway of coagulation through the inhibition of FXI and FXII can reduce the incidence of medical device-associated thrombotic events, and potentially systemic inflammation, without impairing hemostasis. In the following review, we will outline the current in vivo and clinical data encompassing the mechanism of action of drugs targeting the contact pathway. This new class of inhibitors has the potential to herald a new era of effective and low-risk anticoagulation for the management of patients requiring the use of medical devices.

What Should the Surgeons Do at the Family Meeting: A Multi-Disciplinary Qualitative Description of Surgeon Participation in Palliative Care Discussions.

OBJECTIVE: National guidelines have suggested that quality surgical care should incorporate effective palliative care (PC). Numerous barriers to surgeon participation remain and the domains of optimal surgeon participation are unclear. DESIGN: Eight semi-structured and multi-professional focus groups with 34 total participants. Discussion was transcribed, and qualitative approaches were used to encode, identify, and categorize emergent themes. SETTING: Oregon Health & Science University, Portland Oregon. A tertiary care teaching hospital. PARTICIPANTS: 34 multi-disciplinary participants in eight focus groups, identified on a volunteer basis. RESULTS: Key themes defining domains of optimal surgeon/palliative practice include: (1) "primary/secondary PC" which detailed conflict between the surgeon's desire to be part of palliative discussions and competing clinical/time demands. (2) "role/responsibility" described the tension surgeons feel around a desire to provide honest and goal concordant care (3) "teamwork/conflict" detailed the approach to disagreement among multidisciplinary teams. CONCLUSIONS: In this qualitative analysis, emergent themes suggest that surgeons want to be involved in the PC of their patients but are limited by available time and competing for ethical obligations. Tension between competing communication and care obligations and PC goals is common, and discord around patient goals remains an issue. This work highlights the need for a standardized curriculum to improve the PC of surgical patients.

Interfacility Transport of Critically Ill Patients.

OBJECTIVES: To assess recent advances in interfacility critical care transport. DATA SOURCES: PubMed English language publications plus chapters and professional organization publications. STUDY SELECTION: Manuscripts including practice manuals and standard (1990-2021) focused on interfacility transport of critically ill patients. DATA EXTRACTION: Review of society guidelines, legislative requirements, objective measures of outcomes, and transport practice standards occurred in work groups assessing definitions and foundations of interfacility transport, transport team composition, and transport specific considerations. Qualitative analysis was performed to characterize current science regarding interfacility transport. DATA SYNTHESIS: The Task Force conducted an integrative review of 496 manuscripts combined with 120 from the authors' collections including nonpeer reviewed publications. After title and abstract screening, 40 underwent full-text review, of which 21 remained for qualitative synthesis. CONCLUSIONS: Since 2004, there have been numerous advances in critical care interfacility transport. Clinical deterioration may be mitigated by appropriate patient selection, pretransport optimization, and transport by a well-resourced team and vehicle. There remains a dearth of high-quality controlled studies, but notable advances in monitoring, en route management, transport modality (air vs ground), as well as team composition and training serve as foundations for future inquiry. Guidance from professional organizations remains uncoupled from enforceable regulations, impeding standardization of transport program quality assessment and verification.

Developing a National Trauma Research Action Plan: Results from the postadmission critical care research gap Delphi survey.

INTRODUCTION: The 2016 National Academies of Science, Engineering and Medicine report included a proposal to establish a National Trauma Research Action Plan. In response, the Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma and burn care from prehospital care to rehabilitation as part of an overall strategy to achieve zero preventable deaths and disability after injury. The Postadmission Critical Care Research panel was 1 of 11 panels constituted to develop this research agenda. METHODS: We recruited interdisciplinary experts in surgical critical care and recruited them to identify current gaps in clinical critical care research, generate research questions, and establish the priority of these questions using a consensus-driven Delphi survey approach. The first of four survey rounds asked participants to generate key research questions. On subsequent rounds, we asked survey participants to rank the priority of each research question on a 9-point Likert scale, categorized to represent low-, medium-, and high-priority items. Consensus was defined as ≥60% of panelists agreeing on the priority category. RESULTS: Twenty-five subject matter experts generated 595 questions. By Round 3, 249 questions reached ≥60% consensus. Of these, 22 questions were high, 185 were medium, and 42 were low priority. The clinical states of hypovolemic shock and delirium were most represented in the high-priority questions. Traumatic brain injury was the only specific injury pattern with a high-priority question. CONCLUSION: The National Trauma Research Action Plan critical care research panel identified 22 high-priority research questions, which, if answered, would reduce preventable death and disability after injury. LEVEL OF EVIDENCE: Diagnostic Tests or Criteria; Level IV.

Supporting surgical residents learning clinical palliative care: Insights from multi-disciplinary focus groups.

BACKGROUND: A shortage of palliative care (PC) sub-specialists highlights the need for quality PC provided by treating surgeons, although no established curriculum exists to teach surgical residents PC skills. To guide curriculum development, we sought to determine what modifiable factors contribute to surgical residents successfully providing PC. METHODS: Eight focus groups with 34 participants were conducted. Semi-structured interviews were recorded, transcribed, and de-identified. Inductive thematic analysis was utilized to encode, identify, and categorize emergent themes. RESULTS: Barriers to resident involvement in PC included: Limited Knowledge/Inexperience, Communication Difficulties, Time Constraints, and Burnout. Factors supporting resident involvement included: Patient Relationship/Rapport, Expertise Guiding PC Discussions, and Institutional Support. Communication skills that support successful PC delivery include establishing rapport, managing conflicts, avoiding bias, and acknowledging personal/scientific limitations. DISCUSSION: This work identifies modifiable factors that support surgical residents providing PC. Faculty and institutional support, resident education on PC principles, and expanding clinical experience with PC may be the most modifiable from a programmatic perspective. Curriculum and process development focused on these areas will help optimize surgical resident's success delivering PC.

Teaching primary palliative care to general surgical residents: A novel pedagogical approach drawn from multi-disciplinary focus group data.

BACKGROUND: Primary palliative care (PPC) is provided by the primary team and is essential for high-quality surgical care. There is a recognized PPC clinical and research need but little work on the optimal way to teach PPC to general surgery residents. We sought to define important factors of PPC pedagogy (i.e. nature and practice of teaching). METHODS: Eight semi-structured and multi-professional focus groups (n = 34) were performed. Discussion was transcribed, and de-identified. Qualitative approaches were used to encode, identify, and categorize emergent themes. RESULTS: Emergent themes included: establishing a baseline knowledge, use of existing resources, simulation and debriefings, and emphasis on authentic clinical opportunities with graduated responsibility. A tension between resident entrustability and hesitancy of faculty to entrust was identified. CONCLUSIONS: PPC must be taught in surgical residency and the themes identified here will inform development and implementation of a PPC curriculum.

Do I really need this transthoracic ECHO? An over-utilized test in trauma and surgical intensive care units.

INTRODUCTION: Clinical use of transthoracic echocardiogram (TTE) in intensive care units (ICU) has dramatically increased without clear guidance on validated assessment indications, appropriateness, and patient value. METHODS: A retrospective analysis of consecutive TTEs performed among patients admitted to a tertiary trauma/surgical ICU over 2.5 years was performed. A bivariate analysis and Poisson regression was used to compare patients who received a TTE. Sensitivity analysis was performed to assess patient factors that predict change in management based on TTE. An abnormal exam was defined as having at least one of the following: ejection fraction < 55%, wall motion, pericardial effusion, pericardial effusion, or other significant abnormality including filling defect. The effect on management was derived from clinical course. We hypothesize that these studies are usually normal and rarely lead to changes in clinical management. RESULTS: 912 TTEs were performed in 806 patients. The median age was 68 years (IQR 57, 77) and 63.5% were male. Syncope (21.7%) or hypotension/hypovolemia (20.5%) were the most common indications for a TTE. In total, 39.4% TTEs were abnormal and only 7.6% resulted in a change in management. Predictive factors associated with an abnormal exam included: age >50, serum troponin ≥0.1 ng/ml, abnormal ECG, and clinical suspicion of heart failure or acute myocardial infarction. A troponin cutoff level <0.25 ng/mL was the most reliable factor to predict no change in management after TTE with a negative predictive value of 94.3% (95% CI 93.1, 95.3). CONCLUSION: TTE is commonly used for patient assessment in critically ill surgical patients but the majority of exams are normal without change in clinical management. Certain patient factors, such as troponin level, may help distinguish which patients would benefit from this diagnostic test. Given the considerable cost associated with TTE and the minimal effect on management, guidelines on appropriate use would provide improved patient value.

Severe thrombocytopenia in adults undergoing extracorporeal membrane oxygenation is predictive of thrombosis.

Extracorporeal membrane oxygenation (ECMO) provides lifesaving circulatory support and gas exchange, although hematologic complications are frequent. The relationship between ECMO and severe thrombocytopenia (platelet count <50 × 109/L) remains ill-defined. We performed a cohort study of 67 patients who received ECMO between 2016 and 2019, of which 65.7% received veno-arterial (VA) ECMO and 34.3% received veno-venous (VV) ECMO. All patients received heparin and 25.4% received antiplatelet therapy. In total, 23.9% of patients had a thrombotic event and 67.2% had a hemorrhagic event. 38.8% of patients developed severe thrombocytopenia. Severe thrombocytopenia was more common in patients with lower baseline platelet counts and increased the likelihood of thrombosis by 365% (OR 3.65, 95% CI 1.13-11.8, P = .031), while the type of ECMO (VA or VV) was not predictive of severe thrombocytopenia (P = .764). Multivariate logistic regression controlling for additional clinical variables found that severe thrombocytopenia predicted thrombosis (OR 3.65, CI 1.13-11.78, P = .031). Over a quarter of patients requiring ECMO developed severe thrombocytopenia in our cohort, which was associated with an increased risk of thrombosis and in-hospital mortality. Additional prospective observation is required to clarify the clinical implications of severe thrombocytopenia in the ECMO patient population.

Critical decisions in the trauma intensive care unit: Are we practicing primary palliative care?

BACKGROUND: Devastating injuries require both urgent assessment by a trauma service and early attention to patients' goals of care (GOC). American College of Surgeons Trauma Quality Improvement Program (TQIP) guidelines recommend an initial palliative assessment within 24 hours of admission and family meeting, if needed, within 72 hours. We hypothesize that a primary palliative care-based practice improves adherence to TQIP guidelines in trauma patients. METHODS: All adult trauma patients who died while inpatient from January 2014 to December 2018 were reviewed. Timing of GOC discussions, transition to comfort measures only (CMO), and the utilization of specialty palliative services were analyzed with univariate analysis. RESULTS: During the study period, 415 inpatients died. Median Injury Severity Score was 26 (interquartile range [IQR], 17-34), median age was 67 years (IQR, 51-81 years), and 72% (n = 299) transitioned to CMO before death. Documented GOC discussions increased from 77% of patients in 2014 to 95% of patients in 2018 (p < 0.001), and in 2018, the median time to the first GOC discussion was 15 hours (IQR, 7- 24 hours). Specialty palliative care was consulted in 7% of all patients. Of patients who had at least one GOC discussion, 98% were led by the trauma intensive care unit (TICU) team. Median time from admission to first GOC discussion was 27 hours (IQR, 6-91 hours). Median number of GOC discussions was 1 (IQR, 1-2). Median time to CMO after the final GOC discussion was 0 hours (IQR, 0-3). Median time to death after transition to CMO was 4 hours (IQR, 1-18 hours). CONCLUSION: Of those who died during index admission, we demonstrated significant improvement in adherence to American College of Surgeons TQIP palliative guidelines across the 5-year study period, with the TICU team guiding the majority of GOC discussions. Our TICU team has developed an effective primary palliative care approach, selectively consulting specialty palliative care only when needed. LEVEL OF EVIDENCE: Therapeutic/care management, level III.

Pilot Testing of Simulation in the Evaluation of a Novel, Rapidly Deployable Electronic Health Record for use in Disaster Intensive Care.

OBJECTIVES: The SARS-CoV-2 pandemic has highlighted the need for rapid creation and management of ICU field hospitals with effective remote monitoring which is dependent on the rapid deployment and integration of an Electronic Health Record (EHR). We describe the use of simulation to evaluate a rapidly scalable hub-and-spoke model for EHR deployment and monitoring using asynchronous training. METHODS: We adapted existing commercial EHR products to serve as the point of entry from a simulated hospital and a separate system for tele-ICU support and monitoring of the interfaced data. To train our users we created a modular video-based curriculum to facilitate asynchronous training. Effectiveness of the curriculum was assessed through completion of common ICU documentation tasks in a high-fidelity simulation. Additional endpoints include assessment of EHR navigation, user satisfaction (Net Promoter), system usability (System Usability Scale-SUS), and cognitive load (NASA-TLX). RESULTS: A total of 5 participants achieved a 100% task completion on all domains except ventilator data (91%). Systems demonstrated high degrees of satisfaction (Net Promoter = 65.2), acceptable usability (SUS = 66.5), and acceptable cognitive load (NASA-TLX = 41.5); with higher levels of cognitive load correlating with the number of screens employed. CONCLUSIONS: Clinical usability of a comprehensive and rapidly deployable EHR was acceptable in an intensive care simulation which was preceded by < 1 hour of video education about the EHR. This model should be considered in plans for integrated clinical response with remote and accessory facilities.

Thrombosis and Bleeding in Extracorporeal Membrane Oxygenation (ECMO) Without Anticoagulation: A Systematic Review.

Extracorporeal membrane oxygenation (ECMO) causes both thrombosis and bleeding. Major society guidelines recommend continuous, systemic anticoagulation to prevent thrombosis of the ECMO circuit, though this may be undesirable in those with active, or high risk of, bleeding. We aimed to systematically review thrombosis and bleeding outcomes in published cases of adults treated with ECMO without continuous systemic anticoagulation. Ovid MEDLINE, Cochrane CENTRAL and CDSR, and hand search via SCOPUS were queried. Eligible studies were independently reviewed by two blinded authors if they reported adults (≥18 years) treated with either VV- or VA-ECMO without continuous systemic anticoagulation for ≥24 hours. Patient demographics, clinical data, and specifics of ECMO technology and treatment parameters were collected. Primary outcomes of interest included incidence of bleeding, thrombosis of the ECMO circuit requiring equipment exchange, patient venous or arterial thrombosis, ability to wean off of ECMO, and mortality. Of the 443 total publications identified, 34 describing 201 patients met our inclusion criteria. Most patients were treated for either acute respiratory distress syndrome or cardiogenic shock. The median duration of anticoagulant-free ECMO was 4.75 days. ECMO circuity thrombosis and patient thrombosis occurred in 27 (13.4%) and 19 (9.5%) patients, respectively. Any bleeding and major or "severe" bleeding was reported in 66 (32.8%) and 56 (27.9%) patients, respectively. Forty patients (19%) died. While limited by primarily retrospective data and inconsistent reporting of outcomes, our systematic review of anticoagulant-free ECMO reveals an incidence of circuity and patient thrombosis comparable to patients receiving continuous systemic anticoagulation while on ECMO.

Heparin Resistance Is Common in Patients Undergoing Extracorporeal Membrane Oxygenation but Is Not Associated with Worse Clinical Outcomes.

Extracorporeal membrane oxygenation (ECMO) protocols generally require systemic anticoagulation with heparin to prevent circuit thrombosis. The prevalence, risk factors, and outcomes of heparin resistance in this setting are ill-defined. To better understand the prevalence and clinical consequences of heparin resistance in this population, we conducted a retrospective analysis of all patients treated with ECMO at a single academic medical center between 2016 and 2019. Univariate and multivariate analyses were used to evaluate predictors and outcomes of heparin resistance. Of 67 patients in our study, 50.7% met the threshold for heparin resistance for at least 1 day, which was managed in all cases with increases in heparin dose. Patients with heparin resistance were more likely to be male (82.4% vs. 48.5%, p = 0.005) and to have a higher mean platelet count (132 vs. 104 × 103/mL, p = 0.027) compared with those without heparin resistance. Multivariate logistic regression found no significant association between the development of heparin resistance and rates of thrombosis, hemorrhage, or overall survival. Additional prospective studies are required to clarify the clinical implications of heparin resistance in this population.

Effective Palliative Care in the Trauma Setting.

A 55-year-old man undergoes emergent exploratory laparotomy and splenectomy following a motorcycle collision. Following surgery, he is found to have a traumatic brain injury requiring decompressive craniectomy and intracranial pressure monitoring. The patient then continues to have complications throughout his hospital course. Using the American College of Surgeons Trauma Quality Improvement Program guidelines, the surgical team has early and ongoing primary palliative care discussions to foster communication and determine goals of care for the patient. As the patient deteriorates, the surgical team continues meeting with the patient's surrogate decision makers to discuss the best case and worst case scenarios regarding the patient's prognosis and expected quality of life.