Technical Report and Preliminary Clinical Data of a Novel Catheter for Luminal Re-Entry After Subintimal Dissection

Abstract

Although the Outback catheter is safe, the percentage of intraluminal reaccess should be ameliorated through engineering improvements because there is some evidence to suggest that subintimal recanalization could produce improved long-term results.

Bailout Revascularization of Chronic Femoral Artery Occlusions With the New Outback Catheter Following Failed Conventional Endovascular Intervention

“…1,3,4 Hausegger et al 3 used the first-generation model of the Outback system in 10 patients with intermittent claudication as a bailout procedure to cross iliofemoral lesions; they reported a success rate of 80%. Using the same model, Wiesinger et al 4 reported a success rate of only 50%. The low success rate was attributed to insufficient stiffness and sharpness of the system for penetrating, crossing, and puncturing.…”

“…However, heavily calcified lesions limited the re-entry success rate to as low as 50% in early reports using the first-generation Outback catheter. 4 Therefore, the system was redesigned to deploy the needle via a lateral port from the integral hypotube that previously ended in a curved retractable needle. 1,3,4 Using the redesigned system, we were able to achieve a 95% revascularization rate with the Outback LTD catheter in 20 cases of chronic SFA occlusion.…”

“…4 Therefore, the system was redesigned to deploy the needle via a lateral port from the integral hypotube that previously ended in a curved retractable needle. 1,3,4 Using the redesigned system, we were able to achieve a 95% revascularization rate with the Outback LTD catheter in 20 cases of chronic SFA occlusion. The uncontrolled needle deployment and ineffective penetration of the intima initially reported by Wiesinger et al 4 did not occur with the new system in our series.…”

“…1,3,4 IVUS navigation, which is available with the Pioneer catheter, is more expensive and demands an ultrasound console as well as additional skills, whereas the Outback catheter allows direct fluoroscopic navigation. Early studies using the Outback Catheter system reported an inadequate technical success rate, especially in calcified occlusions, 4 so the design was re-engineered to incorporate a stiffer needle and a lateral exit port.…”

Target Balloon-Assisted Antegrade and Retrograde Approach for Recanalization of Thrombosed Fem-Pop Bypass Graft Using the Outback Catheter

“…Previous studies have shown variable success rates of 50 to 100% for re-entry devices in the treatment of infra-inguinal arterial occlusive diseases (2,7,8).…”