Arterial Interventions and Peripheral Arterial Disease (PAD)
Elsie Koh, MD MHL (she/her/hers)
CMO
American Endovascular and Amputation Prevention
Disclosure(s): No financial relationships to disclose
12 month follow up was reviewed from 41 patients (47 lesions) treated for infra-popliteal disease in the Pathfinder Registry (70.7% male, age 67.5 ± 9.23, 73.2% DM, 9.8% CKD, 72.5% CLI), Core Lab analysis of angiograms and duplex ultrasound was utilized in all patients.
Results: Average lesion length was 13.73 (0.85 - 40.00 cm), 46.8% were CTOs, and 34.0% were moderate-severely calcified. Stenosis percentage was 85.2 ± 18.35, 65.0 ± 22.95 and 29.4 ± 18.29 at baseline, post laser and post procedure respectively. There were no procedural perforations, emboli, amputations, or deaths. One (2.1%) mild dissection and 1 (2.1%) bailout stenting post balloon occurred. Freedom from MAEs was 97.4% at 30-days (N=38) with 1 (2.6%) CD-TLR, 94.4% at 6-months (N=36) with 1 (2.8%) amputation, and 94.3% at 12-months (N=35), with no additional MAEs. There were 4 (9.8%) all-cause deaths, unrelated to PAD or the procedure. Rutherford, ABI, and WIQ improved at 12 months (N=23,23,12) comparing to baseline (4.18 ± 0.98 vs. 1.43 ± 1.50; 0.81 ± 0.28 vs. 1.14 ± 0.46; and 26.54 ± 28.46 vs. 36.86 ± 20.82, respectively).
Conclusion:
Initial post market data on real-world cases with Auryon in a variety of complex infra-popliteal lesions demonstrates excellent safety & outcomes. Low CD-TLR rates with improved clinical presentation were consistent with prior data, and stable out to 12 months.