Safety and efficacy of low-cost, off-label balloons during balloon-occluded retrograde transvenous obliteration procedure.

OBJECTIVES

The objective of the study is to assess the technical feasibility, safety, and clinical efficacy of balloon-occluded retrograde transvenous obliteration (BRTO) using low-cost, off-label balloon catheters.

MATERIAL AND

METHODS

A retrospective study was conducted on 31 patients (20 males, 11 females; mean age 56.6 years; range 47-75 years) who underwent BRTO between January 2009 and November 2023. All patients had gastric varices with a demonstrable gastrorenal shunt on pre-procedural computed tomography; six of them presented with intractable hepatic encephalopathy. Off-label balloon catheters (Swan-Ganz, Fogarty, or stone extractor) were selected based on shunt anatomy. Sodium tetradecyl sulfate foam, with or without Lipiodol, was used as the sclerosing agent. Technical success was defined as sustained sclerosant stasis during balloon inflation. Clinical success was defined as cessation of variceal bleeding or resolution of encephalopathy.

RESULTS

Technical success was achieved in 29 of 31 patients (93.5%). Balloon rupture or deflation occurred in two patients; however, hemostasis was successfully maintained without any rebleeding. Of the 25 patients with follow-up data (mean 953.6 days; range 1-4015 days), clinical success was observed in 23 (92%). One patient required surgical shunt creation for immediate post-procedure bleeding, and another experienced rebleeding after 1 year, which was successfully managed with a transjugular intrahepatic portosystemic shunt. Among 17 patients with follow-up imaging or endoscopy, complete obliteration of gastric varices was observed in 70.5% and partial obliteration in 29.5%. Balloon-related complications were rare and not associated with adverse clinical outcomes.

CONCLUSION

BRTO using inexpensive off-label balloon catheters is a technically feasible, safe, and clinically effective treatment for gastric varices and hepatic encephalopathy. In combination with a modified Lipiodol-free sclerosant protocol, this technique offers a cost-effective alternative to conventional BRTO in resource-constrained environments. Prospective studies are needed to confirm these findings and to develop standardized clinical guidelines.