INFORMED CONSENT FOR ENDOVASCULAR LASER VENOUS SYSTEM (ELVS)
AND/OR AMBULATORY PHLEBECTOMY
This Informed Consent Form is designed to provide you with the information you will need to make an informed decision about whether or not to have ELVS and/or ambulatory phlebectomy performed. If you have any questions or do not understand any potential risks, please do not hesitate to ask for help.
WHAT IS ELVS?
Over the last few decades lasers have been used for numerous medical applications throughout the body. Recently, a novel technique utilizing laser energy delivered endovenously directly inside the vein has been developed to treat varicose veins. ELVS utilizes an infrared laser. Through a small fiber placed inside the vein the laser is able to deliver sufficient energy to disrupt the cells lining the vein causing the vein to collapse and close down. ELVS is performed under local anesthesia in the doctor’s office. There is little to no scarring and a relatively short recovery period after the procedure.
HOW IS ELVS PERFORMED?
Prior to your ELVS procedure an ultrasound will be performed to evaluate the abnormal vein to be treated (usually the greater saphenous vein). A special pen will be used, to mark this area. Photographs of the treatment area will be taken.
At the beginning of the procedure, the leg will be prepped with Betadine (to cleanse the skin of bacterial contamination). Next, with the help of ultrasound guidance the treatment area will be anesthetized with Lidocaine. A sterile laser fiber will then be inserted into the vein and positioned under ultrasound guidance. You will be given special goggles to protect your eyes against accidental laser light exposure. Laser energy will be delivered to the target vein. At the end of the procedure, a compression stocking will be applied and must be worn for at least one week.
You will return to the office within 72 hours for an ultrasound examination of the treated vein. Occasionally, repeat laser treatment may be needed.
WHAT IS AMBULATORY PHLEBECTOMY?
Ambulatory phlebectomy is a minimally invasive surgical technique designed to disrupt and remove abnormal varicose veins. This is performed under local anesthesia. Punctures are tiny (sutures are generally not necessary) and typically leave nearly unperceivable scars. The procedure is performed on an out-patient basis in the office setting.
HOW IS AMBULATORY PHLEBECTOMY PERFORMED?
Ambulatory phlebectomy is performed under local anesthesia in the office setting. The area overlying the veins to be removed is prepped with Betadine. Local anesthesia (Lidocaine, similar to what the dentist uses) is used to numb the area where the vein resides. Small tiny punctures are made allowing the vein to be mobilized and removed in whole or part. The incisions used for this procedure are so small that sutures are generally not necessary. The procedure is performed on an out-patient basis either by itself or in combination with ELVS.
At the end of the procedure, a compression stocking will be applied and must be worn for at least one week.
RISKS AND DISCOMFORTS
If you undergo endovascular laser treatment and/or ambulatory phlebectomy for varicose veins, your symptoms of varicose veins may improve, remain the same, or worsen.
The potential side-affects are deep venous and/or arterial thrombophlebitis (clot in the deep vein or artery), pulmonary embolism (clot to the lungs), altered skin sensation, thermal injury (burn) to the overlying skin or intervening tissue, perforation of the vein, breakage of the laser fiber, superficial phlebitis (inflammation of the vein), infection (localized to the treatment area or throughout the body/bloodstream) medication/contrast allergic reaction, hyperpigmentation (darkening of the overlying skin), or neovascularization (growth of new veins). Problems and side-affects that are not known at this time could also occur.
For most people, these procedures performed within the vein do not cause any serious problems; however, they may cause dizziness, minimal bleeding, bruising, discomfort, pain, and rarely infection. Local anesthesia will be used to minimize discomfort. Rarely, people can have an allergy to Lidocaine.
COMPLICATIONS OF NOT UNDERGOING TREATMENT
Potential complications of not undergoing treatment are most often limited to merely a worsening of the condition, ie: an increase in the number of veins or enlargement of the existing veins. In cases of large varicose veins, spontaneous superficial phlebitis or bleeding may occur. Patients with varicose veins associated with underlying venous insufficiency may develop ankle swelling and/or skin changes (eczema, hyperpigmentation, ulceration).
ALTERNATIVE TREATMENTS
Since varicose veins and spider veins are not life-threatening, treatment is not mandatory. Some patients may get adequate symptomatic relief by wearing compression stockings. Alternative treatments for varicose veins include surgical ligation and stripping, ultrasound guided sclerotherapy, or a combination of these treatments.
POTENTIAL BENEFITS
The potential benefits of these procedures are reduction in the size or closure of the treated varicose veins, removal of veins and improvement in varicose vein related symptoms. There is no guarantee that you will receive any medical benefit as a result of endovenous laser treatment and/or ambulatory phlebectomy. It is also possible that your condition may remain the same or worsen.
By signing below, I acknowledge that I have read and understand the above and have been adequately informed of the nature, intended purpose, and significant risks, consequence of the described procedures, as well as alternative treatment methods. I acknowledge that I have reviewed the educational material on “Treatment of Varicose and Spider Veins” and have been given ample opportunity to ask questions about my condition and options. I, hereby, authorize consent to endovascular venous laser system treatment and/or ambulatory phlebectomy performed by Michael Lawless, M.D., George Lyons, M.D., W. Jordan Taylor, M.D., and/or Tom White, M.D. I also authorize taking and usage of photographs.
______________________________ ____________________________ Patient signature Date
______________________________ ____________________________ Witness signature Date
I have discussed the nature and purpose of endovenous laser treatment and ambulatory phlebectomy and associated risks, consequences and available alternatives with the person signing above and I am satisfied that she/he understands them.
________________________________________
(Signature of physician providing explanation)
