INSIDE AngioDynamics changes top management 6 Vascular Solutions recalls Guardian II valves 8 EHR can add to physician burnout 26 SIGVARIS expands Microfiber Shades 28
JUNE/JULY 2016 Vol. 9 No. 4 VEINTHERAPYNEWS.COM
An ACP recognized resource for news and information for and about the phlebology community
New VenaSeal data is revealed at IVC Medtronic plc unveiled new clinical data in April for the VenaSeal closure system that demonstrates consistent long-term durability and improved quality of life in patients with venous reflux disease. The new data presented at the 2016 International Vein Congress in Miami and Charing Cross Symposium in London included two-year outcomes from the VeClose pivotal clinical study, with two additional subanalyses evaluating quality of life and physician ease-of-use; and three-year results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study. VenaSeal is a non-tumescent, nonthermal, non-sclerosant procedure that uses a proprietary medical adhesive to close superficial veins of the lower extremities, such as the great saphenous vein (GSV), in patients with symptomatic venous reflux. “As shown by our unmatched body of Level 1 evidence in the venous industry, Medtronic has demonstrated its deep-rooted
commitment to providing clinically-proven and patient-friendly treatment options for patients with chronic venous insufficiency,” Sandra Lesenfants, vice president and general manager of the endoVenous business in Medtronic’s Aortic and Peripheral Vascular division, said. “We’re enthusiastic about the unveiling of such strong datasets, and we look forward to continuing to build upon this clinical program.”
RATES HIT GOLD STANDARD New two-year results from the VeClose trial were presented at Charing Cross by Raghu Kolluri, MD, medical director of vascular medicine at Riverside Methodist Hospital in Columbus, Ohio; and by Kathleen Gibson, MD, of Lake Washington Vascular in Seattle at the International Vein Congress. VENASEAL continued on page 8
Dr. Cawlfield counsels his patient about the risk of recurrent vein disease.
Two steps forward, one step back
Recurrent varicose veins after thermal ablation By Timothy J. Cawlfield, MD While most patients whom I treat are satisfied with the initial results of vein ablations, there are some patients who return with recurrent leg symptoms — sometimes months, but usually years after the initial treatment. I also have patients with recurrent
symptoms previously treated by other surgeons. These patients are often frustrated because they had no prior knowledge (or forgot) about the risk of recurrent chronic venous insufficiency. They sometimes come to see me, believing that the other surgeon made a mistake.
Recurrent varicose veins after surgery (REVAS) is a documented problem, and has been for several decades. The first international consensus meeting on recurrent varicose veins after surgery was held in Paris in 1998. From this meeting, REVAS was defined as the existence of varicose veins in a lower limb previously operated on for varicosities, with or without adjuvant therapies, which includes true recurrences, residual veins, and new varices, as a result of disease progression.1 The study of the nature, sites and sources of recurrent vein disease then ensued. In 2006, M.R. Perrin’s multi-center, observational study of about 170 patients with recurrent varicose veins after surgery 2 was published. This study could not measure the incidence of disease recurrence, but it did help stratify the types and locations
of REVAS after saphenous ligation and stripping. Etiology of same-site recurrences included: • Technical failure (19.1 percent) • Tactical error (9.6 percent) • Neovascularization (20.1 percent) • Disease progression (31.7 percent) The sources of ref lux were the saphenofemoral junction (47 percent), lower leg perforators (43 percent), thigh perforators (30 percent), saphenopopliteal junction (25 percent), and pelvic veins (17 percent). Most patients who had disease recurrence had more than one source of reflux. It’s not difficult to believe the nature of recurrent varicose veins might be different for modern DR. CAWLFIELD continued on page 24
PRSRT STD US POSTAGE PAID SAN ANTONIO, TX PERMIT#244
Call for a
“The last thing I wanted was to purchase another laser...” endovenouss las http://totalveinpharmacy.com
“But after comparing the results lts of the TVS 1470 and talking to o myy patients patients, I could not help but buy it.” - Kenneth Jesser, MD Vein Specialists Institute Palm Desert, CA
Lowest supply cost per procedure in the industry!
Disclaimer and Liability Statement The information contained in this publication, including text, graphics and images, is for informational purposes only, and is not intended to be a substitute for professional medical advice. Publications & Communications LP (PCI), Publications and Communications LP, and Vein Therapy News, via its Editors, Publisher, Editorial Board members, or staff, accept no responsibility for any injury or damage to persons or property occasioned through the implementation of any ideas or use of any product described herein. In consideration that great care is taken by the Publisher, Editors, staff, and Editorial Board to ensure all information is accurate, we recommend each reader seek independent verification of all product or drug usage, surgical techniques and clinical processes prior to their use or implementation. The opinions expressed in this publication and all related marketing or sales material of this publication are those of the authors and are not attributable to the publication, Publisher, Editor, staff, Editorial Board, advertisers, or sponsors. References made in articles may indicate uses of medical equipment or medical procedures, or of drugs at dosages, for periods of time, and in combinations not included in the current prescribing information. Inclusion of advertising material in this publication, or in reproduction of articles and pages, or in supplemental materials, does not constitute any representation or guarantee by Publications & Communications LP (PCI), Publications and Communications LP, and Vein Therapy News, via its Editors, Publisher, Editorial Board members, or staff, of the quality of such products, or of the claims made by the manufacturers. Trademarks are used in an editorial fashion with no intent to infringe. Reproduction in whole or in part of this publication is strictly prohibited.
Reader Services SUBSCRIPTIONS To subscribe or to purchase back issues of the magazine, please call 800-678-9724 ext. 344 or e-mail Beth Chorba at firstname.lastname@example.org. For more information, please visit veintherapynews.com and click on the Subscribe link. ADVERTISING INFORMATION If you are interested in advertising in Vein Therapy News magazine, online or in our Marketplace, please contact our account executive: Gary Pittman, Jr., 512-637-0373, email@example.com. EDITORIAL SUBMISSIONS Doctors, nurses, clinics, managers, vendors, patients, professors and others are encouraged to submit abstracts, white papers, writings, and ideas for editorial consideration. If you have a paper or story idea to submit, please e-mail firstname.lastname@example.org UPCOMING EVENTS AND PRESS RELEASES Vein Therapy News would like to hear about your organization’s upcoming event, product launch, or announcement. Please e-mail press releases or event listings at least two months in advance to email@example.com.
VEIN THERAPY NEWS JUNE/JULY 2016
Volume 9, Number 4
Editor Larry Storer firstname.lastname@example.org 254-399-6484
VenaSeal data grows
Medtronic unveiled new clinical data in April for the VenaSeal closure system that demonstrates consistent longterm durability and improved quality of life in patients with venous reflux disease. The new data presented at the 2016 International Vein Congress in Miami and Charing Cross Symposium in London.
Art Director Lisa Gouveia email@example.com
Advertising Executive Gary Pittman, Jr. 512-637-0373 firstname.lastname@example.org
SIGVARIS acquires BiaCare
SIGVARIS has completed a definitive agreement to purchase BiaCare in Zeeland, Mich. BiaCare designs and produces short stretch wraps, compression garments and other products designed to treat patients with veno-lymphatic diseases and disorders.
THE PRACTICE 14 New approach to promotion
Accounting Beth Chorba email@example.com
Web and Network Manager Joel Nosal firstname.lastname@example.org
President Gary L. Pittman email@example.com Publications & Communications, LP 13552 Highway 183 N, Suite A Austin, TX 78750 512-250-9023 • 512-331-3950 fax Vein Therapy News is published bimonthly by Publications & Communications, LP, Gary L. Pittman, President, 13552 Highway 183 N., Suite A, Austin, TX 78750 512-250-9023. Subscriptions are available for $45 per year. Payment must accompany orders. Copyright 2016 by Publications & Communications, LP. All rights reserved. Reproduction in any form without written consent from the publisher is strictly prohibited. Postmaster: Send changes to Vein Therapy News Circulation Department, 13552 Highway 183 N., Suite A, Austin, TX 78750. ADVERTISING
Vein practices have discovered a unique software, marketing and consulting platform designed to increase their online results while improving the performance of internal team members. With more than 80 percent of modern medical consumers using the Internet to find and choose a vein provider, Crystal Clear Digital Marketing meets needs in a digital age.
16 Miami Vein Clinic profiled The Miami Vein Center offers a world class patient experience from click to brick. See what Dr. Jose I. Almeida and his staff are doing to attract new patients.
SECOND LOOK 1
When vein ablations reoccur
While most patients are satisfied with the initial results of vein ablations, there are some patients who return with recurrent leg symptoms — sometimes months, but usually years after the initial treatment. But for those who do, physicians must deal with their frustrations as well as their veins.
18 Burnout and Bias This year’s “Medscape Lifestyle Report” covers two important aspects of a physician’s personal life that could affect care of patients: burnout and bias. More than 15,800 physicians from more than 25 specialties responded, providing some surprising responses relating to these issues. The survey also asked physicians about marijuana use and prescribing; political and religious leanings; and whether they were healthy, wealthy and happy
22 Physicians avoiding burnout Dedicating time to monitor your own health can seem like a daunting task without the overtime pay; however, it is vital to recognize the importance of ensuring your own physical and mental wellbeing. Without your guidance, many of the people you tend to would not be able to receive the assistance they need. Setting aside time for a quick vitals check and making small changes to your daily habits may be all you need.
VTNREPORT AMERICAN VEIN ADDS SURGEON Vascular Surgeon Kenneth R. Madsen, MD, joined the American Vein & Vascular Institute Pueblo practice May 16, and is continuing to serve patients throughout Southern Colorado. Dr. Madsen brings more than a decade of surgical expertise to American Vein & Vascular Institute and expands the lines of service to include comprehensive vascular care. Double board certified in general and vascular surgery, Dr. Madsen is a specialist in treating common conditions that affects millions of Americans, such as peripheral artery disease (P.A.D.), carotid artery stenosis, aortic aneurysms, dialysis access and endovascular surgery. “Joining the American Vein & Vascular Institute team is an exciting opportunity. I now have the ability to expand my specialty in the Southern Colorado community in an outpatient capacity,” Dr. Madsen said. “I look forward to a continuance of care for my current patients, as well as offering my services to new patients through American Vein & Vascular Institute.” American Vein & Vascular Institute is a local, family-owned network of seven clinics as well as a top-tier practice management company and health retailer that treats patients with vascular disease. The team of experts perform the latest, minimally invasive therapies to remedy vein and arterial diseases. Also home to The Compression Center, each clinic offers the latest trends in medical and athletic compression stockings that are offered in a variety of price points. READ MORE: americanvein.com
MEDTRONIC HIRES KAREN PAKHILL TO REPLACE GARY ELLIS AS EVP, CFO Karen Parkhill will become executive vice president and chief finance officer at Medtronic June 20, replacing Gary Ellis, Medtronic CFO since 2005. Parkhill was vice chairman and CFO for Comerica for five years before moving to Medtronic. She was also a member of Comerica’s management executive committee and Comerica Bank Board of Directors. In her new role with Medtronic, Parkhill will serve on the executive committee, lead the global finance organization and assume key supporting functions such as treasury, controller, tax, internal audit, investor relations, corporate strategy and business development. Ellis will remain on the Medtronic Executive Committee and will assist in Parkhill’s transition. He’ll also lead key functions within his portfolio of responsibilities, according to an announcement by the company. During his tenure, the company’s market share nearly doubled to $110 billion.
GLOBAL ULTRASOUND GROWTH EXPECTED TO GROW 5.5% FROM 2016-2022; HANDHELDS GROWING FASTER The global ultrasound market is expected to grow at a compound annual growth rate (CAGR) of 5.5 percent from 2016 to 2022, according to P&S Market Research. The market was valued at $6.01 billion (5.3 billion euros) in 2015 and is expected to grow due to increased health spending, technological advancement of ultrasound, increasing demand for minimally invasive diagnostic and therapeutic techniques, and growing geriatric populations. Also, an increase in chronic diseases and improved healthcare infrastructure in developing countries are driving growth. The segment of the market expected to grow the fastest is handheld ultrasound, with a CAGR of 8.8 percent. Meanwhile, the Asia-Pacific market is expected to witness the fastest growth by geographical region, with a CAGR of 6.3 percent during the forecast period.
MEDTRONIC PULLS PLUG ON ENDURANT EVO AAA STENT GRAFT TRIAL; ACQUIRES RELATED FIRMS Medtronic launched a clinical study of its Endurant Evo AAA stent graft system in April 2015 with 140 patients at 30 sites in the U.S. and Europe. Now, the company is pulling the plug on the trial after encountering a setback. Endurant Evo AAA offers an alternative to open surgical repair for patients with abdominal aortic aneurysms. The Minnesota device giant had only one patient left to enroll but decided to stop the study so it could look into unanticipated stent fractures, The Gray Sheet reports. The study was designed to look at how well the device could treat abdominal aortic aneurysms, according to a recent filing at ClinicalTrials.gov. The halted trial is bad news for Medtronic, which has been working hard to expand in abdominal aortic aneurysm repair. The company has shelled out $110 million for Aptus Endosystems to get its hands on Aptus’ aortic aneurysm repair technology, a day later cardiology
company CardioInsight for $93 million, and also on that day made a financial investment in aortic aneurysm company, Arsenal AAA.
MEDTRONIC: NEW U.S. RULES REDEFINING SIZE OF U.S. ACQUISITIONS DO NOT APPLY Medtronic plc officials say it doesn’t appear the U.S. government’s new rules designed to thwart so-called corporate inversions, when companies move out of the U.S. to save on taxes, will affect it. The company, which has its operational headquarters in Fridley, is one of the biggest American businesses to make such a move. In January 2015, it completed the purchase of an Ireland-based maker of medical devices, allowing it to shift its legal headquarters to Dublin and allocate overseas-held cash without facing U.S. repatriation taxes. The Treasury Department unveiled rules that redefined how it classified the size of an overseas company being acquired by a U.S. firm. In doing so, it raised targeted repeat users of the inversion process and made U.S. companies that try to merge with overseas companies more susceptible to existing law that says if shareholders of the former U.S. company own at least 80 percent of the combined firm, the combined business is still subject to U.S. tax law. The change led New York-based Pfizer Inc. to call off its $160 billion merger with Allergan, a now Ireland-based firm that has already gone through several inversions. In a statement, Medtronic said its preliminary review of the new rules showed they “do not have a material financial impact on any transaction undertaken by the company.” The company repeated its stance that its $49.9 billion acquisition of Irish-based Covidien “was undertaken for strategic reasons.”
LUNG BIOTECHNOLOGY PLANS DRONE DELIVERY VIA HIGHWAY-IN-THE-SKY A subsidiary of United Therapeutics has placed an order for up to 1,000 unmanned aerial vehicles (UAVs) from Chinese manufacturer EHang. The plan is to use the UAVs, flying vehicles more commonly known as drones, to ship manufactured lungs and other organs from production facilities to hospitals for transplantation. Many stumbling blocks stand between the United Therapeutics subsidiary, Lung Biotechnology PBC, and the realization of this vision, but the company has seen enough potential to justify committing time and resources to the idea. Lung Biotechnology plans to spend 15 years working to turn the idea into reality with EHang, a Chinese drone developer that unveiled a prototype of an autonomous helicopter in January. The partners plan to rework that prototype, which was designed to carry one passenger, to ferry organs between locations without the active control of a human. Lung Biotechnology thinks the drone is a good fit for its vision of the future of organ transplantation. “The well-known locations of transplant hospitals and future organ manufacturing facilities makes the EHang technology ideal for Highway-In-The-Sky and Low-Level IFR Route programs,” CEO Martine Rothblatt said in a statement. “We anticipate delivering hundreds of organs a day, which means that the [Manufactured Organ Transport Helicopter] system will help save not only tens of thousands of lives, but also many millions of gallons of aviation transport gasoline annually.” If EHang and Lung Biotechnology can work through the engineering obstacles, they will still need to get clearance from the U.S. Federal Aviation Administration (FAA) before they start putting the crafts into the sky. Lung Biotechnology has its own separate set of challenges. The company is working to make pig lungs suitable for transplantation into humans, but the concept has yet to be tested in clinical trials, let alone secure FDA approval. Lung Biotechnology’s order of up to 1,000 drones is contingent on it and its partner winning this mix of regulatory approvals. The 15-year timeframe for the alliance shows both companies know none of this will happen quickly.
REPORT DETAILS ULTRASOUND DEVICE MARKET The “Ultrasound Device Market, Numbers & Forecast Worldwide Analysis” report has been added to the Research and Markets offerings. The Report provides a comprehensive assessment of the high-growth worldwide ultrasound device market. The United States is the leading country in the worldwide ultrasound device market. But in terms of numbers of ultrasound devices, China has the highest market share. By clinical segment, radiology is leading in clinical application. By 2021, the China and India ultrasound markets are expected to be triple and double of their market in 2010, respectively. VT N READ MORE: researchandmarkets.com/research/czfk6n/ultrasound_ device” \t “_blank”
JUNE/JULY 2016 VEIN THERAPY NEWS
INCREASE PRACTICE REVENUE
Learn the art of TUMESCENT LOCAL ANESTHESIA LIPOSUCTION with Dr. Jeffery A. Klein, the Inventor of Tumescent Local Anesthesia. Visit www.lipo101.com
AngioDynamics changes top management AngioDynamics has replaced its president and chief executive officer, interim chief financial officer, and the executive vice president and chief commercial officer. The company has no current plans to backfill the CCO position as the new CEO will oversee the commercial organization. Two weeks after announcing on April 4 that James C. Clemmer would replace Joseph M. DeVivo as AngioDynamics’s CEO, the Lathambased medical device company announced that two other top officials would leave the company. Clemmer has an extensive background in medical manufacturing. Michael Trimarchi, vice president and interim chief financial officer, and James C. Executive Vice President and Chief Clemmer Commercial Officer John Soto, have also left the company. Trimarchi has become chief accounting officer at Albany-based CommerceHub. “Having recently managed operations and driven growth for a $1.8 billion global business, Jim Clemmer is uniquely positioned to lead AngioDynamics as we accelerate our growth and bring innovative products to the patients who need them,” Howard Donnelly, chairman of the AngioDynamics Board of Directors, said. “We are confident Jim’s leadership and expertise will help AngioDynamics improve margins, drive international growth and ultimately maximize shareholder value.” Clemmer began his career in the medical device industry with Sage Products Inc., and joined Covidien as part of the Sage Products acquisition in 1999. He most recently served as president of Covidien’s medical supplies segment, where he was responsible for managing operations and growth of a $2 billion global business, utilizing 15 manufacturing sites around the world. During his 15-year tenure at Covidien, he served as group president of Kendall Healthcare and held several increasingly senior roles in marketing and general management within the SharpSafety and Critical Care division before it was spun off from Tyco. He retired from Covidien in 2015.
GROWTH EXPECTED At the third quarter conference call, Donnelly spoke about the hiring of Clemmer. “This is a key appointment at an important time for our company. With near term regulatory challenges behind us and some growth products across our business segments providing a foundation for the future, it is critical that we’re able to
Congressional bill would shorten MU ’16 reporting deadline With the Department of Health and Human Services already looking past Meaningful Use, Congress is training its sights on the short-term realities of the increasingly loathed electronic health records incentive program. A bipartisan group of representatives and senators introduced on April 20 a succinct bill that would shorten the Meaningful Use reporting period to 90 days for 2016 only,
capitalize on our opportunities to drive the next leg of growth for AngioDynamics,” Donnelly said. “In saying that, we wanted to bring in an experienced leader who has managed successfully in a highly competitive and global marketplace. With over 25 years of industry experience, Jim brings a wealth of knowledge and proficiency in leading a global medical device business… In Jim, we have found a wellrounded executive with both the industry and global experience that was important to us as we considered our next phase of leadership. “I firmly believe that Jim’s wide range of experience and track record of delivering results will be valued by shareholders, customers and employees. We’re confident he is the right person to lead us through an exciting new growth period in the company’s history with a priority on driving growth and innovation, improving margins and ultimately maximizing shareholder value.”
COMPENSATION Included in Clemmer’s compensation package are 250,000 performance shares, 200,000 options and 50,000 restricted stock units. The options will vest in four equal installments beginning on the first anniversary of the grant date, have a strike price equal to the closing price of the company’s common stock as of April 4, 2016 and expire, if not exercised, on April 4, 2023. The restricted stock units will vest in four equal installments beginning on the first anniversary of the grant date. The awards were granted as inducement to Clemmer’s hiring on with AngioDynamics. Clemmer is also being appointed to AngioDynamics’ board.
DEVIVO’S EXIT Little was said about the exit of DeVivo, who has been president and CEO of the medical device manufacturing firm since 2011 and who oversaw the integration of AngioDynamics with Navilyst Medical — following a $327 million acquisition — in 2012. The company said only that DeVivo “has decided to pursue other interests.” There had been no indication prior to the announcement that a succession plan for DeVivo was in the works. “We thank Joe for his contributions and commitment to AngioDynamics over the years, including his leadership in guiding the company through various regulatory challenges, implementing growth drivers into all three business franchises
rather than the full year. Providers would be able to choose any quarter they like this year, according to the two-paragraph Flexibility in Electronic Health Record Reporting Act (H.R. 5001). The legislators, led by U.S. Rep. Renee Ellmers (R-N.C.) and U.S. Sen. Rob Portman (R-Ohio), called the bill “an important first step in addressing the many challenges faced by doctors, hospitals and other medical providers due to the stringent mandates” of Meaningful Use. Co-sponsors include Sens. Michael Bennet (D-Colo.), Tom Price (R-Ga.); and Reps.
and integrating the Navilyst acquisition,” Donnelly said in a prepared statement. In January, the company reported a second-quarter loss of $400,000, or 1 cent per share, on net sales of $89.2 million. That loss followed a loss of $800,000 for the company’s fiscal first quarter, which ended Aug. 31. However, in the third quarter announcement in April, AngioDynamics posted a $630,000 profit. AngioDynamics has struggled to recover from a voluntary recall, launched in 2014, of its Morpheus line of peripherally inserted central catheters. During that second quarter conference call on Jan. 7, DeVivo reviewed and evaluated the company’s progress under his direction. “During our second fiscal quarter of 2016 AngioDynamics showed signs of revenue improvement over the first quarter while strengthening the core foundation of our operations. We improved manufacturing efficiencies and continued to drive our commitment to regulatory excellence. As a result, we generated substantial cash from operations during the quarter and the FDA notified the company that we have resolved all outstanding warning letters and the letters were officially lifted. The significance of this development represents a major achievement for our team and has created opportunities for growth in the future. “When I arrived at AngioDynamics in 2011, the company had two outstanding warning letters. Three months into my tenure, an FDA instructor arrived just before Thanksgiving and did not leave until Valentine’s Day, issuing us 1843 [ph] observations, many of which were repeats. As you recall, we instituted a quality call to action bolstered by the acquisition of Navilyst to aggressively build a culture of quality throughout the organization. DeVivo said he was proud of the company, “not just for adjusting these concerns but for creating today our own culture of quality. Our organization is poised for greater operational excellence and greater international market access as evidenced by nearly 20 clearances in the past six months, mostly from international markets and the more predictable R&D roadmap to commercializing in the future. “Our operational excellence program remains on schedule to complete the product line transition from Queensbury to Glens Falls. We’ve already begun production in our recently opened manufacturing space, our inventory has been reducing, and our cash generation has been improving.” VT N
Marsha Blackburn (R-Tenn.), Ron Kind (D-Wisc.), Bobby Rush (D-Ill.) and Doris Matsui (D-Calif.). Price is a physician and Ellmers is a nurse. Ellmers has led similar efforts in the past. Her 2015 legislation with the same name but a broader scope remains buried in committee. Another stalled bill that she co-sponsored would have barred CMS from writing the Stage 3 regulations until 2017, but that became moot when the final rules came out in October. At least one health IT industry group was happy. “The Flexibility in EHR Reporting
Act of 2016 represents a sensible approach to modifying the Meaningful Use program by granting healthcare providers much-needed flexibility without compromising the goal of further digitizing healthcare,” said Russell Branzell, president and CEO of the College of Healthcare Information Management Executives. “There’s growing acknowledgement across the industry that a 90-day reporting period for Meaningful Use, rather than the current 365day construct, is a more reasoned approach to public policy,” Branzell added. VT N
JUNE/JULY 2016 VEIN THERAPY NEWS
95% of mediven® stockings are made in the U.S.A
Make the ® medi move! Grow your business and proﬁts with medi -Increase compliance with mediven compression -Drive business with your medi territory manager -Increase patient satisfaction with quality products that reﬂect your practices’ standards
The latest medi innovation:
Introducing mediGrip technology mediGrip is a completely seamless and invisible silicone top band for a calf-high stocking. http://www.medi-for-help.com/en
mediven for women vitality Compression that complements:
your style. your life. you. http://www.medi-for-help.com/en
medi. I feel better.
NEWS Online at fda.gov/medwatch/report.htm (form available to fax (1-800-FDA-0178) or mail), or Call FDA 1-800-FDA-1088 to request a reporting form. VT N READ MORE: vasc.com
Vascular Solutions recalls Guardian II hemostasis valves Vascular Solutions Inc. initiated a nationwide recall March 3 of Guardian II hemostasis valves used in catheterization procedures because defective lots pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. This recall only affects the Guardian II hemostasis valves and does not include the Guardian II NC hemostasis valves. No injuries have been reported in association with this issue to date. The condition that led to the recall may affect approximately 2.4 percent of recalled devices. Healthcare facilities that have the affected Guardian II hemostasis valves should remove the products from their inventory and return them to Vascular Solutions. The recalled products were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016. The recalled products are specific lots of Model Numbers 8210 and 8211. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. A total of 26,550 devices have been manufactured, with 5,283 distributed in the United States. Vascular Solutions Inc. voluntarily initiated the recall on March 3 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific lots subject to the recall and included instructions on how to return the affected products. The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between 8 a.m. and 5 p.m. (CST) or by email at firstname.lastname@example.org. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program:
SIGVARIS expands market position with BiaCare purchase SIGVARIS, a leader in graduated compression, has completed a definitive agreement to purchase BiaCare in Zeeland, Mich. BiaCare designs and produces short stretch wraps, compression garments and other products designed to treat patients with venolymphatic diseases and disorders. Through this acquisition, the SIGVARIS Group will continue its international growth strategy of expanding its product offerings for patients in need of medically-complex compression therapy options. The acquisition of BiaCare also allows the SIGVARIS Group to further strengthen its position in a rapidly growing market segment. BiaCare has been manufacturing products for veno-lymphatic patients for 12 years. The company has developed a reputation for
BiaCare is renowned for its high medical standards. being an innovative leader in the design and production of short stretch Velcro wraps, as well as day and night garments for lymphedema and lipedema patients. Urs H. Toedtli, CEO of the SIGVARIS Group, said BiaCare is renowned for its high medical standards and has earned the trust of many physicians and therapists. “This transaction allows us to acquire an established manufacturer with a strong position in the U.S. market,” Toedtli said. “BiaCare’s innovative line of compression products designed to treat lymphedema, lipedema, chronic venous insufficiency and other complex edemas immediately broadens the SIGVARIS offering.” Scot Dubé, president and CEO for SIGVARIS North America, said the acquisition will strengthen SIGVARIS’ market position as well as provide an opportunity to serve even more patients under a single brand. “By sharing our know-how, we create a platform with growth potential in North America to offer additional therapeutic medical products while strengthening our position as a solution provider for medical professionals and patients,” Dube said. VT N READ MORE: biacare.com or sigvaris.com
VENASEAL continued from page 1
At two-years, the complete closure of the GSV was achieved in 94.3 percent of patients treated with VenaSeal compared to 94.0 percent of patients treated with ClosureFast, showing continued, similar long-term noninferiority outcomes (p=0.0075). The VeClose U.S. pivotal clinical study is a prospective, randomized, controlled, noninferiority study that compares the safety and effectiveness of the VenaSeal closure system to the gold standard ClosureFast endovenous radiofrequency ablation procedure. Two hundred and forty-two patients with symptomatic refluxing great saphenous veins were enrolled in the trial. Patients were randomized to receive treatment with VenaSeal and treatment with ClosureFast.
VENASEAL IMPROVES QOL In a separate session presented by Dr. Gibson at Charing Cross, a one-year subanalysis from the VeClose trial compared quality of life improvement factors following treatment with VenaSeal and ClosureFast. Patient improvement was rated on a Venous Clinical Severity Score (VCSS) and an Aberdeen Varicose Vein Questionnaire (AVVQ) that included factors such as age (45-65 years), body mass index (25-35), gender and the diameter size of the GSV. For subjects treated with VenaSeal, mean change in VCSS and AVVQ at 12 months compared to baseline was statistically significant at -4.02 (SD 2.48, p<.0001) and -8.8 (SD 7.5, p<.0001), respectively. Findings showed improvement in VCSS and quality of life across all ages, body mass index, gender and vein diameter size. “This randomized trial demonstrates VenaSeal’s ability to provide a safe and effective treatment for patients with varicose veins,” said Dr. Kathleen Gibson. “With excellent outcomes at two years, VenaSeal offers patients an alternative treatment to traditional therapies for varicose veins, allowing a rapid recovery with minimal downtime and diminished postprocedure bruising.”
MINIMAL LEARNING CURVE In a separate session at Charing Cross, a roll-in phase analysis from the VeClose trial was also presented by Dr. Kolluri. The subset analysis evaluated the safety and effectiveness of 20 patients treated with the VenaSeal closure system by trained physicians with no prior VenaSeal device experience. The roll-in group included the first two patients treated with VenaSeal at 10 enrolling sites; threemonth outcomes were then compared to the randomized patients treated with VenaSeal and ClosureFast. Three-month follow-up results show that 19 of the 20 patients returned for follow-up. The investigators achieved complete closure
of the GSV in 100 percent of these follow-up patients, demonstrating comparable efficacy and safety outcomes to the randomized patients treated with VenaSeal (99%, n=103) and ClosureFast (95.4%, n=103). “Despite having no prior physician experience with VenaSeal, these data demonstrated remarkable ease-of-use and a limited learning curve for first-time-users as compared to experienced users,” said Nick Morrison, MD, Morrison Vein Institute in Scottsdale, Ariz., and national principal investigator of the VeClose trial.
3-YEAR eSCOPE RATE Three-year results from the eSCOPE study were also presented at Charing Cross by Thomas Proebstle, MD, PhD, department of dermatology at the University Medical Center Mainz, Germany. Of the 70 patients treated with VenaSeal, results showed 88.5 percent closure rate at three years, demonstrating durable and consistent outcomes over the long term. eSCOPE is an international, multi-center, prospective, single arm, observational, postmarket study designed to record the clinical outcomes of the CE (Conformité Européenne) Marked VenaSeal.
VENASEAL APPROACH The unique approach of VenaSeal eliminates the risk of nerve injury that is sometimes associated with certain thermal-based procedures. The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks. Patients also report minimal-to-no bruising post procedure.3 The VenaSeal system is currently available in the United States, New Zealand, Chile, South Africa, Australia, Canada, Europe, United Arab Emirates, Hong Kong and Turkey. VT N READ MORE: medtronic.com/ endovenous
Healthcare IT to hit $53B by 2019 Driven by an increase in healthcare costs, the healthcare information systems market is expected to reach $53.2 billion in revenues by 2019, according to a new report by Transparency Market Research. The market will grow at a compound annual growth rate of 7.1 percent from 2013 revenues of $35.1 billion, according to the company. The firm pointed to healthcare cost increases, an expansion in the aging population base, government initiatives, and greater investments by companies in the healthcare IT market as key forces. VTN
JUNE/JULY 2016 VEIN THERAPY NEWS
TI ME F O R A
Vascular Insights LLC 1 Pine Hill Drive Two Batterymarch Park Suite 100 Quincy, MA 02169 +1-203-446-5711
Indication For Use: ClariVein® IC is intended for infusion of physician-speciﬁed agents into the peripheral vasculature. Rx Only. 510(k) Cleared by the Food and Drug Administration for commercialization in the USA. ClariVein® OC is intended for infusion of physician-speciﬁed agents into the peripheral vasculature and for endovascular occlusion of incompetent veins in patients with superﬁcial venous reﬂux. The ClariVein OC is not currently available for commercialization in the USA. The ClariVein OC approvals in international markets include Canada and Australia; and it is CE marked for the European Union. Contraindications: The ClariVein® IC and ClariVein® OC infusion catheters are contraindicated for use in the coronary and cerebral vasculature, in the pulmonary vasculature, in diseased and artherosclerotic arteries; for infusion of blood or blood products; and for patients contraindicated for endovascular procedures. Labeling: Refer to product labeling provided with each product for Description, Directions for Use, Warnings, Precautions, and Potential Complications/Adverse Effects. Read and understand all labeling prior to use. Failure to do so may result in injury and/or equipment failure. The ClariVein® catheters are single use, disposable devices. Note: This material is provided for general informational purposes only and is not intended or recommended as a substitute for professional medical advice. This information is for use only in countries with applicable health authority product registrations. Contact your local representative for product availability in a speciﬁc country.
VEIN THERAPY NEWS JUNE/JULY 2016
NEWS that prevent patients from obtaining their own medical records. Biden also talked at length about the need for researchers to share information with one another to improve potential breakthroughs in the fight against cancer. In the president’s State of the Union Address in January, Obama tasked the vice president with leading the Cancer Moonshot effort to eliminate the disease.
that provide 90 percent of EHRs used by American hospitals signed, as did hospitals in 46 states, including the nation's five largest private healthcare systems. She also called making data work “foundational” to the rest of the federal government’s work in healthcare. In particular, she said that better data will be vital to success under the recently announced Quality Payment Program. “With more reporting and better data, we can start to promote the evidence-based care we all want,” Burwell said. VT N
Vice President Joe Biden
Biden: Sharing data is a matter of life and death Not even the vice president of the United States is immune to poor electronic health record interoperability. In a speech in early May at Health Datapalooza in the District of Columbia, Vice President Joe Biden shared that in the midst of his son Beau’s treatment for brain cancer, the family struggled to have health records sent between providers at Walter Reed National Military Medical Center and the University of Texas MD Anderson Cancer Center. In fact, he said, because the two health systems’ EHRs were not compatible with one another, the information needed to be physically transported from the Bethesda, Maryland-based hospital to Houston. Beau Biden died May a year ago at the age of 48. “I’m the vice president of the United States,” Biden said. “I have a ... very influential sonin-law who’s a first-rate, well-known surgeon. It took all that and more to get [Beau’s data] put on a disk and flown down to Anderson.” Without mentioning Meaningful Use by name, Biden referenced the EHR incentive program started by the Obama administration in 2009, saying that the United States spent $35 billion to avoid such scenarios from unfolding. “We didn’t realize that five different companies would come along and create their own silos,” Biden said. He called the current state of affairs “a matter of life and death,” saying that the industry must eliminate technical roadblocks
The “moonshot” initiative spearheaded by Biden is underway to find a cure for cancer, and health IT will have a big role to play in the effort. “Last year, Vice President Biden said that with a new moonshot, America can cure cancer ... I’m announcing a new national effort to get it done. And because he’s gone to the mat for all of us on so many issues over the past 40 years, I’m putting Joe in charge of Mission Control,” Obama said. “Several cutting-edge areas of research and care ... could be revolutionary,” Biden wrote in his blog. “Innovations in data and technology offer the promise to speed research advances and improve care delivery.” Obama’s Precision Medicine Initiative may also play a large part in the effort, which the president announced during the 2015 State of the Union. Getting information from great numbers of cancer patients and analyzing the data “could provide quick and important advances,” Otis Brawley, M.D., chief medical and scientific officer for the American Cancer Society and professor at Emory University, said. In addition, Brawley says the vice president should try to help improve privacy laws, such as HIPAA, that keep researchers from collecting important patient information. Austin Frakt, Ph.D., a health economist for the Department of Veteran Affairs, also points out the need for data infrastructure. Barriers to obtaining and analyzing data slow research. “Beefing up data availability and data infrastructure and removing regulatory and other obstacles would speed up research,” Frakt said. The use of data in cancer care and research is already becoming more common. CancerLinQ, a project from the American Society of Clinical Oncology that aims to use big data analytics to improve cancer care, is moving toward broader deployment. In addition, the American Association for Cancer Research last November launched an international genomic and clinical datasharing project called GENIE (Genomics, Evidence, Neoplasia, Information, Exchange). “Every day, thousands of people are dying,” Biden said. “Millions more are desperately looking for hope, desperately looking for another day. One more month. Maybe another year. ... We are on the cusp of significant breakthroughs. ... We have to work together.” VT N
EHR global market to hit $24B by 2020
HHS Secretary Sylvia Burwell
Burwell: Despite MU, healthcare still not fully open Health and Human Services Secretary Sylvia Mathews Burwell said she believes that despite the progress of the Meaningful Use incentive program to put electronic health records in the hands of hospitals and clinicians, much work remains to ensure the healthcare system is truly open. Burwell, speaking at Health Datapalooza in the District of Columbia in May, said that while most patients don't have to “lug around” paper from office to office anymore, many issues still hinder data sharing. For instance, technical incompatibilities between disparate systems have proven problematic, as have HIPAA misunderstandings and business cases. The HHS leader outlined three steps for achieving that openness: • Use common standards between organizations. • Change the culture around access to information: “Data blocking can’t be tolerated, and a patient's data needs to be able to move to all the clinicians treating that patient,” Burwell said. • Ensure rules and regulations reﬂect that data movement is vital for market success. She delivered a similar message to the American College of Physicians last week. “Overcoming these challenges won’t be easy,” Burwell said. “Getting different systems to speak the same language can be time-consuming and expensive. Changing the culture is easier said than done.” Burwell touted a data-sharing pledge unveiled at HIMSS16 in Las Vegas and signed by both providers and health IT vendors as progress. For the pledge, companies
The global market for electronic health records (EHRs) will reach $24 billion by the end of 2020, with a compound annual growth rate of 6.4 percent per year, according to a report by Transparency Market Research. Government initiatives to encourage the adoption of EHR systems for healthcare facilities have driven the growth of this market, which was worth $16 billion in 2014. However, a lack of skilled healthcare IT professionals and high installation costs of EHR systems could still hinder market growth, the company said. The market has been divided into client server-based systems and Web-based systems, according to Transparency Market Research. In 2013, client server-based EHR systems held the largest share in the global market, but Web-based EHR system market growth is expected to be significant throughout the forecast period. VT N
Medical imaging market said on way to $35 billion by ’19 The global medical imaging equipment market will hit $35.4 billion by the year 2019, according to a report by Transparency Market Research. The company estimates that compound annual growth will be 5.4 percent between 2013 and 2019, driven by technical advancements and an increase in private and government initiatives. The market for CT and nuclear imaging devices will expand at the highest growth rates. In 2012, the market for CT scanners was $4.4 billion, and the nuclear medicine imaging equipment market was worth $1.5 billion. Transparency projects that these markets will grow at a 5 percent compound annual rate between 2013 and 2019. In 2012, the global market was valued at $24.3 billion, with North America generating the most revenue. Going forward, the AsiaPacific region will prove to be the most active market, a Transparency spokesman said. VT N
JUNE/JULY 2016 VEIN THERAPY NEWS
NEWS HIPAA audits are on the way HIPAA audits are coming, and there are steps providers can take to make sure they are ready to go in the event they are “the lucky winners,” Rebecca Williams, RN, partner and chair for the Health IT & HIPAA Practice group at Davis Wright Tremain LLP, said during the 24th National HIPAA Summit. The Department of Health and Human Services Office for Civil Rights is looking for a diverse pool of covered entities and business associates for the audits, meaning any organization can be impacted, Williams said. OCR Director Jocelyn Samuels said Monday that the effort will comprise more than 200 desk and onsite audits.
C u r r e n t l y, OCR is sending out emails to providers to verify contact information; or g a n i z at ion s should make sure they have received the email – including checking spam Rebecca Williams, MN folders – and that the right people will be in contact with OCR throughout the process, Williams said. Steps organizations should take to prepare for and address a possible audit, according to Williams, include:
Respond to the request: “If you ignore this letter, OCR can still find you, they know where you live,” she quipped. Have an audit response team ready to go now. Read the request carefully: Check if it’s a privacy or security request, calendar the timing and know whether it’s an onsite or desk audit. Get all data for the audit response in on time: OCR may not assess data that comes in late, Williams said. Make sure data is current and on target: Don’t submit extraneous information. Recognize that the audits will be conducted digitally through a secure portal, and make sure your organization’s information can all be submitted electronically.
Know your business associates: “You will be asked to identify your business associates. “I know OCR says, and I recommend, have lists and contact information for BAs. Do that now,” Williams said. Update your risk analysis: “If you have not done one since 2003, it’s time for a new risk analysis. If your risk analysis does not have ransomware addressed, it should,” she said. This is like an “open book test” according to OCR, Williams said. “All the questions are there [protocols] all the answers are there [regulations]. Prepare for this now.” VT N
BE BOLD BE HEALTHY STEP INTO
MICROFIBER SHADES A new graduated compression product series refreshed throughout the year!
For more information: http://www.sigvaris.com
sigvarisusa.com | 800.322.7744
SIGVARIS is a registered trademark of SIGVARIS AG, CH-9014 St.Gallen/Switzerland, in many countries worldwide. © Copyright 2016 SIGVARIS, Inc.
VEIN THERAPY NEWS JUNE/JULY 2016
Available in 15–20 & 20–30mmHg
NEWS CMS unveils new MACRA proposal The Centers for Medicare & Medicaid Services’ new proposed rule implementing the Medicare Access and CHIP Reauthorization Act, as it pertains to the use of electronic health records, varies considerably from physicians’ requirements in the Medicare Meaningful Use program, allowing for streamlined reporting, reduced burdens and more flexibility. The rule, issued April 27, and published in the Federal Register May 9, creates a “Quality Payment Program” to replace the old reporting programs, including the Medicare Meaningful Use Program. The new program includes both the Merit Based Incentive Payment System (MIPS) and advanced alternative payment models, according to CMS Acting Administrator Andy Slavitt.
U n d e r MIPS, eligible professiona ls will be measured on quality, resource use, clinical practice i mprovement s and meaningful use of certified EHR t e c h n o l o g y. Slavitt pointed Andy Slavitt out that the new rule is more “patient centered, practice driven and enhances connectivity.” In a related blog post, Slavitt and National Coordinator for Health IT Karen DeSalvo explained that they reviewed the Meaningful Use program as part of MACRA “with the aim of reconsidering the program so we could move
closer to achieving the full potential health IT offers.” In the new approach, dubbed Advancing Care Information: Physicians will be allowed to select the measures that reflect how they use EHR technology and what suits their practices. CMS will no longer require all-or-nothing EHR measurement or quality reporting. EPs would receive a base score of 50 percent for reporting on their use of EHR technology, and can earn another 50 percent based on their performance; they also can receive a bonus for reporting to more than one registry. The number of measures will be reduced from 18 to a new all-time low of 11. Reporting of clinical decision support and computerized physician order entry will no longer be required. EPs only have to report to a single public health immunization registry.
Some physicians will be exempt from reporting when EHR technology is less applicable. MACRA requires the rule implementing MIPS be published by Nov. 1. It will be effective Jan. 1, 2017. VT N
Now available in a convenient digital format. Visit us online at:
Your Best Protection Against Penalties All physicians who applied for incentive money using VeinDraw have received full payments.
VeinDraw Works For Phlebologists • • • • •
Organization Efficiency Ease of Use Excellent Customer Service and Support Complete EHR Certified for Stage 2 Meaningful Use in 2014
software built exclusively for Phlebologists
To see how VeinDraw can work for you, schedule a live demo by calling www.veindraw.com 877.990.VEIN or visit oVr website athttp://www.veindraw.com www.VeinDraw.com This VeinDraw EMR is 2014 Edition compliant and has attained Complete Ambulatory EHR Certification from the ICSA Labs ONV Health IT Certification (ONC-HIT) Program. It has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services. Certificate number: 140319R00. Certified on November 3rd, 2014.
JUNE/JULY 2016 VEIN THERAPY NEWS
THEPRACTICE Patients must be able to correct errors in own records What is entered into a patientâ€™s medical record â€“ especially inaccuracies â€“ can stay with them forever, Dhruv Khullar, a resident physician at Massachusetts General Hospital, said during Health Datapalooza 2016 in the District of Columbia. The panelists, ranging from a government official to university members, gathered to discuss their experiences and views of patient data safety and data sharing. Khullar said itâ€™s growing more difficult to trust what is in the electronic health records of patients. â€œWhen I speak with patients, I find that their electronic medical record is littered with inaccuracies,â€? he said. There are certain aspects of an EHR that can lead to more inaccuracies than paper records, he added. Those can include the ability to copy and paste, as well as autopopulation features. Physicians can help stem the flow of mistakes in a couple ways, according to Khullar. They need only to capture the most important information -- the data that gives a sense of who the patient is and what their health goals are -- and they must encourage patients to read their medical records, he said. Khullar also noted the need for EHR systems with which people want to engage. Many doctors dread using them, he said, and want an experience that is more intuitive. Patients, according to Dhruv, want records that are as easy to use as a social medical platform, such as Yelp or Instagram. Jocelyn Samuels, director of the Health and Human Services Departmentâ€™s Office for Civil Rights, said the explosion of data in healthcare is â€œtransformativeâ€? for the industry, and noted that OCR understands patient trust is a cornerstone to data sharing. She spoke to OCRâ€™s efforts in this vein, saying the office has a robust enforcement arm and will hold healthcare entities responsible when they violate standards of privacy and security rules. In response to Dhruvâ€™s comments, Samuels said that patients have every right to correct errors in their medical records, â€œand thatâ€™s why recently we have spent so much time prompting and educating people that they have the right to request access to their records.â€? In addition, she said, patients should not wait to be offered such access, they should â€œdemand access.â€? For his part, Daniel Barth-Jones, an assistant professor of clinical epidemiology
Add more... accuracy efficiency mobility comfort
...to your venous reflux studies The VenaPulseÂŽ Hands-Free Augmentation Device Â‡ 'RFXPHQWIURPSHUIRUDWRUVWRVDSKHQRIHPRUDOMXQFWLRQZLWK standardized augmentations* Â‡ Save timeRQHDFKYHQRXVUHĂ€X[H[DPLQDWLRQ Â‡ (DVLO\carry the deviceIURPURRPWRURRP Â‡ Avoid injuryZLWKHUJRQRPLFGHVLJQ
Âł3URVSHFWLYHFRPSDULVRQRIWKHSQHXPDWLFFXŕŻşDQGPDQXDOFRPSUHVVLRQPHWKRGVLQGLDJQRVLQJ ORZHUH[WUHPLW\YHQRXVUHĂ€X[Â´6..DNNRVHWDO9DVF (QGRYDVF6XUJHU\9RO1RSS
Mention This Ad and Get Information About the Free Trial Program for Your Facility: 7ROO)UHH www.ACIMedical.com/VenaPulse $&,0HGLFDOFRP9HQD3XOVH
Proudly made in the USA L 5.72 Rev. 001, 11/09/15
Attention Independent DME Dealers Call ACI Medical for the opportunity to carry the VenaPulseÂŽ device! Flexible options available (888) 453-4356
continued on page 25
VEIN THERAPY NEWS JUNE/JULY 2016
CRYSTAL CLEAR DIGITAL MARKETING Vein practices discovering unique software, marketing and consulting platform By Larry Storer Vein practices across the United States have discovered a unique software, marketing and consulting platform designed to increase their online results while improving the performance of internal team members. With more than 80 percent of modern medical consumers using the Internet to find and choose a vein provider, the pressure has been increasing for practices to develop effective strategies to capture and retain valuable patients in a super competitive marketplace. The bigger challenge was understanding the important connection between digital marketing activities and the people/processes necessary to convert online inquiries into happy loyal patients, according to Tim Sawyer, founder and president of Crystal Clear Digital Marketing (crystalcleardm.com). In other words, looking at technology and marketing as separate from people and process was actually adding to the problem. “Crystal Clear Digital Marketing is an innovative software, marketing and consulting
company that has created a solution to allow vein practices to optimize their sales, marketing and patient satisfaction metrics at every point throughout the patient lifecycle,” Sawyer said. “Our unique platform was built for vein practices to find, serve and keep modern medical consumers.” The Crystal Clear platform includes highend, mobile responsive multimedia websites designed to increase the important conversion rate of unique visitors into online consultation requests, as well as increase traffic to the practice phones. Their marketing efforts include search engine optimization focused on the top treatments and procedures offered by the practice. Sawyer said this includes unique blogging content, a strong back linking strategy, as well as propriety software program that makes search engine optimization easier to manage and measure. “Additional marketing elements include automated email marketing, promotional and specials marketing campaigns, plus consistent social media posting across the major channels such as Facebook, Twitter, Pinterest and LinkedIn.
Cook Medical continues recall of Beacon Tip catheters Cook Medical has initiated a voluntary recall of 4,146,309 catheters with Beacon Tip technology. Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation, which have resulted in 30 Medical Device Reports to date. Potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system and other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs. Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to Cook as soon as possible for credit. Catheters with Beacon Tip technology are intended for use by physicians who are trained
and experienced in each of the procedures for which these devices are indicated for use. Included, but not all, are Beacon Tip Torcon NB Advantage Catheter, which are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. Also, Beacon Tip Royal Flush Plus HighFlow Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip White Vessel Sizing Catheter and Beacon Tip Vessel Sizing Catheter intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. Consumers with medical questions or concerns should contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235. VT N
“There are many solid digital marketing providers offering various components of this platform, but Crystal Clear has found a way to tie all of these elements together in a cohesive way that consistently delivers above average results. The biggest differentiator is our approach to optimizing every point of the sales and marketing funnel. “We have addressed the million dollar question: ‘Once you figure out how to drive more traffic to your website and phones, now what?’ What are the processes and training required to help overworked and undertrained internal team members convert these online submissions and phone calls into happy loyal patients?” The answers to these questions are the difference between success and failure with all marketing initiatives. The Crystal Clear platform offers a comprehensive virtual training lab for practice managers and owners to get the answers to these important questions and more. Sawyer said it’s the simple things like how to respond when a patient asks, “what is the typical cost for sclerotherapy injections?” or “what does the doctor charge for an angiogram treatment?”
These questions are not easy for even well trained front office teams. The virtual training lab offers solutions on how to focus on value over price, as well as the importance of the provider’s experience. He said the fastest growing vein practices have discovered that any marketing and technology solution divorced from the optimization of your people and processes has little to no chance of long term sustainable success. “The Crystal Clear platform makes it easy for practice managers and owners to make intelligent management decisions through their easy to read and understand monthly reports that highlight areas of success, as well as key areas of improvement,” Sawyer said. According to Avron Lipschitz, MD FACS, “Without Crystal Clear, it would be next to impossible to measure, track and manage the most important functions in my practice. The reports keep my staff and I focused on the right things at the right times, which has led us to 50 percent growth over the past 12 months. Something we could not have accomplished on our own.” VT N
Inbound marketing content made simple with marketer’s guide By Mark D. Shipley Writing can be exhausting, but rewarding when it’s done right. That’s the hard part. Healthcare marketing strategies usually include all types of inbound content across a variety of platforms. There’s content for websites and content for social media, press pitches, email blasts and news releases. Then there are e-books, white papers, blog posts and articles. Understanding the strengths of each and what topics are appropriate for certain content types isn’t always clear. What makes a great subject for a blog post may not be suitable for a white paper. Maybe that white paper fits better as an e-book. Or, perhaps, that e-book could have been better summed up in an article. If your organization wants to stand out from the competition and position itself as an industry thought-leader, it’s important to set specific content guidelines. With an abundance of content out there, when you grab a consumer’s attention, it is imperative
they stay interested and impressed with your material. We broke it down and created this guideline to help your organization make a distinction:
E-BOOKS Health systems can greatly benefit from publishing an e-book. Why? Not only do they lend credibility to your claim of expertise, but they also generate on-site conversions by consumers or others who download the book. When crafting an E-book, subjects should be broader and more thoroughly researched. It’s likely with an e-book, you’re attracting the kind of audience who expects high level and consultative narrative. Think about population health issues such as cigarette smoking, obesity, depression or “how to” topics such as lose weight, eat healthy or be happy, hospitals and health systems are well versed on these topics and can easily expand on them. For INBOUND MARKETING continued on page 30
JUNE/JULY 2016 VEIN THERAPY NEWS
THEPRACTICE First NOAC to be assessed in study of patients with blood clots in veins Boehringer Ingelheim of Ingelheim, Germany, will undertake the first prospective, randomized controlled study of a non-vitamin K antagonist oral anticoagulant (NOAC) in patients with blood clots in the veins or venous sinuses of the brain. RE-SPECT CVT will investigate the safety and efficacy of dabigatran etexilate (Pradaxa) compared to warfarin for acute treatment and secondary prevention of cerebral venous thrombosis (CVT). The new study was announced at the 2 nd European Stroke Organization Conference 2016 in Barcelona. Cerebral venous thrombosis (CVT) occurs when a blood clot forms in the brain’s veins or venous sinuses, the channels that drain blood from the brain. If these veins or channels become blocked, blood is unable to leave the brain. This can lead to an increase in intracranial blood pressure, congestion and leakage of blood into the brain tissues, which can eventually lead to a hemorrhagic stroke. Although relatively rare, CVT requires immediate medical attention and can lead to serious long-term complications. Standard therapy for acute CVT treatment and secondary prevention of recurrent blood clots currently involves anticoagulation with unfractionated or low-molecular-weight heparin, followed by a vitamin K antagonist (VKA - warfarin). Dabigatran etexilate has already been shown to be effective in the treatment and prevention of other types of blood clots with a favorable safety profile compared to VKA therapy. RE-SPECT CVT will investigate whether dabigatran etexilate also provides treatment advantages to patients with CVT. “We are very excited about this new study,” said Prof. José M. Ferro, department of neurosciences and mental health at the Hospital Santa Maria in Lisbon, Portugal. .”Patients with CVT need effective treatment and we believe that they can benefit from recent advances in anticoagulation care. The RE-SPECT CVT study will provide physicians with additional knowledge to address unmet medical need in this indication.” The RE-SPECT CVT study is the latest part of Boehringer Ingelheim’s innovation in anticoagulation care for patients and physicians. Boehringer Ingelheim launched dabigatran etexilate, the first NOAC for stroke prevention in patients with atrial fibrillation and in 2015 gained approval for idarucizumab, the first and only specific NOAC reversal agent to be approved for use in emergency situations when immediate reversal of the anticoagulant effect of dabigatran is required. VT N
! W NE Tumescent Delivery System
ON/OFF or Variable Speed Foot Pedals Available
Call for a quote TODAY! 888-868-8346 Tumescent Pump Tubing http://totalvein.com
Your complete vein surgery supply source *Best case prices
VEIN THERAPY NEWS JUNE/JULY 2016
The Miami Vein Center offers a world class patient experience from click to brick
Jose I. Almeida, MD, FACS, RVT
By Tim Sawyer Jose I. Almeida, MD, FACS, RVT and founder of the Miami Vein Center (MVC), is a world-renowned vascular surgeon and pioneer in endovenous therapy. Dr. Almeida is also a well-known thought leader in endovascular venous surgery, evidenced by his work as founder and course director for The International Vein Congress. He and his staff have performed thousands of procedures for varicose and spider veins with outstanding results. The Miami Vein Centers offers their patients a world class experience from the time they walk through the door into the beautifully appointed modern state of the art facility.
In June 2015, Dr. Almeida and his team sought to extend their world class approach outside their doors and onto the internet. They wanted the digital experience for new and existing patients to meet and exceed the demands of the modern medical consumer. They invested in a series of initiatives to improve their online visibility and simplify the process for patients seeking vein treatments in and around Miami. Their integrated digital strategy began with the creation of a fully mobile responsive website that was easy to navigate and offered the important information vein patients need to make educated decisions around choosing the right provider. Dr. Almeida and his team understand the importance of making it easy for patients to search their website via smart phone, tablet, laptop or desktop. Their research confirmed that almost 65 percent of all searches are launched through a mobile device. In addition to the website, their digital strategy included a strong focus on search engine optimization. Through consultations with Crystal Clear Digital Marketing, the team at the MVC decided to place an emphasis on procedural-specific educational blogs to increase value to prospective patients, as well as drive traffic to high conversion multimedia landing pages. One blog alone written in September of 2015, was responsible for the more than 25 percent of the traffic to their website in March 2016, six months later! In addition to search engine optimization and blogging, MVC focused on site conversion of unique visitors to
online appointment requests, social media and more importantly a commitment to measuring their results. From June 2015 to March 2016, Dr. Almeida’s strategy has proven to be a huge success. Consider the following: • The number of new unique visitors to the site increased by more than 124 percent. • Online inquiries via website forms and phone calls increased by more than 69 percent. • The site ranks on the first page organically with Google and Bing for all the important search phrases associated with the Miami Vein Center. • Anecdotally, patients often mention how much they appreciate the MVC”s commitment to providing education through the website, social media and blogging. They enjoy connecting the way they want to connect. It all starts with expert care. Dr. Almeida’s reputation as one of the top vascular surgeons in the world combined with the quality compassionate care offered by his team, has made it possible to consistently attract new patients to the MVC via word of mouth referrals as well as online. VTN.
Tim Sawyer is founder and president of Crystal Clear Digital Marketing. He can be reached by email at email@example.com or by calling 401-519-6110. More about Crystal Clear Marketing is available at crystalcleardm.com . 16
JUNE/JULY 2016 VEIN THERAPY NEWS
BURNOUT & BIAS Medicine’s 2016 ‘Evil Twins’ can affect care of patients computerization as an important stress factor. In support of this, in the Medscape survey, the importance of this issue as a cause of burnout went steadily up as physicians aged, with the youngest group ranking computerization at only 2.96 compared with 5.02 among the physicians between 56 and 65 years of age. This year, the survey added the option “maintenance of certification requirements,” which was in sixth place at 3.66 as a cause of burnout. With changes in maintenance of certification requirements coming from physician accreditation organizations, it can be hoped that this factor, too, will decline as an important cause of burnout as time goes by. Many physicians commented anecdotally, noting some additional causes of burnout. By far, the most frequently mentioned were insurance issues. Other often-cited causes of stress were threat of malpractice, the change to ICD-10, and lack of patient respect and appreciation. Many physicians also added family stress as a factor.
By Carol Peckham This year’s “Medscape Lifestyle Report” covers two important aspects of a physician’s personal life that could affect care of patients: burnout and bias. More than 15,800 physicians from more than 25 specialties responded, providing some surprising responses relating to these issues. The survey also asked physicians about marijuana use and prescribing; political and religious leanings; and whether they were healthy, wealthy and happy.
PHYSICIAN BURNOUT RISING This year’s Medscape survey, echoing other recent national surveys, strongly suggests that burnout among U.S. physicians has reached a critical level. Burnout is generally defined as loss of enthusiasm for work, depersonalization, and a low sense of personal accomplishment. Burnout now even has its own code (Z73.0) in the 10th edition of the International Classification of Diseases (ICD-10), which defines it as a “state of vital exhaustion.” Some experts have suggested that burnout might be an illness in its own right, but research suggests that it is probably a form of depression, rather than a distinct disorder.
GENDER & BURNOUT
BURNOUT PERCENTAGES A survey published this year in the Mayo Clinic Proceedings on all physicians compared burnout between 2011 and 2014, and observed an increase in the percentage of physicians reporting at least one burnout symptom, from 45.5 percent to 54.4 percent. This year’s Medscape lifestyle survey supported these findings, reporting higher burnout rates for the great majority of specialties this year even compared with last year. The highest percentages of burnout occurred in critical care, urology, and emergency medicine, all at 55%. In last year’s report, critical care and emergency medicine were in the top two spots, with only slightly lower burnout percentages (53 percent and 52 percent, respectively), and urologists were in 10th place, at 47 percent. Higher burnout rates among emergency medicine physicians and intensivists have been noted in the literature as well. The effect of this higher rate on these professions compared with others is unclear. In one of the studies, the projected attrition rate among emergency medicine physicians was no greater than in other specialties. Emergency medicine physicians, however, are toward the bottom in burnout severity scores in this year’s Medscape report; in contrast, intensivists reported the highest severity rating, which might have a larger long-term effect on these specialists.
This year, family medicine and internal medicine, in fourth and fifth places, followed the top three closely, with 54 percent reporting burnout. In 2015, these primary care physicians were third and fourth, at 50 percent — still within the top five, but with a lower burnout percentage than this year.
SEVERITY OF BURNOUT Just as the percentages of physicians reporting burnout have increased among nearly all specialties compared with last year’s Medscape Lifestyle Report, so have the severity ratings. Physicians were asked to rate the severity of their burnout on a scale of 1 to 7, where 1 equals “It does not interfere with my life” and 7 equals “It is so severe that I am thinking of leaving medicine altogether.” This year, among all physicians reporting burnout, intensivists and neurologists had the highest average severity ratings (4.74 and 4.42, respectively). Last year, nephrologists at 4.30 and cardiologists at 4.29 were the top two, although their scores were lower than they were this year (4.39 and 4.37, respectively). It is notable that the severity of burnout reported by these two specialties last year — the worst among all specialties — was lower than the severity reported by the top two specialist “winners” this year.
The second lowest severity rating this year was reported by rheumatologists (3.91), who reported the lowest severity of burnout last year. However, consistent with virtually all of physician specialties, the reported severity of burnout in this specialty was higher than last year’s score (3.66). Psychiatrists, at 3.86 this year, reported the lowest average severity — but contrary to most other physicians, that score was slightly lower than the one they reported in 2015 (3.89). Of note, a major recent survey of U.S. physicians reported a decrease in satisfaction with work/life balance between 2011 and 2014, from 48.5 percent to 40.9 percent.
BURNOUT CAUSES The major triggers of physician burnout are certainly work-related stressors. Physicians in this year’s survey who reported burnout were asked to rank the causes on a scale of 1 to 7, with 7 being the most important. Bureaucratic tasks came in first, at 4.84, followed by working too many hours, at 4.14. Increasing computerization came in third (4.02) as a major stressor, which is supported in recent literature. Over time, however, as systems improve and computer knowledge among physicians becomes more widespread, one could anticipate a decrease in
In this year’s Medscape lifestyle survey, as in previous years, more female physicians (55 percent) expressed burnout than their male peers (46 percent). Other research has supported this disparity. These percentages have trended up for both genders since this question was first asked in Medscape’s 2013 survey, when 45 percent of women and 37 percent of men reported burnout. One study identified differences in the type of burnout suffered by female and male physicians, with more women reporting emotional exhaustion and more men scoring higher on depersonalization and personal accomplishment.
WHAT IS BEING DONE NOW TO IMPROVE BURNOUT? Interventions for physician burnout are typically psychologically oriented and skewed toward the individual, although strong evidence suggests that what’s needed are systemic changes in the way physicians are trained and in the organizational cultures that affect physicians throughout their careers. In looking at systemic approaches for reducing burnout, many experts have pinned their hopes on patient-centered medical homes (PCMHs) and accountable care organizations. Several of these programs have been established over the past several years, with the expectations that they would not only improve care and reduce costs but also increase patient and staff satisfaction. The results to date have been mixed. One recent and hopeful study looked at PCMHs in the Veterans Health Administration. Researchers developed
JUNE/JULY 2016 VEIN THERAPY NEWS
SECONDLOOK measures to determine whether effectively implemented PCMHs improved patient satisfaction and reduced staff burnout compared with those that were less effectively set up. Results of the study suggested an association with patient satisfaction, lower staff burnout and improved quality of care in PCMHs with the highest scores for effective implementation. It should be noted that the Veterans Health Administration has a large wellintegrated electronic health record and quality-improvement system. The authors hope, however, “that as accountable care organizations evolve, this type of patientcentered measurement could be adopted by other large integrated health systems,” which could lead to improved physician and patient satisfaction levels.
DO PHYSICIANS HAVE BIAS TOWARD SOME PATIENTS? In this year’s Medscape survey, physicians were asked whether they believed that they had biases toward specific types or groups of patients. Overall, 40 percent of physicians admitted that they did. Within the top 10 of those who expressed some degree of bias were physicians who had the most direct contact with patients: emergency medicine physicians (62 percent), orthopedists (50 percent) and psychiatrists (48 percent), followed by family physicians and OB/GYNS (47 percent). Two of the specialties least likely to report bias were those also least likely to be directly involved with patients: pathologists (10 percent) and radiologists (22 percent). Cardiologists were also in the bottom three and reported a percentage of bias equivalent to that reported by radiologists. One limitation to this survey is the issue of implicit bias — also called “unconscious” or “nonconscious” bias, which can unwittingly perpetuate disparities and affect treatment. Whether identified as a low- or highprejudiced individual, studies indicate that all persons automatically respond to cultural stereotypes. In one study, those who were low-prejudiced tended to repress stereotypical thoughts and replace them with those that reflected equality. Implicit bias plays a strong role both in physician behavior and in patient responses. One physician who responded to this survey commented, “While my subconscious attitudes and perceptions may be affected, I check these at the door and do my best to be empathic no matter what.”
Only EHR interfaced with the American College of Phlebology Pro Venous Registrywhich automatically collects both physician and patient reported outcome data
Achieve Meaningful Use Stage 2– 2014 ONC Certified
Vein specific templates – Consults, Follow ups, Ablations, U/S, Phlebectomy, cosmetic procedures
iPad Clipboard Application & Patient Portal
Endovascular specific templates – DVT treatment, Iliac Stent placement, IVC Filter, Internal Iliac Embolization, Gonadal Vein Embolization
Ideal for Start-up clinics, help with Insurance credentialing & graduated scale billing pricing
PQRS and ICD-10 ready
Templates auto-calculate CEAP & VCSS
Nurses Notes for pre, intra and post op
Advanced Scheduling capabilities – Auto reminder calls
Before & After Leg Photographs – interfaced with Appworx
Structured Reporting Interfaces with Ultrasound Equipment
Integrated PACS and DICOM viewer
No money down, financing available
Integrated inventory management
FACTORS THAT TRIGGER BIAS When physicians who admitted biases were given a list of patient characteristics that might be a potential trigger, the two that
firstname.lastname@example.org Sales@streamlinemd.com http://www.streamlinemd.com A PRC Medical Company www.streamlineMD.com
BURNOUT continued on page 20
VEIN THERAPY NEWS JUNE/JULY 2016
THEPRACTICE However, in the study, anti-fat bias was significant even among the most obese physicians. Race. Although only a small percentage of physicians admitted bias related to a patient’s race (13 percent), implicit bias toward these patients should not be underestimated, particularly in the unconscious effects of stereotyping on treatment. Studies suggest that black and Hispanic patients in emergency departments receive less pain relievers than white patients. Implicit bias in favor of white persons also affects patient response. In one study, black patients tended to react less positively to physicians with relatively low explicit but relatively high implicit bias than to physicians who were either low in both explicit and implicit bias, or high in both explicit and implicit bias. Gender. An even smaller percentage of physicians admitted to gender bias (8 percent). Dermatologists at 20 percent had the highest percentage of gender bias; all other physician group percentages were 12 percent or under. As in race, however, implicit bias should not be underestimated and is known to result in disparate treatment of women vs men, particularly under-treatment. An important example was a major study published in the New England Journal of Medicine, which found that the degree of underuse of arthroplasty for severe arthritis in women was three times greater than that in men.
BURNOUT continued from page 19
garnered the largest responses were emotional problems (62 percent of men and women) and weight (52 percent of all physicians). Other characteristics that were major bias triggers for physicians were intelligence (44 percent), language differences (32 percent) and insurance coverage (23 percent). Less than 20 percent of physicians chose other characteristics. When asked to add other triggers verbally, physicians most frequently cited drug-seeking and abuse. Also mentioned very frequently were malingering, entitled and noncompliant patients. Of interest, patients with chronic pain also evoked bias in many physicians. Responses were similar between men and women, although some differences were observed for weight (48 percent of women vs 56 percent of men), insurance coverage (19 percent of women vs 26 percent of men) and income level (8 percent of women and 17 percent of men). Of interest, very few male or female physicians admitted to gender bias (8 percent and 7 percent, respectively).
DOES BIAS AFFECT TREATMENT? Only a small percentage of all physicians who admitted bias reported that it actually affected their care of patients. As one would expect, specialists who rarely see patients did not believe that this bias affected their treatment of patients (pathology at 1 percent and radiology at 2 percent). Nevertheless, percentages were also low among oncologists, cardiologists and critical care (all 4 percent). The highest percentages of those who report that their bias affects treatment are emergency medicine physicians (14 percent) and plastic surgeons (12 percent). Other physicians who were over 10 percent were orthopedists, family physicians, psychiatrists and rheumatologists (all 11 percent). It should be stressed that the effect of bias on treatment can be negative, positive, or both. The Medscape survey asked physicians two questions on the effects of their biases: whether they resulted in positive treatment (eg, extra time, friendlier manner), or whether they negatively affected treatment (eg, spending less time or being less friendly). Responders could answer “yes” to both questions. One quarter of those whose biases affect treatment believed that they overcompensated and gave patients special treatment, whereas 29 percent admitted that their biases had a negative effect on treatment. Twenty-four percent believed that their biases have both positive and negative effects, and another 22 percent suggested that neither choice was applicable.
EFFECT OF BIAS ON CARE For every specific patient characteristic included in the survey, slightly more physicians reported that biases resulted in positive treatment (more time, more friendly) compared with negative treatment (less time, less friendly). It is useful, however, to look at some of these characteristics separately. The emotional or difficult patient. Sixty-two percent of both women and men who had biases picked emotional problems in their patients as the factor mostly likely to trigger bias. Among the small group of physicians who said biases affected treatment, more of them believed the effect was positive (78 percent) than negative (72 percent). This still meant that nearly three quarters of these physicians were less friendly and/or gave these troublesome patients less time. The emotional patient can fall under the umbrella of “difficult,” a term used to refer to those with whom a physician may have trouble forming a normal therapeutic relationship.
WHICH FACTORS CONTRIBUTE TO BIAS?
Reports describe difficult patients as having depressive or anxiety disorders or severe and multiple somatic symptoms. Indeed, although not listed as an option in the Medscape survey, many physicians who responded verbally to the question on bias triggers, frequently sited chronic pain, which is often included in the criteria for difficult patients. Perhaps the best description of such patients was written by Tom O’Dowd, MD, in the British Medical Journal in 1988: “There are patients in every practice who give the doctor and staff a feeling of ‘heart sink’….They evoke an overwhelming mixture of exasperation, defeat and sometimes plain dislike that causes the heart to sink.” Weight. Weight came in second as a bias trigger, with more than one half of physicians (52 percent) who expressed bias citing it. More men (56 percent) than women (48 percent) reported this bias. Among the small group who said their bias affected treatment, 63 percent said the effect of this bias was positive, but an equally large percentage (61 percent) conceded that the effect was negative. Weight is often cited in studies as a concerning physician bias and has specifically been observed to elicit negative attitudes, including lack of emotional rapport with obese patients. In the Medscape survey, explicit weight bias was strongest among proceduralists, suggesting that the physical difficulties of dealing with an overweight or obese patient may play a strong role in triggering bias. Nevertheless, one should not underestimate the implicit psychological and emotional bias against overweight patients, regardless of the physical difficulties of dealing with obesity and overweight. Weight bias toward patients is observed starting with physician training. One study found that thinner physicians were more likely to have both implicit and explicit bias against heavier patients than physicians who were heavier.
The survey looked at certain physician lifestyle and demographic factors (burnout, age, location, religion, political leaning) in relationship to bias. Some associations were observed, but it would be difficult to draw conclusions from them. Age and bias. When looking at age groups, the percentages of physicians who admitted biases steadily decreased with age. Nevertheless, when looking at the effects of physician age on patient treatment among physicians who admit such effects, negative treatment (less time, less friendly) increases with age as positive treatment decreases (more time, more friendly) More than half of physicians older than 46 years reported that biases affect treatment negatively, compared with less than one half saying that they result in overcompensation and giving patients special treatment. Among those aged 45 years or younger, the reverse holds: More than half report that their biases result in more positive treatment, compared with fewer whose biases result in negative approaches. Location and bias. The greatest percentage of physicians who said they were biased live in the Northwest (49 percent) and the West and Southwest (both 43 percent). The East Coast harbors those who expressed the lowest bias levels: Northeast, Mid-Atlantic, and Southeast (all 37 percent). In general, the longer a physician lives in the United States, the more likely he or she is to develop bias. Only 27 percent of those who came to the United States as adults said they were biased, compared with 38 percent who have lived here since childhood and 43 percent of those who were born in this country. Spirituality and bias. Some research suggests that religious fundamentalism is linked with prejudice toward a wide variety of minorities. The Medscape survey, however, found little relationship between spiritual belief and bias. Similar percentages of physicians who said they had a spiritual belief or had none also said they had no biases toward patients (61 percent and 58 percent, respectively). Political leaning and bias. It is of some interest that regardless of whether they describe themselves as fiscally
JUNE/JULY 2016 VEIN THERAPY NEWS
THEPRACTICE conservative or liberal, physicians who defined themselves as socially liberal had higher percentages of bias (43 percent and 42 percent, respectively) than physicians who said they were socially conservative (38 percent and 35 percent). Of note, a 2013 analysis examining implicit bias toward black persons found a higher rate among conservatives than liberals. Study participants were shown a series of faces that were morphed from 100 percent black to 100 percent white. Participants who selfreported as conservatives were more likely to categorize faces that were racially ambiguous as black. However, the argument on whether conservatives or liberals are more or less biased is itself fraught with bias.
BIAS & BURNOUT: A CONNECTION? In this survey, physicians who reported burnout were more likely to also report bias. Forty-three percent of physicians who expressed burnout reported that they also experienced bias; in contrast, just over one third (36 percent) of non–burned-out physicians reported bias. If one aspect of burnout is depersonalization, then one would expect there to be a particular risk for the burned-out physician to be biased toward the emotional or difficult patient. The Medscape survey, however, showed only a slight relationship between burnout and bias toward “emotional” patients, with 27 percent of burned-out physicians citing these patients as a bias trigger compared with 22 percent of non–burned-out physicians. Nevertheless, difficult patients have been found to increase the chance of not only bias but also burnout. Emergency medicine physicians may be at particular risk. In the Medscape survey, the highest percentage of physicians admitting bias was seen among emergency medicine physicians, who were also in the top three of burned-out specialists. One survey found that a high percentage of emergency medicine physicians were burned out from treating patients who repeatedly used the emergency department inappropriately — for primary care or prescriptions, or as social centers. Three quarters of emergency medicine physicians expressed bias against these patients, and 59 percent had less empathy. An article in Family Practice Management on the difficult patient discussed burnout as a possible factor in exacerbating a negative response to not only these patients but to any patient. “Physicians who are burned out, stressed and generally frustrated over near-term crises or long-term concerns are more likely to react negatively to patients, not just those with characteristics that may contribute to a difficult encounter. Recognizing our own trigger issues and knowing what personal
baggage we bring into the exam room can be valuable.”
MARIJUANA USE & PRESCRIBING This is the second year that Medscape has included questions on marijuana use. Both this year and last, one quarter of physicians claimed to have ever smoked marijuana. No differences in use were observed between 2015 and 2016 among any age groups, with the heaviest use in both years reported among physicians aged 56-65 years (about one third). Given the increase in the number of states where marijuana has been legalized for medical use, physicians in this year’s Medscape survey were asked whether they are now prescribing it. As one would expect, the highest percentages reporting that they had prescribed it resided in the Northwest (10 percent), West (8 percent) and Southwest (7 percent), where medical marijuana is now legal. These percentages are still quite low, given the current limited evidence for its use. In this survey, physicians who prescribed marijuana most often did so for pain management (61 percent). Other conditions for which marijuana had been prescribed included multiple sclerosis (17 percent), glaucoma (10 percent), and inflammatory bowel disease (7 percent), conditions for which there is some evidence of benefit. A recent JAMA review on the benefits of medical marijuana found high-quality evidence supporting its use for chronic and neuropathic pain and for spasticity in multiple sclerosis. Some physicians who prescribed marijuana did so for conditions that are more common, but for which the evidence of efficacy is much weaker (10 percent for insomnia, 12 percent for mood disorders, and 14 percent for drugrelated adverse effects). Forty-three percent also chose “other.” Many of these physicians anecdotally described situations not listed in the survey instrument for which they prescribed marijuana, notably as an appetite stimulant for patients with anorexia, HIV and cancer. Respondents who prescribed marijuana also frequently used it to treat nausea and seizures.
OTHER TOPICS IN THE LIFESTYLE SURVEY Physicians & Happiness This year’s lifestyle survey, as did previous iterations, asked whether physicians were happy at home or at work, and results were ranked by the percentages of those who chose “very happy” or “extremely happy” in both settings. Happy at work. Gender differences were evident in responses to questions about happiness at work, with only 26 percent of all women reporting that they were happy in their work environment compared with one third of men. As noted above, more women
VEIN THERAPY NEWS JUNE/JULY 2016
than men also report burnout (55 percent vs 46 percent), which could certainly contribute to the happiness disparity in the workplace. Among specialists and primary care physicians who said they were either very or extremely happy at work, dermatologists and ophthalmologists were the most content (39 percent and 38 percent, respectively). Dermatologists and ophthalmologists were also the happiest at work in the 2014 Medscape survey, but the percentages that year (53 percent and 46 percent, respectively) were much higher than those reported this year. The least happy at work this year were internists and intensivists (24 percent and 25 percent, respectively). Bottom of the list in 2014 were family and emergency medicine physicians (both 36 percent), followed by internists at 37 percent. These low percentages, however, are still higher than those reported
by nearly all physicians this year, including those toward the top of the scale. Happy at home. Male and female physicians reported the same happiness levels at home (60 percent and 59 percent, respectively). When looking at all physicians, 68 percent of nephrologists reported that they were happy at home, followed by dermatologists (66 percent) and pulmonologists (65 percent). In the 2014 survey, dermatologists were most likely to report that they were happy at home (70 percent)—a higher percentage than that among the physicians most likely to report happiness outside of work this year. The 2016 report documents a small but notable decrease in percentages of respondents
BURNOUT continued on page 23
THE VIM & VIGR DIFFERENCE We have 4 Fabulous Fabric Collections. Something for every season! Listed with the Food and Drug Administration (FDA) COTTON
Partnership with Vascular Surgeons & Vein Clinics
Please contact us at email@example.com to learn more about our wholesale and referral programs.
AVOID BURNOUT Healthy habits aid physical and mental well being 3. Get creative with your water intake – We all know that water is a crucial component to living a healthy life. If drinking eight 8-ounce glasses of water per day ever gets to be a bit bland, try infusing the water with fresh fruits and herbs — remember maintaining your health doesn’t have to be a bore. These supercharged waters are a great way to stay hydrated while also gaining additional vitamins and minerals that will only help improve your health in the long run.
By Ann Nowak As a professional in the business of health and wellness, the vast majority of your hours likely revolve around work — even the days when you aren’t on call. Ninety percent doctor, 10 percent therapist, your job is to listen and focus on the needs of others, and sometimes that can push you past the point of exhaustion. Like a virus left untreated, if you allow the first signs of burnout to go unresolved it will grow into something that can take weeks or months to recover from. Dedicating time to monitor your own health can seem like a daunting task without the overtime pay; however, it is vital to recognize the importance of ensuring your own physical and mental wellbeing. Without your guidance, many of the people you tend to would not be able to receive the assistance they need. Maintaining your personal wellness doesn’t have to feel like a job, either. Setting aside time for a quick vitals check and making small changes to your daily habits is all you need to produce power-packed improvements to your health. This same realization came to Michelle Huie, founder and president of VIM & VIGR, when she moved to Missoula, Mont., from New York City. She found herself sitting for long periods of time at her new job, leaving her with achy, sore legs and new questions about her own health. When she mentioned her new sedentary situation and accompanying discomfort to a physical therapist, he recommended she wear compression socks. But Huie found that the compression industry swayed toward either athletic gear or socks geared around medical use and was unable to find any type of compression legwear that she could seamlessly incorporate into her daily lifestyle. Thus, VIM & VIGR was born as a high-quality compression legwear line with stylish designs to be worn all day, everyday. It was important to Huie to create a line of compression legwear that was not a “prescription” or task on her to-do list that she needed to remember to fulfill each day, but would still alleviate the real and painful symptoms of poor circulation. Thus, she built VIM & VIGR and the innovative compression designs as an easy way to be proactive about your health without completely altering your lifestyle. Huie partnered with vascular surgeons and vein specialists, and uses medical compression knitting machines for each VIM & VIGR product and has her facility listed with the Food and Drug Administration (FDA) so consumers can be assured they are receiving all of the medical benefits of true graduated compression wear. VIM & VIGR utilizes integrally-knit graduated compression so that each product energizes the legs by increasing the circulation of freshly oxygenated blood. VIM & VIGR’s high-quality compression legwear offers two levels of compression: 15-20 mmHg (millimeter per mercury) and 20-30 mmHg, which is a firm compression level that provides extra support if needed. Combining advanced technology and fashionable designs, VIM & VIGR gives people a simple way to be proactive with their health without disrupting their current lifestyle. These innovative knee-high compression socks, leg sleeves and tights help prevent swelling, alleviate achiness and heaviness, reduce and prevent spider and varicose veins and aid in muscle recovery to allow people to put their best foot forward. By maximizing their health and energy levels with compression socks, physicians, nurses, busy moms, office workers, travelers and athletes improve their quality of life with less leg pain and tiredness after long days standing or sitting, simply by
FOR YOUR MENTAL HEALTH 1. Make time for hobbies – It may sound counterproductive, but to avoid burnout, spend more of your time doing things, but in reality it is the polar opposite. Burnout does not solely spark from overextending your energy; it can also begin from an overall dissatisfaction with your current state. Failing to make time for hobbies and the things that make you truly happy, such as running, fishing or reading will leave you with nothing but work to add purpose to your days. Don’t let your PTO reach critical mass — it’s important to remember to build a life while building your career.
getting dressed. This would be a wonderful suggestion for your patients, but more so an easy way for you as a medical professional to care for your own wellbeing without consuming more of your precious time. Here is a list of simple tips to staying physically and mentally fit that you can incorporate and help prevent burnout:
FOR YOUR PHYSICAL HEALTH 1. Energize your legs – You likely prescribe and recommend compression garments to your patients, but do you wear them as well? If you spend most of the day on your feet, feeling exhausted at the end of your shift is understandable. As you know, sometimes the only energy you can muster is enough to heat up leftovers and turn on the TV, where you spend the rest of your evening on the couch. However, wearing compression legwear during the workday will keep your blood flowing and your legs energized, ensuring you’re able to spend your after work hours more productively. VIM & VIGR’s line of compression legwear is available in four fabric collections, including wool, cotton, nylon and moisture-wick nylon; a range of designs; and wide calf availability, making them as versatile for season as they are for body type. Prices range from $32.95 – $34.95 MSRP. VIM & VIGR also offers unisex moisture-wick nylon compression leg sleeves retailing for $24.95 MSRP and compression tights in solid opaque and argyle semiopaque retailing for $49.95 MSRP. 2. BYO lunch – Packing your own lunch allows you to balance the nutritional content of your meal and gives you control over the portion sizes. This is something on every patient’s self-care flyer but not always top of mind when you have only 30 minutes before your next appointment and the fastest meal option is a quesadilla from next door. Bringing your own meal is less expensive than eating out, allows you to save time by avoiding the lunch crowd and can be better for you.
2. Schedule your sleep time – According to the Center for Disease Control and Prevention (CDC), America as a nation is sleep deprived, with approximately 30 percent of adults reporting < 6 hours of sleep per day. As a physician, working long hours is one of the fastest ways to develop fatigue or burnout. In order to ensure you’re achieving your optimal sleep time (typically 7-9 hours) determine when you should fall asleep and when you should wake up to get the amount of sleep you function best with. Treat it like an appointment with one of your VIP patients that you cannot break; you’ll notice the difference in your energy and innovative thinking fairly quickly. 3. Incorporate yoga/stretching into your downtime – When you have a moment to catch your breath during your busy day, take the time to meditate or do a few simple yoga moves to keep your blood circulating. Yoga pulls your focus to your breath and helps you be mindful of the moment rather than the hectic day ahead of you. Overall, the important thing is to be proactive. There is no one prescription for your physical and mental health, so allowing yourself the space and patience to test what works best for you and your lifestyle is essential. And if it takes you several tries before you find which health tips boost your spirits most; remember, failure is the pivotal step in scientific theory! Hypothesis, test, fail, repeat until a solution is found. Keep at it and burnout will be a thing of your past. VT N Ann Nowak is the director of sales for VIM & VIGR, a line of high-quality compression socks that combine innovative technology and fashionable designs. Tasked with growing the VIM & VIGR brand, Nowak works closely with vein clinics throughout the United States to increase the education around the benefits of compression legwear. Nowak manages the 16 sales representatives across the country at the VIM & VIGR headquarters in Missoula. She may be contacted by email at firstname.lastname@example.org.
JUNE/JULY 2016 VEIN THERAPY NEWS
SECONDLOOK BURNOUT continued from page 21
describing themselves as happy outside of work for almost all physician specialties. In support of these results, a major recent survey of U.S. physicians reported a decrease in satisfaction with work/life balance between 2011 and 2014, from 48.5 percent to 40.9 percent.
PHYSICIANS & SAVINGS Men fare slightly better than women in their savings and debt, according to the Medscape survey. Sixty-three percent of male vs 58 percent of female physicians report that they have adequate savings or more, and no debt. Thirty-seven percent of female and one third of male physicians report minimal savings, unmanageable debt or both. In a 2015 Medscape survey on debt and net worth, 61 percent of physicians responded that they live within their means and have little debt, and 24 percent even live below their means. Nevertheless in this survey, only 52 percent of male physicians and 47 percent of their female peers believe their income and assets are sufficient to meet their needs. About one third of both men and women (33 percent and 35 percent, respectively) say that their assets aren’t enough right now, but they expect them to improve; 15 percent of men and 19 percent of women have no hope they will ever be sufficient.
The NEW TVS Radial 360° ™
A round beam… for a round vein… just makes sense! Atraumatic design for short sheath access
Radial tip provides uniform delivery of energy.
PHYSICIANS & HEALTHY LIFESTYLE Physicians and exercise. The most active physicians (those who exercise at least twice a week) are dermatologists (72 percent), orthopedists (69 percent), and ophthalmologists (68 percent). It is perhaps not a coincidence that dermatologists and ophthalmologists are also the happiest physicians at work. The least active are psychiatrists (43 percent) and endocrinologists (50 percent). Physicians and weight. When looking at physicians who reported that they were overweight to obese, of interest, dermatologists and ophthalmologists reported the lowest rates of overweight (23 percent and 28 percent, respectively), and they also had the highest happiness and exercise percentages. The heaviest physicians are pulmonologists (51 percent), family physicians (49 percent), and emergency medicine physicians (47 percent). VT N Carol Peckham is the director of editorial services for the Art Science Code LLC in New York City and she was previously editorial director for Medscape. This is the “2016 Medscape Lifestyle Report,” and is available with graphics and references at medscape.com/ viewarticle/856814 . It is reprinted here with permission.
“The TVS Radial laser ﬁber outperforms all other ﬁbers on the market. It maneuvers easily and has no burn back or ‘smoky taste’, resulting in a more gentle procedure for my patients.” - Michael Leary, MD Newport Beach, CA
Your complete vein surgery supply source
VEIN THERAPY NEWS JUNE/JULY 2016
SECONDLOOK DR. CAWLFIELD
I have occasionally needed patients to use 40-50 mm Hg graduated compression, with full compliance, for recalcitrant venous ulcerations.
continued from page 1
endovenous techniques and more comprehensive preoperative diagnostic ultrasound. The aim of the Recurrent Varicose Veins after Thermal Ablation (REVATA) study 3 was to study the nature of disease recurrence with endothermal techniques in a similar observational capacity. The majority had recurrent disease associated with a pathological perforator. The prevalence of incompetent perforators associated with recurrent disease in the REVATA study (77 percent) was as prevalent as in the REVAS study (73 percent). Recanalization rates in treated saphenous veins occurred in about 20 percent of recurrences and were due to either a perforator or branch inflow. About 24 percent of patients in the REVATA study had reflux detected in untreated anterior accessory saphenous veins. Sixteen percent of patients had recurrence in untreated small saphenous veins and 14 percent had recurrence in untreated great saphenous veins. The combined recurrence rates from the untreated great and small saphenous veins are, likewise, very similar to the disease progression rate of 31.7 percent in Perrin’s REVAS study. While some comparisons can be made between the REVAS and REVATA studies, the REVATA study did not readily mention any causes of recurrence, such as technical error, neovascularization and pelvic venous insufficiency. Perrin’s REVAS study didn’t mention recanalization as a cause of recurrence. This could seem as though some of the mechanisms of recurrence are particular to only one form of treatment, but there have been other studies that report neovascularization after endovenous ablation, and recanalization after ligation and stripping.4 Unfortunately, neither Perrin’s 2006 REVAS study nor the 2013 REVATA study could estimate the true prevalence of recurrent disease, as the patients were not enrolled in the study at the time of initial treatment. There have been several prospective, randomized controlled trials (RCTs) published since Perrin’s REVAS study that estimated the true clinical recurrence rates. But those studies had relatively low patient enrollment, did not include newer ClosureFast RF technology, and had fairly short follow-up periods.5 In January of 2016, O’Donnell published a “must-read” meta-analysis of seven randomized, controlled trials comparing endovenous ablations to ligation and stripping with a two-year minimum follow-up period.4 The study included more than 1,500 limbs, with 686 of those limbs receiving RFA or EVLA. The rates of clinical recurrence in the endovenous arm of the meta-analysis varied from as low as 9 percent in two years, to as high as 46 percent in five years. In all comparisons between endovenous ablation and surgical ligation, there was no statistically significant difference in the rates or locations of recurrence between the two treatment arms. (I had to re-read this section of the results and study Table II and Table V several times before I could believe it). More than half of the patients with recurrence – in both treatment arms of these studies – underwent re-treatment. This made me feel like I did when I found out Santa Claus wasn’t real. Surprised. Sad.
REDUCING RISK If the risk for recurrent varicose veins after endovenous ablations is truly more than 50 percent at five years, let’s reduce that risk. Here’s where to start: • Weight reduction is proven to reduce swelling and venous leg ulcers after bariatric surgery.6 While I do not recommend bariatric surgery as a first-line treatment, I do
counsel patients on the importance of trying to lose weight and why. • Graduated compression stockings worn longterm, after endovenous ablations, combats perpetual disease. A study published in 1994 compared daily use of graduated compression stockings to no stockings after open surgery.7 The author found a 6 percent recurrence rate in the stocking group and a 71 percent recurrence rate in the control (no stocking) group. Unfortunately, this study was hampered by dropout and crossover due to non-compliance, so take care in interpreting the results. Additional randomized controlled trials in this area would be valuable. A Cochrane review involving 466 patients found venous ulcer recurrence was significantly higher among patients who did not wear compression stockings.8 Recurrent vein disease doesn’t always involve ulcerations, so it’s difficult to apply these results to patients with C0 – C4 disease. However, if wearing graduated compression helps reduce the relapse rate of venous ulcers, it’s plausible [that it would] help reduce the recurrence rate of less severe vein disease and also recurrent disease after endovenous ablation. Subsequently, I recommend that my patients wear a minimum of 15-20 mm Hg, knee-high, graduated compression stockings at least five days a week. I also recommend 30-40 mm Hg compression for patients with risk factors for recurrence, such as: • Morbid obesity • Calf muscle pump failure • Previous recurrence • Deep venous insufficiency
With such high recurrence rates, it is no wonder that patients seek further treatment. But, I can only speculate why some patients come to see me after having treatments from another provider. I’ve gathered that these patients were either never educated on the disease process, advised of likelihood of recurrence or simply forgot. Informed consent, including a stated recurrence risk of at least 30 percent – but perhaps as high as 50 percent – should be employed. If patients find the risk of recurrence unacceptable, they may do better with conservative management only. Properly informed patients who experience recurrence usually understand it was not likely a technical or tactical failure. As a physician, my intent is to eliminate recurrent vein disease. However, proper education and counseling ensures that patients return to see me, rather than seek a competitor if need be. VT N Timothy J. Cawlfield, MD, is a phlebologist specializing in the treatment of vein disease at American Vein & Vascular Institute in Pueblo, Colo. Dr. Cawlfield is board certified in family medicine, a diplomate of the American Board of Venous and Lymphatic Medicine and an Advisory Board Member for Vein Therapy News. He has a hospital affiliation with Parkview Medical Center in Pueblo, and has completed the American Vein & Vascular Institute fellowship program. Dr. Cawlfield has written for a number of medical and industry publications. He graduated from the University of Colorado School of Medicine in 2004. He can be reached by email at email@example.com or by phone at 719-543-VEIN (8346). See americanvein.com for additional information.
RESOURCES 1 Perrin MR, Guex JJ, Ruckley CV, dePalma RG, Royle JP, Eklof B, et al. Recurrent varices after surgery (REVAS), a consensus document. REVAS group. Cardiovasc Surg 2000;8:233-45. 2 Perrin, Labropoulos, Leon. Presentation of the patient with recurrent varices after surgery (REVAS). J Vasc Surg 2006; 43(2): 327-34. 3 Bush RG, Bush P, Flanagan J, Fritz R, Gueldner T, Koziarski J, et al. Factors associated with recurrence of varicose veins after thermal ablation: results of the recurrent veins after thermal ablation study. ScientificWorldJournal 2014; 2014:505843. 4 O’Donnell et al. Recurrence of varicose veins after endovenous ablation of the great saphenous vein in randomized trials. J Vasc Surg: Venous and Lym Dis 2016; 4:97-105. 5 Van den Bos R et al. Endogenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg 2009; 49:230-9. 6 Sugerman HJ, Sugerman EL, Wolfe L, Kellum JM Jr, Schweitzer MA, DeMaria EJ. Risks and benefits of gastric bypass in morbidly obese patients with severe venous stasis disease. Ann Surg. 2001; 234:41–46. 7 Travers JP, Makin GS. Reduction of Varicose Vein Recurrence by Use of Postoperative Compression Stockings. Phlebology September 1994;9(3) 104-107 8 Nelson EA, Bell-Syer SE, Cullum NA. Compression for preventing recurrence of venous ulcers. Cochrane Database Syst Rev 2000;4:CD002303.
JUNE/JULY 2016 VEIN THERAPY NEWS
SECONDLOOK ERRORS continued from page 13
at the Mailman School off Public Health, said that de-identification concerns are top of mind when it comes to patient dataa privacy. There are two misconceptions about such data, he said. One is that it doesn’t work; the other is that it works perfectlyy and permanently. “The realityy is, HIPAA A compliance for de-identification provides some pretty important privacyy protections,” Barth-Jones said. However, perfect de-identification is not possible, and there’s no guarantee information will remain de-identified.” He added that there needs to be comprehensive legislation that prohibits re-identification off protected patient health information. VT N
Great jobs reduce stress, cut turnover Healthcare organizations named to Fortune’s 20 Best Workplaces in Health Care share a sense of camaraderie and pride in their work, and offer lessons to other healthcare systems that are trying to create a positive work environment that can attract and retain the best talent. The 20 workplaces ranged in size from 167 employees to 19,152, according to an article accompanying the list. Among the attributes that made them great places to work, the winning organizations: Overcame the natural hierarchy of a healthcare organization to create a friendly, emotionally supportive workplace where
VEIN THERAPY NEWS JUNE/JULY 2016
coworkers feel as though everyone is equal and they can count on coworkers to support them. Create a culture in which employees are proud of what they do and proud of where they work. Publicly recognize and reward employees for exceptional work or just for going the extra mile.
Leverage pride in the workplace to enhance employee engagement in other areas. Develop a shared-governance management structure in which employees and managers regularly work together to solve problems and improve processes. The organizations are rewarded with voluntary turnover rates far below industry averages, according to Fortune – 7 percent to 10 percent in some cases, compared with the industry average of 14.4 percent. The top 5 best healthcare workplaces were: Texas Health Resources in Arlington, Texas; Encompass Home Health and Hospice in Dallas; Preferred Home Health Care & Nursing Services in Eatontown, New Jersey.; Southern Ohio Medical Center in Portsmouth, Ohio; and Martin’s Point Health Care in Portland, Maine. VT N
Half of diagnostic radiologists cite burnout; hints offered to fight stress By Kate Madden That stress you’re feeling isn’t all in your head. Diagnostic radiologists are vulnerable to burnout, with nearly half showing symptoms in a recent study. Fortunately, there are six steps you can take to fight burnout, according to a new report from the American College of Radiology’s Commission on Human Resources. A 2015 survey showed that burnout of radiologists was seventh highest among all physicians, compared with being 18th highest just two years earlier. What’s more, a 2014 survey found that just slightly more than one-third of radiologists (37 percent) said they were happy at work. Burnout is a problem for individuals, but it can also have significant negative consequences for radiology practices and their patients, wrote a team led by Dr. Jay Harolds of Michigan State University in an article published in the Journal of the American College of Radiology (April 2016, Vol. 13:4, pp. 411-416). “Burnout can have adverse effects on professionalism, academic and clinical performance, patient safety, interpersonal relationships, personnel retention, and patient satisfaction,” Harolds wrote. Burnout is a mix of emotional exhaustion, a decreasing sense of accomplishment, and depersonalization -- that is, a negative and detached attitude toward oneself and others. Harolds said it can be caused by many factors: • Declining income • Inadequate training/skills for the job • Isolation in the workplace • Long hours • Poor intellectual stimulation • Poor relationships with colleagues and patients • Severe time constraints for work output • Too much night call • Unfair supervisors • Work overload Other risk factors include making medical errors, having struggles between work and home, poor work and lifestyle balance, and not taking care of one’s physical and emotional needs. Personality traits such as being perfectionistic, self-critical, or idealistic don’t help either, the group wrote. “Decreasing reimbursements mean that in order to make the same amount of income, radiologists need to read more studies,” Harolds told AuntMinnie.com. “Some do this to maintain a particular lifestyle, but others do it because medical school put them into $200,000 worth of debt. As well, technology like PACS has led to greater efficiency, but
Dr. Jay Harolds also to more isolation, since interactions with referring physicians are rare.”
AVOIDING BURNOUT Harolds and colleagues listed six potential risk factors for burnout and ranked them by order of importance. The team then offered suggestions for ways to reduce burnout risk: • Hire adequate staff. Not having enough radiologists to do the work of a practice is a key factor in burnout. “It may be helpful to offer to pay one or more members of the radiology group to work one or multiple additional hours as a volunteer rather than routinely requiring all the radiologists to work longer,” the authors wrote. • Mitigate stress. High-stress environments make doctors 15 times more likely to develop burnout. “Appropriate scheduling, time for adequate rest, a reasonable pace of work, and fairness in the workplace are important for preventing burnout,” they wrote. • Establish a sense of control. Burnout arises when radiologists aren’t involved in their practice’s decision-making, when there’s poor communication, and when staff achievements aren’t acknowledged. “Satisfaction in the workplace is high in organizations that emphasize teamwork, empower healthcare professionals by involving them in decision-making, recognize good work ... and have excellent communication,” according to the authors. They suggested that practices give their radiologists credit for contributions beyond clinical duties, offer mentoring programs, and provide a way for them to identify areas of dissatisfaction -- and then address them.
• Reduce night and weekend call duties. Some practices hire full- or part-time radiologists to handle night and weekend shifts, establish a reading station in another time zone, or make shifts shorter to mitigate this problem. • Encourage a balanced lifestyle. Studies have found that one of the best ways to prevent and treat physician burnout is to seek a balanced lifestyle, including physical, emotional and spiritual balance; taking care of oneself; and getting adequate time off. “A radiologist should seek to maximize time spent in various activities that he or she finds important,” the authors wrote. • Improve efficiency. Ideas for improving radiologist efficiency include hiring staff for dictation; using radiologist assistants, nurse practitioners, or physician assistants; and decreasing the amount of administrative work radiologists do. Practices should also help their radiologists set reasonable financial expectations and goals, reduce their isolation, and even hire professional help if needed, such as an organizational psychologist, Harolds and colleagues wrote. Another resource is the American Medical Association, which has an online module specifically about preventing physician burnout. The module includes the “Mini Zero Burnout Survey,” a free tool that helps track workplace stress among practice members.
AWARENESS IS KEY The Commission on Human Resources would like the radiology community to become more aware of the problem of burnout — and take action to address it, Harolds said. “We’ve got to help radiologists with their lifestyle balance,” he said. “If you’re constantly under tremendous work pressure, and you don’t have time for your family, for exercise, for activities you enjoy, that’s not a good recipe for health or happiness. The radiology community as a whole really needs to acknowledge this problem.” VT N Kate Madden is a staff writer for AuntMinnie.com, and is printed here with permission.
EHR frustration can play role in doctor burnout Doctors’ frustration with electronic health records and clinical quality reporting can
play a role in physician burnout, Steve Stack, MD, president of the American Medical Association, told EHRIntelligence.com. “Doctors will get behind things that support better quality of care and support them in their clinical practice. It’s the nonsensical stuff that makes it infuriating and challenging,” he said. “When we are going to get adverse consequences to ourselves or hospitals by complying with the current thinking in medical treatment rather than outdated quality reporting and regulation,” he continues, “those sorts of things are good examples where regulation is not a good tool at times to try to keep up with the fast pace of medical innovation, and good intentions can lead to undesired adverse consequences.” Providers can feel overworked and unsupported when federal mandates add to the stress of their already busy lives, leaving them working nights and weekends. Stack adds that many aspects of EHRs are frustrating – they are inefficient, they’re often not interoperable with other systems and they go down and paralyze the healthcare systems that depend on them. Stack pointed to recent evidence of physician burnout published last fall in Mayo Clinic Proceedings reporting a significant uptick in physicians reporting at least one sign of burnout over the past several years — from 45 percent in 2011 to 54 percent in 2014 — and what it means to a physician’s practice of medicine. “Now when physicians get burned out, they feel overworked, overburdened, overstressed, under-supported — just like anyone in any other profession, except that in this profession people rely on us to make very high-stakes decisions that directly impact their health and if we don’t get it right, the consequences are not retrievable unfortunately at times,” he maintains. A recent study found that physicians spend more than an hour a day dealing with the notifications they receive from their EHRs. In addition, medical interns spent as much as seven hours a day on EHRs and clocked an additional five hours a day on them even after they got used to the systems, according to a small study published in the Journal of Graduate Medical Education. The AMA is working to ensure that physician voices are better heard in the design of EHRs and in federal quality reporting and reimbursement requirements, Stack says. The situation for doctors participating in the Meaningful Use program may soon get more complicated. Docs in the Medicaid program and hospitals will remain in the MU program, which many have called outdated and overly burdensome; the Medicare doctors will move to theMerit-based Incentive Payment System (MIPS). The question is whether the two programs will be aligned. VT N
JUNE/JULY 2016 VEIN THERAPY NEWS
30TH ANNUAL CONGRESS
Vein Care in the Spotlight November 3-6, 2016
in vein care
Join your colleagues at the American College of Phlebologyâ€™s 30th Annual Congress for the largest and most comprehensive meeting in the U.S. dedicated to venous and lymphatic disease. The scientific program brings together a multi-disciplinary group of experts, addressing the full spectrum of deep and superficial vein care.
The 30th Annual Congress will provide practitioners with: + Opportunities to improve patient care at all levels of skill from basic through advanced + Presentations and exhibitors of the latest research, technology and trends in the field of vein care + Hands-on workshops and demonstrations with renowned experts from around the world
For additional details and and registration information, please visit:
advancing vein care
www.phlebology.org | 510.346.6800 http://www.phlebology.org
VEIN THERAPY NEWS JUNE/JULY 2016
PRODUCTNEWS TVS 1470 is the ultimate plug and play laser; physician says no technician needed: insert safety interlock and turn the key
This user-friendly laser comes in a two styles: a 15-watt desktop design or the compact and versatile 7-watt Nano design. Both offer an easy-to-use touch screen display.
SIGVARIS expands Microfiber Shades by adding four new striped color patterns SIGVARIS North America has launched several new graduated compression product additions to the Microfiber Shades line this summer. Microfiber Shades was designed to give people a fun, new way to wear compression every day, as well as start conversations with new and first time users about the health benefits of wearing compression.
SonoSite gets CE Mark, 501(k) clearance for SonoSite SII FUJIFILM SonoSite Inc. has received the CE Mark and FDA 510(k) clearance for its new mountable ultrasound system, the SonoSite SII. Developed for regional anesthesia, vascular access and trauma applications, the SII empowers efficiency for clinicians through a simple, yet smart user interface that adapts to the user’s imaging needs.
“This line has rapidly gained popularity since it was first introduced last fall,” Crystal Samples, new product development manager, said. “We are excited to deliver several new shades that our customers told us they wanted.” The Microfiber Shades line is available in four striped patterns, including dark navy, pink, onyx and graphite in 15-20mmHg and 20-30mmHg. For people who need to wear graduated compression every day, but want more fun, playful socks to add a pop of color to their wardrobe, these socks deliver. Wearing graduated compression can dramatically help improve overall leg health by increasing circulation to keep legs looking and feeling their best. SIGVARIS graduated compression products are constructed to be The system is portable and can be used across multiple environments, including a zero footprint option for space-constrained rooms. “SonoSite introduced the first mountable ultrasound system in 2007, providing an unparalleled solution for clinicians who valued and needed to accelerate their clinical workflow,” said Brian Leck, vice president, Global Direct Sales, FUJIFILM SonoSite Inc. “The new SII ultrasound system expands on the design goals of our mountable legacy system by offering more functionality, and an even better user experience from start to finish. We listened to clinicians, and delivered a product designed to maximize the efficiency of their ultrasound use. The SII captures the epitome of the SonoSite brand, allowing
Total Vein Systems, a supplier of vein surgery products with a reputation for providing high quality products at competitive prices, is offering the TVS 1470 Laser – what co-owner David Centanni calls the ultimate dream laser: no maintenance, no calibration, just plug and play. This user-friendly laser comes in a two styles: a 15-watt desktop design or the compact and versatile 7-watt Nano design. Both offer an easy-to-use touch screen display. Michael Bardwil, MD, and a user of the TVS 1470 Laser, said installation is as easy as 1-2-3. “No laser technician is necessary. Simply plug the laser in, insert the safety interlock and turn the key!” Studies have indicated that the 1470nm laser wavelength has a much higher interstitial water absorption rate compared to other traditionally used laser wavelengths. The higher rate of absorption by interstitial water allows operating at lower energy density (as
little as 2 watts), resulting in less thermal side effects. “The patients that I have treated with the TVS 1470 have experienced virtually no pain or complications and the results have been superior,” Dr. Bardwil said. Centanni said that in addition to superior results, the TVS 1470 Laser is affordable and compatible with low-cost laser fibers. “It is the only open laser system in this industry,” Centanni said. “Many physicians are requesting the higher wavelength laser systems for their practices. The low cost of the TVS 1470 allows them an economical option. In addition, The TVS 1470 has a universal SMA 905 connector that is compatible with many laser fibers from 380 to 1,000 micron cores. This flexibility allows the physician more cost saving options including reusable fibers” VT N READ MORE: totalvein.com or call 888-868-8346
Compression socks that will start a conversation. tightest at the ankle and decrease in pressure going up the legs, improving circulation and providing relief for tired, achy legs. Microfiber Shades offers wearers both comfort and durability. The advanced microfiber technology wicks away moisture clinicians to confidently use the system from day one.” For regional anesthesiologists, enhancing patient throughput is a critical need, especially as they perform an increasing number of ultrasound-guided procedures on a daily basis. The SII features a new touchscreen user interface with a clinician-driven menu logic that adaptively adjusts to the use case – “what you need, is what you see.” An embedded dual transducer connector also allows quick switching between transducers with two simple taps of the screen, ensuring that the right transducer is always readily available. To further accelerate end-to-end workflow, the SII comes with a new stand, offering elevated
to keep feet dry and comfortable all day long creating the perfect socks for work, travel and daily wear. VT N READ MORE: sigvarisusa.com
transducer holders and additional storage, all while minimizing footprint. The SII features DirectClear technology, a patent-pending process that is available on select transducers. DirectClear elevates transducer performance by increasing penetration and contrast resolution. This transducer innovation contributes to an unsurpassed imaging experience for the clinician. The SonoSite SII transforms the pace of patient care for proceduralists or those clinicians requiring a quick answer at a critical moment. VT N READ MORE: sonosite.com
JUNE/JULY 2016 VEIN THERAPY NEWS
In association with International Vein Congress, Vein Global is a year-round source forr venous education where users can watch high-quality y case videos of GHHSDQGVXSHU¿FLDOYHQRXV disease treatmentt featuring H[SHUWVLQWKH¿HOG.
EDITORIAL BOARD • Jose I. Almeida, MD, FACS, RPVI, RVT • Lowell S. Kabnick, MD, RPhS, FACS
• Edward G. Mackay, MD, FACS, RPVI, RVT • Julian J. Javier, MD, FACC, FSCAI
VIDEO CONTENT INCLUDES EDUCATION: Abstract • Procedure Videos • Case Studies • Slide Presentations RESEARCH: Video Interviews • Literature • Premarket Testing • Regulatory and Finance PRACTICE: ([SHUW2SLQLRQRQ3DWLHQW&DUH2I¿FH0DQDJHPHQW3UR¿OHVRI,QGXVWU\3DUWQHUs
Email us at firstname.lastname@example.org to receive our newsletter and updates regarding our latest videos. http://www.ivcmiami.com Miami, FL | April 20-22, 2017 VEIN THERAPY NEWS JUNE/JULY 2016
29 VeinGlobal LLC | 127 Main Street North | Woodbury, CT 06798
PRODUCTNEWS MIT, Mass General create second skin to cover up aging Research collaborators at MIT and Massachusetts General Hospital have come up with a special material that can act as a “second skin” to impart a youthful nature to aging skin and may be used as a wound dressing or even act as a drug delivery vehicle. The cross-linked polymer layer (XPL) that makes up the artificial skin is composed of a tunable polysiloxane-based material, a silicone-based polymer, which can be adjusted to achieve a specific elasticity, adhesion strength, and even light penetration to match the look of a person’s own skin. It’s applied in its liquid state using a dropper or some other device and it quickly cures after delivery without requiring special light or heat source. The material has been tested in an initial study on twelve subjects with herniated lower eyelid fat pads and demonstrated an impressive two point decrease in herniation appearance on a five point scale. The abstract to the study explains:
“We report the synthesis and application of an elastic, wearable crosslinked polymer layer (XPL) that mimics the properties of normal, youthful skin. XPL is made of a tunable polysiloxane-based material that can be engineered with specific elasticity, contractility, adhesion, tensile strength and occlusivity. XPL can be topically applied, rapidly curing at the skin interface without the need for heat- or light-mediated activation. “In a pilot human study, we examined the performance of a prototype XPL that has a tensile modulus matching normal skin responses at low strain (<40 percent), and that withstands elongations exceeding 250 percent, elastically recoiling with minimal strainenergy loss on repeated deformation. “The application of XPL to the herniated lower eyelid fat pads of 12 subjects resulted in an average 2-grade decrease in herniation appearance in a 5-point severity scale. The XPL platform may offer advanced solutions to compromised skin barrier function, pharmaceutical delivery and wound dressings.” VT N READ MORE: nature.com/ nmat/journal/vaop/ncurrent/full/ nmat4635.html
INBOUND MARKETING continued from page 1
clear indication of your experience in the field.
BLOG POSTS example, the Mayo Clinic has published a dieting book, a pregnancy tip book, a breast cancer book and a handbook for happiness, to name a few.
WHITE PAPERS, ARTICLES In the medical field, white papers can be difficult to write depending on your audience. From our research, we found hospitals mainly publish scholarly articles for scientific research. Which is a great way to impress physicians, but may not be a great way to engage patients. Publishing a white paper is an opportunity to show consumers the level of knowledge your organization has on a health related topic. Although topics may be high level and conceptual, articles should speak to your target audience in a way that is relevant and appealing. Typically, white papers cover a single subject in depth and focus on chief pain points of your target audience. For example, your hospital can write a white paper about health trends among millennial women or the top ten foods that can help lower men’s blood pressure. White papers are valuable because they generate onsite conversions, and provide prospective consumers or patients with a
Blog posts are the easiest way to reach health consumers. Shorter than a white paper, their purpose is to attract targeted visitors to your website and hopefully build traffic and frequency of visits. Blogs can also promote gated content (white papers or e-books), reinforce your claim of expertise demonstrates your healthcare system’s personality and more. They can be timely and refer to a trending subject, or they can simply discuss a problem your organization is comfortable expanding on. Don’t limit your blog posts. Different departments throughout your health system or hospital can host a blog. This may help boost your website’s SEO and help personalize posts. For example, your hospital can create a blog forum for nurses, where they can write about different patient experiences or tools and tips health consumers might find helpful. What areas of expertise could your hospital tap into to attract prospective patients? By understanding the strengths of each, you can tailor your content strategy, allocate resources for each content type and ensure your organization is reaching a large audience and generating meaningful results. VT N
JUNE/JULY 2016 VEIN THERAPY NEWS
Every Case tells a storyâ€Ś
Share one of your cases and you will contribute to the greater body of knowledge so that other physicians can benefit from your expertise, just as you will benefit from the case work of others. In each issue, Vein Therapy News brings case studies from doctors who have shared what they learned from surgeries, problems they encountered and how they resolved the issue for a successful surgery. Case studies are part of the learning experience for thousands of phlebologists around the world. Please look in your files and select one (or more) cases that you would consider sharing with your colleagues in the venous treatment community. Thereâ€™s no word limit, and we can use photos or illustrations if you have them. Please send it to:
Larry Storer: email@example.com or call 254.399.6484 to discuss.
Your trusted compounding provider
USP 795 and 797 compliant. Independent quality, sterility and potency testing.
Call for licensing information in your state.
* Commonly Requested Medications
June / JUly 2016 - Vol.9, No.4