Vein Therapy News by Digital Publisher

INSIDE OCTOBER/NOVEMBER 2015 Vol. 8 No. 6 VEINTHERAPYNEWS.COM

Digital marketing strategies Marketing your vein practice A vein by any other name IAC accreditation tips Educating our educators

16 22 34 36 42

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

VEIN SPECIALISTS OF AMERICA • A DECADE OF SERVICE

1st 50 practices achieve IAC Vein Center accreditation; updated standards published By Lowell Kabnick, MD, RPhS, FACS, FACPh

VSA adds physician training to practice Vein Specialists of America celebrates its 10th year of service by launching a new national Physician Training Academy program under the direction of new Chief Medical Officer Ariel Soffer, MD. See an interview with VSA CEO David Schmiege and Dr. Soffer on page 18.

A milestone for the field of venous evaluation, management and treatment was recently reached as the first 50 vein centers have been recognized as achievers of IAC Vein Center accreditation. Reaching this milestone in under two years since the inception of the accreditation program is reflective of the field’s willingness to embrace a process Related article, that enables vein page 36 centers to evaluate and demonstrate the level of patient care they provide and document their commitment to quality. For the vast majority, the impetus for demonstrating this commitment is voluntarily driven. Yet for vein centers that are providers with Blue Cross Blue Shield of Massachusetts (BCBSMA), effective Sept. 1, those performing endovenous ablation are required to possess IAC Vein Center accreditation as a condition for IAC

continued on page 32

A WAR OF AGENDAS: What they would like you to think about compounding By L. R. DILLON, R.Ph., ASQ CMQ/OE, ASQ CQA, ACHC / PCAB CAC Turn the clock back a hundred years and “compounding” pharmacies were the only pharmacies; manufactured dosage forms simply did not exist, or were quite rare. The pharmacist carefully prepared what the physician ordered based on a unique prescription “recipe.” This required the creative application of the principles of chemistry; art as well as science. As drug manufacturers emerged, the independent pharmacy was pushed towards extinction. Manufacturers would like you to believe there was no solution before their products were

available. However, ask any physician in practice at that time, or in a specialty where such products were not available and their solution likely involved a compounding pharmacy. We are now in the midst of a renaissance of compounding based upon the lucky coalescence of a number of factors, most notably: • The legitimate need for customized, patient-specific dosages or combinations of medications. • The opportunity to prepare various drugs and drug dosage forms deemed unprofitable by drug manufacturers • Analytical laboratory services that allow preparations, as applicable, to be tested for stability, sterility and

endotoxins using methods as rigorous as those employed by pharmaceutical manufacturers. • A willingness – in fact, eagerness – on the part of compounding pharmacists to work closely with prescribers and patients towards the end of successful therapy and outcomes. It is frustrating, then, to observe an ongoing “war” on compounding pharmacies that pits regulators and large

COMPOUNDING

continued on page 36

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Disclaimer and Liability Statement The information contained in this publication, including text, graphics and images, is for informational purposes only, and is not intended to be a substitute for professional medical advice. Publications & Communications LP (PCI), Publications and Communications LP, and Vein Therapy News, via its Editors, Publisher, Editorial Board members, or staff, accept no responsibility for any injury or damage to persons or property occasioned through the implementation of any ideas or use of any product described herein. In consideration that great care is taken by the Publisher, Editors, staff, and Editorial Board to ensure all information is accurate, we recommend each reader seek independent verification of all product or drug usage, surgical techniques and clinical processes prior to their use or implementation. The opinions expressed in this publication and all related marketing or sales material of this publication are those of the authors and are not attributable to the publication, Publisher, Editor, staff, Editorial Board, advertisers, or sponsors. References made in articles may indicate uses of medical equipment or medical procedures, or of drugs at dosages, for periods of time, and in combinations not included in the current prescribing information. Inclusion of advertising material in this publication, or in reproduction of articles and pages, or in supplemental materials, does not constitute any representation or guarantee by Publications & Communications LP (PCI), Publications and Communications LP, and Vein Therapy News, via its Editors, Publisher, Editorial Board members, or staff, of the quality of such products, or of the claims made by the manufacturers. Trademarks are used in an editorial fashion with no intent to infringe. Reproduction in whole or in part of this publication is strictly prohibited.

Reader Services SUBSCRIPTIONS To subscribe or to purchase back issues of the magazine, please call 800-678-9724 ext. 344 or e-mail Beth Chorba at bethc@pcinews.com. For more information, please visit veintherapynews.com and click on the Subscribe link. ADVERTISING INFORMATION If you are interested in advertising in Vein Therapy News magazine, online or in our Marketplace, please contact our account executive: Gary Pittman, Jr., 512-637-0373, garypjr@pcinews.com. EDITORIAL SUBMISSIONS Doctors, nurses, clinics, managers, vendors, patients, professors and others are encouraged to submit abstracts, white papers, writings, and ideas for editorial consideration. If you have a paper or story idea to submit, please e-mail larrys@pcinews.com UPCOMING EVENTS AND PRESS RELEASES Vein Therapy News would like to hear about your organization’s upcoming event, product launch, or announcement. Please e-mail press releases or event listings at least two months in advance to larrys@pcinews.com.

Volume 8, Number 6

Editor Larry Storer larrys@pcinews.com 254-399-6484

Art Director Lisa Gouveia lisag@pcinews.com

Advertising Executive Gary Pittman, Jr. 512-637-0373 garypjr@pcinews.com

Accounting Beth Chorba bethc@pcinews.com

Web and Network Manager Joel Nosal joeln@pcinews.com

President Gary L. Pittman garyp@pcinews.com Publications & Communications, LP 13552 Highway 183 N, Suite A Austin, TX 78750 512-250-9023 • 512-331-3950 fax Vein Therapy News is published bimonthly by Publications & Communications, LP, Gary L. Pittman, President, 13552 Highway 183 N., Suite A, Austin, TX 78750 512-250-9023. Subscriptions are available for $45 per year. Payment must accompany orders. Copyright 2015 by Publications & Communications, LP. All rights reserved. Reproduction in any form without written consent from the publisher is strictly prohibited. Postmaster: Send changes to Vein Therapy News Circulation Department, 13552 Highway 183 N., Suite A, Austin, TX 78750. ADVERTISING 512-637-0373 CIRCULATION 512-637-0344 EDITORIAL 254-399-6484

VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

NEWS 1 IAC hits milestone The Intersocietal Accreditation Commission has reached a milestone with the 50th vein clinic to achieve IAC Vein Center accreditation. The IAC Vein Center also released updated standards on Aug. 3 that became effective immediately. See related article on Page 36.

THE PRACTICE 18 VSA: A decade of service

As Vein Specialists of America (VSA) celebrates its 10th year of service to the phlebology industry and prepares for the next decade, the practice management company has expanded its service by adding a CMO and a new national Physician Training Academy program to its services.

SECOND LOOK 1 A war of agendas: What they would like you to think about compounding An ongoing “war” on compounding pharmacies pits regulators and large pharmaceutical companies against compounding pharmacies and prescribing physicians.

28 Treating pelvis venous congestion

Mel Rossenblatt, MD, reviews the literature and the data supporting therapy in various clinical scenarios.

32 ACP 2015 presentations

Ronald F. Bush, MD, and Peggy Bush, APN, detail their presentations at the ACP 29th Annual Congress.

34 A vein by any other name

James White, MD, has observed a dramatic increase in obstruction techniques by various insurance providers to avoid coverage for varicose vein therapies: Across the board denial for treatment of any accessory saphenous vein[s] not listed as the great or small saphenous vein.

38 CASE STUDIES: Leg swelling

Jeffrey H. Miller, MD, explores two case studies involving swollen legs. A swollen leg may never be what it seems.

40 Enhancing your practice

Manu Aggarwal, MD, says adding adjunctive laser treatments to an already successful phlebology practice ideally satisfies patients’ desires for additional services.

42 Educating our educators

Noel Boyce, RN, recognizes an emerging gap of information in the industry. His solution: Phlebology 2.0.

DEPARTMENTS VTN Report News Take the Lead ACP Update Product News

4 5 16 26 44 3

NEWS THE

VTNREPORT AMERICAN VENOUS FORUM’S 28TH ANNUAL MEETING WILL BE FEB. 24-26 The American Venous Forum’s 28th annual meeting will be Feb. 24-26 in Orlando, Fla., at the Buena Vista Palace Hotel. The 2016 AVF Annual Meeting will bring together more than 600 attendees and associates from the United States and 28 countries from around the world. Included will be the Specialty Symposia, a newly added Science and Innovation Day, various summits and symposia, and fundraising activities such as the Venous Open Golf outing and silent auction. Over the last 28 years, the American Venous Forum has led the field of venous and lymphatic disease by providing the highest quality evidence-based knowledge, raising awareness of the spectrum of venous and lymphatic disorders, improving the treatment options and care of patients with these diseases and preparing a new generation of venous health care specialists. The AVF is continually improving this specialty through research and educational programs, the premier of which is the AVF Annual Meeting. READ MORE: http:veinforum.org/medical-and-allied-healthprofessionals/avf-annual-meetings/2016-annual-meeting/program .

ROBERT CALIFF NOMINATED TO BE THE NEXT FDA COMMISSIONER Robert Califf, MD, has been nominated by President Obama as the new commissioner of the U.S. Food and Drug Administration (FDA). Dr Califf has long been speculated to be in the running for the agency’s top job. He was named deputy commissioner for medical products and tobacco in February. In March 2015, Margaret Hamburg, MD, stepped down after serving nearly six years as commissioner. Stephen Ostroff, MD, is currently serving as acting commissioner of the FDA. A cardiologist, Dr. Califf has had a distinguished career in academic medicine, most notably at Duke University, where he completed his undergraduate and medical degrees. Before joining the FDA, Dr. Califf was vice chancellor of clinical and translational research at Duke University and director of the Duke Translational Medicine Institute. In addition, he was a professor at Duke University School of Medicine and the cofounder of the Duke Clinical Research Institute. Before his nomination to the FDA post, Dr. Califf served on the advisory board of theheart. org at Medscape Cardiology. He had been a contributing editor to theheart.org since its founding in 1999 and was the host of the long-running series “Life and Times of Leading Cardiologists.” Dr. Califf’s nomination to commissioner needs to be confirmed by the U.S. Senate.

FDA EXPANDS WARNING REGARDING DRUGS STORED IN SOME BD SYRINGES The U.S. Food & Drug Administration has expanded its warning about repackaged or compounded drugs stored in certain lots of Becton-Dickinson syringes. The alert now includes 1ml, 10ml, 20ml and 30ml BD syringes, and BD oral syringes. See bd.com/hypodermic/pdf/U)S-Quick-Reference-Guide.pdf to see which lots are affected. The problem is that an interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately. Becton-Dickinson reports that the following drugs in particular can be affected by the stoppers, but the FDA does not know whether other drugs can be affected: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium and remifentanyl.

SMITH & NEPHEW MOVES WOUND CARE UNIT TO TEXAS Smith & Nephew has selected Fort Worth, Texas, as the U.S. headquarters for its Advanced Wound Management division, which will bring about 50 new high-paying jobs to the region. The London-based medical technology firm is consolidating its Fort Worth and St. Petersburg, Fla,, operations in North Texas with the help of a new 55,000-square-foot facility in the new Clearfork development on the Chisholm Trail Parkway. The $35 million facility will house half of Smith & Nephew’s 200 employees in Fort Worth.

BAXTER RECALLS ONE LOT OF IV SOLUTION CITING SEVERAL POSSIBLE PROBLEMS Baxter International Inc. is voluntarily recalling one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port

protectors. Baxter was made aware of these issues through customer complaints. There have been no adverse events associated with this lot reported to Baxter to date. Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs. The lot being recalled, C964601, was distributed to customers and distributors nationwide between Jan. 22 and Feb. 12. For further information, contact Baxter Healthcare Center at 1-888-229-0001, email onebaxter@baxter.com or see baxter.com.

BOSTON SCIENTIFIC GETS FDA OK FOR INNOVA SELF-EXPANDING STENT The FDA has granted approval for Boston Scientific’s Innova Vascular Self-Expanding Stent system to treat patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery. These conditions will cause circulatory disorder called peripheral artery disease, which may result in limb amputation, according to Boston Scientific Peripheral Interventions President Jeff Mirviss. The system features a Nitinol self-expanding bare metal stent with an advanced delivery system, and is available in different sizes ranging 5mm to 8mm in diameter and 20mm to 200mm in length. The platform is said to serve as the foundation for the new Eluvia Drug-Eluting Vascular Stent, which is specifically designed for the superficial femoral artery.

NYC SURGICAL ASSOCIATES ADD HONORED PLASTIC SURGEON NYC Surgical Associates, a multi-specialty surgical practice with seven locations across the New York Metro area, has added two new physicians to the practice. Victor Rosenberg, MD, FACS, specializes in plastic and reconstructive surgery; and Arien Smith, MD, specializes in neurosurgery and spine surgery. The acquisition of Drs. Rosenberg and Smith rounds out the practice’s clinical service areas, which includes diagnostics, internal medicine, anesthesia, general surgery, vascular surgery, weight loss surgery, orthopedics, and neuromuscular and pain, with new specialty services in plastic surgery and neurosurgery/spine. Dr. Rosenberg, whose specialty is cosmetic and complex reconstructive surgery of the entire body, has been in private practice since 1970. For 20 years he was the director of Plastic Surgery at NYU Downtown Hospital. In addition, he has enjoyed a long-time affiliation with Beth Israel Medical Center and The Mount Sinai Medical Center and for many years has been on the staff of Mount Sinai School of Medicine. Dr. Rosenberg is also the inventor of instruments used in Plastic Surgery and other surgical specialties, and has authored papers published in medical journals. He has been a Diplomate of the American Board of Plastic Surgery since 1969, after having completed four years of training in general surgery followed by three more years of training in plastic surgery. All seven years were spent in Mount Sinai, Beth Israel and Albert Einstein, all New York City hospitals. Dr. Rosenberg is an active member of the American Society for Aesthetic Plastic Surgery, the American College of Surgeons, the International College of Surgeons, Society of Military Plastic Surgeons and other professional organizations.

WEARABLES MARKET DECLINES The U.S. market for consumer wearable devices appears to be declining. A new report suggests that explosive growth in demand for fitness bands, smart watches, smart glasses (think Google Glass) and the like peaked in January and has been headed downward ever since. Argus Insights, a research firm based in Los Gatos, Calif., analyzed 327,834 online consumer reviews of wearable sensors between January 2014 and June 2015, and determined that interest dropped precipitously in the first half of this year. While the midyear figure was well above the same month in 2014, the trend has been continuously downward since January. Last year, online chatter increased in 10 of 12 months, and Argus attributed the September 2014 downturn to the preview of the Apple Watch. Consumers expect their wearables to do more than simply count steps, just as they expect to do more than just make phone calls with their handsets, the report stated. VT N

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

NEWS New R&M study provides imaging competitive edge A study has been published that provide a diagnostic imaging industry executives with strategically significant competitor information, analysis and insight crucial to the development and implementation of effective business, marketing and R&D programs. Research and Markets has added the “Future Horizons and Growth Strategies in the Global Ultrasound Market 2015: Strategic Assessments of Leading Suppliers” report to its offering. The study’s major objectives include: • To establish a comprehensive, factual, annually updated and cost-effective information base on performance, capabilities, goals and strategies of the world’s leading ultrasound companies.

• To help current suppliers realistically assess their financial, technological and marketing. • Capabilities vis-à-vis the leading competitors. • To assist potential market entrants in evaluating prospective acquisition and joint venture candidates. • To complement the organizations’ internal competitor information gathering efforts with strategic analysis, data interpretation and insight. VT N READ MORE: researchandmarkets. com /r esea r c h /m 8 x fgh /f ut u r e _ horizons

Report analyzes new P.A.D./PVD pipeline insights Research and Markets has added the report “Peripheral Arterial Disease (P.A.D.)/

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Pulmonary Vascular Disease (PVD)-Pipeline Insights” to its offering. provides in-depth analysis of the pipeline assets across the P.A.D./PVD marketplace. The main objective of this report to track competitor pipeline molecules, related research activities, technology, collaborations, in-licensing and out-licensing deals. It helps to identify emerging players with potentially strong product information and create effective counter-strategies to gain competitive advantage. It covers pipeline molecules at various stages of development such as pre-registration phase, clinical phases (Phase III, Phase II and Phase I), pre-clinical and discovery phases. The report also provides P.A.D./PVD related therapeutic assessments by molecule type, route of administration, monotherapy and combination products. The report also highlights the

discontinued and inactive projects in pipeline for Peripheral Arterial Disease (PAD)/ Pulmonary Vascular Disease (PVD). The scope of the report: • The report provides a P.A.D./PVD landscape across the globe. • The report provides drug profiles which includes product description, MOA, licensors and collaborators, technology, development partner and chemical information. • Coverage of the P.A.D./PVD pipeline on the basis of target, MOA, route of administration, technology involved and molecule type. • The report reviews key players involved in the therapeutics development for P.A.D./PVD and also provide company profiling. VT N READ MORE: researchandmarkets. com/research/gf4vg3/peripheral

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NEWS EKOS publishes PE trial results of SEATTLE II EKOS Corp., a BTG International group company, has published the results of the SEATTLE II trial in the JACC: Cardiovascular Interventions. The study concluded that treatment with ultrasound-facilitated catheter-directed low-dose thrombolysis for acute pulmonary embolism (PE) improves right heart function, reduces blood clot size and decreases pulmonary hypertension in patients with intermediate to high-risk PE. Importantly, no patient experienced intracranial hemorrhage, a serious adverse experience related to full-dose thrombolysis treatment. The SEATTLE II study was a prospective, single-arm, multi-center trial designed to evaluate the safety and effectiveness of ultrasound-facilitated catheter-directed lowdose thrombolysis, using the EKOS EkoSonic Endovascular System. One-hundred fifty patients diagnosed as acute massive (N=31) or submassive (N=119) PE were enrolled. Patients received low dose (24 mg) of tPA (thrombolytic) for 24 hours with a unilateral catheter or for 12 hours with bilateral catheters. The size of the right heart measured as RV/LV ratio significantly decreased from 1.55 to 1.13 (p<0.0001) by 48 hours after start of treatment. For patients with severe PE, the mortality rate is nearly one-third. In the SEATTLE II study, 31 patients presented to the emergency room with massive PE, syncope and hypotension. All 31 survived the 30-day follow up period. Of 150 patients in the study, one death was directly attributed to PE. There were no intracranial hemorrhages and no fatal bleeding events. Major bleeds occurred in 15 patients and were comprised of one severe bleed and 16 moderate bleeds. Six of the major bleeds occurred in patients with co-morbidities known to be associated with an increased risk of bleeding during thrombolytic therapy. “The SEATTLE II findings establish a new rationale for considering ultrasoundfacilitated catheter-directed low-dose thrombolysis in both massive and submassive PE,” said Gregory Piazza, MD, MS, assistant professor of Medicine at Harvard Medical School; staff physician in the Cardiovascular Division at Brigham and Woman’s Hospital in Boston; and principal investigator for SEATTLE II. “Without any intracranial hemorrhage and using a much reduced lytic dose, a substantial and clinically meaningful reduction of the RV/LV ratio was achieved.” Matt Stupfel, EKOS general manager, said the SEATTLE II and ULTIMA trials add to the body of evidence showing treatment with the EkoSonic Endovascular System improves

the standard of care for patients with acute pulmonary embolism. “The only endovascular device cleared by the FDA for the treatment of PE, EkoSonic represents a potential game-changer in the treatment of high-risk PE patients.” Stupfel said. “EKOS® ultrasonic waves greatly accelerate lytic dispersion by driving the drug deeper into the clot and unwinding fibrin to expose plasminogen receptor sites.” EKOS has shown a continued commitment to clinical research in PE. The ULTIMA trial, published January 2014 in Circulation, demonstrated that EKOS treatment was clinically superior to anticoagulation with heparin alone in reversing right ventricular enlargement at 24 hours, without an increase in bleeding complications. Building on the success of SEATTLE II and ULTIMA for treatment of PE, Stupfel said EKOS continues to improve and enhance clinical science knowledge by launching the next study, OPTALYSE PE, to better understand the optimal dose of thrombolytic and duration of its treatment. VT N

VEINS conference set Oct. 31-Nov. 1 The VEINS (Venous Endovascular INterventional Strategies) conference will be Oct. 31-Nov. 1 at the Wynn Las Vegas in a unique multispecialty environment. This twoday interactive course will offer an analysis of the critical issues facing vascular specialists with an interest in acute and chronic venous diseases today. Register at vivaphysicians.org. With pulmonary embolism representing the highest death rate of hospitalized patients and DVT episodes outnumbering heart attacks or strokes in the United States annually, it is now more important than ever to be at the forefront of new, state-of-the-art technologies. Get in on the discussion at the VEIVs Conference. Upon completion of The VEINS, the targeted learners should be able to: • Understand the current medical and emerging endovascular therapy for venous thromboembolic disease. • Appreciate the utility and diagnostic abilities of duplex ultrasound, CTV and MRV in diagnosis and management of venous disease. • Appreciate the complexities and variations of venous anatomy and understand appropriate physiology and therapeutic options available. • Prepare venous interventionalists in proper understanding of the indications for IVC filter implantation, explanation and complications. This is the first course where The VEINS has joined VIVA Physicians for VIVA 15.

Dr. Raghu Kolluri joined the VIVA team to produce The VEINs course at VIVA, complete with a multispecialty faculty, hands-on workshops and intimate breakout discussions. VT N

SIGVARIS pushes Lymphedema Treatment Act For many patients with lymphedema, health insurance does not cover the cost of graduated compression garments. However, graduated compression garments are an effective solution for reducing the medical costs associated with their lymphedema management. Wound care and lymphedema specialist, Robyn Bjork, was recently sponsored by SIGVARIS for a unique opportunity to meet with Jim Cooper, a congressman in Nashville, as part of a team including the Lymphedema Advocacy Group and lymphedema patients. The group provided education about lymphedema, shared personal stories about living with the condition, and explained how compression garments help manage lymphedema and prevent debilitating infections and hospitalizations. “This was a real win in the fight to manage lymphedema,” says Bjork. “You could feel the sigh of relief and surge of joy from our group when Congressman Cooper responded to our plea with full support. It was such a privilege to actively lobby for this cause, and I’m grateful to SIGVARIS for supporting these efforts.” Robyn Bjork is the associate director and global liaison for medical innovation at SIGVARIS. She is also a physical therapist who is a certified lymphedema and wound therapist; founder and CEO of the International Lymphedema & Wound Care Training Institute; and co‐founder and president of ILWTI Medical Missions, an organization dedicated to wound care and lymphedema treatment and training in underserved areas. She works at SIGVARIS to provide medical knowledge on the best treatment options for patients with lymphedema. Scot Dubé, SIGVARIS president and CEO for North America, said the company is proud to support patient needs in regards to better treatment and diagnosis for people with lymphedema and other leg diseases. “We believe that regular use of compression and early intervention can improve lives and reduce related long-term health care costs.” SIGVARIS is also a supporting sponsor of the Lymphedema Treatment Act, and donates hundreds of compression products every year to patients in need in North and South America.

To learn more about how compression products help with lymphedema, see sigvarisusa.com. To learn more about ILWTI, see ilwti.com. VT N READ MORE: http://lymphedematreatmentact.org

Registration open for AVF Fellows Course in Seattle The American Venous Forum’s Fellows Course in Venous Disease is presented for the benefit of fellows within the specialty of vascular surgery, interventional radiology, vascular medicine and associated programs. The fall course is Dec. 4-5 at the University of Washington Medical Center/Renaissance Seattle Hotel in Seattle. Registration is free at veinforum.org/medical-and-alliedhealthprofessionals/education/fellows-courseinvenous-disease. The course program will cover: • Anatomy and Pathophysiology of Venous Disorders and Non-Invasive Diagnostics • Chronic Venous Insuff iciency (Superficial and Deep) • Pregnancy, Upper Extremity Venous Issues, Acute DVT and Wound Care • Future of Venous Disease • The Business of Venous Disease. The goal of the course is to educate and update the fellows regarding the latest theories and developments in the clinical practice of vein disease management. Fellows will gain an overall understanding of vein disease to allow them to successfully incorporate venous knowledge, skills and techniques into their overall practice. VT N

Essential Medical starts Manta trial A spokesman for Essential Medical said the company has launched a clinical study of its Manta large bore vascular closure device in July. The Manta system is designed to close large bore punctures following procedures like transcatheter aortic valve replacements, abdominal aortic aneurysm repairs and balloon aortic valvuplasty. The device is designed to close punctures in less than a minute and provides immediate hemostasis. The study will examine patients treated with the Manta device following TAVR procedures. In initial patients, the Manta device was deployed in less than a minute, and the spokesman said none of the patients have experienced any complications associated with the device. Initial patients in the study were treated by Dr. Nicholas Van Mieghem of the Erasmus Medical Center. VT N

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

NEWS

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Varicose vein foam therapy takes a leap forward The first and only FDA-approved foam for GSV system incompetence 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.

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The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administrationof Varithena®. See Full Prescribing Information for Varithena®.

Find out more at VarithenaProfessional.com © 2014 Biocompatibles, Inc., a BTG International group company All rights reserved US-VAR-2015-0983 Varithena and Varithena Solutions Center are trademarks of Provensis Ltd, a BTG International group company BTG and the BTG roundel logo are registered trademarks of BTG International Ltd

NEWS HHS final rule modifying MU, implementing Stage 3 is now at OMB

Varithena® (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 Brief Summary of Prescribing Information. For complete Prescribing Information, consult official package insert. INDICATIONS AND USAGE Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

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

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

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

Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena®. CONTRAINDICATIONS The use of Varithena® is contraindicated in patients with: • known allergy to polidocanol [see Warnings and Precautions] • acute thromboembolic disease WARNINGS AND PRECAUTIONS Anaphylaxis Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Tissue Ischemia and Necrosis Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Venous Thrombosis Varithena® can cause venous thrombosis [see Adverse Reactions]. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of Varithena® cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice. A total of 1333 patients in 12 clinical trials were evaluated for safety when treated with Varithena® at dose concentrations of 0.125%, 0.5%, 1.0% or 2.0%, including 437 patients treated with Varithena® in placebo-controlled clinical trials. Adverse reactions occurring in 3% more patients receiving Varithena® 1% than receiving placebo are shown in Table 1. Table 1: Treatment-emergent adverse reactions (3% more on Varithena® 1% than on placebo) through Week 8 (n=588) Adverse Reaction Pain in extremity Infusion site thrombosis b Contusion/injection site hematoma Limb discomfort Tenderness/injection site pain Venous thrombosis limbc Thrombophlebitis superficial Deep vein thrombosis

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

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

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

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

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

Since Varithena® induces thrombosis in the treated superficial veins, D-dimer is commonly elevated post-treatment and is not useful diagnostically to assess patients for venous thrombus following treatment with Varithena®. Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician compounded foam sclerosants. None of the 1333 patients in the Varithena® trials experienced clinically important neurological or visual adverse events suggestive of cerebral gas embolism. The incidence of neurologic and visual adverse events within 1 day of treatment in the placebo-controlled studies was 2.7% in the pooled Varithena® group and 4.0% in the placebo groups. Skin discoloration adverse events were reported in 1.1% of the pooled Varithena® group and 0.7% of the placebo group in the placebo-controlled studies. DRUG INTERACTIONS No specific drug interaction studies have been performed. There are no known drug interactions with Varithena®. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of Varithena® in pregnant women. Do not use Varithena® during pregnancy. Labor and Delivery The effects of Varithena® on labor and delivery in pregnant women are unknown. Nursing Mothers It is not known whether polidocanol, the active pharmaceutical ingredient in Varithena®, is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering Varithena® to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

The Department of Health and Human Services has sent the long-awaited final rule that modifies the requirements of the Meaningful Use program for 2015-2017, as well as the rule implementing Stage 3, to the Office of Management and Budget (OMB) for review. The Centers for Medicare & Medicaid Services has confirmed that the modification rule is combined with the final rule implementing Stage 3 of the Meaningful Use program. Providers had expressed concern that the proposed Stage 3 rule was overly ambitious and burdensome. Stage 3 is slated to commence in 2017. CMS said that the final rule should be issued in early fall 2015. The rule, which OMB received Sept. 3, changes the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program EHR reporting period in 2015 to a 90-day period aligned with the calendar year, and also aligns the reporting period in 2016 with the calendar year. In addition, this rule modifies the “patient action measures” in the Stage 2 objectives related to patient engagement, and streamlines the program by removing reporting requirements on measures that have become redundant, duplicative, or topped out through advancements in EHR function and provider performance for Stage 1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs. “We appreciate provider interest in the EHR Incentive Programs and in our final regulations in particular,” CMS said in a statement. “We have just submitted the final rule to OMB for review. CMS intends to finalize a set of requirements that addresses attestation deadlines and reduces the overall reporting burden on providers and provides flexibility for the reporting periods in 2015.” OMB typically has 90 days to review a rule, although that can be extended. There is no minimum period for review. VT N READ MORE: http://www.reginfo.gov/public/ do/eoDetails?rrid=125480

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.

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Provensis Ltd, Biocompatibles UK Ltd, and Biocompatibles, Inc. are BTG International group companies Varithena is a registered trademark of Provensis Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd

online at:

veintherapynews.com 10

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

NEWS

Results Speak Louder Than Words 

Latest two year results show 99.7% closure rate with no DVTs1



Highest long term comparative closure rate:2 Five year results: CoolTouch 1320nm = 84.7% vs. RF = 61.7%

 In-vitro study results demonstrate:3

No vein perforations with the CoolTouch CTEV Nd:YAG 1320nm micro-pulsed laser in contrast to 1470nm continuous wave diode lasers causing perforations in 43% of veins treated Visit us at ACP Booth #400 for more information

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Scan to watch a procedure

1. Moul, Danielle K., Leland Housman, Sara Romine, and Hubert Greenway. "Endovenous Laser Abla�on of the Great and Short saphenous Veins with a 1320‐nm Neodymium:y�rium‐aluminum‐garnet Laser: Retrospec�ve Case Series of 1171 Procedures." Journal of the American Academy of Dermatology 70.2 (2014): 326‐31.

VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

2. Weiss, Robert "Compara�ve Outcomes of Different Endovenous Thermal Systems on Great and Small Saphenous Vein Insufficiency: Long‐term Results."Lasers Surg. Med. Lasers in Surgery and Medicine 47.2 (2015): 156‐60. 3. Kansaku, R., N. Sakakibara, A. "Histological Difference between Pulsed Wave Laser and Con�nuous Wave Laser in Endovenous Laser Abla�on." Phlebology: The Journal of Venous Disease (2014)

THEPRACTICE The

High Performance Photo System for Phlebology and Aesthetics FotoFinder Bodystation  Brilliant Consistent Images of Leg Veins, Face and Body  Easy Image Capture Process with Guided Photography  iPad app for Image Access at Your Fingertips  Mobile and Maximum Efficient System

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phone: 443-283-3865 NEWS toll-free: 888-501-0805

< VEIN THERAPY

THEPRACTICE

ACP Booth#310 VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

Minimal recovery. Maximum results. With greater than 60,000 ClariVein® units in market, the ClariVein® device is designed to benefit patients and physicians alike. The ClariVein® is fully disposable, minimally invasive, and can be efficiently used in an office setting.

Speeds Recovery

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Delivers Proven Results

Reduces Discomfort

Visit Us at American College of Phlebology, November 12 - 15, 2015 -Booth #413

Join the Conversation at our Lunch Symposium Thursday, November 12th at 12:30 pm Hilton Bonnet Creek, Citrus-Collier - Columbia Room

1 Pine Hill Drive Two Batterymarch Park, Suite 100 Quincy, MA 02169 203-446-5711

http://www.clarivein.com

www.ClariVein.com

Indication For Use ClariVein®-OC Intended for infusion of physician-specified agents into the peripheral vasculature. 510(k) Cleared by FDA for commercialization in the USA. Caution: Federal (USA) law restricts this product to sale by or on the order of a physician. Rx Only. ClariVein®-OC Intended for endovascular occlusion of incompetent veins in patients with superficial venous reflux. Approved for commercialization in international markets including Canada and Australia; and is CE markedfor the European Union. Not currently available in the USA. Contraindications: The ClariVein®-IC and ClariVein®-OC catheters are contraindicated for use in the coronary and cerebral vasculature, in the pulmonary vasculature, in diseased and artherosclerotic arteries; for infusion of blood or blood products; and for patients contraindicated for endovascular procedures. Labeling: Description, Directions for Use, Warnings, Precautions, Potential Complications/Adverse Effects: Refer to product labeling provided with each device. Read and understand all labeling prior to use. Observe all instructions. Failure to do so may result in serious patient injury with the equipment and death. The ClariVein® catheters are single use, disposable devices. Other Manufacturer’s Procedural Accessory Products Refer to Manufacturer’s product labeling for Indications and Contraindications for Use, Instructions, Warnings and Potential Complications/Events and Side Effects. Note: This material is provided for general informational purposes only and is not intended or recommended as a substitute for professional medical advice. This information is for use only in countries with applicable health authority product registrations. Contact your local representative for product availability in a specific country. Legal Manufacturer Vascular Insights, LLC One Pine Hill Drive, Two Batterymarch Park, Suite 100 Quincy, MA 02169 www.vascularinsights.com

W E ’RE IN V IT IN G

ONLY THE BEST TO JOIN U S

CENTER FOR VEIN RESTORATION is the largest physician-led provider for the treatment of symptomatic venous insufficiency in this country. We are rapidly expanding our network of clinics, and we’re seeking the very best colleagues to joins us. At CVR, our teams enjoy a culture of collaboration and a world-class support system. CVR offers attractive compensation, and work-life balance, providing physicians freedom from on-call, late-nights and weekend hours. Think you are one of the best? Looking for more satisfaction in your career? We’re looking for cardio, vascular or general surgeons, and interventional radiologists. Give us a call – it might be the right time to make the leap!

Ready to dive in and join the best?

Please contact: Gary O’Gwen, VP New Growth, at (240) 965-3900 or physician.practice@centerforvein.com http://www.centerforvein.com www.centerforvein.com

THEPRACTICE

TAKE THE LEAD.

Internet Marketing Strategies for Success WHAT IS YOUR DIGITAL MARKETING STRATEGY? By Alyssa K. Schmiege If you are looking to increase your vein practice’s visibility and generate more patient inquiries, consultations, procedures, etc., then this article should interest you. My experience as the director of social media for VSA’s client base has provided me with a unique insight into effective digital strategies tailored for vein practices. Building a vein practice in an Alyssa K. Schmiege increasingly competitive market is harder than ever. Many specialists, hospitals and health systems are adding vein care to an already crowded market. To succeed in 2015 and beyond, an independent medical practice must take an entrepreneurial approach to marketing — actively seeking out new patients and referral sources. Entrepreneurial marketing does not need to be expensive. Your vein practice can achieve positive results by consistently utilizing a few proven, effective techniques. Consumers today have many choices when selecting a provider for vein care. To remain competitive, a vein practice should continually deliver a message that focuses on the unique aspects of their practice. That message should capture the attention of both patients and referring physicians alike. The key to entrepreneurial marketing is steady progress. To turn a modest time investment into practice growth, create a solid marketing plan and implement it consistently. An effective plan will identify your unique clinical skills or experience, targeted service area, current and potential competition, and existing and potential referral sources. List specific marketing initiatives, assign responsibilities, and set monthly new-patient goals. Whatever techniques you use, make sure to track referral sources so that you gain an understanding of which efforts are yielding the highest results. Remember, marketing’s job is to make the phone ring. Staff training is responsible for converting patient inquiries to consultations. The physician’s job is to convert consultations to procedures, when medically necessary.

STEP 1. STRATEGY DEVELOPMENT

The first step in developing a multimedia marketing plan should be an intensive strategic planning session. Look at the big picture to build and coordinate all of your branding elements into one cohesive marketing plan that is consistent across all media. Your goals and your level of involvement will determine what your marketing team does for you, and how they go about doing it. Take a few hours away from patient care and answer the following questions for your practice:

What exactly do you want to accomplish through your digital marketing efforts? (The achievement of more visibility for your vein practice/providers as experts in their field? More requests for new patient appointments contacting you through your website? A more visible presence in your community?) How much time in digital marketing activities can you realistically commit to and what will be your monthly/annual budget? (Will you or your designee have time to take photos and videos for your marketing team to use online? Approve Facebook posts, Twitter posts, and relevant newsletter articles before they’re published? Collaborate with your marketing team on new ideas and initiatives?)

STEP 2. TAKE ANOTHER LOOK AT YOUR WEBSITE Your digital presence is only as good as your website. No matter how many people sign up for your email newsletter or engage with your office on social media, your website will still be the major influencing factor in their decision of whether to call for that appointment or not. An unprofessional or “dated” site instantly sets off warning sirens in a prospective patient’s head – if they can’t bother to keep their website up-to-date, what other administrative or clinical corners might they be cutting?” A vein practice’s website should have an ample amount of unique content on vein disease and treatment options, as well as the doctor(s) and other providers level of training and experience. Pictures should be available of the entire clinical care team. Your website should feature a video introduction from each of the clinical providers, as well as at least five new patient testimonials added annually. Video patient testimonials succeed where written testimonials fail. A video testimonial delivers a message that prospective patients can relate to and delivers a subliminal “call to action” to schedule a consultation. Written testimonials, although better than nothing, fail to deliver a personal message from a patient. Video testimonials help the patients you have already treated appear more relatable in the eyes of the prospective patients viewing your website – they represent men and women, young and old, varying weights, etc. … in other words, they have imperfections like the rest of the population and are not paid models. Your patient video testimonials will represent a cross-section of the actual patient population your practice serves. They comfort prospective patients who are intimidated by most cosmetic print ads. It is imperative that your website is easy to navigate, enabling patients to effortlessly find expansive, easy-to-understand explanations of common conditions, along with the causes, symptoms and treatments. Clear, detailed information about how exactly your practice can offer relief is also a must. By making your website a go-to resource for patients seeking information

about vein disease, you are elevating your practice to the status of a trusted expert in vein care. The appearance of your website is extremely important. In many cases, your website is a patient’s first impression of your practice, so maintaining a well-organized, easy-to-navigate, upto-date site is vital to attracting new patients. This is not a onetime effort. Your website should be updated regularly, adapting to market conditions on a continual basis. It should not be an electronic brochure of your practice.

STEP 3. SEARCH ENGINE OPTIMIZATION

With a solid website in place, the next step is to ensure that your SEO (Search Engine Optimization) value is as high as it can possibly be. This process actually begins during the website development process, but it most definitely should not end there. SEO is an ongoing process. New and unique content is a must. Fresh content is a major component in Google’s rankings, so SEO can never be a one-anddone project. From regular blog posts using strategic keywords to updating static pages regularly with the latest research, effective SEO means constant data-driven tweaking of your website. Nowadays, a website just isn’t complete without a blog. Blogs provide a place for a business to demonstrate their expertise, offer valuable information to their audience in order to gain their trust and loyalty, post fresh, keyword-rich content to satisfy the search engines, and create engaging content to be shared via social media and email newsletters. In order to be effective, however, a blog must be replete with relevant, interesting, informative topics and written in a relatable way that will attract readers and hold their interest enough to make them want to return to read your next post. It must also be maintained on a regular basis – if prospective patients notice that your posts are few and far between, or that the last post was published months ago, they’ll wonder what the problem is. Link building is another essential aspect of SEO. Google optimization is based on the principle that the more people linking to your website, the more valuable your site must be, thus deserving a higher search engine ranking. Actively working to build high quality backlinks is very important. This can be done by developing relationships with industry influencers, writing guest posts for other sites, as well as submitting your site to online directories. While social sharing (Tweets, Likes, etc.) may not carry the same weight as other types of links, there is evidence showing that social shares do affect rankings, which is another benefit of a strong social presence. Both visibility and credibility are increased when a medical practice’s name begins to appear regularly on various prominent industry news outlets, whether in print or a digital format. The fact that industry influencers would think highly enough of a doctor or a practice to allow them to contribute to their site gives

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

THEPRACTICE them instant authority as a fellow expert in the eyes of an audience. And any articles published through large, national media outlets only add to that perception.

STEP 4. SOCIAL MEDIA MARKETING

The final piece of the online marketing puzzle is Social Media Marketing. Each different channel (Facebook, Twitter, LinkedIn, Google Plus) must be leveraged in the way best suited to its own particular audience and guidelines. Strategic posts must be made to each platform regularly, in order to gain engagement from their online communities. Regular themed campaigns are also a must, in order to draw renewed attention and interest. With fresh, exciting content to share on a regular basis, the next step is to build an email subscriber list and send that content directly into the audience’s inboxes via an email newsletter. Blog post teasers form the foundation of these communications, but bulking them up with updates about the practice, as well as other relevant tips and tidbits, makes it even more likely that recipients will open them, read them, and then click through to the site to find out more.

VSA gets your vein practice seen online!

STEP 5. MAXIMIZE PATIENT SATISFACTION

Consumers increasingly expect to be able to manage their lives using digital tools. Medical practices that fulfill this expectation will succeed in forging powerful links with a strong patient base. Start with your current EMR. Most systems can easily be configured to support a patient portal, allowing patients to request appointments, pay their bill, receive e-reminders and download medical records. Enhancing your website is another way to create electronic connections with patients. Provide content that keeps visitors coming back. Make patient forms available for download and update your site regularly with seasonal health information, “top ten” health habits or other useful content. Remember that existing patients are your best source of referrals. Build patient satisfaction by listening carefully and communicating concern. Survey patients regularly and make improvements when necessary. Personally thank patients who refer friends and family to your practice. Effectively marketing a vein practice online is anything but simple. It requires a significant investment of time and effort, and even then, there is no guarantee that it will have the desired effect. Your best bet is to work with a digital marketing firm with the experience and expertise to tackle every single step of the process in the most creative, consistent and strategic way possible. VT N Alyssa Schmiege is the director of client social media strategy for Vein Specialists of America. She can be reached at Alyssa@veinbusiness.com or 630-992-0060.

Web Design & Development | Search Engine Optimization Paid Search Campaigns | Social Media Campaigns Contact us to learn more about our digital marketing solutions! Alyssa K. Schmiege Director of Client Social Media Strategy gregg.nell@veinbusiness.com Alyssa@VeinBusiness.com

Tel (630) 992-0060

VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

Vein Specialists of America, Ltd. 900 Oakmont Lane, Suite 100 Westmont, IL 60559 www.veinbusiness.com www.VeinBusiness.com 17

THEPRACTICE

A DECADE

Vein Specialists of America adds a national Physician By Larry Storer As Vein Specialists of America (VSA) celebrates its 10th year of service to the phlebology industry and prepares for the next decade, the practice management company has expanded its service by adding a chief medical officer (CMO) and a new National Physician Training Academy program to its services. This interview is with President and CEO David Schmiege and Ariel Soffer, MD, VSA’s new CMO. VTN: David, celebrating your 30th year in healthcare, what legacy do you to hope to leave? DAVID SCHMIEGE: My team and I would like to be known as having built two companies that helped physicians in independent medical practices - innovate toward better outcomes, lower operating costs and consistently achieve excellent patient satisfaction scores. VTN: What traits have helped you succeed in business? DAVID SCHMIEGE: Focus, attention to detail, perseverance, and team-building. My career has been built on a foundation of accountability, responsibility and results. Being humble and willing to understand what I don’t know, and then being open to learn from that.

I would say our most effective form of generating positive exposure for VSA is without a doubt the ability to author practice management, marketing and revenue cycle management articles for various industry publications. Being recognized as one of the industry thought leaders has opened many doors for our firm. VTN: What is your hope for the future of healthcare? DAVID SCHMIEGE: My hope is that consumers become the real buyers of healthcare services, and therefore effect on it all characteristics of consumer-driven industries in terms of choice, quality, cost and service. VTN: How did you get the idea to start Vein Specialists of America? DAVID SCHMIEGE: In 1979, I started an office equipment company marketing high-end copiers and facsimile machines for Sharp Electronics. In 3 years, the company had grown to $6.5 million in annual sales with 72 employees and three office locations. Presented with an offer I could not refuse, I sold the company in 1982 to a national firm looking to enter the Chicago market through acquisition.

In separate discussions with a few friends who I trusted and sought guidance, a pediatrician and an orthopedic surgeon, I asked for their input as to what I should do next. Both were very convincing that I should enter the medical field to teach medical residents the business skills lacking in their training programs. I discovered a niche market welcoming my experience with open arms. I created a 10-week training program called “The Business Side of Medicine” and began working with residency programs and medical societies to teach business skills to doctors. In 1982, it was very easy to find pharmaceutical companies and medical manufacturers willing to provide the residency programs and medical societies with educational grants to cover our training costs. Over the next few years, through relationships developed with third- and fourth-year residents, I negotiated more than 225 employment agreements with their prospective employers. In many instances, after the employment contracts were executed, our discussions moved on to practice management, marketing or revenue cycle management issues occurring within their medical practice. I was frequently asked if I could take a fresh look at their practice. And with that, MD Management was born in 1985. MD Management created two divisions, Office-based and Hospital-based medical practices. Hospital-based consulting services focused on anesthesiology, emergency medicine, pathology and radiology practices. Our assistance was to act as a collaborative intermediary with hospital administration and to audit our client’s specialty billing companies to make sure that they are being reimbursed at their contracted rates; that their A/R is being aggressively pursued; and that monthly reports contained appropriate analytical data to project future revenue. Office-based consulting services were comprehensive and quite extensive. Basically, all facets of practice management, marketing and revenue cycle management were offered. It is through this division that we began to work with vein practices in 2003. In 2005, we created a separate company – Vein Specialists of America – to focus exclusively on phlebology practices. I saw an opportunity to build a phlebology-specific consulting and advisory firm with experienced healthcare professionals who had the ability to deliver better results, at a better value. Our business concept is based on the belief that proven, collaborative consultants can effectively influence positive results for our clients in a cost-effective manner. The simple fact is that, in large firms, experienced consultants generally sell the work; while talented, but less experienced consultants, do the work. With VSA, our clients work day-to-day with consultants who have the deep healthcare experience necessary to help solve the complex challenges facing their vein practices. VTN: What has been your most effective form of advertising? DAVID SCHMIEGE: I would say our most effective form of generating new business for VSA is a stream of constant referrals from satisfied clients and their colleagues. Throughout the past 10 years, we have gained a tremendous amount of experience while accepting engagements to establish 78 new vein practices from startup, as well as several hundred

problem-centered practice management, marketing and/or revenue cycle management engagements. Without the trust placed in our firm by our clients, none of this would have been possible. I am proud that VSA is successful, but more importantly stable and dependable – a company that has stood the test of time and will continue to be there for our clients. I would say our most effective form of generating positive exposure for VSA is without a doubt the ability to author practice management, marketing and revenue cycle management articles for various industry publications. Being recognized as one of the industry thought leaders has opened many doors for our firm. VTN: What has been your leadership style in guiding VSA’s growth over the last decade?

David Schmiege

A big part of leadership is being authentic to who you are, thinking about what you really believe in and behaving accordingly.

DAVID SCHMIEGE: A big part of leadership is being authentic to who you are, thinking about what you really believe in and behaving accordingly. I learned early in my career through discussions with my father-in-law, my mentor and best friend, that managing through motivation and encouragement is the strongest way to get things done. I believe in listening to the diverse views of employees, respecting and valuing their unique ideas, and giving them the tools to do their jobs and be successful. It’s important that we prepare our staff for the next level of leadership. VSA has become more agile by listening, learning and collaborating with clients to handle new challenges. During the past 10 years, we have refined our methodologies, expanded our services and developed vein-specific best practices that enable us to achieve our goal … to help vein practices improve their day-to-day practice operations, clinical quality and financial strength so that they can continue to care for their patients and surpass their clinical and financial goals. VSA’s reputation for excellence in the vein industry remains a core value since the firm’s inception. The company’s management and staff share a common interest in commitment to quality, reliability, honesty and integrity in doing business. Our employees’ enthusiasm and eagerness to work hard for our clients is stronger than ever. VSA’s top priority is client satisfaction. I am proud of VSA’s accomplishments and very excited about the great opportunities and challenges ahead of us. VTN: What lessons did you learn on your way to becoming a CEO?

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

THEPRACTICE

OF SERVICE

Training Academy to its practice management expertise DAVID SCHMIEGE: The best lesson I’ve learned in life is to always tell the truth, to always do the right thing, no matter what. You can’t be afraid to drive change as long as the interests of your employees, clients and company are at the forefront. Don’t be afraid. You can change and do anything if you set your mind to it. Also, I’ve learned that teams win. If you understand where you are, where you have to go and can get your staff lined up in support of the direction, the company, the staff, is unstoppable! VTN: What lessons have you learned as a CEO? DAVID SCHMIEGE: I think a good leader is a problem solver. How an organization deals with problems, failures and missed opportunities clearly defines an important aspect of its culture. You have to set the tone and strategy, and stay positive, no matter what. There is always something positive to be

VSA is filling a void in the industry by establishing a national Physician Training Academy…nn Ariel Soffer gained, a lesson to be learned, even in big failures. A CEO must have excellent communication skills. Obviously a CEO’s honesty and integrity must be above and beyond reproach, and you’d better have a lot of empathy for people. People are going to make mistakes; when this happens, my first question is always “did they/we learn from this?” Another key challenge is stress management. Leading an organization is a very stressful job. Many of our clients contact us because the stress eats them up physically and mentally. As a leader of a consulting firm or a medical practice, if you can’t manage the stress, you will fail at leading your organization. VTN: What are some common problems faced by medical practices VSA has worked with over the years, and how do you help resolve those problems? DAVID SCHMIEGE: I think these are the most common: Lack of clear direction or focus. VSA helps a vein practice design and implement a strategic plan (operational, marketing, expansion, etc.) at the level and stage that is appropriate for their practice. Most vein practices do not spend enough time evaluating their competitive market and how they will maintain or expand their current market share. Dysfunctional team dynamics. If the physician(s) and the office manager do not work well together, nothing gets done. Occasionally, I’ll have a client call for strategic planning only to find out that we have to do some work changing the practice culture before it makes sense to design/implement a new strategic plan. I work with clients on strengthening their leadership team, cross-training team members and mediating conflicts.

Practice stability determines behavior and often lack of stability in a medical practice isn’t conducive to effective team behavior. Absence of performance feedback. People crave feedback about their work, yet it’s one of the most overlooked management responsibilities in practices. Besides the obvious need to document performance expectations and results, an effective feedback system helps practices identify high-potential staff and weed out those who are ineffective. VSA establishes performance reviews that are followed up with individual development plans and coaching. Developing high-potential staff. Not everyone enters a job with the precise skill set they need to become successful. What enabled you to be successful in one position may not be sufficient when you are promoted. VSA provides staff coaching for clients who want to sharpen already strong skills or build capabilities in areas that key staff will need as they grow with the practice. No clear successor. I’m very sympathetic with practice owners nearing retirement who are so absorbed in their medical practice that they give very little thought to succession planning, and yet it’s essential to capture the value they have created. VSA helps clients figure out what they really want in terms of an exit strategy and to engineer both an exit plan and a leadership transition plan that is palatable and achievable. Like in medicine, the presenting issue with a client isn’t always the underlying problem. I may receive a call for an engagement to design and implement a strategic marketing plan, only to find out that the practice’s goals are unclear, the physicians do not talk to each other, the staff has a turnover problem, or there are other problems in the practice causing friction. Until some of the underlying issues are resolved, implementing a strategic plan is challenging at best. VSA helps practices identify and deal with the real issues that prevent them from being their best. VTN: What is VSA’s strategy for growth? DAVID SCHMIEGE: I am often asked what our strategy is for growth. Although I cannot share with you our strategic plan for growth, I will share with you our philosophy that guides VSA … the answer is simple. While our competitors are in constant pursuit of new clients at what seems to be the expense of their existing clients, VSA will continue to be focused on delivering improved business performance, one-client, one-engagement, one-solution at a time. Referral business from satisfied clients is our key to success. VTN: I understand that Dr. Ariel Soffer has joined VSA as a partner and VSA’s chief medical officer. What is Dr. Soffer’s clinical background? DAVID SCHMIEGE: Dr. Soffer graduated from medical school at the University of Miami, followed by post graduate training at Cedars Sinai / UCLA in Beverly Hills, Calif. He maintains Board Certifications and Re-Certifications in Internal Medicine and in Cardiovascular Disease, and is a Fellow in the American College of Cardiology since 1998. He also has served as the official doctor and chief medical physician and cardiologist for the National Hockey League’s Florida Panthers. Over the past 10 years he has dedicated much of his practice to perfecting the treatment of venous circulation and varicose veins in particular. Dr. Soffer was introduced to me through his

VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

involvement in raising the awareness of cardiologists about this neglected circulatory issue. Dr. Soffer has authored two landmark articles published in peer-reviewed journals describing the importance of venous issues to the cardiovascular community. He has trained hundreds of physicians from all over the world on vein disease treatment options and has been a principal investigator for many multi-national medical manufacturers. Dr. Soffer is currently the chief medical expert for ABC News Miami and hosts a weekly news segment called “Dr. Soffer’s Second Opinion.” He is a frequent lecturer on venous disorders and is the chairman of the New Cardiovascular Horizons Vein Forum (NCVH), held annually in New Orleans. VTN: Dr. Soffer, why does Vein Specialists of America need a chief medical officer, VSA doesn’t provide direct medical care to patients? DR. SOFFER: Since 2005, VSA has been involved in assisting countless vein practices. In many of these engagements, the physicians have had little or no prior experience treating veins. They have received minimal clinical training. Most have either received a few days of training or attended a weekend class. Separately, both of our companies have relationships with various manufacturers where we have worked in a collaborative effort to provide the clinical and practice management skills necessary to assist underperforming vein practices take a prominent position in a competitive market. It made sense to us to combine our efforts. We come from a perspective that when we assist vein practices from both a business and clinical perspective to fulfill their market potential, everyone wins. VSA is filling a void in the industry by establishing a national Physician Training Academy that will not only offer practice management, marketing and revenue cycle management training, but also have regional locations across the country where a physician, ultrasound tech and/or sclerotherapy nurse can receive clinical training and support on an ongoing basis. Our facility in Miami is associated with two large medical schools and has multiple societal accreditations. VTN: Where do you envision the regional Physician Training Academies being located, and how will they work? DR. SOFFER: We began our Physician Training Academy with a fully accredited facility in the Miami area. It is in a brand new facility that has a glass enclosed operating theater, conference facility and adjacent hotel. We offer clinical training in every part of vein work, from the most significant truncal disease, to the tiniest spider vein. When clinicians leave our program, we want them get a complete experience of all that phlebology has to offer and the ongoing resource and friendships that go with it. We have plans in the works to duplicate our protocols, now combined with VSA’s complete practice management solutions, in California, Texas, Chicago, Denver, New York and Atlanta. Our vision is to have 12 to 15 luminaries across the country. By combining 10 years of client practice management, marketing and revenue cycle management support with our ability to educate and train clinicians – our model will not only give our client’s superior experiences, but ensure long lasting success with all that VSA has to offer. VT N

SECONDLOOK

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THEPRACTICE Three steps to optimize value of physician referrals Vein Therapy News practice management expert David Schmeige has written extensively about the value of physician referrals. Medical Marketing & Media has recently come up with three essential steps to optimize physician referrals. While many providers may think focusing on referrals goes against current patientcentered healthcare models, establishing a firm physician referral base can improve outcomes and complement patient-centered marketing, according to the article. A good example that they cite is when the University Hospitals of Cleveland reformed its physician referral system two years ago. It was able to optimize both physician use and staff efficiency. Furthermore, a proposed rule from the Centers for Medicare & Medicaid Services creates new exceptions to physician self-referral laws for certain providers, such as federally qualified health centers and rural health clinics. According to the article, organizations must take the following three steps to get the most out of physician referrals: • Standardize the process: Providers must analyze opportunities by specialty and market; analyze the current referral base; organize physicians according to referral penetration and potential; and formulate a plan for reaching each segment of physicians. • Ensure accurate master physician data: None of the analyses in step one will be effective without accurate data or if the data contain gaps, according to the article. To ensure accuracy, collaborate with third-party data providers during the process. • D eve l o p multichannel marketing strategies: For the most part, patients base their provider choice on physician referrals rather than direct marketing. To strengthen their physician referral bases, organizations must tailor their marketing strategy to attract physicians, making sure to address modes of delivery and the factors that drive physician referrals, including specialists’ medical skills, access to the practice and insurer compatibility. VT N READ MORE: gpo.gov/fdsys/pkg/ FR-2015-07-15/pdf/2015-16875.pdf

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THEPRACTICE

Marketing for independent or solo practitioners If you have a Facebook page that is stagnating with just a few hundred fans, you’ll need to decide if you are happy with this number or if you want to kick start it and grow it into a true marketing force. Many people don’t know this but only 10 to 15 percent of your followers will see any one of your posts so it is incumbent among Facebook Page owners to grow their page as fast as they can. Today, this means setting aside a small budget of $50 to $100 a month to use FB Ads to ad new fans to your page. Twitter—you have a Twitter account but the profile is not blown out…add your picture and a more thorough description with a link to your website. Twitter is one of the better sites to drive traffic to other websites. Targeting women patients? Think about Pinterest as they dominate there and a chiro page would not have a lot of competition for eyes.

By Chris Martin, MPH Small doctor groups or solo practitioners must balance their desire to be independent with the burden of having to pay for all overhead, including practice marketing and promotion. Ultimately, many doctors must choose between what they can do themselves and what they pay others to do for them. Chris Martin This article discusses some of the main marketing categories that most doctors encounter and solo doctors must navigate. For vein specialists running an independent practice with limited or no assistance from a national franchise, this list can help you triage your marketing priorities. First, what is marketing? Loosely defined, marketing is anything you do to promote your practice, from how your phones are answered to how your business cards and search engine optimization performs. The main categories of marketing that a physician should have more than a passing knowledge about are: public relations, website and search engine optimization, social media and advertising. Some forms of marketing are designed to create a direct response, such as advertising, while others work on your reputation and may not pay off immediately.

PUBLIC RELATIONS

Its name might seem like a misnomer, but at its core, public relations is the practice of working with journalists and reporters and their various outlets to get them to cover your practice. This can take the form of writing a news release and issuing it to your local paper on a new therapy or procedure or it can assume the form of you, the physician expert commenting on breaking news about research in your area or a condition of a celebrity, athlete or person in the public eye. To fully engage in public relations, it’s wise to assess your local media—who are the reporters who cover health and medicine or features? Does the local TV station have a health reporter? These tend to be dying breeds as they have been eliminated as part of budget cuts by stations. One thing that is tried and true is that local news still matters to local community newspapers and websites—take some time to learn more about the local press that covers your town and begin engaging with them. What to PR? So you’ve decided to use PR as part of your overall strategy? What next? Think about the news your practice makes. Did you hire a new associate? Begin offering a new therapy or procedure? Just open a new office? These are the types of items that might be of interest to your local media.

YOUR WEBSITE

One of the most basics of all marketing tools today, your website is the front door many of your web-savvy patients will enter. And most of your patients are now web savvy. If you don’t have a website now, you will probably be starting one soon. If you have one already, you should be thinking about how you are going to update and improve it. Be sure visitors get a good feel for who you are and what your practice is about. Can they schedule an appointment with you? Is your bio and picture on the site? Clear mapping and directions to your practice? Is there a clear call to action on the site to encourage

EMAIL MARKETING

appointments and contact with your office? If you have a blog, is it easily seen on the home page? My advice to clients on websites is not so much how to create one but to think of it as an ongoing project or strategy that has no beginning, middle or end. So many people spend a lot of time and money on their website so when it’s completed, they often put it out of their mind. But a website requires regular care and handling because if you stop updating your page, eventually Google will stop recognizing it when potential patients search for it. Some important things to consider when developing or updating your website: • Navigation—can people unfamiliar with your site find the info they want—test it on your friends or good customers • Search Engine Optimization—many websites become static quickly or do not show up in searches. There are a number of free registry sites such as Google, Yahoo and others that will help your website be found. • Regularly updating the site with new info/services/patient testimonials helps. • Blogging…can you write a little? If you can write a 400word blog on a topic you are an expert in, that can help ensure your website stays active and positions you better as an expert. • Videos can help…if you write a blog, you can do a video on the same topic. Most cell phones and digital cameras create video that is good enough to be edited and uploaded to a website.

SOCIAL MEDIA

While social media means more than just Facebook and Twitter, there is a growing recognition that these two top dogs provide the best return for the time you spend with them. That doesn’t mean that Pinterest or Instagram are not good fits for your practice. But Facebook has shaken off its image as just a channel where people post their breakfast pictures by provided real value and results for the money you do spend.

No matter what the industry, many businesses and organizations successfully use email marketing to reach their customers, update them with news and sell products and services. The most popular, Constant Contact and MailChimp, use email addresses from your patients who have opted in to the email as your contact list. If you are going to use email marketing as part of your practice promotion, the first step, obviously, is to collect email addresses from your patience and inform them you are doing so for your email newsletter. It’s very important to allow patients to opt out of the email newsletter. Once you start collecting email addresses, you can use an email newsletter service to create your own design and write your own content. Depending on your writing and design ability, you may wish to hire someone to help you. But these services do provide templates that make it easy to write, design and send email newsletters. Most services also provide you with good reporting to let you know how many people opened your newsletter and compares it to industry averages.

DIY MARKETING • Presentations/speeches—if you haven’t joined your local Chamber of Commerce or service club, this can be a good idea for networking and speeches. Kiwanis and Rotary clubs are always looking for speakers. • Contact your local nursing home or assisted living center to see if you can give a presentation to the residents about a health care topic of your choosing. Volunteer to screen patients for vein disorders. • ZocDoc—This is a more expensive approach but this website helps you fill unused appointments. For a yearly fee, often more than $2000, this service attempts to fill your vacant appointments. • Local advertising…while newspaper and television advertising may be out of your budget, coupon mailing services have been shown to be effective so consider those direct mail companies.

OPTIONS REQUIRING CAUTION

Marketing and promotion is also about avoiding bad investments that may sap your budget and time or end up affecting your reputation:

MARKETING

continued on page 24

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

THEPRACTICE

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VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

THEPRACTICE 2015: Record year for FDA approval of med devices; too much too fast? The U.S. Federal Drug Administration (FDA) is on target to clear more medical devices than in any individual year in the past decade. But not everyone sees this s a good thing. In the first half of 2015, the FDA cleared 26 devices with either premarket approval (PMA) or a humanitarian device exemption (HDE).To put that in perspective, in half a year FDA has already granted more PMAs and HDEs to new devices than it did in 2009, 2010 or 2013. The FDA regulates medical devices based on their level of risk, and allows companies to clear new low-risk products by demonstrating their similarity to already cleared devices. For high-risk (Class III) devices, companies must complete a PMA to demonstrate their device is safe and effective. HDEs are similar to PMAs, except they are granted to devices that treat or diagnose rare diseases and conditions, and do not require companies to prove effectiveness. For devices, FDA defines rare as affecting “fewer than 4,000 individuals” in the U.S. per year.

According to EP Vantage, the average review for devices granted a PMA or HDE took 17.1 and 16.7 months, respectively. Aside from having a productive year for device reviews, FDA has also taken steps to reduce the time it takes to review certain devices and reduce the level of regulatory oversight for others. In April, FDA finalized a new expedited pathway for medium- and high-risk devices that meet an unmet need for certain serious medical conditions. Then, in June, FDA announced it would exempt some 120 classes of low-risk devices from premarket notification requirements, making it substantially easier to bring devices in those classes to market. But a recent JAMA, study indicates that high-risk medical devices may not undergo the appropriate regulatory screening before and after they’re approved, highlighting a conspicuous point of contention to the House-approved 21st Century Cures Act or the FDA current regulatory procedures. The Act argues that if we speed up the approval of drugs and devices, more sick patients will benefit. But critics worry that speeding through the regulatory process will allow for potentially harmful products to make their way to patients.

The JAMA, study, led by Yale University public health researcher Joseph Ross, strengthens this argument. It finds a great deal of variation in the pre-market approval (PMA) pathway. High-risk devices are those that support or sustain human life, prevent illness, or can be dangerous when used in patients. “Further reducing the premarket requirements as proposed by the 21st Century Cures Act threatens to undermine the existing incentives that ensure that high-risk medical devices have been shown to be safe and effective prior to approval, without creating incentives to ensure that evidence is generated for these devices in the post-market period,” Ross wrote to MedCity News, in an email. Indeed, this is a real point of concern about the FDA’s regulatory path for such high-risk devices. Critics worry that the clinical studies leading to approval lack the adequate rigor and are prone to bias. “Most high-risk medical devices are being approved on the basis of a single pivotal trial, and these trials have clear weaknesses,” Ross said. FDA

continued on page 25

MARKETING

continued from page 22

GROUPON—This popular website/ application/email approach will definitely attract new patients for you, but at what cost? You will need to provide a discounted service and if it is popular, your practice may be inundated with a huge number of new patients who are paying 50 cents on the dollar for your service. If you can handle the administrative work and your budget can weather the discounted influx of new patients, Groupon may be right for you. The key question is whether you can develop long-term relationships with interesting and you might pick up some these patients that pays off for the investment you make participating in Groupon. YELP—There are a number of web-based review sites—RateABiz, Google and Yelp, chief among them. Yelp tends to get the lion’s share of attention because of its aggressive sales tactics. Tread lightly when dealing with these sites and be aware of their sales tactics. Yelp has come under fire because clients have found that negative reviews get pushed down their page if they advertise and moved up when they refuse. Many marketing and promotion ideas can be accomplished if the physician has the ability, inclination and time to executive them. An ability to write well, an understanding of the Internet, web and social media are all that is required to dive into these tactics that can help your practice flourish. VT N

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Chris Martin, MPH, owns Chris Martin Public Relations Inc., a Chicago full service public relations and marketing practice. He can be contacted through addcmpr.com.

AngioDynamics launches study AngioDynamics, a provider of minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, has enrolled the first patient into the Registry of AngioVac Procedures In Detail (RAPID) Database at the University of CaliforniaLos Angeles (UCLA) Health. The RAPID Database is designed to evaluate the patterns of use, as well as safety and effectiveness data, of the AngioVac system in the en bloc removal of fresh, soft thrombi or emboli. The national principal investigator is John M. Moriarty, MD, and assistant professor of Radiology and director of Cardiology-Interventional Radiology Innovation at UCLA. He said there has been significant interest in centers wanting to participate in the Registry. “So far, we have centers in 31 states that want to take part in the Registry,” he said. “Our goal is to include as many potential collaborators as possible, and start gathering much needed data regarding procedural and patient outcomes.” Dr. Moriarty added that the registry is also a way to become part of the community of physicians, nurses and technologists who are working in this field, and connecting with researchers who may not be anywhere near you geographically, but by working with RAPID, “you can become part of a wider group of experts.” AngioDynamics’ Senior Vice President Chris Crisman said AngioVac continues to impress clinically as the secondgeneration of the device, cleared for use earlier this year by the U.S. Food and Drug Administration (FDA) and released to the market in April, is driving broader interest among clinicians. “AngioDynamics is a pioneer when it comes to the minimally invasive en bloc removal of fresh, soft thrombi or embol,” he said. “We feel we have a responsibility to work with our physician partners to gather patient data and continue improving our procedures, products and patient outcomes.” The primary objective of RAPID is to capture high-quality patient safety and effectiveness data on use of the AngioVac system for various anatomic locations. The goal will be achieved by capturing a concise set of immediate and shortterm functional and clinical outcome data for all patients who have the AngioVac ANGIODYNAMICS

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OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

THEPRACTICE FDA

continued from page 24

High-risk medical device trials tend to study 250 patients on average; the follow-up lasts for a year or less, and most have no comparator group. Most of the arguments for reducing the premarket clinical trial requirements are actually coupled with proposals for better post-market study, Ross said. But that just isn’t happening. It leads one to question whether passage of the current state of 21st Century Cures might allow for device-makers to further sidestep stronger PMA trials and post-market efficacy studies. The study examined 28 high-risk devices that were approved in 2010 and 2011. On average, each device was tested in only two clinical studies before getting the FDA stamp of approval — most just gauged the basic functionality of the device, as opposed to their long-term clinical outcomes. It’s key, Ross said, to improve our ability to collect information on medical devices after they’ve been on the market. He cited the example of the FDA building out a new Unique Device Identifier (UDI) system — a measure that in theory could help track the safety and efficacy of a medical device. But this will only be effective if electronic health records are adapted to include UDI information so such data can be tracked accurately. In the meantime, there’s a fear that the speeding up of drug and device approvals through the 21st Century Cures Act — or through maintaining the FDA’s status quo — will just lead to more approvals of inadequately tested devices. After all, if it’s flawed now, what might happen should pre-market approval regulations become more lax? Already, it’s very rare for device-makers to actually complete postmarket clinical studies, Ross said — including those that are required by the FDA. “This suggests that there is little ‘new’ information to inform regulators, patients, physicians, or the manufacturers,” Ross said. “Until we have a better way to collect information on medical devices in the post-market period, or more stringent clinical study requirements, it is hard to see how reducing the premarket requirements will lead to more informed patient decision-making. VT N ANGIODYNAMICS

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catheter deployed into their venous system. Secondarily, registry objectives will be to study, assess and benchmark clinical practice patterns. These objectives will be achieved through the capture of selected process data for patients included in the registry. Data collected in this study may also be used to develop and refine standards of care for use of AngioVac and to facilitate the design of randomized clinical trials. VT N

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ACPUPDATE

ACP offers educational options By Mike Armitage In the evolving world of vein care it is critical to have access to the latest training and continuing education. The American College of Phlebology (ACP) has dedicated more than 30 years to providing vein care practitioners with cutting edge education through regional and national symposia, online continuing education and one-on-one training with experts in the field. The ACP’s myriad educational offerings are unparalleled by any other organization, and represent the most comprehensive and innovative selection of topics in the diagnosis and treatment of venous and lymphatic disease.

LIVE EDUCATIONAL MEETINGS & SYMPOSIA

The ACP has been at the forefront of live education with the Annual Congress – the largest annual meeting dedicated to venous and lymphatic disease – and intimate, hands-on regional symposia, which offer practitioners the latest techniques with expert faculty.

THE ANNUAL CONGRESS

As the largest meeting of its kind in the United States, the ACP Annual Congress has long been the premier educational event for physicians and allied healthcare providers in vein care, growing in attendees and scope each year. The 2015 Annual Congress in Orlando, Fla., is no exception. Under the direction of

Program Co-Chairs Lisa Pavone, MD, RVT, and Melvin Rosenblatt, MD, FACPh, the scientific program continues to set the pace for vein care with innovative and engaging content presented by distinguished faculty from around the world.

REGIONAL SYMPOSIA

In 2013, the ACP opened its Training Center as a dedicated facility for hands-on training in a more intimate and interactive environment. To date, the ACP Training Center has hosted more than 10 courses ranging from sclerotherapy to ultrasound. Look for ultrasound, nursing and physician sclerotherapy and phlebology review courses in 2016.

ONLINE EDUCATION

The ACP Online Education Center currently hosts one of the most extensive catalogs of venous related topics on the web with more than 200 courses, ranging from basic to advanced topics, and covering both superficial and deep venous issues. The content features prominent experts from around the world, and courses have been specifically selected from the Annual Congress, the UIP World Meeting and smaller topical symposia for physicians, nurses, sonographers and other healthcare professionals who wish to improve patient outcomes. The array of venous health courses currently online affords the flexibility live sessions can’t, allowing healthcare practitioners to

take courses at any time and at their own pace. The purpose of the Online Education Center is to provide the most up-to-date content and to teach the best practices in the field of vein care. Recently, the ACP began producing regular live online webinars on important topics such as ICD-10 and ultrasound. With the inclusion of streaming content from these types of live events and expanded allied health topics, the Online Education Center continues to expand the educational opportunities for the growing needs of the medical community.

ONE-ON-ONE PRECEPTORSHIPS

their choosing, while giving clinicians the opportunity to train with respected experts in their field. As the needs of vein care practitioners and the technology for producing quality education evolve, the ACP is dedicated to ensuring that the venous disease community has the resources necessary to continue to deliver the best available care. VT N READ MORE: phlebology.org Mike Armitage is the director of marketing and communications at the American College of Phlebology. He may be emailed at: spaces ssssssssssss marmitage@acpmail.org.

Peer-to-peer learning is critical in the medical industry, particularly in a specialized field such as vein care, and the ACP Phlebology Preceptorship Program matches healthcare providers (trainees) with vein care specialists, allowing providers to receive individual training from phlebologists in a clinical setting. The goal of the program is to enhance trainees’ k nowledge in specific areas of

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

PRODUCTNEWS

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+ Opportunities to improve patient care at all levels of skill from foundational through advanced + Presentations and exhibitors of leading research, technology and trends in the field of vein care + Hands-on workshops and demonstrations with renowned experts from all over the world, including topics such as sclerotherapy, compression, non-thermal saphenous vein treatments and superficial venous imaging

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advancing vein care

SECONDLOOK

FACT, FICTION OR DISCRIMINATION?

Treatment for pelvic venous congestion syndrome By Mel Rosenblatt, MD, FACPh The presence of enlarged venous structures in the female pelvis was first described as a “tubo-ovarian varicocele” by Richet in 1875.1 Nearly 75 years later Taylor presented 105 cases of chronic pelvic and gynecologic symptoms that he attributed to vascular congestion and fibrosis.2 This entity, which has been termed pelvic congestion syndrome, has suffered credibility problems from the moment it was described. Taylor, in his original description of this entity wrote that “psychiatric disturbance, usually of an emotional character, are a common accompaniment of pelvic congestion.”3 As a consequence of this observation, Taylor believed that emotional tension, having an effect on the smooth muscle cells and secretory cells of the pelvis, was an important etiologic factor in the development of this condition.4 Unfortunately, this perspective combined with poor clinical response to therapies offered in 1960s 70s and 80s led to the common belief, which persists to this day, that this entity is purely a psychiatric condition. Sometime after Taylor’s original description, the true etiology was discovered to be retrograde blood flow in the gonadal veins resulting in pelvic venous engorgement. This is identical to the process responsible for varicoceles in men. Unfortunately, the erroneous perceptions created by Taylor’s original description not only influenced physicians, but thirdparty payers as well. Gonadal vein embolization, which is considered the most effective therapy for this disorder, is typically not recognized as such by third-party payers. Ironically, coverage requests for embolotherapy to treat painful varicoceles, despite its similarity to pelvic congestion syndrome, are rarely denied. This gender-biased coverage policy is exceedingly difficult to justify in light of the body of medical literature on this topic. This article will endeavor to review the literature and the data supporting therapy in various clinical scenarios.

PREVALENCE

Chronic pelvic pain is defined as pain lasting for at least six months. Venous congestion is not the only causative factor. Uterine fibroids, adenomyosis, endometriosis, hydrosalpynx, pelvic inflammatory disease, ovarian cysts and a variety of gastrointestinal causes are included in the differential diagnosis. The prevalence of chronic pelvic pain is surprisingly high. In the United States. the incidence has been reported to be as high as 39 percent and in the United Kingdom the prevalence is equivalent to that of migraines, back pain and asthma.5 6 In a more recent review of the world literature, the prevalence was noted to be between 5.7 and 26.6 percent of the population.7 With such a high prevalence, it is no surprise that the financial effect on the health care system is staggering, exceeding a billion dollars annually.8 9 However, what is surprising is that 30 percent of patients with chronic pelvic pain can attribute their symptoms solely to pelvic venous incompetence. While pelvic pain can be caused by pelvic reflux, the presence of pelvic reflux and pelvic varicosities is not always associated with any pelvic complaints. This has been demonstrated in a relatively small study, where ovarian vein dilation was noted on CT scan in 63 percent of asymptomatic parous women and in 10 percent of asymptomatic nonparous women.10

However what is often overlooked is that pelvic incompetence can cause lower extremity varicosities in the absence of pelvic symptoms. In our patient population more than 70 percent of patients with confirmed pelvic derived lower extremity varicosities deny pelvic pain, dyspareunia and dysmenorrhea. Thus, when evaluating patients with lower extremity varicosities it is important to note that a significant percentage may have a pelvic source. Lapropoulos reported that the incidence of non saphenous venous reflux is 10 percent with more than one-third of this group having varicosities that arise in the pelvis.11 In another study, 1,350 patients with lower extremity varicosities were evaluated with both duplex ultrasound and CT venography to ascertain the source of reflux. A pelvic reflux source was noted in 8.6 percent of patients.12 In yet another study, 741 female patients with varicose veins from two separate clinics were evaluated with duplex and transvaginal ultrasound. These studies found a pelvic reflux source in 19.5 percent of patients in one group and 21.5 percent in the other with approximately 80 percent of the pelvic reflux emanating from the gonadal vein.13 Multiple additional studies show similar results leading to the conclusion that approximately one in every five untreated female patients will have lower extremity varicosities as a result of pelvic venous disease. In treated patients who developed recurrent varicosities after saphenous vein interventions, the incidence of pelvic reflux is even greater. Monedero reported that the incidence of pelvic venous reflux was 46.3 percent in patients with recurrent varicosities after surgery (REVAS).14 Similarly, Barros reported a 41.3 percent incidence of pelvic reflux in patients who had previous venous surgery.15 Although these studies infer that pelvic reflux is a common source of recurrent varicose veins, it is more likely, given the very high incidences noted, that pelvic reflux was the primary unrecognized cause of varicosities and these cases represents persistence of disease in inadequately treated patients.

ETIOLOGY

Engorgement of the pelvic venous plexus can be caused by venous reflux or obstruction. Obstructive processes, such as May Thurner syndrome, Nutcracker syndrome and IVC obstruction cause mechanical venous hypertension and the formation of varicose collaterals.16-19 Patients who have an obstructive process will require a procedure to relive the obstructed vessel. In the case of May Thurner syndrome, this may necessitate the placement of an iliac stent.20 This is a very different strategy than that needed for the treatment of gonadal vein reflux. Typically, pelvic venous insufficiency is treated with occlusion of the abnormal refluxing vessels. Because obstructive etiologies differ significantly from reflux in the mode of therapy needed for proper treatment, they will not be considered in this review. Venous reflux, which is the most common cause of pelvic congestion, is typically the result of valvular absence or dysfunction in the gonadal veins.21 Complete absence of valves in the gonadal vein is not uncommon and has been reported to occur in 15 percent of women.22 Malfunctioning gonadal vein valves is more common, occurring on the left side in 40 percent of cases and 35 percent on the right.22 Valve failure or absence results in retrograde blood flow in these vessels with eventual engorgement of the peri-

Fig.1 uterine venous plexus. This engorgement is significantly amplified when a pregnancy related 6000 percent increase in vascular capacity is superimposed on these anatomical abnormalities.23 The pelvic venous plexus collateralizes freely with the superficial veins of the lower extremity. These venous connections have been termed “pelvic escape points.” When severe congestion occurs, as in pregnancy, the excess venous volume finds its way into the lower extremity veins forming varicosities in the upper leg and vaginal region. Additionally, pelvic venous connections with the saphenous system may cause saphenous valve failure and mimic the signs and symptoms of superficial venous disease. Pelvic reflux etiologies that do not involve the gonadal veins can also occur. Pelvic venous malformations, which are uncommon, but not rare, are composed of congenitally enlarged venous channels that contain no valves. These lesions can be located in the pelvis and the vaginal wall. The enlarged veins act as a reservoir for blood which can cause symptoms indistinguishable from gonadal vein reflux. In addition, pelvic or vaginal venous malformations can cause sufficient reflux to generate lower extremity varicosities.24 Although the symptoms are similar in charterer to classic gonadal vein reflux, the intensity is usually much worse in the setting of a venous malformation. Imaging studies can sometimes distinguish between these two entities. In the case of a venous malformation, venous engorgement may be appreciated in the absence of gonadal vein enlargement. Unfortunately, this is not always the case and establishing a correct diagnosis can be a challenge.

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

SECONDLOOK TREATMENT STRATEGIES

The classical approach to lower extremity venous reflux is to start therapy from the point of origin downward. Applying this top down concept to pelvic vein reflux leads to an algorithm where secondary imaging is needed to find the reflux origin and once found treated. In the case of gonadal vein reflux this may involve obtaining an MR or CT venogram and then embolization of a refluxing gonadal vessel. In our experience, this therapeutic approach is effective in remedying an individual with pelvic symptoms but frequently ineffective in patients whose symptoms are confined to the lower extremities. Offering a therapy that presumably improves venous physiology but has no perceivable benefit leads to patient frustration and dissatisfaction. To avoid this problem we have adopted a bottom up approach where the varicosities exiting the pelvis are treated first. With this method, the perineal and vulvar varicosities are occluded with a sclerosant that can be delivered with standard injections or with fluoroscopic guidance. To better understand this idea, a conceptualization of pathologic pelvic venous anatomy is helpful. (See Fig. 1) In this image, reflux beginning in the gonadal vein extends in to the peri-uterine varicose plexus where it collateralizes with the internal iliac veins. From this complex network, vessels extend down into the lower extremities causing varicosities and symptoms. If an imaginary line is drawn through middle of the peri-uterine varicose plexus, it is the varicosities above this line (upper component) that are responsible for pelvic symptoms while lower extremity symptoms are caused by the varicosities below (lower component). Occlusion of the upper component vessels (above the line) will not improve symptoms of venous incompetence in the leg, as the countless number of valveless internal iliac vein collateral connections will continue to supply an abundance of retrograde blood flow. It is for this reason that many published series do not demonstrate significant clinical improvement in lower extremities symptoms after gonadal vein embolization alone.25, 26 With the algorithm described above, the choice of treatment depends initially on the patients clinical symptoms. If their symptoms are confined to the extremities then treatment of the lower component is offered. This treatment can be in the form of ultrasound guided injections. However, the lower component varicosities can sometimes be so extensive that this approach fails. In this situation fluoroscopically guided embolization permits the safe administration of large volumes of sclrerosants and increases success rate dramatically. This technique is not only an effective treatment method, but is also an excellent diagnostic tool. The preliminary varicography can often distinguish between different etiologies obviating the need and cost of secondary imaging. Once the lower component is successfully treated, any additional therapy will depend on the patientâ&#x20AC;&#x2122;s clinical follow-up. If after several weeks they still have persistent symptoms or if they develop recurrent varicosities, then it may be necessary to treat the upper component. At this point secondary imaging, if needed, can be obtained followed by gonadal vein embolization. In our experience with this approach, less than 20 percent of patients will return for any secondary imaging or procedures even when followed for several years.

TREATMENT TECHNIQUE

Transcatheter embolization of the gonadal vein has been extensively described and an overly detailed description is beyond the scope of this article.27-32 However, it is important to mention one main feature of treatment that relates to the peri-uterine venous plexus. The plexus can be considered the epicenter of the lesion. It is very important to not only occlude

the refluxing vessel leading to the plexus, but to eliminate the plexus itself. This is best accomplished by filling the venous plexus with a vascular sclerosant. If this is not done then collateral vessels from the internal iliac veins may continue to fill the pelvic varicosities causing persistence symptoms.

are no comparison groups. Unfortunately, this is unavoidable as it is difficult to design a study where the control group, which consists of patients with significant symptoms, gets no treatment, limited treatment or inappropriately aggressive treatment, such as hysterectomy.

OUTCOMES Pelvic Symptoms

Over the past 15 years multiple articles have been published evaluating the effectiveness of gonadal vein embolization for the treatment of symptoms related to pelvic venous congestion. Several of these studies have been case series that have demonstrated significant benefit with this therapy. Table 1 includes studies with 30 or more patients. The technique used in each study varies somewhat in the method of gonadal vein occlusion.

Study Maleux (2000)

Women Technique 41

Glue

Sclerosant and Coils

VAS pre

VAS post

f/u time

Venbrux

7.8

2.7*

1 year

Chung (2003)

7.8

3.2*

1 year

Kim (2006)

127

7.6

2.9*

45 months

Mean f/u (months)

Clinical outcome

Laborda (2013)

179

7.3

0.8*

5 years

19.9

Relief 58.5 percent, partial relief 9.7 percent, no relief 31.8 percent

Nasser (2014)

100

7.3

0.5*

1 year

Hocqulet (2014)

7.4

1.4*

26 months

Venbrux (2002)

Pieri (2003)

Sclerosant 6 and 12

Significant relief in 100 percent

Kim (2006)

127

Sclerosant and Coils

Significant relief 85 percent, no relief 12 percent, 3 percent worsened

Kwon (2007)

Coils

44.8

Significant relief 82 percent, no relief 15 percent, 3 percent worsened

Gandini (2008)

STS Foam

Significant relief in 100 percent

Laborda (2013)

179

Coils

VAS improvement 7.8 to 0.8

22.1

Relief in 96 percent, no relief in 4 percent

Table 1 Several of these studies used pre- and post-treatment 10-point visual analogue scales (VAS) to evaluate patient response to treatment. (See Table 2). The pre-procedural VAS was remarkably similar in the studies, and the improvement was significant after treatment when compared with the VAS before treatment and durable up to 4-5 years in followup.34-36 A valid criticism of this outcome data is that there

VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

Patients

* Statistically significant difference from VAS pre-treatment Table 2 In addition to the numerous case series, a randomized controlled trial comparing hysterectomy to embolization was performed by Chung and Huh.37 118 patients, with well documented pelvic congestion syndrome who failed ovarian suppression therapy, were randomized to embolization or hysterectomy. Patients treated with embolization had shorter hospital stays and a quicker return to full function. In addition, the embolization group demonstrated statistically significant improvement in VAS scores as compared to hysterectomy at 3, 6 and 12 months. All of the published series have demonstrated significant improvement with embolization. However, the results of these studies are somewhat heterogeneous with improvements as high as 100 percent and as low as 58 percent. This heterogeneity may relate to differences in the techniques used, in the selection of patients and in the metrics used for follow-up. As an example, Maleux used glue to occlude the gonadal vein with a relatively low response rate, while the other series used a combination of coils and a sclerosant with much better results. Other technical differences, such as occlusion of refluxing internal iliac veins and sclerosis of the peri-uterine varicose reservoir may have a significant effect on the effectiveness of treatment.26 Therefore, the pooled data we present may reflect outcomes in some incompletely treated patients. Despite this the results are still very good and with technical refinements results will only improve. Pelvic derived lower extremity varicose veins are estimated to be found in up to 20 percent of women with varicose vein.13 The prevalence might be even higher in populations with persistent or recurrent varicose veins after prior treatment.14 15 The data for treating pelvic derived lower extremity varicose veins with pelvic embolization is not as strong as that for the treatment of PCS. A few of the studies combined pelvic embolization and superficial vein surgery which confounds interpretation of the outcome following embolization for recurrent varicose veins after prior surgery.14, 27 PELVIC VENOUS CONGESTION

continued on page 30

SECONDLOOK PELVIC VENOUS CONGESTION

continued from page 29

Ratnam followed 219 patients with pelvic reflux documented by leg and transvaginal US and lower extremity veins after coli embolization of the OV and IIV as needed. They noted a significant reduction in the amount of reflux found on transvaginal US, but did not comment on the change in the leg veins or the patients’ symptoms.38

FOOTNOTES 1

Richet M. Traite Pratique d’Anatomie MedicoChirugicale: Chamerot et Lauwereyns; 1875. 2 Taylor HC, Jr. Vascular congestion and hyperemia; their effect on function and structure in the female reproductive organs; the clinical aspects of the congestion-fibrosis syndrome. American journal of obstetrics and gynecology. 1949;57(4):637-53. 3 Taylor HC, Jr. Vascular congestion and hyperemia; their effect on structure and function in the female reproductive system. American journal of obstetrics and gynecology. 1949;57(2):211-30. 4 Taylor HC, Jr. Life situations, emotions and gynecologic pain associated with congestion. Research publications Association for Research in Nervous and Mental Disease. 1949;29:1051-6. 5 Jamieson DJ, Steege JF. The prevalence of dysmenorrhea, dyspareunia, pelvic pain, and irritable bowel syndrome in primary care practices. Obstetrics and gynecology. 1996;87(1):55-8. 6 Zondervan KT, Yudkin PL, Vessey MP, Dawes MG, Barlow DH, Kennedy SH. Prevalence and incidence of chronic pelvic pain in primary care: evidence from a national general practice database. British journal of obstetrics and gynaecology. 1999;106(11):1149-55. 7 Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain physician. 2014;17(2):E1417. 8 Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, healthrelated quality of life, and economic correlates. Obstetrics and gynecology. 1996;87(3):321-7. 9 Perry CP. Current concepts of pelvic congestion and chronic pelvic pain. JSLS : Journal of the Society of Laparoendoscopic Surgeons / Society of Laparoendoscopic Surgeons. 2001;5(2):105-10. 10 Rozenblit AM, Ricci ZJ, Tuvia J, Amis ES, Jr. Incompetent and dilated ovarian veins: a common CT finding in asymptomatic parous women. AJR American journal of roentgenology. 2001;176(1):119-22. 11 Labropoulos N, Tiongson J, Pryor L, Tassiopoulos AK, Kang SS, Mansour MA, et al. Nonsaphenous superficial vein reflux. Journal of vascular surgery. 2001;34(5):872-7. 12 Jung SC, Lee W, Chung JW, Jae HJ, Park EA, Jin KN, et al. Unusual causes of varicose veins in the lower extremities: CT venographic and Doppler US findings. Radiographics: a review publication of the Radiological Society of North America, Inc. 2009;29(2):525-36. 13 Marsh P, Holdstock J, Harrison C, Smith C, Price BA, Whiteley MS. Pelvic vein reflux in female patients with varicose veins: comparison of incidence between a specialist private vein clinic and the vascular department of a National Health Service District General Hospital. Phlebology / Venous Forum of the Royal Society of Medicine. 2009;24(3):108-13.

Mondero also reported on the treatment of 643 female patients with recurrent varicose veins after surgery.14 He found that 46.3 percent of these patients had recurrence as a consequence of pelvic venous reflux. 215 patients in this group were treated with gonadal vein embolization with 50.2 percent having complete resolution of symptoms and 39.7 percent having partial relief. Castenmiller reported a 12 percent resolution of leg varicose veins and 23 percent had no response in 43 women undergoing

Monedero JL, Ezpeleta SZ, Castro JC, Ortiz MC, Fernández GS. Embolization treatment of recurrent varices of pelvic origin. Phlebology / Venous Forum of the Royal Society of Medicine. 2006;21(1):3-11. 15 Barros FS, Perez JMG, Zandonade E, Salles-Cunha SX, Monedero JL, Hilel ABS, et al. Evaluation of pelvic varicose veins using color Doppler ultrasound: comparison of results obtained with ultrasound of the lower limbs, transvaginal ultrasound, and phlebography. Jornal Vascular Brasileiro. 2010;9:15-23. 16 Hartung O, Grisoli D, Boufi M, Marani I, Hakam Z, Barthelemy P, et al. Endovascular stenting in the treatment of pelvic vein congestion caused by nutcracker syndrome: lessons learned from the first five cases. Journal of vascular surgery. 2005;42(2):275-80. 17 d’Archambeau O, Maes M, De Schepper AM. The pelvic congestion syndrome: role of the “nutcracker phenomenon” and results of endovascular treatment. JBR-BTR : organe de la Societe royale belge de radiologie. 2004;87(1):1-8. 18 Scultetus AH, Villavicencio JL, Gillespie DL. The nutcracker syndrome: its role in the pelvic venous disorders. Journal of vascular surgery. 2001;34(5):812-9. 19 Rastogi N, Kabutey NK, Kim D. Incapacitating pelvic congestion syndrome in a patient with a history of MayThurner syndrome and left ovarian vein embolization. Annals of vascular surgery. 2012;26(5):732 e7-11. 20 Blattler W, Blattler IK. Relief of obstructive pelvic venous symptoms with endoluminal stenting. Journal of vascular surgery. 1999;29(3):484-8. 21 Taylor HC, Jr. Vascular congestion and hyperemia; their effect on function and structure in the female reproductive organs; etiology and therapy. American journal of obstetrics and gynecology. 1949;57(4):654-68. 22 Kaufman JA, Waltman AC, Rivitz SM, Geller SG. Anatomical observations on the renal veins and inferior vena cava at magnetic resonance angiography. Cardiovascular and interventional radiology. 1995;18(3):153-7. 23 Hodgkinson CP. Physiology of the ovarian veins during pregnancy. Obstetrics and gynecology. 1953;1(1):26-37. 24 Ashour MA, Soliman HE, Khougeer GA. Role of descending venography and endovenous embolization in treatment of females with lower extremity varicose veins, vulvar and posterior thigh varices. Saudi medical journal. 2007;28(2):206-12. 25 Smith PC. The outcome of treatment for pelvic congestion syndrome. Phlebology / Venous Forum of the Royal Society of Medicine. 2012;27 Suppl 1:74-7. 26 Asciutto G, Asciutto KC, Mumme A, Geier B. Pelvic venous incompetence: reflux patterns and treatment results. European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. 2009;38(3):381-6. 27 Meneses L, Fava M, Diaz P, Andia M, Tejos C, Irarrazabal P, et al. Embolization of incompetent pelvic veins for the treatment of recurrent varicose veins in lower

only ovarian vein embolization. The remaining 63 percent had additional treatments, again confounding the interpretation of the outcome following embolotherapy.39 They did note that in 24 patients with vulvar varicose veins as a part of their problem, 88 percent of them had disappearance following embolization of refluxing veins. From these studies it is clear that recurrent symptomatic varicose veins are often associated with pelvic venous reflux. If the source of reflux is not treated then recurrence and

limbs and pelvic congestion syndrome. Cardiovascular and interventional radiology. 2013;36(1):128-32. 28 van der Vleuten CJ, van Kempen JA, Schultze-Kool LJ. Embolization to treat pelvic congestion syndrome and vulval varicose veins. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2012;118(3):227-30. 29 Edo Prades MA, Ferrer Puchol MD, Esteban Hernandez E, Ferrero Asensi M. Pelvic congestion syndrome: outcome after embolization with coils. Radiologia. 2012. 30 Bittles MA, Hoffer EK. Gonadal vein embolization: treatment of varicocele and pelvic congestion syndrome. Seminars in interventional radiology. 2008;25(3):261-70. 31 Kwon SH, Oh JH, Ko KR, Park HC, Huh JY. Transcatheter ovarian vein embolization using coils for the treatment of pelvic congestion syndrome. Cardiovascular and interventional radiology. 2007;30(4):655-61. 32 Maleux G, Stockx L, Wilms G, Marchal G. Ovarian vein embolization for the treatment of pelvic congestion syndrome: long-term technical and clinical results. Journal of vascular and interventional radiology : JVIR. 2000;11(7):859-64. 33 Venbrux AC, Lambert DL. Embolization of the ovarian veins as a treatment for patients with chronic pelvic pain caused by pelvic venous incompetence (pelvic congestion syndrome). Current opinion in obstetrics & gynecology. 1999;11(4):395-9. 34 Venbrux AC, Chang AH, Kim HS, Montague BJ, Hebert JB, Arepally A, et al. Pelvic congestion syndrome (pelvic venous incompetence): impact of ovarian and internal iliac vein embolotherapy on menstrual cycle and chronic pelvic pain. Journal of vascular and interventional radiology : JVIR. 2002;13(2 Pt 1):171-8. 35 Laborda A, Medrano J, de Blas I, Urtiaga I, Carnevale FC, de Gregorio MA. Endovascular treatment of pelvic congestion syndrome: visual analog scale (VAS) long-term follow-up clinical evaluation in 202 patients. Cardiovascular and interventional radiology. 2013;36(4):1006-14. 36 Kim HS, Malhotra AD, Rowe PC, Lee JM, Venbrux AC. Embolotherapy for pelvic congestion syndrome: longterm results. Journal of vascular and interventional radiology : JVIR. 2006;17(2 Pt 1):289-97. 37 Chung MH, Huh CY. Comparison of treatments for pelvic congestion syndrome. The Tohoku journal of experimental medicine. 2003;201(3):131-8. 38 Ratnam LA, Marsh P, Holdstock JM, Harrison CS, Hussain FF, Whiteley MS, et al. Pelvic vein embolisation in the management of varicose veins. Cardiovascular and interventional radiology. 2008;31(6):1159-64. 39 Castenmiller PH, de Leur K, de Jong TE, van der Laan L. Clinical results after coil embolization of the ovarian vein in patients with primary and recurrent lower-limb varices with respect to vulval varices. Phlebology / Venous Forum of the Royal Society of Medicine. 2013;28(5):234-8.

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

SECONDLOOK persistence of lower extremity symptoms can be expected. What is not clear is how effective is gonadal vein embolization in eliminating symptoms in the lower extremity. A few studies do suggest that it is at least partially effective in many cases. Complete effectiveness may depend on the technique used. In addition, given the complexity of the venous anatomy in these cases, adjunctive procedures in the leg are likely needed to fully treat a patient’s symptoms. This is analogous to the use of ambulatory phlebectomies and sclerotherapy after ablation of the GSV. Additional studies are needed to determine which embolization technique is most effective and what adjunctive procedures may be needed.

CONCLUSIONS The data supporting the use of pelvic embolization to treat CPP without another cause is strong, based on many nonrandomized studies and one high quality randomized study utilizing VAS as the metric for outcome assessment. Currently the SVS guidelines give pelvic embolization a 2B recommendation; however, not all of the studies listed in this

review, including the randomized study by Chung and Huh, were considered. In our assessment of the literature, patients, with symptomatic pelvic congestion and no other cause for pelvic pain, will likely have great benefit from embolization and this should be considered the treatment of choice. In patients with lower extremity pelvic derived varicose veins the value of pelvic embolization is less clear. In these patients, direct treatment of the varicose veins beginning at their pelvic escape points with either visual or, if needed, image guided chemical ablation is recommended to control these varicosities. These approaches are inexpensive and in our experience, can be effective. This has been confirmed by small case series. If the patients’ varicose veins or leg symptoms are difficult to eliminate or recur on short follow-up, then pelvic venography and embolization is indicated. Based on the impressive results from one study, pelvic embolization may be useful in patients’ with varicose veins primarily found on the labia when the varicosities are substantial in number or size or when antecedent direct injection of a sclerosant is either not successful or not possible.

In summary, embolization as a treatment for gonadal vein reflux in patients with significant pelvic pain and or extensive symptomatic vulvar varicosities has evidence based clinical benefit and shared indemnity for treatment expenses is justified. From a pathophysiologic perspective, there is absolutely no difference between a man with a painful varicocele and a woman with pelvic congestion syndrome. Yet, indemnity plans tend to deny coverage for pelvic congestion and provide coverage for varicocele treatment. This practice is nothing more than gender based discrimination and should be discontinued. VT N Mel Rosenblatt, MD, FACPh, is the owner and medical director of Connecticut Image Guided Surgery in Fairfield, Conn., and was the first doctor in Connecticut to perform the Endovenous Laser and Closure procedures. He has dedicated years to acquiring experience from institutions such as Memorial Sloan Kettering Cancer Center and Yale University School of Medicine. Dr. Rosenblatt is past-president of the board of directors of the American College of Phlebology.

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SECONDLOOK

ACP 2015

IAC

continued from page 1

How sclerotherapy really works By Ronald Bush, MD, FACS Sclerotherapy is the last step in treating telangiectasias. The etiology of the cutaneous venous hypertension and collateral flow must be assessed. Once found and in some cases retrograde flow having been addressed, sclerotherapy can proceed. Most practitioners perform sclerotherapy without knowing the exact mechanism for vessel damage. Too often inappropriate concentrations are used and this can lead to unacceptable cosmetic results. Currently my practice is located at three large dermatology clinics in Florida (Water’s Edge Dermatology). Not only is there a real demand for quality cosmetic vein work, but there are incredible resources available including a dermapathology lab. Over the last two years, I have continued research on cellular and vessel response to chemical and heat injury. The subject I am presenting at the ACP 2015, 29th Annual Congress, deals with the effects of sclerotherapy at different concentrations from a histologic and clinical approach. One of the goals of the study is to find an ideal sclerosant concentration with just the right amount of vessel damage with minimal sequalae. The ideal concentration should not penetrate the smooth muscle wall of a treated

vein; however endothelial cells should be lysed and subintimal damage should be visible with eventual collagen replacement of the vessel wall. Luminal debris and red cells should be minimal at first. Many factors will be discussed regarding safe and effective sclerotherapy in this presentation. I look forward to sharing my original research with you. VT N See Micro-Phlebology Symposium: veinexperts.org/mirco-phlebologysymposium.asp Ronald Bush, MD, FACS, is one of the nation’s leading specialists in venous diseases. Dr. Bush founded and is the medical director for Vein Experts, a national group of venous specialists specializing in venous disease. He is Board Certified in general vascular surgery and was also certified in cardio/thoracic surgery. Dr. Bush is the author of numerous scientific papers and holds patents for surgical instruments. For the past 20 years, he has devoted his practice solely to the treatment of venous disease, and training physicians from around the world. Many of the new procedures now performed in the ambulatory treatment of varicose veins have originated in part from his clinical studies.

Treating facial spider veins By Peggy Bush, APN, CNS, MSN While facial veins cause no harm, cosmetically they are not acceptable to patients. Fair-skinned individuals are more prone to developing facials veins than Fitzpatrick skin types V & VI. The most common veins we see in our practice at Water’s Edge Dermatology, Fla., are the red veins of the nose and cheeks. Red veins are treated with ohmic thermolysis (VeinGogh), or 940nm laser (Dornier). Facial spider veins in most cases are the results of sun exposure although environmental, hereditary and hormonal factors may be present. One to three treatments are typically necessary. The complications are minimal and usually consist of mild skin redness or very tiny areas of skin crusts that disappear quickly. Many patients also seek consultation for large facial veins. Very commonly these are infraorbital veins or they can run from the scalp veins to the angular veins (frontal veins), which are located on each side of the nose. The angular veins are connected to the ophthalmic veins and eventually the cavernous sinus. Treatment of the frontal veins requires certain steps to prevent

disastrous complications. At times, minor surgical technique are used to disconnect the superior aspect of the vein. Infraorbital veins can be treated with a 1064 yag laser or foam sclerotherapy. If using foam sclerotherapy, it is essential to prevent retrograde flow towards the nose while injecting. Phlebectomy can be used, but is not necessary in our experience. For temporal veins, we use foam sclerotherapy. Before treating any facial veins with sclerotherapy it is essential to know the anatomy and the area of drainage you are treating. A very small butterfly must be used with gentle injection using foam sclerotherapy. Learn techniques to treat facial veins and more at the Art of Micro-Phlebology symposium, West Palm Beach, Fla., Jan. 23, 2016. VT N See Micro-Phlebology Symposium: veinexperts.org/mirco-phlebologysymposium.asp Peggy Bush, APN, CNS, MSN is the CEO/ Administrator for Vein Experts & Bush Venous Lectures and Water’s Edge Dermatology.

reimbursement. The official announcement, as issued by BCBSMA can be accessed on the IAC website at intersocietal.org/vein/main/ payment_policies.htm As the concept of vein center accreditation remains a relatively new one, understanding the background of why the program was created and what it entails is useful. With the goal of establishing minimum standards for the daily operations and personnel participating in venous evaluation, management and treatment procedures, in 2010 leaders from the American College of Phlebology and the Society for Vascular Medicine began conversations about the need for a vein care accreditation process. These leaders envisioned a process inclusive of all specialties involved in vein care, with standards created by vein care experts from all of the disciplines treating venous disease. The program offered by the Intersocietal Accreditation Commission (IAC) for vascular testing facilities, which began in 1990 and was known for many years as ICAVL (Intersocietal Commission for the Accreditation of Vascular Laboratories) was considered a model upon which the new vein care accreditation process could be based. Therefore, the IAC was carefully critiqued and ultimately chosen to be the independent accrediting body under which this effort would be developed and the program administered. A board of directors inclusive of representatives from the American Academy of Dermatology (AAD), American College of Phlebology (ACP), American College of Surgeons (ACS), American Society for Dermatologic Surgery Association (ASDSA), American Venous Forum (AVF), Society for Clinical Vascular Surgery (SCVS), Society for Vascular Medicine (SVM), Society for Vascular Surgery (SVS), Society for Vascular Ultrasound (SVU) and the Society of Interventional Radiology (SIR) was formed. Following completion of a detailed pilot program, in late 2013 the accreditation process became available to the field, first through the publication of The IAC Standards for Vein Center Accreditation: Superficial Venous Evaluation and Management in October 2013 and shortly thereafter through the launch of the IAC Vein Center online application in November of that same year. IAC Vein Center defines a vein center as a facility where venous evaluation, management and treatment procedures are performed and accredits facilities with the capability to provide at least two of the four following procedures: sclerotherapy; ambulatory phlebectomy; saphenous vein ablation and/ or non-operative management of chronic venous insufficiency with ulceration. At a minimum, a qualified medical director (MD or DO); appropriate equipment to perform

the procedures and utilization of venous duplex ultrasound diagnostic testing in an IAC Vascular Testing or American College of Radiology (ACR) accredited facility are required. By participating in the accreditation process, vein centers assess every aspect of their daily operation and its effect on the quality of healthcare provided to patients. While completing the application, facilities often identify and correct potential problems, revising policies and validating their quality assurance programs. Participating facilities utilize accreditation as the foundation to create and achieve realistic quality care goals. Most recently, IAC Vein Center released updated standards on Aug. 3 that became effective immediately. The revisions were specific to two key components of the document. First, to ensure consistent, standardized testing and documentation for lower extremity venous insufficiency, minimum requirements are now published for diagnostic venous ultrasound examinations as part of the IAC Vein Center Standards. In addition, the standard related to sclerotherapy/ pharmacologic agents has been expanded to define the appropriate use of compounded liquid sclerosants. Representing the collaborative effort of each specialty group represented on the IAC Vein Center Board of Directors, the Standards are designed and regularly updated to be utilized by facilities as they conduct a self-evaluation to ensure compliance. The published Standards are available at the intersocietal.org/vein/main/vein_standards. htm. Applications are accepted by the IAC at any time; there are no specific deadlines. The application elicits key responses that allow reviewers to objectively judge whether or not substantial compliance to the Standards is met by the applicant vein center. Representative case studies are evaluated as part of each application and carry a significant weight in the final decision. Once the application is submitted via the online application, three venous treatment cases from the submitted procedure log are randomly selected by the IAC for review. The medical director of the applicant vein center is notified of which procedures have been selected and given instructions for submission. Pre-procedure documentation, procedure documentation, post-procedure documentation and follow-up documentation are required. Medical professionals providing venous evaluation, management and treatment procedures are being held to high levels of accountability — by patients, by peers and by insurers. The IAC Vein Center accreditation IAC

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program offers a means by which vein centers can evaluate and demonstrate the level of patient care they provide and document their commitment to quality. Interested facilities are encouraged to learn more about the IAC Vein Center accreditation program by visiting intersocietal.org/vein or calling 800-838-2110. VT N

accuracy efficiency mobility comfort

Lowell Kabnick, MD, RPhS, FACS, FACPh, is immediate past-president of IAC Vein Center and president-elect of the American Venous Forum (AVF).

FDA panels to provide patient perspective to reg operations Seeking to add patient perspective to its regulatory functions, the U.S. Food and Drug Administration is setting up a panel to advise the agency on the use and regulation of medical devices. Patient viewpoints will be most useful in ways including: • To help identify the most important benefits and risks of a technology from a patient’s perspective. • To assess how patients think about the tradeoffs between benefits and risk benefits for a given technology. • To help understand how patient preferences vary across a population. The committee will discuss issues such as where and how best to engage patients across the device development and assessment lifecycle, and how FDA and sponsors should communicate patient preference information to patients. The FDA “may consider rigorous, systematically gathered patient preference information as a part of the totality of the evidence from clinical and nonclinical testing. However, patient preference information will not be used to justify approval of unsafe or ineffective devices,” they stated. The committee will consist of a core of nine voting members, including the chair, all selected by the commissioner or designee from experts who are knowledgeable in areas such as clinical research, primary care patient experience and health care needs of patient groups in the United States. VT N

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A vein by any other name… insurance provider would not approve ablation of the anterior accessory saphenous vein as they only approve radiofrequency ablation of the GSV or the small saphenous vein. Ultrasound review demonstrated an enlarged segment of the left GSV which was accurately labeled in its fascia compartment space. According to the final nomenclature of the committees, the anterior accessory saphenous veins are located extra compartmental subdermal (i.e., outside the saphenous compartment. (See Fig. 3)

Fig. 1 and 1a Noted superficial venous hypertension due to pathologic venous reflux of the left anterior accessory saphenous vein [arrow].

By James White, MD, FACS Our office has noted a dramatic increase in obstruction techniques by various insurance providers to avoid coverage for varicose vein therapies. The newest obstacle in the nonclinical venous realm is across the board denial for treatment of any accessory saphenous vein[s] not listed as the great or small saphenous vein. Any other listed pathologic veins elicit an automatic “experimental” rejection. Accurate nomenclature of the veins of the lower limb has been a challenge for anatomists, radiologists and vascular surgeons over the last 10 years. Incorrect identification of the lower limb veins has been well-documented as an important source of confusion. This nomenclature problem was addressed in detail by various societies to reach consensus...or so we thought. Despite best efforts, we now have found that accurate nomenclature of the veins of the lower limb presents a challenge for coders in terms of insurance benefits and pre-determination of benefits in patients with symptomatic venous stasis disease. We present a 53-year-old male patient with symptomatic venous reflux of the left lower extremity. (See Fig. 1) It is obvious that superficial venous hypertension is present in the medial thigh and calf in association with the great saphenous vein (GSV) distribution. Ultrasound demonstrated enlargement of the GSV at the Saphenofemoral junction (SFJ). The true GSV immediately divided into the true compartmentalized GSV and a subcutaneous anterior accessory saphenous vein (AASV). (See Fig. 2) The anteriorly positioned accessory saphenous vein was noted to be grossly enlarged with

demonstrated venous reflux in an identical course as the true GSV, but in a more superficial plane. The remaining portion of the left GSV was normal in size without demonstrated pathologic venous reflux. But what happens when the true great saphenous vein is normal in size, competent without demonstrated venous reflux and the accessory great saphenous vein is symptomatic with gross venous reflux? Pre-determination request was submitted to the patient's insurance provider. Specifically, we requested determination approval to complete radiofrequency endovenous ablation of the pathologic Anterior Accessory Saphenous vein. To our surprise, the procedure was promptly denied. The denial letter stated that, according to evidenced based medicine, the

Fig. 3 Longitudinal ultrasound image demonstrating the true GSV within the saphenous compartment [red arrow] and the pathologic anterior accessory saphenous veins in the subcutaneous tissues [yellow arrow]. Insurance providers allow pre-determination for endovenous ablation procedures based on individual company criteria. Coverage is usually allowed in symptomatic venous reflux for the great saphenous vein and small saphenous vein, and in years past, pathologic accessory saphenous veins. A peer-to-peer review was requested. After discussion of the formal case, the peer physician recommended that we ignore the nomenclature committee’s recommendations and label the pathologic vein as a Duplicated GSV. He assured me that the pre-determination process would go through without interruption. It seems that the mere mention of the term “great saphenous” will allow the reviewing staff to check the appropriate box allowing the case to achieve the approval status. The case was resubmitted for pre-determination using Duplication of the GSV in place of the Anterior Accessory

Fig. 2 and 2a. Transverse ultrasound images demonstrating the true GSV within the saphenous compartment [red arrow] and the pathologic anterior accessory saphenous veins in the subcutaneous tissues [yellow arrow].

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IAC_VeinTherapyNews_OctNov2015.pdf 1 9/16/2015 5:01:25 PM

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Saphenous Vein. As related, the procedure was promptly approved. As we can attest, the GSV can present in multiple variations. All agree, the veins of the lower extremities are located in two compartments: namely, the superficial and the deep compartments. Within the superficial compartment, as outlined by ultrasound, a separate saphenous compartment has been defined. (See Fig. 4)

http://www.intersocietal.org/vein/main/facilities.htm Fig. 4 Illustration of the GSV within the saphenous compartment, along with anterior accessory saphenous veins in the subcutaneous tissues. Within this compartment, the saphenous veins, accompanying arteries and nerves are located. In true duplication of the GSV: both veins course within the saphenous compartment and are anchored to each other by the saphenous ligament. The accessory saphenous veins (i.e., anterior accessory of the GSV, posterior accessory of the GSV, and superficial accessory of the GSV) lie outside the saphenous compartment, just below the dermis. When the tributaries are large, they may be erroneously considered to be a double or duplicated GSV. Despite our past efforts to delineate the true GSV from its adjacent anterior and posterior accessory veins to ensure appropriate treatment of the culprit vein and accurate discussion in the literature, despite all the agonizing work by the multiple nomenclature committees, the final word appears to be the pre-determination staff with the insurance provider. As Shakespeare wrote, â&#x20AC;&#x153;A rose by any other name would smell as sweet.â&#x20AC;? Unfortunately, a vein by any other name would not pass predetermination review. VT N C

CMY

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

VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

http://www.intersocietal.org/vein

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Tips for achieving IAC Accreditation By Manu Aggarwal, MD Vein Center Accreditation allows practices to share their commitment to venous care with comprehensive evaluation and treatment. This year, Blue Cross Blue Shield (BCBS) of Massachusetts was the first state to require endovenous laser treatments to be performed only in Vein Center Accredited facilities. They had required this accreditation to be achieved by September 1, 2015; however, they have now extended it to Jan. 1, 2016. An accredited Vein Center is defined as a center where venous evaluation and management and/or treatment procedures are performed. The Intersocietal Accreditation Commission (IAC) accredits facilities that provide venous evaluation and management and/or treatment procedures. IAC accreditation is a voluntary process by which vein centers can evaluate and demonstrate the level of patient care they provide. Tips and pearls we found helpful for and during our accreditation process: 1. H ave a recoverable and reviewable image storage database. Like a lot of older practices, our ultrasound images started with printing. We then moved to storing them on a server. The server died. Then someone hacked into our server. We are now finally using a HIPAA-compliant cloud-based image storage system. Yes, this was an expensive process to say the least; however, we could have saved a lot of money by skipping the servers. Servers break, last an average of 5 to 7 years and require maintenance throughout their life. All of these costs are the practice’s responsibility. Last we checked, physicians do not specialize in computer information systems. For our practice, our state medical association (Ohio), for a nominal fee (with a third-party organization) also confirmed for us that our cloud-based storage was HIPAA-compliant. 2. U se a calendar to remind you of important dates/task list. COMPOUNDING

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pharmaceutical companies against these hotbeds of innovation and paragons of patient care. Regarding regulators, there is a long-standing turf battle between state boards of pharmacy and the Food and Drug Administration (FDA) over who should control compounding pharmacies. Regardless of the “right” answer to this issue, the FDA appears to operate under the mantra, “That which we cannot control we must suppress.” Among other tactics, this includes attempting to forbid the compounding of an increasingly long list of products simply by calling them “demonstrably difficult to compound.” Also, “difficult” is not the same as “unsafe.” Let the compounding pharmacy worry about the ease of compounding; let the analyses of these products speak to their safety. Before accepting as gospel any anti-compounding claim, figure out who stands to financially gain from making such a pronouncement. Follow the money.

If you use an online calendar, place all annual/monthly checks in the calendar and label the calendar IAC Vein Center Accreditation. Most calendars can now be synced with your tablet and phone. This keeps your To Do list at your fingertips. Share the calendar with your key

appointment, the staff will be better able to answer questions and even boast about your accreditation. 4. Use a consultant. An accreditation consultant can be very helpful in making sure all the details have been met. The consultant is very helpful in correcting and providing solutions to shortcomings in documentation, procedural policies and more. They also can contact IAC to clarify questions prior to the application submittal and then again prior to the site visit. Though you can contact IAC yourself, the consultant can serve as a great liaison through the accreditation process from start to finish. 5. Keep organized records. Don’t underestimate the power of documentation. Document your procedures (sclerotherapy, endovenous treatments, ambulatory phlebectomy, ultrasound guided sclerotherapy) at the end of each week. We use a simple binder and handwrite any small nuances that may have occurred to review at our biannual quality meeting. This also makes it easy when doing monthly peer reviews of procedures. In addition, keep records of your patient surveys to review at quality meetings. Designate a non-clinical staff member for such records. Binders are very easy to flip through when trying to find something quickly and easily. It is also easy to organize your policies and procedures based on IAC standards when kept in the same order as the standards. VT N

people (practice manager, technical and medical director, ultrasound technicians, etc.) so they all are updated on meetings, peer review due dates, etc. 3. E ngage your entire staff so they are aware of changes/rules to follow. Keeping your nonclinical staff aware of changes and rules allows them to have confidence in the practice and the services you provide to patients. Have your front desk staff sit in on an initial consult, ultrasound, procedure and followup visit. When patients call and ask questions about their

The FDA would also have you believe that pharmaceutical compounding is inherently a “hit-or-miss” affair incapable of consistently producing uniform products. This is simply false: the analysis of samples of compounded preparations by certified, independent laboratories required of all compounders finds a high degree of uniformity in product and process. We are also led to believe that compounded products suffer from a higher incidence of problems (adverse effects, potency issues, contamination, etc.). Compounding mishaps, however tragic, make the front page in the same way that plane crashes do. But what is the occurrence rate of such events compared to those seen with manufactured products? Large pharmaceutical companies would like to put pharmaceutical compounding out of business even if they have no interest in actually producing a similar product; their mantra seems to be: “That which we don’t care to manufacture we want to prevent anyone else from providing.” This is probably a wise tactic on their part; if the public were in fact aware of how much less expensively compounding pharmacies could create many costly manufactured drugs from

Dr. Manu Aggarwal, MHSA, MD, is a board certified family physician and medical director specializing in phlebology at the Vein Care Center. Since 2007, the VCC has been an IAC-accredited vascular laboratory. The VCC has been dedicated to venous disease and laser treatments since 2004. Dr. Manu Aggarwal, MHSA, MD, is a board certified family physician and medical director specializing in phlebology at the Vein Care Center. Since 2007, the VCC has been an IAC-accredited vascular laboratory. The VCC has been dedicated to venous disease and laser treatments since 2004. It is located in Lima, Ohio, with a satellite office in Celina, Ohio.

raw ingredients, the outcry might be deafening. Better to make every effort to crush this potential competition before such a nightmare scenario can unfold. The current reality is, efforts are underway to drastically reduce the number of medications that can be dispensed by compounding pharmacies, as well as the quantities of any compounded medications that can be shipped over state lines. I will not go into details about this other than to say that they appear carefully orchestrated to destroy a key income source of the typical compounding pharmacy. Ironically, these include preparations containing the same ingredients that are present in commercially available products – but in patient-customized proportions. They have been successfully compounded for decades. Provisions meant to restrict the movement of compounded preparations across state lines are completely arbitrary, and are simply meant to prevent business entities completely compliant with other regulatory expectations from expanding their customer base. Yet without this significant income base, physicians may find the compounding pharmacies they have learned to trust

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

SECONDLOOK and rely upon closed for business. They may also find it difficult, if not impossible, to obtain compounded preparations that they prescribe – if that pharmacy happens to reside in another state. If we may assume the compounding pharmacies that create safe, effective and cost-effective preparations are the most likely to grow and expand, these FDA efforts will in effect penalize such excellence and reduce competition. Why not let a properly regulated marketplace work as it does in so many other areas of endeavor? • Look for hidden agendas. Is there a conflict of interest that prevents an unbiased assessment of the situation? • Reject “arguments from authority.” If regulatory or accrediting entities constrict practices or options, demand evidence to back up such actions.

• Ask the consumer. Why do thousands of people from coast to coast go out of their way to purchase compounded products? Maybe they are on to something. VT N Rad Dillon, R.Ph., ASQ CMQ/OE, ASQ CQA, ACHC / PCAB CAC, is a consultant pharmacist and American Society for Quality Certified Quality Manager and Certified Quality Auditor who also serves as a surveyor for the Accreditation Commission for Health Care (ACHC). He currently resides near San Antonio, Texas.

For more industry news and features, please visit us online at VEINTHERAPYNEWS.com

Ulthera gets FDA OK for Cellulite Reduction System on buttock, thigh Merz subsidiary Ulthera received FDA clearance for its Cellfina Reduction System to reduce cellulite on the buttocks and thighs for up to two years. The system is expected to be available in the fall. The system combines proprietary technology with a minor surgical procedure called subcision to treat the structural cause of cellulite. The company claims a clinical study of 55 patients who underwent a single treatment showed 98 percent reported improved appearance at two years and 96 percent were satisfied with their treatment. No severe device-related adverse effects were reported as a result of the treatment.

Before and after (1 year) Merz is a specialty healthcare company that develops treatment solutions in aesthetics, dermatology and neurosciences in the United States and Canada. VT N

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CASE STUDIES: Leg swelling simplified By Jeffrey Miller, MD After enjoying your first cup of coffee in the morning you visit with your first new patient of the day. He is a 48-year-old physically active male, with high cholesterol, complaining of sudden pain and swelling in his right calf (See Fig. 1). He’s extremely concerned because he’s a healthcare professional and had right knee surgery three weeks ago. As for the rest of his history, it’s unremarkable. The only medication he takes is Lipitor. His Review of Systems is non-contributory.

treated her a couple years ago. She’s worried that venous reflux has returned and complains of bilateral lower extremity edema for the past two months (See Fig. 3)

CASE STUDY

CASE STUDY 1

Two questions for you: What’s your next step? What is your presumptive diagnosis? My guess is that your next step is ultrasound with deep venous thrombosis on your radar. Please take a look at a representative image from his right lower extremity ultrasound (See Fig. 2).

Fig. 1 Right leg is swollen

Fig. 3 bilateral pitting edema Venous duplex exam demonstrates prior GSV ablations without reflux. Medications include Coreg, Norvasc and Imuran. Eventual diagnosis: Edema secondary to calcium channel blocker

THE DIAGNOSTIC DILEMMA

Chronic swelling is more complex and diagnostically challenging for physicians. If the underlying cause is not found, healthcare professionals may chart the diagnosis of “edema” leaving patients confused and disappointed. Unfortunately, edema is not a diagnosis but rather a term referring to excess fluid in tissue. We must find the underlying pathologic cause, because fluid is a barrier to oxygen and nutrient transportation to the skin. Edema often makes legs feel heavy and patients want a cure! To complicate matters, edema is often subjective for both patients and physicians. Furthermore, transient (let’s call it normal), peripheral edema is common and relates to posture, climactic conditions and age. Fig. 4

LEG SWELLING: THE BASICS

Fig. 2 Image in popliteal fossa Now what’s your diagnosis? I suppose the included text helped you arrive at the correct answer of ruptured popliteal cyst, also known as Baker’s Cyst. Let’s face it, when patients present to their physician with acute lower extremity swelling, it’s usually not a diagnostic challenge. After a detailed history and physical, often followed by ultrasound, the case is closed. And as healthcare personnel dealing with venous disorders, you presume that acute leg swelling in the absence of other obvious pathology is deep venous thrombosis (DVT) until proven otherwise…

CASE STUDY 2

After your second cup of coffee, an established patient pays you a visit. She’s a 70-year-old female, with history of ulcerative colitis, hypertension and chronic venous insufficiency. You

and the osmotic attraction of the blood for the surrounding fluids.” While not comprehensive, this provides a useful construct from which to further the discussion of leg edema. In essence, Starling’s Hypothesis includes four basic mechanisms of edema: • Increased hydraulic pressure gradient. • Decreased oncotic pressure gradient. • Increased capillary permeability. • Decreased lymphatic flow. Let us go through these four mechanisms to gain an understanding of edema. For those of you outside the medical field, hydraulic or hydrostatic pressure refers to the “pushing” of fluid out of blood vessels (into interstitial space) similar to turning up the faucet on a hose (See Fig.4). Oncotic (or osmotic) pressure refers to a pulling of fluid into a blood vessel to equalize the concentration of solutes in a fluid across a membrane ( See Fig. 5). I hope that makes sense. Also, although veins and lymphatics work as a team to remove fluid, we will consider them as separate and distinct systems for simplification purposes.

The most likely cause of lower extremity edema in persons over the age of 50 is venous insufficiency. No surprises there. On the other hand, leg edema in women under the age of 50 is often idiopathic edema, which can relate to monthly menstrual cycles. When you get a moment, Google this topic, as I won’t do it justice here. While taking your history, another consideration must include medications. I’m never ashamed to use online resources if there is any question about a drug. Lymphedema, with characteristic clinical features, can get diagnosed with relative ease. While you may discover a less common systemic disease from careful history and physical, there are two diagnostic considerations that you must not overlook: pulmonary hypertension and early congestive heart failure. Both of these pathologies can cause leg edema before becoming clinically apparent in other ways.

HISTORICAL CONCEPT TO ENHANCE THE DISCUSSION

In 1896, the famous British physiologist Ernest Starling put forth a useful hypothesis to explain the physiology behind edema at the capillary level. He stated: “At any given time, there must be a balance between the hydrostatic pressure of the blood in the capillaries

Fig. 5

INCREASED CAPILLARY HYDRAULIC PRESSURE

Increase in capillary hydraulic pressure can occur at the arterial or venous end of the capillary. Inflammation and certain medications can cause arteriole sphincter relaxation. With regards to the latter, calcium channel blockers are notorious for causing lower extremity edema. The vasodilator Hydralazine is a good drug to keep in mind, while Pletal, a phosphodiesterase inhibitor used

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

SECONDLOOK in the treatment of claudication, is another medication to consider. By no means is this an exhaustive list. A full discussion of this is way beyond the purpose of this article. Please see Fig. 4 to get a few more ideas. Some drugs to keep in mind:

Antihypertensive drugs • Calcium Channel Blockers • Beta Blockers • Clonidine • Hydralazine • Minoxidil • Methyldopa

Hormones • Corticosteroids • Estrogen • Progesterone • Testosterone

Other • NSAIDs • Pioglitazone, Rosiglitazone • Monoamine oxidase inhibitors Moving to the venous side of the capillary, simple limb dependency can cause “normal” physiologic swelling while the most common cause of pathologic swelling relates to venous insufficiency as we discussed above. Getting back to the hose analogy, too much water in the hose would become problematic. With this in mind, there are a variety of medical conditions causing excess fluid volume that must be considered such as congestive heart failure and renal disease with secondary aldosteronism. Hormones, especially estrogen and progesterone, can tip the scale on the venous end of the capillary. And similar to the arterial end, medications must be considered.

NSAIDs are a good example of medications that affect this end of the capillary. Two relatively new terms to keep in mind are Obesity Related Chronic Lymphoedema-Like Swelling, and Elephantiasis nostras verrucosa, which refers to the monstrous leg swelling and lipodermatosclerosis seen in morbidly obese patients. Presumably, the weight of abdomen causes venous compression in sitting position.

DECREASED ONCOTIC PRESSURE GRADIENT

A decrease in plasma colloid osmotic pressure can result from any protein wasting condition such as malnutrition; enteropathies, such as Crohn’s disease; protein-losing nephropathy; and hepatic disease through decreased plasma protein production. An increase in the interstitial oncotic pressure can occur due to an accumulation

of macromolecules in the interstitium from lymphatic obstruction or the deposition of other osmotically active substances. An example of the latter is mucopolysaccharide deposits related to hypothyroidism.

INCREASED CAPILLARY PERMEABILITY

Moving on to the third mechanism, causes of increased capillary permeability include allergy, inflammation and endothelial damage from burns, toxins or trauma. Allergic reactions result in histamine release that causes endothelial cells to shrink, which increases the distance between cell margins and hence increased capillary permeability. As for inflammation, this can occur with infections, or systemic conditions (ie lupus, SWOLLEN LEGS

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Become a credentialed Phlebology Sonographer! The Registered Phlebology Sonographer (RPhS) credential is for physicians, sonographers, nurses, physician assistants and other associate health professionals who utilize ultrasound to diagnose vein disorders.

What is covered in the RPhS exam? The following illustrates the general distribution of questions and the relative weight or emphasis given to a skill or content area on the exam. A detailed outline can be found at www.cci-online.org. Content Category A. Maintain Information, Facility, and Safety B. Patient Diagnosis C. Performance of Diagnostic Testing D. Conservative Treatment / Therapy of Patients E. Minimally Invasive & Invasive Treatment of Patients Total

Approx. % of Exam 6% 22% 35% 9% 27% 100%

Credentials administered by CCI are accredited by the American National Standards Institute (ANSI) based on the ISO/IEC 17024 Accreditation Standard.

VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

Attending ACP Annual Congress? Photoat courtesy of Morrison Vein Institute and Compudiagnostics Visit CCI Booth #411 39

SECONDLOOK

Adjunctive laser treatments enhance practice By Manu Aggarwal Adding adjunctive laser treatments to an already successful phlebology practice ideally satisfies patients’ desires for additional services. Don’t miss the opportunity to expand your services and keep your practice income steady as many factors influence your ability treat your patient and keep your doors open. Market analysis shows that revenues from aesthetic laser services will reach $3.6 billion by 2016, with an average revenue of nearly $1 million dollars per facility. Sales are forecast to grow 18 percent per year to 2016. Here are the top reasons we feel phlebology practices are very suitable for adjunctive laser treatments; including tips to add these services to your phlebology practice. 1. Phlebologists know their lasers. If you are treating venous disease, you are using lasers. You understand the technology. We started treating leg and facial veins with 940nm (same platform we used to do our EVLT procedures). We treated a lot of our patients at no cost to try the technology that we already had. We quickly realized that patients wanted more (benign pigmented lesions, larger veins, etc.) and there were some limitations with the treatments (0.5mm and 1mm spot size, etc.) After about a year, we moved to a 1064nm/532nm platform that opened up doors to treating everything our patients requested – and expanding our patient base to non-venous patients for treatments. 2. Venous patients desire laser treatment options. Spider veins on the legs and facial/body veins can be treated with laser very effectively and safely. In addition, laser treatments can be combined with traditional sclerotherapy to very effectively treat spider veins. The 1064nm Nd:YAG long-pulse laser after polidocanol microfoam injection dramatically improves the result of leg vein treatment: A randomized controlled trial on 517 legs with a three-year follow-up by Javier Moreno-Moraga, Adriana Smarandache, Mihail L Pascu, Josefina Royo, and Mario A

TrellesPhlebology, December 2014; vol. 29, 10: pp. 658-666., first published on Aug. 29, 2013. When you combine aesthetic laser services to your other “usual” services, it not only can enhance those “usual” treatments, but also open doors to treat other types of cosmetic concerns. For example, a 1064nm laser can also be used to treat orbital veins, facial and leg veins as well as venous lakes, hemangiomas and more. A 532nm laser can be used to treated facial and leg telangectasia, matting and pigment changes (benign and hemosiderin staining). The most important reason phlebologists are best equipped to treat leg veins is ultrasound capability. There are many practices that suffer from failed laser and sclerotherapy treatments due to lack of ultrasound scanning prior to treatment. Complications and poor outcomes arise when perforators and underlying venous disease is not identified. 3. Involve and educate your staff. If your front desk staff cannot answer simple questions regarding how the laser treatments work and what they feel like, you will lose clients. Having staff members (one at a time) watch laser treatments as you perform them, or even offer them a service, will allow the staff to be more aware of how to answer questions when patients ask over the phone. 4. Have a process. Ensure that a consent is signed and a picture is taken each time the patient comes in. More often than not patients may

Market analysis shows that revenues from aesthetic laser services will reach $3.6 billion by 2016, with an average revenue of nearly $1 million dollars per facility.

not notice a change in their area of concern, especially when it is very subtle. By showing them before and after photographs, patients can see the change immediately. It is important to take photographs with the same background and aligned properly so that the camera doesn’t seem to be at different angles each time. Sometimes if one person is designated to take the photographs can help; placing marks on the floor where the patient stands can also be helpful to ensure the same photograph each time. Consents should be signed each time to show that benefits/ risks were discussed several times with the patient. Cosmetic lasers are one of the most litigious types of services medical professionals provide. Though consents do not necessarily protect you, repeated consents show that the patient was informed each time prior to each treatment. 5. Create a look book. Before and after photographs are key in showing patients what their potential treatment could look like. By offering several patients free treatments, you can have them return weekly to document what a treated area looks like for the first two weeks and then one month later and then 3 months later (depending on what you are treating). This helps show the patient what the treated area looks like from start to finish. A look book can be created easily online using several programs and can be then used on your website and social media; they can also be printed pretty inexpensively and placed in your waiting room. VT N Dr. Manu Aggarwal, MHSA, MD, is a board certified family physician and medical director specializing in phlebology at the Vein Care Center. Since 2007, the VCC has been an IACaccredited vascular laboratory. The VCC has been dedicated to venous disease and laser treatments since 2004. Dr. Manu Aggarwal, MHSA, MD, is a board certified family physician and medical director specializing in phlebology at the Vein Care Center. Since 2007, the VCC has been an IAC-accredited vascular laboratory. The VCC has been dedicated to venous disease and laser treatments since 2004. It is located in Lima, Ohio, with a satellite office in Celina, Ohio.

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

SECONDLOOK September events called attention to P.A.D. facts, costs, outlook September was Peripheral Artery Disease Month. It certainly is worthy of all the attention because P.A.D. is one of the most widespread chronic diseases. Currently afflicting almost 20 million U.S. citizens, P.A.D. prevalence is exceeded only by diabetes and venous disease. Costing an estimated $212 to $389 billion, P.A.D. direct disease costs exceed those of diabetes and coronary disease, as well as all cancers combined. Elaborating on the reasons for high costs, Mary L. Yost, president of THE SAGE GROUP, explained: “The majority of costs

are inpatient (62 percent-87 percent) with P.A.D.-specific treatments only one factor driving up spending. Cardiovascular events, such as heart attacks and strokes, and related treatments account for more than 40 percent costs, adding significantly to total costs.” “Despite the magnitude of the national bill, P.A.D. remains underestimated, underdiagnosed, undertreated and underresearched,” Yost said. “This highly prevalent, costly and deadly disease continues to be largely ignored, resulting in unnecessary mortality, morbidity and amputations. Ignorance, under-diagnosis and undertreatment increases disease costs. “As U.S. healthcare spending consumes an increasing share of economic output, it is important to keep in mind that early diagnosis is a key factor in reducing the costs of chronic diseases, such as P.A.D.,” Yost said.

P.A.D. can be diagnosed by a simple, noninvasive test. This inexpensive test, known as the ankle-brachial index (ABI), is a cost-effective method to detect disease in asymptomatic patients. Although Medicare currently offers testing for patients with symptoms, P.A.D. is most commonly asymptomatic. According to Yost, approximately 75 percent are asymptomatic. “Asymptomatic does not mean the disease is benign. P.A.D. is not just a leg problem; it is also a heart and a brain problem,” she said. “Asymptomatic patients are hospitalized at similar rates and cost as much as symptomatic patients, not because of leg treatments but due to heart attacks and strokes.” If diagnosed in the early stages, P.A.D. patients can be treated with appropriate lifestyle modifications and drug therapies to reduce the risks of heart attack and

stroke; exercise therapy to reduce the pain of claudication; or if blockages are more severe, with minimally invasive revascularization technologies. “However, if the disease is not diagnosed until critical limb ischemia (CLI) occurs, interventional therapy is more costly. If gangrene is so severe that the limb cannot be salvaged, the patient must undergo amputation, the most costly procedure. “Amputation is not only extremely undesirable from the patient’s viewpoint, it is socially undesirable in terms of costs. According to our estimates, CLI amputations cost $25 billion,” she concluded. VT N READ MORE: thesagegroup.us

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SECONDLOOK

EDUCATING OUR EDUCATORS

RN looks back on evolution of medical specialty into Phlebology 2.0 By Noel Boyce, RN It was not until I was five years into my career as a nurse that I heard the word, “phlebology.” You mean phlebotomy? No. It is, indeed, phlebology. Now, with phlebology clinic management under my belt and almost a decade in the traditional business environment, I recognize a gap of information in this industry. And I have a solution. Let’s call it, “Phlebology 2.0.” Phlebology 2.0 is a new approach to medicine with significant improvements for patients. While swollen legs typically point to a greater cardiovascular condition, many times an underlying component of venous insufficiency can complicate thorough treatment. In our clinic, patients come with a hope of improving their health, their daily activities and their overall wellness. They come to us after being told time and time again, “There isn’t anything that can be done.” I know now that there is a lot that can be done – but in general, the consumer health population and many potential referring healthcare providers don’t know what is possible. Unfortunately, traditional medical and allied healthcare offers a minimum necessary education in many capacities – especially with phlebology – from MA to mid-level, from sonographer to provider. This takes us back to “phlebology” vs “phlebotomy.”

While both words have form and function related to the circulatory system, they are wholly different concepts. The history of phlebotomy has roots in the concept of “bloodletting,” a practice that dates back to ancient Greek times. The specialty of Phlebology, however, is new to the vernacular of even the most recent graduates in any healthcare specialty. Perhaps the inauspicious origins of Phlebology challenge its understanding. In many ways the field of Phlebology is still in its adolescence. We can all likely recall stories of friends, friends-of-friends or relatives admitted to the hospital for surgical removal of varicose veins or dysfunctional veins, usually removing the diseased vein or veins in their entirety under general anesthesia. The procedure would last roughly an hour, but the recovery time was much longer. Often the scars and physical effects of “vein stripping” surgery still reside decades later. Fortunately, technology has advanced this specialty. We can now accomplish more in 30 minutes within an office/clinic setting than in any hospital surgical suite and arguably with better outcomes and lower morbidity. Our particular practice at American Vein & Vascular Institute (AVVI) takes that one step further. Having an onsite arterial center headed by founder and vascular interventional radiologist, Dr. Gordon Gibbs, we have the ability to move beyond the vein stripping of yesteryear, as well as contemporary treatments of venous reflux disease. With fluoroscopy,

Dr. Gordon F. Gibbs, founder and chief medical executive of AVVI, works alongside Dr. Emma Stout, a family practitioner turned vein disease specialist through the phlebology fellowship program directed by Dr. Gibbs. All AVVI clinics act as teaching sites with state-of-the-art technology and high diagnostic standards.

Lindsay Chlebus, a vascular sonographer at AVVI, is performing a scan. we treat patients with arterial disease in the extremities. AVVI offers arterial and venous outpatient services in a comfortable office setting, on par with the leading major institutions across the nation. We’re patient-focused, patientcentered and quality- and outcomes-driven. Our goal is to reduce overall procedure costs to the patient and payer alike. In doing so, we’re able to get the patient treated and back on their feet in less than half a day, recovering in the comfort of their own home. No more hospital stay. We’ve managed to find a sweet spot nestled right between saving time and saving money. AVVI staff also has the ability to take what was formerly a diagnostic for a deep venous thrombosis (DVT) and turn that into an interventional success. In a matter of hours we’ve taken patients from a referral, to DVT diagnosis, to an inferior vena cava (IVC) filter placement, to being on their way back home. As a former ER nurse, my history lies with acutely ill patients. Some of the sickest patients came through the hospital emergency room doors. With regularity, those same patients would have complications beyond the scope of emergency medicine. Swollen legs, ulcerations, or varices were rarely addressed, nor were we able to correct such issues in the course of a single visit. In most cases, there was no time. As mentioned, I wasn’t aware

that anything could be done – nor were my ER colleagues. In fact, I found the exposure to specifics within vascular health and disease to be as far back as a biology class, beginning with the concept of the circulatory system. I recall a crude representation of arteries and veins as depicted by nylon yarn strewn lightly around an artificial bone. Anatomy and physiology courses took things one step further, and the use of a cadaver helped solidify that understanding – being able to touch, to see a human body. For many, working on a cadaver was the first time they held an organ or body system in their hands. I have since discovered that it would also be the last. As a nurse clinic manager, I am also a community liaison, a patient educator, a financial advisor (“How am I going to pay for this?”), and a sounding board for educational institutions as well as for referring physicians and primary care providers. I am an HR specialist, an operations militant, a budget enforcer, a marketing machine and, above all else, a hands-on patient care professional and advocate – a man of many hats. With a background in the ER, in business and now in phlebology, I see firsthand the gaps between critical care and the venous specialty. Part of Phlebology 2.0 is tasking educators to provide more learning opportunities and a broader knowledge base for healthcare

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

SECONDLOOK professionals in training as well as those already out in the field, interested in knowing more or looking for other opportunities. Allied health professionals, in particular, are given the daunting task of needing to know nearly everything about almost anything that may arise. We act in a spectrum of sorts, from having the most basic of knowledge to the most intricate details about one particular specialty. Fortunately, there is no way that one person will ever be solely responsible for all information. Certificate programs touch the surface. Associate degrees put us waist-deep. Bachelor’s degrees move us to the deep end of the pool. Advanced degrees and physician credentials lift those individuals to the top. What we can offer and what we can do for our patients is only as good as the awareness and education offered specific to the medical specialty. In this case, that means the symptoms, diagnosis and treatments for vein disease. If providers are not aware that something can be done, we’ll continue to miss the mark when it comes to providing the best care that this nation has to offer. And try as we might, we’ll never be able to educate every primary office about the solutions Phlebology has to offer. This is where our educators need to step up and do their best to offer their own version of Phlebology 2.0. If we can reach the source early and often, through the hands of our educators, the specialty of Phlebology will continue to flourish. I’m a firm believer that every student exiting any allied health program should have the fundamentals to lead them to be able to, at the very least, recall that something can be done. Perhaps this recall will happen years down the road, but all it takes is for one patient in need to pull our knowledge from long-term memory and turn it into action. VT N

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Noel Boyce, RN, in addition to serving on the AVVI staff (www.avviusa.com), founded, planned, designed and executed the health care startup Urban Mobile Health. Urban Mobile Health provides fee-for-service house calls to patients on an on-demand basis. He holds a Bachelor of Science in nursing, and certifications in basic, advanced and pediatric life support, Colorado HITECH (Health Information Technology for Medical and Information Technology Professionals), emergency preparedness and trauma nurse training. He can be reached at nboyce@avviusa.com.

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Not a drop of water penetrates Repel.

Centanni finds firsthand that Repel keeps bandages dry David Centanni, owner and general manager of Total Vein Systems, draws innovation from a challenging circumstance. “About four years ago I had an ankle surgery and found myself using garbage bags and other contraptions at my surgeon’s recommendation to shower. Nothing seemed to work though, and the sterile bandages kept getting wet, resulting in my surgeon prescribing a round of antibiotics. “I thought, ‘There must be a better way’.” As a result, Centanni said he developed the Repel waterproof limb protector designed to comfortably and effectively guard bandages and dressings against water when showering. It is made with a proprietary polyethylene cover and elasticized band. “Last month I had the need to use the Repel following a knee surgery,” Centanni said. “I used the same one multiple times and there was not one drop of water on my bandages! What really makes me feel good is the Repel costs less than $5.” VT N READ MORE: totalvein.com

the agency. It is used to help control bleeding during surgery. Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding. Raplixa, manufactured by The Medicines Company’s ProFibrix BV, contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. The two protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the risk for the transmission of bloodborne viruses. The fibrin sealant components are then spray-dried, blended and packaged in a vial. Raplixa can be applied directly from the original product vial or by spraying with a delivery device onto a bleeding site. It is approved for use in conjunction with an absorbable gelatin sponge. Karen Midthun, MD, and director of the FDA’s Center for Biologics Evaluation and Research, said this approval provides surgeons an additional option to help control bleeding during surgery when needed. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial Dr. Midthun said. “This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature.” In support of approval, the FDA reviewed data from a clinical study involving 719 participants, over 11 months, undergoing different types of surgical procedures. The study demonstrated Raplixa’s effectiveness by comparing the reduction in the time needed for bleeding to stop when using this fibrin sealant and the time needed for bleeding to stop when using an absorbable sponge alone. The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever and decreased blood pressure. VT N

FDA approves spray-dried fibrin to stop surgery bleeding

ArtVentive EOS device praised by first surgical team to use for various vascular apps

The U.S. Food and Drug Administration has approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by

NYC Surgical Associates (NYCSA), a multi-specialty surgical practice with seven locations across the New York Metro area,

has become the first practice in the NYC area to use ArtVentive Medical Group Inc.’s Endoluminal Occlusion System (EOS) device. The ArtVentive EOS is designed for use in the peripheral vasculature and offers immediate and complete occlusion in arterial and venous settings. At the cutting edge of medical technology, this occlusive device can be deployed using precise, real-time imaging and used to cut off the excess blood flow without the need for incision or traditional surgery, with the entire procedure being performed through an IV catheter. NYCSA’s Elie S. Semaan, MD and a specialist in vascular and endovascular surgery, was the surgeon that deployed the EOS device in this case. David Greuner, MD, co-founder and the managing director of NYC Surgical Associates and a cardiovascular and thoracic surgeon, praised the ArtVentive EOS “NYC Surgical Associates is proud to be at the forefront of innovation and provide our patients with the most advanced technology to effectively treat various vascular diseases and disorders,” Dr. Greuner said. “The EOS device meets the clinical needs of our patients with efficiency and assurance. As an embolization device to cut off extra, problem-causing blood flow, the EOS can be used in treating everything from uterine fibroids, to removing the blood flow to shrink benign and malignant tumors, to resolving issues such as varicocele and pelvic congestion syndrome, which are situations in which there is too much blood pooling from malfunctioning veins in the pelvis.” Dr. Semaan said that compared to other similar devices, what he likes most about the EOS is its flexible delivery with precise deployment, ability to reduce the amount of foreign material - such as metal coils - left behind, a minimization of image artifact in future imaging studies like CT scan, and less procedure time. It also decreases our cost to perform case. Dr. Greuner considers a 100% blood flow reduction in the target vessel as it acts as an expandable plug a huge advantage of the EOS, whereas all of the other devices on the market require packing, often of multiple devices, to create a seal. “This means that with the EOS device, only one step leads to a very precise seal, minimizing operative time, effort and hardware used,” he said. “Because a complete seal is achieved immediately, when correctly deployed it also results in a reduction of dye used to check and recheck each step of the procedure, which is overall much more healthy for the patient.” VT N READ MORE: nycsurgical.net

FDA OKs Finacea (azelaic acid) for rosacea treatment The U.S. Food and Drug Administration (FDA) has approved topical azelaic acid 15 percent foam (Finacea, Bayer Healthcare) for treatment of the inflammatory papules and pustules of mild to moderate rosacea. The approval is based on results from two pivotal vehicle-controlled 12-week clinical trials examining the efficacy and safety of twice-daily application of azelaic acid in more than 1,300 individuals 19 to 92 years old with papulopustular rosacea. In both trials, active treatment with azelaic acid foam led to a higher Investigator’s Global Assessment success rate compared with vehicle control (32.1 percent vs 23.4 percent in trial 1 and 43.4 percent vs 32.5 percent in trial 2). Both trials also demonstrated a greater reduction in the mean nominal change of inflammatory lesion count from baseline to end of treatment at week 12 with active treatment (−13.2 vs −10.3 in trial 1 and −13.3 vs −9.5 in trial 2). The most common adverse reactions with azelaic acid (≥0.5 percent) are local application site pain (6.2 percent), pruritus (2.5 percent), dryness (0.7 percent), and erythema (0.7 percent), the company stated. A Bayer Healthcare spokesman said there have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, they advise that clinicians monitor these patients for early signs of hypopigmentation. Azelaic acid may cause irritation of the eyes, and contact with the eyes, mouth or other mucous membranes should be avoided. The propellant in Finacea foam is flammable, and patients should be instructed to avoid fire, flame and smoking during and immediately after application. The package should not be punctured or incinerated or exposed to heat. Finacea became available by prescription beginning in September. VT N

OCTOBER/NOVEMBER 2015 < VEIN THERAPY NEWS

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VEIN THERAPY NEWS < OCTOBER/NOVEMBER 2015

PRODUCTNEWS arm – Cleveland Clinic Innovations. Ohio BioValidation Fund, a state-supported early stage venture fund, has previously backed the company. Fuller was the former CEOin-residence of Cleveland’s BioEnterprise life sciences accelerator. VT N READ MORE: centerlinebiomed.com/

SonoSite gets CE Mark for its new iViz point of care solution

3D Vascular Navigation System

Centerline offers visualization without radiation Early stage medical device company Centerline Biomedical, which developed a 3D Vascular Navigation System to help surgeons to carry out procedures, has raised $1.7 million, according to a company statement. The system is akin to GPS for vascular surgery. The surgical platform was developed by Cleveland Clinic surgeons from the Heart & Vascular Institute and researchers at Lerner Research Institute. It is designed to be used for procedures that currently require X-ray technology to help surgeons guide their instruments in the bodies of vascular disease patients. These procedures can take several hours and risk exposing surgical teams to radiation and can take longer because of navigation challenges to surgeons. “The opportunity to positively impact a growing number of patients and providers alike is significant…Centerline’s platform technology solves an immediate need and has the ability to transform many vascular and non-vascular procedures by reducing radiation, improving outcomes and saving costs,” Matthew Eagleton, MD and chair of the Medical Advisory Board for Centerline, said. Centerline Biomedical, led by CEO William Fuller, is a Cleveland Clinic spinout and got its start last year. It was formed through Cleveland Clinic’s commercialization

FUJIFILM SonoSite Inc., a specialist in designing cutting-edge ultrasound tools and world-leading education for access to pointof-care visualization, has announced the CE mark for its newest point-of-care solution: the iViz. Inspired by clinicians, the iViz is a new platform that augments the value of ultrasound for clinical users from hospital settings to clinics in remote villages with the ability to perform ultrasound when and where it is needed. “FUJIFILM SonoSite delivers a powerful and valuable solution to the market with the launch of iViz,” Masayuki Higuchi, president and CEO of FUJIFILM SonoSite, said. “ It is a revolutionary tool that reaches new levels of mobility, image performance, and connectivity. Clinicians will now have access to technology that can be used on-the move, in-the-field or on-the ground.” The iViz represents the next generation architecture and platform for Fujifilm’s integration of ultrasound with medical IT. The iViz goes beyond traditional ultrasound abilities and provides clinicians with seamless access to patient vitals, online applications and learning resources. It also integrates with hospital IT and EMR systems to obtain patient demographics and submit reports, and connects securely with cloud services for sharing studies with remote providers for near-time assessments. The iViz is lightweight and specifically designed for emerging point-of-care settings where there is need for a highly accessible and mobile solution. It features a high resolution seven-inch display touchscreen, a wide dynamic range over a large viewing angle with high definition vibrant color flow images, wifi capabilities, Bluetooth connectivity, and interface ports for USB, HDMI, and audio. In addition to high resolution 2D imaging, the system supports M-Mode and Color Velocity Doppler. The iViz is available with a P21v phased array 5MHz transducer, and features proprietary software technologies: SonoHD2 Imaging Technology, and SonoADAPT Tissue Optimization Technology. VT N READ MORE: sonosite.com

SWOLLEN LEGS

continued from page 39

vasculitis). Just prior to menstruation, fluid retention can occur due to capillary permeability. This is termed idiopathic edema. Speaking about idiopathic edema, other potential theories include chronic consumption of diuretics, and “re-feeding” in women who drastically cut down on food consumption to lose weight.

DECREASED LYMPHATIC FLOW

Although the last of the mechanisms of edema listed, it is certainly not the least important. Actually, if you were paying attention, you will have seen it mentioned in the “oncotic pressure section,” but I digress. Much is written on the topic of lymphedema. You are more likely to see the secondary form of this condition related to the obstruction or disruption of the lymphatic system from tumors, surgery, trauma, infection/inflammation or radiation. Buzzwords to describe the clinical appearance of this entity include “pillow feet” and “sausage toes” (See Fig. 6). Potential complications of lymphedema include recurrent Fig. 6 “Pillow foot” cellulitis, lymphangitis and lymphangiosarcoma. Of note, the latter typically looks initially like a non-healing ulcer.

EDEMA…NOT!

You may occasionally chat with patients who complain of swelling, but really only have increased adipose tissue in their legs, known as lipedema.

SUMMARY

I said from the onset that chronic leg swelling is a difficult topic and I suggest reading the many excellent articles and book chapters on the topic. Things to keep in mind not mentioned above include whether the swelling is unilateral, bilateral and the

symmetry or lack there of. Furthermore, the consideration as to how gravity affects the swelling and time of day are other important factors. To simplify our thought process, see Fig. 7. Some patients you chat with will complain about swelling when in fact it’s simply normal, “physiologic,” edema. You know that the most common etiology in those over 50 years of age is venous insufficiency, but don’t forget to think about idiopathic edema in women who are a bit younger. Always look closely at medications. When common etiologies are excluded, dig deep into the possibility of a systemic disease. Don’t miss pulmonary hypertension or early congestive heart failure. Lastly, a strong history and physical will lead you to the diagnosis of lymphedema when present. I hope that helps. VT N

REFERENCES • Kloner RA, Weinberger M, Pool JL, et al. Comparative effects of candesartan cilexitil and amlodipine in patients with mild systemic hypertension. Am J Cardiol. 2001;87:727-731. • Cho S, Atwood JE. Peripheral edema. Am J Med. 2002;113: 580-586. • www.UpToDate.com Idiopathic edema By Richard H Sterns, MD • Venous Ulcers; John J Bergan & Cynthia K. Shortell: Chapter 6, page 67-74 by Warner P. Bundens • Phlebology 2014, Vol. 29 (10) 645-647 • Ely S, et al. “Approach to Leg Edema of Unclear Etiology.” Journal of American Board of Family Practice, 2006 Vol.19 No.2 Jeffrey H. Miller, MD, is the founder and CEO of Miller Vein, with five locations in Southeast Michigan. Dr. Miller has received numerous awards and honors in his field, including being named one of Hour Detroit Magazine’s “Top Docs.” His multi-site company has received numerous accolades including Coolest Place to Work by Crain’s Business Detroit, Novi Chamber of Commerce’s Customer Service Excellence Award and several Corp! Michigan’s Economic Bright Spots Awards.

Complaint of swelling

Normal (physiologic) or Lipedema

Pathologic

Venous

Systemic Illness Lympha c Idiopathic Medica ons

Fig. 7 Chronic Swelling Oversimplified

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