Intestinal fatty acid-binding protein as a potential biomarker for gastrointestinal complications after complex endovascular aortic surgery.

OBJECTIVE: This study aimed to investigate the association between intestinal fatty acid-binding protein, acute gastrointestinal injury grade, and gastrointestinal complications after fenestrated or branched endovascular aortic aneurysm repair. METHODS: A total of 17 patients undergoing endovascular aortic repair for thoracoabdominal, juxtarenal, suprarenal or pararenal aneurysm between May 2017 and September 2018 were enrolled. Blood samples were collected preoperatively and during postoperative intensive care. The blood samples were analyzed for intestinal fatty acid-binding protein with enzyme-linked immunosorbent assay. Gastrointestinal function was assessed according to the acute gastrointestinal injury grade every day during postoperative intensive care. RESULTS: Higher concentrations of intestinal fatty acid-binding protein at 24 h and 48 h correlated to higher acute gastrointestinal injury grade on postoperative days 1, 2 and 3 (p=0.032 and p=0.048, p=0.040 and p=0.018, and p=0.012 and p=0.016, respectively). Patients who developed a gastrointestinal complication within 90 days postoperatively had a higher overall acute gastrointestinal injury grade than those who did not develop a gastrointestinal complication (p<0.001), as well as higher concentrations of intestinal fatty acid-binding protein at 48 h (p=0.019). Patients developing gastrointestinal dysfunction (acute gastrointestinal injury grade ≥2) had a higher frequency of complications (p=0.009) and longer length of stay in the intensive care unit (p=0.008). CONCLUSIONS: In patients undergoing endovascular aortic repair for complex aneurysm increased postoperative plasma intestinal fatty acid-binding protein concentrations and postoperative gastrointestinal dysfunction, evaluated using the acute gastrointestinal injury grade, were associated with gastrointestinal complications, indicating that these measures may be useful in the postoperative management of these patients.

The effect of an endovascular Heaney maneuver to achieve total hepatic isolation on survival, hemodynamic stability, retrohepatic bleeding, and collateral flow in a porcine model.

PURPOSE: Combining resuscitative endovascular balloon occlusion of the aorta (REBOA) and the inferior vena cava (REBOVC) with open surgery is a new hybrid approach for treating retrohepatic vena caval injuries. We compared endovascular total hepatic isolation with supraceliac REBOA ± suprahepatic REBOVC and no occlusion in experimental retrohepatic vena cava bleeding regarding survival, bleeding volume, hemodynamic stability, and arterial collateral blood flow. METHODS: Twenty-five anesthetized pigs (n = 6-7/group) were randomized to REBOA; REBOA + REBOVC; REBOA + infra and suprahepatic REBOVC + portal vein occlusion (endovascular Heaney maneuver, four-balloon-occlusion, 4BO) or no occlusion. After balloon inflation, free bleeding was initiated from an open sheath in the retrohepatic vena cava. Bleeding volume, right internal thoracic artery (RITA) blood flow, hemodynamics, and arterial blood variables were measured until death or up to 90 min. RESULTS: The REBOA group had a longer median survival time (63 min) compared with the 4BO (24 min, P = 0.02) and no occlusion (30 min, P = 0.02) groups, not versus the REBOA + REBOVC group (49 min, P > 0.05). The first 15 min accumulated bleeding was comparable in all groups (P > 0.05); Thereafter, bleeding volume was higher in the REBOA group versus the 4BO group (P < 0.05), not versus the other groups. RITA blood flow and MAP were higher in the REBOA group versus the other groups after 10 min of bleeding (P < 0.05). CONCLUSIONS: Endovascular Heaney maneuver was not beneficial for survival or hemodynamic stability in this porcine model, whereas supraceliac REBOA was. Anatomical differences in thoracoabdominal collaterals between pigs and humans must be considered when interpreting these results.

Consensus on resuscitative endovascular balloon occlusion of the aorta in civilian (prehospital) trauma care: A Delphi study.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) could prevent lethal exsanguination and support cardiopulmonary resuscitation. In prehospital trauma and medical emergency settings, a small population with high mortality rates could potentially benefit from early REBOA deployment. However, its use in these situations remains highly disputed. Since publication of the first Delphi study on REBOA, in which consensus was not reached on all addressed topics, new literature has emerged. The aim of this study was to establish consensus on the use and implementation of REBOA in civilian prehospital settings for noncompressible truncal hemorrhage and out-of-hospital cardiac arrest as well as for various in-hospital settings. METHODS: A Delphi study consisting of three rounds of questionnaires was conducted based on a review of recent literature. REBOA experts with different medical specialties, backgrounds, and work environments were invited for the international panel. Consensus was reached when a minimum of 75% of panelists responded to a question and at least 75% (positive) or less than 25% (negative) of these respondents agreed on the questioned subject. RESULTS: Panel members reached consensus on potential (contra)indications, physiological thresholds for patient selection, the use of ultrasound and practical, and technical aspects for early femoral artery access and prehospital REBOA. CONCLUSION: The international expert panel agreed that REBOA can be used in civilian prehospital settings for temporary control of noncompressible truncal hemorrhage, provided that personnel are properly trained and protocols are established. For prehospital REBOA and early femoral artery access, consensus was reached on (contra)indications, physiological thresholds and practical aspects. The panel recommends the initiation of a randomized clinical trial investigating the use of prehospital REBOA for noncompressible truncal hemorrhage. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level V.

Critical systolic blood pressure threshold for endovascular aortic occlusion-A multinational analysis to determine when to place a REBOA.

BACKGROUND: Systolic blood pressure (SBP) is a potential indicator that could guide when to use a resuscitative endovascular balloon occlusion of the aorta (REBOA) in trauma patients with life-threatening injuries. This study aims to determine the optimal SBP threshold for REBOA placement by analyzing the association between SBP pre-REBOA and 24-hour mortality in severely injured hemodynamically unstable trauma patients. METHODS: We performed a pooled analysis of the aortic balloon occlusion (ABO) trauma and AORTA registries. These databases record the details related to the use of REBOA and include data from 14 countries worldwide. We included patients who had suffered penetrating and/or blunt trauma. Patients who arrived at the hospital with a SBP pre-REBOA of 0 mm Hg and remained at 0 mm Hg after balloon inflation were excluded. We evaluated the impact that SBP pre-REBOA had on the probability of death in the first 24 hours. RESULTS: A total of 1,107 patients underwent endovascular aortic occlusion, of these, 848 met inclusion criteria. The median age was 44 years (interquartile range [IQR], 27-59 years) and 643 (76%) were male. The median injury severity score was 34 (IQR, 25-45). The median SBP pre-REBOA was 65 mm Hg (IQR, 49-88 mm Hg). Mortality at 24 hours was reported in 279 (32%) patients. Math modeling shows that predicted probabilities of the primary outcome increased steadily in SBP pre-REBOA below 100 mm Hg. Multivariable mixed-effects analysis shows that when SBP pre-REBOA was lower than 60 mm Hg, the risk of death was more than 50% (relative risk, 1.5; 95% confidence interval, 1.17-1.92; p = 0.001). DISCUSSION: In patients who do not respond to initial resuscitation, the use of REBOA in SBPs between 60 mm Hg and 80 mm Hg may be a useful tool in resuscitation efforts before further decompensation or complete cardiovascular collapse. The findings from our study are clinically important as a first step in identifying candidates for REBOA. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level IV.

Emergent vessel embolization for major traumatic and non-traumatic hemorrhage: Indications, tools and outcomes.

Endovascular embolization of bleeding vessels in trauma and non-trauma patients is frequently used and is an important tool for bleeding control. It is included in the EVTM (endovascular resuscitation and trauma management) concept and its use in patients with hemodynamic instability is increasing. When the correct embolization tool is chosen, a dedicated multidisciplinary team can rapidly and effectively achieve bleeding control. In this article, we will describe the current use and possibilities for embolization of major hemorrhage (traumatic and non-traumatic) and the published data supporting these techniques as part of the EVTM concept.

A 12-year experience of endovascular repair for ruptured abdominal aortic aneurysms in all patients.

OBJECTIVE: Endovascular aneurysm repair (EVAR) has been increasingly performed for ruptured abdominal aortic aneurysms (rAAAs). However, multiple randomized trials have failed to demonstrate a survival benefit compared with open aortic surgery. During a 12-year period, 100% of patients without a history of aneurysm surgery had undergone EVAR for a rAAA at Örebro University Hospital, with no emergent open aortic surgery performed. In the present study, we evaluated the mortality and technical success during this "EVAR-only" period. METHODS: A single-center, retrospective observational study was conducted. We identified all patients who had presented to Örebro University Hospital with a rAAA between October 2009 and September 2021. Patients with isolated iliac artery, thoracic, and thoracoabdominal aortic ruptures were not included. Patients who had received previous aortic interventions (open or endovascular) and patients who had received palliative treatment instead of surgical intervention were also excluded. The patient characteristics, perioperative and postoperative data, and mortality rate were investigated. RESULTS: EVAR had been performed in 100 patients. Preoperative hemodynamic instability had been present in 54 patients (54%), and 18 (18%) had undergone aortic balloon occlusion. The aneurysm location was infrarenal in 89 patients (89%). Bifurcated stent grafts had been used in 97 patients (97%), and adjunct endovascular techniques had been used for 27 patients (27%). Of 98 patients, EVAR had been performed with the patient under local anesthesia for 62 patients (63%). Peri- and postoperative complications at 30 days had occurred in 20 of 100 patients (20%) and 22 of 79 patients (28%), respectively. The overall mortality at 30 days was 27% (27 of 100 patients), and the mortality for those with an isolated infrarenal rAAA was 24% (21 of 89 patients). The overall mortality at 1 year was 39% (39 of 100 patients) and for those with an isolated infrarenal rAAA was 37% (33 of 89 patients). The presence of preoperative hemodynamic instability and the use of ABO were statistically significantly and independently associated with increased 30-day mortality on multivariate logistic regression analysis. CONCLUSIONS: All 100 patients who had undergone surgery for a rAAA had been treated using EVAR and endovascular adjuncts, with a relatively low mortality rate, thus continuing the "EVAR-only" approach. A low proportion of rAAA patients were considered surgically unsuitable. These findings support the applicability of EVAR for the treatment of all rAAAs at suitable centers.

Semi-Conservative Treatment Versus Radical Surgery in Abdominal Aortic Graft and Endograft Infections.

OBJECTIVE: Abdominal aortic graft and endograft infections (AGIs) are rare complications following aortic surgery. Radical surgery (RS) with resection of the infected graft and reconstruction with extra-anatomical bypass or in situ reconstruction is the preferred therapy. For patients unfit for RS, a semi-conservative (SC), graft preserving strategy is possible. This paper aimed to compare survival and infection outcomes between RS and SC treatment for AGI in a nationwide cohort. METHODS: Patients with abdominal AGI related surgery in Sweden between January 1995 and May 2017 were identified. The Management of Aortic Graft Infection Collaboration (MAGIC) criteria were used for the definition of AGI. Multivariable regression was performed to identify factors associated with mortality. RESULTS: One hundred and sixty-nine patients with surgically treated abdominal AGI were identified, comprising 43 SC (14 endografts; 53% with a graft enteric fistula [GEF] in total) and 126 RS (26 endografts; 50% with a GEF in total). The SC cohort was older and had a higher frequency of cardiac comorbidities. There was a non-significant trend towards lower Kaplan-Meier estimated five year survival for SC vs. RS (30.2% vs. 48.4%; p = .066). A non-significant trend was identified towards worse Kaplan-Meier estimated five year survival for SC patients with a GEF vs. without a GEF (21.7% vs. 40.1%; p = .097). There were significantly more recurrent graft infections comparing SC with RS (45.4% vs. 19.3%; p < .001). In a Cox regression model adjusting for confounders, there was no difference in five year survival comparing SC vs. RS (HR 1.0, 95% CI 0.6 - 1.5). CONCLUSION: In this national AGI cohort, there was no mortality difference comparing SC and RS for AGI when adjusting for comorbidities. Presence of GEF probably negatively impacts survival outcomes of SC patients. Rates of recurrent infection remain high for SC treated patients.

A porcine study of ultrasound-guided versus fluoroscopy-guided placement of endovascular balloons in the inferior vena cava (REBOVC) and the aorta (REBOA).

Objectives: In fluoroscopy-free settings, alternative safe and quick methods for placing resuscitative endovascular balloon occlusion of the aorta (REBOA) and resuscitative endovascular balloon occlusion of the inferior vena cava (REBOVC) are needed. Ultrasound is being increasingly used to guide the placement of REBOA in the absence of fluoroscopy. Our hypothesis was that ultrasound could be used to adequately visualize the suprahepatic vena cava and guide REBOVC positioning, without significant time-delay, when compared with fluoroscopic guidance, and compared with the corresponding REBOA placement. Methods: Nine anesthetized pigs were used to compare ultrasound-guided placement of supraceliac REBOA and suprahepatic REBOVC with corresponding fluoroscopic guidance, in terms of correct placement and speed. Accuracy was controlled by fluoroscopy. Four intervention groups: (1) fluoroscopy REBOA, (2) fluoroscopy REBOVC, (3) ultrasound REBOA and (4) ultrasound REBOVC. The aim was to carry out the four interventions in all animals. Randomization was performed to either fluoroscopic or ultrasound guidance being used first. The time required to position the balloons in the supraceliac aorta or in the suprahepatic inferior vena cava was recorded and compared between the four intervention groups. Results: Ultrasound-guided REBOA and REBOVC placement was completed in eight animals, respectively. All eight had correctly positioned REBOA and REBOVC on fluoroscopic verification. Fluoroscopy-guided REBOA placement was slightly faster (median 14 s, IQR 13-17 s) than ultrasound-guided REBOA (median 22 s, IQR 21-25 s, p=0.024). The corresponding comparisons of the REBOVC groups were not statistically significant, with fluoroscopy-guided REBOVC taking 19 s, median (IQR 11-22 s) and ultrasound-guided REBOVC taking 28 s, median (IQR 20-34 s, p=0.19). Conclusion: Ultrasound adequately and quickly guide the placement of supraceliac REBOA and suprahepatic REBOVC in a porcine laboratory model, however, safety issues must be considered before use in trauma patients. Level of evidence: Prospective, experimental, animal study. Basic science study.

Learning insertion of a Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) catheter: Is clinical experience necessary? A prospective trial.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging and potentially life-saving procedure, necessitating qualified operators in an increasing number of centres. The procedure shares technical elements with other vascular access procedures using the Seldinger technique, which is mastered by doctors not only in endovascular specialties but also in trauma surgery, emergency medicine, and anaesthesiology. We hypothesised that doctors mastering the Seldinger technique (experienced anaesthesiologist) would learn the technical aspects of REBOA with limited training and remain technically superior to doctors unfamiliar with the Seldinger technique (novice residents) given similar training. METHODS: This was a prospective trial of an educational intervention. Three groups of doctors were enroled: novice residents, experienced anaesthesiologists, and endovascular experts. The novices and the anaesthesiologists completed 2.5 h of simulation-based REBOA training. Their skills were tested before and 8-12 weeks after training using a standardised simulated scenario. The endovascular experts, constituting a reference group, were equivalently tested. All performances were video recorded and rated by three blinded experts using a validated assessment tool for REBOA (REBOA-RATE). Performances were compared between groups and with a previously published pass/fail cutoff. RESULTS: Sixteen novices, 13 board-certified specialists in anaesthesiology, and 13 endovascular experts participated. Before training, the anaesthesiologists outperformed the novices by 30 percentage points of the maximum REBOA-RATE score (56% (SD 14.0) vs 26% (SD 17%), p<0.01). After training, there was no difference in skills between the two groups (78% (SD 11%) vs 78 (SD 14%), p = 0.93). Neither group reached the endovascular experts' skill level (89% (SD 7%), p<0.05). CONCLUSION: For doctors mastering the Seldinger technique, there was an initial inter-procedural transfer of skills advantage when performing REBOA. However, after identical simulation-based training, novices performed equally well to anaesthesiologists, indicating that vascular access experience is not a prerequisite to learning the technical aspects of REBOA. Both groups would need more training to reach technical proficiency.

Fully covered self-expandable metal stent placed over a stapled colon anastomosis in an animal model: A pilot study of colon metabolism over the stent.

Background and Aim: Anastomotic leakage (AL) in colorectal resection and primary anastomosis is a common and feared complication. Fully covered self-expandable metal stents (FCSEMSs) have been used for the treatment of AL. It is still unknown whether FCSEMSs affect anastomosis healing negatively by causing ischemia. In an animal study, we investigated the metabolic effects over a FCSEMS covering a stapled colon anastomosis. Methods: Seven pigs were investigated using microdialysis after laparotomy, colon resection, and anastomosis with stent placement. Measurements were done at the proximal and distal ends of the anastomosis and at a reference catheter placed at the small intestine. Measurements of glucose, pyruvate, lactate, glycerol, and the lactate/pyruvate ratio (L/P) were carried out. Results: Lactate and L/P were significantly higher at the oral part of the anastomosis, while glucose showed a small declining tendency. At the distal part of the anastomosis, glucose decreased significantly after the resection but did not reach zero. Lactate increased significantly whereas L/P increased only slightly. Glycerol levels were stable. Conclusion: Colon resection caused initially hypermetabolism in the intestinal ends next to the resection site. This hypermetabolism neither deteriorated nor turned into ischemia during the initial postoperative course, but the start of hypoxemia could not be excluded during the study and after the placement of an FCSEMS.

Altered mRNA Expression Due to Rectal Perforation in a Porcine Model - A Pilot Study.

BACKGROUND: Anastomotic leakage is the most serious and unwelcome complication in rectal surgery. It has a great impact on postoperative morbidity and mortality. In this pilot study, changes of mRNA expression in blood were analyzed in an animal model designed to imitate anastomotic leakage. MATERIALS AND METHODS: Twelve pigs were randomized into two groups: A sham-operated control group and an experimental group in which iatrogenic rectal perforation was performed. The changes in the mRNA expression at 4 hours after creating the perforation were studied. Microarray analysis was performed using Gene Chip whole porcine genome array. mRNA expression of 19,124 genes was investigated. RESULTS: Significantly increased levels of genes with a fold change greater than 2 were found, including 276 coding for unknown proteins and 48 coding for known proteins. Eleven of those which coded for known proteins were up-regulated with a fold change >4. CONCLUSION: Eleven known genes were highly up-regulated after rectal perforation. These genes were mainly involved in inflammatory response, intracellular signaling and cell membrane regulation. Their corresponding proteins might potentially be clinical biomarkers of anastomotic leakage and should be evaluated in further clinical studies.

Use of REBOA in the universe of magical realism: a real-world review / Uso de REBOA en el universo del realismo mágico: revisión de vida real

Abstract While reading the novella "Chronicle of a Death Foretold" by the Colombian Nobel Laureate Gabriel García-Marquez, we were surprised to realize that the injuries sustained by the main character could have been successfully treated had he received modern trauma care in which REBOA may have been considered. This is a discussion of Mr. Nasar's murder to explore whether he could have been saved by deploying REBOA as a surgical adjunct to bleeding control and resuscitation. In reading García-Marquez's novel we noted the events that unfolded at the time of Santiago Nasar's murder. To contextualize the claim that Mr. Nasar could have survived, had his injuries been treated with REBOA, we explored and illustrated what could have done differently and why. On the day of his death, Mr. Nasar sustained multiple penetrating stab wounds. Although he received multiple stab wounds to his torso, the book describes seven potentially fatal injuries, resulting in hollow viscus, solid viscus, and major vascular injuries. We provided a practical description of the clinical and surgical management algorithm we would have followed in Mr. Nasar's case. This algorithm included the REBOA deployment for hemorrhage control and resuscitation. The use of REBOA as part of the surgical procedures performed could have saved Mr. Nasar's life. Based on our current knowledge about REBOA in trauma surgery, we claim that its use, coupled with appropriate surgical care for hemorrhage control, could have saved Santiago Nasar's life, and thus prevent a death foretold.

Resumen Leyendo la novela "Crónica de una muerte anunciada" del Nobel de Literatura Gabriel García Márquez, nos sorprendió reconocer que las heridas provocadas al personaje principal se habrían podido tratar exitosamente en un centro de trauma moderno donde hubieran optado por REBOA. Hacemos referencia al asesinato del señor Nasar para explorar la posibilidad de que se hubiera podido salvar de haberse utilizado REBOA como adyuvante de la cirugía para reanimación y control de la hemorragia. En la lectura de la novela de García Márquez tomamos nota de los sucesos que tuvieron lugar en el momento del asesinato de Santiago Nasar. Para contextualizar la afirmación de que Nasar habría podido sobrevivir si le hubieran manejado sus heridas con REBOA, exploramos e ilustramos lo que habría podido hacerse de otra manera y porqué. El día en que murió, el señor Nasar sufrió múltiples heridas por arma blanca y si bien muchas de ellas fueron en el torso, el libro describe siete heridas mortales que comprometieron los órganos sólidos, además de lesiones vasculares mayores. Presentamos una descripción práctica del algoritmo para el manejo clínico y quirúrgico que habríamos seguido en el caso del señor Nasar. Este algoritmo incluye el uso de REBOA para el control de la hemorragia y la reanimación, el cual, como parte de los procedimientos quirúrgicos realizados, habría podido salvarle la vida a la víctima. Basados en nuestro conocimiento actual acerca del uso de REBOA en la cirugía de trauma, planteamos que, junto con la atención quirúrgica apropiada para controlar la hemorragia, este procedimiento habría podido salvarle la vida a Santiago Nasar y, por tanto, evitar una muerte anunciada.

Advanced bleeding control in combat casualty care: An international, expert-based Delphi consensus.

BACKGROUND: Hemorrhage from truncal and junctional injuries is responsible for the vast majority of potentially survivable deaths in combat casualties, causing most of its fatalities in the prehospital arena. Optimizing the deployment of the advanced bleeding control modalities required for the management of these injuries is essential to improve the survival of severely injured casualties. This study aimed to establish consensus on the optimal use and implementation of advanced bleeding control modalities in combat casualty care. METHODS: A Delphi method consisting of three rounds was used. An international expert panel of military physicians was selected by the researchers to complete the Delphi surveys. Consensus was reached if 70% or greater of respondents agreed and if 70% or greater responded. RESULTS: Thirty-two experts from 10 different nations commenced the process and reached consensus on which bleeding control modalities should be part of the standard equipment, that these modalities should be available at all levels of care, that only trained physicians should be allowed to apply invasive bleeding control modalities, but all medical and nonmedical personnel should be allowed to apply noninvasive bleeding control modalities, and on the training requirements for providers. Consensus was also reached on the necessity of international registries and guidelines, and on certain indications and contraindications for resuscitative endovascular balloon occlusion of the aorta (REBOA) in military environments. No consensus was reached on the role of a wound clamp in military settings and the indications for REBOA in patients with chest trauma, penetrating axillary injury or penetrating neck injury in combination with thoracoabdominal injuries. CONCLUSION: Consensus was reached on the contents of a standard bleeding control toolbox, where it should be available, providers and training requirements, international registries and guidelines, and potential indications for REBOA in military environments.

Low profile REBOA device for increasing systolic blood pressure in hemodynamic instability: single-center 4-year experience of use of ER-REBOA.

BACKGROUND: Hemodynamic instability due to torso hemorrhage can be managed with the assistance of resuscitative endovascular balloon occlusion of the aorta (REBOA). This is a report of a single-center experience using the ER-REBOA™ catheter for traumatic and non-traumatic cases as an adjunct to hemorrhage control and as part of the EndoVascular resuscitation and Trauma Management (EVTM) concept. The objective of this report is to describe the clinical usage, technical success, results, complications and outcomes of the ER-REBOA™ catheter at Örebro University hospital, a middle-sized university hospital in Europe. METHODS: Data concerning patients receiving the ER-REBOA™ catheter for any type of hemorrhagic shock and hemodynamic instability at Örebro University hospital in Sweden were collected prospectively from October 2015 to May 2020. RESULTS: A total of 24 patients received the ER-REBOA™ catheter (with the intention to use) for traumatic and non-traumatic hemodynamic control; it was used in 22 patients. REBOA was performed or supervised by vascular surgeons using 7-8 Fr sheaths with an anatomic landmark or ultrasound guidance. Systolic blood pressure (SBP) increased significantly from 50 mmHg (0-63) to 95 mmHg (70-121) post REBOA. In this cohort, distal embolization and balloon rupture due to atherosclerosis were reported in one patient and two patients developed renal failure. There were no cases of balloon migration. Overall 30-day survival was 59%, with 45% for trauma patients and 73% for non-traumatic patients. Responders to REBOA had a significantly lower rate of mortality at both 24 h and 30 days. CONCLUSIONS: Our clinical data and experience show that the ER-REBOA™ catheter can be used for control of hemodynamic instability and to significantly increase SBP in both traumatic and non-traumatic cases, with relatively few complications. Responders to REBOA have a significantly lower rate of mortality.

Hemodynamic Effect of Resuscitative Endovascular Balloon Occlusion of the Aorta in Hemodynamic Instability Secondary to Acute Cardiac Tamponade in a Porcine Model.

BACKGROUND: The pre-hospital use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is increasing, although it remains controversial, in part because of suggested contraindications such as acute cardiac tamponade (ACT). As both the pre-hospital and in-hospital use of REBOA might potentially occur with concurrent ACT, knowledge of the hemodynamic effect of REBOA in this setting is crucial. This study, therefore, aimed at investigating the physiological effects of REBOA in hemodynamic instability secondary to ACT in a porcine model. We hypothesize that REBOA can temporarily increase systemic blood pressure and carotid blood flow, and prolong survival, in hemodynamic shock caused by ACT. METHODS: Fourteen pigs (24-38 kg) underwent ACT, through true cardiac injury and hemorrhage into the pericardial space, and were allowed to hemodynamically deteriorate. At a systolic blood pressure (SBP) of 50 mm Hg (SBP50) they were randomized to total occlusion REBOA in zone 1 or to a control group. Survival, hemodynamic parameters, carotid blood flow (CBF), femoral blood flow (FBF), cardiac output (CO), end-tidal CO2, and arterial blood gas parameters were analyzed. RESULTS: REBOA intervention was associated with a significant increase in SBP (50 mm Hg to 74 mm Hg, P = 0.016) and CBF (110 mL/min to 195 mL/min, P = 0.031), with no change in CO, compared to the control group. At 20 min after SBP50, the survival rate in the intervention group was 86% and in the control group 14%, with time to death being significantly longer in the intervention group. CONCLUSIONS: This randomized animal study demonstrates that REBOA can help provide hemodynamic stabilization and prolong survival in hemodynamic shock provoked by ACT. It is important to stress that our study does not change the fact that urgent pericardiocentesis or cardiac surgery is, and should remain, the standard optimal treatment for ACT.Level of evidence: Prospective, randomized, experimental animal study. Basic science study, therapeutic.

Editor's Choice - Outcome of Radical Surgical Treatment of Abdominal Aortic Graft and Endograft Infections Comparing Extra-anatomic Bypass with In Situ Reconstruction: A Nationwide Multicentre Study.

OBJECTIVE: Abdominal aortic graft and endograft infection (AGI) is primarily treated by resection of the infected graft and restoration of distal perfusion through extra-anatomic bypass (EAB) or in situ reconstruction/repair (ISR). The aim of this study was to compare these surgical strategies in a nationwide multicentre retrospective cohort study. METHODS: The Swedish Vascular Registry (Swedvasc) was used to identify surgically treated abdominal AGIs in Sweden between January 1995 and May 2017. The primary aim was to compare short and long term survival, as well as complications for EAB and ISR. RESULTS: Some 126 radically surgically treated AGI patients were identified - 102 graft infections and 24 endograft infections - treated by EAB: 71 and ISR: 55 (23 neo-aorto-iliac systems, NAISs). No differences in early 30 day (EAB 81.7% vs. ISR 76.4%, p = .46), or long term five year survival (48.2% vs. 49.9%, p = .87) were identified. There was no survival difference comparing NAIS to other ISR strategies. The frequency of recurrent graft infection during follow up was similar: EAB 20.3% vs. ISR 17.0% (p = .56). Survival and re-infection rates of the new conduit did not differ between NAIS and other ISR strategies. Age ≥ 75 years (odds ratio [OR] 4.0, confidence interval [CI] 1.1 - 14.8), coronary artery disease (OR 4.2, CI 1.2 - 15.1) and post-operative circulatory complications (OR 5.2, CI 1.2 - 22.5) were associated with early death. Prolonged antimicrobial therapy (> 3 months) was associated with reduced long term mortality (HR 0.3, CI 0.1 - 0.9). CONCLUSION: In this nationwide multicentre study comparing outcomes of radically treated AGI, no differences in survival or re-infection rate could be identified comparing EAB and ISR.

Developing a tool to assess competence in resuscitative endovascular balloon occlusion of the aorta: An international Delphi consensus study.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emergency procedure that is potentially lifesaving in major noncompressible torso hemorrhage. It may also improve outcome in nontraumatic cardiac arrest. However, the procedure can be technically challenging and requires the immediate presence of a qualified operator. Thus, evidence-based training and assessment of operator skills are essential for successful implementation and patient safety. A prerequisite for this is a valid and reliable assessment tool specific for the procedure. The aim of this study was to develop a tool for assessing procedural competence in REBOA based on best-available knowledge from international experts in the field. METHODS: We invited international REBOA experts from multiple specialties to participate in an anonymous three-round iterative Delphi study to reach consensus on the design and content of an assessment tool. In round 1, participants suggested items to be included. In rounds 2 and 3, the relevance of each suggested item was evaluated by all participants to reach consensus. Interround data processing was done systematically by a steering group. RESULTS: Forty panelists representing both clinical and educational expertise in REBOA from 16 countries (in Europe, Asia, and North and South America) and seven different specialties participated in the study. After 3 Delphi rounds and 532 initial item suggestions, the panelists reached consensus on a 10-item assessment tool with behaviorally anchored rating scales. It includes assessment of teamwork, procedure time, selection and preparation of equipment, puncture technique, guidewire handling, sheath handling, placement of REBOA catheter, occlusion, and evaluation. CONCLUSION: We present the REBOA-RATE assessment tool developed systematically by international experts in the field to optimize content validity. Following further studies of its validity and reliability, this tool represents an important next step in evidence-based training programs in REBOA, for example, using mastery learning. LEVEL OF EVIDENCE: Therapeutic, level V.

Reliable and valid assessment of procedural skills in resuscitative endovascular balloon occlusion of the aorta.

BACKGROUND: Valid and reliable assessment of skills is essential for improved and evidence-based training concepts. In a recent study, we presented a novel tool to assess procedural skills in resuscitative endovascular balloon occlusion of the aorta (REBOA), REBOA-RATE, based on international expert consensus. Although expert consensus is a strong foundation, the performance of REBOA-RATE has not been explored. The study aimed to examine the reliability and validity of REBOA-RATE. METHODS: This was an experimental simulation-based study. We enrolled doctors with three levels of expertise to perform two REBOA procedures in a simulated scenario of out-of-hospital cardiac arrest. Procedures were video-recorded, and videos were blinded and randomized. Three clinical experts independently rated all procedures using REBOA-RATE. Data were analyzed using Messick's framework for validity evidence, including generalizability analysis of reliability and determination of a pass/fail standard. RESULTS: Forty-two doctors were enrolled: 16 novices, 13 anesthesiologists, and 13 endovascular experts. They all performed two procedures, yielding 84 procedures and 252 ratings. The REBOA-RATE assessment tool showed high internal consistency (Cronbach's α = 0.95) and excellent interrater reliability (intraclass correlation coefficient, 0.97). Assessment using one rater and three procedures could ensure overall reliability suitable for high-stakes testing (G-coefficient >0.80). Mean scores (SD) for the three groups in the second procedure were as follows: novices, 32% (24%); anesthesiologists, 55% (29%); endovascular experts, 93% (4%) (p < 0.001). The pass/fail standard was set at 81%, which all experts but no novices passed. CONCLUSION: Data strongly support the reliability and validity of REBOA-RATE, which successfully discriminated between all experience levels. The REBOA-RATE assessment tool requires minimal instruction, and one rater is sufficient for reliable assessment. Together, these are strong arguments for the use of REBOA-RATE to assess REBOA skills, allowing for competency-based training and certification concepts. LEVEL OF EVIDENCE: Diagnostic test, no or poor gold standard, level V.

A randomized porcine study of the hemodynamic and metabolic effects of combined endovascular occlusion of the vena cava and the aorta in normovolemia and in hemorrhagic shock.

BACKGROUND: Mortality from traumatic retrohepatic venous injuries is high and methods for temporary circulatory stabilization are needed. We investigated survival and hemodynamic and metabolic effects of resuscitative endovascular balloon occlusion of the aorta (REBOA) and vena cava inferior (REBOVC) in anesthetized pigs. METHODS: Twenty-five anesthetized pigs in normovolemia or severe hemorrhagic shock (controlled arterial bleeding in blood bags targeting systolic arterial pressure of 50 mm Hg, corresponding to 40-50% of the blood volume) were randomized to REBOA zone 1 or REBOA+REBOVC zone 1 (n = 6-7/group) for 45 minutes occlusion, followed by 3-hour resuscitation and reperfusion. Hemodynamic and metabolic variables and markers of end-organ damage were measured regularly. RESULTS: During occlusion, both the REBOA groups had higher systemic mean arterial pressure (MAP) and cardiac output (p < 0.05) compared with the two REBOA+REBOVC groups. After 60 minutes reperfusion, there were no statistically significant differences between the two REBOA groups and the two REBOA+REBOVC groups in MAP and cardiac output. The two REBOA+REBOVC groups had higher arterial lactate and potassium concentrations during reperfusion, compared with the two REBOA groups (p < 0.05). There was no major difference in end-organ damage markers between REBOA and REBOA+REBOVC. Survival after 1-hour reperfusion was 86% and 100%, respectively, in the normovolemic REBOA and REBOA+REBOVC groups, and 67% and 83%, respectively, in the corresponding hemorrhagic shock REBOA and REBOA+REBOVC groups. CONCLUSION: Acceptable hemodynamic stability during occlusion and short-term survival can be achieved by REBOA+REBOVC with adequate resuscitation; however, the more severe hemodynamic and metabolic impacts of REBOA+REBOVC compared with REBOA must be considered. LEVEL OF EVIDENCE: Prospective, randomized, experimental animal study. Basic science study, therapeutic.

REBOA as a New Damage Control Component in Hemodynamically Unstable Noncompressible Torso Hemorrhage Patients / El REBOA como nuevo actor en el control de daños del paciente hemodinámicamente inestable con hemorragia no compresible del torso

Abstract Noncompressible torso hemorrhage is one of the leading causes of preventable death worldwide. An efficient and appropriate evaluation of the trauma patient with ongoing hemorrhage is essential to avoid the development of the lethal diamond (hypothermia, coagulopathy, hypocalcemia, and acidosis). Currently, the initial management strategies include permissive hypotension, hemostatic resuscitation, and damage control surgery. However, recent advances in technology have opened the doors to a wide variety of endovascular techniques that achieve these goals with minimal morbidity and limited access. An example of such advances has been the introduction of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA), which has received great interest among trauma surgeons around the world due to its potential and versatility in areas such as trauma, gynecology & obstetrics and gastroenterology. This article aims to describe the experience earned in the use of REBOA in noncompressible torso hemorrhage patients. Our results show that REBOA can be used as a new component in the damage control resuscitation of the severely injured trauma patient. To this end, we propose two new deployment algorithms for hemodynamically unstable noncompressible torso hemorrhage patients: one for blunt and another for penetrating trauma. We acknowledge that REBOA has its limitations, which include a steep learning curve, its inherent cost and availability. Although to reach the best outcomes with this new technology, it must be used in the right way, by the right surgeon with the right training and to the right patient.

Resumen La hemorragia no compresible del torso es una de las principales causas de muerte prevenibles alrededor del mundo. Una evaluación eficiente y apropiada del paciente traumatizado con hemorragia activa es la esencia para evitar el desarrollo del rombo de la muerte (hipotermia, coagulopatía, hipocalcemia y acidosis). Actualmente, las estrategias de manejo inicial incluyen hipotensión permisiva, resucitación hemostática y cirugía de control de daños. Sin embargo, los recientes avances tecnológicos han abierto las puertas a una amplia variedad de técnicas endovasculares que logran esos objetivos con una morbilidad mínima y un acceso limitado. Un ejemplo de estos avances ha sido la introducción del balón de resucitación de oclusión aortica; REBOA ( Resuscitative Endovascular Balloon Occlusion of the Aorta , por sus sigla en inglés ), el cual, ha tenido gran provecho entre los cirujanos de trauma alrededor del mundo debido a su potencial y versatilidad en áreas como trauma, ginecología y obstetricia, y gastroenterología. El objetivo de este artículo es describir la experiencia lograda en el uso del REBOA en pacientes con hemorragia no compresible del torso. Nuestros resultados muestran que el REBOA puede usarse como un nuevo actor en la resucitación de control de daños del paciente con trauma severo, para este fin, nosotros proponemos dos nuevos algoritmos para el manejo de pacientes hemodinámicamente inestables: uno para trauma cerrado y otro para trauma penetrante. Se reconoce que el REBOA tiene sus limitaciones, las cuales incluye un periodo de aprendizaje, su costo inherente y la disponibilidad. A pesar de esto, para lograr los mejores resultados con esta nueva tecnología, el REBOA debe ser usado en el momento correcto, por el cirujano correcto con el entrenamiento y el paciente correcto.