Resuscitative Endovascular Balloon Occlusion of Aorta: A Systematic Review.

BACKGROUND: The data on resuscitative endovascular balloon occlusion of the aorta (REBOA) use continue to grow with its increasing use in trauma centers. The data in her last 5 years have not been systematically reviewed. We aim to assess current literature related to REBOA use and outcomes among civilian trauma populations. METHODS: A literature search using PubMed, EMBASE, and JAMA Network for studies regarding REBOA usage in civilian trauma from 2016 to 2020 is carried out. This review followed preferred reporting items for systematic reviews and meta-analysis guidelines. RESULTS: Our search yielded 35 studies for inclusion in our systematic review, involving 4073 patients. The most common indication for REBOA was patient presentation in hemorrhagic shock secondary to traumatic injury. REBOA was associated with significant systolic blood pressure improvement. Of 4 studies comparing REBOA to non-REBOA controls, 2 found significant mortality benefit with REBOA. Significant mortality improvement with REBOA compared to open aortic occlusion was seen in 4 studies. In the few studies investigating zone placement, highest survival rate was seen in patients undergoing zone 3. Overall, reports of complications directly related to overall REBOA use were relatively low. CONCLUSION: REBOA has been shown to be effective in promoting hemodynamic stability in civilian trauma. Mortality data on REBOA use are conflicting, but most studies investigating REBOA vs. open occlusion methods suggest a significant survival advantage. Recent data on the REBOA technique (zone placement and partial REBOA) are sparse and currently insufficient to determine advantage with any particular variation. Overall, larger prospective civilian trauma studies are needed to better understand the benefits of REBOA in high-mortality civilian trauma populations. STUDY TYPE: Systematic Review. LEVEL OF EVIDENCE: III- Therapeutic.

Increased mortality with resuscitative endovascular balloon occlusion of the aorta only mitigated by strong unmeasured confounding: An expanded analysis using the National Trauma Data Bank.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is being increasingly adopted to manage noncompressible torso hemorrhage, but a recent analysis of the 2015 to 2016 Trauma Quality Improvement Project (TQIP) data set showed that placement of REBOA was associated with higher rates of death, lower extremity amputation, and acute kidney injury (AKI). We expand this analysis by including the 2017 data set, quantifying the potential role of residual confounding, and distinguishing between traumatic and ischemic lower extremity amputation. METHODS: This retrospective study used the 2015 to 2017 TQIP database and included patients older than 18 years, with signs of life on arrival, who had no aortic injury and were not transferred. Resuscitative endovascular balloon occlusions of the aorta placed after 2 hours were excluded. We adjusted for baseline variables using propensity scores with inverse probability of treatment weighting. A sensitivity analysis was then conducted to determine the strength of an unmeasured confounder (e.g., unmeasured shock severity/response to resuscitation) that could explain the effect on mortality. Finally, lower extremity injury patterns of patients undergoing REBOA were inspected to distinguish amputation indicated for traumatic injury from complications of REBOA placement. RESULTS: Of 1,392,482 patients meeting the inclusion criteria, 187 underwent REBOA. After inverse probability of treatment weighting, all covariates were balanced. The risk difference for mortality was 0.21 (0.14-0.29) and for AKI was 0.041 (-0.007 to 0.089). For the mortality effect to be explained by an unmeasured confounder, it would need to be stronger than any observed in terms of its relationship with mortality and with REBOA placement. Eleven REBOA patients underwent lower extremity amputation; however, they all suffered severe traumatic injury to the lower extremity. CONCLUSION: There is no evidence in the TQIP data set to suggest that REBOA causes amputation, and the evidence for its effect on AKI is considerably weaker than previously reported. The increased mortality effect of REBOA is confirmed and could only be nullified by a potent confounder. LEVEL OF EVIDENCE: Therapeutic/care management, level IV.

Is there a role for REBOA? A system assessment.

INTRODUCTION: To analyze our experience to quantify potential need for resuscitative endovascular balloon occlusion of the aorta (REBOA). METHODS: Retrospective review of patients over a three-year period who presented as a trauma with hemorrhagic shock. Patients were divided into two groups: REBOA Candidate vs. Non-candidates. Injuries, outcomes, and interventions were compared. RESULTS: Of 7643 trauma activations, only 37 (0.44%) fit inclusion criteria, of which 16 met criteria for candidacy for potential REBOA placement. The groups did not differ in terms of injury severity, physiology, age, timing of intervention, nor massive transfusion. Survival was linked to TRISS (p = 0.01) and Emergency Room Thoracotomy (p = 0.002). Of Candidates, 8 (50%) had injuries that could have benefited from REBOA, while 7 (44%) had injuries that could be associated with potential harm. DISCUSSION: The volume of patients who would potentially benefit from REBOA appears to be small and does not appear to support system wide adoption in the studied region. LEVEL OF EVIDENCE: IV.

The majority of major amputations after resuscitative endovascular balloon occlusion of the aorta are associated with preadmission trauma.

OBJECTIVE: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a potentially life-saving intervention. However, recent reports of associations with limb loss and mortality have called its safety into question. We aimed to evaluate patient and hospital characteristics associated with major amputation and in-hospital mortality among patients undergoing REBOA for trauma. METHODS: The National Trauma Data Bank (2015-2017) was queried for patients presenting to trauma centers and treated with REBOA. We included REBOA performed on hospital day 1 in patients who survived 6 or more hours from presentation. Univariable and multivariable analyses evaluated associations with major amputation and in-hospital mortality. RESULTS: A total of 316 patients underwent REBOA and survived in the acute period after presentation. Overall, mean age was 45 ± 20 years and the majority were male (73%) and White (56%). Most patients presented to level I trauma centers (72%) after blunt injuries (79%) with an average Injury Severity Score (ISS) of 31 ± 15, indicating major trauma. In 15 patients (5%), there were 18 major amputations-7 above knee and 11 below knee. A subgroup of 11 amputations were either traumatic amputations (73%) or mangled limbs requiring amputation within 24 hours (27%). Of the remaining amputations, 71% were associated with ipsilateral vascular or orthopedic lower extremity injuries of serious to severe Abbreviated Injury Scale severity. Comparing patients with amputations with those without amputations, there were no significant differences in patient demographics, comorbidities, or hospital characteristics. During hospitalization, patients requiring amputation more frequently received open peripheral vascular interventions (40% vs 10%; P = .002), underwent similar numbers of endovascular interventions (6.7% vs 4.7%; P = .5), and more often developed compartment syndrome (13% vs 2%; P = .04). Overall, there were 110 deaths (35%). The major amputation prevalence was similar between patients who died vs those who survived (3.6% vs 5.3%; P = .5). In multivariable analysis, prehospital cardiac arrest (odds ratio [OR], 8.47; 95% confidence interval [CI], 1.47-48.66; P = .02), penetrating vs blunt trauma (OR, 5.5; 95% CI, 1.05-28.82; P = .04), decreased Glasgow Coma Scale score (OR, 1.18; 95% CI, 1.05-1.32; P = .01), older age (OR, 1.06; 95% CI, 1.03-1.10; P < .001), and increased Injury Severity Score (OR, 1.05; 95% CI, 1.0-1.1; P = .03) were associated with higher mortality. CONCLUSIONS: The majority of major amputations in patients undergoing REBOA were secondary to the initial traumatic mechanism. Injury type and severity, as well as initial hemodynamic derangements, are associated with mortality after REBOA. Despite concerns about prohibitive limb complications of REBOA, baseline injuries seem to be the primary cause of limb loss, but further prospective analysis is needed.

Revised Injury Severity Classification II (RISC II) is a predictor of mortality in REBOA-managed severe trauma patients.

The evidence supporting the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in severely injured patients is still debatable. Using the ABOTrauma Registry, we aimed to define factors affecting mortality in trauma REBOA patients. Data from the ABOTrauma Registry collected between 2014 and 2020 from 22 centers in 13 countries globally were analysed. Of 189 patients, 93 died (49%) and 96 survived (51%). The demographic, clinical, REBOA criteria, and laboratory variables of these two groups were compared using non-parametric methods. Significant factors were then entered into a backward logistic regression model. The univariate analysis showed numerous significant factors that predicted death including mechanism of injury, ongoing cardiopulmonary resuscitation, GCS, dilated pupils, systolic blood pressure, SPO2, ISS, serum lactate level and Revised Injury Severity Classification (RISCII). RISCII was the only significant factor in the backward logistic regression model (p < 0.0001). The odds of survival increased by 4% for each increase of 1% in the RISCII. The best RISCII that predicted 30-day survival in the REBOA treated patients was 53.7%, having a sensitivity of 82.3%, specificity of 64.5%, positive predictive value of 70.5%, negative predictive value of 77.9%, and usefulness index of 0.385. Although there are multiple significant factors shown in the univariate analysis, the only factor that predicted 30-day mortality in REBOA trauma patients in a logistic regression model was RISCII. Our results clearly demonstrate that single variables may not do well in predicting mortality in severe trauma patients and that a complex score such as the RISC II is needed. Although a complex score may be useful for benchmarking, its clinical utility can be hindered by its complexity.

Does Clamshell Thoracotomy Better Facilitate Thoracic Life-Saving Procedures Without Increased Complication Compared with an Anterolateral Approach to Resuscitative Thoracotomy? Results from the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery Registry.

BACKGROUND: Resuscitative thoracotomy (RT) is life-saving in select patients and can be accomplished through a left anterolateral (AT) or clamshell thoracotomy (CT). CT may provide additional exposure, facilitating certain operative procedures, but the added blood and heat loss and time to perform it may increase complications. No prospective multicenter comparison of techniques has yet been reported. STUDY DESIGN: The observational AAST Aortic Occlusion for Resuscitation in Trauma and Acute care surgery (AORTA) registry was used to compare AT and CT in RT. RESULTS: AORTA recorded 1,218 RTs at 46 trauma centers from June 2014 to January 2020. Overall survival after RT was 6.0% (AT 6.6%; [59 of 900]; CT 4.2% [13 of 296], p = 0.132). Among all RTs, 11.1% (142 of 1,278) surviving at least 24 hours were used tocompare AT (112) and CT (30). There was no difference between the 2 groups withregard to age, sex, Injury Severity Score, or mechanism of injury (Table 1). CT was significantly more likely to be used in patients needing resection of the lung or cardiac repair. CT was not associated with increased local thoracic/systemic complications, higher transfusion requirement, or greater ventilator, ICU, or hospital days compared with AT. CONCLUSIONS: Clamshell thoracotomy facilitates thoracic life-saving procedures withoutincreased systemic or thoracic complications compared with AT in patients undergoing RT.

Application of Aortic Balloon Occlusion in Total Aortic Arch Replacement with Frozen Elephant Trunk on Clinical Endpoints for Aortic Dissection Patients.

PURPOSE: Total aortic arch replacement (TAR) with frozen elephant trunk (FET) is the standard operation for treating aortic dissection (AD) patients involving aortic arch with high operative risk due to long circulatory arrest (CA). We used aortic balloon occlusion technique that safely reduced the CA time to 5 min in average and investigated whether it can improve the clinical endpoints. METHODS: All patients diagnosed with AD and underwent TAR with FET operation (123 with aortic balloon occlusion and 221 with conventional method) in Fuwai Hospital during August 2017 and February 2019 was reviewed in this retrospective observational study. RESULTS: After propensity score matching, the 30-day mortality of aortic balloon occlusion group and conventional group was 4.88% and 11.38% (P = 0.062), respectively. In multivariate analysis, aortic balloon occlusion is one of the factors that reduced the risk for renal and hepatic injury, shortened postoperative conscious revival time, and reduced red blood cell (RBC) transfusion during operation. CONCLUSIONS: The aortic balloon occlusion technique, as a perfusion strategy during operation, could alleviate postoperative complication. This method deserves further attention in future clinical practice for its value in treating patients with higher operative risks.

Survival outcome in severe left-sided congenital diaphragmatic hernia with and without fetal endoscopic tracheal occlusion in a country with suboptimal neonatal management.

OBJECTIVE: To evaluate the impact of fetal endoscopic tracheal occlusion (FETO) on improving survival of fetuses with severe left-sided congenital diaphragmatic hernia (CDH), as compared with contemporaneous cases managed expectantly during pregnancy, in a country with suboptimal neonatal management. METHODS: In this prospective cohort study, consecutive fetuses with isolated left-sided CDH, normal karyotype and severe pulmonary hypoplasia (defined as liver herniation and observed/expected lung-to-head circumference ratio below 26%) were selected for FETO at less than 32 weeks of gestation in a single tertiary referral center in Queretaro, Mexico. Postnatal outcome (survival up to 28 days after birth) was compared between fetuses treated with FETO and contemporaneous cases with similar lung size managed expectantly during pregnancy. RESULTS: Twenty-five fetuses with isolated severe left-sided CDH treated with FETO were matched individually with 25 cases managed expectantly during pregnancy. Endotracheal placement of the balloon was performed successfully on the first attempt in all cases. The median gestational age (GA) at balloon placement was 29.1 (range, 25.6-31.8) weeks and 34.1 (range, 30.0-36.1) weeks at balloon removal. There were no technical problems with the introduction or removal of the balloon in any cases. The median GA at delivery was significantly lower in the group treated with FETO than in those managed expectantly (35.3 vs 37.7 weeks; P = 0.04). The survival rate was significantly higher in the group treated with FETO than in those without fetal intervention (32% vs 0%; P < 0.001). CONCLUSION: In settings with suboptimal neonatal management, FETO was associated with improved neonatal survival in fetuses with isolated left-sided CDH and severe pulmonary hypoplasia. Copyright © 2020 ISUOG. Published by John Wiley & Sons Ltd.

Resultado de supervivencia en una hernia diafragmática congénita grave del lado izquierdo, con y sin oclusión traqueal endoscópica fetal en un país con un tratamiento neonatal subóptimo OBJETIVO: Evaluar el impacto de la oclusión traqueal endoscópica fetal (OTEF) en la mejora de la supervivencia de los fetos con hernia diafragmática congénita (HDC) grave del lado izquierdo, en comparación con los casos actuales tratados como embarazo gestante, en un país con un tratamiento neonatal subóptimo. MÉTODOS: En este estudio prospectivo de cohortes, se seleccionaron fetos consecutivos con HDC aislada del lado izquierdo, cariotipo normal e hipoplasia pulmonar grave (definida como hernia hepática y una proporción observada/esperada de la circunferencia pulmonar-cabeza inferior al 26%) para una OTEF antes de las 32 semanas de gestación, en un único centro de medicina especializada terciaria en Querétaro (México). El resultado postnatal (supervivencia hasta los 28 días después del nacimiento) se comparó entre fetos tratados con OTEF y los casos contemporáneos con tamaño pulmonar similar, tratados como embarazo gestante. RESULTADOS: Veinticinco fetos con HDC grave aislada del lado izquierdo que habían sido tratados con OTEF fueron emparejados individualmente con 25 casos tratados como embarazo gestante. La colocación endotraqueal del globo se realizó con éxito en el primer intento en todos los casos. La mediana de la edad gestacional (EG) en el momento de la colocación del globo fue de 29,1 (rango, 25,6-31,8) semanas y 34,1 (rango, 30,0-36,1) semanas cuando se retiró el globo. En ningún caso hubo problemas técnicos con la introducción o la retirada del globo. La mediana de la EG en el momento del parto fue significativamente menor en el grupo tratado con OTEF que en el grupo tratado como gestante (35,3 vs 37,7 semanas; P=0,04). La tasa de supervivencia fue significativamente más alta en el grupo tratado con OTEF que en los casos sin intervención fetal (32% vs 0%; P<0,001). CONCLUSIÓN: En los entornos con un tratamiento neonatal subóptimo, la OTEF se asoció con una mejora de la supervivencia neonatal en los fetos con HDC aislada del lado izquierdo y con hipoplasia pulmonar grave. Copyright © 2020 ISUOG. Published by John Wiley & Sons Ltd.

Balloon Tamponade and Esophageal Stenting for Esophageal Variceal Bleeding in Cirrhosis: A Systematic Review and Meta-analysis.

Failure to control variceal bleeding with current recommendations occurs in 10 to 20% of cases. This systematic review and meta-analysis analyzes the experience, results, and complications of "bridge" therapies for failure to control acute variceal bleeding: balloon tamponade and esophageal stents. The main outcomes assessed were failure to control bleeding and mortality in the short-term and medium-term follow-up, and adverse events. Balloon tamponade studies had a pooled rate of short-term failure to control bleeding of 35.5%, and adverse events in over 20% of cases; 9.7% resulting in death. Stenting failed to control bleeding in the short term and medium term in 12.7 and 21.5% of cases of severe or refractory variceal bleeding, respectively, despite stent migration in 23.8% of cases. Medium-term mortality rates were similar in both therapies. Although only one trial compared these treatments, the available evidence consistently supports that stents serve as a better and safer bridge therapy in refractory acute variceal bleeding.

Balloon Retrograde Transvenous Obliteration Versus Endoscopic Cyanoacrylate in Bleeding Gastric Varices: Comparison of Rebleeding and Mortality with Extended Follow-up.

PURPOSE: To assess short- and long-term mortality and rebleeding with endoscopic cyanoacrylate (EC) versus balloon-occluded retrograde transvenous obliteration (BRTO). MATERIALS AND METHODS: A retrospective cohort comparison was conducted of 90 EC patients and 71 BRTO patients from 1997 through 2015 with portal hypertension who presented due to endoscopically confirmed bleeding cardiofundal gastric varices. Patients underwent either endoscopic intra-varix injection of 4-carbon-n-butyl-2-cyanoacrylate or sclerosis with sodium tetradecyl sulfate with balloon occlusion for primary variceal treatment. RESULTS: Seventy-one BRTO patients and 90 EC patients, of whom 89% had cirrhosis and 35% were women, were included, with a respective average Model for End-Stage Liver Disease (MELD) score of 13.4 and 14.4, respectively. Mortality at 6 weeks was 14.4% for EC patients and 13.1% for BRTO patients (Kaplan-Meier/Wilcoxon, P = .85). No long-term mortality difference was observed (Cox hazard ratio [HR] = 0.89, P = .64). Also, 5.1% of EC patients and 3.5% of BRTO patients (Kaplan-Meier/Wilcoxon, P = .62) rebled at 6 weeks, but at 1 year, 22.0% of EC patients and 3.5% of BRTO patients had rebled (Kaplan-Meier/Wilcoxon, P < .01). Lower rates of long-term rebleeding were found with BRTO (Cox HR = 0.25, P = .03). No difference was seen in the rate of new portal hypertensive complications (Cox HR = 1.21, P = .464). However, 16/71 patients who underwent BRTO had simultaneous transjugular intrahepatic portosystemic shunt. Age, sex, MELD score, and presence of cirrhosis were the primary predictors of mortality. One death in the EC group and 5 deaths in the BRTO group were deemed to be procedurally related (chi-square, P = .088). CONCLUSIONS: BRTO is associated with a lower rate of rebleeding but no change in mortality.

Ruptured Abdominal Aortic Aneurysm Treated by Double-Balloon Technique and Endovascular Strategy: Case Series.

PURPOSE: Mortality in patients with ruptured abdominal aortic aneurysms (rAAAs) has remained high despite advances in interventions. Endovascular aneurysm repair (EVAR) was recently developed for treatment of rAAAs. In this study, we assessed our endovascular strategy including a double-balloon technique for rAAA. METHODS: We analyzed 12 consecutive patients with rAAAs who were treated by our double-balloon technique and endovascular strategy from March 2013 to July 2016. RESULTS: The 30-day and 1-year mortality rates were both 17%. The mean times from admission to arrival at the hybrid operating room, from admission to aortic occlusion, and from admission to completion of EVAR were 46.8, 63.5, and 110.0 minutes, respectively. CONCLUSION: This study indicates that the herein-described double-balloon endovascular technique is feasible for use in the management of rAAA.

Traumatic cardiac arrest and resuscitative endovascular balloon occlusion of the aorta (REBOA): a preliminary analysis utilizing high fidelity invasive blood pressure recording and videography.

PURPOSE: Aortic occlusion (AO) increases proximal perfusion and may improve rates of return of spontaneous circulation (ROSC). The objective of this study was to investigate the hemodynamic effects of cardiopulmonary resuscitation (CPR) and AO by REBOA on patients in traumatic cardiac arrest. METHODS: Patients admitted between February 2013 and May 2017 at a tertiary center who suffered traumatic arrest, had an arterial line placed during resuscitation, and received CPR and REBOA which were included. In-hospital CPR data were obtained from videography. Arterial waveforms were recorded at 240 Hz. RESULTS: 11 consecutive patients were included, 82% male; mean (± SD) age 37 ± 19 years. 55% suffered blunt trauma and the remaining penetrating injuries. 64% arrested out of hospital. During compressions with AO, the mean systolic blood pressure (SBP) was 70 ± 22 mmHg, mean arterial pressure (MAP) 43 ± 19 mmHg, and diastolic blood pressure (DBP) 26 ± 17 mmHg. Nine (82%) had ROSC, with eight having multiple periods of ROSC and arrest in the initial period. In-hospital mortality was 82%. Cardiac ultrasonography was used during arrest in 73%. In two patients with arterial line data before and after AO, SBP (mmHg) improved from 51 to 73 and 55 to 96 during arrest after AO. CONCLUSIONS: High-quality chest compressions coupled with aortic occlusion may generate adequate perfusion pressures to increase the rate of ROSC. New technology capable of transducing central arterial pressure may help us to understand the effectiveness of CPR with and without aortic occlusion. REBOA may be a useful adjunct to high-quality chest compressions during arrest.

Balloon protection of the left subclavian artery in debranching thoracic endovascular aortic repair.

OBJECTIVES: Since 2012, we have routinely applied balloon protection of the proximal left subclavian artery to prevent embolic events through the left vertebral artery during debranching thoracic endovascular aortic repair. This study aimed to study the effectiveness of balloon protection of the proximal left subclavian artery. METHODS: We reviewed the medical records of 157 patients who underwent debranching thoracic endovascular aortic repair between 2007 and 2017. Of these, 71 patients for whom balloon protection of the proximal left subclavian artery was used were assigned to the balloon protection of the proximal left subclavian artery group (58 men; age: 78 ± 6.7 years), and 86 patients were assigned to the control group (66 men; age: 78 ± 8.9 years). A total of 51 patients from each group were matched by their propensity scores to adjust for differences in the patients' characteristics. RESULTS: Perioperative stroke was significantly lower in the balloon protection of the proximal left subclavian artery group than in the control group (0%: 0/71 vs 7.9%: 7/86, P = .014). Freedom from all causes of mortality at 2 and 4 years was significantly higher in the balloon protection of the proximal left subclavian artery group compared with the control group (93%/76% vs 77%/59%, P = .015). Freedom from aortic death at 2 and 4 years was similar in both groups (97%/97% vs 91%/86%, P = .094). Propensity score matching yielded similar results of better freedom from all causes of mortality in the balloon protection of the proximal left subclavian artery group (93%/93% vs 81%/63%, P = .017) and equivalent aortic death in both groups (95%/95% vs 92%/88%, P = .30). CONCLUSIONS: Debranching thoracic endovascular aortic repair using balloon protection of the proximal left subclavian artery demonstrated more appropriate early and late outcomes. Evaluation using propensity score matching enhanced the efficacy of balloon protection of the proximal left subclavian artery.

External aortic clamping versus endoaortic balloon occlusion in minimally invasive cardiac surgery: a systematic review and meta-analysis.

OBJECTIVES: Minimally invasive cardiac valve surgery is safe, effective and increasingly popular. It is performed worldwide with the use of either external aortic clamping or endoaortic balloon occlusion. METHODS: We conducted a literature search using MEDLINE, EMBASE, Scopus and Web of Science. Primary outcomes included aortic dissection, conversion to sternotomy, mortality, stroke and cross-clamp time. Secondary outcomes included atrial fibrillation, acute kidney injury, reoperation for bleeding, cardiopulmonary bypass times, myocardial infarction, use of intra-aortic balloon pump and length of hospital stay. The random effects model was used to calculate the outcomes of both binary and continuous data. RESULTS: Thirty retrospective studies were included in the meta-analysis. The incidence of aortic dissection (pooled odds ratio = 3.88, 95% confidence interval = 1.06-14.18; P =0.04) and conversion to sternotomy (pooled odds ratio = 3.07, 95% confidence interval = 1.33-7.10; P = 0.009) was higher in the endoaortic balloon occlusion group than in the external aortic clamping group, in whom a direct comparison was possible. The remaining observational studies did not show any significant differences in either group. There was no significant difference in 30-day mortality (P = 0.37), stroke (P = 0.26), cross-clamp time (P = 0.20), atrial fibrillation (P = 0.18), acute kidney injury (P = 0.49), reoperation for bleeding (P = 0.24), cardiopulmonary bypass time (P = 0.06), myocardial infarction (P = 0.74), use of intra-aortic balloon pump (P = 0.11) or length of hospital stay (P = 0.47). CONCLUSIONS: External aortic clamping may be safer than endoaortic balloon occlusion with respect to aortic dissection and conversion to sternotomy. However, mortality, length of stay, stroke, cross-clamp time and other cardiovascular complication rates were similar between the 2 techniques.

Resuscitative Endovascular Balloon Occlusion of the Aorta for Hemorrhage Control in Trauma Patients: An Evidence-Based Review.

Traditionally, resuscitative efforts for uncontrolled noncompressible torso hemorrhage are achieved by cross-clamping the proximal aorta via thoracotomy to deliver temporary hemodynamic stability during injury repair. A less commonly used method of promoting early resuscitation and hemorrhagic control in trauma patients is resuscitative endovascular balloon occlusion of the aorta (REBOA). The focus of this literature review is to examine the effectiveness of REBOA in the management of noncompressible pelvic hemorrhage when compared with traditional methods of hemorrhage control in trauma patients. A literature search was performed by using the PubMed database to explore studies that defined the efficacy of REBOA or compared the use of REBOA with resuscitative thoracotomy with aortic cross-clamping for hemorrhage control. Studies encompassed in the review included 3 experimental studies utilizing swine, 2 retrospective studies that reviewed data collected from procedures performed in empirical situations, and a case series that described the implementation of REBOA. Trauma patients with noncompressible torso hemorrhage that is intervened with REBOA have higher mean arterial pressures and systolic blood pressures, require fewer boluses of intravenous fluids and vasopressors, avoid severe acidosis and ischemia, and have significantly lower rates of mortality, thus ensuring enhanced long-term outcomes. Evidence suggests that hemodynamic stability, physiological effects, and mortality rates are improved in patients who receive REBOA for torso hemorrhage control when compared with traditional methods.

Partial occlusion, conversion from thoracotomy, undelayed but shorter occlusion: resuscitative endovascular balloon occlusion of the aorta strategy in Japan.

INTRODUCTION: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a viable alternative to resuscitative thoracotomy (RT) in refractory hemorrhagic patients. We evaluated REBOA strategies using Japanese multi-institutional data. PATIENTS AND METHODS: The DIRECT-IABO investigators registered trauma patients requiring REBOA from 18 hospitals. Patients' characteristics, outcomes, and time in initial treatment were collected and analyzed. RESULTS: From August 2011 to December 2015, 106 trauma patients were analyzed. The majority of patients were men (67%) (median BMI of 22 kg/m, 96% blunt injured). REBOA occurred in the field (1.9%, all survived >30 days), emergency department (75%), angiography suite (17%), and operating room (1.9%). Initial deployment was at zone I in 93% and partial occlusion in 70% of cases. RT and REBOA were combined in 30 patients (RT+REBOA group) who showed significantly higher injury severity score (44 vs. 36, P=0.001) and chest abbreviated injury scale (4 vs. 3; P<0.001) than the REBOA-alone group (n=76). Frequent cardiopulmonary resuscitation (73%), longer prothrombin time-international normalised ratio, lower pH, and higher lactate were observed in the RT+REBOA. Among 24 h nonsurvivors (n=30) of the REBOA alone, preocclusion systolic blood pressure was lower (43 vs. 72 mmHg; P=0.002), indicating impending cardiac arrest, and duration of occlusion was longer (60 vs. 31 min; P=0.010). In the RT+REBOA (n=30), six survived beyond 24 h, three beyond 30 days, and achieved survival discharge. CONCLUSION: Partial occlusion was performed in 70% of patients. Undelayed deployment of REBOA without presenting impending cardiac arrest with shorter balloon occlusion (<30 min at zone I with partial occlusion) might be related to successful hemodynamic stabilization and improved survival. Further evaluation should be performed prospectively.

Contemporary outcomes for ruptured abdominal aortic aneurysms using endovascular balloon control for hypotension.

OBJECTIVE: Ruptured abdominal aortic aneurysm (rAAA) continues to portend significant mortality, despite ruptured endovascular aneurysm repair (rEVAR), enhanced perioperative care, and endovascular balloon control (EBC) for hypotension. We review our academic institution's experience using a protocol of EBC for all hypotensive patients, irrespective of type of repair. METHODS: A retrospective review was conducted of 66 cases of rAAA treated at a single academic institution from 2007 to 2016 using EBC for hypotensive patients. Demographics, comorbidities, intraoperative parameters, and clinical outcomes were recorded. Patients were studied with respect to hemodynamic status, rEVAR, or ruptured open aortic repair in the setting of EBC for hypotension. RESULTS: rEVAR was performed in 43 patients (65%) and ruptured open aortic repair in 23 patients (35%). rAAA was treated in 51 men (77%). Mean rAAA size was 7.6 mm, and mean age of the patients was 73 years. Perioperative survival was 82%. Overall survival at 30 days, 1 year, and 5 years was 71%, 65%, and 52%. Blood transfusion and severe hypotension were significant predictors of mortality at 30 days on multivariable analysis (odds ratio of 1.2 [P = .08] and 39 [P = .03], respectively). Severe hypotension was defined as a mean arterial blood pressure <65 mm Hg and vasopressor use and was present in 59% of the cohort. Normotension was defined as an absence of these conditions and was present in 12%, with 29% of patients exhibiting moderate hypotension. There was no difference in 30-day survival between normotensive and moderately hypotensive patients. The 30-day survival for severely hypotensive patients was 61% vs 85% for moderately hypotensive patients (P = .003), with a significant difference between groups that persisted at 1 year (85% vs 51%; P = .008) and 5 years (66% vs 51%; P = .017). CONCLUSIONS: Good midterm outcomes for moderately hypotensive and normotensive patients can be obtained using an EBC protocol for hypotension with a regionalized transport system directly to the operating room. Severely hemodynamically unstable rAAA patients still pose a significant challenge despite mitigation of hypotension by EBC, suggesting that survival may be compromised by factors other than hypotension alone. We still advocate for the use of EBC for all hypotensive patients as part of a defined rAAA protocol before definitive repair.

Resuscitative endovascular balloon occlusion of the aorta in trauma patients in youth.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) has received increasing attention for critically uncontrolled hemorrhagic shock. However, the efficacy of REBOA in patients in youth is unknown. OBJECTIVES: The aim of this study was to evaluate the mortality and characteristics of patients of age ≤18 years with severe traumatic injury who received REBOA. METHODS: We retrospectively analyzed observational cohort data from the Japan Trauma Data Bank (JTDB) from 2004 to 2015. All patients ≤18 years old who underwent REBOA were included. Clinical characteristics and mortalities were analyzed and compared among patients ≤15 years old (young children) and 16-18 years old (adolescents). RESULTS: Of the 236,698 patients in the JTDB (2004-2015), 22,907 patients were 18 years old or younger. A total of 3,440 patients without survival data were excluded. Of the remaining 19,467, 54 (0.3%) patients underwent REBOA, among which 15 (27.8%) were young children. Both young children and adolescents who underwent REBOA were seriously injured (median Injury Severity Score [ISS], 41 and 38, respectively). Also, 53.3% of young children and 38.5% of adolescents survived to discharge after undergoing REBOA. CONCLUSION: In a cohort of young trauma patients from the JTDB who underwent REBOA to control hemorrhage, we found that both young children and adolescents who underwent REBOA were seriously injured and had an equivalent survival rate compared to the reported survival rate from studies in adults. REBOA treatment may be a reasonable option in severely injured young patients in the appropriate clinical settings. Further prospective studies are needed to confirm our findings. LEVEL OF EVIDENCE: Epidemiologic study, level III; therapeutic study, level IV.

Treatment Results of Radiotherapy Combined with Balloon-occluded Arterial Infusion Chemotherapy for Invasive Bladder Cancer.

AIM: We present preliminary results from our clinical study evaluating the effectiveness of combination of radiotherapy with balloon-occluded arterial infusion (BOAI) and hemodialysis (HD) for bladder cancer. PATIENTS AND METHODS: We investigated 134 patients with a median age of 67 years (range=38-88 years) and a median follow-up time of 31 months. According to the UICC classification, 89 patients were at clinical stage T2, 40 at T3, and 5 at T4. All patients received external-beam radiation therapy (EBRT) of 50 Gy to the whole pelvis with 10 Gy to the bladder as a boost. During EBRT, BOAI of cisplatin (CDDP) (100 mg/body) was administered from bilateral internal iliac arteries with simultaneous HD to prevent back-flow of CDDP into the systemic circulation. RESULTS: Three-year local control and overall survival (OS) rates were 68% and 80%, respectively, and 3-year bladder preservation rate was 90%. Univariate and multivariate analysis showed that T stage and primary effect were significant prognostic factors for OS. In addition, primary effect was a significant prognostic factor for bladder preservation. None of the patients had grade 2 or more severe hematological toxicity. Late grade ≥3 genitourinary (GU) and gastrointestinal (GI) complications were observed in 6% and 2% of the patients, respectively. CONCLUSION: Combination of radiotherapy with BOAI and HD, associated with reduced hematological toxicity, may be regarded as a curative therapy for patients with bladder cancer. Late GU and GI complications were within acceptable limits. T stage is an important predictive factor for the outcome of this therapy.

Resuscitative endovascular balloon occlusion of the aorta (REBOA): Comparison with immediate transfusion following massive hemorrhage in swine.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is less invasive than emergency department thoracotomy for the treatment of massive hemorrhage. We evaluated the effects of REBOA on carotid blood flow (Qcarotid) in a porcine model of massive hemorrhage. We hypothesized that REBOA restores Qcarotid faster than reinfusion of blood. METHODS: Spontaneously breathing sedated Sinclair pigs underwent exponential hemorrhage of 65% total blood volume in 1 hour. They were randomized into three groups. Positive control (PC, n = 7) underwent immediate transfusion of shed blood. REBOA (n = 21) received a novel 7 Fr ER-REBOA catheter (Pryor Medical, Arvada, CO) placed into aortic Zone 1 via a femoral artery introducer for 30 minutes or 60 minutes, with transfusion either after deflation or midway through inflation. Negative control (n = 7) received no resuscitation. Qcarotid was recorded continuously using an ultrasonic flow probe. Survival and time between Qcarotid, min and both a stable maximal value (Qcarotid, max) and restoration of baseline flow (Qcarotid, new BL) were compared by Kaplan-Meier analysis. RESULTS: Median time to Qcarotid, max was 3.0 minutes in the REBOA group versus 9.6 minutes in the control group (p = 0.006). Median time to Qcarotid, new BL was 6.0 minutes in the REBOA group versus 20.5 minutes in the PC group (p = 0.11). Slope of the linear regression between Qcarotid, min and Qcarotid, new BL was 16.7 in REBOA and 10.4 in PC (p = 0.31). Four-hour survival was 95% (20 of 21) in the REBOA group versus 71% (5 of 7) in the PC group (p = 0.06) and 0% in the negative control group. CONCLUSION: REBOA resulted in the restoration of Qcarotid ("cerebrovascular resuscitation") at least as rapidly as retransfusion of shed blood, with equivalent 4-hour survival. Further studies of REBOA, to include mitigation of end-organ effects and longer follow-up, are needed.