Five-Year Results Announced From Covidien’s ClosureFast Study in Patients With Lower Limb Venous Disease
December 20, 2012—Covidien (Mansfield, MA) announced the 5-year results of the ClosureFast long-term European multicenter study in patients with chronic venous insufficiency. The study evaluated the Venefit endovascular procedure, which uses the ClosureFast radiofrequency ablation catheter. Thomas Proebstle, MD, of the Universitaets Hautklinik Heidelberg, Germany, recently delivered the study results at the American College of Phlebology’s 26th Annual Congress, which was held on November 15–18, 2012, in Hollywood, Florida.
In Covidien’s press release, Dr. Proebstle commented, “The 5-year final analysis from the ClosureFast study shows sustained treatment success in anatomical and clinical categories and supports its leading position in endovenous vein treatment.”
According to the company, the prospective study was conducted at eight centers in Europe from April 2006 to June 2007, and enrolled 235 patients to treat 295 lower limbs that were diagnosed with superficial venous reflux, the underlying cause of varicose veins and chronic venous insufficiency. These patients were treated with the minimally invasive Venefit procedure using the ClosureFast radiofrequency ablation catheter. Patients were evaluated postprocedurally by duplex ultrasound imaging and clinical examination at 3 days, 3 months, 6 months, and in yearly intervals up to 5 years. Of the 295 treated limbs, 233 (79%) were available for examination at 5 years.
At 5-year follow-up by Kaplan-Meier analysis, full occlusion of the treated vein was observed in 92% of patients (vs 98% at 1 year). The vast majority (95%) of patients were free of pathological venous reflux (vs 99% at 1 year). This demonstrates the durable results of the Venefit procedure out to 5 years. The average Venous Clinical Severity Score (a multifactorial score measuring disease severity and quality of life) improved from 3.9 ± 2.1 before treatment to 1.3 ± 1.7 at 5 years. In addition, only 14% of limbs were CEAP (clinical, etiologic, anatomic, pathophysiologic disease severity classification) class 3 or higher at 5 years, whereas at baseline, 48% of limbs were in the same category.
During the Venefit procedure, the ClosureFast catheter is inserted into the diseased vein and radiofrequency energy is used to seal the vein shut. Blood that would normally return to the heart through the diseased vein travels back through other veins instead. Over time, the treated vein shrinks and is absorbed by the body. Compared with surgical options, minimally invasive ablation of the vein can result in less pain and quicker recovery time, stated Covidien.