Resuscitative endovascular balloon occlusion of the aorta (REBOA) as adjunct treatment in life threatening postpartum hemorrhage: Fourteen years' experience from a single Norwegian center.

INTRODUCTION: Postpartum hemorrhage (PPH) remains a global health problem. The introduction of resuscitative endovascular balloon occlusion of the aorta (REBOA) in 2008 sought to enhance the management of hemorrhagic shock during PPH. In this study, we present a single Norwegian center's experience with REBOA as a supportive treatment in combating life threatening PPH. MATERIAL AND METHODS: This is a historical cohort study from St Olav's University Hospital, with data from period 2008-2021. It includes all patients who underwent REBOA as an adjunct treatment due to life threatening PPH, analyzing the outcomes and trends over a 14-year period. RESULTS: A total of 37 patients received REBOA as an adjunct treatment. All procedures were technically successful, achieving hemodynamic stability with an immediate average increase in systolic blood pressure of 36 ± 22 mmHg upon initial balloon inflation. Additionally, a downward trend was noted in the frequency of hysterectomies and the volume of blood transfusions required over time. No thromboembolic complications were observed. CONCLUSIONS: Our 14 years of experience at St Olav's Hospital suggests that REBOA serves as a safe and effective adjunct interventional technique for managing life-threatening PPH. Furthermore, the findings indicate that incorporating a multidisciplinary approach to enable rapid aortic occlusion can potentially reduce the necessity for blood transfusions and hysterectomies.

Learning insertion of a Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) catheter: Is clinical experience necessary? A prospective trial.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging and potentially life-saving procedure, necessitating qualified operators in an increasing number of centres. The procedure shares technical elements with other vascular access procedures using the Seldinger technique, which is mastered by doctors not only in endovascular specialties but also in trauma surgery, emergency medicine, and anaesthesiology. We hypothesised that doctors mastering the Seldinger technique (experienced anaesthesiologist) would learn the technical aspects of REBOA with limited training and remain technically superior to doctors unfamiliar with the Seldinger technique (novice residents) given similar training. METHODS: This was a prospective trial of an educational intervention. Three groups of doctors were enroled: novice residents, experienced anaesthesiologists, and endovascular experts. The novices and the anaesthesiologists completed 2.5 h of simulation-based REBOA training. Their skills were tested before and 8-12 weeks after training using a standardised simulated scenario. The endovascular experts, constituting a reference group, were equivalently tested. All performances were video recorded and rated by three blinded experts using a validated assessment tool for REBOA (REBOA-RATE). Performances were compared between groups and with a previously published pass/fail cutoff. RESULTS: Sixteen novices, 13 board-certified specialists in anaesthesiology, and 13 endovascular experts participated. Before training, the anaesthesiologists outperformed the novices by 30 percentage points of the maximum REBOA-RATE score (56% (SD 14.0) vs 26% (SD 17%), p<0.01). After training, there was no difference in skills between the two groups (78% (SD 11%) vs 78 (SD 14%), p = 0.93). Neither group reached the endovascular experts' skill level (89% (SD 7%), p<0.05). CONCLUSION: For doctors mastering the Seldinger technique, there was an initial inter-procedural transfer of skills advantage when performing REBOA. However, after identical simulation-based training, novices performed equally well to anaesthesiologists, indicating that vascular access experience is not a prerequisite to learning the technical aspects of REBOA. Both groups would need more training to reach technical proficiency.

Operators believe patient-specific rehearsal improve individual and team performance.

INTRODUCTION: Rehearsing endovascular aortic aneurysm repair on patient-specific data is recent within virtual reality simulation and opens up new possibilities for operators to prepare for complex procedures. This study evaluated the feasibility of patient-specific rehearsal (PsR) and assessed operators' appraisal of the VIST-LAB simulator from Mentice. MATERIAL AND METHODS: CT-data was segmented and uploaded to the simulator, and simulated for 30 elective EVAR patients. Operators were asked how they perceived the PsR on a Likert scale after the PsR (once) and after the following procedure (each time). RESULTS: Patients were simulated and operated by 14 operators, always in pairs of one vascular surgeon and one interventional radiologist. The operators estimated that PsR improved individual and team performance (median 4), and recommended the use of PsR in general (median 4) and for difficult cases (median 5). The simulator realism got moderate scores (median 2-3). Inexperienced operators seemed to appreciate the PsR the most. CONCLUSIONS: PsR was feasible and was evaluated by operators to improve individual and team performance. Inexperienced users were more positive towards PsR than experienced users. PsR realism and the ease of importing patient-specific data can still be improved, and further studies to quantify and precisely identify benefits are needed.

Reliable and valid assessment of procedural skills in resuscitative endovascular balloon occlusion of the aorta.

BACKGROUND: Valid and reliable assessment of skills is essential for improved and evidence-based training concepts. In a recent study, we presented a novel tool to assess procedural skills in resuscitative endovascular balloon occlusion of the aorta (REBOA), REBOA-RATE, based on international expert consensus. Although expert consensus is a strong foundation, the performance of REBOA-RATE has not been explored. The study aimed to examine the reliability and validity of REBOA-RATE. METHODS: This was an experimental simulation-based study. We enrolled doctors with three levels of expertise to perform two REBOA procedures in a simulated scenario of out-of-hospital cardiac arrest. Procedures were video-recorded, and videos were blinded and randomized. Three clinical experts independently rated all procedures using REBOA-RATE. Data were analyzed using Messick's framework for validity evidence, including generalizability analysis of reliability and determination of a pass/fail standard. RESULTS: Forty-two doctors were enrolled: 16 novices, 13 anesthesiologists, and 13 endovascular experts. They all performed two procedures, yielding 84 procedures and 252 ratings. The REBOA-RATE assessment tool showed high internal consistency (Cronbach's α = 0.95) and excellent interrater reliability (intraclass correlation coefficient, 0.97). Assessment using one rater and three procedures could ensure overall reliability suitable for high-stakes testing (G-coefficient >0.80). Mean scores (SD) for the three groups in the second procedure were as follows: novices, 32% (24%); anesthesiologists, 55% (29%); endovascular experts, 93% (4%) (p < 0.001). The pass/fail standard was set at 81%, which all experts but no novices passed. CONCLUSION: Data strongly support the reliability and validity of REBOA-RATE, which successfully discriminated between all experience levels. The REBOA-RATE assessment tool requires minimal instruction, and one rater is sufficient for reliable assessment. Together, these are strong arguments for the use of REBOA-RATE to assess REBOA skills, allowing for competency-based training and certification concepts. LEVEL OF EVIDENCE: Diagnostic test, no or poor gold standard, level V.

Influence of patient-specific rehearsal on operative metrics and technical success for endovascular aneurysm repair.

INTRODUCTION: Patient-specific rehearsal (PsR) is a recent technology within virtual reality (VR) simulation that lets the operators train on patient-specific data in a simulated environment prior to the procedure. Endovascular aneurysm repair (EVAR) is a complex procedure where operative metrics and technical success might improve after PsR. MATERIAL AND METHODS: We compared technical success and operative metrics (endovascular procedure time, contralateral gate cannulation time, fluoroscopy time, total radiation dose, number of angiograms and contrast medium use) between 30 patients, where the operators performed PsR (the PsR group), and 30 patients without PsR (the control group). RESULTS: The endovascular procedure time was significantly shorter in the PsR group than in the control group (median 44 versus 55 min, p = .017). The other operative metrics were similar. Technical success rates were higher in the PsR group, 96.7% primary and assisted primary outcome versus 90.0% in the control group. The differences were not significant (p = .076). CONCLUSIONS: PsR before EVAR reduced endovascular procedure time, and our results indicate that it might improve technical success, but further studies are needed to confirm those results.

Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest.

Background Few patients survive after out-of-hospital cardiac arrest and any measure that improve circulation during cardiopulmonary resuscitation is beneficial. Animal studies support that resuscitative endovascular balloon occlusion of the aorta (REBOA) during cardiopulmonary resuscitation might benefit patients suffering from out-of-hospital cardiac arrest, but human data are scarce. Methods and Results We performed an observational study at the helicopter emergency medical service in Trondheim (Norway) to assess the feasibility and safety of establishing REBOA in patients with out-of-hospital cardiac arrest. All patients received advanced cardiac life support during the procedure. End-tidal CO2 was measured before and after REBOA placement as a proxy measure of central circulation. A safety-monitoring program assessed if the procedure interfered with the quality of advanced cardiac life support. REBOA was initiated in 10 patients. The mean age was 63 years (range 50-74 years) and 7 patients were men. The REBOA procedure was successful in all cases, with 80% success rate on first cannulation attempt. Mean procedural time was 11.7 minutes (SD 3.2, range 8-16). Mean end-tidal CO2 increased by 1.75 kPa after 60 seconds compared with baseline (P<0.001). Six patients achieved return of spontaneous circulation (60%), 3 patients were admitted to hospital, and 1 patient survived past 30 days. The safety-monitoring program identified no negative influence on the advanced cardiac life support quality. Conclusions To our knowledge, this is the first study to demonstrate that REBOA is feasible during non-traumatic out-of-hospital cardiac arrest. The REBOA procedure did not interfere with the quality of the advanced cardiac life support. The significant increase in end-tidal CO2 after occlusion suggests improved organ circulation during cardiopulmonary resuscitation. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03534011.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) in non-traumatic out-of-hospital cardiac arrest: evaluation of an educational programme.

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) is a critical incident with a high mortality rate. Augmentation of the circulation during cardiopulmonary resuscitation (CPR) might be beneficial. Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) redistribute cardiac output to the organs proximal to the occlusion. Preclinical data support that patients in non-traumatic cardiac arrest might benefit from REBOA in the thoracic level during CPR. This study describes a training programme to implement the REBOA procedure to a prehospital working team, in preparation to a planned clinical study. METHODS: We developed a team-based REBOA training programme involving the physicians and paramedics working on the National Air Ambulance helicopter base in Trondheim, Norway. The programme consists of a four-step approach to educate, train and implement the REBOA procedure in a simulated prehospital setting. An objective structured assessment of prehospital REBOA application scoring chart and a special designed simulation mannequin was made for this study. RESULTS: Seven physicians and 3 paramedics participated. The time needed to perform the REBOA procedure was 8.5 (6.3-12.7) min. The corresponding time from arrival at scene to balloon inflation was 12.0 (8.8-15) min. The total objective assessment scores of the candidates' competency was 41.8 (39-43.5) points out of 48. The advanced cardiovascular life support (ACLS) remained at standard quality, regardless of the simultaneous REBOA procedure. CONCLUSION: This four-step approach to educate, train and implement the REBOA procedure to a prehospital working team ensures adequate competence in a simulated OHCA setting. The use of a structured training programme and objective assessment of skills is recommended before utilising the procedure in a clinical setting. In a simulated setting, the procedure does not add significant time to the prehospital resuscitation time nor does the procedure interfere with the quality of the ACLS. TRIAL REGISTRATION NUMBER: NCT03534011.

Fluoroscopy-free Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for controlling life threatening postpartum hemorrhage.

BACKGROUND: Severe postpartum hemorrhage occurs in 1/1000 women giving birth. This condition is often dramatic and may be life threatening. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) has in recent years been introduced as a novel treatment for hemorrhagic shock. We present a series of fluoroscopy-free REBOA for controlling life threatening postpartum hemorrhage. METHODS: In 2008 an 'aortic occlusion kit' was assembled and used in three Norwegian university hospitals. The on-call interventional radiologist (IR) was to be contacted with a response time < 30 minutes in case of life threatening PPH. Demographics and characteristics were noted from the medical records. RESULTS: This retrospective study includes 36 patients treated with fluoroscopy-free REBOA for controlling severe postpartum hemorrhage in the years 2008-2015. The REBOA success rate was 100% and no patients died from REBOA related complications. Uterine artery embolization was performed in 17 (47%) patients and a hysterectomy in 16 (44%) patients. A short (11cm) introducer length was strongly associated with iliac artery thrombus formation (ρ = 0.50, P = 0.002). In addition, there was a strong negative correlation between uterine artery embolization and hysterectomy (ρ = -0.50, P = 0.002). CONCLUSIONS: Our Norwegian experience indicates the clinical safety and feasibility of REBOA in life threatening PPH. Also, REBOA can be used in an emergency situation without the use of fluoroscopy with a high degree of technical success. It is important that safety implementation of REBOA is established, especially through limited aortic balloon occlusion time and a thorough balloon deflation regime.

Acute endovascular repair of iatrogenic right internal carotid arterial laceration.

Carotid arterial bleeding is a feared and possible life-threatening complication of transsphenoidal surgery. We present a case of a meningioma that during resection had a serious complication with laceration of the internal carotid artery (ICA). These patients rarely undergo endovascular treatment, with indications mainly due to the development of pseudoaneurysms or penetrating trauma. However, endovascular treatment with covered stents of carotid arterial bleedings is a feasible alternative due to technical advances and smaller sized stentgrafts that expand treatment options.