Purpose: Results are reported from the PEARL I Registry for procedures where a mid-length AngioJet catheter was used for thrombosed hemodialysis arteriovenous grafts and fistulae. Methods: The PEARL I Registry was a prospective, multicenter, observational database collecting information on the AngioJet procedures for a variety of thrombotic conditions. Patient demographics, procedural information, outcome data, and safety information were collected through 3 months postprocedure on AngioJet procedures. This paper describes the data collected for subjects presenting with hemodialysis access thrombosis. Results: A total of 72 (16%) of the 452 subjects enrolled in the PEARL 1 Registry had thrombosed hemodialysis access sites. Procedural success was reported in 66/72 subjects (92%); surgical interventions were required in 6/72 subjects (8%). There was a statistically significant improvement (p<0.0001) in vessel occlusion from baseline to final angiography. Eighty-eight percent of access sites were patent at the end of the procedure and 97% of vessels showed improved occlusion status of ≥1 grades. Among prosthetic grafts, 53% (20/38) remained patent at the 3-month follow-up, 18% (7/38) were restenosed, and 29% (11/38) rethrombosed. Among autologous fistulas, 86% (18/21) remained patent without intervention at the 3-month follow-up; 3 fistulas rethrombosed. Four subjects (5%) died; none of the deaths were considered related to the AngioJet device or procedure. Conclusions: Outcomes from the PEARL I registry corroborate other studies of AngioJet thrombectomy and the overall literature of endovascular thrombectomy procedures. A high procedural success rates with acceptable near-term patency rates and low rates of adverse events are achieved with AngioJet thrombectomy.
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