Twelve-month outcomes of the VenaSeal Spectrum venous leg ulcer (VLU) trial, assessing time to ulcer healing following treatment with the VenaSeal (Medtronic) closure system, have demonstrated an 81.3% ulcer healing rate at one year.
Manj Gohel (Cambridge, United Kingdom) presented the results in a podium-first presentation during Thursday afternoon’s deep venous challenges session. The VenaSeal system uses cyanoacrylate glue to treat underlying venous insufficiency.
The single-arm study prospectively assessed time to ulcer healing in patients with an active venous leg ulcer classified as C6 as the primary endpoint, and a secondary endpoint of vein closure through 12 months. Gohel stated that studies have frequently evaluated the C2 to C5 ulcer population, leaving “an evidence gap” where C6 ulcers are concerned.
The Spectrum VLU trial included 125 venous leg ulcer patients with a median ulcer age of 169 days and a maximum of 6,816 days (18 years and eight months). Gohel stated that the chronicity of the ulcers included was indicative of the severity of disease in their patient cohort, representing a “much harder to treat population than most other randomised studies”, he said.
On healing potential, Gohel reported 81.3% ulcer healing, 82% anatomic closure and 83% freedom from ulcer recurrence at one year, after healing had occurred.
Gohel highlighted safety and effectiveness endpoints, which underwent review by an independent committee. He stated that the VenaSeal system-specific events were consistent with prospective literature, and that events included hypersensitivity (0.8%), phlebitis (8.8%), granuloma (1.6%), and ablation-related thrombus extension (2.4%).
No device- or procedure-related deaths were recorded; however, eight serious adverse events occurred following treatment. These were identified as four infections, three superficial vein thromboses, and one granuloma.
Gohel stated that the high rate of other serious adverse events unrelated to the procedure or device, with 8% mortality within one year of the study, demonstrates the level of comorbid conditions prevalent in this patient population. This fact was also seen via quality-of-life measures, as patients often scored poorly across assessments prior to treatment.
These metrics did improve following treatment—however—providing “good evidence across a number of domains”, said Gohel.
“This is the largest prospective study of patients with C6 disease treated with cyanoacrylate in terms of effectiveness. Healing rates are good and comparable to other studies,” said Gohel. “I would suggest that there is good evidence that this can be a part of the toolkit to manage patients with C6 disease.”
Following his talk, an audience member queried Gohel on the ulcer recurrence rate in the VenaSeal data. In response, he highlighted that deep venous reflux and obese patients were included in the study, both of which have venous hypertension for a number of reasons. “That kind of recurrence rate is very typical in this population, and these are patients that are always going to be at high risk of ulceration,” he stated.
Correction: An earlier version of this article, which appeared in CX Daily News, incorrectly stated an 80% rate of mortality within one year. This has been updated to correctly state that the rate was 8%. This correction was made on 25 April to ensure accuracy.
