INSIDE Medicaid work rule works for some Thank you nurses for all you do Dermaka has new enhanced formula Improved Beacon Tip catheters back
JUNE/JULY 2018 Vol. 11, No. 3 VEINTHERAPYNEWS.COM
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An ACP recognized resource for news and information for and about the phlebology community
2018 RESEARCH SUMMIT
Work begins to analyze data in rapidly expanding ACP PRO Venous Registry By Vanessa Salvia Contributing Editor
Once analyzed, the ACP can deliver the data, the questions and a grant from the ACP Foundation to fund the research.
Anticipation was high for many members of the phlebology community going into an April 21 closed-door research summit held alongside the International Vein Congress in Miami, convened to discuss how to make the most of the American College of Phlebology’s Patient Recorded Outcome Venous Registry, or PRO Venous Registry. This is the second annual research summit. The first one on April 21, 2017, brought together American College of Phlebology (ACP) leadership and other industry and registry thought leaders for an open discussion about the data captured by the ACP PRO Venous Registry and the immediate needs of the medical community and items that can be addressed using the database. The registry, which was first envisioned in 2009 by Marlin Schul, MD, a specialist in venous and lymphatic medicine in Lafayette, Ind., currently has 109 physicians participating. Most submit their data through an electronic medical records process, but a few participate using manual entry. There are more than 36,000 individual patients and more than 150,000 patient records to date. With more than 640
✓ ACP steps into lymphedema
✓ 32nd Annual Congress opens signup
✓ ACP moves to Chicago in June
data fields covering aspects of deep and superficial venous disease and lymphatic disease, the ACP PRO Venous Registry comprehensively represents the practice of vein and lymphatic care. Soon, the 67 vein centers owned by Vein Clinics of America and the 70 centers owned by the Centers for Vein Restoration will also begin importing their data on a weekly basis into the PRO Venous Registry. As the ACP advances on its “New Horizon” campaign to embrace advocacy, education and research, the summit brought together a committee led by seven physicians and directed by Joseph Jenkins, MD, a vein surgeon from Dubuque, Iowa, with the intention of determining how to develop quality measures for vein care along with research questions that can be asked of the data in the registry. RESEARCH SUMMIT
continued on page 28
Managing persistent swelling after endovenous ablation
By Tim Cawlfield, MD I have practiced phleboloby for six years and I learned early in my career that patients with swelling in the lower extremities – swelling that cannot be contained by elastic graduated compression stockings – do not benefit from endovenous ablations.
My general rule of thumb is that if a patient’s lower extremity swelling is contained with elastic compression and CVI is suspected, then endovenous ablations should significantly improve swelling in the affected leg. I have encountered only a handful of patients throughout my practicing career who have partially responded to elastic compression stockings and have fared worse after endovenous ablations. A recent example is “April,” (name changed), a 71-year-old, active female. She presented with bilateral lower extremity swelling and erythema. She was obese (BMI 32), took Synthroid for hypothyoidism, but was in otherwise good health. She had 1+ pitting edema below the left distal calf and trace pitting edema in the right ankle. There was corona phlebectatica over both medial ankles and dilated venulectasias over the left distal-medial calf.
“April” had increased swelling after endovenous ablation in her left leg without objective evidence of venous obstruction. Both calves were lightly erythematous, but without warmth or induration. There was no skin thickening or fibrosis in the lower extremities without a Stemmer’s sign. Wearing elastic graduated compression stockings partially reduced her swelling and discomfort, but she continued to have symptoms that interfered with daily activities. The duplex ultrasound of the LYMPHEDEMA
continued on page 22
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NEWS 1 PRO Venous Registry taking shape
Work began April 21 in the closed door 2018 Research Summit to discuss and plan how to analyze and use the data in the rapidly expanding American College of Phlebology’s Patient Recorded Outcome Venous Registry. The ACP PRO Venous Registry will guarantee high-level targeted research based on the thousands of patient records now flowing into the registry.
8 Here come the lymphatics!
The ACP is a member society dedicated to venous and lymphatic medicine and is now dedicated to providing education for a new specialty section of the membership committed to lymphedema. The American Board of Phlebology is also changing its name to the American Board of Venous and Lymphatic Medicine.
11 ACP staff moving to Chicago
The American College of Phlebology and as many of its staff members who want to trade the sun of San Leandro, Calif., for the windy city of Chicago will pack up and move in June. The historic move puts the staff in the Chicago neighborhood with the American Medical Association and 65 other medical societies.
THE PRACTICE 16 Don’t drown in The Sea of Sameness
Healthcare bleeds conformity, and these techniques have become the gold standard. Physicians don’t deviate from these standards until empirical evidence of another approach produces better results. This is considered good medicine. However, it’s just the beginning of the extraordinary level of conformity within our healthcare system. So how do we disrupt the status quo?
20 Secret sauce for the ‘killer app’
Email is the acknowledged ‘killer app.” But if you don’t manage it carefully, you’ll learn first-hand what “killer app” really means. Don’t wring your hands because you can now harness the power of the autoresponder, making your email the most useful and friendly tool for getting and keeping patients. A free offer in this article helps you handle autoresponder.
SECOND LOOK 1 Swelling after endovenous ablation
American Vein & Vascular Institute phlebologist Timothy Cawlfield, MD, has a personal rule of thumb: If a patient’s lower extremity swelling is contained with elastic compression and CVI is suspected, then endovenous ablations should significantly improve swelling in the affected leg. He presents a case study of “April.” Does she prove the rule?
24 Fighting venous disease at skin level
Water’s Edge Dermatology phlebologist and researcher Ronald Bush, MD, has been researching the pathophysiology of venous disease manifested at the skin level. He reasons that virtually all stages of venous disease can be evident from just examining the skin, yielding clues to abnormalities in the systemic and venous system.
VTNREPORT SURMODICS BUYS EMBOLITECH’S THROMBECTOMY PLATFORM, TECHNOLOGY, ASSETS FOR $5 MILLION UPFRONT Eden Prairie, Minn.-based SurModics has acquired Embolitech’s thrombectomy platform and associated intellectual property in a deal worth $5 million up front, with additional payments based on regulatory milestones. The technology platform acquired May 14 is designed for use in the peripheral vasculature to remove hard blood clots. SurModics plans to leverage its design, development and manufacturing capabilities to advance the platform into different peripheral and vascular applications. SurModics President and CEO Gary Maharaj said he expects to record a 49 cents per share charge to earnings during its third quarter of the fiscal year 2018 related to in-process R&D expenses and deal costs. “The Embolitech technology offers next-generation innovation that may eliminate the need for the use of thrombolytics, reducing the likelihood of ICU time and bleeding complications that significantly affect patient recovery and outcomes,” Maharaj said. “In addition, the technology is anticipated to reduce procedure time and the need for multiple procedures, and it does not require any additional, external capital equipment.” In April, the FDA granted 510(k) clearance for the SurModica .018-in. low-profile percutaneous transluminal angioplasty balloon dilation catheter designed for peripheral vascular use.
34 ORGANIZATIONS ASK CONGRESS TO OVERTURN PATIENT IDENTIFIER BAN Nearly three dozen organizations have asked Congress to include language in the fiscal year 2019 Department of Health and Human Services (HHS) budget that allows federal agencies to provide technical assistance for patient matching. The American Health Information Management Association, the American Medical Association and America’s Health Insurance Plans are among the 34 organizations that signed the letter that includes clarifying language on the unique patient identifier ban. Congress has banned HHS from using funds to implement a unique patient identifier dating back to 1999, a move driven primarily by privacy concerns. But the organizations argued patient matching issues have reached a critical level. “The quality, safety and cost-effectiveness of healthcare across the nation will improve if a national strategy to accurately identify patients and match those patients to their health information is achieved,” the groups wrote. READ MORE: http://bok.ahima.org/PdfView?oid=302512
MEDTRONIC PLANS $1.2B DEBT, SHARE BUYBACK PLAN IN FY 2019 Medtronic is launching a $1.2 billion share and debt buyback effort, looking to redeem the full amount over the course of its 2019 fiscal year. The Fridley, Minn.-based company said it expects to redeem $400 million in 5.6 percent senior notes due 2019 and $765.6 million in 4.45 percent senior notes due 2020, which had a redemption date of April 27. Medtronic said that it “believes the redemption represents an attractive opportunity to deploy its capital efficiently, given the economic benefit of lower net interest expense and lower average cost of debt outstanding,” according to an SEC filing. The repurchasing is in addition to the company’s planned repurchases to offset employee compensation dilution, Medtronic said, and will be made pursuant to the company’s existing $5 billion share repurchase program. Funding for the repurchasing efforts will be funded with cash and cash equivalents on hand, Medtronic said.
COOK MEDICAL RE-LAUNCHES BEACON TIP CATHETERS IN THE UNITED STATES, CANADA Cook Medical is re-launching its Beacon Tip Torcon NB advantage catheters in the United States and Canada, after having recalled the devices due to complaints related to device tips on the items degrading and fracturing. The Bloomington, Ind.-based company recalled all catheters that used its Beacon Tip locating technology in May 2016 over complaints of tip splitting, affecting a total of approximately four million devices.
The company first noticed the problem in early 2015, initially recalling only the smallest size Beacon Tip angiography catheter. Cook Medical said its engineering team completed significant testing after the recall, and that the devices are now shipped with a new foil outer packaging to provide a barrier against environmental factors it identified as contributing to the recall. “When we saw the catheters acting in unexpected ways without a clear root cause, we knew we had to recall. We knew the product was in high demand, and how heavily physicians relied on this product. But, patient safety comes first, period,” Cook Medical vascular division VP Mark Breedlove stated in a press release.
HHS SECRETARY AZAR SAYS POWER OF THE PEN IS STRONG ENOUGH TO CURB DRUG PRICE HIKES President Trump’s plan to curb drug prices will allow Medicare to negotiate prices in a “more aggressive approach than has ever been tried before,” Health and Human Services Secretary Alex Azar said May 14. And he said he can do much of it without Congress’ help. Azar, along with CMS Administrator Seema Verma and FDA Commissioner Scott Gottlieb, explained how they expect to execute the plan President Trump announced May 11 aimed at curbing drug prices in the U.S. The HHS secretary intends to use his ability to regulate, modify programs, conduct demonstration programs and experiment through the Centers for Medicare and Medicaid Innovation. “This pen has a lot of power at HHS,” Azar said, picking up a generic ballpoint pen that sat in front of him as he addressed a room of reporters. “And we intend to use the full scope of the power contained in this pen on any of these rather than sitting back and waiting for Congress.” In addition, he said Medicare would return to Part B price bidding program; pressure brand-name drug-makers by naming price abusers’ company names; force drug company price transparency; and exercise authority over the anti-kickback statute to examine how the safe harbor could be “modified in the same way it was created.
CMS RELEASES MARKET SATURATION AND UTILIZATION DATA TOOL UPDATE The Centers for Medicare & Medicaid Services (CMS) has developed a Market Saturation and Utilization Data Tool that includes interactive maps and a dataset that shows national-, state-, and county-level provider services and utilization data for selected health service areas. Market saturation, in the present context, refers to the density of providers of a particular service within a defined geographic area relative to the number of the beneficiaries receiving that service in the area. The seventh release of the data tool includes a quarterly update of the data to the fourteen health services areas from release 6, and also includes Federally Qualified Health Centers and Ophthalmology data. Also new to Release 7 is a trend analysis graphing tool that allows users to graph the percentage change and trend over time at the national level for the available metrics and health services areas. The Market Saturation and Utilization Data Tool is one of many tools used by CMS to monitor and manage market saturation to help prevent potential fraud, waste and abuse. The tool is available through the CMS website at: https://data.cms.gov/market-saturation.
OPIOID CRACKDOWN ARRESTS 30 MED PROFESSIONALS, REVOKES LICENSES OF 147 PRESCRIBERS TO CURB ABUSE Over 45 days in February and March, the Drug Enforcement Administration undertook an enforcement “surge” to identify and investigate prescribers and pharmacies that dispensed large amounts of drugs, including prescription opioids. The Drug Enforcement Administration also revoked the licenses of 147 prescribers to keep them from dispensing controlled substances as part of a nationwide effort to curb opioid abuse. In all, the review of drug transactions ordered by Attorney General Jeff Sessions sparked 188 investigations that resulted in the arrests and other enforcement actions including the immediate revocation of DEA registrations to dispense controlled drugs. VT N
JUNE/JULY 2018 < VEIN THERAPY NEWS
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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 intraarterial injection of polidocanol occurs, consult a vascular surgeon immediately. Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena® © 2017 Biocompatibles, Inc., a BTG International group company All rights reserved NA-VAR-2016-0786(2) 01/18 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
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.
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.
Table 1: Treatment-emergent adverse reactions (3% more on Varithena® 1% than on placebo) through Week 8 (n=588)
Manufactured for Provensis Ltd by: Biocompatibles UK Ltd Chapman House, Weydon Lane, Farnham, UK, GU9 8QL. Distributed by: Biocompatibles, Inc. Five Tower Bridge, Suite 810 300 Barr Harbor Drive West Conshohocken, Pennsylvania 19428 USA 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).
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ACP takes the next step into lymphedema By Dean J. Bender Over the past several years, the leadership of the American College of Phlebology (ACP) recognized that the treatment and management of patients with lymphedema in this country remains under-recognized and underserved. As such, the ACP began a concerted effort to further educate our membership and the field about this debilitating condition in an effort to develop physician specialists willing and able to work with these patients. This commitment began with the American Board of Phlebology changing its name to the American Board of Venous and Lymphatic Medicine; it continued with the ACP beginning to offer dedicated
lymphedema learning sessions at its Annual Congress; and it culminated in 2016 when, in cooperation with LE&RN, the ACP hosted Kathy Bates as the keynote speaker for the Annual Congress! So now, the question is where does this commitment go next? When I accepted the position as CEO of the ACP, it was with the clear support of the Board of Directors for the ACP to expand its mission and commitment beyond vein care to include the treatment and management of lymphedema. The ACP is a member society dedicated to venous and lymphatic medicine whose principal purpose is to advocate for the field, to invest in research and to provide education for our membership and those that specialize
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in venous and lymphatic medicine. The way we are able to advance the cause is by engaging with our membership. The next step then for the ACP is to develop a new specialty section of the membership committed to lymphedema. This membership section will be developed among our physician members who specialize in lymphedema along with lymphedema therapists who are searching for a society where they can serve to develop a future for patients with lymphedema to have a better outcome and an improved quality of life. This summer, the ACP will be conducting a membership drive to develop this specialty section by bringing into the membership lymphedema therapists and specialists. This drive will also provide a scholarship to enable new lymphedema therapist members to participate in this year’s Annual Congress, which will include a dedicated program in lymphedema led by our own Dr. Stan Rockson from Stanford University along with Dr. Robert Damstra and Ad Hendrickx, a Physical Therapist from Nij Smellinghe Hospital in the Netherlands and a leading center in Europe for the research and treatment of Lymphedema.
The ACP will follow up the Annual Congress with a couple regional meetings in 2019 in order to reach the lymphedema community more directly. In addition, the ACP is committed to supporting advocacy in lymphedema along with new research in the field. In summary, the American College of Phlebology is taking the next step by providing a society where physicians, therapists and other specialists in lymphedema can come alongside each other in a concerted effort to change the world for those affected with the debilitating condition of lymphedema. Now the question is: Are you willing and able to join the ACP and make a difference? We look forward to having you join our effort. See you in Nashville this November! VT N Dean J. Bender is CEO and executive director of the American College of Phlebology and the American College of Phlebology Foundation. He has been a member of the ACP since 2008 and has served as a board member and treasurer for the ACP Foundation.
ACP opens early registration for its 32nd Annual Congress in Nashville Early registration for the American College of Phlebology (ACP) 32nd Annual Congress Nov.8-11 at the Gaylord Opryland Hotel and Convention Center in Nashville is now open. To register, see acpcongress.org/application-form-1. Stephen Daugherty, MD, and the ACP invite all physicians to “Raise your Voice” as the New Horizon at the 32nd Annual Congress approaches. More than 1,000 medical practitioners and 400 industry experts specializing in venous and lymphatic disease will gather this year to discuss the latest in healthcare policy and advocacy, to debate the latest research and to learn the latest approaches in caring for those affected with these chronic and debilitating conditions. “This year’s Annual Congress is one of the most comprehensive programs in our history covering all aspects of venous and lymphatic medicine,” Dr. Daugherty said. “In addition, the 32nd Annual Congress is also packed with numerous opportunities for society members to gather and socialize among peers, to build relationships and to learn from each other. The Welcome Reception is planned for Wednesday evening, Nov. 7, and this year’s Annual Congress starts at 8 a.m. Thursday, Nov. 8. The Congress concludes at noon Sunday, Nov. 11, after the first Venous and Lymphatic Village at the Congress. “You do not want to miss this great new addition to the Congress.” The Venous and Lymphatic Village opens at 9 a.m. Sunday, and provides an opportunity for attendees to participate in an exchange of information between expert practitioners and industry experts in an interactive and casual setting. The “Village” will be divided into multiple “neighborhoods” based on particular venous and lymphatic conditions such as thrombosis, chronic venous obstruction, small veins, compression and wound care, superficial vein treatment, and pelvic venous reflux. Within each neighborhood will be various experts and representatives to answer any questions or demonstrate and offer hands-on instruction for various techniques and tools for venous and lymphatic treatment. The ACP Foundation Silent Auction will return this year, and the ACP Foundation Fun Run & Walk will be Saturday, Nov. 10. VT N
JUNE/JULY 2018 < VEIN THERAPY NEWS
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ACP moves California headquarters to Chicago By Amanda Godwin After 30 years in San Leandro, Calif., the American College of Phlebology (ACP) is relocating its headquarters to Chicago. The move is expected to be completed by the end of June, and the new address will be 434 W. Ontario St., Suite 200, Chicago, IL, 60654. This move is one of several new initiatives by the ACP Board of Directors to improve the representation of venous and lymphatic healthcare providers in the medical industry. The APC will join more than 65 medical associations already operating in Chicago, including the American Medical Association, allowing the organization to better represent its members as a part of the national medical discussion. The move to the Midwest also provides a more central location for its almost 2,000 members located across the United States. “We are excited about the decision to relocate the headquarters to Chicago as it positions the College in a place where we will better be able to pursue the strategic initiatives of our membership,” said Neil Khilnani, MD and president of the ACP Board of Directors.
John Chuback, MD, FACS
Dr. John Chuback joins VTN Editorial Advisory Board John Chuback, MD, FACS and chief medical officer at Chuback Medical Group in Paramus, N.J., has joined the Vein Therapy News (VTN) Editorial Advisory Board. Dr. Chuback is involved in teaching, entrepreneurship, writing and philanthropy. He is also co-founder of BiosupportMD and Chuback Education. He is an author of numerous articles and books and is a lecturer throughout the United States on medical and non-medical subjects. He graduated Magna Cum Laude from Fairleigh Dickinson University with a B.S.
“By placing ourselves closer to the majority of our membership as well as in the same city as the American Medical Association (AMA) we expect to be able to further improve the value the College is able to deliver to our membership, the field and most importantly our patients.” Dean Bender, executive director of the ACP, said the relocation should be complete by the end of June. “I want to make sure that every one of our membership knows they have an open invitation to stop and visit us anytime they are in or are passing through Chicago. We will always have a cup of coffee waiting for you!” For more than 30 years in California the ACP has been an advocate for the advancement of vein and lymphatic care through education, resources and research. Some of the staff will be unable to move to Chicago. Bender said the APC is grateful for its roots and all the staff and volunteers who have helped grow the association to its current success. “Relocation is always a bitter sweet proposition as we are excited about a new future in Chicago, but unfortunately it means degree in biology, and then attended Rutgers University New Jersey Medical School where he earned his MD degree. Subsequently, Dr. Chuback completed his general surgery residency at Monmouth Medical Center & Newark Beth Israel Hospital. He then did his residency in cardiovascular and thoracic surgery at Strong Memorial Hospital and The University of Rochester Medical Center in New York. He is board certified in general surgery and thoracic surgery. Dr. Chuback practiced cardiac surgery for the first six years of his professional career and then launched a successful private practice focused on venous disease and cosmetic procedures. Over the course of his career, he has been the recipient of many awards and honors. He is a member of numerous societies and is a Fellow of the American College of Surgeons. He will periodically write for the “SecondLook” section of medical in-depth articles in each issue of VTN and advise editor Larry Storer as needed. “Vein Therapy News is fortunate to have a physician of Dr. Chuback’s experience, training, education, skill and background,” Executive Vice President Gary Pittman Jr. said after meeting with Dr. Chuback at IVC. “His passion for treating venous disease will result in compelling insights for our physician readers.” VT N
Neil Khilnani, MD
leaving some great people behind,” Bender said. “The leadership, the membership and myself owe our deepest gratitude to the various members of our staff that have contributed greatly to the College over the past years. We wish you all the best success.” VT N
Amanda Godwin is the senior marketing coordinator at the American College of Phlebology. She can be contacted by email at firstname.lastname@example.org.
APC issued advocacy alert for draft LCD advancing vein care
APC seeks abstracts for 2018 Congress by June 20 deadline The American College of Phlebology (ACP) is now accepting abstracts to be presented at the 2018 ACP Annual Congress Nov. 8-11 in Nashville. Deadline is June 20. All seasoned practicing clinicians, research scientists, young investigators, physician extenders, nurses, lymphedema therapists, ultrasound technicians, and medical students are encouraged to submit original scientific research and innovative solutions. Accepted papers can be presented to more than 1,000 venous and lymphatic medicine experts, and accepted abstracts will be published in Phlebology Journal. In addition, presenters receive 10 percent off Annual Congress registration. Cash awards include Young Investigators recognition and travel scholarships are available. VT N READ MORE: acpcongress.org/ abstract
The American College of Phlebology issued an advocacy alert in May, which encouraged physicians in the 12 affected states to attend the open meeting that was held May 31 in Mechanicsburg, Penn., with Novitas Inc. The meeting is to discuss the Local Coverage Determination (LCD) draft policy of the Centers for Medicare and Medicaid Services (CMS). Novitas Inc., a Medicare Administrative Contractor (MAC), has proposed a draft LCD regarding information relative to new drugs, new or revised indications, or marketing information of forthcoming drugs or devices. This LCD was a combined meeting for both MAC JH (jurisdiction H) and MAC JL (jurisdiction L) contract areas that would affect the 12 states within the Centers for Medicare and Medicaid Services (CMS) jurisdiction J-H, which includes: Arkansas, Colorado, Delaware, District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania and Texas. Although the meeting is over, ACP also encouraged physicians to join the ACP in its continuing campaign. If you have questions, email Robert White, ACP’s director of healthcare policy and advocacy, at email@example.com. VT N
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MEDICAID WORK RULE
Med societies out-of-step with members on proposal Three out of four physicians favor a new federal policy that allows states to require applicants to work or seek a job in order to obtain Medicaid benefits despite opposition from professional associations that represent them, according to a survey by Merritt Hawkins, a national physician search firm and a company of AMN Healthcare. The single-question survey asked physicians what their position is on the new Medicaid work requirements policy. Over half (56.6 percent) said they feel very favorably about the policy, while 17.8 percent indicated they feel somewhat favorably. By contrast, only 9.2 percent of physicians said they feel very unfavorably toward the policy while 8.4 percent said they feel somewhat unfavorably. The remaining 8 percent were neutral. “The survey strongly suggests that the majority of physicians would like to move away from the Medicaid status quo,” said Travis Singleton, executive vice president of Merritt Hawkins. “Many physicians have been frustrated for years because Medicaid
often pays less than their costs of providing care. Physicians have to limit the number of Medicaid patients they treat for that reason and want to focus on those who need care the most.” Three states, including Kentucky, Indiana and Arkansas, are proceeding with the work requirements policy as of March. In Kentucky, able-bodied Medicaid applicants 19-64 years old will be required to put in 80 hours of community engagement a month to qualify for Medicaid benefits: working, going to school, training for a job, or volunteering. The policy in Indiana and Arkansas has similar requirements. The survey was conducted by email in early March and was completed by 667 physicians. According to experts in statistical response analysis at the University of Tennessee, the survey has a margin of error (MOE) of <1.0 percent. The survey showed individual physicians feel differently than some of the professional associations that represent them.
The American Medical Association at its interim meeting last fall passed a resolution opposing work requirements as a criteria for Medicaid eligibility. In February, the American College of Physicians submitted letters urging the Centers for Medicare & Medicaid Services to reject proposals from state Medicaid agencies to make eligibility contingent on working, searching for work or volunteering. The idea is also opposed by most Democrats in Congress. The issue may ultimately be decided in the courts. VT N
SIR panel promotes its IR treatment The Society of Interventional Radiology (SIR), in conjunction with U.S. Rep. Mia Love (R-Utah) participated in a panel discussion in the Cannon House Office Building in Washington D.C., exploring how the toughest medical challenges can be treated by interventional radiologists. In the panel discussion, three interventional radiologists – Theresa M. Caridi, MD, MedStar Georgetown University Hospital; Arshad A. Khan, MD, FSIR, MedStar Washington Hospital Center; and Venu Vadlamudi, MD, Association of Alexandria Radiologists and Inova Alexandria Hospital – explained how they treat conditions as varied as stroke, fibroids, postpartum hemorrhage, cancer and pain, using advanced imaging, a small incision and innovative devices. Jeannie Franklin, an interventional radiology patient, participated in the panel to describe how her quality of life was restored thanks to an interventional radiology treatment for uterine fibroids called uterine fibroid embolization (UFE). “This briefing highlighted the urgent need to ensure that an adequate number of interventional radiologists are trained to meet the needs of patients,” said SIR Executive Director Susan E. Sedory, who moderated the panel. “This is why SIR supports Rep. Love’s bill, HR 1167, the Enhancing Opportunities for Medical Doctors Act, which will reallocate currently unused federally funded graduate
medical education training slots to rural hospitals, new medical schools and new specialties, like interventional radiology, to ensure our nation’s medical community is keeping up with the demand for services.” Rep. Love declared that the country is at a critical point in healthcare. “I believe we must do everything we can to encourage innovation and workforce development in the medical field,” she said. “I’m excited at such advancements in interventional radiology and am proud that my bill would make a difference in making these things happen.” VT N READ MORE: www.sirweb.org
PVD pipeline report offered The “Peripheral Vascular Disease Pipeline Highlights – 2017 Update” report has been added to the ResearchAndMarkets.com offering. The report provides the most up-todate information on key pipeline products in the global peripheral vascular disease market. It covers emerging therapies for peripheral vascular disease in active clinical development stages. 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 outlicensing deals. The report provides peripheral vascular disease pipeline products by clinical trial stages including both early and late stage development – phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research, and discovery stage. It also provides peripheral vascular disease pipeline products by their dominant mechanism of action. This helps executives categorize products based on their drug class and also assess the strengths and weaknesses of compounds. “Peripheral Vascular Disease Pipeline Highlights – 2017 Update” provides peripheral vascular disease pipeline products by the company. It will also indicate which peripheral vascular disease pipeline products will be launched in the United States. VT N READ MORE: researchandmarkets. c o m / r e s e a r c h /q w n p p k / peripheral?w=4
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Your patients are looking for safe and effective treatment of their venous disease, but if you’re only treating above the knee, you could leave them with a persistent problem. Residual symptoms and the need for reintervention are reported in nearly 50% of patients if the refluxing GSV below the knee is left untreated.1 The VenaCure 1470 nm laser and NeverTouch fiber have been shown to safely and effectively ablate the GSV below the knee, with minimal complications (postoperative paresthesia occurred in 4% of patients, and resolved within 4 weeks).1 Learn more about the procedure that has been performed more than 1 million times and help your patients get relief from their venous disease symptoms by treating below the knee.
1 - Gifford, S.M. et al. Reflux in the below-knee great saphenous vein can be safely treated with endovenous ablation. Journal of Vascular Surgery Venous and Lymphatic Disorders. 2014. 2:4; 397-402.
Refer to Directions for Use provided with products for indications, complete instructions, warnings, and precautions. INDICATION FOR USE: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs. CONTRAINDICATIONS: Patients with thrombus in the vein segment to be treated, patients with an aneurysmal section in the vein segment to be treated or patients with peripheral artery disease as determined by the Ankle Brachial Pressure Index with a value of <0.9 should not have their varicosities ablated. CAUTION: Federal (USA) law restricts the sale of these devices by or on the order of a physician. AngioDynamics, the AngioDynamics logo, VenaCure EVLT, the VenaCure EVLT logo and NeverTouch are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2018 AngioDynamics, Inc. ANGAD 560 GL Rev 03 03/18
VEIN THERAPY NEWS < JUNE/JULY 2018
Read us online. Updated daily.JUNE/JULY 2018 www.VeinTherapyNews.com
< VEIN THERAPY
THEPRACTICE Simple Duke form improves patient visit satisfaction Duke Health has developed a simple one-page survey to help improve patient satisfaction with doctor visits. The form, given to patients ahead of their doctor visit, asks them to list three concerns they want to discuss with their physician and asks them for feedback at the conclusion of the visit. The form, tested with more than 14,000 patients seen by a dozen doctors at the Duke Spine Center outpatient practice, improved patient satisfaction with the care they received, according to a study published in Neurosurgery. The survey improved communication between doctors and patients, and also allowed for real-time feedback. At the end of the visit, the survey asks patients if all their questions were addressed and if they were satisfied, giving doctors immediate feedback on how well they addressed patients’ needs. The form also includes an open-ended question that asks how the clinic could better support patient care. “National surveys show that up to half of all patients leave the clinic visit with an unvoiced need,” said lead author Oren Gottfried, MD and clinical vice chair for quality in the Department of Neurosurgery at Duke University School of Medicine. More than 14,600 patients were included in the study and completed the form 96% of the time. If a patient responded that were not satisfied with their visit or that all their questions were not answered, physicians followed-up, either returning to the exam room or calling the patient within 24 hours. Doctors who participated in the study found the one-page tool and its immediate patient feedback loop superior to the government’s patient satisfaction tool known as the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS). Duke Health is not alone in seeking to improve the patient experience during office visits. Hawaii Pacific Health, a nonprofit network of hospitals, clinics, physicians and care providers, saw its overall performance on physician communication scores on patient surveys improve dramatically after it used a checklist and a coaching program to improve some doctors’ communication skills. VT N
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JUNE/JULY 2018 < VEIN THERAPY NEWS
What is the role of conformity in vein treatment? By James R. Williams Healthcare bleeds conformity. And for the most part, for good reason. Physicians are trained to rely on statistically proven techniques to treat a condition. These techniques become the gold standard. Physicians are taught not to deviate from these standards until empirical evidence of another approach produces better results. This is considered good medicine. However, it’s just the beginning of the extraordinary level of conformity within our healthcare system. The seemingly endless list of regulatory agencies creates even more conformity by enforcing standards designed to protect the patient and control the way healthcare is delivered. Insurance companies create a different level of conformity. Physicians are often instructed by payors as to which conditions are covered; what symptoms must be present; under what terms coverage will be approved; and what other hoops must be jumped through to ensure payment. In the most extreme examples, the practice of medicine seems to be based on conforming to payor requirements and not on what is taught in medical school. According to Beran T.N., Kaba A., Caird J., and McLaughlin K. (2014) there is evidence of potentially detrimental conformity within medical schools and residency training whereby basic peer pressure is preventing students from challenging or questioning information that seems incorrect.
CONFORMITY AFFECTS INNOVATION Every layer of conformity, no matter how well intended, is a major barrier to innovation. How does one stand out when we are expected to blend in? How do you disrupt an industry with innovation when conformity is expected, and non-conformity is often opposed or even penalized? Despite a long record of innovation in the areas of diagnostic procedures, therapies, drugs and devices, there has been very little innovation in provider care models and patient experience. It’s no wonder that we have been slow to disrupt other areas of healthcare, such as the way it’s packaged, delivered and communicated – we face constraints and conformity at every single touchpoint.
VEIN THERAPY NEWS < JUNE/JULY 2018
HERE’S THE GOOD NEWS Innovations don’t have to break the entire system to create breakthrough value. Even the slightest innovation can trigger larger innovations down the line and improve patient care, the provider experience, and payor value. You might be asking “but what does that look like?” I have more than 30 years of experience in building and growing companies within traditional as well as non-traditional healthcare spaces. I’m going to share a few examples of disruption and its impact on patient care, access and overall business value.
Disrupt Your Budget Process (and then some) I was part of a large physical medicine and rehabilitation system early in my career. While approaching the budget cycle for the next year, we noted that the traditional departmentalbased budget not only discouraged collaboration among departments but encouraged them to compete against each other for the biggest budget. With that, the budget was radically transposed (or innovated) from a departmental format to service line groupings such as Spinal Cord, Brain Injury, Stroke, etc. Gone were departments such as Physical Therapy, Occupational Therapy and Speech. This required the department managers to remove themselves from the comfort of their silos and work together through the continuum and across the former departmental lines for the greater good of the patient. When the new Brain Injury Service Line was asked to identify the biggest force that could create the biggest change for them (positive or negative) over the next 3 to 5 years, they collectively replied that the advent of air bags and seat belt laws would create a (fortunate) decline in patients over the coming years. (This took place in the early 1990s). The Orthopedic Service Line was most concerned with how Physical Therapy prior to and immediately following hip or knee replacement could affect inpatient rehabilitation length of stay and even admissions over time. (How true was that vison
– patients are now ambulating just an hour after surgery and many times in an outpatient surgical center). It was insights like this that were bred by a simple but innovative change to budgeting. Instead of selfishly thinking in silos, all department managers worked together to envision a future that just wasn’t visible under the old way of doing business. But this view of the future was just the start of our innovation. Armed with this realistic expectation of a declining patient base, we innovated a new treatment model that: • captured a new segment of patients, • expanded our geographic market, • delivered an entirely new level of care, and • created greater brand awareness beyond our hospital walls. We did this by developing joint ventures with nursing homes and converting a section of beds to sub-acute status. These units fueled new growth and helped mitigate the effects of air bags, seat belts and pre- and post-surgical physical therapy while delivering needed services to those who needed them most.
Innovate the Way You View Your Competition I was part of an eyecare start-up that acquired ophthalmology practices, practice-based optical shops and ambulatory surgical centers. We ramped up quickly and saw even more explosive growth with the FDA approval of LASIK. Very quickly we saw optometrists as the biggest competitor and barrier to success. It was simple. Optometrists wanted to sell glasses while we wanted to make them obsolete. Rather than compete with the optometrists, we considered them a partner. Optometrists were offered the opportunity to perform the extensive pre-procedure testing and evaluation, as well as the post-procedure follow up. These were value-added services that earned the optometrist a co-management fee that often exceeded the lifetime margin generated from the average patient. This also helped better HOW TO FLY HIGH
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THEPRACTICE HOW TO FLY HIGH
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retain the patient with the optometrist, so they could continue to perform annual exams, as well as sell the occasional sunglasses. This was a relatively simple innovation with winwin results and, in fact, was one of the key drivers that led to our biggest break-through – a successful initial public offering.
Innovate Medical Coverage It’s equally important to discuss failures in innovation. Sometimes it’s a bad idea, but sometimes it’s just not the right execution, or the right time. This was an idea we just couldn’t make work, but maybe it will inspire you to think of a new twist that could. I was part of a development group that created the largest network of Cyberknife Cancer Centers in the United States. Cyberknife is a form of radiation oncology known as Stereotactic Body Radiotherapy or SBRT. Our company competed against a long list of urologists who owned their own radiation oncology equipment and were able to refer their prostate cancer patients directly to this technology through the in-office Stark Law exception. Their technology was referred to as intensity-modulated radiotherapy or IMRT. To make it even more competitively challenging, the largest payor in the region covered the urologist’s IMRT, but not the SBRT that we used. Adding to this frustration, IMRT was paid on a fee-forservice basis. This meant each of the 44 fractions or treatments were covered by payors. SBRT could treat that same patient and deliver comparable outcomes with only 5 treatments and we would have been satisfied accepting 50 percent of the IMRT reimbursement. My partners and I developed an innovative pilot study that was presented to the largest payor. This study would: • promote more active surveillance and less radiation, • deliver more 5-fraction SBRT when radiation therapy is needed, • replace the FFS with a case rate, • incorporate pay for performance to ensure quality outcomes and patient satisfaction, as well as • shift the risk from the payor to the provider. The patient would benefit from more active surveillance meaning less radiation, as well as the convenience and less risk of 5 versus 44 separate treatments. The payor would benefit from decreased reimbursement and the shift of risk from themselves to the provider. Based on a pilot study goal of 254 patients, payor savers were projected at $5.7M! When we finally walked into the meeting with the payor’s decision-maker, we thought it was a slam dunk. How could they say no to such a sound proposal? Well, they did say no. When pressed for reasoning, they simply told us this is not a top priority and the dollar amount was not significant enough. Sometimes even the best innovations fail. This one failed because we were solving a problem that was important to us, but one which our biggest stakeholder did not think was important enough to solve. And for those of you who thought this story sounded familiar, it should. We see this same phenomenon occurring in vein disease where one provider will consolidate treatments while another will spread treatment out over time, by ablating individual branches or worse, even parts of branches, over multiple,
separately reimbursed visits. it’s not good for patients and it’s not good for payors, yet it continues.
BRINGING INNOVATION INTO CHRONIC VENOUS INSUFFICIENCY
While working within the necessary conformity that keeps patients safe, where can we innovate the treatment of chronic venous insufficiency (CVI)? Perhaps we first need to conduct a self-assessment. If we were each to look into the mirror, we’d likely see some striking similarities. We as an industry have fallen victim to conformity just like many other areas of medicine. In fact, I would argue that conformity has such a tight grip on us that the treatment of CVI is now a commodity. Thermal ablation is producing excellent and almost ubiquitous results, making it nearly impossible to differentiate ourselves based on outcomes. We all promote the same value proposition of being “virtually pain free.” “covered by insurance” and “no downtime.” We all tout our “patient experience,” but are any of us really doing anything remarkable? We are even targeting the same patient. Estimates suggest there are more than 30M people in the United States with CVI, yet only about 1.9M people at any given time are seeking treatment. Arguably, most, if not all vein specialists are targeting this 1.9M segment because it’s comprised of people who mostly understand they have CVI, recognize the affect it has on their quality of life, and as such, are most motivated to receive treatment. For these reasons it’s also the easiest segment to target.
DISRUPT OR BE DISRUPTED
I believe that we as an industry are comfortably fishing in a shallow clear pond of 1.9M people, rather than venturing out to the dark, deep waters to reach the larger 28.1M people. A great example of being too comfortable is how ride-sharing was able to completely disrupt the taxi industry. Taxi drivers were quite happy. They had predictable hours as well as a predictable cost/margin structure and medallions that they
could sell for retirement. That all got disrupted by outsiders who solved for problems that taxi drivers were not thinking about. These disrupters focused on two stakeholders – taxi customers and people who were looking for extra, flexible income. Lyft and Uber replaced these “skilled” drivers with other drivers who were thrilled to have this extra income. They replaced branded taxis with cars. They elevated the experience with on-demand technology. And they did all of this for a lower price. Taxi drivers did not realize they were disposable. They are scrambling to compete while some are sadly left with medallions that are now worthless. Similarly, we’ve gotten too comfortable with the predictable flow of those 1.9M people and we are ripe for disruption. Our healthcare system is complicated and it’s difficult to disrupt, but it doesn’t mean we should stop trying. The history of CVI treatment has taken us from the medieval and only partially effective surgical stripping, to thermal ablation, to new non-thermal, non-tumescent techniques. With this advancement in technology we have far better outcomes and greater convenience for the patient ,as well as less pain and no recovery. Yet after all this progression, we are still only reaching about 1/20th of the population. To innovate our staid industry, we need to get uncomfortable. I suggest we start with two questions: 1) I f the lowest hanging 1.9M people disappeared tomorrow, what would you do? Would you reach the 28.1M people, and if so, HOW? Who are these people? Why don’t they seek treatment? Are there sub-segments of the 28.1M that are more inclined than others to seek treatment? Why? What could motivate them? Is there a different delivery model that is more effective? Is there an alternative treatment or product that could be introduced to them and lead to subsequent treatment? What do they know about vein disease? Where are their gaps in knowledge? What motivates them? 2) Next, if we shifted our assumptions about patient attitudes, to one where patients see CVI treatment as entirely elective, regardless of the medical complexity and quality of life what would you do differently? How would we create a “want” for vein treatment versus a “need?” We don’t need to look far to find parallel worlds where patients have developed a strong desire or want for health far beyond those who need a solution. Look at the growth of “gut health,” now one of the top areas for research and product innovation in the direct to consumer and over the counter spaces. If you were to look at the revenue generated 10 years ago by providers who were specifically caring for the severe symptoms of gut health, such as Diverticulitis or Crohn’s Disease, for example, you would think the “need” focused pond is very limited. Now, look at what totally unrelated industries did to reach consumers and create a powerful “want” that exceeds the need. Companies in totally different industries created an awareness for gut health that drove consumer awareness and motivation with different messaging, different solutions, and different payor models. Two major categories made gut health a “want” for consumers: • Probiotics/Digestive Supplements: There has been an explosive growth in the probiotics industry in the past five years as well as in the number of supplements displacing vitamins on shelves.
JUNE/JULY 2018 < VEIN THERAPY NEWS
THEPRACTICE • Greek Yogurt: Chobani’s dynamic launch into the stratosphere marketed totally different benefits. As a result, the Greek yogurt category commanded more fridge space in most grocery stores, disrupting Dannon and other giants, leaving them to quickly try to follow with digestive health benefit claims. We not only have an opportunity to disrupt the treatment of CVI, we have a pressing need to do so. We have great examples of innovation all around us. Let’s use these as a source of inspiration to fuel our future with positive disruption. The greatest innovations are those that leave a reaction of “what a simple concept, why didn’t I think of that?” Sharing a ride is as simple as it gets. It’s the artful execution that is the breakthrough. Everyone who has a part in the treatment of CVI from front office staff to med techs to physicians and administrators can influence and bring about innovation and likely already have some great ideas. Your patients are a wealth of knowledge – ask them why they think such few people seek treatment and what you could do differently to change that.
Perhaps, our professional associations could lead a unified effort across our industry. At a minimum they could appoint work groups and/or dedicate time at annual conferences for this discussion. These are small first steps, but over time can lead to much needed innovation and will hopefully spare us from going the way of our taxi drivers. VT N Many thanks and credit to Tracy Thirion, innovation consultant, Bamboo Worldwide for her contributions to this article.
James R. Williams has more than 30 years of experience building regional/national healthcare companies and executing successful exit strategies. His primary focus is disruptive outpatient spaces including LASIK, varicose vein disease, proton therapy and other emerging cancer treatment modalities. As President of Miller Vein, he is leading the
A great example of being too comfortable is how ride-sharing was able to completely disrupt the taxi industry. Taxi drivers were quite happy and did not realize they were disposable until Uber and Lyft came along. development of a comprehensive operational infrastructure that will drive and support rapid growth. Additionally, he is an advisor to numerous healthcare companies and private equity investors.
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THE MARKETING BOT
How to use your tireless, high-ROI marketing genius By Scott Harvey It’s been said, and it’s pretty well-accepted, that e-mail is the “killer app” that turned the Internet from an interesting technology into the behemoth it has become. There’s no question that email, and its offspring such as various messaging apps such as Facebook Messenger and WhatsApp, have become the most powerful of all online marketing techniques. Think that’s too bold of a claim? Read on. Yes, if you want to aggressively expand your practice, you should have a Facebook page, and you need to be doing Facebook advertising. And SEO. And Pay-Per-Click advertising on Google (AdWords) and Bing. You should have some videos on YouTube and Vimeo. And I could go on. What those things do, however, is expose you to people who might visit your website or give you a call. Almost never are those people going to immediately make an appointment for a consult. You need to get those people to know, like and trust you. You need to “nurture” the relationship over time. The way you do that? You get their email addresses, usually by offering something of value in exchange.
Then a few more messages with pure good content, then another offer. And so on. How many messages? No limit. Seasoned users of sophisticated autoresponder sequences talk of conversions many months, even a couple of years down the road. (“Conversion” is marketing talk for “she did what you wanted her to do” -- in this case probably a phone call and a consult.) The genius of a good autoresponder sequence is that everybody doesn’t have to get the same message. The person who clicked to your website from your varicose vein ad on Facebook can get a different series of messages than the lady who read your blog post about spider veins. The woman who shows up for her consult, but doesn’t schedule, gets a different series of messages from the one who does schedule, which is different from the messages received by the woman who no-showed.
ENTER THE AUTORESPONDER
Here’s where the “Autoresponder” comes in. You’ve undoubtedly heard of the autoresponder, and you know that it’s software that sends out emails. We’ve found, though, that very few clinicians understand the power, the flexibility or the simplicity of a well-designed autoresponder sequence. So let’s dig in to that a little more. First you need the software. There are dozens of providers, such as MailChimp, Get Response, AWeber, iContact and even a weak offering by Constant Contact. The cost is trivial – from about $30 a month for most practices. Then you need a plan. We’ll come back to that in a minute. Then you need to sit down, or pay someone to sit down, and write a bunch of email messages. The beauty of the autoresponder is that once the emails are written, and the plan is designed, the emails go out absolutely automatically. Staff has to spend no time on sending them out, and over time you build a relationship with your prospective patient who begins to know, like and trust you. And because you’re in constant communication with her, you’re “top of mind” on that crucial day when she decides to actually do something about that varicose vein, or whatever else you’ve been talking about – and you’re the one she calls.
BACK TO THE PLAN
First, we’re not talking about a “blast” email that goes out once a month, or whenever you get around to it, where everyone on your list gets the same “GET YOUR VEIN ABLATION HERE!! TEN PERCENT OFF THIS MONTH!!” message. You can send, for example, a “thank you for subscribing” email immediately after someone opts in or subscribes to your blog, or otherwise gives you her email address. The next day, you send her some valuable content to “train” her to open and read your emails. Then you wait a few days before sending another email with great content, and at the bottom tie it in to a product or procedure you offer – GENTLY.
When someone has a vein ablation, she gets one series. A laser procedure, a different series. When she buys compression stockings, a different series. It’s not as complicated as it sounds. You and your marketing resource simply think through and flowchart out what you want to happen when something else happens (or when something hasn’t happened). You write the messages or have them written. You load them into MailChimp or whichever provider you decided on, with the appropriate settings and you’re done. When you bite the bullet and sit down to write a bunch of emails, you’ll probably find that you really get into the “flow,” and it will go more quickly than you thought. And if you really hate to write, there are plenty of people you can find on the web who can clean up your thoughts and make your messages pretty and persuasive. Think about it this way: Do you think that building a solid relationship with your prospects, automatically, would help just one more of them schedule a procedure in a month? What’s your average lifetime customer value? Five Hundred dollars? A Thousand? Five Thousand? More?
Let’s say its “only” $500, and you only get one new patient a month. Hmmm… Spend $30 and a little time to bring in $500 – sound like a good deal? SeeWhy (a company that works with large eCommerce websites) did a study a few years back about how people arrived at a particular website’s shopping cart, and what the “conversion rate” was from those visitors. (Conversion rate simply means who bought from the website, versus those who “abandoned” their cart – they didn’t purchase.) As with most, this study isn’t perfect because it can’t possibly track the entire process, and we don’t know every detail about the study. And sure, an eCommerce site isn’t a medical practice. However, here are some of the numbers: • 56.8 percent of the people that made it to the shopping cart came from an email sent by the company. 56.8 percent! • 4.3 percent of the shopping cart traffic came from social media. • 67.4 percent of the conversions (completed sales) came from the email visitors. • 2.1 percent (yes, just 2.1 percent) of the completed sales came from website visitors referred from social media sites Now before you start screaming that this is a completely unfair comparison, I agree with you! There is a huge difference in somebody on a company’s email list (typically either customers or at least qualified prospects) compared to somebody who was looking at pictures of Justin Bieber or cat videos on their friend’s Facebook feed and then decided to click over to the company’s website. And that’s my whole point! Get people on your email list who are decent prospects, then nurture them the right way with an autoresponder series, and most likely they will eventually schedule. So, when someone gets to your site, don’t immediately go for the sale. Don’t even go for the sale with some amazing discount. The odds are against you, because you haven’t built up the trust. Don’t offer her a free consultation. Just get her on your email list and nurture the relationship until she can’t wait to schedule! VT N Scott Harvey is the Co-Founder of Cosmetic Funnels LLC, a medical-only marketing agency, and author of “Plastic Surgeons: Are You Getting Your Share?”
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JUNE/JULY 2018 < VEIN THERAPY NEWS
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Changing from elastic bandages to short-stretch bandages increases working pressure, can decrease swelling and control patient discomfort. Cotton tubular stockinettes and reusable short-stretch bandages (BiaForm used here) are more convenient for patients who can change their own bandages. LYMPHEDEMA
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bilateral lower extremities demonstrated axial reflux in the bilateral great saphenous veins. She had technically successful endovenous ablations and was feeling well at her one-week evaluation. Several weeks after her procedures, she developed increased swelling, a “tight” discomfort in the calves and worsening erythema in the left leg. Her right lower extremity had done well and was asymptomatic, but her left leg now felt worse. Repeated duplex ultrasound did not demonstrate residual superficial or deep vein disease, and she was unable to don her compression stocking on the left leg. A CT venogram of the pelvic veins was performed and the findings were unremarkable. Although rare, I have seen similar episodes of increased swelling after endovenous ablations, without objective evidence of venous obstruction. As with these other rare episodes, typical causes of lower extremity swelling (e.g. congestive heart failure, pulmonary hypertension, iliac vein compression syndrome, residual chronic venous insufficiency, deep venous thrombosis, renal failure and hepatic failure) were excluded. Asheekh A, et al published a study in 2017 reporting that 16 percent of patients had persistent swelling despite successful endovenous saphenous vein closure and iliac vein stenting. Although routine iliac vein stenting is controversial, the results of this study suggest that residual swelling after endovenous ablations can have little to do with the venous circulation. I suspect that many cases of persistent swelling after vein ablations are due to phlebolymphedema. Chronic venous hypertension will increase pressure in the blood capillaries and increase peri-capillary fluid. E. Kaiserling reports “glomerularlike convolution of a few capillaries” that decrease shear-stress and promote transmigration of inflammatory immunocytes. The accumulation of antigens, foreign material, and immune complexes in the interstitial space causes chronic localized inflammation, fibrosis and stagnant lymphatic flow.
A Stemmer’s sign is a classic diagnostic tool for lymphedema, but not a required one. Secondary lymphedema can often affect tissues in a “descending” or localized pattern. There can be affected areas in the leg that spare the skin thickening over the base of the second toe. Remember though, a negative Stemmer’s sign does not exclude lymphedema. Pittaluga et al conducted a retrospective review of lymphatic complications after varicose vein surgery in 2012. Of 5,407 surgical limbs, 118 (or 2.2 percent) had lymphatic complications; however, the majority of these complications were a result of saphenous stripping and revision surgeries. There was a 0.5 percent lymphatic complication rate with isolated phlebectomies. Although they did not measure the rate of lymphatic complications with endovenous ablations, I suspect the complication rates are similar. Pittaluga et al were also able to identify three factors that can increase risk for developing lymphatic complications after surgery: age, trophic skin changes and obesity. Pittaluga et al noted a 14.7-fold increase in lymphedema if the BMI was greater than 30 (31.4 percent vs. 5.4 percent). The group with lymphatic complications was also older (age 59 vs. 53) and had higher rates of C4-C6 disease (22 percent vs. 6.5 percent). Failure of elastic, or circular-knit, compression stockings to contain lower extremity swelling is often my first clue identifying post-operative lymphedema. Higher protein loads in lymphatic fluid increase viscosity and require higher pressures for fluid egress. Changing from elastic bandages to short-stretch bandages increases working pressure, can decrease swelling and control patient discomfort. Gauze rolls and cohesive bandages are an inexpensive shortstretch option, but the materials are difficult to apply without creases and often slip. Cotton tubular stockinettes and reusable short-stretch bandages (I use BiaForm, 5m rolls in varying widths) are more convenient for patients who have learned how to apply their own leg wraps. For patients who have discomfort from uneven wrap-pressure distributions, padding may be required. An additional layer of open-cell foam (I use LympheSoft 12cm x 2.5m x 0.4cm) will often redistribute bandage pressures, increase patient comfort and help maintain position of the bandages.
Changing “April’s” compression stockings to short-stretch bandages reduced her swelling to normal levels. She now wears a Velcro compression garment daily on the left leg that contains her swelling and her right leg remains asymptomatic. Although this was not her expected outcome, her symptoms are now controlled, and she is now more active than before her treatments. We are fortunate to have a certified lymphedema therapist near our clinic, and I referred April to her for manual lymphatic therapy. It seems venous and lymphatic circulations are inextricably tied. Lower extremity edema should be defined as lymphedema, regardless of its primary cause. Response to compression types would then be less related to disease classification and more related to lymph protein loads and an individual’s lymph transport capacity. It may be difficult to ascertain a patient’s underlying lymphatic health, especially in patients who have latent, or stage 0 lymphedema. I now discuss the possibility of procedure-related lymphatic complications with patients I consider to be at risk: age greater than 60, BMI greater than 30 and presence of C4-C6 disease. VT N Timothy Cawlfield, MD, is a phlebologist specializing in the treatment of vein disease at American Vein & Vascular Institute. As a general practitioner licensed to practice medicine in Colorado with specialties in vascular disease and family medicine, Dr. Cawlfield has a hospital affiliation with Parkview Medical Center in Pueblo, Colo.
1. Carlson J. Lymphedema and subclinical lymphostasis (microlymphedema) facilitate cutaneous infection, inflammatory dermatoses, and neoplasia: A locus minoris resistentiae. Clin Dermatol 2014 Sep-Oct;32(5):599-619 2. Pittaluga P, Chastanet S. Lymphatic complications after varicose veins surgery: risk factors and how to avoid them. Plebology 2012;27(suppl. 1):139-142
JUNE/JULY 2018 < VEIN THERAPY NEWS
EVLA KIT ALL THREE ONLY 3. T he diagnosis and treatment of peripheral lymphedema: 2013 consensus document of the ISL. Lymphology 2013 Mar;46(1):1-11 4. Abouelkheir G, Upchurch B, Rutkowski J. Lymphangiogenesis: fuel, smoke, or extinguisher of inflammation’s fire? Experimental Biology and Medicine 2017 Mar; 8:884-895 5. A lsheekh A, Hingorani A, Marks N, Ostrozhynskyy Y, Asher E. Clinical correlation with failure of endovenous therapy for leg swelling. Vascular 2017 Apr;25(3):249-252 6. Farrow W, Phlebolymphedema – A Common Underdiagnosed and Undertreated Problem in the Wound Care Clinic. J Am Col Certif Wound Spec 2010 Apr 22;2(1):14-23 7. Földi E, Földi M, Lymphostatic diseases. In Földi’s Textbook of Lymphology. 3rd ed. Munich, Germany: Elsevier; 2012. p. 175-218. 8. Földi M, Chronic venous insufficiency. In Földi’s Textbook of Lymphology. 3rd ed. Munich, Germany: Elsevier; 2012. p. 374-384 9. K aiserling E, Morphological findings in lymphedema and tumors. In Földi’s Textbook of Lymphology. 3rd ed. Munich, Germany: Elsevier; 2012. p. 262-266.
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Global CVC market to grow at 3.94% The “Global Central Venous Catheters (CVCs) Market 2017-2021” report has been added to Research and Markets’ offering. The CVCs market is expected to grow at a CAGR of 3.94 percent during the period 2017-2021. The report has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The latest trend gaining momentum in the market is the rising popularity for antimicrobial CVCs. CVCs are the prominent way of facilitating fluids, medications, and intravenous nutrition especially for oncology patients and people living with other chronic conditions. CVCs reach little longer and deeper into major veins that are designed for long term secure durable IV access. VT N
VEIN THERAPY NEWS < JUNE/JULY 2018
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Most venous disease can be classified as cosmetic
By Ronald Bush, MD, FACS In 1992, I left a busy practice of thoracic and vascular surgery and began the in-office treatment of varicose veins. At that time, high ligation and stripping using tumescent with ultra sound guided assistance was our treatment of choice for saphenous insufficiency. Since that time, many changes have occurred in the treatment of venous disease including, but not limited to, lasers, radio frequency, foam sclerotherapy, glue and numerous other devices for the treatment of deep venous pathology. I have been associated with many of the vein conferences over the years. However, most of these conferences lack specific information on how to deal with the many aspects of venous disease. About 80 percent of all patients can be classified as cosmetic even if they have saphenous insufficiency. Many times, the insufficiency is secondary to the cosmetic issue. Most patients present with either spider veins or enlarged veins in other areas of the body such as the hand and face. Very little is written about the pathophysiology of venous disease manifested at the skin level. All stages of venous disease can be evident from just examining the skin. The skin, being the largest organ of the body, contains clues to abnormalities located in the systemic and venous system. Think of this concept as follows: • Class I – Spider veins are the result of transmitted pressure (Cutaneous Venous Hypertension from a deeper source). Based on our extensive histological research, all telangiectasia occurs in the reticular dermis. The average depth is 700 microns. • Class II – Class ll disease is actually a manifestation of varicosities, which are subdermal. • Class III – Class lll disease is manifested as edema or swelling of the dermal and subdermal tissue. • Class IV-V – Class IV- V is manifested by changes in both the dermis and squamous layer. So, in essence, all forms of venous disease are manifested by transmission of pressure to a small area that measures only 1.5mm in thickness. Based on our extensive work in the dermatopathology lab at Water’s Edge Dermatology, we have been able to determine the effects of different modalities of treatment to various
Intact Vascular praises analysis of TOBA BTK clinical trial study Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, has praised the publication of the Tack Optimized Balloon Angioplasty Below the Knee (TOBA BTK) clinical trial results in the current issue of Catheterization and Cardiovascular Intervention. This multi-center pilot study focused on collecting data supporting the safety and performance of the Tack Endovascular System® in subjects with Critical Limb Ischemia (CLI) due to vascular disease below the knee. Thirty-five subjects were enrolled at six sites in Europe and New Zealand in the TOBA BTK study, which targeted diseased tibial arteries for dissection repair following plain balloon angioplasty.
Large dilated spider veins are contained in the reticular dermis.
Dilated intradermal spider vein aneurysms
pathological venous conditions. We have also been able to incorporate micro-surgical techniques based on our extensive studies.
in using foam sclerotherapy on the face is not blindness, but superior ophthalmic vein or cavernous sinus thrombosis. None of the established vein conferences discuss in detail the mechanism and possible complications of sclerotherapy for telangiectasia. Aesthetic Vein Conference provides details on cellular interaction in sclerotherapy as well techniques to avoid and treat complications. Aesthetic Vein Conference goal is to provide a scientific basis for the treatment of venous disease in all locations and discuss techniques to provide rapid cosmetically superior results. The following images represent a challenge in treating spider veins. Spider vein aneurysm dilations is more prominent than you might think, and special techniques must be done to clear them up. VT N
AESTHETIC VEIN CONFERENCE
Due to the lack of specific knowledge that most practitioners have in the treatment of numerous cosmetic issues of venous disease, we have developed the Aesthetic Vein Conference, an intensive course based on histology and anatomic principles that allow for safe and effective treatment for many vein related problems. The next Aesthetic Vein Conference is Oct. 13. For additional information, call 407-900-8346 or see aestheticveintraining. com. Conference fee is $400 and is limited to the first 75 to register. A few of the topics included in the conference include spider veins, varicose veins, hand veins, breast veins and, most importantly, veins of the face. Ultrasound, ohmic thermolysis, laser and sclerotherapy will be demonstrated in patients with complex problems. In our clinic, we have treated more than 200 patients with dilated facial veins using foam sclerotherapy. Aesthetic Vein Conference will demonstrate new techniques as well as debunk many of the long-held tenants of the treatment of venous disease. Our guidelines for treatment of facial veins are based on anatomic principles and foam containment. The greatest risk
Ronald Bush, MD, FACS is one of the nation’s foremost specialists in venous disease and practices at Water’s Edge Dermatology in Stuart, Fla. Dr. Bush co-founded and is the medical director for Vein Experts, a national group of professionals specializing in the care and treatment of venous disease. He has published numerous peer reviewed journal articles and is an innovator of many techniques utilized in the treatment of venous disease. He is board certified in vascular surgery. Dr. Bush is also course director of Aesthetic Vein Conference, held twice each year.
The analysis of the TOBA BTK data demonstrates one-year primary patency via Kaplan-Meier estimate of 77.4 percent. Additionally: • 93.5 percent freedom from Clinically Driven Target Lesion Revascularization (CD-TLR) • 93.5 percent freedom from Clinically Driven Target Vessel Revascularization (CD-TVR) • 84.5 percent amputation-free survival (AFS). “The number of patients being treated for critical limb ischemia is rapidly growing, making it vitally important to optimize post-angioplasty results and minimize metal burden to improve blood flow and allow wound healing” said Professor Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, Medical University Graz in Austria. “I believe that the Tack Endovascular System provides a promising option to treat post-angioplasty dissection in this very challenging patient population.” The TOBA BTK multi-center pilot study was the first known industry-sponsored study designed to investigate a
permanent vascular implant in arteries below the knee for focal dissection repair. The Tack® implant is a first-of-its kind device for precision dissection repair following balloon angioplasty. The system is designed to help maintain vessel integrity and improve blood flow to promote healing, improve outcomes and preserve limbs. The system leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options, according to Bruce Shook, Intact Vascular’s President and CEO. Unrepaired dissections – which are frequent following balloon angioplasty – increase the probability of acute arterial occlusion and may continue narrowing the artery, which leads to lower long-term patency rates. “We are very pleased with the results from the TOBA BTK study and the expanding publication of peer-reviewed clinical evidence supporting the Tack Endovascular System,” Shook said. VT N
JUNE/JULY 2018 < VEIN THERAPY NEWS
SECONDLOOK American Vein aids Health4Haiti by donating 50 sets of scrubs American Vein & Vascular Institute recently donated more than 50 sets of scrubs to Health4Haiti, a non-profit that improves lives and healthcare outcomes for the citizens of Gonaives, Haiti. Gonaives is currently served by one public hospital, according to Health4Haiti’s website (healthfourhaiti.com), and that hospital has been destroyed twice due to hurricane flooding in 2004 and 2008. There remains a great need for additional support to improve the area’s medical care infrastructure. Health4Haiti is a 501(c)(3) medical humanitarian organization dedicated to improving the lives and health care of people in Gonaives, a city of more than 350,00 people in Haiti. The Health4Haiti Partnership began as a series of mission trips made by parishioners of Pueblo, Colorado’s Ascension Episcopal Church in 1999. After Hurricane Jeanne flooded the city in 2004, the original group asked St. MaryCorwin Health Foundation in Pueblo for its help to re-equip the hospital and to re-open its operating rooms. The result was a three-year grant from Catholic Health Initiatives (CHI) in support of this mission, sending a medical team each year to re-open and maintain the operating rooms, to treat patients, and to build a new clinic at the Episcopal Church and School. Five other foundations have provided grant support as well. Since receiving the grant, Health4Haiti has re-equipped the hospital twice with desperately needed equipment such as anesthesia machines, X-ray machines, surgical instruments, neonatal incubators, oxygen concentrators and beds. “Health4Haiti is grateful for your generosity and support,” Jim Smith, MD and president of Health4Haiti, said. “The employees of the clinic in Gonaives, Haiti will be happy to have new scrubs to wear at work. The clinic has been providing much-needed healthcare to the citizens of Gonaives since 2010.” American Vein & Vascular Institute is an award-winning network of vein and arterial diagnosis and treatment centers in Colorado and Texas. For further information, see americanvein.com. VT N
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Whether you read it on the web May 6 or here in July, there’s no healthcare without nurses By Larry Storer I hesitate to observe worthy days or weeks because with Vein Therapy News (VTN) being a bimonthly, it is difficult to put the printed version in your hands on that date or even that week. But National Nurses Day was May 6 and National Nurses Week ended May 12, and we did praise the work nurses did on May 6 on the VTN website, which we are able to update daily. I also wanted to observe that day in the printed version as well, so if it seems like we’re a month late, well we are. National Nurse’s Week ended on May 12, which is Florence Nightingale’s birthday. Nurse Nightingale, who came to prominence while serving as a British manager and trainer of nurses during the Crimean War, is the founder of modern nursing and it’s appropriate that on her birthday we celebrate the nursing heroism in our lives.
The dedication and sacrifice of nurses, who often provide the leadership that keeps the practice running smoothly, is often overlooked and unappreciated. Last week, I suppose I talked with at least a half-dozen physicians, and not one could do his or her job without the nurse or nurses who stand next to them. Some of the physicians on the VTN Editorial Advisory Board regularly praise the nurses in their lives and working in their vein practices – such as Cassi White, RDMS, at Advanced Surgical Concepts in Chattanooga, Tenn.; and Peggy Bush, MSN, ACNS-BC, at Vein Med Consultants and Water’s Edge Dermatology in Palm Beach Gardens, Fla. Every day, compassionate and dedicated nurses do the preparation for and the followup necessary to promote better patient care. I know this from a personal as well as a professional viewpoint. Before I get my 10 minutes with my own doctor, a good nurse does a thorough triage so the conversation with the doctor is more meaningful and productive with less time spent looking at the computer and more time looking at and listening to me. And after my doctor leaves the room, the nurse answers all the questions I meant to ask Doc and forgot, and he – or sometimes she – does it all with kindness, compassion and care. Everyone works hard in small and large practices throughout our phlebology community, but nurses are always short on
time and wear many hats. The dedication and sacrifice of nurses, who often provide leadership that keeps the practice running smoothly, is often overlooked by a physician focused on healing; and unappreciated by patients who may be having the worst day of
their life. As one physician said last week, her nurses provide extraordinary care to every patient, every time whether the nurse is having a good day or not; or is feeling great or silently enduring pain in his head or in her back or
probably always in their feet. But the nurses who enhance my personal healthcare and those who sometimes help with getting information for articles in VTN may not have read this message on May 6 or May 12 or not even until June when their copy arrives in the mailbox because with a bimonthly print schedule, I would had to have had the forethought to extend my thanks for your compassion and care way back on March 6 to get it in the May print issue – and I just don’t think that far in advance very often anymore. Whenever you read this – whether it was in May on the website or in June when it arrives in the mail – my wish is that someone much more important to you than me regularly tells you “Thank YOU” for selflessly serving the patients who come in with problems related to their veins; “thank YOU” for staying late to support the doctor, the patients and their families; and “thank YOU” for coming in early to get things ready for the day. Thank you for your crucial, critical and essential service, and Happy Nurses Week every week. VT N
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VEIN THERAPY NEWS < JUNE/JULY 2018
SECONDLOOK RESEARCH SUMMIT
ACP can provide a grant from the ACP Foundation to fund the research. “We are on the cutting edge,” Dr. Jenkins said.
“I walked out of the summit thinking that myself and my committee have a lot to do,” Dr. Jenkins said with a laugh. “We have all this information and we need to start delving in and analyzing the data.” Naomi Sinclair, the ACP research and registry director, spoke highly of the summit outcome. “It went well,” she described. “We broke people out into small groups that matched what they do for a living with each group headed by an appointed table leader. Each group worked together to develop research/registry questions and presented their results. We obtained some very useful information.” Participants were experts from seven areas: endovenous ablation headed by Kathleen Gibson, MD; sclerotherapy headed by Domenic Zambuto, MD; ambulatory phlebectomy headed by James Heinz; deep veins/pelvic veins headed by Peter Pappas, MD; lymphedema headed by Chris Pittman, MD; compression headed by Yung-Wei “Willy” Chi, DO; and venous ulcerations headed by Caroline Fife, MD. “I thought it was a very successful meeting,” said ACP Board of Directors President Neil Khilnani, MD. “The idea is try to craft new research questions that we could answer using our registry in seven different subject areas, and then also to craft what might be considered quality measures that track the performance of physicians.” Each of the presenters used a variety of techniques, from paper to PowerPoints, to illustrate the challenges and opportunities they had in their area of expertise. Dr. Khilnani said each table did a fantastic job in the time that was allotted to identify where the gaps in the data are, identify the types of questions that would be appropriate, and the types of data that would have to be collected to answer those questions. “Ultimately at each table we determined the more impactful, important issues and we can now drive towards them being answered,” Dr. Khilnani explained. “Our plan is to take those research questions, put them into individual documents that each table captain will present to the ACP’s research committee and eventually work toward both answering the questions and potentially even changing what we’re collecting in our registry so we have the data we need in order to accomplish what we want to accomplish.”
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NEW RESEARCH FRONTIERS
About 5 percent of the patients in the registry are lymphedema patients and about 2 percent are thrombotic patients, Dr. Schul said. The rest are a mix. That’s a lot of data on interventions and complications, and plans are now in place to take great strides to use that data effectively through research, partnering with industry on products and market research, and improved patient care for those disorders where less is understood about procedures and interventions. Dr. Jenkins said that with the amount of data that is in the ACP PRO Venous Registry, it will be possible to answer some large-scale research questions. “Instead of having 75 people in a study done by a tertiary care center or university medical center to answer some of these questions, the hope is we can answer them with several thousand people,” he said. “That’s the beauty of the registry.” It’s soon to be achievable, he explained, given the questions that the tables asked at the research summit. Once the data is analyzed, ACP can take the data to the research committee and ask them to find someone to research the questions. Then the researcher will already have the data and the questions, and
Back in 2009, Dr. Schul hired an assistant to put all his patients into an existing registry. It was costly, duplicate work. The data also revealed a lack of quality of life measures. “The question became, ‘What should we capture and how were we going to show a benefit from this? because the data available at that time just wasn’t powerful.” Drs. Schul and Chi had a vision of capturing patient’s voices as they collected data, avoiding duplicate entry and automating the data entry. That was not possible until they started working on their platform of templatized data. “It’s the aggregate of data that matters,” Dr. Schul explained. “It’s how you establish best practices when you’ve got many different technologies that are being used and many different providers with different approaches.” With a large amount of data and some quality measures in place, it is much easier to show that one approach works better than another at reducing pain, or that risk of recurrence is less with one approach than with another. “All of these things are reportable,” he explained. “Patients do their part by filling out these questionnaires – and these questionnaires are simple, using six questions and 18 more that are about the severity of a given symptom – so it’s easy and with that then you get more users, you get more compliance, you get something that can actually measure vein care in our country. We’re on the cusp of that.”
QUALITY MEASURES DEFINED
Each table was given the information (mapping document) within ACP PRO Venous Registry, and was tasked with coming up with a minimum of two questions in their area of expertise that needs to be answered from a research standpoint. The other goal was to discuss what was needed to achieve Centers for Medicare and Medicaid Services (CMS) certification of the registry. In 2016, ACP PRO Venous Registry was designated a Meaningful Use specialized registry by CMS as part of its EHR Incentive Program. However, as of now it is not CMS-certified as a sub-specialty registry. To achieve that, the team is tasked with developing quality measures that satisfy CMS. MIPS, Medicare’s Merit-Based Incentive Payment System, and MACRA, the Medicare Access and CHIP Reauthorization Act, are the programs that determine Medicare payment adjustments whereby eligible professionals may receive a payment bonus, a payment penalty or no payment adjustment. In 2017, Dr. Jenkins said the quality portion of MIPS reporting accounted for 60 percent of a physician’s score. MIPS and MACRA don’t provide payment adjustments unless their quality measures are reached, but for many venous patients, and particularly lymphedema patients, there are no accepted quality measures. Dr. Jenkins said he is meeting quality measures by asking some of his patients things that don’t reflect his vein care, such as whether one of his vein patients has received a colonoscopy screening for cancer. Not only is that extra data he has to put into his records that doesn’t affect his vein care, it’s not asking the questions that truly matter regarding this patient’s venous disease experience. “The point of getting the registry certified by CMS is that you’re providing them with quality measures that are useful in the vein world.” Only one quality measure is currently recognized and that’s one provided by the Society of Interventional Radiologists regarding endovenous ablation of the great saphenous vein.
In order to provide that quality measure, the physician must be a member of that society, so Dr. Jenkins’ and others’ vein practices don’t qualify. “I have to use six other measures from primary care,” he said. “I’m measuring colonoscopy, BMI, smoking, fall risk, medications in the elderly and pneumococcal vaccines. I don’t even give pneumococcal vaccines but I use that and we collect that.” Dr. Jenkins and his committee are now focused on having at least six quality measures that are vein-specific.
PRO VENOUS REGISTRY The ACP’s PRO Venous Registry is one of three registries in the vascular and venous space for research. The Vascular Quality Initiative or VQI, is now governed by the Society for Vascular Surgery Patient Safety Organization. The other one, Venous Patient Outcome Registry (VPOR), is a registry database that is now the property of the ACP. While the others are built on manual data entry, the PRO Venous Registry uses EMR exports of information. When the doctor fills out EMR forms to be transmitted to CMS so they can be paid, the PRO Venous Registry taps into those EMR forms and automates the data submission process to map the physician’s EMR exports into the registry. This means that the participating physician fills out the forms one time for CMS, but the PRO Venous Registry allows them weekly or monthly exports of all their patient outcome information automatically into the registry.
PLANNING FOR THE FUTURE Dean Bender, ACP and ACP Foundation executive director, said the biggest benefit to the summit lies in the fact that it can successfully bring together influencers from industry as well as patient care to discuss where resources need to be invested to understand venous and lymphatic disease and help patients. “Our corporate partners, as well as our physician partners, come together and share different ideas of what the future will be and we’re able to do that in a way that’s not commercially driven or rife with ulterior motives,” Bender said. Dr. Schul agreed. “This type of meeting is great because there’s no ego,” he said. “It’s really about what’s best for the collective body of physicians and the patients. We’ve got a lot of bright minds that are focused on patients that want to come out of this summit with a new set of initiatives. We’ve got a machine that’s collecting data and that data is growing exponentially, and it’s soon to be the largest registry in the world. That’s not a bad position to be in.” VT N
JUNE/JULY 2018 < VEIN THERAPY NEWS
SAVE THE DATE!!
Spring and Fall Residents & Fellows Courses 2018 Spring Residents and Fellows Course May 18-20, 2018
2018 Fall Residents and Fellows Course December 7-9, 2018
Englewood Hospital and Medical Center 350 Engle St, Englewood, NJ 07631
University of Texas San Antonio San Antonio, TX
The Residents and Fellows Course in Venous Disease is presented for the benefit of Fellows and Residents within the specialty of vascular surgery, interventional radiology, cardiology, vascular medicine and associated programs.
Dress is casual including dinners.
The goal of the course is to educate and update the Fellows and Residents regarding the latest theories and developments in the clinical practice of vein disease management. Residents and Fellows will gain an overall understanding of vein disease to allow them to successfully incorporate venous knowledge, skills and techniques into their overall practice as they make the transition from training to the clinical practice.
FEES Residents and Fellows in an accredited training program, do not pay registration fees to attend. In addition, the AVF provides a travel stipend, hotel accommodations, and meals while at the Course. “Attendees must provide a credit card to hold their hotel reservation. If registration is not cancelled three weeks prior to the event, the credit card will be charged for one-night hotel”
ADDITIONAL BENEFITS OF ATTENDING By attending the 2018 Courses you will receive complimentary registration to AVF’s 2019 31st Annual Conference scheduled to take place at the Westin Mission Hills Golf Resort and Spa in Rancho Mirage, CA from February 19-22, 2019. You will also receive one-year complimentary Resident/Fellow membership to the American Venous Forum, and all of the membership benefits associated with an AVF membership. (Please note that the complimentary conference registration and membership are nontransferable or redeemable for cash).
FELLOWS GRANT - TRAVEL REIMBURSEMENT The courses are funded through a Grant Program that covers registration and travel expenses. To be eligible for the grant, all participants are required to attend the entire course. Each will receive two nights of lodging at the designated hotel, transportation to and from the airport, and food and beverage supplied during the course. AVF will reimburse travel expenses up to a total of $550. This includes travel to and from the course (i.e., coach airfare, gas mileage, train ticket, etc.), parking and nominal food and beverage purchases on days of travel. Please note that our policy is that all travel reimbursements must be submitted within 30 days of the completion of the course.
NOTE: Alcoholic beverages will not be reimbursed. A travel reimbursement form will be provided. Each Resident and Fellow must complete their own reimbursement form and forward it to the AVF office along with itemized receipts to receive reimbursement. Failure to provide completed form will delay reimbursement. NOTE: Failure to attend the entire course will result in forfeiture of any travel reimbursement.
http://www.veinforum.org For more information regarding the Spring and Fall Residents and Fellows Courses or anything AVF related please contact the AVF office at (727) 350-1580 or email us at email@example.com, or www.veinforum.com, or check us out on social media.
Dermaka has new enhanced natural healing formula Dermaka cream is an all-natural plantbased product that aids in skin healing, rejuvenation, and substantially reduces redness and bruising. Dermaka cream was developed by Ronald Bush, MD, FACS, to minimize bruising and inflammatory responses of the skin in the post-operative period. While the product has been around for several years, it now has a new enhanced formula. The new formulation, dermatology tested and approved for a variety of skin issues, remains completely natural. The current changes include increasing the concentration of arnica and licorice root extract. Lab studies have demonstrated that the new formulation of Dermaka is providing an even more rapid resolution of bruising and inflammation. Licorice root extract, nature’s most potent whitener, lightens skin imperfections. Dr. Bush said that histological evaluation reveals rapid absorption of red blood cells in the reticular dermis. Patients report diminished redness and bruising. Using Dermaka cream will improve patient outcomes! “Physicians who have incorporated Dermaka cream into their treatments have seen excellent results,” he said “Dermaka cream has also been very effective on patients who are on blood thinners.” Dr. Bush said clinical tests of this unique combination of natural extracts, essential oils and vitamins have demonstrated excellent results and exceptional satisfaction. The natural plant extracts include • Arnica Montana flower extract and Bromelain (pineapple extract), which are effective natural ingredients to decrease redness and bruising; • Gllycrrhiza Glabra (licorice) extract is a potent agent that helps reduce discoloration (red and brown) after treatment; • Camellia Sinensis (Green tea) extract is a powerful anti-oxidant that protects from the harmful effects of skin damage; • Chamomilla Recutita (Chamomile extract) has both anti-inflammatory and antiseptic properties and helps calm the skin; and
Then essential oils and vitamins were added to the extracts, including: • Tocopheryl Acetate (Vitamin E), which is a natural skin conditioning agent and antioxidant; and • Retinyl Palmitate (Vitamin A), which has suburb antioxidant and moisturizing capabilities. Vitamin A helps to regenerate damaged cells. Dr. Bush explained that all these ingredients are inert and well-tolerated by most people with little chance of adverse reaction. In the several years that Dermaka has been in the marketplace, no side effects have been reported. Like any skin product, if irritation to skin occurs during use, it should be discontinued. John Happel. MD, FACS, who owns Happel Laser and Vein Center in Pittsburgh, Penn., said Dermaka cream is amazing. “As a board certified vascular surgeon specializing in veins, I recommend it to my patients to decrease bruising and inflammation and to speed up healing after vein treatments,” Dr. Happel said. “It can also be used in other circumstances like after plastic surgery or after everyday bruising. Best of all, it’s all natural which my patients love.” Dermaka should be applied two to three times daily or as instructed by a healthcare professional. Apply by lightly massaging into skin for 15 seconds. Dermaka is odorless, colorless and leaves no residue. The product is sold from its website, and from some vein clinics. VT N READ MORE: dermaka.com
Fujifilm release visualization units to improve minimally invasive procedures Fujifilm is releasing a couple surgical visualization systems that were designed to improve minimally invasive procedures. The Fujifilm EL-580FN Ultra-Slim Video Laparoscope System uses the firm’s own Super-Honeycomb CCD sensor to produce high quality images that are sharp and reproduce colors accurately. So-called “Chip on the Tip” high definition digital image processing helps improve quality and antifogging features allow for a quality image to appear in the first place. The imaging device is autoclaveable, light and features a 3.8mm distal end diameter, nearly half that of most of the competition. The EPX-4440FN Digital Video Processor System that it works with generates 1080i HD imaging. Automated lighting and anti-blur capabilities work together to maintain a highfidelity image. The Fujifilm Full High Definition Surgical Visualization System comes with a choice of rigid scopes, cameras, and processing options,
depending on the specialty and application. If features algorithmic edge enhancement, selective color enhancement, automatic gain and dynamic contrast, helping to maintain a well seen image during varying procedures. There are smoke reduction features as well. Strong illumination makes sure the scene is well lit, but the surgeon can adjust the level of the LED light anywhere from 5 percent to 100 percent power.VT N READ MORE: Fujifilmusa. c o m /p r e s s /n e w s /d i s p l a y_ news?newsID=881395
Flexitouch Plus activates lymphatic system to move trapped fluids away Lymphedema is a disease in which fluid is retained in the legs, arms, and other parts of the body, resulting in pain, discomfort, and even disability. A new device from Tactile Medical, a company out of Minneapolis, Minn., is designed to activate the lymphatic system so as to help move fluids away from where they’ve gotten trapped. The Flexitouch Plus, cleared by the FDA last year, consists of a blanket with dozens of individual air pockets and a controller pump that sequentially inflates and deflates the pockets. The result is a pressure wave over the affected part of the body that works like a programmed and perfectly timed massage to help move the fluids. This is the third of the Flexitouch devices and new features include a color screen, new interface, and a way to save multiple therapy presets. Both legs can now be treated at the same time, reducing the overall time of each therapy session. The Flexitouch system is an advanced intermittent pneumatic compression device (lymphedema pump) used by tens of thousands of patients to self-manage lymphedema and nonhealing venous leg ulcers. “I am pleased to announce the full commercial launch of our new Flexitouch system, Flexitouch Plus, following the success of our limited market release,” Tactile Medical CEO Gerald R. Mattys stated. “The design of this next-generation system was influenced by feedback obtained from our patient and clinician customers and was developed with the goal of enhancing the overall user experience. “Based upon the positive reception we received during our limited market release, we believe we have designed a system that will allow our patients to treat their lymphedema more easily and efficiently.” VT N READ MORE: tactilemedical. com/products/flexitouch-system/
FDA OKs SurModics low-profile PTA dilation catheter SurModics Inc., a provider of medical device and in vitro diagnostic technologies to the healthcare industry, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its .018-in. low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed and indicated for a broad range of peripheral vascular applications. Gary Maharaj, president and CEO, said the product is the result of the company’s ongoing investment in a pipeline of highly differentiated whole-product solutions. SurModics expects to make the product available for distribution in the coming months. He said this new low-profile product combines its most advanced balloon technologies with SurModics’ proprietary, lowfriction, low-particulate Serene hydrophilic coating for superb tracking and unmatched lesion crossing performance, while delivering high pressures and a broad offering ranging from 2mm to 10mm diameter. “We are delighted to announce this latest of three recent FDA clearances, adding further depth to our proprietary product offerings,” Maharaj said. “With the .018-in. low-profile PTA balloon catheter, we continue building upon SurModics’ portfolio of differentiated products that are designed to advance the treatment of vascular disease. “This regulatory milestone adds to the recent clearances of the Telemark .014-in. Support Microcatheter and the .014-in. BTK Balloon Dilatation Catheter.” VT N READ MORE: surmodics.com
Beacon tip catheters back after recall Physicians in the United States and Canada are once again able to order the Beacon Tip Torcon NB Advantage 5 Fr Catheter that is used in angiographic procedures. In 2015 and 2016, Cook recalled all Beacon Tip Catheters due to an unexpected increase in complaints. The relaunch comes after significant testing by engineering following the global recall. A change that customers will notice is a new foil outer packaging that provides a barrier against environmental factors that were identified as contributing to the recall. After the recall Cook received a high volume of physician responses demanding the product. The company devoted many resources to determine the most efficient path back to market. VT N READ MORE: CookMedical.com/beacon
JUNE/JULY 2018 < VEIN THERAPY NEWS
Innovation and Exploration in Venous Interventions
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VEIN 31 THERAPY NEWS < JUNE/JULY 2018
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CJ van Vlijmen, SA Gauw, P Pronk, MC Mooij, MTW Gaastra, JA Lawson. Randomized study Endovenous Laser Ablation versus RF VNUS ClosureFAST of Incompetent Great Saphenous Vein Using Tumescent Anesthesia Saphenous Vein: One year results. Veldhoven, Netherlands 31 May 2013
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JUNE/JULY 2018 < VEIN THERAPY NEWS