An Interview With Elna Masuda, MD
The current American Venous Forum President discusses the current top goals of the society, recent EVRA trial results, practicing in Hawaii, and more.
What are some of the unique opportunities and challenges of practicing in Hawaii?
One of the challenges and opportunities of practicing in Hawaii is to be able to offer services beyond the highly populated island of Oahu, to the rural areas including the “Big Island” of Hawaii, which was recently struck by earthquakes and volcanic eruptions. There is a great need for vascular specialists in the Pacific islands as a whole, because many face the increasing challenges of diabetes, obesity, cardiovascular disease, venous disease, deep vein thrombosis, stroke, and more. The greatest problem is the lack of access to vascular specialists in the Pacific region and the need to travel by air to receive proper care.
As the current President of the American Venous Forum (AVF), what are the primary goals of your term?
The AVF’s mission is to improve and save lives by reducing venous and lymphatic disease through research, advocacy, and education. Through our Health Policy Committee, we are proactively addressing coverage issues, particularly for nonthermal methods of venous ablation such as cyanoacrylate, proprietary foam, and mechanochemical ablation, which have shown promising results.
We are also addressing the issue of inappropriate venous care. Since ablation techniques became more widely used, there has been an explosion of vein centers and outpatient clinics for venous treatment. Some of this care has been long overdue, whereas others are associated with overuse and abuse. We have developed an Ethics Task Force to address concerns of appropriate treatment, and we aim to develop a consensus for standards of appropriateness in venous care.
What are the pros and cons of thrombophilia testing for venous thromboembolism?
The biggest pro of thrombophilia testing is that you can identify a case of genetic thrombophilia (and occasionally acquired thrombophilia, such as antiphospholipid antibody syndrome), which may alter your management of patient care for prophylaxis in the future by anticoagulation and provide increased awareness. The most beneficial cases are those in which identifying the hypercoagulable condition leads to treatment that will reduce the risk for recurrence, or in the case of young women of child-bearing age, thrombophilia is occasionally associated with spontaneous abortions and prophylactic anticoagulation may reduce the risk for fetal loss.
The downside of identifying a positive thrombophilic test is that the person may not be at high risk, yet is labelled as being at risk, which can influence health care third-party payers or life insurance coverage.
What is your decision-making process for choosing a treatment approach to pathologic perforator veins? Are there any recent technologic or technical innovations in which you see promise?
Despite several randomized controlled trials comparing perforator treatment with nonoperative treatment, the decision on when to treat perforator veins is unclear. One major reason for the inconsistency in outcomes from randomized controlled trials is that most of these studies include concurrent intervention of saphenous vein interruption with perforator treatment. This type of concurrent treatment makes it impossible to determine the direct effect of removing perforators.
However, what we do know is that perforators with high outward flow, large diameters, and those associated with an active ulcer, healed ulcer, or skin at risk for ulceration are most likely to be pathologic and contributors to clinical signs (clinical, etiology, anatomy, pathophysiology [CEAP] C4–C6). These should be considered for treatment. For less severe cases (CEAP C2, varicose veins but with symptoms), perforator treatment is less likely to help but may be useful if the perforator leads to a specific point of discomfort and pain. There is no evidence that treating perforators for asymptomatic disease is of clinical benefit.
Methods for perforator elimination have shifted from subfascial endoscopic perforator surgery to open direct interruption and cutdown and, more recently, to thermal ablation or foam sclerotherapy. Thermal ablation techniques show results comparable to open techniques when performed by trained physicians with sufficient technical skills.1,2 Thermal techniques are an attractive alternative to open techniques due to their less invasive approach. Foam sclerotherapy also provides treatment of the perforator and additionally allows obliteration of other associated veins, including the periulcer venous network that surrounds ulcers, eliminating feeding veins into the ulcer bed.
If you could change one element of saphenous vein care across the United States to better ensure appropriate delivery, what would it be?
Appropriateness in venous care is important. To ensure appropriate delivery of care, providers and insurers have to agree on the indication for treatment. Currently, there is no national coverage determination (NCD) that is implemented by all insurers. Having a single NCD that represents appropriate venous care or working with insurers to agree on general coverage policy would provide consistency in indications and would limit inappropriate treatments. Clinical guidelines provide some evidence for determining appropriateness. However, due to variability among providers, nuances of individual cases, and variability in resources, they are limited in application. Appropriateness statements or criteria provide recommendations based on expert panel ratings and existing evidence, which serve to address scenarios not completely covered by guidelines.
What are your thoughts on the EVRA trial results presented at Charing Cross and published in The New England Journal of Medicine? Do you think these data will have an effect on United States–based practices (and reimbursement)?
The recently published EVRA trial3 consisted of 450 patients with venous ulcers who were randomized to either early endovenous ablation of superficial venous reflux or early compression alone. The primary outcome was time to ulcer healing, and the investigators found that early endovenous ablation resulted in faster healing in terms of leg median time to healing of 56 days (95% confidence interval [CI], 49–66 days) as compared with 82 days in the early compression group (95% CI, 69–92 days). This resulted in more patients with healed ulcers in the early ablation group (hazard ratio for ulcer healing, 1.38; 95% CI, 1.13–1.68; P = .001). These findings are in contrast to the previously published ESCHAR trial findings,4 in which ulcer recurrence was reduced by saphenous treatment but not the rate of ulcer healing. The EVRA data provide scientific evidence that supports early intervention and should lead to improved care in the United States. As such,
I believe that the data should provide insurers with more evidence to support early intervention.
What is one theme or message from the 2018 AVF annual meeting that you would want broadcast to all venous practitioners?
There are many areas that AVF is working on for the upcoming future, including research, advocacy, and appropriateness of venous care. We believe appropriateness is one of our top priorities as we look to 2019. We are also looking at potential ways to revise and improve the CEAP classification and develop guidelines for compression after ablation, endothermal heat-induced thrombosis, and utilization of postablation ultrasound.
1. Dillavou ED, Harlander-Locke M, Labropoulos N, et al. Current state of the treatment of perforating veins. J Vasc Surg. 2016;4:131-135.
2. Lawrence PF, Alktaifi A, Rigberg D, et al. Endovenous ablation of incompetent perforating veins is effective treatment for recalcitrant venous ulcers. J Vasc Surg. 2011;54:737-742.
3. Gohel MS, Heatley F, Liu X, et al. A randomized trial of early endovenous ablation in venous ulceration [published online April 24, 2018]. N Engl J Med.
4. Barwell JR, Davies CE, Deacon J, et al. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004;363:1854-1859.
Elna Masuda, MD
Hawai‘i Pacific Health, Straub Medical Center Department of Vascular Surgery