ESVS 2023 丨Prof. Qizhuang Jin’s team: 12-month results of a peripheral intervention scoring balloon dilatation catheter (BrosMed Tri-Wedge™) in the treatment of stenotic lesions of arteriovenous fistula

The 37th Annual Meeting of the European Society for Vascular Surgery 2023 (ESVS 2023) was successfully held in Belfast, United Kingdom, from September 26 to 29. The ESVS Annual Meeting is widely recognized as one of the most important congresses in vascular surgery, attracting specialists, professors, and physicians from around the world each year. During the four-day event, a wide range of educational sessions, interactive case discussions, and hands-on workshops were organized, offering participants advanced training opportunities across five academy areas: aortic, carotid, peripheral arterial disease (PAD), vascular access, and venous disease.

During the Annual Meeting, Prof. Qizhuang Jin’s team from Peking University First Hospital delivered an excellent presentation titled “Scoring Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas: A Multicenter Randomized Controlled Trial.” The presentation shared the 12-month results of a clinical study evaluating the BrosMed Tri-Wedge™ PTA Scoring Balloon Dilatation Catheter in the treatment of stenotic lesions in autologous arteriovenous fistulas.

Background of the Study

Vascular stenosis is one of the common complications of arteriovenous fistulas (AVFs) and is a major cause of AVF thrombosis and eventual loss of function. Percutaneous transluminal angioplasty (PTA) is the preferred treatment option for AVF stenosis. However, stenosis in hemodialysis access is often characterized by intimal hyperplasia (IH) and highly resistant lesions. After conventional PTA using a standard PTA balloon dilatation catheter, restenosis may occur easily and the prognosis can be poor.

The use of specialty balloons may improve procedural success. However, high-pressure balloons may cause excessive vessel injury, while improper use of scoring balloons may increase the risk of vessel rupture. Therefore, how to safely and effectively treat stenotic lesions in AVFs remains a major clinical challenge.

Purpose of the Study

Few clinical studies have reported the use of scoring balloons for the treatment of stenotic lesions in autologous arteriovenous fistulas. The aim of this study was to evaluate the safety and efficacy of a peripheral scoring balloon dilatation catheter in the treatment of stenotic lesions in autologous arteriovenous fistulas.

Study Design

This multicenter, randomized, controlled, non-inferiority clinical trial was led by Prof. Qizhuang Jin, Chief Physician of Nephrology at Peking University First Hospital. A total of 168 eligible subjects from six study centers in China were enrolled in the study. Subjects were randomly assigned to the experimental group, treated with the BrosMed Tri-Wedge™ PTA Scoring Balloon Dilatation Catheter (n = 83), or the control group, treated with a high-pressure PTA balloon catheter (n = 85).

The primary endpoint was technical success rate, defined as residual stenosis of the target lesion <30% immediately after angioplasty. Secondary endpoints included device success, procedural success, dilation pressure, subject pain score, degree of stenosis at 48 hours after angioplasty, and target lesion primary patency (TLPP) at 12 months. Safety endpoints included vascular rupture, serious adverse events, death, heart failure, stroke, and device defects.

Study Results

The results showed that the technical success rate in the experimental group treated with the BrosMed Tri-Wedge™ PTA Scoring Balloon Dilatation Catheter was 96.8%, compared with 88.7% in the control group (P = 0.033). At 12 months after the procedure, target lesion primary patency was 67.6% in the BrosMed Tri-Wedge™ PTA Scoring Balloon group and 48.5% in the control group (P = 0.047).

The mean dilation pressure for stenotic lesions was 16.8 ± 3.8 atm in the experimental group and 18.0 ± 4.1 atm in the control group (P = 0.013). The degree of stenosis at 48 hours after angioplasty was 22.05 ± 11.26% and 27.11 ± 12.25%, respectively (P = 0.004).

The incidence of serious adverse events was 6 events in 6 subjects (7.2%) in the experimental group and 8 events in 5 subjects (5.9%) in the control group (P = 0.724). No vascular rupture, death, heart failure, or stroke occurred in the BrosMed Tri-Wedge™ PTA Scoring Balloon group. In the control group, one case of vascular rupture, one case of heart failure, and one case of stroke were reported, with no deaths. No device defect-related events were reported in either group.

Overview

The BrosMed Tri-Wedge™ PTA Scoring Balloon demonstrated a higher technical success rate than the conventional high-pressure balloon, without an increase in serious adverse events. The BrosMed Tri-Wedge™ PTA Scoring Balloon achieved adequate lesion expansion at a lower dilation pressure and resulted in better lumen maintenance at 48 hours after the procedure.

Additional data are needed to further evaluate the long-term efficacy of BrosMed Tri-Wedge™ PTA Scoring Balloon angioplasty for the treatment of arteriovenous fistula stenosis.

Expert Profiles

Prof. Qizhuang Jin

Chief Physician of Nephrology, Peking University First Hospital, China
Member of the Asian Pacific Society of Dialysis Access (APSDA)
Principal Investigator of the BrosMed Tri-Wedge™ PTA Scoring Balloon Dilatation Catheter Trial in China

Yanqi Yin, M.D.

Attending Physician of Nephrology, Peking University First Hospital, China
Member of the Asia-Pacific Angiology Academic Association
Sub-investigator of the BrosMed Tri-Wedge™ PTA Scoring Balloon Dilatation Catheter Trial in China