A prospective safety and effectiveness study using endovenous laser ablation with a 400-µm optical fiber for the treatment of pathologic perforator veins in patients with advanced venous disease (SeCure trial).

BACKGROUND: Treatment of pathologic perforator veins (PPVs) can shorten time to healing and reduce recurrence of ulcers in patients with advanced venous disease. Because of limited clinical evidence and device options, widespread adoption of PPV treatment is controversial. The objective of this study was to evaluate the safety and efficacy of endovenous laser therapy using a 400-µm optical fiber to treat PPVs. METHODS: This study was a single-arm, prospective, seven-center, nonblinded clinical study examining patients with advanced skin changes or healed or active ulceration (Clinical, Etiology, Anatomy, and Pathophysiology clinical class C4b, C5, and C6). Patients received treatment with a 1470-nm laser. Procedural technical success and 10-day primary closure were evaluated. All device-related adverse events were reported. Follow-up of patients was continued for 12 months after initial ablation. RESULTS: The primary PPV closure (at 10-day visit) rate was 76.9% (95% confidence interval, 70.3%-82.4%). Successful primary closure rates of 75.7%, 70.3%, 62.1%, 68.8%, and 71.3% of PPVs were achieved at 1 month, 3 months, 6 months, 9 months, and 12 months, respectively. Statistically significant improvements (P < .05) were seen in patients' quality of life at 1 month, 3 months, 6 months, 9 months, and 12 months compared with screening. The percentage of patients with ulcers (22.9% at screening, 14.1% at 1 month, 13.7% at 3 months, 10.1% at 6 months, 12.3% at 9 months, and 11.1% at 12 months) displayed improvement during the course of the study. Tibial deep venous thrombosis and procedural pain were the only device-related adverse events observed. CONCLUSIONS: Endovenous laser therapy for PPV using the 400-µm optical fiber with the 1470-nm laser yielded safe and effective outcomes with no major adverse sequelae.

Impact of lesion location on procedural and acute angiographic outcomes in patients with critical limb ischemia treated for peripheral artery disease with orbital atherectomy: A CONFIRM registries subanalysis.

OBJECTIVES: This analysis compares the procedural and acute angiographic outcomes in patients with critical limb ischemia (CLI) treated with orbital atherectomy in above-the-knee (ATK)/popliteal (POP) lesions versus below-the-knee (BTK) lesions. BACKGROUND: Lesion location affects the procedural outcomes and the opportunity for limb salvage in patients with CLI suffering from peripheral artery disease (PAD). METHODS: The CONFIRM registry series was analyzed and includes 1109 real-world patients (1544 lesions) suffering from CLI treated with orbital atherectomy. The rates of dissection, perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation were compared between CLI patients with ATK/POP lesions and BTK lesions. RESULTS: Patients with ATK/POP lesions had a higher final residual stenosis (10 vs. 9%; P = 0.004) and use of more adjunctive therapies (e.g. balloons and stents; 1.3 vs. 1.1%; P < 0.001) compared to patients with BTK lesions. Patients with BTK had higher incidence of perforation (1.5 vs. 0.2%; P = 0.005), slow flow (7.7 vs. 5.0%; P = 0.03) and spasm (10.3 vs. 4.2%; P < 0.001) but lower incidence of embolism (0.4 vs. 5.1%; P < 0.001). CONCLUSIONS: Plaque modification with orbital atherectomy was successful in CLI patients regardless of lesion location. BTK lesions were associated with increased rates of perforation, slow flow and spasm which may be explained by more challenging procedural characteristics in these patients such as smaller vessel size and tortuosity. The higher incidence of emboli in ATK/POP lesions is most likely attributed to the higher prevalence of severe calcium observed in this cohort.

Augmented balloon-assisted maturation (aBAM) for nonmaturing dialysis arteriovenous fistula.

PURPOSE: The surgically placed dialysis arteriovenous fistula (AVF) is considered by the Kidney Disease Outcomes Quality Initiative (KDOQI)and the Fistula First Breakthrough Initiative to be the ideal choice for hemodialysis access. A significant number of newly placed AVFs either slowly or never adequately mature sufficiently to provide for adequate dialysis. The balloon-assisted maturation (BAM) procedure utilizes serial angioplasty to promote and accelerate AVF maturation. We present a minimally invasive AVF maturation technique utilizing angioplasty, stent-graft, and coil embolization. METHODS: A 41-year-old white woman presented with an nonmaturing AVF with multiple venous outflow channels. An adequately functioning AVF was achieved after 2 treatments including coil embolization, angioplasty, and stent-graft placement. RESULTS: Adequate thrill and dialysis flow was achieved. Patient has done well during short-term follow-up without further intervention. CONCLUSIONS: BAM techniques can be an effective tool to help a dialysis patient achieve an adequately mature AVF. Additional vascular interventional techniques may be utilized to further improve clinical results. For the purpose of this report we call this technique "augmented balloon-assisted maturation," or aBAM.

Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study).

PURPOSE: The present study was designed to address the hypothesis that radiofrequency (RF) thermal ablation, as represented by the ClosureFAST system, is associated with improved recovery and quality-of-life (QOL) parameters compared with 980-nm endovenous laser (EVL) thermal ablation of the great saphenous vein (GSV). MATERIALS AND METHODS: Eighty-seven veins in 69 patients were randomized to ClosureFAST or 980-nm EVL treatment of the GSV. The study was prospective, randomized, single-blinded, and carried out at five American sites and one European site. Primary endpoints (postoperative pain, ecchymosis, tenderness, and adverse procedural sequelae) and secondary endpoints (venous clinical severity scores and QOL issues) were measured at 48 hours, 1 week, 2 weeks, and 1 month after treatment. RESULTS: All scores referable to pain, ecchymosis, and tenderness were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. Minor complications were more prevalent in the EVL group (P = .0210); there were no major complications. Venous clinical severity scores and QOL measures were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. CONCLUSIONS: RF thermal ablation was significantly superior to EVL as measured by a comprehensive array of postprocedural recovery and QOL parameters in a randomized prospective comparison between these two thermal ablation modalities for closure of the GSV.