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July 2016
Sponsored by Medtronic
The VenaSeal™ System in Clinical Practice
A discussion with two venous experts on incorporating this minimally invasive procedure into their armamentarium.
How has the VenaSeal™ system (Medtronic) benefitted your practice?
Dr. Watson: This product is a valuable addition to any comprehensive vein practice. By offering multiple treatments, the physician can tailor a plan to fit individual patient needs. Without the need for additional equipment, tumescence, pumps, postoperative dressing, or compression,* the VenaSeal™ procedure was an easy integration into our practice model. It is wonderful to be able to offer patients a treatment where they can walk out of the office with only a bandage in place.
The greatest benefit to the physician is being able to better care for the individual patient. Multiple veins can be treated at the same time, which is convenient for patients and allows for fewer visits to the office. The self-pay model allows for flexibility within the practice and often appeals to patients with high-deductible plans. Given that most venous practices have a self-pay cosmetic side, integration of a self-pay product was not difficult.
This product is a great option for patients who fear needles and intraprocedural pain or cannot tolerate postprocedural compression. The VenaSeal™ adhesive is ideal for the busy patient who wants immediate treatment with fewer office visits. We have seen patients treated with the VenaSeal™ procedure return to work and normal activities with very little postprocedural discomfort. One patient reported that the diagnostic ultrasound was more uncomfortable than the procedure itself.
Dr. Carr: Before we offered the VenaSeal™ system, there were restrictions that confined patients to following the sometimes-rigid pathways of their insurance policies, which often make coverage decisions based on arbitrary data and health care policy panels. High deductible and conservative management requirements often delay care or postpone therapy that can offer a significant, near-immediate improvement in their quality of life. When we incorporated the VenaSeal™ procedure into our busy vein practice, we did not have to add staff time in the preauthorization process—no need to call insurance companies to explain and often fight for approvals due to common anomalies not mentioned in coverage policies.
Another major advantage we appreciated with the VenaSeal™ system was that there was no capital outlay to add this program to an established vein practice.
Other benefits to our practice include cost savings for not adding tumescent anesthesia and no requirement for compression hose therapy before or after the treatments. We have found that the often 3-month conservative management trial with compression hose therapy and other measures is quite adverse to many patients, especially those who have been suffering with symptoms for many years, elderly or arthritic patients, and those who live in very warm climates in the summer.
Other patients have low pain tolerances and high nociceptive sensitivities (eg, noxious multiple needle sticks). The VenaSeal™ procedure only requires a single needle stick, and no tumescent anesthesia is needed, which is usually the source of discontent for the thermal ablation techniques.
How have you incorporated the VenaSeal™ procedure into your practice?
Dr. Watson: By offering this product, you provide your patient with options. The self-pay model allows for maximum patient flexibility. Patients can have immediate treatment without waiting for insurance approval. They do not have to pay multiple copays or purchase compression stockings, and they often miss fewer days of work.
Dr. Carr: At first, I was concerned with how a self-pay model would work in my community. The adoption has been better than expected, and frankly, we have been a little surprised. Patients are disenfranchised with the Medicare and commercial insurance restrictions on their choice for care. In my view, patients very much care about their lifestyle and quality of life. I have had several Medicare patients, who I would not have expected, opt for the VenaSeal™ procedure because of their quality of life and conservative management restrictions.
After I identify symptomatic disease that would benefit from interventional therapy, I usually explain to patients there are now two options that we are able to offer: thermal and nontumescent, nonthermal (NTNT) therapy. I tell them up front that the thermal techniques are usually covered by Medicare and commercial insurance with certain stipulations, but the NTNT options are not covered at this time and would be self-pay only. If they are interested in hearing about the NTNT VenaSeal™ adhesive, I describe its advantages, including a streamlined treatment schedule and no requirement for compression hose therapy* and conservative management waiting intervals. I explain the benefits of the different treatment options and emphasize there are no proven outcome differences based on published data. Both therapies are safe and efficacious, but there are distinct advantages for many patients with NTNT therapy. I spend a few extra minutes with my patients explaining the differences and let them decide.
What was your learning curve like with the VenaSeal™ system? What training is available?
Dr. Carr: As an experienced phlebologist, I felt very comfortable adopting the VenaSeal™ procedure. Having said that, there is a learning curve, as is the case with most new devices. Fortunately, the learning curve is very short. The handling and preparation of medical adhesive requires some training for the staff involved in the procedure. The US Food and Drug Administration requires that only experienced endovenous operators perform the VenaSeal™ procedure. Medtronic offers an online training module that must be completed prior to the first case, and live case support is provided.
Data presented by Dr. Raghu Kolluri at Charing Cross this year showed that experienced phlebologists who had no experience with the VenaSeal™ adhesive had similar closure rates with their first two patients treated compared with those treated with more experience later in the trial.1
Dr. Watson: Personally, I found the product very easy to use. Any provider who is proficient with venous ultrasound and ablation techniques, such as radiofrequency ablation and laser, should have no problems adopting this technology. The available online and hands-on training are very useful.
What are the most common questions asked by patients when you present VenaSeal™ adhesive as a treatment option?
Dr. Watson: Patients usually inquire about intraprocedural pain and postprocedural expectations. As in most health care settings, cost and the need for additional procedures are also common questions.
Dr. Carr: Patients will also ask, “Is it as effective as the other options—thermal? Will I have to come back for more procedures? Is it permanent? Will my varices or spider veins go away with this treatment? What are the side effects or complications?”
Tell us about your most memorable case with the VenaSeal™ system. What made it special?
Dr. Watson: One of our first patients treated with the VenaSeal™ procedure had experienced previous interventions and was very fearful of needles. He was grateful to have another option. After the procedure, he reported that as soon as he stood up, he felt like he had a “new leg.” He walked out of our office with a beaming smile and did not require any secondary interventions on follow-up. The instantaneous results in this case were very gratifying to see.
Dr. Carr: I had a patient who wanted to get back to working on remodeling a house and didn’t want to slow down. She is a decorator-contractor who had a deadline to get a house completed but was markedly held back by chronic, progressive discomfort and problems with her legs. Despite following conservative treatment advice, she had to stop and elevate her legs several times a day just to function. She was quite worried she couldn’t finish the job and meet her contractual obligations. We treated her with the VenaSeal™ adhesive in one day, and she was back working full time the next day. Her leg symptoms all resolved promptly, and she finished the job ahead of schedule. She was so grateful that she was able to keep working, and her legs felt better than they had for many years.
1. Kolluri R. VeClose roll-in patient results. Presented at Charing Cross; April 26, 2016; London, UK.
*Some patients may benefit from the use of compression stockings postprocedure
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