Preoperative Prophylactic Balloon-Assisted Occlusion of the Internal Iliac Arteries in the Management of Placenta Increta/Percreta.

Background and Objectives: Preoperative prophylactic balloon-assisted occlusion (PBAO) of the internal iliac arteries minimizes blood loss and facilitates surgery performance, through reductions in the rate of uterine perfusion, which allow for better control in hysterectomy performance, with decreased rates of bleeding and surgical complications. We aimed to investigate the maternal and fetal outcomes associated with PBAO use in women with placenta increta or percreta. Material and Methods: The records of 42 consecutive patients with a diagnosis of placenta increta or percreta were retrospectively reviewed. Of 42 patients, 17 patients (40.5%) with placenta increta or percreta underwent cesarean delivery after prophylactic balloon catheter placement in the bilateral internal iliac artery (balloon group). The blood loss volume, transfusion volume, postoperative hemoglobin changes, rates of hysterectomy and hospitalization, and infant Apgar score in this group were compared to those of 25 similar women who underwent cesarean delivery without balloon placement (surgical group). Results: The mean intraoperative blood loss volume in the balloon group (2319 ± 1191 mL, range 1000-4500 mL) was significantly lower than that in the surgical group (4435 ± 1376 mL, range 1500-10,500 mL) (p = 0.037). The mean blood unit volume transfused in the balloon group (2060 ± 1154 mL, range 1200-8000 mL) was significantly lower than that in the surgical group (3840 ± 1464 mL, range 1800-15,200 mL) (p = 0.043). There was no significant difference in the postoperative hemoglobin change, hysterectomy rates, length of hospitalization, or infant Apgar score between the groups. Conclusion: PBAO of the internal iliac artery prior to cesarean delivery in patients with placenta increta or percreta is a safe and minimally invasive technique that reduces the rate of intraoperative blood loss and transfusion requirements.

A Randomized Controlled Trial using iTClamp, Direct Pressure, and Balloon Catheter Tamponade to Control Neck Hemorrhage in a Perfused Human Cadaver Model.

BACKGROUND: Penetrating neck wounds are common in the civilian and military realms. Whether high or low velocity, they carry a substantial morbidity and mortality rate. OBJECTIVES: We endeavored to ascertain whether the iTClamp is equivalent to direct manual pressure (DMP) and Foley catheter balloon tamponade (BCT). METHODS: Using a perfused cadaver, a 4.5-cm wound was made in Zone 2 of the neck with a 1-cm carotid arteriotomy. Each of the hemorrhage control modalities was randomized and then applied to the wound separately. Time to apply the device and fluid loss with and without neck motion was recorded. RESULTS: There was no significant difference between the fluid loss/no movement (p > 0.450) and fluid loss/movement (p > 0.215) between BCT and iTClamp. There was significantly more fluid lost with DMP than iTClamp with no movement (p > 0.000) and movement (p > 0.000). The iTClamp was also significantly faster to apply than the Foley (p > 0.000). CONCLUSIONS: The iTClamp and BCT were associated with significantly less fluid loss than DMP in a perfused cadaver model. The iTClamp required significantly less time to apply than the BCT. Both the iTClamp and the BCT were more effective than simple DMP. The iTClamp offers an additional option for managing hard-to-control bleeding in the neck.

Thoracic trauma in military settings: a review of current practices and recommendations.

PURPOSE OF REVIEW: To examine current literature on thoracic trauma related to military combat and to explore its relevance to the civilian population. RECENT FINDINGS: Damage control resuscitation (DCR) has improved the management of hemorrhaging trauma patients. Permissive hypotension below 110 mmHg and antifibrinolytic use during DCR is widely accepted, whereas the use of freeze-dried plasma and whole blood is gaining popularity. The Modified Physiologic Triaging Tool can be used for primary triage and it may have applications in civilian trauma systems. Although Tactical Combat Casualty Care protocol recommends the Cric-Key device for surgical cricothyroidotomies, other devices may offer comparable performance. Recommendations for regional anesthesia after blunt trauma are not well defined. Increasing amounts of evidence favor the use of extracorporeal membrane oxygenation for refractory hypoxemia and resuscitative endovascular balloon occlusion of the aorta (REBOA) for severe hemorrhage. REBOA outcomes are potentially improved by partial occlusion and small 7 Fr catheters. SUMMARY: The Global War on Terror has provided opportunities to better understand and treat thoracic trauma in military settings. Trauma registries and other data sources have contributed to significant advancements in the management of thoracic trauma in military and civilian populations.

Current Approaches to the Treatment of Gastric Varices: Glue, Coil Application, TIPS, and BRTO.

Gastric varices are less common than esophageal varices, and their treatment is quite challenging. Gastric varix bleedings (GVB) occur less frequently than esophageal varix (EV) bleedings and represent 10% to 30% of all variceal bleedings. They are; however, more severe and are associated with high mortality. Re-bleeding may occur in 35% to 90% of cases after spontaneous hemostasis. GV bleedings represent a serious clinical problem compared with esophageal varices due to their location. Sclerotherapy and band ligation, in particular, are less effective. Based on the anatomic site and location, treatment differs from EV and is categorized into two groups (i.e., endoscopic or radiologic treatment). Surgical management is used less frequently. Balloon-occluded retrograde transvenous obliteration (BRTO) and cyanoacrylate are safe but there is a high risk of re-bleeding. Portal pressure elevates following BRTO and leads to worsening of esophageal varix pressure. Other significant complications may include hemoglobinuria, abdominal pain, fever, and pleural effusion. Shock and atrial fibrillation are major complications. New and efficient treatment modalities will be possible in the future.

Predictors of a Persistent Status of Pulmonary Vein Electrical Isolation by a Cryoballoon Application for Drug-Refractory Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation (PVI) using a cryoballoon (CB) is utilized for treating atrial fibrillation. This study aimed to assess the effect of the procedural characteristics of CB-based PVI (CB-PVI) on late PV reconnections.Methods and Results:A total of 389 consecutive patients underwent the CB-PVI as their index procedure; 45 consecutive patients underwent re-do procedures (184±87 days after the index CB-PVI). A total of 146 of 178 PVs (82%) remained isolated. The occlusion grade was evaluated in 171 PVs. Complete PV occlusion by the CB (grade 4) was obtained in 122 of 171 PVs (71%) during the index CB-PVI and the PVI status was maintained in 111 PVs (91%). Among the remaining 49 CB-PVIs without complete PV occlusion (grades 1-3), 20 PVs (41%) had late PV reconnections despite successful PVI during the index CB-PVI. A "pull-down maneuver" was performed in 20 PVs because of leakage of blood at the inferior aspect of the PVs, and all those PVs with a successful pull-down maneuver maintained their PVI status. A multivariate analysis demonstrated that the presence of complete PV occlusion was the only independent predictor for persistence of PVI. CONCLUSIONS: The occlusion grade was a reliable predictor of the long-term durability of PVI.

Study of the utility and problems of common iliac artery balloon occlusion for placenta previa with accreta.

AIMS: We investigated whether common iliac artery balloon occlusion (CIABO) was effective for decreasing blood loss during cesarean hysterectomy (CH) in patients with placenta previa with accreta and was safe for mothers and fetuses. METHODS: Of the 67 patients who underwent CH for placenta previa with accreta at our facility from 1985 to 2014, 57 patients were eligible for the study. The amount of intraoperative bleeding during CH was compared between three groups: surgery without blood flow occlusion (13 patients), internal iliac artery ligation (15 patients) and CIABO (29 patients). Additionally, multivariate analysis was performed to assess risk factors for massive bleeding during CH. RESULTS: The mean blood loss in the CIABO group (2027 ± 1638 mL) was significantly lower than in the other two groups (3787 ± 2936 mL in the no occlusion, 4175 ± 1921 mL in the internal iliac artery ligation group; P < 0.05). Multivariate analysis showed that spontaneous placental detachment during surgery (odds ratio [OR] 49.174, 95% confidence interval [CI] 4.98-1763.67), a history of ≥ 2 cesarean sections (OR 9.226, 95% CI 1.07-231.15) and no use of CIABO (OR 26.403, 95% CI 3.20-645.17) were significantly related to massive bleeding during surgery. There was no case of necrosis resulting from ischemia. The mean radiation dose during balloon placement never exceeded the threshold value for fetal exposure. CONCLUSION: Bleeding during CH for placenta previa with accreta can be decreased by CIABO. This study also confirmed the safety of CIABO in regard to maternal lower limb ischemia and fetal radiation exposure during balloon placement.

Resuscitative Endovascular Balloon Occlusion of the Aorta Using a Low-Profile Device is Easy and Safe for Emergency Physicians in Cases of Life-Threatening Hemorrhage.

BACKGROUND: Bleeding from hemorrhagic shock can be immediately controlled by blocking the proximal part of the hemorrhagic point using either resuscitative thoracotomy for aortic cross-clamping or insertion of a large-caliber (10-14Fr) resuscitative endovascular balloon occlusion of the aorta (REBOA) device via the femoral artery. However, such methods are very invasive and have various complications. With recent progress in endovascular treatment, a low-profile REBOA device (7Fr) has been developed. OBJECTIVE: The objective of this study was to report our experience of this low-profile REBOA device and to evaluate the usefulness of emergency physician-operated REBOA in life-threatening hemorrhagic shock. METHODS: Ten patients with refractory hemorrhagic shock underwent REBOA using this device via the femoral artery. All REBOA procedures were performed by emergency physicians. The success rate of the insertion, vital signs, and REBOA-related complications were evaluated. RESULTS: Median age was 54 years (interquartile range 33-78 years). The causes of hemorrhagic shock were trauma (n = 4; 1 blunt and 3 penetrating), ruptured abdominal aortic aneurysm (n = 3), and obstetric hemorrhage (n = 3). Two patients had cardiopulmonary arrest upon arrival. REBOA procedure was successful in all patients, and all became hemodynamically stable to undergo definitive interventions after REBOA. There were no REBOA-related complications. The mortality rate within 24 h and 30 days was 40%. CONCLUSIONS: This REBOA device was useful for emergency physicians in life-threatening hemorrhagic shock because of its ease in handling and low invasiveness.

A comparison of Selective Aortic Arch Perfusion and Resuscitative Endovascular Balloon Occlusion of the Aorta for the management of hemorrhage-induced traumatic cardiac arrest: A translational model in large swine.

BACKGROUND: Survival rates remain low after hemorrhage-induced traumatic cardiac arrest (TCA). Noncompressible torso hemorrhage (NCTH) is a major cause of potentially survivable trauma death. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) at the thoracic aorta (Zone 1) can limit subdiaphragmatic blood loss and allow for IV fluid resuscitation when intrinsic cardiac activity is still present. Selective Aortic Arch Perfusion (SAAP) combines thoracic aortic balloon hemorrhage control with intra-aortic oxygenated perfusion to achieve return of spontaneous circulation (ROSC) when cardiac arrest has occurred. METHODS AND FINDINGS: Male Yorkshire Landrace cross swine (80.0 ± 6.0 kg) underwent anesthesia, instrumentation for monitoring, and splenectomy. TCA was induced by laparoscopic liver lobe resection combined with arterial catheter blood withdrawal to achieve a sustained systolic blood pressure <10 mmHg, cardiac arrest. After 3 min of arrest, swine were allocated to one of three interventions: (1) REBOA plus 4 units of IV fresh whole blood (FWB), (2) SAAP with oxygenated lactated Ringer's (LR), 1,600 mL/2 min, or (3) SAAP with oxygenated FWB 1,600 mL/2 min. Primary endpoint was survival to the end of 60 min of resuscitation, a simulated prehospital phase. Thirty animals were allocated to 3 groups (10 per group)-5 protocol exclusions resulted in a total of 35 animals being used. Baseline measurements and time to cardiac arrest were not different amongst groups. ROSC was achieved in 0/10 (0%, 95% CI 0.00-30.9) REBOA, 6/10 (60%, 95% CI 26.2-87.8) SAAP-LR and 10/10 (100%, 95% CI 69.2-100.0) SAAP-FWB animals, p < 0.001. Survival to end of simulated 60-minute prehospital resuscitation was 0/10 (0%, 95% CI 0.00-30.9) for REBOA, 1/10 (10%, 95% CI 0.25-44.5) for SAAP-LR and 9/10 (90%, 95% CI 55.5-99.7) for SAAP-FWB, p < 0.001. Total FWB infusion volume was similar for REBOA (2,452 ± 0 mL) and SAAP-FWB (2,250 ± 594 mL). This study was undertaken in laboratory conditions, and as such may have practical limitations when applied clinically. Cardiac arrest in this study was defined by intra-aortic pressure monitoring that is not feasible in clinical practice, and as such limits the generalizability of findings. Clinical trials are needed to determine if the beneficial effects of SAAP-FWB observed in this laboratory study will translate into improved survival in clinical practice. CONCLUSIONS: SAAP conferred a superior short-term survival over REBOA in this large animal model of hemorrhage-induced traumatic cardiac arrest with NCTH. SAAP using an oxygen-carrying perfusate was more effective in this study than non-oxygen carrying solutions in TCA. SAAP can effect ROSC from hemorrhage-induced electrocardiographic asystole in large swine.

Resuscitative Endovascular Balloon Occlusion of the Aorta: Principles, Initial Clinical Experience, and Considerations for the Anesthesiologist.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an endovascular technique that allows for temporary occlusion of the aorta in patients with severe, life-threatening, trauma-induced noncompressible hemorrhage arising below the diaphragm. REBOA utilizes a transfemoral balloon catheter inserted in a retrograde fashion into the aorta to provide inflow control and support blood pressure until definitive hemostasis can be achieved. Initial retrospective and registry clinical data in the trauma surgical literature demonstrate improvement in systolic blood pressure with balloon inflation and improved survival compared to open aortic cross-clamping via resuscitative thoracotomy. However, there are no significant reports of anesthetic implications and perioperative management in this challenging cohort. In this narrative, we review the principles, technique, and logistics of REBOA deployment, as well as initial clinical outcome data from our level-1 American College of Surgeons-verified trauma center. For anesthesiologists who may not yet be familiar with REBOA, we make several suggestions and recommendations for intraoperative management based on extrapolation from these initial surgical-based reports, opinions from a team with increasing experience, and translated experience from emergency aortic vascular surgical procedures. Further prospective data will be necessary to conclusively guide anesthetic management, especially as potential complications and implications for global organ function, including cerebral and renal, are recognized and described.

An Inexpensive Esophageal Balloon Tamponade Trainer.

BACKGROUND: Emergency medicine practitioners must be able to perform rare, life-saving procedures. One such example is esophageal balloon tamponade, which is complex, fraught with complications, and difficult to demonstrate and practice. DISCUSSION: We constructed a simple, inexpensive model esophagus and stomach that we attached to a mannequin, allowing emergency medicine residents to visualize and practice esophageal balloon tamponade device placement. CONCLUSION: Our esophageal balloon tamponade model was easy to construct and allowed demonstration, conceptual visualization, and simulated performance of the procedure.

Ultrasound-Guided Resuscitative Endovascular Balloon Occlusion of the Aorta in the Resuscitation Area.

BACKGROUND: In trauma resuscitation with resuscitative endovascular balloon occlusion of the aorta (REBOA), urgent and accurate placement of the catheter in the resuscitation area without fluoroscopy can shorten the time from admission to REBOA, allowing rapid, temporary control of bleeding. DISCUSSION: The experience-based protocol in our center for ultrasound-guided REBOA in the resuscitation area without fluoroscopy is as follows: the femoral artery is punctured and a guidewire inserted; sonography is used to verify that the guidewire is in the abdominal aorta; the position of the balloon is confirmed with ultrasound after estimating the distance to the clavicle, and the pressure in the radial artery and sheath is used to monitor correct positioning; connect the pressure transducer to the catheter sheath for continuous monitoring of the blood pressure in the sheath, and inflate the balloon until the blood pressure tracing at the sheath has disappeared; check the pulse in the left radial artery, and withdraw the catheter slightly if the pulse in the radial artery is not palpable or is decreased (if this pulse is not palpable or decreased, the balloon is in the aortic arch). In this retrospective review of our REBOA protocol, between April 2012 and March 2016, 34 patients were enrolled. Two patients had complications, including dissection of the femoral artery in one and difficult percutaneous vascular access in another. Median time needed to complete the procedure was 8 min. Overall, 24 of 34 patients survived more than 24 h (72%), and overall mortality was 47%. Patients who lived more than 24 h, and then died had severe traumatic brain injury or septic shock. CONCLUSIONS: Ultrasound-guided REBOA is presented. Monitoring the blood pressure in the left radial artery allows us to determine adequate positioning of the balloon, and the blood pressure in the catheter sheath located in the femoral artery should also be monitored to prevent aortic injuries caused by the overinflation of the balloon.

Resuscitative endovascular balloon occlusion of the aorta versus aortic cross clamping among patients with critical trauma: a nationwide cohort study in Japan.

BACKGROUND: Measures of aortic occlusion (AO) for resuscitation in patients with severe torso trauma remain controversial. Our aim was to characterize the current use of resuscitative endovascular balloon occlusion of the aorta (REBOA) and resuscitative open aortic cross-clamping (ACC), and to evaluate whether REBOA should be an alternative method to resuscitative open ACC. METHODS: This study was a retrospective cohort study between 2004 and 2013 from a nationwide trauma registry in Japan. Participants were selected who underwent either REBOA or ACC. Their characteristics, interventions, and outcomes were analyzed to compare REBOA and ACC directly. The primary outcome was in-hospital mortality and the secondary outcome was mortality in the emergency department. Logistic regression analysis was performed to compare the outcomes between REBOA and ACC with adjustment for severity; 1:1 propensity score matching was also performed. RESULTS: Of the 159,157 trauma patients, 903 were eligible based on the selection criteria. Overall, 405/607 patients (67%) who had REBOA died compared to 210/233 patients (90%) who had ACC. Patients with REBOA had higher revised trauma score (RTS) (mean ± SD, 5.2 ± 2.0 vs. 4.2 ± 2.2; P < 0.001) but higher Injury Severity Score (ISS) (median (interquartile); 34 (25) vs. 34 (20); P < 0.001), and higher probability of survival (0.43 ± 0.36 vs. 0.27 ± 0.30; P < 0.001) compared to those with ACC. REBOA had an odds ratio (OR) for in-hospital mortality of 0.309 (95% confidence interval (CI) = 0.190-0.502) adjusting for trauma and injury severity score using a logistic regression model (n = 903). Similar associations were observed adjusting for RTS (OR = 0.224; 95% CI = 0.129-0.700) or adjusting for ISS (OR, 0.188; 95% CI, 0.116 to 0.303). In the propensity score-matched cohort (n = 304), REBOA was associated with lower mortality compared to ACC (OR, 0.261; 95% CI, 0.130 to 0.523). Patients with REBOA had less severe chest complications than those with ACC (Abbreviated Injury Scale thorax, 3.8 ± 0.8 vs. 4.2 ± 0.8; P < 0.001), although physiological severity and backgrounds were similar in this population. CONCLUSIONS: Patients who underwent AO had a high mortality. REBOA might be a favorable alternative method to resuscitative ACC for severe torso trauma although some indication bias could still remain. Further studies are needed to elucidate optimal indications.

A PROMPT Update on Partial REBOA: Initial Clinical Data and Overview of the DoD-Funded Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) Study.

INTRODUCTION: Retrograde Endovascular Balloon Occlusion of the Aorta (REBOA) is an effective management for the transient responder, but the ischemic consequences of complete aortic occlusion currently limit its use. Multiple DoD-funded preclinical studies have clearly demonstrated that partial REBOA reduces distal ischemia to potentially extend safe occlusion times, while still providing effective temporization of noncompressible torso hemorrhage. Early versions of REBOA devices were designed to completely occlude the aorta and had little ability to provide partial occlusion. Recently, a new REBOA device (pREBOA-PRO) was designed specifically to allow for partial occlusion, with the hypothesis that this may reduce the complications of aortic occlusion and extend safe occlusion times while maintaining the benefits on cardiac and cerebrovascular circulation as well as reductions in resuscitation requirements. MATERIALS AND METHODS: To ascertain the impact of a new purpose-built partial REBOA device on the extension of safe occlusion time, the Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) trial compared available data from the pREBOA-PRO with existing data from 200 clinical uses of pREBOA-PRO and available data in the AAST AORTA Registry were reviewed to design primary endpoints and clinical evidence for a prospective multi-center trial, the PROMPT Study. Together with the endpoints identified in preclinical studies of partial REBOA, primary endpoints for the PROMPT study were identified and power analyses were conducted to determine the target patient enrollment goals. RESULTS: Results from the clinical implementation of partial REBOA at a single trauma center were used to conduct the initial power analysis for the primary endpoint of Acute Kidney Injury (AKI) after prolonged occlusion. The rate of AKI after complete REBOA was 55% (12/20) compared to 33% (4/12) after partial REBOA (Madurska et al., 2021). With an alpha of 0.05 and power (ß) of 0.8, the projected sample size for comparison on a dichotomous outcome is 85 patients for the assessment of AKI. Initial power and endpoint analyses have been confirmed and extended with the ongoing analysis of partial and complete REBOA reported in the AORTA database. These analyses confirm preclinical findings which show that compared to complete REBOA, partial REBOA is associated with extended occlusion time in zone 1 (complete: 31 min vs. partial: 45 min, P = 0.003), lower rates of AKI after zone 1 occlusion (complete: 33% vs. partial: 19%, P = 0.05) and reduced resuscitation requirements (e.g., 25% reduction in pRBC administration: complete: 18 units vs. partial: 13 units, P = 0.02). CONCLUSIONS: The DoD-funded PROMPT study of partial REBOA will provide prospective observational clinical data on patients being treated with pREBOA-PRO. Outcomes will be stratified based on partial or complete occlusion to address whether partial REBOA has additional clinical benefits over complete REBOA, such as decreased distal ischemia, extension of safe occlusion time, improved hemodynamics during transition to and from occlusion, and reduced interoperative bleeding and blood product use. The results from this study are expected to confirm previous data demonstrating reduction of ischemic sequalae, improved transition to reperfusion, and reduced resuscitative requirements compared to complete REBOA.

When Every Minute Counts: REBOA Before Surgery Is Independently Associated With a 15-Minute Delay in Time to Definitive Hemorrhage Control.

INTRODUCTION: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a temporizing hemorrhage control intervention, but its inevitable effect on time to operating room (OR) has not been assessed. The aim of our study is to assess the impact of undergoing REBOA before surgery (RBS) on time to definitive hemorrhage control surgery. METHODS: In this retrospective analysis of 2017-2021 ACS-TQIP database, all adult (≥18 years) patients who underwent emergency hemorrhage control laparotomy (≤4 hours of admission) and received early blood products (≤4 hours) were included, and patients with severe head injury (Head-abbreviated injury score > 2) were excluded. Patients were stratified into those who did (RBS) vs those who did not undergo REBOA before surgery (No-RBS). Primary outcome was time to laparotomy. Secondary outcomes were complications and mortality. Multivariable linear and binary logistic regression analyses were performed to identify the independent associations between RBS and outcomes. RESULTS: A total of 32,683 patients who underwent emergency laparotomy were identified (RBS: 342; No-RBS: 32,341). The mean age was 39 (16) years, 78% were male, mean SBP was 107 (34) mmHg, and the median injury severity score was 21 [14-29]. The median time to emergency hemorrhage control surgery was 50 [32-85] minutes. Overall complication rate was 16% and mortality was 19%. On univariate analysis, RBS group had longer time to surgery (RBS 56 [41-89] vs No-RBS 50 [32-85] minutes, P < 0.001). On multivariable analysis, RBS was independently associated with a longer time to hemorrhage control surgery (ß + 14.5 [95%CI 7.8-21.3], P < 0.001), higher odds of complications (aOR = 1.72, 95%CI = 1.27-2.34, P < 0.001), and mortality (aOR = 3.42, 95%CI = 2.57-4.55, P < 0.001). CONCLUSION: REBOA is independently associated with longer time to OR for hemorrhaging trauma patients with an average delay of 15 minutes. Further research evaluating center-specific REBOA volume and utilization practices, and other pertinent system factors, may help improve both time to REBOA as well as time to definitive hemorrhage control across US trauma centers. LEVEL OF EVIDENCE: III. STUDY TYPE: Epidemiologic.

Foam sclerotherapy using polidocanol for balloon-occluded retrograde transvenous obliteration (BRTO).

PURPOSE: To evaluate the clinical safety and effectiveness of foam sclerotherapy using polidocanol for the treatment of gastric fundal varices by balloon-occluded retrograde transvenous obliteration (BRTO). MATERIALS AND METHODS: From November 2005 to June 2009, foam sclerotherapy using polidocanol for the treatment of gastric fundal varices by BRTO was performed in 16 patients (male/female 11:5; age range 46-84 years, median 67 years). Foam was made of 3% polidocanol (Aethoxysklerol; Kreussler Pharma, Wiesbaden, Germany), room air, and contrast media, with a ratio of 1:2:1, respectively. The amount of polidocanol (2-24 mL; median 7 mL) depended on the volume of varices. RESULTS: Technical success was achieved in 15 of 16 patients (93.8%). Technical failure occurred in one patient. All patients were without pain during sclerotherapy. One patient experienced pulmonary edema after the procedure but completely recovered with medical treatment. There was no procedure-related mortality. Patients were followed by endoscopy, computed tomography, or both. Four patients were lost to follow-up. Clinical success was achieved in 10 of 11 patients (91%). Rebleeding occurred in one case during follow-up. CONCLUSIONS: Foam sclerotherapy using polidocanol is clinically safe and effective for the treatment of gastric fundal varices during BRTO.

Experiment on endoscopic balloon dilation for esophageal stenosis after endoscopic submucosal dissection in pigs.

BACKGROUND AND AIM: Endoscopic balloon dilation (EBD) is effective for esophageal stenosis caused by ESD. However, an efficient EBD method has not been established. We, therefore, conducted EBD experiments on porcine esophageal stenosis models. METHODS: Study 1: in dilation models (day 22 after ESD), the thickness of the outer muscle layer (as an index of the extension effect) and the area of muscle fiber bundle necrosis in the inner muscle layer (as an index of thermal damage) were evaluated. Study 2: in restenosis models (day 43 after ESD), the thickness of the fibrous plexus (as an index of restenosis) was evaluated. In total, 12 porcine models were created. RESULTS: Study 1: the thickness of the outer muscle layer was 1243 ± 322 µm in surrounding locations and it was 803 ± 145 µm beneath the laceration (p = 0.005). In cases of muscular layer injury, the area of necrosis was 15,500 ± 10400 µm2 in surrounding locations and it was 40,200 ± 12900 µm2 at the laceration site (p < 0.001). Study 2: the thickness of the fibrous plexus was 1359 ± 196 µm in surrounding locations and it was 1322 ± 136 µm2 in the laceration scar site (p = 0.74). CONCLUSION: Since thermal damage persists until the completion of stenosis, EBD in the initial stage should be carefully performed. An extension effect was observed only at the laceration site and it later returned to a status similar to that of surrounding locations. Additional intervention would be required for preventing restenosis.

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.

Resuscitative endovascular balloon occlusion of the aorta (REBOA): a scoping review protocol concerning indications-advantages and challenges of implementation in traumatic non-compressible torso haemorrhage.

INTRODUCTION: Haemorrhage remains the leading cause of preventable death in trauma. Damage control measures applied to patients in extremis in order to control exsanguinating bleeding from non-compressible torso injuries use different techniques to limit blood flow from the aorta to the rest of the body. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is regaining momentum recently as an adjunct measure that can provide the same results using less invasive approaches. This scoping review aims to provide a comprehensive understanding of the existing literature on REBOA. The objective is to analyse evidence and non-evidence-based medical reports and to describe current gaps in the literature about the best indication and implementation strategies for REBOA. METHODS AND ANALYSIS: Using the five-stage framework of Arksey and O'Malley's scoping review methodology as a guide, we will perform a systematic search in the following databases: MEDLINE, EMBASE, BIOSIS, COCHRANE CENTRAL, PUBMED and SCOPUS from the earliest available publications. The aim is to identify diverse studies related to the topic of REBOA. For a comprehensive search, we will explore organisational websites, key journals and hand-search reference lists of key studies. Data will be charted and sorted using a descriptive analytical approach. ETHICS AND DISSEMINATION: Ethics approval is not necessary as the data are collected from publicly available sources and there will be no consultative phase. The results will be disseminated through presentations at local, national, clinical and medical education conferences and through publication in a peer-reviewed journal.

Does the conventional landmark help to place the tip of REBOA catheter in the optimal position? A non-controlled comparison study.

Background: Resuscitative endovascular balloon occlusion of the aorta (REBOA) for patients with traumatic torso hemorrhagic shock is available to keep a minimum level of circulatory status as a bridge to definitive therapy. However, the trajectory for placement of REBOA in the aorta has not yet been clearly defined. Methods: We conducted a retrospective observational cohort study in the two tertiary critical care and emergency center from December 2014 to October 2018. A total of 28 patients who underwent focused assessment with sonography for trauma (FAST) were studied via contrast computed tomography (CT), and 27 were analyzed. Results: We divided patients into two groups based on our CT findings. The REBOA deflate group included 16 patients, and the inflate group included 11 patients. The median trace value (interquartile range) of the blood vessel center line from the common femoral artery to the tip of REBOA (blood vessel length) and the length of REBOA itself from the common femoral artery to the tip of REBOA (REBOA insertion length) were 56.2 cm (54.5-57.2) and 55.2 cm (54.2-55.6), respectively (p < 0.0001) for the deflated group, and 51.4 cm (42.1-56.6) and 50.3 cm (42.3-55.0) (p = 0.594), respectively, for the inflated group. Conclusions: If REBOA was deflated, it was placed 1.0 cm longer than the insertion length of REBOA catheter itself, but that was not the case when inflating REBOA. The individual difference was large to the extent that the balloon inflated and the extent to which the balloon was pushed back toward the caudal depending on the degree of blood pressure. Further studies would be needed to validate the study findings.

Radiofrequency Identification of the ER-REBOA: Confirmation of Placement Without Fluoroscopy.

INTRODUCTION: Non-compressible torso hemorrhage accounts for 70% of battlefield deaths. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technology used to mitigate massive truncal hemorrhage. Use of REBOA on the battlefield is limited by the need for radiographic guided balloon placement. Radiofrequency identification (RFID) is a simple, portable, real-time technology utilized to detect retained sponges during surgery. We investigated the feasibility of RFID to confirm the placement of ER-REBOA. MATERIALS AND METHODS: This was a single-arm prospective proof-of-concept experimental study approved by the institutional review board at Naval Medical Center San Diego. The ER-REBOA (Prytime Medical Devices, Inc, Boerne, TX, USA) was modified by placement of a RFID tag. The tagged ER-REBOA was placed in zone I or zone III of the aorta in a previously perfused cadaver. Exact location was documented with X-ray. Five blinded individuals used the RF Assure Detection System (Medtronic, Minneapolis, MN, USA) handheld detection wand to predict catheter tip location from the xiphoid process (zone I) or pubic tubercle (zone III). RESULTS: In zone I, actual distance (Da) of the catheter tip was 11 cm from the xiphoid process. Mean predicted distance (Dp) from Da was 1.52 cm (95% CI 1.19-1.85). In zone III, Da was 14 cm from the pubic tubercle. Mean Dp from Da was 4.11 cm (95% CI 3.68-4.54). Sensitivity of detection was 100% in both zones. Specificity (Defined as Dp within 2 cm of Da) was 86% in zone I and 16% in zone III. CONCLUSIONS: Using RFID to confirm the placement of ER-REBOA is feasible with specificity highest in zone I. Future work should focus on refining this technology for the forward-deployed setting.