Treatment of chronic venous insufficiency in Latin America.

OBJECTIVE: Venous disease is common in Latin America, with an estimated 68.11% prevalence of chronic venous disease. The diverse social, political, and economic characteristics of the many nations that make up Latin America mean that different conditions affect how these diseases are diagnosed and treated, which may differ markedly from the way they are treated by the health care systems of the United States and Europe. Our goal was to review the current state of treatment of chronic venous insufficiency (CVI) in Latin America. METHODS: This is a narrative review of the medical literature on the subject and synthesizes sometimes fragmentary information on CVI across a large and diverse region. RESULTS: CVI represents an unmet medical need in Latin America. Conservative treatments, such as compression stockings, may be used at first, and there are nonpharmacologic and complementary and alternative medicine approaches in use. Endovenous approaches, such as endovenous thermal ablation, have largely replaced surgical interventions. In Europe and the United States, such procedures are mainly carried out in ambulatory facilities, whereas they are mainly performed in the hospital in Latin America. CONCLUSIONS: Recent strong economic growth in Latin America and improvements in social security and health care suggest that innovative approaches to chronic venous disease and CVI will be implemented.

Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence.

OBJECTIVE: The objective of this study was to evaluate the long-term safety and effectiveness of endovenous cyanoacrylate (CA)-based closure of incompetent great saphenous veins. METHODS: This was a prospective, single-arm, single-center feasibility study conducted at the Canela Clinic (La Romana, Dominican Republic) to assess the effectiveness and safety of a CA-based adhesive for great saphenous vein closure at 36 months after treatment. Thirty-eight subjects were treated by injection of small boluses of CA under ultrasound guidance and without the use of perivenous tumescent anesthesia or postprocedure graduated compression stockings. Periodic scheduled follow-up was performed during 36 months. RESULTS: At month 36, there were 29 subjects who were available for follow-up. Complete occlusion of the treated veins was confirmed by duplex ultrasound in all subjects with the exception of two subjects showing recanalization at month 1 and month 3. Kaplan-Meier analysis revealed an occlusion rate at month 36 of 94.7% (95% confidence interval, 87.9%-100%). The mean Venous Clinical Severity Score (VCSS) improved from 6.1 ± 2.7 at baseline to 2.2 ± 0.4 at month 36 (P < .0001). Pain, edema, and varicosities (VCSS subdomains) improved in 75.9%, 62.1%, and 41.4% of subjects, respectively, at month 36. Overall adverse events were mild or moderate and self-limited. CONCLUSIONS: CA adhesive appears to be an effective and safe treatment for saphenous vein closure, with long-term occlusion rates comparable to those of other thermal and nonthermal methods and with no reported serious adverse events.

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.

Endovascular Treatment of Deep Vein Thrombosis.

Venous thromboembolism (VTE) is associated with substantial morbidity and mortality. Conventional treatment with anticoagulation therapy may undertreat the condition. Patients with VTE are at risk for recurrence with increasing time passage. Endovascular approaches exist for treating VTE, including deep vein thrombosis, but it is unclear which patients are appropriate candidates for endovascular versus medical approaches. Many new endovascular technologies are in development, and new oral anticoagulants are also on the market. Clinicians must be mindful of these new products and use them appropriately to better manage VTE.

First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence.

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.