What types of FDA-approved therapies are available in the modern vein treatment era?
The first two heat methods available that replaced the old stand-by of ligation/stripping use intense heat to destroy veins. Both are still cornerstone to most vein treatments performed in the U.S. in specialty vein practices. The two heat ablation (endovenous thermal ablation) methods are:
- Radiofrequency thermal ablation (RFA): this method for vein treatment started in 1999 and continues very popular today. This technology has advanced now several generations with prior generations phased out of clinical use. A RFA fiber is inserted in to the problem vein to be heated, guided by ultrasound to position properly. A generator attached to the RFA fiber generates electrical heat that is concentrated at the end metal coil portion of the fiber. A numbing agent is instilled around the vein to be heated through several needle sticks to avoid the patient feeling any heat/pain. The RFA fiber is then withdrawn slowly through the vein, in essence “cooking” it to destroy it. The segments of vein treated by RFA are not removed from the body. Once a vein is RFA “cooked”, it is rendered ineffective, dies, and is slowly reabsorbed by the body.
- Endovenous Laser Ablation (EVLA): this method for vein treatment started in 2000 and continues very popular today. This technology has advanced now several generations, with the biggest change being moving to higher wavelengths of laser energy (i.e. light energy) to heat and destroy problem veins. A laser fiber is a glass fiber encased in plastic. This laser fiber is inserted through a catheter placed in the target vein using ultrasound guidance. One end of the laser fiber is connected to the laser (light generating) machine, and the other end is passed through a catheter placed in the target vein. A numbing agent is instilled around the vein to be heated through several needle sticks to avoid the patient feeling any heat/pain. The laser is activated and the laser fiber and associated catheter is then withdrawn slowly through the vein, in essence “cooking” it to destroy it. The segments of vein treated by EVLA are not removed from the body. Once a vein is EVLA “cooked”, it is rendered ineffective, dies, and is slowly reabsorbed by the body.
Unlike with RFA, multiple wavelength laser machines are still in use around the country, with vein providers having their individual preferences, since in proper hands, older technology (lower wavelength) lasers and newer technology (higher wavelength) lasers have comparable, excellent long-term success rates and similar low risk profiles. The newer generation, higher wavelength lasers seem to have a slight advantage over lower wavelength lasers tending to cause somewhat less post-procedure bruising and discomfort during the recovery phase, but in most cases it equates to “shades of gray” and not “apples to oranges”. VSA at-present uses a newer generation higher wavelength endovenous laser (1470nm wavelength).
Should I choose RFA or EVLA?
If the provider recommends one over the other, it may be because they only utilize one of the endovenous thermal technologies. At VSA, we utilize both thermal technologies and tailor the decision to the vein anatomy we see on initial consultation, including the duplex vein ultrasound. There is some medical data, and our providers’ own significant clinical experience, that will steer the decision to EVLA or RFA. Most commonly, if a discovered bad vein is larger diameter, RFA may be recommended over EVLA. By same token, if a bad vein is smaller diameter or shorter length, the catheter used for EVLA is slightly smaller/technically easier and may be recommended over RFA.
In early years of these new thermal technologies, some insurers only recognized either RFA or EVLA to be reimbursed under the insurance plan. Now that we are almost 2 decades in to use of both modalities, insurers with the rarest exception will allow either to be performed, thus relying on the expert opinion of the vein surgeon who is to perform the procedure.
What is the outcome data for RFA and EVLA to effectively eliminate the bad vein(s) and patient satisfaction?
This has been analyzed in multiple studies over many years with many patient subjects. The well-designed studies come to the same conclusions comparing the newest generation RFA and EVLA:
- Risks/Side Effects are minimal and equal for both, especially compared to prior major surgical Ligation/Stripping
- Recovery is quick for both in most cases, able to resume usual daily activities in a day or two, with minimal discomfort the norm—perhaps a slight advantage in post-procedure soreness and healing time with RFA
- Success rate from experienced vein providers performing procedures, and following patients over several years (gauged as successful ablation of the offending main thermally treated vein): Equal for both. Many of the more recent published studies report a success rate following patients out to 5 years in the range of 92-98% for both EVLA and RFA.
Are there other available Non-Thermal Ablation methods to close main problem veins?
- Ultrasound-guided sclerotherapy (UGS) of main problem veins (often termed “truncal” and/or “perforator” veins) has been in practice for decades by some vein providers, even during the era when Ligation/Stripping was mainstay. Limitation to this modality to ablate a major truncal vein is the amount of chemical sclerosant to be injected at a session. Chemical sclerosants share the one major side effect to be avoided: Deep Vein Thrombosis (DVT). The more of a chemical sclerosant used in a session, the higher the risk of DVT. DVT can rarely be a fatal event, and at minimum, a temporary lifestyle hit for several weeks-months. As a general rule, the less chemical sclerosant used in a procedure, reduces risk of DVT. For this reason, at VSA, we choose to limit chemical sclerosant use, usually as an adjunct to other needed vein procedure(s), and rarely as a standalone treatment. When it is necessary in a patient’s treatment plan, VSA providers are always cognizant to use the least amount possible, phasing treatments if needed for this reason.
- MechanoChemical Ablation (MOCA): This is a newer FDA-approved ablation technique designed to treat the main truncal veins that cause the varicose vein problem in the first place. This can be considered an alternative treatment to either of the thermal ablation techniques for truncal vein ablation (RFA or EVLA). The main advantage to this technique is that in most cases, numbing shots are not necessary, or if needed, significantly fewer than for RFA or EVLA. The MOCA device is inserted in to the problem vein using ultrasound guidance. When properly positioned, it is activated to begin a very high revolution spinning tip that begins to irritate the inside lining of the vein. Simultaneously, while the tip is spinning and being pulled through the vein, chemical sclerosant (same as above) is injected to enter the vein in proximity to the spinning tip. With the combination of spinning tip and sclerosant injected, vein damage enough to cause permanent closure usually result. This modality is much newer than the thermal methods (EVLA and RFA) but in a published 2-year review (11/2015), successful closure of the treated vein mirrors longer-term results of EVLA and RFA with similar very low side effect/risk profile, and superior patient scores for healing discomfort and time. Plus, compared to sclerotherapy (chemical ablation) alone for truncal veins, results are superior, with an advantage of slightly less risk/side effects, especially DVT risk. Some insurers do not yet cover MOCA.
- VenaSeal©: This is the newest kid on the block to be FDA-approved. It is a proprietary device owned by one of the major vein medical supply companies in the country. It uses a proprietary cyanoacrylate “super glue” formulation that is delivered through a catheter inserted in to a problem main vein by ultrasound guidance. The glue is instilled in the vein as the catheter is withdrawn from the vein to permanently seal the vein and thus induce vein ablation. From medical outcome data presented to the FDA, success rate is very high and risk profile/side effects low and return to normal activities even quicker (compared to EVLA, RFA, and MOCA). The glue is shown to be inert in the body. This technology has the advantage of allowing two legs to be treated simultaneously if needed (whereas risks inherent in the other modalities—EVLA, RFA, and MOCA—limit only one leg’s procedure(s) being performed on a given day). The negative to this technology thus far is the lack of a paying code to be submitted to insurers to authorize and pay for it. As such, likely until 2018, any patient felt to be a candidate for this modality who opts for it, will have to pay out-of-pocket, without insurance coverage in the loop.
- Microphlebectomy (a.k.a. Ambulatory Phlebectomy): This method is most often employed at VSA to deal with the actual lumpy visible/palpable veins on the leg surface—the actual varicose veins. The varicose veins are actually bad vein branches resulting from the primary source of vein problems, the bad “trunk” vein. Microphlebectomy involves numbing the skin over the area of the lumpy veins, making a very small incision with a sharp blade (approximately 1-2 millimeters in diameter), then using a hook to located and pull the lumpy segment of the varicose vein through the surface where it is intentionally torn (avulsed). The result is segments of the bad branch varicose veins are removed and the remnant is no longer viable, and any remnant pieces of the varicose vein branch remaining in the leg die and are slowly reabsorbed by the body. Although not the primary intent, microphlebectomy has the added cosmetic plus of eliminating the visible “lumps” on the leg, while rarely leaving any visible scarring from the very small incisions required.
Do I have any options if I have recurring vein problems after having my veins stripped or prior endovenous thermal ablation in the past?
Most times, yes. VSA frequently sees patients who present with recurrent varicose veins problems after prior stripping surgery and less frequently after prior endovenous thermal ablations (term “REVAS”). The determination depends on venous duplex ultrasound examination. Once the recurrent vein problem is determined, a treatment plan will be devised that might involve one or more of the treatment modalities noted above.
The “REVAS” may just be another vein has developed valve failure that was not treated previously. Genetic predisposition is the main reason for varicose veins in the first place, and even with proper treatment, a patient can just have more veins go bad over time solely due to the inherited trait.
One more common cause of REVAS found in a significant number of patients is termed “groin neo-vascularization”—literally meaning new vein growth. Although new vein growth sounds like a positive term, when this new vein growth occurs in the groin of a prior stripped patient, it is often the source of vein symptoms and can be very difficult to completely eradicate. As such, the goal of it’s treatment, usually with either ultrasound-guided sclerotherapy and/or microphlebectomy, is to eliminate symptoms of leg pain/swelling, and then wait/watch to see if it will become clinically relevant again in the future.
If I have a major “trunk” vein closed (ablated) by one of the methods described, how does the vein from that leg get back to the heart?
The blood returns to the heart by routing as it normally would to the deep vein system in the leg. The change involves all of the blood that previously partially drained through the now ablated trunk vein, now using the back-up system termed “perforator veins” (a.k.a. connector veins) primarily to perform this function. Each leg has approximately 100 perforator veins that always function to help carry vein blood from the superficial vein system to the deep vein system. This God-given ancillary perforator vein system works beautifully as a back-up system to pick up the slack in areas where diseased trunk and/or branch veins are ablated.
Are the vein procedures painful?
Yes, but only in regard to needed local numbing shots required for almost all procedures. Some patient procedure plans require more such numbing shots since more work is involved. Some procedures themselves require more numbing shots than others. The worst of these numbing shots is the small needle “poke” discomfort through the skin. The numbing medication itself is prepared to minimize the “sting” and usually feels more like heavy pressure when instilled.
For patients who are extremely needle phobic, options are available to receive oral sedation medication (for office-based procedures) or more-deeply sedating IV medication (if performed in an outpatient surgery center setting). In either sedation scenario, having a person to drive you to/from the procedure is mandatory.
The post-procedure period has some degree of discomfort during healing and this varies person to person, and also depends on how many vein procedures are needed to fully treat. As a general rule, the post-procedure discomfort is very tolerable and self-limited. Bruisy soreness and a “tight” feeling in the treated leg are common and last from several days to 2 weeks on average, rarely longer. The discomfort generally is a minor nuisance and easily managed with over-the-counter analgesics such as Ibuprofen or Naproxen, topical and/or oral natural Arnica, and wearing compression hose on the treated leg(s) for 1-2 weeks after. Rarely is the pain so intense that prescription pain killers are needed.
Can Varicose Veins and Spider Veins be prevented?
In most cases, no. The trait for varicose veins and spider veins is genetically pre-determined in all but the rarest case. As an inherited trait, signs and symptoms tend to manifest as time marches on, with varied age of onset. Things that may lessen vein symptoms and cosmetic worsening include: maintaining a healthy body weight; maintain regular leg movement in the form of regular exercise; and for females, avoiding pregnancy.
Do compression hose help?
Wearing daily compression hose of Class 2 (20-30mm Hg) or higher strength may provide some relief in degree of leg discomfort and swelling due to vein problems. Compliance must be strictly adhered to in order to hopefully achieve symptom improvement. Even with regular wearing of compression hose, most published studies on leg vein problems report that progression of the vein problems still occurs over time, but worsening may be slowed.
On another note, compression therapy has been proven helpful to prevent deep vein thrombosis both in a major-surgical post-operative convalescence period and during prolonged sedentary travel (such as prolonged car, air, rail travel), so compression in these circumstances should be adhered to by any person, regardless of leg vein disease.
Are there any medications that might help with the leg symptoms due to the vein problem?
There are sound medical papers on using daily oral over-the-counter supplements to reduce leg symptoms: Horse Chestnut and/or Butcher’s Broom—both naturally occurring plant-based medicines. Another OTC product that may help is Diosmin. Diosmin is also available in a combination prescription product Vasculera.
Should I wait until I am finished having children to seek treatment?
No. Unlike the era of vein stripping where most physicians would have counseled their patients to wait until all planned pregnancies were completed, now with much less invasive vein procedures not requiring hospital stays or major surgery, a woman can safely undergo vein procedures after pregnancy with expected quick recovery and much lower risk of recurrence, even with successive pregnancies.
What if I am pregnant or breastfeeding?
Treatments during pregnancy is not indicated. Generally, symptoms and appearance of varicose veins worsens in pregnancy, especially in the latter stages of pregnancy. Wearing maternity compression hose should be strictly adhered to if you suffer with varicose veins while pregnant. Once the pregnancy is over, sometimes the appearance and symptoms of the varicose veins dramatically improves, such that continued daily compression therapy is all that is needed.
If you are breastfeeding, then certain of vein procedures can be performed without interruption. If a chemical sclerosant is indicated to appropriately treat your vein problem, then most vein specialists recommend “pumping/dumping” breast milk from the time the sclerosant is used and for a span of 72 hours after.
Will treating my vein problems get rid of my restless leg symptoms (RLS)?
Yes, completely or almost completely in most cases. A fact very poorly understood is that in up to 50% of patients with RLS, vein problems of the legs are either fully or mostly to blame. If vein problems are diagnosed and successfully treated, published papers support 85% lasting improvement in RLS symptoms. In the experience of VSA, when RLS sufferers with vein problems are treated, resolution of RLS symptoms approaches 100%.
Are chronic leg skin changes and/or skin ulcers related to vein problems?
Yes, in at least half of all cases. Sometimes, concurrent arterial and vein problems are to blame, and much less commonly, arterial disease alone. The risk of having arterial problems to blame goes up with chronic cigarette smoking or heavy second-hand cigarette smoke exposure and longstanding diabetes. If vein problems of the legs are diagnosed in such a patient, treating the vein problem typically increases speed of healing of the unhealthy skin (including skin ulcers) and markedly reduces recurrence risk of skin ulceration.
What if I have vaginal varicose veins?
Some women develop varicose veins in the external (and sometimes internal) vagina, along with leg varicose veins. Vaginal varicosities usually occur with pregnancy, and often will regress following the pregnancy. The incidence goes up with repeat pregnancies. If vaginal veins are painful, they can usually be successfully treated with sclerotherapy, but it is common to require several treatments, and treatment might involve treating something called “PCS”. (See next).
What if I have significant pelvic pain, with or without visible leg or vaginal varicose veins?
Be sure to mention this to your vein provider. A condition termed “Pelvic Congestion Syndrome” may be to blame and may be dismissed by non-vein trained providers. PCS is due to internal varicose veins surround the female reproductive organs (uterus, fallopian tubes, ovaries, vagina). Risk of PCS goes up with successive pregnancies and is most common in women who have the genetic trait for varicose veins and have 4 or more pregnancies, but fewer pregnancies can cause. Symptoms typically are pelvic pain much worse around mestruation and with intercourse. PCS pain with intercourse is typically described as a deep intense ache that worsens with coitus and often is most severe with climax. PCS pain can be so intense that women intentionally avoid intercourse.
How long does a typical vein procedure take?
In most cases, less than an hour. If vein problems are advanced and multiple procedures are necessary, over an hour. If the problem is particularly complex, your procedures for one leg may have to be spread over 2 or more treatment sessions.
Will insurance cover vein evaluation/procedures?
Yes. All major insurances, including commercial insurers (such as Premera, Aetna, Cigna, United Healthcare), and government insurers (Medicare, Medicaid, Tricare) realize that vein disease of the legs is a true medical condition that causes unwanted and unhealthy problems. If a patient has these symptoms (at minimum pain and/or RLS and swelling ), then all insurers will pay for a vein consultation to fully assess. And if the consultation confirms vein disease to be culprit and the resulting leg symptoms are refractory to a trial of daily compression hose and other conservative measures (such as medication), then insurers will generally approve in-office or outpatient minor vein procedures.
If the vein problem is determined to be just a cosmetic problem, like spider veins, insurers will not cover standalone cosmetic treatment.
Is there anything I can do to prevent developing vein problems, or if I had vein problems treated, to try to prevent recurrent vein problems?
Yes and No. The “No” means that in almost all vein sufferer patients, he/she inherited the vein problem from one or more relatives. As such, the veins that go bad are pre-determined to go bad with time.
However, the “Yes” of same story is that even if you inherited the trait, there are things within your power to lessen the chances of the vein problem manifesting itself in a clinically significant way.
These vein-healthy measures include for both men and women:
- Avoiding periods of prolonged standing or sitting. (Veins enjoy being active to “exercise” them, so frequent walking is advised)
- Maintaining a healthy body weight (Veins are stressed much more in overweight people)
- When sitting, try to elevate the legs to hip height and remember to pump the feet back/forth (like pushing/letting off gas pedal) several times an hour)
- Wear compression hose daily during upright hours. (There is no concrete data that this will prevent development of vein problems in a genetically predisposed person, but it won’t hurt)
Additional vein-healthy measures for women:
- Avoid pregnancy. Hormone changes of pregnancy make veins more likely to fail. (Obviously, if pregnancy is desired or occurs, wearing adequate prescribed maternity compression pantyhose throughout may help)
- Avoid regular use of high-heeled footwear. (High-heeled footwear do not allow the lower extremities to go through natural walking movement by inhibiting the “calf pump”. The calf pump is the main mechanism that blood is propelled upwards out of the legs back to the heart. In essence the calf pump is the “heart” in the legs for the veins).