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.

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.

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.

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.

[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.

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.

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.

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.

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.

Esophageal balloon tamponade versus esophageal stent in controlling acute refractory variceal bleeding: A multicenter randomized, controlled trial.

UNLABELLED: Balloon tamponade is recommended only as a "bridge" to definitive therapy in patients with cirrhosis and massive or refractory esophageal variceal bleeding (EVB), but is frequently associated with rebleeding and severe complications. Preliminary, noncontrolled data suggest that a self-expandable, esophageal covered metal stent (SX-ELLA Danis; Ella-CS, Hradec Kralove, Czech Republic) may be an effective and safer alternative to balloon tamponade. We conducted a randomized, controlled trial aimed at comparing esophageal stent versus balloon tamponade in patients with cirrhosis and EVB refractory to medical and endoscopic treatment. Primary endpoint was success of therapy, defined as survival at day 15 with control of bleeding and without serious adverse events (SAEs). Twenty-eight patients were randomized to Sengstaken-Blakemore tube (n = 15) or SX-ELLA Danis stent (n = 13). Patients were comparable in severity of liver failure, active bleeding at endoscopy, and initial therapy. Success of therapy was more frequent in the esophageal stent than in balloon tamponade group (66% vs. 20%; P = 0.025). Moreover, control of bleeding was higher (85% vs. 47%; P = 0.037) and transfusional requirements (2 vs 6 PRBC; P = 0.08) and SAEs lower (15% vs. 47%; P = 0.077) in the esophageal stent group. TIPS was used more frequently in the tamponade group (4 vs. 10; P = 0.12). There were no significant differences in 6-week survival (54% vs. 40%; P = 0.46). CONCLUSION: Esophageal stents have greater efficacy with less SAEs than balloon tamponade in the control of EVB in treatment failures. Our findings favor the use of esophageal stents in patients with EVB uncontrolled with medical and endoscopic treatment. (Hepatology 2016;63:1957-1967).

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.

Important surgical measures and techniques at cesarean hysterectomy for placenta previa accreta.

For cesarean hysterectomy with placenta previa accreta, "universally achievable" measures are required. We propose eight measures: (i) placement of intra-iliac arterial occlusion balloon catheters; (ii) placement of ureter stents; (iii) "holding the cervix" to identify the site to be transected; (iv) uterine fundal incision; (v) avoidance of uterotonics; (vi) "M cross double ligation" for ligating the ovarian ligament; (vii) "filling the bladder" to identify the bladder separation site and "opening the bladder" for placenta previa accreta with bladder invasion; and (viii) to continue to clamp the medial side of the parametrium or the cervix or employment of the "double edge pick-up" to ligate it. These eight measures are simple, easy, effective, and thus "universally achievable".

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.

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.

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.

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.

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.