Safety and feasibility report on nonimplantable endovenous valve formation for the treatment of deep vein reflux.

OBJECTIVE: Definitive treatment techniques for symptomatic deep venous reflux have been relegated to complex and invasive open surgery which is rarely performed today. The BlueLeaf System provides an endovenous method for the formation of deep venous valves without an implant, avoiding the complications associated with permanent foreign materials. The system has the adaptability to form valves within the femoral and popliteal veins at multiple levels in a single procedure. The aim was to determine the midterm safety and efficacy of this novel device in an early feasibility study. METHODS: Feasibility of endovenous deep venous valve formation was assessed in patients with chronic venous insufficiency (Clinical, Etiologic, Anatomic, Pathophysiologic [CEAP] 4-6). Follow-up was completed through 1 year, assessing vein patency and reflux time (RT) with duplex ultrasound examination. Venous clinical improvement was evaluated using the revised Venous Clinical Severity Scale. RESULTS: Of the 14 patients, 13 (93%) had successful formation of at least one monocuspid valve, with a mean number of 1.4 valves (range, 0-3 valves) per patient. There were no device-related serious adverse events during the index procedure. There were no deep venous thromboses reported at any time point, including 10 patients through the 1-year follow-up. In patients with at least one valve formed, site reported duplex ultrasound examination measured the average RT in the popliteal vein below valve formations, was 3.0 ± 1.0 seconds at baseline, 3.9 ± 3.1 seconds at 30 days, and 3.6 ± 2.1 seconds at 360 days. The revised Venous Clinical Severity Scale improved in all 13 successfully treated patients, decreasing from 15.0 ± 6.0 at baseline to 11.6 ± 5.5 at 30 days, 10.7 ± 5.3 at 210 days, and 9.4 ± 5.0 at 360 days (P = .0002; baseline to 360 days). Among the five patients with an ulcer who reached the 360-day follow-up visit, all (100%) healed at least one ulcer. Two patients (40%) healed all ulcers and three patients (60%) had a decrease in ulcers number but remained at C6 at 360 days. The five patients with a total of nine active ulcers at baseline had four active ulcers at 360 days. CONCLUSIONS: The BlueLeaf System holds promise as a minimally invasive means to safely form fully autogenous deep venous valves. Reconstructed deep veins remained patent, without deep venous thrombosis and symptomatic improvement was consistently observed; however, a decrease in the RT was not. Incremental device design improvements have been undertaken to improve valve function. The results of these iterations await further clinical evaluation.

Adjunctive ultrasonography during carotid artery stenting to minimize iodine contrast use.

Carotid artery stenting (CAS) in patients with chronic kidney disease carries a significant risk of contrast-induced nephropathy. We report a case of CAS with adjunctive sonography to reduce the amount of contrast medium during angiography. A 71-year-old man presented with a symptomatic right carotid stenosis. He was selected for CAS due to significant medical comorbidity, which included severe renal impairment. A preoperative noncontrast CT was performed to assess anatomical suitability and to plan arch vessel cannulation. We undertook CAS with the use of intraoperative ultrasound. Sonography was used to monitor the manipulation of wires, catheters, and stents. Four milliliters of contrast was required to complete the procedure successfully with no deterioration in postoperative renal function. Adjunctive ultrasound is feasible to reduce contrast use in patients with severe renal impairment undergoing CAS.

Adjunctive ultrasonography to minimize iodinated contrast administration during carotid artery stenting: a randomized trial.

PURPOSE: To report a single-center, prospective randomized controlled trial that compared contrast use during ultrasound-assisted carotid artery stenting (CAS) to CAS procedures without ultrasound. METHODS: Between August 2010 and November 2011, 22 patients (18 men; mean age 72.8 years, range 62-84) with 25 severe symptomatic (n=3) or asymptomatic (n=22) carotid stenoses undergoing an endovascular intervention were randomly allocated (~1.1) to ultrasonography-assisted (n=13) or stand-alone (n=12) CAS. The primary endpoints were contrast use and number of selective cerebral injections. Secondary endpoints were procedure time, fluoroscopy time, any stroke, renal function assessment, major adverse cardiac events (MACE), and death. RESULTS: In the study period, 23 of 25 scheduled CAS procedures (12 ultrasound-assisted, 11 control) were completed in 20 patients; 2 procedures were aborted owing to friable plaque and difficult guidewire access, respectively. There were no deaths, stroke, MACE, or precipitation of dialysis-dependent renal failure in either group. Iodinated contrast usage was reduced by 61% (45.4±24.4 vs. 17.8±11.9 mL, p=0.002) and number of selective cerebral contrast injections by 49% (8.3 vs. 4.2, p=0.002). Neither time taken to complete the procedure (32.5 vs. 35.4 minutes, p=0.38) nor fluoroscopy time (14.5 vs. 13.9 minutes, p=0.54) differed significantly between the groups. Creatinine levels remained stable after CAS and did not differ between groups. CONCLUSION: Ultrasonography-assisted CAS is feasible and safe. Its use can significantly lower the usage of iodinated contrast and the number of selective cerebral circulation injections while not prolonging the length of the procedure or the fluoroscopy time.

Endovascular reconstruction of the occluded aortoiliac segment using "double-barrel" self-expanding stents and selective use of the Outback LTD catheter.

PURPOSE: To present the early and midterm results of endovascular stent reconstruction of the occluded aortoiliac segment with selective use of the Outback LTD re-entry catheter. METHODS: Between April 2004 and February 2010, 8 patients (5 women; mean age 58.4 years, range 47-68) with occlusion of the infrarenal aorta extending to the common or external iliac arteries underwent endovascular reconstruction with double-barrel self-expanding stents. Indications for treatment were severe claudication in 6 and ulceration in 2 patients. RESULTS: The technical success rate was 100%, facilitated by the use of the Outback LTD catheter for accurate wire re-entry in 3 cases. There was no in-hospital mortality. One patient had a major complication (femoral artery dissection, brachial artery thrombosis, and retroperitoneal hematoma) unrelated to the re-entry device. Mean operating time was 137 minutes (range 70-253) and length of stay was 1.5 days (range 1-2). During a mean follow-up of 12.5 months (range 6-29), primary patency was 100% with no secondary interventions. CONCLUSION: Total endovascular reconstruction of the occluded infrarenal aorta that extends into the iliac arteries is durable at midterm follow-up. Adjunctive use of the Outback LTD re-entry catheter can facilitate technical success.