Safety and Efficacy of Balloon Lithotripsy for Percutaneous Biliary Stone Management

Purpose: Conventional laser or electrohydraulic lithotripsy (EHL) wires are used to target individual biliary stones under direct visualization, through a large sheath. In contrast, intravascular lithotripsy (IVL) balloons, intended to treat arterial calcifications, can deliver shockwaves to multiple biliary stones simultaneously under fluoroscopic guidance through a smaller access. The purpose of this study was to report the efficacy and safety of IVL balloons for treatment of biliary stones.

Materials and Methods: In this single institution retrospective study, 12 patients (8 males; mean age=68.5 years (43-81)) underwent attempted balloon lithotripsy for biliary stones. Technical success was defined as any stone fragmentation based on cholangiography. Clinical success was defined as not needing any additional stone removal procedures prior to drain removal.

Results: Stones were in the common bile duct in 10 patients and in intrahepatic ducts in 2 patients. Stones were 5-30 mm (mean=15.6) in size and 1-innumerable (median=2) in number. All IVL procedures were performed under moderate sedation through 7-12 Fr (median=8) sheaths a median of 20 days (range=0-56) after initial biliary access. IVL balloons used were 6-12 mm (median=8) in diameter. Among 12 patients, 8 procedures were technically successful (67%) and 6 were clinically successful (50%) with PBD removal a median of 19.5 days after IVL (range=12-55 days). The 6 patients with clinical failure required subsequent percutaneous cholangioscopic EHL (n=5) or surgical (n=1) stone removal. Cases with smaller stones were more likely to be clinically successful (10.8 versus 20.3 mm, p=0.02); however, stone number trended higher in successful (2.8 versus 1.8, p = 0.28) cases. There were 2 major complications (biliary sepsis, n=1; readmission for pericatheter leakage and a fluid collection along the PBD tract, n=1), both occurring when IVL was performed at the time of initial biliary access. There was 1 minor complication (minor bleeding in the CBD limiting cholangiographic and cholangioscopic visualization).

Conclusion: IVL yielded approximately 67% technical and 50% clinical success for management of biliary stones. Applying this technique to smaller stones and avoiding balloon lithotripsy at the index biliary access procedure may enhance efficacy and safety. Overall IVL is a safe and effective option for fracturing multiple stones at once, particularly when EHL or laser equipment is not available.