A new, pressure-regulated balloon catheter for partial resuscitative endovascular balloon occlusion of the aorta (REBOA)

Background: Hemorrhage is the leading cause of death in trauma settings. Non-compressible torso hemorrhage, which is caused by abdominopelvic and thoracic injuries, is an important cause of subsequent organ dysfunction and poor outcomes in multiple trauma patients. The management of hemodynamically unstable patients with non-compressible torso hemorrhage has changed, and the concept of damage control resuscitation has been developed in the last decades. Currently, resuscitative endovascular balloon occlusion of the aorta (REBOA) as a method of temporary stabilization is the modern evolution of bleeding control, and it is in the middle of a paradigm shift as a treatment for non-compressible torso hemorrhage. Despite its effectiveness in patients with hemorrhagic shock, the application of REBOA remains limited because of lack of experience and troubleshooting guidelines. Objectives: The aim of study was to provide useful tips for the implementing a step-by-step procedure for REBOA in various hospital settings and capabilities. Methods: We introduced REBOA procedures using a REBOA-customized 7 Fr balloon catheter through the animation models or radiography from preparation to access, catheter management, and device removal after procedure completed. Results: We have described REBOA procedures as follows: identification of the common femoral artery, arterial access for placement of a guidewire, precautions during a sheath insertion, guidewire and balloon positioning in the aorta, occlusion zones and adjustment of balloon location, REBOA strategy for extending the occlusion time, balloon deflation and removal, sheath removal, and medical records. Conclusion: We believe that the practical tips mentioned in this article will help in performing the REBOA procedure systematically and developing an effective REBOA framework.

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Improving the safety of resuscitative endovascular balloon occlusion of the aorta – Compliant versus semi-compliant balloon systems

Vascular ◽

10.1177/1708538120922106 ◽

2020 ◽

Vol 28 (5) ◽

pp. 612-618

Author(s):

Marta J Madurska ◽

Curtis Franklin ◽

Michael Richmond ◽

Sakib M Adnan ◽

Gerard P Stansby ◽

...

Keyword(s):

Safety Valve ◽

Balloon Catheter ◽

Balloon Occlusion ◽

Quadratic Model ◽

Second Phase ◽

Relief Valve ◽

Pressure Relief ◽

Resuscitative Thoracotomy ◽

Working Length ◽

Endovascular Balloon Occlusion

Objectives Resuscitative endovascular balloon occlusion of the aorta is an alternative to resuscitative thoracotomy in non-compressible torso haemorrhage. Low-profile, compliant balloon catheter systems have been developed, which can be deployed without the need for fluoroscopy. However, concern exists for over inflation and aortic injury, especially as compliant balloon material can stretch reducing syringe feedback and limiting the effectiveness of a safety valve. An alternative material would be a semi-compliant balloon material, but its performance is unknown. The aim of this study was to compare the inflation characteristics of compliant versus semi-compliant balloon systems and to determine whether a pressure relief safety valve can be practically applied to a semi-compliant balloon catheter as a safety device. Methods This was an ex vivo study using porcine segments of thoracic aorta. The study consisted of two phases. The first phase involved intermittent inflation of six compliant balloon and six semi-compliant balloon balloons until balloon or aortic rupture. In the second phase, six semi-compliant balloons with the pressure-relief valve set at 0.45 atmospheres were inflated in the aortas until the valve release, followed by injection with additional 30 mL. Data including pressure, volume, balloon working length, diameter and circumferential stretch ratio were collected. Results At failure, mean balloon volume was almost double in compliant balloon group vs semi-compliant balloon group – 49.83 mL (±23.25) and 25.16 mL (±8.93), respectively ( p = 0.004), with 36% increase in working length in the compliant balloon group – 81.17 mm (±19.11) vs 59.49 (±4.86) for semi-compliant balloon ( p = 0.023). When plotted, the relationship pattern between volume and pressure fit a linear model for the compliant balloon, and a quadratic model for the semi-compliant balloon. Following attempted over inflation with the pressure valve, there was no change in parameters before and after attempted over inflation. Conclusions The inflation profile differs between balloon designs. In contrast to semi-compliant balloons, compliant balloons will accommodate more volume to mitigate increase in pressure. This does not completely eliminate the risk of over inflation. The inflation characteristics of the semi-compliant balloon permit pairing it with a safety valve, which could lead to a development of a safer balloon technology in the future.

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Loop formation by an aortic occlusion balloon catheter during resuscitative endovascular balloon occlusion of the aorta (REBOA)

Radiology Case Reports ◽

10.1016/j.radcr.2018.10.018 ◽

2019 ◽

Vol 14 (2) ◽

pp. 184-186

Author(s):

Yasuyuki Onishi ◽

Hiroyuki Kimura ◽

Mitsunori Kanagaki ◽

Shojiro Oka ◽

Genki Fukumoto ◽

...

Keyword(s):

Balloon Catheter ◽

Balloon Occlusion ◽

Aortic Occlusion ◽

Loop Formation ◽

Occlusion Balloon ◽

Endovascular Balloon Occlusion ◽

Occlusion Balloon Catheter

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Partial Resuscitative Endovascular Balloon Occlusion of the Aorta via the Tri-Lobe Balloon Catheter

Journal of Surgical Research ◽

10.1016/j.jss.2020.11.056 ◽

2021 ◽

Vol 260 ◽

pp. 20-27

Author(s):

Lammers Daniel ◽

Marenco Christopher ◽

Forte Dominic ◽

Morte Kaitlin ◽

Bingham Jason ◽

...

Keyword(s):

Balloon Catheter ◽

Balloon Occlusion ◽

Endovascular Balloon Occlusion

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Approximation of Pediatric Morphometry for Resuscitative Endovascular Balloon Occlusion of the Aorta

Journal of Endovascular Resuscitation and Trauma Management ◽

10.26676/jevtm.v3i3.95 ◽

2019 ◽

Vol 3 (3) ◽

Author(s):

Erik Scott DeSoucy ◽

Alfred Francois Trappey ◽

Andrew M Wishy ◽

Meryl A Simon ◽

Anders J Davidson ◽

...

Keyword(s):

Femoral Artery ◽

Pediatric Patients ◽

Balloon Catheter ◽

Vessel Diameter ◽

Balloon Occlusion ◽

Solid Organ ◽

Regression Equations ◽

Access Site ◽

Normal Ranges ◽

Endovascular Balloon Occlusion

Background Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) may be beneficial in the management of traumatic and iatrogenic vascular and solid organ injuries in children, but requires an understanding of vessel diameter at the access site and landing zones. We sought to adapt the Broselow™ Tape method to estimation of aortic and femoral artery diameters for this purpose. Methods Computed tomography scans from trauma and non-trauma pediatric patients at a level 1 trauma center were reviewed for vascular dimensions at aorta Zone I, Zone III and the common femoral artery (CFA). Vessel size was measured by two providers using a vascular software suite with a 10% interobserver comparison. Height was used to create linear regression equations for each location and calculate ranges for each Broselow™ Tape category. Results We reviewed scans from 110 patients ages 2-14 years with less than 8% interobserver variability. 64% were male and 46% were trauma patients. Height based regression equations were closely correlated with vessel diameter: Zone I(mm)=[0.093±0.006·height(cm)]+0.589±0.768; R2=0.714, p<0.001 Zone III(mm)=[0.083±0.005·height(cm)]–0.703±0.660; R2=0.728, p<0.001 CFA(mm)=[0.043±0.003·height(cm)]+0.644±0.419; R2=0.642, p<0.001 These equations, along with the minimum and maximum length for each Broselow™ Tape color, were used to define color coded normal ranges for each REBOA landing zone and access site. Conclusion Knowledge of the access vessel and occlusion zone diameters in pediatric patients is crucial for future research and application of REBOA in this population. Furthermore, an adapted Broselow™ Tape including these measurements would assist in appropriate sheath and balloon catheter selection in emergent settings.

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Successful Control of Massive Vaginal Bleeding with Resuscitative Endovascular Balloon Occlusion of the Aorta and Pelvic Packing

Journal of Endovascular Resuscitation and Trauma Management ◽

10.26676/jevtm.v3i3.92 ◽

2019 ◽

Vol 3 (3) ◽

Cited By ~ 1

Author(s):

Emre Özlüer ◽

Çagaç Yetis ◽

Evrim Sayin ◽

Mücahit Avcil

Keyword(s):

Vaginal Bleeding ◽

Balloon Occlusion ◽

Emergency Physicians ◽

Pelvic Packing ◽

Gynecological Malignancies ◽

Life Threatening ◽

Successful Control ◽

Endovascular Balloon Occlusion

Gynecological malignancies may present as life-threatening vaginal bleeding. Pelvic packing and Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) may be useful along with conventional vaginal packing when in terms of control of the hemorrhage. Emergency physicians should be able to perform these interventions promptly in order to save their patients from exsanguination.

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AORTA Registry 7F vs 11-12 F access

Journal of Endovascular Resuscitation and Trauma Management ◽

10.26676/jevtm.v3i1.79 ◽

2019 ◽

Vol 3 (1) ◽

Cited By ~ 1

Author(s):

Reviewer Joseph DuBose ◽

Jonathan Morrison ◽

Megan Brenner ◽

Laura Moore ◽

John B Holcomb ◽

...

Keyword(s):

Ultrasound Guidance ◽

Balloon Occlusion ◽

Aortic Occlusion ◽

Severely Injured ◽

Distal Extremity ◽

Low Profile ◽

Transfusion Requirements ◽

Thrombotic Complications ◽

Device Use ◽

Endovascular Balloon Occlusion

ABSTRACT Introduction: The introduction of low profile devices designed for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) after trauma has the potential to change practice, outcomes and complication profiles related to this procedure. Methods: The AAST Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry was utilized to identify REBOA patients from 16 centers -comparing presentation, intervention and outcome variables for those REBOA via traditional 11-12 access platforms and trauma-specific devices requiring only 7 F access. Results:From Nov 2013-Dec 2017, 242 patients with completed data were identified, constituting 124 7F and 118 11-12F uses. Demographics of presentation were not different between the two groups, except that the 7F patients had a higher mean ISS (39.2 34.1, p = 0.028). 7F device use was associated with a lower cut-down requirement for access (22.6% vs. 37.3%, p = 0.049) and increased ultrasound guidance utilization (29.0% 23.7%, p = 0.049). 7F device afforded earlier aortic occlusion in the course of resuscitation (median 25.0 mins vs. 30 mins, p = 0.010), and had lower median PRBC (10.0 vs. 15.5 units, p = 0.006) and FFP requirements (7.5 vs. 14.0 units, p = 0.005). 7F patients were more likely to survive 24 hrs (58.1% vs. 42.4%, p = 0.015) and less likely to suffer in-hospital mortality (57.3% vs. 75.4%, p = 0.003). Finally, 7F device use was associated with a 4X lower rate of distal extremity embolism (20.0% vs. 5.6%, p = 0.014;OR 95% CI 4.25 [1.25-14.45]) compared to 11-12F counterparts. Conclusion: The introduction of trauma specific 7F REBOA devices appears to have influenced REBOA practices, with earlier utilization in severely injured hypotensive patients via less invasive means that are associated with lower transfusion requirements fewer thrombotic complications and improved survival. Additional study is required to determine optimal REBOA utilization.

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Resuscitative endovascular balloon occlusion of the aorta (REBOA) enables operative management of the peripartum trauma patient in hemorrhagic shock

Journal of Endovascular Resuscitation and Trauma Management ◽

10.26676/jevtm.v3i1.78 ◽

2019 ◽

Vol 3 (1) ◽

Author(s):

Kelvin Allenson ◽

Laura Moore

Keyword(s):

Maternal Death ◽

Motor Vehicle ◽

Operative Management ◽

Balloon Occlusion ◽

Motor Vehicle Accidents ◽

Gravid Uterus ◽

Intrauterine Pregnancy ◽

Vehicle Accidents ◽

Pelvic Hemorrhage ◽

Endovascular Balloon Occlusion

Trauma related injury is the leading cause of non-obstetric maternal death. The gravid uterus is at risk for injury, particularly during motor vehicle accidents. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a means of controlling pelvic hemorrhage in the setting of trauma. We report the use of REBOA in a hemodynamically unstable, multiply-injured young woman with viable intrauterine pregnancy.

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Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as a bridge to endovascular aortic repair (EVAR) in blunt abdominal aortic injury (BAAI).

Journal of Endovascular Resuscitation and Trauma Management ◽

10.26676/jevtm.v3i1.74 ◽

2019 ◽

Vol 3 (1) ◽

Author(s):

Valentina Chiarini

Keyword(s):

Trauma Center ◽

Aortic Rupture ◽

Damage Control ◽

Aortic Injury ◽

Balloon Occlusion ◽

Traumatic Lesion ◽

Abdominal Aortic ◽

Aortic Injuries ◽

Accepted Practice ◽

Endovascular Balloon Occlusion

BAAI is a rare but challenging traumatic lesion. Since BAAI is difficult to suspect and diagnose, frequently lethal and associated to multiorgan injuries, its management is objective of research and discussion. REBOA is an accepted practice in ruptured abdominal aortic aneurysm. Conversely, blunt aortic injuries are the currently most cited contraindications for the use of REBOA in trauma, together with thoracic lesions. We reported a case of BAAI safely managed in our Trauma Center at Maggiore Hospital in Bologna (Italy) utilizing REBOA as a bridge to endovascular repair, since there were no imminent indications for laparotomy. Despite formal contraindication to placing REBOA in aortic rupture, we hypothesized that this approach could be feasible and relatively safe when introduced in a resuscitative damage control protocol.

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