2017 Phlebology Review Course set 4 IAC publishes ‘Standards’ review 8 Peripheral Vascular Disease pipeline 12 Who speaks for you in social media? 16 Sigvaris adds to men’s sock line 31
FEBRUARY/MARCH 2017 Vol. 10 No. 1 VEINTHERAPYNEWS.COM
An ACP recognized resource for news and information for and about the phlebology community
Excitement builds for AVF, IVC meetings AVF gathers in Big Easy for Valentine’s Day start
Remembering the past, looking to our future
By Lowell Kabnick, MD, FACS, FAC Ph
By Edward Mackay, MD, RVT, RPVI
Over the last 29 years, the American Venous Forum has led the field of venous and lymphatic disease by providing the highest quality evidence-based knowledge and guidelines, raising awareness of the spectrum of venous and lymphatic disorders, improving the treatment options and care of patients with these diseases and preparing the future of venous health care specialists. The AVF is continually improving the delivery of venous and lymphatic healthcare
Thinking back to the first International Vein Congress (IVC) in 2003 and the excitement enjoyed by many as this new field was exploding before our eyes. The registration had to be closed six weeks prior to the meeting because it reached its capacity of 200 participants, which was more than the venue could handle. Within six months, a second meeting was scheduled and it too filled with a repeat scenario of premature registration closure several weeks prior to the meeting. Due to the
AVF continued on page 30
Lowell Kabnick, MD, is co-director of the IVC and president of the American Vein Forum.
IVC continued on page 28
Collaboration without unification: What will the future hold? By Mel Rosenblatt, MD, FACPh and Neil M. Khilnani, MD For more than a decade, the question of ACP and AVF unification has been discussed among society leaders. While each society developed from a slightly different primordial
soup, our collective evolution has led us to essentially the same place. With such striking similarities it seemed almost illogical to continue along our independent and sometimes competitive path. For when we act individually we are limited by our inherent weaknesses. No matter how gifted one may be, he still cannot brush his teeth and tie his shoes at the same
time. When we act in concert we are able to minimize our weakness. Tasks, impossible for an individual, are easily accomplished collaboratively. By the same token, we each possess unique strengths. When we act in concert, our strengths are amplified and our weakness minimized. These very basic and intuitive concepts are what fueled the most recent
attempt at unification. The two societies went through a very formal process with professional assistance and in the end, the decision was to continue independently with a greater focus on collaboration. DR. ROSENBLATT continued on page 24
LETTER: Dr. Morrison responds to pharmacist regarding webinar criticism Dear Editor: I acknowledge Michael Haulsee, PharmD for his comments which appeared in the December 2016 edition of Vein Therapy News (VTN), regarding the American College of Phlebology (ACP) webinar entitled “Responsible Use of Compounded Sclerosant Agents” that I presented in October 2016 regarding drugs made by compounding pharmacies.
Having read the VTN article by Mr. Haulsee, I admit I was at first surprised and upset about his report of a statement I apparently made that “all pharmacists lie.” I didn’t remember making such an ignorant statement and certainly do not believe it personally. DR.MORRISON continued on page 8
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VEIN THERAPY NEWS < FEBRUARY/MARCH 2017
NEWS 1 AVF’s 29th Annual Meeting
AVF is convening its 29th Annual Meeting Feb. 14 in New Orleans. We have used Dr. Lowell Kabnick’s welcome to the meeting as inspiration to attend this important conference.
1 IVC: 14 years since beginning
Course Director Dr. Edward Mackay remembers the first International Vein Congress 14 years ago in 2003, and all of the major milestones in the treatment of venous disease as they were presented at the IVC over the years since. He then details all of the great things happening in the 2017 Congress, and wonders with the treatments for virtually every condition that a patient with lower extremity venous disease may present, what will IVC be like 14 years from now in 2027.
SECOND LOOK 1 A path forward This summer, the unification of ACP and AVF discussions ended. So where does this medical specialty turn in its efforts to affect significant changes in policy? While now is not the time for unification, it is time for collaboration. The 10 or so societies to which our physicians depend, can be much stronger working together than separately.
1 Physician responds to article
In the last issue of VTN, pharmacist and author Michael Haulsee took Dr. Nick Morrison to task for the content of his October 2016 webinar on compounding drugs. In this issue, Dr. Morrison responds and clarifies his position.
20 A Roundtable Discussion
Vein Therapy News and VEIN Magazine have shared articles on what not to do in venous disease treatment. The VTN article by Dr. Ed Mackay last issue took doctors to task for unprofessional practices, will appear in the Winter VEIN. The roundtable discussion, first published in the Fall issue of VEIN, is a panel of doctors discussing the same subject.
30 Anti-embolism stockings
Sigvaris has taken elements of traditional anti-embolism stockings and every day compression stockings to give patients a garment that will aid in their overall recovery process. They feature 18-23mmHg of graduated compression, a unique opentoe design that allows for easy inspection of feet, and an anatomical foot design that makes it easy to wear from bed to physical therapy.
PRODUCT NEWS 34 Aprima OK for venous registry
Aprima Medical Software’s electronic health record (EHR) has met certain minimum criteria, ensuring that data fields match and provides a consistent interface between the user and the American College of Phlebology PRO Venous Registry.
VTNREPORT 2017 PHLEBOLOGY REVIEW COURSE SET The 2017 Phlebology Review Course, a comprehensive two-day lecture series reviewing the essentials of venous disease and its care, will be Feb. 24-25 at the ACP Training Center in San Leandro, Calif. The course is provided by experienced phlebologists from several different primary disciplines who are exceptional educators. The content has been oriented toward the knowledge-base required by the board examination of the American Board of Venous and Lymphatic Medicine (ABVLM). Aimed at physicians who care for patients with venous problems, topics covered during the course will be emphasized based on the anticipated importance of these topics on the Board Certification Exam. READ MORE: netforum.avectra.com/eweb/DynamicPage.aspx? Site=ACP&WebCode=EventDetail&evt_key=0ef bae49-9621- 4613- 8424 d0e2accd497a
ABBOTT, ST. JUDE ACQUISITION SET; BOAST $8.7B IN COMBINED PORTFOLIO Abbott closed the acquisition of St. Jude Medical Inc. on Jan. 4. The announcement followed receipt of all regulatory clearances necessary for closing. Together, the combined cardiovascular and neuromodulation portfolio has annual sales of approximately $8.7 billion. The acquisition of St. Jude Medical is expected to be accretive to Abbott’s adjusted earnings per share in the first full year and increasing thereafter, with approximately 21 cents of accretion in 2017 and an estimated 29 cents in 2018. The combination is anticipated to result in annual pre-tax synergies of $500 million by 2020, including both sales and operational benefits.1 The transaction establishes Abbott as a leader in the medical device arena and provides expanded opportunities for future growth. The addition of St. Jude Medical is an important part of the company’s ongoing effort to develop a strong, diverse portfolio of devices, diagnostics, nutritionals and branded generic pharmaceuticals. St. Jude Medical’s strong positions in fast-growing areas such as atrial fibrillation, heart failure, structural heart and chronic pain complement Abbott’s strong positions in coronary interventions and mitral valve disease. Together, the company will compete in nearly every area of the $30 billion cardiovascular market and hold the No. 1 or 2 positions across large and highgrowth cardiovascular device markets. While Abbott’s St. Jude tie-up had a happy ending, Abbott continues its struggle to escape its $5.8 billion deal to acquire diagnostics maker Alere. In late 2016, Abbott filed a complaint in Delaware Chancery Court to terminate the deal because of a series “damaging business developments” at Alere that unfolded since the deal was struck in February. The action followed a suit filed by Alere in the same court seeking to force Abbott to complete the acquisition.
SPECIALTIES NOW LAUNCHING TELEHEALTH CARE Specialists can now launch their own telehealth offering care to an array of patients, often in remote areas, rather than those near urban centers. Specialties such as dermatology, psychology, psychiatry, audiology, ophthalmology and dentistry fit especially well into this business model, reported Health Intelligence. Telestroke is among the most widely used practices of telehealth, bringing a neurologist into the treatment as quickly as possible to a person who suffers from a stroke. Children’s Hospital of Philadelphia connects specialists to doctors in rural regions of the Southwest practicing with the Indian Health Service. Some health systems set up telehealth platforms that allow clinicians access to specialty consults, reducing the need to make referrals. For many of these programs, cross-state licensure remains a major hurdle, but is an issue being addressed by the Federation of State Medical Boards and other groups. To provide telehealth services, providers must ensure their IT infrastructure can reliably and securely handle the growing traffic. And reimbursement and a patchwork of various state regulations remain major barriers.
SHIRE PAYS RECORD SETTLEMENTS FOR FALSE CLAIM IN MARKETING DEMAGRAFT SKIN SUBSTITUTE The U.S. Department of Justice has cited Shire for “flagrant and systemic kickback activity” designed to increase use of the skin substitute Dermagraft.
Shire set aside $350 million last summer to settle federal marketing allegations over the product. The settlement resolves claims that sales reps bribed clinics and doctors – including Veterans Administration physicians – to use Dermagraft, using “lavish” dinners, drinks, entertainment and travel. The reps also offered docs medical equipment and supplies, the government says, as well as “unwarranted” payments for “purported speaking engagements” and “bogus” case studies. Cash, credits and rebates also figured in. The result? Shire and Dermagraft-maker Advanced BioHealing, which the Dublin drugmaker acquired in 2011 and sold in 2014, “submitted or caused to be submitted to federally-funded health care programs hundreds of millions of dollars of false claims for Dermagraft,” the DOJ says. It’s one of pharma’s heftiest marketing settlements in recent years, and it’s the largest-ever False Claims Act settlement involving a medical device, the Justice Departments’ civil division head, Benjamin Mizer, said in a statement. Shire, which sold off its Dermagraft assets early in 2014, has found itself here before, though for a fraction of the fine. In September 2014, the Shire paid $56.5 million to put to rest allegations that the company marketed ADHD star Vyvanse for unapproved uses and made unsupported claims about the med’s use – that it would prevent car accidents, divorce, arrests and unemployment, for example.
HOFFMAN NAMED VP AT SIEMENS HEALTHINEERS Matt Hoffman has been named vice president of interventional radiology and advanced therapies sales management for North America at Siemens Healthineers. His new duties will cover interventional radiology go-to-market strategies, including the development of new industry partnerships and a focus on new growth areas in interventional radiology, as well as leading the angiography field sales team Hoffman most recently served as the company’s modality regional vice president in the south Texas region. His 10-year tenure at Siemens has included sales roles in molecular imaging, ultrasound, field sales and field sales management.
LESS AGGRESSIVE TARGET FOR TREATING HIGH BP IN ADULTS OVER 60 RECOMMENDED Two leading medical organizations are recommending a less aggressive target for the treatment of high blood pressure in adults 60 and older who are otherwise healthy. Traditionally, the threshold for high blood pressure has been set at 140 mmHg systolic blood pressure. But the new guideline says doctors should now begin treatment when adults 60 and older have persistent systolic blood pressure that’s at or above 150 mmHg, to reduce their risk of heart problems, stroke and death. A less aggressive target like this offers a suitable balance of benefits and potential harms for these patients, according to the new guideline from the American College of Physicians and the American Academy of Family Physicians. Any additional benefit from more aggressive treatment is small, the groups say. Doctors specializing in the cardiac care of older patients said the new guidelines may be warranted.
DEADLY DRUG-RESISTANT BACTERIA IS MORE WIDESPREAD IN U.S. HOSPITALS THAN THOUGHT A type of potentially deadly drug-resistant bacteria is more widespread in U.S. hospitals than previously thought and needs to be more closely monitored, a new study suggests. Researchers checked for cases of illness caused by carbapenem-resistant Enterobacteriaceae (CRE) in a sample of four U.S. hospitals and identified a wide variety of CRE species. Three hospitals are in the Boston area and one is in California. The CRE family of germs causes about 9,300 infections and 600 deaths in the United States each year, according to the U.S. Centers for Disease Control and Prevention. Those numbers are on the rise, the researchers said. CDC Director Dr. Tom Frieden has called CRE “nightmare bacteria” due to their resistance to carbapenems, which are last-resort antibiotics used to treat drug-resistant infections. In the study, the researchers also discovered that CRE has a wide range of genetic traits that make it resistant to antibiotics and that these traits are easily transferred between various CRE species. VT N
FEBRUARY/MARCH 2017 < VEIN THERAPY NEWS
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NEWS Dr. Aggarwal appointed to VTN edit board Manu Aggarwal, MHSA, MD, a board certified family physician and ABVLM certified physician at the Vein Care Center Laser Specialists, has become a member of the Vein Therapy News Editorial Advisory Board. The Vein Care Center has been an IACaccredited vascular laboratory since 2007. In 2015 the Vein Care Center Laser Specialists was one of the first 50 practices in the country to also be an IAC-accredited vein center. The Vein Care Center has been dedicated to venous disease and laser treatments since 2004. It is located in Lima, Ohio. VT N
European patients with venous thromboembolism detailed in report Insights into venous thromboembolism epidemiology, venous thromboembolism diagnosed patients and venous thromboembolism treatment rate for five European Union pharmaceutical markets is now available The Research and Markets study measures key indicators such as prevalence of venous thromboembolism derived from epidemiological analysis, percentage of patients diagnosed with venous thromboembolism,
and percentage of patients treated with a therapy. “Europe Venous Thromboembolism Epidemiology and Patient Flow Analysis 2017” helps executives estimate venous thromboembolism market potential, assess unmet need, develop drug forecasting models, and build population-based health management frameworks. The information presented in this study is used to evaluate market opportunities, effectively identify target patient population, and align marketing decisions. The report provides estimates and forecasts of venous thromboembolism prevalence, venous thromboembolism diagnosis rate, and venous thromboembolism treatment rate for the period 2016 - 2025.
The key features of the report include: • Venous thromboembolism patient flow, • Venous thromboembolism prevalence, • Venous thromboembolism diagnosed patients, and • Venous thromboembolism treated patients. The report includes a definition of Venous thromboembolism: disease; the patient flow in Europe in general, and venous thromboembolism patient flow in Germany, France, Spain, Italy and the United Kingdom. VT N R EAD MORE: researchandmarkets.com/ research/642phf/europe_venous
Intended Use/Indications: The VenaSeal closure system (VenaSeal™ system) is indicated for use in the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by 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 VenaSeal™ adhesive or cyanoacrylates, acute superficial thrombophlebitis, thrombophlebitis migrans, acute sepsis exists. Potential Adverse Effects of the Device on Health: Below is a list of the potential adverse effects (e.g., complications) associated with the use of the VenaSeal system. The adverse 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 and anaphylactic shock, arteriovenous fistula, bleeding from the site of access, deep vein thrombosis (DVT), edema in the treated leg, embolization, including pulmonary embolism (PE), hematoma, hyperpigmentation, infection at the access site, non-specific mild inflammation of the cutaneous and subcutaneous tissue, pain, paresthesia, phlebitis, superficial 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.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. DC00037656
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FEBRUARY/MARCH 2017 < VEIN THERAPY NEWS
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NEWS IAC Vein Center publishes revisions to Standards The Intersocietal Accreditation Commission (IAC) Vein Center has published updates to its Standards for vein center accreditation. This content reflects the most recent public comment period (Oct. 5, 2016, to Dec. 5, 2016), and the new Standards will go into effect for clinics seeking accreditation after June 1. As an accreditation organization, IAC Vein Center is committed to maintaining a program that balances the changing needs of both the vein center community and the general public by influencing the quality of patient care provided. The IAC Standards & Guidelines for Vein Center Accreditation: Superficial Venous Evaluation and Management is the most important component of that commitment. Composed by physicians, nurses and technologists from the IAC sponsoring organizations, the Standards are reviewed periodically by the Board of Directors and revised as needed. A nonprofit organization, IAC Vein Center is supported by the following organizations while operating independently of their activities. Representatives from these organizations make up the IAC Vein Center Board of Directors. The Board of Directors and Sponsoring Organizations include a representative from: American Academy of Dermatology (AAD), American College of Phlebology (ACP), American College of Surgeons (ACS), American Society for Dermatologic Surgery (ASDS), American Venous Forum (AVF), Society for Clinical Vascular Surgery (SCVS), Society for Vascular Medicine (SVM), Society for Vascular Nursing (SVN), Society for Vascular Surgery (SVS), Society for Vascular Ultrasound (SVU), and Society of Interventional Radiology (SIR). As a component of the accreditation process, once approved by the IAC Vein Center Board of Directors, these proposed standards are posted to the IAC Vein Center website for a 60-day public comment period. Facilities applying for accreditation after June 1 must comply with these new highlighted standards. To download the Standards, see intersocietal.org/vein/seeking/vein_standards. htm?utm_source=IAC+Vein+Center+Email+ Contact+List&utm_campaign=1bf3eba25cVe i n + C e n t e r + S t a n d a r d s + E - m a i l _ 1 9 -17& u t m _ m e d i u m = e m a i l & u t m _ term=0_227ef1b20e-1bf3eba25c-16157973 . The standards that are highlighted are content changes that were made as part of the Jan. 9 revision. Some of the changes made are a clarification or explanation of the previous
standards, however, in several instances, the requirements have been modified. Facilities that perform fluoroscopy can find additional standards at intersocietal. org/vein/standards/IACVeinStandards2017_ Fluoroscopy.pdf . The IAC is fully staffed with clinical and administrative personnel trained to guide clinics through the IAC application process. Call 800-838-2110 or e-mail vein@ intersocietal.org for assistance. VT N
IAC research grant process is now open The IAC Research Committee supports innovative and meritorious research relevant to accreditation and quality improvement through its annual IAC Research Award Program. The purpose of the research award is to gain insights into the accreditation process and its value to medicine and society. For 2017, the IAC Research Committee will be awarding grants up to a maximum of $75,000 (including institutional overhead). Awards are for one year, although continuation awards are possible. This application process initially involves a letter of intent, and if accepted, a subsequent full proposal. Interested individuals are encouraged to submit proposals that advance the IAC Research Committee’s mission of “Strengthening Accreditation through Research.” The important 2017 dates are: • Letter of Intent Submission Due – March 1 • Notification for Letter of Intent Decision – April 3 • Proposal Submission – June 1 • Notification of Award – September Participants applying for this opportunity should review complete details and submit a letter of intent to IAC no later than March 1. For questions or a variables list, please contact Mary Beth Farrell, MS, IAC Director of Research, at 800-838-2110 or e-mail email@example.com. For complete details about the IAC Research Award Program, including links to published abstracts and manuscripts, see intersocietal. org/research . VT N
Varian Medical spins off Imaging Components firm Varian Medical Systems announced a new spin-off of its imaging components business as Varian Imaging Components, a standalone company. It manufactures x-ray tubes, flatpanel detectors, connectors, and imaging accessories, and also supplies workstations
DR. MORRISON continued from page 1
For the record, such a statement would cast aspersions upon a well-regarded profession, and had I made this statement, I would sincerely apologize to all pharmacists whom I would have offended, and especially to the listeners whom I would have unintentionally misled. However, in reviewing the ACP webinar, which will be publicly available on the ACP website (www.phlebology.org), I discovered that rather than saying “all pharmacists lie,” as Mr. Haulsee reported, I actually was discussing my personal experience with some compounding pharmacies. In response to a question asked, I said “Another problem is compounding pharmacies will flat out lie to you.” In fact I was explaining that this has been my personal experience with some compounding pharmacies. And I am currently aware of one case in Arizona in which the same gross misinformation being discussed in the webinar was given to a physician who used a sclerosant from a compounding pharmacy that he was assured was FDA-approved by the vendor, following which his patient developed ulcerations and eventually sued the physician for malpractice. Not only did this misinformation from the compounding pharmacy result in the physician wrongly believing he was using an FDA-approved sclerosant, it also resulted in an adverse outcome for the
and software for computer-aided diagnostics and image processing. In 2016, Varian’s CEO Dow Wilson says the spinoff will positively impact operations, creating “two strong, independent companies. “It will enable Varian to focus on expanding its position as a global cancer company with leading technology and services – and empower the new company to grow as a global leader in components, software, and services for expanded imaging applications and markets.” In the Jan. 28 distribution, Varian stockholders received 0.4 share of Varex common stock for every one share of Varian common stock held as of Jan. 20, the record date for the distribution. No fractional shares of Varex were issued. Trading will begin for Varex shares on the Nasdaq Global Select Market under the ticker symbol “VREXV.” VT N READ MORE: varian.com/
patient and ultimately a lawsuit for the physician. For more insight, it might interest readers to Google “Michael Haulsee – FDA”. During the webinar I should have said “some compounding pharmacies could flat out lie to you, as they have done to me,” and for that omission I sincerely apologize to VTN readers and all legitimate compounding pharmacists. In summary, while I stand by the presentation, I should have stated more clearly that there are valid reasons for using compounded drugs, and that by no means are most legitimate compounding pharmacies as unethical as some with which we unfortunately have to deal in the phlebologic field. The fact remains that it is simply not possible to obtain an FDA-approved sclerosant from any compounding pharmacy. And most insurers, including Medicare, require the use of FDA-approved drugs for patients under their coverage as a requirement for payment. Failure to do so can not only put the patient at risk, it puts the provider at significant legal and medico-legal risk. Nick Morrison, MD President, International Union of Phlebology Past-President, American College of Phlebology Member, American College of Phlebology Foundation
R&M adds report detailing crural venous leg ulcers The report, “Venous Leg Ulcers – Pipeline Review, H2 2016 Venous Leg Ulcers (Crural ulcer),” has been added to the Research and Markets offerings. The venous leg ulcers (crural ulcer) pipeline therapeutics constitute close to 15 molecule, of which approximately all are developed by companies. Venous leg ulcers develop when persistently high blood pressure in the veins of the legs (venous hypertension) causes damage to the skin, which eventually breaks down and forms an ulcer. This report outlays comprehensive information on the therapeutics under development for venous leg ulcers (crural ulcer), complete with analysis by stage of development, drug target, mechanism of action, route of administration and molecule type that are being developed by companies and universities. VT N
FEBRUARY/MARCH 2017 < VEIN THERAPY NEWS
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Offer a comprehensive GSV system solution for above and below the knee. Varithena® (polidocanol injectable foam) 1% reaches veins that others can’t—treating a wide range of sizes and any vein shape including tortuous and varicosities above and below the knee. Varithena’s UDSS formulation—uniform density, size and stability—results in a long dwell time and thorough cohesion with the vein wall. Most importantly it addresses underlying venous incompetence, improves vein appearance and shows significant PRO improvements with an established safety profile. Now, with a 30-day post-activation shelf life, treating patients with Varithena® is easier than ever.
Now approved with a 30-day post-activation shelf life.
For more information on treatment, visit Varithena.com INDICATIONS Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. IMPORTANT SAFETY INFORMATION The use of Varithena is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia, or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena®
© 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
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
NEWS Cook Medical iliofemoral venous stent study in U.S. is now underway Cook Medical has completed enrollment in the first clinical study of an iliofemoral venous stent conducted in the United States under an FDA-approved Investigational Device Exemption (IDE). The VIVO Clinical Study is a prospective, non-randomized, multi-center study intended to evaluate the safety and effectiveness of the Zilver Vena Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction. “I view the completion of enrollment for this trial as an important milestone in development of options for managing patients with proximal venous obstruction,” said one of the study’s principal investigators, Dr. Anthony Comerota of the Jobst Vascular Institute, said. Dr. Lawrence “Rusty” Hofmann, co-principal investigator from Stanford University Hospital, agreed. “I am excited to see the full enrollment of the first FDAapproved venous stent trial,” he said. “This has the opportunity to help many patients.” A total of 243 patients with acute or chronic symptomatic iliofemoral venous outflow obstruction were enrolled in the VIVO Clinical Study, which has a one-year primary endpoint. The study is being conducted in 29 active sites throughout the United States as well as one in Taiwan. Cook Medical recently completed a similar first-of-its-kind study in the European Union on the safety and performance of the Zilver Vena stent. Dr. Gerard O’Sullivan, interventional radiologist at Galway University Hospitals in Ireland, presented data from the VIVO-EU study on Nov. 18 at the VEITHsymposium. “This is an area of medicine with few treatment options. In fact, there is no FDAapproved venous stent to treat this painful condition,” said Mark Breedlove, vice president and global leader of Cook Medical’s Peripheral Intervention clinical division. “It is our mission to become a valued partner in the treatment of symptomatic iliofemoral venous obstruction.” VT N READ MORE: clinicaltrials.gov/ ct2/show/NCT01970007?term=VIV O+Cook+Medical&rank=3
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NEWS CDO wearable wound care therapy studied A recently completed, double-blind study demonstrated positive results for chronic wound patients who received Continuous Diffusion Oxygen (CDO) therapy using the TransCu O2 System by EO2 Concepts. Double-blind studies, in which patients and physicians are “blinded” to which patients are receiving treatments or a placebo, are rare for medical devices. In this study, patients and physicians did not know if patients were wearing a treatment device or a placebo. Healthcare professionals consider such studies the gold standard for medical research. EO2 Concepts is a privately held, advanced wound-care technology company and the developer of a progressive, FDA-cleared Class II medical device that provides therapy to difficult-to-heal wounds. The TransCu O2 System is an electrochemical tissue oxygenation and wound monitoring system for use with OxySpur Oxygen Diffusion Dressings as an adjunctive therapy to continuously treat oxygen-compromised wounds TransCu O2 is a wearable system that provides a continuous flow of humidified oxygen to a moist wound for 24 hours a day. It is small, simple, easy to use and allows for constant treatment without limiting mobility. “We supported four study publications last year and currently have 945 patients in our patient registry,” EO2 President Joseph Moffett said. “EO2 Concepts has committed itself to developing the right kind of collaborative research data to meet the demands of the evolving evidence-based healthcare system.” The trial, completed in November 2016, is part of the company’s ongoing effort to conduct research and obtain the highest level of evidence a medical device can achieve. Moffett expects complete study data to be published soon in a leading peer-reviewed journal. More than 10 million Americans suffer from non-healing wounds such as pressure ulcers, skin grafts and burns, according to the Agency for Healthcare Research and Quality. Roughly 1 million new cases of diabetic foot ulcers and venous leg ulcers are diagnosed each year. Oxygen plays a pivotal role in wound healing and CDO is one of the most targeted approaches in wound care today. The treatment is a key part of efforts to reduce the negative effects of diabetes. Diabetic foot ulcers cost more to treat than the five costliest forms of cancer. In addition, 50 percent of diabetic wounds get infected and every 20 seconds someone undergoes an amputation due to diabetic complications, according to David G. Armstrong, MD and director of the Southern Arizona Limb Salvage Alliance (SALSA). Dr. Armstrong is widely known for his work in amputation prevention.
He has produced hundreds of peer-reviewed manuscripts and authored nearly 100 book chapters. “Technology like (TransCu O2) has previously shown some potential to have a positive healing impact,” said Dr. Armstrong, who also is a professor of surgery at the University of Arizona. “It’s frankly inspiring that EO2 Concepts and all of the study sites and investigators worked to complete a study like this, because it’s complicated to do blinded device trials and theirs is one of the few that has been seen through to completion.” EO2 additionally has collected real-world results on patients during the last several years in its clinical registry. This data shows that CDO can close wounds in 59 days that have been open for an average of 359 days prior to receiving CDO and, in most cases, have been unresponsive to other advanced therapies. EO2’s Tier One study gives additional credence to other less rigorous studies that have shown similar results. For instance, Gabriel Urrea-Botero, MD and a wound care specialist at Gonzaba Medical Group in San Antonio, also discovered that when he used CDO on 20 of his patients who were suffering from unresponsive toe ulcers, they healed faster. “This therapy deserves attention as a viable treatment option,” Dr. Urrea-Botero wrote in a PodiatryToday.com publication that reported his findings. “I believe the TransCu O2 oxygen delivery system may be appropriate not just in the clinical scenarios, but also as a first-line treatment for other chronic wounds. There is an emerging body of credible clinical evidence for this modality. Overall, the patients reported the system to be more convenient than other systems and particularly liked that the device is silent and allows for mobility. VT N READ MORE: eo2.com
Using the Surfacer to place a central venous catheter.
Bluegrass Vascular gets CE Mark for Surfacer Inside-Out Access Catheter Sys. Bluegrass Vascular Technologies, has received CE Mark approval and is launching limited commercial sale of its Surfacer InsideOut Access Catheter System. The Surfacer System is indicated for obtaining central
venous access to facilitate catheter insertion into the central venous system via a novel Inside-Out approach. “The launch of the Surfacer System in Europe brings a much-needed solution to a growing population of patients requiring vascular access for vital treatments and who currently have limited options due to obstructed upper body access,” said Gürkan Sengölge, MD, associate professor of medicine, nephrology and intensive care medicine at the Medical University of Vienna in Austria. “I was very pleased with my first commercial use of the Surfacer System. No other device offers such an innovative Inside-Out method for restoring access and preserving options in patients with chronically occluded veins. Based on my initial experience, I am confident that the Surfacer System will change the standard of care going forward.” The Surfacer System is designed to reliably, efficiently and repeatedly gain central venous access by inserting the Surfacer System through the femoral vein and navigating it up through the patient’s venous system with an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. This proprietary Inside-Out approach allows for the placement and maturation of permanent arteriovenous access options that are associated with improved patient outcomes and reduced cost of care for both hospitals and hemodialysis providers. John Gurley, MD and interventional cardiologist at the University of Kentucky Medical Center, said multiple central venous occlusions can cause significant long-term morbidity. Dr. Gurley is Bluegrass Vascular founder and developer of the Inside-Out method. “The novel Inside-Out approach is an innovative and simple method that restores and preserves right-sided venous access despite chronic occlusion and retains the viability of other existing central veins,” Dr. Gurley said. Gabriele Niederauer, Ph.D., CEO and president of Bluegrass Vascular, said after successful use of the device in initial commercial cases and previously under Germany’s Compassionate Use Program, we are eager to commercialize the system in Europe and meet the clinical demand from physicians treating patients with occluded central veins.” Bluegrass Vascular has launched the Surfacer System in limited markets, including the UK, Germany, Austria, Italy and the Benelux. The company will also commence enrollment of the Surfacer System to Facilitate Access in Venous Occlusions (SAVE) Study, an observational, post-market registry. The United States Patent and Trademark Office (USPTO) recently issued two patents related to Bluegrass Vascular’s technology for the Surfacer Inside-Out Access Catheter System. U.S. patent number 9,289,577 B2,
“Occlusion Access System,” covers a method for providing access to a central venous system of a patient. U.S. patent number 9,314,595 B2, “Central Venous Access System,” covers a catheter system for use in accessing a patient’s central venous system at a location near the neck. VT N
Peripheral vascular disease pipeline products updated “Peripheral Vascular Disease Pipeline Highlights - 2016 Update” drug pipelines has been added to the Research and Market’s 2017 offerings. The update provides the most up-to-date information on key pipeline products in the global peripheral vascular disease (PVD) market. It covers emerging therapies for PVD in active clinical development stages including early and late stage clinical trials. The pipeline data presented in this report helps executives for tracking competition, identifying partners, evaluating opportunities, formulating business development strategies and executing in-licensing and out-licensing deals. VT N R EAD MORE: researchandmarkets.com/ research/ljfjj2/peripheral
CMS delays e-CQM Meaningful Use hospital deadline Hospitals will get a two-week extension to report 2016 electronic Clinical Quality Measure data under the Meaningful Use program, the Centers for Medicare & Medicaid Services has announced. CMS is extending the (e-CQM) reporting deadline for hospitals participating in the Hospital Inpatient Quality Reporting (IQR) and the Medicare Electronic Health (EHR) Record Incentive programs from Feb. 28 to March 13, according to a post by Kate Goodrich, CMS Chief Medical Officer and director of the Center for Clinical Standards and Quality. Goodrich added that CMS is preparing to make changes to e-CQM requirements outlined in the 2017 Inpatient Prospective Payment System (IPPS) final rule. During last year’s comment period, industry leaders criticized the reporting requirements, arguing that they were too much of a burden to hospitals. Meanwhile, CMS reported that many EHRs were not equipped to accurately report e-CQMs. The proposed changes will be included in the 2018 IPPS proposed rule, expected to release in spring of 2017. VT N
FEBRUARY/MARCH 2017 < VEIN THERAPY NEWS
APPROVED BY FDA • 87% PATIENT SATISFACTION VS. 64% WITH STS*
Her legs aren’t the only place where the results will show. You may also see it in her expression.
Not an actual patient
In a clinical trial, 95% of patients treated with Asclera® (polidocanol) Injection for spider and reticular veins showed “good improvement” or “complete treatment success,” with a patient satisfaction rating significantly higher than STS (87% vs. 64%).*
See full Prescribing Information for data.
INDICATIONS: Asclera (polidocanol) Injection is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter. IMPORTANT SAFETY INFORMATION: For intravenous use only. CONTRAINDICATIONS: Asclera (polidocanol) Injection is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases. WARNINGS AND PRECAUTIONS: Anaphylaxis: Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are most frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately. Accidental injection into an artery can cause severe necrosis, ischemia, or gangrene. If this occurs, consult a vascular surgeon immediately. Inadvertent Perivascular Injection of Asclera can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected.
VEIN THERAPY NEWS < FEBRUARY/MARCH 2017
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  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  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  of Full Prescribing Information). To report SUSPECTED ADVERSE REACTIONS, contact Merz Aesthetics, Inc. at 1-866-862-1211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. POST-MARKETING SAFETY EXPERIENCE: The following adverse reactions have been reported during use of polidocanol in world-wide experience; in some of these cases, these adverse events have been serious or troublesome. Because these reactions are reported voluntarily from a population of uncertain size and without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma Nervous system disorders: Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness
Cardiac disorders: Cardiac arrest, palpitations Vascular disorders: Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis Respiratory, thoracic, and mediastinal disorders: Dyspnea Skin and subcutaneous tissue disorders: Skin hyperpigmentation, dermatitis allergic, hypertrichosis (in the area of sclerotherapy) General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush Injury, poisoning, and procedural complications: Nerve injury USE IN SPECIFIC POPULATIONS: Pregnancy: Pregnancy Category C. Polidocanol has been shown to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose. This effect may have been secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women. Asclera should not be used during pregnancy. Animal Studies: Developmental reproductive toxicity testing was performed in rats and rabbits with intravenous administration. Polidocanol induced maternal and fetal toxicity in rabbits, including reduced mean fetal weight and reduced fetal survival, when administered during gestation days 6-20 at doses of 4 and 10 mg/kg, but it did not cause skeletal or visceral abnormalities. No adverse maternal or fetal effects were observed in rabbits at a dose of 2 mg/kg. No evidence of teratogenicity or fetal toxicity was observed in rats dosed during gestation days 6-17 with doses up to 10 mg/kg. Polidocanol did not affect the ability of rats to deliver and rear pups when administered intermittently by intravenous injection from gestation day 17 to post-partum day 21 at doses up to 10 mg/kg. Human Studies: There are no adequate and well-controlled studies on the use of Asclera in pregnant women. Labor and Delivery: The effects of Asclera on labor and delivery in pregnant women are unknown. Nursing Mothers: It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering to a nursing woman. Pediatric Use: The safety and effectiveness of Asclera in pediatric patients have not been established. Geriatric Use: Clinical studies of Asclera did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. OVERDOSAGE: Overdose may result in a higher incidence of localized reactions such as necrosis. HOW SUPPLIED/STORAGE AND HANDLING: Asclera is supplied in single-use, preservative-free ampules in the following packages: NDC 46783-121-52 Five 0.5% ampules (2 mL) NDC 46783-221-52 Five 1.0% ampules (2 mL) Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years. Store at 15-30°C; (59-86°F). PATIENT COUNSELING INFORMATION: Advise the patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime. Compression stockings or support hose should be thigh or knee high depending upon the area treated in order to provide adequate coverage. Advise the patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days. For two to three days following treatment, advise the patient to avoid heavy exercise, sunbathing, long plane flights, and hot bath or sauna.
AngioDynamics and the AngioDynamics logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. Asclera is a registered trademark of Chemische Fabrik Kreussler & Co., GmbH. < © 2016 AngioDynamics, Inc. ANGAD 371 US Rev 1 11/16
VEIN THERAPY NEWS
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“Individuals play the game, but teams, beat the odds.” – SEAL Team motto
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Bronx, New York • Hartford, Connecticut • Richmond, Virginia Joining CVR means letting us do the heavy lifting, freeing you of administrative responsibilities unrelated to hands-on patient care.
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Board certified physicians treating varicose and spider veins.
Nine steps to lock down your cybersecurity
By Clinton Henry “Dear Client.” That’s how the letter usually begins. The next few sentences are a little trickier; there is really no good way for someone to hear that their data has been stolen. Unfortunately, getting this letter is becoming an all too common occurrence in business. Businesses lose more than $100 billion a year to cyber-attacks and fraud globally. While a security breach might be one of the last things on your mind, the most recent Travelers Risk Index report shows that it’s a top concern for your clients, customers and contractors – “Personal Privacy Loss and Identity Theft” went from barely ranking on their survey a few years ago to being Number 2, right behind “Financial Security.” The expectation of cybersecurity has to be met with the same fervor and drive that you strive to meet all your other clients’ expectations. 1. Engage and educate your employees It’s important that you create a culture of security within your organization because security is everyone’s responsibility. If you don’t have buy-in from all your team members, you’re exposing your business to unnecessary risk. The majority of attackers gain access to networks via social engineering and the manipulation of a user within an organization, not via command line “hacking” from a dark, Cheetos-filled basement somewhere, as the movies often portray. Why would someone spend days trying to crack your accountant’s password when they can simply call your IT desk pretending to be your accountant and ask him to reset it to something new? 2. Anti-Virus Having an up-to-date anti-virus deployed on all of your desktops and servers is vital. An unprotected computer is an easy target for a motivated attacker. Don’t make it easy on them – pay for anti-virus and make sure it’s regularly updated by your IT staff. 3. Password Management It’s important that you and your employees leverage strong, complicated passwords that aren’t easy to guess. here are now hacking applications you can plug into a computer that will run through the most common 10,000 passwords used in about four minutes, trying each of them. You’d be surprised how many folks with access to critical data have the password
6. P rotect your banking information Make sure that all financial data, accounts, and records are kept secure and segregated from the rest of your business’ general shared drives. If financial transactions are conducted electronically, ensure they are done over an encrypted connection and that your employees never e-mail account numbers, credit card information, or sensitive financial documents.
Ganna Todica | Dreamstime.com
of “password,” or if they are feeling clever, “password1” (Did this just guess your password? Go change it!). 4. Secure Your Networks Without getting too technical, just know that having a firewall between your corporate network and the Internet is very important. If you don’t, there is very little stopping someone from freely accessing your data. 5. Secure Your Cloud
No matter what cloud provider or service you use, make sure you do your due diligence on their security practices. If they can’t easily and quickly tell you how your data is secured, odds are it isn’t. Also, for any accounts used to access your firm’s data, make sure you have strong passwords and only access it via a computer you own or trust. If you access your cloud on an infected machine, a hacker could potentially learn your password and use it later on without your knowledge.
7. Backups One of the most common types of breaches now being seeing are called “ransomware” attacks. Instead of “stealing” data from your organization, these attackers find your critical data and then encrypt it (digitally locking you out of it), making it so only the person with the digital “key” can unlock and access that data. The hackers then offer the victim access to the “key” for a very large fee. If you’re hit with one of these attacks you have two options: Pay the fee or restore the locked data from a recent backup. This is why backups are so important. Recently a very large hospital, a police department, and a public school (along with literally thousands of other victims) have been
CYBERSECURITY continued on page 35
Who mentions the practice in social media? Vein Clinics can learn a valuable lesson from the public relations nightmare a Cleveland Clinic doctor’s anti-vaccine blog caused in January. The furor prompted a warning to employees from CEO Toby Cosgrove not to connect their personal views to the organization. Sure, the First Amendment gives everyone the right to have their say over virtually any topic. But as Daniel Neides, MD, has learned: Be sure it is clear you are speaking only for yourself and not for the organization that pays you. The warning came in the wake of the backlash from the medical community in response to a column on his blog by Daniel Neides, MD, who promoted a long discredited theory that preservatives in vaccines may be linked to increased cases of autism. He identified himself as a Cleveland Clinic physician and the Cleveland Clinic logo appeared above the column. Dr. Neides is the director and chief operating officer of the Cleveland Clinic Wellness Institute, but Cleveland Clinic officials said he didn’t put the column through the usual channels and it was published without their approval. Dr. Neides has since apologized, but has learned the hard way that he cannot “un-ring a bell.” The Cleveland Clinic has promised disciplinary action against Dr. Neides.
The national publication STAT obtained a copy of the e-mail Cosgrove sent to employees and he reportedly told staff that publishing discredited ideas under the Cleveland Clinic banner can potentially cause confusion and controversy that may undermine the organization’s broader mission. He didn’t mention Dr. Neides’ by name, but said his opinions are not supported by evidence-based medicine and Cleveland Clinic advocates vaccinations to prevent the spread of communicable diseases. But the damage has been done, as STAT noted that anti-vaccine supporters have used Dr. Neides’ column to promote their efforts. The medical community fears that these types of views will erode the public’s trust in vaccines, especially in light of President-elect Donald Trump’s stance on vaccines and his reported interest in having Robert F. Kennedy Jr., a well-known vaccine skeptic, lead a panel on vaccine safety. In addition to disciplinary action, a clinic spokesman said it may no longer sell some alternative medicine products sold by the wellness institute. Owners of clinics should publish the policy on how employees directly and by inference use the name of their organization on social media, and discuss the reason for the policy before all individuals are hired. VT N
FEBRUARY/MARCH 2017 < VEIN THERAPY NEWS
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Some docs say they would trade money for time A growing number of doctors lack adequate time for their personal lives, a psychologist and writer says. According to Catherine Hambley, Ph.D., 71 percent of physicians who responded to the 2016 Great American Physician (GAP) survey said they don’t have enough time for themselves and more than half of respondents said they have a poor work-life balance. Hambley, who provides a preview of the survey in a piece for Physicians Practice, said most doctors work between 41 and 60 hours a week and some put in more than 80 hours. Many doctors would like to cut their work hours, with 61 percent saying they would consider going part-time if they could. She said that for many doctors, time is more valuable than money. Many said they would select a specialty that offered more time for their personal lives, which was more important to them than a more financially lucrative specialty. Too often physicians pay a price for that imbalance between work and life, which ran result in fatigue, poor health and burnout, Hambley wrote. But there are steps doctors can take to relieve stress. Doctors can start by assessing their priorities and values, she says, looking at work, personal life and their own well-being. Then they can track and manage their time based on those values. There are also practical ways doctors can improve work-life balance. Among Hambley’s recommendations: Physicians must learn to delegate, only check e-mail three to four times a day, spend quality time with their significant other and take a team approach if they work in a group practice. VT N
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A ROUNDTABLE DISCUSSION
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What not to do in venous disease treatment EDITOR’S NOTE: Ethical concerns are a growing issue for many vein specialists and patients alike. As such, Vein Therapy News and Vein Magazine teamed up to help disseminate this important information. Here, from our friends at VEIN, is a reprint of their roundtable discussion from the Fall issue, moderated by VEIN’s medical director, Steve Elias. Read VTN’s December/January article by Dr. Ed Mackay in VEIN’s Winter issue. Taking stimulus from VEIN Magazine’s earlier roundtable on the topic of ethics of venous disease treatment, “Absurd Vein Care: Can We Fix It?,” vascular surgeon, AVF founder and one of the most respected venous experts in the world, Bob Kistner, conceived of another topic for discussion. “It struck me that improper practices is something that we all see. Industry leaders have done a lot of good work with guidelines to help physicians who want to do things right. However, we have not at any time taken the exercise to identify things that should not be done,” he says. Identifying the need to help guide physicians – particularly those who come into the field without a lot of background – away from improper practices, Bob undertook the exercise of creating a “list of don’ts.” To this end, VEIN Magazine invited some of the most experienced people in the field – Drs. Lowell Kabnick, of New York University; Jose Almeida, of Miami Vein Center; Steve Elias, of the Center for Vein Disease at Englewood Hospital; and two non-physician experts, Joe Zygmunt RVT, RPhS with Medtronic Vascular, and AJ Riviezzo, CEO of American Physician – to join him in a spirited discussion of what improper actions they are currently seeing in the field.
By making this list, the panel hopes this list will help those who do procedures and those who pay the bills understand that these things are off base. They should curtail reimbursement for such practices and discontinue the routine practice of maximizing income through shortcuts and improper and unnecessary treatments. The conversation covered two primary areas: ethics and education. The resulting list is intended to appeal to those who know better but are stretching the boundaries of good vein care, as well as those who do not know better and who, despite their best intentions, have lost their way along the path – perhaps due to a lack of proper training. This discussion was about superficial disease. Deep disease will be a whole other roundtable discussion. After an hour and a half conversation, and many more hours of thought and deliberation, our panel put forward the following list of what not to do in your vein practice.
1. D on’t treat a vein just because it has reflux, be sure there is clinical correlation Bob: It’s not clear to me. I don’t think I’ve ever seen it in print, what extent of reflux would warrant an ablation versus one that would be treated by sclerotherapy, or treatment of the peripheral veins, and not warrant ablation of the GSV. That bothers me a great deal because one can exhibit a small focal area of reflux in the GSV and ablate the whole thing, and that is an improper thing. That’s not stated anywhere, so it may be that we haven’t given ourselves proper guidelines or proper communication about what really warrants an ablation.
Lowell: We’ve talked about the amount of time it takes for reflux, location of reflux, and size. The insurance companies set it at the start of the saphenofemoral junction, and we all know that that’s probably not true. It has to be a certain size, and that may or may not be true, according to some of the pathophysiology. We all have done consults on patients who have come from another doctor who indicated four vessels of disease in one leg; yet, when you do your ultrasound, you demonstrate no reflux. If ultrasound is the diagnostics that the interventionalist relies on after considering other parts of the constellation, then how do we determine the accuracy of the test? Jose: We’ve all seen in our practices that segmental reflux, either at primary disease (virgin leg) or in follow up, is often asymptomatic and don’t need treatment, they just need follow up. I think the key point for venous practice is that you should follow your patient. Just because they have some segmental reflux now, doesn’t mean they won’t open up later and need something in two years. But that doesn’t mean they need something now. Maybe that could be some type of direction for guidelines without any real, empirical evidence to answer the question that you’re asking. Bob: Maybe this isn’t the place to try to solve the answer, but to identify the problem.
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Dr. Bob Kistner
Dr. Steve Elias
Dr. Lowell Kabnick
Dr. Jose Almeida
Steve: There are multiple components that come into the picture as to who should have an ablation and who shouldn’t. One data point, either reflux volume or reflux time or size of vein, doesn’t in and of itself say whether someone needs an ablation or not. That’s where the problem comes in regarding vein disease. We don’t have one or two particular data points to hang our hat on to make a decision whether or not someone would benefit from an ablation. The treatment of vein disease is a Gestalt; multiple data points come into your decision process.
Lowell: We don’t have real objective criteria or findings for C-0, 1, and 2, like we do for 4, 5, and 6. That takes some of the guesswork out for us on the upper end. It’s the bottom end that we’re having issues with, and nobody knows whether we really need to treat those patients. We know that only about 20 percent of those patients are going to progress to C-4A by the Bonn study. That being said, what do we do? As Bob said, I don’t think we need to clarify that, but we should all agree on what we shouldn’t do.
VEIN THERAPY NEWS < FEBRUARY/MARCH 2017
2. Don’t treat four vessels habitually or in C1 disease Lowell: Can we agree that if somebody has C-0, C-1, C-2 disease that you shouldn’t be ablating four vessels in the same leg? Bob: If you’re going to have an agreement, it ought to be something less than universal because there’s always an exception. Steve: What percentage of patients in a practice should have four veins ablated all the times? Perhaps 5 percent. We’ve said for C-0, C-1 disease, probably don’t ablate the saphenous axial incompetence. What percentage of people do we think need more than one vein ablated for C-2 disease? Jose: For C-1 disease, can’t say all, but the majority don’t even need an ultrasound, and the majority definitely do not need an ablation. Even C-1 with a little bit of reflux, if they happen to get an ultrasound, still doesn’t need ablation.
SECONDLOOK Steve: Exactly. If I’m doing an ablation for a patient who has varicosities and spider veins, you ablate the saphenous. Yes, the varicosities will be impacted many times, but the spider veins, almost never. “People make claims that taking care of the saphenous vein will help cure the spider veins. They use words like “cure.” I think that may not be fraud; it may be miseducation. If we can put that out there, that would help a lot. There’s a lot of C-1 disease getting four vessels fried. I see that every day.” Jose: People make claims that taking care of the saphenous vein will help cure the spider veins. They use words like “cure.” I think that may not be fraud; it may be miseducation. If we can put that out there, that would help a lot. There’s a lot of C-1 disease getting four vessels fried. I see that every day. Steve: It’s hard to say the number of patients who need more than one or two vessels ablated in a single leg for C-2 disease. What are the guidelines that we should say to the insurers and to us and society; you’d better think twice about this doctor or this organization, they’re ablating two or three vessels on one leg for C-2 disease? Joe: The challenge with your question is that we don’t have the data. It’s one of the things I’m hoping will come out of the Registries that have been started by the AVF and ACP. AJ: Doing all the billing for multiple practices, where I really get nervous is when I start seeing a consistent pattern of both GSV and both SSV almost every single time. Whether they had the anterior accessory ablated or not is almost immaterial at that point. Bob: It all depends on what’s wrong with the vein and what the symptoms are. One thing I think we should be able to agree on is what was already said: If you find four or more refluxing truncal and/or perforator vessels that require ablation as a more than rare occurrence in your practice, there is something wrong with that practice. “There is nothing in the literature that helps us with not the degree, but the length of reflux. We’re looking at just one item. The reality is that it’s a constellation of symptoms, findings, and duplex findings. Even if you had rip roaring reflux of the great saphenous vein and you had no symptoms, there would be little, if any, indication for intervention.”
3. Don’t do prophylactic ablations AJ: Everybody is getting cracked down by the payers for prophylactic treatments. Bob: Prophylaxis of progressive disease by ablating normal veins is one practice that we should say that we don’t have supporting data for. Steve: We have no data. We have zero data. Bob: That’s a good point to include in the “list of don’ts.” Steve: For C-2 disease, there is no data that says you need to treat it now because something terrible is going to happen five, 10 or 15 years later. Don’t ablate a great saphenous vein from a prophylactic viewpoint in C-2 disease to prevent problems in the future.
4. D on’t ablate GSV without report of reflux in GSV Steve: You can’t ablate a saphenous vein that does not have a report that it is significantly incompetent. Even if it is, you still need the correct constellation of symptoms.
Lowell: As Bob said, there is nothing in the literature that helps us with not the degree, but the length of reflux. We’re looking at just one item. The reality is that it’s a constellation of symptoms, findings, and duplex findings. Even if you had rip roaring reflux of the great saphenous vein and you had no symptoms, there would be little, if any, indication for intervention. Jose: Dr. Raju published a recent paper quantifying saphenous reflux where he looked at reflux volume, and he has presented at meetings. He looked at duplex measured median time-averaged velocity, duration, and diameter to calculate reflux volume. The bottom line of the paper was that you need greater than 30cc of reflux volume and a greater than 5.5 mm diameter for it to be clinically significant. Then, Davies and Lane published a study stating that saphenous size does not matter. This nidus for this study was to provide evidence against insurance companies’ capricious and arbitrary policies. Then the Merchant paper from 2002 where they first described recanalization from the sapheno-femoral junction; that greater than 5 cm length of reflux would be clinically significant. “You should not do an ablation unless you can also manage or have someone you refer to that manages the branch varicosities. One needs the ability to finish the job, if necessary, either themselves or by referral.”
Steve: Sooner or later, sclerotherapy becomes a phlebectomy or an operation, whether you have to evacuate the hematomas. But it should not be billed as evacuation of hematoma. AJ: Don’t just do the ablation, treat the whole leg. Steve: You should not be doing an ablation unless you can manage the venous reservoirs by yourself or by referral (e.g. the varicosities). I tend to agree with Lowell. In general, you should be able to manage a disease state, and the exception should be that you can’t manage it. But the goal should be that you can manage it. Phlebectomy is not a difficult procedure. Anyone who has done any kind of procedure should be able to do it.
7. D on’t begin your venous patient care with only an industry or a brief venous course Jose: Is there any statement we can make on minimal education requirements? Are there really people out there who just buy a box and get a rep to teach them their first case? Is that really what’s going on? They go from there without any CME or anything or any vein course? Can we make some statement for the purposes of this article so people are at least thinking about it? What is the purpose of this whole IAC accreditation then? Nobody is following any of this stuff. Lowell: There are no teeth to accreditation yet and we would hope that it would come to fruition.
5. Don’t ablate GSV for short segment reflux Bob: If you have reflux and it doesn’t have anything to do with producing venous hypertension in the area of the symptoms or signs, the reflux is not an indication for ablation. If you’re talking about ulcer disease, one of the really important things is axial reflux directly into the ulcer bed. There is pretty much agreement on that. There could be a minimum limit, so you could say reflux of 3cm, or 10cm, or 20cm in the GSV at the thigh certainly doesn’t warrant sacrificing a saphenous vein.
6. D on’t just treat the portion of the leg you are familiar with (e.g. GSV ablation), but be able to diagnose and treat the whole leg Jose: The exceeding majority of ablative cases just require one truncal vein ablation and a phlebectomy. It would be nice if everybody could do a phlebectomy. Don’t do vein work if you can’t do a phlebectomy. There’s another “don’t” for you. These massive varicosities we all see ... I believe sclerotherapy is a disservice to these patients; these are best removed. Lowell: You’re going to get criticism on that because some people just do sclerotherapy and get good results. Steve: How about this way--you should not do an ablation unless you can also manage or have someone you refer to that manages the branch varicosities. One needs the ability to finish the job, if necessary, either themselves or by referral.
Steve: Jose, if someone goes to the IVC, what is the maximum number of CME credits they can get? Jose: They get about 21-22 CMEs. Steve: Do we think we should say that people should get somewhere between 25 and 30 CMEs in specific venous courses? Jose: Should we say they should at least attend one dedicated venous meeting? Steve: I agree with you that people should have attended at least one dedicated venous meeting within the year. AJ: We almost need to flip it slightly, that if you’re going to be in the phlebology space, be sure to go to at least one meeting, be sure to take advantage of the ultrasound, sclerotherapy and phlebectomy classes that are out there. Almost from a proactive standpoint, if you’re going to be doing this, do it right. Steve: I think what we’ve come up with for things you should do is attend at least one dedicated venous meeting within the year. Lowell: Don’t expect to practice venous disease appropriately by a weekend course or getting a box and having someone in the industry help you.
AJ: Sclerotherapy instead of a phlebectomy generates a lot of hematomas that they then bill for. This is inappropriate.
Jose: Don’t expect to learn venous disease from a mobile ultrasound company.
Lowell: I’m involved and hearing a lot of it, and I’m a phlebectomist from the word “go,” but it’s silly out there.
Joe: Don’t expect your industry education to be your only source of education on venous disease—attend a conference and visit colleagues.
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SECONDLOOK Steve: Don’t expect your industry education to be the only source of the guidelines for managing venous disease. “One of the big warnings I would put out there is verify what you’re doing. You’re the physician; you’re the one responsible if something were to go bad or is done inappropriately. Further, if you were to have an insurance audit, they’re not going to penalize a mobile ultrasound servicer; they’re going to hold you accountable.”
8. D on’t incentivize the sonographer to show reflux Bob: There are various reports about the sonographer being instructed to do a bilateral examination in 15 minutes. Joe, are there things in that area that we could agree would not be appropriate, not be allowable? Joe: A lot of new physicians who are just starting have these “experienced” techs come in—mobile services—and they’re like, “I’ll find reflux in 95 percent of your patients. We’ll get you busy real fast. We’ll get you making lots of money.” If I’m a doc and I hear that, I would hope I’d run the other way. That would be the advice; I would try to get out of there. From a sonographer’s standpoint, if you’re getting pressure, if your physician is telling you to go back in the room and find reflux and don’t come out until you do, maybe make an analogy to a carotid exam or something like that. You can’t fake results. You have an ethical and a moral responsibility to do the right thing and hopefully, as a sonographer, that’s what you’re doing. AJ: I think we need to put the onus on who is responsible for the practice for that read, and that is the physician. The sonographers, some of them feel trapped. Advising them to do something better isn’t going to go as far as we would like. Steve: Sonographers should be compensated not based on whether they find incompetence or not; they should be compensated because they are doing a good exam.
9. D on’t take the sonographer’s work as absolute, as you are responsible for the sonographer’s accuracy Steve: I think we need to start with where we get the data from. We get the information as to whether a vein is normal or abnormal from the ultrasound exam. It all starts there. Whether it’s performed by the physician or an ultrasonographer, we can assume problems arise when either: a) people stretch what they call “pathologic reflux” or maneuver to elicit reflux that may or may not be pathologic reflux; or b) people honestly believe the patient has reflux but no one determines whether or not that exam was done correctly. Joe: Doc, do you know how to interpret studies properly? Have you read the literature about appropriate techniques for diagnosis? What I mean by that is, doc, you’re purchasing services from your sonographer, whether it is a mobile service or an internal person. You are 100 percent responsible for the quality of that work. Do they know how to do a study? Are they doing it properly? Is it being interpreted properly? Are you interpreting it and not simply listening to what they’re telling you? AJ: Don’t expect the ultrasound tech to be the physician for you. Bob: That’s a good point, to define that the physician confirms the sonographer’s reported reflux is real and is appropriate to the patient’s symptoms.
Joe: One of the big warnings I would put out there is verify what you’re doing. You’re the physician; you’re the one responsible if something were to go bad or is done inappropriately. Further, if you were to have an insurance audit, they’re not going to penalize a mobile ultrasound servicer; they’re going to hold you accountable. And you’re not going to say, “The sales rep said this was ok.” Again, Doc, you are the person who will be held responsible in an audit. Realize that Medicare LCDs require sonographer credentialing for reimbursement. There are many who simply get the credential by taking a course and passing the test, but they’re still the ones that are out there doing poor studies. I know we don’t have a licensure for sonographers right now, but to actually see something happen where there are some techs that suffer penalties and have those be publicized, not in the public community, but in the medical community, to let physicians know you just can’t trust the guy who walks in off the street or who gets put up in front of you as somebody reputable by a sales rep, because the rep is trying to make a sale, right? Some of these mobile services that are simply crooked, they’ll swear up and down that what they do is right, but you never see them at a meeting or writing an article or printing a chapter in a book or anything. These guys exist on the fringe, and I think we need to warn our brethren as to who and what to watch out for.
There are many who simply get the credential by taking a course and passing the test, but they’re still the ones that are out there doing poor studies. -Joe Zygmunt Lowell: As we know, RVTs or technicians with similar credentials, interventionalists and technicians know that a reflux test is a very specific test that a lot of people do not know how to do well. There is no standard of judging those people going through and getting their certificates. In combination with accreditation in which the sites are observed as well as the RVT doing the procedure for reflux testing, I think that’s another step where we could ascertain the ability of an ultrasonographer. I have asked ICAVL, if we’re basing a lot of our decision process on reflux testing, how do we know that the ultrasonographers are performing the test well and are accurate? Joe, you and I have sat on the board of CCI for the venous module. That exam is a little bit more specific for venous disease, although, again, we don’t test the ability of an ultrasonographer performing the test. I think there should be some way of testing an ultrasonographer as to their competency to perform a reflux test. Joe: The problem isn’t that it’s one of the most challenging exams to perform. The problem is that people have found sneaky ways to falsify things. When you really think about it, most of the time, what an insurance company gets is a dictated report. They almost never look at images, many of which I have seen in audits that are simply “non-diagnostic.” Lowell, you make a good point, a physical demonstration of scanning would be a very helpful testing parameter, although perhaps challenging to implement. I would be in favor of that for sure, kind of like the old oral exams physicians took. Jose: One way to get to the bottom of all this is to become a significant stakeholder (e.g. Joint Venous Council) that can
VEIN THERAPY NEWS < FEBRUARY/MARCH 2017
align with payers. We could review claims-based data and find the outliers. We could make recommendations to centers not practicing within the standard of care—these centers should not be reimbursed until X, Y, and Z criteria are met. It seems like it’s at the endpoint, the payer, where we’re going to have an effect. Bob: In support of that, I think there are two areas to look at: One of these is the insurance companies who are processing these claims; the other one is the sonographers. A lot of the sonographers are exposed to practices that they recognize are well below the standard, and even sometimes much worse than that. Communication with those people in some way could be a source of discovering how big the problem is. We don’t really know how big the problem is.
10. D on’t believe that just because a patient has varicose veins, the leg symptoms are always venous in origin (sciatica, knee/ hip, lymphedema, obesity etc.) Lowell: Sometimes it is very difficult to discern whether the patient’s symptoms are truly from the varicose veins or other leg issues. There can be significant overlap. This is where the history is important: type, location, duration, and progression of symptoms. Do graduated compression hose help? Steve: I agree with you, and good, honest vein specialists let the patients know which symptoms are venous and which are not, and therefore won’t be helped by treating the vein component. The more upsetting thing is that all of us see everyday patients who have varicose veins but whose symptoms are not venous at all. Yet, the MD tells the insurance the patient has daily pain and trouble ambulating and, unfortunately, a reflux exam shows a problem. I am talking about pure non-venous symptoms of pain, swelling, etc. such as sciatica, knee/ hip osteoarthritis, lymphedema. The practitioners ablating the veins in these patients either have not taken a good history or are abusing the system when they know full well that the symptoms are not venous. A (symptoms) + B (insufficiency) does not always equal C (venous symptoms).
In Conclusion: A Word of Caution The panel raised concerns about both vein franchises who pressure doctors to meet volume requirements and vendors who tie monthly catheter purchases to “free generators.” Asked for comment on the issue, Joe Zygmunt adds: “I would simply caution not to be too hasty in judgment and understand this better. Most often these have relatively low thresholds and can come with a higher per catheter price as a result. My concern is for any physician who feels pressure to do increasing volume of cases, either for a generator or from their employer. One of my highest hopes for the registries is that some information is developed on practice norms (e.g. the number of refluxing veins per patient). When you hear that a physician did three separate procedures to ablate the GSV from the groin to the knee, I cringe. This type of outlier will surely show in the data. Medicine is a higher calling, caring for our fellow man, has ethical and moral responsibilities. Physician judgment should be free from business pressures of volume or revenue generation. Having run multiple practices over almost 18 years, I believe if we treat our patients well, like we would want our family treated if they needed it, the business will follow.” VT N
SECONDLOOK DR. ROSENBLATT
THE MEDCAC EXPERIENCE
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On July 20, 2016, the Centers for Medicare & Medicaid Services (CMS) convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC panel was tasked with examining the scientific evidence underpinning the benefit and risk of existing lower extremity chronic venous disease treatments. The meeting was also used to identify evidence gaps that relate to lower extremity chronic venous disease. CMS concurrently initiated a technology assessment by the Agency for Healthcare Research and Quality (AHRQ). The assessment, which was published online just prior to the July MEDCAC meeting , was based on a literature review dating back only to the year 2000. Unfortunately this postdated much of the literature that provides the evidence that underpins modern venous disease treatment. Consequently, the Duke research group concluded the following: “The available evidence for treatment of patients with LECVD is limited by heterogeneous studies that provide comparisons of multiple treatment options, varied outcomes measured, and disparate time points of outcome assessment. Very little comparative effectiveness data has been generated to study new and existing diagnostic testing modalities for patients with LECVD. “Several advances in care in endovenous interventional therapy have not been rigorously tested, and very few studies on conservative measures (eg, lifestyle modification, compression therapy, exercise training) exist in the contemporary literature. Additionally, the potential additive effects of many of these therapies are unknown. “The presence of significant clinical heterogeneity of these results makes conclusions for clinical outcomes uncertain and provides an impetus for further research to improve the care of patients with LECVD.” These conclusions, if taken as unflawed fact, could have had a catastrophic effect on coverage for venous disease treatment. Shortly after the MEDCAC meeting date was announced, Dr. Neil Khilnani, current president of the American College of Phlebology, spearheaded the creation of a coalition of 10 societies and organization to deliver coordinated presentations for the benefit of the MEDCAC panel. These organizations included the Alliance for Wound Care Stakeholders, the American College of Cardiology, the American College of Phlebology, the American College of Radiology, the American Heart Association, the Society for Vascular Medicine, the Society of Interventional Radiology, the Society for Cardiovascular Angiography and Intervention, the US Compression Alliance, and Vascular Interventional Advances.
This conclusion was very disappointing to many as the external healthcare environment seemed to demand a strong amalgamated voice that could only come through unification. However, unification is not the only pathway forward. Collaboration, not just with a single society but with several societies, on issues of shared interest is an alternative pathway that offers many potential advantages. Through this type of collaboration we have an opportunity to amplify our voice significantly to positively influence health care policy as it relates to venous and lymphatic disease. Several unique and large scale collaborations have already taken place. Other cooperative advocacy projects are ongoing and many new initiatives are being developed. So, in this new era, what will the future of inter-society collaboration look like for the ACP?
COLLABORATION AND ADVOCACY Most medical societies were created to allow physicians with a specific medical specialty interest to gather together and learn from each other. However, over the past decade the health care environment has changed drastically. Health care rationing through the creation of multiple complex rules and regulations based on whim, pseudoscience and the absence of science have frustrated both physician and patient alike. Policies vary from one third-party payer to another and change frequently. New technologies, even when they possess a unique Current Procedural Terminology (CPT) code, are not recognized as reimbursable. Or, if they are recognized, the reimbursement is set at a ridiculously low level, which is often below the cost of the procedure. The provider often has to argue every case with the payer and must employ several individuals to negotiate the bureaucratic insurance labyrinth that serves as a barrier to patient care. When individual providers try to educate the payers as to their policy inaccuracies and contradictions they often make little headway. Individual providers cannot fight these battles alone. Societies, representing larger groups of physicians, need to intercede on behalf of the providers to try to break down these barriers. Societies have to identify evidence gaps and structure research initiatives to fill those gaps so that the science supports the standard of care. Societies need to actively monitor the health care landscape for care-limiting policies and respond quickly and proactively. To accomplish these, and many other essential advocacy tasks, societies need to work together to face and overcome these obstacles to patient care.
Six coordinated presentations were put together by the coalition in the short time between the announcement of the panel and the deadline for submission. These presentations to the MEDCAC represented the consensus opinion of the societies and were designed to address the questions posed by CMS. The presentations offered an honest appraisal of the strength of the data and the presentations were very well received. The SVS and AVF did not participate in the Coalition but independently offered their own opinions to the panel, which were very similar to those of the Coalition. Immediately following the MEDCAC meeting, the Coalition, facing only a twoweek deadline, drafted a written response to the AHRQ technology assessment report. The coalition concluded that although the authors had conducted an extensive review, the exclusion of publications prior to the year 2000, the focus on patient conditions without description, broad and overlapping questions, and stringent study inclusion criteria limited the assessment of the evidence and consequently its ability to effectively inform policy decisions. Currently, the coalition of venous societies is preparing a manuscript reviewing the entire literature related to the MEDCAC questions and will submit it for peer reviewed publication in early 2017. Developing consensus from multiple societies on such short notice was an amazing feat. Typically when a large group is assembled, the disparate opinions and the internal politics of each society hamper the efficiency and productivity of any project. This was not the case with this collaborative effort. Each representative was actively engaged in the process, participating in several conference calls, responding to daily e-mails and offering multiple edits to the drafted response. The coalition truly acted in unison and must be commended for their efforts. Collaborative efforts such as this serve as a model for how societies can and should respond to issues of significant importance. The lesson learned is that societies do not have to merge to address critical issues in unison. However, what is absolutely essential, is that society leadership must reach out to other societies to collaborate and when needed to rally around a single cause.
COLLABORATION WITH THE SIR
The ACP and the SIR have a long history of working together to address issues of common interest. Several leader of the ACP were very involved with the SIR long before they were members of the ACP. These relationships helped to foster the communication between the ACP and the SIR over the years. The SIR, being a larger organization, has a dedicated reimbursement and health policy staff of six individuals who monitor and respond to issues that arise within this large
complex and political space. They are also very involved with several AMA committees that determine reimbursements for interventional procedures, many of which relate to the treatment of venous disease. The close communication that has developed between the SIR staff and ACP leadership has been an immense help. The SIR health policy staff was instrumental in helping to coordinate the MEDCAC coalition. The success of this project has helped to deepen the relationship between the two organizations as it relates to shared advocacy issues. Commonly, the SIR will alert us to changes in insurance reimbursement policies for venous disease. We then coordinate our responses and draft letters to the carriers addressing elements of the policy that may prevent patients from getting the care they require. Recently, staff as well as physician representatives from the ACP, SIR and SVS collaborated to prepare for the Relative Value Scale Update Committee (RUC) meeting in Bonita Spring, Fla. At this meeting, new CPT codes for nonthermal venous ablation procedures were being presented for valuation. It was critical to the process to have a content expert to help explain the survey results and provide detail on how these procedures are performed. The ACP filled that role and attended the meeting, along with physician representatives and staff from each organization. This experience emphasized the importance of society staff members in this process. The SIR and SVS staff members were well versed in the nuances of this very complex process and served as excellent advisors to the physician representatives. The staff members are the constant, with years of experience while the physician representatives are typically transient and inexperienced. The enormous value a dedicated society advocacy staff member brings to these activities is the important lesson learned from these experiences.
ADVOCACY STAFF FOR THE ACP
The ACP plans to develop a Physician Advocacy staff position as part of its new strategic plan. The person who will be recruited for this position will have had experience understanding health care policy and economics as well as experience working with CMS policymakers and commercial insurance carrier medical directors. The advocacy staff would network with peers in other societies and will allow our collective organizations to proactively address coverage issues to benefit our physicians and their patients. We also hope this person will be able to develop relationships with the policy makers at CMS, encouraging them
FEBRUARY/MARCH 2017 < VEIN THERAPY NEWS
the premier association for vein care professionals. The American College of Phlebology (ACP) is comprised of more than 2,000 physicians and allied health care professionals, who are setting the pace and direction for growth in the field of vein care. The ACP offers members advocacy, continuing education and training in the latest procedures with the goal of improving standards and the quality of patient care. If you treat or have an interest in venous and lymphatic disease, the ACP is an unequivocal resource for your practice.
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SECONDLOOK Victory finally a ‘sure thing’
Senate reintroduces medical excise tax repeal A bipartisan group of senators reintroduced the Medical Device Access and Innovation Protection in late January, which would do away entirely with the 2.3 percent excise tax on medical devices. The move came as Republicans in Congress prepared to repeal Obamacare. The bill, sponsored by Sens. Orrin Hatch (R-Utah) and Amy Klobuchar (D-Minn.), would amend the Internal Revenue Code to repeal the medical device tax. In early January, House representatives Erik Paulsen (R-Minn.) and Ron Kind (D-Wis.) introduced a bill, the Protect Medical Innovation Act of 2017, that also seeks to remove the levy on all U.S. sales of prescribed medical devices.
The tax was suspended for two years in December 2015 through another bill sponsored by Paulsen. Medical device lobby group AdvaMed praised the legislation and urged swift congressional movement. “Senate introduction of this legislation brings us one step closer to eliminating this burdensome tax, which has proven to be a drag on the medical technology industry’s ability to innovate on behalf of patients and to create good-paying American jobs,” AdvaMed President & CEO Scott Whitaker, said. “AdvaMed thanks the bill’s lead sponsors, Sens. Hatch and Klobuchar, for their leadership and their consistent support for improving patient care through innovation. We also
thank the bill’s other original co-sponsors: Sens. Robert Casey (D-Penn.), Joe Donnelly (D-Ind.), Al Franken (D-Minn.), Johnny Isakson (R-Ga.), Rob Portman (R-Ohio), Jeanne Shaheen (D-N.H.), Pat Toomey (R-Pa.) and Todd Young (R-Ind.). The bipartisan support of this measure and its prominence as one of the earliest bills introduced in the new Senate clearly demonstrates that the members understand this tax needs to go now. “Patients and the U.S. economy are already benefiting from the temporary suspension of the tax, as medical technology companies have been able to reinvest those funds into new R&D, infrastructure improvements and new hiring”. But Whitaker said these benefits are not assured.
“In order for these benefits to continue, companies need the certainty of permanent repeal to support long-term planning that will allow for future patient innovations and job growth. With bipartisan device tax repeal legislation now introduced in both the House and Senate, we urge Congress and the new administration to move swiftly on permanent repeal of this tax.” As Republican lawmakers have moved to repeal the Affordable Care Act, they say that there’s very little reason to fear that the tax will return under the incoming administration. Sen. Hatch said his Medical Device Access and Innovation Protection Act was first introduced in January 2015.
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SECONDLOOK “Every dollar medical device manufacturers spend on this onerous tax is a dollar taken away from American innovation, job growth, and the ability to provide groundbreaking medical technologies to patients in need,” Hatch said after he introduced the bill two years ago. “Both Republicans and Democrats understand just how bad this tax really is, and we owe it to the American people to ensure the development of life-saving medical devices are not plagued by high-costs.” VT N
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DR. ROSENBLATT continued from page 24
to turn to societies for assessments of the literature as needed when making coverage policy decisions. Similar relationships with medical directors at insurance companies would be nurtured with the hope that they consider our physician experts and those at our alighted societies as content experts to help with coverage decisions.
While unification between the ACP and the AVF is no longer being pursued, collaboration between the two societies will continue. The two largest vein societies will need to work together to accomplish their missions. In addition the ACP will forge new and stronger bonds with other societies and organizations that share common interests. These collaborations will focus on advocacy issues and treatment standards for both venous and lymphatic disease. Without doubt, such collaborations will become essential for the future success of the organization. The ACP is committed to patient and physician advocacy and recognizes the value that larger groups of physicians can bring to addressing challenges in the ever changing and increasing complex health care environment. VT N Mel Rosenblatt, MD, FACPh is past-president of the board of directors of the American College of Phlebology (APC). He is owner and medical director of Connecticut Image Guided Surgery in Fairfield, Conn. His clinical expertise lies in endovascular surgery and interventional radiology. Rosenblatt has held positions at the Yale-New Haven Hospital and Memorial Sloan-Kettering Hospital and has taught at Yale University Medical School. Neil M. Khilnani, MD, is president of the APC board of directors. He practices at the Weill Cornell Medicine Vein Treatment Center in New York.
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SECONDLOOK IVC continued from page 1
increased volume, IVC had to find a new venue in downtown Miami. Endothermal ablation was only four years old, having just entered the market in 1999 with the VNUS closure and followed shortly thereafter with the EVLT. Previously the options for axial reflux were ligation and stripping, known for its negative reputation for pain and scarring, and ultrasound guided sclerotherapy proved to have a very high recurrence rate. Beyond endothermal ablation there few new treatments for varicosities and post phlebitic syndrome. Varicosities were still treated by phlebectomy or liquid sclerotherapy. New treatments for acute deep venous thrombosis (DVT) were being introduced using thrombolysis but post phlebitic syndrome was still largely treated with compression alone and reassurance that it will probably not get better. Now 14 years later Jose Almeida, MD, FACS, RPVI, RVT, has come with a lot more things to talk about.
The first day of the meeting always starts with the basics, beginning with talks on venous disease classification, physiology and pathology. The clinical, etiologic, anatomic and pathophysiologic classification (CEAP) has changed since the first meeting and has taken on an important role for justifying treatment. In addition, the VCSS score and quality of life measures take increasing importance as our specialty comes under scrutiny to demonstrate to payors and others the benefits we are giving our patients. With the new technologies, there has been an explosion in the number of people being treated and therefore the need to demonstrate the value we give them. New insight is being garnered into why some patients’ diseases progress and others do not. Someday we hope to be able to identify those and adjust treatment accordingly. The all-important diagnostics section will cover the basics of the duplex examination. As most of you know, this is the very important part of the patients’ evaluations. The duplex exam guides all the treatment, and a poorly performed exam leads to poor results for our patients. This section also includes talks by Seshadri Raju, MD, on IVUS, which has done for deep venous disease what the duplex has done for superficial disease. Additionally, we will hear from William Marston, MD, about air phlethsmography, which has the potential to differentiate severity of disease and when this study may need to be incorporated in the patients work-up.
Nick Morrison, MD, is president of the International Union of Phlebology and will share his observations on the broader stage.
Many live cases will be presented at IVC 2017. Endothermal ablation is still the mainstay of axial treatment and Peter Gloviczki, MD, FACS, will review the evidence that makes it now the gold standard of treatment. But new options are being discussed including preservation of the saphenous vein, Lowell Kabnick, MD, RPhS, FACS, FACPh, will dicuss when that is appropriate. New methods of saphenous treatment are gaining traction, including the ClariVein catheter, which uses mechanical and chemical ablation (MOCA) but without the need for tumescent anesthesia. Steve Elias, MD, will share his vast experience with this device and how its own CPT code and RVU’s should help expand its use. Two other techniques that also do not require tumescent anesthesia are the VenaSeal (cyanoacrylate) and Varithena (polidocanol microfoam), which will also be discussed including updated information from their trials. Of course, laser ablation and RF ablation will still be major parts of the morning. It has been amazing the new technologies that have come out since that first meeting in 2003. What will we be discussing in 10 more years? Things on Thursday afternoon just keep getting better. Talks on the treatment of recurrences, the swollen leg and spider veins start in the afternoon. Secondary varicosities and spider vein treatment haven’t changed much since the 2003 Congress, with phlebectomy and sclerotherapy, still the mainstay. But foam
Seshadri Raju, MD, will share his knowledge of deep venous treatment and venous hemodynamics.
sclerotherapy has come a long way and dramatically improved the results of varicose veins treatment. Proper technique is important for phlebectomy and sclerotherapy, and we will hear pearls from several experienced professionals. The video theater will be on perforator veins and will review the most current thought on when it should be done and possibly when its being overly done, as well as new techniques. The day ends with a look at the ethics and what our governing bodies are doing to curb the problems we all are seeing in our communities – over utilization and poor quality of care. This is certainly not unique to vein care, but still a concern for many of us. Several leaders of our societies will be here, including presidents and former presidents of the Society for Vascular Surgery (SVS), American Venous Forum (AVF), International Union of Phlebology and American College of Phlebology will be speaking during the conference. They will speaking throughout the conference on many issues affecting our practices and patients access to care.
The second day begins with and is filled with live cases. Attendees have reported this as one of the best parts and unique aspects of the conference. Included will be deep venous interventions, thermal ablations, MOCA (Clarivein), chemical
Steve Elias, MD, will discuss his experience with the MOCA (Clarivein) procedure, and explain how easy it will be to bill this year because it now has its own CPT code.
FEBRUARY/MARCH 2017 < VEIN THERAPY NEWS
SECONDLOOK the talks or more contentious subjects where experts may not all agree. Bring your toughest questions and get those experts debating their usually much differing opinions.
Jose Almeida, MD, is course director for IVC 2017. ablation with polidocanol microfoam (Varithena) and, of course, phlebectomies. You will hear from a panel of highly experienced physicians assessing the techniques used. There usually is much to critique with many differing opinions. Between cases there will be more talks beginning with the keynote speaker Peter Lawrence, MD, one of the pundits in our field. As former president of the SVS, he has unique insights into the problems and opportunities that we all face. The morning will end with more talks on deep venous interventions. This is where the new explosion in the venous space has taken place, treating patients who before were told only to wear stockings and no other options were available. This is an area where techniques are rapidly being developed to treat some of the most difficult situations. The afternoon will be entirely live cases.
Saturday opens with the video theater looking specifically at methods to improve inflow to an iliac stent in the post thrombotic patient. This is followed by treatment of thromboembolic disease in an effort to avoid the post thrombotic syndrome, as well as prevention and treatment of pulmonary embolism. The morning ends with the V2 symposium: Ask the Experts with Dr. Elias as the master of ceremony. This has become very popular among attendees because they get a chance to ask those questions that weren’t answered in
In the afternoon, Mark Meissner, MD, looks at pelvic venous problems and gives us a new paradigm to ponder. Timothy Leim, MD, will speak in the renal vein nutcracker syndrome and Constantino Pena, MD, will present tips for crossing the difficult central venous stenosis. This will be followed by the session on evidence-based guidelines from the SVS and AVF to let us differentiate between what we know, what we think we know and we do not know. A lot of science has yet to be done in the venous space and this session reminds of what we still need to work on. The final session of the afternoon provides an overview of practice management and insurance issues. Dr. Kabnick will discuss where he sees reimbursement going and as president of the AVF he has special insight into those issues. I cannot think of many other issues that could possibly be covered during a conference on vein disease. The field has come a long ways since the first IVC back in 2003. At the time, specializing in venous disease seemed like a very narrow field, but now there subspecializations within vein disease – deep, superficial, acute thrombotic, pelvic. It is hard to imagine any one person being proficient in all of them. Now there are treatments for virtually every condition that the patient with lower extremity venous disease may present. Makes you wonder what IVC 2027 will be like. VT N
Berating a child’s doctors or other medical professionals who provide care has “devastating effects on medical performance,” according to the findings of the study, published in Pediatrics. A Johns Hopkins study estimated that more than 250,000 deaths are attributed to medical errors in the United States each year. The effects of rudeness account for more than 40 percent of the variance in practitioner performance that can lead to medical errors, according to management professor Amir Erez, Ph.D., one of the study authors. “People may think that doctors should just ‘get over’ the insult and continue doing their job. However, the study shows that even if doctors have the best intentions in mind, as they usually do, they cannot get over rudeness because it interferes with their cognitive
functioning without an ability to control it,” Erez said in an announcement about the study. In the study, researchers compared teams made up of two doctors and two nurses in 39 neonatal intensive care units in Israel. They simulated five scenarios in which the teams treated infant medical mannequins in emergency situations. An actress playing the baby’s mother scolded some of the teams, while the others were not subjected to rude behavior. Teams who experienced rudeness performed poorly and were deficient in all of the study’s 11 measures, which included diagnostic accuracy, information sharing, therapy plan and communication. The behavior continued to affect the team members the entire day. VT N
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.
Warning caregivers, patients: Be civil While much has been written about the need to put an end to some doctors’ rude and bullying behavior, a new study shows the need for patients and families to also control their behavior. Parents and caregivers who are rude to medical professionals may find it backfires. Indeed, doctors who are subjected to rude behavior may actually provide worse care to
their patients even if they don’t intend to, according to a study by University of Florida researchers. Emotions can run high in hospitals, so it’s not uncommon for patients or their loved ones to be rude to medical professionals if they think care is inadequate. But that type of bad behavior can lead to worse care for a child, the researchers warn.
VEIN THERAPY NEWS < FEBRUARY/MARCH 2017
New anti-embolism stocking aligns with industry standards
By Robyn Bjork, MPT, CWS, CLT-LANA, CLWT Physicians and medical professionals encourage patients to be up and moving as soon after surgery as possible. Sigvaris’ AntiEmbolism Stockings address these needs with a new garment that makes it easy to go from bed to recovery and even rehabilitation or physical therapy. Deep vein thrombosis (DVT) is a real concern for any patient recovering from surgery. In fact, up to 60 percent of blood clots develop during or after hospitalization, according a 2013 article entitled “The Global Burden of Unsafe Medical Care.” “Bedridden patients and those who are undergoing surgery should ask their physician about wearing anti-embolism stockings to help aid in the prevention of a deep vein thrombosis (DVT),” explained President and CEO Scot Dube. “DVTs can break loose and cause a pulmonary embolism, which has the potential to become fatal.” With this in mind, Sigvaris wanted to design a new anti-embolism stocking that would be extremely comfortable for patients to wear while recovering from surgery and in bed, but also, provide the continued support as patients leave the bed and get up and moving during the recovery process.
Sigvaris’ Anti-Embolism Stockings feature 18-23mmHg of graduated compression, a unique open-toe design that allows for easy inspection of feet, and an anatomical foot design that makes it easy to wear from bed to physical therapy to ensure that patients maintain the benefits of improved blood flow while traveling to and from therapy. The very soft stockings feature a wide comfortable top-band and are latex free. Available in both calf-length and thigh-highs styles, the anti-embolism stockings were also designed to help reduce leg discomfort and swelling. In addition to helping patients recover from surgery or hospital stays while minimizing the risk of a DVT, the new Sigvaris’ AntiEmbolism Stockings are also helping to raise awareness about the differences between an anti-embolism stocking and a compression stocking.
ANTI-EMBOLISM OR COMPRESSION
Many medical professionals often use antiembolism stockings to help with chronic venous insufficiency for both themselves and for patients. Anti-embolism stockings were traditionally designed for use by bedridden patients. Graduated compression stockings are all designed for everyday wear and long-term use to help promote leg health every day. They
AVF continued from page 1
through research and educational programs, the premier of which is the AVF Annual Meeting. The AVF Annual Meeting brings together the world’s leading authorities on venous and lymphatic disease. The highest quality innovative, unpublished research is presented and discussed. Attendees of the AVF Annual Meeting are introduced to current thinking in effective clinical management of venous disease as well as insight into the future directions from critical analysis of investigative findings. I am excited that the 2017 AVF Annual Meeting will take place in New Orleans, La., at the beautiful Hilton Riverside Hotel, from Feb. 14 to 17. The 2017 AVF Annual Meeting will bring together more than 600 attendees and associates from the United States and numerous countries from around the world. From our Specialty Symposia and Day of Innovation and Science to our various summits and Interactive Symposia, including fundraising activities such as the Venous Open Golf outing, the AVF Annual Meeting is certain to be the crown jewel of the venous scientific meetings of the year.
are also designed to help manage more serious issues such as chronic venous insufficiency, varicose veins and edema, depending on the compression level. Sigvaris’ Anti-Embolism Stockings are perfect for use while recovering and when a patient is initially up and moving postsurgery but prior to transiting into a long-term compression therapy garment designed for everyday use. Sigvaris has taken elements of traditional anti-embolism stockings and every day compression stockings to give patients a garment that will aid in their overall recovery process. VT N READ MORE: sigvarisusa.com Robyn Bjork is a licensed physical therapist, a certified wound specialist through the American Board of Wound Management, a certified lymphedema therapist through the Lymphology Association of North America and a certified lymphedema and wound therapist through the International Lymphedema & Wound Care Training Institute. She is founder, CE program director and instructor for the International Lymphedema & Wound Care Training Institute (ILWTI), co-founder of
The Program Committee has completed the arduous task of selecting the papers to be presented from the many outstanding submissions this year. Since the AVF requires that the submissions be new research and be presented first at the Forum, it is quite an honor to be selected. We have extended the Day of Innovation and Science, and the Specialty Symposia have been designed to be more interactive with more opportunities for audience participation. Two named sessions this year will be quite remarkable: The David S. Sumner Venous Summit and the Villavicencio Session. The David S. Sumner Venous Summit will explore the scientific evidence underpinning the benefit and risk of existing lower extremity chronic venous disease treatments, and to identify evidence gaps that exist with the aim of improving health outcomes in the Medicare population. The Villavicencio Session seeks to answer the pressing question: Is the unethical treatment of venous disease out of control? Concurrently, the city of New Orleans, acclaimed for its exceptional cuisine and being the birthplace of jazz music, will be rife with celebrations, parades and special activities that will reach a zenith on Feb. 28 with The Big Easy’s most notorious party of all – Mardi Gras. We look forward to seeing you in New Orleans Feb. 14-17. VT N
ILWTI Medical Missions, past founder and director of a thriving, hospital-based wound and lymphedema clinic and director of Innovation & Medical Education for Sigvaris Inc. Bjork is a speaker at numerous regional and national conferences and teaches workshops nationally and internationally.
Lowell S. Kabnick, MD, FACS, FAC Ph, joined the NYU faculty in 2007 as an associate professor and as the director of the NYU Vein Center where he devotes his practice entirely to venous disease. He is the founder and was the director of the Vein Institute of New Jersey. In 2010, he was chosen to be the American College of Phlebology (ACP) Fellowship Program Director at NYU. He was the first vascular surgeon in the U.S. to perform the Closure (radiofrequency) procedure and the VenaCure (laser) procedure. He is the 2016-2017 president of the American Venous Forum.
29th ANNUAL MEETING February 14-17, 2017
Hilton New Orleans Riverside New Orleans, La.
FEBRUARY/MARCH 2017 < VEIN THERAPY NEWS
SIGVARIS adds to Midtown Microfiber compression sock line with navy pair SIGVARIS in the United States has expanded the Midtown Microfiber compression collection for men to include navy socks in two compression levels. SIGVARIS’ Midtown Microfiber line makes it easy for men to focus on their health with a compression therapy collection that is perfect for work, travel and daily wear. SIGVARIS has expanded the line by adding navy socks in the 15–20mmHg and 20–30mmHg compression levels. For men who wear graduated compression daily, Midtown Microfiber is the combination of comfort, therapeutic relief and durability.
It is constructed from an extremely fine, breathable microfiber nylon that makes it comfortable all day, every day. The variety of styles and options provides men with the ability to wear the compression level they need to help manage varicose veins, leg pain and swelling, and also, keeps them looking great. The complete Midtown Microfiber line is available in 15–20mmHg, 20–30mmHg and 30–40mmHg, and is available in socks, socks with a grip-top (for men with large calf muscles or slim legs), and thigh-highs (featuring a discreet top band that gives
the appearance of socks when worn under pants). The line is currently offered in black, tan-khaki, steel gray and navy, and is also available in extended foot length socks. Check individual styles for available color options. 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. They also help with the treatment and prevention of varicose veins and other venous disorders. VT N READ MORE: sigvarisusa.com
VEIN THERAPY NEWS < FEBRUARY/MARCH 2017
CALL FOR REGISTRATION REGISTRATION REGISTRATION OPEN OPEN ABSTRACTS NOW OPEN AVF American Venous Forum
29th Annual Meeting February 14-17, 2017 Hilton New Orleans Riverside New Orleans, Louisiana
Abstract Submission Deadline Visit veinforum.org for2016 more info! September 21, http://www.veinforum.org www.veinforum.org
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PRODUCTNEWS R&M offers new wound care report for North America Pantheris device
Avinger’s P.A.D. device becomes both therapeutic and diagnostic tool The FDA expanded the indication of Avinger’s image-guided atherectomy device for the treatment of peripheral artery disease (P.A.D.), allowing its use in both therapeutic and diagnostic procedures. Now, the Pantheris device may be used for diagnostic imaging and treatment of P.A.D. simultaneously. It is the first and only imageguided atherectomy system to be cleared for both, according to the release. In addition to using the device for atherectomy – a catheterbased treatment that removes plaque from a blood vessel – physicians may also use it to identify features of blood vessels, including necrotic cores, fibroatheromas calcium and stent struts. Being able to see from inside the artery during an atherectomy procedure facilitates P.A.D. procedures for doctors, Avinger said in the statement. The Lumivascular technology in the Pantheris catheter guides doctors with optical coherence tomography (OCT) imaging while they treat P.A.D. lesions. Previously, physicians had to depend on X-ray images and touch or feel to steer their tools during the procedure. “The FDA clearance of Pantheris as a diagnostic tool reflects what we as clinicians have already seen first-hand in our practices: that Pantheris OCT images provide important clinical information during our procedures, allowing us to see complicated plaque characteristics in real time as we treat the vessel,” said Suhail Dohad, MD and an interventional cardiologist with Cedars Sinai Hospital in Los Angeles, in the statement. Peripheral artery disease affects as many as 9 million people in the U.S., according to the American Heart Association. It refers to narrowed blood vessels that constrict blood flow to the limbs and commonly causes pain in the legs. Other treatments for P.A.D. include Shockwave Medical’s recently cleared angioplasty balloon, which breaks up calcified plaques using ultrasound shockwaves. VT N READ MORE: avinger.com/ products/pantheris
Research and Markets has added the “North American Active Wound Care Market - Opportunities and Forecasts, 2014 - 2022” report to its offering. The key factors driving the growth of the North American active wound care market are rapidly aging population, government initiatives, rising incidence of diabetes and rising awareness regarding new technologies used in market. However, high cost of technologically advanced products is a factor hindering the growth of the market. Acquisitions by major manufacturers present opportunities for growth in the market. The North American active wound care market is segmented into application, method, end user and country. The application segment is further divided into surgical wounds, ulcers and other wounds. Ulcers are further classified into diabetic foot ulcers, venous ulcers, pressure ulcers and arterial ulcers. The market is further classified based on method into dressings and grafts. The dressings segment is further categorized into antimicrobial dressings, gauze, foam dressings, hydrocolloids collagen, hydrogels, film dressings, composites and alginate dressings. However, the grafts segment is further classified into composite skin grafts and biologic grafts. Biologic grafts are further classified into autografts, allografts and xenografts. The end user includes in- patient facilities and outpatient facilities. Geographically, the market is segmented into the United States and Canada. VT N READ MORE: researchandmarkets.com / research/gs6hz2/north_american
HawkOne 6F Gets FDA OK Medtronic has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new smaller HawkOne 6 French (6F) directional atherectomy system to treat peripheral artery disease (P.A.D.) patients. The HawkOne system has been designed to remove plaque from the vessel wall and restore blood flow. The HawkOne 6F size is an advanced option to treat patients with multi-level P.A.D., both above and below the knee, helping to address lesions of various length, morphology and location. It allows physicians to treat severe calcified lesions more effectively with no increase in cut depth.
VEIN THERAPY NEWS < FEBRUARY/MARCH 2017
The system features a preloaded flush tool that enables to improve cleaning time by up to 55 percent when compared to the TurboHawk high efficiency cutter. The firm’s directional atherectomy portfolio also features TurboHawk and SilverHawk systems, which were supported by about 15 peer-reviewed studies. “The expansion of our HawkOne system provides physicians with more options to optimize directional atherectomy as an approach to P.A.D. management, particularly for lesions below the knee,” said Medtronic aortic and peripheral vascular division’s peripheral business general manager Mark Pacyna. “The HawkOne 6F clearance, as well as the recent approval of our 150mm length IN.PACT Admiral drug-coated balloon and clearance of the Trailblazer angled support catheter, reflects our commitment to a full portfolio of products to meet the needs of patients and physicians.” According to the company, P.A.D. is a serious and chronic condition, which affects more than 200 million people and 12 million in the US. VT N
Thrombectomy device market detailed in report A new Research and Markets report titled, “Thrombectomy Devices Market – Global Opportunity Analysis and Industry Forecast, 2014 - 2022,” states that the global thrombectomy devices market was $913 million in 2015 and is expected to reach $1,389 million by 2022, growing at a CAGR of 5.9 percent from 2016 to 2022. Mechanical thrombectomy would continue to be the preferred technology throughout the analysis period. North America dominated with around half of the market share in 2015 and is projected to maintain the lead throughout the forecast period. High occurrences of acute myocardial infarction, peripheral artery disease, deep vein thrombosis, Venous Thromboembolism (VTE) and pulmonary embolism owing to the sedentary and unhealthy lifestyle majorly drives the market growth. VTE is most common in adults (>60 years). Some of the restraints associated with the thrombectomy devices market are scarcity of trained professionals, lack of awareness, and the complicated use of devices. VTN READ MORE: researchandmarkets. com /research /mmh4wc/ thrombectomy
PRODUCTNEWS ACP certifies Aprima EHR consistent with PRO Venous Registry Aprima Medical Software’s electronic health record (EHR) has met certain minimum criteria, ensuring that data fields match and provides a consistent interface between the user and the American College of Phlebology PRO Venous Registry. Aprima Medical Software is a Richardson, Texas, provider of EHR, practice management (PM) and revenue cycle management solutions (RCM) for medical practices, according to CEO and President Michael Nissenbaum. “We are proud to be the first and only non-vein-specific EHR vendor to earn ACP certification,” Nissenbaum said. “We have incorporated tools to make it easy for phlebology practices to document different types of treatments for specific vein conditions and have streamlined the reporting capabilities for the ACP Venous Registry.”
The Aprima EHR is available with phlebology-specific forms to facilitate the documentation of a variety of vein-specific conditions. The Aprima solution also includes built-in support to help practices meet requirements for Medicare performance programs and quality reporting initiatives, including PQRS, Meaningful Use and the current 2017 MACRA/MIPS program. Joseph T. Jenkins, MD, FACS, of the Dubuque, Iowa, Tri-State Vein Center, said that what he liked about Aprima is the ability to easily customize the system for his practice’s specific needs. “Since the first day our practice went live, all I have had to do was document procedures with a few clicks and I am done,” Dr. Jenkins said. “The staff in my office have embraced Aprima EHR, which is important because my team is a vital part of the practice’s success.” Nissenbaum said the Aprima EHR/PM sets the benchmark for ease-of-use, speed and flexibility, thanks to its single database and customizable design that adapts automatically to individual physician workflows. The Aprima solution has earned Certification for Meaningful Use Stage 2 and been awarded pre-validation status for NCQA PCMH recognition. The company performs
all development, support and implementation from within the United States. VT N READ MORE: aprima.com
Medtronic’s Solitaire stent retriever reduces stroke disability Medtronic’s Solitaire stent retriever has notched another indication, this time for the reduction of stroke-related disability in some patients suffering from acute ischemic stroke. Originally cleared in March 2012, the device is designed to restore blood flow in patients experiencing acute ischemic stroke by removing a clot from blood vessels in the brain. The new indication allows the company to market the device as an initial therapy to ward off disability brought on by acute ischemic stroke in patients with persistent, proximal anterior circulation, large vessel occlusion and smaller core infarcts, a Medtronic spokesman said in a statement. Acute ischemic stroke may result in paralysis and speech difficulties, among other disabilities. The Solitaire stent retriever should be used after patients have received the clot-dissolving drug IV-tPA and within six hours of symptoms appearing, according to the statement. “Stroke is the fifth leading cause of death in the United States, and the number one cause of severe disability,” said Dr. Jeffrey Saver, a professor of neurology at UCLA’s Geffen School of Medicine and director of the UCLA Comprehensive Stroke Center. “The availability and access to a technology that reduces stroke disability is critically important because with such innovations, stroke patients and their families may experience less physical, emotional and financial burdens from their condition.” This expanded approval is backed by data showing that treating patients with the Solitaire device in addition to administering IV-tPA “significantly” reduced disability following a stroke, according to the statement. The combined treatments also boosted the number of patients who were functionally independent within 90 days post-stroke. Manish Gupta, senior director, global medical affairs for Medtronic Neurovascular, explained that the resulting data “showed that 62.7 percent of patients who were treated with Solitaire in addition to IV-tPA were able to regain almost full function at 90 days poststroke and are able to look after their own affairs without assistance, compared to only 36.8 percent of patients who were able to do the same when treated with IV t-PA alone. “This expanded indication will further improve patients’ access to a technology that reduces stroke disability,” Gupta said.
Medtronic’s Solitaire stent retriever “Physicians now have clear guidelines from the American Heart Association/American Stroke Association and FDA on when and how to use the Solitaire stent retriever for patients experiencing acute ischemic stroke. The next step will be to ensure that more and more hospitals have treatment protocols in place to provide this technology.” Meanwhile, the FDA cleared two Stryker clot retrieval devices as a first-line therapy for ischemic strokes to be used alongside tPA with hopes of reducing stroke-related disabilities. The devices were first cleared in 2012 to retrieve blood clots in patients who were ineligible to receive tPA, or for whom the drug did not work. VT N READ MORE: Medtronic.com
Medtronic launches Evolut R 34mm TAVR in Europe Medtronic announced that it had received a CE mark for its Evolut R 34 mm transcatheter aortic valve replacement (TAVR) system. The company also said in the Jan. 17 news release that it had launched the valve in Europe. The system was approved for patients with severe aortic stenosis who are at intermediate-, high- or extreme-risk for surgery and have an annulus size from 26 to 30mm. Medtronic said that approximately 20 to 25 percent of Europeans eligible for TAVR fit into that category. The valve is delivered through a catheter and features a self-expanding nitinol frame designed to fit within the native aortic valve. The FDA approved the Evolut R 34 mm TAVR system in October. The agency originally approved the system in June 2015 in 23mm, 26mm and 29mm sizes. “We look forward to working with physicians across Europe to offer this highly anticipated valve size to the thousands of patients who were previously unable to receive TAVI due to valve size,” Heart Valve Therapies General Manager Rhonda Robb said in prepared remarks. “With this approval, the Evolut R platform now treats the broadest annulus range of any TAVI system on the market and expands the patient population that can now receive this life-saving therapy.” VT N
FEBRUARY/MARCH 2017 < VEIN THERAPY NEWS
PRODUCTNEWS Fujifilm adds two X-ray systems to Imaging portfolio Fujifilm Medical Systems U.S.A. Inc., a provider of diagnostic imaging products and medical informatics solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the marketing of its most recent innovation in digital radiography – the FDR Visionary Suite and the simultaneous release of its FDR Clinica X-Ray Components. While the Visionary Suite is a digital X-ray suite designed for mid-to-large sized hospitals and health systems, the FDR Clinica X-ray Components were specifically created with outpatient facilities in mind. Rob Fabrizio, director of Strategic Marketing, Digital Radiography and Women’s Health, said these newly-released innovations are welcomed additions to our full portfolio of DR room offerings and meet the exacting standards in performance the market has come to expect from Fujifilm. The FDR Visionary Suite is Fujifilm’s next generation complete X-ray room system. It was designed to deliver optimized imaging workflow while expanding clinical capabilities. A flexible fully automated positioning system, offering a broad range of easy-to-use advanced applications including tomosynthesis, energy subtraction and long length imaging – giving facilities the tools they need to better support challenging exams and diagnosis. Fujifilm is now shipping Visionary Suite. Fujifilm’s FDR Clinica X-ray components offer high-quality, cost-effective digital X-ray solutions with features designed to
CYBERSECURITY continued from page 16
forced to pay tens of thousands of dollars to get their data back. Making sure your data is backed and stored separately from your main repository can help protect you from attacks such as these. 8. Physical Security This one is self-explanatory but you’d be surprised how much client data is left lying around the office. Ensure your partners, trusted employees and finance team lock away any sensitive documents when they aren’t working with them. 9. Mobile Devices While they are a convenience and increase productivity of the staff, mobile devices mean that your clients’ sensitive
enhance workflow and improve patient care, particularly in active outpatient settings. The FDR Clinica X-ray Components provide a flexible, versatile solution offering a range of power ratings that can be matched to a facility’s specific requirements – be it a medium-sized X-ray department, a rural or remote facility with unstable power supply, or a large facility that demands a rigorous workload. VT N READ MORE: fujifilmhealthcare.com
“Vscan Extend completely changes the game in how we are able to use ultrasound both inside and outside hospitals,” says Guy Lloyd, MD, clinical cardiologist and lead for echocardiography at Barts Heart Centre in London. “For the first time on handheld ultrasounds, we can pre-populate the device with images thanks to the DICOM integration, which then cascades the images through PACS, enabling seamless collaboration with colleagues in our hospital system.” Vscan Extend, which weighs 14.3 ounces, integrates with hospitals’ DICOM systems to complement existing documentation and reporting technologies, along with cloud-based image storage and communication, according to Rob Walton, general manager of primary care ultrasound for GE Healthcare. VT N READ MORE: gehealthcare.com/ en/global_gateway
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GE Healthcare Vscan Extend
GE Healthcare brings pocket sized US to U.S. GE Healthcare has unveiled Vscan Extend, a pocket-sized, dual-probe ultrasound that became commercially available in the United States in late January. From the hospital, clinic and ambulance to more rural environments, Vscan Extend uses advanced image quality and wireless connectivity to help users increase clinical confidence and improve patient care. data can potentially walk out your firm’s door without you ever knowing it. Make sure that all mobile devices used to access corporate data have passwords (your email server can force this requirement), and if you have employees that use laptops you should look at having the hard drives for those machines encrypted. Most modern operating systems have encryption built in (you just have to enable the feature), and it’s foolish not to leverage it. If an employee accidently leaves a laptop on a plane or in the back of a taxi, you’ll be guaranteed that all data on it is secure and protected. VT N
CONCLUSION Your business, your brand and your bottom line depend on the trust you develop with your clients. Handling the items listed above will go a long way in protecting all three. READ MORE: ClintonHenry.com
VEIN THERAPY NEWS < FEBRUARY/MARCH 2017
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