A Prospective Randomized Controlled Trial Comparing Hydrostatic Dilatation with Balloon Angioplasty Versus Hydrostatic Dilatation with Malleable Vascular Dilator for 2 mm or Less Caliber Veins During Creation of Arteriovenous Fistula for Hemodialysis

Cephalic vein ≤ 2.5 mm is associated with high failure rate. Preoperative balloon angioplasty in ≤ 2 mm veins improve the patency rate of arteriovenous fistula (AVF) compared with hydrostatic technique. This study was done to determine difference in the efficacy between two surgical techniques (hydrostatic dilatation with balloon angioplasty (HD + BA) versus hydrostatic dilatation with malleable dilatation (HD + MD)) on patency rates of AVF in patients with cephalic veins ≤ 2 mm in diameter. This randomized controlled trial was conducted in the Department of Surgical Disciplines, AIIMS, New Delhi between 2017 and 2018. Two hundred patients of chronic kidney disease (CKD) were evaluated for AVF, 120/200 (60%) agreed to participate in the study. Computer generated randomization via sealed envelope was done into two groups, i.e., HD + BA (n = 60) or HD + MD (n = 60). Efficacy on clinical maturation (CM) and radiological maturation (RM) of AVF was observed. CM—use of AVF for repetitive (≥ 3) hemodialysis. RM—cross-sectional diameter > 4 mm and intra-access flow rate > 500 ml/h. CM and RM between HD + BA versus HD + MD at the end of 8 and 24 weeks was 83.63% and 58.2%: 83.6% and 58.11% versus 85.71% and 64.3%: 82.1% and 64.28% (p values 0.81 and 0.51: p value 0.83 and 0.29). CM and RM in brachiocephalic AVF (BCAVF) subgroup at 24 weeks was 40/43 (93.0%) and 30/43 (69.70%). CM and RM in RCAVF subgroup at 24 weeks were 52/68 (76.4%) and 38/68 (55.8%). Both surgical techniques were equally effective in increasing the patency of AVF. HD + BD is not superior to HD + MD at 6 months of follow-up. Trail registration: CTRI/2017/05/008543, Registered on 12/5/2017. [ABSTRACT FROM AUTHOR]