Results of a peripheral cutting balloon prospective multicenter European registry in hemodialysis vascular access.
OBJECTIVE
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.


CONCLUSIONS
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.
Peregrin
Jan H
JH
Department of Diagnostic and Interventional Radiology, Institute for Clinical and Experimental Medicine, Vídenská 1958/9, 14021 Prague 4, Czech Republic. jape@medicon.cz
Rocek
Miloslav
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects; D005060:Europe; D005121:Extremities / Q000098:blood supply; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology* / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology; D011446:Prospective Studies; D012042:Registries; D006435:Renal Dialysis / Q000009:adverse effects*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency; D014655:Vascular Resistance