Safety and Efficacy Outcomes of the Pioneer Plus Catheter in Endovascular Revascularization of Lower Extremity Chronic Total Occlusions.

Abstract Objective Our aim was to evaluate efficacy and safety outcomes of the Pioneer Plus catheter (Philips, San Diego, CA) and to report in-hospital and thirty-day outcomes of lower extremity chronic total occlusion (CTO) interventions assisted by the Pioneer Plus catheter. In addition, we explored factors that were associated with procedural success. Methods We conducted a retrospective review of 135 consecutive procedures on 116 patients from July 2011 until September 2018 performed by 8 operators with various levels of experience at a high-volume center where the Pioneer Plus catheter was utilized for lower extremity CTOs. Patient demographics, pre-procedural symptoms, pre-procedural testing results, procedural setting, and angiography findings were abstracted. The outcomes were divided into device-related and procedure-related outcomes. Device-related efficacy outcome included procedural success. Device-related safety outcomes included device-related complications. Procedure-related outcomes included procedure-related complications, thirty-day major adverse cardiovascular events (MACE), and thirty-day major adverse limb events (MALE). We conducted univariate comparisons of provider, patient, and procedural characteristics by procedural success. Results Procedural success was observed in 118 procedures overall (87.4%), and rates up to 95.8% success were observed in operators with an experience level of >25 devices deployed. There were no device-related complications of pseudoaneurysm formation, vessel perforation, or arteriovenous fistula formation. The Pioneer Plus catheter was mostly commonly used for CTOs in the superficial femoral and popliteal arteries. Overall, procedure-related complications included access site hematoma (5.2%), major bleeding (0.7%), pseudoaneurysm formation (0.7%), distal embolization (1.5%), and acute arterial thrombosis (1.5%). Thirty-day MALE occurred in 5.9% of the procedures which included index limb unplanned amputation (0.7%), index limb reintervention (4.4%), and index limb acute limb ischemia (0.7%). The only factor associated with procedural success was operator experience (p Conclusions The Pioneer Plus catheter use is safe and effective when used to cross lower extremity CTOs, however, further investigation is needed to identify patient and provider level factors to optimize patient outcomes.