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EL PASO INTEGRATED PHYSICIANS GROUP, P.A. Endovenous Radiofrequency Ablation (VNUS Closure®) Informed Consent Form This form is designed to provide you with 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 ablation 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 procedure 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, and 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. Possible complications of NOT TREATING varicose veins: With rare exceptions, everyone will experience a worsening of their condition, such as 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. Other treatments or procedures available: Because varicose veins and spider veins are not life or limbthreatening, 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 generally 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. 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 procedure 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. 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. By signing below, I acknowledge that I have read the foregoing informed consent form and that _______________________________ (explaining provider) has adequately informed me of the risk and benefits of the VNUS Closure procedure, 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 freedom from 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: ________________________________________________ (Procedure Provider) Date _______________, 201____ Patient name ______________________________________ Date of Birth:_________________ Patient’s signature _________________________________________________________________ Witness __________________________________________________________________________ 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