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Valuable Opinion on Vein Glue

November 21, 2017

Valuable Opinion on Vein Glue: Newer Not Always Better

James D Albert, M.D., RPVI of Albert Vein Institute

Having practiced Cardiac Surgery for over 25 years, I saw many FDA-approved heart valves promoted by industry as “revolutionary” advances in patient care that subsequently were recalled or failed expectation, resulting in re-operation or devastating patient outcomes.

You may have seen physicians claiming they are the “first” or the “only” provider in a State using “vein glue” adhesive. The product is not difficult to use and requires no specific technical expertise. The inference is that somehow these providers who make these claims are superior to those physicians who choose not to use the technology. Let’s objectively look at what we know and claims made about this product.

  1. RETAINED FOREIGN BODY

The company that promotes the product of “vein glue” has recently categorized it as an “implant.” In medicine, an implant refers to something like a heart valve or an artificial knee and can carry risk of infection.

“Vein Glue” is essentially the same product used to glue hip and knee replacements into patients’ bones. Therefore, we can assume it is never absorbed by the body and is a lifelong foreign body that stays in the vein. Results of vein closure at one year are promising but there are concerns about a foreign body that may never absorb and prevent the vein from absorbing. Infection may only be cured with full surgical excision of the glue infused vein. With standard laser and radio frequency ablation procedures, the treated vein usually disappears within one year. In these standard treatments, rare infections are almost always cured with antibiotics and NO surgery.

  1. LOCAL ANESTHESIA IS AVOIDABLE—WRONG!

The “straw man” argument is that the local anesthesia, which takes approximately 2 minutes to administer and is well tolerated by the vast majority of patients, would not be required with the use of vein glue. Most qualified vein care physicians perform not only ablation to treat the cause of the problem (saphenous vein) but perform the important micro-incision phlebectomy simultaneously to remove the result of the problem (varicose vein). Since local anesthesia is required for microphlebectomy, it is disingenuous to claim that local anesthesia is totally avoidable. If microsurgery is not performed in coordination with vein glue procedures, it is likely the big veins will not go away and they might clot.

  1. NOT USING LOCAL ANESTHESIA MEANS LESS PAIN—WRONG!

In the comparative studies of Vein Glue vs. Radio frequency or Laser Ablations, there were NO DIFFERENCES in the perceived pain levels whether local anesthesia was used or not. One can only conclude that patients feel pain when the glue comes in contact with the inside of the vein.

  1. INSURANCE COVERAGE IS NOT BEING PAID

At this time, there are recent insurance billing codes but no one is paying them. Patients who opt for this new technology will incur significantly more personal financial responsibility to receive this procedure.

  1. THERE ARE NO POTENTIAL RISKS OF VEIN GLUE—WRONG!

The list below is a published list of potential risks and complications that may occur with “vein glue” per the manufacturer. Although the incidence of these issues is low, this list is similar to those listed for Laser or Radio frequency Ablations.

POTENTIAL RISKS OF VEIN GLUE 

The {vein glue} procedure is minimally invasive and catheter-based. As such, it may involve the following risks. Your doctor can help you understand these risks:

ALLERGIC REACTION TO THE {vein glue}L ADHESIVE

ARTERIOVENOUS FISTULA (i.e., an abnormal connection between an artery and a vein)

BLEEDING FROM THE ACCESS SITE

DEEP VEIN THROMBOSIS (i.e., blood clot in the deep vein system)

EDEMA (i.e., swelling) in the treated leg

HEMATOMA (i.e., the collection of blood outside of a vessel)

HYPERPIGMENTATION (i.e., darkening of the skin)

INFECTION AT THE ACCESS SITE

NEUROLOGICAL DEFICITS INCLUDING STROKE AND DEATH

NON-SPECIFIC MILD INFLAMMATION OF THE CUTANEOUS AND SUBCUTANEOUS TISSUE

PAIN

PARESTHESIA (i.e., a feeling of tingling, prickling, numbness or burning)

PHLEBITIS (i.e., inflammation of a vein)

PULMONARY EMBOLISM (i.e., blockage of an artery in the lungs)

URTICARIA (i.e., hives) or ulceration may occur at the site of injection

VASCULAR RUPTURE AND PERFORATION

VISIBLE SCARING

CONCLUSION

The 1.5-year follow-up on the 100’s of patients who have received vein glue is dwarfed by the 10-15 year follow-up on millions of patients who have received either laser or radio frequency ablations. The potential benefit of being able to do both legs in a single day as local anesthesia is avoided is inviting but again would only be applicable for patients that did not require microphlebectomy (very rare).  Microphlebectomy is important for complete vein care.

The risks appear similar and the potential long-term side effects and efficacy of vein glue have yet to be determined. Additionally, the fact that it is not covered by insurance at this time places significant financial burden on patients and patients get no deductible credit. Even if a deductible is large, patients want to get credit against their deductible for other medical procedures that may be required in the same calendar year.

It is our opinion at Albert Vein Institute (AVI) that these potential unknowns and potential financial burden make the use of this product at this time only appropriate for the following types of patients:

– Patients with actual documented local anesthesia (lidocaine) allergy which is extremely rare.

– Patients who do not need simultaneous microphlebectomy (rare) who want to do both legs in the same day and have no concerns about procedure cost.

Dr. James D. Albert, RPVI is the Founder and Practicing Physician of Albert Vein Institute (AVI)–Colorado’s Vein Specialist – founded in 2006. A nationally respected Phlebologist, Dr. Albert has led AVI to become Colorado’s ONLY nationally recognized IAC ACCREDITED VEIN CENTER. Dr. Albert trained at the nation’s most reputable medical institutions, holds double Board Certifications in Cardiovascular Surgery and Phlebology, and is humbled to bring 30 years of a successful surgical career to patients needing vein care.

Posted in Blog, Featured by Jen Johnson