What is the Venous Closure Procedure?
The Venous Closure procedure is a minimally invasive treatment for superficial venous reflux. This procedure provides less pain and less bruising when compared to traditional vein stripping surgery and laser treatment. Using the Closure system, Dr. Villa closes the diseased veins by inserting a thin Closure catheter into a vein and heating the vein wall using temperature-controlled RF energy. Heating the vein wall causes collagen in the wall to shrink and the vein to close. After the vein is sealed shut, blood then naturally reroutes to healthy veins.
Venous reflux or venous insufficiency develops when the valves that usually keep blood flowing out of your legs become damaged or diseased.
What are the benefits of the Venous Closure Procedure?
- Minimally Invasive Outpatient Procedure: Closure catheters are inserted into the vein via a tiny incision in the lower leg, eliminating the need for groin surgery and general anesthesia. The Closure procedure can be performed using local anesthesia in the Office of Dr. Villa.
- Clinically Proven Less Post-Operative Pain: The Closure procedure does not involve pulling the diseased vein from the thigh as with vein stripping surgery, or using 700° C laser energy which boils blood to occlude a vein as with endovenous laser (EVL). In the RECOVERY Trial, a multi-center head-to-head comparative randomized trial comparing the Closure procedure with EVL, the Closure procedure was found to have less patient pain and less patient bruising than EVL for the best patient recovery experience available from a minimally invasive vein treatment. Additionally, in other randomized comparative studies have shown that patients receiving the Closure procedure return to normal activity and work significantly faster than those receiving vein stripping.
- Excellent Clinical Outcomes: The Closure FAST catheter, which represents the latest advancement in the Closure procedure, has been shown in a multi-center study to have a 97.4 efficacy rate at one-year. This shows that the treatment is highly effective and, as proven in the RECOVERY trial, is gentle on the patient.
- Cosmetically Appealing: Because treatment with Closure is minimally invasive and is catheter-based, it results in little to no scarring. As with any medical procedure, you are encouraged to review all safety information associated with the procedure by consulting your physician.
How does it work to treat Superficial Venous Reflux?
Since valves can”t be repaired, the only alternative is to re-route blood flow through healthy veins. Traditionally, this has been done by surgically removing (stripping) the troublesome vein from your leg. The Closure procedure provides a less invasive alternative to vein stripping by simply closing the problem vein instead. Once the diseased vein is closed, other healthy veins take over and empty blood from your legs.
How is the Venous Closure Procedure different from Vein Stripping?
During a stripping procedure, the surgeon makes an incision in your groin and ties off the vein, after which a stripper tool is threaded through the saphenous vein and used to pull the vein out of your leg through a second incision just above your calf.
In the Closure procedure, there is no need for groin surgery. Instead, the vein remains in place and is closed using a special (Closure) catheter inserted through a small puncture. This may eliminate the bruising and pain often associated with vein stripping (i.e., that may result from the tearing of side branch veins while the saphenous vein is pulled out). Vein stripping is usually performed in an operating room, under a general anesthetic, while the Closure procedure is performed on an outpatient basis, typically using local or regional anesthesia.
Three randomized trials of the Closure procedure vs. vein stripping, including the most recent multi-center comparative trial, show very similar results. In the multi-center comparative trial, the Closure procedure was superior to vein stripping in every statistically significant outcome. In the study, 80.5% of patients treated with the Closure procedure returned to normal activities within one day, versus 46.9% of patients who underwent vein stripping. Also, Closure patients returned to work 7.7 days sooner than surgical patients. Patients treated with the Closure procedure had less postoperative pain, less bruising, faster recovery and fewer overall adverse events.
How long does the Venous Closure Procedure take?
The Closure procedure takes approximately 45-60 minutes, though patients normally spend 2-3 hours at the medical facility due to normal pre- and post-treatment procedures.
Is the Venous Closure Procedure painful?
Patients report feeling little, if any, pain during the Closure procedure. Your physician will give you a local or regional anesthetic to numb the treatment area.
Will the Venous Closure Procedure require any anesthesia?
The Closure procedure can be performed under local, regional, or general anesthesia.
How quickly after the Venous Closure Procedure treatment can I return to normal activities?
Many patients can resume normal activities immediately. For a few weeks following the treatment, your doctor may recommend a regular walking regimen and suggest you refrain from very strenuous activities (heavy lifting, for example) or prolonged periods of standing.
How soon after the Venous Closure Proceduretreatment will my symptoms improve?
Most patients report a noticeable improvement in their symptoms within 1-2 weeks following the procedure.
Is there any scarring, bruising, or swelling after the Venous Closure Procedure?
Patients report minimal to no scarring, bruising, or swelling following the Closure procedure.
Are there any potential risks and complications associated with the Venous Closure Procedure?
As with any medical intervention, potential risks and complications exist with the Closure procedure. All patients should consult their doctors to determine if their conditions present any special risks. Dr. Villa will review potential complications of the Closure procedure at the consultation, and can be reviewed in the safety summary. Potential complications can include: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia (numbness or tingling) and/or skin burn.
Is the Venous Closure Procedure suitable for everyone?
Dr. Villa can tell you if the Closure procedure is a viable option for your vein problem. Experience has shown that many patients with superficial venous reflux disease can be treated with the Closure procedure.
Is age an important consideration for the Venous Closure Procedure?
The most important step in determining whether or not the Closure procedure is appropriate for you is a complete ultrasound examination by Dr. Villa. Age alone is not a factor in determining whether or not the Closure procedure is appropriate for you. The Closure procedure has been used to treat patients across a wide range of ages.
How effective is the Venous Closure Procedure?
Data from a prospective multicenter study have shown 97.4% vein occlusion 1 year post-treatment.
What happens to the treated vein left behind in the leg?
The vein simply becomes fibrous tissue after treatment. Over time, the vein will gradually incorporate into surrounding tissue. One study reported that 89% of treated veins are indistinguishable from other body tissue one year after the Closure procedure was performed.
Is the Venous Closure Procedure covered by my insurance?
Many insurance companies are paying for the Closure procedure in part or in full. Most insurance companies determine coverage for all treatments, including the Closure procedure, based on medical necessity. The VNUS Closure procedure has positive coverage policies with most major health insurers. Dr. Villa can discuss your insurance coverage further at the time of consultation.
What are patients saying about the Venous Closure Procedure?
98% of patients who have undergone the Closure procedure are willing to recommend it to a friend or family member with similar leg vein problems.
Comparison Table of Treatment Options
| The Venous Closure Procedure | Endovenous Laser | Vein Stripping & Ligation | |
| Method of action | Collagen contraction resulting in a fibrotic seal | Boiling of blood resulting in a thrombotic occlusion | Surgical removal |
| Multi-center registry | 97.4% closure at 1 year | None | No multi-center studies |
| Post-operative bruising | 4% | 38% | 19% |
| Return to normal activities within 24 hours | 89.1% of patients | 69.8% of patients | 46.9% of patients |