Vein Therapy News

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ANNIVERS

OCTOBER/NOVEMBER 2017 Vol. 10, No. 5 VEINTHERAPYNEWS.COM

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An ACP recognized resource for news and information for and about the phlebology community

23 VNUS patents expire, ending royalties

By Larry Storer Twenty-three patents that generated millions of dollars in royalties for VNUS Medical Technologies and its subsequent owners for 20 years expired in September. Because these royalties no longer have to be paid, vein ablation product suppliers could pass that savings on to physicians or fund new products developed by innovators who have been stifled by the active patents.

Expired is U.S. Patent Numbers 6,258,084 (the ‘084 patent), which is also published as eight other patents, all of which relate to the apparatus for applying energy to biological tissue, including the use of tumescent tissue compression, and the method physicians are supposed to follow.

In addition to the ‘084 patent, which expired Sept. 11, are U.S. Patent Nos. 6,752,803 (‘803 patent), 6,969,388 (‘388 patent), 7,396,355 (‘355 patent), 20,010,016,739 (‘739 patent), 20,010,041,888 (‘888 patent), 20,040,243,201 (‘201 patent),

20,080,039,793 (‘793 patent) and 20,080,039,829 (‘829 patent).

Also expired Sept. 11 is the 6,769,433 (the ‘433 patent), which is also published as 13 other patents, all of which relate to an expandable vein ligator catheter having multiple electrode leads, and the method for using it.

VNUS PATENTS

continued on page 18

REIMBURSEMENT With a proactive path, medicine is still good business

By Gordon Gibbs, MD The term “business” is defined by Miriam Webster Dictionary as “the activity of making, buying, or selling goods or providing services in exchange for money.” In its most basic form, success in business is simply making more money than you spend.

When applied to the business of medicine, the lines of success become murky.

Success (profitability) in any modern American health care business is a challenge because money is typically not exchanged at the time of service provided; it’s reimbursed by a third-party insurance (private or government-run Medicaid/Medicare) at a later date.

Unfortunately, the amount reimbursed and the timeline for it to appear can become a gray area that will mercilessly run some physicians out of business. It’s a cash flow reality that must be factored when opening or running any size medical operation.

Our experience with both private and government forms of reimbursement have introduced different challenges. With private insurance, patients must be pre-authorized and coverage estimates clearly explained upfront so the patient (the customer) can best prepare for any out-of-pocket expenses.

Among colleagues in a spectrum of medical specialties, we’ve seen a fair share of resubmittals related to incomplete documentation, erroneous documentation or challenges to

medical need with commercial insurance (think Aetna, United, Blue Cross/Blue Shield, etc.). Once the paperwork is properly submitted and the patient successfully treated, these large insurance companies may take longer to reimburse but the amount is larger than Medicaid or Medicare, which pays very little but previously (and reliably) paid quickly.

Medicaid/Medicare presents a different and far more complex set of issues. In our case, the unprecedented growth of “covered lives” since the expansion of Medicaid through Obamacare created a significant uptick in patient volumes at some of our locations.

Because of the patient volumes and one-sided payer mix, any hiccup to the system is quickly felt. Our experience has been that the state system that oversees and approves of their health care is, quite simply, overwhelmed.

In March 2017, Colorado’s Medicaid department deployed a complex new computer software to manage physician reimbursement. The software required providers to re-enroll their credentials with a new third-party provider, DXC Technology.

More than 5,000 providers have since enrolled and Colorado’s Medicaid department says it’s largely reduced the number of uncompensated claims.

However, we can tell a different story, along with many of our professional colleagues. We still await reimbursement for claims submitted when the system first went online.

One of the “bread and butter” codes covers regular office visits and evaluations. The “E/M” codes constitute a large number of new patient and follow-up office visits that deal REIMBURSEMENT

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INSIDE THIS ISSUE ACP plans changes for 31st Congress Physician, take care of yourself first Investigating hypotonic solutions for sclerotherapy CASE STUDY: Swollen legs lead to finding cancer Protecting your data: Local or in the cloud

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NEWS 1 23 VNUS patents expire

Twenty-three patents that generated millions of dollars in royalties for VNUS Medical Technologies and its subsequent owners for 20 years expired Sept. 11. Because some royalties no longer have to be paid, vein ablation product suppliers could pass that savings on to physicians or fund new products developed by innovators who have been stifled by the active patents.

17 ACP 31st Annual Congress

The 31st Annual American College of Phlebology Congress (APC) will be Nov. 2-5 at the JW Marriott in Austin. More than 75 companies and organizations representing treatment, compression, practice management and medical associations are expected to exhibit to about 1,000 expected attendees.

THE PRACTICE 22 Is IAC certification worth it?

Manu Aggarwal, MHSA, MD, and Ashley Watercutter, RVT, discuss whether the Intersocietal Accreditation Commission (IAC) vein clinic certification is worth going through the process.

Dr. Aggarwal explains why the Vein Care Center Laser Specialists was one of the first practices to earn the IAC certification.

SECOND LOOK 1 Is medicine still good business?

By taking a “proactive versus a reactive” approach, there is a path to a win/win for clinicians and the insurers when it comes to reimbursement. Gordon Gibbs, MD, concludes that contrary to the concerns of traditional business lenders and advisors, medicine can still be good business.

26 Hypotonic water solutions

Ronald Bush, MD, is researching sclerosant strength concentrations for sclerotherapy, and is using Sotradecol 0.1 percent diluted with 1/2 normal saline. Histologic findings reveal significant sub-intimal damage, very little cellular debris, and in many instances, vessel wall fusion.

28 CASE Studies: Swollen legs

Every so often, what seems like a routine problem can surprise you. Deborah L. Manjoney, MD, shares two case studies that were both interesting and surprising.

DEPARTMENTS VTN Report

4 Product News 36 Advisory Board 38

EDITORIAL 254-399-6484

VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2017

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NEWS THE

VTNREPORT CEO OF CLEVELAND CLINIC ABU DHABI TO SUCCEED DR. COSGROVE AS CEO, PRESIDENT The CEO of Cleveland Clinic Abu Dhabi will become the new head of the Cleveland Clinic in January. The world-renowned organization announced Sept. 1 that it had selected Tomislay “Tom” Mihaljevic, MD, as its next CEO and president to succeed the Toby Cosgrove, MD, who is stepping aside.

Dr. Mihaljevic, 53, joined Cleveland Clinic in 2004 as a cardiothoracic surgeon specializing in minimally invasive and robotically assisted cardiac surgeries. Since 2015, he has served as CEO of Cleveland Clinic Abu Dhabi, overseeing the hospital’s strategy and operations as the first U.S. multispecialty hospital to be replicated outside of North America, including directly managing the hospital’s patient experience and strategy & business development programs.

Dr. Mihaljevic was the Board of Governors and Board of Directors unanimous choice to succeed Dr. Cosgrove based on the unanimous recommendation of a nomination committee that conducted an extensive review of potential successors.

Dr. Cosgrove will transition Dr. Mihaljevic through the end of the year. Dr. Cosgrove intends to move to an advisory role on Jan. 1, 2018, when Mihaljevic assumes the full duties of president and CEO. A native of Croatia and a naturalized American citizen, Dr. Mihaljevic earned his medical degree from the University of Zagreb, before moving to the United States in 1995 to join Brigham and Women’s Hospital in Boston. He moved to Cleveland Clinic in 2004 as a cardiothoracic surgeon and helped to build Cleveland Clinic into the world’s largest robotic practice.

MEDTRONIC GIVES MAZOR ROBOTICS $40M MORE FOR MEETING GOALS EARLY Mazor Robotics, which entered a robotic surgery partnership with Medtronic last year, has reached the next stage of the collaboration ahead of schedule, picking up another $40 million from Medtronic.

Medtronic is assuming global distribution rights for the Mazor X Surgical Assurance Platform in the spine market. The duo is also co-developing products that combine Mazor’s surgical planning chops with Medtronic’s expertise in surgical navigation and implant systems. They plan to unveil the first fruits of this collaboration in the fall.

Mazor CEO Ori Hadomi said the strategic partnership between Mazor and Medtronic has already resulted in 59 Mazor X system orders since the October 2016 launch and reflects an accelerated sales cycle due to customers’ eagerness to adopt its solutions.

ABBOTT RELEASES SOFTWARE TO PROTECT PACEMAKERS FROM HACKER ATTACKS Abbott has released a software security update to protect its cardiac pacemakers from hacking.

The firmware update is intended to fix a cybersecurity weakness that allowed hackers to affect the battery life and pacing of 465,000 devices implanted in patients in the United States.

The FDA signed off on the update in late August, clearing health care providers to start moving their patients over to the new firmware. Patients will need to visit their doctors to receive the update, which is delivered by holding a wand over the site of the implant. Based on the failure rate of previous firmware updates, Abbott thinks there is a less than 0.03 percent chance of the device losing its settings or functionality.

Abbott and the FDA are advising doctors and patients to discuss these risks and the cybersecurity dangers the patch addresses at their next scheduled visit. In some cases, the risks may necessitate the performance of the procedure at a facility with a temporary pacemaker generator. Neither organization recommends the prophylactic removal of the devices.

Patients with unpatched devices are vulnerable to hacking. The FDA has reviewed information that suggests hackers could use commercially-available equipment to gain access to a patient’s device. Once the hacker has control, they can rapidly deplete the battery or alter the pacing, putting the health of patients who rely on their pacemakers at risk.

MED DEVICE FIRM, INCUBATOR RETHINK Health care PRODUCTS, APPLICATIONS Two Illinois-based organizations have formed a partnership to rethink health care innovation.

Deerfield-based Baxter International, a medical device company, and Chicago-based Matter, a health technology incubator, will work together to improve health care quality and value via new ideas and products.

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More specifically, Baxter will supply Matter startups with the tools they need to advance their innovations. In turn, Matter will introduce Baxter to its member companies and provide exclusive access to technologies in development.

Matter CEO Steven Collens has said the two organizations have been talking for a long time.

But it’s only in the last two months or so that Matter has gotten to know the individuals at Baxter who are thinking strategically about new technologies. “[Baxter is] really getting strategic about how they’re going to work with startups and entrepreneurs,” Collens said. David Roman, vice president of strategy for Baxter’s global business, noted his company’s interest in innovative thinking.

“Our work with Matter will help Baxter provide meaningful support for health care innovation in Chicago,” he said.

CONSUMER FITNESS GADGETS FIND HOME PARTNERING WITH INSURANCE COMPANIES Fitbit’s push to make its fitness trackers more than a consumer fitness gadget and play a role in health care and corporate wellness programs through Fitbit Group Health and other initiatives has led to partnerships with UnitedHealth care, Qualcomm and other organizations. Equally important for a publicly traded company, those collaborations offer ways to help Fitbit continue to expand its customer base. It also added digital health experts such as Adam Pellegrini, who was previously Walgreens’ vice president of digital health.

Apple and Aetna seem to be taking a page from those efforts. After these companies formed an alliance last year, CNBC reports that Aetna has now found someone to lead those wellness efforts. Ben Wanamaker hails from Walmart where his job has entailed heading up business development and strategy for the company’s health, wellness and e-commerce businesses, with a focus on partnerships.

About one year ago, when the alliance with Apple was first announced, Aetna said it would subsidize the purchase of Apple Watches, becoming the first payer to do so. Although the amount of the subsidy would depend on the plan, Aetna noted at the time that some employer group participants could pay the balance of the cost of the Apple Watch through payroll deductions.

Aetna also said it would offer several iOS-exclusive health initiatives, including apps that run on the Apple Watch, iPhone and iPad. Aetna is working on apps for care management and wellness, medication and adherence, health plan enrollment and to integrate with Apple Wallet to allow members to pay medical bills from their mobile devices.

POLICE, NURSE INTERACTION LEADS UTAH HOSPITAL TO BAN POLICE FROM ER University of Utah Hospital updated its policy for police interactions the day after an officer arrested a nurse who refused to take a blood sample from an unconscious patient. It now requires police officers to interact directly with the hospital supervisor.

The policy was officially put in place in mid-August following the incident in late July, reports The Salt Lake Tribune. The arrest made headlines in late August after the nurse, Alex Wubbels, and her attorney released body camera footage that shows her interactions with the Salt Lake City police officer.

Salt Lake City detective Jeff Payne asked Wubbels to draw blood from a patient on the burn ward for the investigation into a fiery car accident; however, the patient was unconscious and unable to consent to a blood draw, and the police did not have a search warrant. When Wubbels refused to comply with the officer’s request, she was manhandled by angry police, handcuffed and put into a patrol car, according to camera footage.

Gordon Crabtree, University of Utah Health’s interim CEO, said in a press conference Sept. 4 that Wubbels followed its patient privacy policies and “handled the situation with utmost courage and integrity.”

Crabtree and Chief Nursing Officer Margaret Pearce, Ph.D., laid out the hospital’s updated policies at the press conference. Officers will not interact with nurses or other frontline staff and instead must meet with the hospital supervisor. Law enforcement officials will also not be allowed to enter certain areas of the hospital like the emergency department, burn ward or other patient areas.

Crabtree said the incident at University of Utah Hospital should prompt other hospitals to reexamine and update their policies for police interactions.

Wubbels was not charged with anything and as of yet has not filed suit against the Utah police department. VT N

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

Not actual patients.

Help your patients get back to living.

Venous leg ulcers recur in 70% of patients.

For a patient with a venous leg ulcer, everyday pleasures can seem out of reach, and may lead to feelings of isolation and depression.1,2 FDA-approved Varithena®, a Microfoam UDSS procedure, improves C5/C6 symptoms and treats the underlying symptoms of venous insufficiency. Varithena® can go where other wire-based ablation devices can’t, treating GSV system veins above and below the knee of any shape, www.varithena.com and of diameters up to 25.9mm.3 Visit Varithena.com

Before Varithena®

3 months after Varithena®

1. Nogueira, G. et al. “Quality of Life of Patients with Chronic Venous Ulcers and Socio-Demographic Factors.” Wounds. 24.10, 2012, 289-292.

2. Jones, J. et al. “Depression in patients with chronic venous ulceration.” BJoN. 15.11, 2006, 17-23.

3. See https://www.btg-im.com/BTG/media/Varithena/materials/Varithena_Full_Prescribing_Information.pdf Section 6.1.

INDICATIONS

Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

IMPORTANT SAFETY INFORMATION The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.

Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.

Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.

Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism or recent (within 3 months) major surgery, prolonged hospitalization or pregnancy are at increased risk for developing thrombosis.

The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis and deep vein thrombosis.

Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena®.

© 2017 Biocompatibles, Inc., a BTG International group company. All rights reserved. Varithena is a trademark of Provensis Ltd, a BTG International group company. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. NA-VAR-2017-0867

Varithena® (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 Brief Summary of Prescribing Information. For complete Prescribing Information, consult official package insert.

INDICATIONS AND USAGE Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

In Varithena®-treated patients, 80% of pain events in the treated extremity resolved within 1 week.

DOSAGE AND ADMINISTRATION Varithena® is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities.

Proximal symptomatic venous thrombi occurred in <1% of patients treated with Varithena®. Approximately half (49%) of patients with thrombi received treatment with anticoagulants.

Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena®.

CONTRAINDICATIONS The use of Varithena® is contraindicated in patients with: • known allergy to polidocanol [see Warnings and Precautions] • acute thromboembolic disease WARNINGS AND PRECAUTIONS Anaphylaxis Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.

Tissue Ischemia and Necrosis Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.

Venous Thrombosis Varithena® can cause venous thrombosis [see Adverse Reactions]. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis.

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of Varithena® cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice.

A total of 1333 patients in 12 clinical trials were evaluated for safety when treated with Varithena® at dose concentrations of 0.125%, 0.5%, 1.0% or 2.0%, including 437 patients treated with Varithena® in placebo-controlled clinical trials.

Adverse reactions occurring in 3% more patients receiving Varithena® 1% than receiving placebo are shown in Table 1.

Table 1: Treatment-emergent adverse reactions (3% more on Varithena® 1% than on placebo) through Week 8 (n=588) Adverse Reaction Pain in extremity Infusion site thrombosis b Contusion/injection site hematoma Limb discomfort Tenderness/injection site pain Venous thrombosis limbc Thrombophlebitis superficial Deep vein thrombosis

Placebo (N=151) 14 (9.3) 0 9 (6.0) 5 (3.3) 5 (3.3) 0 2 (1.3) 0

Varithena® 1.0% (N=149) 25 (16.8) 24 (16.1) 23 (15.4) 18 (12.1) 16 (10.7) 12 (8.1) 8 (5.4) 7 (4.7)

Pooleda Varithena® (N=437) 65 (14.9) 46 (10.5) 38 (8.7) 32 (7.3) 30 (6.9) 24 (5.5) 40 (9.2) 10 (2.3)

a Includes Varithena® 0.125%, 0.5%, 1.0%, and 2.0% from the placebo-controlled trials. b Retained coagulum. c Common femoral vein thrombus extension (non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein).

In the 1333 patients treated with Varithena®, the following venous thrombus adverse events occurred: common femoral vein thrombus extension (2.9%), proximal deep vein thrombosis (DVT) (1.7%), distal DVT (1.1%), isolated gastrocnemius and soleal vein thrombosis (1.4%).

Since Varithena® induces thrombosis in the treated superficial veins, D-dimer is commonly elevated post-treatment and is not useful diagnostically to assess patients for venous thrombus following treatment with Varithena®.

Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician compounded foam sclerosants. None of the 1333 patients in the Varithena® trials experienced clinically important neurological or visual adverse events suggestive of cerebral gas embolism. The incidence of neurologic and visual adverse events within 1 day of treatment in the placebo-controlled studies was 2.7% in the pooled Varithena® group and 4.0% in the placebo groups.

Skin discoloration adverse events were reported in 1.1% of the pooled Varithena® group and 0.7% of the placebo group in the placebo-controlled studies.

DRUG INTERACTIONS No specific drug interaction studies have been performed. There are no known drug interactions with Varithena®.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of Varithena® in pregnant women. Do not use Varithena® during pregnancy.

Labor and Delivery The effects of Varithena® on labor and delivery in pregnant women are unknown.

Nursing Mothers It is not known whether polidocanol, the active pharmaceutical ingredient in Varithena®, is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering Varithena® to a nursing woman.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Of the 1333 subjects in clinical studies treated with Varithena®, 9.1% (n=121) were ≥65 years of age. No clinically important differences in safety or efficacy were observed between older and younger patients in all studies.

OVERDOSAGE There are no known cases of overdosage with Varithena®. In clinical studies, total volumes of up to 60 mL of Varithena® per treatment session have been administered.

Manufactured for Provensis Ltd by: Biocompatibles UK Ltd Chapman House, Weydon Lane, Farnham, UK, GU9 8QL. Distributed by: Biocompatibles, Inc. 115 Hurley Road, Building 3, Oxford, CT 06478 Provensis Ltd, Biocompatibles UK Ltd, and Biocompatibles, Inc. are BTG International group companies Varithena is a registered trademark of Provensis Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd

http://www.centerforvein.com/WeAreCVR

NEWS

LimFlow study yields positive results for CLI LimFlow SA has published positive results from the pilot study of the LimFlow Percutaneous Deep Vein Arterialization System (pDVA) in the July issue of the Journal of Endovascular Therapy.

The paper is entitled “Midterm Outcomes from a Pilot Study of Percutaneous Deep Vein Arterialization for the Treatment of No-Option Critical Limb Ischemia.”

The LimFlow System is a novel, purely percutaneous device for the treatment of end-stage critical limb ischemia (CLI) when all other revascularization efforts have been exhausted.

The authors conclude that, “pDVA is an innovative approach for treating no-option CLI and represents an alternative option for the ‘desert foot,’ potentially avoiding major amputation. Our results demonstrate its safety and feasibility, with promising early clinical results in this small cohort.”

The prospective, open-label, single-arm pilot study was led by primary investigator Steven Kum, MD, of Changi General Hospital in Singapore, and encompassed seven no-option CLI patients with an average

Aesthetic Vein Conference offers all new information

By Ron Bush, MD, FACS Many physicians that treat venous disease have a very limited knowledge of the pathophysiology of large and small vessel disease. Most vein conferences cover the same material year after year with little new information. In order to have a successful vein practice in the future, the physician will have to address all facets of venous disease.

Insurance reimbursements are decreasing rapidly and may disappear forever for the treatment of venous disease. Eighty percent of all patients, even with varicosities, may be classified as cosmetic in the future. The vast majority of patients that you will see in a venous practice will have spider telangiectasia or veins of the face and hands.

Based on years of clinical experience and research in the dermatopathology lab, I have developed techniques that will improve patient outcome, avoid complications and give you the physician a sound grounding in all aspects of venous disease.

Aesthetic Vein Conference is dedicated to an aspect of venous disease that for the most part is ignored and research and publications are lacking.

The first 2018 Aesthetic Vein Conference, which will be open to only 75 physicians, will

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age of 85. All patients had diabetes and were Rutherford Class 5 or 6, with 86 percent (6 of 7) also classified as WIfI (Wound Ischemia foot Infection) “high risk.”

All primary safety endpoints were met in 100 percent of patients, with no deaths, above-the-ankle amputations or major reinterventions at 30 days. All patients demonstrated symptomatic improvement with formation of granulation tissue, resolution of rest pain, or both. The technical success rate was 100 percent.

At six months, 86 percent of patients (6 of 7) had avoided major amputation, and at 12 months 71 percent of patients (5 of 7) had done so. Complete wound healing was achieved in 57 percent of patients (4 of 7) at six months and in 71 percent of patients (5 of 7) at 12 months. The median healing time was 4.6 months.

Perfusion – or blood circulation through tissues in the foot – rose dramatically in the LimFlow patients, from 8 mmHG preprocedure to 59 mmHG (p=0.080) at the time of healing.

be April 14 at the Hilton Palm Beach Airport.

The second conference will be Oct. 13. Ronald Bush, MD, FACS, will be course director.

Content will describe cutaneous venous hypertension from spider veins to ulcers.

Objectives with spider veins will be: • Understanding the histology • Recognize the pathways of pathophysiology • Demonstrate new techniques that provide for rapid clearance and improved cosmetic results • New sclerosant solutions • Utilizing micro-surgical techniques • Avoiding complications • Post treatment care.

Facial veins objectives include: • Understand the complex venous network • Avoid potential complications when treating • Demonstrate the use of foam sclerotherapy as the primary treatment for all large facial veins • Safer and more effective than any laser • Post treatment care Hand vein objectives include: • Recognize the variations in venous anatomy • Avoid nerve injury or other complications • When to perform micro-phlebectomy or foam sclerotherapy • Illustrate the technique of hand vein phlebectomy • Post treatment care

The authors commented that, “The immediate angiographic appearance was dramatic. One patient who had prior lumbar sympathectomy and was on high doses of opioids for chronic pain had a dramatic resolution of her pain within 48 hours and was opioid free.”

There were two instances of myocardial infarction within 30 days, each with minor clinical consequences. Three patients died of causes unrelated to the procedure or device at 6, 7, and 8 months, respectively.

“It is our mission to reduce the incidence of amputation, resolve pain and promote wound healing in a previously hopeless patient population and we are very encouraged by the early promising results of the LimFlow System,” said LimFlow Chief Executive Officer Dan Rose.

“The high technical success rate also demonstrates that our novel concept of percutaneous and minimally-invasive bypass below the knee is an achievable and reproducible technique. We look forward to the results from our U.S. feasibility study, which is currently enrolling, and

Breast/Chest Veins Objectives include: • When and how to treat • Avoid potential complications when treating Also covered in this segment will be: • Cosmetic venous issues that commonly occur after reconstructive surgery • Obtaining superior cosmetic results for patients with varicosities • Special session on difficult case studies • How I treat perforators Complete information is available online at aestheticveintraining.com/conferences/.

Vein Med Consultants in Palm City, Fla., can be contacted by calling 407-900-8346 or by emailing veinmedconsultants@gmail.com. VT N Ronald Bush, MD, FACS, is one of the nation’s foremost specialists in venous disease.

Dr. Bush co-founded and is the medical director for Vein Experts, a national group of professionals specializing in the care and treatment of venous disease. He has published numerous peer reviewed journal articles and is an innovator of many techniques utilized in the treatment of venous disease. He is board certified in vascular surgery. Current research is devoted to the manifestations of cutaneous venous hypertension. Dr. Bush has developed a targeted approach to the treatment of venous ulcers and has published his technique in various journals.

our international post-market, multi-center study outside of the U.S. to validate these early findings.”

The LimFlow System is designed to restore perfusion to the ischemic foot, which may relieve rest pain, promote chronic wound healing, reduce major amputations and restore mobility for patients when used as part of a multi-disciplinary team approach.

It uses proprietary ultrasound-guided catheters and covered nitinol stents to uniquely bypass diseased arteries and divert blood flow into the tibial vein to vascularize the ischemic foot.

LimFlow is a private, venture-backed medical device company transforming the treatment of CLI in Europe.

The LimFlow System received the CE Mark in October 2016 and is currently available commercially in Europe. The LimFlow System is only available for investigational use in the United States, and has not been approved for sale in the United States, Canada or Japan. VT N READ MORE: limflow.com

AVF’s 2017 Fall Fellows Course in Venous Disease registration open The American Venous Forum’s 2017 Fall Fellows Course in Venous Disease will be Dec. 8-10 at Harborview Medical Center in Seattle, Wash. Fellows in an accredited training program do not pay registration fees to attend. In addition, the AVF provides a travel stipend, hotel sleeping room and meals while at the course for fellows.

The course is presented for the benefit of fellows and residents within the specialty of vascular surgery, interventional radiology, cardiology, vascular medicine and associated programs.

The goal of the course is to educate and update the attenders regarding the latest theories and developments in the clinical practice of vein disease management.

Fellows will gain an overall understanding of vein disease to allow them to successfully incorporate venous knowledge, skills and techniques into their overall practice as they make the transition from training to the clinical practice. VT N REGISTER AT: crm.veinforum. org/public/event/details/0b5b7c9 85ac3ced39a8d76e951304bd9f 945 1a26/1

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

APPROVED BY FDA • 87% PATIENT SATISFACTION VS. 64% WITH STS*

Her legs aren’t the only place where the results will show.

You may also see it in her expression.

Not an actual patient

In a clinical trial, 95% of patients treated with Asclera® (polidocanol) Injection for spider and reticular veins showed “good improvement” or “complete treatment success,” with a patient satisfaction rating significantly higher than STS (87% vs. 64%).*

BEFORE

AFTER

See full Prescribing Information for data.

*

INDICATIONS: Asclera (polidocanol) Injection is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter.

IMPORTANT SAFETY INFORMATION: For intravenous use only.

CONTRAINDICATIONS: Asclera (polidocanol) Injection is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.

WARNINGS AND PRECAUTIONS: Anaphylaxis: Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are most frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately.

Accidental injection into an artery can cause severe necrosis, ischemia, or gangrene.

If this occurs, consult a vascular surgeon immediately.

Inadvertent Perivascular Injection of Asclera can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected.

Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and the smallest effective volume at each injection site should be used.

After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reactions.

Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.

ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera and were more common with Asclera than placebo: injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, neovascularization, injection site thrombosis.

Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.

NEWS

Asclera® (polidocanol) Injection Rx Only BRIEF SUMMARY. PLEASE CONSULT FULL PRESCRIBING INFORMATION PRIOR TO ADMINISTRATION. INDICATIONS AND USAGE: Asclera (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity.

Asclera has not been studied in varicose veins more than 3 mm in diameter.

DOSAGE AND ADMINISTRATION: For intravenous use only. The strength of the solution and the volume injected depend on the size and extent of the varicose veins. Extensive varicosities may require multiple treatment sessions.

Uncomplicated spider veins (varicose veins ≤ 1 mm in diameter): Use Asclera 0.5%.

Uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter): Use Asclera 1%.

Use 0.1 to 0.3 mL for each injection into each varicose vein. Do not use more than 10 mL per session (see Dosage and Administraion [2] of Full Prescribing Information).

Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.

DOSAGE FORMS AND STRENGTHS: Asclera is available as a 0.5% and 1% solution in 2 mL glass ampules.

CONTRAINDICATIONS: Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.

WARNINGS AND PRECAUTIONS: Anaphylaxis: Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are more frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately.

Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and use the smallest effective volume at each injection site.

After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reaction (see Dosage and Administration [2] of full prescribing information).

Accidental Intra-arterial Injection: Intra-arterial injection can cause severe necrosis, ischemia, or gangrene. If this occurs consult a vascular surgeon immediately.

Inadvertent Perivascular Injection: Inadvertent perivascular injection of Asclera can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected.

ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera and were more common with Asclera than placebo: injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, revascularization, and injection site thrombosis (see Adverse Reactions [6] of Full Prescribing Information).

To report SUSPECTED ADVERSE REACTIONS, contact Merz Aesthetics, Inc. at 1-866-862-1211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

POST-MARKETING SAFETY EXPERIENCE: The following adverse reactions have been reported during use of polidocanol in world-wide experience; in some of these cases, these adverse events have been serious or troublesome. Because these reactions are reported voluntarily from a population of uncertain size and without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma Nervous system disorders: Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness

10

Cardiac disorders: Cardiac arrest, palpitations Vascular disorders: Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis Respiratory, thoracic, and mediastinal disorders: Dyspnea Skin and subcutaneous tissue disorders: Skin hyperpigmentation, dermatitis allergic, hypertrichosis (in the area of sclerotherapy) General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush Injury, poisoning, and procedural complications: Nerve injury USE IN SPECIFIC POPULATIONS: Pregnancy: Pregnancy Category C. Polidocanol has been shown to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose. This effect may have been secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women. Asclera should not be used during pregnancy.

Animal Studies: Developmental reproductive toxicity testing was performed in rats and rabbits with intravenous administration. Polidocanol induced maternal and fetal toxicity in rabbits, including reduced mean fetal weight and reduced fetal survival, when administered during gestation days 6-20 at doses of 4 and 10 mg/kg, but it did not cause skeletal or visceral abnormalities. No adverse maternal or fetal effects were observed in rabbits at a dose of 2 mg/kg. No evidence of teratogenicity or fetal toxicity was observed in rats dosed during gestation days 6-17 with doses up to 10 mg/kg. Polidocanol did not affect the ability of rats to deliver and rear pups when administered intermittently by intravenous injection from gestation day 17 to post-partum day 21 at doses up to 10 mg/kg.

Human Studies: There are no adequate and well-controlled studies on the use of Asclera in pregnant women.

Labor and Delivery: The effects of Asclera on labor and delivery in pregnant women are unknown.

Nursing Mothers: It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering to a nursing woman.

Pediatric Use: The safety and effectiveness of Asclera in pediatric patients have not been established.

Geriatric Use: Clinical studies of Asclera did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

OVERDOSAGE: Overdose may result in a higher incidence of localized reactions such as necrosis.

HOW SUPPLIED/STORAGE AND HANDLING: Asclera is supplied in single-use, preservative-free ampules in the following packages: NDC 46783-121-52 Five 0.5% ampules (2 mL) NDC 46783-221-52 Five 1.0% ampules (2 mL) Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years. Store at 15-30°C; (59-86°F).

PATIENT COUNSELING INFORMATION: Advise the patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime. Compression stockings or support hose should be thigh or knee high depending upon the area treated in order to provide adequate coverage. Advise the patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days.

For two to three days following treatment, advise the patient to avoid heavy exercise, sunbathing, long plane flights, and hot bath or sauna.

Distributed by:

AngioDynamics and the AngioDynamics logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. Asclera is a registered trademark of Chemische Fabrik Kreussler & Co., GmbH. < © 2016 AngioDynamics, Inc. ANGAD 371 US Rev 01 11/16

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NEWS

All scrubs easily contaminated despite fabric New research shows scrubs can easily be contaminated with bacteria even when nurses wear clothing made with antibacterial fabric.

Researchers from Duke University Hospital tested whether the antimicrobial scrubs were effective in preventing bacteria contamination on 40 nurses who worked in medical and surgical intensive care units caring for one to two patients per shift at the 936-bed tertiarycare hospital.

The nurses wore three different types of scrubs over three consecutive 12-hour shifts and researchers took a series of cultures from each nurse’s clothing, patients and the environment before and after each shift.

Nurses didn’t know whether they were wearing scrubs made with traditional cottonpolyester clothing that contained silver-alloy embedded in its fibers or surgical scrubs treated with a combination of antibacterial materials.

The research team analyzed more than 2,900 cultures from bed rails, beds and supply carts in each room and 2,185 cultures from the sleeve, abdomen and pocket of nurses’ scrubs. They found no differences in contamination based on the type of scrubs worn by the nurses.

Researchers identified new contamination in 33 percent of the shifts. Scrubs were newly contaminated with bacteria during 16 percent of the shifts studied. Three of those cases occurred while nurses cared for patients who were on contact precautions because they were infected with drug-resistant bacteria and personnel entering the room were required to put on gloves and gowns.

The most commonly transmitted bacteria was Staphylococcus aureus, including MRSA and methicillin susceptible S. aureus.

The findings were published in August in Infection Control & Hospital Epidemiology, the journal of the Society for Health care Epidemiology of America.

12

Study authors said the scrubs were likely ineffective at reducing bacteria because of the low-level disinfectant capabilities of the textiles coupled with repeated exposure in a short time frame. They suggest antimicrobialimpregnated textiles might be effective if used in bed linens and patient gowns, given the prolonged exposure to patients.

“Health care providers must understand that they can become contaminated by their patients and the environment near patients,” lead author Deverick J. Anderson, MD and director of the Center for Antimicrobial Stewardship and Infection Prevention at Duke University Medical Center, said in a study announcement. “Although not effective, we looked to eliminate this risk for contamination by changing the material of nurses’ scrubs.”

Furthermore, he noted, bacteria and pathogens will always be in the hospital environment. Therefore, he said, hospitals must create and use protocols to improve cleaning of the health care environment, and patients and family members must feel comfortable asking health care providers if they are doing everything they can to keep their loved one from being exposed to bacteria in the environment. VT N

Disaster relief funds still needed EDITOR’S NOTE: This is an open letter from Marc A. Passman, MD and president of the American Venous Forum; and Lowell S. Kabnick, MD and president of the American Venous Forum Foundation.

Over the past several weeks, we have seen the devastation and destruction left in the paths of tremendous storms and strong earthquakes.

Our thoughts and prayers are with these communities in Florida, Texas, Mexico and Puerto Rico as they face the daunting task of rebuilding while mourning their losses.

It is during times like these, when even through the most horrific of events, we have the opportunity to witness the strength and resolve of the human spirit. When the news headlines of today relentlessly report on the lines of division in our nation, it is reassuring to see differences of politics and culture being set aside in order to heal the wounded and come to the aid of those in need. This is the true spirit of America; coming together in the time of crisis.

To the first responders who put their own lives in peril, to all the neighbors from next door and from across the country who donate basic necessities like water and diapers, and to all of the physicians, nurses and allied health professionals who have been working around the clock to heal the wounded, we are

DISASTER RELIEF

continued on page 29

UIP World Congress 2018 will convene Feb. 4 in Melbourne The UIP World Congress of Phlebology will be Feb. 4-8 in Melbourne, hosted by the Australian College of Phlebology.

DAILY SESSIONS

On Tuesday, Feb. 6, the first session will be Endovenous Interventions. The session will provide a hands-on experience of the latest endovenous methods to ablate the saphenous veins: laser, radiofrequency, glue and MOCA. The second session on Feb. 6 will be Sclerotherapy. In this session the latest techniques of foam sclerotherapy, glue sclerotherapy and vascular laser therapy will be demonstrated.

Session 3 on Feb. 6 will be Interventional Radiology, designed to expose attenders to a range of interventional techniques and the latest in interventional radiology.

On Wednesday, Feb. 7, the first session will be Endovenous Interventions 2. This session will continue from Day one by providing a hands-on experience of venous ablative methods including endovenous glue, MOCA and foam sclerotherapy.

Session two on Feb. 7 will be Cross-specialty, during which a range of new treatments in related specialties will be presented, including endovascular laser treatment of hemorrhoids, sclerotherapy treatment of vulvar veins, vaginal rejuvenation system and vaginal sensation improvement system.

Session three on Feb. 7 will be Venous Assessment and Pharmacotherapy, dedicated to vascular assessment, venoactive drugs and new oral anticoagulants.

On Thursday, Feb. 8, the first session will be compression, providing hands-on training in the latest compression technology. The second session that day will be Lymphedema, designed to teach attenders all about lymphedema.

HANDS-ON SESSIONS

There will be hands-on training sessions each day, providing a structured comprehensive practical experience for physicians interested in venous diseases.

The UIP 2018 Hands-on Sessions will include 32 stations spanning eight sessions.

Each session is 120 minutes. Each station is manned by at least one faculty member and a product specialist.

This allows access to a non-biased presentation of the technology and direct access to highly experienced clinicians.

The number of participants is limited to allow direct interaction with the instructors.

Sessions are informal allowing a relaxed learning experience.

Each station may include presentations, live demonstrations, models and tools. The focus will be on hands-on training on procedures and devices. Given the limited available spots and to ensure we maintain small numbers in each group, workshop allocations will be made on a first-in first-served basis.

The program and registration is at http:// uip2018.com/?mc_cid=604a059c7e&mc_ eid=841f2d5110. VT N

Amicus Therapeutics ESSENCE trial fails A drug for rare skin disease epidermolysis bullosa that Amicus Therapeutics acquired in an $847 million deal two years ago has failed a key phase 3 trial.

The ESSENCE study of SD-101 – formerly known as Zorblisa – showed that the topical wound healing agent failed to meet its primary and secondary objectives, and Amicus has now decided to scrap the program. The decision is a massive blow for patients with EB, a group of rare and life-shortening genetic skin conditions that cause the skin to blister and tear at the slightest touch. It currently has no FDA-approved therapies.

SD-101 was being assessed for its ability to treat skin blistering and lesions associated

with the disorder, but showed no improvement over placebo in hastening wound closure and increasing the number of patients with closed wounds after three months, the two primary endpoints in the trial.

Amicus’ CEO John Crowley (pictured) said at a conference that EB is among the most devastating of rare diseases, and the outcome of ESSENCE is doubly disappointing for patients and their families as it as the largestever trial of a therapeutic conducted for EB. A higher-than-expected placebo effect, perhaps due to a higher level of bandaging and wound care, could have confounded the results. VT N

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NEWS MedTech boot camp provides compliance data MedTech Compliance 101:Boot Camp,” Oct. 24-25 in Washington, will provide attendees with a thorough understanding of the compliance framework and practical approaches for addressing challenges and effectively managing compliance in a medical device company.

Topics will include: • The foundation of your compliance program and tools to support your company as it evolves • Recent Government Enforcement Actions & Areas of Focus • Identifying and mitigating your major compliance risk areas • The most recent First Amendment Developments • Managing promotional, medical, & investor communications • Health care compliance and all its glory in the medtech industry • Sunshine Act reporting so far and transparency developments at the state level. VT N READ MORE: advamed.org/compliance-101-2017

Webinar covers communication to enhance care FierceHealthIT is offering an hour-long webinar at p.m. EST Oct. 25 titled “Embed Patient Communication Tools to Enhance Care Management.”

Sponsors said patient-centered care drives care quality, and streamlined communication is the bridge between the two.

“Providers can tap into new tools and technology to facilitate better care, simplify the patient experience and make a big impact on outcomes, and learn how to protect patient data and privacy on mobile and cloud-based platforms,” said Joy Lee, a research scientist at the Center for Health Services Research at Regenstrief Institute and one of the webinar speakers.

This webinar will cover: • Optimizing the connection between patient satisfaction and engagement and quality clinical care.

• Using technology to simplify the patient experience, including appointment and health reminders.

• Measuring the success of patient communication programs.

• Protecting patient data and privacy on mobile and cloud-based platforms. VT N R E GI ST E R : ht tps://pages. q ueste x w e b.c om /S olut ion r eac h -

14

R e g i s t r a t i o n - 1 0 2 5 1 7 . html?source=FHITfull0925

MedTech workshop tackles compliance “MedTech Compliance 201: A Deeper Dive,” Oct. 25-26 in Washington, will tackle some of the thornier pressing problems confronting compliance departments across the industry.

During each interactive session, topics will receive a thorough analysis of the associated problems and approaches to manage the predictable risks and unintended consequences.

Topics will include: • Expectations, individual liability, financial implications of failure, and the future of compliance in medtech • Assessing your company’s risk profile with senior management • New demands from (potential) customers and managing the associated risks • Privacy: policies and practices • AdvaMed’s five strategic pillars and compliance • Sales compensation • Co-marketing between medtech companies and health care providers • Conducting internal compliance investigations. VT N READ MORE: advamed.org/compliance-201-2017

anticlotting medication. However, Medtronic notes, guidelines for DAPT “vary geographically and by patient presentation.”

The new trial will take place at about 70 sites worldwide and enroll up to 2,000 patients, according to Medtronic. It will assess DAPT outcomes for patients implanted with either the Resolute Onyx stent or another drug-eluting stent. Current DAPT guidelines favor bare metal stents for patients with stable ischemic heart disease; the study is intended to inform DAPT guidelines for the newer drug-eluting stents.

“We’re continuously looking at ways to invest in clinical evidence and expand our product portfolio to help address the most important unanswered questions and unmet needs in interventional cardiology,” said Martin Rothman, MD, vice president of medical affairs for Medtronic’s Coronary and Structural Heart division. In addition to generating new, meaningful evidence to help guide clinical practice, we are also looking to develop nextgeneration technologies that will build on the exceptional deliverability that physicians have come to expect with our stent platforms.”

The Resolute Onyx received FDA clearance in May, but the device has been on the European market for two years. Made of a single strand of cobalt alloy wire with a platinum-iridium core, the device has thinner struts and is more flexible without sacrificing strength. It is the largest drug-eluting stent available in the United States. VT N

FDA finalizes new guidelines for med device interoperability The Resolute Onyx elutes the drug zotarolimus to prevent the formation of scar tissue in the artery in which it is implanted.

Medtronic seeks 2,000 patients for DAPT clinical trial Medtronic is looking for patients for a randomized clinical trial that to investigate one-month dual-antiplatelet therapy (DAPT) in patients who have been implanted with Resolute Onyx, its drug-eluting stent.

Bare metal and drug-eluting stents are implanted in coronary arteries to prop them open. Drug-eluting stents are designed to prevent scar tissue from forming in the artery and requiring a follow-up procedure. After receiving a stent, patients typically receive DAPT, a combination of aspirin and a second

The Food and Drug Administration has finalized new guidance for medical device manufacturers that focuses on transparency, risk management and the use of consensus standards to ensure safe and effective interoperability with connected devices.

The new 16-page recommendations, released on Sept. 5, maintain the FDA’s steady stream of digital health guidance that has emerged as a priority under Commissioner Scott Gottlieb.

Medical device interoperability is one of several policies the agency outlined in its Digital Health Innovation Plan released in July, and it comes on the heels of finalized guidelines on the use of real-world data to regulate innovative medical devices.

Highlighting the value of data generated by medical devices across the health care ecosystem, Bakul Patel, the FDA’s associate director for digital health at the Center for Devices and Radiological Health (CDRH), said safety is the agency’s foremost concern. Consistent data formatting and greater transparency from manufacturers regarding their products interface can limit the possibility of inadvertent

medical errors.

“It’s not likely that medical device interoperability is a part of the everyday vocabulary of American consumers – and frankly, we hope it stays that way,” Patel wrote in a post on FDA’s blog. “At CDRH, we want patients and consumers to have confidence that medical devices work as intended without concern over how these devices operate together.”

The FDA references several existing consensus standards that focus on the development and design of interoperable devices. But the guideline provides leeway for device manufacturers by allowing the use of customized design standards as long as it’s openly available to all users.

With more medical devices connected to the network, manufacturers are toeing a fine line between increasing interoperability, which can provide providers with valuable real-time data on their patients, and combating cybersecurity threats.

In late August, the FDA announced a firmware update for Abbott-manufactured pacemakers to resolve cybersecurity vulnerabilities that would have allowed unauthorized users to access the implanted devices. Industry leaders have called on medical device manufacturers to take the lead on developing cybersecurity standards amid a growing number of threats against health care. VT N

Endologix ends randomization in LEOPARD trial; praises results Endologix has announced positive interim results from the LEOPARD (Looking at EVAR outcomes by primary analysis of randomized data) clinical study.

LEOPARD is the first and only head-tohead, prospective, multicenter, randomized clinical study comparing currently available endovascular abdominal aortic stent grafts.

LEOPARD directly compares the Endologix AFX and AFX2 endografts to other commercially available bifurcated aortic endografts.

LEOPARD was initiated in 2015 and has since randomized 458 patients. The primary endpoint in the study is freedom from aneurysm-related complications such as aneurysm rupture, conversion to open repair, endoleaks, migration, aneurysm enlargement and secondary interventions.

Based on the patients that have completed their one-year follow-up, freedom from aneurysm-related complications with AFX/ AFX2 is 84.7 percent, compared to 82 percent with the other devices. These preliminary results demonstrate similar outcomes between the endografts under investigation, but there is a trend towards better performance for AFX/ AFX2. VT N READ MORE: endologix.com

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NEWS

The Future of Vein Care November 2-5, 2017 + JW Marriott + Austin, Texas

Join us this November in Austin, Texas for the largest and most inclusive meeting dedicated to venous and lymphatic disease. The scientific program brings together a multi-disciplinary group of experts, addressing the full spectrum of deep and superficial vein care.

New this year: • Pelvic ultrasound session • Keynote presentations both Friday & Saturday • Overhaul of the Advanced Venous & Lymphatic sessions

• International perspectives from the UIP Symposium • Sessions specific to allied health providers

For details and registration information, please visit:

acpcongress.org http://www.acpcongress.org

advancing vein care

2017

31 ANNUAL CONGRESS ST

http://www.phlebology.org www.phlebology.org | 510.346.6800

16

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

NEWS ACP expands topics in its 31st Annual Congress Nov. 2-5 in Austin The 31st Annual American College of Phlebology Congress (APC) will be Nov. 2-5 at the JW Marriott in Austin. More than 75 companies and organizations representing treatment, compression, practice management and medical associations are expected to exhibit to about 1,000 expected attendees.

The quantity of topics covered and quality of distinguished experts representing vein care from around the world makes this one of the most important conferences available each year. In the past 31 years, the ACP Annual Congress has grown to be the largest and most comprehensive meeting dedicated to venous and lymphatic disorders in the United States.

The 2017 Annual Congress Program Committee, under the direction of Chair, Armen Roupenian, MD, FACS, FACPh, RPhS, RVT, RPVI, is presenting what the APC is promoting as a new and innovative program that will truly distinguish it from its competition.

“As the organization and larger venous and lymphatic medical community continue to grow, the Annual Congress needs to grow with them,” Dr. Roupenian said. “We wanted to expand the topics covered, types of learning and over-all depth of the program with an eye to the future of the specialty.”

Subtle changes affect the goals set out by Dr. Roupenian and the Program Committee.

Traditionally it has been a three-day conference, but this year the Annual Congress will incorporate the “Pre-Congress” day and Sunday Practice Management Symposium to create a full four-day program designed to improve patient care and valuable practice management skills.

“Most of our members aren’t allowed to just be clinicians,” Dr. Roupenian said. They’re asked to be managers, marketers and billing experts. All the while, costs are growing and reimbursements are shrinking.

“We want to equip attendees with the skills they need to be able to focus on their passion for helping patients.”

To address these skills, a completely redesigned Practice Management Symposium on Sunday will focus on process improvement, billing best practices, marketing and techniques that make a practice more efficient.

Other changes to the program include emerging treatments and topics not typically covered outside of highly specialized one- or two-day symposia. The exclusive, handson Pelvic Ultrasound Workshop will give participants a highly individualized interaction

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VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2017

17

NEWS VNUS PATENTS

continued from page 1

In addition to the ‘433 patent, the other related patents that expired Sept. 11 are U.S. Patent Nos. 7,406,970 (‘970 patent), 6,165,172 (‘172 patent), 6,200,312 (‘312 patent), 6,237,606 (‘606 patent), 7,901,402(‘402 patent), 8,267,931(‘931 patent), 8,679,110 (‘110 patent), 20,020,007,181(‘181 patent), 0,040,267,258 (‘258 patent), 20,080,249,519 (‘519 patent), 20,090,005,775 (‘775 patent), 20,090,054,884 (‘884 patent), and 20,090,137,998 (‘998 patent).

MEDTRONIC HOLDS PATENTS PROTECTING CLOSUREFAST

The vein ablation patents that aged out in September came to Medtronic with the January 2015 acquisition of Covidien, which had received the patents from TYCO Health care Group doing business as VNUS Medical Technologies.

Krystin I. Hayward, director of communications for Medtronic Aortic and Peripheral Vascular, said that Medtronic continues to own patents that protect the many innovations found in the ClosureFast catheter, such as U.S. Patent Nos. 7,828,793; 8,043,285; and 8,852,178, as well as patents to the RFS stylet to treat perforator veins and proprietary software in the ClosureFast RFG generator.

“Medtronic is the only company that offers a diverse portfolio of proven radiofrequency ablation (ClosureFast) and non-tumescent, non-thermal, and non-sclerosant solutions (VenaSeal) to treat chronic venous insufficiency (CVI),” she said.

“It is important to note the long-term clinical data as a key differentiator. The ClosureFast endovenous radio frequency ablation catheter is the only minimally invasive treatment with long-term results demonstrating its sustained success in treating patients with chronic venous insufficiency (CVI). VenaSeal has also demonstrated strong clinical outcomes out to three years.”

EVL, RF CHANGED VEIN TREATMENT LANDSCAPE

The medical method patents to treat varicose veins came about after the introduction of the laser and Diomed’s endovenous laser ablation (EVL), and the VNUS Radio Frequency (RF) generator and its Closure system.

EVL is the minimally invasive procedure that uses an optical fiber that delivers laser energy to heat the blood inside the vein. The laser energy heat damages the vein by directly perforating the vein or indirectly through the boiling of the blood and producing steam.

The optical fiber is withdrawn while laser energy is delivered, inducing thermal damage and a blood clot to occlude the length of the treated vein. The blood then flows to healthy veins.

18

The VNUS Closure system operates in a somewhat similar fashion to close a diseased vein by inserting a proprietary catheter into a vein to heat the vein wall with temperatures controlled by RF energy. Heating the vein wall causes collagen in the wall to shrink and the vein to close. The blood then flows to a healthy vein.

The cliché “familiarity breeds contempt” was never intended to describe patent infringement, but it almost explains it. Just the similarities in the two descriptions in the previous two paragraphs eventually launched eight infringement suits against 16 defendants.

It is the expiration of these 23 VNUS patents that brings to an end many of the patent infringement suits that marked this very litigious period from 2004-2011. VNUS filed three lawsuits against nine defendants, beginning with a suit against laser company Diomed Holdings in 2005 and ending with a $45.84 million judgment against two defendants in 2011: Total Vein Solutions LLC (now Total Vein Systems) and Biolitec Inc. In addition to suing Diomed, Total Vein and Biolitec, VNUS also sued AngioDynamics, Vascular Solutions, New Star Lasers dba CoolTouch Inc. (now Syneron Medical), Dornier MedTech America Inc. and Total Vein co-owners David Centanni and Tyri Schick.

Only U.S. Patent No. 6,398,777 (the ‘777 patent) is still collecting royalties on behalf of the now defunct medical laser company Diomed Holdings. For its part, Diomed filed five lawsuits against seven defendants beginning with a suit against AngioDynamics in 2004. In addition to suing AngioDynamics, Diomed also sued Vascular Solutions, New Star Lasers dba CoolTouch (now Syneron Medical), Dornier, Total Vein and its co-owners Centanni and Schick.

Diomed never survived its own legal costs, going bankrupt in 2008. Its assets were acquired by AngioDynamics.

Diomed royalties from the ‘777 patent are collected by Endolaser Associates LLC on behalf of inventors Luis Navarro, Carlos Bone Salat, Nester Navarro and Joaquina Fructoso.

The ‘777 patent and its related patents will expire in 2019.

WILL PHYSICIANS BENEFIT FROM END OF ROYALTIES?

Companies that have been paying royalties to VNUS and then Medtronic can either pass the new savings on to their customers, or they could use the money to fund new research and development.

Total Vein Systems, which fought all of the medical method patent wars and refused to settle right to the end, reduced prices on vein ablation supplies as soon as they were free from the royalties in September, owner David Centanni said. “When the RF patent ‘084 expired Sept. 11, it freed us from having to pay these costly royalty payments.

“Now that the royalty payments are gone, Total Vein can resume its mission of providing the highest quality products and the lowest cost to the vein community.

“For example, we now offer a new TVS Freedom Package that contains all of the necessary supplies for EVL for only $99.95,” Centanni said. “The package, valued at $229, contains a single-use laser fiber, SlimCath long Micro-Introducer Kit and a procedure pack.”

Hayward said Medtronic does not comment on pricing or royalty payments.

AngioDynamics, which has been paying royalties to VNUS and its subsequent owners as part of the settlement of a four-year-long lawsuit won by VNUS in 2008, did not respond by deadline as to what the end of royalties might mean for its customers.

Syneron Medical (CoolTouch); Dornier; and Teleflex (which acquired Vascular Insights) also did not comment by deadline.

MEDICAL COMMUNITY’S LITIGATION OUTRAGE

It was not just the companies who had to defend themselves in court that opposed the medical method patents and the onslaught of litigation. The medical community – from doctors practicing phlebology to the inventors of the patented products to the American Medical Association and the World Medical Association – all opposed the litigation.

“Additional litigation will indirectly affect medical practices because of the need by suppliers to pass on costs when they are pummeled by obscene awards,” Deborah Manjoney, MD, FACS and owner of the Wisconsin Vein Center and MediSpa, said in 2008 during the height of the litigation.

“Or worse, suppliers will be able to upcharge because they have forced competitors out of business.”

Jeffrey L. Light, Esq., told Vein Therapy News that patent litigation had become a revenue-generating business strategy. He is founder of Patients Not Patents Inc. “An increasingly common business model is the patent-holding company, whose sole activity is bringing lawsuits for patent infringements,” Light said.

The late John V. Dunne, MD, in 2008 a cardiothoracic and vascular surgeon, made an astute observation at the time when he said that he was most concerned about the chilling effect all the litigation might have on new thinking.

“Medical method patents inhibit the development of new procedures and techniques,” Dr. Dunne told VTN. “Anyone who has to start looking over his or her shoulder in developing new techniques, and figure out who they are going to have to pay off for patent rights, are going to think twice about it.”

Dr. Dunne passed away this spring.

The late John Kingsley, MD, told Vein Therapy News in 2008 that lawsuits are the

Achilles Heel of medicine. “The obvious result of the business-to-business lawsuits is that you and I, as practicing phlebologists, will ultimately pay the price.”

Dr. Kingsley passed away in July of 2015.

SO, HOW RICH ARE THE VNUS PATENT INVENTORS?

This may be the most interesting part of the story. Dermatologists Mitchell (Mitch) Goldman, MD, and Robert A. Weiss, MD, are the co-inventors of the now expired VNUS ‘084 and related patents.

Dr. Goldman told Vein Therapy News while we were doing an update article on the VNUS patents in 2008 that he was opposed to medical method patents.

He explained that VNUS Medical first came to them with just an idea and asked for help on a procedure and a device to help improve patient care. “We figured it out quickly, and then with the lasers it was the same thing.”

Dr. Goldman said that at the time VNUS had a “horrible” radiofrequency device. “Bob and I figured out how to make it better. It was easy. We put the tumescent anesthesia around the vein to compress the vein, and that revolutionized the entire vein industry.

“Two dermatologists who do liposuction taking one of our techniques in liposuction and using it for veins demonstrates why crossspecialty is so important in medicine – we’re not even vascular surgeons or radiologists.

“But my advice to a doctor who comes up with a new idea worth patenting is to read Shakespeare,” he said. “Shakespeare said that the first thing we are going to do is to kill all the lawyers.”

It’s easy to see where Dr. Goldman’s frustration was coming from.

“When Bob and I set out to do this, it was to benefit patient care. And he and I each got a check from VNUS for $10. I don’t know why it wasn’t just a dollar! They sent us that check and I never cashed it. It’s in a folder some place because it’s ridiculous.

That $20 was the best money VNUS ever spent because the work of the two dermatologists resulted in millions in royalties and lawsuit decisions. And all of the litigation among the companies made dozens of lawyers happy as well.

“I am totally opposed to medical method patents,” Dr. Goldman said at the time. “It is a waste of time and money. When we take our oath to be doctors, part of that oath is to teach and to advance patient care. I think that some people have forgotten their oath and it’s appalling.

“And it’s not even mostly the doctors,” he concluded. “There are a few doctors who have forgotten their oath, but mostly it is these business people. They take advantage of wellmeaning physicians.” VT N

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THEPRACTICE

Digital marketing helps practice find new patients

By Dan Stempel, MBA, MS, BS When it comes to driving new patients into your medical practice, digital marketing delivers a better ROI than traditional media – here’s why.

Over the past decade, the Internet has completely transformed the process of how people seek out medical information and make decisions about treatment. Today, more than 77 percent of patients conduct healthrelated searches online, and Google alone now processes more than 28 billion medical inquiries per year.

For vein practices, this trend represents a massive opportunity to reach a much wider audience and generate more patient appointments, all while reducing costs. In fact, recent market research conducted among hundreds of American College of Phlebology (ACP) member practices suggests that digital advertising now drives more new referrals at less than half the cost of traditional media (print, television, radio).

KEY ADVANTAGES

Why is digital marketing so much more effective than traditional media? Simple: targeting, flexibility and analytics.

Digital advertising platforms like those offered by Google and Facebook allow

vein practice marketers to build campaigns using incredibly specific qualifying criteria.

Audiences can be targeted based on a variety of factors, including gender, age, geographic location, household income and demonstrated interests. Advanced analytics enables clinics to make critical adjustments to messaging and targeting, or scale their spending in specific areas in order to optimize campaign performance over time.

On the other hand, when it comes to traditional media, it’s often a question of throwing things against the wall and seeing what sticks.

For example, if you purchase a set number of TV or radio spots, all you can really do is sit back and hope that your message reaches the right ears and that they’re reached the decisionmaking stage in their path to treatment. That is to say, your degree of visibility, flexibility, and transparency is extremely limited – and all three are critical to ROI.

SEARCH ENGINE MARKETING

Search engine advertising is the best way to generate tangible results over a short period of time. Search engine optimization (SEO) will, of course, play a vital role in a practice’s longterm success, but for the vast majority of vein practices, search ad-driven conversions tend to outnumber organic ones by a significant margin.

In fact, vein clinics that boasted the topthree organic search rankings in a given geographic market found that 29 percent of available referrals came from organic search, whereas 71 percent came from pay per click (PPC) ads.

That said, simply investing in search ads isn’t enough to guarantee success. You have to be able to reach the right patients with the right materials at the precise moment they exit the symptom/diagnosis phase of their online research and become transactional. This requires a very specific approach to keyword targeting in which your strategy focuses on conversion-driven search terms.

For example, a patient searching broad terms such as “varicose veins,” or “phlebitis” is likely in the symptom/diagnosis stage of their patient journey, and therefore less likely to convert.

However, a patient using keywords such as “vein treatment nyc,” “EVLA treatment near me,” or “which insurance covers varicose vein procedures in Florida?” has likely reached the decision-making stage. That means they’re far more likely to click on an ad and book an actual appointment or attend your next screening day.

FINDING THE RIGHT PARTNER

I see a lot of digital agencies in our industry focusing on “vanity metrics” such

as traffic, search rankings for general terms and impressions as indicators of success. This can be incredibly misleading. You might be driving all the traffic in the world to your site, but that doesn’t necessarily guarantee a direct correlation to an increase in your patient volume.

Vein practices should look for marketing vendors with years of industry-specific experience who can also point to positive ROI they’ve generated in the past. Having generated more than 300,000 online referrals for vein practices over the years, MD Connect has the specialty-specific knowledge and experience to deliver consistent, tangible results.

Case in point, back in March of 2016 we developed a campaign for the Muto Surgical Center with the goal of driving patient appointments for an upcoming free vein screening event.

We generated 37 online referrals at a cost of $46.43 per lead, ultimately leading to 20 screening appointments booked and an estimated 10 times ROI. The campaign’s impressive performance secured us a slot as finalists for the 2016 Search Engine Land “Landy” Awards, which recognize successful SEM campaigns across one or multiple searchbased advertising platforms.

If you’d like to learn more about how digital advertising can help boost new patient appointments for your vein clinic, contact us today. New business is out there and ripe for the taking – let us help you capture it in the most time – and cost-efficient way possible. VT N Dan Stempel has been directly involved with the vein treatment market since 2005, first as the director of EVLT Marketing with Diomed Inc., and since 2008 as president of MD Connect Inc., an award-winning digital marketing firm focused solely on performancebased programs. He has worked extensively with more than 200 vein practices on digitally-focused marketing initiatives. Stempel has more than 20 years of marketing, management and technical experience in the medical industry, and he has been a faculty speaker multiple times at American College of Phlebology conferences. He holds a BS from Cornell University and an MBA and MS from Stanford University. He may be contacted by email at dstempel@mdconnectinc.com.

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OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

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21

THEPRACTICE

IAC VEIN CENTER

Accreditation assures patients of highest vein care standards Editor’s Note: One of the points physicians cite when discussing problems in our specialty is the inconsistency in practices of experienced phlebologists and other physicians entering the field as a secondary revenue flow. One tool to make practices consistent is the Intersocietal Accreditation Commission (IAC) accreditation.

One of the first practices to embrace IAC accreditation was the Vein Care Center Laser Specialists in Lima, Ohio, with a satellite office in Celina, Ohio. For this article, Manu Aggarwal, MHSA, MD, discussed IAC accreditation with RVT Ashley Watercutter.

Q. WATERCUTTER: When did you obtain your Vein Center accreditation?

A. AGGARWAL: The Intersocietal Accreditation Commission (IAC) has been a part of the practice since 2007. That is when we first obtained our vascular accreditation for venous ultrasound. Since then, we have been successful in maintaining our accreditation for Vascular (with a focus on venous). When the IAC introduced Vein Center Accreditation in 2013, I knew just then that we had to apply and try to be one of the first to obtain it. So myself, and our technical director, started looking at the guidelines as soon as they were made available and began creating guidelines for clinical processes that we were already doing.

Then in 2015, it was announced that Blue Cross Blue Shield (BCBS) of Massachusetts would require any facility performing endovenous laser ablations to be Vein Center Accredited by Sept. 1, 2015. This was later extended to Jan. 1, 2016. We obtained our Vein Center Accreditation in May 2015.

Q. Did you find it an easy process?

A. In the beginning, no. Anything new always appears daunting at first. We actually used a consultant to help us. It was their first time with Vein Center Accreditation…so it was a learning process for all of us.

The fortunate thing was that we were already Vascular Accredited (which is required) and so many of the process of quality improvement and quality assurance were already in place and being done. We just had to actually type out what we were already doing.

We had to buy a crash cart and stock it.

Then we had to create a checklist for the cart to meet the Ohio State Board of Pharmacy rules as well and obtain a license from them as well. Just more checks and balances.

But, it is good in the end. It allows everyone in the practice to know a standard of care in the practice of venous medicine. The front

22

When patients see this IAC accreditation seal of approval, they can be assured that the facility they are trusting to treat their venous disorder has voluntarily gone through a rigorous evaluation of its medical and technical procedures by a group of medical experts who have evaluated each procedure and determined that it meets each requirement.

Areas evaluated include physician training, physician experience, disease management, patient outcomes, complication rate per procedure, chart reviews, ultrasound imaging, continuing education, and detailed inspection of equipment and the facility among others. desk knows protocols all the way back to clinical staff and practice manager.

Q. Why did you decide to become Vein Center Accredited?

A. Our team feels strongly about board certification and then additional certifications for both physicians, staff and the facilities in which they practice. With mid-level providers now in the forefront, we need standard of care protocols established so that teams can all be on the same page.

Initially, when the news of BCBS of Massachusetts came out, we thought this was going to eventually trickle down to other insurance companies and Medicare.

And it has. Medicare Novitas (Arkansas, Colorado, Delaware, District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, VA and Indian Health Services) requires accreditation (Vascular) for reimbursement when performing ultrasounds.

So, we would like to think we are ahead of the times. Eventually, we all will need to be accredited and our entire team feels that it’s a good thing. We see patients from other facilities where ultrasounds do not match or plan of care doesn’t match what is seen on the ultrasound. It’s scary and it needed to be addressed. We think the IAC Accreditation is a start.

Q. Does the Vein Center Accreditation help your patients?

A. We would like to think yes. However, do patients care? We don’t believe our patients even realize the extent of our knowledge and quality assurance programs we have implemented and perform on a daily basis.

We like to tell our patients we are on the only Vein Center Accredited facility in the area. We

don’t think they care. They say, “Oh, okay.”

They are probably more focused on what we will do to help them than the letters after everyone’s name or the accreditation stickers on the front door.

What we had hoped for, aside from avoiding any reimbursement issues down the road, was for the accreditation to serve as a “stamp of approval” for primary care physicians and providers to seek us out for their patients.

We were one of the first 50 in the country to obtain Vein Center Accreditation and the fourth one in the state of Ohio. We are still the only facility in our area. We do love bragging about that! However, it doesn’t help when we have a larger problem of recognition with early diagnosis and treatment for simple conditions like venous eczema, superficial venous thrombophlebitis and worse, venous ulcers.

Yes, there was a small thought in our heads that we may be able to help educate our community on venous care and the early

diagnosis and treatment needed, especially when it comes of venous ulcers. Unfortunately, that has not been the case. We still continue to battle cellulitis vs. phlebitis, ascending phlebitis vs worsening cellulitis, deep venous thrombosis treatment management and lymphedema diagnosis and treatment. It is an ongoing, uphill, educational obstacle course.

Q. Do you feel it was worth it?

A. Of course. We are so very proud of our team. We all believe in practicing venous medicine to the best of our abilities. We all are certified (ARDMS, CCI, Ohio State Medical Board, etc.) and we hold on to those designations dearly. We feel that standardizing vascular ultrasound and then Vein Center will improve patient outcomes. VT N Manu Aggarwal, MHSA, MD, is a board certified family physician and ABVLM certified physician at the Vein Care Center Laser Specialists.

Since 2007, the VCC has been an IAC-accredited vascular laboratory. In 2015 the VCC was one of the first 50 practices in the country to also be Vein Center accredited. The VCC has been dedicated to venous disease and laser treatments since 2004, and is located in Lima, Ohio, with a satellite office in Celina, Ohio. She may be contacted at www. yourveincarecenter.com.

Co author is Ashley Watercutter, RVT at the Vein Care Center Laser Specialists.

DVT prevention device OK’d California-based ManaMed has launched the U.S. Food and Drug Administration (FDA) approved deep vein thrombosis (DVT) prevention device PlasmaFlow in the United States.

The portable, tubeless and digital PlasmaFlow, which comes with multiple pressure functions, helps to prevent the onset of DVT in patients by revitalizing blood flow in the extremities.

ManaMed co-founder and CEO Trevor Theriot said that the easy-to-operate sequential compression system can be used

at home or hospital to help mitigate the risk to 600,000-plus new cases of DVT every year in the United States.

“Blood Clots are a silent killer in the medical industry and we decided to up the fight against DVT related deaths,” Theriot said.

PlasmaFlow can also be used to improve blood circulation, manage post-operative pain and swelling and help in faster wound healing time.

MANAMED DEVICE

continued on page 36

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

THEPRACTICE Project studies care quality and effectiveness Patient engagement in developing measures of care quality can boost their effectiveness and paint a fuller picture of an organization’s march to quality improvement, according to a new project.

PatientsLikeMe, a project jointly backed by the Robert Wood Johnson Foundation and National Quality Forum, examined some of the benefits of including patient-reported outcomes information in creating clinical quality measures. The patient’s voice is “often silent or barely audible within existing measures,” the group found.

“To achieve and sustain a highperforming health care system, measurement must catalyze progress towards care that is not only safe and effective, but also patient-centered,” according to the report. “Moreover, as pay-for-performance programs continue to gain ground in the public and private sectors, it has never been more important to develop measures that assess health care quality in a way that matters to patients.”

The report identifies four major benefits to including patient-reported data when developing quality measures: 1. Improve the quality of data. Gathering more patient-reported data can also improve symptoms data and minimize recall bias.

2. Get a full look at the patient experience. Collecting patient-reported data provides a more complete picture of their experiences and will offer a broad spectrum of data for providers.

3. Flag patient concerns.

Patient-reported data can offer a glimpse at their priorities to help sort out better indicators of quality.

4. Establish symptom priorities. When providers are able to determine what patients want from a quality-of-life perspective, they can better prioritize what symptoms to assess when analyzing quality.

According to the report, gathering this data will also require a new approach to patient engagement. One solution is online communities that provide a broader look at patient priorities and experiences. PatientsLIkeMe itself is a large online community that includes more than 500,000 patients as members, gathering 43 million data points. VT N

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SECONDLOOK

SELF CARE

Physician, practice what you preach

By Sophie Van Sickle

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We expect nutritionists to properly nourish themselves, personal trainers to regularly exercise, and psychologists to have strong mental health. Shouldn’t physicians be held to the same standard?

A doctor’s duty is to provide patients with proper care that will ultimately help them to live a healthier and more fulfilling life. However, if health care providers aren’t properly looking after their own health, clients may find it difficult to trust their doctor’s recommendations and follow through with their advice.

It may be a cliché, but practicing what you preach is of utmost importance in this field.

Health care revolves around general wellness – treating the body to proper nutrition and exercise, keeping up with medications if necessary, and making life adjustments to alleviate stress. Health care professionals’ recommendations are consistent only when they follow their own guidelines to living a healthy life.

The practice of self-care is essential in creating healthy relationships with patients.

It is also crucial in promoting wellness and general health authentically.

Here are a few self-care tips for health care professionals to help provide a more authentic healing environment in the workplace.

PRIORITIZE WORK BREAKS

Long hours, stressful situations, and finding solutions to complex problems are all in a day’s work – and it can be exhausting. Carve out time slots throughout the day to sit down, gather your thoughts and breathe.

Make sure you nourish your body with the proper foods throughout the day and avoid

24

skipping meals, even if you feel strapped for time. Taking just ten minutes to de-stress and rejuvenate your mind and body will help you to be more efficient once you get back to work.

Recognize your limitations Acknowledge your stress levels and be mindful of how your workload affects your efficiency. Accept that you are more successful when you prioritize quality care over quantity of hours worked – because internal stress affects the quality of your patient care.

BUILD SUPPORT NETWORK

A strong network of family and friends is crucial in maintaining control over stress levels and caring for personal health. In addition to the friends in your personal life, it’s crucial to establish relationships with your colleagues.

Set aside time to grab coffee or lunch with them to discuss work’s stresses and connect – your colleagues understand your responsibilities like no one else will.

CHOOSE WELLNESS

Always keep in mind how to live your life to its healthiest potential. Make sleep, nutrition, and exercise some of your top priorities.

Healthy choices can be as simple as the clothes you wear.

For example, compression socks like the fashionable options from VIM & VIGR and others use therapeutic graduated compression to increase the circulation of freshly oxygenated blood back into your legs, reducing fatigue and achiness due to long hours on your feet.

In addition to managing your physical health, make sure you also address your emotional needs and stresses. Use your vacation days and spend time with family,

friends or even just yourself. When you get back to work, you will be happier, better rested and ultimately – a more successful physician.

Health care is a consistently high-stress and demanding occupation. As such, it is imperative that you invest in the time to look after your mental and physical health. You will thank yourself for it in the future. VT N Sophie Van Sickle is a marketing associate at VIM & VIGR Compression Legwear in Missoula, Mont. She is a recent graduate of Calvin College.

Doctor bias said big reason that women get CPM In recent years, research has found that more and more women are opting for a double mastectomy. Now, a study published in JAMA Surgery finds that the reason behind this increase is driven in part by the surgeons performing the procedure – even if it’s not medically necessary.

With many other treatment options available, doctors generally discourage women at average risk to undergo a contralateral prophylactic mastectomy, also known as CPM. A CPM involves removing both breasts when only one breast has cancer. If the woman has a higher risk gene, like BRCA, then a doctor will typically recommend a CPM.

DOCTOR BIAS

continued on page 29

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

SECONDLOOK Who makes the best leaders: Clinicians or administrators?

Clinicians and administrators bring different strengths to the table, so one of the most effective health care leadership strategies is a “dyad model” that leverages both approaches, according to a new survey.

Nearly three-quarters (72 percent) of the 868 respondents to the latest NEJM Catalyst Insights Council survey said that their organizations employ this approach, and 85 percent say that a dyad approach is effective.

Clinical leaders bring their medical knowledge and credibility with the hospital workforce to a leadership team, while nonclinical managers are more likely to have experience in human resources and finance, and have operations know-how. A dual leadership model bridges those gaps, the survey respondents said.

But a clear structure is also key to the dyad approach.

“With any shared responsibility, such as in the dyad model, clarity of roles and defined decision-making processes are imperative,” Stephen Swenson, MD and medical director for professionalism and peer support at Intermountain Health care, and Namita S. Modha, MD and an internist and clinical editor for NEJM Catalyst, said in their analysis of the survey.

“There is risk of confusion among teams and staff if the organizational structure is not clear.”

The survey also delved into the most valuable skills for health care leaders, and the respondents overwhelmingly said that interpersonal skills are important, regardless of a leader’s professional background. Eightytwo percent said these skills are required to lead a health care organization, and 90 percent said they’re key to leading a team of physicians.

The survey respondents, who included clinicians, health care executives, payers and others, were split on which group is best suited to leadership roles. Just more than half (53 percent) said physicians make better leaders, though many of the respondents were themselves doctors.

“There is an understanding of what it is like in the trenches. Credibility and ‘been there’ goes a long way,” a clinician at a large nonprofit hospital in the Midwest said. “The responsibilities one feels for another person’s life is something that cannot be imagined and helps lead in a ‘first among equals’ manner that empowers others to do their best.” VT N

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25

SECONDLOOK

SCLEROSANT STRENGTH

Investigating hypotonic solutions for sclerotherapy 2) Subdermal tumescent for treatment of telangiectasia, and 3) Varying pH for sclerosant solutions, just to name a few.

I have practiced vascular surgery for many years with the last 20 years devoted only to venous disease. My work in the histology of normal and abnormal veins has made me realize that much of what is published or discussed has weak scientific basis.

The study of normal and abnormal histology yields very important information in the field of Phlebology, as well as challenging commonly held views. VT N

By Ron Bush, MD Everyday vein practices use sclerotherapy for the treatment of both large and small veins. In fact, the most common complaint, vein-related, is spider veins.

Most physicians determine sclerosant strength based on prior comparison studies or their own clinical experience. While helpful, these methods were far from accurate. Even most vein conferences glance over the topic of spider veins even though the majority of patients have them and for most patients are the reason they seek treatment.

My practice is unique in that I work in the largest dermatology practice in Florida.

The practice has an excellent Derm-Path lab where I do my studies. I am fortunate in being able to access the lab for a variety of clinical research investigations.

Last year, Peggy and I published a paper on the ideal sclerosant concentration for 1mm telangiectasia.

The findings were based on more than 60 1mm punch biopsies completed after sclerotherapy with different sclerosant concentrations of Sotradecol (Mylan) and Polidocanol (Asclera). While the findings are important and should serve as a general guideline for sclerotherapy concentrations, the results only hold true for dilutions using 0.9 percent normal saline (NS).

The next question we asked is what happens when the sclerosant concentration is diluted

Sotradecol 0.12 percent diluted with normal saline

Sotradecol 0.12 percent diluted with half normal saline

with bacteriostatic water to 0.45 percent NS, 0.33 percent NS, and diluted with only bacteriostatic water. Although nearly completed, the results are all significant.

Simply diluting 0.15 percent Sotradecol with 0.33 percent NS or 0.45 percent NS makes the concentration two to three times stronger with unacceptable vessel response.

Histologic exams at these dilute concentrations (not made with 0.9 NS) revealed intraluminal debris, significant wall thinning, and in some cases, immediate thrombosis. While effective in destroying the vessel, adverse sequalae such as staining or a prolonged inflammatory response may occur.

At the present time, our concentration for sclerotherapy is Sotradecol 0.1 percent diluted with 1/2 normal saline. Histologic findings reveal significant sub-intimal damage, very little cellular debris, and in many instances, vessel wall fusion. Lower dilutions are being done, and we await these findings before a final consensus is obtained. However, in all cases, not using 0.9 NS for dilution results in vessel damage two to three times greater than when using standard 0.9NS. Other studies we are doing include: 1) In vivo effectiveness of foam based on endothelial cell counts at varying distances from injection,

Ronald Bush, MD, FACS, is one of the nation’s foremost specialists in venous disease.

Dr. Bush co-founded and is the medical director for Vein Experts, a national group of professionals specializing in the care and treatment of venous disease. He has published numerous peer reviewed journal articles and is an innovator of many techniques utilized in the treatment of venous disease. He is board certified in vascular surgery. Areas of research currently are devoted to the manifestations of cutaneous venous hypertension. Dr. Bush has developed a targeted approach to the treatment of venous ulcers and has published his technique in various journals. His practices at Water’s Edge Dermatology in Stuart, Fla., and he can be contacted at wederm.com/stuart.

Whiteley Protocol details ‘varicose eczema’ cure Varicose eczema, or venous eczema, usually occurs just above the ankle on the inside of the leg. It is caused by either visible varicose veins or “hidden varicose veins.”

If a patient is lucky enough to see the varicose veins, they know it is varicose eczema. If they are less lucky and have “hidden varicose veins” (medically called superficial venous reflux or chronic venous incompetence) there are no varicose veins to be seen on the surface. These patients are often misdiagnosed by doctors and nurses and are given steroid creams and/ or compression stockings rather than be referred for a curative endovenous treatment.

The patient shown in the picture is a 70-year-old man who came to The Whiteley Clinic with extensive varicose veins of his left leg, with some ankle swelling and eczema just above the ankle. This was typical of

26

varicose eczema, being just on the inner aspect of the lower leg.

Following both the NICE guidelines (nice.org.uk/guidance/cg168/) on varicose veins and also The Whiteley Protocol (thewhiteleyclinic.co.uk /the-whiteleyprotocol/), he was scanned by a clinical vascular scientist. A venous duplex ultrasound scan was performed. Although this is standard for The Whiteley Clinic, such an in-depth scan is often called an “extended venous duplex ultrasound scan.”

Research has shown that when a doctor performs his own quick scan, significant venous disease is often missed. Hence this never happens at The Whiteley Clinic.

Venous duplex ultrasonography confirmed truncal vein ref lux and incompetent perforators. The patient underwent local anesthetic endovenous laser

ablation, TRLOP closure of perforators and phlebectomies. Four weeks later he had no symptoms, varicose eczema had stopped itching and had almost completely gone, the swelling of the ankle had resolved and the varicose veins had disappeared.

He was given the option of continuing to improve the cosmetic look of the veins around the ankle with ultrasound guided foam sclerotherapy and micro-sclerotherapy but the patient had only wanted to get rid of varicose eczema. He did not want the risk of deterioration to leg ulceration.

VARICOSE ECZEMA: CEAP C4

For many years, varicose veins have erroneously been thought of as cosmetic only. In fact, research has shown that 4-5 percent of people with varicose veins deteriorate to getting swollen ankles, venous

eczema, brown stains around their ankles or even leg ulceration per year.

Hence it is not surprising that the National Institute for Health and Care Excellence (NICE) produced guidelines in 2013 that recommended that anyone with varicose veins and any symptoms or signs at all should undergo duplex ultrasound scanning and endovenous treatment.

Varicose eczema is classified as CEAP C4.

If it is not treated, it can deteriorate to CEAP C6, which is venous ulceration.

The Whiteley Protocol is the culmination of more than 20 years of research and development by Professor Mark Whiteley and his team. His continuing audits have shown that the risk of recurrent varicose veins after treatment with The Whiteley Protocol is the lowest that is humanly possible – approximately 3.3 percent per

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

SECONDLOOK

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with expert clinicians and sonographers in pelvic derived venous insufficiency. The 1:3 proctor to student ratio provides a unique opportunity to build knowledge and practice skills in a small group setting with immediate feedback.

Interactivity is at the core of the program, which has been designed to afford as much face-to-face interaction with the best and brightest in venous and lymphatic care today.

Outside of the daily educational sessions, a number of social activities are planned, allowing for participants to make connections with respected practitioners in a relaxed, congenial atmosphere.

In addition to receptions, lunches and a Texas-sized after-party, attendees have an opportunity to get out of the conference space with two events organized by the ACP Foundation – the Golf Outing and 5K Fun Run & Walk.

Now in its 11th year, the ACPF Golf Outing allows duffers and scratch golfers alike a day on the links with ACP Board Members and industry partners. The 5K Fun Run & Walk will provide early risers an opportunity to see the sunrise on Lady Bird Lake, while getting some exercise, all for a good cause.

After more than three decades, the ACP continues to define education for the venous and lymphatic community. The ACP Annual Congress will provide attendees at all levels of skill with the tools needed to improve their practice and patient care.

To view the changes and latest content and to register, please see acpcongress.org. VT N

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27

SECONDLOOK

Simultaneous causalities for leg pain, swelling

Sometimes just one diagnosis doesn’t tell the whole story

By Deborah L. Manjoney, MD Treatment of venous disease, at least in an office-based practice, is often straight-forward and moderately easy to address. Someone has varicose vein disease with symptoms, ultrasound is performed, and treatment can be rendered after all of the insurance priorauthorization rules are followed and authorization is obtained.

Every so often pelvic congestion syndrome is seen, venous ulcers can become a bit of a challenge or unexpected deep vein thrombosis can be found. Interesting enough, variation for dayto-day practice occurs, but it is rare to find the truly unexpected.

There are a few cases that I have seen over the last several years that proved to be a bit more of a challenge, or at least a surprise. I will summarize two in the following reports.

CASE 1

A 15-year-old young woman was brought into my office by her mother for evaluation of a swollen right lower extremity. Several months earlier, she had had a bicycle accident, falling with right knee injury. She had had pain, but no swelling, and had seemingly recovered. One month ago, she awoke with leg pain, swelling and difficulty walking.

She was seen by her pediatrician, referred to an orthopedist and an MRI of the knee was performed a few days before this visit. It showed a large right Baker’s cyst with probable rupture and soft tissue edema and joint effusion. All ligament and cartilage were intact.

An ultrasound had also been performed which was interpreted as “normal.” Leg discomfort had improved, but the patient could still not stand with her right heel flat because of pain high in her leg and groin.

Family history was remarkable because the patient was adopted, and her biological father, a native American, had severe extremity swelling, as did many family members.

On examination, vital signs were entirely normal. The patient was 5-foot-7 and 170 pounds. She stood with her right knee slightly bent, and heel elevated, walking on her toes with a limp, and leaning towards the right.

Abdominal exam was somewhat obese abdomen, non-tender without obvious masses. Lower extremity exam revealed that the right leg was obviously enlarged compared to the left, 1-inch larger at ankle, calf and thigh. No adenopathy was found. Arterial pulses were intact throughout. There was 2+ pitting to proximal

CASE STUDY

calf. Skin was well perfused, without markings. Leg was nontender and no varicosities were seen.

Venous duplex evaluation was performed. Deep vein drainage was impaired with patient supine. While standing, there was continuous flow in the deep veins, and elevated baseline of continuous flow in the great and small saphenous veins with a delayed, rounded return to baseline with augmentation. Both great and small saphenous veins are competent. A large Bakers Cyst was seen with marked fluid collection in the gastrocnemius muscle. Soft tissue edema was present from proximal thigh to ankle. No adenopathy was present.

Impression was significant venous obstruction proximal to the common femoral vein. I was suspicious for pelvic mass or iliofemoral thrombosis.

CT angio with venous phase imaging revealed what appeared to be a dermoid tumor of the right ovary with external compression of the iliac vein.

I contacted Children’s Hospital, and the patient was seen immediately by Pediatric Surgery. Surgery was performed with removal of the dermoid cyst and complete resolution of symptoms.

This young patient appears to have had two causalities of leg pain and swelling. The ruptured Bakers Cyst certainly played a role because of the extensive fluid in the gastrocnemius muscle.

However, the proximal thigh edema and the patient’s posture to prevent peritoneal tension over her ovarian cyst were alerts that something else was amiss.

CASE 2

A 56-year-old female was referred to my office by her orthopedist to evaluate chronic left leg swelling prior to potential knee replacement surgery. The patient had a history of left knee pain for the last three years with throbbing and aching discomfort. She also had a history of chronic back pain for which she was on complete disability.

One year earlier, the patient had been hospitalized with cellulitis of the left lower extremity. She had had new onset of pitting edema at that time that never has abated. She had had venous duplex that showed no evidence of deep venous obstruction, and she was told that another study ruled out lymphedema. She noted skin oozing and tears on the left anterior calf beginning one week earlier. Patient is physically unable to apply compression hose.

Below, center: IVUS image prior to treatment showing vein diameter Right: IVUS image following placement of stent

The patient is morbidly obese at 5 feet tall and 260 pounds, and she has difficulty with all ambulation. She must hold onto a wall as she walks because of pain and instability. BP is elevated at 160/92. Examination of the lower extremities reveals skin of the left calf is mildly erythematous, and that of the right has hemosiderin staining consistent with venous stasis.

On the left, there is severe 3+ pitting edema from ankle to proximal thigh. Mild edema is seen in the left foot. There are three areas of skin breakdown of 1cm size on anterior and medial calf. Right lower extremity also has 2+ non-pitting edema.

Bilateral pulses are 1+ at DP and PT. Measurements were: Ankle L 12, R 11.5, Calf L 19, R 17.7, Thigh L 33, R 30.

Venous CSS was 12 on the left. CEAP classification C3,C4a,C6,Ep,As,Pr, symptomatic on the left.

Venous duplex of the left lower extremity revealed continuous flow pattern at the common femoral vein, and mild pulsation within all deep and superficial veins. Great and small saphenous veins were competent. Soft tissue edema was seen throughout the lower extremity.

The patient was fitted with a ReadyWrap compression device for the left calf, and ulcer care was provided. She was strongly encouraged to use a cane which she had at home. She noted some improvement in her leg pain immediately after application of the compression.

CT Venogram was performed and revealed May-Thurner compression of the left iliac vein. She was coincidentally seen to have an acute proximal fibula fracture on the left. IVUS has confirmed May-Thurner compression of the iliac vein and stenting has been performed. Results are pending.

It is interesting that this woman, who had had knee pain for years, and left leg edema for over a year, had an acute proximal fibula fracture. She admits that her instability while walking has caused her to fall multiple times and she likely suffered the fracture in a recent fall. The increased edema of the calf causing skin tears and oozing probably was related to the fracture.

However, the May-Thurner compression, along with her obesity is the cause of her chronic whole leg edema. VT N Deborah L. Manjoney, MD, opened the Wisconsin Vein Center and MediSpa in 2002,and in 2004 she left her 18-year practice in cardiovascular and thoracic surgery to devote herself to full-time practice of phlebology. She offers a broad range of non-invasive and minimally invasive services, and she was one of the first in the area to add the “medispa” concept to her practice.

A CTV of May-Thurner compression

28

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

SECONDLOOK DOCTOR BIAS

continued from page 24

Time reports that the number of women choosing to remove both breasts has increased “nearly six fold from 1998 to 2011.”This is also seen mostly with younger women with early stages of cancer in one breast and who have no genetic risk factors.

This new study shows that there are many reasons for the increasing demand for CPM. However, it notably mentions that 20 percent of the accountability in variations is due to the woman’s doctor.

Researchers surveyed 5,080 women at average risk with early-stage breast cancer, along with 377 of their surgeons. They found that doctors largely agreed initially to recommend breast conserving surgery over CPM. However, that didn’t necessarily match up with what was eventually performed.

They found that if a woman went to a surgeon who was hesitant to perform a CPM, she had only a four percent chance of undergoing it. If she went to what researchers referred to as a surgeon open to performing a CPM, she had a 34 percent chance of having both breasts removed, even with their initial reluctance.

The surgeons explained that their reasons for offering a CMP was “to give patients a peace of mind,” and “avoid patient conflict.”

These choices were in no way linked to increase survival rates or decrease recurrence.

Old Lyme, Conn., plastic surgeon Vinod Pathy, MD, said, “Like other colleagues of mine, I have seen an increase in contralateral prophylactic mastectomies in certain populations in recent years in my practice, particularly in the younger population.”

He also notes that while the study is interesting, it is not surprising that surgeons

have an influence on the treatment offered to the patient based on the doctor’s bias.

“It is clear from the recent study that medicine and surgery are just as much art as they are science at times,” Dr. Pathy said.

“Regarding a bilateral mastectomy, it is important for us as surgeons to gather not only the typical scientific data regarding survival rates and recommendations by our respective societies and governing bodies, but also to listen to our patients, impart our expertise in general, but do our best to remove some of our biases one way or another in providing the best options for care.”

But that’s not to say that the decision is based on just one factor. “Because breast oncologic care should be a true team approach, the best care for the patient ultimately is brought about by discussions with the entire team,” adds Dr. Pathy. VT N

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continued from page 12

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29

SECONDLOOK

Presentation on June 5. Right leg with about a six week progression of swelling.

Presentation on June lymphedema therapy.

12

for

Right leg presentation on June 19.

This photograph taken on July 10 showing indentation where the compression wraps were placed and really no improvement in swelling of the right leg.

Leg swelling evaluation leads to finding cancer

By Manu Aggarwal, MD, and Bethany Jensen, C-OT CLT The patient is a well-nourished, elderly, 86-year old female who presented to us on June 5, 2017 with her daughter as a self-referral.

She states that approximately three weeks ago, she presented to her primary care physician (PCP) for right lower e x t rem it y swelling.

Since then, she states the leg had gotten worse in terms of redness, not swelling, and would like it evaluated.

Her PCP did order an ultrasound to rule out a deep vein thrombosis. It was done at a local hospital and it was negative. The patient had no symptoms of fevers, chills or night sweats. Per her daughter, and initial intake forms, the patient does have dementia. She has a caretaker and lives in an assisted living facility.

She was also concerned with what she believed to be varicose and spider veins. At the time of presentation, another ultrasound was not warranted given the patient’s history and recent ultrasound. She presented to our office with the right leg shown above (left).

On examination, her right leg was larger in size than the left leg. The leg circumference measurements were as follows: right ankle 24cm, calf 40cm vs. the left leg ankle 19cm and calf 33cm. There was pitting edema and slight redness. Upon palpation, her skin was warm and appeared somewhat “glossy”. She had normal femoral pulses bilaterally. Dosalis pedis and posterior tibial pulses were strong and easily palpable.

Given her classic presentation of lymphedema, she elected to have Complete

CASE STUDY

30

Decongestive Therapy (CDT) with a certified lymphedema therapist in our office. She was also started on Bactrim DS twice daily for suspected cellulitis.

The patient began CDT the following week on June 12, however, she had discontinued her Bactrim after three days as her children thought it was making her “see things and talk out of her head.” Upon examination, the patient’s redness and swelling had worsened and she was started on Keflex, 500mg, twice daily.

Two days later, a phone call was received from the patient’s daughter stating that her swelling was worsening and now she had developed blisters and seeping of clear fluid.

She still had no fevers, chills or night sweats.

Her leg did not hurt per the patient. She was still encouraged to come in. She presented for follow-up on June 19, four days later, for a clinical visit to assess the swelling.

The patient presented four times for lymphedema therapy (Complete Decongestive and Manual) from June 12, 2017-July 5, 2017.

On July 5, the therapist asked to have the patient re-examined. There was minimal improvement in the swelling and leg measurements. She actually seemed to have worsened, with increased swelling in the thighs, buttocks and lower abdomen. She still continued to not complain of pain – only swelling.

She was then brought back on July 10 and another ultrasound was performed. At this time, there again was no DVT. However, the swelling was now extended into the lower abdomen. An ultrasound showed overall swelling in the soft tissues of the lower abdomen and a non-compressible vein the abdominal wall with distention.

SENT TO THE ER At this particular appointment, her caretaker was present and they agreed that due to her worsening condition and concerning ultrasound, it warranted further studies and blood work. They agreed that testing would be best carried out in the hospital.

The patient was sent the ER and admitted.

She had an abdominal CT scan which showed enlarged lymph nodes measuring 1cm-3cm in the iliac chain, periaortic and retroperitoneal areas – but no structural defect of any structures. She was began on IV antibiotics for cellulitis. The hospital had reviewed and compared her current image to a previous CT imaging done in 2016, where gastric wall thickening. The patient did recently have some changes in her bowel habits in the last month.

The patient also received IV antibiotics for suspected cellulitis/lymphangitis.

This patient, upon review, we feel, had timely care in diagnosis and treatment. We see oftentimes, swelling in the tissues (by definition is lymphedema) is treated with diuretics and patients live with lymphedema for quite some time prior to diagnosis and treatment. In this case, lymphedema treatment was not progressing and seemed unsuccessful, which prompted further investigation.

The patient had a normocytic cell count without any abnormalities. Initially, NonHodgkins Lymphoma was high on the differential. However, ultimately, biopsy of the lymph nodes revealed primary colon cancer with secondary neuroendocrine cancer.

She is currently undergoing treatment with chemotherapy Etoposide and Carboplatin.

Her bone marrow biopsy was negative for metastatic malignancy.

LYMPHEDEMA TREATMENT

Complete Decongestive Therapy, also called Combined, Complex or Comprehensive Decongestive Therapy, is the main treatment for lymphedema. Experts who treat lymphedema consider CDT the “gold standard” of treatment. CDT consists of an initial reductive phase (Phase I) followed by a maintenance phase (Phase II). In Phase I, the main goals are reducing the size of the affected part and improving the skin. After Phase I, patients move to Phase II, a self- management phase to make sure the gains of Phase I are maintained long term.

The effects of CDT, from the National Lymphedema Network, are to decrease swelling, increase lymph drainage, improve the skin condition, improve patient’s function, relieve discomfort and improve quality of life, and reduce the risk of cellulitis and Stewart-Treves-Syndrome, a rare form of angiosarcoma.

The components of CDT, from the National Lymphedema Network, are manual lymph drainage (MLD), multi-layer, shortstretch compression bandaging, lymphatic exercise, skin care, education in lymphedema self-management, and elastic compression garments.

CDT is performed until the reduction of fluid volume is at its maximum benefit, which can take 4 to 8 weeks or longer. At the completion of Phase I CDT, the person with lymphedema is set up on a self-management program that includes self-lymph drainage, home lymphatic exercises, a skin care regimen, and compression garments or bandages that the individual learns to apply.

CDT ISSUES

Compression garments must be replaced every 4-6 months to be effective. Manual lymph drainage is an essential part of CDT. It

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

SECONDLOOK is a specialized manual (hands-on) technique that appears to work by two mechanisms.

It stimulates superficial lymphatic vessels to remove excess interstitial fluid. MLD is a light, skin technique learned by certified lymphedema therapists.

Compression bandaging refers to utilizing multiple layers of several materials to create safe and effective gradient compression.

The necessary components of compression bandaging are tubular bandage lining; digit bandages; polyester, cotton or foam undercast padding; and multiple layers of shortstretch bandages with 50 percent overlap and 50 percent stretch to cover the entire limb Therapists providing CDT should have completed at least 135 hours of training. Our office uses a board certified occupational therapist who is also certified in lymphedema therapy.

To obtain an effective compression gradient, short-stretch bandages must be applied with low-to-moderate tension using more layers distally. Pressure within the shortstretch bandages is low when the patient is not moving (“resting pressure”). Muscle contractions increase interstitial fluid pressure to assist the fluid to move out of congested areas (“working pressure”).

Maintaining hygiene of the skin is critical in patients with lymphedema. Nail and skin health should include nail clipping regularly and hydration/emollients to prevent dryness.

Cracking and scaling skin can cause itchiness, which can lead to skin breakdown if disturbed.

Once maximal volume reduction with Phase I CDT is achieved, patients are fitted with a compression garment. The patient should receive two garments at a time for each affected body part: one to wear and one to wash and dry.

Venous practices must be aware of the all the causes of swelling (lymphedema) – venous and non-venous. Not all veins are created equal and neither are all patients with lymphedema. VT N Manu Aggarwal, MHSA, MD, is a board certified family physician and ABVLM certified physician at the Vein Care Center Laser Specialists.

Since 2007, the VCC has been an IAC-accredited vascular laboratory. In 2015 the VCC was one of the first 50 practices in the country to also be Vein Center accredited. The VCC has been dedicated to venous disease and laser treatments since 2004, and is located in Lima, Ohio, with a satellite office in Celina, Ohio. She may be contacted at www. yourveincarecenter.com.

Co author is Bethany Jensen, C-OT CLT.

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SECONDLOOK REIMBURSEMENT

continued from page 1

with documenting the patient history, doing a physical examination, diagnosing a problem and creating a treatment plan. This is where the doctor/patient bond is often created and yet, the code was mysteriously and erroneously disallowed by the system upon launch.

This particular coding issue was caused by human error and resulted in millions of dollars in late or non-payment to providers around our state. The system was modified at the start of the Colorado fiscal year, as coders end-dated E/M codes effective June 30, causing the system to no longer recognize the code and thereby not process payment for such services.

On the Colorado Department of Health Care Policy and Financing website, there are about 50 “resolved issues” since March. Clearly, there are bugs for the providers awaiting payment as well as for the state of Colorado and the DXC system.

When reviewing other states that launched the same system, it can take up to 9 months to find some equilibrium of business. In the meantime, the state is offering interim payments to enrolled providers experiencing financial hardships due to problems with the DXC system.

In fact, we were initially offered an interestfree loan by Medicaid for our hardship amounting to about 6 percent of the amount due to our practice for previously provided services to Medicaid patients. We responded that it wasn’t enough. After considerable noise and complaining, their next attempt at making peace was closer to the amount needed, but still vastly short of the requirements of running a healthy business.

The situation is broad and deep. In Colorado, even the hospitals are suffering. The Colorado Hospital Association (including 100 hospitals and health systems) filed a lawsuit against the State of Colorado on behalf of its members.

The lawsuit is currently pending in District Court in Denver and “asserts that in implementing parts of the revalidation system, the Department did not follow proper administrative procedures.” The outcome of this remains to be seen. In Colorado, Medicaid comprises the majority of the state budget – above transportation, education and other more vocal and visible topics on a politician’s tongue. Colorado has a goal of reimbursing up to 80 percent of claims by December.

Any mild complaint we had prior to March related to Medicaid/Medicare was quickly replaced by a combination of horror and all-out protest at the train wreck that it became.

Software glitches, a steep learning curve

The American Vein & Vascular Institute financial packet and significant human error led to a halt in payments, resulting in millions of dollars of uncompensated claims. Without that “reliable” income, many health care providers (medical businesses) had to borrow money just to get by, meet payroll, purchase supplies and keep seeing patients. Our lenders advised us to stop

accepting new Medicaid patients altogether.

“This isn’t good business,” they said.

On the flip side, commercial insurance does reimburse at a higher rate than our U.S. government programs, but it doesn’t mean there aren’t challenges as well. Specifically, credentialing and continuous monitoring of

Is the health care plan ‘greener’ on the other side of the pond?

Is the grass greener on the other side? Do we have it all wrong? Or are we the best of the bunch? As our government debates the merits and drawbacks of the Affordable Care Act, and our congressmen and senators argue over repealing the Affordable Care Act, you decide. Health care is a political hot-potato in many developed countries, especially Europe:

UNITED KINGDOM Tax-funded health care for everyone The concept of “universal health care” is at work in the UK through the National Health Service (NHS) where every citizen has access to health care, funded by taxes and required national insurance contributions. However, the math is not working. The NHS has a deficit of £2.5 billion and although there are promises to increase funding, much more is required to address deficiencies. Some citizens opt for private insurance in addition to government-funded insurance, and now the private coverage option is offered as a benefit by employers.

PROS: • Care is “free” at the point of delivery across the UK CONS: • High taxes • Long waits • Limited choice of hospital or physician • Unhappy hospital doctors due to new restrictive employment contracts

32

GERMANY

Choice, but at a price Like the UK, every German citizen has access to “free” health care, paid for by a hybrid “public/private” approach utilizing a required “sickness fund.” Each person pays a premium according to income, half is paid by the individual and the other half by the employer. Unemployed people are covered by the government. If you make a lot of money, you can choose a private insurer instead of a public fund.

PROS: • Choice in what provider to see • No gatekeeper function. You can see a specialist without seeing a GP first • Affordable for the individual • Universal coverage CONS: • High taxes • Overtreatment and unnecessary admissions • Expensive to maintain with an aging population • Easy system to defraud

FRANCE

There’s not enough money to support the system The French health system covers all citizens and is funded by taxes. Patients are still expected to pay for up to 20 percent of treatments, and most working French have private insurance provided by employers to bridge this gap. Private premiums are based on income, rather than health risks.

PROS: • Easy access • Choice of providers • Preventive care is covered CONS: • High taxes • High unemployment creates a hole in coverage • Government mandated use of generic medicines (to lower costs) • Limited coverage for different specialty care • Movement to increase the patient payments (to cover the government deficits)

CANADA Wait for it…

Like most other developed countries, Canada offers universal coverage funded by taxes.

PROS: • Highly rated care – long life expectancy, comprehensive cancer care, low rates of heart disease and stroke.

• Universal care and access for all citizens CONS: • Each province has slightly different rules.

• Long waits for elective surgeries (joint replacements especially) • Private insurance is restricted in some areas – not every provider can accept private payments for faster care.

–By Dr. Gordon Gibbs

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

SECONDLOOK old and new physicians providing services can be difficult.

For the most efficient reimbursement, it’s essential to continually touch base with third-party commercial insurers to validate the physicians that are providing services are appropriately credentialed in their systems, and that all new physicians are credentialed prior to providing any reimbursable services.

By creating a quarterly monitoring or “check in” process with your commercial insurers, this may help streamline reimbursements for successfully completed procedures. A little extra time setting up a master spreadsheet and checking in regularly can lend to minimal (if any) delays in reimbursements.

If all documentation is complete and adequately documented (i.e., clean claims), claims themselves tend to be paid within four

to six weeks after submission. The Health care Financial Management Association (HFMA) has stated that a healthy Accounts Receivable for health care organizations is having Accounts Receivable being paid in less than 40 days for three consecutive years.

With that as the standard and clinicians doing their homework up front to ensure the aforementioned credentialing and complete clean claim submission, then commercial insurers are doing their part to pay within this time frame and everyone is happy living up to expectations.

Bushwhacking through the wilderness of reimbursement is not for the faint of heart and doing one’s best for the patient and the business requires grit and focus. By taking a “proactive versus a reactive” approach, there is a path to a win/win for clinicians and the insurers.

Contrary to the concerns of traditional business lenders and advisors, medicine can still be good business. VT N Gordon Gibbs, MD is owner/ founder and chief medical executive at American Vein & Va sc ul ar In stitute, headquartered in Pueblo, Colo., since 2009 with seven additional locations in Colorado and Texas. Dr. Gibbs is a vascular interventional radiologist, a Diplomate of the American Board of Venous & Lymphatic Medicine, a faculty instructor for Medtronic Master’s and Summit courses, a board member of the American College of Phlebology Foundation and director of Diagnostic and Interventional Radiology at St. Mary-Corwin Medical Center.

The American Vein & Vascular Institute diagnostic ultrasound

Cardiovascular Credentialing International www.cci-online.org • 1-800-326-0268 Credentialing Cardiovascular Professionals since 1968

Distinguish yourself as a phlebology professional – Earn the RPhS credential today!

The Registered Phlebology Sonographer (RPhS) credential is for physicians, sonographers, nurses, physician assistants, and other associate health professionals working in the area of phlebology ultrasound or treatment of venous diseases.

ACP Congress Attendees: Visit CCI Booth #305 Credentials administered by CCI are accredited by the American National Standards Institute (ANSI) based on the ISO/IEC 17024 Accreditation Standard.

VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2017

Courtesy Morrison Vein Institute and Compudiagnostics

33

SECONDLOOK

CLOUD OR LOCAL How to find the right vascular reporting and image solution for your practice

By Stefani Barbero If your facility is in the market for a vascular reporting solution, your options hinge on one big decision, cloud or local?. It’s a simple question, but reaching the answer is more complicated than it seems. Vendors don’t make it any easier.

They each provide reasons why one option is better than the other, and some even offer a hybrid solution, making your decision even harder. The truth is, cloud can be the right choice. But so can local, or even a hybrid. It all depends on your needs.

To make the right choice, you’ll need to ask the right questions about image access, data security, and cost – and that’s just the beginning. Here are some questions you’ll want to ask as you search for the right solution.

STORAGE ISSUES

Will my data be stored locally or in hosted storage?

Local storage means you will be responsible for managing the data. As your storage needs grow, that can mean additional costs for hardware and personnel. With hosted or cloud storage, your vendor manages the hardware and dedicated personnel.

Pricing for hosted storage varies, so be sure you understand the costs up front. With some vendors you will need to pay for a block of storage capacity, even if you don’t fill it up. With others, you pay only for the storage you use, which keeps costs in line with the growth of your practice. However, with this

option, your storage costs are more variable, increasing steadily as your needs grow.

measures, and whether they have documented plans for data recovery and continuity of service in the event of a disaster.

ACCESS ISSUES

COMPATIBILITY ISSUES

Where and when can I access my images and reports?

With a local solution, accessing the data requires a connection to the local network that you manage, which can be limiting. If you need to review studies and images from a remote location, a virtual private network (VPN) is likely the only secure option.

Using a VPN can affect speed and performance, especially when viewing cine loops.

With a hosted solution, be sure to ask the vendor how you will access the images and reports. Some hosted solutions require a VPN for access. Others offer secure access from any Internet connected device with no VPN required.

Will the solution work with my machine?

Some solutions only work with machines from certain vendors. Others are vendor neutral. If you have different models from different vendors, or you anticipate purchasing a new machine in the future, having a vendor neutral solution can help you maintain a simple, continuous workflow even as your practice grows.

You’ll also want to ask which study measurements the solution can transfer directly from the machine. If some measurements don’t transfer automatically. In that case, technologists will need to enter them manually, which takes time and increases the risk of human error and cost.

SECURITY ISSUES

EASE OF USE ISSUES

How will the security of my patients’ data be maintained?

If your data is stored locally, you will be responsible for maintaining data security and for meeting other HIPAA requirements for data storage.

With cloud solutions, you’ll need to find out if the vendor maintains multiple copies of the data in different locations, what type of encryption they use, whether they conduct penetration testing to assess the effectiveness of their security

How flexible and easy to use are the interpretation tools?

A solution is only right for your facility if it meets the needs of your physicians and technologists.

• Is the tool “smart” enough to provide calculations and findings, or will you have to enter everything manually?

CLOUD OR LOCAL

continued on page 36

Can your practice recover from a disaster?

When Patricia Farris, MD, pulled her car into the parking lot of her dermatology practice in Metairie, La., after Hurricane Katrina, she shook her head in despair and parked next to pieces of the building’s roof.

According to the Insurance Institute for Business and Home Safety, 25 percent of companies are unable to resume operations after a major disaster. But don’t let Mother Nature catch your practice off-guard.

While some physicians will be rebuilding their practices from hurricanes Harvey and Irma, Dr. Farris shares some tips that may help them and others before the next flood, wildfire, earthquake, hurricane or tornado comes knocking at or through your door.

Here are some action steps to take before then.

1. GET BUSINESS INTERRUPTION INSURANCE A few weeks before Katrina hit, Dr. Farris questioned her accountant on the value of the practice’s business interruption policy. I said, “This seems ridiculous.” He said, “No, you need it in case a disaster strikes.”

During the seven months of no income, she still had to pay malpractice, rent and other bills. She also paid employees throughout the period. “That policy paid an incredible amount of my losses, and is worth the expense.”

2. RECORD OFFICE ASSETS Periodically, record a smart-phone video of office assets.

Your insurance policy is going to want documentation of losses.

“Don’t forget little areas like the cabinets,” Dr. Farris says.

34

4. EMERGENCY PLAN Create and communicate a reliable emergency response plan. The plan should include how you will protect employees and customers, manage business operations and communicate during and after the disaster.

Questions to consider: How easy is it to exit your office? How long will it take to reach the designated meeting place? Who might need mobility assistance? Where are emergency numbers posted in the office? Employees should (literally) know the drill. If you need help, check out this business continuity plan from FEMA at www.ready.gov/business-continuity-planningsuite.

Also, keep insurance information and contact names and numbers in a safe place. Knowing where to access this information in the event of an emergency will expedite the claim process.

3. UNDERSTAND REPORTING FEATURES OF YOUR EMR

Understand how to access reporting features of your electronic medical record system. It doesn’t take a hurricane to knock out power, so understand how to take a virtual inventory of what you need to communicate to patients.

“Know how to access biopsy reports and other important information no matter your location,” Dr. Farris says. Old Metairie Dermatology uses the cloud-based EMR called EZDERM. Also, regularly back up all critical data not stored in an EMR, including tax records and financial documents.

THRIVING AGAIN At Old Metairie Dermatology, disaster and patience eventually gave way to advancement and patients. Today, from the same location that was affected by Katrina, the practice focuses on integrative medicine, and offers the latest in general and cosmetic dermatology for clients experiencing a range of skin conditions.

“We learned our lesson,” Dr. Farris says. “I can’t say this strongly enough – a little planning can make the difference between staying in business and losing everything.” VT N This case study was published in the April issue of Aesthetic Plastic Surgery.

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

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35

PRODUCTNEWS

Medtronic shows Concerto 3D Detachable Coil Medtronic has unveiled its new Concerto 3D Detachable Coil System that is intended to be used for embolizations in the peripheral arteries and veins. The device was unveiled at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) meeting in Copenhagen, Denmark in September. The device, which is now available to physicians in the United States and Europe, is intended to be used for embolizations in the peripheral arteries and veins.

The Concerto 3D Detachable Coil System folds into a dense and knotty shape which helps to fill in an aneurysm, for example, similar to how neurovascular aneurysms are now commonly treated. The Concerto 3D also has tiny fibers protruding from the length of the Nylon and PGLA coil, which help to increase turbulence and so promote clotting that fills in and solidifies an aneurysm.

It can also be used in conjunction with Medtronic’s Concerto Helix device, which uses the same delivery system. It appears that the only difference between the Concerto Helix and the Concerto 3D are their shapes. VT N

Boston Scientific to distribute Veniti VICI Venous Stent Veniti Inc., a player in the advancement of treatment for deep venous disease, announced Sept. 11 that Boston Scientific will distribute the VICI Venous Stent under a limited global distribution agreement. The terms of the agreement and specific regions and countries involved were not disclosed.

Launched in 2014, the VICI Venous Stent has gained wide market acceptance for the balance of end-to-end strength, flexibility and lumen quality for addressing the challenging requirements of venous disorders.

According to Jeff Elkins, president and CEO of Veniti, said it is available in a conventional delivery system, as well as the VICI VERTO Venous Stent® System, providing more control

36

in the landing of stents in areas of critical blood flow.

“The VICI Venous Stent is widely recognized as state-of-the-art technology for Venous Stents and physicians routinely praise the product for its performance qualities,” Elkins said. “We are extremely pleased to be partnering with a global industry leader like Boston Scientific to advance the VICI Venous Stent in the marketplace,” “Boston Scientific’s market leadership and reach will provide more physicians treating patients suffering from venous outflow obstruction around the world greater access to leading-edge technology.”

Venous obstructive disease affects more than 1.1 million people in the United States and Western Europe annually. Deep venous thrombosis is one of the most common and serious conditions associated with chronic venous disease and the financial impact is well established.

Physicians treat the obstructive component of chronic venous disease through minimallyinvasive endovascular stenting procedures.

Although not available commercially in the United States, Veniti is currently conducting the VIRTUS Trial to evaluate the safety and efficacy of the VICI Venous Stent for the treatment of chronic iliofemoral venous outflow obstruction under a U.S. Food and Drug Administration Investigational Device Exemption.

Partnering with leading physicians in the development and training for therapies to care for the millions of patients suffering from venous disease, VENITI has developed the VICI Venous Stent specifically for the challenges of treating iliofemoral venous outflow obstruction. The product was awarded the Frost & Sullivan 2015 European New Product Innovation Award for Peripheral Vascular Devices.

The VICI Venous Stent and VICI VERTO Venous Stent are CE marked under the European Medical Devices Directive (93/42/ EEC) and commercially available in Europe.

The VICI Venous Stent is approved by the Australian Therapeutic Goods Administration and commercially available in Australia. VT N

Reva Medical’s scaffolding study yields good results after six months As some companies have worked to improve drug-eluting stents by making them bioresorbable, some voices in the coronary intervention space have expressed concern over the rates of late stent thrombosis and repeat percutaneous coronary intervention seen with the devices.

In a study published in the September issue of JACC: Cardiovascular Intervention, Reva

Medical‘s Fantom coronary bioresorbable vascular scaffold succeeded after six months.

The device was designed to address challenges like strut size and expansion capacity, the researchers wrote.

The sirolimus-eluting device was studied with 117 patients with single de novo native coronary artery lesions. The primary angiographic endpoint was mean late lumen loss at six months. The study’s primary clinical endpoint was major adverse cardiac events at six months, including cardiac death, myocardial infarction or clinically driven target lesion revascularization.

Short-term technical success, short-term procedural success and clinical procedural success was met in 96.6 percent, 99.1 percent and 99.1 percent of participants, the authors reported. The mean in-stent late lumen loss was 0.25 millimeters (+/- 0.40) after six months. The team reported observing binary restenosis in two patients.

Major adverse cardiac events happened in three patients within the six-month study period, including two myocardial infarctions and two target lesion revascularizations.

Scaffold thrombosis was seen in one patient, the team added. VT N READ MORE: i nter v ent ions.on li nejacc.or g/ content /10/18/18 32?sso=1&sso_ redirect_count=2&access_token=

ASA, CAE offer virtual training operating room Anesthesia providers have been unable to improve their education and management of anesthetic emergencies in a virtual online environment, on-demand, from a simple laptop – until now.

The American Society of Anesthesiologists (ASA), and CAE Health care unveiled Anesthesia SimSTAT – Trauma, the first in a series of Anesthesia SimSTAT interactive screen-based simulation modules. Anesthesia SimSTAT – Trauma is specifically designed to offer anesthesia providers an advanced training involving accident victims.

“Anesthesia SimSTAT is a first-of-itskind virtual O.R., that allows the learner to immerse themselves in an evolving and intuitive, virtual, clinical environment and brings the simulation center directly to the learner,” said Adam I. Levine, MD, editor in chief of the ASA Interactive Computer-Based Education Editorial Board.

“Anesthesiology has been at the forefront of simulation technology for the past 20 years.

With Anesthesia SimSTAT, ASA and CAE Health care, a simulation technology leader, continue to push the envelope in a time when the medical community has increased interest in simulation and virtual reality technologies, and demands innovation in these areas.”

With Anesthesia SimSTAT – Trauma, learners can navigate in a three-dimensional, fully functioning operating room and participate in a series of high-fidelity simulation scenarios with a hyper-realistic trauma patient who responds to their use of accompanying monitors, ventilators, anesthesia machines and other interactive medical equipment.

SimSTAT monitors and records the learner’s performance over the course of the scenarios and offers feedback at the critical junctures or after completion of a session. And by using the platform, physician anesthesiologists can fulfill their continuing medical education (CME) and MOCA 2.0® Part II and IV requirements from their laptop anytime, anywhere. VT N READ MORE: asahq.org/ education/simulation-education/ anesthesia-simstat MANAMED DEVICE

continued from page 22

The sequential compression device can also help in treating stasis dermatitis, arterial and diabetic leg ulcers, chronic venous insufficiency, venous stasis ulcers, and edema in the lower limbs.

Additionally, PlasmaFlow finds it use as an aid in the prophylaxis for DVT by people who do not move around much for long durations.

Theriot said that the device incorporates step-up-technology while featuring a onebutton operation and soft cuffs made of highgrade medical material.

PlasmaFlow comes with a rechargeable battery that can sustain itself for up to 10 hours on one charge. It also has a couple of LCD screens to track usage and pressure. VT N CLOUD OR LOCAL

continued from page 34

• Does it include helpful interactive diagrams and options for entering clinical notes that don’t display on the final report?

• Can the tool and the reports be customized to align with your facility’s standards and practices?

• Do reports meet accreditation guidelines?

PRACTICE CUSTOMIZATION

How is the solution customized to meet the specific needs of a vascular practice?

Some solutions offer specialized worksheets and reporting for a range of vascular studies.

You’ll want to find out if they meet SVU, IAC-vascular and ACR guidelines. VT N Stefani Barbero is with Core Sound Imaging.

Core Sound Imaging offers Studycast, a cloud reporting and image storage solution, can be contacted at booth 802 at ACP or by email at.

Stefani@corestudycast.com.

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

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Procedures designed for your patients

No patient or procedure is the same.

The VenaCure EVLT laser ablation system features multiple fiber lengths and types, audible tracking of pullback rate, variable aiming beam modes/laser brightness for enhanced visibility, and a Fiber Recognition System with pre-set parameters, allowing you to tailor each procedure to the individual needs of your patients.

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Leading innovation of venous disease treatment for more than 20 years

Refer to the Instructions for Use/Directions for Use/Ownerâ&#x20AC;&#x2122;s Manual provided with the product for a complete list of Warnings and Precautions.

INDICATION FOR USE: The VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs.

CONTRAINDICATIONS: Patients with thrombus in the vein segment to be treated, patients with an aneurysmal section in the vein segment to be treated or patients with peripheral artery disease as determined by the Ankle Brachial Pressure Index with a value of <0.9 should not have their varicosities ablated.

CAUTION: FederalNEWS (USA) law restricts sale of these devices by or on the order of a physician.

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AngioDynamics, the AngioDynamics logo, VenaCure EVLT and the VenaCure EVLT logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. Š 2017 AngioDynamics, Inc. ANGAD 483 GL Rev 01 05/17

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ADVISORY REVIEW BOARD

Dr. Aggarwal

Manu Aggarwal, MHSA, MD, is a board certified family physician and ABVLM certified physician at the Vein Care Center Laser Specialists. Since 2007, the VCC has been an IAC-accredited vascular laboratory. In 2015 the VCC was one of the first 50 practices in the country to also be Vein Center accredited. The VCC has been dedicated to venous disease and laser treatments since 2004, and is located in Lima, Ohio, with a satellite office in Celina, Ohio. She may be contacted at www.yourveincarecenter.com.

Ronald Bush, MD, FACS, is one of the nation’s leading specialists in venous diseases. He founded and is the medical director for Vein Experts, a national group of venous specialists specializing in venous disease. He is Board Certified in general vascular surgery; and was also certified in cardio/thoracic surgery, having trained at Walter Reed Medical Center and Indiana University Medical Center. Dr. Bush is the author of numerous scientific papers and holds patents for surgical instruments. For Dr. Bush the past 20 years, he has devoted his practice solely to the treatment of venous disease and one of the first in the nation to do so. Physicians throughout the world have visited and have been trained by Dr. Bush. Many of the new procedures now performed in the ambulatory treatment of varicose veins have originated in part from his clinical studies.

Laura Ellis, MD, is founder of the Laura Ellis MD Skin Care & Vein Centre PLLC (formerly named the Asheville Vein Center and Medical Spa) in Asheville, N.C. She is one of the first members of Vein Affiliates, a national venous surgery organization of surgically trained vein specialists committed to quality care, ongoing education, and research in the field of venous disease; and she is also on the faculty of the Bush Venous Lectures.

Lowell S. Kabnick, MD, FACS, FAC Ph and director of the New York University Vein Center, is a world-renowned surgeon-teacher who provides a patientcentered approach to vein care, enabling the creation and improvement of many of today’s most advanced non-invasive vascular surgery techniques. Dr. Kabnick is recognized by his peers as an international authority on the diagnosis and treatment of venous disease. He was the first vascular surgeon in the United States to perform Dr. Kabnick the VNUS Closure (radiofrequency ablation) and the VenaCure EVLT (endovenous laser) procedure – two breakthrough technologies for treating the underlying causes of many varicose vein problems. Dr. Kabnick is president of the American Venous Forum Foundation; a Fellow of the American College of Surgeons as well as the American College of Phlebology, serves on the Board of Directors for the American College of Phlebology, and is president of the Intersocietal Accreditation Commission for Vein Centers.

Edward Mackay, MD, RVT, RPVI, is a co-director of the International Vein Congress, a major conference for vascular specialists in Miami that is attended annually by more than 500 physicians. He was the first physician in the state of Florida to offer VNUS Closure in 1999, and in 2001 the first in the bay area to offer endovenous laser treatment (EVLT). He has offices in St. Petersburg and Palm Harbor, Fla. Dr. Mackay

Deborah Manjoney, MD, opened the Wisconsin Vein Center and MediSpa in 2002, and in 2004 she left her 18-year practice in cardiovascular and thoracic surgery to devote herself to full-time practice of phlebology. She offers a broad range of non-invasive and minimally invasive services, and she was one of the first in the area to add the “medispa” concept to her practice.

Dr. Ellis

Dr. Manjoney

Jeffrey H. Miller, MD, is the founder and CEO of Miller Vein, with five locations in Southeast Michigan. Dr. Miller has received numerous awards and honors in his field, including being named one of Hour Detroit Magazine’s “Top Docs.” His multi-site company has received numerous accolades including Coolest Place to Work by Crain’s Business Detroit, Novi Chamber of Commerce’s Customer Service Excellence Award and several Corp! Michigan’s Economic Bright Spots Awards.

Dr. Miller

Melanie L. Petro, MD, is board certified in Facial Plastic and Reconstructive Surgery, Otolaryngology, Cosmetic Surgery, and certified by the American Board of Venous and Lymphatic Medicine. She practices aesthetics and phlebology at Petro Cosmetic Surgery and Alabama Vascular and Vein Center and they share AAAHC accredited surgical center.

Dr. Petro

Mel Rosenblatt, MD, FACPh, is past-president of the board of directors of the American College of Phlebology (APC). He is owner and medical director of Connecticut Image Guided Surgery in Fairfield, Conn. His clinical expertise lies in endovascular surgery and interventional radiology. Rosenblatt has held positions at the Yale-New Haven Hospital and Memorial Sloan-Kettering Hospital and has taught at Yale University Medical School.

Dr. Rosenblatt

Dr. White

shweiki.com Dr. Wright

38

James E. White, MD, FACS, who is board certified in general surgery, phlebology and cosmetic surgery, owns Advanced Surgical Concepts, in Chattanooga, Tenn., a practice in phlebology and cosmetic surgery. He was graduated Magna Cum Laude from the Medical College of Georgia in 1990. He then completed a General surgery residency at the University of Tennessee, Chattanooga in 1996. He is a Diplomat with the American Board of Phlebology and the American Academy of Cosmetic Surgery.

J. Gordon (Jay) Wright, MD, FACS, RVT, is the founder of the Midwest Vein Center in Chicago and practices out of the Downers Grove office. His special area of expertise in phlebology is in the treatment of venous stasis ulcers and combined arterial and venous problems. With Maged Mikhail, MD, Dr. Wright is the co-inventor and co-developer of VeinDraw EMR. The ACP elected him chairman of its AACME Committee and the College’s Preceptorship Committee. VTN

OCTOBER/NOVEMBER 2017 < VEIN THERAPY NEWS

In collaboration with:

Redefining Vein Care April 19-21, 2018 Miami Beach, FL

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