Results of a Peripheral Cutting Balloon prospective multicenter European registry in hemodialysis vascular access
Abstrakt
Purpose: To report initial experience with the Peripheral Cutting Balloon (PCB) in treatment of failing hemodialysis shunts. Methods: A total of 190 patients (95 men, 95 women; average age 64.4 +/-11.9 years, range 32-87 years) who were treated with the PCB for pressure-resistant stenosis, restenosis or failed percutaneous transluminal angioplasty (PTA) in the venous limb of an arteriovenous shunt were followed in seven European centers using a simple registry.
The group consisted of 109 de novo lesions (57%) and 79 restenotic lesions (43%). Results: Technical success was achieved in 88.9% of cases.
Primary patency was as follows (the results for whole group and simultaneous results for de novo lesions and restenoses are presented): 1 month (140 patients followed): 94%, 98%, and 93%; 3 months (116 patients followed): 93%, 98%, and 92%; 6 months (40 patients followed): 85%, 92%, and 79%; 12 months (27 patients followed): 74%, 87%, and 48%. No complication occurred.
Patients experienced an equal or lower level of pain during the procedure compared with conventional PTA. Conclusion: The PCB proved to be successful in dilating pressure-resistant stenoses.
We cannot conclude whether PCB angioplasty can lower the restenosis rate in hemodialysis access lesions, but the long-term patency for de novo lesions is high. A further randomized study is advisable.