Abstract: TH-PO341
Comparison of Peripheral Cutting Balloon vs. Conventional Balloon Angioplasty for Hemodialysis Vascular Access Stenosis: Prospective Randomized Controlled Trial
Session Information
- Vascular Access - I
November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 704 Dialysis: Vascular Access
Authors
- Murakami, Masaaki, Shizuoka General Hospital, Shizuoka, Japan
- Mori, Kiyoshi, University of Shizuoka, School of Pharmaceut Sci, Shizuoka, Japan
- Mukoyama, Masashi, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan
Background
Adequate vascular access is essential for undergoing hemodialysis treatment. Even though clinical success rate of PTA is high, the patency of conventional PTA is relatively low. The cutting balloon which has small blades to create sharp incisions into neointimal hyperplasia is designed to minimize vessel damage. Although few randomized trials have evaluated cutting balloon angioplasty for vascular access, larger study are needed.
Methods
This prospective, randomized single-center clinical trial included patients who had a hemodynamically significant vascular access stenosis within 6 months after the previous procedure. The study was designed to evaluate the efficacy and safety of cutting balloon (cutting balloon group) as compared with conventional balloon angioplasty (conventional balloon group) for the short-time patency cases in the previous treatment. The Kaplan-Meier method was performed to assess the primary and secondary patency of treatment lesion and whole access circuit. A log-rank test was used to evaluate the differences of patency between each group.
Results
One hundred fifty-seven patients provided informed consent and were randomly assigned to undergo cutting balloon angioplasty or conventional balloon angioplasty from December 2012 to November 2017. The clinical success rate was 100% in the both groups. The anatomical success rates were 64.0% in cutting balloon group and 53.9% in conventional balloon group. The primary patency of target lesion was significantly better in the cutting balloon group (28.3%) than in the conventional balloon group (14.1%) at 6 months (P=0.009). The mean pain scale measured using Visual Analogue Scale during the cutting balloon dilation (38.8±25.1) was much lower than the conventional balloon (57.5±28.5) (P<0.001). The average percent stenosis decreased significantly after PTA using the cutting balloon (Δ-49.1%) compared with the conventional balloon (Δ-40.9%) (P=0.0007). Access flow measured by the duplex doppler ultrasonography improved after PTA in both groups. Change in access flow in the cutting balloon group (Δ+308±221) was greater than conventional balloon group (Δ+240±152) (P=0.027).
Conclusion
Our data suggest that cutting balloon angioplasty is effective for patients whose vascular access were short-lived.