INSIDE RIMI expands varicose vein therapy 6 VenaSeal comes to Colorado 12 34 groups ask for shortened MU deadline 16 Getting onboard with secure texting 18 How to “market” new physicians 21
APRIL/MAY 2016 Vol. 9 No. 3 VEINTHERAPYNEWS.COM
An ACP recognized resource for news and information for and about the phlebology community
Jury acquits Vascular Solutions, Root of ‘off-label’ promotion of its Vari-Lase Short Kit Vascular Solutions and CEO Howard Root have been found not guilty in a federal court case claiming that the company improperly marketed a device to treat varicose veins. A jury in the Western District of Texas in San Antonio unanimously ruled not guilty on all charges against Vascular Solutions and Root over alleged “off-label” promotion of the company’s Vari-Lase Short Kit. The ruling prompted Senior U.S. District Judge Royce Lamberth to submit an order to dismiss the case that is final and not subject to appeal. But Root is still angry about the former allegations and wants the Department of Justice (DOJ) to own up to its false claims about the company. “The company and I are vindicated by today’s verdict, but outraged by the obscene legal process we were forced to endure,” Root said in a statement. “There is simply no excuse for abusive and dishonest conduct in any U.S. governmental agency, much less
What comes first. . .
HAPPINESS or SUCCESS? By Jeff Miller It’s Monday. You walk by your front desk and overhear a conversation between your office manager and receptionist who are oblivious to your presence. The lobby is empty since it’s early in the morning
and your first patient hasn’t arrived. They are talking football! And they are laughing and having a blast recounting last night’s big game. HAPPINESS
continued on page 22
in the Department of Justice and our law enforcement agencies.” Root specifically called out Assistant U.S. Attorneys Bud Paulissen and Christina Playton of the Western District of Texas, Consumer Protection Branch Trial Attorneys Timothy Finley and Charles Biro, and FDA Special Agent George Scavdis. In 2013, grand jurors in the San Antonio court charged Root and Vascular Solutions with conspiracy and illegal promotion of its Vari-Lase Short Kit after a former employee filed a whistleblower suit against the company. Vascular Solution’s device was approved to treat varicose veins near the surface of the skin, but Root was charged with telling sales teams to market the product for short vein segments deeper in the leg.
VASCULAR SOLUTIONS
continued on page 25
Merz selects AngioDynamics to market Asclera to vein clinics AngioDynamics has signed an agreement with Merz North America to be the exclusive distributor of Asclera (polidocanol) Injection within the vein market in the United States. Merz has always been the sole marketer of Asclera. Going forward, AngioDynamics will market Asclera to the venous market while Merz continues to market it to the dermatology market. AngioDynamics has had a longstanding distribution deal with Mylan Labs to market Sotradecol, a competing drug, but that agreement ends in June. Asclera was approved by the U.S. Food and Drug Administration in 2010 for the treatment of uncomplicated spider and uncomplicated reticular (small varicose) veins. Asclera, like other pharmaceutical sclerosing agents, irritates the interior walls of the vein, causing them to constrict and close.
This prevents the flow of blood through the affected vein and can effectively eliminate the swelling, bulging, discomfort and discoloration which may be caused by small varicose veins or spider veins. In a multicenter, randomized, double-blind, placebo and comparator-controlled trial of patients with spider or reticular varicose veins, 95 percent of patients treated with Asclera showed good improvement or complete treatment success as rated by physicians; and 87 percent of patients were satisfied or very satisfied with their Asclera treatment . “At AngioDynamics, we believe that Asclera represents the future of sclerotherapy vein treatment,” said Joseph M. DeVivo, president
ANGIODYNAMICS
continued on page 30
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Reader Services SUBSCRIPTIONS To subscribe or to purchase back issues of the magazine, please call 800-678-9724 ext. 344 or e-mail Beth Chorba at bethc@pcinews.com. For more information, please visit veintherapynews.com and click on the Subscribe link. ADVERTISING INFORMATION If you are interested in advertising in Vein Therapy News magazine, online or in our Marketplace, please contact our account executive: Gary Pittman, Jr., 512-637-0373, garypjr@pcinews.com. EDITORIAL SUBMISSIONS Doctors, nurses, clinics, managers, vendors, patients, professors and others are encouraged to submit abstracts, white papers, writings, and ideas for editorial consideration. If you have a paper or story idea to submit, please e-mail larrys@pcinews.com UPCOMING EVENTS AND PRESS RELEASES Vein Therapy News would like to hear about your organization’s upcoming event, product launch, or announcement. Please e-mail press releases or event listings at least two months in advance to larrys@pcinews.com.
VEIN THERAPY NEWS < APRIL/MAY 2016
Volume 9, Number 3
Editor Larry Storer lstorer@hot.rr.com 254-399-6484
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President Gary L. Pittman garyp@pcinews.com Publications & Communications, LP 13552 Highway 183 N, Suite A Austin, TX 78750 512-250-9023 • 512-331-3950 fax
1 Vascular Solutions exonerated
Vascular Solutions and CEO Howard Root was found not guilty in a federal court case claiming that the company improperly marketed a device to treat varicose veins. A jury in the Western District of Texas in San Antonio unanimously ruled not guilty on all charges against Vascular Solutions and Root over alleged “off-label” promotion of the company’s Vari-Lase Short Kit.
1 AngioDynamics to sell Asclera
AngioDynamics has signed an agreement with Merz North America to be the exclusive distributor of Asclera (polidocanol) Injection within the vein market in the United States. AngioDynamics has had a longstanding distribution deal with Mylan Labs to market Sotradecol, a competing drug, but that agreement ends in June.
THE PRACTICE 20 The next disruption
From the perspective of a vein clinic, what is the next disruptive? How are innovators nibbling at the edges in the healthcare industry? The answer is always the same: In a free market system, the provider that delivers the superior product at the lowest cost always succeeds in the end. So, the very existence of physician-owned office-based vein clinics is in itself an example of nibbling around the edges. The next evolution of outpatient endovascular treatment will be far more disruptive.
20 Developing physician leaders
Good physician leaders are in short supply. It’s up to organizations to close the gap and identify the right people who have the personality, temperament, skills and experience for the role. But organization must then train, support and mentor these individuals so they successfully transition to leadership.
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.
SECOND LOOK
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.
23 Ultrasound-induced DVTs
ADVERTISING 512-637-0373
1 Happiness or success?
How important are the small momentary blips of positivity that pepper our lives each day? A new book says happiness in the workplace can be the difference between success and a neverending rat race without happiness.
A rare occasion for sure, but ultrasound exams performed for a deep vein thrombosis can dislodge blood clots that can then embolize into the vasculature and cause a pulmonary embolism.
26 Patient-generated data
Despite the high-level of technology that can provide patient-generated data, it appears that doctors don’t want the data.
CIRCULATION 512-637-0344 EDITORIAL 254-399-6484
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NEWS THE
VTNREPORT EXPERT VENOUS MANAGEMENT COURSE OPEN TO 75 SEASONED DOCS The Expert Venous Management course, June 3-4 at Englewood, N.J., Hospital, Medical Center, addresses the needs of those physicians who have been treating venous disease but want to build on their basic knowledge and take patient management to the next level. The course is not for beginners. This course is limited to 75 “seasoned veterans” to enable maximum discussion. There will be live patient imaging, interactive case discussion, and an industry session and an ethics sessions. Attendees may submit cases before the course to present during the course. Steve Elias, Englewood Hospital and Medical Center; Antonios Gasparis, Stony Brook Medicine; and Nicos Labropoulos, Stony Brook Medicine, are course directors. Faculty includes Jose Almeida, Miami Vein Center; Mark Meissner, University of Washington; Peter Pappas, Brooklyn Hospital; and William Marston, University North Carolina. Registration can be accomplished by calling 732-678-6038 or online at expertvenousmanagement.com.
AVINGER’S NEW PANTHERIS OCT IMAGE-GUIDED ATHERECTOMY DEVICE CLEARED BY FDA Avinger, a Redwood City, Calif. firm, obtained 510(k) clearance from the FDA to introduce its latest Pantheris lumivascular atherectomy device. It’s the only image-guided atherectomy device of its kind used to treat peripheral artery disease (P.A.D.). The new version of the Pantheris features better controls, ergonomics, and new manufacturing technology. The system uses optical coherence tomography (OCT) to image the 3D structure of the arterial lumen and plaque within. This is provided in real time as the device is used to repeatedly shave off layers of plaque. So seeing progress live on the screen helps to adjust the tool to optimally remove as much build-up as possible without damaging the vessel.
JOHN GRISHAM’S NOVEL PROMOTES USE OF FOCUSED ULTRASOUND Author John Grisham, who serves as a board member for the Focused Ultrasound Foundation, has written a new novel that promotes the use of focused ultrasound treatment. “The Tumor” is a fictional account of a 35-year-old father named Paul, who is diagnosed with a brain tumor and dies nine months later despite having received invasive brain surgery, radiation and chemotherapy, according to the Focused Ultrasound Foundation. The book then explores an alternate future in 2025, in which Paul is diagnosed with the same brain tumor, but receives several rounds of life-sustaining focused ultrasound treatment before the tumor eventually claims his life.
MEDTRONIC CLOSES COVIDIEN’S MASSACHUSETTS HQ BUILDING Medtronic is shutting down Covidien’s Massachusetts headquarters building as part of its restructuring following the merger. Building 4 used to be Covidien’s main building and home to the company’s executive offices. Medtronic spokesman Fernando Vivanco told The Sun Chronicle that the move is part of the company’s plan to roll out a “flexible workspace concept” that gives employees the option to work from home or remotely. Covidien employed about 1,700 workers at its headquarters and adjacent buildings prior to the Medtronic deal. Dublin-based Medtronic has laid off 150 jobs in its Dublin call center, but is staying quiet about more potential layoffs. But the company has said that there would be fewer back-office support jobs as it integrates with Covidien.
STOCKHOLDERS VS MEDTRONIC VERDICT HAS MEDTRONIC APPEALING TO MINNESOTA SUPREME COURT A lawsuit filed by Medtronic shareholders was revived in a Minnesota appeals court yesterday concerning the merger with Covidien – the biggest medical device acquisition ever, closing at $50 billion. The acquisition was announced during the summer of 2014, and soon after, shareholder Lewis Merenstein sued in Hennepin County District Court. He claimed that the conversion of Medtronic stock to the combined company would lead to a substantial loss for Medtronic shareholders. The deal left Covidien stockholders with about a 30 percent stake in Medtronic. “Medtronic stockholders will be forced to pay taxes on any gains in Medtronic stock,” according to Merenstein’s complaint. “But because the sale does not generate cash proceeds that
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would allow stockholders to pay the taxes, Medtronic stockholders who have held the stock for over a year could see federal tax rates of 15 percent to 30 percent on the gain.” A three-judge panel of the Minnesota Appeals Court has ruled that the lower court should not have tossed 11 of the 12 claims in the Merenstein lawsuit. Medtronic plans to appeal the decision to the Minnesota Supreme Court.
JOSE ALMEIDA PROMISES EXPLANATION OF BAXTER STRATEGIES ON MAY 9 Former Covidien head Jose Almeida, who seized the reins at Baxter at the start of the year, offered a window onto his long-term strategy for the company after spinning off the biopharma Baxalta last year. On a Feb. 2 earnings call, he laid out his priorities as trimming operating expenses, reallocating capital to support innovation and growth, and making smaller acquisitions. Almeida held back on the details, but promised to explain everything at Baxter’s upcoming investor day on May 9 – including specific long-term financial targets for three years and 5 years out. He didn’t take large acquisitions off the table, but said that they would require at least a couple of years so they aren’t in any near-term picture.
OLYMPUS SETTLES CRIMINAL, CIVIL CHARGES WITH $646 MILLION IN FINES The largest distributor of endoscopes in the United States, Olympus, has settled with the U.S. Department of Justice (DOJ) for $646 million over a series of criminal and civil charges that state it rewarded and won business by making illegal payments to doctors and hospitals. In addition, the company has an ongoing compliance burden to demonstrate that it is not continuing such activities. The DOJ sees this as a systemic problem that it must continue to address within the medical device industry. The settlement is the largest amount ever paid by a medical device company, according to a statement from the law firm that represented the whistleblower in the case, who was Olympus’ former corporate compliance officer. Ironically, he was the first to hold that position at the company and he was fired due to his objections to the company’s practices. No mention was made of the company’s years-long difficulties with contaminated duodenoscopes and how it might relate to these bribery and kickback charges, although the DOJ is also conducting a separate investigation into that. It includes $623.2 million for claims related to kickbacks to doctors and hospitals in the U.S.; roughly half of that is considered a criminal penalty, while the other half goes to address civil charges. In addition, its subsidiary will pay an additional $22.8 million for charges related to Latin America.
AVF SPRING FELLOWS COURSE STILL OPEN The American Venous Forum (AVF) spring Fellows Courses May 15-17 in Englewood, N.J. still had space at press time. The Fellows Course in Venous Disease is presented for the benefit of fellows within the specialties of vascular surgery, interventional radiology, vascular medicine and associated programs. The course program will cover: • Anatomy and pathophysiology of venous disorders and non-invasive diagnostics. • Chronic venous insufficiency (superficial & deep). • Pregnancy, upper extremity venous issues, acute DVT and wound care. • Future of venous disease. • The business of venous disease. The goal of the course is to educate and update the fellows regarding the latest theories and developments in the clinical practice of vein disease management. Fellows will gain an overall understanding of vein disease to allow them to successfully incorporate venous knowledge, skills and techniques into their overall practice as they make the transition from training to the clinical practice. Host for the spring course is Steve Elias, MD, FACS. Elias is the director of the Center for Vein Disease at Englewood Hospital and Medical Center N.J. as well as the director of The Wound Care Center at Englewood Hospital. The faculty consists of AVF leaders in the field of venous disease and local experts from each host site. VT N READ MORE: veinforum.org/UserFiles/file/FellowsApplication-SpringandFall.pdf
APRIL/MAY 2016 < VEIN THERAPY NEWS
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References: 1. Morrison, N. Use of Cyanoacrylate adhesive for Treatment of Incompetent Great Saphenous Veins: 12-month Results of the VeClose Trial, European Venous Forum, 2015. 2. Proebstle TM, Alm BJ, Gockeritz O, et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. The British Journal of Surgery, Feb 2015;102(3):212-218.
Clinically demonstrated therapies for venous reflux disease. Visit Medtronic at SIR and IVC. DC00041757 © 2016 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company.
NEWS Rhode Island Medical Imaging expands vein therapy centers Rhode Island Medical Imaging has expanded its varicose vein therapy service line. Effective immediately, The Vein Institute at Rhode Island Medical Imaging, formerly the Rhode Island Vascular Institute, will offer patients access to the only dedicated image guided vein therapy centers in Rhode Island. “We believe our current patients will continue to benefit greatly from the state-ofthe-art care offered at The Vein Institute at
RIMI and that our expansion will make it more convenient and comfortable for patients receiving the very best care in the treatment of venous disease,” John Pezzullo, MD and president of Rhode Island Medical Imaging, said. “Our radiologists are committed to the delivery of world class diagnostic imaging and imaging guided treatments, and our team of physicians leading The Vein Institute is comprised of some of the top vein specialists in the country.” The Vein Institute at RIMI specializes in the comprehensive care of varicose veins and other venous diseases. Led by interventional radiologists specially trained to navigate the venous system, The Vein Institute offers
patients a complete clinical evaluation and treatment plan all in one consult. Gregory M Soares, MD and director of The Vein Institute at RIMI, was the first physicians to offer EndoVenous Laser (EVLA) Therapy in Rhode Island more than 14 years ago. He was one of the earliest physicians to implement EVLA in the country and is regionally and nationally recognized for his expertise in the management of patients with venous disease. “The Vein Institute has revolutionized the way we treat venous diseases in Rhode Island,” Dr. Soares said. “As the state’s first and still sole provider of dedicated image-guided varicose vein treatment, we have the skill, experience and technology to expertly manage
all aspects of venous disease in the safest, least invasive fashion available anywhere.” RIMI is committed to providing world class, state-of-the art diagnostic imaging services to the people of Rhode Island from its out-patient offices throughout the state. With current locations in Providence and East Greenwich, and new locations opening this spring in Pawtucket and Barrington, The Vein Institute at RIMI will be staffed by six board certified interventional radiologists, making it the most experienced and highest volume varicose vein practice in Rhode Island. VT N READ MORE: rimirad.com or call 401-432-2400
Intended Use/Indications: The VenaSeal closure system (VenaSeal™ system) is indicated for use in the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS). Contraindications: Separate use of the individual components of the VenaSeal closure system is contraindicated. These components must be used as a system. The use of the VenaSeal system is contraindicated when any of the following conditions exist: previous hypersensitivity reactions to the VenaSeal™ adhesive or cyanoacrylates, acute superficial thrombophlebitis, thrombophlebitis migrans, acute sepsis exists. Potential Adverse Effects of the Device on Health: Below is a list of the potential adverse effects (e.g., complications) associated with the use of the VenaSeal system. The adverse events associated with the device are similar to those with traditional endovenous thermal ablation procedures. In addition, there are several risks unique to the VenaSeal system due to its material and product design as an implant. These potential adverse events include, but are not limited to, allergic reactions to cyanoacrylates, such as hives, asthma, hay fever and anaphylactic shock, arteriovenous fistula, bleeding from the site of access, deep vein thrombosis (DVT), edema in the treated leg, embolization, including pulmonary embolism (PE), hematoma, hyperpigmentation, infection at the access site, non-specific mild inflammation of the cutaneous and subcutaneous tissue, pain, paresthesia, phlebitis, superficial thrombophlebitis, urticaria or ulceration may occur at the site of injection, vascular rupture and perforation, visible scarring. Warnings, precautions, and instructions for use can be found in the product labeling at http://useifu.venaseal.com.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. DC00037656
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APRIL/MAY 2016 < VEIN THERAPY NEWS
NEWS Velano Vascular raises $3.5M for needle-free blood draw technology Velano Vascular received $3.5 million in a financial round backed by former Becton Dickinson CEO Ed Ludwig in an effort to gain market share for its needle-free blood draw device. Previous investors such First Round Capital, White Owl Capital, Kapor Capital and The Children’s Hospital of Philadelphia chipped in funding, and nine new investors including Ludwig and Qosina founder Stuart Herskovitz.
San Francisco-based Velano plans to use the cash to flesh out its blood-draw technology in adults and children, and to beef up marketing for its device. The company’s disposable device helps reduce problems associated with blood draws by taking blood through patients’ indwelling peripheral IV catheter, reducing the need for repeat needle sticks and central blood line draws. This provides many benefits. For one, a lot of people are afraid of needles, especially kids (pediatrics is a big focus for Velano). Also, it prevents risks of infection for patients, it lowers the risk of practitioner infection from accidental needle pricks, especially when treating patients with HIV and hepatitis, and it also allows practitioners to take samples without disrupting a patient’s sleep cycle.
For patients who are diabetic, elderly or obese, challenges with blood draws are much greater and can be even more invasive. Not only that, CEO Eric Stone says that their technology in the end is more economical for a hospital, so it’s essentially a win-win for both patients and hospitals. Velano has already gained traction for its blood draw device. The company pulled in $5 million in a Series A round last year, building on initial funding from angel investors. In June, the company got a CE mark for its device. In late Fbruary, the company got an FDA signoff for a new version of its device, which includes a clamp for use with syringe draws, a common method of drawing blood from children. The agency also cleared the device to be more widely used with indwelling peripheral IV catheters.
Bolstered by its recent success, Velano is already working on its technology with research institutions such as Boston’s Brigham and Women’s Hospital, and has kicked off clinical trials of the device in the United States. In 2016, Velano wants to launch pilot studies that look at how its devices perform “in medical centers and departments that serve both adult and pediatric patients,” setting its sights on a fast-growing pediatric market. Investors seem convinced that Velano can deliver on its goals. “Based on progress to date, as well as the market and product development activities currently underway, I am confident that this investment can have a significant impact in establishing a new and better standard of care,” Ludwig said. VT N
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April 28-30, 2016 | Miami Beach, FL The 14th annual International Vein Congress delivers exciting, cutting edge venous education to vascular surgeons, interventional radiologists, and cardiologists. Live procedures, case studies, and the interactive V2 Symposium are just a few of the reasons that venous specialists attend IVC annually. Learn from renowned faculty, including Dr. Seshadi Raju, one of the original pioneers in venous stenting. IVC qualifies for Part 2 of the ABS MOC Program
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APRIL/MAY 2016 < VEIN THERAPY NEWS
NOW AVAILABLE from ANGIODYNAMICS YOUR EXCLUSIVE VENOUS DISTRIBUTOR
APPROVED FOR THE TREATMENT OF UNCOMPLICATED SPIDER AND UNCOMPLICATED RETICULAR VEINS Asclera® (polidocanol) Injection is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter.
AFTER
Uncomplicated reticular veins treatment* (1-3 mm). Results at 4 weeks after last treatment. * Individual results may vary depending on varicose vein severity, disease progression, skin tone, and number of treatments.
Actual patient Indication Asclera (polidocanol) Injection is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter. IMPORTANT SAFETY INFORMATION For intravenous use only. CONTRAINDICATIONS: Asclera (polidocanol) Injection is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases. WARNINGS AND PRECAUTIONS Anaphylaxis: Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are most frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately. Accidental injection into an artery can cause severe necrosis, ischemia or gangrene. If this occurs, consult a vascular surgeon immediately. Inadvertent Perivascular Injection of Asclera can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected. VEINSevere THERAPY < APRIL/MAY adverseNEWS local effects, including tissue2016 necrosis, may occur following
extravasation; therefore, take care in intravenous needle placement and the smallest effective volume at each injection site should be used. After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reactions. Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis. ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera and were more common with Asclera than placebo: injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, neovascularization, injection site thrombosis. Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.
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Asclera® (polidocanol) Injection Rx Only BRIEF SUMMARY. PLEASE CONSULT FULL PRESCRIBING INFORMATION PRIOR TO ADMINISTRATION. INDICATIONS AND USAGE: Asclera (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter. DOSAGE AND ADMINISTRATION: For intravenous use only. The strength of the solution and the volume injected depend on the size and extent of the varicose veins. Extensive varicosities may require multiple treatment sessions. Uncomplicated spider veins (varicose veins ≤ 1 mm in diameter): Use Asclera 0.5%. Uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter): Use Asclera 1%. Use 0.1 to 0.3 mL for each injection into each varicose vein. Do not use more than 10 mL per session (see Dosage and Administraion [2] of Full Prescribing Information). Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis. DOSAGE FORMS AND STRENGTHS: Asclera is available as a 0.5% and 1% solution in 2 mL glass ampules. CONTRAINDICATIONS: Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases. WARNINGS AND PRECAUTIONS Anaphylaxis: Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are more frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and use the smallest effective volume at each injection site. After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reaction (see Dosage and Administration [2] of full prescribing information). Accidental Intra-arterial Injection: Intra-arterial injection can cause severe necrosis, ischemia or gangrene. If this occurs consult a vascular surgeon immediately. Inadvertent Perivascular Injection: Inadvertent perivascular injection of Asclera can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected. ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera and were more common with Asclera than placebo: injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, revascularization, and injection site thrombosis (see Adverse Reactions [6] of Full Prescribing Information). To report SUSPECTED ADVERSE REACTIONS, contact Merz Aesthetics, Inc. at 1-866-862-1211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C. Polidocanol has been shown to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose. This effect may have been secondary to maternal toxicity. There are no adequate and well controlled studies in pregnant women. Asclera should not be used during pregnancy. Animal Studies: Developmental reproductive toxicity testing was performed in rats and rabbits with intravenous administration. Polidocanol induced maternal and fetal toxicity in rabbits, including reduced mean fetal weight and reduced fetal survival, when administered during gestation days 6-20 at doses of 4 and 10 mg/kg, but it did not cause skeletal or visceral abnormalities. No adverse maternal or fetal effects were observed in rabbits at a dose of 2 mg/kg. No evidence of teratogenicity or fetal toxicity was observed in rats dosed during gestation days 6-17 with doses up to 10 mg/kg. Polidocanol did not affect the ability of rats to deliver and rear pups when administered intermittently by intravenous injection from gestation day 17 to post-partum day 21 at doses up to 10 mg/kg. Human Studies: There are no adequate and well-controlled studies on the use of Asclera in pregnant women. Labor and Delivery: The effects of Asclera on labor and delivery in pregnant women are unknown. Nursing Mothers: It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering to a nursing woman. Pediatric Use: The safety and effectiveness of Asclera in pediatric patients have not been established. Geriatric Use: Clinical studies of Asclera did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. OVERDOSAGE: Overdose may result in a higher incidence of localized reactions such as necrosis. HOW SUPPLIED/STORAGE AND HANDLING: Asclera is supplied in singleuse, preservative free ampules in the following packages: NDC 46783-121-52 Five 0.5% ampules (2 mL) NDC 46783-221-52 Five 1.0% ampules (2 mL) Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years. Store at 15-30°C; (59-86°F). PATIENT COUNSELING INFORMATION: Advise the patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime. Compression stockings or support hose should be thigh or knee high depending upon the area treated in order to provide adequate coverage. Advise the patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days. For two to three days following treatment, advise the patient to avoid heavy exercise, sunbathing, long plane flights, and hot bath or sauna.
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AngioDynamics and the AngioDynamics logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. Asclera is a registered trademark of Chemische Fabrik Kreussler & Co., GmbH. © 2016 AngioDynamics, Inc. ANGAD 176 US Rev 01 03/16
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NEWS American Vein brings VenaSeal to Colorado American Vein & Vascular Institute is the first and only practice in Colorado to treat patients suffering with venous reflux disease using the latest technology, VenaSeal closure system, according to owner/founder Gordon F. Gibbs, MD. Dr. Gibbs has performed 17 VenaSeal procedures since its release in November 2015. Moreover, American Vein & Vascular Institute is one of two elite training sites for the new technology in the Western United States, educating both physicians and the sales staff by the manufacturer, Medtronic. The VenaSeal closure system is a new, minimally invasive procedure utilizing advanced medical adhesive to close diseased veins in patients with symptomatic venous
reflux disease. This procedure is an improvement as patients experience less pain and bruising than other contemporary treatments, and it does not require use of compression stockings. "I am honored to be one of the selected physicians performing and teaching the VenaSeal closure system," said Dr. Gibbs, chief medical executive of American Vein & Vascular Institute. "This is a simpler and more elegant treatment option than laser or radiofrequency. Patients experience less discomfort and can get back to their active lives more easily." VenaSeal is a new and innovative treatment with demonstrated effective clinical results. It is the only procedure to use medical adhesive to coat and seal diseased veins, with high closure rates across three clinical trials. Unlike other heat-based (thermal) treatments, VenaSeal does not require tumescent anesthesia (multiple injections of a dilute local
Every Case tells a story… 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. There’s no word limit, and we can use photos or illustrations if you have them. Please send it to:
Larry Storer: larrys@pcinews.com or call 254.399.6484 to discuss. 12
The VenaSeal system anesthetic), and eliminates the risk of burning or nerve injury associated with thermal based procedures. In most cases, patients do not need to use compression stockings as required with other treatments. "In addition to working as an ER nurse for 20 years, I am a very active person, and my worsening leg pain due to vein disease was affecting me personally, professionally and emotionally," said Keila Dremstedt, a VenaSeal closure system patient of Dr. Gibbs. "When Dr. Gibbs began performing the VenaSeal closure system procedure, I immediately requested this treatment. It was important to me to minimize the total number of injections, overall pain and recovery time. Within two weeks, I was back to running and walking two to three miles at a time!" A Mayo Clinic trained interventional radiologist, Dr. Gibbs is board certified in
diagnostic radiology and fellowship trained in vascular/interventional radiology. He serves on the teaching faculty and strategic advisory board for Medtronic to develop minimally invasive treatments for peripheral vascular disease. He is the first in Colorado to utilize the cutting edge VenaSeal closure system, attracting physicians and medical staff from around the country to observe and be trained in the technology. He is a Diplomate of the American Board of Venous and Lymphatic Medicine and holds medical licenses in Minnesota, Colorado and Texas. A philanthropist and sought-after speaker and instructor, Dr. Gibbs is also medical director of Diagnostic and Interventional Radiology at St. Mary-Corwin Medical Center in Pueblo Colo. VT N
ACP offers course on ultrasound duplex imaging of deep and superficial venous
• Recognize anatomy, physiology and pathophysiology of the deep and superficial venous systems: Deep vein thrombosis (DVT), superficial vein thrombosis (SVT), superficial thrombophlebitis (STP), deep venous insufficiency (DVI), and superficial venous insufficiency (SVI); and typical and unusual presentations of venous hemodynamics. • Recognize roles of b-mode, color and spectral Doppler ultrasound in making the diagnosis of DVT, DVI, SVT and SVI. • Perform an all-inclusive lower extremity venous examination using proper technique and protocol on patients with common and complicated venous disorders. • Document all pertinent findings and suspected pathology and create a comprehensive and precise venous mapping. • Recognize the main pitfalls in venous extremity ultrasound, and apply the technical and clinical pearls and tips. VT N READ MORE: phlebology.org/ w p - c o n t e n t / u p l o a d s / 2 0 1 5 / 11 / Ultrasound_program_FINAL.pdf
The American College of Phlebology is offering a one-day course on ultrasound duplex imaging of the deep and superficial venous system April 9 at the Marina Inn in San Leandro, Calif. Program Chair Linda Antonucci, RPhS, RVT, RDCS, said this course is intended for providers, sonographers and other allied healthcare professionals who desire to improve their comprehension of venous ultrasound physics and instrumentation, and develop their ability to perform venous lower extremity ultrasound evaluation and mapping for vein ablation procedures. “The one day condensed format includes a combination of didactic lectures and hands-on skills training, and is designed to cover both the investigation protocols and diagnostic criteria. Additionally, the course includes a brief overview and application of venous ablation techniques.” As a result of attending this course, the participant will be able to:
APRIL/MAY 2016 < VEIN THERAPY NEWS
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NEWS Boston Scientific gets CE Mark for Eluvia stent Boston Scientific has received a CE mark for its Eluvia Drug-Eluting Vascular Stent System to treat peripheral artery disease (P.A.D.) patients with narrowing of the arteries above the knee. It will launch the product immediately in the EU and has already started a pivotal trial aimed at FDA and Asia approvals, with primary endpoint data due in early 2018. Eluvia is a drug-polymer combo stent, which the company notes is the first such stent approved in Europe for above-the-knee P.A.D. This also makes Boston Scientific the first company with a drug-eluting stent and a drugeluting balloon, Boston Scientific President and CEO Michael Mahoney said.
Eluvia uses the anti-restenotic drug paclitaxel in conjunction with a polymer; it offers sustained release of the drug over the time restenosis is most likely to occur, thereby preventing tissue growth that might have blocked the stented artery. Last quarter, the company started enrollment for the IMPERIAL trial to test Eluvia as compared to the Zilver PTX Stent from Cook Medical. The trial is aimed at undergirding U.S. and Asia approvals in the above-the-knee P.A.D. indication and will include about 485 patients at 75 sites worldwide. IMPERIAL is to report data on primary outcome measures – major adverse events over 12 months and primary patency of the target lesion at 12 months as assessed by duplex ultrasound at an independent lab – in January 2018 with completion of the trial in January 2022.
The CE mark was based on the prospective, multicenter clinical trial MAJESTIC, which found Eluvia had a primary patency rate of more than 96 percent. That’s the highest 12-month patency rate reported for an interventional treatment of femoropopliteal artery lesions among comparable trials, according to Boston Scientific. “The exceptional 12-month results presented in the MAJESTIC trial, which included a high percentage of patients with complex lesions, demonstrate that this technology is a safe and efficacious solution for patients needing stents for the treatment of peripheral artery disease,” said Dr. Stefan Müller-Hülsbeck, principal investigator at the Vascular Center Diako Flensburg and head of the Department of Diagnostic and Interventional Radiology and Neuroradiology at the Academic Hospitals in Flensburg, Germany.
Eluvia Drug-Eluting Vascular Stent System. Courtesy of Boston Scientific “The approval is a testament to the strength of the data, and will be welcome news to physicians and patients who have not previously had access to a polymer based, drug-eluting stent, specifically developed for the superficial femoral and proximal popliteal arteries.” VT N
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APRIL/MAY 2016 < VEIN THERAPY NEWS
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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.
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NEWS ICD-9 to ICD-10 transition smooth says CMS director
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Teamwork, accountability and a focus on stakeholder concerns all have enabled a smooth transition for the healthcare industry to date from ICD-9 to ICD-10, according to Centers for Medicare & Medicaid Services Acting Administrator Andy Slavitt. In a post to The CMS Blog Feb. 24, Slavitt touts the effort put forth by CMS and the industry at large to make the shift, although he stops short of calling it a win. “With good implementation, we never declare victory, and are still at the ready to continually improve,” Slavitt said. To that end, he said, “Y2K fears” never materialized, and the transition was one that most outside of the healthcare industry weren’t even aware of. “Instead, ICD-10 became like what actually occurred on Y2K,” Slavitt said. The implementation, prior to last fall, had been delayed three times, including once by Congress. Slavitt writes that within the first month of implementation, 100 percent of the 1,000 inquiries made to CMS regarding the transition received responses within three business days. Working with partners such as the American Medical Association, the American Hospital Association and the American Health Information Management Association, among others, was critical, he says, to ensuring resources were allocated and concerns were addressed. “Because healthcare is still fragmented, CMS can’t work alone in implementing major changes,” he says. Despite Slavitt’s optimism, however, a Bloomberg BNA article notes that concerns linger, particularly regarding the potential for government audits. George Breen, an attorney with District of Columbia-based law firm Epstein Becker & Green, tells Bloomberg healthcare organizations must be prepared for “aggressive payer audits, both private and public.” In addition, Medical Group Management Association Director of Health Information Technology Policy Robert Tennant tells Bloomberg that some physicians have experienced “slowed payments or denied claims” for patient screenings stemming from “faulty local coverage determination system edits.” Medicare Advantage Contractors that rejected such claims, however, have worked with providers to remedy those situations, he said. VT N READ MORE: https://blog.cms. gov/2016/02/24/lessons-learnedref lections-on-cms-and-thesuccessful-implementation-of-icd
34 organizations ask CMS for MU shortened deadline A collation of 34 provider organizations, including the College of Healthcare Information Management Executives (CHIME), has asked the Centers for Medicare & Medicaid Services to shorten the Meaningful Use reporting period for 2016 from 365 to 90 days. In a March 15 letter to CMS Acting Administrator Andy Slavitt, the coalition expresses its appreciation for the shortened reporting period from 365 days to 90 days for 2015 and requests that the same policy offered then be provided in 2016. The coalition also recommends that CMS allow participants to report on any 90-day period in 2016, as was allowed in 2015. “Doing so will continue the significant progress providers are making to harness the use of technology to succeed in new payment and care delivery models,” the letter states. “Further, announcing this as soon as possible will reduce the number of providers who will feel compelled to rely on filing for a hardship.” The letter also points out that retaining the 365-day reporting period for 2016 leaves providers and vendors with no downtime to improve usability and innovation, which it says could result in many providers having no baseline data for quality reporting if they’re unable to report in 2016. In addition, the letter notes that a year-round reporting period would make it harder for providers to transition to the Medicare Access and CHIPS Reauthorization Act, which moves most physicians into a different EHR-incentive program, called the Merit Based Incentive Payment System (MIPS). In a related announcement from CHIME about the “loud chorus” asking CMS to act quickly, CHIME CEO Russell Branzell and Board Chair Marc Probst note that “until the final MACRA rules are issued, providers will be greatly challenged to meet the reporting requirements. Maintaining 365-day reporting period also will force providers to pull resources away from using health IT to innovate care processes and workflows.” Additionally, they say, a longer reporting period will limit the amount of time both providers and vendors can spend on improving interoperability and information exchange. VT N
Senate health panel passes health IT bill revising HIT Act The Improving Health Information Technology Act and six other bills cleared the Senate health committee with bipartisan support at a hearing in February. Notably, the revised Improving HIT Act, for which draft legislation was unveiled in late January, removes verbiage calling for the creation of a Health IT Advisory Committee through a combination of the current Health IT Policy and Health IT Standards committees. It also does not carry over language mandating electronic health record products to be capable of trusted exchange with “multiple other EHR products.” The bill passed unanimously. Commenting on the bill at the hearing, Sen. Sheldon Whitehouse (D-R.I.) lauded the effort, calling it an important step forward. However, he added that a lot of work remains, flagging three concerns: “[First] we’ve got to provide a lot more support in health information exchanges rather than just continuing with Meaningful Use,” Whitehouse said. “Two, we’ve got to address privacy issues that are bedeviling these systems. ... Finally, we need to do something for behavioral health and for nursing homes that are outside of the Meaningful Use parameters.” Committee Chair Lamar Alexander (R-Tenn.) added that such legislative efforts are necessary, particularly as many new federal efforts – including the Precision Medicine Initiative and the reformation of payment models – require the use of EHRs and other health information technology. “Our goal is to make our country’s electronic health record system something that helps patients rather than something that doctors and hospitals dread so much that patients are not helped,” Alexander said. “We have worked for months – with input from those who actually use the system – to help improve health information technology and I’m glad to see this legislation move forward as part of a successful first meeting on our committee’s bipartisan biomedical innovation agenda.” VT N
APRIL/MAY 2016 < VEIN THERAPY NEWS
NEWS Value-based payment trend is increasing Pearl Harbor. The dot-com bubble. Valuebased payments. All have one thing in common. Leaders missed subtle signals that warned of pending danger. Michael Leavitt, former secretary of the Department of Health and Human Services, urged healthcare leaders not to ignore the signals accompanying the shift from fee-forservice to value-based payments. Major intelligence failures are failures of analysis, not failures of collection, Leavitt told healthcare executives in mid-March at the American College of Healthcare Executives 2016 Congress. It's true for the government, it's true for business and it's true for healthcare, he said. Leavitt, the founder and chairman of consulting firm Leavitt Partners, said leaders of hospitals and healthcare systems must pay attention to the signals about the accelerated move toward value-based payments. They are happening at different rates depending on the local market, but signals by the federal government are no longer weak: They're profoundly real, he warned. VT N
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Health Canada OKs AngioDynamics’ new Celerity device AngioDynamics has won approval from Health Canada for its Celerity with Navigation tip location system for peripherally inserted central catheters. Latham, N.Y.-based AngioDynamics won Health Canada approval for the first Celerity iteration back in September 2013. The new version is designed to allow real-time catheter tracking, the company said. “This is an important milestone as it is the first clearance for Celerity with Navigation,” President and CEO Joseph DeVivo said. “We are pleased to bring this technology to PICC teams throughout the country.” DeVivo said AngioDynamics filed for U.S. FDA 510(k) clearance in November 2015 and are hoping to receive approval before the end of the company’s fiscal year in November.” Vascular Access Senior Vice President Chuck Greiner said the technology allows more clinicians and patients to experience the clinical benefits of BioFlo. “The launch of Celerity with Navigation will allow those customers to access the anti-thrombogenic benefits that BioFlo offers along with the increased ease-of-use that the technology offers. We are now better positioned than ever to compete in the global PICC market.” VT N
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THEPRACTICE
Getting physicians to jump on the secure text messaging bandwagon
Doc Vader videos humorously highlight pager, fax woes DrFirst, a provider of electronic prescribing, secure texting and other SaaS software and services for healthcare, has teamed-up with physician, medical satirist and primary care clinic founder Dr. Zubin Damania to release a series of comedy videos that highlight the healthcare industry’s continued reliance on seemingly antiquated forms of healthcare communication. Each humorous episode addresses a serious issue — the communication breakdowns that occur throughout hospitals every day and which are often exacerbated by the industry’s stubborn reliance on pagers, faxes and other outdated communication technologies. The “Doc Vader” trilogy of videos can be accessed at PagerMenace.com. VT N
By Jason Stanaland Let’s say you use iMessage and are happy with the app. All of your friends are on the platform and you are able to chat away. Then, suddenly your world is turned upside down. A few of your friends start using Facebook Messenger instead. You start feeling like you are missing out on the conversation, so you download it and start using the app as well. What once was one has now become two. You find yourself using the two messaging apps…until the day another friend starts using WhatsApp — and just like nuclear fission, your world of messaging splits again. With the average smartphone user accessing three or more messaging apps, the world of
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messaging is exploding. Messaging apps are used more than any other type of app on smartphones: Yahoo’s mobile analytics arm Flurry reports that “daily use of messaging apps is 4.7 times greater than other apps.” We all love to send quick messages via our phones – and physicians and nurses are no different. If you've taken a recent trip to the hospital, you've probably noticed some tweeting, chirping, swooshing and ringing coming from your clinicians’ smartphones. They all spend a lot of time receiving and responding to notifications from one another, from clinical systems, from the EMR and CPOE, as well as non-work messages from their friends and family. So, what apps are physicians and nurses using to send and receive all of these messages? According to a 2014 study in the journal Telemedicine and e-Health, the cold hard truth is that 61 percent of physicians say they receive work-related messages in consumer text messaging apps, with 30 percent admitting that they have received PHI via consumer text messaging. Of course, this can present significant risk to a hospital or clinic, and cause a great deal of anxiety for business and IT leaders. The good news is that, according to analyst reports, about 60 percent of hospitals plan to implement secure text messaging within the next year (largely in order to mitigate this risk). However, hospitals that have already implemented a secure text messaging tool often find end-user clinician adoption to be difficult. So why is it so hard to get physicians to use a secure text messaging app as opposed to iMessage, WhatsApp, WeChat, Skype, Viber, Snapchat, FB Messenger, Kik, or whichever consumer app it is that they are using? After all, many of them already use multiple messaging apps in their personal lives, so what's one more for the workplace? A large part of this challenge is in winning over end-user preference. To solve this problem, let's consider why a user picks a messaging app in the first place. We all choose the messaging apps we use in our personal lives for very specific reasons, and for the most part, physicians and nurses prefer to use certain messaging apps in the hospital for those same reasons. Of course, there are user experience (UX) and user interface (UI) considerations. All users demand a clean, simple interface in a modern messaging app. But at the core of end-user preference is the ability for the user to quickly find who they are looking for, send a message, and get a fast response. End-user expectations can guide hospitals on where to focus when rolling out a secure text messaging application in a hospital. This will help ensure that an application that
has warranty and utility for the end-user is delivered. Based on the core preferences outlined above, here are some solutions: 1. End-users need to be able to find who they're looking for. Connection of the secure text messaging app to a hospital directory is essential to this. An accurate and up-todate database of enterprise contacts needs to be provided as soon as possible. It is also important to scale the rollout quickly so users can message anyone they need to reach. If they can’t find who they’re looking for on just a few occasions, they will stop using the app. 2. End-users need to feel confident that messages they send will be delivered to the intended recipient. Ubiquitous wireless coverage is essential to ensuring reliability of service, which will help end-users trust the application. It is important to ensure that both Wi-Fi and mobile data connectivity are available everywhere possible. Hospitals that are rolling out secure text messaging should consider Wi-Fi to be business-critical infrastructure, and should consider revising their funding models to proactively fund wireless infrastructure along with utilities. 3. End-users need to get responses that are aligned with their expectations. With the use of a messaging app in healthcare, expectations are equivalent to “now.” Most secure text messaging applications offer priority ringtones and alerts, which can help with this. However, this requirement also has a strong cultural component. It is important to socialize the expectations for timely response. This should be communicated through centralized channels and documented within policies. Compliance should be rewarded. All of these things will help users quickly find who they are looking for, send a message, and get an appropriate response — which is what they want, and arguably what they need. To provide further incentives, it is important to integrate clinical systems for the additional value of alerting, to consider stipends and to standardize on one messaging platform of choice. If we focus on why end-users choose to use messaging apps in the first place and create an experience that aligns with their core needs, we will achieve better adoption rates for secure text messaging. VT N READ MORE: http://www.spok. com /solut ions/secu re -hospita lcommunications
APRIL/MAY 2016 < VEIN THERAPY NEWS
THEPRACTICE Consumption of online content depends on the generation Fractl and Buzzstream recently conducted a study on how Millennials, Gen X-ers and Baby Boomers consume content online with some interesting conclusions for physicians minding their social media outreach. Stereotypically, Millennials are the main focus of digital content, but this study shows that Baby Boomers actually spend more hours per week consuming digital content – including getting their health information – than Millennials and Gen-Xers. According to the study, Millennials and Gen-Xers spend about 5-10 hours per week consuming online content, and Baby Boomers spend 20-plus hours per week consuming online content. This is especially useful information for healthcare organizations as most service lines target this demographic. Here are some more insights from the study on online content consumption among the different generations: • The most popular time frame when Millennials and Gen-Xers consume online content is from 8 -11:59 p.m. • The most popular time frame when Baby Boomers consume online content is from 9-11:59 a.m. • The most popular device for consuming online content across all three generations is a laptop, followed closely by a desktop computer. • Millennials are about as likely to consume online content on a desktop as a mobile phone. • All three generations prefer blog posts. Their least favorite type of online content is white papers. • All three generations prefer to consume content that is about 300 words long. • The most popular content genre consumed by all three generations is entertainment. • The second most popular content genre for Gen-Xers is healthy living. • All three generations use Facebook most often to share online content. This study shows that content is a viable marketing tactic to reach all three generations. Blog posts are generally quick and easy to generate compared to other types of content. Plus, more casual and allow for an entertainment factor that all three generations respond to. Schedule posts in the late morning to reach Baby Boomers and during prime time to reach Gen-Xers and Millennials. VT N READ MORE: adweek.com/ socialtimes/how-differentgenerations- consume - contentonline-infographic/619882
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THEPRACTICE
Nibbling at the edges: THE NEXT DISRUPTION
By Sean M. Mullen A Vein practice client recently forwarded an article to me from the March 3, 2016, issue of the New England Journal of Medicine. The article titled “Uber’s Message for Healthcare” and authored by Alan Detsky, MD and Alan Garber, MD, caught my attention because it was introducing the concept of disruption from a business model perspective in the healthcare industry. While the article was quick to point out the vast differences between healthcare and taxi services, the conclusion arrived at by the authors is well represented by the following excerpt from the commentary: “Successful innovators will find ways to solve the problems of unmet expectations and breach artificial barriers to market entry. Because health care is multidimensional, companies can either attack traditional providers to gain market share… or start by nibbling at the edges in ways that could ultimately disrupt the industry…” From the perspective of a vein clinic, what does that mean? How are innovators nibbling at the edges in the healthcare industry? The answer is always the same. In a free market system, the provider that delivers the superior product at the lowest cost
always succeeds in the end. So, the very existence of physicianowned office-based vein clinics is in itself an example of nibbling around the edges. Offering patients a more comfortable, service-oriented, and cost-effective solution to a traditional hospital environment is disruptive. But the impact to the hospital is not really material. Varicose Vein treatment is not a big money maker for hospitals as compared to other endovascular procedures. That said, I believe the next evolution of outpatient endovascular treatment will be far more disruptive. Over the past few years a growing community of entrepreneurs has emerged who have been building cath labs and providing a much broader (with significantly higher levels of reimbursement) array of endovascular procedures in an office setting. Known by Medicare as an Extension of Practice, these new office-based facilities can offer everything from iliac stent placement, to atherectomies, to gonadal vein embolizations, to IVC filters. In fact, my company, StreamlineMD, has several vein clinic customers who have recently built, or are in the process of building, such facilities. I expect the pace to increase over the next few years.
In my opinion, this is a win-win across the board. For a physician with the skill set to perform these more complicated endovascular procedures, this evolution presents a very compelling business opportunity. For the patient it offers a more comfortable, convenient and affordable treatment option. And for the payers, it is a way to help counter balance escalating healthcare costs. To tie this back to the NEJM article, for the traditional providers (i.e. hospitals) it represents additional, much needed, disruption to the industry. VT N President Sean M. Mullen founded StreamlineMD in 2004. He holds an AB from Columbia College and an MBA from Columbia Business School. StreamlineMD, a subsidiary of PRC Medical, the only EMR that is certified to upload clinical data to the ACP Pro Venous Registry. The company’s services include state-of-the-art electronic health records, practice management software, medical coding, medical billing and advisory services. StreamlineMD has physician practice customers in 39 states. Mullen can be contacted by e-mail at smullen@streamlinemd com or by phone at 330-564-2664.
How to develop new physician leaders By Ilene MacDonald The need for competent, effective physician leaders has never been greater. But many doctors are thrust into the role even though they don’t have the skills or temperament for the job. To ensure physicians selected for leadership positions are successful, organizations must develop them and align leaders to common goals, Brian Lipman, MD, president of the ProHealth Care Medical Group in Wisconsin, and Andrew Ziskind, MD, managing partner of Huron Consulting Group, told attendees of the American College of Healthcare Executives 2016 Congress. “In a nutshell, good physician leaders are in short supply,” Dr. Ziskind said. It’s up to organizations to close the gap and identify the right people who have the personality, temperament, skills and experience for the role. But organization must then train, support and mentor these individuals so they successfully transition to leadership. Physician leaders who have the greatest chance for success are individuals who communicate well, are adaptable, fast learners, have strong problem-solving skills, focus on results, can look at the broader health system and are willing to take a risk. They also have a high degree of emotional intelligence, self-awareness, patience, humility and have strong decisionmaking skills. “When you are selecting physician leaders ... look for experience, a track record of success,” Dr. Ziskind said, adding that a person’s credentials do not matter because they have nothing to do with a track record.
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He also warned attendees of signs the person is wrong for the role. “You don’t want folks who defend their turf, appear disinterested, who ignore under-performers or who try too hard to please everybody,” he said. Once you find the right person, you must develop their skills. Physicians need to learn how to function in a dyad, manage difficult colleagues, run meetings and get people on board. Finally, Dr. Ziskind said, the goals for the physician leaders must align with the organization’s goals.
MODEL TRAINING PROGRAM As an example of a comprehensive training program, Dr. Lipman explained the model that ProHealth Care uses. The organization includes a 317-bed tertiary hospital, a 75-bed community hospital and has a pluralistic medical model with employed and independent physicians working together. The medical group includes 188 physicians, 98 advanced practice providers and 42 associated clinicians. To promote strong physician engagement and optimally manage the medical group, ProHealth Care Medical Group’s governance structure includes: • a physician leadership council made up of six physicians; • a practice advisory group, which is made up of 20 physician; • a clinical operations committee, which includes six physicians; • a financial and compensation committee, which is made up of six physicians; and • a professional practice and quality committee, which is made up of six physicians.
To support these physician leaders, the organization holds a physician leadership academy that meets every three months over a three-year period. Participants are a mix of hospital and clinic division physician leaders who are paired with operational dyad leaders. Attending together, Dr. Lipman said, lets them get to know each other better in a less harried environment. A new class will begin in 2017 with 24 members (12 dyads). In addition, ProHealth Care sends all new physician leaders in the hospital division to a Horty Springer Annual Leadership Conference for four days where they learn about hospital governance. The medical group also conducts annual half-day retreats for leaders and staff. The first year the retreat focused on executing quality through team-based care. In year two, they learned how to build high-functioning teams and in the third year the focus was on leading teams to higher achievement together. Dr. Lipman said the organization also uses a web-based adult learning tool where all providers and staff can learn about different topics, such as patient-centered care, quality and safety, physician leadership, high-performing teams and difficult clinical encounters. Finally, the organization has a strategic advisory council, led by the system’s CEO, where physician leaders meet with senior system executives to review and advise on system strategic issues. VT N Ilene MacDonald is a staff writer for Fierce Practice Management newsletter. She covered the American College of Healthcare Executives 2016 Congress in Chicago in mid-March.
APRIL/MAY 2016 < VEIN THERAPY NEWS
THEPRACTICE How to market new physicians Whenever a medical practice or hospital hires a new physician, the first thought is: we should run a print ad (or billboard) with Joe Schmo’s picture to get patients to call and schedule appointments. But why cast such a wide net? Not everyone in your community is looking for a new physician, so why waste your media dollars targeting everyone? The solution is to specifically target people who are looking for a physician, and nurture relationships with current patients. Here are three tips to get you started: 1. Make it easier for prospective patients to find you with search engine optimization and search marketing. This means running search ads targeting people who are actively looking for a new physician, and optimizing the content on your website so it pops up on the first page of a Google search. 2. In addition to having great content on your website, invest in social ads to push that content out to your audience when they’re not on Google. The best channels to reach them are Facebook and Pinterest, especially if you’re trying to reach women. 3. Last, but not least, ensure physicians and employees deliver on the marketing promise made in your content. Friendly, helpful receptionists and physicians with good bedside manner make a lasting impression on patients. Focus on making every interaction a patient has with your office or hospital a positive one. It seems simple, but it goes a long way in patient retention. As competition increases and patient loyalty decreases, physician practices that could once get by with the occasional advertisement or billboard are finding themselves in a whole new world. Marketing physician practices is no longer something that can be put on the back burner. Whether you’re a seasoned marketing pro or you’re feeling overwhelmed at the prospect of creating a marketing plan, here are four things to keep in mind. Most of these suggestions do not require large budgets, but they do require time and dedication.
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VEIN THERAPY NEWS < APRIL/MAY 2016
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SECONDLOOK HAPPINESS
continued from page 1
How would you feel and what would you think? Some considerations floating around in your brain might include: a) These people are stealing from me. I’m not paying them to talk football. I’m going to fire them both right now. b) These people are stealing from me and need to get back to work. c) My office manager should know better than that and won’t work for me anymore. d) I’m so happy to see my staff enjoying themselves. Assuming your goal is to run a successful, busy practice that delivers world-class service, which do you think is the most appropriate choice to act on? Would it surprise you that to get maximum performance of your office staff, the best answer is d? The obvious caveat is that if your staff did nothing but chitchat all day long and didn’t pay attention to your patients, you would soon become out of business. There’s a difference between kindness and stupidity. Accountability for every role in your operation is an absolute must. In today’s business world, as well as educational system, there is a tendency to hand out participation trophies just for showing up. Unfortunately, these unwarranted atta-boys and atta-girls are harming our kids as well as the modern worker. Business is a game, with winners and losers…and yes, we need to keep score!
HOW TO WIN THE GAME
According to Shawn Anchor, author of “The Happiness Advantage,” small momentary blips of positivity that pepper our lives each and every day are very important. So a quick conversation with a friend about football, a
short humorous video clip, or even a small gift of candy can produce significant and immediate boosts in cognitive power and job performance. By embracing these moments in your company, you increase your odds of victory in the game of business.
THE HAPPINESS ADVANTAGE
So, what comes first: happiness or success? Most people believe that if they work hard and become successful that this will lead to happiness. This leads to the proverbial rat race. Anchor argues that this formula is wrong. His book is filled with research that demonstrates that happiness actually leads to success, not the other way around. In fact, a meta-analysis of happiness research that brought together the results of more than 200 scientific studies on nearly 275,000 people found that happiness leads to success in nearly every domain of our lives, including marriage, health, friendship, community involvement, creativity, and in particular, our jobs, careers, and business. Happy workers have higher levels of productivity, produce higher sales, perform better in leadership positions and receive higher performance ratings and higher pay. They also enjoy more job security and are less likely to take sick days, to quit, or to become burned out. Most managers appreciate the employee who can go the longest without breaks or vacation, constantly grinding out the work without time wasted socializing. It is this non-stop, relentless worker who is most likely to get burned out. Other than the mandated lunch breaks, very few bosses encourage their employees to take time out from their workdays to exercise or leave early to do charity work even though research proves there is a great return on investment. Most employees are embarrassed or ashamed if the boss walks by as they are
laughing at a YouTube video, or chatting with their 5-year-old daughter on the phone, or telling a joke to colleagues in the hallway. Again, it is these practices that provide exactly the kinds of quick bursts of positive emotions that can improve performance. And the bosses who discourage positivity in their employees are at a double disadvantage, because these people tend to harbor the greatest negativity. You need not try to emulate Google with scooters in the hallway, video game in the break room or hiring a gourmet chef. One way to infuse happiness into the office is to provide frequent recognition and encouragement. Studies show this results in a substantial increase in employees’ productivity. In fact, studies also suggest that when recognition is specific and deliberately delivered, it is even more motivating than money! Of course if your office has no vision, or “why” you do what you do, it will still have major trouble. Each employee has to own his or her responsibilities and work for the common cause. Otherwise you are doomed.
A few of Anchor’s recommendations to improve happiness: • Write down three new things that you are grateful for each day. • Meditate for two minutes. This will help undo the negative effects of multitasking. • Write two minutes a day describing one positive experience you had over the last 24 hours. His book, “The Happiness Advantage,” is filled with useful information and tips and I highly recommend it.
WHAT IS HAPPINESS? Tal Ben-Shahar, Ph.D., wrote a very interesting book called “Happier,” based on his popular course at Harvard. Reading this book gives you a different way to think about happiness and especially about the common rat race we find ourselves in. Imagine four quadrants, with the future benefit at the top and future detriment on the bottom of a vertical axis. Couple this with present benefit on the right and present detriment on the left of a horizontal axis. With
Academics raise questions on physician burnout Two new academic papers raise fresh questions about physician burnout and patient safety risks associated with electronic health records. One, a study in the Journal of Graduate Medical Education, found that first-year residents in internal medicine spent 5 to 7 hours a day – about 40 minutes per patient – reading and entering data into EHRs. The time dwindles as they get more proficient, but it’s still a major portion of the work day. The investigators, including students, residents, faculty and IT professionals at New York Methodist Hospital/Weill Cornell Medical College and at St. Georges University School of Medicine in the island nation of Grenada, wrote: “While electronic records are easier to read, significantly more time is spent on the EHR compared with paper charts. Recent studies have found that physicians spend more time on electronic documentation than providing direct patient care, and other studies have reported that clinical computer work constitutes the highest proportion of time spent by physicians.”
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While they didn’t discuss the issue of EHRs compromising patient safety, Dr. Mark Friedberg of Rand Corp. did. Writing on the Agency for Healthcare Research and Quality’s Patient Safety Network journal-style forum, took a look at how physician professional dissatisfaction can be a safety risk. Citing a 2013 study Rand conducted with the American Medical Association, Friedberg noted: In both qualitative and quantitative analyses, we found many specific factors contributing to physician professional dissatisfaction that will probably sound familiar to patient safety experts. These included clinic leaders who ignored physicians’ ideas for improving patient care, payers that refused to cover necessary services, practice models that did not foster collegiality with other care providers, schedules that prevented physicians from spending enough time with each patient and mandated activities that physicians perceived as distractions from patient care.
Physicians also reported frustrations with certain aspects of electronic health records that can undermine patient safety: crowded and poorly designed user interfaces, lack of health information exchange, and degradation of the quality of clinical documentation (including the proliferation of information that physicians do not trust). He recommended that executives at hospitals and healthcare systems pay attention to complaints about EHR usability. “[T]he best leaders will avoid the temptation to dismiss physician reports as whining or to apply quick but ineffective fixes. Instead, as with other indicators of threats to quality and safety, the best responses to physicians’ perceptions of these problems will be to seek corroborating evidence, assess the magnitude of threat, carefully design and implement solutions and check to make sure the solutions worked – ideally with the same physicians who reported the original problem,” Friedberg wrote. VT N
APRIL/MAY 2016 < VEIN THERAPY NEWS
SECONDLOOK Ben-Shahar defines happiness as “the overall experience of pleasure and meaning.” He goes on to explain that a happy person enjoys positive emotions while perceiving her life as purposeful. The definition does not pertain to a single moment but to a generalized aggregate of one’s experiences: a person can endure emotional pain at times and still be happy overall.
this matrix in mind, Ben-Shahar describes four archetypes that help us think about happiness (See fig. 1) • Rat-Race Archetype - the upper left hand corner of the matrix represents present detriment with future benefit. • Nihilism Archetype - lower left hand corner describes present and future detriment. • Hedonism Archetype - lower right hand corner characterizes present benefit but future detriment. • Happiness Archetype - upper right hand corner signifies present and future benefit. Rat Race Present Detriment Future Benefit
Happiness Present Benefit Future Benefit
Nihilism Present Detriment Future Detriment
Hedonism Present Benefit Future Detriment
Fig. 1 Many people spend a little time in each quadrant without much thought. Let’s face it; the rat-race mentality is extremely common in both medicine and the business world. Too often we work, work, work, without much thought to living in the
SUMMARY
If you want to develop a more successful practice, you may wish to think about happiness and success in a different way. I’d highly recommend reading the “Happiness Advantage” as well as “Happier.” VT N Jeffrey H. Miller, MD, is the founder and CEO of Miller Vein with five offices located in Southeast Michigan. Dr. Miller is a board certified interventional radiologist and certified by the American Board of Venous and Lymphatic Medicine. He has received numerous awards and honors in his field, including being named one of Hour Detroit Magazine’s “Top Docs.”
REFERENCES
The Happiness Advantage, Shawn Anchor Happier, Tal Ben-Shahar, Ph.D., page 33
moment. Joining the Happiness Archetype, or way of life, becomes a choice.
Study probes PE caused by ultrasound for DVTs Although it's an extremely rare event, ultrasound exams performed for deep vein thrombosis (DVT) can dislodge blood clots that can then embolize into the vasculature and cause a pulmonary embolism (PE), according to a paper published online in Seminars in Thrombosis and Hemostasis. In a comprehensive literature review, a multi-institutional and multinational research team found eight original cases in which ultrasound was reported to have caused clot embolization. Senior author Dr. Behnood Bikdeli from the Yale University School of Medicine said radiologists and clinicians need to be aware of this serious and potentially fatal complication and take precautions. “We agree that this phenomenon is rare, but we also have concerns that it is underrecognized and underreported and hope that our study will address this unmet need.” Extremity ultrasonography is by far the most common test for diagnosing upper or lower extremity DVT. There's been a theoretical concern, however, that excessive pressure applied during ultrasound studies may lead to blood clots breaking off and embolizing into pulmonary vasculature, said first author Dr. Ghazaleh Mehdipoor from Shahid Beheshti University of Medical Sciences in Tehran, Iran. Because a quick review of the literature did not support any notions for or against this phenomenon, the researchers sought to investigate this issue in a systematic way. Other members of the research team included Dr. Abbas Arjmand Shabestari, also of Shahid Beheshti University of Medical Sciences in Tehran, Iran, and Dr. Gregory Lip from the University of Birmingham in Birmingham, U.K., and Aalborg University in Aalborg, Denmark. The group searched PubMed for all studies between Jan. 1, 1960, and April 10, 2015, that reported possible or confirmed pulmonary embolism as a consequence of extremity ultrasound assessment in patients with suspected DVT. All cohort studies, cases series, and case reports were included in the analysis (Semin Throm Hemost, Jan. 25, 2016). Of the 3,625 articles reviewed by the researchers, 15 reported on the issue of clot dislodgement and embolization following
VEIN THERAPY NEWS < APRIL/MAY 2016
extremity ultrasound. One was a systematic review that did not find any relevant original reports on the subject, while six were narrative reports that discussed concern over the possibility of extremity ultrasound causing embolization but did not share any original cases. There were, however, eight original case reports involving seven confirmed PE cases and one probable case from seven men and one woman with an age range of 21 to 75. The first case was reported in 1970, with the last published in 2012. Two of the PE cases resulted in fatalities. Five of the PE cases were in the right lower extremity and three were in the left. The thrombus was present in the femoral veins in six cases, and four of those were right-sided. Also, thrombus echogenicity was detected in six of the cases, while the other two cases did not provide any information on echogenicity, according to the authors. In two cases, the thrombus was reported to have a free-floating tail. Six of the eight PE cases were symptomatic, with symptoms (dyspnea, orthopnea, and pleuritic chest pain) occurring within seconds to several hours after ultrasound assessment. In two of the cases, the clot dislodgement was witnessed in the middle of the ultrasound examination. In all of these PE cases, compression ultrasound was used with or without adjunct technologies, according to the researchers. “Clot embolization does occur in some cases after ultrasonography,” Mehdipoor said. “The time course and clinical characteristics in reports that we found puts it beyond doubt that ultrasound was the causative factor.” The researchers are concerned that clot embolization after ultrasound is underreported, Bikdeli said. “For example, many of the reports we found about clot embolization after ultrasonography had claimed to have described this phenomenon for the first time,” he said. Another recent systematic review also claimed to have found no relevant cases, whereas the researchers found 15 reports, including eight original cases, Bikdeli said.
Mehdipoor noted that while the real mechanism for clot embolization after ultrasound is unknown and the phenomenon is rarely reported, use of the compression maneuver during the ultrasound scan was a commonality among the reported cases. As a result, radiologists or sonographers should exercise caution when investigating extremities for suspected DVT, he said. “It is not necessary to apply excessive pressure for ultrasonographic studies of patients with suspected DVT, and it is prudent to avoid compression or augmentation maneuvers if the thrombus is already visualized on twodimensional ultrasonography,” Mehdipoor said. “Be aware of this ominous, rare complication when the clot disappears during the ultrasound examination.” Mehdipoor said that radiologists, and likewise clinicians, should seriously consider the possibility of a pulmonary embolism if the patient reports less swelling (with or without chest discomfort, tachycardia, etc.) after the ultrasound exam. The main thing is to be cognizant of the possibility of clot embolization and provide treatment as needed, Bikdeli said. “If there's evidence of hemodynamic collapse, bedside [transthoracic echocardiography] for looking for clots in transit might be helpful, and advanced therapies, e.g., thrombolysis or thrombectomy, [might be considered] on a case-by-case basis,” Bikdeli said. The key next steps for studying this phenomenon are to identify the specific thrombus and patient characteristics and ultrasound study factors (such as the compression maneuvers and the augmentation maneuver, etc.) that increase the risk of clot embolization, Bikdeli said. “The significance of each of these factors should be ideally assessed in prospective studies of ultrasonography for suspected DVT,” he said. VT N This article was written by AuntMinnie staff writer Erik L. Ridley, and is reprinted with permission from the Feb. 4 AuntMinnie news report.
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SECONDLOOK MARKETING DOCS
continued from page 21
created by the marketing department; it is every single interaction that a patient has with the practice beginning with the very first phone call (if not before). Staff members need to be aware of external marketing campaigns and understand their roles in bringing them to fruition. This leads us to number two. Focus on the patient experience. As our society becomes increasingly focused on convenience and instantaneous satisfaction, gone are the days of extremely loyal patients who would wait for hours in the waiting rooms and then take every word the physician said to heart. Now, patients want to partner with physicians in their care. In addition, one bad experience with a nurse or receptionist can have them walking out the door and never returning. Pay attention to customer service, wait times and hold times. Survey your patients on a continuous basis and read the results. Surveys provide excellent opportunities for service recovery. Even if you can’t fix the scenario, there are times when patients are astounded that you took the time to call. Make it easy for patients to find you. With more than 80 percent of Americans looking online for health information, why not provide content that is accurate and valuable? By investing in search engine marketing, search engine optimization and your website, you can ensure that you position your practice as an expert in your field and in your market.
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Go where your patients go and provide value. While I just harped on the importance of investing in your website, don’t wait for your patients to find you on the Internet. Go where they already are and share valuable content. Subsequently, you’ve got to know your audience. Pinterest is a natural fit for our OB-GYN practice, although your practice may be more closely tied to some other social media. The shelf life on Pinterest appears to be much longer than some of the other social networking sites. Infographics that we posted months ago are still getting repinned daily. VT N This blog originally appeared on the Go Junto blog: gojunto.com/four-tips-in-marketingphysician-practices/
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APRIL/MAY 2016 < VEIN THERAPY NEWS
SECONDLOOK VASCULAR SOLUTIONS
continued from page 1
Throughout the proceedings, Vascular Solutions attorneys maintained the innocence of the company and of Root. The company was “subjected to five years of attacks which forced us to hire 10 separate law firms at a cost of more than $25 million to defend against a criminal prosecution that clearly was never warranted by the facts,” Root said. Plus, the case was only focused on one of the company’s more than 100 medical devices that comprised 0.1 percent of its sales and never harmed patients. “To say that this prosecution was wrong-headed and disproportionate would be the understatement of the year,” Root said. Now Root wants the DOJ to issue a press release correcting its earlier claims about the company and its alleged off-label marketing. The agency should also think about changing its own Howard practices to make sure that Root its claims aren’t “based on false allegations made by a money-motivated disgruntled former employee,” Root said. “Vascular Solutions is fortunate to have had the financial strength and dedicated employees necessary not only to fight, but to win. Most other companies would have been destroyed before they even set foot in the courtroom. “In order to ensure that what happened to Vascular Solutions doesn’t happen to a defenseless company or individual, changes need to be made in the personnel and culture at the Department of Justice. “Every investigation that is being conducted by the prosecutors who were assigned to our case needs to be independently reviewed by the Department of Justice to make sure that their abusive and dishonest tactics are not being used on others. Furthermore, every current investigation of a medical device company concerning “off-label” promotion needs to be reviewed by the Department of Justice to make sure their prosecutors’ theories comply with the law, not just their wishes.” Root said that Vascular Solutions can now return its full focus and resources to developing medical devices to improve patient lives and create American jobs – vital pursuits that he said were clouded while they were defending “ourselves against a malicious prosecution.” Fortunately, throughout this process our employees have continued to carry on with business as usual. That commitment and our successful business model has positioned Vascular Solutions very well for continued success, especially now that this senseless distraction is behind us.” VT N
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SECONDLOOK
PATIENT-GENERATED DATA
What will it take for physicians to try new technology? By Joseph Kvedar, MD For about 10 years now, we’ve been collecting data from patients, mostly from sensors in their environment (activity trackers, blood pressure cuffs, weight scales, etc.), trying to break free from less-than-reliable self-reported data. We’ve shown that, properly used, patient-generated data is: • Central to improved quality of care for chronically ill patients (i.e., patients with heart failure in a telemonitoring program had significant improvement in mortality compared to controls). • Useful in engaging patients around lifestyle choices to improve the care of both diabetes and hypertension. • Useful in engaging patients in interventions that encourage them to improve their own care. Despite these studies and a bevy of evidence from other investigators in the field, I still get routinely reminded, when I am out presenting on connected health, that “physicians don’t want this data.” This is a resounding theme that ranks right up there with concerns about liability and reimbursement. On the one hand this response is predictable. Physicians’ time is squeezed more than ever these days. The thought of having to pour over reams of normal values seems daunting. I take this objection as evidence that we aren’t clear in communicating our vision – or the true benefits of having realtime, real-world patient data available. In so many other industries, software has been designed to troll through complex data sets and cull out the meaningful relationships or events, and then presenting them succinctly as actionable information or valuable insight rather than just raw data. We can do this for patient generated data too. Then there is the objection that it is complex and costly to collect such data. Things are getting better on this front. We’ve shown that for diseases such as congestive heart failure, remote monitoring programs that use patient generated data
lead to a significant drop in hospital readmissions and, more importantly, a decrease in total medical expenses. These major cost savings quickly add up, while improving the quality of care delivered. It is hard to object to that combination. Validic, a forward-thinking company, is one example of an organization providing software that enables easy collection and normalization of all sorts of patient-generated data. The company just came up with an exciting innovation that allows a patient to take a picture of any data-collecting device (imagine the screen on a home blood pressure monitoring device) with her mobile phone camera and have that data flow into the electronic record. This is analogous to taking a picture of your check and having it deposited in your checking account. This will lower costs significantly. The objection that irks me the most, though, is the one that basically admits to striking out before even getting up to bat: “I don’t know what I’d do with all of those readings anyway.” This approach disappoints me in many ways. First as physicians, we’re trained in the scientific method. We’re supposed to be curious, to think about novel ways of providing care and above all, ways to improve care. Yet, some health care providers feel completely at ease that a disease as significant as hypertension can be adequately assessed by taking a few readings in the doctor’s office once or twice a year. Maybe that made sense when the sphygmomanometer (aka blood pressure cuff) was first invented. But now that these devices are ubiquitous and can be purchased in every drug store, why would we not want to take advantage of the extra data points from home readings? We made the leap for glucometers decades ago. The new white coat of anxiety is a phrase I use to describe the myriad concerns and changes taking place in health care today that are causing providers angst. Chief among them is apprehension to change. Change is coming from all sides: shifting payment models, changing from face-to-face
interactions to virtual care, a lack of awareness about personal connected health trackers and real anxiety over what to do with all of this data. My friend Dr. Steve Ommen, associate dean at the Center for Connected Care at the Mayo Clinic in Rochester, Minn., told me when I interviewed him for my book: “Providers will come to see that incorporating connected care into clinical practice will be of benefit to both their practice and their patients, but it’s not the way we’ve all been trained to practice medicine for 150 years.” Many don’t realize that when Laennec introduced the stethoscope it was ridiculed. In fact, it took 20 years for it to be accepted as a standard tool for clinical practice. The analogy may be apt, but we don’t have 20 years to wait for healthcare providers to embrace patient generated data. As we embrace the world of value-based provider compensation, it is imperative that we look at collecting information from and about our patients differently. VT N Joseph C. Kvedar, MD, is the vice president of Connected Health, Partners HealthCare. He is creating a new model of healthcare delivery by leveraging personal connected health technologies and remote monitoring tools to better manage chronic conditions, maintain health and wellness, and improve adherence, engagement and clinical outcomes. He is the author of the book, “The Internet of Healthy Things,” describing how everyday objects will capture and use real-time biometric data to ultimately change behavior to improve our health. Dr. Kvedar created “Wellocracy,” a leading source of impartial, easy-to-understand information to encourage the sustained use of personal “self-health” technologies. His popular cHealth Blog provides his insights and vision for connected health.
Cook Medical recalls single-lumen central venous catheters Cook Medical has recalled 17,827 single-lumen central venous catheters and pressure monitoring sets and trays because of concerns about catheter tip fracture and/or separation. The FDA posted the Bloomington, Ind., company's recall on its website, an action it takes from time to time to publicize recalls that are critical to patient safety. “During an internal inspection, a catheter exhibited the potential for catheter tip fracture and/or separation. Further investigation revealed that the technique used by the product assembler while tipping the catheter likely contributed to this nonconformance. No reports of illness or injury have been associated with this issue to date. Potential adverse events that may occur as a result of catheter tip fracture and/or separation include loss of device function, the need for medical intervention to retrieve a separated segment, and complications resulting from a separated tip occluding blood flow to end organs. Examples of such complications include stroke, kidney injury, or damage to the intestines or limbs, Cook wrote in its release.
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The recalled catheter sets and trays are for femoral artery pressure monitoring, radial artery pressure monitoring, according to the release. It contains specific information about the versions and lot numbers of the individual devices that should be discontinued, quarantined and returned to Cook Medical for possible credit. The devices were distributed between April and October 2015 in the United States, Australia, Chile, Finland, India, Panama, Spain and other countries around the world. Tip separation was also responsible for the company's August Class I recall of 95,167 Beacon Tip Angiographic Catheters, which it later expanded in October. Then in January, its Class I recall for beacon tip angiographic
catheters was widened to include additional lots. The company added an additional eight catalog numbers and 63 lot numbers to the recall, according to an FDA press release. The recall affects Cook Medical’s Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip HighFlow Catheters, Slip-Cath Beacon Tip Hydrophilic Catheters and Shuttle Select Slip-Cath Catheters. It was also cited in the 2013 Class I recall of Cook’s Zilver PTX Drug-Eluting Peripheral Stent. One death occurred when the tip of the device’s delivery catheter separated itself from the instrument, according to the FDA’s recall database. VT N READ MORE: fda.gov/Safety/Recalls/ ucm485898.htm?mkt_tok=3RkMMJWWf F9ws Rokuq3Bc%2B%2FhmjTEU5z14%2B4kUKW0lM I%2F0ER3fOvrPUfGjI4FScJlPK%2BTFAwTG5to ziV8R7LMKM1ty9MQWxTk#recall-photos
APRIL/MAY 2016 < VEIN THERAPY NEWS
SECONDLOOK Is P.A.D. testing over utilized?
P.A.D. SCREENING CONTROVERSY
See Below the Skin’s Surface
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Despite little growth in the prevalence of peripheral arterial disease (P.A.D.), utilization of tests for the condition grew rapidly from 2001 to 2013. This increase may reflect overutilization and possibly the effects of selfreferral among cardiologists and surgeons, according to a new study. On the bright side, utilization rates have flattened since 2010 for duplex ultrasound of lower extremity arteries and decreased for noninvasive physiologic testing of extremity arteries (NPT), according to a review of Medicare data files by researchers from Thomas Jefferson University. Radiologists have lowered their ultrasound utilization rate; however, surgeons and cardiologists have continued to show an increase, raising the question of a possible self-referral problem, according to the team led by Dr. David C. Levin. Levin presented the results at the RSNA 2015 meeting in Chicago earlier this year.
Unlike coronary artery disease or carotid artery disease which can result in heart attack or stroke, P.A.D. only rarely results in catastrophic consequences if not detected early, Levin said. “There are almost no catastrophes [from P.A.D.]; it is kind of a disease that has a very gradual onset,” he said. “If you’re late in diagnosing it, it probably doesn’t make that much difference to the clinical outcome of the patient. You don’t really need to treat P.A.D. until it’s really quite symptomatic. Testing for the early presence of disease is not urgent.” At the same time, the prevalence of P.A.D. is increasing at a very slow rate of 1 percent per year in developed countries, according to a recent study. Nonetheless, screening for P.A.D. remains a controversial issue. The Society of Interventional Radiology recommends screening, while the Society for Vascular Surgery is against it, Levin said. The researchers set out to study recent utilization trends for the two most common noninvasive tests used to screen for and initially diagnose P.A.D.: duplex ultrasound of the lower extremities and noninvasive physiologic testing, which includes procedures such as the ankle-brachial index, pulse volume recordings, segmental pressure measurements, and bidirectional Doppler waveforms. The team accessed Medicare Part B Physician/Supplier Procedure Summary Master Files for 2001-2013, which provide data such as exam volume and allowed payments for each CPT code. Utilization rates per 100,000 Medicare beneficiaries were
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P.A.D.
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VEIN THERAPY NEWS < APRIL/MAY 2016
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PRODUCTNEWS
FDA OKs Gore Excluder Device W. L. Gore & Associates Inc. has announced the Food and Drug Administration (FDA) approval of the Iliac Branch Endoprosthesis (IBE), making it the first off-the-shelf aortic branch device approved in the United States and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The first-of-its-kind device is a complete, fully engineered system that received CE Mark in 2013. The device is used in conjunction with the Gore Excluder AAA Endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries. The device is built on Gore’s technology platform and designed using the same durable, expanded polytetrafluoroethylene (ePTFE) graft and nitinol stent material. The IBE offers an all-in-one system with improved outcomes for the treatment of iliac artery aneurysms while preserving flow to the iliac arteries, which is the recommended treatment by vascular surgery societies to sustain patient quality of life. Preservation of blood flow in the internal iliac arteries is found to avoid pelvic flow disruption and reduce the rate of buttock claudication, sexual dysfunction, and colonic ischemia. “Historically, options to preserve flow to the internal iliac arteries during endovascular aneurysm repair were very limited despite the involvement of the iliac arteries in about 25 percent of AAA cases,” said Darren Schneider, MD, chief of Vascular and Endovascular Surgery and associate professor of surgery at Weill Cornell Medicine and principal investigator for the national Gore Excluder Iliac Branch Device Clinical Study. He is also a paid consultant to W. L. Gore & Associates. “However, through our research and the subsequent FDA approval, physicians now
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have a new therapeutic option to preserve pelvic perfusion in order to improve clinical outcomes and maintain patient quality of life.” The IBE system provides a treatment range of 6.5-13.5mm for the internal iliac arteries, and a treatment range of 6.5-25mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16 Fr introducer sheath for the iliac branch component, and a flexible 12 Fr, reinforced introducer sheath for the internal iliac component. The Gore Excluder Iliac Branch Device Clinical Study, a prospective, multicenter, non-randomized, single-arm study designed to assess the safety and effectiveness of the IBE in treating common iliac artery aneurysms or aortoiliac aneurysms, completed enrollment in February 2015. A total of 62 patients received the device, which met the FDA required enrollment of 60 patients. The trial also enrolled an additional 32 patients through Continued Access (as of Feb. 15, 2016), which expanded treatment options to allow for bilateral placement of the IBE in addition to unilateral IBE device placement, which was evaluated in the Primary Enrollment. “FDA approval of this device is extremely important as it provides an iliac branch solution for a patient group with a previously unmet treatment need,” said Ryan Takeuchi, Gore Aortic business leader. “The Gore Excluder Iliac Branch Device has demonstrated high patency, conformability, and durability and provides physicians with an on-label, minimally invasive method of preserving flow to the internal and external iliac arteries. Not only is IBE the first offthe-shelf aortic branch device approved in the United States, it is a part of a complete portfolio of aortic branch solutions that are currently in clinical evaluation.” VT N READ MORE: GoreMedical@ Chempetitive.com
Report details EHR market until 2020 Research and Markets has added the “Global Electronic Health Record Systems (EHR) Market Size, Share, Development, Growth and Demand Forecast to 2020” report to itsoffering. The global electronic health records (EHR) systems market was worth $20,961.2 million in 2014, and it is expected to grow at a CAGR of 6.2 percent during 2015-2020. The need for better healthcare facilities through improved and effective quality of treatments is driving the demand for integrated healthcare systems. The increasing investments from healthcare IT players are also escalating the demand of EHR systems globally. In addition, number of hospitals is also increasing worldwide, which would require
Report: Vascular interventions to reach $3.4 billion by 2022 By 2022, the global market for lower extremity stents, percutaneous transluminal angioplasty (PTA) balloons, PTA drug-eluting balloons, carotid stents, renal stents and other peripheral vascular interventions will increase to $3.4 billion, up from $2.1 billion last year. GlobalData, a research and consulting firm, provided the estimates in a report released in March titled “MediPoint: Peripheral Vascular Interventions – Global Analysis and Market Forecasts.” The company noted that the market would increase as a result of recent electronic health records systems for costeffective and efficient healthcare services. The restraints associated with EHR systems market include high maintenance and service expenses for EHR systems. Purchase, installation and maintenance of information systems, which help in producing EHRs, are expensive processes; and require timely service. This elevates the cost of healthcare services provided. In addition, lack of skilled professionals for efficient handling of the EHR systems and lack of privacy and security are also restraining the growth of the market. VT N READ MORE: researchandmarkets.com / research/m49tzf/global_electronic
First patients treated with Endologix Nellix Two patients in Japan have been treated with the Nellix endovascular sealing system for abdominal aortic aneurysm (AAA). These first two cases were treated under Japan’s “compassionate use” system, which allows physicians to use medical treatments not yet approved in the country for patients diagnosed with advanced diseases, who are not responding to existing treatment options. The procedures were performed by Toru Kuratani, MD and chairman of the Department of Minimally Invasive Cardiovascular Medicine at Osaka University Graduate School of Medicine, Osaka, Japan. “The unique aneurysm sealing technology of the Nellix system presents a significant opportunity to treat AAA patients that previously had no other treatment options,” Dr. Kuratani said. “Type II endoleaks occur in more than 30 percent of our EVAR cases in Japan, and this device is excellent solution for prevention of this endoleak. “In addition, Nellix is very well positioned to treat the anatomical challenges associated
advances such as drug-eluting stents and balloons, bioabsorbable stents and polytetrafluoroethylene-covered stents to treat peripheral artery disease. This report includes data from North America, Europe, Asia-Pacific and Brazil. VT N READ MORE: cardiovascularbusiness.com/ topics/vascular-endovascular/ report-estimates-globalm a rket - p e r iphe r a l -v a sc u l a r inter ventions-will-reach- 34 billion-2022
Endologix’s Nellix with Asian patients, including difficult iliac anatomy. The first two procedures were completed as planned, and the initial imaging confirms that Nellix effectively sealed and treated the AAAs. We look forward to treating more AAA patients under Japan’s compassionate use system.” The Nellix EVAS System is a new generation of AAA therapy designed to seal the entire aneurysm sac. It is the first and only EVAS product, developed to reduce all types of endoleaks and improve and long-term patient outcomes. Nellix is an investigational device in the United States. VT N READ MORE: vascularnews. com /v n-latest-news/vascularnews---latest-news/first-patientstreated-with-endologix-nellix-injapan#sthash.VKyjzms2.dpuf
Flexible electronics may make its way into med wearables At the École polytechnique fédérale de Lausanne, Switzerland researchers have created a new method for making stretchable electronics that may end up being integrated into wearables and medical devices. The
APRIL/MAY 2016 < VEIN THERAPY NEWS
PRODUCTNEWS P.A.D.
“At a time when the prevalence of P.A.D. was growing very slowly, the use of these tests grew rapidly,” he said. “This raises a concern about overutilization.”
continued from page 27
prototype films can stretch up to four times their original shape and relax back without suffering any degradation in its electrical properties. The researchers’ main achievement was in making very narrow wires out of liquid metal (gold/gallium alloy) that bend along with the rest of the film but do not break down into individual pieces.. They’re only a few nanometers in width, and so can be used to connect multiple components within a single larger flexible device. VT N
calculated for two duplex ultrasound CPT codes (93925 and 93926) and three NPT CPT codes (93922, 93923, and 93924). The researchers then used the Medicare specialty codes to identify the physician specialties for the studies.
INCREASE IN UTILIZATION
In bad news, the group found a significant increase in exam volume and utilization rates per 1,000 Medicare beneficiaries for both duplex ultrasound and NPT studies The utilization rates per 1,000 Medicare beneficiaries have increased by 88 percent for ultrasound and by 63 percent for NPT from 2001 to 2013.
SURGEONS, CARDIOLOGISTS ARE BUCKING THE TREND
The researchers also found that radiologists’ use of ultrasound has been flat since around
Utilization of extremity arterial ultrasound for PAD by specialty Specialty
2013
Increase from 2001
Radiology
210,477
93 percent
Surgery
258,104
108 percent
Cardiology
187,275
267 percent
On the bright side, growth in ultrasound utilization flattened out and NPT use has declined since 2010. This trend is likely due to overall efforts in healthcare and imaging to restrict rapid growth in testing, Levin said.
2009, while surgeons and cardiologists continued to perform more studies. That
P.A.D.
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Cardiovascular Credentialing International Credentialing Cardiovascular Professionals since 1968 http://www.cci-online.org (800) 326-0268 • www.cci-online.org
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VEIN THERAPY NEWS < APRIL/MAY 2016
Photo courtesy of Morrison Vein Institute and Compudiagnostics
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PRODUCTNEWS
FDA OKs Avinger P.A.D. device Avinger, a Redwood City, Calif., firm, obtained 510(k) clearance from the FDA to introduce its latest Pantheris lumivascular atherectomy device. It’s the only image-guided atherectomy device of its kind used to treat peripheral artery disease (P.A.D.). The new version of the Pantheris features better controls, ergonomics, and new manufacturing technology. The system uses optical coherence tomography (OCT) to image the 3D structure of the arterial lumen and plaque within. This is provided in real time as the device is used to repeatedly shave off layers of plaque, so seeing progress live on the screen helps to adjust the tool to optimally remove as much build-up as possible without damaging the vessel. In March, the company registered for the sale of up to $50 million of its stock. The company said the deal with Cowen & Co. doesn’t oblige it to sell any shares. VT N
FDA OKs Chemence Exofin tissue adhesive for closing wounds Chemence Medical has won FDA 510(k) approval for its Exofin topical skin adhesive designed for wound closure. The Alpharetta, Ga.-based company said it will offer the Exofin sealant in two sizes, and claimed the product is the “fastest polymerizing 2-octyl cyanoacrylate topical adhesive” available, with the highest viscosity formulation. “After spending more than two years observing and talking to healthcare professionals throughout all departments of hospitals across America, it became clear that no single topical adhesive had all of the attributes that mattered most,” President Jeff Roberson said.
“Chemence Medical has combined your feedback with the very best R&D department in the USA and created a topical skin adhesive that delivers on all of the requirements you asked for,” Roberson stated. The company offers the Exofin with a “soft and flexible” applicator with a transparent tip. Chemence said it will enable the operator to see the adhesive prior to expression to allow for a solid seal. “Exofin delivers the speed, strength and innovation customers have asked for while being easy to use. c is excited to introduce the next generation of topical skin adhesive,” Roberson said. VT N READ MORE: medicalglue.com
ANGIODYNAMICS
continued from page 1
and CEO of AngioDynamics. “Asclera offers a unique benefit for patient care. “As a single-dose treatment, Asclera is an effective treatment option that simplifies the delivery of patient care for our vein customers. We are excited to partner with healthcare providers to ensure patients have access to this safe, effective vein treatment option and continue to provide even more value to our vein customers as part of our overall venous disease treatment plan.” Jim Hartman, U.S. head of Merz Aesthetics Injectables Division, said Merz sees this as an important strategic partnership furthering treatment access for patients who want to treat and improve the appearance of uncomplicated spider and uncomplicated reticular veins. “AngioDynamics . . . has the organization, sales force and existing relationships to capitalize on this opportunity with the goal of reaching more physicians and inevitably patients.” Asclera adds to AngioDynamics’ venous disease treatment options, which include the market-leading VenaCure EVLT endovenous laser vein treatment system. VT N READ MORE: angiodynamics.com
RESOURCE
1 Weiss, Voigts, Howell (2011) Absence of Concentration Congruity in Six Compounded Polidocanol Samples Obtained for Leg Sclerotherapy. American Society for Dermatologic Surgery, Inc., Volume 37: 1-4
shweiki.com 30
Research & Markets report explores catheter devices Research and Markets has added “Catheter Stabilization Device/Catheter Securement Devices Market - Global Forecast to 2020” report to its offering. The global catheter stabilization device market is expected to reach $1,372.35 million by 2020 from $957.26 million in 2015, growing at a CAGR of 7.47 percent between 2015 and 2020. Increasing healthcare expenditures and demand for minimal invasive surgeries will drive the growth of the securement devices market. This report segments the global catheter stabilization device market by products, applications and end users. The global market product segments included in the report comprises of arterial securement devices, central venous catheter securement device, peripheral securement devices, abdominal drainage tubes securement devices, epidural securement devices, chest drainage tube securement devices, and all-site devices. The geographic segments included in this report are North America, Europe, Asia and rest of the world. The geographic analysis reveals that North America accounted for the largest share in the global securement devices market in 2015. Asia regional segment, on the other hand, is expected to register a faster growth from 2015 to 2020, due to the increasing healthcare expenditure and aging population from this region. VT N READ MORE: researchandmarkets.com / research/c66qjq/catheter
P.A.D.
continued from page 29
raises concern over self-referral issues, Levin said. The team did find a decline in NPT among all specialties since 2010. Levin noted that the increases in the overallutilization rates of duplex ultrasound and NPT were not related to an increase in screening, as Medicare does not cover the use of these tests for screening purposes. It’s good, though, that radiologists retain a strong role in P.A.D. testing, especially in lower extremity duplex ultrasound, Levin said. “Angiography and peripheral vascular interventions have been taken over pretty much by surgeons, and I think that’s unfortunate,” he said. “I don’t think they’re nearly as welltrained as radiologists and their results are not as good. That was a development I was really unhappy about.” VT N
APRIL/MAY 2016 < VEIN THERAPY NEWS
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The 2016 Congress Program Planning Committee of the American College of Phlebology invites you to submit an abstract for consideration at the 30th Annual Congress, to be held November 3-6, 2016 in Anaheim, California, on the following topics:
1. BASIC VENOUS AND LYMPHATIC SCIENCE 2. CHRONIC VENOUS INSUFFICIENCY AND VENOUS
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