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

ABSTRACT

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.