Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia.

BACKGROUND: Observational studies have shown that fetoscopic endoluminal tracheal occlusion (FETO) has been associated with increased survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, but data from randomized trials are lacking. METHODS: In this open-label trial conducted at centers with experience in FETO and other types of prenatal surgery, we randomly assigned, in a 1:1 ratio, women carrying singleton fetuses with severe isolated congenital diaphragmatic hernia on the left side to FETO at 27 to 29 weeks of gestation or expectant care. Both treatments were followed by standardized postnatal care. The primary outcome was infant survival to discharge from the neonatal intensive care unit. We used a group-sequential design with five prespecified interim analyses for superiority, with a maximum sample size of 116 women. RESULTS: The trial was stopped early for efficacy after the third interim analysis. In an intention-to-treat analysis that included 80 women, 40% of infants (16 of 40) in the FETO group survived to discharge, as compared with 15% (6 of 40) in the expectant care group (relative risk, 2.67; 95% confidence interval [CI], 1.22 to 6.11; two-sided P = 0.009). Survival to 6 months of age was identical to the survival to discharge (relative risk, 2.67; 95% CI, 1.22 to 6.11). The incidence of preterm, prelabor rupture of membranes was higher among women in the FETO group than among those in the expectant care group (47% vs. 11%; relative risk, 4.51; 95% CI, 1.83 to 11.9), as was the incidence of preterm birth (75% vs. 29%; relative risk, 2.59; 95% CI, 1.59 to 4.52). One neonatal death occurred after emergency delivery for placental laceration from fetoscopic balloon removal, and one neonatal death occurred because of failed balloon removal. In an analysis that included 11 additional participants with data that were available after the trial was stopped, survival to discharge was 36% among infants in the FETO group and 14% among those in the expectant care group (relative risk, 2.65; 95% CI, 1.21 to 6.09). CONCLUSIONS: In fetuses with isolated severe congenital diaphragmatic hernia on the left side, FETO performed at 27 to 29 weeks of gestation resulted in a significant benefit over expectant care with respect to survival to discharge, and this benefit was sustained to 6 months of age. FETO increased the risks of preterm, prelabor rupture of membranes and preterm birth. (Funded by the European Commission and others; TOTAL ClinicalTrials.gov number, NCT01240057.).

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia.

BACKGROUND: Fetoscopic endoluminal tracheal occlusion (FETO) has been associated with increased postnatal survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, but data are lacking to inform its effects in infants with moderate disease. METHODS: In this open-label trial conducted at many centers with experience in FETO and other types of prenatal surgery, we randomly assigned, in a 1:1 ratio, women carrying singleton fetuses with a moderate isolated congenital diaphragmatic hernia on the left side to FETO at 30 to 32 weeks of gestation or expectant care. Both treatments were followed by standardized postnatal care. The primary outcomes were infant survival to discharge from a neonatal intensive care unit (NICU) and survival without oxygen supplementation at 6 months of age. RESULTS: In an intention-to-treat analysis involving 196 women, 62 of 98 infants in the FETO group (63%) and 49 of 98 infants in the expectant care group (50%) survived to discharge (relative risk , 1.27; 95% confidence interval [CI], 0.99 to 1.63; two-sided P = 0.06). At 6 months of age, 53 of 98 infants (54%) in the FETO group and 43 of 98 infants (44%) in the expectant care group were alive without oxygen supplementation (relative risk, 1.23; 95% CI, 0.93 to 1.65). The incidence of preterm, prelabor rupture of membranes was higher among women in the FETO group than among those in the expectant care group (44% vs. 12%; relative risk, 3.79; 95% CI, 2.13 to 6.91), as was the incidence of preterm birth (64% vs. 22%, respectively; relative risk, 2.86; 95% CI, 1.94 to 4.34), but FETO was not associated with any other serious maternal complications. There were two spontaneous fetal deaths (one in each group) without obvious cause and one neonatal death that was associated with balloon removal. CONCLUSIONS: This trial involving fetuses with moderate congenital diaphragmatic hernia on the left side did not show a significant benefit of FETO performed at 30 to 32 weeks of gestation over expectant care with respect to survival to discharge or the need for oxygen supplementation at 6 months. FETO increased the risks of preterm, prelabor rupture of membranes and preterm birth. (Funded by the European Commission and others; TOTAL ClinicalTrials.gov number, NCT00763737.).

Is cerebral perfusion maintained during full and partial resuscitative endovascular balloon occlusion of the aorta in hemorrhagic shock conditions?

BACKGROUND: Partial resuscitative endovascular balloon occlusion of the aorta (pREBOA) is a technology that occludes aortic flow and allows for controlled deflation and restoration of varying distal perfusion. Carotid flow rates (CFRs) during partial deflation are unknown. Our aim was to measure CFR with the different pREBOA balloon volumes and correlate those to the proximal mean arterial pressure (PMAP) and a handheld pressure monitoring device (COMPASS; Mirador Biomedical, Seattle, WA). METHODS: Ten swine underwent a hemorrhagic injury model with carotid and iliac arterial pressures monitored via arterial lines. Carotid and aortic flow rates were monitored with Doppler flow probes. A COMPASS was placed to monitor proximal pressure. The pREBOA was inflated for 15 minutes then partially deflated for an aortic flow rate of 0.7 L/min for 45 minutes. It was then completely deflated. Proximal mean arterial pressures and CFR were measured, and correlation was evaluated. Correlation between CRF and COMPASS measurements was evaluated. RESULTS: Carotid flow rate increased 240% with full inflation. Carotid flow rate was maintained at 100% to 150% of baseline across a wide range of partial deflation. After full deflation, CFR transiently decreased to 45% to 95% of baseline. There was strong positive correlation (r > 0.85) between CFR and PMAP after full inflation, and positive correlation with partial inflation (r > 0.7). Carotid flow rate had strong correlation with the COMPASS with full REBOA (r > 0.85) and positive correlation with pREBOA (r > 0.65). CONCLUSION: Carotid flow rate is increased in a hemorrhagic model during full and partial inflation of the pREBOA and correlates well with PMAP. Carotid perfusion appears maintained across a wide range of pREBOA deflation and could be readily monitored with a handheld portable COMPASS device instead of a standard arterial line setup.

A REBOA Complication: EtCO2 Is Not Just a Marker of Cardiac Output.

We describe an as yet undescribed complication, namely, the perforation of the balloon at a distance from its introduction and the use of EtCO2 to suspect the diagnosis. Following a high-kinetic motorcycle accident, a 25-year-old patient was admitted in our level 1 trauma center, and benefited from a resuscitation thoracotomy followed by a REBOA catheter in zone 3. The use of a small caliber introducer could be responsible for balloon injury. EtCO2 is not only a marker of cardiac output and its sudden increase in this situation should raise questions about the recirculation of ischemia product and therefore the effectiveness of the occlusion balloon.

A novel partial resuscitative endovascular balloon aortic occlusion device that can be deployed in zone 1 for more than 2 hours with minimal provider titration.

BACKGROUND: Hemorrhage is a leading cause of mortality in trauma. Resuscitative endovascular balloon occlusion of the aorta (REBOA) can control hemorrhage, but distal ischemia, subsequent reperfusion injury, and the need for frequent balloon titration remain problems. Improved device design can allow for partial REBOA (pREBOA) that may provide hemorrhage control while also perfusing distally without need for significant provider titration. METHODS: Female Yorkshire swine (N = 10) were subjected to 40% hemorrhagic shock for 1 hour (mean arterial pressure [MAP], 28-32 mm Hg). Animals were then randomized to either complete aortic occlusion (ER-REBOA) or partial occlusion (novel pREBOA-PRO) without frequent provider titration or distal MAP targets. Detection of a trace distal waveform determined partial occlusion in the pREBOA-PRO arm. After 2 hours of zone 1 occlusion, the hemorrhaged whole blood was returned. After 50% autotransfusion, the balloon was deflated over a 10-minute period. Following transfusion, the animals were survived for 2 hours while receiving resuscitation based on objective targets: lactated Ringer's fluid boluses (goal central venous pressure, ≥ 6 mm Hg), a norepinephrine infusion (goal MAP, 55-60 mm Hg), and acid-base correction (goal pH, >7.2). Hemodynamic variables, arterial lactate, lactate dehydrogenase, aspartate aminotransferase, and creatinine levels were measured. RESULTS: All animals survived throughout the experiment, with similar increase in proximal MAPs in both groups. Animals that underwent partial occlusion had slightly higher distal MAPs. At the end of the experiment, the partial occlusion group had lower end levels of serum lactate (p = 0.006), lactate dehydrogenase (p = 0.0004) and aspartate aminotransferase (p = 0.004). Animals that underwent partial occlusion required less norepinephrine (p = 0.002), less bicarbonate administration (p = 0.006), and less fluid resuscitation (p = 0.042). CONCLUSION: Improved design for pREBOA can decrease the degree of distal ischemia and reperfusion injury compared with complete aortic occlusion, while providing a similar increase in proximal MAPs. This can allow pREBOA zone-1 deployment for longer periods without the need for significant balloon titration.

Novel intraperitoneal hemostasis device prolongs survival in a swine model of noncompressible abdominal hemorrhage.

BACKGROUND: Noncompressible torso hemorrhage (NCTH) of the abdomen is a challenge to rapidly control and treat in the prehospital and emergency department settings. In this pilot study, we developed a novel intraperitoneal hemostasis device (IPHD) prototype and evaluated its ability for slowing NCTH and prolonging survival in a porcine model of lethal abdominal multiorgan hemorrhage. METHODS: Yorkshire male swine (N = 8) were instrumented under general anesthesia for monitoring of hemodynamics and blood sampling. Animals were subjected to a 30% controlled arterial hemorrhage followed by lacerating combinations of the liver, spleen, and kidney. The abdomen was closed and after 2 minutes of NCTH, and the IPHD was inserted into the peritoneal cavity via an introducer (n = 5). The balloon was inflated and maintained for 60 minutes. At 60 minutes postdeployment, the balloon was deflated and removed, and blood resuscitation was initiated followed by gauze packing for hemostasis. The remaining animals (n = 3) were used as controls and subjected to the same injury without intervention. RESULTS: All animals managed with IPHD intervention (5 of 5 swine) survived the duration of the intervention period (60 minutes), while all control animals (3 of 3 swine) died at a time range of 15 to 43 minutes following organ injury (p = 0.0042). Animals receiving IPHD remained hemodynamically stable with a mean arterial pressure range of 44.86 to 55.10 mm Hg and experienced increased cardiac output and decreased shock index after treatment. Controls experienced hemodynamic decline in all parameters until endpoints were met. Upon IPHD deflation and removal, all treated animals began to hemorrhage again and expired within 2 to 132 minutes despite packing. CONCLUSION: Our data show that the IPHD concept is capable of prolonging survival by temporarily stanching lethal NCTH of the abdomen. This device may be an effective temporary countermeasure to NCTH of the abdomen that could be deployed in the prehospital environment or as a bridge to more advanced therapy.

First clinical multicenter experience with the new Scepter Mini microballoon catheter.

BACKGROUND: Balloon-assisted techniques can improve the endovascular treatment of cerebrospinal vascular malformations. The aim of this study was to report the first clinical multicenter experience with the new Scepter Mini dual-lumen microballoon catheter. METHODS: Patients with cerebral or spinal vascular malformations treated with the Scepter Mini at seven European neurovascular centers were retrospectively reviewed. Clinical data, angiographic features of the vascular malformations, procedural parameters including the type of application, navigability, technical failures, complications and embolization success were assessed. RESULTS: The usage of 34 Scepter Mini microballoon catheters in 20 patients was analyzed. Most treated malformations (80.0%) were cerebral arteriovenous malformations. Four different applications were reported: embolization via Scepter Mini (n=23, 67.6%), balloon-occlusion with simultaneous embolization via a second microcatheter (n=3, 8.8%), diagnostic angiography with simultaneous balloon-inflation for flow arrest (n=4, 11.8%), and navigation support (n=4, 11.8%). The mean diameter of the blood vessels in which the Scepter Mini was inflated was 1.9±0.5 mm. The navigability of the Scepter Mini was rated as 'easy' or 'very easy' in 88.2% of cases. Complete occlusion of the malformation was achieved in 60.9% of cases. Technical failures occurred in 4/23 embolization procedures, and all were related to insufficient stability of the balloon within the vessel. No complications related to the Scepter Mini were observed, while unrelated complications occurred in three patients (15.0%). CONCLUSIONS: The Scepter Mini is a promising new device for balloon-assisted embolization of cerebrospinal vascular malformations via small feeders. Beyond embolization, the Scepter Mini can also be used for other applications, such as superselective flow arrest and navigation support.

The Use of a Urinary Balloon Catheter to Control Hemorrhage From Penetrating Torso Trauma: A Single-Center Experience at a Major Inner-City Hospital Trauma Center.

INTRODUCTION: Use of a urinary catheter balloon tamponade (UCBT) in controlling traumatic hemorrhage is a frequently employed but infrequently described technique. We aim to discuss the experience of balloon tamponade as a bridge to definitive hemorrhage control in the operating room. METHODS: This is retrospective review at a single institution from January 2008 to December 2018. We identified patients with active bleeding from penetrating torso trauma in whom UCBT was used to tamponade bleeding. We used revised trauma score (RTS), injury severity score (ISS), and new trauma and injury severity score (TRISS) to quantify injury severity. All surviving patients required definitively hemorrhage control in the operating room. Primary endpoint was mortality at 24 hours and 30 days. RESULTS: Twenty-nine patients were managed with UCBT. Nine had hemorrhage controlled in the trauma bay, including 4 with neck trauma and 5 with cardiac trauma. Twenty patients had hemorrhage controlled in the operating room, including 15 with cardiac trauma and 5 with intra-abdominal hemorrhage. Mean RTS, ISS, and TRISS in this population were: 5.93, 19.31, and 83.78, respectively. Of the 9 patients treated in the trauma bay, 1 (11.1%) died in the first 24 hours and 2 died in the first 30 days (22.2%). Of the 20 patients treated in the operating room, 0 (0%) patients died in the first 24 hours and 3 died in the first 30 days (15.0%). CONCLUSION: UCBT is an effective tool that can be used to stabilize and bridge an actively bleeding patient to definitive hemorrhage control in the operating room.

A contemporary assessment of devices for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA): resource-specific options per level of care.

PURPOSE: Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as adjunct for temporary hemorrhage control in patients with exsanguinating torso hemorrhage is increasing. Characteristics of aortic occlusion balloons (AOB) are diverse and evolving as efforts are made to improve the technology. It is important to select a device that fits the requirements of the medical situation to minimize the risk of failure and complications. The aim of this study is to appraise guidance in the choice of an AOB in a specific situation. METHODS: We assessed 29 AOB for differences and outline possible advantages and disadvantages of each. Bending stiffness was measured with a three-point bending device. RESULTS: Diameter of the AOB ranged from 6 (ER-REBOA™) to 10 (Coda®-46) French. However, some need large-bore access sheaths up to 22 French (Fogarty®-45 and LeMaitre®-45) or even insertion via cut-down (Equalizer™-40). Bending stiffness varied from 0.08 N/mm (± 0.008 SD; Coda®-32) to 0.72 N/mm (± 0.024 SD; Russian prototype). Rescue Balloon™ showed kinking of the shaft at low bending pressures. The only non-compliant AOB is REBOA Balloon®. ER-REBOA™, Fogarty®, LeMaitre®, REBOA Balloon®, and Rescue Balloon™ are provided with external length marks to assist blind positioning. CONCLUSION: In resource-limited settings, a guidewire- and fluoroscopy-free, rather stiff device, such as ER-REBOA™, Fogarty®, and LeMaitre®, is warranted. Of these devices, ER-REBOA™ is the only catheter compatible with seven French sheaths and specifically designed for emergency hemorrhage control. Of the over-the-wire devices, Q50® has several features that facilitate use and reduce the risk of malplacement or vessel damage.

Predictive score for complete occlusion of intracranial aneurysms treated by flow-diverter stents using machine learning.

BACKGROUND: Complete occlusion of an intracranial aneurysm (IA) after the deployment of a flow-diverter stent is currently unpredictable. The aim of this study was to develop a predictive occlusion score based on pretreatment clinical and angiographic criteria. METHODS: Consecutive patients with ≥6 months follow-up were included from 2008 to 2019 and retrospectively analyzed. Each IA was evaluated using the Raymond-Roy occlusion classification (RROC) and dichotomized as occluded (A) or residual (B/C); 80% of patients were randomly assigned to the training sample. Feature selection and binary outcome prediction relied on logistic regression and threshold maximizing class separation selected by a CART tree algorithm. The feature selection was addressed by a genetic algorithm selected from the 30 pretreatment available variables. RESULTS: The study included 146 patients with 154 IAs. Feature selection yielded a combination of six variables with a good cross-validated accuracy on the test sample, a combination we labeled DIANES score (IA diameter, indication, parent artery diameter ratio, neck ratio, side-branch artery, and sex). A score of more than -6 maximized the ability to predict RROC=A with sensitivity of 87% (95% CI 79% to 95%) and specificity of 82% (95% CI 64% to 96%) in the training sample. Accuracy was 86% (95% CI 79% to 94%). In the test sample, sensitivity and specificity were 89% (95% CI 77% to 98%) and 60% (95% CI 33% to 86%), respectively. Accuracy was 81% (95% CI 69% to 91%). CONCLUSION: A score was developed as a grading scale for prediction of the final occlusion status of IAs treated with a flow-diverter stent.

Partial Resuscitative Endovascular Balloon Occlusion of the Aorta via the Tri-Lobe Balloon Catheter.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) provides a minimally invasive alternative to resuscitative thoracotomy. The high morbidity associated with prolonged aortic occlusion has given rise to the concept of partial REBOA (pREBOA). We evaluated the novel use of the GORE Tri-Lobe Balloon Catheter (GORE) as a functional pREBOA catheter and compared it with existing REBOA and pREBOA techniques in a porcine hemorrhagic shock model. MATERIALS AND METHODS: Fifteen male Yorkshire swine were subjected to hemorrhagic shock with zone 1 aortic occlusion via standard REBOA techniques or a partial occlusion approach using a prototype pREBOA or GORE catheter. Continuous invasive monitoring was performed and laboratory values were analyzed every 30 min. RESULTS: One animal from the GORE cohort was excluded because of early demise from nonstudy factors. Survival to 120 mins was comparable between all study groups: REBOA resulting in 40% survival, pREBOA 60%, and Gore 50% (P = 0.685). No differences in lactate, base deficit, and pH between the cohorts were demonstrated at all measured time points; however, trends toward more physiologic values were appreciated in the GORE and pREBOA cohorts. Urine output was significantly improved during the course of the study in the GORE cohort (8.77 mL/kg) versus REBOA (5.46 mL/kg) and pREBOA (4.48 mL/kg) (P = 0.001). CONCLUSIONS: The GORE Tri-Lobe Balloon Catheter represents a potentially viable and commercially available alternative device for pREBOA that may achieve survivable hemorrhage control while preventing lethal reperfusion injury. Further studies should be performed after instrument refinement with larger study populations to confirm this potential.

Validation of a novel partial resuscitative endovascular balloon occlusion of the aorta device in a swine hemorrhagic shock model: Fine tuning flow to optimize bleeding control and reperfusion injury.

OBJECTIVES: Partial restoration of aortic flow during resuscitative endovascular balloon occlusion of the aorta (REBOA) is advocated by some to mitigate distal ischemia. Our laboratory has validated the mechanics and optimal partial REBOA (pREBOA) flow rates using a prototype device. We hypothesize that pREBOA will increase survival when compared with full REBOA (fREBOA) in prolonged nonoperative management of hemorrhagic shock. METHODS: Twenty swine underwent placement of aortic flow probes, zone 1 REBOA placement, and 20% blood volume hemorrhage. They were randomized to either solid organ or abdominal vascular injury. The pREBOA arm (10 swine) underwent full inflation for 10 minutes and then deflation to a flow rate of 0.5 L/min for 2 hours. The fREBOA arm (10 swine) underwent full inflation for 60 minutes, followed by deflation/resuscitation. The primary outcome is survival, and secondary outcomes are serologic/pathologic signs of ischemia-reperfusion injury and quantity of hemorrhage. RESULTS: Two of 10 swine survived in the fREBOA group (2/5 solid organ injury; 0/5 abdominal vascular injury), whereas 7 of 10 swine survived in the pREBOA group (3/5 solid organ injury, 4/5 abdominal vascular injury). Survival was increased (p = 0.03) and hemorrhage was higher in the pREBOA group (solid organ injury, 1.36 ± 0.25 kg vs. 0.70 ± 0.33 kg, p = 0.007; 0.86 ± 0.22 kg vs. 0.71 ± 0.28 kg, not significant). Serum evidence of ischemia was greater with fREBOA, but this was not significant (e.g., lactate, 16.91 ± 3.87 mg/dL vs. 12.96 ± 2.48 mg/dL at 120 minutes, not significant). Swine treated with pREBOA that survived demonstrated trends toward lower alanine aminotransferase, lower potassium, and higher calcium. The potassium was significantly lower in survivors at 60 minutes and 90 minutes time points (5.97 ± 0.60 vs. 7.53 ± 0.90, p = 0.011; 6.67 ± 0.66 vs. 8.15 ± 0.78, p = 0.029). Calcium was significantly higher at 30 minutes, 60 minutes, and 90 minutes (8.56 ± 0.66 vs. 7.50 ± 0.40, p = 0.034; 8.63 ± 0.62 vs. 7.15 ± 0.49, p = 0.019; 8.96 ± 0.64 vs. 7.00, p = 0.028). CONCLUSION: Prolonged pREBOA at a moderate distal flow rate provided adequate hemorrhage control, improved survival, and had evidence of decreased ischemic injury versus fREBOA. Prophylactic aggressive calcium supplementation may have utility before and during the reperfusion phase.

Use of bilobed partial resuscitative endovascular balloon occlusion of the aorta is logistically superior in prolonged management of a highly lethal aortic injury.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a viable technique for management of noncompressible torso hemorrhage. The major limitation of the current unilobed fully occlusive REBOA catheters is below-the-balloon ischemia-reperfusion complications. We hypothesized that partial aortic occlusion with a novel bilobed partial (p)REBOA-PRO would result in the need for less intraaortic balloon adjustments to maintain a distal goal perfusion pressure as compared with currently available unilobed ER-REBOA. METHODS: Anesthetized (40-50 kg) swine randomized to control (no intervention), ER-REBOA, or pREBOA-PRO underwent supraceliac aortic injury. The REBOA groups underwent catheter placement into zone 1 with initial balloon inflation to full occlusion for 10 minutes followed by gradual deflation to achieve and subsequently maintain half of the baseline below-the-balloon mean arterial pressure (MAP). Physiologic data and blood samples were collected at baseline and then hourly. At 4 hours, the animals were euthanized, total blood loss and urine output were recorded, and tissue samples were collected. RESULTS: Baseline physiologic data and basic laboratories were similar between groups. Compared with control, interventions similarly prolonged survival from a median of 18 minutes to over 240 minutes with comparable mortality trends. Blood loss was similar between partial ER-REBOA (41%) and pREBOA-PRO (51%). Partial pREBOA-PRO required a significantly lower number of intraaortic balloon adjustments (10 ER-REBOA vs. 3 pREBOA-PRO, p < 0.05) to maintain the target below-the-balloon MAP. The partial ER-REBOA group developed significantly increased hypercapnia, fibrin clot formation on TEG, liver inflammation, and IL-10 expression compared with pREBOA-PRO. CONCLUSION: In this highly lethal aortic injury model, use of bilobed pREBOA-PRO for a 4-hour partial aortic occlusion was logistically superior to unilobed ER-REBOA. It required less intraaortic balloon adjustments to maintain target MAP and resulted in less inflammation.

Resuscitative endovascular balloon occlusion of the aorta for thoracic trauma: A translational swine study.

Noncompressible torso hemorrhage in trauma is particularly lethal. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has the potential to stabilize these patients, but currently is contraindicated for major thoracic bleeding. The goal of this study was to evaluate the effect of REBOA on the hemodynamic and metabolic profile as well as its effect on early survival in a porcine model of thoracic hemorrhage and shock. METHODS: Forty-eight male Yorkshire swine (60-80 kg) underwent 30% hemorrhage and were randomized to three thoracic injuries, with and without zone 1 REBOA occlusion: pulmonary parenchymal injury, thoracic venous injury, or subclavian artery injury. Following hemorrhage, thoracic injuries were induced (time of major thoracic injury) and allowed to bleed freely. The REBOA groups had zone 1 occlusion after the thoracic injury, with deflation at the end of prehospital. All groups had whole blood resuscitation at the end of prehospital and were euthanized at end of the hospital care phase. Survival, total blood loss, mean arterial pressure, end-tidal CO2, and arterial blood gas parameters were analyzed. Statistical significance was determined by t tests and two-way repeated-measures analysis of variance. RESULTS: The use of REBOA improved the hemodynamics in all three injury patterns, with no differences observed in the outcomes of short-term survival and thoracic blood loss between the REBOA and non-REBOA groups. All groups showed equivalent changes in markers of shock (pH, HCO3, and base excess) prior to resuscitation. CONCLUSION: In this animal study of hemorrhage and major thoracic bleeding, the addition of zone 1 REBOA did not significantly affect short-term survival or blood loss, while providing hemodynamic stabilization. Therefore, in noncompressible thoracic bleeding, without immediate surgical capability, long-term outcomes may be improved with REBOA, and thoracic hemorrhage should not be considered contraindications to REBOA use.

Recanalization of Embolized Endovascular Intracranial Aneurysms and Changes in the Blood Viscosity: A Pilot Study.

BACKGROUND The purpose of our research was to evaluate the relationships between blood viscosity and recanalization of coiled intracranial aneurysms. MATERIAL AND METHODS The study included consecutives patients treated endovascularly by a team of experienced neurosurgeons and neuroradiologists due to brain aneurysm. A total of 50 patients (the average age was 57.48 years, SD=13.71) were assigned to 2 groups: group A with recanalization (4 male and 8 female patients) and group B without recanalization (10 male and 28 female patients) were examined. All patients underwent a 6-month follow-up of the whole-blood viscosity test with a Brookfield DV III+pro cone-plate viscometer using the Rheocalc program. Differences between groups were assessed using the Statistica 12 computer program (StatSoft Inc., Tulsa, OK, USA). RESULTS Studies have shown no significant difference in the age range between group A and B (P=0.31). In group A, higher viscosity values were found for whole blood [median: 4.14 dyn×sec/cm² (mPa×sec) quartile range 0.42], compared to group B [median: 3.92 dyn×sec/cm² (mPa×sec); quartile range 0.40; (P=0.04)]. This difference was significant (P=0.04). Additionally, the level of hematocrit was positively related with recanalization, the higher the hematocrit, the more frequent recanalization. A very strong and statistically significant relationship occurred between the frequency of recanalization and smoking (P<0.001). CONCLUSIONS The occurrence of higher values of whole blood viscosity which increase turbulent flow through the vessels may be a risk for recanalization of the coiled intracranial aneurysm.

Practice, Practice, Practice! Effect of Resuscitative Endovascular Balloon Occlusion of the Aorta Volume on Outcomes: Data From the AAST AORTA Registry.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an endovascular adjunct to hemorrhage control. Success relies on institutional support and focused training in arterial access. We hypothesized that hospitals with higher REBOA volumes will be more successful than low-volume hospitals at aortic occlusion with REBOA. METHODS: This is a retrospective study from the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery Registry from November 2013 to January 2018. Patients aged ≥18 y who underwent REBOA were included. Successful placement of REBOA catheters (defined as hemodynamic improvement with balloon inflation) was compared between high-volume (≥80 cases; two hospitals), mid-volume (10-20 cases; four hospitals), and low-volume (<10 cases; 14 hospitals) hospitals, adjusting for patient factors. RESULTS: Of 271 patients from 20 hospitals, 210 patients (77.5%) had successful REBOA placement. Most patients were male (76.0%) and sustained blunt trauma (78.1%). cardiopulmonary resuscitation (CPR) was ongoing at the time of REBOA placement in 34.5% of patients. Inpatient mortality was 67.4%, unchanged by hospital volume. Multivariable logistic regression found increased odds of successful REBOA placement at high-volume versus low-volume hospitals (odds ratio [OR], 7.50; 95% confidence interval [CI], 2.10-27.29; P = 0.002) and mid-volume versus low-volume hospitals (OR, 7.82; 95% CI, 1.52-40.31; P = 0.014) and decreased odds among patients undergoing CPR during REBOA placement (OR, 0.10; 95% CI, 0.03-0.34; P < 0.001) when adjusting for age, sex, mechanism of injury, prehospital CPR, CPR on admission, transfer status, hospital location of REBOA placement, Glasgow Coma Scale ≤ 13, and injury severity. CONCLUSIONS: Hospitals with higher REBOA volumes were more likely to achieve hemodynamic improvement with REBOA inflation. However, mortality and complication rates were unchanged. Independent of hospital volume, ongoing CPR is associated with a decreased odds of successful REBOA placement.

A standardized trauma-specific endovascular inventory.

We believe that the rapid and widespread adoption of resuscitative endovascular balloon occlusion of the aorta as well as enthusiasm for catheter-based strategies has led to increased interest in basic endovascular techniques among trauma surgeons. The aim of this article was to describe the most commonly performed endovascular procedures for trauma patients, the basic capital equipment and room set up, and a parsimonious inventory of disposable supplies needed to perform each procedure. Together, these make a standardized trauma-specific endovascular inventory. LEVEL OF EVIDENCE: Economic/decision, level V.