Jose I. Almeida

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.

Saphenous Laser Ablation at 1470 nm Targets the Vein Wall, Not Blood

The 2 primary objectives of this study were to investigate whether the 1470-nm wavelength can close a saphenous vein painlessly and determine safety, efficacy, and side effects of the 1470-nm laser. In all, 26 limbs were treated in the Dominican Republic, with a radially-emitting fiber at low energy ranging from 20 J/cm to 30 J/cm. Perivenous anesthesia was used selectively. Then 41 veins were treated with the 1470-nm laser at 30 J/cm at 5 watts, using standard perivenous tumescent anesthesia in Miami and compared to a historical control (980 nm, 80 J/cm, and 12 watts). We demonstrated that the 1470-nm wavelength endovenous laser system could not close saphenous veins without use of anesthesia. Closure with a dramatic reduction in energy when compared to a 980-nm wavelength control demonstrated a marked reduction in postoperative pain and ecchymosis; this implies that vein-wall perforations are minimized with this system.

Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence

Objectives To evaluate the safety and effectiveness of endovenous cyanoacrylate-based embolization of incompetent great saphenous veins. Methods Incompetent great saphenous veins in 38 patients were embolized by cyanoacrylate bolus injections under ultrasound guidance without the use of perivenous tumescent anesthesia or graduated compression stockings. Follow-up was performed over a period of 24 months. Result Of 38 enrolled patients, 36 were available at 12 months and 24 were available at 24 months follow-up. Complete occlusion of the treated great saphenous vein was confirmed by duplex ultrasound in all patients except for one complete and two partial recanalizations observed at, 1, 3 and 6 months of follow-up, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92.0% (95% CI 0.836–1.0) at 24 months follow-up. Venous Clinical Severity Score improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.3 ± 1.1, 1.5 ± 1.4 and 2.7 ± 2.5 at 6, 12 and 24 months, respectively (p < .0001). Edema improved in 89% of legs (n = 34) at 48 hours follow-up. At baseline, only 13% were free from pain. At 6, 12 and 24 months, 84%, 78% and 64% were free from leg pain, respectively. Conclusions The first human use of endovenous cyanoacrylate for closure of insufficient great saphenous veins proved to be feasible, safe and effective. Clinical efficacy was maintained over a period of 24 months.

Cyanoacrylate Adhesive for the Closure of Truncal Veins: 60-Day Swine Model Results

Background: The introduction of cyanoacrylate (CA) within a blood vessel triggers polymerization, followed by an inflammatory reaction. Methods: A sheath was positioned 2.0 cm caudad to the junction of the superficial epigastric and abdominus rectus veins in 2 swine, followed by ultrasound-guided injection of 0.16 mL of CA glue. After glue delivery, the catheter was pulled back 3 cm, compression was applied to the treatment site, and the process was repeated for the entire length. At 60 days postimplantation, the veins were harvested surgically and examined histologically. Results: The histologic changes were consistent with a chronic foreign-body-type inflammatory response. Venous closure, segmental wall thickening, and fibrosis were observed. Conclusion: Injection of CA is feasible for closure of superficial veins in animal models. Vein closure is achieved via an inflammatory process which ultimately leads to fibrosis.

Novel vein closure procedure using a proprietary cyanoacrylate adhesive: 30-day swine model results

Purpose To conduct a pilot study to demonstrate a novel method of using a proprietary cyanoacrylate (CA) for closure of superficial veins. Materials and Methods Right and left superficial epigastric veins from two swine models were utilized due to the veins similarities with the human great saphenous vein. Under ultrasound guidance, access was gained and a 5-F delivery catheter was advanced to the junction of the superficial epigastric and abdominus rectus veins. A dispenser gun was then utilized to inject 0.16 mL of CA while compression was applied cephalad to the end of the catheter. Immediately after delivery, the catheter was pulled back 3 cm and manual compression was employed for 30 seconds. After this first injection, the ultrasound probe was repositioned caudad to the injection and cephalad to the catheter tip and another 0.16 mL injection was delivered with immediate 3 cm pullback of the delivery system. Manual compression was applied at the caudad end of the treated vein for 30 seconds. This process was repeated until the entire target segment was treated. Results At 30 days postimplantation, the treated veins were occluded with no evidence of recanalization or migration. Histological findings revealed that the lumen was dilated by coalescing, arborizing clear spaces with entrapped lytic erythrocytes, demarcated by a thin band of granular eosinophilic material. Spindle cells with dense eosinophilic matrix replaced the tunica intima and disrupted the tunica media. Conclusion Results of this initial study demonstrated that intravascular injection of CA is feasible for closure of superficial veins in animal models. These findings warrant further animal studies of this proprietary CA to assess efficacy, safety and its effects on perivenous structures.

Ambulatory Phlebectomy in the Office

Ambulatory phlebectomy is a minor, office-based surgical procedure designed to remove varicose veins. It is a perfect complement to endovenous thermal ablation of the saphenous vein. With this combination, patients can expect all varicose veins to vanish following a 1-hour procedure that employs only local anesthesia in the comfort of a physicians office. Advantages of office-based surgery are ease of scheduling for doctors and patients, less paperwork, elimination of travel time, and cost containment for the health care system. Furthermore, a procedure that is performed by the same staff daily is more streamlined and safe.

Gastrointestinal bleeding as the initial manifestation of a polyarteritis nodosa-associated hepatic artery aneurysm-duodenal fistula a case report

The authors report an unusual case of upper gastrointestinal bleeding from a hepatic artery aneurysm-duodenal fistula in a 21-year-old male. Arteriography revealed multiple visceral artery aneurysms. Biopsy of the hepatic artery aneurysm (HAA) revealed focal areas of necrosis, medial degeneration, fibrosis, and giant cells. The necrotizing vasculitis plus the multiple visceral aneurysms were highly suggestive of polyarteritis nodosa (PAN). This report reviews the pathophysiology and management of PAN and the diagnosis and management of HAA.

Three-Year Follow-Up of First Human Use of Cyanoacrylate Adhesive for Treatment of Saphenous Vein Incompetence.

Severity score improvement was better in overweight and obese patients (P 1⁄4 .019). There was no difference in satisfaction across groups. More obese patients than normal-weight patients had recanalization of treated veins at 5 years (60% vs 29%; P < .0005, c trend). They were also more likely to have required re-treatment by 5 years (28% vs 7%; P 1⁄4 .026). Conclusions: Despite more severe venous disease at baseline, overweight and obese patients had greater symptomatic improvement after UGFS than normal-weight patients did. Although they were more likely to have recanalization and recurrence, their long-term satisfaction remainedhigh.

Laser Ablation of Cutaneous Leg Veins

Patients presenting with lower-extremity telangiectasias, commonly known as spider veins, are a frequent presentation for vascular surgeons. The use of lasers in the treatment of lower-extremity spider veins has gained increased popularity during the past 5 years. This technology, driven by consumer demand, has been effective in treating vessels that are refractory to sclerotherapy treatment, vessels that arise from telangiectatic matting, and in patients who experience a phobia to needles. One laser wavelength per machine limits what the practitioner can do. That is, each type of vein responds best to a specific wavelength. Light skin is more forgiving to complications than dark skin. The devices are a complement to good sclerotherapy, not a substitute.

Use of the Clinical, Etiologic, Anatomic, and Pathophysiologic classification and Venous Clinical Severity Score to establish a treatment plan for chronic venous disorders.

To be useful in clinical practice and in the evaluation of clinical therapies for chronic venous disorders, a measurement instrument should be objective, inclusive of all severities of venous disease, and rapidly performed by clinicians. The Clinical, Etiologic, Anatomic, and Pathophysiologic classification helps us identify the etiology, whether it is congenital, nonthrombotic, or post-thrombotic; anatomic segments involved, whether deep, superficial, or perforators; and pathophysiologic data, such as reflux or obstruction. The Venous Clinical Severity Score can be used to observe patients longitudinally, especially after interventions, although the total score is biased with regard to advanced disease, such as C4 through C6. To be able to predict progression of disease, more patient-validated instruments are needed. Physician-reported outcomes (the Venous Clinical Severity Score and the Clinical, Etiologic, Anatomic, and Pathophysiologic classification) in association with a patient-reported outcome may be the solution for the development of an ideal treatment plan.