VNUS® Closure® Informed Consent Form

This form is designed to document that you have been given information regarding your venous problem. The potential risks and benefits of treating and NOT treating your condition are presented below so you can make an “informed decision” about your own condition and treatment options.

The endovenous radio frequency obliteration technique also known as the VNUS Closure is a relatively new and unique method of eliminating the abnormal saphenous vein. The most common potential risks of the VNUS Closure include: 1) Failure to close the vein, 2) Hyperpigmentation or discoloration, 3) Leg swelling, 4) Phlebitis (redness and tenderness over the treated vein, 5) Numbness or tingling, 6) Skin burns. In addition to the above, there are also risks that are associated with any surgical procedure such as blood loss, infection, blood clot formation, and allergic reactions.

The possible complications of NOT TREATING varicose veins: With rare exceptions, everyone will experience a worsening of their condition- usually noting more numerous veins or enlargement of existing veins. In cases of large varicose veins, spontaneous phlebitis or clotting may occur. Veins that bulge markedly may rupture & bleed- often with little or no trauma. Additionally, skin discoloration and ulcerations may develop in the ankle region of patients with long-standing varicose veins and underlying venous insufficiency.

Are there other treatments or procedures available?

Because varicose veins and spider veins are not life or limb-threatening, treatment is not mandatory in every patient. Some patients get adequate relief from graduated compression stockings. Light therapy such as laser is generally not effective in larger veins and therefore is not appropriate. Ambulatory phlebectomy is a procedure in which certain varicose veins can be removed through a small surgical incision. This can be done under local anesthesia and carries the same risks and benefits with the addition of small scars. Large varicose veins (especially those associated with significant reflux such as the saphenous vein) are often best treated with vein stripping. This procedure can also be performed under local anesthesia. There are cases in which the VNUS Closure was attempted and failed due to any number of factors. This is felt to be rare, but in these cases a vein stripping may be done instead.

What if I experience a problem after receiving the treatment?

You will be given information on what to expect after the VNUS Closure . Should you experience any adverse reaction, or have any questions, please contact our office immediately. Possible Benefits of the VNUS Closure : Varicose veins commonly cause symptoms such as pain, heaviness, and leg fatigue, especially after standing for long periods of time. In many cases, this is due to malfunctioning valves in the saphenous vein (the main external vein of the lower extremity). The resulting increased pressure in the saphenous vein is transmitted backwards to varicose veins. Satisfactory treatment of varicose vein symptoms is usually achieved by obliterating the saphenous vein. Although closure of the saphenous vein using the VNUS Closure should reduce the pressure in the varicose veins and thus relieve many of the symptoms, the VNUS Closure does not include actual removal of the saphenous vein. Successful closure with the VNUS Closure system should result in less bruising and scarring compared to traditional surgical approaches.

By signing below, I acknowledge that I have read the foregoing informed consent form and that Dr.___________________________ has adequately informed me of the risk and benefits of the VNUS Closure, alternative methods of treatment, and the risks of not treating my condition. I understand that the doctors have not guaranteed either the results of the procedure or freedomfrom potential complications.
I also acknowledge that I have been given ample opportunity to ask questions about my condition and options. I hereby consent to undergo the VNUS Closure treatment performed by

Dr.____________________________ Date _______________, 201__

Patient’s signature __________________________________________

Witness _________________________________________________

In the unlikely event that the VNUS Closure can not be performed, I hereby give

Dr.____________________ permission to perform the surgical alternative of obliterating my saphenous vein such as saphenous vein ligation, division, and stripping.

Date _____________________, 201__

Patient’s signature___________________________________________


Post-Treatment Regimen Card

___ Return to normal activities
___ Refrain from strenuous activities for:___days
___ Pain medication: plain Tylenol or Tylenol #3 if necessary
___ Compression stockings: 18 days after elastic wraps removed
___ Ambulation instructions: 5 minutes each hour while awake for two weeks days
___ Remove bandage after: 3 days at the time of the post-closure duplex ultrasound examination or any time the dressings feel too tight or cause numbness of the extremity
___ Follow-up visit: 7 to 14 days after procedure
___ Do not take aspirin or aspirin containing medications for 2 weeks after closure

It is normal to experience some tenderness and possibly bruising along the areas where local anesthesia was administered on the inside of the thigh.

Call your physician immediately if you experience any of the following:
• Prolonged tenderness, redness or warmth along the treated segment
• Moderate to severe pain preventing return to normal activities
• Shortness of breath
• Swelling in the treated limb

Content reviewed and updated on August 3, 2013.