Prospective, Multi-center, Single-Arm Study of the Auryon Laser System for Treatment of Below-the-Knee Arteries in Patients With Chronic Limb-Threatening Ischemia: 30-Day Results of the Auryon BTK.

The 355 nm Auryon laser (AngioDynamics, Inc., Latham, New York) has been shown to be effective and safe in treating various morphology lesions in the femoropopliteal arteries. There are limited data on the Auryon laser in treating below-the-knee (BTK) arteries in patients with chronic limb-threatening ischemia. We present the 30-day efficacy and safety findings from the ongoing Auryon BTK study. Patients with chronic limb-threatening ischemia were prospectively enrolled in the Auryon BTK study between March 2022 and February 2023 in 4 US centers after obtaining written informed consent. The primary safety end point included major adverse limb events + postoperative death at 30 days, defined as a composite of all-cause death, major amputation, and target vessel revascularization. Demographic, procedural, angiographic, and outcome data were collected. A total of 60 patients (61 lesions) were treated. The mean age was 74.6 ± 10.3 years, with 65.0% men, 58.3% with diabetes, 43.3% Rutherford Becker (RB) IV, and 56.7% RB V. Of the 61 lesions, 59% had severe calcification, 31.1% were chronic total occlusions, and 90.2% were de novo disease. The baseline diameter stenosis was 80.2 ± 16.4%, after laser 57.4 ± 21.7%, and after final treatment 24.0 ± 23.1% (p <0.0050). The primary performance end point showed a procedure success rate of 37 of 68 (63.8%). Bailout stenting occurred in 1 of 61 lesions (1.6%). The RB category was 100% RB IV or higher at baseline versus 35.3% at 30 days. At 30 days, there was no target vessel revascularization and the patency was 88.9% (Peak Systolic Velocity Ratio (PSVR) ≤2.4). In conclusion, the Auryon laser is safe and relatively effective in treating BTK lesions with minimal complications.

Treatment effect of medial arterial calcification in below-knee after Auryon laser atherectomy using micro-CT and histologic evaluation.

PURPOSE: To determine the frequency of medial arterial calcification (MAC) fracture following Auryon laser atherectomy using micro-CT and histologic evaluation in an atherosclerotic human cadaveric limb model. METHODS: Two below-the-knee calcified arterial segments from human cadaver limbs underwent treatment with the Auryon laser system with or without plain old balloon angioplasty (POBA). Micro-CT and angiography were performed before and after treatment followed by histological evaluation of regions showing calcium disruption. RESULTS: All treatment zones were successfully treated with the Auryon laser (n = 9). Six of 9 treatment zones showed calcium fracture on micro-CT. Each treatment zone was further subdivided using micro-CT analysis (36 evaluated sections) of which 18 sections revealed calcium fracture. Sections with calcium fracture had significantly more confluent and uninterrupted circumferential calcification than sections without calcium fracture (arc of calcification 360.0 [323.7-360.0] vs 312.8 [247.4-314.2] degree, p = 0.007), whereas there were no differences in size of calcium burden (3.4 [2.8-3.9] vs 2.8 [1.3-4.6] mm2, p = 0.46). No arterial dissection or rupture was seen. CONCLUSIONS: Auryon laser atherectomy produced fractures of medial arterial calcification in this cadaveric human atherosclerotic peripheral artery model. This effect was observed in arterial segments with a pattern of circumferential uninterrupted calcification (i.e. larger arc of calcification) regardless of calcium burden. Our pilot data suggests Auryon laser may be a promising therapy for calcified lesions.

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.

Role of BMP signaling during early development of the annelid Capitella teleta.

The mechanisms regulating nervous system development are still unknown for a wide variety of taxa. In insects and vertebrates, bone morphogenetic protein (BMP) signaling plays a key role in establishing the dorsal-ventral (D-V) axis and limiting the neuroectoderm to one side of that axis, leading to speculation about the conserved evolution of centralized nervous systems. Studies outside of insects and vertebrates show a more diverse picture of what, if any role, BMP signaling plays in neural development across Bilateria. This is especially true in the morphologically diverse Spiralia (≈Lophotrochozoa). Despite several studies of D-V axis formation and neural induction in spiralians, there is no consensus for how these two processes are related, or whether BMP signaling may have played an ancestral role in either process. To determine the function of BMP signaling during early development of the spiralian annelid Capitella teleta, we incubated embryos and larvae in BMP4 protein for different amounts of time. Adding exogenous BMP protein to early-cleaving C. teleta embryos had a striking effect on formation of the brain, eyes, foregut, and ventral midline in a time-dependent manner. However, adding BMP did not block brain or VNC formation or majorly disrupt the D-V axis. We identified three key time windows of BMP activity. 1) BMP treatment around birth of the 3rd-quartet micromeres caused the loss of the eyes, radialization of the brain, and a reduction of the foregut, which we interpret as a loss of A- and C-quadrant identities with a possible trans-fate switch to a D-quadrant identity. 2) Treatment after the birth of micromere 4d induced formation of a third ectopic brain lobe, eye, and foregut lobe, which we interpret as a trans-fate switch of B-quadrant micromeres to a C-quadrant identity. 3) Continuous BMP treatment from late cleavage (4d â€‹+ â€‹12 â€‹h) through mid-larval stages resulted in a modest expansion of Ct-chrdl expression in the dorsal ectoderm and a concomitant loss of the ventral midline (neurotroch ciliary band). Loss of the ventral midline was accompanied by a collapse of the bilaterally-symmetric ventral nerve cord, although the total amount of neural tissue was not greatly affected. Our results compared with those from other annelids and molluscs suggest that BMP signaling was not ancestrally involved in delimiting neural tissue to one region of the D-V axis. However, the effects of ectopic BMP on quadrant-identity during cleavage stages may represent a non-axial organizing signal that was present in the last common ancestor of annelids and mollusks. Furthermore, in the last common ancestor of annelids, BMP signaling may have functioned in patterning ectodermal fates along the D-V axis in the trunk. Ultimately, studies on a wider range of spiralian taxa are needed to determine the role of BMP signaling during neural induction and neural patterning in the last common ancestor of this group. Ultimately, these comparisons will give us insight into the evolutionary origins of centralized nervous systems and body plans.