Four-dimensional flow magnetic resonance imaging for assessment of hemodynamic changes in the portal venous system before and after balloon-occluded retrograde transvenous obliteration: a pilot feasibility study.

BACKGROUND: The effectiveness of four-dimensional (4D) flow magnetic resonance imaging (MRI) for assessing hemodynamic changes before and after balloon-occluded retrograde transvenous obliteration (BRTO) remains unclear. PURPOSE: To evaluate the feasibility of 4D flow MRI for assessing hemodynamic changes in the portal venous system before and after BRTO. MATERIAL AND METHODS: We included 10 patients (7 men, 3 women; mean age = 67 years) with liver cirrhosis who had a high risk of gastric variceal bleeding or hepatic encephalopathy. Non-contrast 4D flow MRI of the upper abdomen was performed before and after BRTO. In addition, we compared the blood flow rates in the portal vein (PV), superior mesenteric vein (SMV), splenic vein (SV), left renal vein, and inferior vena cava before and after BRTO. Moreover, the flow directions of the SMV and SV before and after BRTO were assessed using both portography and 4D flow MRI. RESULTS: There was a significant post-BRTO increase in the blood flow rate in the PV and SV (P < 0.05). There was no significant post-BRTO change in the blood flow rates in the SMV, inferior vena cava, and left renal vein. In four patients, portography confirmed that hepatofugal flow in the SV and SMV changed to hepatopetal flow after BRTO. Moreover, 4D flow MRI correctly assessed the flow directions in the SMV and SV in 70%-100% of the patients. CONCLUSION: 4D flow MRI can be used to detect hemodynamic changes in the portal venous system before and after BRTO.

The clinical evaluation of IIA balloon occlusion in caesarean delivery for patients with PAS: a retrospective study.

OBJECTIVE: The aim of this study is the clinical evaluation of IIA balloon occlusion in the caesarean delivery in patients with a diagnosis of placenta accreta spectrum. BACKGROUND: High incidence of cesarean section leads to the increasing incidence of placenta accreta spectrum (PAS), which contributes to serious consequences such as severe obstetric postpartum hemorrhage or even maternal mortality. METHODS: Fifty-eight patients with a diagnosis of PAS were retrospectively reviewed. The balloon group consisted of 23 patients, who underwent a caesarean delivery with internal iliac artery occlusion. 35 patients were in the control group, who had a standard caesarean delivery. The primary outcomes were estimated blood loss (EBL). The secondary outcomes were cesarean hysterectomy, blood transferring volume, operating time, intraoperative hemostatic approaches, surgical complications, balloon catheter-related complications, length of maternal stay, cost of hospitalization, and neonatal outcomes. RESULTS: No difference was observed in estimated blood loss (EBL), blood transferring percentages and volume, additional measures to secure hemostasis, surgical complications, hospital stay postoperatively and newborn outcomes. More than 40% of the balloon group underwent hysterectomy because of uncontrollable postpartum bleeding (10 [43.48%] vs. 11 [31.43%], P=0.350). Complications related to occlusion of IIA did not occur. The duration of the surgery of the balloon group was significantly longer than that of the control group (123.52 min±74.76 versus 89.17±48.68, P=0.038), and the total hospitalization cost was also significantly higher than that of the control group (45116.67±9358.67 yuan versus 30615.41±11587.44 yuan, P=0.000). CONCLUSION: It does not permit to draw final conclusions for us on the effectiveness of the balloons IIA given the heterogeneity of selection of cases undergoing the procedures in the retrospective design. However, it is possible that IIA balloon occlusion may contribute to limiting intraoperative blood loss in more severe cases, particularly those undergoing peripartum hysterectomy.

Needs assessment of resuscitative endovascular balloon occlusion of the aorta (REBOA) in patients with major haemorrhage: a cross-sectional study.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) can be used as an adjunct treatment in traumatic abdominopelvic haemorrhage, ruptured abdominal aortic aneurysms, postpartum haemorrhage (PPH), gastrointestinal bleeding and iatrogenic injuries during surgery. This needs assessment study aims to determine the number of patients eligible for REBOA in a typical Norwegian population. METHODS: This was a retrospective cross-sectional study based on data obtained from blood bank registries and the Norwegian Trauma Registry for the years 2017-2018. Patients who received ≥4 units of packed red blood cells (PRBCs) within 6 hours and met the anatomical criteria for REBOA or patients with relevant Abbreviated Injury Scale codes with concurrent hypotension or transfusion of ≥4 units of PRBCs within 6 hours were identified. A detailed two-step chart review was performed to identify potentially eligible REBOA candidates. Descriptive data were collected and compared between subgroups using non-parametric tests for statistical significance. RESULTS: Of 804 patients eligible for inclusion, 53 patients were regarded as potentially REBOA eligible (corresponding to 5.7 per 100 000 adult population/year). Of these, 19 actually received REBOA. Among the identified eligible patients, 44 (83%) had a non-traumatic aetiology. Forty-two patients (79%) were treated at a tertiary care hospital. Fourteen (78%) of the REBOA procedures were due to PPH. CONCLUSION: The number of patients potentially eligible for REBOA after haemorrhage is low, and most cases are non-traumatic. Most patients were treated at a tertiary care hospital. The exclusion of non-traumatic patients results in a substantial underestimation of the number of potentially REBOA-eligible patients.

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.

Is there a role for REBOA? A system assessment.

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

Post-occlusional hyperemia for fractional flow reserve assessment and pull-back curve analysis.

Balloon occlusion is a potential method for inducing hyperemia to measure post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR). The objective of this study was to determine the clinical usefulness of post-occlusional hyperemia. FFRs measured using post-occlusional hyperemia caused by 30 (FFRoccl30) and 60 s (FFRoccl60) of balloon occlusion after PCI were compared in 60 lesions from 60 patients. The duration of hyperemia was also measured. There was a strong correlation between FFRoccl30 and FFRoccl60 (r = 0.969, p < 0.01). The duration of hyperemia was significantly longer with FFRoccl60 than with FFRoccl30 (68 ± 23 vs. 37 ± 15 s, p < 0.01). The time required for pullback curve analysis was around 45 s. However, in 7 (12%) cases, the duration of hyperemia with FFRoccl60 was < 45 s, which was not enough for pull-back curve analysis. To predict the duration of hyperemia with FFRoccl60 ≥ 45 s, the receiver operating characteristic curve analysis revealed a cut-off value of 25 s of hyperemia with FFRoccl30. FFRoccl30 is sufficient for diagnostic purposes. FFRoccl60 is suitable for pull-back curve analysis in select cases based on predictions made using the duration of hyperemia with FFRoccl30.

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.

Mobile forward-looking infrared technology allows rapid assessment of resuscitative endovascular balloon occlusion of the aorta in hemorrhage and blackout conditions.

INTRODUCTION: Objective assessment of final resuscitative endovascular balloon occlusion of the aorta (REBOA) position and adequate distal aortic occlusion is critical in patients with hemorrhagic shock, especially as feasibility is being increasingly investigated in the prehospital setting. We propose that mobile forward-looking infrared (FLIR) thermal imaging is a fast, reliable, and noninvasive method to assess REBOA position and efficacy in scenarios applicable to battlefield and prehospital care. METHODS: Ten swine were randomized to a 40% hemorrhage group (H, n = 5) or nonhemorrhage group (NH, n = 5). Three experiments were completed after Zone I placement of a REBOA catheter. Resuscitative endovascular balloon occlusion of the aorta was deployed for 30 minutes in all animals followed by randomized continued deployment versus sham in both light and blackout conditions. Forward-looking infrared images and hemodynamic data were obtained. Images were presented to 62 blinded observers for assessment of REBOA inflation status. RESULTS: There was no difference in hemodynamic or laboratory values at baseline. The H group was significantly more hypotensive (mean arterial pressure 44 vs. 60 mm Hg, p < 0.01), vasodilated (systemic vascular resistance 634 vs. 938dyn·s/cm, p = 0.02), and anemic (hematocrit 12 vs. 23.2%, p < 0.01). Hemorrhage group animals remained more hypotensive, anemic, and acidotic throughout all three experiments. There was a significant difference in the temperature change (ΔTemp) measured by FLIR between animals with REBOA inflated versus not inflated (5.7°C vs. 0.7°C, p < 0.01). The H and NH animals exhibited equal magnitudes of ΔTemp in both inflated and deflated states. Blinded observer analysis of FLIR images correctly identified adequate REBOA inflation and aortic occlusion 95.4% at 5 minutes and 98.8% at 10 minutes (positive predictive value at 5 minutes = 99% and positive predictive value at 10 minutes = 100%). CONCLUSIONS: Mobile thermal imaging is an easy, rapid, and reliable method for assessing distal perfusion after occlusion by REBOA. Smartphone-based FLIR technology allows for confirmation of adequate REBOA placement at the point of care, and performance was not degraded in the setting of major hemorrhage or blackout conditions.

Assessment of Blood Flow Patterns Distal to Aortic Occlusion Using CT in Patients with Resuscitative Endovascular Balloon Occlusion of the Aorta.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used to decrease hemorrhage below the level of aortic occlusion (AO); however, the amount of collateral blood flow below the level of occlusion is unknown. Our aim was to investigate blood flow patterns during complete AO in patients who underwent CT scan after REBOA. STUDY DESIGN: Between February 2013 and January 2017, patients who received REBOA and underwent CT scan with intravenous contrast during full AO were included. Patients were excluded if they had a CT scan performed with the balloon partially or fully deflated. RESULTS: Nine patients (8 men) were included; all had blunt trauma. Mean Injury Severity Score (±SD) was 48 ± 8 and mean age was 45 ± 19 years. Four had supra-celiac AO, and 5 had infra-renal AO. Arterial contrast enhancement was noted below the level of AO in all patients, and distal to REBOA sheath placement in 5. Collateralization from arteries above and below the AO was identified in all patients. Contrast extravasation distal to AO was identified in 4 patients, and hematomas in 8. Distal vascular enhancement patterns varied by level of AO and contrast administration site. CONCLUSIONS: Aortic occlusion appears to dramatically decrease, but does not completely impede, distal perfusion during REBOA due to multiple pathways of collateralization. Active extravasation and hematomas can still be detected in the setting of full AO, with purposefully timed contrast and image acquisition. Blood flow persists below the level of both the AO and in-dwelling sheath. Dynamic flow studies are needed to determine the contribution of AO and sheath placement to distal tissue ischemia.

An Inexpensive Esophageal Balloon Tamponade Trainer.

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

Radiologic assessment of fetal tracheal balloon occlusion.

Fetal endoscopic tracheal occlusion (FETO) is a novel technique to treat cases of isolated severe congenital diaphragmatic hernia (CDH). Although there are benefits of MRI over ultrasound in assessing lung volumes, it is unknown whether there are benefits of MRI for localizing the tracheal balloon. This is a retrospective study reviewing the imaging characteristics of FETO in patients who underwent both MRI and ultrasound exams done to localize tracheal balloons.

Clinical efficacy, safety, and costs of percutaneous occlusive balloon catheter-assisted ureteroscopic lithotripsy for large impacted proximal ureteral calculi: a prospective, randomized study.

PURPOSE: To evaluate the clinical efficacy, safety, and costs of percutaneous occlusive balloon catheter-assisted ureteroscopic lithotripsy (POBC-URSL) for large impacted proximal ureteral calculi. PATIENTS AND METHODS: 156 patients with impacted proximal ureteral stones ≥1.5 cm in size were randomized to ureteroscopic lithotripsy (URSL), POBC-URSL, and percutaneous nephrolithotomy (PNL) group between May 2010 and May 2013. For URSL, the calculi were disintegrated with the assistance of anti-retropulsion devices. POBC-URSL was performed with the assistance of an 8F percutaneous occlusive balloon catheter. PNL was finished with the combination of an ultrasonic and a pneumatic lithotripter. A flexible ureteroscope and a 200 µm laser fiber were used to achieve stone-free status to a large extent for each group. Variables studied were mean operative time, auxiliary procedure, postoperative hospital stay, operation-related complications, stone clearance rate, and treatment costs. RESULTS: The mean lithotripsy time for POBC-URSL was shorter than URSL, but longer than PNL (42.6±8.9 minutes vs 66.7±15.3 minutes vs 28.1±6.3 minutes, p=0.014). The auxiliary procedure rate and postoperative fever rate for POBC-URSL were significantly lower than URSL and comparable to PNL (p<0.01, p=0.034). POBC-URSL was superior to URSL with regard to the stone clearance rate at 3 days postoperatively, and as good as PNL (98.1% vs 75.0% vs 96.2%, p<0.01). The postoperative hospital stay and hematuria rate were lower in POBC-URSL group than PNL group and similar to URSL group (p=0.016, p<0.01). The treatment costs were lowest in POBC-URSL group ($1205.0±$113.9 vs $1731.7±$208.1 vs $2446.4±$166.4, p=0.004). CONCLUSIONS: For large impacted proximal ureteral calculi, POBC-URSL was associated with a higher stone clearance rate, fewer complications and costs. POBC-URSL combined the advantages of URSL and PNL.

Transcatheter closure of perimembranous ventricular septal defect: is the risk of heart block too high a price?

The late development of heart block in paediatric patients following device closure of a perimembranous ventricular septal defect may be a cause for concern.

Echocardiographic assessment and percutaneous closure of multiple atrial septal defects.

Atrial septal defect closure is now routinely performed using a percutaneous approach under echocardiographic guidance. Centrally located, secundum defects are ideal for device closure but there is considerable morphological variation in size and location of the defects. A small proportion of atrial septal defects may have multiple fenestrations and these are often considered unsuitable for device closure. We report three cases of multiple atrial septal defects successfully closed with two Amplatzer septal occluders.

Endovascular treatment of cerebral aneurysms--a cost analysis.

OBJECTIVES: To determine if endovascular treatment of cerebral aneurysms is cost effective when compared with conventional surgical treatment. DESIGN: A retrospective study. SUBJECTS: Seventeen patients treated between August 2002 and August 2003 had posterior communicating artery aneurysms. This group was selected for detailed analysis. OUTCOME MEASURES: Total treatment costs, in South African rands (R), were calculated for each patient. Average treatment costs for each group were then compared. RESULTS: Surgically clipped and endovascularly coiled groups were comparable for age, sex and clinical condition. The average cost for endovascular treatment per patient was R37 041. Surgical treatment was more expensive at R44 104, a difference of 16%. CONCLUSIONS: Despite the high cost of endovascular devices, appropriate use of this technology ultimately offers less expensive treatment than microsurgical clipping of aneurysms.

Surgical and transcatheter (Amplatzer) closure of atrial septal defects: a prospective comparison of results and cost.

OBJECTIVE: To compare effectiveness, complications, and cost of Amplatzer with surgical atrial septal defect (ASD) closure. DESIGN: Prospective study. SETTING: Tertiary cardiac referral centre. PATIENTS: 43 consecutive patients (excluding non-UK residents) aged between 2.1 and 56.8 years (median 7) undergoing ASD closure. MAIN OUTCOME MEASURES: Procedural success, complications, regression of right ventricular dilatation (up to one year postprocedure), cost, inpatient stay, and home convalescent time. RESULTS: Amplatzer ASD closure was successful in 24 of 27 (89%) patients. Surgical closure was successful in all 19 cases. Cardiac complications affecting management occurred in three (11%) of the Amplatzer group (two procedural failures, one device embolisation) and 4 of 19 (21%) surgical patients (one pericardial pain, one global pericardial effusion requiring drainage, and one patient with anaemia requiring haematinics in addition to an incidental pericardial effusion and one further incidental pericardial effusion) (p = NS). There were complications that did not affect management in a further 5 of 19 surgical patients. There was no significant difference in regression of right ventricular dilatation by six months postprocedure (median right ventricular end diastolic diameter decrease: Amplatzer group 17.5%, surgical group 15.1%; median cardiothoracic ratio decrease: Amplatzer 7.9%, surgical 7.5%). Both hospital stay and home convalescent times were significantly shorter after Amplatzer closure (median hospital stay: Amplatzer one day, surgery six days; median convalescent time: Amplatzer two weeks, surgery 5.5 weeks). Median cost was similar for both groups (Amplatzer pound5375, surgical pound5412). CONCLUSIONS: Amplatzer ASD closure has a lower chance of success with a single procedure than surgery. Overall, there were more complications in the surgical group but the majority of these were minor and did not require any change in management. Resolution of right ventricular dilatation over the study period was similar for both techniques. Time spent in hospital and away from work or school was shorter for the Amplatzer group. The cost of both techniques was similar.