A Single-Center Retrospective Analysis of the Efficacy of a New Balloon Catheter in Autogenous Arteriovenous Fistula Dysfunction Resistant to Conventional Balloon Angioplasty.

ABSTRACT

PURPOSE: The purpose of the study was to present a new alternative balloon catheter option for autogenous arteriovenous fistula (AVF) dysfunction with a stiff constriction resistant to conventional balloon angioplasty. METHODS: Our first series of 51 patients with autogenous AVF dysfunction who were simultaneously treated with VascuTrak™ balloon catheter, following failed conventional balloon therapy (failure was defined as residual stenosis of >30%), were retrospectively observed and analyzed. The indices that were used to evaluate the clinical efficacy of VascuTrak balloon catheter included the immediate technical success rate, residual stenosis, successful dilation times, degree of pain assessed using the Visual Analog Scale, complications, and follow-up patency rate. RESULTS: The stenotic or occlusive lesions of all 51 cases resistant to conventional balloon angioplasty were promptly eliminated or alleviated (residual stenosis rate ≤ 30%), with a 100% immediate technical success rate. VascuTrak balloon catheters were successful in achieving full dilation under working pressure, of which 44 cases required a 1-time dilation (86.3%) and 7 cases required 2 dilations, which differed significantly from the average of 2.4 dilations required by the preceding conventional balloon therapy (P < 0.0001). A statistically significant improvement in the degree of pain experienced by patients who received VascuTrak balloon dilation was observed compared to that of the preceding conventional balloon dilation (P < 0.0001). One case of a brachial artery pseudoaneurysm complication occurred in the perioperative period. The primary patency rate was 88.2% at 6 months and 74.5% at 12 months. CONCLUSION: The use of VascuTrak balloon catheter to treat autogenous AVF dysfunction resistant to conventional balloon angioplasty appears to be safe and effective, although further, large randomized controlled trials are necessary.