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INSIDE CVR, American Vein open new clinics 8 Veniti funds venous stent system 18 Treating spider veins can be complex 30 Physician designs scientific leg rest 34

OCTOBER/NOVEMBER 2016 Vol. 9 No. 6 VEINTHERAPYNEWS.COM

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

AVF, ACP suspend merger talks

ACP will continue closer collaboration with AVF, others By Mark Forrestal, MD, FACPh Over the past year, the American College of Phlebology (ACP) and the American Venous Forum (AVF) actively engaged in discussions to merge our respective organizations. To that end, both organizations assembled a negotiating team, and a consultant seasoned in these types of inter-societal unifications was enlisted to guide the process and provide insight into the opportunities and challenges that lay ahead.

Because of the similar missions of the two groups, the ACP leadership was confident unification would strengthen our collective voice for venous and lymphatic health and help us accomplish our common goals more efficiently and effectively. While the benefits were numerous and important, it was understood from the beginning that merging our two cultures would not be without its challenges. In late July, it was determined the timing for a formal merger was not appropriate, but a desire for closer collaboration between our

two societies on projects of common interest endures, with the intent of reconsidering a merger in the future. Although this round of negotiations did not result in unification, the process was instructive for the ACP and its leadership, illuminating the desire from community leaders MERGER

continued on page 14

ELECTION 2016

How the outcome could affect you By Jeffrey Miller, MD As we approach the 2016 presidential election, we have many issues to consider before casting our vote. This epic event is perhaps one of the craziest election cycles in history. Unless something bizarre happens, one of the two major party candidates will become the next president. And before the November choice arrives, it’s worthwhile to consider the current state of affairs.

STATE OF AFFAIRS We have the lowest labor participation rates in over three decades. 20 percent of U.S. families don’t have a single member who is employed, and median household income is down. With this in mind, it should come as no surprise that home ownership is nearing a 48-year-low. Speaking of homes, more young Americans now live with their parents than at any time since The Great Depression. Forty-three percent of student loan borrowers aren’t making any loan payments. At the same time, the U.S. debt is steadily climbing and approaching $20 trillion. This corresponds to the national debt per person in the U.S. at $59,783, which is a staggering figure indeed. Furthermore, food stamp usage has reached an all-time high, with up to one

in every five Americans enrolled in the program. If all of this is not scary enough, the death toll of terrorism around the globe has jumped nearly 800 percent in the past five years. The authors of a study, which tabulated the numbers, say that the exponential increase shows two troubling trends: 1) More attacks are happening, and 2) They tend to be deadlier than ever. The list of important issues on which to base your decision is long: the economy, foreign policy, immigration, entitlement

ELECTION 2016

continued on page 32

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VEIN THERAPY NEWS OCTOBER/NOVEMBER 2016

AVF, ACP suspend merger talks

Because of the similar missions of the American Venous Forum and the American College of Phlebology, leadership of the two organizations have been discussing unification of the two groups in an effort to strengthen the collective voice for venous and lymphatic health and accomplish common goals more efficiently and effectively. It was decided this July that now was not the right time for this merger and talks have been suspended.

Election 2016 and YOU

As we approach the 2016 presidential election, we have many issues to consider before casting our vote. This epic event is perhaps one of the craziest election cycles in history. Unless something bizarre happens, one of the two major party candidates will become the next president. And before the November choice arrives, it’s worthwhile to consider the current state of affairs.

THE PRACTICE 20 Gen X or Y or Baby Boomers As an owner of a business, one of the questions you likely ask yourself is, "how do I get more customers?" A wonderful goal, but to answer this you continually need to place yourself in your target audience's shoes (or socks) and instead ask, "what do my customers want?"

22 HIPAA at 20 All physicians are familiar with HIPAA as a medical privacy and security law. But it is that and so much more. It is time to take a second look as this federal law that is now 20 years old.

SECOND LOOK 26 State of the profession Since the first ACP meeting 17 years ago, there has been an explosion in physicians interested in venous disease. The ACP has grown dramatically and the meeting has become much more scientific and more academic types have become interested in the burgeoning field. It has been fun to watch, but there is also a dark side. Some have entered the field with poor training and even poorer ethics.

36 CASE STUDY: Watch varices As phlebologists, we need to be committed to investigating further— patients who present with varices that extend upward toward the labia or scrotum or ask them about the possibility of pelvic pain when we see such varices affecting their quality of life. However, given that most of the women with PCS are premenopausal, we need to be vigilant in the vitality of the ovaries; trading pelvic pain for possible long-term hormone replacement is not for everyone.

38 Giving for strong communities Building business and advancing a career in healthcare is a choice and a vocation. But there is always more we can do as professionals and as people. A simple survey of vein industry professionals indicates that we are! Philanthropy and service inside and outside the workplace is not uncommon at all.

NEWS THE

VTNREPORT ANGIODYNAMICS ANGIOGRAPHIC PRODUCTS TAKES UP SLACK FROM COOK MEDICAL RECALL Taking advantage of the market vacuum created by the Cook Medical recall of its angiographic products, Angiodynamics has added a second production line at its Queensbury, N.Y., production facility. AngioDynamics hired 75 workers this summer and brought back a retired supervisor to help make angiographic catheters used in medical imaging procedures. The manufacturing line making angiographic products had been operating on a single shift but has added more workers for a second shift. “We’ve beefed up our second shift … because those lines were just idle on the second shift so that’s where we put our labor, and we’ve been running into overtime so we can get those other 20 to 25 folks in and trained,” Jeremy Sharp, director of the company’s New York operations, told the Albany Business Review. Previously, the company had been consolidating manufacturing operations at its Glens Falls location and turning the Queensbury site into a distribution center. All except the angiographic line have been moved. Senior Vice President of Global Operations Barbara Kucharczyk said the consolidation plans were put on hold because of the increased demand following Cook Medical’s recall.

DESALVO RESIGNS AS ONC NATIONAL COORDINATOR; DEPUTY TAKES OVER Dr. Vindell Washington, formerly principal deputy national coordinator in the Office of the National Coordinator for Health Information Technology, has been nominated to replace Dr. Karen DeSalvo, who resigned. Washington will be the first African-American to hold the top job at ONC, an office created in 2004. Washington has been DeSalvo’s deputy since January. Like DeSalvo, he came from Louisiana; Washington previously was president of Franciscan Missionaries of Our Lady Health System Medical Group in Baton Rouge, as well as CMIO of the health system. DeSalvo’s departure from ONC has been expected for a long time. She was named acting assistant secretary in October 2014, specifically to help address the Ebola outbreak that was raging at the time. In May 2015, President Obama formally nominated DeSalvo for the assistant secretary position. She had a confirmation hearing from a Senate committee in August 2015, but her nomination never got to the floor of the Senate in gridlocked Washington.

COVALON WINS SAUDI CONTRACT TO SUPPLY IV CLEAR ANTIMICROBIAL SILICONE VASCULAR ACCESS DRESSING Covalon Technologies Ltd, an advanced medical technologies company, has won another major contract to supply its IV Clear antimicrobial silicone vascular access dressing to Ministry of Health facilities in Saudi Arabia at a minimum guaranteed value of $3.5 million over 12 months. IV Clear will be used on adults and children to help protect them from infections arising as a result of intravenous catheters, such as IV catheters, central venous lines, peripherally inserted central catheters, hemodialysis catheters, other intravascular catheter and percutaneous devices. IV Clear is the only antimicrobial clear silicone vascular access dressing that combines silver and chlorhexidine to provide broad-spectrum antimicrobial activity for 7 days. The soft silicone adhesive provides greater patient comfort, does not macerate or damage the skin, and was shown to be up to 10 times less painful upon removal when compared to acrylic adhesives. In addition to IV Clear, Covalon markets a full line of advanced wound management dressings for both acute and chronic wounds under its ColActive Plus and CovaWound brands. As well, Covalon is also the only provider of a dual antimicrobial silicone adhesive surgical dressing called SurgiClear, which is designed to protect surgical incisions by helping to prevent infections and medical adhesive skin injuries, while providing total incision site visibility to the healthcare provider.

INCLOSURE VCD GETS CE MARK OK FOR CLOSING LARGE BORE ARTERIAL PUNCTURES InSeal Medical has received CE mark approval for its large bore vascular closure device, InClosure VCD, which will close large bore arterial punctures ranging from 12F to 21F. Large bore delivery systems are used in different catheter based procedures such as transcatheter aortic valve replacement (TAVR) and percutaneous endovascular treatment of abdominal aortic aneurysms (PEVAR).

The InClosure VCD, which is implanted percutaneously, requires no pre-procedure or sheath exchange. It is based on a biodegradable membrane paired to vessel wall by a thin nitinol frame. The flexible membrane is said to exploit blood pressure to enhance sealing, providing reliable hemostasis even in calcified arteries. InClosure clinical study principal investigator Ran Kornowski, MD, said: “The InClosure VCD significantly simplified large bore puncture closure which is still one of the last major challenges in TAVR. While TAVR and EVAR systems have progressed, the procedures are still limited by suboptimal vascular closure technologies. We’re very excited to help change this as the InClosure VCD becomes available in Europe.”

ANGIODYNAMICS HIRES EXEC VP AND CFO Michael Greiner, 43, was appointed executive vice president and chief financial officer of AngioDynamics Inc. effective Aug. 16. A day after Greiner was hired, the company and Mark Stephens agreed that Stephens would leave the company. Prior to his appointment as executive vice president and chief financial officer, Greiner most recently was chief financial officer of Extreme Reach Inc. Prior to this position, he served as senior vice president of corporate finance and chief accounting officer for Vistaprint N.V., where he had global responsibility across treasury, tax, financial systems, controllership and SEC reporting, internal audit and corporate real estate Greiner is a certified public accountant and earned his B.S. and M.S. degrees in accounting at Fairleigh Dickenson University, as well as an MBA at Columbia University Business School.

MEDTRONIC HIRES BUSINESS VP Medtronic has hired Mark Ploof as its new senior vice president of global operations and business services effective Oct. 31. He will serve on the company’s executive committee and will lead its global operations; information technology, facilities; and real estate and business services functions, which also include its ongoing efforts to integrate the businesses it acquired in its purchase of Covidien in 2015. Ploof joins Medtronic from marketing firm YP, where he served as chief customer experience officer. He will replace Gary Ellis, who is retiring after 27 years with the company.

PURSUIT VASCULAR RAISES $2.1 MILLION Maple Grove, Minn.-based Pursuit Vascular, which produces the ClearGuard HD end caps for hemodialysis catheters that are designed to kill bacteria inside long-term hemodialysis catheters, has raised $2.1 million in a new round of debt financing. The caps are designed with a chlorhexidine-coated rod that extends into the catheter hub to eliminate bacteria, and can be used in place of regular end caps for a single use. The device won FDA approval in late 2013. The $2.1 million is the maximum the company was looking for in the round, according to the SEC filing. Money in the round came from 31 unnamed sources, though the company has not yet said how it plans to spend funds in the round. Last April, the company raised more than $5.1 million through a new equity offering. Executives disclosed the new cash infusion in a regulatory filing, though specific investors are not mentioned. Last February, Pursuit Vascular had secured $1.6 million in a debt and securities offering to 33 unnamed investors.

MEDTRONIC CLOSED A $1.1B ACQUISITION OF IMPLANTABLE CARDIAC PUMP MAKER HEARTWARE Medtronic closed the $1.1 billion acquisition of implantable cardiac pump maker HeartWare International in late August. HeartWare’s implantable left ventricular assist devices are designed for end-stage heart failure patients, either as a destination therapy until death or as a bridge to heart transplantation. The $58-per-share deal clears the field of the two major cardiac assist device makers, after Medtronic’s cross-town rival, St. Jude Medical, paid $3 billion for Thoratec in October 2015 (St. Jude is now being acquired by Abbott for $25 billion). The deal does not affect its fiscal 2017 forecast. HeartWare’s effect on earnings per share is expected to be zero to minimal for the first two years and accretive after that. “Not only does the current HeartWare portfolio expand Medtronic leadership across the heart failure continuum, its product pipeline – when married with our expertise – can result in progressively less-invasive heart pumps that have the potential to benefit even more patients,” GM Dr. David Steinhaus said. VT N

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

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The essential NTNT choice. Offer a comprehensive GSV system solution for above and below the knee. VarithenaÂŽ (polidocanol injectable foam) 1% reaches veins that others canâ&#x20AC;&#x2122;tâ&#x20AC;&#x201D;treating a wide range of sizes and any vein shape including tortuous and varicosities above and below the knee. Varithenaâ&#x20AC;&#x2122;s UDSS formulationâ&#x20AC;&#x201D;uniform density, size and stabilityâ&#x20AC;&#x201D;results in a long dwell time and thorough cohesion with the vein wall. Most importantly it addresses underlying YHQRXV LQFRPSHWHQFH LPSURYHV YHLQ DSSHDUDQFH DQG VKRZV VLJQLĂ&#x20AC;FDQW 352 LPSURYHPHQWV ZLWK DQ HVWDEOLVKHG VDIHW\ SURĂ&#x20AC;OH 1RZ ZLWK D GD\ SRVW DFWLYDWLRQ VKHOI OLIH WUHDWLQJ patients with VarithenaÂŽ is easier than ever.

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For more information on treatment, visit Varithena.com INDICATIONS VarithenaÂŽ (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. VarithenaÂŽ LPSURYHV WKH V\PSWRPV RI VXSHUĂ&#x20AC;FLDO YHQRXV LQFRPSHWHQFH DQG WKH DSSHDUDQFH RI YLVLEOH YDULFRVLWLHV 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. VarithenaÂŽ 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, FRPPRQ IHPRUDO YHLQ WKURPEXV H[WHQVLRQ VXSHUĂ&#x20AC;FLDO WKURPERSKOHELWLV DQG GHHS YHLQ WKURPERVLV 3K\VLFLDQV DGPLQLVWHULQJ 9DULWKHQDÂŽ 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 VarithenaÂŽ

ÂŠ 2016 Biocompatibles, Inc., a BTG International group company All rights reserved NA-VAR-2016-0786(1) 08/16 Varithena is a registered trademark and Varithena Solutions Center is a trademark of Provensis Ltd, a BTG International group company BTG and the BTG roundel logo are registered trademarks of BTG International Ltd btg-im.com

NEWS 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

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

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NEWS • Recipient of peer-reviewed funding from the NIH and other institutions for his basic science research into the underlying causes of chronic venous diseases. VT N READ MORE: centerforvein.com

American Vein opens its second facility in Pueblo, Colo. Peter Pappasa, MD

CVR opens 61st clinic in Union. N.J. The Center for Vein Restoration (CVR), the nation’s largest, physician-led, vein treatment medical organization, has opened a new office in Union, N.J., at 2333 Morris Ave. The practice will be under the guidance and direction of Peter Pappas, MD, who also oversees the nearby Basking Ridge, N.J. location. “I am pleased that the Center For Vein Restoration has opened a new office in Union,” Dr. Pappas said. “The Union area has a great need for specialized vein care and we are pleased to offer our services to the Union community and its surrounding areas.” Dr. Pappas is a board certified general and vascular surgeon with these professional milestones: • A graduate from Rutgers-Robert Wood Johnson Medical School. • Completed his general surgery residency at Cooper Hospital University Medical Center, a Robert Wood Johnson affiliate. • His vascular surgery fellowship was completed at Rutgers-New Jersey Medical School • Full professor of surgery at RutgersNew Jersey Medical School for more than 15 years and during that time period he was: chief of the division of vascular surgery, medical director of the Non-invasive Vascular Laboratory, program director of the general surgery and vascular surgery residency and the recipient of several teaching awards. • Former chairman of the Department of Surgery at The Brooklyn Hospital Center, Dr. Pappas oversaw 10 divisions and a fully accredited, free-standing general surgery and podiatric residency program. • Past president of the Vascular Society of New Jersey, the American Venous Forum and the American Venous Forum Foundation. • Nationally recognized for his basic science and clinical research on chronic venous disorders with more than 66 peer-reviewed publications and 30 book chapters.

American Vein & Vascular Institute has opened a second facility located on the North side of Pueblo, Colo., specializing in the diagnosis and treatment of arterial disease. Their flagship vein clinic remains open on the Historic Arkansas Riverwalk of Pueblo (HARP). The new arterial facility opened Sept. 6 and is staffed by Dr. Kenneth Madsen, a widely known and respected vascular surgeon. Located at 1515 Fortino Blvd., Suite 150, the new clinic offers the same services as American Vein & Vascular Institute’s first arterial center in Colorado Springs, which opened in the fall of 2014. Gordon F. Gibbs, MD, founder and chief medical executive of American Vein & Vascular Institute, said the Pueblo facility advances the company’s commitment to comprehensive vascular care as Southern Colorado’s first office-based endovascular center to diagnose and treat patients with peripheral artery disease (P.A.D.), chronic venous insufficiency (CVI) and venous thromboembolism (VTE). “American Vein & Vascular Institute was founded and developed in Pueblo,” Dr. Gibbs said. “Opening a second clinic here and deepening our commitment to the health and well being of the Pueblo and Southern Colorado community is very meaningful to us. We are excited to bring expert and convenient vascular disease treatments and services to this region.” The new location offers the same expertise and welcoming staff that American Vein is known for and has delivered since opening in January 2010. The state-of-the-art facility provides comprehensive diagnostic and vascular care for many arterial conditions in a safe, cost-effective, office-based environment. Dr. Madsen, a vascular surgeon who is double board certified in general and vascular surgery, has advanced training in treating common arterial conditions with minimally invasive vascular surgeries. A team of highly skilled medical staff, including vascular nurses, medical assistants, registered phlebology sonographers and registered vascular technicians support Dr. Madsen. “Being a part of The Arterial Center allows me to practice my specialty in the Southern Colorado community in an outpatient capacity,” Dr. Madsen said. “I look forward to continuing the tradition of providing exceptional patient experiences at American Vein & Vascular Institute’s newest location.”

This is the seventh clinic opened in Colorado, as well as one in Texas. A formal grand opening event will host local Pueblo dignitaries, American business partners, staff and their families. VT N READ MORE: americanvein.com

Essential Medical wins FDA IDE for vascular sealer trial Malvern, Penn.-based Essential Medical has won an Investigational Device Exemption from the FDA to begin a trial of its X-Seal 6F vascular closure device. The 180-patient pivotal study will run across 10 to 16 sites in the United States, Canada and the European Union. “The X-Seal device provides a necessary improvement to current closure devices,” CMO Gary Roubin, MD, said in a statement. “Combining proven technology with novel deployment control features, the X-Seal device allows for consistent closure performance. I am pleased that the device is one step closer to U.S. commercial availability.” The trial will examine the safety and efficacy of the X-Seal device through the comparison of complication rates, time-to-hemostasis and time-to ambulation rates, the company said. Dr. Roubin said Essential Medical has already received CE Mark approval in and completed a post-market study of the device in February. The device is designed to close punctures in less than one minute, providing immediate hemostasis, using absorbable biomaterials in an “anchor/plug” sealing technology, according to Essential Medical’s website. VT N READ MORE: essmedclosure.com/

AVF seeks apps for two grants The American Venous Forum (AVF), a multidisciplinary, international medical society whose members are dedicated to saving and improving lives – by reducing venous and lymphatic disease through education, innovative research, and advocacy – is seeking applications for two distinguished and highly sought after grants that will be awarded to applicant pursuing venous research. The grants will be awarded at the 29th Annual Meeting Feb. 14-17, 2017, in New Orleans, according to Kathleen J. Ozsvath, MD, FACS, chair of the AVF Research Committee. The BSN-Jobst Research Grant provides a two-year grant to a research fellow chosen through a competitive peer-review selection process. A committee of distinguished vascular physicians, appointed by the AVF Foundation, determines the fellowship recipient and

announces its selection during the opening session of the Annual Meeting. Throughout the years many recipients of this prestigious award have become leaders and scholars in the treatment of venous and lymphatic disease. The Servier Traveling Fellowship in Venous and Lymphatic Disease is provided to two fellow/resident awardees to travel to the AVF annual meeting and then travel to the European Venous Forum to present their research. This award is also selected through a competitive peer review process. Further information and application procedure can be found on the AVF website at veinforum.org. VT N

SIGVARIS expands product line with BiaCare acquisition SIGVARIS has completed its acquisition of BiaCare Corp., located in Holland, Mich. Known in the industry for innovative medical compression product lines such as CHIPSLEEVE and COMPREFLEX, BiaCare brings to SIGVARIS an assortment of products that have already gained the trust of physicians and therapists worldwide. “BiaCare has a strong reputation for being a pioneering leader in the design and production of medical short stretch wraps, compression garments and other garments for patients in need of therapy options,” Scot Dubé, president and CEO for SIGVARIS North America, said. “We feel that BiaCare’s core product assortment is strongly aligned with SIGVARIS’ commitment of providing the best products in the market in terms of comfort, quality, fit and therapeutic value.” The addition of BiaCare products also strengthens SIGVARIS’ market position in both North America and globally by providing an opportunity for SIGVARIS to serve even more patients under a single brand,” Dubé added. BiaCare’s advanced line of compression products are designed to treat lymphedema, lipedema and chronic venous insufficiency, giving SIGVARIS a worldwide brand for patients with veno-lymphatic diseases and disorders. Dan Karadsheh, vice president of the BiaCare Corp., said the two companies are perfectly aligned, “not only in our passion to see patients with complex edema have better outcomes and an improved quality of life, but also, in a common culture of teamwork and continuous innovation based on feedback from the patient and clinical communities.” Keith Hoffman, president of the BiaCare, said this acquisition significantly increases the ability to provide physicians and therapists the compression solutions they need, utilizing the well-established SIGVARIS brand. VT N

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

NOW AVAILABLE from ANGIODYNAMICS YOUR EXCLUSIVE VENOUS DISTRIBUTOR

APPROVED FOR THE TREATMENT OF UNCOMPLICATED SPIDER AND UNCOMPLICATED RETICULAR VEINS 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.

AFTER

Uncomplicated reticular veins treatment* (1-3 mm). Results at 4 weeks after last treatment. * Individual results may vary depending on varicose vein severity, disease progression, skin tone, and number of treatments.

Actual patient Indication 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.

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. www.fda.gov/medwatch at 1-866-862-1211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 singleuse, 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.

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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 176 US Rev 01 03/16

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NEWS CSI website: ‘Take A Stand Against Amputation’ Cardiovascular Systems Inc. (CSI) launched a public awareness and patient advocacy program, “Take A Stand Against Amputation,” during P.A.D. Awareness Month in September to provide education about peripheral artery disease (P.A.D.) and treatment options. Up to a staggering 18 million Americans1 suffer from this potentially life-threatening disease.1 According to the American Heart Association, P.A.D. patients have a six to seven times greater risk of coronary artery disease, heart attack and stroke than the rest of the population. If left untreated, those who suffer from P.A.D. are at risk of serious consequences. In fact, each year 160,000 to 180,000 Americans undergo amputation of a limb as a result of complications associated with P.A.D.2 Of those suffering from P.A.D., up to 3.5 million have progressed to critical limb ischemia (CLI)3, the most severe and potentially deadly form of P.A.D., where the blood vessels become dangerously narrow, leading to pain at rest, open sores on toes and feet, or gangrene. If left untreated, this can lead to amputation of toes, a foot or even a leg. Despite the severity of P.A.D., many Americans are not familiar with it, making it a large and growing problem in the United States. CSI wants to raise awareness of peripheral artery disease. Early screening and treatment are crucial. This program also focuses on increasing awareness of CLI, the advanced stages of P.A.D., which puts people at high risk of amputation, and stresses that there are treatment options. CSI’s goal with this program is to raise awareness and reduce the number of amputations to under 100,000 within three years. The “Take A Stand Against Amputation” website, StandAgainstAmputation.com, contains information about P.A.D. and CLI for people with P.A.D., those who are concerned they may have P.A.D., and their families and caregivers. The website also contains materials physicians can use to educate people about the disease. One in 20 Americans over the age of 50 has P.A.D.4, and among adults age 65 and older, 12 to 20 percent may have P.A.D.5 Smoking, the single greatest risk factor, increases the chance of developing P.A.D. three to five times. But other common risk factors include diabetes, high blood pressure, abnormal cholesterol levels and heart disease6. In fact, one in three people over the age of 50 with diabetes has P.A.D.7 Those people with diabetes and P.A.D. have a ten times greater risk of amputation than people without diabetes7.

“Considering the high number of people who suffer from P.A.D. and the seriousness of its effects, this disease is disturbingly overlooked,” said Mary Yost, President/ Co-Founder of THE SAGE GROUP, a leading P.A.D. research consulting firm. “People should be aware of the risks, and talk to a physician if they think they may have P.A.D.” The symptoms of P.A.D. can often be mistaken for symptoms of aging by those suffering from the disease, which may allow the disease to progress to a more severe state before it is diagnosed. The most common symptoms are: • Leg pain that occurs when walking or exercising and disappears when the activity stops • Leg muscle tiredness, heaviness or cramping • Leg and/or foot pain that disturbs sleep • One leg/foot feels cooler than the other • Toes or feet that look pale, discolored or blue • Thick or yellow toenails that aren’t growing • Sores/wounds on toes, feet or legs that heal slowly, or not at all (more associated with CLI) P.A.D. is a serious condition for which early diagnosis and treatment are very important. The good news is there are treatment options for P.A.D. that your doctor can prescribe to help you reclaim your quality of life. Treatment options can include lifestyle adjustments, such as quitting smoking and eating healthier; as well as medications for many people with P.A.D. In more severe cases, procedures including minimally invasive vascular procedures or bypass surgery may be necessary to restore blood flow to the feet to help prevent an amputation. Dr. Bryan Fisher, a vascular surgeon from Tri-Star Centennial Medical Center in Nashville, said P.A.D. Awareness Month presented an opportunity to ensure that patients know they have treatment options. “If someone receives a diagnosis of P.A.D. or CLI and the recommended treatment is amputation, they should ask for a second opinion,” Dr. Fisher said. “There have been important advances.” Dr. Fisher also encouraged other physicians – especially primary care physicians, podiatrists and wound care specialists – to become educated about these new treatment options. These healthcare professionals are often the first to learn about or see first-hand the symptoms of P.A.D. “These healthcare professionals can find specialists in their area who can help them deliver improved outcomes for their patients,” Dr. Fisher said. “This disease can have a serious impact on the quality of life.” VT N READ MORE: StandAgainstAmputation.com

LITERATURE: 1

Schiavetta A, et al. Stem Cells Translational Medicine. 2012; 1:572-578 and Sage Report 2010 2 Allie et al. J Endovasc Ther. 2009 Feb; 16 Suppl 1:134-46 3 Schiavetta A, et al. Stem Cells Translational Medicine. 2012; 1:572-578 and Sage Report 2010; 4 Stay in Circulation. Peripheral Artery Disease. National Heart, Lung and Blood Institute (NIH) h t t p : // w w w. n h l b i . n i h . g o v / h e a l t h / educational/P.A.D./. Accessed 09Mar2016 5 Mahameed, AJ. Peripheral Arterial Disease. From the Cleveland Clinic Foundation Center for Continuing Education Disease Management series, January, 2009, and clevelandclinicmeded. com/medicalpubs/diseasemanagement/ cardiology/peripheral-arterial-disease/;

Joosten MM, Pai JK, Bertoia ML, et al. Associations between Conventional Cardiovascular Risk Factors and Risk of Peripheral Artery Disease in Men. JAMA 2012;308(16):1660-1667 7 Living with Diabetes. Peripheral Arterial Disease. American Diabetes Association website, diabetes.org/living-withdiabetes/complications/heart-disease/ peripheral-arterial-disease.html?loc=footcomplication. Accessed. 8 Graziani L, Piaggesi A. Indications and Clinical Outcomes for Below Knee Endovascular Therapy: Review Article. Catheterization and Cardiovascular Interventions. 2010; 75:433–443.

SAGE GROUP president says many amputations unnecessary According to research conducted by THE SAGE GROUP, in 2015 almost 20 million Americans suffered from peripheral artery disease (P.A.D.) representing an economic burden of $212-$389 billion. “Almost 15 years ago we wrote that P.A.D. was underestimated, underdiagnosed and undertreated,” Mary L. Yost, president of THE SAGE GROUP LLC, said in September, which was P.A.D. awareness month. “Unfortunately, this is still true.” Reflecting on the current state of P.A.D. and the changes that have occurred Yost observed, “While there have been many positive developments, especially technological innovations in treatment, we have seen many disappointments. P.A.D. is still an ‘orphan disease’ in terms of knowledge and awareness, as well as in treatment.” “The availability of new endovascular technologies and access techniques now enables skilled interventionists to treat almost all patients and all lesions, whether located above or below the knee. In addition, multidisciplinary limb preservation programs have been established in many hospitals, resulting in a significant reduction in P.A.D.-related amputations.” “However, progress in increasing disease awareness among the public and the gatekeeper physicians has been slower than we anticipated,” she said. “The result is continued underdiagnosis and undertreatment, causing unnecessary mortality and morbidity.

“P.A.D. is not just a leg problem. It is also a heart and a brain problem,” explained Yost. “Within five years, approximately 50 percent of P.A.D. patients experienced a heart attack or stroke, 30 percent of these are fatal. This mortality rate exceeds that of breast cancer and coronary artery disease.” If diagnosed in the early stages, P.A.D. patients can be treated with appropriate lifestyle modifications and drug therapies to reduce the risks of heart attack and stroke; exercise therapy to reduce the pain of claudication; or if blockages are more severe, with minimally invasive revascularization technologies. However, compared with coronary disease patients, risk factor treatments are underutilized in P.A.D. patients. Describing the current therapeutic situation for critical limb ischemia (CLI), the most severe stage of the disease, Ms. Yost said that frequently there is a significant disconnect between what is possible technologically and the actual treatments offered to CLI patients. “Even though amputations have declined, primary amputation is often the first and the only treatment offered for CLI,” she continued. “60 to 70 percent of CLI patients who undergo major amputation have no attempt at revascularization prior to the amputation. Furthermore, an angiogram has been shown to be highly protective against major amputation, reducing the odds by 90 percent. VT N

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NEWS MERGER

continued from page 1

and supporters for greater unityy and also for providingg a blueprint for future conversations with other organizations focused on improving venous and lymphatic patient care. The ACP and AVF will continue to look for ways to collaborate movingg forward and this decision should not diminish nor obscure the considerable achievements the ACP has made in their workk in buildingg consensus and collaborative partnerships within venous and lymphatic care. Our commitment to collaboration remains community-wide, and several examples illustrate the dedication of the ACP and its leadership to providingg a voice for the specialty. In July, the Venous Care Partnership (VCP), a coalition of 10 organizations led byy incomingg ACP President Dr. Neil Khilnani, presented a unified message to the Center for Medicare & Medicaid Services (CMS) Medicare Med ca e Evidence v de ce Development Deve op e t and a d

Coverage Advisoryy Committee (MEDCAC) charged with reviewingg treatment strategies for patients with lower extremityy chronic venous disease. The coalition brought together a wide range off venous and lymphatic interests, including: the American College off Phlebology, Society for Interventional Radiologyy (SIR), American College of Cardiology (ACC), American College off Radiologyy (ACR), American Heart Association (AHA), Societyy for Cardiovascular Angiography and Interventions (SCAI), Society for Vascular Medicine (SVM), Alliance off Wound Care Stakeholders, VIVA Physicians (Vascular Interventional Advances) and the US Compression Alliance. The presentations were well received byy CMS, and highlighted the broad spectrum off physicians treatingg venous disease, as well as the need for the collection off meaningful and reliable data in evidence-based outcomes. In addition, the ACP has been a driving force for the specialtyy as a votingg member of the American Medical Association (AMA)

House off Delegates, buildingg consensus with fellow w members off the Relative Value Scale Update Committee (RUC) and Current Procedural Terminologyy (CPT) committee. Most recently, ACP-led efforts resulted in recommendations from AMA A to CMS on new w CPT codes for the Mechano-Chemical Vein Ablation (MOCA) procedure. The ACP is committed to supportingg the full range off practitioners workingg in the specialty, collectingg meaningful dataa through the ACP PRO Venous Registry, and seekingg collaborative partnerships in advocacy, education, and research. So, while merger with the AVF is offf the table for now, the ACP will continue to do what it has done for the past 30 years â&#x20AC;&#x201C; to unifyy a diverse and vibrant community, build consensus, and advance venous and lymphatic care. VTN

Largest HIPAA fine is levied Advocate Health Care Network, the largest integrated healthcare system in Illinois, has agreed to pay $5.55 million in penalties in a settlement with the Health and Human Services Departmentâ&#x20AC;&#x2122;s Office for Civil Rights (OCR), the largest HIPAA enforcement action yet against a single entity. The hefty penalty was due to the extent and duration of the alleged noncompliance and the large number of patients affected. The fine is the result of three breaches that Advocate Health Care Network reported in 2013, according to the OCR. The health system reported the theft of four desktop computers containing the electronic private health information of approximately 4 million patients. VTN READ MORE: hhs.gov/about/ n e w s / 2 0 1 6 / 0 8 / 0 4 /a d v o c a t e healthcare -settles-potentialhipaa-penalties-555-million.html

Intended Use/Indications: The VenaSeal closure system (VenaSealâ&#x201E;˘ V\VWHP LV LQGLFDWHG IRU XVH LQ WKH SHUPDQHQW FORVXUH RI ORZHU H[WUHPLW\ VXSHUĆŹFLDO WUXQFDO YHLQV VXFK DV WKH JUHDW VDSKHQRXV YHLQ *69 WKURXJK HQGRYDVFXODU HPEROL]DWLRQ ZLWK FRDSWDWLRQ 7KH 9HQD6HDO V\VWHP LV LQWHQGHG IRU XVH LQ DGXOWV ZLWK FOLQLFDOO\ V\PSWRPDWLF YHQRXV UHĆŽX[ DV GLDJQRVHG E\ duplex ultrasound (DUS). Contraindications: Separate use of the individual components of the VenaSeal closure system is contraindicated. These components must be used as a system. The use of the VenaSeal system is contraindicated when any of the following conditions exist: previous hypersensitivity reactions to the VenaSealâ&#x201E;˘ DGKHVLYH RU F\DQRDFU\ODWHV DFXWH VXSHUĆŹFLDO thrombophlebitis, thrombophlebitis migrans, acute sepsis exists. 3RWHQWLDO $GYHUVH (ĆŞHFWV RI WKH 'HYLFH RQ +HDOWK %HORZ LV D OLVW RI WKH SRWHQWLDO DGYHUVH HĆŞHFWV H J FRPSOLFDWLRQV DVVRFLDWHG ZLWK WKH XVH RI WKH 9HQD6HDO V\VWHP 7KH DGYHUVH events associated with the device are similar to those with traditional endovenous thermal ablation procedures. In addition, there are several risks unique to the VenaSeal system due to its material and product design as an implant. These potential adverse events include, but are not limited to, allergic reactions to cyanoacrylates, such as hives, asthma, hay fever DQG DQDSK\ODFWLF VKRFN DUWHULRYHQRXV ĆŹVWXOD EOHHGLQJ IURP WKH VLWH RI DFFHVV GHHS YHLQ WKURPERVLV '97 HGHPD LQ WKH WUHDWHG OHJ HPEROL]DWLRQ LQFOXGLQJ SXOPRQDU\ HPEROLVP 3( KHPDWRPD K\SHUSLJPHQWDWLRQ LQIHFWLRQ DW WKH DFFHVV VLWH QRQ VSHFLĆŹF PLOG LQĆŽDPPDWLRQ RI WKH FXWDQHRXV DQG VXEFXWDQHRXV WLVVXH SDLQ SDUHVWKHVLD SKOHELWLV VXSHUĆŹFLDO thrombophlebitis, urticaria or ulceration may occur at the site of injection, vascular rupture and perforation, visible scarring. Warning, precautions, and instructions for use can be found in the product labeling. For VenaSeal, this labeling can be found at http://useifu.venaseal.com.

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NEWS Firms conduct subanalysis of AMPLIFY Phase 3 to manage P.E., DVT as first-line therapy Bristol-Myers Squibb Co. and Pfizer Inc. have announced results from a posthoc early time course subanalysis of the Phase 3 AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis as First-Line Therapy) trial. The subanalysis demonstrated Eliquis (apixaban) was comparable to conventional therapy (subcutaneous enoxaparin overlapped and followed by oral warfarin dose-adjusted to an international normalized ratio of 2.0 to 3.0) in recurrent VTE and VTE-related death with significantly less major bleeding during the first 7, 21 and 90 days after starting treatment. These data were published in Thrombosis and Haemostasis. Venous thromboembolism, or VTE, encompasses two serious conditions: deep vein thrombosis (DVT), a blood clot in a vein, usually in the lower leg, thigh or pelvis, which partially or totally blocks the flow of blood; and pulmonary embolism (PE), a potentially life-threatening condition in which a blood clot blocks blood vessels in the lungs. Estimates suggest that the number of adults in the United States with VTE is projected to nearly double from 0.95 million in 2006 to 1.82 million in 2050. Approximately one million patients in the European Union are diagnosed with VTE every year. Once a VTE has occurred, up to 11 percent of people may have a VTE reoccurrence, which could potentially be fatal. Giancarlo Agnelli, MD, professor of internal medicine at the University of Perugia, Italy, director of the department of internal and cardiovascular medicine and stroke-unit at the University Hospital in Perugia, Italy, chair of the AMPLIFY steering committee, and co-author of the publication, said these findings indicate that the favorable benefit-torisk profile of Eliquis was demonstrated early during treatment for VTE, including the use of a higher Eliquis dose of 10mg twice daily for the initial seven days.”

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The results of the subanalyses at each prespecified time interval were consistent with the overall results of the AMPLIFY trial at six months, which demonstrated non-inferiority of Eliquis versus conventional therapy in the primary efficacy endpoint of recurrent VTE and VTE-related death; and superiority in the primary safety endpoint by showing significantly fewer major bleeding events, with a 69 percent relative risk reduction (RRR) (absolute risk reduction [ARR] of 1.1 percentage points [95 percent CI, -1.7 to -0.6]) compared to conventional therapy. In this post-hoc early time course subanalysis, recurrent VTE and VTE-related death at 7, 21, and 90 days after starting treatment occurred in 18 (0.7 percent), 29 (1.1 percent), and 46 (1.8 percent), patients who were given Eliquis, respectively, and in 23 (0.9 percent), 35 (1.3 percent), and 58 (2.2 percent) patients given conventional therapy, respectively. Outcomes at each time point were similar in patients by index event (deep vein thrombosis (DVT) alone or pulmonary embolism (PE with or without DVT) and were consistent with the results for the entire study period. Major bleeding at the corresponding time points occurred in 3 (0.1 percent), 5 (0.2 percent), and 11 (0.4 percent) patients, who received Eliquis, respectively, and in 16 (0.6 percent), 26 (1.0 percent), and 38 (1.4 percent) patients given conventional therapy, respectively. Eliquis was non-inferior to conventional therapy in recurrent VTE and VTE-related death at each time point analyzed, with no excess of early recurrences; and patients treated with Eliquis were less likely to have major bleeding early in the course of treatment than those treated with conventional therapy. The AMPLIFY trial was a double-blind, randomized, multicenter study that compared the efficacy and safety of Eliquis (at a dose of 10 mg orally twice daily for seven days, followed by 5 mg orally twice daily for six months) with those of conventional therapy in 5,395 patients with symptomatic proximal DVT or symptomatic PE with or without DVT. The primary efficacy outcome was the incidence of the adjudicated composite of recurrent symptomatic VTE or death related to VTE that occurred by the end of the treatment period. The primary safety outcome was adjudicated major bleeding that occurred by the end of the treatment period. For this subanalysis, efficacy and safety outcomes were analyzed for days 7, 21, and 90 after randomization, substratified for the index event (DVT alone, or PE with or without DVT). VTN

Medtronic enrolled first patients in the VIVA Reality P.A.D. outcome study

Stefan Kiesz, MD

P.A.D. patient first to use new device that saved his leg Hugo McDonald, 54, is walking on his own without pain for the first time in two years since being diagnosed with peripheral artery disease (P.A.D.). He blames his out-ofcontrol diabetes for the complication, which often results in amputation, because the lack of circulation in the artery due to plaque buildup eventually leads of ulceration of the bone. “It literally felt as though I was walking on the bones of my feet,” McDonald explained. “Very, very painful. I think the most troubling thing for me was when my feet began to turn black.” That’s when McDonald met up with Dr. Stefan Kiesz, a cardiologist, who is credited for the first stent placement. He says McDonald was an impossible case, with blockages of the artery all the way down his leg to his ankle. Traditional methods failed, so Kiesz tried the new FDA approved, Pantheris system by Avinger. With the system’s developer standing by, Dr. Kiesz performed what had been considered impossible. The three-pronged approach apparently offered the surgeon the best view of the artery, the precise ability to locate the plaque and finally, an intensely precise removal. “We were using a special device that cuts the plaque but this device also sees inside,” Dr. Kiesz said. “So you don’t cut the plaque blindly like we do with the traditional device, we actually see the plaque, then we take it out. So that actually saved his leg.” McDonald said he is grateful that he will soon return to a passion of his: fishing. “There is another option for these patients so they are not going to go right under the knife, which is something that we should avoid at any costs,” Dr. Kiesz said. VTN READ MORE: avinger.com

Medtronic has enrolled the first patients in the VIVA-sponsored Reality study assessing outcomes of peripheral artery disease (P.A.D.) patients treated with directional atherectomy and drug-coated balloons. The study is slated to enroll up to 250 subjects across 15 sites, investigating the use of Medtronic’s HawkOne, TurboHawk and In.Pact Admiral DCB for calcified and symptomatic femoropoliteal P.A.D. patients. “P.A.D. is a complex and progressive disease,” co-principal investigator Dr. Krishna Rocha-Singh of the Prairie Heart Institute of Illinois said in a statement. “The severity of the disease can often have an impact on treatment options for patients. Long lesion length and severe calcification are obstacles that challenge both our ability to gain acute luminal gain and to maintain long-term patency. Reality is driven by the need to look at a viable treatment paradigm that combines the use of directional atherectomy and DCB therapy to address the challenges of treating complex P.A.D.” Dr. Rocha-Singh said the study plans to include angiographic and duplex ultrasound core lab adjudication, with primary patency assessed by duplex ultrasound at 12 months. Patients in the trial will be followed up to 24 months post-procedure to explore clinically driven target lesion revascularization rates. Dr. Roger Gammon of the Austin Heart Central-Heart Hospital, who treated the first patient enrolled in the study said: “We know that directional atherectomy and DCB perform well as standalone treatments; and early data suggests that combined therapy may improve patient outcomes in more Dr. Roger Gammon complex lesions. Through Reality we hope to answer this critical question with rigorous clinical data in this well designed study.” Medtronic peripheral business General Manager Mark Pacyna said Medtronic is committed to improving patient lives through unique clinical partnerships, exemplified by the Reality study. “This study is designed to further refine the P.A.D. Mark Pacyna treatment algorithm by providing greater evidence for vessel preparation with directional atherectomy prior to treatment with DCB.” VTN

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

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NEWS

Veniti locks down funding for venous stent system trial Veniti has locked down $25 million in Series D financing from Boston Scientific to finish a clinical trial for its venous stent system. The funds will help Veniti wrap up the 200-patient, 60-month VIRTUS trial of its Vici Venous Stent. The study is being run under an investigational device exemption from the FDA, and final data collection is planned for May 2017, according to ClinicalTrials.gov. Veniti also plans to use the Series D funding to beef up product development and commercialization for its device, the company said in a statement. “We are extremely pleased to be partnering with such a high quality industry leader to advance our core technology, the Vici Venous Stent,” Veniti CEO Jeff Elkins said in the statement. “This financing will allow us to complete a number of critical milestones and support more physicians treating patients suffering from venous outflow obstruction around the world.” Veniti, which was founded in 2010, has already attracted funding for its stent system. In 2012, the St. Louis, Mo.-based company raised $15 million from investors including Baird Venture Partners. In 2013, Veniti brought in $9.7 million of an anticipated $12 million round. Last year, the company raised $17 million to complete its VIRTUS trial. Previous investors such as Baird Capital and Tekla Healthcare led the equity portion of the financing. VTN

Feds bust Florida docs for $1B fraud Need more evidence that Medicare fraud is the unofficial state sport of Florida? This summer, federal prosecutors unsealed an indictment against three Miamiarea residents, charging the suspects with conspiracy, obstruction, money laundering and healthcare fraud estimated at $1 billion. “This is the largest single criminal healthcare fraud case ever brought against individuals by the Department of Justice,” Assistant Attorney General Leslie R. Caldwell said in a DOJ press release. Philip Esformes, 47, operated a network of more than 30 skilled nursing and assisted

living facilities in South Florida, according to DOJ. He is charged with Medicaid and Medicare fraud for providing “medically unnecessary” services to perhaps thousands of beneficiaries who did not qualify for federal reimbursement. Esformes and the other two defendants, hospital administrator Odette Barcha, 49, and physician assistant Arnaldo Carmouze, 56, allegedly paid kickbacks to themselves for referring many of the same patients to other healthcare providers for similarly unnecessary services. VTN

GORE TIGRIS Vascular Stent

GORE TIGRIS Vascular Stent gets FDA approval The U.S. Food and Drug Administration (FDA) has approved the GORE TIGRIS Vascular Stent, a dual-component stent with a unique fluoropolymer/nitinol design. The W. L. Gore & Associates Inc. GORE TIGRIS device, which gained CE Mark approval in 2011, is a third generation, self-expanding stent. The device was designed explicitly to improve anatomical conformability with the natural movement of the knee when treating peripheral artery disease (P.A.D.). The vascular stent uses a dual component structure, made from a single-wire nitinol stent with flexible and biocompatible fluoropolymer interconnections. The stent has been designed to weather biomechanical forces (extension, compression, flexion and torsion) without fractures, even in the most complex anatomies, namely in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). In the U.S. clinical study that supported FDA approval of the GORE TIGRIS Vascular Stent, the TIGRIS stent was found to have zero fractures, while the control arm devices experienced a 27 percent fracture rate. “The TIGRIS Vascular Stent has an innovative design that is very different from any of the other nitinol stents that we currently use,” said John R. Laird, MD, an interventional cardiologist in Davis, Calif. “The extreme flexibility of this stent makes it well suited for the superficial femoral artery and proximal popliteal artery, and the delivery system is highly accurate. The precision offered by this flexible, dual component device allows for easy insertion and predictable clinical

outcomes, even in challenging anatomy.” The GORE TIGRIS Vascular Stent also features Gore’s CBAS Heparin Surface, the proven, lasting heparin bonding technology designed to resist thrombus formation, a problem common in both bare metal and drug-eluting stents. End-point covalent bonding keeps heparin anchored to the stent surface, while the bioactive site remains free to interact with the blood to help prevent clotting.1 P.A.D. is prevalent in older populations, a rapidly growing demographic in developed countries. In the United States alone, approximately 8 to 12 million people suffer from some form of P.A.D. The disease can manifest in mild symptoms such as chronic leg pain, and more serious complications include poor wound healing, increased risk of stroke and amputation. Endovascular treatment, via angioplasty and stenting of a blocked artery, is designed to treat P.A.D. without the complications that can accompany open surgery. VTN READ MORE: goremedical.com/ tigrisna

LITERATURE 1

Thaveau F, Méteyer V, LeJay A, Chakfé N. Latest generation of conforming dual component stent. In: Greenhalgh RM, ed. Charing Cross 2016-Vascular & Endovascular Challenges Update. 2016 ed. Fulham, London, United Kingdom: BIBA Publishing; 2016:423-428.

Nanoparticles help platelets stick together to stop bleeding At the August National Meeting & Exposition of the American Chemical Society, researchers from the University of Maryland in Baltimore County reported on the development of nanoparticles that can help speed up blood clotting. So far tested only on pig’s blood, the goal of the research is to provide clinicians with a more effective way of treating internal bleeding. The new nanoparticles took effort to create because besides promoting activated platelets to link together, they have to spread out when injected and not cause an immune response. A special molecule attached to each nanoparticle sticks to a glycoprotein produced by activated platelets, providing the particles’ targeting abilities. But because the nanoparticles stuck to each other, the team added a slick polymer to prevent them from immediately aggregating. The next steps will involve trying the particles on human blood, and somehow evaluating whether they will increase the chances of thrombus formation and subsequent

strokes. Nanoparticles (green) help form clots in an injured liver. The researchers added color to the scanning electron microscopy image after it was taken. VTN

Surgeon’s degree of specialization indicates success? A surgeon’s degree of specialization may be a better predictor of whether a patient lives or dies than how many times the doctor performed a procedure, according to new research published in The BMJ. The study looked at nearly 700,000 Medicare records of patients who underwent one of eight common procedures over a five-year period. Researchers from Harvard, Dartmouth and the National Bureau of Economic Research, led by Nikhil R. Sahni of the Forum for Growth and Innovation at Harvard Business School, found a surgeon’s specialization level was a major predictor of patient mortality, even after controlling for factors such as staffing ratios and individual hospitals’ financial health. In fact, according to Sahni and his team, specialization, or the number of times the surgeon has performed the procedure divided by their operative volume for all procedures, predicts mortality better than simply experience. They say specialization can be credited for between 9 percent and 100 percent of the risk reduction commonly attributed to experience. However, the level of reduced risk varied by procedure; for example, specialization reduced coronary artery bypass mortality risk by 15 percent, whereas it reduced valve replacement risk by 46 percent. Despite this variability, researchers found a clear reduction for six of the eight procedures. “When selecting a surgeon, patients, referring physicians and administrators assigning operative workload may want to consider a surgeon’s procedure specific volume as well as the degree to which a surgeon specializes in that procedure,” the researchers wrote. VTN READ MORE: bmj.com/content/354/bmj.i3571

For even more of the latest industry news and features, please visit us online at VEINTHERAPYNEWS.com

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

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THEPRACTICE Mastering the ABCs. . .

Understanding, reaching and acquiring new patients

By Michelle Huie As a business owner, one of the questions you likely ask yourself is, “how do I get more customers?” A wonderful goal, but to answer this you continually need to place yourself in your target audience’s shoes (or socks) and instead ask, “what do my customers want?” Understanding your customers is a great place to start. There are a few defining factors for today’s generations that set each apart, including their purchasing habits and preferences. Studies from Pew Research to published works by professors and psychologists have determined the below:

BABY BOOM GENERATION (BORN 1946-1964) According to the U.S. Census Bureau statistics, there are approximately 74 million Baby Boomers across the United States. Boomers are often driven and seen as workaholics who want a prestigious title and the corner office. When dealing with money, Boomers tend to use the mentality of buy now, spend later, leaving a legacy of consumerism and self-indulgence.

GENERATION X (BORN 1965-1979) It’s estimated that there are more than 48 million “Gen Xers” in the United States. These individuals are self-reliant, adaptable, value time and want freedom in the workplace. When dealing with money, they are more conservative and cautious, opting to put their money into savings over spending frivolously.

MILLENNIALS, AKA GENERATION Y (BORN 1980-1999) To date, there are more than 75 million Millennials, which is the largest cohort size in history. This means that they have a very influential $200 billion in annual buying power. Millennials are multitasking workers who prefer meaningful work, which is why many lean toward entrepreneurship. They’re the first generation of digital natives, and their affinity for technology helps shape how they shop. When dealing with money, convenience and options are a big factor into their decision to make a purchase. They are also accustomed to instant access to price comparisons, product information and peer reviews. Who are your customers and how are you appealing to your target audiences?

Though not all (if any) of your patients in the vein clinic profession will be Millennials, it’s important to note the change in thought toward how business is done now that Millennials make up such a large part of the population. For example, due to having grown up with readily accessible technology, Millennials view companies that are not digitally accessible, via a website and/or social media, as inferior. And this thought has spread to many other businesses and consumers, regardless of which generation they fall under. So, how do you get more customers? It’s as easy as A, B, C.

ALWAYS PROVIDE OPTIONS Every person is unique. A one-size-fits-all model of offered services is bad business, especially in the health and wellness space where every patient is different from the next and treatments must be tailored to specific needs. At VIM & VIGR, we offer an array of designs to provide options for each individual’s personal style, from polka dots and argyle patterns to neutral stripes and camo prints. We also make sure our products are available for people of all body types. I started VIM & VIGR because I needed compression for health reasons and could not find anything that I would wear on a daily basis that fit my life(style); I would hate to be part of the problem by restricting my products to the one-size-fits-all thinking. We offer sizes small through large, as well as wide calf, so that any body can enjoy our products and the health benefits of compression. Take a look at your services and build out options for your patients. Perhaps you do provide this service but do not advertise as such. Make sure that when people think of your clinic, they feel comfortable knowing they will pay for exactly what they need, no more and no less.

BE(COME) DIGITALLY ENGAGING As seen in the Millennial purchasing characteristics earlier, having a digital presence and a digital storefront (if applicable) is becoming standard practice, and those who do not follow suite are losing out on business. Clearly, with any medical practice, the service must be performed in person; however, consider being very transparent and posting your prices online. This will satisfy the Gen Xer’s desire to save time, as well as the Millennial base who prefer to research and shop around for the best price. Also keep in mind customer reviews; particularly when searching for a medical practitioner, reviews from actual

customers help potential patients trust your business. This can be done by claiming ownership of websites such as Yelp! or by providing a forum for patients to leave reviews straight through your website. On vimvigr.com we provide the option for our customers to send us a quick message or leave a review. We currently have more than 90 reviews posted to our website and I think that in itself helps people new to VIM & VIGR feel confident in our brand and the quality of product we offer. We also like to select a few reviews each month to share on our social channels as a “thank you” for those who took the time to write us. Small gestures can go a long way in building brand loyalty, but the bottom line is, you have to meet people where they spend most of their time and in our current society, that is through digital channels.

CONNECT WITH PAST PATIENTS Do you know the best way to reach potential patients? Word of mouth. People trust their friends and family as a referral source over even the most targeted advertisement. Connect with your past patients. Genuinely follow up and see how they are doing post-op and how their recovery is going. Send them a care package (with compression socks!) as they leave the clinic. I’ve always believed that the quality of your customer service can make or break your business, regardless of how excellent your treatment may be. Because one sour apple truly can ruin the bunch. Pamper them with stellar customer service and bedside manner and they will not forget you. In your follow-ups, be sure to offer them incentives to refer a friend. Word of mouth is the cheapest and most effective form of brand awareness. Treat your customers in a way that will make them want to share their experience with others and let your loyal fans take care of the rest. VTN Working in the biotechnology and pharmaceutical industry for over 14 years, Michelle Huie has dedicated her adult life to introducing innovative technology and products to people that need them most. In 2013, Huie founded VIM & VIGR: a high-quality compression legwear line with stylish designs to be worn all day. Today, she leads the VIM & VIGR team as they set out to bring the benefits of their products to people everywhere. To contact VIM & VIGR for questions and inquiries, please email info@vimvigr.com.

Study reveals patient’s Internet search habits Before the Internet, patients who wanted to learn more about their healthcare providers had to rely on word-of-mouth networks. Now, patients can easily search for information about individual physicians – and radiologists need to know what they're finding, according to an Aug. 30 study in the American Journal of Roentgenology (AJR). "As patients more readily access the names of radiologists interpreting their imaging studies, they will likely seek information about these radiologists with increasing frequency," wrote a team led by Arvind Vijayasarathi, MD, from Emory University Hospital.

And it's important to keep in mind that when patients use search engines such as Google, they tend to focus on the first page of results, according to the group’s study. "Google is the most popular search engine in the United States, but most users view only the first page of Google search results, suggesting that information provided on the first page disproportionately influences the knowledge and opinions of patients," the authors wrote. To learn more about what patients find when they Google radiologists, Dr. Vijayasarathi and colleagues used data from the U.S. Centers for Medicare and Medicaid Services (CMS) to

identify all Medicare-participating U.S. radiologists. The group tracked the top 10 Google search results for each radiologist, categorizing the website domains found as physician – or institution-controlled, third-party physician rating sites, social media or other sits according to the AJR article. From the CMS data, 30,601 providers identified themselves as radiologists. There was a least one search result for 99 percent of these, which resulted in a total of 305,795 websites. SEARCH HABITS

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OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

THEPRACTICE

AORN: Bullying of nurses common; patients suffer The Association of periOperative Registered Nurses hosted a Facebook discussion on the issue of nurse bullying on Sept. 1, and nurses commenting on the stream noted experiences that ran the gamut from an offhand comment to repeated intimidation. Other nurses, doctors and healthcare leaders are often the culprits. Linda Groah, RN, executive director and CEO of AORN, said in the video that such behavior is enough to make both new and veteran nurses question their choice of profession. Indeed, even rolling your eyes at a new trainee or acting impatient as a new employee learns the ropes can have a real, negative effect on a young nurse, said Lisa Spruce, RN, the organization’s director of evidence-practice. Making new staff members feel excluded or treating them differently can also hurt team morale, she said. “Nurses are such a caring, compassionate and kind group of people, who treat our patients amazingly well, but then sometimes with each other we don’t do so well,” she said. AORN is coordinating a series of leadership seminars on bullying, titled “Bringing Shadow Behavior into the Light of Day,” which will run through November. Gayle Davis, AORN’s director of corporate communications, said it’s important that nurses, physicians and industry leaders all understand what bullying is and how common it is, so that they can support victims and train bullies on better behavior. Groah noted that it’s crucial that leaders learn more about bullying because survey data has found that only 30 percent of managers actually did anything about reported bullying. In addition to the mental toll bullying can take on nurses – who are said to already be at incredibly high risk for stress and burnout – such behavior may also hurt patients. “There is potential for patient harm in those situations…if you feel like a fool for bringing something up, the next time around you’re not going to be so likely to speak up,” Groah said. VTN

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THEPRACTICE Twenty years ago, the summer games of the XXVI Olympiad had just ended in Atlanta. We were dancing to the “Macarena,” the number one song on the radio. The first cellular phones were just hitting the market. And on Aug. 21, 1996, our nation committed to transforming health care coverage with the enactment of historic, bipartisan legislation called the Health Insurance Portability and Accountability Act of 1996, or HIPAA for short.

HIPAA at 20

A bipartisan achievement! All physicians are familiar with HIPAA as a medical privacy and security law. But it ŝƐ ƚŚĂƚ ĂŶĚ ƐŽ ŵƵĐŚ ŵŽƌĞ͘ ŬĞǇ ĐŽŵƉŽŶĞŶƚ ŽĨ ,/W ͛Ɛ ŝŶŝƟĂů ƉƵƌƉŽƐĞ ǁĂƐ ƚŽ ĂůůŽǁ ƉĞŽƉůĞ ƚŽ ƚƌĂŶƐĨĞƌ ĂŶĚ ĐŽŶƟŶƵĞ ŚĞĂůƚŚ ŝŶƐƵƌĂŶĐĞ ĂŌĞƌ ƚŚĞǇ ĐŚĂŶŐĞ Žƌ ůŽƐĞ Ă ũŽď͘ dŚŝƐ ǁĂƐ ĮƌƐƚ ŵĂĚĞ ƉŽƐƐŝďůĞ ŝŶ ϭϵϴϱ ďǇ ƉĂƐƐĂŐĞ ŽĨ ŚĞĂůƚŚ ŝŶƐƵƌĂŶĐĞ ĐŽŶƟŶƵĂƟŽŶ ƉƌŽǀŝƐŝŽŶƐ ŝŶ ƚŚĞ ŽŶƐŽůŝĚĂƚĞĚ KŵŶŝďƵƐ ƵĚŐĞƚ ZĞĐŽŶĐŝůŝĂƟŽŶ Đƚ ; K Z Ϳ͘ ,/W ƚŚĞŶ ďƵŝůƚ ƵƉŽŶ ƚŚĞƐĞ ŐĂŝŶƐ͕ ĂŶĚ ŵŽƐƚ ƌĞĐĞŶƚůǇ͕ ƚŚĞ īŽƌĚĂďůĞ ĂƌĞ Đƚ ; Ϳ ĂŵĞŶĚĞĚ ĂŶĚ ĞǆƉĂŶĚĞĚ ŵĂŶǇ ŽĨ ƚŚĞ ŽƌŝŐŝŶĂů ,/W ĐŽŶƐƵŵĞƌ ƉƌŽƚĞĐƟŽŶƐ͘ WƌŝŽƌ ƚŽ ƚŚĞ ƉĂƐƐĂŐĞ ŽĨ ,/W ͕ ŵĂŶǇ ƉĞŽƉůĞ ǁĞƌĞ ĂĨƌĂŝĚ ƚŽ ĐŚĂŶŐĞ ũŽďƐ ŽƵƚ ŽĨ ĨĞĂƌ ƚŚĂƚ Ă ƉƌĞĞǆŝƐƟŶŐ ŵĞĚŝĐĂů ĐŽŶĚŝƟŽŶ ǁŽƵůĚ ƉƌĞǀĞŶƚ ƚŚĞŵ ĨƌŽŵ ƌĞĐĞŝǀŝŶŐ ŚĞĂůƚŚ ŝŶƐƵƌĂŶĐĞ ĐŽǀĞƌĂŐĞ͘ ,/W ĂĚĚƌĞƐƐĞĚ ƚŚŝƐ ĐŽŶĐĞƌŶ ƚŚƌŽƵŐŚ ŝƚƐ ƉŽƌƚĂďŝůŝƚǇ ƉƌŽǀŝƐŝŽŶƐ͕ ǁŚŝĐŚ ůĞƐƐĞŶĞĚ ƚŚĞ ƉŽƐƐŝďŝůŝƚǇ ƚŚĂƚ ĂŶ ŝŶĚŝǀŝĚƵĂů ǁŽƵůĚ ůŽƐĞ ŚĞĂůƚŚ ĐĂƌĞ ĐŽǀĞƌĂŐĞ ĨŽƌ Ă ƉƌĞĞǆŝƐƟŶŐ ĐŽŶĚŝƟŽŶ ǁŚĞŶ ĐŚĂŶŐŝŶŐ ƚŽ Ă ŶĞǁ ĞŵƉůŽǇĞƌ͛Ɛ ŐƌŽƵƉ ŚĞĂůƚŚ ƉůĂŶ Žƌ ǁŚĞŶ ƐĞĞŬŝŶŐ ĐŽǀĞƌĂŐĞ ŝŶ ƚŚĞ ŝŶĚŝǀŝĚƵĂů ŵĂƌŬĞƚ͘ ,/W ĂůƐŽ ƌĞƋƵŝƌĞĚ ŐƌŽƵƉ ŚĞĂůƚŚ ƉůĂŶƐ ƚŽ ƉƌŽǀŝĚĞ ƐƉĞĐŝĂů ĞŶƌŽůůŵĞŶƚ ƉĞƌŝŽĚƐ ĨŽƌ ĞŵƉůŽǇĞĞƐ ĂŶĚ ƚŚĞŝƌ ĚĞƉĞŶĚĞŶƚƐ ǁŚŽ ĞǆƉĞƌŝĞŶĐĞ Ă ƋƵĂůŝĨǇŝŶŐ ĞǀĞŶƚ ƐƵĐŚ ĂƐ ůŽƐƐ ŽĨ ŽƚŚĞƌ ŐƌŽƵƉ ĐŽǀĞƌĂŐĞ͕ ďŝƌƚŚ ŽĨ Ă ĐŚŝůĚ Žƌ ŵĂƌƌŝĂŐĞ͘ ,/W ƉƌŽŚŝďŝƚĞĚ ŐƌŽƵƉ ŚĞĂůƚŚ ƉůĂŶƐ ĨƌŽŵ ĚŝƐĐƌŝŵŝŶĂƟŶŐ ďĂƐĞĚ ŽŶ ŚĞĂůƚŚ ƐƚĂƚƵƐ ĂŐĂŝŶƐƚ ĂŶ ĞŵƉůŽǇĞĞ Žƌ Ă ĚĞƉĞŶĚĞŶƚ ŝŶ ƚĞƌŵƐ ŽĨ ĞůŝŐŝďŝůŝƚǇ Žƌ ĐŽƐƚ ŽĨ ĐŽǀĞƌĂŐĞ͘ dŚĞ ĞǆƉĂŶĚĞĚ ƚŚŝƐ ƉƌŽǀŝƐŝŽŶ ƚŽ ĐĞƌƚĂŝŶ ŝŶĚŝǀŝĚƵĂů ŚĞĂůƚŚ ŝŶƐƵƌĂŶĐĞ ƉŽůŝĐŝĞƐ͘ ,/W ĂůƐŽ ŵĂŶĚĂƚĞĚ ƚŚĂƚ Ăůů ŝŶĚŝǀŝĚƵĂů ĂŶĚ ŐƌŽƵƉ ŚĞĂůƚŚ ŝŶƐƵƌĂŶĐĞ ĐŽǀĞƌĂŐĞ͕ ŝŶĐůƵĚŝŶŐ ƐŵĂůů ĞŵƉůŽǇĞƌƐ ǁŝƚŚ ϮͲϱϬ ĞŵƉůŽǇĞĞƐ͕ ďĞ ŐƵĂƌĂŶƚĞĞĚ ƌĞŶĞǁĂďůĞ Ăƚ ƚŚĞ ŽƉƟŽŶ ŽĨ ƚŚĞ ŝŶĚŝǀŝĚƵĂů Žƌ ĞŵƉůŽǇĞƌ͘ dŚĞ ĐŽŶƟŶƵĞĚ ƚŚŝƐ ƉƌŽƚĞĐƟŽŶ ĨŽƌ ďŽƚŚ ůĂƌŐĞ ĂŶĚ ƐŵĂůů ĞŵƉůŽǇĞƌƐ͕ ĂŶĚ ŵŽƐƚ ƐŝŐŶŝĮĐĂŶƚůǇ͕ ƚŽ ŝŶĚŝǀŝĚƵĂůƐ ĂŶĚ ĨĂŵŝůŝĞƐ ƉƵƌĐŚĂƐŝŶŐ ŝŶĚŝǀŝĚƵĂů ŵĂƌŬĞƚ ŚĞĂůƚŚ ŝŶƐƵƌͲ ance policies. dǁĞŶƚǇ ǇĞĂƌƐ ĂŐŽ͕ Ă ĐŽŶƐŝĚĞƌĂďůĞ ƉŽƌƟŽŶ ŽĨ ĞǀĞƌǇ ŚĞĂůƚŚ ĐĂƌĞ ĚŽůůĂƌ ǁĂƐ ƐƉĞŶƚ ŽŶ ĂĚŵŝŶŝƐƚƌĂƟǀĞ ŽǀĞƌŚĞĂĚ ŝŶ ƉƌŽĐĞƐƐĞƐ ƚŚĂƚ ŝŶǀŽůǀĞĚ ŶƵŵĞƌŽƵƐ ƉĂƉĞƌ ĨŽƌŵƐ ĂŶĚ ƚĞůĞͲ ƉŚŽŶĞ ĐĂůůƐ͕ ŶŽŶͲƐƚĂŶĚĂƌĚ ĞůĞĐƚƌŽŶŝĐ ĐŽŵŵĞƌĐĞ͕ ĂŶĚ ŵĂŶǇ ĚĞůĂǇƐ ŝŶ ĐŽŵŵƵŶŝĐĂƟŶŐ ŝŶĨŽƌŵĂƟŽŶ ĂŵŽŶŐ ĚŝīĞƌĞŶƚ ůŽĐĂƟŽŶƐ͘ dŚŝƐ ƐŝƚƵĂƟŽŶ ĐƌĞĂƚĞĚ ĚŝĸĐƵůƟĞƐ ĂŶĚ ĐŽƐƚƐ ĨŽƌ ŚĞĂůƚŚ ĐĂƌĞ ƉƌŽǀŝĚĞƌƐ͕ ŚĞĂůƚŚ ƉůĂŶƐ͕ ĂŶĚ ĐŽŶƐƵŵĞƌƐ͘ hŶĚĞƌ ,/W ͕ ƐƚĂŶĚĂƌĚƐ ǁĞƌĞ ĚĞǀĞůŽƉĞĚ ƚŽ ŝŵƉƌŽǀĞ ƚŚĞ ǁĂǇ ŚĞĂůƚŚ ĐĂƌĞ ĚĂƚĂ ŝƐ ĞǆĐŚĂŶŐĞĚ ĞůĞĐƚƌŽŶŝĐĂůůǇ͘ ,/W ƐŝŵƉůŝĮĞĚ ĂŶĚ ĞŶĐŽƵƌĂŐĞĚ ƚŚĞ ĞůĞĐƚƌŽŶŝĐ ƚƌĂŶƐĨĞƌ ŽĨ ŝŶĨŽƌŵĂƟŽŶ ďǇ ƌĞƋƵŝƌͲ ŝŶŐ ƚŚĞ ,,^ ƚŽ ĂĚŽƉƚ ƐƚĂŶĚĂƌĚƐ ĨŽƌ ĐĞƌƚĂŝŶ ĞůĞĐƚƌŽŶŝĐ ƚƌĂŶƐĂĐƟŽŶƐ͕ ĂŶĚ ŶŽǁ ϵϯ͘ϴй ŽĨ Ăůů ŚĞĂůƚŚ ĐĂƌĞ ĐůĂŝŵƐ ƚƌĂŶƐĂĐƟŽŶƐ ƚŽĚĂǇ ĂƌĞ ĐŽŶĚƵĐƚĞĚ ŝŶ ƐƚĂŶĚĂƌĚ ĨŽƌŵ͘

dŚĞ ,/W ƐƚĂŶĚĂƌĚƐ ŚĂǀĞ ŚĞůƉĞĚ ƉĂǀĞ ƚŚĞ ǁĂǇ ĨŽƌ ƚŚĞ ŝŶƚĞƌŽƉĞƌĂďŝůŝƚǇ ŽĨ ŚĞĂůƚŚ ĚĂƚĂ ƚŽ ĞŶŚĂŶĐĞ ƚŚĞ ƉĂƟĞŶƚ ĂŶĚ ƉƌŽǀŝĚĞƌ ĞǆƉĞƌŝĞŶĐĞ͘ ,/W ĂůƐŽ ĞŶŚĂŶĐĞĚ ƉƌŝǀĂĐǇ ĂŶĚ ƐĞĐƵƌŝƚǇ ƉƌŽƚĞĐƟŽŶƐ ĨŽƌ ĐŽŶƐƵŵĞƌ ŚĞĂůƚŚ ĚĂƚĂ ďǇ ĞƐƚĂďůŝƐŚŝŶŐ ƌĞƋƵŝƌĞŵĞŶƚƐ ĨŽƌ ŵŽƐƚ ŚĞĂůƚŚ ĐĂƌĞ ƉƌŽǀŝĚĞƌƐ͕ ŚĞĂůƚŚ ƉůĂŶƐ ĂŶĚ ŽƚŚĞƌ ĞŶƟƟĞƐ ƚŚĂƚ ƉƌŽĐĞƐƐ ŚĞĂůƚŚ ŝŶƐƵƌĂŶĐĞ ĐůĂŝŵƐ͕ ĂŶĚ ƚŚĞŝƌ ďƵƐŝŶĞƐƐ ĂƐƐŽĐŝĂƚĞƐ ƚŽ ƐĂĨĞͲ ŐƵĂƌĚ ŝŶĨŽƌŵĂƟŽŶ͘ ,/W ͛Ɛ WƌŝǀĂĐǇ ZƵůĞ ŐŝǀĞƐ ŝŶĚŝǀŝĚƵĂůƐ ŝŵƉŽƌƚĂŶƚ ƌŝŐŚƚƐ ƚŽ ƚŚĞŝƌ ŚĞĂůƚŚ ŝŶĨŽƌŵĂƟŽŶ͕ ĂŶĚ ƐĞƚƐ ƌƵůĞƐ ĨŽƌ ŚŽǁ ƚŚĞ ŝŶĨŽƌŵĂƟŽŶ ĐĂŶ ďĞ ĂĐĐĞƐƐĞĚ͕ ƵƐĞĚ ĂŶĚ ĚŝƐĐůŽƐĞĚ͘ &Žƌ ĞǆĂŵƉůĞ͕ ƚŚĞ ,/W WƌŝǀĂĐǇ ZƵůĞ ŐŝǀĞƐ ŝŶĚŝǀŝĚƵĂůƐ ƚŚĞ ƌŝŐŚƚ ƚŽ Ă ĐŽƉǇ ŽĨ ƚŚĞŝƌ ŚĞĂůƚŚ ŝŶĨŽƌŵĂƟŽŶ ŝŶ ƚŚĞ ĨŽƌŵ ĂŶĚ ĨŽƌŵĂƚ ƚŚĂƚ ƚŚĞǇ ƌĞƋƵĞƐƚ ʹ ŝŶĐůƵĚŝŶŐ ĂŶ ĞůĞĐͲ tronic copy. dŚĞ ,/W ^ĞĐƵƌŝƚǇ ZƵůĞ ƌĞƋƵŝƌĞƐ ŚĞĂůƚŚ ĐĂƌĞ ŽƌŐĂŶŝǌĂƟŽŶƐ ƚŽ ƐĂĨĞŐƵĂƌĚ ƚŚĞ ĞůĞĐͲ ƚƌŽŶŝĐ ŚĞĂůƚŚ ŝŶĨŽƌŵĂƟŽŶ ƚŚĞǇ ŚŽůĚ͘ ŵŽŶŐ ƚŚĞ ƌƵůĞ͛Ɛ ƌĞƋƵŝƌĞŵĞŶƚƐ͕ ŽƌŐĂŶŝǌĂƟŽŶƐ ĐŽǀĞƌĞĚ ďǇ ,/W ŵƵƐƚ ĞŶŐĂŐĞ ŝŶ ĐŽŵƉƌĞŚĞŶƐŝǀĞ ƌŝƐŬ ĂŶĂůǇƐĞƐ ĂŶĚ ƌŝƐŬ ŵĂŶĂŐĞŵĞŶƚ ƚŽ ĞŶƐƵƌĞ ƚŚĂƚ ŚĞĂůƚŚ ŝŶĨŽƌŵĂͲ ƟŽŶ ŝƐ ƐĞĐƵƌĞ͘ dŚŝƐ ŝŶĐůƵĚĞƐ ŝŵƉůĞŵĞŶƟŶŐ ƉŚǇƐŝĐĂů͕ ƚĞĐŚŶŝĐĂů͕ ĂŶĚ ĂĚŵŝŶŝƐƚƌĂƟǀĞ ƐĞͲ ĐƵƌŝƚǇ ŵĞĂƐƵƌĞƐ ƐƵĸĐŝĞŶƚ ƚŽ ƌĞĚƵĐĞ ƌŝƐŬƐ ŝŶ Ăůů ƉŚǇƐŝĐĂů ůŽĐĂƟŽŶƐ ĂŶĚ ŽŶ Ăůů ƉŽƌƚĂďůĞ ĚĞǀŝĐĞƐ ƚŽ Ă ƌĞĂƐŽŶĂďůĞ ĂŶĚ ĂƉƉƌŽƉƌŝĂƚĞ ůĞǀĞů͘ &ŝŶĂůůǇ͕ ,/W ǁĂƐ ŵŽĚŝĮĞĚ ŝŶ ŝŵƉŽƌƚĂŶƚ ǁĂǇƐ͕ ŝŶĐůƵĚŝŶŐ ƚŚĞ ƌĞƋƵŝƌĞŵĞŶƚƐ ƚŚĂƚ ďƌĞĂĐŚĞƐ ŽĨ ƵŶƐĞĐƵƌĞĚ ŚĞĂůƚŚ ŝŶĨŽƌŵĂƟŽŶ ĂƌĞ ƌĞƉŽƌƚĞĚ ƚŽ ĂīĞĐƚĞĚ ŝŶĚŝǀŝĚƵĂůƐ͕ ƚŚĞ h͘^͘ ĞƉĂƌƚŵĞŶƚ ŽĨ ,ĞĂůƚŚ ĂŶĚ ,ƵŵĂŶ ^ĞƌǀŝĐĞƐ ;,,^Ϳ͕ ĂŶĚ ŝŶ ƐŽŵĞ ĐĂƐĞƐ ƚŚĞ ŵĞĚŝĂ͘ dŚŝƐ ƌĞƋƵŝƌĞŵĞŶƚ ŚĞůƉƐ ŝŶĚŝǀŝĚƵĂůƐ ŬŶŽǁ ŝĨ ƐŽŵĞƚŚŝŶŐ ŚĂƐ ŐŽŶĞ ǁƌŽŶŐ ǁŝƚŚ ƚŚĞ ƉƌŽƚĞĐƟŽŶ ŽĨ ƚŚĞŝƌ ŝŶĨŽƌŵĂƟŽŶ ĂŶĚ ŚĞůƉƐ ŬĞĞƉ ŽƌŐĂŶŝǌĂƟŽŶƐ ĂĐĐŽƵŶƚĂďůĞ ĨŽƌ ƉƌŝǀĂĐǇ and security. ,,^ ŝƐ ĐĞůĞďƌĂƟŶŐ ƚŚĂƚ ,/W ŚĂƐ ĐŽŵĞ Ă ůŽŶŐ ǁĂǇ ŝŶ ϮϬ ǇĞĂƌƐ͕ ďƵƚ ŝƚƐ ǁŽƌŬ ŝƐ ŶŽƚ yet done. ͞ ǀĞƌǇ ĚĂǇ͕ ǁĞ ĂƌĞ ƐĞĞŝŶŐ ďƌĞĂŬƚŚƌŽƵŐŚƐ ŝŶ ŵŽďŝůĞ ŚĞĂůƚŚ͕ ŝŶĐůƵĚŝŶŐ ŵĂŶǇ ŵŽƌĞ ĐŽŶƐƵŵĞƌͲĨĂĐŝŶŐ ŚĞĂůƚŚ ĂƉƉƐ ǁŝƚŚ ƚŚĞ ƉĂƟĞŶƚ Ăƚ ƚŚĞ ĐĞŶƚĞƌ ŽĨ ƚŚĞ ĐŽŶǀĞƌƐĂƟŽŶ͕͟ Ă ƐƚĂƚĞŵĞŶƚ ĨƌŽŵ ,,^ ƐĂŝĚ͘ ͞tĞ ĂƌĞ ƐĞĞŝŶŐ ŝŵƉƌŽǀĞŵĞŶƚƐ ŝŶ ŚĞĂůƚŚ ĐĂƌĞ ĚĞůŝǀĞƌǇ͕ ǁŝƚŚ ŵĂŶǇ ƐŽůƵƟŽŶƐ ƟĞĚ ƚŽ ŝŵƉƌŽǀĞŵĞŶƚƐ ŝŶ ŚĞĂůƚŚ ĐĂƌĞͲƌĞůĂƚĞĚ ƐǇƐƚĞŵƐ͘ ,ĞĂůƚŚ ĐĂƌĞ ŝŶŶŽǀĂƟŽŶ ŝƐ ŝŶĐƌĞĂƐŝŶŐůǇ ŶŽƚ ĂďŽƵƚ ŝŶĚŝǀŝĚƵĂů ƐŽůƵƟŽŶƐ ĐĂƉƚƵƌŝŶŐ ĚĂƚĂ Ăƚ ƚŚĞ ƉŽŝŶƚ ŽĨ ĐĂƌĞ͕ ďƵƚ ƌĂƚŚĞƌ ŚŽǁ ŝŶĨŽƌŵĂƟŽŶ ĐĂŶ ďĞ ĂƉƉůŝĞĚ ĂŶĚ ƐŚĂƌĞĚ ĂĐƌŽƐƐ ƐǇƐƚĞŵƐ ĨŽƌ ƚŚĞ ŐŽŽĚ ŽĨ ƚŚĞ ƉŽƉƵůĂͲ ƟŽŶ ĂƐ Ă ǁŚŽůĞ͘ VTN

HIPAA has been a blue print for health care reform, paving the way for the future by making health care delivery more efficient and expanding coverage to more Americans. Together, we celebrate 20 years of this historic legislation. 22

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THEPRACTICE

Physician-owned practices: MIPS or APMs?

By John Squire Listening to the cautions of the American Association of Family Physicians that small practices are not prepare for the Medicare Access and CHIP Reauthorization Act (MACRA), the acting head of the Centers for Medicare and Medicaid Services recently acknowledged the possibility of a delay in the new reporting requirements set to begin Jan. 1, 2017. If you are a physician-owned practice, this announcement of a delay in reporting is no reason for complacency. MACRA payment adjustments will begin on Jan. 1, 2019, so now is the time to make some fundamental choices. MACRA does not change the role of Medicare’s physician fee schedule. It simply establishes a new system to increase or decrease payments based on “value.” Under the unified framework of this quality payment program, eligible clinicians will be paid higher if they perform well, and lower if they do not perform well. Small practices should take this extra time to explore their options for implementing the MACRA quality payment program. The most significant decision you will make is the choice between Advanced Alternative Payment Models (APMs) and the Merit-Based Incentive Payment System (MIPS). APMs and MIPS represent a fork in the road for Medicare providers, and the path you choose will have profound implications for the future of your small practice. In a nutshell, MACRA provides financial incentives for either: high performance in MIPS; or assuming risk in the APMs. Your choice does not need to be permanent; you can do MIPS in year one and then switch to an AMP in year two. Which track is better for you? It depends, but we believe MIPS will be the best option for the vast majority of practices with one to 10 eligible clinicians.

WHAT IS MIPS? MIPS combines elements of the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier (VPM), and the electronic health records Meaningful Use program into a single incentive payment system. Incentives and penalties under MIPS start at 4 percent and can reach as high as 9 percent by 2022.

Clinicians will be measured on the Clinical Practice Score (CPS), a new composite measure of performance. The CPS has four components: quality, resource utilization, health technology and clinical practice improvement. Although the weighting of these components will change over time, the emphasis initially is on quality measures that take the place of PQRS (50 percent of the total score). For solo physicians and small practices, MIPS makes sense because it requires minimal investment in new technology. Whereas the accurate risk adjustment required by APMs may work for large enterprises, it remains completely untested for small practices.

WHAT ARE APMs? Clinicians who take a further step towards care transformation by participating in APMs would be exempt from MIPS payment adjustments and would qualify for higher payments through a 5 percent Medicare Part B incentive payment starting in 2026. APMs are the path where clinicians accept both financial risk and reward for providing coordinated, high quality, and efficient care. Yes, there is an annual lump-sum incentive payment, but it can be “clawed back” if goals are not met – that’s the “shared” risk part. Accountable Care Organizations (ACO) and Comprehensive Primary Care Plus are some examples of APMs in which small practices can participate. Patient-centered medical homes are not designated as APMs, but leading physician organizations asked CMS to add them to the list. At the time of this writing, no ruling has been made on this issue.

APMs MAY BE WRONG FOR SMALL PRACTICES As noted above, APMs require accurate risk adjustment. The larger the number of eligible clinicians and the larger patient populations, the more accurately risk can be predicted. In a small practice, a few patients with bad outcomes or higher resource utilization can put goals out of reach. In a very large enterprise, the negative effects of a few outliers has a smaller impact. APMs also require more investment in new technology, such as patient portals, telemedicine tools and population

health analytics, as well as more rigorous practice operational requirements. For these two reasons – risk adjustment and technology investment – some small practices will be tempted to join an enterprise. However, there is really no guarantee of security, particularly if the enterprise itself has high costs or poor quality. That’s why many small practices will likely do better remaining independent with MIPS.

SURVEY OF USERS Recent research surveyed small, independent practices about their attitudes toward the MACRA quality payment program. The results found that approximately 30 percent of participate in an ACO, so they will likely continue down the path to APM if their ACO qualifies for participation. In terms of current payment incentive programs, about 50 percent of respondents plan to attest to Meaningful Use Stage 2, while about 70 percent will file PQRS reports. Based on these numbers, we predict that approximately 75 percent of small practices will move to the MIPS program. No matter what decision you make over the next 30 months, do not become complacent about MACRA. Despite the proposed delay in implementation, by law, the date of payment adjustment remains Jan 1, 2019, which may sound far away now, but will be here before you know it. VTN This post appears through the MedCity News MedCitizens program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCitizens. For details read: medcitynews.com/medcitizen/ John Squire is COO and president of Amazing Charts. He has previous experience in sales, marketing and product management roles at IBM, Dassault Systems, Formation Systems, and Interleaf, and he has overseen more than 30 successful product launches. He holds a BS in physics and computer science from Ursinus College and an MBA from Harvard. Squire writes for MedCity News.

Remember HIPAA in Reply Best public response to online criticism is invite the patient to come in to discuss Patients increasingly have shown a willingness to write online reviews of their healthcare experiences and opine on social media, and there are plenty of places for them to do so. Sometimes, though, this feedback prompts physicians and their staff to want to defend themselves. And sometimes, providers react too strongly. A pediatric practice in Fort Myers, Fla., reportedly cut ties with eight families in July over negative comments posted in a private Facebook group. “Most physician practices are still not really comfortable with all-out engagement online,” said Sunnie Southern, CEO of Cincinnati-based health innovation firm Viable Synergy and founder of the Innov8 for Health online community. Southern and Emily Washcovick, manager of local business outreach for consumer rating site Yelp, will discuss online behavior during an Oct. 18 session at MedCity ENGAGE in San

Diego. They will explore how to keep conversations productive, Diego. They willfor explore howand to keep conversations civil and useful patients healthcare providersproductive, alike. civil and useful for patients and healthcare providers alike.

MedCity ENGAGE (events.medcitynews.com/engage/) is an executive-level event that features the most innovative thinking from hospital systems, providers, insurers, health IT, doctors and other innovators to discuss best-in-class approaches to advance patient engagement and healthcare delivery. The 4th annual MedCity ENGAGE will be Oct. 18-19 in San Diego. In case of a negative review, Washcovick recommends being polite and offering a private way to follow up. This is especially pertinent in healthcare, where HIPAA comes into play. As a doctor responding to a negative review, say that you appreciate the feedback and provide a way to connect offline. Express empathy by making sure acknowledge and perhaps apologize for the negative experience, Washcovick advised. “Thanks for reaching out. Please call the office to discuss” is a good way to handle it, she believes. “It shows every other person looking at your review that you take the patient experience seriously.”

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

SECONDLOOK She added that responding to negative reviews can help to get new patients as well. Southern agreed. “At the end of the day, patients have a voice that they never had before,” she said. With that in mind, Viable Synergy offers physician practices customized marketing content to distribute both in the office and online. For example, there might be a brochure, branded with the practice’s name, explaining how meditation can be beneficial to health, and then offering tips for a 5-minute meditation that patients can do while sitting in the office. To reinforce the message, Viable Synergy produces “staff flags” – buttons or stickers for office staff to wear – with messages to help engage patients. If the brochure does in fact talk about meditation, a flag might say, “Tell me about your 5-minute meditation,” Southern explained. “It puts a personal element to it.” Printed material might include a takeaway item like a card saying, “If you like the 5-minute meditation, here’s a 10-minute meditation to try at home.” The card also lists a URL that could link to the practice’s

Facebook and Yelp pages because it’s sometimes hard to find social and feedback links on practice websites, she said. Online rating sites do tend to come up high in Google searches, and often, rating sites list outdated phone numbers, hours and even addresses, so it’s important for practices to make sure their own listings are current. It goes without saying that practices should make it easy for people visiting their websites to find the phone number and business hours, Southern said. Similarly, in the name of customer service, practices should never try to suppress online reviews, Southern said. Instead, they should actively engage the public. “It’s no longer a ‘nice to do’ anymore. It’s an absolute ‘have to do,'” she said. Practices are truly starting to care when patients have a bad experience, Southern said. It does help, though, if they pay attention to what’s being said online. “They begin to understand how patients are seeing them,” she said. VTN READ MORE or REGISTER: events. medcitynews.com/engage/

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SECONDLOOK

STATE OF THE PROFESSION

Poorly trained physicians without ethics peddle poor patient care By Edward Mackay, MD, RVT, RPVI I started a vein clinic in 1996 with hopes of offering high quality care in a comfortable environment. I was in general and vascular surgery, and had become disillusioned by the hospital and its cold inefficiencies. I felt patients were treated like a number as they were shuttled through the bureaucratic maze. I also thought I would have more control over my schedule as the OR would bump cases so they could send employees home early in order to save money. I did find the office setting much more to my liking and by 1999 made the practice of venous disease my full time endeavor. There were very few other practices in Florida dedicated to just venous disease. My first American College of Phlebology (ACP) meeting was in 1999 (then called the North American Society of Phlebology). The meeting had approximately 120 attendees in a small Scottsdale resort. The members were very warm and inviting. The talks were not strictly scientific, but more instructional and the VNUS RF catheter was just being introduced. Since that meeting 17 years ago there has been an explosion in physicians interested in venous disease. The ACP has grown dramatically, the meeting has become much more scientific and more academic types have become interested in the burgeoning field. It has been fun to watch, but there is also a dark side. Some have entered the field with poor training and even poorer ethics. It’s always great to catch up with friends each year but for some, their first question to me after a year

Phlebectomies done on a patient and billed as extended phlebectomies.

Complication from an EVLT done by a poorly trained physician board certified in venous and lymphatic medicine. was how many ablations did you do last year. At first it seemed more of an interest in how fast we all were gaining experience in these new procedures. But it became more as if your worth as a vein specialist was measured by that number (maybe your net worth is). I think this has translated to extremely poor patient care. So as vein doctors try to become ”top of the market” by performing more procedures, I believe it has led to a problem. Routinely, I see patients seeking a second opinion with minimal symptoms who have been recommended to have four to six ablations in addition to phlebectomies and sclerotherapy just from their first consult. Other times, it is after they have had all the ablations and these pseudo phlebectomies (see pic) and there is no way of knowing if there were refluxing veins even present. Consequently, most of their symptoms have either not improved or have even worsened. Their complaints range from fatigue, swelling usually with no visible varicose veins, to spider veins with cosmetic issues and, yes, even some with varicose veins but usually on one leg. In cases like this we then perform a repeat ultrasound for which we have difficulty getting paid because it is so recent since the previous one. Our sonographers spend around 45 minutes examining the patient with the usual compression maneuvers. The patient then describes how their previous ultrasound

took less than 5 minutes lying down the entire time (yes, some of these are from IAC certified labs). When we find no refluxing vein, or maybe just one after they were told they have six, they become quite concerned and even sometimes angry. They question our results requiring me to spend more time with them than the straightforward patient with varicose veins. They have even been told they need to have the procedures done to “prevent blood clots and if they do not they are at significant risk of dying.” We have to then convince them how that is not true at all. The patients who have had treatment many times come in because they now have complications such as nerve injuries or wound problems (see pic). Some of these patients are referred from the physician who did the ablation(s), but failed to address the varicosity or spider veins and I am left to “clean up,” because the previous physician was not trained in phlebectomies or sclerotherapy. These doctors range the gamut from board certified vascular surgeons to cardiologists and other specialties with boards in venous and lymphatic medicine. The ultrasounds are done by RVTs and some are from IAC certified labs. So do not count me as one who feels all we need to do is require boards or intersocietal accreditation of vein centers to fix the problem. These people seem to hide behind those groups.

Maybe it’s not the doctors who are the problem but ultrasound techs instead. Many techs sell their services to poorly trained doctors telling them they will direct their care. I have heard that in some practices the RVT gets venous access and performs the tumescent. I have heard from some RVTs that they are paid on how many refluxing veins they find. So a normal ultrasound means that they do not get paid. The only goal is for every patient to meet the insurance criteria for as many ablations as there are superficial veins in the leg. These doctors are not only rewarded from the insurance companies, but also from the industry as they get preferred pricing on catheters and fibers. Higher volume or procedures yields a higher net. The reps fall all over themselves providing other perks. They can afford to market heavily as every patient that comes through their door represents upwards of ten thousand dollars of revenue. The more they advertise, the better prices they get on advertising. All rewards are geared towards higher volume of ablations. I know this is not only a problem with vein practices as I see patients all the time recommended arterial interventions with little or no indication. Do I have any solutions to this problem? No. I am no fan of accountable care organizations or capitated care either. The same doctors would then refuse care to patients who need treatment so they can make more money. I remember some doctors from capitates systems boasting that they would have their varicose vein patients see them every year plus one day so they could prescribe them stockings and get paid for comprehensive venous management. You either have ethics or you do not. One of the advantages for patients when their doctor does his or her work in a hospital is that word gets around pretty quick when a surgeon is doing some questionable work. In large group practices there may be more “peer pressure” to do the right thing, but in the solo office the doctor is the only quality control. I don’t pretend to be a Boy Scout (actually I was). I want to get paid well for what I do and I do my best to get my patients authorized by the insurance. But I feel the resistance that I am getting from insurances is directly related to the over-treatment that these other doctors do and that it is making harder for the rest of us. When I discuss this situation with other doctors outside of the venous field, they feel this is beyond malpractice and actually more criminal. Not just fraud either, but an assault

PROFESSION

continued on page 28

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THEPRACTICE

Using ohmic thermolysis to treat small facial veins By Peggy Bush, APN, ACNS-BC, MSN Ohmic thermolysis is not laser or lightbased; it is the process of using electrical resistivity to deliver a microburst of highfrequency energy into the vessel. The energy is instantly converted to heat, which coagulates the blood and collapses the vessel wall, while minimizing damage to the surrounding skin. Ohmic thermolysis is very effective on red veins 0.3mm or less and facial veins. As with any device, a test should be done before treating your patient. To minimize pain, you can try ice for five seconds, cooling device, topical anesthetic spray and pre-treatment cream. There can be skin tracking and small blisters when using this device. Most of the skin issues will resolve over a period of a month or two. If you use the machine properly (Training is essential), very few problems will occur. We see 4-5 patients per week for red facial veins on the face, especially around the nose. In Florida, sun exposure is the most common etiology for these vessels. To date, we have treated more than 200 patients with ohmic thermolysis for small veins of the face. We have seen no complications to date. Usually one treatment per vein is sufficient. Ohmic thermolysis is also excellent in the treatment of angiogenesis, venous lake tumors and skin tags. VTN Peggy Bush, APN, CNS, MSN is the CEO/ administrator for Vein Experts and Bush Venous Lectures. See veinexperts.org for information and CME accredited courses.

continued from page 26

with a deadly weapon when recommending a clearly unnecessary procedure that has potential complications reach that level. Maybe there should be criminal investigations. Sending a few doctors to jail for a few years might slow it down, but to borrow a phrase from a popular song: “It’s the lure of easy money; it’s got a very strong appeal.” VTN

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 annually. 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.

This is a biopsy of a leg telangiectasia treated with the VeinGogh device. Note the absence of endothelial cells, fusion of lumen, electrodessication of tissue and the small area of collateral damage. © 2012 by www.veinexperts.org

VeinGogh Settings • Only use the VeinGogh device for tiny red veins less than 0.3 mm. If you use it for larger veins, you will have an unhappy patient. Do sclerotherapy first, especially on larger veins. • Bristle needle: 5% power / 0.3 pulses - Must see vessel blanch and if not, turn up to 10%.

Typical notes that Dr. Mackay says he sees where every possible vein is recommended to be ablated on top of multiple additional procedures.

• Ballet needle: 20% power/ 0.3 pulses

Only about one in three surgeons respond to adverse events by discussing how to prevent the problem from reoccurring, according to a study published in JAMA Surgery. Researchers, led by A. Rani Elwy, Ph.D., of the Veterans Affairs Boston Healthcare System and the Boston University School of Public Health, analyzed surgeons’ reports of error disclosures and surveys of their experiences, polling 35 surgeons across multiple specialties. They found that most respondents used five of the eight recommended disclosure procedures: • An explanation of why the error occurred (92 percent of respondents) • Expression of regret for the event (87 percent) • Expression of concern for the patient (95 percent) • Disclosure within 24 hours of the adverse event (97 percent) • Discussing steps they took to address any future problems (98 percent) However, they found the remaining three recommended procedures were less common: only 55 percent apologized to patients or

Boston Scientific acquisition aids neuromodulation pain treatment unit Boston Scientific is acquiring Cosman Medical, which makes radiofrequency ablation systems to treat chronic pain. The Burlington, Mass., firm will become part of Boston Scientific’s neuromodulation business. Cosman products include RF generators, electrodes, cannulae, among others. Therapies that offer neuromodulation use electric pulses to disrupt signals from the brain. In RF ablation, heat is used to target a certain area of nerve tissue to interrupt pain signals. Boston Scientific’s neuromodulation unit is one of its smallest businesses and earned $121 million in revenue in the first quarter of this year, up from $114 million in the same year-ago period. The unit makes spinal cord stimulators to treat pain and deep brain

PROFESSION

stimulation systems to manage Parkinson’s, dystonia and essential tremor. By bringing in Cosman Medical, founded in 2000, Boston Scientific will be drawing on Cosman’s roots going back decades. The products made by Cosman Medical have been used in neurosurgery and pain management. The medtech industry has been developing a device approach to managing pain for several decades. And now may be the time that neuromodulation and RF ablation as an alternative to drug therapy, gain further ground. A market research report published in October 2015 projected that the devices pain management market, will grow to $3.5 billion in 2020, up from $3.1 million last year. VTN

Adverse events handled differently discussed whether anything could have been done to prevent the error, whereas only 32 percent discussed how to prevent recurrences. Of the 45 percent of surgeons less likely to have discussed prevention with patients, two thirds said the event in question was very to extremely serious, and 26 percent said they had difficulty discussing it. Both these groups more likely to report that the event negatively affected them. Anxiety about outcomes ran higher among surgeons with negative attitudes about disclosure, according to Rani and her team. “Surgeons who reported they were less likely to discuss preventability of the adverse event, or who reported difficult communication experiences, were more negatively affected by disclosure than others,” researchers wrote. “Quality improvement efforts focused on recognizing the association between disclosure and surgeons’ well-being may help sustain open disclosure policies.” VTN READ MOR E: archsurg. ja m a net w ork.com /a r t ic le. aspx?articleid=2534133

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

HOW MUCH IS TOO MUCH?

SECONDLOOK

Screening for malignancy in patients with unprovoked venous thromboembolism By Gary H. Dworkin, MD RPVI Unprovoked venous thromboembolism (VTE) is a fairly common patient presentation and can account for as much as 40% of all VTE cases. This includes all DVTs or pulmonary embolisms that occur without a clear provocation, such as major surgery, trauma, paralysis, pregnancy or confinement to bed for three or more days. Up until recently, I believed that there was a 10 percent chance of discovering occult cancer in these unprovoked venous thromboembolism patients. And, if we found an early malignancy, perhaps we could cure the patient. We have accepted, since 1860, that Trousseau Syndrome or migratory superficial thrombophlebitis is recognized as

a harbinger of occult lung or pancreatic cancer. But other questions persist: • How common is occult cancer in the unprovoked VTE patient? • What are the typical malignancies discovered during such a work up? • How hard should we look for them? • Do our efforts searching for an occult malignancy make a difference in life expectancy? Well, I think we are pretty close to the answer. Published less than a year ago in the NEJM (NEJM 2015;373:697-704), a large Canadian study randomized unprovoked VTE patients to undergo limited screening with blood work; CXR; and breast, pelvic or prostate exams.

A second identical group of unprovoked VTE patients underwent the same limited screening, but with the addition of a comprehensive CT of the abdomen and pelvis. From the time of randomization to one year of follow up, 3.2% of patients in the limited screening group and 4.5% in the limited screening+CT group had a new diagnosis of occult cancer, (P=0.28). Cancer related mortality at one year was also not different between study groups (1.4% and 0.9%, P=0.75). Each study group had an initial false-negative diagnostic rate of about 25%. In other words, in both groups, about 25% of the patients who were found to have an occult cancer were not discovered to have that cancer during the initial screening, yet MALIGNANCY SCREENING

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SECONDLOOK

Spider vein treatment more complex than you think

By Ronald Bush, MD, FACS Spider veins are not just a cosmetic issue to be treated without a diligent examination of the superficial and deep venous system. Spider veins are just one of the manifestations of cutaneous venous hypertension. Other examples include stasis changes and venous ulceration. Simply stated, all patients with spider veins have a source of venous hypertension that is transmitted to the dermal vessels. • The first step to treat telangiectasia is to identify the source. • The second step is to eradicate the cutaneous venous hypertension. • The third step is to treat the spider veins. To successfully do these steps, a combination of surgical and chemical treatment is necessary. An ultrasound first at a depth of 2cm and then tracing to 4cm is done. Every spider complex has a source of pathology. The reticular veins are conduits of pressure transmission, not the source. Spider veins are the result of dermal perforating branches from reticular veins. 90% of visible spider veins are 300-700 microns below the squamous layer and are located in the reticular dermis. So treating spider veins involves much more than a simple session of sclerotherapy. Based on numerous studies at our dermpath lab at Water’s Edge Dermatology in Palm Beach Gardens, Fla., the precise concentration of a sclerosant has been determined. Only FDA approved sclerosants are used to ensure patient safety and avoid any legal ramifications of problems that have occurred with the use of compounded formulations. With proper dilution, the cost per patient treatment is in the average of $25 per session which is 1/10-1/12th the average charge of a session of sclerotherapy. The goal in our clinical practice is to achieve >80% resolution in the first treatment and minimize the common sequelae of staining, thrombosis and inflammatory occurrences. It is not possible to describe in detail in this brief discussion the precise treatment. However, proper diluted sclerosant is

MALIGNANCY SCREENING continued from page 29

did have a cancer subsequently diagnosed within the first year of the study. Also, there was no difference between the two exam groups in the mean time to a cancer diagnosis (4.2 months in the limited screening group and 4.0 months in the screening + CT group, P=0.88). Finally, the types of cancers discovered over the oneyear study were not significantly different between exam groups though a trend towards more colorectal cancers being discovered in the limited screening + CT group was seen. This trend was possibly due to the use of virtual CT colonoscopy image protocols. Finally, despite omitting a chest CT as a component of the screening + CT evaluation group, no occult lung cancers were diagnosed in either group initially or during follow up. In summary, for patients who have a first unprovoked venous thromboembolism, the prevalence of occult cancer seems lower than previously reported.

always combined with a micro-surgical technique. Tumescent infusion of the complexes is also routinely done as well. Other techniques such as dilution of sclerosant with 1/3th NS or hypotonic saline flushes are used in some patients. Delegating spider vein treatment to a “sclero-therapist” will not always yield optimal results. Only by understanding the complicated pathophysiology and applying multiple modalities can successful treatment be done. Presented below are a few interesting findings from our lab and clinical experience. To learn more about spider vein treatment, attend “The Art of Micro-Phlebology” symposium in West Palm Beach, Fla., March 11, 2017. • Angiogenesis occurs in the papillary dermis. • Most sclerosant concentrations above 0.2% Sotradecol and 0.37% Polidocanol produce intraluminal cellular debris. • 60% of patients complaining of spider veins have lateral reticular pathology. • All spider complexes of the medial thigh are the result of GSV or GSV branch pathology. • 30% of patients who present only with spider veins have GSV insufficiency. • Diluting sclerosants with hypotonic saline increases the sclerosant ability by a factor of 3 (not always a good thing). • The best instrument for spider vein treatment is a 1mm punch biopsy. • Avoid foam in spider complexes. • Proper and precise tumescent infiltration (not intradermal) is one technique that is essential to learn. VT N Dr. Ronald Bush is board certified in four surgical specialties: surgery, thoracic surgery, general vascular surgery and laser surgery, which gives him a high level of expertise not often found in a community setting. His knowledge and skill as a surgeon qualify him as a Fellow in the American College of Surgeons. Dr. Bush trained

Routine screening for malignancy using CT of the abdomen and pelvis in these patients does not provide significant benefit. Limited age-appropriate screening in these cases likely maximizes healthcare value and lowers costs. VT N Gary H. Dworkin, MD RPVI is a board certified cardiovascular and thoracic surgeon; a Diplomat of the American Board of Thoracic Surgery; and a member of the American College of Phlebology and the American Venous Forum. He is also a pastpresident of the Florida Society of Thoracic and Cardiovascular Surgeons; and immediate past-president of the Cleveland Clinic Alumni Association. He practiced cardiovascular and thoracic surgery for more than 18 years, but today, Dr. Dworkin dedicates his medical career to the treatment of venous disease at Vein Specialists of Tampa (tampaveinspecialists.com).

A 1mm spider vein treated with Polidocanol 0.37%. Note the loss of endothelium, fibrin replacement of smooth muscle and jagged appearing subintimal surface. Also, few intraluminal cellular debris are present. in general surgery at Indiana University, did his vascular fellowship at Baylor University Medical and his cardiothoracic fellowship at Walter Reed Army Medical Center. He is the author of numerous scientific papers and holds patents for surgical instruments. SEARCH HABITS

continued from page 20

Physician rating sites made up 70 percent of the search results, according to Dr. Vijayasarathi's team. After these, 18 percent were physician- or institution-controlled, 1 percent were social media platforms, 2.1 percent were other, and 9.5 percent were not classified. The following were the top 10 most frequently occurring domains: Healthgrades.com, Vitals.com, Health.usnews.com, Doximity.com, Ucomparehealthcare.com, Doctor.webmd. com, Sharecare.com, Healthcare6.com, Zocdoc.com and Topnpi.com. With the exception of Doximity.com, all of these are thirdparty physician rating sites, the authors noted. So what was their conclusion? The online presence of radiologists is shaped by these third-party sites, which means that radiologists don't have much control over the content that patients find. “These results are particularly important for radiology in the modern era, as patients are granted increasing access to their medical records and the names of interpreting radiologists,” Vijayasarathi and colleagues wrote. “In many circumstances, a web search may be the only mechanism by which patients can learn about their interpreting radiologists.’

BE PROACTIVE Compared with other physicians, a strong web presence could be of greater importance to radiologists because they have limited direct contact with patients and, therefore, limited opportunities to influence patients' perceptions. So the field is wide open, according to the authors. VT N

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

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SECONDLOOK ELECTION 2016

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reform, and the national debt, to mention just a few. However, because all of you reading this publication are in the healthcare sector, let’s discuss two issues that are certain to directly affect you: Taxes and the Affordable Care Act (a.k.a. Obamacare). This is not to diminish the importance of all the issues we face. And, while there are more than two individuals pursuing the office of the presidency, what follows will stick to the two major party candidates.

TAXES AND THE ECONOMY Study after study demonstrates that higher wages can easily be stimulated for our nation by one “simple” change: cut corporate tax rates! Both left- and right-leaning countries have done this over the past two decades, including Japan, Canada and Germany. Yet, our policymakers in Washington continue to undermine wage growth with the highest corporate tax rate in the developed world. An analysis which used data gathered on international tax rates and manufacturing wages in 72 countries over 22 years, confirmed that the corporate tax is, for the most part, paid by workers.

TAXES AND THE CANDIDATES Leaders from both parties have proposed lowering America’s 35 percent corporate tax rate, the highest in the developed world. President Obama has called for cutting it to 28 percent (25 percent for manufacturers), while Donald Trump proposes 15 percent. Hillary Clinton’s plan is to keep taxes high at the corporate level, to increase taxes on business income at the individual level, and to punish firms that move overseas in response to these high taxes. How would each of these proposed tax policies affect you? It’s more complicated than you would think. Thus, I’d recommend you discuss it with your accountant.

PROMISE OF OBAMACARE It seems like just yesterday we were promised the following: Obamacare will cut the cost of our healthcare, not increase the deficit, and create jobs. We were promised that if we like our healthcare plan, we could keep it – and perhaps most importantly – “If you like your doctor, you will be able to keep your doctor. Period.” It’s probably worthwhile for you to consider whether these promises have been kept. One notable fact is that premiums are up. If we look at employer-sponsored benefits, the average premium increase for single coverage is up $1,427, while family coverage has increased by $4,170. Perhaps more important is what our candidates will do going forward. For this, VTN interviewed healthcare expert and widely known author, Sally Pipes, president and CEO of the Pacific Research Institute. VTN: What’s the big picture for the candidates regarding Obamacare? PIPES: Clinton will keep and expand upon Obamacare. Expansion will make it more government-run and bordering dangerously close to a single-payer system. As the Democratic candidate, she is moving hard left in her healthcare views in response to Bernie Sanders’s support of her. Her latest idea has been to support the “public option,” a government insurance plan to compete with private insurers in the exchanges, which would be a huge blow to the healthcare industry. Trump will repeal Obamacare, including the individual and employer mandates, and replace it with something else.

Trump’s seven-point healthcare agenda, as it stands now, would hugely benefit both the insureds and healthcare providers. Repealing Obamacare would reduce the burden on insurers who are losing significant money from participating in the Obamacare exchanges. Insurers would no longer lose the millions of dollars they have been losing from poor enrollment numbers in the Obamacare exchanges – which recently downgraded to 11.1 million enrollees reported in July, compared to 12.7 million in March. The major problem is that not enough young, healthy individuals have enrolled to cover the cost of claims for those who are older and sicker. VTN: How accessible would health insurance be under each candidate? PIPES: Clinton – under universal healthcare, everyone must have insurance. Clinton has been moving closer to the idea of universal healthcare since the beginning of her campaign. She supports the idea of “Medicare for More” – allowing those 55 or older to join Medicare, the government-run healthcare program for seniors. It’s only a matter of time before she supports a “Medicare for All” system and institutes a single-payer system in America. She has also endorsed the “public option,” as has President Obama in July of this year. A single-payer system will mean universal coverage, but not universal access. As is already the case in Canada, there will be long waits for getting doctors and treatments – it takes 18.3 weeks in Canada to see a primary care doctor and get treatment from a specialist. Patients will also have to deal with rationed care and lack of access to the latest treatments and procedures. Trump – free-market principles, including interstate sales of insurance. Trump would get rid of restrictions on the interstate sale of health insurance so that individuals who live in high-cost states could buy coverage from lower-cost states. A national market would reduce restrictions on insurers as to where they could sell and would allow them to expand their subscriber base. VTN: How does each candidate vow to make healthcare more affordable? PIPES: Clinton will use government subsidies. Clinton’s healthcare plan seems like it would lower healthcare costs, but it is unsustainable for insurers and would actually drive up premiums for consumers. Clinton’s plan bars insurers and providers from charging patients for out-of-network services received at an in-network hospital. It would also strengthen state authority to block insurance premium increases that were deemed unreasonable. This would be devastating for insurers who are already dealing with major financial losses from participating in Obamacare’s exchanges. Many more insurers would likely be forced to leave

the exchanges. Trump would promote tax-advantaged Health Savings Accounts (HSAs), which went into effect January 2004. This will help not only consumers, but also employers, reduce costs. HSAs allow individuals with high-deductible health plans to set aside money tax-free for healthcare expenses. Trump would also allow funds to be passed onto the next of kin tax-free, following the death of the HSA holder. Having people save more of their own funds for healthcare would lessen the burden on employers to cover the cost of health care. Consumers would become more careful about how they spend their own money. Trump also called for eliminating Obamacare’s costly essential health benefit mandates, which would make health care much more affordable for patients. People would be free to purchase low-cost plans with high deductibles that don’t cover procedures they don’t want or need. VTN: How will each candidate ensure quality healthcare? PIPES: Clinton wants to build on Obamacare – Obamacare 2.0. She would place even more mandates and regulations onto hospitals, insurers and healthcare providers. However, more requirements will only lower and restrict the quality of patient care. First, she’d pad health plans with additional “free” services. She wants to require insurers to provide three sick visits to a doctor each year without affecting their deductible, in addition to the preventive care mandates already included under Obamacare. Not only would these additional requirements be a huge burden on insurers, they’d also compromise the quality of healthcare. Patients will face unending waits to actually find doctors and get care. Trump calls for a healthy market of private insurers in which consumers can choose the plans that best fit their needs. Repealing Obamacare would also eliminate Obamacare’s “guaranteed issue” and “community rating” rules, which require insurers to sell policies to all comers, regardless of health status, age or history, and forbid them from charging the elderly or those with pre-existing conditions anymore than three times what they charge the young. These rules may seem fair, but they encourage people to wait until they get sick to buy insurance. Instead, Trump’s vision for a private insurance market protects those with pre-existing conditions by barring insurers from raising a person’s premiums because of health status or history, as long as that person has maintained continuous coverage. This encourages people to buy and keep insurance – not to manipulate the system under the special enrollment program. VTN: What are each candidate’s plans for Medicaid and Medicare? PIPES: Clinton would expand both programs, which could very well lead to a full-fledged single-payer healthcare system, which was the main focus of Bernie Sanders’ campaign. Under her “Medicare for More” agenda, Clinton would allow those 55 or over to buy into Medicare voluntarily. Seniors who have just joined Medicare are already having a hard time finding doctors who will take them as patients. Lowering the age will only make it worse. Clinton would also expand access to Medicaid. She supports President Obama’s proposal to give three years of full federal funding to states that sign up for Medicaid expansion. However, Obamacare’s Medicaid expansion is saddling taxpayers with billions in new health costs – much of which ELECTION 2016

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Vascular surgeon approached leg elevation from scientific view By Larry Storer Chris Dickson, MD, a board certified vascular surgeon and Fellow of the American College of Surgeons from Greensboro, N.C., observed that when an order was written to elevate a patient's legs while in the hospital, the patients were often found in ineffective positions. If the nurses couldn’t get their legs in the right position in the hospital, what was the chance it would happen at home? This led Dr. Dickson on a mission to develop the most medically effective leg elevation rest on the market. He said proper leg elevation is important because it helps lower venous pressure, increase venous flow, reabsorbs interstitial fluid, and reduces leg swelling. Finding the optimum position for elevation is critical. After extensive review of the medical literature on elevation, he determined the most effective position for leg elevation that would maximize venous and lymphatic flow. In addition, the most effective position turned out to be the most comfortable position also. Dr. Dickson then created the Lounge Doctor Leg Rest, which comes in a number of sizes with options to fit your needs. This is the only patented leg rest designed by a physician and actually based on science. Leg elevation is the standard of care for many medical conditions including: deep vein thrombosis (DVT), chronic venous insufficiency (CVI), varicose veins, phlebitis, lymphedema, leg injuries, and leg swelling. Leg elevation is also useful for women who are pregnant, those having surgery, or those with back pain. It is also helpful for those who stand or sit all day at work, or those who travel. Athletes can use leg elevation to speed muscle recovery and improve performance. Dr. Dickson notes that everyone can benefit from daily leg elevation for 20 minutes given the challenges of gravity that affect venous blood flow. “Feedback from many of our users have been extremely positive,” Dr. Dickson continues. “It seems so many people have been waiting on something like this.”

WHO NEEDS TO USE THE LOUNGE DOCTOR DAILY? • Vein Problems Varicose veins are large dilated, superficial veins that can be painful. 20-30 percent of the adult population has varicose veins. Leg elevation relieves the pressure in the veins and alleviates the pain and swelling associated with venous engorgement. Leg elevation is also used after varicose vein surgery or laser ablation of the saphenous vein. CVI affects 40 percent of the adult population. With this condition, the vein valves don't work properly. For this reason, venous blood flow becomes stagnant and venous pressure increases. Red blood cells are squeezed out of the capillary into the surrounding tissue. Milder forms of CVI are associated with brownish discoloration of our skin. More severe forms result in thick scarred skin and venous ulcers. Leg elevation is used to treat the leg swelling and ulcers associated with chronic venous insufficiency. This is a chronic problem and patients with CVI need to make daily leg elevation a part of their lifestyle. DVT is a blood clot in the larger, deep veins. More than 500,000 hospitalized patients develop DVT each year. Leg elevation is part of the standard treatment for DVT because it increases venous flow, lowers venous pressure, prevents venous stasis or stagnant venous flow, and reduces swelling. High venous pressure and swelling are both responsible for the

The Lounge Doctor aching pain associated with DVT. Leg elevation has also been shown to prevent DVT. Phlebitis is inflammation around a clotted superficial vein. This is treated with leg elevation, warm compresses and ibuprofen. Leg elevation reduces the swelling and pain associated with phlebitis. • Pregnant Women Dr. Dickson said 40 percent of pregnant women will develop varicose veins. This is largely due to hormonal changes that take place during pregnancy. Of those women who develop varicose veins, they begin in the first trimester 75 percent of the time, in the second trimester 20 percent of the time, and in the third trimester 5 percent of the time. Elevating the legs during the first and second trimesters helps to lower pressure in the veins and therefore reduce the pain and swelling associated with varicose veins. During the third trimester, it is most helpful to lie on the left side in order to take the weight of the uterus off of the inferior vena cava. Pregnant women all retain fluid during pregnancy, and after delivery, leg elevation helps to remove the extra fluid. • Workers Who Sit or Stand Hours at the Job People who have jobs that require prolonged standing often complain of aching, heavy legs. Prolonged standing results in the accumulation of fluid in the soft tissue and high pressure in the veins. Both of these cause pain and discomfort. Veins must get the venous blood back to the heart and therefore must work against gravity. Veins have valves to help keep blood flowing in the right direction. These valves only come into play when we are walking or are active. When the calf muscles contract, they squeeze the veins causing the valves to close and only allow blood flow back towards the heart. This is called the “calf muscle pump.” When we are simply standing or sitting, the valves are open which results in high pressure in the veins and leg swelling. Patients with venous disease often have valves that don’t function, or incompetent valves. This makes it very difficult for venous blood to get back to the heart, as the “calf muscle pump” is no longer effective. Studies have shown that even in patients without venous disease, after five hours of standing the veins can become enlarged and this can result in the valves not working properly. This results in even higher venous pressure, which can hurt and result in even more swelling.

The same principles apply when sitting, but the pressure in the veins is not as high as when we are standing. At the end of the work day, leg elevation lowers the venous pressure and empties the fluid that has accumulated in our legs all day. After standing or sitting all day, 20 minutes with the legs elevated will help to ease that pain. • Surgical Patients Many surgical patients are at risk for developing lymphedema after surgery. Lymphatic vessels are tiny microscopic vessels that collect fluid from the soft tissue in our legs and eventually empty this fluid back into a vein in the chest. The groin region and pelvic region have lots of lymphatic channels. Incisions heal by forming scar tissue which obstructs these lymphatic channels. Radiation therapy for cancer in these areas can also obstruct lymphatic flow. Surgeries that can result in lymphedema include coronary artery bypass (because the vein is taken from the leg); knee replacement surgery; hip replacement surgery; surgery in the pelvis for gynecologic cancer, prostate cancer, or colon cancer; and lymph node biopsy in the groin. Leg elevation reduces the swelling associated with lymphatic obstruction. Leg elevation also has been shown to lower the risk of DVT that can occur in the perioperative period. Also, for those having foot surgery, leg elevation reduces post operative pain. • Low Back Pain While the Lounge Doctor cannot cure the issues that result in reoccurring back pain, lying down on a flat surface with legs properly elevated may take the pressure off the back and relieve the pain from low back pain. This can occur because flexing the thigh 40 degrees, which occurs when using the Lounge Doctor, which also relieves tension on the psoas muscle. • Travelers Regardless of how we travel, when traveling we spend a lot of time sitting. If we are traveling by plane, we may also spend a lot of time standing in line. Travel can also be stressful. Leg elevation is a great way to relieve the aching pain associated with standing and sitting much when we travel. It is also a great way to relax.

THE LOUNGE DOCTOR The Lounge Doctor Leg Rest comes in a variety of sizes (small, medium, large, and extra-tall). The patient’s height is used in order to choose the correct size. The leg rest comes in a variety of models, including an inflatable version that makes traveling easy. The standard Lounge Doctor Leg Rest is 18 inches wide. This is the least expensive model and fits well on a couch. There is an extra-wide version which is 24 inches wide for those who like some extra room and is best used in bed, as it does not fit as well on a couch. Both the standard and the extra-wide versions have a memory foam option. The memory foam version has a 2 inch layer of coolACTIVE memory foam and is the most comfortable model. All of the products have the same patented shape whether they have memory foam or not.

HOW TO BUY The Lounge Doctor can be purchased online at loungedoctor. com/store.html with choices of types and sizes ranging from $39.95 - $124.95, as well as replacement covers and pump. VT N See: loungedoctor.com/store.html

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

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the states will eventually have to shoulder on their own. The program’s new beneficiaries may have coverage, but they must deal with long waits at the doctor’s office, difficulty finding doctors and increased ER use that is very expensive – and what Obama wanted to avoid. And, the care they receive is often of low quality. Trump would convert Medicaid into a block grant program for states to run it. This would put an end to the already rampant abuse of federal Medicaid dollars. Currently, the feds pick up as much as 75 percent of a state’s Medicaid tab. This arrangement encourages states to spend without restraint. As a result, Medicaid consumes about 15 percent of U.S. health spending. Today, 76 million are enrolled in Medicaid and CHIP, an increase of 15 million since the ACA became law. In 2014, almost 7 percent of Medicaid payments were “improper” – a result of either fraud or mismanagement. That’s 7 percent of $495 billion, or $34.65 billion! By switching to block grants, the government can challenge states to spend their Medicaid dollars wisely. States could tailor their programs to meet the specific needs of their state’s low-income population. As Trump correctly notes, “The state governments know their people best and can manage the administration of Medicaid far better without federal overhead.”

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VTN: Any other ways the candidates’ plans differ, and what is the potential impact? PIPES: Clinton’s plan would move America closer to a single-payer, “Medicare for All” system where government is the sole provider of health care. It is hoped that Trump’s plan will move to empower doctors and patients, not the federal government. VT N Jeffrey H. Miller, MD, is the founder and CEO of Miller Vein with five offices located in Southeast Michigan. Dr. Miller is a board certified interventional radiologist and certified by the American Board of Venous and Lymphatic Medicine. He has received numerous awards and honors in his field, including being named one of Hour Detroit Magazine’s “Top Docs.”

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VEIN THERAPY NEWS OCTOBER/NOVEMBER 2016

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CASE STUDY

Patient presented with bleeding vulvar varicose veins, leg pain By Manu Aggarwal, MHSA, MD In September 2015, a pleasant 43-year-old female presented to our office for evaluation via a free screening. She had concerns of bleeding vulvar varicose veins and venous symptoms in the legs (severe achiness). Her main concern was her bleeding labial veins that caused burning, itching and pain for more than eight years. Due to insurance requirements and findings of some reflux in her legs, we recommended graduated compression stockings (20-30mmHg, thigh high) and to schedule an initial o f f i c e visit (for complete venous mapping) and further clinical evaluation for possible work up of pelvic venous congestion. At her initial office visit, a complete history and physical was obtained. The patient stated that she had a DVT in 2007 (unprovoked) in 2007 in the right leg. She was not currently on anticoagulation at the time of her presentation with us, however, she had been in 2007. She complained of heaviness and severe pelvic pain with long periods of standing. She also complained these symptoms were worse after intercourse and began after her children were born (she had given birth vaginally to two children). She also complained of dysmenorrhea and was advised that this was not a symptom of PVC/PVI. A venous mapping was performed at our IAC accredited facility (Vascular and Vein Center). The exam revealed that the deep venous system consisting of the right common femoral, superficial femoral, popliteal, posterior tibial, and peroneal veins were scanned. The deep veins are seen to be patent with no evidence of thrombus. There is excellent augmentation and compression seen, with no evidence of deep vein reflux. There are multiple perforators also identified in the right thigh and calf, none of which are incompetent.

CASE STUDY

RIGHT LEG Venous duplex study of superficial venous systems was performed with gray scale, spectral and color Doppler (if indicated). The Great Saphenous Vein has positive reflux from the knee to the mid-calf and the vein measures 6.5mm at the saphenofemoral junction and measures 1.85 seconds of reflux, 4.5mm proximal, 4.0mm at the mid thigh, 7.0mm above the knee and 4.1mm below the knee. • The Anterior Accessory Vein: Normal and vein measures 3.8mm. • The Posterior Accessory Vein: Not seen. • The Small Saphenous Vein: Has positive reflux from the sapheno popliteal junction

to the mid-calf and vein measures 5.6mm and measures 1.23 seconds of reflux.

LEFT LEG The deep venous system, consisting of the left common femoral, superficial femoral, popliteal, posterior tibial, and peroneal veins, was scanned. The deep veins are seen to be patent with no evidence of thrombus. There is excellent augmentation and compression seen, with no evidence of deep vein reflux. • The Common Femoral Vein was continuous waveform. • Venous duplex study of superficial venous systems was performed with gray scale, spectral and color Doppler (if indicated). • There are multiple perforators also identified in the left thigh & calf none of which are incompetent. • Venous duplex study of the superficial venous systems is normal with no evidence of thrombus or reflux. • The Great Saphenous Vein measures 7.4mm at the saphenofemoral junction, 4.6mm Proximal, 3.9 mm at the midthigh, 4.3mm above the knee and 5.3mm below the knee. • The Anterior Accessory Vein was not seen. • The Posterior Accessory Vein was normal and the vein measures 3.6mm. • The Small Saphenous Vein was normal and the vein measures 4.7mm. • The Superior Extension of the Small Saphenous Vein (SSV) was not seen. • The patient did not have varicose veins on the legs. She only had spider veins. She did have bleeding vessels on the labia. We scheduled the patient for a CT venogram to be performed. (Note: We are still working with our staff and local ultrasonographers for pelvic ultrasound evaluation for PVC/PVI). This patient was found to have periovarian and periuterine varicose veins, with the right gonadal vein 9mm and left 8mm in size. She elected to undergo treatment and was treated by bilateral gonadal vein embolization with coils and sotradecol by a local Interventional Radiologist in January 2016. Since her treatments, the patient has had complete resolution of her symptoms. She does not have pelvic pain with intercourse nor does she have itching, burning or pelvic heaviness with long periods of standing or sitting. The patient was treated in our office with the Cuteral Excel V (Nd:Yag 1064nm) laser to the bleeding areas on the labia in March 2016. Three weeks later, there is complete resolution of her lesions. A cooling gel was used for treatment and the patient tolerated the treatment very well. She was asked to wear a thin pad for a day and use ice on the area 20 minutes three times a day for one day.

Above: The right leg Top right: Bleeding angioma on labia before surface laser treatment. Bottom right: One month after treatment with Cutera Excel V Nd:Yag (1064nm) laser.

Statistics show that 10-15% of patients present to the gynecologist for chronic pelvic pain (noncyclical pain that lasts greater than six months). Of those patients, up to 30% of patients have PCS. However, many of these women suffer through extensive negative workups (bloodwork, imaging, consultations) despite the pain. This pain may be worsened by the following: sitting or standing for long periods of time, during or after intercourse (dyspareunia). Other symptoms of pelvic congestion are nonspecific and vary in intensity. Affected women may have generalized fatigue, depression, abdominal or pelvic pain, vaginal discharge, dysmenorrhea, swollen vulva with veins, lumbosacral neuropathy, rectal discomfort, or urinary urgency. On examination, patients can have cervical motion tenderness or point tenderness over the ovaries or uterus on bimanual exam. Patients may complain of hemorrhoids, varicose veins of the perineum, buttocks or lower extremities. Additionally, these problems may overlap with other pathology, making diagnosis and

treatment even more difficult. Medical treatment of PCS includes psychotherapy, progestins, danazol, phlebotonics, gonadotropins receptor agonists (GnRH) with hormone replacement therapy (HRT), dihydroergotamine, and NSAIDS. The literature supports use of medroxyprogesterone acetate (MPA), or the GnRH analogue goserelin in an effort to suppress ovarian function and/ or increase venous contraction. MPA may be given orally 30mg/day for six months. Goserelin acetate is dosed as an injection of 3.6mg monthly over a six-month period. Non-medicinal treatment was introduced in the 1980s. However, these surgical techniques had some associated morbidities. In 1993, percutaneous venous embolization was introduced. Since its introduction in 1993 by Edwards et al, this modality has changed the treatment of PCS. The procedure is usually performed at the time of venography using a variety of embolic agents, including sclerosant foam and coils. In several published series in the 1990s, success rates for reduction of chronic

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

SECONDLOOK pelvic pain ranged from 50 to 80%. With advancements in technique, clinical success is achieved in 70 to 85% of treated patients. Our office has noted a 100% improvement in patient symptoms (dyspaurenia, pelvic heaviness, etc.) following emoblization of the ovarian veins. As phlebologists, we need to be committed to investigating further – patients who present with varices that extend upward toward the labia or scrotum or ask them about the possibility of pelvic pain when we see such varices affecting their quality of life (as well as symptoms as listed above). Often times, patients are “cured” with a TAHBSO. However, given that most of the women with PCS are premenopausal, we need to be vigilant in the vitality of the ovaries; trading pelvic pain for possible longterm hormone replacement is not for everyone. I would encourage our colleagues to keep current on the literature for PCS and the evaluation and treatment. This case study just briefly speaks about the condition. Seek competent and proficient providers for emobilization and utilize institutions for further evaluation and treatment if need be. Your patients will be eternally grateful! VT N Dr. Manu B. Aggarwal, 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. It is located in Lima, Ohio, with a satellite office in Celina, Ohio. She can be contacted at yourveincarecenter.com. ELECTION 2016

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Give away something you’ve earned How we share our time and money defines in part who we are “The best way to find yourself is to lose yourself in the service of others.” – Mahatma Gandhi By Erin Gibbs In the business of medicine, some say the daily routine and delivery of care to patients can feel like charity work. Regulatory pressures, jammed schedules, adequate knowledge and training combined with the need for quality care, integrity and the healing of the human body and human spirit is endless. And the difficulties in getting paid – in full and in a timely manner – within an industry based on reimbursement for service, can be slow, intricate and painful. But as we head into fall – often the busiest time for patient appointments – it’s essential to visit the importance of “charity” and “doing for others.” Building business and advancing a career in healthcare is a choice and a vocation. There is always more we can do as professionals and as people. A simple survey of vein industry professionals indicates that we are! Philanthropy and service inside and outside the workplace – either supported by the company or done by individuals – is good personally, professionally and especially – good for building strong communities. “It seems counter-intuitive to give away something we’ve earned. Something we rightfully possess to someone who may never be able to payback in kind what they receive from us,” Brian Neff, founder of The Social Physician, said. “Yet, giving, in its own remarkable way, pays back in full measure what the debtor cannot.” While there seems to be no reasonable persuasion to “give,” one can easily discover what happens when you give what you have – however large or small – to someone who can never return that offering. Neff mentions a television commercial created in 1971 that popularized the phrase, “Try it. You’ll like it!” This commercial was for Alka-Seltzer, a product developed to combat indigestion, but the concept is apropos – selflessly giving provides a relief that miraculously occurs after you try. You will like it, once you’ve tried it! One industry veteran said that if you are managing to turn a bit of a profit, you should consider donating to the industry that is providing you your revenue. As a private employer, an American College of Phlebology Foundation (ACPF) committee co-chair and my husband a new ACPF Board member, I have a front row seat to a group of employees as well as to donors and volunteers within the ACP and vein specialty. I queried some employees and some phlebology colleagues to understand the spectrum of activities people are involved with – here’s just a sample of what I found: Dr. Andrea Brennan, OTD, OTR/L, CLT-LANA, DAPWCA, is an ACPF volunteer, noted phlebologist and outside of the industry she speaks at various breast cancer survivor group meetings with “Bosom Buddies” in the Phoenix metro area. She also speaks about lymphedema to schools and organizations who can benefit from learning about the condition. Joe and Andrea Brennan together participate in offering charity phlebology care to patients in Matagalpa with “Amigos

Dr. Ron Bush performs surgery during one of his trips to Haiti. de Salud,” in conjunction with the Fara Foundation. Organized by Nick Morrison MD, and Terri Morrison, it’s a week of patient care free of charge in Nicaragua. The group continues to grow and this year, there were phlebologists from the United States, Australia, Argentina, Ireland and Italy. Ronald Bush MD, FACS, and his wife, Peggy, APN, have been going to Haiti since 2007, working with various organizations including United Methodist Missions, Friends of the Children of Haiti and Life’s Path – which also supports a school in Cyvadier, Haiti. Their care extends beyond venous patients and helps educate health providers in Haiti on how to effectively treat venous disease (for as little as $5 per patient according to Dr. Bush). The Bush’s plan to offer similar low-cost treatment to patients in Florida who do not have insurance and have limited ability to pay. “They deserve care as well and cannot afford a thermal ablation,” Mrs. Bush said. By making venous treatment available to even the poorest patients in Haiti, Dr. and Mrs. Bush have created a huge shift in terms of patients they can help and the cost of helping. You can learn more about their inspiration and their story at: http://lifespathhaiti.org/brockgebhardt-learning-center.html Among many volunteer and philanthropic endeavors – one that is most important to Morrison Vein Institute owners/ founders Nick Morrison MD and Terri Morrison RN is Amigos de Salud Inc., a 501(c)(3) charity without any paid administrators.

The Morrisons and a multidisciplinary group of volunteer doctors, nurses, sonographers and other health professionals, created Amigos De Salud. The organization has volunteered in Ecuador, Mexico, Peru, Costa Rica and Nicaragua. Over the last five years, The Fara Foundation of Austin Texas/Nicaragua has helped coordinate trips and work with their donors to assist in free care for the poor in Nicaragua. Just back from an early September trip – Italy, Australia, Argentina, Ireland and U.S. docs represented this year’s volunteer team from several states. Compudiagnostics provides diagnostic and treatment ultrasounds and supports in kind on such volunteer trips. Saskia Handschin, medical marketing and education manager at SIGVARIS, donates stockings and volunteers at the Clarkston Community Health Clinic in greater Atlanta. Clarkston is the largest refugee community in the United States today and Handschin and her fiancé, currently a cardiology fellow at Emory who was formerly a refugee himself, participate in the clinic along with several other Emory physicians. The clinic offers free services to anyone in need and is open every Sunday. Handschin said she noticed the refugee community needed education on leg health and compression stockings. SIGVARIS now donates compression stockings on a monthly basis to the clinic and fits them for stockings on Sundays. Annette Budnik Suchy, U.S. market development manager at Medtronic endoVenous, volunteers for both the ACP Foundation Silent Auction Committee and also the ACP Public Health Committee. She highlights a few of Medtronic’s many charities – including help with assembly of Cheeriodical boxes for children’s hospitals, volunteering at a Minneapolis, Minn., homeless shelter and food kitchen, sponsorship and participation in the Minneapolis heart walk and mission-driven venous healthcare relief work in Nicaragua (along with Amigos de Salud). At American Vein & Vascular Institute we own and manage clinics in Colorado and Texas. I was delighted to learn what our vein staff does outside of patient care! Ashley Miklich, RVT is a volunteer and south state agent for Big Bones Canine Rescue and is a church volunteer working with small children. Cyndie Gelroth, clinic manager, donates to St. Jude, Heifer International and the ASPCA. She also volunteers at the annual Danny Dietz Foundation charity event in Denver. The foundation mentors at-risk youth with the values, discipline and leadership of the Navy Seals). Married to a Navy veteran, Gelroth supports vets in any way possible. Polly Johnson, medical receptionist/assistant has coached for Girls on the Run and tutored for The Literacy Project. She said it’s fun and rewarding to watch some of these girls “find” their voice and learn how to navigate challenging social situations. The Literacy Project was an eye-opener to the chaos of some public middle schools and how overwhelmed the teachers can be. Hannah Delagardelle, marketing director, volunteers for Cowgirls’ and Cocktails after being invited to join by founder Cindy Fowler in 2011 (Cindy Fowler died of breast cancer in 2012). The money brought in through this event has been able to provide mammograms, taxi vouchers for rides to hospital visits, post-surgery camisoles, wigs, groceries and pre-made

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

SECONDLOOK meals for families of the patient. Delagardelle said, “There is nothing more rewarding than knowing your efforts helped save a life or a deteriorating soul. At a balloon release I knew I wanted to join the committee. Guests at the event wrote notes to their loved ones and released them all at once. I wrote my note to my grandmother – such an emotional moment. It was beautiful!” Belva Zmerzlikar, accounting manager, is a foster parent for Big Bones Canine Rescue. Providing a loving long term foster home for displaced/rescued dogs gives her an opportunity to contribute to the ones with no voice. She says, “It provides us so much back: Entertainment, extra love and the gratitude from our foster fur babies!”

VOLUNTEERISM

continued on page 41

Peggy Bush encourages children during visits to the Friends of the Children of Haiti and Life’s Path school in Cyvadier, Haiti.

Short on time? Big on inspiration? Consider donating an item or service to the 2016 ACP Foundation Silent Auction at the 30th Annual ACP Congress, Nov. 1-4. Please also consider participating as a committee volunteer! Contact Erin Gibbs: egibbs@ americanvein.com

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VEIN THERAPY NEWS OCTOBER/NOVEMBER 2016

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SECONDLOOK VOLUNTEERISM

continued from page 39

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Angie Higgs, practice director says that volunteering is a huge part of her identity. â&#x20AC;&#x153;I choose services that remind me of where Iâ&#x20AC;&#x2122;ve been, obstacles Iâ&#x20AC;&#x2122;ve overcome, but most importantly the ones that teaches me humility.â&#x20AC;? Currently, she works with ManeGait Therapeutic H o r s e m a n s h i p â&#x20AC;&#x2122;s 9th Annual Gala, DME Exchange and Clean the Park. Maggie Morales, bilingual medical receptionist volunteered for Door of Hope in Johannesburg Cyndie Gelroth South Africa in St. Jude, Heifer the summer of Intl., ASPCA, 2013, spending six Danny Dietz weeks taking care Foundation of basic needs for abandoned babies. â&#x20AC;&#x153;It allowed me to see how the world works around the world. It was a humbling feeling, which led me to live my life differently and be more aware of other peopleâ&#x20AC;&#x2122;s needs,â&#x20AC;? Morales said. â&#x20AC;&#x153;My favorite part of the trip was knowing that these little babies will never remember who I was or what I did for them. It was amazing to just love and care for them because Christ has shown me love and how to love.â&#x20AC;? Morales went to Orphan Outreach in Bungoma, Kenya, in September for 10 days to volunteer at a school of 250 kids. The volunteers ran medical clinics and extra curricular activities, told Bibles stories and generally provided support. Emma Stout, MD, supports Newborn Hope on an annual basis with time and financial donations. Inspired yet? Ready to sign up for a committee or organization in need of your services? Hereâ&#x20AC;&#x2122;s why you should be: â&#x20AC;˘ Volunteerism creates connections â&#x20AC;˘ Volunteerism is good for your mind and body â&#x20AC;˘ Volunteerism can advance your career â&#x20AC;˘ Volunteerism creates fulfillment â&#x20AC;˘ Volunteerism is the right thing to do In closing, Brian Neff shared with me a well-known tale of a man walking on a beach after a violent storm. The force of the storm uprooted countless starfish and deposited them on the sandy shores for as far as the eye could see. Undaunted, a man walks the beach, picking up star fish after star fish and placing them back into the water. An onlooker approached the man with another starfish in hand and says, â&#x20AC;&#x153;With VOLUNTEERISM

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VEIN THERAPY NEWS OCTOBER/NOVEMBER 2016

SECONDLOOK

Bringing real healthcare to more patients

How a mid-level provider can help your practice expand By Laura Ellis, MD Four years ago I founded medAge for two reasons. To influence the course of primary healthcare from a system of treating diseases to one of preventing or reversing early stages of disease. And to provide my existing vein and aesthetic patients with the opportunity to improve their lives drastically. Now, as medAge has expanded across the country, to continue to reach goal number one, I’ve added a physician’s assistant to the team in our primary East Coast office. This allows medAge to care for and educate more patients, increasing the demand for real healthcare, ultimately putting more and more pressure on other providers to do the same, on corporations to supply their employees with “wellness” programs and on third-party payers to participate – I hope. Why goal number two? Because when I review the medical history of my vein and aesthetic patients, I find it shocking how many of them are Type II diabetics, have metabolic syndrome, are peri- or post-menopausal and on anxiolytics, antidepressants and drugs for insomnia instead of on HRT and the list goes on. Their primary care providers either don’t have the time or the inclination to deal with WHY they’re diabetic or WHY they’re depressed. These patients don’t want to treat preventable and reversible conditions with drugs, but they’re often given no other options. They jump at the opportunity to learn about how to live healthier lives. It’s mostly education – and it works. As I coach other physicians on how to incorporate a medAge program into their existing practices, I suggest starting with a mid-level provider, a nutritionist or dietitian, a fitness trainer and a patient coordinator. Right out of the gate, this allows the physician-owner to continue business as usual while adding a cash-based, “holistic wellness” practice that they simply manage. As vein surgeons we’re accustomed to being on the cutting edge of medicine, deviating from traditional practices. We offer concierge level services that include a healthy mix of cash and insurance-paid procedures. Our patients fit the perfect demographic for expanding into a medAge type program. But, if you’re like me, you’re already at the limit of numbers of patients per day. To add more would compromise their care by limiting provider/patient contact. That is certainly not how we define ourselves. To see more patients and continue to be “the best place in town” as our patients call us, we need to add providers.

The most cost effective, of course, would be a nurse practitioner or physician’s assistant. Another significant benefit to adding a mid-level provider is that they tend to take direction and supervision from you much better than another physician might. One of the best decisions I ever made was in 2003. I left my position as a department head in a large hospital and opened a private practice, alone. No partners. I remain independent and love being the boss. Despite having no formal business or

The most cost effective way to see more patients is to add a nurse practitioner or physician’s assistant. marketing education, I’ve made critical business decisions and hired and fired many employees over the years – all on my own. For many years now, I’ve had a harmonious office with happy, productive employees and two medical practices with multiple locations and continued upward growth. With the addition of medAge to my vein practice, I created SOPs, standard operating procedures, for each aspect of the program. Team members use these as guides when caring for patients. For example, once a patient is established, has had extensive lab and clinical testing and is on a customized regimen of care, the SOP for monitoring patient progress and providing accountability clearly outlines how the patient is to be contacted, by whom, how often and puts each patient into an algorithm that ensures successful achievement of that particular patient’s goals. I don’t have to continuously monitor the teams’ activities. I do however, get regular reports that keep me in the loop. Whether you want to increase numbers of patients in your current practice or you decide to provide offerings that expanded into anti-aging, functional, and integrative medicine programs such as medAge, I highly recommend bringing a mid-level provider into the fold.

VOLUNTEERISM

continued from page 41

neighborhoods, our specialty of vein care and our communities – in addition to modern American healthcare. VT N

all of these starfish on the beach, you can’t possibly make a difference.” The man looks at the starfish in his hand and says, “I can for this one.” Just as there are millions of people around the world in need of quality vein care – in need of quality general health care – there are people in need for a variety of issues within each population. The difference you and/or your organization can make to even one person in need – whether it’s related to phlebology or something else altogether – is critical to the future of strong

Erin Reilly Gibbs is passionate about volunteerism, philanthropy and fundraising. In addition to serving three years as Co-Chair of the American College of Phlebology Foundation Silent Auction raising money for the ACP Foundation, she also served the Southern Colorado community as the campaign chairwoman for the Breast Center of Excellence (BCOE) where she led a $1.5 million campaign for St. Mary Corwin Medical Center in Pueblo, Colo. She served as a board member

MEDAGE COMPREHENSIVE HEALTH PROGRAM The medAge Comprehensive Health Program, founded in 2012 by Dr. Ellis, is a comprehensive functional medicine program, focusing on the prevention, apprehension, and reversal of degenerative and age-related illness. The medAge protocol is built on a holistic foundation with four pillars: • Scientific Stress Management • Custom Nutrition • Optimized Exercise • Bio-identical Hormone Replacement This results in: • Prevention and reversal of osteopenia/osteoporosis { Reduced risk of heart disease { Reduced risk of many cancers • Alleviation of menopausal symptoms such as night sweats and hot flashes • Better cognition/clearer thinking • Maintenance of muscle mass • Better skin integrity/appearance • Alleviated depression/anxiety • Improved quality of sleep • Improved sexual function/desire • Better exercise strength, performance and recovery The medAge Comprehensive Health Program is systematized for replication and licensing opportunity. For more information on the medAge Comprehensive Health Program and how to establish a medAge practice within your existing clinic, see MymedAge.com, or call 828-684-1212. VT N Dr. Laura Ellis is a wellness doctor and vein surgeon. Her national medAge practice specializes in hormone replacement and anti-aging medicine. Dr. Ellis is author of “The Hormone Handbook.” She is host of “The Dr. Laura Ellis Show” at Sunset Gower Studios in Hollywood, and a motorcycle road racer with championship wins.

with St. Mary Corwin Medical Center Foundation Board and CSU-Pueblo Foundation Board in addition to supporting in time, leadership and donations to Cowboys Kickin’ Cancer – also in Pueblo. Erin and her husband, Gordon F. Gibbs, MD, opened the doors of American Vein & Vascular Institute on Jan 1, 2010. Erin is CEO of the practice management company that goes by the same name of the clinics as well as a health retail company, The Compression Center. Together, Erin and Gordon are parents to three children, two dogs, a hamster and five horses. As a family, the Gibbs’ actively support the advancement of phlebology, as well as the arts, education, youth sports and schools.

Hannah Delagardelle volunteers for Cowgirls’ and Cocktails providing support to cancer victims.

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

PRODUCTNEWS

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SIGVARIS adds 2 heather colors to MICROFIBER SHADES socks SIGVARIS North America is once again breaking the stereotype that compression socks are for â&#x20AC;&#x153;old peopleâ&#x20AC;? with the launch of two new additions to the MICROFIBER SHADES line â&#x20AC;&#x201C; navy heather and graphite heather socks. â&#x20AC;&#x153;People are always amazed by the number of fashionable options that exist for compression stockings,â&#x20AC;? David Rosenberg director of marketing for SIGVARIS North America. â&#x20AC;&#x153;We decided to kick our style up a notch even more by adding new stripe and heather options to attract an even younger crowd to the importance of establishing good leg health practices early in life,â&#x20AC;? Rosenberg added. The MICROFIBER SHADES Line is available in pink stripe, onyx stripe, graphite stripe, dark navy stripe, graphite heather and navy heather in the 15-20mmHg compression level. The pink stripe, onyx stripe and dark navy stripe are also available in the 20-30mmHg compression level. â&#x20AC;&#x153;For people who need to wear graduated compression every day but want more fun, playful socks to add a pop of color to their wardrobe, these socks deliver with the added health benefit of improving circulation,â&#x20AC;? he said. â&#x20AC;&#x153;Wearing graduated compression can dramatically help improve overall leg health by increasing circulation to keep legs looking and feeling their best. SIGVARIS graduated compression products are constructed to be tightest at the ankle and decrease in pressure going up the legs, improving circulation and providing relief for tired, achy legs.â&#x20AC;? He said MICROFIBER SHADES offers wearers both comfort and durability. The advanced microfiber technology wicks away moisture to keep feet dry and comfortable. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s the perfect compression sock for work, travel and daily wear.â&#x20AC;? VT N READ MORE: sigvarisusa.com

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PRODUCTNEWS SonoSite Sll wins Silver in IDSA's design contest FUJIFILM SonoSite Inc., specialists in developing ultrasound solutions and providing point-of-care visualization access, has been named a Silver winner in the 36th Annual International Design Excellence Awards (IDEA) announced by the Industrial Designers Society of America (IDSA). FUJIFILM SonoSite’s SII Ultrasound Machine is among more than 1,700 projects from 30-plus countries that competed in IDEA 2016.

Craig Chamberlin, director of experience design at FUJIFILM SonoSite Inc. said:“This award demonstrates that we achieved our design goals of creating a mountable ultrasound system that is functional, efficient, and provides a great user experience.” Developed for regional anesthesia, vascular access and trauma applications, the SonoSite SII empowers efficiency for clinicians through a simple, yet intelligent interface that adapts to the user’s imaging needs. The system is portable and appropriate for multiple hospital environments, including a zero footprint option for space-constrained rooms. IDEA 2016 winners span a wide range of 21 categories such as social impact; medical and scientific innovations; transportation; home and garden; office; personal accessories; children’s products; sporting goods; and much more. IDSA Board of Directors Chair John Barratt – himself a former IDEA jury chair – hails the competition as “the authority on design” – showcasing new designs in products that are used every day, and products featuring first-of-a-kind innovations. VT N READ MORE: sonosite.com/uk/ product/sonosite-sii

Shockwave Medical Lithoplasty System gets FDA approval Peripheral artery disease, where plaque builds up in arteries in the legs and in other places preventing blood flow, is usually treated using balloon angioplasty and stents, if a procedure is called for.

Shockwave Lithoplasty System Now, one California startup is hoping to provide another option to physicians who can use the device to either replace current treatments or use it in conjunction with them. The U.S. Food and Drug Administration has approved Shockwave Medical's Lithoplasty System as treatment for calcified plaque in patients with peripheral artery disease. In January 2015, the Lithoplasty System received the CE Mark. The Lithoplasty System integrates two technologies, sound waves (lithotripsy) and angioplasty balloon catheters, to target hardened calcium in patients with cardiovascular disease. Lithotripsy pulses disrupt superficial and deep vascular calcium but minimize injury to soft tissue. Then an angioplasty balloon restores blood flow at low pressures. Lithoplasty Technology is powered by a treatment system that includes Lithoplasty Technology Balloon Catheters, a connector cable and generator. These are familiar devices for interventionalists, making the technology inherently familiar, easy to learn, adopt, and use on a day-to-day basis. Lithoplasty Balloon Catheters are prepared and delivered exactly like traditional balloon angioplasty devices. The catheters have proximal and distal markers, so they can be accurately placed within the lesion. At the touch of a button, miniaturized lithotripsy emitters apply pulsatile mechanical energy along the length and diameter of the balloon. The FDA approval is based on data from the Disrupt P.A.D. study, which the company says demonstrated the Lithoplasty System's safety and effectiveness in all patient subgroups in increasing blood flow in treated vessels. A limited U.S. commercial release of the Lithoplasty System is planned for 2017. VT N READ MORE: shockwavemedical. com /us/o us -l it hopl ast ytec h nolog y/ lit hoplast y- sy stem overview/

technology to extract blood clots in acute ischemic stroke patients more quickly and safely, the company said. The device, which is part of the company’s Penumbra System, was designed with a new tracking platform from hub to tip, and features a unique coil winding geometry along 16 transitions to deliver an optimal tracking profile. The announcement, along with supporting data, was made in September at the Society of NeuroInterventional Surgery’s 13th Annual Meeting in Boston. “The ACE68 provides an opportunity to reverse strokes faster and with less expense,” Adam Arthur, MD and a professor in the neurosurgery department at the SemmesMurphey Neurologic & Spine Institute in Memphis, Tenn., said in a statement. “The larger lumen seems to allow better clot capture, which may reduce the need for adjunctive devices, simplify the procedure and reduce procedure cost – important considerations as hospitals look to expand stroke services.” The Alameda, Calif.-based company markets medical devices that include several neurovascular access products, the ACE system, neurovascular embolization products,

a neurosurgical tool as well as peripheral embolization and thrombectomy devices. Penumbra, which raised about $125 million when it went public a year ago, has seen its stock price trade in a 52-week range of $35.31 to $61.87. In May, Penumbra reported total revenue grew to $57.9 million in Q1 versus $39 million for the same period a year ago. Analysts had set a consensus estimate of $53.1 million. Revenue for neuro products grew to $41.3 million for the period, and sales of peripheral vascular products increased to $16.6 million. VT N READ MORE: businesswire.com/ news/home/20160725005231/en/

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Penumbra unveils thrombectomy product to U.S. Penumbra has unveiled its latest thrombectomy product to the U.S. market. Called the ACE 68 Reperfusion Catheter, the vascular device uses the latest tracking

VEIN THERAPY NEWS OCTOBER/NOVEMBER 2016

PRODUCTNEWS FDA approves drug-coated ‘balloon’ for P.A.D. treatment, study The US Food and Drug Administration has approved Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) as the first DCB to treat in-stent restenosis (ISR) in patients with peripheral artery disease (PAD), the company announced. The approval is based on data from the IN.PACT Global Study, which demonstrated the DCB’s safe and effective treatment of complex ISR when compared with a standard percutaneous transluminal angioplasty (PTA) control The study showed a 1-year primary patency rate of 88.7% for a difficult-to-treat ISR patient subgroup, with a clinically driven target revascularization rate of 7.3%. Lesions had a mean length of 17.2 cm, and 34% of lesions were occluded. Medtronic officials said the IN.PACT study was designed "to look at challenging lesions in real-world patients.' The primary mode of action for the DCB is physical dilation of the vessel lumen by PTA. Physicians can use it to treat claudication and restenosis in patients with superficial femoral artery disease. The balloon is coated with paclitaxel, which is used to minimize scar tissue formation and prevent artery narrowing. The IN.PACT Admiral DCB, which received the CE Mark in 2009 and was approved by the FDA to treat superficial femoral and popliteal arteries in 2014, has been used to treat more than 150,000 patients, according to Medtronic. The Bard Lutonix paclitaxel-coated DCB received FDA approval in 2014 for treatment of initial stenosis but not for restenosis. VT N

EmnoTrap restores flow without compressing clot Neuravi has received Conformité Européenne (CE) Mark approval and launch of the company’s newly available enhancements to the EmboTrap stent retriever platform, the EmboTrap® II Revascularization Device. Adoption of endovascular stroke therapy procedures for the treatment of acute ischemic stroke continues to grow significantly following compelling data from multiple largescale randomized trials last year. These trials confirmed the value of using stent retriever thrombectomy to rapidly clear occlusive clots from large cerebral vessels. The novel EmboTrap was fully commercialized in Europe last year, and

EmboTrap II Revascularization Device with the introduction of the EmboTrap II, Neuravi is bringing further innovation to the market. The new device leverages the EmboTrap platform design, engineered to trap and remove a variety of clot types and rapidly re-establish flow, with an integrated fragment protection zone. The EmboTrap II device is designed to address a broader range of clot lengths, with sizes that are deliverable through a 0.021” microcatheter. “The EmboTrap platform has been a great addition to my clinical practice. In my first nine cases using the device, Christian Taschner, MD, professor of Radiology, University of Freiburg, Germany, said. “I was able to get TICI 2b-3 reperfusion in one pass. Now with the EmboTrap II, I’ve had comparably good results when treating longer occlusions. “In fact, in early evaluations of the EmboTrap II 5×33 at six centers, 16 of 17 cases resulted in TICI 2b-3 flow. The open design of the device helps trap clot inside and also makes it quite flexible, which is important when removing clot from the arteries of the brain.” CEO Eamon Brady said Neuravi is committed to ongoing research to deepen understanding of the science of clot and to find new ways to advance stroke therapy. “As the company continues to gain new insights into clot-device interaction, that learning informs ongoing innovation. We believe this scientific approach not only improves our technology to make it better and easier to use for physicians, but will also maximize clinical benefits for patients.” The EmboTrap and EmboTrap II revascularization devices are available in Europe to treat patients with acute ischemic stroke. The EmboTrap is currently available for investigational use only in the U.S. under the ARISE II clinical trial, an international clinical trial assessing safety and effectiveness in the United States and Europe. Data from the trial will support a U.S. Food and Drug Administration (FDA) submission for approval to market the device in the United States. VT N READ MORE: neuravi.com

Report examines US device market Research and Markets has added the "Global Ultrasound Devices Market Size,

Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2012 to 2022" report to its offering. This new market research report forecasts on the ultrasound devices market, providing complete market figures, consisting market size and estimation by ultrasound devices market application and products depending upon geographical location for the forecasting period 2012 to 2022. Further, the ultrasound devices market research report study also encompasses complete industry background, with ultrasound devices market drivers, competitive market dynamics, market restraints, market growth opportunities, industry challenges and critical success factors (CSFs). The ultrasound devices market research report examines top industry competitors, offering organization market share analysis and detailed outlines of these firms, with product benchmarking. VT N READ MORE: researchandmarkets.com / r e s e a r c h / h 3 h 6 5 b /g l o b a l _ ultrasound

Vascular guidewire market will grow 6% CAGR until 2020 The global vascular guidewires market is expected grow at a CAGR of close to 6 percent during the period 2016-2020, according to Technavio’s latest report. In this report, Technavio covers the market outlook and growth prospects of the global vascular guidewires market for 2016-2020. The market is further categorized into two product segments: coronary guidewires and peripheral guidewires, of which the coronary guidewires segment accounted for more than 77 percent of the market in 2015. “The rise in cardiovascular diseases or coronary heart diseases is the primary market driver for the coronary guidewires market,” Barath Palada, a cardiovascular devices research expert from Technavio, said. Technavio’s healthcare and life sciences research analysts segment the global vascular guidewires market into the following regions: Americas, EMEA and APAC.

AMERICAS The vascular guidewires market in the Americas is expected to reach $676 million by 2020, growing at a CAGR of more than 5 percent. The vascular guidewires market in the Americas is projected to grow at a steady rate during the forecast period because of the increased adoption of technologically advanced interventional vascular devices. Also, the increase in coronary and peripheral procedures in the United States have led to a rise in demand for vascular guidewires. The growing awareness about

CVDs, CHDs, and peripheral vascular disease has led many individuals to undergo regular tests and check-ups. The incidence of hypertension in countries such as Canada and Brazil is gradually increasing, which is projected to boost the growth of the market during the forecast period. In addition, most companies are focusing on expanding their market in Latin America, especially Brazil, by making strategic alliances with local vendors for the distribution of their products.

EMEA The vascular guidewires market in EMEA is expected to exceed $446 million by 2020, growing at CAGR of more than 5 percent. EMEA is the second major revenue contributor for the global vascular guidewires market with the UK, France, Italy, Spain, and Germany being the major revenue contributors. The increase in population with CVDs is the primary driver of the market. Heart failure affects 23 million people globally, and Europe accounts for 10 million of them. The market in these countries is witnessing growth due to growing adoption of MI surgeries, which enable faster patient recovery. Growing approvals from the regulatory authorities and new product launches will further boost market growth. Also, favorable reimbursement policies in Germany and the UK have significantly contributed to market growth. MEA has a negligible share in the global vascular guidewires market which is likely to change with a rise in awareness and adoption of new procedures. This will further help the market grow during the forecast period.

APAC The vascular guidewires market in APAC is expected to reach exceed $315 million by 2020, growing at a CAGR of more than 7 percent. APAC is the fastest growing market for vascular guidewires. The market is untapped in emerging countries such as India, China, Indonesia and Malaysia. The rise in disposable income and growing medical tourism is increasing the demand for guidewires. Growing awareness about the use of MI procedures in treating various vascular diseases has led to the increased adoption of guidewires. Also, focus on preventive treatment in these regions will aid the growth of this market. VT N READ MORE: technavio.com/ r e p o r t /g l o b a l - c a r d i o v a s c u l a r devices-global-vascularguidewires-market-2016 2020?utm _ source=T1&utm _ m e d i u m = B W & u t m _ campaign=Media

OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS

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