TWENTY-FOUR MONTH RESULTS FROM A RANDOMIZED TRIAL OF CYANOACRYLATE CLOSURE VERSUS RADIOFREQUENCY ABLATION FOR THE TREATMENT OF INCOMPETENT GREAT SAPHENOUS VEINS. Journal of Vascular Surgery Venous and Lymphatic Disorders. September 2018
CHICAGO, Illinois, September 2018 – New level I evidence reveals excellent mid-term results for a nonthermal, nontumescent (NTNT) technique to treat saphenous vein reflux for as long as two years after surgery.
Chronic venous insufficiency (CVI) is a common condition that affects 10 - 35% of adults in the United States. It occurs when valves in the leg or arm veins quit working properly and blood pools in the extremities. CVI is a fairly common condition, especially in women after pregnancy and in older adults, and can be progressively debilitating.
Treatments for chronic venous insufficiency, particularly those for isolated superficial venous disease, have undergone significant transformation over the past two decades. Minimally-invasive, office-based closure of the saphenous veins has largely replaced open surgical stripping with excellent results.
The initial transformation was accomplished using either radiofrequency or laser thermal energy to coagulate the vein. This requires tumescent treatment of the surrounding tissues for protection of these tissues and pain relief. More recent advances include nonthermal, nontumescent techniques such as cyanoacrylate closure (CAC). In addition to avoiding the need for tumescent injections, CAC also achieves its results without the need for compression stockings.
As reported in the September 2018 edition of the Journal of Vascular Surgery: Venous and Lymphatic Disorders, a multi-center research team led by Kathleen Gibson, MD from the Lake Washington Vascular in Bellevue, Wash., provide their mid-term (24 months) results comparing radiofrequency ablation (RFA) versus cyanoacrylate closure (CAC) of the great saphenous vein. The trial was conducted between March and September 2013, randomizing mainly (87%) CEAP class C2 or C3 patients.
Of their 222 randomized patients, 171 completed the full 24-month follow-up (87 CAC, 84 RFA) with the following for CAC vs. RFA:
• Complete closure: 95.3% vs. 94.0%• Comparable symptom relief and quality of life survey• No significant device- or procedure-related late adverse events“For both RFA and CAC patient groups, there were statistically significant improvements in both VCSS and the QoL measures from baseline at all time points of the trial,” Dr. Gibson notes. “These improvements plateaued at six months and persisted through 24 months.
“The strengths of this trial include its randomized design, its careful assessment of clinical outcomes and symptom scores, and ultrasound assessments at each time point,” adds Dr. Gibson. “We plan on continuing to observe the patient cohorts over the next three to five years.”
The full article is open source online through Oct. 31 at vsweb.org/CAC.
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The Society for Vascular Surgery® (SVS) is a 5,800-member, not-for-profit professional medical society, composed primarily of specialty-trained vascular surgeons, which seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness.
Journal of Vascular Surgery: Venous and Lymphatic Disorders aims to be the premier international Journal of medical, endovascular and surgical management of venous and lymphatic disorders. The Journal publishes high quality clinical and laboratory research papers, case series, reviews, guidelines, techniques and practice manuscripts on venous, lymphatic disease, and wound care with an emphasis on the practicing clinician. Journal of Vascular Surgery: Venous and Lymphatic Disorders is the official publication of the Society of Vascular Surgery® and the American Venous Forum.