VDM: Please give some background on the study.
Gibson: The VeClose trial was a randomized trial that compared VenaSeal (Medtronic), a cyanoacrylate adhesive, to radiofrequency ablation for closure of the great saphenous vein (GSV) for patients with symptomatic varicose veins. The trial was conducted in a randomized fashion so half of the patients were treated with radiofrequency ablation and half were treated with VenaSeal closure. There were no concomitant procedures allowed at the same time so there was no confounding of treatment. We followed safety events, closure of the vein on duplex ultrasound, patient pain during the procedure, bruising, quality of life, and venous clinical severity score. The results at a year showed that there was noninferiority between VenaSeal and radiofrequency ablation in vein closure. Vein closure rates were high in both groups. At 12 months, GSV closure rates were approximately 97% in both groups. All procedures were well tolerated. There was significantly less bruising in the VenaSeal group at 1 week and quality of life and venous clinical severity scores improved in a similar manner in both groups as well.
VDM: Can you describe a little bit about what’s different about VenaSeal and the benefit it could provide?
Gibson: We’ve used endothermal ablation for over 10 years and it’s very effective but it does involve multiple needle sticks because it requires tumescent anesthesia. There is also, although rare, a chance of injuring cutaneous nerves with the endothermal heat ablation and the patients in most practices are advised to wear compression stockings for several weeks afterwards. A major difference with VenaSeal is that it doesn’t require tumescent anesthetic. There’s a single needle stick for introducing the catheter to treat a GSV. Pain is minimal during the procedure. There’s a gentle pressure on the skin that’s held as the vein is closed and afterwards patients do not have to wear compression stockings. However, if there were adjuvant treatments that were performed simultaneously, the patient may benefit from stockings, but previous trials have shown that compression is not necessary for good results. No sedation is needed. It’s a quick in-and-out of the office procedure. Out in clinical practice, we’re currently not limiting our patients in terms of activities after the procedure. We instruct our patients that they can return to normal activities immediately. They can exercise. They can even go back to work the same day if they wish.
VDM: What would a vascular clinician do differently using this as opposed to what they might be using now?
Gibson: The skillset to do this procedure is really the same as with other endovenous procedures. It’s a catheter and wire technique. The main difference is that you don’t have to perform a tumescent anesthetic. Also there’s no bandaging afterwards other than a small adhesive bandage, but the workup of the patient is the same. It’s treating the same disease process so the same thoughts about whether or not the vein needs to be ablated is identical to what we’re already doing for endothermal ablation.
VDM: Is there any other important point that venous and vascular clinicians need to know for getting started, technical tips and tricks?
Gibson: It’s very straightforward to use. The access is very similar to what we do with endothermal ablation. The one thing that is important is that it has a proprietary catheter through which the adhesive is delivered that doesn’t stick inside the body. The catheter is a very special piece of equipment that you do not want to kink or bend. It does not come as a peel-pack separate item. You have to be organized with your back table and make sure that none of the items in the kit fall off of your back table. Other than that, to get started, you need to have some catheter and wire skills. There are some training modules online that you have to complete and you must be proctored for your first 2 cases.
VDM: Any other points about the study or the procedure itself that you would like to add?
Gibson: Our patients have been very impressed with the immediate difference in their leg when they got off the table. One thing that was striking for us or different when compared to endothermal ablation is that when you finish an endothermal ablation, the inside of the patient’s leg is numb and you have placed a stocking or wrap on the limb, so when the patient gets up from the table, they can’t yet see any difference in their leg and it feels like it was “worked on” because of the tumescence. With VenaSeal, when patients get up off the table, when they look down at their leg, they note that the side branches are smaller and some patients have said, “Wow, my leg feels less heavy,” and they notice a difference immediately because they don’t have a stocking on and because you haven’t performed a tumescent anesthetic. All of the procedures we have at our disposal reach our ultimate goal: all get the patient to the same place eventually and all of them are effective, it’s just that the journey there that is different. I think that Venaseal offers patients a unique way to achieve their goal of making their leg look and feel better that is minimally invasive and very well tolerated.
Editor’s note: Dr. Gibson reports consultancy, grants, and travel reimbursements from Medtronic.