1. A Multicenter Randomized Clinical Trial of Hemodialysis Access Blood Flow Surveillance Compared to Standard of Care: The Hemodialysis Access Surveillance Evaluation (HASE) Study
- Author
-
Paul J. Feustel, Arif Asif, Aamir Jamal, Laisel Martinez, Gabriel Contreras, Abid Rizvi, Christina E Manning, Ivy Machado, Nicolle Bateman, Marwan Tabbara, Patricia Briones, Roberto I. Vazquez-Padron, and Loay Salman
- Subjects
medicine.medical_specialty ,hemodialysis access surveillance ,Randomization ,medicine.medical_treatment ,ultrasound dilution technique ,030232 urology & nephrology ,Arteriovenous fistula ,030204 cardiovascular system & hematology ,Disease cluster ,arteriovenous graft ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,arteriovenous access thrombosis ,Randomized controlled trial ,law ,Clinical Research ,medicine ,arteriovenous access blood flow ,arteriovenous fistula ,business.industry ,Blood flow ,medicine.disease ,Thrombosis ,Surgery ,Stenosis ,Nephrology ,Hemodialysis ,business - Abstract
Introduction Arteriovenous (AV) access thrombosis remains 1 of the most troubling AV access–related complications affecting hemodialysis patients. It necessitates an urgent and occasionally complicated thrombectomy procedure and increases the risk of AV access loss. AV access stenosis is found in the majority of thrombosed AV accesses. The routine use of AV access surveillance for the early detection and management of stenosis to reduce the thrombosis rate remains controversial. Methods We have conducted a multicenter, prospective, randomized clinical trial comparing the standard of care coupled with ultrasound dilution technique (UDT) flow measurement monthly surveillance with the standard of care alone. Results We prospectively randomized 436 patients with end-stage renal disease on hemodialysis with arteriovenous fistula (AVF) or arteriovenous graft (AVG) using cluster (shift) randomization to surveillance and control groups. There were no significant differences in the baseline demographic data between the 2 groups, except for ethnicity (P = 0.017). Patients were followed on average for 15.2 months. There were significantly less per-patient thrombotic events (Poisson rate) in the surveillance group (0.12/patient) compared with the control group (0.23/patient) (P = 0.012). There was no statistically significant difference in the total number of procedures between the 2 groups, irrespective of whether thrombectomy procedures were included or excluded, and no statistically significant differences in the rate of or time to the first thrombotic event or the number of catheters placed due to thrombosis. Conclusion The use of UDT flow measurement monthly AV access surveillance in this multicenter randomized controlled trial reduced the per-patient thrombotic events without significantly increasing the total number of angiographic procedures. Even though there is a trend, surveillance did not reduce the first thrombotic event rate., Graphical abstract
- Published
- 2020