A contemporary assessment of devices for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA): resource-specific options per level of care.

PURPOSE: Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as adjunct for temporary hemorrhage control in patients with exsanguinating torso hemorrhage is increasing. Characteristics of aortic occlusion balloons (AOB) are diverse and evolving as efforts are made to improve the technology. It is important to select a device that fits the requirements of the medical situation to minimize the risk of failure and complications. The aim of this study is to appraise guidance in the choice of an AOB in a specific situation. METHODS: We assessed 29 AOB for differences and outline possible advantages and disadvantages of each. Bending stiffness was measured with a three-point bending device. RESULTS: Diameter of the AOB ranged from 6 (ER-REBOA™) to 10 (Coda®-46) French. However, some need large-bore access sheaths up to 22 French (Fogarty®-45 and LeMaitre®-45) or even insertion via cut-down (Equalizer™-40). Bending stiffness varied from 0.08 N/mm (± 0.008 SD; Coda®-32) to 0.72 N/mm (± 0.024 SD; Russian prototype). Rescue Balloon™ showed kinking of the shaft at low bending pressures. The only non-compliant AOB is REBOA Balloon®. ER-REBOA™, Fogarty®, LeMaitre®, REBOA Balloon®, and Rescue Balloon™ are provided with external length marks to assist blind positioning. CONCLUSION: In resource-limited settings, a guidewire- and fluoroscopy-free, rather stiff device, such as ER-REBOA™, Fogarty®, and LeMaitre®, is warranted. Of these devices, ER-REBOA™ is the only catheter compatible with seven French sheaths and specifically designed for emergency hemorrhage control. Of the over-the-wire devices, Q50® has several features that facilitate use and reduce the risk of malplacement or vessel damage.

Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease.

OBJECTIVE: Arterial closure devices (ACDs) seem to be safe and effective to obtain hemostasis for cardiac interventions and diagnostic vascular procedures. However, only limited evidence is presented on therapeutic interventions in patients with peripheral atherosclerotic disease. We compared ischemic and hemorrhagic complications of an ACD vs manual compression (MC) after puncture of the femoral artery for endovascular lower extremity procedures. METHODS: The records of all subsequent endovascular interventions for peripheral artery disease performed in a large teaching hospital, from January 2012 to April 2014, were retrospectively reviewed. The primary outcome was an ischemic complication requiring reintervention. Secondary outcomes were hematoma (needing conservative or invasive intervention) and infection (needing intervention or antibiotics). Multivariate analysis was performed to identify predictors for any complication. RESULTS: The Angio-Seal (St. Jude Medical, Minnetonka, Minn) closure device was used in 244 of 463 endovascular interventions (54%). Five patients (2%) who received an ACD needed emergency surgery for ischemic complications vs none in the MC group (P = .06). Hematomas occurred in 22 patients (9%) after ACD vs in six (3%) after MC (adjusted odds ratio [OR], 3.4; 95% confidence interval [CI], 1.4-8.9; P = .015). There were no infections in either group. ACD (OR, 3.8; 95% CI, 1.5-9.7) and current smoking (OR, 2.6; 95% CI, 1.01-6.7) were independent predictors for any complication. CONCLUSIONS: This study demonstrates that ACD use in patients with peripheral artery disease can lead to serious adverse events resulting in increased morbidity. Therefore, the potential benefits of an ACD over MC should be carefully weighed.