Andrew R Forauer1, Eric K Hoffer, Karen Homa. 1. Department of Vascular and Interventional Radiology, Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH 03756, USA. andrew.r.forauer@hitchcock.org
Abstract
PURPOSE: To examine prospectively the effects of balloon inflation time on the technical success of balloon angioplasty in dialysis access venous stenosis and on postintervention primary patency. MATERIALS AND METHODS: The study design was approved by the institution's Committee for the Protection of Human Subjects, and informed consent was obtained. Demographic information and access-specific data were collected. Patients with thrombosis, prior stent placement within the access circuit, and allergy to heparin were excluded. Patients were randomly assigned to a balloon inflation time of either 1 or 3 minutes. Balloon sizing, inflation pressure, balloon type, and heparin administration were controlled variables. The technical success of the angioplasty, defined as less than 30% residual stenosis, was evaluated for each lesion. RESULTS: A total of 48 patients were enrolled: 27 patients (40 stenoses) randomly assigned to the 1-minute group and 21 (36 stenoses) to the 3-minute group. There were no significant demographic differences between the two inflation groups. Technical success rates in the 1- and 3-minute inflation groups were 75% and 89%, respectively. Logistic regression analysis, which controlled for patient age, sex, and age of the access, demonstrated that technical success was 4.7 times more likely in the 3- versus the 1-minute inflation group (95% confidence interval: 1.1, 20.1). The 1-, 3-, and 6-month postintervention patencies were not significantly different between the two groups. CONCLUSION: Although a 3-minute inflation time significantly improved the likelihood of technical success for percutaneous transluminal angioplasty of dialysis access venous stenoses, there was no significant difference in postintervention access patency. (c) RSNA, 2008.
RCT Entities:
PURPOSE: To examine prospectively the effects of balloon inflation time on the technical success of balloon angioplasty in dialysis access venous stenosis and on postintervention primary patency. MATERIALS AND METHODS: The study design was approved by the institution's Committee for the Protection of Human Subjects, and informed consent was obtained. Demographic information and access-specific data were collected. Patients with thrombosis, prior stent placement within the access circuit, and allergy to heparin were excluded. Patients were randomly assigned to a balloon inflation time of either 1 or 3 minutes. Balloon sizing, inflation pressure, balloon type, and heparin administration were controlled variables. The technical success of the angioplasty, defined as less than 30% residual stenosis, was evaluated for each lesion. RESULTS: A total of 48 patients were enrolled: 27 patients (40 stenoses) randomly assigned to the 1-minute group and 21 (36 stenoses) to the 3-minute group. There were no significant demographic differences between the two inflation groups. Technical success rates in the 1- and 3-minute inflation groups were 75% and 89%, respectively. Logistic regression analysis, which controlled for patient age, sex, and age of the access, demonstrated that technical success was 4.7 times more likely in the 3- versus the 1-minute inflation group (95% confidence interval: 1.1, 20.1). The 1-, 3-, and 6-month postintervention patencies were not significantly different between the two groups. CONCLUSION: Although a 3-minute inflation time significantly improved the likelihood of technical success for percutaneous transluminal angioplasty of dialysis access venous stenoses, there was no significant difference in postintervention access patency. (c) RSNA, 2008.
Authors: Pietro Ravani; Robert R Quinn; Matthew J Oliver; Divya J Karsanji; Matthew T James; Jennifer M MacRae; Suetonia C Palmer; Giovanni F M Strippoli Journal: Cochrane Database Syst Rev Date: 2016-01-07