Efficacy and Safety of MáLEI (Minimal Arterial Access Lower Extremity Intervention) Via Peripheral Orbital Atherectomy

Purpose:
Peripheral atherectomies are routinely performed via transfemoral access. However, due to increased risks for complications, time to discharge, and patient satisfaction, transfemoral access can be undesirable. The Cardiovascular Systems, Inc. (CSI) Diamondback 360^® Peripheral Orbital Atherectomy System (OAS) has allowed transradial access for peripheral orbital atherectomies due to their compatibility with 6 French long radial sheaths. This study aimed to evaluate the efficacy and safety of MáLEI (Minimal Arterial Access Lower Extremity Intervention) using peripheral orbital atherectomy in patients with mild to severe PAD.

Material and Methods:
A retrospective, unmatched, cohort, chart review study was conducted on patients with lower extremity PAD secondary to atherosclerosis (Rutherford Classification Category 2-6) who underwent at least one transradial peripheral atherectomy. The primary objective was to evaluate the clinical success of transradial peripheral atherectomies and the secondary objectives was to assess the acute complications. For the primary efficacy analysis, success rate was calculated as the proportion of procedures meeting the clinical success criteria (total number of successful transradial peripheral atherectomy procedures without conversion to transfemoral access). The primary safety analysis was calculated based on the incidence of acute complications overall.

Results:
Forty-seven patients, ages 44 to 91, underwent a transradial peripheral atherectomy. The baseline Rutherford Classification was 46.8% Grade 3, 12.8% Grade 4, 12.8% Grade 5, and 27.7% Grade 6. All procedures (n=47; 100%) resulted in clinical success. Vessels treated were the common femoral artery (n=5), anterior tibial artery (n=6), superficial femoral artery (n=27), peroneal artery (n=6), common iliac artery (n=4), popliteal artery (n=11), posterior tibial artery (n=4), and other (n=6). Average procedure time was 76.6 minutes, average fluoroscopy time was 28.3 minutes, and median time to discharge was 6.5 hours. No complications were noted.

Conclusions
For patients with severe PAD (Rutherford Grade 3-6), utilizing a MáLEI-transradial approach for peripheral atherectomies is a safe alternative to the transfemoral method. Findings from this analysis demonstrate that performing orbital atherectomies in the lower extremities is an efficacious and safe method with minimal complications.