RESUMO
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 investigational device exemption study. At present, real-world data are not available. In this study, we analyze major adverse events and 6-month outcomes with the Auryon laser system in treating infrainguinal arterial disease in all comers at a single center. METHODS: Consecutive patients treated with the Auryon laser between September 2017 and March 2021 were retrospectively reviewed from a single operator at a single center. Demographic, procedural, angiographic, and outcome data were extracted from patients' medical records. Descriptive and survival analyses were performed. The study's primary endpoint was the assessment of freedom from TLR at 6-month follow-up. Secondary endpoints included acute procedural results, distal embolization, bailout stenting (dissection type D or higher by National Heart, Lung, and Blood Institute [NHLBI] classification, and/or residual narrowing >30%), unplanned major amputation, death, or vascular complications. RESULTS: A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, 66.1% were males, 48.2% were diabetics, and 25% had 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 in 28.6%). The majority of treated vessels were femoropopliteal (88.6%) and 29.2% had 2 or more prior interventions. Mean stenosis was 91.3 ± 9.7% at baseline, 56.0 ± 17.3% post laser, and 11.4 ± 11.2% post final treatment. Lesion length was 117.1 ± 101.2 mm and treated length was 174.0 ± 116.0 mm. Bailout stenting occurred in 11/70 lesions (15.7%). There were no NHLBI type D dissections post laser and 1 type D dissection post laser + percutaneous transluminal angioplasty. A total of 47.1% received Lutonix drug-coated balloons (BD/Bard), 27.1% received In.Pact drug-coated balloons (Boston Scientific), and 1.4% received both. The probability of freedom from TLR per procedure was 95.6% at 6 months. CONCLUSION: In a real-world cohort of patients with complex disease, the Auryon laser had excellent freedom from TLR at 6 months, although these findings need to be replicated in a randomized trial.
