By Ranjan Shetty, MD, DM
Chronic occlusions account for a significant portion of peripheral vascular lesions and have historically represented a serious technical challenge to endovascular interventionalists using conventional guide wires and catheters. The purpose of this study was to determine the safety and efficacy of a CTO device, the Frontrunner XP CTO Catheter (FRXP; Cordis Corp), for recanalization of chronic total occlusion of femoral-popliteal arteries after guidewire failure. The Frontrunner catheter was used in 22 patients. The overall technical success rate was 95.5%. Nineteen (86.4%) patients had lesions in the superficial femoral artery (SFA), and 2 (9.1%) patients had a lesion in the popliteal artery. The mean occlusion length was 18.0 ± 10.1 cm. All the lesions were considered complex (TASC D) and 86.4 % of the lesions were mild calcified. Diabetes was present in 12 (54.5%) patients and 14 (63.6%) patients had arterial hypertension. Twenty-two (66.7%) of the 33 cases had failed previous attempts of percutaneous intervention with conventional guidewire. The Frontrunner catheter was used to treat 22 CTOs after guidewire failure. TIMI 3 flow was achieved in all target vessels after further balloon angioplasty or stenting.
The Frontrunner catheter was thought to selectively cause disruption of plaques and the adventitia and is designed to improve the technical success of traversing complex lesions. To date, however, recanalization success with this new device and the impact of the technology are unknown for peripheral arteries, and it has not been tested in large trials or randomized studies. This paper reports a single- center experience with the Frontrunner-XP in revascularization of complex femoropopliteal arterial occlusions (TASC D lesions). In our study, 22 patients with CTOs of FP arteries were enrolled after intraluminal guidewire failure. The indications for treatment were severe claudication, pain at rest, and minor trophic changes of the limb. Primary end points of the study were immediate technical and clinical success. In our study, the success rate using the Frontrunner catheter was 95.5%. Although the number of patients was small and calcium in the lesions was not assessed, our study included only patients with failure of guidewire advancement into the CTO.
Coronary success rates, however, are somewhat variable depending on location, ranging from a low of 57% in the RCA to 70% in the left coronary anatomy. This variability in the coronaries is thought to be primarily due to vessel tortuosity and the right coronary arteries size and predisposition to dissection. Generally, higher success rates in the periphery may be due to straighter, less complex vessel anatomy.
Safety and Efficacy of the Frontrunner XP Catheter for Recanalization of Chronic Total Occlusion of the Femoropopliteal Arteries
Ranjan Shetty, MD DM, G. Vivek, MD DM, Ashok Thakkar, PhD, Rajaram Prasad, MD, Umesh Pai, MSc, Krishnananda Nayak, MSc