INSIDE AngioDynamics changes top management 6 Vascular Solutions recalls Guardian II valves 8 EHR can add to physician burnout 26 SIGVARIS expands Microfiber Shades 28
JUNE/JULY 2016 Vol. 9 No. 4 VEINTHERAPYNEWS.COM
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New VenaSeal data is revealed at IVC Medtronic plc unveiled new clinical data in April for the VenaSeal closure system that demonstrates consistent long-term durability and improved quality of life in patients with venous reflux disease. The new data presented at the 2016 International Vein Congress in Miami and Charing Cross Symposium in London included two-year outcomes from the VeClose pivotal clinical study, with two additional subanalyses evaluating quality of life and physician ease-of-use; and three-year results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study. VenaSeal is a non-tumescent, nonthermal, non-sclerosant procedure that uses a proprietary medical adhesive to close superficial veins of the lower extremities, such as the great saphenous vein (GSV), in patients with symptomatic venous reflux. “As shown by our unmatched body of Level 1 evidence in the venous industry, Medtronic has demonstrated its deep-rooted
commitment to providing clinically-proven and patient-friendly treatment options for patients with chronic venous insufficiency,” Sandra Lesenfants, vice president and general manager of the endoVenous business in Medtronic’s Aortic and Peripheral Vascular division, said. “We’re enthusiastic about the unveiling of such strong datasets, and we look forward to continuing to build upon this clinical program.”
RATES HIT GOLD STANDARD New two-year results from the VeClose trial were presented at Charing Cross by Raghu Kolluri, MD, medical director of vascular medicine at Riverside Methodist Hospital in Columbus, Ohio; and by Kathleen Gibson, MD, of Lake Washington Vascular in Seattle at the International Vein Congress. VENASEAL continued on page 8
Dr. Cawlfield counsels his patient about the risk of recurrent vein disease.
Two steps forward, one step back
Recurrent varicose veins after thermal ablation By Timothy J. Cawlfield, MD While most patients whom I treat are satisfied with the initial results of vein ablations, there are some patients who return with recurrent leg symptoms — sometimes months, but usually years after the initial treatment. I also have patients with recurrent
symptoms previously treated by other surgeons. These patients are often frustrated because they had no prior knowledge (or forgot) about the risk of recurrent chronic venous insufficiency. They sometimes come to see me, believing that the other surgeon made a mistake.
Recurrent varicose veins after surgery (REVAS) is a documented problem, and has been for several decades. The first international consensus meeting on recurrent varicose veins after surgery was held in Paris in 1998. From this meeting, REVAS was defined as the existence of varicose veins in a lower limb previously operated on for varicosities, with or without adjuvant therapies, which includes true recurrences, residual veins, and new varices, as a result of disease progression.1 The study of the nature, sites and sources of recurrent vein disease then ensued. In 2006, M.R. Perrin’s multi-center, observational study of about 170 patients with recurrent varicose veins after surgery 2 was published. This study could not measure the incidence of disease recurrence, but it did help stratify the types and locations
of REVAS after saphenous ligation and stripping. Etiology of same-site recurrences included: • Technical failure (19.1 percent) • Tactical error (9.6 percent) • Neovascularization (20.1 percent) • Disease progression (31.7 percent) The sources of ref lux were the saphenofemoral junction (47 percent), lower leg perforators (43 percent), thigh perforators (30 percent), saphenopopliteal junction (25 percent), and pelvic veins (17 percent). Most patients who had disease recurrence had more than one source of reflux. It’s not difficult to believe the nature of recurrent varicose veins might be different for modern DR. CAWLFIELD continued on page 24
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