Phase I results of pullback atherectomy for hemodialysis access

Balloon angioplasty and directional atherectomy frequently have short-lived results for stenoses associated with hemodialysis. Results are reported for a phase I trial of the pullback atherectomy catheter (PAC) for treatment of hemodialysis access-related stenoses.

Six intragraft and six venous stenoses in nine patients were treated with the PAC. Two lesions were treated with adjunctive balloon angioplasty, and two were treated with adjunctive directional atherectomy. Clinical and angiographic follow-up were obtained for all patients. All specimens were examined histologically.

Initial procedural success was achieved in 83% of stenoses (10 of 12). For intragraft stenoses, the 6-month primary patency was 60% (three of five) and the 6-month secondary patency was 80% (four of five). All six venous stenoses restenosed or thrombosed within 3 months. All specimens contained fibrous plaque or intimal hyperplasia. In addition, all six venous stenosis specimens contained media and two contained adventitia. Significant complications during treatment of venous stenoses included severe venous spasm in three and venous pseudoaneurysms in two. One PAC tip fracture occurred during treatment of an intragraft stenosis.

Pullback atherectomy is potentially safe and effective for intragraft stenoses; however, it is not safe or effective for venous stenoses.