Auryon Laser in Treating Symptomatic Infrainguinal Arterial Disease: 1-Year Outcome

Background: The Auryon 355-nm laser atherectomy system (AngioDynamics, Inc) showed a low rate of target-lesion revascularization (TLR) at 6-month follow-up in the EX-PAD-03 investigational device exemption study and the Auryon single-center experience (SCE) in treating infrainguinal arteries. In this study, we present the 1-year outcomes of the Auryon SCE study on TLR in all comers at a single center.

Methods: The Auryon SCE was a retrospective study that evaluated the outcomes of all comers treated with the Auryon laser for infrainguinal arterial disease. There was no TLR seen at 6-month follow-up. We present the TLR rate at 1 year in the same cohort of patients. TLR rates were obtained from medical record review of patients enrolled in the study who had completed office visit follow-up at 1 year. Secondary endpoints included unplanned major amputation and total mortality. Kaplan-Meier survival analysis was performed to estimate the freedom from TLR rate following index procedure. Statistical differences were analyzed for ankle-brachial index (ABI) between baseline and 1 year.

Results: A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, with 66.1% males, 48.2% diabetics, and 25% demonstrating limb ischemia. Of the 70 lesions, 31.4% had severe calcification, 38.6% were chronic total occlusions, and 48.6% were de novo disease (in-stent restenosis, 29.6%). Stenting was performed in 24/70 lesions (34.3%), with 11/70 (15.7%) bailout procedures. Embolic filters were used in 26/65 procedures (40%). The majority of treated lesions were femoropopliteal (90.0%); of all procedures, 29.2% had 2 or more prior interventions. Drug-coated balloon usage was 47.1% Lutonix (BD/Bard), 27.1% In.Pact (Boston Scientific), and 1.4% both in all lesions treated. Distal embolization occurred in 1/65 procedures (1.5%). At 1 year, mortality occurred in 3/56 patients (5.4%). Of 65 limbs treated, 2 (3.1%) had major amputation at 1 year. The probability of freedom from TLR was 83.7%.

Conclusion: In a realworld cohort of patient with complex disease, the Auryon laser had excellent freedom from TLR at 1 year.