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.

Short-term rebleeding rates for isolated gastric varices managed by transjugular intrahepatic portosystemic shunt versus balloon-occluded retrograde transvenous obliteration.

PURPOSE: To assess the short-term rebleeding rate associated with the use of a transjugular intrahepatic portosystemic shunt (TIPS) compared with balloon-occluded retrograde transvenous obliteration (BRTO) for management of gastric varices (GV). MATERIALS AND METHODS: A single-center retrospective comparison of 50 patients with bleeding from GV treated with a TIPS or BRTO was performed. Of 50 patients, 27 (17 men and 10 women; median age, 55 y; range, 31-79 y) received a TIPS with covered stents, and 23 (12 men and 11 women; median age, 52 y; range, 23-83 y) underwent a BRTO procedure with a foam sclerosant. All study subjects had clinical and endoscopic evidence of isolated bleeding GV and were hemodynamically stable at the time of the procedure. Clinical and endoscopic follow-up was performed. Kaplan-Meier analysis was used to evaluate rebleeding rates from the GV. RESULTS: The technical success rate was 100% in the TIPS group and 91% in the BRTO group (P = .21). Major complications occurred in 4% of the patients receiving TIPS and 9% of patients the undergoing BRTO (P = .344). Encephalopathy was reported in 4 of 27 (15%) patients in the TIPS group and in none of the patients in the BRTO group (0%; P = .12). At 12 months, the incidence of rebleeding from a GV source was 11% in the TIPS group and 0% in the BRTO group (P = .25). CONCLUSIONS: BRTO appears to be equivalent to TIPS in the short-term for management of bleeding GV. Further comparative studies are warranted to determine optimal management strategies in individual patients.

Treatment of type II endoleak using Onyx with long-term imaging follow-up.

PURPOSE: The purpose of our study is to report our experience with the use of an ethylene vinyl alcohol copolymer (Onyx) in an off-label fashion for the treatment of type II endoleak after endovascular repair of the thoracic (TEVAR) and abdominal (EVAR) aorta. METHODS: A retrospective review of patients with type I and/or II endoleak treated with Onyx was performed. Data regarding the technical, clinical, and imaging outcomes were collected. Technical success was defined as decreased or eliminated endoleak on the first imaging follow-up. Clinical success was defined as unchanged or decreased aneurysm sac size on subsequent follow-up. RESULTS: Eighteen patients (15 male, 3 female) with a mean age of 79 years (range 69-92) met inclusion criteria (16 abdominal aortic aneurysm, 2 thoracic aortic aneurysm). Sixteen patients had type II endoleak, and 2 had complex type II endoleak with a type I component. The interval between endograft placement and treatment was a mean of 30 months. Direct sac treatment approach was used in 13 patients; transarterial approach was used in 3 patients. Seven patients required the use of coils, N-butyl cyanoacrylate glue, or Amplatzer vascular plugs. The average volume of Onyx used per treatment was 5.6 mL (range 2.5-13). Duration of imaging follow-up was 0.75-72.5 months (mean 32.8). Sixteen of 18 (88.9 %) patients had initial technical and clinical success. Two of 18 patients (11.1 %) were initial technical failures, and 1 remained a failure despite a second treatment and attempted surgical ligation. Eight of 18 (44.4 %) of patients eventually required a second intervention, 5 (27.8 %) of them due to delayed clinical failure. Complications included 1 psoas hematoma, 1 transient L2 nerve paresis, and 1 intraperitoneal Onyx leak; all of these were without clinical sequelae. CONCLUSION: Onyx with or without coil/glue/Amplatzer plug embolization is safe and useful in the treatment of type II endoleak after TEVAR and EVAR. However, long-term clinical and imaging follow-up is needed for early detection and management of recurrence of the primary endoleak or the development of new, secondary endoleaks or enlargement of the aneurysm sac.

Bleeding gastric varices obliteration with balloon-occluded retrograde transvenous obliteration using sodium tetradecyl sulfate foam.

PURPOSE: Balloon-occluded retrograde transvenous obliteration (BRTO) of bleeding gastric varices (GV) is well described in the literature. Using ethanolamine oleate as the sclerosing agent in BRTO, but it is not readily available in the United States in the desired concentrations. The authors' aim is to describe their initial experience with BRTO using sodium tetradecyl sulfate (STS) foam as an alternative sclerosing agent. MATERIALS AND METHODS: The authors performed a retrospective review of their initial series in which STS foam was used to treat bleeding GV using BRTO. All study subjects had endoscopic evidence of gastric variceal bleeding. STS foam was made using a combination of agents with a 3:2:1 ratio of gas: 3% STS: Lipiodol (Ethiodol; Savage Laboratories, Melville, New York). Mean values and ranges were calculated for each variable, and clinical and imaging outcomes were assessed. RESULTS: The authors performed BRTO in 22 cirrhotic patients (11 men and 11 women) with a mean age of 52 years (range, 23-83 years). Technical success was achieved in 20 of 22 (91%) patients. Complications occurred in three of 22 (14%) patients. The overall mean dose of STS used was 300 mg (range, 30-600 mg) with mean total volume of sclerosant mixture of 34.1 mL (range, 10-65 mL). Follow-up imaging was available for 18 of 20 (90%) technically successful procedures with a mean period of 89 days (range, 1-359 days). Complete obliteration of GV was achieved in 16 of 18 (89%) patients. There were no cases of recurrent variceal bleeding with a mean clinical follow-up period of 130 days (range, 1-510). CONCLUSIONS: BRTO utilizing STS foam appears effective in obliterating bleeding GVs with good short-term outcomes.

Preoperative embolization of Castleman's disease using microspheres.

Castleman's disease is a rare form of lymph node hyperplasia most commonly presenting as a solitary hypervascular mediastinal mass. Surgical resection is the treatment of choice, but this can be associated with significant blood loss due to its hypervascularity. We report two cases with a preoperative diagnosis of mediastinal Castleman's disease in whom preoperative embolization with Trisacryl gelatin microspheres (Biosphere Medical, Rockland, MA) was performed. Compared with the literature, a decrease in the amount of perioperative bleeding was noted in both cases.