V E I N I N D U S T RY N E W S
VOLUME 3 ISSUE 2 • SPRING 2010
w w w. ve i n d i re c t o r y. o r g
EYES WIDE OPEN
Should You Add Laser Lipolysis & Liposuction to Your Vein Practice?
The ATTRACT Study 22nd Annual AVF Meeting Highlights Striking the Balance Between Vein Clinical Practice & Research Acronyms and Education
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24th Annual Congress
.OVEMBER 2ENAISSANCE /RLANDO 2ESORT AT 3EA7ORLD &LORIDA
Call for Abstracts The 2010 Program Committee of the American College of Phlebology invites you to submit an abstract for consideration on the following topics: s !DVANCES IN $EEP 6ENOUS 4HROMBOSIS AND 4HROMBOPHILIA s !DVANCES IN THE $IAGNOSIS AND 4REATMENT OF 6ENOUS 5LCERS AND #HRONIC 6ENOUS )NSUFlCIENCY s !DVANCES IN %NDOVENOUS !BLATION s !DVANCES IN 0RE 0OST 4HERAPEUTIC !SSESSMENT AND #ARE s !DVANCES IN 3CLEROTHERAPY OF 6ARICOSITIES s !DVANCES IN 4REATMENT OF 4ELANGIECTASIAS s !DVANCES IN 6ENOUS 3URGERY AND !MBULATORY 0HLEBECTOMY s !LLIED (EALTH RELATED AREAS SUCH AS #ODING 2EIMBURSEMENT 264 .URSING
s #OMPRESSION -ODALITIES s )NDIVIDUAL #ASE 0RESENTATION s ,ASER 2ELATED ,IGHT 3OURCE 4REATMENT OF 4ELANGIECTASIAS 2ETICULAR 6EINS s ,EG 5LCERATION s ,YMPHEDEMA s .EW 2ESEARCH AND "ASIC 3CIENCE OF 6ENOUS $ISEASE s 0OST 4HROMBOTIC 3YNDROME WITH $EEP 6EIN )NSUFlCIENCY s 0RIMARY AND 3ECONDARY 6ARICOSE 6EINS s 6ASCULAR -ALFORMATIONS
Deadline for submissions is Friday, June 4, 2010 Abstracts must be submitted online and are limited to 350 words. To obtain more details or to submit an abstract for presentation at the 24th Annual Congress, please visit
www.acpcongress.org
\ WWW ACPCONGRESS ORG \ WWW PHLEBOLOGY ORG
Vol. 3 Number 2 4
Editor’s Note
6 Letter from the Medical Director Opportunities and Options in Venous Education 8
VEIN Industry Calendar
10 Event Preview IVC 2010 Preview of the 8th Annual International Vein Congress by Jose I. Almeida, MD, FACS, RVT 12 Medical Diary American Venous Forum’s 22nd Annual Meeting by David L. Gillespie, MD, RVT, FACS. 16 Cinical Training AVF Announces Fellows’ Course in Venous Diseases by Peter Pappas, MD and AVF President Cover Story
18 Eyes Wide Open
Perspectives From Dr. E.J. Sanchez: Adding Laser Lipolysis and Liposuction to your Vein Practice
by Andrea B. Epstein
24 Technology Briefs Veinwave: Bringing Excitement to the Telangiectatic Therapeutic Market
by Jennifer Heller, MD and Lowell Kabnick, MD
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24 Featured Doctor A Conversation with Clint Hayes, MD, Director of the Vein Center of North Texas
by Andrea B. Epstein
34 Cinical Studies The ATTRACT Study: Open for Patient Enrollment
by Suresh Vedantham, MD
36 Techniques & Technolgy Thrombophilia Testing: Who, What, Where, How & Why
by J. Gordon Wright, MD, FACS, RVT
40 Technology Briefs Venowave: Improving the Management of CVI and Reducing the Risk of DVT
by Ethan Light, M.D.
42 Practice Management New FTC Guides Concerning the Use of Endorsements and Testimonials in Advertising
by Andrea B. Epstein
44 Education SCUBA, MAUD, and the Manhattan Project: Acronyms and Education by Steve Elias, M.D., FACS 48 Practice Management The Blue Prints to Radio Spot Architecture by Lyndsay Ballengee 50 Speaking Out Educating One Provider and One Patient at a Time by Marlin Schul, MD, MBA, FACPh, RVT 50 News and New Products
On the cover The pros and cons of adding laser lipolysis and liposuction to your vein practice.
www . vein D I R E C T O R Y . O R G
Editor’s Note The Season for Growth, Development and Rejuvenation This is the time of year to think about growth and rejuvenation. Your patients may be considering cosmetic treatments to get them ready for the imminent summer sun (and beach, for those of you in coastal terrain), either to rid themselves of varicose veins or other treatments to enhance their appearance. It’s also a great time to take a step back and evaluate your opportunities for practice growth. For that reason, it’s appropriate for this issue of VEIN to offer perspectives from practicing physicians who have enhanced their practice through new services or the pursuit of research studies. From the business side of growing your practice, we also offer some insights on practice advertising from the perspectives of industry and government experts. We take a different approach to our cover story this issue with an in-depth interview with Dr. E.J Sanchez, an interventional cardiologist who broadened his practice to first include vein care and more recently, laser lipolysis and liposuction. He offers great insights into the investment of resources required and further provides a cautionary perspective on all the factors to consider so that you go into this potential opportunity with your “eyes wide open.” On the research front, Dr. Suresh Vedantham provides an overview of the opportunity to enroll patients in the ATTRACT trial, which is focused on new treatments for deep vein thrombosis (DVT) and their potential longerterm impact on patients. We also delve into research opportunities available for phlebologists in this issue’s Featured Doctor profile. Here, we interview Dr. Clint Hayes, the Director of the Vein Center of North Texas who has built a thriving vein practice in a rural area of northeastern Texas. Dr. Hayes has successfully pursued grants to fund research in the area of Restless Legs Syndrome (RLS) and as a member of the ACP Research Programs Committee, offers insights on the current opportunities to secure research funding for a wide range of studies. On the practice development front, we share details from an interview with Federal Trade Commission’s (FTC) Assistant Director of the Bureau of Consumer Protection in the FTC guidelines pertaining to the use of testimonials and endorsements in advertising. While not specifically focused on physicians, the questions posed are highly relevant to practitioners considering using testimonials on broadcast (television or radio) or web site advertising. Speaking of broadcast advertising, we also offer insights from Lyndsay Ballengee, industry marketing executive, on how to build a strategic radio campaign for your vein practice. Education for phlebologists remains a core focus of VEIN and this issue is no exception. Our Education columnist, Dr. Steve Elias, takes a step back and looks at the value of acronyms in phlebology education (though he doesn’t include the few I’ve already used in a few short paragraphs in this letter (i.e., ATTRACT, RLS, DVT, and FTC)! We also include a recap of the recent American Venous Forum meeting in Amelia Island, Florida and preview the upcoming 8th International Vein Congress to be held in May in Miami Beach. Our Medical Director, Dr. Marlin Schul, also addresses the role of each phlebologist in advancing venous disease awareness in this issue’s Speaking Out column. One final note. We are very pleased that Lawson Mollica has returned to VEIN in the role of Associate Publisher. Our team remains committed to being your source of cutting-edge clinical, technological and business information pertaining to venous disease treatment. We welcome your feedback and input to future issues; contact me at editor@veindirectory.org with your suggestions. Many thanks for your continued support of VEIN Magazine. All the best, Andrea Epstein
Medical Director Marlin W. Schul, MD, MBA, RVT, FACPh Editor in ChIEf Andrea B. Epstein editor@veindirectory.org Associate Publisher Lawson Mollica lawson@healthnews.org CONTRIBUTING WRITERS Jose Almeida, MD Lyndsay Ballengee Steve Elias, MD, FACS, FACPh David L. Gillespie, MD, RVT, FACS Lowell Kabnick, MD, FACS, FACPh Ethan Light, MD Peter Pappas, MD Michael J. Sacopulos J.D Marlin W. Schul, MD, MBA, RVT, FACPh Jeffrey Segal, MD, J.D. Suresh, Vedantham, MD J. Gordon Wright, MD, FACS, RVT PRODUCTION Creative Director Frank Chlarson Graphic Design ADVERTISING Director Lawson Mollica 714-348-5066 lawson@healthnews.org www.VeinDirectory.org Director of Sales Lauren Wright (949) 752-7096 lauren@healthnews.org Administration Emily Jones support@veindirectory.org PRINTER Color Graphics Sergio Rodriguez, Account Executive VEIN Magazine is a publication of www.veindirectory.org www.healthnews.org and Internet Brands 909 North Sepulveda Ave., 11th Floor El Segundo, CA 90245 800.431.2500
Printed in the U.S.A. Copyright Internet Brands. All rights reserved. VEIN Magazine is printed 4 times per year by Internet Brands. Address all subscription correspondence to VEIN Magazine, 909 North Sepulveda Blvd., 11th Floor, El Segundo, CA 90245. Please allow at least six weeks for change of address. Include your old address as well as new, and if possible, enclose an address label from your recent issue.
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Letter from Our Medical Director
Opportunities and Options in Venous Education Welcome to the spring issue of VEIN Magazine! Our cover story represents the heterogeneity of providers that practice phlebology. As warmer weather is approaching, many pursue figure enhancing procedures in addition to managing unsightly veins. Dr. EJ Sanchez, an accomplished interventional cardiologist, shares his reflections on adding laser lipolysis / liposuction to a thriving interventional cardiology/phlebology practice. Dr. Sanchez’s personal research and investment of time offers valuable as one entertains adding this procedure to an established vein practice. The annual scientific meeting of the American Venous Forum was not without surprises, as new scientific discoveries were shared including a landmark discovery by Dr. Paolo Zamboni and associates. In an oral abstract presented by Dr. Zamboni, it was revealed that cerebral venous obstructive pathology is a common finding in (18/20) twenty patients studied having multiple sclerosis (MS). This pilot study of relieving venous obstruction patterns is offering new hope to patients suffering this debilitating disease state. A thorough review of AVF meeting highlights is shared in this issue. VEIN Magazine has printed giftedly written phlebology education articles by Dr. Steve Elias. Dr. Elias has addressed many questions while documenting the scope of the problem and need for formal phlebology education. Where there is a dearth of phlebology material currently taught in medical schools and residency programs, the AVF Fellows course and scholarship programs to attend the Annual Congress of the American College of Phlebology represent effective tools to reach and train interested medical providers. Despite these promising programs, the size of the potential audience is seemingly endless as the general public and majority of medical providers, ancillary personnel, and hospital administrators possess little knowledge about venous disease and the epidemics of deep vein thrombosis and stasis ulcers. Medical societies, industry, and individual medical providers each own a responsibility to meet the education demands to help enhance awareness of common complications of vein disease, including DVT/PE and stasis ulcers.The benefits working together to meet these demands serve many purposes. The general public:
The 55 year old patient being hospitalized for total hip surgery may ask their surgeon about DVT prophylaxis. Medical providers of all types (medical students, nursing students, ancillary providers in hospitals, established medical and surgical personnel): • Provide impressionable medical and nursing students with knowledge about venous disease and measures to promote vein health. • Help established primary care physicians recognize the prevalence of chronic venous disease, the common skin findings, and complications of venous stasis. • Help providers take initiatives to build DVT risk assessment plans for their patient population, AND for all hospitalized patients. • Help providers identify means to reduce the risk of DVT/PE through screening and prophylaxis according to the American College Chest Physician guidelines. • Familiarize providers with stasis ulcers and means to reduce recurrence. Hospital Administrators: • Bring further awareness to NEVER events and means to reduce the incidence of VTE complications in hospitalized patients. • Encourage hospital administrations to see the clear benefit of routine risk assessment of all hospitalized patients and select outpatients for VTE risk. At the end of the day, if industry, academia, medical societies, and private practitioners work together for a common purpose, the goals of reducing VTE incidence and enhancing overall venous health in society will be obtained. This cannot and will not happen overnight, but a concerted effort across societies, providers of all backgrounds and industry partners will yield dividends of public and provider awareness and an outcome of elevated level of vein care throughout our communities. If we think about venous education there are many potential roles. Is it to educate other physicians? Teach impressionable medical students? Increase public awareness and participate in a National Venous Screening program such as that of the AVF? Or to simply educate your patients and your local physician pool one patient, one physician at a time? What is your role?
• Patients with occupational risk may utilize compression routinely to support their venous health. • The pregnant patient may elect to wear compression during the first trimester in an attempt to limit venous stasis.
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Marlin W. Schul MD, MBA, RVT, FACPh
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Vein Industry Calendar
DOMESTIC EVENTS 13-15 May 2010 8th International Vein Congress Fontainebleau Hotel Miami Beach, FL www.ivcmiami.com 2-5 June 2010 New Cardiovascular Horizons 2010 The Roosevelt Waldorf-Astoria New Orleans, LA newcvhorizons.com 10-13 June 2010 Vascular Annual Meeting Society for Vascular Surgery Hynes Convention Center Boston, MA www.vascularweb.org 28 July – 1 August 2010 31st Annual Meeting, Rocky Mountain Vascular Surgical Society The Village at Squaw Valley Lake Tahoe, CA www.administrare.com 24-26 September 2010 37th Annual Meeting, New England Society for Vascular Surgery Seaport Hotel Boston, MA www.nesvs.vascularweb.org 24-26 September 2010 Association for Vascular Access 2010 Annual Conference Gaylord National Hotel & Convention Center National Harbor, MD www.avainfo.org 3-7 October 2010 96th Annual American College of Surgeons Clinical Congress American College of Surgeons Washington, DC www.facs.org 17-19 October 2010 52nd Annual World Congress of the International College of Angiology University of Kentucky Lexington, Kentucky www.intlcollegeofangiology.org 18-22 October 2010 VIVA 2010 Aria Las Vegas Las Vegas, NV www.vivapvd.com 4-7 November 2010 24th Annual Congress of the American College of Phlebology Renaissance Orlando Hotel at Sea World Orlando, Florida www.phlebology.org
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Re-emerging from the glamour of its grand opening in 1954, the recently revamped Fontainebleau represents the next generation of Miami Beach iconicity, infused with the sexy, ultramodern spirit of the eccentric original.
17-21 November 2010 37th Annual VEITH Symposium Hilton New York New York, NY www.veithsymposium.org INTERNATIONAL EVENTS 24-26 June 2010 11th Annual Meeting of the European Venous Forum Hilton Hotel Antwerp, Belgium www.europeanvenousforum.com 16-19 September 2010 XXIV Annual Meeting of the European Society for Vascular Surgery Amsterdam RAI Convention Center Amsterdam,The Netherlands www.esvs.org 2-6 October 2010 CIRSE 2010 Feria Muestrario Internacional de Valencia Valencia, Spain www.cirse.org 12-14 October 2010 XIV Pan-American Congress on Phlebology and Lymphology Hotel Hilton Colon Guayaquil-Ecuador www.sociedadecuatorianadeflebologia.com
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24-26 November 2010 Vascular and Surgical Society of Great Britain and Ireland Annual General Meeting Hilton Brighton Metropole Brighton, England www.vascularsociety.org.uk
Submissions to the calendar should be e-mailed to the editor at editor@veindirectory.org. Please include the event’s name, date, time, location, admission price and contact information. Inclusion in the calendar is subject to available space.
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Event Preview
IVC 2010:
A Preview of the 8th Annual International Vein Congress by Jose I. Almeida, MD, FACS, RVT Course Director Our move to the beautiful and newly refurbished Fontainebleau last year was an instant hit with the participants; the vibe that this venue has added to the meeting cannot be understated. Whether you are a newbie or an IVC veteran, this classic hotel is a prime venue on Miami Beach that offers something for everyone. All of one’s needs can be met on-site, with a nice array of restaurants, shops and amenities- and the energy at night is palpable! With this in mind, guests should bring their whole family, and combine a wonderful learning experience with some relaxation. I want to emphasize what has not changed at IVC. Now in its eighth year, IVC continues to stand as the most important meeting serving professionals involved with the treatment of venous disease in the office setting. My commitment, along with that of our co-directors and faculty, remains to the practitioners and allied health staff whom have dedicated themselves to staying at the top of the field. Through an annually strong program, IVC offers an important opportunity to learn about new techniques and technology. Our faculty provide the kind of insight that only comes from years of experience. Our live case demonstrations provide an unparalleled chance to observe office-based procedures selected for their high educational value - and then dissected by a panel of experts. Our Exhibit Hall provides information about products and services that perfectly complements the meeting’s clinical and practical content. Dr. Bo Eklof will be flying in from Sweden to deliver the keynote address “Reducing Venous Ulcers by 50% in Ten Years.” This topic is most timely. As the IVC meeting has matured over the years, it has come to appreciate the multisystem involvement of advanced disease. Therefore, talks discussing the role of the deep system, perforator system, and the importance of iliofemoral outflow will complement Dr. Eklof’s talk on C6 disease.
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Photo: American College of Phlebology
Course Director Jose Almeida speaks to the atendees.
Our live case demonstrations provide an unparalleled chance to observe office-based procedures - selected for their high educational value - and then dissected by a panel of experts.
IVC does not subscribe to political correctness. “Do We Really Need a Phlebology Specialty Board?” is one of the questions of the day, and the issue will be debated in the star-studded V2 symposium moderated annually by Dr. Steve Elias. Our closing session on Saturday, “The Battle With 3rd Party Payers,” likewise will have provocative talks addressing the future of insurance reimbursement and how we as doctors need to get involved to make changes. Registration has hit a new trajectory this year and we are expecting 1000 participants from 30 different countries, and over 50 exhibitors. We hope to see to see you in Miami Beach in May - be there or be square! For more information please visit us at www.IVCmiami.com.
Luxurious private cabanas with flat-panel TVs and butler service are available for rent, as are beach cabanas and personal watercraft.
Medical Diary
Latest Treatments and Research on Venous Disease Presented at the
American Venous Forum’s 22nd Annual Meeting by David L. Gillespie, MD, RVT, FACS Nearly 500 healthcare providers who treat Clinical Severity Score (VCSS), a classification venous disease attended the 22nd Annual Meeting system originally developed ten years ago. Dr. of the American Venous Forum (AVF), February 10Vasquez discussed changes to the system that 13, on Amelia Island, FL, where medical experts in update terminology, simplify application and the field provided up-to-date treatment strategies better address the issues of patients at the lower and presented new research to advance the care end of the venous disease spectrum. This revision for people with venous disease. The attendees ensures that the VCSS is an appropriate evaluative represented 23 countries, making this an important instrument that is responsive to changes in Dr. David L. Gillespie international meeting for doctors and allied health disease severity over time and treatments. professionals seeking to learn about the latest Other highlights included the presentation developments and cutting-edge interventions for this patient of ground-breaking research by William A. Marston, MD, population. University of North Carolina-Chapel Hill, on the incidence Among the highlights was the Eugene Strandness, Jr. lecture, which was presented by Professor Juan Ignatio Arcelus, from Grenada, Spain, who discussed the 30,000 patient computerized registry that is based in Spain. This registry on venous thromboembolism – known as RIETE, an acronym for its Spanish name – draws 350 new patients every month from 137 centers around the world. The data derived from the registry, which has already resulted in 48 published manuscripts, represents real world experience of patients suffering from venous thromboembolism.
of Ilio-caval venous obstruction in patients with venous ulcers utilizing CT or MR venography in combination with duplex imaging, and Paolo Zamboni, MD, University of Ferrara (Italy) on the relationship of jugular venous outflow obstruction on CSF drainage in patients with multiple sclerosis. The “Ask the Experts” session was also extremely well attended, with Anthony Gasparis, MD, SUNY-Stony Brook, heading an internationally recognized group of experts who discussed case scenarios related to chemical and mechanical venous thrombectomy.
“The RIETE database is a valuable tool for clinicians as they work to provide the best care for their patients,” said Joseph Caprini, MD, SM, FACS, RVT, past president of the AVF. “We are grateful to Dr. Arcelus for his contributions to the registry. I am confident it will continue to be an increasingly important data bank for clinicians worldwide.”
Meeting attendees confirmed the value of the presentations, symposiums and workshops offered throughout the meeting with feedback that outlined how they will incorporate their learnings into their clinical practice. Many said they would be more aggressive in their treatment of venous disease, utilize new technologies and conduct a more comprehensive approach for complete venous care.
Another key presentation at the meeting was delivered by Michael Vasquez, MD, Department of Surgery, State University of New York-Buffalo. He and his colleagues on the AVF’s committee on outcomes assessment updated the Venous
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In addition, they recognized that the AVF offered a good mix of clinical and research projects and appreciated the scientific format that prevailed throughout the meeting. Papers that
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were presented were cited as “top quality” and “rigorously screened,” thus providing attendees with a high level of pertinent data. The AVF’s Annual Meeting offers an array of programs over the course of four days. Multiple symposia, presentations and workshops are available on a range of clinical issues related to venous disease, including deep vein thrombosis, chronic venous insufficiency, superficial vein disease, IVC and filters, lymphedema and compression and other critical aspects of venous disease. A post-graduate course featuring a debate on venous disease topics, such as stent grafting, criteria for caval interruption devices and more, was another component of the meeting.
D and aprini, M Joseph C as, MD pp Peter Pa
Symposium were also offered on community practices, including coding, billing and insurance. American Medical Association (AMA) Physician’s Recognition Award (PRA) Category 1 Credits™ were provided for most program elements.
(L-R) Mark M ei Brajesh Lal, an ssner, d Tony Comer ota.
The physicians who attended the meeting felt that the meeting was enjoyable and extremely well done. Said one attendee, “This it the best vein meeting around.” “The AVF continues to deliver high quality presentations, workshops and symposia,” said Peter J. Pappas, MD, title, President of the AVF. “We expect that next year will be even bigger and better as our program committee is already planning the addition of new features for our members.”
The Ritz-Carlton, Amelia Island, a place where magnificent live oaks and Southern charm meet Florida’s warm ocean wav es and white sand beaches.
Joseph Caprini, MD Peter Pappas, MD Mark Meissner, MD Brajesh Lal, MD Tony Comerota, MD , RVT Nicos Labroupolos, PhD
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Clinical Training
American Venous Forum Announces
Fellows’ Course in Venous Diseases Program and Schedule
by Peter Pappas, MD and AVF President The American Venous Forum’s Vascular Fellows’ Course is pleased to announce the partnership with Steve Elias, MD, FACS, FACPh, Founder and Director of The Fellows’ Course in Venous Diseases. Education of new and practicing physicians is one of the AVF’s mission priorities and its leadership is recognized throughout the world as thought leaders and experts in venous disease. This partnership makes good educational sense and this unified effort benefits all concerned with venous disease care. AVF and Dr. Elias are committed to continuing the consistent high quality, interactive and hands-on experience that has made the Fellows’ Course in Venous Disease so successful. Faculty-fellow interaction is crucial for the fellows’ experience during the course; therefore enrollment is limited to 35 attendees per each course site. The faculty consists of AVF leaders in the field of venous disease and local experts from each host site. The course program will cover: • Anatomy and pathophysiology of venous disorders and noninvasive diagnostics • Chronic venous insufficiency (superficial, perforator & deep) • Pregnancy, upper extremity venous issues, acute DVT and wound care • Future of venous disease • The business of venous disease
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AVF will offer three regional courses in 2010: May 2-4, 2010 Host: Steve Elias, MD Englewood Hospital and Medical Center Englewood, NJ September 12-14, 2010 Host: Mark Meissner, MD University of Washington Medical School Seattle, WA December 2-4, 2010 Host: Joann Lohr, MD Good Samaritan Hospital Cincinnati, OH By holding true to the much-admired informal, interactive, intimate format; the course continues to provide training of best practices in evaluation and management of venous disease through a balanced mix of didactic and clinical experiences. Fellows’ travel, lodging and meal expenses are supported by unrestricted medical educational grants and industry sponsorship. Fellows are registered on a first-come, firstserved basis and each application must be accompanied by a Letter of Endorsement from their Program Director in order to be considered. The AVF is excited for the 2010 courses and look forward expanding the tradition of providing free access to the highest quality education for young trainees in the field of venous disease. The AVF’s Fellows’ Course in Venous Disease is open to Vascular Surgery and Interventional Radiology Fellows. For more information and an application, please go to www. veinforum.org/fellowscourse.html or call the national office at 978-744-5005.
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Cover Story
Perspectives from Dr. E.J. Sanchez of Laser & Vein Center at Batey
Adding Laser Lipolysis and Liposuction to your Vein Practice
by Andrea B. Epstein According to the most recent statistics from the American Society of Plastic Surgeons (ASPS), cosmetic surgeries in the U.S. are not just for the Hollywood crowd; more than 12.1 million of these procedures were performed in 2008. Even with continued gloom in the economic forecast projected for the remainder of 2010 and possibly 2011, cosmetic surgery is big business. Of the top five cosmetic procedures listed by the ASPS, number three is liposuction, with 245,000 procedures performed 2008. Though the reported liposuction procedure volume was down 19% from the prior year, there is clearly a vast supply of patients still demanding this procedure. Should you consider adding this to your vein practice to meet the continued demand for liposuction and laser lipolysis? VEIN spoke with Dr. E.J. Sanchez, a Florida based cardiologist who practices at Laser &Vein Center at Batey Cardiovascular in the Tampa Bay area. Since joining the practice in the mid-1990s, Dr. Sanchez has continued to be a pioneer in expanding his practice with new service offerings, including laser lipolysis and liposuction. Below, he offers valuable insights to other vein physicians seeking to broaden their practices.
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As background, how did your practice first evolve and expand over time from cardiology to vein care? I am an invasive cardiologist, board certified in internal medicine, cardiology, and nuclear cardiology. I joined a cardiology practice in 1994 and my primary focus was and continues to be clinical cardiology – from diagnosis to intervention. My practice has always been busy. I wasn’t really looking to add other disciplines but this (veins) fell in my lap. A friend asked if I had given any thought to adding vein care to my practice. I already had a good reputation in my community. I treat many doctors and their families, and people know that I won’t perform any type of procedure without doing my due diligence first. Originally, my cardiology practice was only involved with the aspects of thromboembolic venous disease and bypass grafts. Veins are a natural progression for a cardiologist who already is doing endovenous procedures. Anything with catheters is really second nature and it can be a smooth transition. I attended the IVC meeting in Miami and then followed up with training with Dr. Jose Almeida in April 2006. I visited other practices that year and by October, I added vein treatment to my practice. I dedicated one day per week to veins but then it quickly Dr. E.J. Sanchez became two and then three days per week. I built my credibility as a cardiologist; once the community heard I was adding vein care to my practice, I received a lot of referrals. I also made it a point to educate other doctors, showing them how to identify all presentations and manifestations of vein conditions so they could refer these types of cases to me. As the vein side of my practice grew, I knew I needed help, as it was taking too much time away from my cardiology practice. I brought in Dr John Mauriello; with his expertise in research, we began attracting and participating in research trials. How many years were you in an established vein practice before you opted to add laser lipolysis and liposuction to your services? Through discussions at many meetings, I discovered that many phlebologists were also offering laser lipolysis. They were using tumescent anesthesia and a laser; I already used both. I believed that I could add this to my practice without needing much additional staff training. For these reasons, I became interested in the procedures. I started by doing site visits with several physicians. I visited a successful doctor in Napa who provided vein care and added laser lipolysis. I worked with a Colorado plastic surgeon to get on-site training and then went to investigate different
technologies. I also began investigating VASER (ultrasound lipolysis) and became very interested in this technology. My VASER research took me to Miami; I spent two weeks with a surgeon to learn this procedure via hands-on training. How were you able to spend the time away from your practice to research and train in laser lipolysis? I was able to spend the time because I have a number of partners. The practice trusts me to research new procedures. In total, I probably spent about 100 hours in training, reading and working with other physicians before I brought laser lipo into my practice. What are the biggest challenges with adding laser lipolysis to your practice? There is a lot of myth about laser lipolysis. Mainly, physicians need to realize that by adding these services, there is more potential to hurt a practice than to have it grow. Phlebologists oversimplify what’s involved in adding this to their practice. There are several key things to consider when adding laser lipolysis to a vein practice. First, the complications are different. Second, you are adding a service that is purely cosmetic. This is in direct contrast to phlebology, which is still clinical medicine, requiring management of real clinical issues such as ulcers and phlebitis. There is a big difference between treating these types of patients and those who come in seeking to improve how their arms or legs look. Moving into pure cosmetic procedures may lead you to offer other services, which in turn may influence how you are perceived in the community. In short, some may perceive that you are adding procedures just to make more money. This can backfire in terms of your reputation as a phlebologist or whatever you primary specialty is. Doctors need to ask themselves one question. What am I trying to accomplish here? For certain practitioners, there are some procedures that may cheapen the community perception of your practice. How much time did you spend researching these procedures before you moved forward with adding them to your practice? To add laser lipolysis and liposuction to my practice, I invested about three times the amount of research and training time that I spent to add other services to my practice (i.e., adding veins to my cardiology practice.) The cost of my time alone probably exceeded $100,000. I spent more than 100 hours in research; I read every book on laser lipolysis. For my first case – using VASER – I brought in a cosmetic surgeon, and paid him a stipend to scrub in and be a part of the procedure.
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Phlebologists considering adding this to their practice need to know that it’s not a walk in the park. If you can’t take care of the complication, you shouldn’t be doing the procedure. Clearly, if you don’t train and prep properly, the risk is much greater to your established vein practice than the upside you can gain in new patients and revenue. You have shared that phlebologists are well positioned to deliver this service. Why do you believe phlebologists offer the natural skill set for this procedure? Phlebologists are the nicest, most willing doctors in terms of wanting to share information. My feeling is that if you are successful in what you are doing now, you can be successful in laser lipolysis. Be aware, though, that the amount of time and the resources required to add this to your practice cannot be taken lightly. Any physician must look at the entire picture - in terms of the business model - to figure out if this addition will really augment his or her practice financially.
Reception area at the Laser and Vein Center at Baley in Bradenton, Florida. VASER Lipo System
Take a laser lipolysis procedure, for example. It may take three hours of procedure time, but six total hours of work, with an operating cost of $1800. That equates to $300 per hour. This is often overlooked when creating a business model for your practice. Did you encounter any hurdles in acquiring malpractice coverage for these procedures? This is a key issue. Should you modify your insurance, and should you address this before or after you start investing in adding this service? You have to do your due your diligence; ask your malpractice insurance representative about your options. I told my rep that I already offer laser and tumescent anesthesia and explained that this (laser lipolysis) was basically an add-on procedure; as a result, I was able to get the coverage. Make sure you test the waters with your rep before you spend the money on purchasing equipment. My premiums went up about $5,000 when I added lipolysis to my practice. What equipment do you consider essential for these procedures? Companies will prey on you to buy a $150,000 piece of equipment. A 980 laser is sufficient and most phlebologists already own this. Some companies will say your 980 only provides 15 watts versus 30 watts. That just means the procedures will take an extra five minutes to complete but you’ll save $50,000 in new equipment costs. I purchased VASER (ultrasound lipolysis) versus laser lipolysis. I wanted to set myself apart from the plastic surgeons
who primarily offer laser but not VASER. Most plastic surgeons shy away from ultrasound lipolysis because early generations had some issues with complications which are not seen in the newer ultrasound lipolysis equipment. Additional equipment costs can include the tumescent pump, suction, and cannulae. However, you don’t have to buy these; you can opt to pay by the case. This is a more costeffective option since buying the equipment outright can be a substantial expense, with costs varying between $30,000 and $60,000. To be clear, the per case payment option requires an upfront payment for 25% of the total equipment cost. A wireless chip in the machine sends information to the company on your equipment usage and you are then billed for your variable usage. Your cost per case also goes down as your volume goes up. It is a less expensive approach if your caseload for these procedures is sporadic. Another cost to consider is back-up electricity if you don’t have this already. You don’t want to be in an office if the lights go out and a larger 3000 cc tumescent has been injected into a patient’s belly. I purchased a generator to avoid the risk of losing power in the middle of this type of procedure. Do you perform these cases in an accredited surgical center or an office setting? Which do you recommend? I recommend the office setting for these procedures. This is your competitive advantage over plastic surgeons that perform these procedures in a surgery center. With an office setting, you can promote convenience to your patients. Also, you can price these services more competitively without the burden of the surgery center overhead. If you are going to offer these procedures in the office setting, a sterile environment needs to be emphasized. You Continued on page 22
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must have the right personnel. I use a surgical scrub nurse every time I do these cases; she also works with one of the local plastic surgeons. I pay her on a per case basis. This is less costly than hiring an employee when the cases are sporadic. Since she is an RN, she can mix tumescent and also handle the wound care. What are the key factors that a vein physician should consider before deciding to add these services to his or her practice? If you are not a busy phlebologist, this can be a good procedure to add to your practice. It’s important to keep in mind that this is a different patient market than a vein practice. Less than 20% of lipo patients will have a venous procedure too. Physicians need to do their homework. It takes intense preparation to successfully add this to a vein practice. You need to go in with your eyes wide open. Take a hard look at the economics of your individual practice. You may end up taking procedures just for the short-term money but may not be able to cover your costs longer term. Also, consider that some patients require touch-ups six months later and for these, you can typically bill only to cover your costs. When you put pencil to paper, it may not work out. Another key piece of advice I can offer is to find a friendly plastic surgeon who wants to be your referral source for advanced cases or complications. Turn these potential competitors or adversaries into your friends. They also will back you up when you have a complication that you refer to them. Finally, remember that you can never be too cautious. Make sure that you are ACLS trained and certified. When patients come to my practice, safety is a top priority. These patients are seen pre-op for lab work, medications and an exam because infection is a big concern with laser lipolysis. A catastrophic event can be avoided with proper safety preparation and precautions. What are the main differences between laser lipolysis, liposuction and ultrasound lipolysis? There is no difference between the outcomes for laser lipolysis and liposuction in the right hands. If you went out and marketed traditional liposuction as an addition to your practice, you would have no competitive edge. That’s the reason to offer laser or VASER. In terms of results, there is no difference between laser and traditional liposuction. Rather than raking up fat, you are melting it with the laser, but suction is still required. Skin retraction is not dependent on the procedure but rather on the operator (i.e., the physician doing the procedure). VASER offers a smoother contour but also has its pros and cons.
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I recommend that before any physician embarks on this, he or she takes a traditional liposuction course; laser lipolysis and VASER can be added afterwards. You have offered a great deal of information to consider before a phlebologist should proceed with adding laser lipolysis to his or her practice. In closing, can you offer a brief summary of your key recommendations? My overriding advice is that you have to be serious about adding this to your practice and go into this with your eyes wide open. In summary, there are five key areas that must be evaluated seriously: 1. LEARN THE BASICS FIRST: Take a CME accredited program; don’t waste your time trying to learn the techniques with a solo practitioner promoting his laser. You will end up with a skewed point-of-view. 2. ESTIMATE YOUR BUDGET: What resources – in terms of time and money – is it going to take for you to do this? If you have a 980 laser, you’ll still need to purchase a tumescent infusion and suction pump which can run about $10,000. If you don’t have a laser box, and are going to offer laser lipolysis or VASER, you’ll have to make a significant financial investment. 3. ALLOCATE THE TIME/HOURS NEEDED: Upfront research and training is essential. I spent countless hours before I made the decision to move ahead and followed up with many hours scrubbing in with plastic surgeons. 4. INVEST IN MARKETING: You must address the question: How am I going to get patients for these new services? Advertising is expensive. Phlebology patients won’t ask for these services as it’s not really a natural fit. I did invest substantial dollars in advertising, including radio and television ads. Be aware that it’s still a difficult time to attract patients for elective, cash procedures in this economy. 5. BE COLLEGIAL WITH PLASTIC SURGEONS: Develop collegial ties with local plastic surgeons and establish cross referral relationships. I will still refer out to these surgeons if laser lipolysis isn’t the right solution for a specific aesthetic patient (or in cases where the patient that wants more cosmetic services with their laser lipo). In summary, I hope I have conveyed my cautionary perspective about the wide range of things that you must consider before adding this to your practice. It’s not simple and not a quick return on your investment. For me, adding laser lipolysis has not brought a significant increase in net revenue to my practice. I continue to emphasize cardiology and veins, and in truth, the bulk of my new patients are in phlebology. For more information on Dr. Sanchez and his practice, go to www. veinscenter.com.
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Technology Briefs
A New Wave of Excitement Has Brandished the Telangiectatic Therapeutic Market:
Veinwave
™
by Jennifer Heller, MD and Lowell Kabnick, MD
Lowell Kabnick, MD
In an effort to improve upon these limitations, a group of European phlebologists, spearheaded by Dr. Brian Newman, joined together to create a new technique for spider vein treatment. Their development was created in the form of a radiofrequency device called Veinwave™. In July 2001, Veinwave™ was introduced in Great Britain as well as to the International Phlebology Community. In June 2009, the FDA provided Veinwave™ clearance to market in the United States.
Figure 1a: Nose Pre-Treatment
Figure1b: Nose PostTreatment with Veinwave
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Long established as effective modalities, injection sclerotherapy, and to a lesser extent laser and IPL, have dominated the market for patients who desire resolution of unsightly spider veins. Although these treatment options are reliable and provide reasonably good results with more pronounced C1 disease, such as Jennifer A. Heller, MD the dark blue reticular veins and the thick red spider veins, limitations do exist for eradication of very fine spider veins. Additionally, patients must be compliant with use of compression stockings and avoid sun exposure for several weeks post-treatment in order to optimize results and minimize complications such as hyper/ hypopigmentation and pain - side effects which have been documented particularly with IPL and laser treatment.
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“In June 2009, the FDA provided Vein wave™ clearance to market in the United States.”
Figure 2a: Leg Pre-Treatment.
Figure2b: Leg PostTreatment with Veinwave
Veinwave™ is a radiofrequency-desktop-device, which uses a pen-like needle holder into which an ultra-fine insulated needle is inserted. Utilizing the principle of thermocoagulation, this needle emits safe energy (regulated by a footpedal) via a uni-polar current at the needle-tip. The Veinwave™ system enables the practitioner to specifically target each individual vein for treatment. The technique involves a subepidermal insertion of the needle-tip along the length of the vein, but without penetration of the target (vessel). A unique micro sheath surrounding the needle protects the epidermis from any trauma. The patient can appreciate the remarkable, practically instantaneous change in the appearance of these fine veins. In contradistinction to other spider vein treatment, patients who undergo Veinwave™ therapy may resume normal activity immediately following their appointment. Abstaining from Continued on page 26
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“The patient can appreciate the remarkable, practically instantaneous change in the appearance of these fine veins.” without the concern of Fitzpatrick skin types, sun exposure, and hyper/hypopigmentation.
sun exposure is only recommended for a couple of days instead of weeks. Some patients leave the treatment without significantly visible skin signs, while others with more sensitive skin, may have minor erythema, which should disappear within a four to twenty-four hours. The sensation experienced during treatment is similar to that of a warm pin prick or a minor sting. Any discomfort is said to be less painful than most laser or IPL treatments. Our present but limited experience (confirmed by Dr. Newman) reveals a 60% area reduction of leg telangiectasias less than 0.3 mm and greater than 90% of facial veins (see figure 1 and 2). This appears to be similar to cutaneous laser
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Veinwave™ will not likely replace other techniques for treatment; rather, it will enhance our ability to treat all forms of spider veins and allow phlebologists to treat the very fine spider veins in concert with the larger telangiectasias, thereby increasing patient and phlebologist satisfaction alike. Early reports are extremely optimistic, and undoubtedly, Veinwave™ will occupy a bright light in the armamentarium for spider vein treatment. Lowell Kabnick, MD, FACS, FACPh, RPhS is the Director of the New York University Vein Center and an Associate Professor at New York University Langone Medical Center, Division of Vascular Surgery. Jennifer A. Heller, M.D., FACS, is Assistant Professor of Vascular Surgery at The Johns Hopkins University School of Medicine, and Medical Director and Chief of The Johns Hopkins Vein Center.
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Featured Doctor
Striking the Balance between Clinical Practice and Research
A Conversation with
Clint Hayes, MD, FACS, FACPh Director of the Vein Center of North Texas
by Andrea B. Epstein
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Establishing a thriving vein practice in rural northeast Texas certainly presents its share of challenges. So too does the pursuit of research which critically assesses the link between venous insufficiency and Restless Legs Syndrome (RLS), a condition primarily treated with prescription medication and no known cure. Dr. Clint Hayes, Director of the Vein Center of North Texas, a member of the ACP Research Program Committee and an ACP BSN-JOBST grant recipient, has managed to successfully pursue both at the same time – all within the span of five years. VEIN Magazine caught up with Dr. Hayes to gain his perspective on how to build a successful vein practice, design and implement clinical research, and reap the multifaceted benefits of balancing both - far from a metropolitan hub in rural Texas. How did you first become involved in vein care and what was your specialty prior to opening your vein center? I graduated from Texas Tech Medical School in Lubbock, Texas and then received classic general surgery training in Birmingham, Alabama under Dr. Henry Laws. My training was an old-fashioned general surgery fellowship. I was comfortable doing a wide range of cases – everything from advanced laparoscopy, to aortic repairs, carotid endarterectomies, endoscopy, trauma and cancer. Today that type of broad general surgery practice is mostly ancient history. A true general surgeon who performs the gamut of procedures is rare today -- almost a dinosaur. My brother, Dr. Martin Hayes, is one of the last of the breed (he practices in rural Oklahoma about 90 milesnorth of us) -- and even he is doing fewer big cases these days. I practiced general surgery for seven years in Denison (Texas) before specializing in phlebology. When and why did you start the Vein Center of North Texas? I trained at Carraway Methodist Medical Center in Birmingham. Dr. John Kingsley was our vascular professor, and he taught vascular surgery including conventional arterial and venous cases, which at that time consisted primarily vein stripping and phlebectomies. In 2004, I heard him speak about the revolution occurring in the diagnosis of venous diseases with duplex scanning and treatment using endovenous techniques, and that really piqued my interest. My wife, Sunni (who is my practice manager) and I discussed looking into phlebology. We traveled to Dr. Kingsley’s office for some advanced training, and I began performing endovenous thermal ablations, phlebectomies, and sclerotherapy as additional procedures in my surgery repertoire. The phlebology portion of my practice eclipsed the general surgery portion fairly rapidly. It took about two years to complete that transition. We closed down my general surgery practice in 2006 to focus exclusively on vein care. Why do you think your vein practice grew so rapidly? There are several reasons for our rapid growth. First, there is a large backlog of patients. Historically, most people with varicose veins rejected vein stripping due to its reputation for causing considerable post-operative pain and poor long-
term success rate. As these patients became aware of the new minimally invasive alternatives that result in minimal downtime and are over 95% effective, they began coming in for relief of their chronic symptoms. Secondly, we have advertised quite heavily to reach the general public with billboards, radio and television. I have given educational presentations with referring physicians, including primary care physicians, nurse practitioners, physician assistants, podiatrists, orthopedic surgeons and ob-gyns to educate them on what we are doing since this (modern phlebology) wasn’t in existence when they received their medical education. I believe this type of education outreach to health care providers is part of our responsibility as phlebologists. We must educate other health care providers that phlebology is a viable emerging specialty and just how significant the impact of currently available vein treatments is on the quality of patients’ lives. Another reason that we became so busy so quickly is that I was the first practicing phlebologist in this region. I was here for seven years and had an established reputation as a general surgeon before I made the transition to vein care. The “first cat out of the bag” usually seems to be the most successful in a particular area, especially if he or she has become wellestablished before competition shows up. Trying to break into a market dominated by an experienced phlebologist with a good reputation is an uphill battle. Of course, none of this would have made much difference without Sunni running such a tight ship. I would have been broke years ago without her business acumen. What has been the main source of your patients? Even with my physician outreach education efforts, most of our patients actually come from other patients – and not from referring doctors. This underscores the importance of effective treatment, attention to detail, and of course a good bedside manner. If you treat patients the way they should be treated and have good outcomes, referrals from other patients naturally follow. Once these word-of-mouth referrals hit a critical mass, we became very busy. Of course, the effectiveness of word- of- mouth is probably magnified in a smaller community, as everyone here knows everyone else. Continued on page 30
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Share some insights on your current practice — what you emphasize, the types of patients you see, what your geographic reach is (i.e., how far patients drive to see you). We are currently in Denison, Texas, but are building a new Vein Center in Sherman, which is just down the road. The two cities together have about 60,000 residents. We draw patients from a largely rural area covering Northeastern Texas and Southeastern Oklahoma. Some people drive up to 1 ½ hours to our practice, though most are within a 45 minute drive. There are no other phlebologists in this immediate area, so patients are willing to make the drive. We still advertise fairly heavily. We run spots on television and radio, and promote our services on billboards. We are launching a direct consumer DVD that we will give to our patients, with clips posted on our website. Our website developer has worked hard to keep our website updated in terms of appearance and functionality. We have also recently hired a marketing person to help us coordinate our marketing in terms of selecting the right marketing tools for our advertising campaigns. Talk about your past and current research. How you have accessed research funds to pursue clinical studies? In 2006, I was awarded the ACP-BSN-Jobst Research Award to study the connection between venous insufficiency and Restless Legs Syndrome (RLS). This grant funded the entire study. It took about six months to complete but was a lot more work than we had anticipated. We had to start from nothing and didn’t have any of the guides or resources that are available today through the ACP to help phlebologists undertake clinical research studies.
Can you elaborate on your past and current research regarding Restless Legs Syndrome? Several years ago, a patient came to my office with severe RLS –she was taking five different medications including a sleeping pill, a benzodiazepine, hydrocodone, Requip® and an antidepressant. We operated on her to treat her venous insufficiency. When she came in six weeks later, she looked ten years younger. She said that treating her venous disease had cured her RLS and had changed her life - so much so that she was able to quit taking all five of these medications. For years, she hadn’t been able to sleep and couldn’t keep a job; when she went to bed at 9pm, she wouldn’t fall asleep until at 3am. After fixing her venous disease, she went to sleep as soon as she went to bed. At the time, her primary care practitioner told me that RLS was widely considered a lifelong condition with no cure. This motivated me to look into and eventually study RLS. In our first RLS study, we selected patients with RLS that was of moderate to severe intensity. All patients filled out a standardized, validated RLS questionnaire and had an ultrasound to determine the presence of venous insufficiency. Patients were split into operative and control groups. For the operative group, venous insufficiency was treated with a Cool-Touch 1320 nanometer endovenous laser. At six weeks, the operative and control groups repeated the RLS questionnaire. It was a pretty simple study. We found that there is an 80-90% chance of an 8090% improvement of RLS symptoms with treatment of venous insufficiency and concluded that anyone with RLS symptoms
Recent advancements in ultrasound systems and minimallyinvasive surgical techniques have transformed the diagnosis and treatment of venous disease. One of the problems shared by all rapidly advancing medical specialties is a lack of quality studies that demonstrate the benefits of the emerging technology. The ACP realizes that this lack of data can have a big impact on government and third-party insurance reimbursement policies. I have been a member of the ACP Research Programs Committee for the last couple of years, and have been impressed with just how eager the ACP is to facilitate research that demonstrates the benefits of modern phlebology. If the project has merit, we will do what we can to support it. We have created helpful guides on how to design a research study and how to write a grant proposal. There are tens of thousands of dollars available from the ACP Foundation to help finance quality studies. Despite these available funds and assistance, fewer research proposals come in to the ACP than we would like. Clearly, there are opportunities for studies to be conducted. If you have a good study, there is a good chance you will be able to secure funding.
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Areas of Research of Interest to the ACP Foundation Wound healing and role of compression therapy Edema/lymphedema management and outcomes Venous hemodynamics with compression Comparative studies with various sclerosants Foam and ultrasound guided foam sclerotherapy Efficacy of compression hose prior to and after venous interventions Scientific basis for the treatment of varicose veins Source: ACP Research Programs Advisory Committee
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should be evaluated for underlying venous insufficiency. Our original study was similar to a 1995 sclerotherapy/RLS study by Dr. Alan Kanter, and was the first prospective study to show that a surgical procedure can relieve RLS symptoms. This is particularly important because RLS is widely believed to stem from abnormalities in the central nervous system. We have presented our findings at the 2006 ACP Clinical Congress, the 2008 International RLS Study Group and Restless Legs Foundation Meeting at Johns Hopkins, the 2009 Annual Meeting of the North Texas Chapter of the American College of Surgeons, and the 2009 XVI World Meeting of Union Internationale de Phlébologie and seemed to be well received. This study pointed out that if you don’t treat the underlying cause of RLS, you may be unnecessarily subjecting patients to lifelong maintenance therapy with medications like Requip® or Mirapex®.
life. When these patients’ chronic symptoms are suddenly gone, they have a profound sense of relief. As a clinician and a surgeon, it is extremely gratifying to be impacting the quality of patients’ lives to this degree. You have built a vein practice and successfully pursued research --yet you are not in a major metropolitan area. What advice can you offer VEIN readers who also seek to pursue research but don’t practice in a major medical hub? I believe that a clinician who does research helps the specialty of phlebology and the advancement of medicine, yet also helps that physician’s practice. Good, high-quality research can help establish a physician because it shows your community that you are at the top of your game and adds to your credibility with patients and referring physicians. Clinical studies take a lot of time but can be extremely rewarding on multiple levels; ultimately it can help you promote your practice too.
Our current research is moving In both patient care and research, slowly because we have very narrow you have to have a passion for what criteria. We haven’t added another you are doing. I have a passion for patient in a few weeks. The ACP has RLS because I have suffered with it again funded our follow-up study. my whole life. I actually didn’t know This time we are using Actigraphy, an what the annoying sensations in my emerging technology that allows you legs were until I began researching to evaluate the extent of periodic RLS. (This was before the RLS media leg movement disorder (PLMD), blitz by Requip® and Mirapex®.) which is a condition frequently Having RLS allows me to relate to associated with RLS. In this study, patients who have these problems patients wear actigraphy units so Clint Hayes, MD, FACS, FACPh sleeping and are told that it’s not a we measure a patient’s PLMD; then real condition, or that it is “all in their we operate to see if relieving the head.” For me, surgery won’t work because I don’t have any venous insufficiency impacts the PLMD. The operative group associated venous disease. I believe that RLS may somehow is treated with same Cool-Touch 1320nm endovenous laser be linked to edema because when I wear graded compression used in our previous study. We hope that adding PLMD to stockings in the operating room, I sleep just fine that night. If the study will give more objective data than a study based I don’t wear my stockings while I operate, I notice pretibial purely on patient questionnaires. edema when I get home, and I kick all night long. This is What is most rewarding about your vein practice? another study that needs to be done: to determine the impact When I practiced general surgery, I worked with a lot of of compression hose on venous insufficiency and RLS. trauma patients in life and death situations. Phlebology, on the other hand, is focused on quality of life – not saving lives. I would suggest that phlebologists who want to undertake What is most surprising about the difference in patients’ clinical studies spend the time to research and read heavily to reactions is that trauma patients don’t really seem to say become expert in that area. It’s also important to verify that “thank you” very often -- even when you save their lives. On the research hasn’t already been done, so you aren’t duplicating the other hand, if you cure a patient’s restless legs syndrome a study that has recently been reported. If you are passionate – or have healed a venous leg ulcer -- these patients show a about the subject, you will want to read and research all you lot more gratitude than someone whose life you have saved. can so that you can design a study that will make a difference. This difference in reaction never fails to surprise to me. For me, that area has unquestionably been RLS. Why is this true? Possibly because patients that have For more information about Dr. Hayes, his practice, and RLS, go dealt with their venous disease for so long, they have almost to www.vcnt.com. To learn more about research grants available through the ACP, go to www.phlebology.org/research. resigned themselves to suffering with these conditions for
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Clinical Studies
The ATTRACT Study:
for Patient Enrollment by Suresh Vedantham, MD The ATTRACT (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) Study, which may define the future of DVT treatment, is now OPEN to patient enrollment! This study will determine if new clot-busting treatments for patients with large blood clots of the leg (deep vein thrombosis or DVT) can prevent long-term disability. Despite the use of standard blood-thinning drugs, 25-50% of DVT patients will develop the Post-Thrombotic Syndrome (PTS), a long-term condition that typically causes daily pain, heaviness, fatigue, and swelling of the leg. Because these symptoms are aggravated by standing or walking, affected patients are often forced to alter their daily activities to include periods of rest or leg elevation in order to avoid severe pain and swelling. In the more severe cases, PTS can lead to an inability to walk without pain, inability to hold a steady job or perform household duties, changes in leg skin color and texture, and/or open sores (leg ulcers). As a result, PTS has been shown to significantly reduce quality of life (QOL) in DVT patients. Indeed, PTS has been shown to be the leading determinant of long-term health-related QOL in DVT patients. Preliminary studies suggest that patients who have their blood clots removed using new clot-busting treatments may be less likely to develop PTS. However, because these procedures are somewhat more invasive and costly up front, doctors do not agree on when to use them. The ATTRACT Trial is being performed to answer this important question. Says Dr. Suresh Vedantham, an interventional radiologist from Washington University in St. Louis who is the study’s Principal Investigator, “This study could define a new standard of care for DVT treatment. Since 1960, physicians have focused almost exclusively upon preventing pulmonary embolism in patients with DVT using blood-thinning drugs. Long-term consequences of DVT such as post-thrombotic syndrome have been largely neglected by physicians, but in actuality have a major negative impact upon patients’ lives. If the ATTRACT Trial is positive, it will create a major shift in the paradigm for
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initial DVT treatment by spurring physicians to also remove the clot that has already formed in order to reduce long-term patient disability.” The ATTRACT Trial was built as a truly multidisciplinary endeavor that recruits the skills of leading DVT researchers from interventional radiology, cardiovascular medicine, vascular surgery, pulmonary medicine, hematology, epidemiology, health economics, and biostatistics. The trial’s most senior leadership includes a proceduralist (Dr. Vedantham), a nonproceduralist medical physician (Dr. Samuel Z. Goldhaber, Professor of Medicine at Harvard Medical School), and a clinical trials methodologist with specialized experience with trials of DVT (Dr. Clive Kearon, Professor of Medicine at McMaster University in Hamilton, Ontario (Canada)). Its Clinical Coordinating Center is based at the Mallinckrodt Institute of Radiology at Washington University in St. Louis, and its Data Coordinating Center is based at the renowned Ontario Clinical Oncology Group at McMaster University in Hamilton, Ontario (Canada). Core labs for ultrasound and economic assessment are located at VasCore at the Massachusetts General Hospital in Boston, MA and the St. Luke’s Mid America heart Institute in Kansas City, MO, respectively. The Society of Interventional Radiology (SIR) Foundation played a major role in the trial’s development and continues to collaborate with the investigator team. The SIR Foundation, the American Venous Forum, and the American College of Phlebology have all endorsed the study. The ATTRACT investigator network includes over 250 researchers from a broad variety of disciplines, including the ones noted above.
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On June 28, 2009, the ATTRACT Investigator Meeting was honored by the presence of Dr. James M. Galloway, Assistant U.S. Surgeon General. In his keynote address, Dr. Galloway highlighted the study’s relevance to U.S. public health, telling the attendees that “The Surgeon General is passionate for the ATTRACT Trial to go forward.” The ATTRACT Trial was officially opened to subject accrual on November 16, 2009 and has enrolled 20 patients to date. Of the 60 U.S. Clinical Centers in the ATTRACT research network, 28 are now fully activated and many more will become activated during the next 1-2 months. Investigators who are interested in participating in the study should contact the study team as soon as possible. Physicians who see patients with proximal DVT should contact the ATTRACT study team to determine if their patients can be referred to a local ATTRACT Trial Clinical Center. The ATTRACT Trial is primarily sponsored by the National Heart Lung and Blood Institute, part of the National Institutes of Health, under grants U01-HL088476 and U01-HL088018. Additional support is being provided by BSN Medical (maker of the elastic compression stockings that are being used in study patients), Covidien – Bacchus Vascular (manufacturer of the Trellis Peripheral Infusion System which is being featured in the study), Genentech (manufacturer of the Study Drug Activase® or tissue plasminogen activator), and Medrad Interventional – Possis (manufacturer of the AngioJet device which is also featured in the study). For more information, please visit the ATTRACT Study website at www.attract.wustl.edu. Dr. Suresh Vedantham is a practicing interventional radiologist and an Associate Professor of Radiology & Surgery at the Mallinckrodt Institute of Radiology at the Washington University School of Medicine in St. Louis, MO.
ABPh Announces
2011 Exam Schedule The American Board of Phlebology is pleased to announce the next certification exam will be April 16-23, 2011. Applications are being accepted through February 11, 2011. Certification demonstrates that physicians have met rigorous standards of education, experience, and evaluation. Apply online at www. americanboardofphlebology.org /2011exam/
Upholding the highest standards of knowledge and care through board certification in Phlebology.
Techniques & Technolgy
Thrombophilia Testing:
Who, What, When, How Why
&
by J. Gordon Wright, MD, FACS, RVT
Clotting disorders that result in a tendency to ask ourselves this question: What would we do form thromboses are referred to as thrombophilias. differently based on the test results? Would we These genetic defects and acquired deficiencies recommend a treatment with a lower risk of VT, are known to increase the risk of thrombosis, fetal like graduated compression stockings instead of loss, and gestational complications. The first specific sclerotherapy? Would we modify our treatment inheritable cause to be identified was antithrombin plan using a longer period of post-procedure III (AT3) deficiency, discovered in 1965. It was not compression or peri-procedure heparin? If the until 1992 that the Leiden mutation of Factor answer to all these types of questions is NO, then J. Gordon Wright, MD V (F5L) was discovered in the laboratory and it laboratory testing for thrombophilia makes no was not until 1994 that it was found to be one of the most sense, and neither does asking a series of screening questions. prevalent causes of so-called “idiopathic” thromboses. Many On the other hand, if you feel that you would recommend other causes of thrombophilia, both genetic and acquired, have something like low molecular weight heparin (LMWH) for been discovered since then, and we now know that the two some selected patients considering an EVLT, then you should most common causes of thrombophilia are genetic (F5L and do so on a discriminating and rational basis. the G20210A mutation of prothrombin), and the third most Screening with Laboratory Tests – NO! Indiscriminant common cause of thrombophilia is acquired (antiphospholipid laboratory testing for thrombophilia, even in a vein syndrome). With the explosion of knowledge about the practice, makes no sense. When I talk about “screening number of causes of thrombophilia, the percentage of patients with laboratory tests” I mean ordering blood and genetic who have idiopathic episodes of venous thrombosis has tests for thrombophilia on everyone who comes into the decreased from approximately 85% in 1985 to only about practice, regardless of their personal or family history and 15% currently. With this welcomed explosion of information consideration of other risk factors. has come a somewhat intimidating explosion in the amount In fact, indiscriminant ordering of tests for thrombophilia of information that must be mastered and processed, and is not only wasteful of medical and financial resources, it can the number of tests that can be ordered, without a clear actually harm our patients if misinterpreted or if bad clinical consensus about who should have what test(s) ordered, and decisions are made on the basis of indiscriminant laboratory under what conditions. How should we interpret the results? testing. This is especially true if thrombophilia testing is used What tests (if any) will really make a difference in what I to decide on when to stop Vitamin K anticoagulant (VKA) do? Although I cannot profess to have all of the answers to therapy (e.g. coumarin derivatives) after a DVT or pulmonary these questions, I can share with you my thoughts, opinions embolus (PE). Several studies dating from 2004 have and algorithms regarding testing for thrombophilia from the repeatedly demonstrated that the presence thrombophilia perspective of a full-time phlebologist in a busy practice that has no bearing on the risk of recurrent DVT or PE, so the is currently seeing a little over 1200 new patients per year. results of laboratory testing for thrombophilia have no Will the test results change your treatment plan? A basic principle of clinical practice is that if you are not going to do anything different based on a test, then don’t order the test. I should mention here that there is no evidenced-based medicine that I am aware of to support any of the treatment decisions described here. We are talking more about the art of medicine here, and not so much science, so experts will vary in their opinions on this topic. Still, each of us must
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bearing on the length of time a patient should be subjected to VKA treatment. However, if inappropriate laboratory testing for thrombophilia results in a false-positive diagnosis, and if the physician inappropriately continues the patient on VKA, then the patient is exposed to a risk of hemorrhage for no real benefit. Furthermore, it is important to recognize that because of the low incidence (< 1%) of thrombophilia in the general
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population, and because the false-positive rate for “panels” of thrombophilia tests is about 5%, the expected result of screening 100 patients with laboratory tests is five false positives and only one true positive. Screening with Personal and Family History – YES! Screening by asking smart questions and taking a good personal and family history makes a lot of sense in a vein practice, especially if the physician is recommending treatment. For those patients who are not already anticoagulated with Vitamin K anticoagulant (VKA) therapy (e.g. coumarin derivatives), the practical decision-making here revolves around the decision to order tests for thrombophilia, which would imply that we will be doing something different based on the test results. What are the smart questions to ask? The most comprehensive and established system of predicting the risk of DVT based on screening questions in hospitalized patients, is the system devised by Dr. Joseph Caprini . Because Dr. Caprini’s excellent system was devised to prevent DVTs and PEs in hospitalized patients, it is not directly applicable to an office based environment. Because of this, the “point system” used by Dr. Caprini to weight the various questions
and to guide therapeutic decisions regarding the use of unfractionated heparin, LMWH, or sequential compression devices, cannot be translated into an equivalent point system for an office based phlebology practice. Furthermore, to quote from in Dr. Caprini’s system, “No orders for venous thromboembolic prophylaxis required” is an option, even for patients at highest risk (those with a total risk factor score of 5 or more). Even with the above caveats as to why Dr. Caprini’s system is not directly applicable to an office based phlebology practice, it does provide a useful starting point for asking smart questions to our patients who are considering any vein treatment that increases their risk of VT. Figure 1 illustrates my own view of how Dr. Caprini’s list of screening questions could be modified for use in an office based phlebology practice. In this modified system, I have eliminated those situations that are not seen in an office setting (like acute myocardial infarction, spinal cord injury, etc) and I have added a few items that are not on Dr. Caprini’s original list, but I feel are useful in the phlebology environment. In Figure 1, I have indicated my own modifications or additions by italicizing them.
Figure 1 – A Modification of Caprini’s Risk Assessment Scoring System for deciding on when to order tests for Thrombophilia in patients considering vein treatment (not including ST for spiders).
Factor = 100 (Always order tests) History of idiopathic DVT or PE Three or more episodes of idiopathic SVT One episode of VT following vein treatment Idiopathic VT in a patient aged <25 years. Idiopathic PE in a patient aged <50 years. History of Acquired thrombophilia Initial presentation is an active STP or DVT. SVT or DVT during Rx with more Rx planned Factor = 3 points Age >75 years Family history of idiopathic VT, DVT or PE Factor = 2 points Age 60–74 years History of Malignancy One or two episodes of idiopathic SVT Odd Location (eg Jugular Vein) of idiopathic VT For patients with a personal or family history of DVT, PE, or VT, I believe we should distinguish between a history of an idiopathic event and a history of an easily explainable or expected event. Consider the fully recovered patient who has a history of a DVT following reconstructive knee surgery that was performed following a major car crash with some brain injury while she was pregnant, on birth control pills and in a coma! In this patient, if none of those risk factors are present anymore, then I would not consider her to be at high risk for VT and I would give her 1 point in the modified Caprini Score, not 3 points.
Factor = 1 point Age 41–60 years Minor surgery planned (not ST for spider veins) Varicose veins or axial reflux History of inflammatory bowel disease Swollen legs (current) Obesity (body mass index >25) Serious lung disease Abnormal pulmonary function Easily explainable SVT, DVT or PE Factor = 1 point (women only) Current use of oral contraceptives Current hormone replacement therapy Unexplained stillbirth or abortion Premature birth with toxemia Factor = Negative 1000 (Never order tests) On lifelong VKA (eg prosthetic aortic valve) Active Visceral Malignancy I believe it is also reasonable to order a panel of thrombophilia tests regardless of the patient’s Caprini Score, for those patients who have a history of an idiopathic DVT or PE, or multiple (>=3) episodes of idiopathic SVT and are considering venous interventions like sclerotherapy for varicose veins, phlebectomy, or endovenous ablation. Also, I order thrombophilia tests on any patient who has a history of a DVT or PE, or a significant SVT, as a complication of venous treatment. By significant SVT I mean something unexpected and problematic. In a real sense, 100% of our patients who have treatment get at least some SVT. For 95% of our patients,
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it is sub-clinical and insignificant. I am speaking here of the patient with an obvious, iatrogenic SVT that is problematic and requires attention. Finally, if the patient’s initial presentation to my office is an SVT or a DVT, I routinely order tests for thrombophilia unless the patient is on lifelong VKA or has well documented genetic thrombophilia.
4) When a patient who I have treated has an episode of non-trivial STP as a complication of treatment and is considering additional treatment. 5) In a patient who has at least one other risk factor and an anatomic situation that I consider to be at high risk for developing STP as a complication of treatment. For example, a cluster of varicose veins that communicate with a refluxing GSV in the proximal thigh and has a distal connection with the refluxing GSV in the distal thigh, and I am intending on ablating the entire length of the refluxing GSV, but leaving the cluster of varicose veins untreated, thereby creating what appears to be a “blind loop” of varicose tributaries in the thigh. 6) If none of the above pertains, but the Modified Caprini Score is 5 or higher, then I order thrombophilia testing.
Personally, I find this system of scoring to be daunting and a little more burdensome than I am likely to use. An electronic medical record may provide decision support for a Modified Caprini System, to avoid overlooking the patient with seemingly innocuous clinical clues. If I had a paper-based documentation system, I am sure I would use a paper form for the same purpose
One of the most important things to understand about the timing of thrombophilia tests is when to NOT order the tests.
When to NOT order the tests? One of the most important things to understand about the timing of thrombophilia tests is when to NOT order the tests. Tests for AT3, PC and PS deficiencies should NOT be ordered following an acute thrombotic event (within 3 weeks) because of possible “consumption” of these factors, leading to falselow values. Furthermore, PC and PS tests should NOT be ordered on patients who are on VKA, and AT3 should not be ordered on patients who are on heparin, again, because false-low values can be obtained. Tests for Activated Protein C Resistance (APCR) and Lupus Anticoagulant (LA) can be either falsely elevated or depressed in patients receiving either VKA or Heparin. Repeat testing of a genetic cause of thrombophilia makes no sense unless the previous test results are strongly contradictory to the current clinical picture. When to order the tests? Unless the patient has had a thrombotic event in the last three weeks or is on VKA, the tests can be ordered at any time as long as they are indicated. The hard question is “When are they indicated?” Again, recognizing that we are sailing in unchartered waters with no evidenced based medicine, I can only offer you my unsubstantiated opinions, which are hopefully reasonable and rational. I believe that thrombophilia testing is indicated before initiating or continuing any further treatment in the following situations: 1) When patients present to me for their initial evaluation as a result of an episode of non-trivial STP. 2) When patients present with a history of three or more episodes of non-trivial, idiopathic STP, or one episode of an idiopathic DVT or PE. 3) When patients present with a family history of recurrent episodes of non-trivial idiopathic STP or DVT plus at least one clear cut personal history of a non-trivial idiopathic STP.
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Although my method for deciding who should be tested for thrombophilia is based on a combination of the best published literature I can find and my own clinical experience, there are no Grade-1A recommendations for who should be tested in the office setting. All of the guidelines are designed for either for hospitalized patients, pregnant patients, or population based studies. In fact, the most commonly cited reference on the diagnosis and prophylaxis of DVT and PE is totally silent on the subject of the fully ambulatory, office-based patient . In the current state-of-the-art, there are no clear guidelines on who should be tested in a phlebology practice, so a commonsense approach has to be implemented instead of a pristine, crystal-clear evidenced based approach. As stated earlier, I cannot profess to know all the answers on this subject as there remains a great deal of uncertainty in the medical literature on this topic. It is clear that random “true screening” can actually cause more harm than good, yet I feel that in certain selected situations, thrombophilia testing makes sense from the perspective of a full-time office based phlebologist. I hope some of you have found some of this advice practical and useful. REFERENCES Kamphuisen PW, Rosendaal FR. Thrombophilia screening: a matter of debate. Neth J Med 2004;62(6):180-187. Favaloro EJ, McDonald D, & Lippi G. Laboratory Investigation of Thrombophilia: The Good, the Bad, and the Ugly. Semin Thromb Hemost 2009;35:695-710. Bahl V, Hu HM, Henke PK, Wakefield TW, Campbell DA Jr, Caprini JA. A validation study of a retrospective venous thromboembolism risk scoring method. Ann Surg. 2010 Feb;251(2):344-50. Hirsh J; Guyatt G; Albers GW; Harrington R, et al. Antithrombotic and thrombolytic therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun; 133(6). Dr. Wright practices Phlebology full time and is the founder of the Midwest Vein Center which has three offices in the Chicagoland area. Dr. Wright is also the Clinical Director of Vein Technology Solutions and the co-inventor of the company’s electronic medical record, Vein-Draw.™
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Technology Briefs
Venowave A Long Awaited Leap to Improve the Management of CVI and Reduce the Risk of DVT
By Ethan Light, M.D. The Venowave, a new venous-return assist device that consists of a small peristaltic pump attached around the calf and may be worn when ambulant, has recently been launched globally and specifically addresses the issues underlying compliance concerns with intermittent pneumatic compression devices and elastic compression. It also addresses the significant need for an effective, easy to use and safe method to prevent deep vein thrombosis (DVT). The Venowave, developed by inventor and entrepreneur John Saringer in collaboration with Dr. Jack Hirsh, and McMaster University, is a battery-operated mobile and ultra lightweight peristaltic pump that is discreetly strapped to the patient’s calf applying upward pressure in a repetitive wave motion thereby increasing venous return and velocity. Both comfortable and clearly effective, the Venowave allows for an active lifestyle while delivering impressive clinical efficacy across a range of applications.The benefits of Venowave use can be considerable. Patients who have used the device as instructed by their physician have reported significant improvement of symptoms and overall quality of life. CLINICAL DATA The Venowave was evaluated in a randomized clinical trial entitled VENOPTS, designed to assess its effectiveness in treating severe post-thrombotic syndrome. Severe postthrombotic syndrome (PTS) is responsible for considerable disability, reduced quality of life and increased health care costs. Current therapies are limited and often ineffective. A two-centre, randomized, cross-over controlled trial to evaluate Venowave, a novel lower-limb venous-return assist device, for the treatment of severe PTS was performed. Eligible subjects were allocated to receive, in randomized order,Venowave for eight weeks and control device for eight weeks. The eight-week treatment periods were separated by a four-wheel period when the device was used (i.e. washout period). The primary outcome measure was a ‘clinical success’ defined as: i) reported benefit from the device; and ii) moderate or greater improvement in symptoms of PTS; and iii) willingness to continue using the device. Secondary outcome measures included quality of life (QOL) as measured by VEINES-QOL questionnaire (higher scores indicate better QOL), and PTS severity as measured by the Villalta PTS scale
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(higher scores indicate more severe PTS). The study was registered with ClinicalTrials.gov (NCT00182208). Thirty-two patients were enrolled. Of these, 26 (80%) were also using graduated compression stockings. Twenty-six participants completed both trial periods. Clinical success occurred in 10 (31%) participants receiving Venowave and four (13%) participants receiving the control device, with two (6%) participants reporting a clinical success with both devices (P=0.11). Mean VEINES-QOL score at the end of study period was significantly greater (P=0.004) for Venowave (52.5;SD 5.8) compared to control (50.2;SD 6.2). Mean Villalta scale score at the end of study period was significantly decreased (P=0.004) for Venowave (12.2;SD 6.3) compared to control (15.0;SD 6.1). In conclusion, Venowave appears to be a very promising new therapy for patients with severe PTS, which may be used alone or in combination with graduated compression stockings (1). The application of mechanic compression devices to treat PTS is not entirely new, but the earlier devices were large, and therefore not very practical nor usable in a continuous ambulant state. The Venowave does not possess these disadvantages. INDICATIONS The Venowave has been cleared by the FDA, Health Canada, TGA in Australia and it has received the CE mark to treat CVI, lymphedema, leg swelling due to vascular insufficiency, varicose veins and intermittent claudication. In addition, the device has been approved to aid in the prevention of deep vein thrombosis (DVT) and, primary thrombosis, as well as managing the symptoms of postthrombotic syndrome (PTS), diminishing post-operative pain, swelling, and enhancing blood circulation. 1. O’Donnell M, McRae S, Kahn SR, et al. Evaluation of venousreturn assist device to treat severe post-thrombotic syndrome (VENOPTS): A randomized controlled trial. Thromb Heamost 2008;99:623-629. 2. Kahn SR, Ducruet T, Lamping DL, et al. Prospective evaluation of health-related quality of life in patients with deep venous thrombosis. Arch Intern Med 2005;165:1173-1178 3. Olin JW, Beusterien KM, Childs MB, et al. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med 1999;4:1-7
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Practice Management
FEDERAL TRADE COMMISSION ANNOUNCES NEW GUIDES CONCERNING THE USE OF
Endorsements and by Jeffrey Segal, M.D. J.D. and Michael J. Sacopulos J.D.
The Federal Trade Commission on October 5, 2009 released “Guides Concerning the Use of Endorsements and Testimonials in Advertising.” This is the first update the FTC has made on this topic in approximately thirty years. Much of the new Guides address social media. The Federal Trade Commission works to prevent fraudulent, deceptive, and unfair business practices. The Commission does this in large part by bringing legal actions under the FTC Act. Although the most recent Guides concerning the use of endorsements and testimonials are not specifically directed towards the healthcare industry, they are certainly applicable to healthcare advertisers. In the recent past, the Commission has taken an interest in such healthcare fields as weight loss. With an increased number of healthcare practices and hospitals embracing an Internet presence, the FTC Guides Concerning the Use of Endorsement and Testimonials in Advertising may have broader ramifications in the healthcare industry than might be suspected. Medical Justice’s General Counsel, Michael Sacopulos, recently sat down to speak with FTC Assistant Director of Bureau of Consumer Protection, Rich Cleland, to discuss the impact of the new Guides on the medical community. Below follows a portion of the conversation between Michael Sacopulos (Medical Justice-MJ) and Rich Cleland (Federal Trade Commission-FTC). MJ: The FTC recently published final Guides governing the use of endorsements and testimonials in advertisements. How, if at all, do you foresee these changes will impact medical providers? FTC: Medical providers in terms of their promotions are subject to the FTC Act. Therefore, all of the Guidelines could theoretically apply to promotions advanced by medical providers. MJ: The Guides used to allow for a disclaimer of “results not typical.” The revised Guides no longer contain this safe harbor. How should health care providers that 4 2
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perform aesthetic procedures, for example, and advertise via testimonials and photographic results adjust to the revised Guides?
FTC: One of the things that is going to be different has to do with the impression left from the ad regarding the typical experience or results. Not only is it advisable to indicate that results may vary, I would go beyond that and try to identify factors that may account for the variability of results. Ultimately, it all depends on the wording and layout of the advertisement. MJ: Just to be clear, does the Commission consider a photograph an endorsement? FTC: Depending on its use, a photograph could be well be considered an endorsement, even if it is not accompanied by text. MJ: There are a variety of Internet sites that “rate” physicians. Some provide critiques of many industries such as Angie’s List and Yelp.com, where as others are industry specific to the medical field such as DrScore.com and RateMDs.com. Because of the anonymity of bloggers on this site, there is a general fear in the medical community that the sites are being manipulated either positively or negatively. Is this generally a concern for the Federal Trade Commission? If so, can you generally describe the Federal Trade Commission’s approach to this situation? FTC: There are two issues here. If a physician goes onto a rating site and posts a glowing review of his or her services and does not disclose his or her identity, that would be a violation of the FTC Act. Secondly, negative comments about an individual would not be considered an “endorsement.” However, should the negative comments be posted by an ex-spouse or former employee posing a patient, this would be considered deceptive. Deceptive comments in this forum would also be considered a violation of the FTC Act even though this is not specifically addressed in the recent Guides.
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Testimonials i n Adv ertising MJ: Does the Federal Trade Commission have legal authority to determine the identity of anonymous bloggers? FTC: If the anonymous blogger in question is relevant to an ongoing investigation of the FTC, the FTC has the legal authority to determine the identity of the blogger. MJ: The revised Guides provide additional information on what the Commission considers a “material connection.” More specifically, a “material connection” is a relationship between an advertiser and endorser which a third party consumer would not expect. If a physician reduces his or her standard fee for a procedure for a specific patient, would that fee reduction be considered a “material connection” between the physician that patient? FTC: The answer is yes. However, it may be helpful for me to give you a factual situation where I don’t think a disclosure would be required. Let’s say I went into a doctor’s office and I don’t have insurance, the physician goes ahead and treats me and decides that since I don’t have insurance, the physician will cut the [fee in] half. I’m so elated that I go on Craig’s List and post a comment on how wonderful the doctor is. This is not the kind of endorsement that would be covered under the Guides. If, on the other hand, the physician tells me that he will take $500.00 off of the charges if I will appear in an advertisement for his practice, this is clearly an endorsement that would be covered under the Guides. I am getting something in exchange for the price reduction. MJ: Are there any other areas of concern for the Federal Trade Commission when dealing with individual medical practitioners? If so, could you please share those?
of before and after pictures on cosmetic surgery may become of interest. The idea of manipulating things or doing something at the core, would be prohibited by Section 5 of the Guides. For example, digital alteration of before and after photographs would be a violation of the FTC Act. Given the recent revisions in endorsements and testimonials concerning advertisements, medical providers would be well advised to review their websites to verify compliance. Any endorsements by individuals who have received compensation now require a disclosure. Further, before and after photographs should be accompanied with a disclaimer noting that results vary from patient to patient and should list several factors accounting for variability of results. Finally, if a medical provider believes that he or she is a victim of malicious and false blogging, the FTC may provide assistance. Should you have additional questions and concerns about the new FTC Guides, you should contact counsel. Jeff Segal, MD, JD, FACS is founder and CEO of Medical Justice, a membership based organization that offers patented services to protect physicians from frivolus lawsuits, demands for refunds and internet defamation. Michael J. Sacopulos, JD is General Counsel for Medical Justice For more information, go to www.medicaljustice.com
FTC: I don’t think that there are any specific areas of concern for the FTC at the moment. However, the issue
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Education
SCUBA, MAUD, and the Manhattan Project:
Acronyms and Education by Steve Elias, MD, FACS, FACPh
SEPS ESCHAR RECOVERY EVOLVeS PETRAC PAPS TRLOP EVA EHITVUMIT EVLT AVF HHD CINAHL DUMSAD IVUS NIVL REVAS LDSM
Nineteen hundred and thirty-eight. Divers diving and dying.Too much oxygen in their blood.We need a new device.We need a new program. We need a smart inventor. We need a problem solved. Most of us know that Jacques Cousteau invented scuba diving. Some of Steve Elias, M.D. us may also know what the acronym SCUBA stands for. Some of us involved with vein treatment may even know what LASER stands for. Jacques Cousteau did not invent scuba gear and Jacques Cousteau did not coin the acronym SCUBA. Christian Lambert invented scuba gear in 1939 under the auspices of the U.S. military’s Self Contained Underwater Breathing Apparatus program specifically set up to solve the diving problem. The program was “somewhat successful” according to official documents but divers were still dying. Personally, I wouldn’t call these results “somewhat successful.” Perhaps “somewhat lethal” is a better description. Luckily Jacques Cousteau does come to the rescue. In 1943, he and Emile Gagnan developed the Aqualung which had a demand regulator that eliminated oxygen toxicity. These two men are considered the fathers of modern scuba diving,
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though they did not invent scuba diving nor did they invent the acronym SCUBA. In this issue, the Education column addresses some acronyms and abbreviations in venous disease that may be confusing, misleading or right on target. The use of many of these is helpful in day-to-day management of patients. However, at times the original intent or original concept is lost, especially by practitioners new to venous disease and venous education. Let’s start out with some recent examples: The VEIN Project and The VEINES Study. Is the first one just involved with creating one vein? If so, the VEINES project must have as its goal making many veins. Seriously, the VEIN project is an acronym for the VEnous INtervention project. This was presented as a supplement in Phlebology in 2009. The stated goal is “to define how services should be provided for patients with symptomatic, uncomplicated varicose veins and the way the interventions should be delivered.” The VEINES Project means something different despite only two additional letters in the acronym; VEnous INsufficiency Epidemiologic and Economic Study. This was an international cohort study regarding chronic venous disorders.
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Do these acronyms really help us remember the intent of these studies? It certainly is quicker to pronounce the acronyms than to recite their full name. And by the way, for VEINES, do we pronounce this as “veins” or should we say “venous”? Of course, once you have projects, next come the trials. There are a lot of trials. A lot of them have really clever acronyms. Sometimes the intent of the trial is lost in the acronym and sometimes not. Even if we never read the results of the Dutch SEPS Trial (which are worthwhile reading), most of us, including newly educated venous specialists, would have some idea what the Dutch Trial was about. The ESCHAR Trial is an example of an often referenced trial, the true “name” of which I am sure many people can’t recite. The original article in the British Medical Journal in 2007 is entitled, “Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomized controlled trial.” Although a very good trial addressing ulcer recurrence, the ESCHAR trial acronym is about as informative as the State vs. John Scopes (The Monkey Trial). Why would they put a monkey named Scopes on trial?
The EVOLVeS Study: Prospective Randomized Study of Endovenous Radiofrequency Obliteration Versus Ligation and Stripping, published in 2003, also studied an important issue. The results of the study were somewhat intuitive to those of us utilizing radiofrequency therapy but many times good trials are done to quantify and document perceived ideas. Not a bad acronym. Is the implication that vein care evolves from an educated viewpoint? It does give us a sense of trial intent even through it incorporates upper and lower case letters. Now we come to the PErforator TReatment ACronym better known as PETRAC. The oldest is the SEPS (Subfascial Endoscopic Perforator Surgery) procedure. I find that as we poll vascular and interventional radiology fellows about SEPS during the Fellows Course in Venous Disease, they have rarely heard of this technique. The acronym describing the use of radiofrequency to treat perforators is TRLOP or TRansLuminal Occlusion of Perforators.The all encompassing acronym PAPS (which is a play on the acronym SEPS) or Percutanous Ablation of PerforatorS describes any method used percutaneously to ablate incompetent perforators including TRLOP (i.e., laser, radiofrequency, liquid, foam, or anything else that may come along.). From an educational intent, these acronyms adequately describe the procedure being performed. For such a small vessel (perforator), there are a lot of acronyms. Perforators seem to be very popular with the acronym crowd.
SEPS ESCHAR RECOVERY EVOLVeS PETRAC PAPS TRLOP EVA EHIT VUMIT EVLT AVF HHD CINAHL DUMSAD IVUS NIVL REVAS LDSM
Two very important and well done trials are the RECOVERY Trial and the EVOLVeS Trial. Personally, I feel it is a bit of a stretch when creating an acronym that has lower case letters mixed with bold upper case letters. Come on, be a little more creative. Keep it all upper case or all lower case.
The RECOVERY trial, published in 2009 under the full title, Radiofrequency Endovenous ClosureFAST versus Laser Ablation for The Treatment of Great Saphenous Reflux (RECOVERY) addressed an important aspect of saphenous venous incompetence treatment and its results should be understood by phlebologists - especially those phlebologists interested in comparing RF and Laser procedure pain and discomfort, which were the trial’s intent (RECOVERY). I am not sure it is a true acronym but it appears to be as it’s all in capital letters and it does give us an idea as to what was studied during the trial.
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Next there are the acronyms describing whatever it is that some of us observe at the SFJ (saphenofemoral junction) or the SPJ (saphenopopliteal junction) after EVA (endovenous ablation). It is that “thing” observed by ultrasound that none of us want to call “clot”. It has been called EHIT (Endovenous Heat Induced Thrombus), VUMIT (Vascular Ultrasound Incidental Minor Thrombus). USHIT (Ultrasound Seen Heat Induced Thrombus).You would think an entity with so many acronyms must be clinically worrisome and needs immediate treatment but nowadays we rarely do anything about it. Maybe the acronym should really be IGNORE or SOWHAT? From an educational aspect, these are somewhat descriptive and certainly entertaining. Then we have a lot of abbreviations that relate to things we do to incompetent saphenous veins. I list them in no particular order and for completeness only: EVA,VNUS, RFA,
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EVLT Closure, VariSolve, ClariVein etc. More to come for sure. Many of these are duplicates and interchangeable. Finally let us pursue some things from the “official” list of abbreviations of the “Handbook of Venous Disorders” ed. Gloviczki in conjunction with the American Venous Forum (AVF). Some of my favorites are: HHD, CINAHL and DUMSAD. HHD of course is Hand Held Doppler. HHD is different from FHD (Foot Held Doppler) or MHD (Mouth Held Doppler) I won’t even mention the infamous PHD. I leave that one to your imagination. Where else do we hold a Doppler but in our hand? CINAHL is a much quoted abbreviation that anyone involved with venous education should quickly recognize. CINAHL according to the Handbook of Venous Disease is the often quoted “Cumulated Index to Nursing and Allied Health Literature. Finally, there is DUMSAD or Duplex Ultrasound in a Multicenter Study of Acute Deep Venous Thrombosis.” The abbreviation omits the “V” and “T” at the end, and of course, this abbreviation is pronounced: “dumb sad.” I am sure it is not a comment about the study or its authors. Some newer and important abbreviations among others in the handbook are IVUS, NIVL, and REVAS. These are abbreviations of important issues in Phlebology and venous education. They should be around and applied for a long time. When thinking about how to remain obscure, acronyms or abbreviations can help. The original name of The Manhattan Project was LDSM (Laboratory for the Development of Substitute Materials). The government thought this might stir up some suspicions so they called it the Manhattan Project. Manhattan was the perfect place in those days to figure out how to make an atom bomb. This goal makes minimally invasive vein treatment and venous education seem so unimportant. In those days, Manhattan was teeming with disgruntled European scientists who could not wait to put their efforts together for the good of mankind and develop a really good atom bomb. Also, Columbia University was a center for early nuclear re-
search. The U.S. worked in conjunction with Britain’s MAUD (Military Application of Uranium Detonation). If the Germans or Japanese knew what MAUD was an acronym for, U.S./British secrecy would have been lost. Ultimately bombs were made in various shapes and sizes with various names: Fat Man, Thin Man, Little Boy, etc. I am glad that those of us in Phlebology have not given such code names to any devices, techniques or Phlebologists (at least not openly). Finally, you will soon be hearing about a new educational meeting: ELIAS (Endovenous Lessons Intervention And Surgery). It is also sometimes known as Everyone Likes Insignificant AcronymS (about themselves).
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Practice Management
The Blue Prints to
Radio Spot Architecture by Lyndsay Ballengee
Today’s practices have become more than healthcare centers, they have also become revenue generating businesses. A radio advertisement, also known as a radio “spot”, is a great way to reach target demographic groups for a practice to gain business and revenue. While many office managers recognize the importance of effective radio advertising, few know where to begin. How do you craft a message that effectively entices the audience to pick up the phone and schedule an appointment? First, start with the foundation. Determine your patient demographic and find a radio station that best matches your desired target audience. Radio today is inundated with commercials selling everything from jewelry and diet aids to health services. It is imperative to choose a radio station based on their core demographic to ensure your message is being heard by the appropriate people. For example, you should not run a commercial for your practice on the local sports talk radio station if you wish to target female decision makers.
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Secondly, construct an advertising framework by determining your budget and, consequently, your radio spot length. Radio stations sell standard spot lengths of 15, 30 and 60 seconds. Your budget will determine the length and quantity your practice can purchase. The “prime time” spots are drive times, when most people are commuting to and from work. Prime time spots come with premium price tags because they have the largest listening base. Be precise when writing your commercial; radio stations run on strict timetables and can be fined for deviating from schedule. A radio spot script should be written in 12-point font with double line spacing so it can be read easily by the voice talent. Write about 4 lines for 15 seconds, 8 lines for 30 seconds and approximately 15 lines for a 60 second spot. Remember that you will have to read the commercial out loud to time it correctly. Now that you have the framework for your spot, you can start writing.
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“What are you selling? What sets your clinic apart from the rest? How do people contact you?” Decide what the key points of your message will be, while understanding the amount of copy you are writing. What are you selling? What sets your clinic apart from the rest? How do people contact you? The K-I-S-S rule applies to any form of advertising, but especially to radio advertising. Keep your message clear and to the point.Your message isn’t meant to close the deal, it is meant to get the phone ringing or to fill up the email box. Begin with a strong opening. Your opening line will determine whether the listener continues to listen, changes the station or simply tunes out.You may have heard, “Are you ready to propose to your girlfriend?”, “Are you tired of being overweight?” or “Are you paying too much for car insurance?” These commercials compel the listener to want to learn more. Most important in the structure of an ad is your name and contact information.
“Convey your message to your target audience in a clear, concise way…”
You have very limited time to tell the listener who you are, what you do, why they should contact you and how to do so. Say your practice’s name a minimum of two times. In a 60 second spot, try to work your practice name in four times. Be sure to give your contact information clearly, preferably twice, because your listeners may be driving or working and won’t be able to write down your information. We are in the era of the “informational highway”. Listeners will expect to hear more than just phone number. Provide both your phone number and a web address, and remember to give them twice to maximize audience retention. Convey your message to your target audience in a clear, concise way and your radio commercials will generate responses and lead to more revenue for your business. Effective radio spot campaigns don’t have to be painful, lacking response and leaving you feeling that your money was wasted. Use these blue prints to construct an effective message and your practice will reap the benefits. Lyndsay Ballengee, Marketing Communications Manager for BioMedix Vascular Solutions, Inc. is a seasoned marketing professional with previous experience in the medical aesthetic industry. She can be reached at lballengee@biomedix.com
www . vein D I R E C T O R Y . O R G
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Speaking Out
Educating
One Provider and One Patient at aTime
by Marlin Schul, MD, MBA, FACPh, RVT superficial thrombophlebitis with antibiotics and trivialize patient symptoms when presenting with bulbous varices and dire requests for advice on what they should do. As there is generally no established curriculum in residencies, medical schools, nursing schools, or other allied specialties, there are plenty of opportunities to enhance awareness of phlebology and in particular, stasis ulcers and thrombotic phenomena. Despite the abundance in educational objectives, hurdles often exist, impeding access to impressionable students and faculty interested expanding their knowledge base.
Educating medical providers regarding two epidemic topics is not easy. The education gap between vein providers and the lay public and medical professionals offers a teaching endeavor that we must pursue to enhance venous health in addition to building awareness of phlebology. Prospects for educating medical providers about venous disease are seemingly endless. Societies are in the beginning phases of incorporating phlebology science and catheter based procedures into formal curricula, while no formal exposure is often the rule in medical schools. Unfortunately, many medical students may get their only exposure to vein disease through the unfortunate VTE complications that occur on clinical rotations. Vein disease is commonly trivialized throughout our nation and abroad as being purely a cosmetic problem. The lack of formal exposure in medical school to venous disease and complications of venous stasis lead many physicians to treat
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Why fight and what is a worthy audience? Letâ&#x20AC;&#x2122;s face it, phlebology is a new specialty, yet stasis ulcers and deep vein thrombosis occur now as they have in the days of Hippocrates. The education gap is acknowledged by nearly every society dedicated to Phlebology. Despite these well established facts, we continue to see medical students, nursing students, residents, and fellows graduate from high quality programs void in knowledge in venous disease. The reason to educate the medical communities and the lay public is simple: to enhance the awareness of common vein problems and preventable complications, while promoting venous health. DVT Prevention/Awareness In 2005, the United States Senate passed a resolution declaring the month of March as National DVT Awareness month. The Joint Commissions and the National Quality Forum have been working closely since that same time to develop measures to reduce the incidence of deep vein thrombosis in the hospital setting where it is the third leading killer. Six VTE measures have been created and tested since 2005, and have been aligned with the Centers for Medicare & Medicaid Services (CMS). The VTE measure set is available as a core measure selection by hospitals, and may be used to meet their accreditation requirements. In an effort to
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curb reimbursement for complications related to VTE after total hip or knee surgeries, CMS has created “never events” suggesting that the complication of VTE is NEVER supposed to happen when proper prevention of VTE is considered and implemented in these select orthopedic cases.
• Inform local primary care providers and referring sources about the importance of VTE risk assessment through problem focused newsletters, and educational hospital functions such as grand rounds, lunch-n-learns, etc.
Awareness of the epidemic of VTE is apparent to the governmental bodies; is it also apparent to local hospitals? Do the local hospitals screen all admissions for risk of VTE? Is there a protocol in place to trigger VTE prophylaxis consistent with the 2008 American College of Chest Physicians recommendations? To further the relative importance of DVT prevention, do the local hospitals screen all admissions for VTE risk in your area?
• Participate in electronic forums, including Facebook, Twitter, industry sponsored blogs, CME webinars, and remote telemedicine round-table discussions.
Venous thromboembolic events are fortunate in their ability to be prevented and unfortunate in their life and limb threatening consequences. There needs to be no horse in the race to build awareness of VTE in the hospital setting and opportunities to perform better by proactively reducing the risk of VTE with proper screening and appropriate prophylaxis. Promoting Venous Health Leg ulcers are still poorly misunderstood. A retiring vascular surgeon at the UIP in Monaco proposed skin grafting as a first line treatment. We can argue about the ESCHAR trial and comprehensive control of reflux, but does this statement not expose the clear disconnect between those who understand venous disease and those who do not? The same concern may be applied to the wound centers who fail to recognize the influence of superficial venous insufficiency on stasis ulcers. Promoting venous health involves an array of issues to include recognizing occupational risks, and the prevalence of venous insufficiency in society. Given the abundance of venous pathology and the epidemic of stasis ulcers, one can share the protective benefit of compression therapy and the wide indications for use. Case presentations of superficial thrombophlebitis could be openly discussed identifying the current standard of care that fails to identify the utility of antibiotic therapy. What educational opportunities do we have? The educational opportunities are abundant, and include many of the following: • Establishing multidisciplinary teams dedicated to reducing the risk of VTE at local hospitals. • Participation in established Venous Screening Programs resembling that found with the American Venous Forum.
• Solicit local medical schools for opportunities to educate impressionable medical students, nursing students, and residents. • Provide timely updates in venous care through the routine communications within a community of physicians. • Offer clinical rotations for nursing students, nurse practitioners, physician assistants, medical students, and residents. • Change ad campaigns to reflect a medical message. Prospective patients will notice. The audience is public and the message is real. We have thrombotic phenomena occurring in epidemic proportions and a growing population afflicted with stasis ulcers. Every practicing and retired physician can become involved; the question lies in how involved the phlebologist wishes to do so. Participating in VTE awareness/risk assessment and stasis ulcers serves a noble purpose: the principles to enhance awareness of while minimizing complications from preventable VTE, and incidence of stasis ulcers. Grass roots efforts have power, and makes any and every effort put forth – one patient and one physician at a time – worthwhile. Every provider has an opportunity to participate, and arguably a duty given the largely misunderstood practice we have chosen. Working together with industry to bridge the education gap will bring a broadened understanding to venous health and the prevention of deep vein thrombosis. I urge you to get involved in your practice, your local hospitals, your communities, and identify means to enhance knowledge of these common problems with your patient population and your physician network. Working together within a community and across societies will help us achieve the common goal of optimizing venous health in our populations.
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News and New Products
N +New Products w s Billing & Collections Service Introduced by Acentec, Inc.; Expands with FL Office March 9, 2010 - Acentec, Inc., (www. Acentec.com), the leader in providing EMR and practice management software and related services, announces its new Billing & Collection Service to medical doctors and practices nationwide. With the introduction of this new service, Acentec has opened a Sarasota, FL office with a focus on medical practice billing and collections. As a value-added reseller, trainer and user of Medinformatix practice management software, Acentec has the in-house expertise to track, bill, collect and report on medical claims and accounts receivables in real time. In today’s economy, there is nothing more important from a business standpoint than accurately and timely submitting, monitoring and aggressively collecting medical claims. This is true for every medical practice and the expertise needed to perform this service is paramount. Acentec’s Billing & Collection Service provides the needed industry expertise along with automatic charge capture, bundling of charges for common procedures, a review and updating of claims prior to submission, the most technologically advanced tools for timely collections, real time A/R reporting and more. Jeff Mongelli, CEO of Acentec states, “We have a combination of the unique expertise and technology needed to provide a comprehensive billing and collection service to medical doctors and practices. Cash flow is a real issue for most businesses today, and we have the staff and expertise to streamline, maximize and accelerate your collections process. Contact us Acentec, Inc. today at (800) 970-0402, by email at info@Acentec.com, or visit us at www.Acentec.com for more information. The American Board of Phlebology Announces Exam Dates for 2011 Reston,VA, April 7, 2010 – The American Board of Phlebology will open their fourth phlebology exam cycle beginning in the fall of 2010. Applications will be processed starting October, 2010, and all are to be submitted online at http://www.abph.net/ application/default.asp. Prior to this date, applications will be accepted but will not be reviewed or processed until the start of the application review period. The application submission deadline is February 11, 2011. The computer-based exam will be given electronically between April 16 and April 23, 2011. Those who successfully pass the exam next April will be recognized as official ABPh Diplomates, 5 2
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and will join a group of nearly 500 candidates who have already achieved this status during the first three exam cycles. To become an ABPh Diplomate, an applicant must complete the requisite training or experience qualifications, meet the continuing medical education requisites, and pass a stringent certification examination. Certification periods are ten years and maintenance is dependent upon the ability of the Diplomate to display competency in four areas of assessment: evidence of professional standing, evidence of commitment to lifelonglearning and periodic self-assessment, evidence of cognitive expertise, and evaluation of performance in practice. BioMedix Vascular Solutions, Inc. Joins the California P.A.D. Task Force Committee St. Paul, MN, February 4, 2010 — BioMedix Vascular Solutions, Inc. announced that John Romans, CEO and Meg Heim, RN, Vice President of Marketing were invited to participate as members of the P.A.D.Task Force Committee on behalf of the Governor of California, Arnold Schwarzenegger, The California Podiatric Medical Association and the California Department of Chronic Disease and Injury Prevention (CDPH). The committee will meet on February 4th, 2010 in the California State Capitol, Governors conference room. The meeting was led by Dr. Michael R. Jaff, P.A.D. Task Force Chairman and Moderator, Associate Professor of Medicine, Harvard Medical School, Medical Director, Vascular Center, Massachusetts General Hospital, Boston, Massachusetts and comprised of 15 respected medical scholars. The goal of the Committee was to outline a path of preventative wellness including a collaborative care approach that will support the early identification and treatment of P.A.D., leading to decreased cost and better outcomes for the people of California. Additionally, a Committee goal is to generate a position paper centered on recommendation guidelines for statewide initiation of P.A.D. awareness and surveillance of at risk patients to be published in the next year. About BioMedix BioMedix Vascular Solutions, Inc. provides an integrated suite of hardware, software and online services designed to cost-effectively detect Peripheral Arterial Disease (P.A.D.) and Chronic Venous Insufficiency (CVI). Vascular specialists, primary care providers, hospitals and health systems use our products to identify these patients. Our devices and software reduce mistakes, provide data for sound analysis, build practice revenue and streamline reimbursement while providing a platform that supports the continuum of care and increased quality outcomes. For more information, call 877854-0014 or log on to www.BioMedix.com. Bauerfeind launches VenoTrain Perfect Fit Sizing system Celebrating 80 years of servicing customers with premium quality compression therapy and orthopedic soft goods solutions, Bauerfeind is announcing a new and improved sizing system for the well known VenoTrain brand. The new Perfect-Fit sizing system is based on more than 100.000 leg measurements acquired through the unique and patented Image 3D measurement system. With the new Perfect-Fit sizing system, more than 90% of all patients will enjoy the benefits of a custom-like fit in a ready-to-wear garment. Fit is key for optimum wearing comfort, compliance and positive therapy results.
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Congratulations to our newest members of
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Saltzer Vein Clinic Dr Steven Williams Nampa, ID
Regional Heart & Vein Clinic Wood Deming, MD Jackson & Memphis, TN
Atruim Laser Vein Clinic Dr. Arun Goyal Mt Kisco, NY
Deak Vein NJ Clinic Dr. Steven T Deak Somerset, NJ
Total Vein Care Center KathyLee Santangelo, M.D., FACS Midwest City, OK
Vanish Vein & Laser Center Dr. John Landi, FACS, RPVI, RPhS - Medical Director Naples, FL
Connecticut Image Guided Surgery, PC Melvin Rosenblatt, MD The Oregon Vein Center Robert W. DuPriest, MD, FACS and Robert J. Swangard,MD, FACS Eugene, OR Vein & Vascular Center of Philadelphia Richard J Gray, MD Philadelphia, PA Louis Domenico, MD Philadelphia, PA
The Vein & Vascular Inst of Tampa Bay Thomas M Kerr MD, FACS Tampa Bay, FL
The Vein Center Jody Bolton-Smith, MD, Danielle Leighton, MD, Rochelle Wolfe, MD Sartell, MN Chuback Veins John Chuback, MD Ridgewood, NJ Vein and Laser Center of New Jersey Sarat K Dash, MD, FACS Sparta, NJ Midwest Vein and Laser Center Richard Davis, MD, FACS, AACS Lima, OH
North East Laser Vein Institute Ned Majid, MD â&#x20AC;&#x201C; Ridgewood, NJ Dr. Dennis H. Olson Vascular Surgery & Phlebology Wheatridge, CO
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For more information on VenoTrain, Image 3D and the new Perfect-Fit sizing system, please contact: Scott Borjeson, Director of Sales & Marketing- Phlebology Bauerfeind USA, Inc. 3005 Chastain Meadows Pkwy NW, Suite 700 USA-Marietta, GA 30066 Phone (980) 297-9395 Fax (770) 429 8477 E-Mail sborjeson@bauerfeindusa.com www.bauerfeindusa.com CopaVin releases Sclerotherapy DVD training program, first of its kind Miami, Fl- CopaVin, an institution specializing in Sclerotherapy, in partnership with Crown Medical Clinic has expanded its training program to include a DVD series designed to train health care providers with the information necessary to perform the removal of varicose veins. This course is the first and only educational program exclusively for Sclerotherapy. According to The National Women’s Health Information Center, 60% of all American women and men suffer from some form of vein disorder. In response to the growing demand for Sclerotherapy, CopaVin exclusively created these DVDs as complete protocols that take a professional step by step through the cycle, covering all the necessary details that guarantee a successful treatment. Following the launch of its training guides, the first and only Sclerotherapy textbooks currently published, this course of ten DVDs is available in two formats, Adobe, intended to be viewed on a computer, and on standard DVD. Each DVD represents a chapter of the textbook guide, offering visual instruction of the injection process. Technical assistance is also provided to each professional as they begin performing the treatment. CopaVin medical consultant, Dr. Aymee Valdes, “The DVD series provides a visual component to the course, allowing the viewer to gain full understanding of the procedure and have the option to rewind and completely engage in the process.” Instructed by medical professionals, the DVDs teach the procedure and how to take into account skin pigmentation, the medication concentration to be used and the number of therapies needed. Sclerotherapy is a method for the treatment of varicose veins and venous malformations. Injecting the unwanted veins with a sclerosing solution causes the target vein to immediately shrink, and then dissolve over a period, as the body naturally absorbs the treated vein. This course is designated for an American Medical Association Physician’s Recognition Award Category 1 credit. Seminars are accredited by different agencies and associations depending on the course and location.Verification of Continuing Medical Education or other may vary and are subject to change. About CopaVin CopaVin has trained hundreds since 2000 and in March of 2009, CopaVin together with Crown Medical released the Sclerotherapy book collection. These training manuals are based on the practical experience of more than 26 years of doctors, nurses, and administrators dedicated exclusively to the treatment of varicose veins with sclerotherapy. CopaVin is accredited by the Florida Medical Association/American Academy of Family Physicians to provide continuing medical education for physicians. For more information, visit www. copavin.com
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ClariVein® Catheter for Varicose Veins: Clinical Trial Final Results Announced Madison, Conn. April 21, 2010 — Results from the initial clinical trial of the ClariVein® catheter, used in a new minimally invasive treatment for varicose veins, have been announced. The device combines mechanical and chemical modalities to accomplish vein treatment in an inoffice setting. Steve Elias MD FACS FACPh was the principal investigator of this IRB-regulated trial conducted at Englewood Hospital and Medical Center, NJ. “Results were excellent,” Dr. Elias stated. “The initial success rate is equal to that from radiofrequency or laser treatment of great saphenous vein disease.” Thirty patients with an average age of 55 were part of this first-in-man trial. Most patients had symptomatic varicose veins, with some having more advanced vein disease such as swelling and skin changes. Mean vein diameter was 8.1 mm. Treatment for each vein averaged 5 minutes and overall procedure time was 14 minutes. At six-month follow-up, 29 of the 30 veins treated were successfully closed. The only vein that did not respond was that of the first patient. Subsequent to the trial, to date 22 other patients have had the ClariVein® procedure, with all being successful. “The main advantage of this new technique in comparison to older endovenous therapies,” Dr. Elias said, “is that it does not require tumescence anesthesia infusion, saving significant time and decreasing patient discomfort. In addition, a generator is not required, and therefore capital and maintenance cost is reduced. This in-office procedure takes about 15 minutes to perform and patients resume normal activity that day, including exercise. All patients would recommend the procedure to others.” Steve Elias MD FACS FACPh, is Associate Professor of Surgery at Mount Sinai Hospital, NY and the Director of The Centers for Vein Disease at Mount Sinai and Englewood Hospitals. The ClariVein® catheter is a product of Vascular Insights LLC (http://vascularinsights.com) of Madison, CT. The company engages in the design, development, manufacture, and marketing of medical devices for the minimally invasive treatment of peripheral vascular disease. Vascular Insights has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ClariVein® for infusion of physician-specified agents in the peripheral vasculature. The company holds certification from BSI (the British Standards Institution) that the design, development, manufacture, and distribution of the ClariVein® device comply with the requirements of ISO 13485: 2003. Omnia Education Announces CME Education Schedule Omnia Education, a continuing medical education CME provider, announces a new series of CME education activities and workshops,Venous Insufficiency Program. The Venous Disease Management course is a comprehensive, one and a half-day course designed for those interested in treating patients with venous insufficiency and covers all aspects of venous reflux disease including basic anatomy, pathophysiology, diagnosis techniques, treatment options and the use of endovenous ablation technology. Ultrasound Techniques: Venous Insufficiency Diagnosis and Treatment course is a one-day workshop designed for sonographers and physicians interested in ultrasound assessment of venous disease. A complete understanding will
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be gained on disease processes and venous anatomy, as well as treatment options. Advanced Endovenous Ablation of Incompetent Perforators course is a full-day activity for physicians wanting to enhance their ablation procedure skills The courses are designed to meet the Continuing Medical Education needs of Cardiologists, General Surgeons,Vascular Surgeons, Thoracic Surgeons, Interventional Radiologists, Interventional Cardiologists, Sonographers and other healthcare professionals with an interest in venous disease management and assessment. Details about the activities and workshops can be found at www.omniaeducation.com/vip. Omnia Education CME Activity & Workshop Schedule: May 21-22, 2010 Venous Disease Management 11.5 CME credits or 11 SDMS CME credits The Westin Grand, Washington DC June 18, 2010 Advanced Endovenous Ablation of Incompetent Perforators 7 CME credits Varicosity Medical Spa, Birmingham, AL July 16-17, 2010 Venous Disease Management 11.5 CME credits or 11 SDMS CME credits The Westin St. Francis, San Francisco, CA July 23rd, 2010 Ultrasound Techniques:Venous Insufficiency Diagnosis and Treatment .75 CME credits or 7.75 SDMS CME credits Sheraton Bloomington Hotel, South Minneapolis, MN September 10, 2010 Advanced Endovenous Ablation of Incompetent Perforators 7 CME credits Foote Hospital, Jackson MI September 24-25, 2010 Venous Disease Management 11.5 CME credits or 11 SDMS CME credits The Westin Michigan Avenue, Chicago, IL October 22, 2010 Ultrasound Techniques:Venous Insufficiency Diagnosis and Treatment 7.75 CME credits or 7.75 SDMS CME credits Sheraton North Houston at George Bush Intercontinental, Houston, TX December 3-4, 2010 Venous Disease Management 11.5 CME credits or 11 SDMS CME credits The Westin City Center Dallas, Dallas, TX December 10, 2010 Ultrasound Techniques:Venous Insufficiency Diagnosis and Treatment .75 CME credits or 7.75 SDMS CME credits Hyatt Regency Phoenix, Phoenix, AZ December 11, 2010 Advanced Endovenous Ablation of Incompetent Perforators 7 CME Credits Center for Venous Disease, El Paso, TX About Omnia Education Omnia Education is fully accredited by the Accreditation Council for Continuing Medical Education (ACCME) and is 5 6
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devoted to being a resource for innovative and cutting-edge content and materials to the medical community. Visit www. omniaeducation.com or call 800.889.4944 for upcoming events! Cushioned Core-Spun by Therafirm® Gradient Compression Socks Therafirm’s Core-Spun Gradient Compression Socks now with a cushioned sole for exceptional comfort! Core-Spun by Therafirm™ Cushioned Support Socks are made with the unique technology of core-spun yarns for a patent pending, true gradient compression sock that is ultra stretchy, easier to put on, and more comfortable to wear. • Made with the unique technology of core-spun yarns for a patent pending, true gradient compression sock that is ultra stretchy, easier to put on, and more comfortable to wear. • Cushioned sole for added comfort • Delivers a controlled amount of pressure greatest at the ankle and gradually decreases towards the top of the sock to promote better circulation and reduce leg fatigue • Moisture wicking fibers create a superior wicking effect so moisture evaporates from the skin quickly, therefore providing a comfortable coolness • Comfort top is non-restrictive while staying in place • Available in Light 10-15mmHg, Mild 15-20mmHg, Moderate 20-30mmHg, and Firm 30-40mmHg Support Levels • Available in White, Black, and Navy in Knee-High length • Wide calf sizes available Terason Supports Duke Raleigh Hospital/UNC Chapel Hill Haiti Relief Efforts Team Performs over 100 Surgeries on Critically Injured Victims With only two weeks to plan, volunteers from Raleigh Hospital and UNC Chapel Hill Medical Center in North Carolina successfully organized several surgeons, anesthesiologists and nurses to volunteer for a Haiti Relief Mission to care for critically injured victims of the devastating earthquake that struck in January. Prior to departure, volunteers had amassed the necessary medical supplies, but were unsuccessful in acquiring an ultrasound machine for performing regional anesthetics. That is, until a last minute connection with Terason provided them with this critical piece of equipment. During the mission, the volunteer team performed over 100 successful surgeries on critically injured victims and the Terason unit proved especially valuable for amputation revision patients, where nerve stimulation to perform regional blocks is almost impossible on an amputated limb (especially when a language barrier prevents the patient from understanding or describing a “phantom” muscle twitch). The images obtained from the Terason ultrasound were easily obtained and very high quality. The volunteers were able to successfully image the sciatic and femoral nerves for lower extremity anesthesia, and were able to image the brachial plexus of a seven-year-old patient well enough to perform a superclavicular approach on a wrist fracture, which never would have been attempted with a ‘blind’ approach. All of this was accomplished using a Terason ultrasound unit that was shipped to Haiti in a backpack and secured to the cross bar of a double IV pole with surgical tape to create a rolling work station.
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Stated Donald Edmondson, MD, Chaiman, Department of Anesthesiology at Duke Raleigh Hospital, “I want to express my gratitude to Terason for allowing their ultrasound system to make the difficult journey to Haiti, especially knowing there was some risk that it would not return in one piece or even at all. Despite some fairly brutal treatment, I was happy to return it in working condition.” For more information, please contact Terason, 77 Terrace Hall Avenue, Burlington, MA 01803 781-270-4143; 781-270-4145 (F), www.terason.com Venous Disease Coalition Announces Call for Nominations for Venous Disease Research Awards Lakewood, CO, March 24, 2010 – The Venous Disease Coalition’s Venous Disease Research Awards recognize important research relevant to the understanding and/or treatment of venous disease. The Coalition seeks to identify exceptional contributions to venous disease research. These annual awards assist health care practitioners, medical journals, the media, and the public by featuring important new knowledge in the field of venous disease. Nominations will be accepted in three award categories, 1) basic science, 2) clinical outcomes and 3) implementation of quality improvement activities. Nominated research papers should provide important or novel insights into the basic science of thrombogenesis and thrombus resolution; clinical outcomes; or the implementation of quality improvement activities related to venous disease. These categories are not intended to be all inclusive and additional relevant areas of research may be equally worthy of recognition. Submission requirements include: • A short description (150-300 words) of the features that makes this research meritorious and deserving of the 2010 Venous Disease Research Award. • A copy of the article (articles must have been published between January 2009 and June 2010) • Up-to-date contact information for the lead author of the article • Submissions due June 25, 2010 to: Ellen Cohig,Venous Disease Coalition, ellen. cohig@vdf.org, fax: 303.989.0200; telephone: 303.989.0500, www.VenousDiseaseCoalition.org The awards will be presented at the Vascular Disease Foundation’s dinner in Washington DC on September 20, 2010. A monetary award and travel and hotel expenses for the recipient of the awards is provided. Winners will be notified mid-July 2010. About the Venous Disease Coalition The Venous Disease Coalition (VDC) (www. venousdiseasecoalition.org) promotes the urgent need to make venous thromboembolism or “VTE” a major U.S. public health priority. The VDC is an alliance of leading health professional societies and patient advocacy groups that have united around a common goal: to improve the survival rates and quality of life for individuals with, or at risk for, venous disease. It is a division of the Vascular Disease Foundation
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Registration for VIVA™ 2010: Vascular InterVentional Advances is now open! VIVA™ 2010 will be held October 19-22, 2010 at ARIA in Las Vegas, Nevada. This leading multispecialty, collaborative education symposium is focused solely on peripheral vascular disease. This year the first VIVA/SVM Comprehensive Endovascular Board Review Course will be available as well as the following pre-symposia sessions: • Venous Thromboembolism: Advancing the New Frontier • Vascular Closure for Large Devices: Paving the Road for Porcutaneous Valves and Future Devices • Allied Health Professional Symposium • Fellows Endovascular Case Competition Please join us as we present more live cases including transmission from LINC live and provide an opportunity for you to interact with multidisciplinary national and international faculty. Space is limited ~ visit our website at www.vivapvd.com.
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