RESUMEN
PURPOSE: The present study sought to evaluate the performance of the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) in the treatment of native fistula thrombosis in a U. S. hemodialysis population. Specifically, the technical success, clinical success, complication rate and type, primary and secondary patency rates, effect of adjunctive thrombolytic therapy, and any variables that affected outcomes of procedures in which this device was used were analyzed. MATERIALS AND METHODS: Forty-two patients with 44 thrombosed native fistulas (17 radiocephalic, 10 brachiocephalic, 10 transposed or superficialized, five graft/fistula hybrids, and two leg fistulas) were treated with 62 mechanical thrombolysis procedures with use of the PTD. All patients had large clot burden. The device type was recorded in 43 procedures: standard (n = 21), over-the-wire (OTW; n = 19), or both (n = 3). No device was used in two cases because of inability to cross the anastomosis. Adjunctive therapies (n = 18) included the use of tissue plasminogen activator (tPA; n = 16) and deployment of the AngioJet device with (n = 1) or without tPA (n = 1). Stents were inserted in four procedures. Outcome variables included technical and clinical success, complications, and primary and secondary patency. Cox proportional-hazards regression and Kaplan-Meier analyses were performed. RESULTS: The technical success rate was 87% (54 of 62) and the clinical success rate was 79% (49 of 62). Percutaneous transluminal angioplasty was performed in all but two procedures. Complications occurred in 13% of procedures (n = 8); three resulted in technical failure. The primary patency rates were 38% at 6 months and 18% at 12 months; secondary patency rates were 74% and 69%, respectively. Outcomes were not affected by adjunctive techniques, fistula type, age of fistula, device type (ie, OTW vs standard), or patient sex. Secondary patency was superior when no residual clot or stenosis was present (P = .003). CONCLUSIONS: The PTD is effective for percutaneous treatment of thrombosed hemodialysis fistulas, with good short- and long-term outcomes in a U.S. population. Within the limitations of a retrospective study with a small sample size, use of an adjunctive thrombolytic agent did not appear to improve results compared with the use of the device alone.
