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

Abstract

Introduction: 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. Methods: 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. Results: 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). Conclusion: Use of a PTA balloon with an integrated injection port shows potential for significant reduction in contrast dose, fluoroscopy time, and procedure time.

Chameleon™ PTA balloon catheter: A single device in managing thrombosed AV access

“…The reason for this observation is threefold: (1) a direct angiogram is less likely to embolize residual thrombus than a retrograde occlusive, (2) the higher pressure of a retrograde occlusive may hide residual lesions, and (3) the higher pressure of a retrograde occlusive may lead to vessel dissection post angioplasty. [10][11][12] The ability to keep a wire in the central vasculature while performing a pullback venogram is both time saving and, in the case of difficult to cross lesions, can ensure that the operator does not need to traverse the lesion twice. Further, the presence of the injection port at the site of the lesion in question can reduce both contrast and fluoroscopy dose to the patient 13 which is particularly important in the setting of contrast allergy as well as in ESRD patients who continue to have residual renal function.…”

“…The reason for this observation is threefold: (1) a direct angiogram is less likely to embolize residual thrombus than a retrograde occlusive, (2) the higher pressure of a retrograde occlusive may hide residual lesions, and (3) the higher pressure of a retrograde occlusive may lead to vessel dissection post angioplasty. 10–12…”