A core outcome set for resuscitative endovascular balloon occlusion of the aorta: A consensus based approach using a modified Delphi method.

BACKGROUND: The utilization of resuscitative endovascular balloon occlusion of the aorta (REBOA) in trauma has grown exponentially in recent years. However, inconsistency in reporting of outcome metrics related to this intervention has inhibited the development of evidence-based guidelines for REBOA application. This study sought to attain consensus on a core outcome set (COS) for REBOA. METHODS: A review of "landmark" REBOA articles was performed, and panelists (first and senior authors) were contacted for participation in a modified Delphi study. In round 1, panelists provided a list of potential core outcomes. In round 2, using a Likert scale (1 [not important] to 9 [very important]), panelists scored the importance of each potential outcome. Consensus for core outcomes was defined a priori as greater than 70% of scores receiving 7 to 9 and less than 15% of scores receiving 1 to 3. Feedback was provided after round 2, and a third round was performed to reevaluate variables not achieving consensus and allow a final "write-in" round by the experts. RESULTS: From 17 identified panelists, 12 participated. All panelists (12 of 12, 100%) participated in each subsequent round. Panelists initially identified 34 unique outcomes, with two outcomes later added upon write-in request after round 2. From 36 total potential outcomes, 20 achieved consensus as core outcomes, and this was endorsed by 100% of the participants. CONCLUSION: Panelists successfully achieved consensus on a COS for REBOA-related research. This REBOA-COS is recommended for all clinical trials related to REBOA and should help enable higher-quality study designs, valid aggregation of published data, and development of evidence-based practice management guidelines. LEVEL OF EVIDENCE: Diagnostic test or criteria, level V. TRIAL REGISTRATION: Core Outcomes in Trauma Surgery: Development of a Core Outcome Set for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) http://www.comet-initiative.org/Studies/Details/1709.

Fetal and neonatal outcomes following maternal aortic balloon occlusion for hemorrhage in pregnancy: A review of the literature.

BACKGROUND: Hemorrhage is a leading cause of maternal death worldwide, with increased risk in women with abnormal placentation. Aortic balloon occlusion (ABO), including resuscitative endovascular balloon occlusion, has been used for obstetrical hemorrhage for 20 years, and is associated with decreased operative blood loss, fewer transfusions, and lower rates of hysterectomy. However, the effect of aortic occlusion on fetal/neonatal outcomes is not well known. METHODS: A literature review on ABO for obstetrical or traumatic hemorrhage was performed. Cases were included if fetal/neonatal outcomes were reported. Data were collected on timing of balloon inflation (predelivery or postdelivery), fetal/neonatal mortality, and Apgar scores. Secondary maternal outcomes included blood loss, need for hysterectomy, ABO-related complications, and mortality. RESULTS: Twenty-one reports of ABO in 825 cases of obstetrical hemorrhage were reviewed (nine case reports/series and twelve comparative studies). 13.5% (111/825) had aortic occlusion prior to delivery of the fetus. Comparative cohorts included 448 patients who underwent iliac artery balloon occlusion (n = 219) or no vascular balloon occlusion (n = 229). The most common neonatal outcome reported was Apgar scores, with no difference in fetal/neonatal outcomes between ABO and non-ABO patients in any study. One neonatal mortality occurred in the sole reported case of ABO use in a pregnant trauma patient at 24 weeks gestation. One maternal mortality occurred because of aortic dissection. Five comparative studies reported significantly decreased blood loss in ABO patients compared to non-ABO patients, and four studies reported significantly lower rates of hysterectomy in ABO patients. ABO-related complications were reported in 1.6% of patients (13/825). CONCLUSION: Obstetrical hemorrhage is a devastating complication, and ABO may potentially decrease blood loss and reduce the hysterectomy rate without compromising fetal and neonatal outcomes. Further research is needed to determine the safety of predelivery aortic occlusion as this occurred in 14% of the cases.

Use of a disposable vascular pressure device to guide balloon inflation of resuscitative endovascular balloon occlusion of the aorta: a bench study.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) for rapid hemorrhage control is increasingly being used in trauma management. Its beneficial hemodynamic effects on unstable patients beyond temporal hemostasis has led to growing interest in its use in other patient populations, such as during cardiac arrest from nontraumatic causes. The ability to insert the catheters without fluoroscopic guidance makes the technique available in the prehospital setting. However, in addition to correct positioning, challenges include reliably achieving aortic occlusion while minimizing the risk of balloon rupture. Without fluoroscopic control, inflation of the balloon relies on estimated aortic diameters and on the disappearing pulse in the contralateral femoral artery. In the case of cardiac arrest or absent palpable pulses, balloon inflation is associated with excess risk of overinflation and adverse events (vessel damage, balloon rupture). In this bench study, we examined how the pressure in the balloon is related to the surrounding blood pressure and the balloon's contact with the vessel wall in two sets of experiments, including a pulsatile circulation model. With this data, we developed a rule of thumb to guide balloon inflation of the ER-REBOA catheter with a simple disposable pressure-reading device (COMPASS). We recommend slowly filling the balloon with saline until the measured balloon pressure is 160 mmHg, or 16 mL of saline have been used. If after 16 mL the balloon pressure is still below 160 mmHg, saline should be added in 1-mL increments, which increases the pressure target about 10 mmHg at each step, until the maximum balloon pressure is reached at 240 mmHg (= 24 mL inflation volume). A balloon pressure greater than 250 mmHg indicates overinflation. With this rule and a disposable pressure-reading device (COMPASS), ER-REBOA balloons can be safely filled in austere environments where fluoroscopy is unavailable. Pressure monitoring of the balloon allows for recognition of unintended deflation or rupture of the balloon.

High resuscitative endovascular balloon occlusion of the aorta procedural volume is associated with improved outcomes: An analysis of the AORTA registry.

BACKGROUND: The use of resuscitative endovascular balloon occlusion of the aorta (REBOA) is controversial. We hypothesize that REBOA outcomes are improved in centers with high REBOA utilization. METHODS: We examined the Aortic Occlusion in Resuscitation for Trauma and Acute Care Surgery registry over a 5-year period (2014-2018). Resuscitative endovascular balloon occlusion of the aorta outcomes were analyzed by stratifying institutions into low-volume (<10), average-volume (11-30), and high-volume (>30) deployment centers. A multivariable model adjusting for volume group, mechanism of injury, signs of life, systolic blood pressure at initiation, operator level, device type, zone of placement, and hemodynamic response to aortic occlusion was created to analyze REBOA mortality and REBOA-related complications. RESULTS: Four hundred ninety-five REBOA placements were included. High-volume centers accounted for 63%, while low accounted for 13%. High-volume institutions were more likely to place a REBOA in the emergency department (81% vs. 63% low volume, p = 0.003), had a lower mean systolic blood pressure at insertion (53 ± 38 vs. 64 ± 40, p = 0.001), and more Zone I deployments (64% vs. 55%, p = 0.002). Median time from admission to REBOA placement was significantly less in patients treated at high-volume centers (15 [7-30] minutes vs. 35 [20-65] minutes, p = 0.001). Resuscitative endovascular balloon occlusion of the aorta mortality was significantly higher at low-volume centers (67% vs. 57%; adjusted odds ratio, 1.29; adj p = 0.040), while average- and high-volume centers were similar. Resuscitative endovascular balloon occlusion of the aorta complications were less frequent at high-/average-volume centers, but did not reach statistical significance (adj p = 0.784). CONCLUSION: Resuscitative endovascular balloon occlusion of the aorta survival is increased at high versus low utilization centers. Increased experience with REBOA may be associated with earlier deployment and subsequently improved patient outcomes. LEVEL OF EVIDENCE: Therapeutic/Care Management, level IV.

Effect of prophylactic balloon occlusion of internal iliac artery in pregnancies complicated by placenta previa and accreta.

BACKGROUND: Placenta previa and accreta are serious obstetric conditions that are associated with a high risk of intraoperative massive hemorrhage, the prophylactic intravascular balloon occlusion technique is increasingly used in managing uncontrolled hemorrhage in cesarean section (CS). We aim to examine the clinical effectiveness of prophylactic balloon occlusion of the internal iliac artery (PBOIIA) during CS in improving maternal outcomes for patients with placenta previa and accreta. METHODS: A total of 420 women with placenta previa and accreta who underwent CS from January 2014 to December 2018 were included retrospectively. Patients were divided into balloon group in which patients had PBOIIA (n = 248) and the control group in which patients did not have PBOIIA (n = 172). Meanwhile, we performed a subgroup analysis in whether taking parallel transverse uterine incision (PTUI) surgery. Information on conditions of patients and newborns, perioperative blood indicators, surgical outcomes were collected. RESULTS: Median estimated blood loss (mEBL) was 2200 mL in the balloon group and 2150 mL in the control group respectively, there was no significant difference between two-groups comparison (P > 0.05), and the rate of patients with hysterectomy was also has no difference between the two groups (36.3% verus 35.5%, P > 0.05), while there is a significant difference between two groups in the amount of PRBCs transfused [3 (0-31.5) verus 3 (0-39), P <0.05], moreover, the proportion of PRBCS> 8 units in the balloon group is significantly lower than that in control group (11.29% verus 23.26%, P <0.05).. However, the total hospitalization costs (45,624.4 ± 11,061.9 verus 37,523.1 ± 14,662.2, CYN) and surgery costs (19,910.6 ± 2622.6 verus 11,850.5 ± 3146.1, CYN) in balloon group were significantly higher than those in control group (P < 0.05). Subgroup analysis showed PTUI surgery had no significant differences in EBL (P >0.05), but it could significantly decrease hysterectomy rates (P <0.05). CONCLUSIONS: PBOIIA has no significant effect on reducing intraoperative EBL and hysterectomy rate in patients with placenta previa and accreta. and although it could reduce the intraoperative PRBCs in patients with massive hemorrhage, it significantly increases the financial cost for patients. Therefore, PBOIIA should not be routinely recommended to patients with placenta previa and accreta.

Prehospital continuous vital signs predict need for resuscitative endovascular balloon occlusion of the aorta and resuscitative thoracotomy prehospital continuous vital signs predict resuscitative endovascular balloon occlusion of the aorta.

BACKGROUND: Rapid triage and intervention to control hemorrhage are key to survival following traumatic injury. Patients presenting in hemorrhagic shock may undergo resuscitative thoracotomy (RT) or resuscitative endovascular balloon occlusion of the aorta (REBOA) as adjuncts to rapidly control bleeding. We hypothesized that machine learning along with automated calculation of continuously measured vital signs in the prehospital setting would accurately predict need for REBOA/RT and inform rapid lifesaving decisions. METHODS: Prehospital and admission data from 1,396 patients transported from the scene of injury to a Level I trauma center via helicopter were analyzed. Utilizing machine learning and prehospital autonomous vital signs, a Bleeding Risk Index (BRI) based on features from pulse oximetry and electrocardiography waveforms and blood pressure (BP) trends was calculated. Demographics, Injury Severity Score and BRI were compared using Mann-Whitney-Wilcox test. Area under the receiver operating characteristic curve (AUC) was calculated and AUC of different scores compared using DeLong's method. RESULTS: Of the 1,396 patients, median age was 45 years and 68% were men. Patients who underwent REBOA/RT were more likely to have a penetrating injury (24% vs. 7%, p < 0.001), higher Injury Severity Score (25 vs. 10, p < 0.001) and higher mortality (44% vs. 7%, p < 0.001). Prehospital they had lower BP (96 [70-130] vs. 134 [117-152], p < 0.001) and higher heart rate (106 [82-118] vs. 90 [76-106], p < 0.001). Bleeding risk index calculated using the entire prehospital period was 10× higher in patients undergoing REBOA/RT (0.5 [0.42-0.63] vs. 0.05 [0.02-0.21], p < 0.001) with an AUC of 0.93 (95% confidence interval [95% CI], 0.90-0.97). This was similarly predictive when calculated from shorter periods of transport: BRI initial 10 minutes prehospital AUC of 0.89 (95% CI, 0.83-0.94) and initial 5 minutes AUC of 0.90 (95% CI, 0.85-0.94). CONCLUSION: Automated prehospital calculations based on vital sign features and trends accurately predict the need for the emergent REBOA/RT. This information can provide essential time for team preparedness and guide trauma triage and disaster management. LEVEL OF EVIDENCE: Therapeutic/care management, Level IV.

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.

Endoscopic Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration for Prevention of Gastric Variceal Bleeding: A Randomized Controlled Trial.

BACKGROUND AND AIMS: The optimal treatment for gastric varices (GVs) is a topic that remains open for study. This study compared the efficacy and safety of endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous obliteration (BRTO) to prevent rebleeding in patients with cirrhosis and GVs after primary hemostasis. APPROACH AND RESULTS: Patients with cirrhosis and history of bleeding from gastroesophageal varices type 2 or isolated gastric varices type 1 were randomized to cyanoacrylate injection (n = 32) or BRTO treatment (n = 32). Primary outcomes were gastric variceal rebleeding or all-cause rebleeding. Patient characteristics were well balanced between two groups. Mean follow-up time was 27.1 ± 12.0 months in a cyanoacrylate injection group and 27.6 ± 14.3 months in a BRTO group. Probability of gastric variceal rebleeding was higher in the cyanoacrylate injection group than in the BRTO group (P = 0.024). Probability of remaining free of all-cause rebleeding at 1 and 2 years for cyanoacrylate injection versus BRTO was 77% versus 96.3% and 65.2% versus 92.6% (P = 0.004). Survival rates, frequency of complications, and worsening of esophageal varices were similar in both groups. BRTO resulted in fewer hospitalizations, inpatient stays, and lower medical costs. CONCLUSIONS: BRTO is more effective than cyanoacrylate injection in preventing rebleeding from GVs, with similar frequencies of complications and mortalities.

Fetal endoscopic tracheal occlusion reverses the natural history of right-sided congenital diaphragmatic hernia: European multicenter experience.

OBJECTIVE: To evaluate the neonatal outcome of fetuses with isolated right-sided congenital diaphragmatic hernia (iRCDH) based on prenatal severity indicators and antenatal management. METHODS: This was a retrospective review of prospectively collected data on consecutive cases diagnosed with iRCDH before 30 weeks' gestation in four fetal therapy centers, between January 2008 and December 2018. Data on prenatal severity assessment, antenatal management and perinatal outcome were retrieved. Univariate and multivariate logistic regression analysis were used to identify predictors of survival at discharge and early neonatal morbidity. RESULTS: Of 265 patients assessed during the study period, we excluded 40 (15%) who underwent termination of pregnancy, two cases of unexplained fetal death, two that were lost to follow-up, one for which antenatal assessment of lung hypoplasia was not available and six cases which were found to have major associated anomalies or syndromes after birth. Of the 214 fetuses with iRCDH included in the neonatal outcome analysis, 86 were managed expectantly during pregnancy and 128 underwent fetal endoscopic tracheal occlusion (FETO) with a balloon. In the expectant-management group, lung size measured by ultrasound or by magnetic resonance imaging was the only independent predictor of survival (observed-to-expected lung-to-head ratio (o/e-LHR) odds ratio (OR), 1.06 (95% CI, 1.02-1.11); P = 0.003). Until now, stratification for severe lung hypoplasia has been based on an o/e-LHR cut-off of 45%. In cases managed expectantly, the survival rate was 15% (4/27) in those with o/e-LHR ≤ 45% and 61% (36/59) for o/e-LHR > 45% (P = 0.001). However, the best o/e-LHR cut-off for the prediction of survival at discharge was 50%, with a sensitivity of 78% and specificity of 72%. In the expectantly managed group, survivors with severe pulmonary hypoplasia stayed longer in the neonatal intensive care unit than did those with mildly hypoplastic lungs. In fetuses with an o/e-LHR ≤ 45% treated with FETO, survival rate was higher than in those with similar lung size managed expectantly (49/120 (41%) vs 4/27 (15%); P = 0.014), despite higher prematurity rates (gestational age at birth: 34.4 ± 2.7 weeks vs 36.8 ± 3.0 weeks; P < 0.0001). In fetuses treated with FETO, gestational age at birth was the only predictor of survival (OR, 1.25 (95% CI, 1.04-1.50); P = 0.02). CONCLUSIONS: Antenatal measurement of lung size can predict survival in iRCDH. In fetuses with severe lung hypoplasia, FETO was associated with a significant increase in survival without an associated increase in neonatal morbidity. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

The impact of nephrostomy balloon inflation volume on post percutaneous nephrolithotomy hemorrhage.

INTRODUCTION: the study aims to match different volumes of nephrostomy balloon inflation to point out the foremost effective volume size of post percutaneous nephrolithotomy (PCNL) bleeding control. METHODS: we have retrospectively reviewed "560" medical records of patients who underwent percutaneous nephrolithotomy between (the years 2017 and 2018) at Prince Hussein Urology Center. The Patients were divided into two teams, group-1 (a number of 280 patients) with nephrostomy balloon inflated concerning three ml and group-2 (a number of 280 patients) the balloon inflated concerning one ml. The preoperative and postoperative hematocrit, the operation duration, the stone size, the postoperative pain severity, the transfusion rate and the duration of hematuria between the two groups were compared during hospitalization. RESULTS: regarding patients with ages (between 18 and 68 years); the preoperative hematocrit (mean values ± SDs) was (40.35% ± 3.57) vs (39.95% ± 3.43) for groups-1 and 2, respectively; the p value=0.066. The postoperative hematocrit was (37.91% ± 3.96) vs (34.38 ± 2.78), respectively; the p value was (0.008); the blood transfusion rate was 11.2% vs 13.4% (the p value was 0.039), respectively. The Postoperative pain score was (4.93 ± 1.44) vs (3.89 ± 1.45) (the p value was 0.012), respectively. CONCLUSION: increasing the nephrostomy balloon volume to a "3cc" competes for a task to decrease bleeding which was found to be as a secure and considerable effective procedure-related factor. However, the disadvantage of this technique resulted in increasing the postoperative pain in patients undergoing such a procedure.

[Preliminary study on the application of abdominal aortic balloon occlusion in the treatment of cesarean scar pregnancy].

Objective: To explore the clinical value by analyzing the application of abdominal aortic balloon occlusion in the uterine curettage treatment for patients with cesarean scar pregnancy (CSP). Methods: Totally 42 CSP patients in the first Affiliated Hospital of Zhengzhou University were analyzed retrospectively, 21 cases in the observation group, placing the balloon catheter to the abdominal aorta under the renal artery under the digital substraction angiography(DSA), conducting curettage under hysteroscopy or uterine laparoscopy immediately, and making intermittent blockage in abdominal aorta blood flow during the surgery;21 patients in the control group, conducting uterine artery embolization (UAE) before operation, conducting curettage under hysteroscopy or uterine laparoscopy after 1-3 days. The fluoroscopy time under DSA, body surface radiation dose, intraoperative blood loss, operation time, incidence of postoperative adverse reactions, hospitalization time and follow-up menstruation were comparatively analyzed. Results: All patients operated and retained the uterus successfully. In the control group, all 21 patients had different degrees of fever, pain and other symptoms after UAE. In the observation group and control group, the fluoroscopy time and body surface radiation dose under DSA respectively were (7.4±1.4) s, (5.4±1.1) mGy and (1 142.8±315.5) s, (1 442.0±300.0) mGy (both P<0.01);the average amount of intraoperative blood loss were (22±15), (19±14) ml (P>0.05), the time of uterine curettage were (37±20), (42±19) minutes (P>0.05);hospitalization time were (5.0±0.9), (7.7±1.3) days (P<0.01). The follow-up period was more than 3 months, no adverse reactions were observed in the observation group; 4 cases of menstrual reduction and 1 case of intrauterine adhesions were found in the control group. Conclusion: Abdominal aortic balloon occlusion and UAE could effectively reduce intraoperative bleeding in uterine curettage for patients with CSP; abdominal aortic balloon occlusion has significant reduction of the X-ray dose, shorter hospitalization time, and fewer adverse events comparing to UAE.

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.

Training and assessment of competence in resuscitative endovascular balloon occlusion of the aorta (REBOA) - a systematic review.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a potentially life-saving but high-risk emergency procedure in patients with haemorrhagic shock. Lack of physicians with competence in the procedure is a barrier to implementation of REBOA. It is currently unclear how training and assessment of competence should be done. OBJECTIVES: To report and evaluate research in training and assessment of competence in REBOA and femoral arterial access with the aim to investigate the effect of simulation-based training in the procedure and to provide suggestions for the future design of training programs and assessment tools. METHODS: Following PRISMA guidelines, PubMed, Embase, and Cochrane Library databases were searched for studies on training or assessment of competence in REBOA and femoral arterial access. Bias assessment was done using the Medical Education Research Study Quality Instrument. Evidence level was assessed using GRADE. RESULTS: Sixteen studies were included, six of them published as abstracts. Full-text studies included 189 trainees ranging in experience level from military medics to surgical specialists. Outcome measures were heterogenous; the most used were rater checklists, knowledge testing, and procedure time. All studies confirmed an effect of training of REBOA on procedural competence in a simulation setting but had a high degree of bias. No study developed or used an assessment tool supported by validity evidence and no study investigated mid and long-term outcomes. CONCLUSION: Simulation-based training of REBOA improves skills, however, the evidence level is very low and data cannot answer important questions on effect size, skill transfer and retention, and optimal course design. To advance research and training programmes, an assessment tool supported by validity evidence with broad applicability is needed.

Retrospective analysis of 586 cases of placenta previa and accreta.

In this study, we conducted a retrospective investigation of all cases of placenta previa and accreta that were treated at a tertiary-level hospital to assess the effectiveness of balloon catheterisation at different levels. We evaluated the surgical and neonatal outcomes of 586 cases of placenta previa and accreta that were treated at our facility. This is the largest study of its kind. Depending on the severity and position of accreta, patients underwent balloon catheter placement in the aorta (n = 252) or common iliac artery (n = 38) before delivery by caesarean section. Data were collected regarding the duration of the surgery, number of cases (percentage) of balloon occlusion, and annual rate of hysterectomy. The blood loss (2207.89 ± 2044.95 ml) and transfusion volume (7.42 ± 7.872 U) in the common iliac occlusion group was greater than those in the aortic occlusion group (1967.66 ± 1466.64 ml and 6.54 ± 5.67 U, respectively); however, this difference did not reach statistical significance (p > .05). With the increase in the number of procedures performed over the years of study, the surgeons' skills improved significantly. The choice of balloon catheterisation must be made with careful consideration. Our results highlight the significance of suture skill and the experience level of surgeons.IMPACT STATEMENTWhat is already known on this subject: The optimal method for the management of placenta accreta remains debateable. Prophylactic balloon catheters placed within arteries to control intraoperative bleeding play an important role in the management of patients with placenta accreta.What the results of this study add: The common iliac artery occlusion group tended to have a greater amount of blood loss and a higher requirement of transfusion than the aortic occlusion group; however, this difference was not statistically significant. We also analysed the difference in the complications across different periods of the study period and observed a clear improvement in the operative procedures over time.What the implications are of these findings for clinical practice and/or further research: Our study revealed that the surgeons' proficiency increases over time, leading to improved results and a lower rate of hysterectomy over the course of several years. We recommend that the choice for balloon catheter occlusion be made with caution and after careful consideration.

Comparison of infrarenal aortic balloon occlusion with internal iliac artery balloon occlusion for patients with placenta accreta.

BACKGROUND: The study was designed to compare the role of infrarenal aortic artery balloon occlusion (IAABC) with internal iliac artery balloon occlusion (IIABOC). METHODS: One hundred seventy-four cases with placenta accreta were retrospectively analyzed.74 cases who had IAABC were in group A, while the others who had IIABOC were in group B. RESULTS: Amount of estimated blood loss (EBL), the rate of major blood loss, the rate of blood transfusion and uterine packing, length of hospitalization were not different in both groups. The rate of uterine artery embolization (UAE), balloon occlusion time, operation time and fetus radiation dose in group A were less than those in group B. CONCLUSIONS: IAABC resulted in better clinical outcomes than IIABOC.

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for Severe Torso Trauma in Japan: A Descriptive Study.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) has the potential to be an alternative to open aortic cross-clamping (ACC). However, its practical indication remains unknown. We examined the usage trend of REBOA and ACC in Japan for severe torso trauma and investigated whether these procedures were associated with the time of death distribution based on a large database from the Japan Trauma Data Bank (JTDB). METHODS: The JTDB from 2004 to 2014 was reviewed. Eligible patients were restricted to those with severe torso trauma, which was defined as an abbreviated injury scale score of ≥4. Patients were classified into groups according to the aortic occlusion procedures. The primary outcomes were the rates of REBOA and ACC use according to the clinical situation. We also evaluated whether the time of death distribution for the first 8 h differed based on these procedures. RESULTS: During the study period, a total of 21,533 patients met our inclusion criteria. Overall, REBOA was more commonly used than ACC for patients with severe torso trauma (2.8% vs 1.5%). However, ACC was more frequently used in cases of thoracic injury and cardiac arrest. Regarding the time of death distribution, the cumulative curve for death in REBOA cases was elevated much more slowly and mostly flat for the first 100 min. CONCLUSIONS: REBOA is more commonly used compared to ACC for patients with severe torso trauma in Japan. Moreover, it appears that REBOA influences the time of death distribution in the hyperacute phase.

Resuscitative Endovascular Balloon Occlusion of the Aorta: Assessing Need in an Urban Trauma Center.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged as a bridge to definitive hemostasis in select patients with noncompressible torso hemorrhage. The number of patients who might benefit from this procedure, however, remains incompletely defined. We hypothesized that we could quantify the number of patients presenting to our center over a 2-year period who may have benefited from REBOA. METHODS: All patients presenting to our trauma center from 2014 to 2015 were included. Potential REBOA patients were identified based on anatomic injuries. We used ICD-9 codes to identify REBOA-amenable injury patterns and physiology. We excluded patients with injuries contraindicating REBOA. We then used chart review by two REBOA-experienced independent reviewers to assess each potential REBOA candidate, evaluate the accuracy of our algorithm, and to identify a cohort of confirmed REBOA candidates. RESULTS: Four thousand eight hundred eighteen patients were included of which 666 had injuries potentially amenable to REBOA. Three hundred thirty-five patients were hemodynamically unstable, and 309 patients had contraindications to REBOA. Sixty-four patients had both injury patterns and physiology amenable to REBOA with no contraindications, and these patients were identified as potential REBOA candidates. Of these, detailed independent two physician chart review identified 29 patients (45%) as confirmed REBOA candidates (interrater reliability kappa = 0.94, P < 0.001). CONCLUSIONS: Our database query identified patients with indications for REBOA but overestimated the number of REBOA candidates. To accurately quantify the REBOA candidate population at a given center, an algorithm to identify potential patients should be combined with chart review. STUDY TYPE: Therapeutic study, level V.

How many patients could benefit from REBOA in prehospital care? A retrospective study of patients rescued by the doctors of the Paris fire brigade.

INTRODUCTION: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a technique to control haemorrhage by placing a retrograde catheter in an artery and inflating a balloon at its tip. This retrospective study aimed to evaluate the proportion of injured people who could potentially have benefited from this technique prior to hospitalisation, including on the scene or during transport. METHODS: A retrospective analysis was conducted of all patients with trauma registered in the Paris Fire Brigade emergency medical system between 1 January and 31 December 2014. Inclusion criteria included all patients over 18 years of age with bleeding of supposedly abdominal and/or pelvic and/or junctional origin, uncontrolled haemorrhagic shock or cardiac arrest with attempted resuscitation. RESULTS: During this study period, a total of 1159 patients with trauma (3.2%) would have been eligible to undergo REBOA. Death on scene rate was 83.8% (n=31) and six patients had a beating heart when they arrived at the hospital. Ten out of the 37 patients had spontaneous circulatory activity. Among them, four people died on the scene or during transport. Thirty-six out of 37 patients were intubated, one benefited from the use of a haemostatic dressing and one benefited from a tourniquet. CONCLUSIONS: REBOA can be seen as an effective non-surgical solution to ensure complete haemostasis during the prehospital setting. When comparing the high mortality rate following haemorrhage with the REBOA's rare side effects, the risk-benefit balance is positive. Given that 3% of all patients with trauma based on this study would have been eligible for REBOA, we believe that this intervention should be available in the prehospital setting. The results of this study will be used: educational models for REBOA balloon placement using training manikins, with an ultimate aim to undertake a prospective feasibility study in the prehospital setting.

Resuscitative endovascular balloon occlusion of the aorta or resuscitative thoracotomy with aortic clamping for noncompressible torso hemorrhage: A retrospective nationwide study.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging treatment for noncompressible torso hemorrhage. It remains unclear if REBOA is superior to resuscitative thoracotomy with aortic cross-clamping (RT) in terms of improving outcomes. This study compared in-hospital outcomes between REBOA and RT in trauma patients with uncontrolled hemorrhagic shock, using data from a national inpatient database in Japan. METHODS: Using the Diagnosis Procedure Combination database, we identified patients who received REBOA or RT within 1 day after admission from July 1, 2010, to March 31, 2014. We excluded those with penetrating thoracic injuries. Propensity score-adjusted analyses were performed to compare in-hospital mortality and other in-hospital outcomes. RESULTS: Eligible patients (n = 259) were classified into the REBOA group (n = 191) or the RT group (n = 68). In the propensity score-adjusted Cox regression analysis, the two groups did not differ significantly with respect to in-hospital mortality (hazard ratio, 0.94; 95% confidence interval, 0.60-1.48). There were also no significant differences between the groups in ventilator-free days, intensive care unit-free days, total amount of fluid infusion within 1 day after admission, total amount of transfusion within 1 day after admission, or total hospitalization costs. CONCLUSION: In this retrospective nationwide study, in-hospital outcomes were not significantly different between REBOA and RT in trauma patients with uncontrolled hemorrhagic shock. LEVEL OF EVIDENCE: Therapeutic/care management, level III.

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.