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MáLEI (Minimal Arterial Access Lower Extremity Intervention) in Severe Peripheral Arterial Disease



Imraan Ansaarie, MD1; Rebecca F. Goldfaden, PharmD, CCRP2; Khyati Rana, PharmD2; Jessica Reid, PharmD2; Stephanie Niman, PharmD2; Rushab R Choksi, PharmD2; Nicole Ansaarie, BSN, RN, MS1

1Ansaarie Cardiac and Endovascular Center of Excellence

2East Coast Institute for Research, LLC

Abstract Number

Transfemoral access remains the primary method for peripheral revascularizations despite the availability of transradial access. Furthermore, in patients with severe peripheral arterial disease (PAD) Rutherford Classification Grade 4-6, the transradial approach is even more underutilized due to the length or difficulty of the lesions. Terumo designed two long-length sheaths, Glideasheath Slender and R2P Destination Slender, for peripheral procedures. This study aimed to evaluate the efficacy and safety of transradial access (MáLEI- Minimal Arterial Access Lower Extremity Intervention) compared to transfemoral access in patients with severe PAD.

Material and Methods:
A retrospective, unmatched, cohort study was conducted on patients with lower extremity PAD who had at least one transradial, transfemoral, or translunar peripheral revascularization. A post-hoc analysis based on stratification of severity of PAD (Rutherford Classification Grade 4-6) was conducted to compare clinical success (final residual diameter stenosis < 30%) with radial access to femoral access, as well as procedure time, fluoroscopy time, time to discharge, and complications.

Ninety patients with severe PAD (Rutherford Grade 4-6) underwent a transradial or transfemoral peripheral revascularization. Amongst the transradial and transfemoral groups, baseline Rutherford Grade 4, 5, and 6 was 15.9% vs. 14.8%, 11.1% vs. 37%, and 31.7% vs. 11.1%, respectively, of the total population. All procedures (n=90) resulted in clinical success. For transradial versus transfemoral, Rutherford Grade 5 average procedure time was 85.7 vs. 107.0 min, average fluoroscopy time was 29.6 vs. 43.1 min, and median time to discharge was 11.3 vs. 11.6 hr. Rutherford Grade 6 average procedure time was 110.9 vs. 121.7 min, average fluoroscopy time was 40.0 vs. 37.3 min, and median time to discharge was 88.8 vs. 51.7 hr. One transfemoral patient (3.7%) experienced an access site bleed (BARC Type 1) and no other complications were noted.

Despite the severity PAD (Rutherford Grade 4-6), a transradial approach for peripheral revascularizations is a comparative alternative to transfemoral. Findings from this analysis demonstrate that utilizing transradial access has similar efficacy and safety for successful peripheral revascularizations compared to transfemoral access, even in patients with minor tissue loss, ulceration, or gangrene.

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