Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia.

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

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia.

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

Vascular complications secondary to resuscitative endovascular balloon occlusion of the aorta placement at a Level 1 Trauma Center.

OBJECTIVE: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is designed to manage severe hemorrhagic shock. Popularized in medical care during military conflicts, the concept has emerged as a lifesaving technique that is utilized around the United States. Literature on risks of REBOA placement, especially vascular injuries, are not well-reported. Our goal was to assess the incidence of vascular injury from REBOA placement and the risk factors associated with injury and death among these patients at our institution. METHODS: We performed a retrospective cohort study of all patients who underwent REBOA placement between September 2017 and June 2022 at our Level 1 Trauma Center. The primary outcome variable was the presence of an injury related to REBOA insertion or use. Secondary outcomes studied were limb loss, the need for dialysis, and mortality. Data were analyzed using descriptive statistics, χ2, and t-tests as appropriate for the variable type. RESULTS: We identified 99 patients who underwent REBOA placement during the study period. The mean age of patients was 43.1 ± 17.2 years, and 67.7% (67/99) were males. The majority of injuries were from blunt trauma (79.8%; 79/99). Twelve of the patients (12.1%; 12/99) had a vascular injury related to REBOA placement. All but one required intervention. The complications included local vessel injury (58.3%; 7/12), distal embolization (16.7%; 2/12), excessive bleeding requiring vascular consult (8.3%; 1/12), pseudoaneurysm requiring intervention (8.3%; 1/12), and one incident of inability to remove the REBOA device (8.3%; 1/12). The repairs were performed by vascular surgery (75%; 9/12), interventional radiology (16.7%; 2/12), and trauma surgery (8.3%; 1/12). There was no association of age, gender, race, and blunt vs penetrating injury to REBOA-related complications. Mortality in this patient population was high (40.4%), but there was no association with REBOA-related complications. Ipsilateral limb loss occurred in two patients with REBOA-related injuries, but both were due to their injuries and not to REBOA-related ischemia. CONCLUSIONS: Although vascular complications are not unusual in REBOA placement, there does not appear to be an association with limb loss, dialysis, or mortality if they are addressed promptly. Close coordination between vascular surgeons and trauma surgeons is essential in patients undergoing REBOA placement.

The BALTO Registry: Long-term results of percutaneous BALloon pericardioTomy in oncological patients.

OBJECTIVES: The aim of this study was to analyze the efficacy and safety of percutaneous balloon pericardiotomy (PBP) in oncological patients who present with a malignant pericardial effusion (MPE). BACKGROUND: The use of PBP as a treatment for MPE is not standardized due to the limited evidence. Furthermore, the performance of a second PBP for a recurrence after a first procedure is controversial. METHODS: The BALTO Registry (BALloon pericardioTomy in Oncological patients) is a prospective, single-center, observational registry that includes consecutive PBP performed for MPE from October 2007 to February 2022. Clinical and procedural, characteristics, as well as clinical outcome were analyzed. RESULTS: Seventy-six PBP were performed in 61 patients (65% female). Mean age was of 66.4 ± 11.2 years. In 15 cases, a second PBP procedure was performed due to recurrence despite the first PBP. The procedure could be performed effectively in all cases with only two serious complications. Ninety-five percent of cases were discharged alive from the hospital. During a median follow-up of 6.3 months (interquartile range [IQR], 0.9-10.8), MPE recurred in 24.5% cases although no recurrences were reported after the second procedure. No evidence of malignant pleural effusion developed on follow-up. The median overall survival time was 5.8 months (IQR, 0.8-10.2) and the time to recurrence after the first PBP was 2.4 months (IQR, 0.7-4.5). CONCLUSIONS: PBP is a safe and effective treatment for MPE. It could be considered an acceptable therapy in most MPE, even in those who recur after a first procedure.

Outcomes Associated With Aortic Balloon Occlusion Time in Patients With Zone 1 Resuscitative Endovascular Balloon Occlusion of the Aorta.

INTRODUCTION: Resuscitative endovascular balloon occlusion of the aorta (REBOA) has the potential to cause clinically relevant systemic ischemic burden with long durations of aortic occlusion (AO). We aimed to examine the association between balloon occlusion time and clinical complications and mortality outcomes in patients undergoing zone 1 REBOA. METHODS: A retrospective cohort analysis of American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acuteregistry patients with Zone 1 REBOA between 2013 and 2022 was performed. Patients with cardiopulmonary resuscitation on arrival or who did not survive past the emergency department were excluded. Total AO times were categorized as follows: <15 min, 15-30 min, 31-60 min, and >60 min. Clinical and procedural variables and in-hospital outcomes were compared across groups using bivariate and multivariate regression analyses. RESULTS: There were 327 cases meeting inclusion criteria (n = 51 < 15 min, 83 15-30 min, 98 31-60 min, and 95 > 60 min, respectively). AO >60 min had higher admission lactate (8 ± 6; P = 0.004) compared to all other time groups, but injury severity score, heart rate, and systolic blood pressure were similar. Group average times from admission to definitive hemorrhage control ranged from 82 to 103 min and were similar across groups (85 min in AO >60 group). Longer AO times were associated with greater red blood cell, fresh frozen plasma transfusions (P < 0.001), and vasopressor use (P = 0.001). Mortality was greatest in the >60 min group (73%) versus the <15 min, 15-30 min, and 31-60 min groups (53%, 43%, and 45%, P < 0.001). With adjustment for injury severity score, systolic blood pressure, and lactate, AO >60 min had greater mortality (OR 3.7, 95% CI 1.6-9.4; P < 0.001) than other AO duration groups. Among 153 survivors, AO >60 min had a higher rate of multiple organ failure (15.4%) compared to the other AO durations (0%, 0%, and 4%, P = 0.02). There were no differences in amputation rates (0.7%) or spinal cord ischemia (1.4%). acute kidney injury was seen in 41% of >60 min versus 21%, 27%, and 33%, P = 0.42. CONCLUSIONS: Though greater preocclusion physiologic injury may have been present, REBOA-induced ischemic insult was correlated with poor patient outcomes, specifically, REBOA inflation time >60 min had higher rates of mortality and multiple organ failure. Minimizing AO duration should be prioritized, and AO should not delay achieving definitive hemostasis. Partial REBOA may be a solution to extend safe AO time and deserves further study.

Collateral Round Ligament Arterial Supply of Placenta Accreta Spectrum and Considerations for Prophylactic Balloon Occlusion Catheter Placement.

Internal iliac artery (IIA) balloon occlusion catheters have been commonly inserted to decrease the risk of postpartum hemorrhage in placenta accreta spectrum disorders; however, there has been mixed success in clinical studies. Placement of an infrarenal aortic balloon has shown more consistent effectiveness in recent studies. A possible reason for this is collateral arterial supply to the placenta from external iliac artery branches. Retrospective chart review was conducted of angiography images during prophylactic IIA balloon occlusion catheter insertion over a 7-year period. Sixty-two individual cases were identified. Digital subtraction angiography (DSA) was performed in 32 (52%) cases, and 20 (62%) showed collateral blood supply from branches of the external iliac arteries, namely the round ligament artery. In conclusion, a high proportion of placenta accreta spectrum cases have arterial blood supply from branches of the external iliac artery, which may explain the discrepancy in effectiveness seen between IIA and infrarenal aortic sites of balloon occlusion catheter placement.

REBOA Improves Outcomes in Hybrid Surgery for Ruptured Abdominal Aortic Aneurysms.

BACKGROUND: Despite advancements in diagnostic methods and emergency interventions, mortality rates of ruptured abdominal aortic aneurysm (rAAA) continue to remain high. To address this issue, the resuscitative endovascular balloon occlusion of the aorta (REBOA) technique has been designed to provide temporary control of bleeding. We aimed to compare the impact of the REBOA technique during open aortic surgery for rAAA. METHODS: Between January 2014 and November 2021, 53 consecutive patients (46 males, 7 females; mean age 71.9 ± 7.9 years; range 51-89 years) who underwent emergency open aortic surgery for rAAA were retrospectively analyzed. Patients were divided into REBOA (21 patients) and non-REBOA (32 patients) groups. The primary outcomes were postoperative 24-hr and 30-day mortality. The secondary outcomes were intensive care unit (ICU) stay, in-hospital stay, bleeding, postoperative renal failure, bowel ischemia, and transient ischemic attack (TIA)/stroke rate. RESULTS: The REBOA group showed a significant reduction in mortality rates at both 24 hr (9.5% vs. 37.5%, P = 0.029) and 30 days (14.2% vs. 43.7%, P = 0.035) compared to the non-REBOA group. In-hospital stay (12.8 ± 3.48 vs. 15.6 ± 4.74 days, P = 0.02) and ICU stay (2.42 ± 2.08 vs. 5.09 ± 5.79 days, P = 0.048) were shorter among the REBOA group. Total procedure time and bleeding were reduced among the REBOA group without significant differences in terms of postoperative renal failure, bowel ischemia, and TIA/stroke rate. CONCLUSIONS: The REBOA group demonstrated significantly improved survival rates compared to the non-REBOA group, without a significant difference in complication rates. REBOA is considered a less invasive option compared to the traditional method for open aortic cross-clamping. This study demonstrated that the use of REBOA may be considered as a first-line treatment option for open surgery in cases of rAAA particularly when an off-the-shelf endovascular aneurysm repair device is not suitable.

International registry on aortic balloon occlusion in major trauma: Partial inflation does not improve outcomes in abdominal trauma.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a method for temporary hemorrhage control used in haemodynamically unwell patients with severe bleeding. In haemodynamically unwell abdominal trauma patients, laparotomy remains the initial procedure of choice. Using REBOA in patients as a bridge to laparotomy is a novel option whose feasibility and efficacy remain unclear. We aimed to assess the clinical outcome in patients with abdominal injury who underwent both REBOA placement and laparotomy. METHODS: This is a retrospective study, including trauma patients with an isolated abdominal injury who underwent both REBOA placement and laparotomy, during the period 2011-2019. All data were collected via the Aortic Balloon Occlusion Trauma Registry database. RESULTS: One hundred and three patients were included in this study. The main mechanism of trauma was blunt injury (62.1%) and the median injury severity score (ISS) was 33 (14-74). Renal failure and multi-organ dysfunction syndrome (MODS) occurred in 15.5% and 35% of patients, respectively. Overall, 30-day mortality was 50.5%. Post balloon inflation systolic blood pressure (SBP) >80 mmHg was associated with lower 24-h mortality (p = 0.007). No differences in mortality were found among patients who underwent partial occlusion vs. total occlusion of the aorta. CONCLUSIONS: Our results support the feasibility of REBOA use in patients with isolated abdominal injury, with survival rates similar to previous reports for haemodynamically unstable abdominal trauma patients. Post-balloon inflation SBP >80 mmHg was associated with a significant reduction in 24-h mortality rates, but not 30-day mortality. Total aortic occlusion was not associated with increased mortality, MODS, and complication rates compared with partial occlusion.

Balloon-occluded retrograde transvenous obliteration for treatment of portal hypertensive related varices.

PURPOSE OF REVIEW: Balloon-occluded retrograde transvenous obliteration (BRTO) is becoming a more commonly used procedure to manage various complications of liver disease. It is important to understand the technique of the procedure, the indications for its use, and also potential associated complications. RECENT FINDINGS: BRTO is superior to endoscopic cyanoacrylate injection and transjugular intrahepatic portosystemic shunt for bleeding gastric varices associated with a portosystemic shunt and should be considered a first line therapy in these patients. In addition, it has been shown to be useful in controlling ectopic variceal bleeding, improving portosystemic encephalopathy, and also in modulating blood flow in the post liver transplant setting. Modified versions of BRTO, plug assisted retrograde transvenous obliteration and coil assisted retrograde transvenous obliteration, have been developed to reduce procedure time and improve complication rates. SUMMARY: As the use of BRTO expands in clinical practice it will be important for gastroenterologists and hepatologists to better understand the procedure. There are still many research questions left to answer regarding the use of BRTO in specific situations and for specific patient populations.

Arterial Access Complications Following Percutaneous Femoral Access in 24-Hour Resuscitative Endovascular Balloon Occlusion of the Aorta Survivors.

INTRODUCTION: With the use of resuscitative endovascular balloon occlusion of the aorta (REBOA) comes the potential for vascular access site complications (VASCs) and limb ischemic sequelae. We aimed to determine the prevalence of VASC and associated clinical and technical factors. METHODS: A retrospective cohort analysis of 24-h survivors undergoing percutaneous REBOA via the femoral artery in the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute care surgery registry between Oct 2013 and Sep 2021 was performed. The primary outcome was VASC, defined as at least one of the following: hematoma, pseudoaneurysm, arteriovenous fistula, arterial stenosis, or the use of patch angioplasty for arterial closure. Associated clinical and procedural variables were examined. Data were analyzed using Fisher exact test, Mann-Whitney-U tests, and linear regression. RESULTS: There were 34 (7%) cases with VASC among 485 meeting inclusion criteria. Hematoma (40%) was the most common, followed by pseudoaneurysm (26%) and patch angioplasty (21%). No differences in demographics or injury/shock severity were noted between cases with and without VASC. The use of ultrasound (US) was protective (VASC, 35% versus no VASC, 51%; P = 0.05). The VASC rate in US cases was 12/242 (5%) versus 22/240 (9.2%) without US. Arterial sheath size >7 Fr was not associated with VASC. US use increased over time (R2 = 0.94, P < 0.001) with a stable rate of VASC (R2 = 0.78, P = 0.61). VASC were associated with limb ischemia (VASC, 15% versus no VASC, 4%; P = 0.006) and arterial bypass procedures (VASC 3% versus no VASC 0%; P < 0.001) but amputation was uncommon (VASC, 3% versus no VASC, 0.4%; P = 0.07). CONCLUSIONS: Percutaneous femoral REBOA had a 7% VASC rate which was stable over time. VASC are associated with limb ischemia but need for surgical intervention and/or amputation is rare. The use of US-guided access appears to be protective against VASC and is recommended for use in all percutaneous femoral REBOA procedures.

Inferior Vena Cava-Balloon Occlusion and Its Effect on the Myocardium During Endograft Deployment in the Arch.

PURPOSE: To evaluate the impact of cava balloon occlusion on the myocardium during endovascular repair of thoracic aortic pathologies. MATERIAL AND METHODS: A prospective observational cohort study of 21 patients who underwent endovascular repair of aortic arch and thoracic aorta in a single tertiary referral center with use of inferior vena cava (IVC) balloon occlusion as a method of intraoperative cardiac output reduction. Pre-, intra-, and postoperative measurements of heart rate, blood pressure, stroke volume index, and central venous oxygen saturation were noted. High-sensitive serum troponin levels were also analyzed according to a pre-established protocol. Endpoints were cardiac troponin T levels after induced hypotension and left ventricular ejection fraction during follow-up. Secondary endpoints were procedure technical success and overall survival. RESULTS: Twenty-one patients (18 male, median age 69, (62-75, IQR)) enrolled in the study between May 2015 and January 2019. Indication for endovascular treatment was an aortic arch aneurysm (n=10), descending aortic aneurysm (n=8), lusorian artery aneurysm (n=2), and thoracoabdominal aortic aneurysm (n=1). Median time to reach half mean arterial pressure was 60 seconds while median recovery time of blood pressure was 135 seconds. In 5 (24%) cases, we observed a > 50% change of Troponin T on the reference level. Technical success was achieved in all cases. Two (10%) patients developed new and persistent atrial fibrillation and 1 (5%) suffered a peri-operative ST-elevation myocardial infarction. CONCLUSION: The use of IVC balloon occlusion is a feasible technique for cardiac output reduction during endovascular repair of thoracic aortic pathologies. One fourth of the patients develop significant troponin leakage but the significance of the finding needs further studies.

Short-Term Results of Plug-Assisted Retrograde Transvenous Obliteration for Portal Steal from Complicated Portosystemic Shunts in Living-Donor Liver Transplantation.

PURPOSE: To investigate the effectiveness of plug-assisted retrograde transvenous obliteration (PARTO) for portal steal from complicated portosystemic shunts (PSSs) in living-donor liver transplantation (LDLT). MATERIALS AND METHODS: This retrospective study included consecutive patients who underwent LDLT and intraoperative or postoperative PARTO for complicated PSS between January 2020 and December 2021. PARTO was performed when hepatofugal portal flow steal was identified during intraoperative cineportography, and afferent vein embolization was difficult because of multiple afferent veins or incomplete afferent vein embolization. Liver volume, complete obliteration of PSS, technical success, adverse events, and follow-up clinical and laboratory data were evaluated. RESULTS: Thirty-seven patients were included, and the technical success rate was 100% with no major adverse events. During the median follow-up of 20.0 months, all patients recovered well with suitable regeneration of the liver without graft dysfunction related to a portal steal. The liver volume significantly increased within 1 month (median, 956 vs 1,198 mL; P < .001). Complete obliteration of a PSS occurred in 36 of 37 (97.3%) patients, and there was no recurrence during follow-up. The Child-Pugh score, serum albumin and total bilirubin levels, and prothrombin time showed significant improvement over serial follow-up. Compared with preprocedural values (14.9 cm/s), follow-up portal flow (median) peaked on the first day (71.2 cm/s, P < .001) and then remained significantly high at 1 week (60.3 cm/s, P < .001) and 1 month (53.1 cm/s, P < .001), in accordance with the graft regeneration. CONCLUSIONS: PARTO is an effective procedure for the treatment of complicated PSS in LDLT.

Intraoperative Multivessel Embolization Reduces Blood Loss and Transfusion Requirements Compared to Internal Iliac Artery Balloon Placement during Cesarean Hysterectomy for Placenta Accreta Spectrum.

PURPOSE: To evaluate the effectiveness and safety of prophylactic multivessel selective embolization (MVSE) compared to those of internal iliac artery occlusion balloon (IIABO) placement in patients undergoing cesarean hysterectomy for placenta accreta spectrum (PAS). MATERIALS AND METHODS: An institutional review board-approved retrospective series was conducted with consecutive patients with PAS at a single institution between 2010 and 2021. MVSE was performed in a hybrid operating room after cesarean section prior to hysterectomy. IIABO was performed with balloons placed into the bilateral internal iliac arteries, which were inflated during hysterectomy. Median blood loss, transfusion requirements, percentage of cases requiring transfusion, and adverse events were recorded. RESULTS: A total of 20 patients treated with embolization and 34 patients with balloon placement were included. Placenta percreta and previa were seen in 60% and 90% of patients, respectively. Median blood loss in the MVSE group was 713 mL (interquartile range [IQR], 475-1,000 mL) compared to 2,000 mL (IQR, 1,500-2,425 mL) in the IIABO group (P < .0001). The median total number of units of packed red blood cell transfusions (0 vs 2.5) and percentage of cases requiring a transfusion (20% vs 65%) were less in the MVSE group (P < .01). A median of 4 vessels (IQR, 3-9) were embolized during MVSE. No major adverse events or nontarget embolization consequences were observed. CONCLUSIONS: Prophylactic MVSE is a safe procedure that reduces operative blood loss and transfusion requirements compared to those of IIABO in patients undergoing cesarean hysterectomy for presumed higher-degree PAS.

Prophylactic Uterine Artery Embolization in Placenta Accreta Spectrum-An Active Intervention to Reduce Morbidity and Promote Uterine Preservation.

PURPOSE: To evaluate the feasibility and safety of early and proactive involvement of interventional radiology (IR) in the management of placenta accreta spectrum (PAS) by performing the cesarean operation and prophylactic uterine artery embolization in the IR angiography suite as a combined procedure. MATERIALS AND METHODS: This study evaluated the effectiveness and safety of prophylactic uterine artery embolization prior to placental separation in cases of antenatally proven or suspected abnormal placentation. Over a 5-year period, 16 consecutive patients with PAS underwent combined IR and obstetric intervention. In all cases, cesarean delivery was performed in the IR angiography suite. Vascular access was obtained prior to surgery with balloon placement into both internal iliac arteries. These balloons were inflated after delivery, followed by uterine artery embolization (14 of 16) if there was evidence of active postpartum bleeding or inability to deliver the placenta. RESULTS: There was no fetal or maternal mortality and no significant IR or surgical adverse events. Mean blood loss was 1900 mL. Seven patients (44%) underwent hysterectomy. CONCLUSIONS: In patients with PAS, cesarean section in the angiography suite preceded by prophylactic balloon placement and followed by uterine artery embolization was feasible, safe, and effective in preventing massive blood loss, with a 56% uterine sparing rate.

REBOA: Expanding Applications From Traumatic Hemorrhage to Obstetrics and Cardiopulmonary Resuscitation, From the AJR Special Series on Emergency Radiology.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged over the past decade as a technique to control life-threatening hemorrhage and treat hemorrhagic shock, being increasingly used to treat noncompressible traumatic torso hemorrhage. Reports during this time also support the use of a REBOA device for an expanding range of indications including nontraumatic abdominal hemorrhage, postpartum hemorrhage, placenta accreta spectrum (PAS) disorder, and cardiopulmonary resuscitation (CPR). The strongest available evidence supports REBOA as a lifesaving adjunct to definitive surgical management in trauma and as a method to help avoid hysterectomy in select patients with postpartum hemorrhage or PAS disorder. In comparison with initial descriptions of complete REBOA inflation, techniques for partial REBOA inflation have been introduced to achieve hemodynamic stability while minimizing adverse events relating to reperfusion injuries. Fluoroscopy-free REBOA has been described in various settings, including trauma, obstetrics, and out-of-hospital cardiac arrest. As the use of REBOA expands outside the trauma setting and into nontraumatic abdominal hemorrhage, obstetrics, and CPR, it is imperative for radiologists to become familiar with this technology, its proper placement, and its potential adverse sequelae.

Long-Term Prognosis and Related Factors in Patients with Cirrhosis Treated with Balloon-Occluded Retrograde Transvenous Obliteration.

INTRODUCTION: Balloon-occluded retrograde transvenous obliteration (BRTO) was developed as an effective treatment for gastric varices in patients with cirrhosis. Because liver fibrosis in these patients is assumed to be advanced, their prognosis is expected to be poor. In this study, we investigated the prognosis and characteristics of the patients. METHODS: We enrolled 55 consecutive patients with liver cirrhosis treated with BRTO between 2009 and 2021 at our department. To evaluate factors related to variceal recurrence and long-term prognosis, survival analysis was performed on 45 patients, excluding those who died within 1 month, had an unknown prognosis, or whose treatments were converted to other treatments. RESULTS: During a mean follow-up period of 2.3 years, esophageal varices recurred in 10 patients and could be treated endoscopically. Non-alcoholic steatohepatitis (NASH) was related to the variceal recurrence (hazard ratio [HR] = 4.27, 95% CI: 1.17-15.5, p = 0.028). The survival rate after the procedure at 1, 3, and 5 years was 94.2%, 74.0%, and 63.5%, respectively, and 10 patients died of hepatocellular carcinoma (n = 6), liver failure (n = 1), sepsis (n = 1), and unknown reasons (n = 2). The estimated glomerular filtration rate (eGFR) level was proved to be a significant poor prognostic factor (HR = 0.96, 95% CI: 0.93-0.99, p = 0.023). The comorbid hypertension (HTN) was the main cause of low eGFR, and HTN was also significantly related to survival (HR = 6.18, 95% CI: 1.57-24.3, p = 0.009). Most of the patients with HTN were treated with calcium channel blocker and/or angiotensin receptor blocker. CONCLUSION: The clinical course of patients with cirrhosis treated with BRTO was dependent on the metabolic factors including renal function, comorbid HTN, and NASH.

Temporary atrial septal defect balloon occlusion test as a must in the elderly.

BACKGROUND: Atrial septal defect (ASD) can often remain asymptomatic until adulthood. It still remains unclear whether large ASD closure in senior people should be performed or not. Temporary ASD balloon occlusion test has been suggested as a tool to assess the risk of acute left ventricular heart failure post-ASD closure, and it allows to better distinguish responders from non-responders. CASE PRESENTATION: An 83-year-old man with a long-standing uncorrected secundum ASD was admitted for recently decompensated right-sided heart failure. During hospitalization, this patient was studied with trans-esophageal echocardiography, cardiac magnetic resonance imaging, and right heart catheterization, showing high Qp:Qs ratio and favorable anatomical conditions for percutaneous closure. Because of patient's increasing need for intravenous diuretics and worsening renal function, it was considered that transcatheter ASD closure could improve symptoms, hence it was performed an attempt of percutaneous closure of the ASD with a fenestrated device. Unfortunately, irrespective of ASD being hemodynamically significant, it was found a very significant increase in pulmonary capillary wedge pressure during the temporary balloon occlusion test, supporting the existence of concealed left ventricular diastolic dysfunction. As a result, it was decided to abandon the procedure and not to close the ASD. CONCLUSION: This clinical case illustrates the value of temporary balloon occlusion test before permanent percutaneous closure of ASD in elderly patients, regardless of left ventricular (systolic or diastolic) dysfunction.

Resuscitative Endovascular Balloon Occlusion of the Aorta is Associated with Increased Risk of Extremity Compartment Syndrome.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) has been used as a temporizing procedure to control intra-abdominal or pelvic bleeding. Theoretically, occlusion of the aorta and the resulting ischemia-reperfusion of the lower extremities may increase the risk of extremity compartment syndrome (CS). To date, no study has addressed systematically the incidence and risk factors of CS following REBOA intervention. The purpose of this study was to address this knowledge gap. METHODS: Adult trauma patients from the American College of Surgeons Trauma Quality Improvement Program (ACS-TQIP) database (2016-2019) were included. Patients who received REBOA within 4 h of admission were compared to patients without REBOA after propensity score matching for demographics, vital signs on admission, comorbidities, injury severity of different body regions, pelvic and lower extremity fractures, vascular trauma to the lower extremities, fixation for fractures, angioembolization (AE) for pelvis, preperitoneal pelvic packing (PPP), laparotomy, and venous thromboembolism (VTE) prophylaxis. The primary outcomes were rates of lower extremity CS and fasciotomy and acute kidney injury (AKI). Secondary outcomes included mortality. RESULTS: There were 534 patients who received REBOA matched with 1043 patients without REBOA. Overall, patients in the REBOA group had significantly higher rates of CS than no REBOA patients [5.4% vs 1.1%, p < 0.001, OR: 5.39]. The risk of CS remained significantly higher in the subgroups of patients with or without pelvic or lower extremity fractures, as well as in the subgroup of patients with associated extremity vascular injury [11.2% vs 1.5%, p < 0.001, OR: 8.12].The fasciotomy and AKI rates were significantly higher in the REBOA group (5.8% vs 1.2%, p < 0.001 and 12.9% vs 7.4%, p< 0.001 respectively). CONCLUSION: REBOA use is associated with a higher risk of lower extremity CS, fasciotomy and AKI, especially in patients with associated lower extremity vascular injuries. These complications should be taken into account when considering REBOA use, and close observation for this complication should always be part of the routine monitoring.

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

Importance: Bleeding is the most common cause of preventable death after trauma. Objective: To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage. Design, Setting, and Participants: Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days. Intervention: Patients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44). Main Outcomes and Measures: The primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death. Results: Of the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours. Conclusions and Relevance: In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone. Trial Registration: isrctn.org Identifier: ISRCTN16184981.

The use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Civilian Trauma in an Israeli Level 1 Trauma Center.

BACKGROUND: Massive, non-compressible bleeding is a leading cause of preventable trauma mortality. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a minimally invasive procedure in which a balloon catheter is maneuvered into the aorta to temporarily occlude large vessels and enable stabilization of the exsanguinating patient. OBJECTIVES: To present experiences in assimilating REBOA at a single level 1 trauma center in Israel, to evaluate the technical aspects of the procedure, and to describe patient characteristics and outcomes. METHODS: This retrospective cohort study comprised civilians admitted with hemorrhagic shock to our trauma department who were treated with REBOA between November 2017 and July 2021. Descriptive statistics of the patients, characteristics of the injuries and patient outcomes are presented. RESULTS: The study included 22 patients (median age 30.1 years, 21 male). The mean systolic blood pressure (SBP) before REBOA inflation was 59.6 ± 11.4 mmHg, and the mean SBP measured after the procedure was 115.2 ± 26.3 mmHg. In 20 patients (91%), the SBP was normalized (> 90 mmHg) shortly after inflation of the balloon, and they survived the treatment in the trauma department; 15 (75%) survived the first 30 days. CONCLUSIONS: REBOA is an effective method for the initial resuscitation and hemorrhage control of patients with massive, non-compressible bleeding and is relatively easy to assimilate in a hospital. The achievement of immediate normalization of SBP enables medical personnel to correct physiological parameters and obtain accurate imaging before proceeding to the operating theater.