Morrison Vein Institute

ObjectiveTo evaluate the 36-month efficacy and safety of cyanoacrylate closure for the treatment of incompetent great saphenous veins in comparison with radiofrequency ablation.MethodsIn this multicenter, prospective, randomized controlled trial, 222 symptomatic subjects with incompetent great saphenous veins were assigned to either cyanoacrylate closure or radiofrequency ablation. The primary endpoint, complete closure of the target great saphenous vein, was determined using duplex ultrasound examination starting from three-month visit.ResultsAt month 36, the great saphenous vein closure rates were 94.4% for the cyanoacrylate closure group and 91.9% for the radiofrequency ablation group. Stable improvement in symptoms and quality of life was observed in both groups. Adverse event rates between the 24- and 36-month visits were similar between the groups as were serious adverse events which were infrequent and judged unrelated to either the device or the procedure in both groups.ConclusionsThis trial continues to demonstrate the safety and efficacy of cyanoacrylate closure for the treatment of great saphenous vein incompetence with great saphenous vein closure rate at 36 months similar to that of radiofrequency ablation, indicating non-inferiority of cyanoacrylate closure to radiofrequency ablation. The improvement in quality of life outcomes were also sustained and similar between the two treatment groups.

Diagnosis is a prerequisite for all treatment strategies. Duplex ultrasound is the best diagnostic tool for varicose veins for all expressions of the disease (Nicolaides Circulation 102:126–163, 2000). All types of intervention on varicose veins have their own special demands on ultrasound. Ultrasound-guided vein mapping on the skin is very helpful prior to saphenous stripping (See Sect. 12.1), and it is absolutely indispensible for CHIVA (See Sect. 12.2). In endovascular thermal therapies (See Sect. 12.3) or foam sclerotherapy of trunk veins (See Sect. 12.4), ultrasound is an essential part of the treatment process. The actual procedures will only be explained here in relation to ultrasound.

Sclerotherapy is routinely performed only by licensed physicians in most countries, but whether other medical providers are allowed to do so may vary according to individual governmental regulations. In many states in the U.S., registered nurses are allowed to do sclerotherapy, while others authorize sclerotherapy by physician assistants and nurse practitioners. Permitting only physicians to perform sclerotherapy while excluding the practice by nurses, seems to fly in the face of the fact that nurses routinely inject patients with potentially lethal medication as a matter of standard nursing practice. The reason it makes a difference as to who should be doing sclerotherapy is that in a phlebology practice, the physician’s time can be much more productive performing more complex procedures than sclerotherapy. Certainly the physician should be quite adept at sclerotherapy, since many of the skills required to do sclerotherapy are directly related to the performance of other phlebologic procedures. But as patient volume in a phlebology practice grows, sclerotherapy is one of the tasks that may readily be assumed by other members of the staff, leaving the physician time to interact with patients in consultations, perform diagnostic testing as needed, and treat patients using more complicated modalities that do not lend themselves to performance by other staff members. However it is necessary to consult governmental regulations to be certain the phlebology practice is operating within appropriate guidelines.

Traditional surgical ligation and stripping for the treatment of saphenous vein incompetence has been replaced by minimally invasive alternative treatments during the last five years. Endovenous ablation with radiofrequency (RP) and laser (EVL) have proven to be safe, durable, and widely accepted by patients. Catheter-delivered sclerotherapy (CDS) with foam and liquid for ablation of the great saphenous vein is also under investigation. In this technique, vein volume must be measured accurately by ultrasound just prior to the procedure and can require up to 11 diameter measurements. The purpose of this study was to identify an abbreviated method of determining vein volume to expedite associated endovenous procedures. Seventy-five veins were treated in 55 subjects with catheter-directed sclerotherapy in a three-center clinical study using a standardized protocol. Vein volume was carefully calculated by determining vein diameter over the Treatment Length in 4 cm intervals. These measurements were compared to vein volume calculations where only three measurements were taken. Our results suggest that the abbreviated method is capable of significantly reducing the number of diameter measurements without sacrificing accuracy. We found the method produced a vein volume that fell within 1 mL or 15% of the actual vein volume in 80% of cases. The abbreviated method cannot be used with accuracy in veins that are Erratic.