Cutting balloon angioplasty of autogenous infrainguinal bypasses: short-term safety and efficacy.

PURPOSE: This study evaluated the safety and efficacy of cutting balloon angioplasty in the treatment of infrainguinal vein bypass graft stenosis.

METHODS: Data from a prospective database, supplemented by chart review, were obtained on all patients who underwent cutting balloon angioplasty of lower extremity vein bypass grafts at a single institution during a 4-year period. Noninvasive duplex ultrasound imaging of grafts, along with measurement of ankle-brachial indices and digital pressures, was performed on all patients before and after treatment with the cutting balloon. Efficacy of cutting balloon angioplasty and procedural complications were analyzed. Data from noninvasive vascular testing were compared using the two-tailed paired Student t test. Patency rates were calculated using the Kaplan-Meier method. Differences in patency rates were compared using the log-rank test.

RESULTS: From July 2002 to February 2006, 109 cutting balloon angioplasties were performed on 70 bypasses in 61 patients. There were 12 complications in 109 procedures (11%), only one of which required immediate operative intervention. Initial technical success was 96%. Noninvasive vascular testing indicators significantly improved immediately after intervention: peak systolic graft velocity decreased from 360 +/- 158 cm/s to 143 +/- 67 cm/s (P < .001), ankle-brachial index improved from 0.55 +/- 0.3 to 0.85 +/- 0.2 (P < .001), and digital pressure increased from 31 +/- 30 mm Hg to 62 +/- 32 mm Hg (P < .001). Patency rates at 6 months according to the Kaplan-Meier method were primary patency, 48% (95% confidence interval [CI], 0.36 to 0.60); assisted primary patency, 72% (95% CI, 0.61 to 0.83); and secondary patency, 99% (95% CI, 0.97 to 1.00). At 6 months, cumulative limb salvage was 94% (95% CI, 0.89 to 1.00).

CONCLUSIONS: Cutting balloon angioplasty of infrainguinal vein bypass graft stenosis is technically feasible but is associated with a relatively high complication rate and a relatively low short-term patency rate.