Cutting balloon angioplasty shows no benefit when compared to high pressure balloon inflation for de novo lesions

Recent research from the University of Ottawa calls into question the use of cutting balloon angioplasty in the treatment of de novo stenosis within autogenous fistulae for hemodialysis. 39 patients were included in this randomized controlled trial with vessel sizes ranging from 4-8 mm in diameter. The regions treated included juxtaanastomotic (38%), perianatomotic (38%), midcephalic (9%), and cephalic arch (14%). Stenoses greater than 50% were randomized to high-pressure balloon inflation versus cutting balloon. For the high-pressure balloon arm, a Blue Max balloon (Boston Scientific, Natick, Massachusetts) with a rated burst pressure (RBP) of 20 atm or a Conquest balloon (Bard Peripheral Vascular, Tempe, Arizona) with an RBP of 26–30 atm was inflated twice for 20-30 sec until the waist was effaced of the max RBP was achieved. For the cutting balloon arm, an appropriately sized 20 mm cutting balloon (Flextome; Boston Scientific) was inflated until the waist was effaced or the max RBP (10 atm) was reached. Technical success was achieved in all patients. Mean follow-up was 8.5 mo. At 3, 6, and 12 months, the postinterventional primary patency rates for the cutting balloon group were 61.1%, 27.7%, and 11.1%, respectively, compared with 70.0%, 42.1%, and 26.3%, respectively, for the high-pressure balloon group (P < 0.3 at each interval). At 48–72 hours after angioplasty, there was no difference in mean flow rate in the cutting balloon group versus the high-pressure balloon group. At the end of the study period, no patients with followup in either group exhibited unassisted patency. The only procedure-related complication was a contained vessel rupture in the cutting balloon group resulting in the formation of a 1.8-cm aneurysm that did not require any treatment and remained stable on follow-up. The authors concluded that there is no significant difference in postintervention primary patency rates when comparing high pressure and cutting balloon angioplasty.

Commentary:

This interesting manuscript calls into question the assumption that using a cutting balloon can provide better patency by reducing barotrauma injury to the vessel wall. While there have been prior RCTs comparing cutting balloon to high pressure balloon inflation, the present study includes more defined patient selection criteria and includes longer follow-up while adhering to SIR reporting guidelines. However, several limitations remain including sample size and highly selective inclusion criteria. Further, the current study evaluates the use of cutting balloon on de novo lesions that have not undergone treatment in the past. While this methodology most effectively studies the true patency of cutting balloon versus high pressure balloon and may discredit the theory that decreased barotrauma of cutting balloon allows improved patency, it may not accurately reflect the current most common use of this tool for the interventionalist. Often times, one may use the cutting balloon on lesions resistant to balloon inflation or with residual, hemodynamically significant narrowing despite adequate waist effacement. In this setting, recent studies have suggested superiority in primary and secondary target lesion patency when compared with high-pressure balloon inflation (2). Depending on your practice pattern and current approach to de novo lesions, this manuscript may affect your treatment algorithm for stenotic lesions in AVFs.

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1. Rasuli P, Chennur VS, Connolly MJ, et al. Randomized trial comparing the primary patency following cutting versus high-pressure balloon angioplasty for treatment of de novo venous stenoses in hemodialysis arteriovenous fistulae. J Vasc Interv Radiol 2015; 10.1016/j.jvir.2015.08.024

2. Aftab SA, Tay KH, Irani FG, et al. Randomized clinical trial of cutting balloon angioplasty versus high-pressure balloon angioplasty in hemodialysis arteriovenous fistula stenoses resistant to high-pressure balloon angioplasty. J Vasc Interv Radiol 2014; 25:190–198.

Post Author:
Luke R. Wilkins, MD