Jose I Almeida1, Julian J Javier2, Ed Mackay3, Claudia Bautista4, Thomas M Proebstle5. 1. Miami Vein Center, Miami, Fla. 2. Vein Center at Physicians Regional, Naples, Fla. 3. Mackay Vein Institute, St. Petersburg, Fla. 4. Canela Clinic, La Romana, Dominican Republic. 5. Department of Dermatology, University Clinic of Mainz, Mainz, Germany. Electronic address: thomas.proebstle@web.de.
Abstract
OBJECTIVE: The primary objective of this study was to assess the feasibility of an endovenous cyanoacrylate (CA) adhesive implant, delivered with a catheter-based administration system engineered with a nonstick surface, for the treatment of incompetent great saphenous veins (GSVs). The primary safety end point was the rate of serious adverse events related to the procedure. The primary efficacy end point was vein occlusion during follow-up. Secondary end points included the rate of all adverse events and the change in Venous Clinical Severity Scores (VCSSs). METHODS: Thirty-eight incompetent GSVs in 38 symptomatic patients were treated by catheter deployment of CA under ultrasound guidance via a repetitive bolus injection algorithm. By protocol design, perivenous tumescent anesthesia and compression stockings were omitted. Duplex ultrasound imaging and clinical follow-up were performed immediately after the procedure, at 48 hours, and 1, 3, 6, and 12 months. RESULTS: The mean total volume of endovenous CA delivered was 1.3 ± 0.4 mL (range, 0.6-2.3 mL). Immediately after the procedure and at the 48-hour follow-up, the 38 patients (100%) demonstrated complete closure of the GSV. One complete and two partial recanalizations were observed during follow-up at 1, 3, and 6 months, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92% at 12 months of follow-up. Side effects were generally mild and self-limited, most frequently, phlebitis in six patients (15.8%) requiring nonsteroidal anti-inflammatory drugs for an average of 5.7 days. Eight patients (21.1%) showed thread-like thrombus extensions into the common femoral vein of a mean length of 12.6 mm (range, 3.5-35 mm), which resolved spontaneously without anticoagulation. VCSS improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.5 ± 1.4 at 12 months (P < .0001). Edema improved in 34 legs (89%) at the 48-hour follow-up. At the 12-month follow-up, and without additional adjunctive treatment, 18 legs (50%) were free from visible varicosities and an additional eight legs (25%) showed limited varicosities. CONCLUSIONS: The first human use of endovenous CA for closure of insufficient GSVs proved to be feasible, safe, and effective. Endovenous delivery of CA may prove to be an alternative for the correction of saphenous incompetence and may be used without tumescent anesthesia and medical compression stockings.
OBJECTIVE: The primary objective of this study was to assess the feasibility of an endovenous cyanoacrylate (CA) adhesive implant, delivered with a catheter-based administration system engineered with a nonstick surface, for the treatment of incompetent great saphenous veins (GSVs). The primary safety end point was the rate of serious adverse events related to the procedure. The primary efficacy end point was vein occlusion during follow-up. Secondary end points included the rate of all adverse events and the change in Venous Clinical Severity Scores (VCSSs). METHODS: Thirty-eight incompetent GSVs in 38 symptomatic patients were treated by catheter deployment of CA under ultrasound guidance via a repetitive bolus injection algorithm. By protocol design, perivenous tumescent anesthesia and compression stockings were omitted. Duplex ultrasound imaging and clinical follow-up were performed immediately after the procedure, at 48 hours, and 1, 3, 6, and 12 months. RESULTS: The mean total volume of endovenous CA delivered was 1.3 ± 0.4 mL (range, 0.6-2.3 mL). Immediately after the procedure and at the 48-hour follow-up, the 38 patients (100%) demonstrated complete closure of the GSV. One complete and two partial recanalizations were observed during follow-up at 1, 3, and 6 months, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92% at 12 months of follow-up. Side effects were generally mild and self-limited, most frequently, phlebitis in six patients (15.8%) requiring nonsteroidal anti-inflammatory drugs for an average of 5.7 days. Eight patients (21.1%) showed thread-like thrombus extensions into the common femoral vein of a mean length of 12.6 mm (range, 3.5-35 mm), which resolved spontaneously without anticoagulation. VCSS improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.5 ± 1.4 at 12 months (P < .0001). Edema improved in 34 legs (89%) at the 48-hour follow-up. At the 12-month follow-up, and without additional adjunctive treatment, 18 legs (50%) were free from visible varicosities and an additional eight legs (25%) showed limited varicosities. CONCLUSIONS: The first human use of endovenous CA for closure of insufficient GSVs proved to be feasible, safe, and effective. Endovenous delivery of CA may prove to be an alternative for the correction of saphenous incompetence and may be used without tumescent anesthesia and medical compression stockings.