Procedural comparison of a standard PTA balloon for fistula and graft maintenance procedures with the novel Chameleon™ PTA balloon catheter.

Abstract

The incidence of cephalic arch (CA) and central venous (CV) stenosis has been reported in the range of 30% in the literature. The purpose of this study is to compare contrast use, fluoroscopy time, and procedure time between standard imaging by injection of contrast through the access sheath versus injection of contrast through a novel PTA balloon with an integrated injection port. A multi-centered, retrospective evaluation of consecutive patients treated for CA and CV stenosis was performed. Data captured included demographics, co-morbidities, lesion characteristics/location, procedural details, volume of contrast used, fluoroscopy time, and procedure time. The control group was imaged and treated using standard practice with pre and post imaging performed through the sheath and intervention using standard PTA balloon. Imaging and treatment were performed using the Chameleon™ PTA catheter in the treatment arm. A total of 68 consecutive patients were included. There were 34 patients in Group A and 34 patients in Group B. Average age was 65.2 versus 66.5 (p = 0.284), respectively. There were no significant gender differences between groups. Prevalence of co-morbidities of hypertension, coronary artery disease, and diabetes was similar to national rates in both groups. Contrast volume, fluoroscopy time, and procedure time in Group B were significantly less when compared by multiple regression to Group A, correcting for potential confounders (p = 0.0001, 0.0180, and 0.0008, respectively). Use of a PTA balloon with an integrated injection port shows potential for significant reduction in contrast dose, fluoroscopy time, and procedure time.