Abstract
Purpose
To investigate the safety and effectiveness of lutonix paclitaxel-coated balloon (PCB) for the treatment of dysfunctional dialysis access.
Materials and Methods
This was a single-center, single-arm, retrospective analysis of 39 patients (23 male, 59 %) undergoing 61 interventions using 69 PCBs in a 20-month period. There was a balance between arteriovenous fistulae (AVF) and grafts (AVG) (20 AVFs, 19AVGs), and the majority of lesions were restenotic (25/39, 64.1 %). Mean balloon diameter used was 6.6 mm and length 73.4 mm. Primary outcome measure was target lesion primary patency (TLPP) at 6 months, while secondary outcome measures included factors affecting TLPP and major complications. As there were lesions treated more than once with PCB, authors also compared patency results after first and second PCB angioplasty.
Results
TLPP was 72.2 % at 6 months with a median patency of 260 days according to the Kaplan–Meier survival analysis. No major complications occurred. TLPP between AVFs and AVGs (311 vs. 237 days, respectively; p = 0.29) and de novo and restenotic lesions was similar (270.5 vs. 267.5 days, respectively; p = 0.50). In 14 cases, in which lesions were treated with two PCB angioplasties, a statistically significant difference in TLPP after the second treatment was noted (first intervention 179.5 days vs. second intervention 273.5 days; p = 0.032).
Conclusion
In this retrospective analysis, Lutonix PCB proved to be safe and effective in treating restenosis in dysfunctional dialysis access with results comparable to the literature available. Larger studies are needed to prove abovementioned results.
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The authors would like to state that there is no financial arrangement or other relationship that could be construed as a conflict of interest. Stavros Spiliopoulos has received consultancy fees from MEDTRONIC. Konstantinos Katsanos has received travel sponsorship and lecture honoraria by MEDTRONIC and BOSTON SCIENTIFIC. Dimitrios Karnabatidis has received consultancy fees from MEDTRONIC, BARD and BOSTON SCIENTIFIC.
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Kitrou, P.M., Spiliopoulos, S., Papadimatos, P. et al. Paclitaxel-Coated Balloons for the Treatment of Dysfunctional Dialysis Access. Results from a Single-Center, Retrospective Analysis. Cardiovasc Intervent Radiol 40, 50–54 (2017). https://doi.org/10.1007/s00270-016-1479-y
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DOI: https://doi.org/10.1007/s00270-016-1479-y