INSIDE
APRIL/MAY 2018 Vol. 11, No. 2 VEINTHERAPYNEWS.COM
BTG outlines OPTALYSE PE at a year 8 Email vein questions to IVC panel 10 Sage Group says P.A.D. raging in Asia 12 Push for personal patient identifiers 22 War weary doc 3D prints stethoscopes 30
An ACP recognized resource for news and information for and about the phlebology community
Varithena is an elegant solution for C6 ulcer By Kenneth Otah, MD, MSc, FACC Patients with venous ulcers make up over up more than 70 percent of nonhealing ulcers. By the time these patients are referred to us, many have been suffering debilitating pain and lack of mobility for months – even years – as well as extreme frustration at the endless rounds of futile treatment they’ve endured. Other patients I see with challenging chronic venous disease have extensive varicose veins with tortuous venous anatomy in refluxing accessory veins or tributaries. Varithena from BTG International Group, a novel sclerosing agent, offers an effective therapeutic solution to treat these types of complex venous disease.
PAST METHODS
Before Varithena became available, physician-compounded foam (PCF) sclerotherapy and phlebectomy were the only options to treat extensive varicosities and tortuous segments not amenable to catheter-based ablation. Sclerotherapy was also used for varicosities below the knee to avoid the potential risk VARITHENA
continued on page 24
Before Patient had a C6 necrotic ulcer on his right foot (see inset) when he was first evaluated Nov. 23, 2016. He was treated with Varithena April 17, 2017, to ablate the pathologic varicosities surrounding the ulcer bed. This is his foot at a follow-up visit March 16, 2018.
‘WAKE-UP CALL’ Cleveland Clinic’s study shows CIED extraction injuries
Transverse section of a fibrous cuff dissected from around an extracted lead with evidence of transmural venous injury.
The first large study to characterize the histopathology of extracted leads from cardiac implantable electronic devices (CIEDs) shows that microscopic venous injuries during transvenous lead extraction (TLE) are common but may not be recognized clinically. “This was a wake-up call,” says Cleveland Clinic electrophysiologist Khaldoun G. Tarakji, MD, MPH and principal author
of the study, which was presented at the American Heart Association Scientific Sessions 2017 and published simultaneously in Heart Rhythm. “Between 1.2 and 1.4 million CIEDs are implanted each year. These devices have saved thousands of lives and improved the quality of life for many more patients.
“However, with this increase in CIEDs, we have been encountering more cases where these devices and leads need to be removed, whether due to infection, lead malfunction or other indications. Extraction of these leads is usually performed percutaneously using CIED
continued on page 28
ACP adds new energy, approach to ’18 Nashville Annual Congress By Amanda Godwin The American College of Phlebology (ACP) is expanding the Annual Congress experience with new educational opportunities, cuttingedge science and research all centered around the latest in healthcare policy.
The annual event will offer something for all experience levels of venous, lymphatic and wound care providers and encourage creative problem-solving and a sense of community. The 32nd ACP Annual Congress will be held ACP
continued on page 27
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VEIN THERAPY NEWS < APRIL/MAY 2018
Volume 11, Number 2
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NEWS 1 ACP touts new Congress approach
The American College of Phlebology (ACP) is expanding the
Annual Congress experience with new educational opportunities, cutting-edge science and research all centered around the latest in healthcare policy, beginning with the 2018 event in November.
8 Chinese see U.S. vein procedures
American Vein & Vascular Institute owners Gordon F.
Gibbs, MD, and Erin Gibbs have returned from 10 days in China teaching Chinese doctors contemporary vascular healthcare practices. In partnership with Medtronic, Dr. and Mrs. Gibbs traveled to Beijing and Shanghai, teaching 50 Chinese doctors through presentations, training sessions and patient visits.
THE PRACTICE 18 Manage your online reviews
In our focus this month, two experts give you tips on what
to do – and not do – to manage your online reviews. If you don’t approach your social media presence and reviews carefully, you can send your business to the new guy down the street. Both of our experts have offered to do a free reputation management analysis on your practice’s social media site.
SECOND LOOK 1 Wake-up call on CIED injuries
The first large study to characterize the histopathology of
extracted leads from cardiac implantable electronic devices at the Cleveland Clinic shows that microscopic venous injuries during transvenous lead extraction are common but may not be recognized clinically.
1 Varithena process heals C6 ulcer
Patients with venous ulcers make up over up more than
70 percent of nonhealing ulcers and suffer debilitating pain and a lack of mobility for months to years. In this case study, the patient had a C6 necrotic ulcer on his right foot that was treated and healed with Varithena.
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THE
VTNREPORT IAC RESEARCH COMMITTEE SETS APRIL 2 AS DEADLINE FOR RESEARCH PROGRAM LETTER OF INTENT The Intersocietal Accreditation Commission’s research committee has set April 2 as the deadline for a letter of intent to submit a research proposal that would advance the IAC Research Committee’s mission of “Strengthening Accreditation through Research.” Grants up to a maximum of $75,000 (including institutional overhead) will be given to selected proposals. Awards are for one year, although continuation awards are possible. This application process initially involves the letter of intent, and if accepted, a subsequent full proposal. Mary Beth Farrell, MS and IAC director of research, can answer questions by calling 800-838-2110 or emailing research@intersocietal.org. READ MORE: intersocietal.org/research/2018.htm?utm_source=I AC+Vein+Center+Email+Contact+L ist&utm _campaign= 9c0 0 09f 53cVe i n _ R e s e a r c h+ C a m p a i g n _ 3 - 15 - 18 & u t m _ m e d i u m = e m a i l & u t m _ term=0_227ef1b20e-9c0009f53c-16157973
CIGNA PURCHASING EXPRESS SCRIPTS FOR $67B ON HEELS OF CVS-AETNA VERTICAL MERGER Cigna, which failed in an attempt to merge with Anthem last year, is now going to purchase Express Scripts, the country’s largest pharmacy benefit management (PBM) firm, for $67 billion. Cigna will also assume about $15 million in Express Scripts debt. Cigna spokesmen say the merger will offer more choice for consumers, increased collaboration with providers and additional opportunities for personalization. The combined entity would retain the name Cigna, and Cigna’s headquarters in Bloomfield, Conn., will oversee the joint venture. Express Scripts will continue to operate in St. Louis. Cigna CEO David Cordani will become CEO of the joint venture, and Express Scripts CEO Tim Wentworth will continue as president of the PBM. The deal was approved by the boards of both companies and will include both stocks and cash. The Cigna-Express Scripts deal comes on the heels of a similar vertical merger, the one planned between CVS and Aetna. That deal, valued at $69 billion, would also combine one of the nation’s largest payers with a major PBM. Consumers advocates warn the CVS and Aetna deal could be anticompetitive and lead to fewer options for patients. However, both CVS and Aetna have pledged that the deal, if confirmed, would not lead to service restrictions.
MEDTRONIC CLOSES $28 MILLION BUYOUT OF QT VASCULAR’S CHOCOLATE PTA BALLOON Medtronic (closed the $28 million acquisition of the Chocolate PTA non-drug-coated balloon made by QT Vascular at the end of January, after taking an option on the device almost a year ago. In February 2017 the companies signed a five-year deal calling for Medtronic to distribute the Chocolate PTA device. Last May, Medtronic agreed to the option deal on Chocolate PTA, which was triggered in part after QT Vascular successfully shifted production to a third-party contract manufacturer. “Through our distribution agreement with QT Vascular, we have seen a lot of excitement from physicians about this unique, specialty balloon,” Medtronic Peripheral General Manager Mark Pacyna said. “The acquisition of the Chocolate PTA balloon will strengthen our portfolio, providing customers with a both a stand-alone and adjunctive treatment option for peripheral artery disease above and below the knee.”
DR. JOSE ALMEIDA ANNOUNCES 2018 IVC KEYNOTE The 2018 International Vein Congress (IVC) keynote address, titled “Data is King: To Measure Clinical Outcomes, to Shape Policy, for Payer Negotiations, for Peer Oversight and Governance,” will be given by Jack L. Cronenwett, MD, vascular surgeon at Dartmouth-Hitchcock Medical Center. IVC will also offer a multitude of other venous governance-related sessions to keep health policy in the minds of attendees throughout the conference. The conference will be April 19-21 in Miami Beach, Fla. READ MORE: https://10times.com/international-vein-congress
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RECORDINGS OF 2017 ACP CONGRESS AVAILABLE More than 100 hours of recorded sessions from the ACP’s 31st Annual Congress are now available. Improve patient care with the 2017 ACP Annual Congress session recordings, addressing topics covering the full range of vein care. If you pre-ordered the recordings in Austin, then you can now access them through your Online Education Center profile. To purchase, see http://acop.informz.net/z/cjUucD9taT03MjMxNjIyJnA9MSZ1PTEwNzM1MTI3NzgmbGk9NTA0OTg3Njk/index.html .
AUSTRALASIAN COLLEGE OF PHLEBOLOGY ANNUAL SCIENTIFIC MEETING DATE, LOCATION ANNOUNCED Save the date: The next Australasian College of Phlebology Annual Scientific Meeting (ACP ASM) will be May 5-7, 2019 in Cairns. Photos from the 2018 UIP World Congress of Phlebology in Melbourne in February are available at phlebology.com.au/photoalbum/viewalbums/10?mc_ cid=cf777d71e5&mc_eid=841f2d5110 .
AHA CREATES CYBERSECURITY POST The American Hospital Association has named a longtime FBI official to a newly created role focusing on cybersecurity in healthcare. John Riggi, who served in various roles at the FBI over a 28-year career, will join AHA as a senior advisor for cybersecurity and risk, the association announced. During his time at the Cyber Division of the FBI, Riggi led a national program to foster industry partnerships and helped investigate cyberattacks against healthcare organizations. The cybersecurity post was created after discussions with member hospitals and state associations revealed hospitals needed more support and resources to prevent and respond to a growing number of cyberattacks.
CMS CUTS DIRECT DECISION SUPPORT MODEL The Centers for Medicare & Medicaid Services (CMS) announced on Feb. 2 that it was not going to test the Direct Decision Support (DDS) Model. CMS is not moving forward with the DDS Model due to operational and technical issues with the proposed Model design. CMS determined that the design and operational changes necessary to continue with the DDS Model would be too significant and burdensome for participants, and would require a new solicitation. The Centers for Medicare & Medicaid Services (CMS) identifies strengthening beneficiary engagement as one of the agency’s goals to help transform our healthcare system into one that delivers better care, smarter spending, healthier people, and puts individuals at the center. Specifically, the “CMS Quality Strategy envisions health and care that is person-centered, provides incentives for the right outcomes, is sustainable, emphasizes coordinated care and shared decision making, and relies on transparency of quality and cost information.”
ENDOLOGIX CEO TO REMAIN AT POST UNTIL BOARD FINDS REPLACEMENT Amid continued and anticipated losses, Endologix, a California-based developer and marketer of innovative treatments for aortic disorders, has announced that John McDermott is stepping down as the company’s CEO. He will remain in his current role until a successor is found. In a separate announcement, the company also released its financial results for the fourth quarter and fiscal year ended Dec. 31, 2017, stating the 2018 revenue is anticipated to be in the range of $170 million to $180 million, representing a decrease of 1 percent to 6 percent compared to 2017. Endologix anticipates 2018 GAAP loss in the range of $0.89 to 0.95 per share. The decrease continues from 2017, in which the company reported a net loss of $66.4 million, or $0.89 per share, compared to a net loss of $154.7 million or $1.91 per share for the year ended Dec. 31, 2016. Addressing his stepping down as CEO, McDermott said, “Our vision is clear, the value proposition is compelling, and our pipeline of new products positions us for significant longterm growth. I remain deeply committed to our employees, physicians, and patients and will do whatever I can to support an effective leadership transition.” VT N
APRIL/MAY 2018 < VEIN THERAPY NEWS
Not actual patients.
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Offer a comprehensive GSV system solution for above and below the knee. Varithena® (polidocanol injectable foam) 1% reaches veins that others can’t—treating a wide range of sizes and any vein shape including tortuous truncal veins above and below the knee. Varithena’s UDSS formulation—uniform density, size and stability—results in a long dwell time and thorough cohesion with the vein wall. Most importantly it addresses underlying venous incompetence, improves vein appearance and shows significant PRO improvements with an established safety profile. Now, with two dedicated CPT codes, treating patients with Varithena® is easier than ever.
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For more information on treatment, visit Varithena.com INDICATIONS Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. IMPORTANT SAFETY INFORMATION The use of Varithena is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia, or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intraarterial injection of polidocanol occurs, consult a vascular surgeon immediately. Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena® © 2017 Biocompatibles, Inc., a BTG International group company All rights reserved NA-VAR-2016-0786(2) 01/18 Varithena is a registered trademark and Varithena Solutions Center is a trademark of Provensis Ltd, a BTG International group company BTG and the BTG roundel logo are registered trademarks of BTG International Ltd btg-im.com
INDICATIONS AND USAGE Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
In Varithena®-treated patients, 80% of pain events in the treated extremity resolved within 1 week.
DOSAGE AND ADMINISTRATION Varithena® is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities.
Proximal symptomatic venous thrombi occurred in <1% of patients treated with Varithena®. Approximately half (49%) of patients with thrombi received treatment with anticoagulants.
Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena®. CONTRAINDICATIONS The use of Varithena® is contraindicated in patients with: • known allergy to polidocanol [see Warnings and Precautions] • acute thromboembolic disease WARNINGS AND PRECAUTIONS Anaphylaxis Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Tissue Ischemia and Necrosis Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Venous Thrombosis Varithena® can cause venous thrombosis [see Adverse Reactions]. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of Varithena® cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice. A total of 1333 patients in 12 clinical trials were evaluated for safety when treated with Varithena® at dose concentrations of 0.125%, 0.5%, 1.0% or 2.0%, including 437 patients treated with Varithena® in placebo-controlled clinical trials. Adverse reactions occurring in 3% more patients receiving Varithena® 1% than receiving placebo are shown in Table 1.
In the 1333 patients treated with Varithena®, the following venous thrombus adverse events occurred: common femoral vein thrombus extension (2.9%), proximal deep vein thrombosis (DVT) (1.7%), distal DVT (1.1%), isolated gastrocnemius and soleal vein thrombosis (1.4%).
Since Varithena® induces thrombosis in the treated superficial veins, D-dimer is commonly elevated post-treatment and is not useful diagnostically to assess patients for venous thrombus following treatment with Varithena®. Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician compounded foam sclerosants. None of the 1333 patients in the Varithena® trials experienced clinically important neurological or visual adverse events suggestive of cerebral gas embolism. The incidence of neurologic and visual adverse events within 1 day of treatment in the placebo-controlled studies was 2.7% in the pooled Varithena® group and 4.0% in the placebo groups. Skin discoloration adverse events were reported in 1.1% of the pooled Varithena® group and 0.7% of the placebo group in the placebo-controlled studies. DRUG INTERACTIONS No specific drug interaction studies have been performed. There are no known drug interactions with Varithena®. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of Varithena® in pregnant women. Do not use Varithena® during pregnancy. Labor and Delivery The effects of Varithena® on labor and delivery in pregnant women are unknown. Nursing Mothers It is not known whether polidocanol, the active pharmaceutical ingredient in Varithena®, is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering Varithena® to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Of the 1333 subjects in clinical studies treated with Varithena®, 9.1% (n=121) were ≥65 years of age. No clinically important differences in safety or efficacy were observed between older and younger patients in all studies. OVERDOSAGE There are no known cases of overdosage with Varithena®. In clinical studies, total volumes of up to 60 mL of Varithena® per treatment session have been administered.
Table 1: Treatment-emergent adverse reactions (3% more on Varithena® 1% than on placebo) through Week 8 (n=588)
Manufactured for Provensis Ltd by: Biocompatibles UK Ltd Chapman House, Weydon Lane, Farnham, UK, GU9 8QL. Distributed by: Biocompatibles, Inc. Five Tower Bridge, Suite 810 300 Barr Harbor Drive West Conshohocken, Pennsylvania 19428 USA a Includes Varithena® 0.125%, 0.5%, 1.0%, and 2.0% from the placebo-controlled trials. b Retained coagulum. c Common femoral vein thrombus extension (non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein).
Provensis Ltd, Biocompatibles UK Ltd, and Biocompatibles, Inc. are BTG International group companies Varithena is a registered trademark of Provensis Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd
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NEWS
BTG OPTALYSE PE TRIAL
Results reinforce safety, efficacy of shorter, lower dose EKOS therapy for PE BTG plc highlighted OPTALYSE PE one-year trial results, presented at the International Society on Endovascular Therapy in Florida in February. The findings confirm that bilateral pulmonary embolism (PE) patients treated in as little as two hours with a total tissue plasminogen activator (tPA) dose as low as 8mg continue to show improvements in RV/LV ratio over the long term with a very low all-cause mortality rate of 2 percent, an equally low recurrent PE rate of 2 percent, and continued quality of life improvements – further demonstrating the efficacy and safety of the OPTALYSE PE treatment regimens. “The long-term follow-up results reinforce that a new interventional standard is being set for PE treatment,” said principal investigator Victor Tapson, MD and director of the VTE and Pulmonary Vascular Disease Research Program at Cedars-Sinai Medical Center in Los Angeles. “The 2 percent one-year all-cause mortality rate observed in OPTALYSE PE is much lower than the ~8 percent rate seen in comparable anticoagulation studies1, Dr. Tapson said. “This is important for institutions that are adopting the new low-dose, shorter-duration treatments explored in OPTALYSE PE.” PE is a condition that occurs when a piece of a blood clot breaks off from a clot in the legs and travels through the vasculature – getting trapped in the pulmonary arteries. When this happens, the clot keeps blood from getting to some areas of the lungs to receive oxygen. This may lead to excessive strain on the right side of the heart, ultimately leading to heart failure and/or cardiovascular collapse. PEs can be immediately fatal, but if diagnosed and appropriate therapy started, mortality can be reduced from approximately 30 percent to less than 10 percent. The authors followed the 12-month outcomes of 101 patients at 17 centers who participated in the OPTALYSE PE study in which the patients were randomized one of four cohorts. These patients were diagnosed with acute proximal PE in at least one main or proximal lobar pulmonary artery and a RV/ LV diameter ratio greater or equal to 0.9 on chest computed tomographic angiography (CTA). Patients received treatment within 48 hours of diagnosis. The four cohorts ranged from two to six hours in treatment duration and 8mg to 24mg total tPA for bilateral PE.
EKOS SYSTEM THERAPY
All cohorts saw a significant reduction in RV/LV by approximately 23 to 26 percent taken via CTA at 48 hours. For follow-up, patients received echocardiograms at four hours, 48 hours, 30 days, 90 days, and at one-year post-EKOS therapy. The initial significant reductions in RV/LV continued to improve in all cohorts through one year with mean RV/LV ratios in the 0.70 range at one-year for all cohorts. Multiple quality of life measurements showed valuable improvements between 30 days and 365 days – further demonstrating the long-term benefit of EKOS therapy. The EKOS system uses ultrasonic waves in combination with clot-dissolving thrombolytic drugs to effectively dissolve clots and restore healthy heart function and blood flow. EKOS is the only device cleared for the treatment of PE. In clinical studies, EKOS therapy has been shown to speed time-to-clot dissolution, increase clot removal and enhance clinical improvement compared to either standard catheterdirected drug therapy or thrombectomy. EKOS therapy requires significantly shorter treatment times and less thrombolytic
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compared to standard catheter-directed drug therapy, lowering the risk of bleeding and other complications. “This is the first time that long-term mortality and quality of life data has been reported for an interventional PE treatment, which continues to show our commitment to evidence-based innovation, predictable and cost-effective procedures, and strong safety profiles that improve patient outcomes and help make the most challenging cases easier,” said EKOS Vice President and General Manager Matt Stupfel. “Within a short time we have seen the science advance so that patients today can be treated in as little as 2 hours and with total tPA doses as low as 8mg, providing greater flexibility to clinicians, improved safety to patients, and potential cost savings to hospitals at a time when healthcare systems need these efficiencies.” EKOS Vice President and General Manager Matt Stupfel said EKOS is the only device cleared for the treatment of pulmonary embolism. “This is the first time that long-term mortality and quality of life data has been reported for an interventional PE treatment, which continues to show our commitment to evidence-based innovation, predictable and cost-effective procedures, and strong safety profiles that improve patient outcomes and help make the most challenging cases easier. “Within a short-time we have seen the science advance so that patients today can be treated in as little as two hours and with total tPA doses as low as 8mg, providing greater flexibility to clinicians, improved safety to patients, and potential cost savings to hospitals at a time when healthcare systems need these efficiencies.”
KNOCOUT PE REGISTRY STUDY
A separate registry study, KNOCOUT PE, is currently underway to measure how hospitals are adopting and benefiting from the new standard of care. At full enrollment, the KNOCOUT PE study is expected to include as many as 100 centers internationally. Cases will include those from before and after the release of the original OPTALYSE PE study. Physicians seeking to participate in the KNOCOUT PE study or to learn more should contact the BTG IV Clinical Affairs department.
MULTI-CENTER TRIALS
The OPTALYSE PE, ULTIMA and SEATTLE II studies were multi-center trials examining ultrasound-facilitated,
Men can now use all Walgreens’ restrooms Walgreens ended 2017 by directed its stores to allow men full and unrestricted access to women’s restrooms in all of its 8,100 stores. Walgreens Transgender Inclusion memo stated: “All individuals have a right to use restroom facilities that correspond to the individual’s gender identity, regardless of the individual’s sex assigned at birth. The intent of the policy is “to support transgender individuals in our stores and facilities and foster an environment of inclusion and mutual respect.” VT N
catheter-directed thrombolysis using a low dose of a standard clot dissolving medication called tPA to treat both acute massive and sub-massive pulmonary embolism. ULTIMA, a randomized controlled study comparing EKOS therapy to anticoagulation, looked at 59 patients across eight centers. SEATTLE II, a prospective single-arm study, looked at 150 patients across 22 centers. OPTALYSE PE included 101 patients with acute proximal PE at 17 centers randomized to one of four treatment cohorts. The first cohort received 4mg of tPA per catheter over two hours. The second cohort received 4mg of tPA per catheter over four hours. The third cohort received 6mg of tPA per catheter over six hours. The fourth cohort received 12mg of tPA per catheter over six hours. All cohorts saw a significant reduction in the main indicator of right-heart strain from PE (measured as RV/LV by approximately 23 to 26 percent. The OPTALYSE PE results also showed a very low bleeding rate of 3 percent compared to 10 percent in the previous SEATTLE II study where patients were treated with 24mg for 12 or 24 hours. VT N READ MORE: btgplc.com
RESOURCES 1
Konstantinides, MD, et al, “Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism” Journal of the American College of Cardiology; vol 69, pp.1536-1544, 2017.
Healthcare.gov moving to cloud by April 2019 The Centers for Medicare and Medicaid Services (CMS) will transition Healthcare.gov to the cloud by April 2019, according to Ret. Col. Bobby Saxon, acting chief technology officer for the Center for Consumer Information & Insurance Oversight. That is the CMS agency that oversees Healthcare.gov. It issued a mandate when Saxon came aboard in January 2017 that the ACA exchange website would run entirely on the cloud by the end of the first quarter of 2019. Saxon has led several cloud planning and analysis sessions over the last six months and issued a draft plan with “highlevel milestones” for Healthcare.gov’s technical infrastructure. A couple of legacy data systems will likely operate on a hybrid cloud-warehouse platform, but the plan is to push the entire platform to an Amazon-hosted cloud infrastructure over the course of the next year, Saxon told a group of reporters at HIMSS in March. Saxon said that moving to the cloud will provide the system with elasticity and flexibility, improve the agency’s disaster recovery posture and reduce costs. Saxon also said the CMS is also planning to roll out several new API-based initiatives in the fall aimed at helping industry partners connect to the system and improving the user experience. Almost 12 million people signed up for AA exchange plans through Healthcare.gov during open enrollment in 2018, a small decline from the previous year. VT N
APRIL/MAY 2018 < VEIN THERAPY NEWS
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NEWS for employers, as employees tend to have higher rates of absenteeism and declining productivity. “Employers play a key role in helping shape the future of healthcare in America, and we’re excited to create a forum for these organizations to share insights and ignite the transformation necessary to reduce costs and improve health outcomes.” VT N READ MORE: https://hlth.co or hlth.co/speakers or hlth.co/ sponsors/.
Erin Gibbs
Gordon Gibbs
Dr. Gibbs travels to China to teach U.S. cutting edge vein procedures
general anesthesia and up to a three-day stay in the hospital after the procedure. In the United States, the same varicose veins can be performed on an outpatient basis, utilizing a more contemporary minimally invasive method with a catheter insertion, and the patient is oftentimes back to normal activities the same day. “American Vein is focused on decreasing the great disparity in the level of care available to patients in China as compared to United States’ patients,” Dr. Gibbs said. This trip was the first visit of Dr. Gibbs to see physicians in China. Dr. Gibbs, in partnership with Medtronic, has hosted doctors from China several times in the American Vein Colorado Springs and Metro Denver clinics (americanvein.com). Dr. and Mrs. Gibbs opened the first American Vein & Vascular Institute (formerly Rocky Mountain Vein Institute) in 2009 located in Pueblo, Colorado. The network of vein and arterial centers has since grown to eight locations with more than 50 employees in Colorado and Texas. VT N
American Vein & Vascular Institute owners Gordon F. Gibbs, MD, and Erin Gibbs have returned from 10 days in China teaching Chinese doctors contemporary vascular healthcare practices. In partnership with Medtronic, Dr. and Mrs. Gibbs recently traveled to Beijing and Shanghai, teaching 50 Chinese doctors through presentations, training sessions and patient visits. During their 10-day visit, Dr. Gibbs met with physicians and patients, demonstrating modern surgical procedures for venous disease to improve patient outcomes in China. In China, varicose veins are commonly treated in the hospital with traditional surgical stripping, an invasive procedure that requires
HLTH reaches 250 speakers for new health conference of all stakeholders HLTH, a new conference for healthcare innovation, has cleared a major milestone by securing 250 senior executive speakers and 75 sponsors. The conference will be May 6-9 at The Aria in Las Vegas. It is a large-scale forum for individuals, companies and policymakers who are reshaping the healthcare industry to learn, collaborate and evolve. The event is unique in bringing together all key stakeholders, ranging from established payers, providers, employers and pharma services to disruptive startups and prolific investors, as well as representatives from government, media and analysts.
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In addition, HLTH announced its new Employer Program, taking place on May 8 and May 9, which will focus on how employers are reframing the concept of health to lower costs, engage employees and improve the quality of care. According to Constance Sjoquist, chief content officer of HLTH 2018, said the new Employer theme is “Shift or Get off the Pot!” It will unite large employers like Walmart, Comcast, Sharecare, Sodexo and industry trade associations to discuss how employers are implementing policies to lower medical spend, improve quality of care, engage employees and align benefits offered to the value provided. “Health issues, including chronic health conditions, such as obesity, diabetes and heart disease, continue to erode our nation’s overall health status, while driving costs upward at unsustainable levels,” Sjoquist said. “These conditions prove to be even more costly
Email vein questions for panel experts to reply at IVC April 21 It’s common for clinical questions to come up in your practice throughout the year. The International Vein Congress is providing an opportunity for you to have those answered by a panel of experts during the Annual V2 Symposium at IVC, Saturday, April 21. The V2 Symposium is where an interactive discussion happens with the moderator, attendees, and the panel of experts. Click on https://ivcmiami.com/ v2symposiumquestions.php and send your vein questions by email. Steve Elias, MD, will present the questions to a panel during the 90-minute session. Anything is fair game, and faculty welcome challenging questions. This year’s panel includes course director Dr. Jose Almeida; course co-director Lowell Kabnick, MD; Alan Dietzek, MD, FACS; Peter Gloviczki, MD, FACS; Neil M. Khilnani, MD; Peter F. Lawrence, MD; Nick Morrison, MD; and Paul McNeill, MD. In addition to the questions emailed to the panel there will be an open mic for attendees to ask questions. Dr. Kabnick said that they do their best to cover all aspects of vein care and the business of vein care in the conference agenda. “The V2 Symposium gives everyone the chance to seek clarification of IVC content as well as answers to issues that might be unique to them and their practice.” VT N
LimFlow completes enrollment in its U.S. feasibility study LimFlow SA, a developer of minimallyinvasive technology for the treatment of end-stage critical limb ischemia (CLI), has completed enrollment of the original 10-patient cohort in the U.S. feasibility study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System. The company also announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s proposal to expand the
feasibility study by an additional 15 patients and three new sites, bringing the total number of patients enrolled in the feasibility study to 25 U.S. subjects and six U.S. institutions. The LimFlow device is a novel and purely percutaneous therapy for “no-option” CLI patients when all other revascularization efforts have been exhausted and a patient is facing a major amputation. “This is the biggest advance I’ve seen for people at risk of amputation in my 25 years in practice,” said Daniel Clair, MD and chair of the department of surgery at the University of South Carolina and the Palmetto Health-USC Medical Group. Dr. Clair performed the 10th case in the feasibility study on Jan. 25. “In the past, the only thing we had to offer these no-option patients was a segmental amputation of parts of their foot, and most patients ended up losing their entire foot,” Dr. Clair explained. “Major amputation has a very poor overall prognosis in terms of mortality and quality of life for patients and must be improved.” The FDA also accepted the LimFlow System into its Breakthrough Device Program, a designation previously known as the Expedited Access Pathway (EAP). The designation is intended to speed patient access to breakthrough technologies that provide for more effective treatment of life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offers significant advantages over existing approved or cleared alternatives. LimFlow Chief Executive Officer Dan Rose said they were excited to be among the first technologies treating lower extremity disease to be granted access to the FDA’s Breakthrough Device Program. “Their decision recognizes the novelty of our system and the promise it holds in treating the epidemic of critical limb ischemia,” Rose said. “More than 100,000 patients in the U.S. have a major ischemic lower limb amputation every year and we look forward to closely collaborating with the FDA to soon bring the LimFlow technology to U.S. patients with no good options today.” To relieve the symptoms of CLI today, patients are often treated with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints. The LimFlow System uses proprietary ultrasound-guided catheters and covered nitinol stents designed to restore perfusion to the ischemic foot by bypassing diseased arteries and diverting blood flow into the tibial vein to vascularize the foot. Achieving tissue perfusion may relieve rest pain, promote chronic wound healing, reduce major amputations and restore mobility for patients. VT N READ MORE: limflow.com
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NEWS The Sage Group offers new analysis on Asian incidence of P.A.D., CLI cases A new analysis published by The Sage Group concludes that 4.2 to 6.2 million Asian Indians suffer from the most severe form of peripheral artery disease (P.A.D.) and critical limb ischemia (CLI). “Although it is commonly believed that P.A.D. is a ‘Western’ disease with a lower prevalence in Asian Indians, our research indicates that this is not the case,” Mary L. Yost, president of The Sage Group, said. “P.A.D. appears to afflict Indian diabetics at similar to higher rates as those found in European and U.S. populations in the same age groups. “Diabetes has some unique characteristics in Indians, which appear to increase their susceptibility to P.A.D. These include a genetic predisposition to diabetes, the ‘Asian Indian Phenotype’ and a high prevalence of young onset diabetes occurring before age 40, as well as under-diagnosis and inadequate treatment of diabetes.” Commenting on P.A.D. risk factors in India, Yost said, “P.A.D. prevalence increases with age, duration of diabetes, hypertension, abnormal HbA1c levels, smoking and dyslipidemia. However, in contrast to most United States and European studies, P.A.D. is significantly more frequent in females.” “P.A.D. may be more prevalent in rural than in urban diabetics. Since 70 percent of Indians still live in rural locations and healthcare is inaccessible and unaffordable for the majority, this indicates a significant problem. We believe that in India, P.A.D. is a major, underestimated chronic disease,” she concluded.
CLI PREVALENCE BY RUTHERFORD CATEGORY
A new analysis published by The Sage Group concludes that 503,000 to 838,000 CLI patients in the United States suffer from rest pain (Rutherford Category 4). “CLI is the most severe and deadly form of peripheral artery disease (P.A.D.),” Yost said. “According to our estimates, 2 to 3.4 million U.S. citizens have CLI. In general, CLI estimates are sparse. To our knowledge no other estimates of disease prevalence by Rutherford Category have been published.” “The Rutherford system categorizes CLI by severity into three stages: rest pain (R-4), non-healing ulcers (R-5) and gangrene (R-6). Mortality and the risk of amputation increase with Rutherford Category. Treatment costs also increase with disease severity. Yet before this analysis, basic data was lacking on how many of those with CLI have rest pain, ulcers and gangrene,” she said.
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Regarding costs, Yost said, “Over the last 10 years, CLI patients have increased as a percentage of P.A.D. patients treated. Since treatment costs increase with severity, this is a significant factor driving P.A.D. costs upward.” This report contains a comprehensive analysis of the United States prevalence of CLI by Rutherford Category for the 20152030 periods. Estimates begin with The Sage Group’s high and low series of CLI numbers. The percentage prevalence of CLI patients in each Rutherford Category reflects recently published peer-reviewed data. Within each Rutherford Category, patients are assumed to be treated with revascularization, amputation or palliative therapies. Patient prevalence by treatment pathway is projected for each Rutherford Category for 2015-2030. Because only a fraction of patients is diagnosed and treated, the current market, or those treated, is estimated by treatment pathway for each Rutherford Category in the report. Because CLI is commonly bilateral, all estimates are also made for limbs as well as for patients. VT N READ MORE: thesagegroup.us/ pages/reports/cli-us-rutherford. php or thesagegroup.us/pages/ reports/india-2018.php
CSI LIBERTY 360° 18-month outcome presented at CRT18 William Gray, MD and interventional cardiologist at Lankenau Heart Institute in Wynnewood, Penn., presented the 18-month outcomes of the Cardiovascular Systems Inc. (CSI) LIBERTY 360° study at the Cardiovascular Research Technologies (CRT) 2018 interventional cardiology conference in Washington, D.C. in March. The study was to evaluate the acute and long-term clinical and economic outcomes of endovascular device interventions, including CSI’s orbital atherectomy system, in treating peripheral artery disease (P.A.D.). LIBERTY 360° is a prospective, observational, multi-center post-market study that enrolled more than 1,200 patients at 51 sites across the United States, including 501 patients with claudication (RC2-3), 603 patients with critical limb ischemia (CLI; RC4-5) and 100 patients with the most severe form of CLI (Rutherford 6). The study included any endovascular device FDAapproved for treatment of P.A.D. Enrollment was completed in February 2016 and patients are being followed for five years. LIBERTY 360° is among the first P.A.D. studies to investigate patients across the spectrum of symptomatic P.A.D. and assesses numerous parameters including procedural success, rate of major adverse events, duplex ultrasound findings, quality of life, six-
minute walk test, wound status and economic outcomes. Dr. Gray’s presentation highlighted the continued high freedom from (FF) 18-month major adverse events (MAE) in Rutherford Classifications (RC) 2-3 (76.9%) and RC4-5 (68.2%). Even when considering advanced disease in RC6, MAEs are not driven by major amputation (FF 81.7%). In addition, quality of life improved significantly from baseline to 18 months in all RC arms of the LIBERTY study. “LIBERTY 360° represents an unrestricted real-world experience with various endovascular strategies across different RCs, many of whom would never be included in clinical trials, especially, RC6 patients,” Dr. Gray said. “The results we’ve seen in this novel, all-comers P.A.D. study indicate that endovascular peripheral vascular intervention is a reasonable treatment option for RC2-3, RC4-5 and RC6.” He also noted that an orbital atherectomy sub analysis of the LIBERTY data indicated high FF major amputation in all Rutherford Classes (RC2-3, 100%; RC4-5, 95.3%; and RC6, 91.3%). Primary amputation is not necessary in RC6 as peripheral vascular intervention (PVI) can be successful in this patient population. CSI Chairman Scott Ward said results continue to show that PVI, including the use of orbital atherectomy, can lead to amputation free survival for patients with claudication or critical limb ischemia. VT N READ MORE: csi360.com or ClinicalTrials.gov (identifier: NCT01855412)
Cook Med launches Limb Preservation Solutions program Cook Medical has launched its new Limb Preservation Solutions program to emphasize its focus on saving limbs. The Limb Preservation Solutions program was formerly called BTK (below the knee) or CLI (critical limb ischemia). “We wanted to more accurately reflect our focus and our customers’ focus on limb preservation,” Chris Mobley, global product manager for P.A.D. said. “Because our products help achieve minimally invasive solutions using wires, catheters, and stents, the Limb Preservation Solutions name more accurately describes our goals for patient care.” The name change was announced at last year’s VIVA 2017. Cook also hosted a symposium entitled “Limb preservation: A focus on diabetic foot,” featuring John Rundback, MD; George Adams, MD; and Dr. Peter Schneider, according to Mobley.
“Dr. Rundback discussed the cost of amputation to Medicare, to the hospital, and to the patient,” Mobley said. “That’s why limb preservation is our focus at Cook. “Dr. Adams discussed when an endovascular-first approach might be the best option for a diabetic foot patient, while Dr. Peter Schneider provided context on when a surgical-first approach might be necessary. “If a physician has, or plans to have a focused limb preservation program, having both surgical and endovascular skills available is critical to the success of their program.” VT N
Bluegrass Vascular enrolling patients in SAVE-US pivotal trial Bluegrass Vascular Technologies is enrolling 30 patients in the Surfacer System to Facilitate Access in Venous Occlusions–United States (SAVE-US) pivotal trial. The patients will be enrolled at up to 10 centers in the United States with additional centers in Europe. The SAVE-US trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Surfacer Inside-Out Access Catheter System to facilitate reliable upper body central venous access suitable for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods. Initial patient enrolments were performed by interventional radiologists Chris Loh and Mahmood Razavi at St Joseph Hospital in Orange, Calif., and by Eric Peden, a vascular surgeon at Houston Methodist Hospital in Houston. “Central venous obstruction is a serious disease that often causes a domino effect of vascular destruction, leaving haemodialysis patients and their physicians with limited options,” Dr. Razavi said. “The Surfacer System has the potential to change the standard of care by offering a new strategy that allows reliable and repeated access to the right internal jugular vein, the optimal location for catheter placement.” Dr. Peden said use of the Surfacer System helps preserve and restore venous territory for vascular access, supporting fistula and graft placement, and reduces catheterrelated infections and costs. “I am excited to participate in the SAVE-US trial and help bring this clinically beneficial technology to patients in my practice and across the country.” Bluegrass Vascular secured CE mark approval of the Surfacer System in 2016 and has been enrolling patients in its post-market SAVE Registry in Europe. The Surfacer System is distributed in Europe by Merit Medical. VT N
APRIL/MAY 2018 < VEIN THERAPY NEWS
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Your patients are looking for safe and effective treatment of their venous disease, but if you’re only treating above the knee, you could leave them with a persistent problem. Residual symptoms and the need for reintervention are reported in nearly 50% of patients if the refluxing GSV below the knee is left untreated.1 The VenaCure 1470 nm laser and NeverTouch fiber have been shown to safely and effectively ablate the GSV below the knee, with minimal complications (postoperative paresthesia occurred in 4% of patients, and resolved within 4 weeks).1 Learn more about the procedure that has been performed more than 1 million times and help your patients get relief from their venous disease symptoms by treating below the knee.
1 - Gifford, S.M. et al. Reflux in the below-knee great saphenous vein can be safely treated with endovenous ablation. Journal of Vascular Surgery Venous and Lymphatic Disorders. 2014. 2:4; 397-402.
Refer to Directions for Use provided with products for indications, complete instructions, warnings, and precautions. INDICATION FOR USE: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs. CONTRAINDICATIONS: Patients with thrombus in the vein segment to be treated, patients with an aneurysmal section in the vein segment to be treated or patients with peripheral artery disease as determined by the Ankle Brachial Pressure Index with a value of <0.9 should not have their varicosities ablated. CAUTION: Federal (USA) law restricts the sale of these devices by or on the order of a physician. AngioDynamics, the AngioDynamics logo, VenaCure EVLT, the VenaCure EVLT logo and NeverTouch are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2018 AngioDynamics, Inc. ANGAD 560 GL Rev 03 03/18
VEIN THERAPY NEWS < APRIL/MAY 2018
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APRIL/MAY 2018 < VEIN THERAPY NEWS
NEWS Tech guru tells healthcare execs, docs to move data to cloud quickly The former executive chairman of Alphabet and an executive with Sun Microsystems has a message for healthcare providers: Move your data to the cloud. And fast. Eric Schmidt, now a technical adviser for Google’s parent company, urged providers during his keynote address at HIMSS18 to ditch their data warehouses and let technology companies take on the task of data storage. He said cloud computing is safer and more effective than for providers to invest the time, money and effort building their own data warehouses. Schmidt said he didn’t care whether doctors, clinics and hospitals used Google’s cloud storage or one of its competitors’. Providers should be more worried about how to improve care for patients than where to store data. During his speech and subsequent Q&A with HIMSS CEO Hal Wolf, Schmidt also touched on the predictive benefits of artificial intelligence and the need for a “killer app” that can drive the industry forward. While that app isn’t here yet, he’s confident that the groundwork that went into EHR adoption will set the stage for innovation in healthcare, particularly when it comes to analytics and machine learning. “We need to help automate and make clinicians even more productive,” he said. Schmidt briefly reflected on Google’s initial attempt to harness medical data. Now, with electronic access to medical records, plus FHIR standards to build application programming interfaces, startups have a way to pull out data that can enhance healthcare predictions. But he also argued that data would increasingly come from outside the EHR, from smartphones and wearables, to provide a complete picture of patient health. And while he criticized the healthcare industry for being a late adopter of technology, he also acknowledged inherent barriers within the industry. At times he struck an optimistic tone, particularly when discussing the “unimaginable” impact of AI and clinical decision support that he believes will make a bigger mark on healthcare in the years to come. “We’re closer than you think we are,” he said. VT N
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Analysts say 350M wounds to be treated in negative pressure care in 2018 There is an increasing prevalence of acute and chronic wounds such as those caused by burns or venous and diabetic ulcers. It is estimated that globally up to 350 million acute wounds will be treated year, and an additional 5 million burns will be treated. Technavio market research analysts forecast that the global negative pressure wound therapy (NPWT) market will grow at a CAGR of close to 8 percent during the period 2018-2022, according to a new report. “Global Negative Pressure Wound Therapy Market 20182022” segments the global negative pressure wound therapy by product (conventional NPWT and single-use NPWT) by end-user (hospitals and clinics, ambulatory surgery centers and home healthcare). This report also presents a detailed analysis of the market’s growth in regions such as the Americas, Pacific rim and Europe. Surgical and traumatic wounds comprise of abrasions, punctures, lacerations and incisions, while chronic wounds include venous ulcers, diabetic ulcers, and pressure ulcers, which
Fluidx Medical gets patents for its GPX Embolic Particle device The United States Patent & Trademark Office (USPTO) issued two more patents to Fluidx Medical Technology March 13 for the GPX Embolic Particle device, a biocompatible catheter delivered embolic technology designed for use in arteries and veins. According to Fluidx Medical Technology President David Blossom, GPX is a biocompatible gel-particle embolic device that transforms from low-viscosity particles in a syringe to a solid particle after injection into a vessel. It is water-based and does not polymerize or precipitate. Therapeutic catheter delivered embolization is performed to stop or slow arterial or venous blood flow into certain organs or anomalies to control bleeding; seal arterial venous malformations; treat aneurysms; selectively block blood flow into specific organs and conditions (prostate, uterine fibroid, etc.); and vascularize certain tumors to starve them of blood. Embolic devices include particulates, coils and liquids/glues. Particulates, sometimes referred to as beads, are injected thorough catheters, flow downstream with the blood flow, and can embolize large spaces. Particles, however, are hard to control and do not allow the clinician to create a plug. Metallic coils can create a plug to occlude a variety of vessels, but lack precision and may require numerous expensive deployments to occlude. Liquid embolics, including glues, have advantages for certain procedures, but are
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are a significant burden on patients, healthcare professionals, and the healthcare system. Venous ulceration is the most common type of leg ulceration, and diabetic ulcers are responsible for most of the foot and leg amputations in the United States. It is estimated that on an average, approximately 17.5 million diabetic patients globally develop foot ulcers every year. Approximately, 8 million to 9 million pressure ulcers occur in hospitals every year. “The increasing global prevalence of acute wounds such as surgical and traumatic wounds and chronic wounds is expected to drive the market during the forecast period,” a senior Technavio analyst said. “The introduction of portable NPWT devices and singleuse NPWT devices facilitates the early discharge of patients from hospitals and allows them to continue with the required care in outpatient settings.” Based on end user, the global NPWT market is segmented into hospitals and clinics, ambulatory surgery centers and home
associated with clumping and accidentally entrapping catheters in the body that can be catastrophic for the patient. “We created GPX to solve a number of unmet patient needs in therapeutic embolization,” Blossom said. The two patents issued March 13 cover many anticipated arterial and venous uses for the GPX Embolic Particle device. Clinicians are particularly interested in GPX’s inability to adhere to catheters and/or accidentally glue a catheter into a patient’s body. “This intellectual property specifically covers GPX’s use with reinforcing components for additional x-ray radiopacity and/or viscosity, as well as GPX’s use without such components where x-ray radiopacity and reinforcement are not needed. “We are excited about these new patents and GPX’s potential to help patients,” Blossom said. “GPX is pre-mixed and pre-packaged, non-cytotoxic, easy to visualize under fluoroscopic x-ray, does not stick to catheters, and deploys on target through small and large catheters.” GPX is under development at Fluidx Medical Technology in Park City, Utah, and has not been cleared by the FDA at this time. VT N
Carestream Vue Cloud manages 26B Healthcare images Rochester, N.Y.-based Carestream Health’s Vue Cloud, a healthcare imaging cloud service based on the Carestream Clinical Collaboration Platform, now manages more than 26 billion images in public and private cloud data centers around the world.
healthcare. Hospitals and clinics account for the major market share in the global NPWT market. They are followed by ambulatory surgery centers and home healthcare. The high market share of hospitals is due to the high adoption of NPWT devices in hospitals, high awareness about the clinical benefits of NPWT, the increasing incidence of acute and chronic wounds, favorable reimbursement scenarios, and the focus of key vendors on hospitals. The Americas was the leading region for the global negative pressure wound therapy market in 2017, accounting for a market share of 54 percent. Technavio’s sample reports are free and contain multiple sections of the report such as the market size and forecast, drivers, challenges, trends and more. VT N READ MORE: technavio.com/report/globalne g at iv e -pr essu r e -w ou nd - t he r ap y-m a rketanalysis-share -2018?utm _ source=t10&utm _ medium=bw&utm_campaign=businesswire
Vue Cloud Services enable physician or hospitals to access Carestream’s Clinical Collaboration Platform, driven by a unified backend that provides image and workflow management and vendor-neutral archiving as well as advanced multimedia and interactive reporting capabilities. The unified backend includes security, data protection, and disaster recovery for multiple types of clinical data and standards such as DICOM, PDF, JPEG, and XDS. Healthcare clinics and enterprises, radiology imaging centers, and hospitals of all sizes continue to select Carestream’s Vue Cloud Services over other cloud solutions due to its increased security, comprehensive functionality, and affordable cost. It equips desktop and mobile users with rapid, easy access to patients’ medical images and radiology reports. Vue Cloud Viewing Services allow direct access to reports and imaging studies by physicians. It also offers secure, zero-footprint access for distribution and reading by remote physicians with Carestream’s Vue Motion enterprise viewer – a KLAS 2018 category leader. All services can be fully integrated with a facility’s electronic medical record. Ludovic d’Aprea, Carestream’s general manager for healthcare information, said the solution’s ability to optimize cloud performance and collaborate with firms like Intel is paying off with increased demand from healthcare providers across the globe. “We are expanding the capabilities of our Clinical Collaboration Platform to be more powerful than ever with advances such as an orchestrated workflow,” d’Aprea said. “We are also adding new data centers, including one in China, and more countries are expected to adopt our platform in 2018.”
Cloud services offer advantages for facilities of all sizes because they deliver highperformance applications with a predictable fee that eliminates the need for a large capital investment and continuous maintenance, management, and technology upgrades. VT N READ MORE: carestream.com/en/us
FDA extends shelf life for Silver PTX Silver PTX, the world’s first drug-eluting stent for treatment of vascular disease in the superficial femoral artery (SFA), has received two-year shelf life approval from the U.S. Food and Drug Administration (FDA). An extended shelf life reduces the occurrence of expired product and decreases financial risk to the hospital. It is only one of the recent FDA approvals granted to Zilver PTX. In addition to a new, longer shelf life, Zilver PTX is now FDAapproved to treat total lesion lengths up to 300mm per patient. Zilver PTX has continued to expand its revenue-based market share among all competitive SFA stents and has held the market-leading position for SFA stents in the United States since 2015. Zilver PTX is the only drug-eluting SFA stent with five-year published data. Results from the 479-patient multicenter, prospective, randomized study showed that, after five years, provisional Zilver PTX maintained 72 percent primary patency compared to 53 percent patency for patients who received provisional Zilver bare-metal stent placement. VT N READ MORE: cookmedical.com/ peripheral-intervention/.
APRIL/MAY 2018 < VEIN THERAPY NEWS
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THEPRACTICE
GETTING ONLINE REVIEWS
How to ask all patients to review your practice online By Natalia Luneva It’s no secret that customer reviews are an important element in a business’ success. As a customer, writing a review is an easy feat, one that can help other customers decide whether or not a particular service or product is worth their time. But when it comes to services that are less commercial and are more private and intimate, just how important are customer reviews for such practices, specifically those that are medical in nature?
JUST HOW IMPORTANT ARE PATIENT REVIEWS? While medical practice isn’t easy to quantify, there isn’t a shortage on reviews done by patients. In one survey, 72
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percent of respondents said that understanding a physician’s online reputation is the first step to finding a doctor. In fact, 48 percent of these respondents said they would willingly branch out of their insurance doctors in favor of a doctor with stellar reviews.
ENCOURAGE REVIEWS As a physician, you might be thinking that asking your patients for reviews is a little bit out of touch. After all, you’re not running a hotel or a restaurant. The biggest reason why you should encourage all of your patients to leave an online review is to establish a good online reputation. Patients respond better to providers who have been proven to be good at their job, and having dozens of praises
attached to your name can give your practice a significant boost. More importantly, asking for regular reviews offsets the bad ones because most of these reviews will come out positive. By encouraging all of your patients to respond to you online, you can create a fair projection of your skills and professionalism online as opposed to having one or two bad reviews embody your reputation. Don’t know how to get started? Here are four ways to ask your patients for online reviews: 1. Claim Your Profiles The first step to taking charge of your online reputation is to claim all of your public profiles on most popular websites like Google, Facebook, Yelp, Vitals and WebMD. The trick here is
APRIL/MAY 2018 < VEIN THERAPY NEWS
THEPRACTICE to look up your practice name, note any directories that come up on the first few pages, claim profiles on those websites, and make sure all information displayed is correct. I can’t tell you how many times we find incorrect phone numbers and even address details whenever we first start working with clients. 2. Ask for Review There’s absolutely no reason why you should feel uncomfortable to ask the patient yourself. Instead of telling your receptionist to follow up on this task, mentioning it to your patients after the appointment creates a sense of authenticity, which will likely leave a good impression on the patient and compel them to leave a good review. The trick is to ensure that you phrase your request properly. Let them know that they are doing you a favor and that this is completely optional and would not affect the quality of care you provide for them. 3. Automate the Process Despite the fact that more and more people are turning to online reviews when selecting their physician, the majority of people don’t leave reviews online themselves.
You can use multiple review tools that will help you automate the process of asking for reviews. We use medical review generator called Review To Go (ReviewToGo.com) for our clients, but you can choose any that works best for your needs. The main goal is to make it extremely easy for patients to leave a review. We encourage the clinics that we work with to give every patient a card that explains how they can leave a review for your practice. Websites like Google, Yelp, Vitals or WebMD are among the most important review sites. More importantly, those public sites appear on search engines, and the added exposure can significantly boost traffic to your practice website.
gain. More than anything, it’s to help your community of patients experience a better level of care every single time. VT N Natalia Luneva is a marketing and a practice management consultant. She is the founder of Practice Secret, a marketing agency dedicated to helping medical practices expand patient reach and improve patient satisfaction. Luneva has worked with more than 50 vein clinics nationwide. She helps medical practices reach new levels of growth by developing and implementing effective marketing systems.
4. Respond to Reviews Try to respond to every review online, both positive and negative. Read a blog post I wrote about “How Vein Clinics Should Respond To Online Reviews.” (practicesecret.com/blog/ how-medical-practices-should-respond-to-online-reviews/) Ethics and Reviews At the end of the day, the goal is to ensure that your patients understand that their online reviews are not just for your own
Want to find out more? Book a strategy session at http://practicesecret.com.
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THEPRACTICE
Do competitive practices send you huge gift baskets?
By Scott Harvey Paid Online Advertising is one of the wonders of the business world. You can precisely target prospective patients who are actively seeking your services. You can stop or start your ads any time. Change your budget on any whim. Tell Google, Facebook, LinkedIn and others to “retarget” interested people who have visited your website. You know this. And that’s why you’ve spent a larger and larger part of your total advertising budget on digital media over the years. We think that’s absolutely the right thing to do. But only if you have top-notch ratings on all the review sites. You know this too – and as frustrating as Yelp! or RealSelf or Google reviews can be, they’re here to stay. Let’s keep it simple and say you’re targeting “unsightly varicose veins {cityname}.“ Even with a great Quality Score in AdWords, you’re still probably paying $6.50+ CPC (Cost per Click.) So, she looks at your website, sees the pretty pictures of her “future self,” keeps digging and sees some great before-and-after shots, then your diplomas, teaching positions, department chairs, etc. Your office pictures look good. Your staff looks friendly and approachable. Congrats, you made it through step 1. What’s step 2? She types in “Yelp.com.” And then RealSelf.com. And then Google. com. If you have a great overall rating average and a reasonably large number of reviews and respond thoughtfully to any negative comments and have enough strong, detailed reviews that are pertinent to the procedure they want to have you perform, congratulations – you’ll get to the next step where they contact you. And if not? Then you just spent $6.50 to send that prospective patient to the practice that DOES have all those good reviews. That’s why they should be sending you that huge gift basket – all the free advertising they get from you! Don’t despair, the whole review ecosystem isn’t as frustrating and random as it seems. Let’s talk about some real-world statistics you need to know and then dig in on some of the most important strategies. That way you’ll ensure that you aren’t spending lots of money to send your patients to the surgeon down the street. (And if you take action on this, show me – and I’ll send you the gift basket instead…) There are few markets where online reviews are more closely scrutinized. People aren’t just spending a bundle of money. They’re baring their physical body and their insecurities – and at best they’ll be out of circulation for a
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while and uncomfortable for a bit before they see their outstanding results. At worst, they’ll be one of the unlucky few that they’ve all heard a horror story or two about. Preaching to the choir, I know. Because online reviews can be make-orbreak for a practice, we thought it would just be piling on to continually write on the topic. We thought that every practice had already been brutalized enough by unreasonable, post-op-instruction-ignoring patients, vicious competitors and disgruntled former employees. Remarkably, that still doesn’t seem to be the case for many of the practices we talk to. And the disturbing thing? Most practices are just giving up and resigning themselves to the fact that “that’s just the way it is in this brave new social-media world.” That’s going to stop – RIGHT NOW. You can take the power back. Really. I know you’re already connected to your reviews in a visceral way – I get that. But in case you start slipping back to the “that’s just the way it is” thinking, here are a few quick statistics to spur you on before we talk solutions. • 90 percent (+) of consumers consult online reviews before making a decision • Harvard Business Review reported that for each star gained, gross revenue went up 5-9 percent • 90 percent (+) of consumers hesitate to do business with companies that have fewer than 4 stars • Unhappy customers are 11 times more likely to leave a review than happy customers • Forbes Magazine reported that companies risk losing 22 percent of their potential revenue when prospects find just
1 negative review on the first page of search results; 44 percent with 2 negative reviews on the first page; and 59 percent with 3 negative reviews.
FOCUS ON CRITICAL THINGS It’s sheer insanity the way that the bad guys can damage your livelihood, and the good guys need to fight back. Each practice’s situation is obviously unique and quite fluid, so there’s no one-size-fits-all cookbook. But here are the critical things to focus on: 1. Quantity. This is at the top of the list because it can cure lots of other ills. There are two main reasons for this. First, the more reviews you have, the smaller incremental difference any one review can make to hurt you. For example, if you have a 5-star average, but only 5 reviews total, just one 1-star review will drop you from 5 stars to 4.3. A second 1-star review will drop you to 3.9 (remember the statistic above about 90 percent of consumers hesitating to do business with companies under 4 stars?) Second, a large number of reviews effectively create a “moat” around your business. If the aforementioned difficult patient who wants to make up facts to hurt you sees that you only have 10 reviews, she knows that she can significantly harm your practice by leaving a scathing, 1-star review. (Same with competitors and former employees.) But if you’ve got 100 reviews, let’s say with a 4.3 average, a single 1-star review will not actually affect your numerical average. They aren’t doing that calculation of course, but they do see a bunch of overwhelmingly positive reviews and know that their negative review will get lost in the noise. And if they do a nasty review anyway, you’d be surprised how often those 100 reviewers will jump in and defend you. That’s powerful.
YELP NOTE: When it comes to Yelp! don’t “try to get more reviews” – they try to penalize businesses who actively solicit reviews. 2. Quality. We can’t talk quantity without quality of course – a bunch of short, bland 5-star reviews from people who have only done 1 review in their life will be ignored by prospective patients – thinking they are written by employees or friends. (And that’s if they don’t get automatically “filtered” by Yelp! as I’m sure you’ve had happen.) Many consumers want to let other people think for them, and if they see low-quality reviews, they’re just going to pass and go on to the next practice without a second thought. Conversely, the high-quality patients that you really want are getting more and more savvy about the review ecosystem. Even a decentlywritten 5-star review might not move them nearly as much as a long, detailed, thoughtful 4-star review. 3. Respond. You absolutely must reply to negative reviews. But you should wait just a beat before you do for two reasons. First, it gives you time to cool off and be more introspective. (If you don’t need that when an unreasonable patient takes shots at you, you’re stronger than I am.) Second, on Yelp! more than any other platform, if the reviewer has done fewer than three reviews total (of any business), have few if any “friends” and have been on the review site for a month or less, there’s a pretty strong chance that the review will automatically be scrubbed. (If it’s a real patient with a real issue, and you can turn it into a positive, reply anyway.) But if it is one of the myriad fraudulent-
GIFT BASKETS
continued on page 22
APRIL/MAY 2018 < VEIN THERAPY NEWS
THEPRACTICE Seniors less likely to have minimally invasive surgeries Medicare enrollees are significantly less likely than others to undergo minimally invasive surgical procedures, suggesting they lose out on chances to receive care with better outcomes and likely shorter hospital stays. That’s the conclusion of researchers at Johns Hopkins University, who examined the records of more than 200,000 Medicare patients culled from the 2014 Provider Analysis and Review Inpatient Limited Data Set. The patients underwent seven common surgical procedures: Gallbladder removal, bariatric surgery, colectomy, hysterectomy, and repairs of inguinal, thoracic and ventral hernias. The findings were published recently in the journal Surgical Endoscopy. Of this group, about 102,000 patients underwent conventional surgery, while another 131,000 underwent minimally invasive surgery. Readmission rates and time spent in the hospital were lower for six of the seven minimally invasive procedures. And costs were lower for four of the surgeries when they’re minimally invasive, ranging from about $3,000 to $4,800 less per procedure. Medicare also reimbursed at lower level for three of the surgeries, ranging from about $840 to $940 less per procedure. “This study shows there is an opportunity for Medicare and other payers to spend healthcare dollars more wisely so that they reward high-value care over low-value care” said study author Martin Makary, MD, a professor of surgery at the Johns Hopkins University School of Medicine, in a press release about the findings. Other experts have suggested physician bias may play a role in who receives a minimally invasive procedure and who does not. Too many providers may rely on their individual judgment and skill sets to make a decision, and that can lead to variations in care. Instead, experts recommend that provides make such decisions based on data and outcomes specifically. However, not all minimally invasive surgeries are more cut-and-dried than traditional procedures. Data published in 2015 indicated that minimally invasive surgeries conducted by robots have led to significant levels of complications. The robots themselves have also malfunctioned thousands of times. Injury rates were particularly high for cardiothoracic and head and neck surgery. And robotic surgery for colonoscopies conferred no benefit compared to laparoscopic surgery, but costs significantly more. VT N
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THEPRACTICE GIFT BASKETS
Instead of trying to get more reviews “when you can” and “after office fire xyz is put out,” you have to work it into your daily process. Which patients you’ll work most closely with. When you’ll approach them. How you’ll approach them (email, text, etc.) What you’ll say. When you’ll follow up. What you’ll say when you respond to negative (again, and positive) reviews. Let’s get real. We’re all working extremely hard throughout our day, and anything that isn’t written down and easy to execute on just isn’t going to happen. One last bit of levity to help illustrate how idiotic this whole online review world can be. Go ahead and look up … Yelp! They have a 2.0 star average. VT N
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looking reviews that doesn’t match up with any known patient names for your practice, it’s best to just give it 48-72 hours and see what happens – if you reply quickly, even if Yelp! was going to scrub it, your reply makes it “real” and then it will stay. There’s a strategy behind the right way to reply to reviews that you are 99 percent sure are done by former employees and competitors, but that’s beyond the scope of this article. But as you may have guessed, one of the worst things you can do is say something along those lines, even if you are all but certain. Above I said you absolutely must reply to negative reviews. But you should really reply to positive reviews as well. It just makes a practice look even more on top of things when you thank the positive people as well. Finally, because your response to the negative reviews are so critical, I wanted to go back to this quickly. Steven Covey says that people listen trying to reply instead of listening trying to understand. Even though the patient didn’t do any of the things you told her to do after her procedure and is now blaming you, you need to – as difficult as it is – take responsibility for some of that in your reply and not make them wrong for their feelings. Again, not enough room to go deep into this here. It’s not reasonable to assume that the practice is always wrong and you should take the fall for everything, every time. The closer you can get to the patient’s side though – as frustrating as it can be – the better that is for future readers of the review. So now let’s bring this all back making progress for your practice on your reviews. Do you know what it is that will help
Healthcare officials ask Congress to overturn rule banning patient identifier Citing the potential to minimize misidentification and medical errors, health informatics leaders from England, Scotland and the United States are calling on Congress to lift a 20-year ban on using federal funds to establish a unique patient identifier. John Halamka, MD and CIO at Beth Israel Deaconess Medical Center, and David Bates, MD, senior vice president and chief innovation officer at Brigham and Women’s Hospital, were joined by health IT leaders at Britain’s National Health Service and the University of Edinburgh in advocating for the use of patient identifiers in the United States. Although HIPAA initially required the creation of a health identifier in 1998, Congress overruled the legislation, barring federal agencies from investigating or creating patient identifiers out of privacy concerns. In an article in NEJM Catalyst, the group said Congress responded to a “highly vocal minority” and called on the Office of the National Coordinator for Health IT to push lawmakers to lift the decades-old ban and begin piloting possible solutions. “When accurate information is attached to the right patient, data access is timelier for clinical, administrative, quality improvement and research purposes; inappropriate care, redundant tests and medical errors are reduced; and health information exchange becomes easier – within organizations as well as between,” the authors wrote. “Identifiers are also beneficial for patient mobility, allowing information to be linked to patients and following them as they move.”
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Scott Harvey is the co-founder of Cosmetic Funnels LLC, a medical-only marketing agency, and author of “Plastic Surgeons: Are You Getting Your Share?”
you in terms of the three pillars mentioned above (quantity, quality, and responding?) A system. Health IT and provider groups have long supported the development of a unique patient identifier. Last year, 25 organizations – including the American Medical Association and HIMSS – called on lawmakers to allow ONC to provide “technical assistance” to efforts led by the private sector. Other organizations like the Center for Data Innovation have made similar pleas, arguing that patient identifiers would assist with interoperability. However, private efforts to develop a patient identifier have faltered. Late last year, the College of Health Information Management Executives (CHIME) called off its National Patient ID Challenge that industry and government officials were watching closely. A spokesperson said the effort “ultimately did not achieve the results we sought to this complex problem.” There are some signs that Congress is willing to relax its hardline stance. Last year, the House Committee on Appropriations included funding for patient matching research in its 2018 budget bill. Lawmakers also asked the Government Accountability Office to expand the scope of a planned review on patient matching to include consideration of a national strategy. ONC has also nibbled at the edges, launching a new patient demographic tool in December designed to assist organizations with data management. But the NEJM authors advocate for more encompassing efforts at the federal level, pointing to the successful implementation of unique patient identifiers within the NHS system and efforts at the state level to legalize patient identifiers. “With billions of dollars having been spent on EHR implementation, the healthcare system must vigorously investigate more efficient ways to connect fragmented patient data, an effort that is increasingly relevant as the U.S. moves from a fee-for-service to a value-based health care system focusing on outcomes and populations,” they wrote. VT N
For a free, personalized, real-world action plan to improve your online reviews, visit http://cosmeticfunnels.com/baskets (These are very time-intensive, so we need to limit it to the first 10 practices who request it. Don’t worry, no veiled sales pitch here!)
Enhanced license allows nurses to extend career A new Enhanced Nurse Licensure Compact (eNLC), implemented Jan. 19 will make it easier for nurses to practice in other states and using telemedicine. A National Council of State Boards of Nursing announcement stated that the enhanced compact is effective in 29 states, allowing nurses with eNLC multistate licenses to begin practicing in any of those states without the need for an additional license. Nurses who live in a state that adopted the original Nurse Licensure Compact – an interstate agreement that allows nurses to practice in multiple states with one license – and that also enacted the enhanced compact, are “grandfathered’ into the eNLC if they held a multistate license on July 20, 2017. Nurses living in Florida, Georgia, Oklahoma, West Virginia and Wyoming who want to obtain a multistate license need to complete the compact license application on their state board of nursing website at ncsbn.org . “The eNLC not only benefits nurses with increased mobility to practice, it also increases access to care for patients. Additionally, new provisions in the eNLC enhance patient safety,” said Sue Tedford, the chair of the Interstate Commission of Nurse Licensure Compact Administrators, and executive director of the Arkansas State Board of Nursing. The eNLC allows registered nurses and licensed practical/ vocational nurses to have one multistate license that allows them to practice in person or via telehealth in both their home state and other eNLC states. It does not apply to advanced practice nurses. VT N
APRIL/MAY 2018 < VEIN THERAPY NEWS
SECONDLOOK
ALEX AZAR
Patients not getting their money’s worth AZAR: Patients not getting money’s worth HHS Secretary Alex Azar told the Federation of American Hospitals executives in March that they are not delivering outcomes commensurate with costs and accelerating the path to value-based payment systems and reducing healthcare costs are two of his four top priorities. The four areas of emphasis are giving consumers greater control over health information through interoperable and accessible health information technology; encouraging transparency from providers and payers; using experimental models in Medicare and Medicaid to drive value and quality throughout the entire system; and removing government burdens that impede this value-based transformation. “One of the key commitments President Trump has made across this administration has been to see the private sector as our partners, not as just entities to be regulated or overseen. We at HHS see stakeholders, including our nation’s hospitals, as part of the solution to our country’s many healthcare challenges. We recognize that it’s not just government that wants better healthcare for all Americans. Our partners in the private sector, all of you, want the same. He said it is an exciting time to take over the helm as Secretary of HHS, full of both challenges and opportunities. The same goes for stakeholders, as advances in science are transforming medicine. “It seems like it’s every other week that FDA is approving some novel therapy, or NIH announces a finding that revolutionizes how we think about a key piece of biology.” But according to Azar, innovation in payment and delivery systems is not proceeding at the same pace. “When I was at HHS in the 2000s, concepts like personalized medicine and cell therapies for cancer were in their infancy. Now, personalized medicine has come to life, and cell therapies are receiving FDA approval. “Meanwhile, on the delivery side, back in the 2000s, shifting to a value-based system was just getting going as well. And yet here we are today – more than a decade later – and value-based payment is still far from reaching its potential. Azar admitted the process is frustrating. “Providers have been understandably reluctant to charge into a completely new payment paradigm. Massive new processes and data-gathering requirements have been instituted, without any fundamental changes to our delivery system. Results for the early stages of federal efforts to encourage
accountable care organizations have been, to be honest, underwhelming. He said there is no turning back to an unsustainable system that pays for procedures rather than value. In fact, the only option is to charge forward – for HHS to take bolder action, and for providers and payers to join with us. “This administration and this president are not interested in incremental steps. We are unafraid of disrupting existing arrangements simply because they’re backed by powerful special interests.” The secretary outlined four broad shifts in policy that he said will accelerate the move toward a system that rewards value:
1. M oving ownership and control of electronic health records from providers to patients.
Azar said lack of interoperability among current systems is the main barrier to patients’ ability to take control of their own healthcare information.
2. P roviding payers and providers with incentives to be more transparent about healthcare costs.
The increasing prevalence of highdeductible insurance plans have made consumer awareness of the cost of their care much more important, according to Azar. He called on doctors, hospitals, drug companies and pharmacies to get more transparent about their costs and outcomes. If they fail to do so, he promised that the federal government has “plenty of levers to pull that would help drive this change.”
3. U sing Medicare and Medicaid to drive industry change.
Calling the results of previous efforts to drive innovation such as efforts around affordable care organizations “lackluster,” the secretary promised “bold measures” that will “create a true competitive playing field where value is rewarded handsomely.”
Alex Azar
4. R educing burdens.
regulatory
Azar promised that the government would address any regulatory burdens that impede progress toward value-based care provision. He particularly singled out reporting rules and FDA policies around communications
AZAR
continued on page 24
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SECONDLOOK VARITHENA
continued from page 1
of saphenous and sural nerve paresthesia from the tumescent anesthesia required in thermal ablation modalities. These options, however, are fraught with pain and a very high chance of reoccurrence. We have used PCF in the past, but results were disappointing. The consistency of PCF can be variable, causing the venous endothelium to be ablated in a haphazard way. In about 50 percent to 60 percent of cases, PCF fails to completely ablate the vein, requiring multiple sessions of sclerotherapy for the patient. Also, I prefer not to use PCF because of the risks of adverse neurological events. PCF is produced from polidocanol mixed with room air, which contains 70 percent nitrogen. Nitrogen is poorly soluble in blood, creating a small risk of gas embolic events – stroke, seizure or transient ischemic attack. Compared with PCF, Varithena has a superior safety profile. Varithena is generated from a 2-to-1 mixture of oxygen to carbon dioxide, both of which are easily soluble in blood, and contain only trace amounts of nitrogen (<0.8 percent). And while PCF contains bubbles of varying sizes, Varithena’s microbubbles are of uniform size and density with a median bubble diameter of approximately 100 microns and no bubbles greater than 500 microns. Consequently, Varithena’s microfoam resists degradation and allows extended contact with the venous endothelium, making it more effective in closing veins. In January, Varithena procedures acquired a new Current Procedural Terminology (CPT) Category 1 code that is streamlining claim reviews and the reimbursement process. We’re hopeful that the CPT code will enable more patients to have access to Varithena treatments that are covered by their insurers. Having a CPT code for Varithena will also allow us to do research to compare outcomes of various minimally invasive therapies for varicose veins.
11.23.16
2.1.17
5.17.17
CONCLUSION
CASE STUDY When “Tom,” 46, was referred to me from a wound care center, he had a necrotic ulcer measuring 7.5cm x 3.4cm on his right foot, a C6 classification based on the CEAP (ClinicalEtiological-Anatomical-Pathological) system (11.23.16 above). An IT professional, Tom had taken a leave of absence at work, unable to walk without help due to pain, and embarrassed by the odor from his wound. Time-consuming treatments from the wound center also interfered with his ability to work. Over the previous two years, Tom
5.31.17
CASE STUDY
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of his wound (2.1.17 left). In addition, Tom had multiple comorbidities, including hypertension and type 2 diabetes mellitus. Tom reported two years of bilateral leg swelling and pain, with the pain being more severe in the right leg. Initially, the swelling was relieved when Tom elevated his feet at night, but within 6 months, his symptoms worsened, along with the ulceration, hyperpigmentation and pruritus around the ankles. Palpable pulses were noted on his right foot, with a normal ankle brachial index (ABI) of 1 and a normal toe brachial index (TBI). When we conducted a venous study on Tom, we found that reflux of the right saphenofemoral junction (SFJ) was 620 and reflux of the right great saphenous vein (GSV) ranged from 4000 to 4260 ms. Vein diameters of the right proximal, mid, and distal GSV were 5.7, 2.9, and 4.3 mm, respectively. There were also significant large foot and calf incompetent perforator veins with venous reflux of >1000 ms. We found no evidence of superficial or deep venous thrombosis. For Tom, treatment with Varithena was the ideal option to ablate the pathologic varicosities surrounding the ulcer bed that contributed to the ulcer formation. Tom was placed in the Trendelenburg position with his leg elevated 45 degrees. Varithena was administered in 5cc doses through three access sites, for a total dose of 15cc. When the foam column arrived, we applied pressure at the SFJ and held it until we noted venospasm. Tom’s legs were wrapped with Coban and Polymen after the procedure, and he was instructed to walk daily. At Tom’s one-week follow-up visit, there was significant improvement in the size of the wound. By 4 weeks post-treatment, the wound had healed significantly (5.17.17 left)). At approximately 8 weeks post-treatment, Tom’s wound had completely resolved, and he had returned to work. At 4 months post-treatment, Tom’s wound remained closed and he stated that he was very satisfied with the treatment.
3.16.18 Final Follow-up had undergone numerous interventions that failed, including compression, debridement and skin grafting with skin substitutes. He also had daily hyperbaric oxygen therapy for two months with only moderate healing
I’ve used Varithena to treat a large number of patients with venous ulcers, some of whom have mixed arterial and venous disease. Our success rate is 100 percent with resolution in as little as 6 weeks in patients who have had nonhealing ulcers for years. VT N Dr. Kenneth Otah, MD, MSc, FACC is an interventional cardiologist and endovascular specialist whose practice, Total Heart Cardiovascular Consultants in Sugar Land, Texas, mainly focuses on limb salvage. Dr. Otah also practices at Memorial Herman Wound Center in Houston. He reports no financial conflicts.
Hospitals absorb 11% of private practices The number of physicians employed by hospitals grew by 14,000 between July 2015 and July 2016, representing nearly 11 percent growth. According to FierceHealthcare, the trend goes hand-in-hand with the rising number of hospitals that are buying physician practices – a whopping 5,000 transactions during the same period. The data, compiled by the Physicians Advocacy Institute (PAI) and consulting firm Avalere Health, is further evidence of a larger movement toward consolidation in the healthcare industry. The healthcare sector remains in flux as policy, regulation, technology and trends shape the market. The PAI report shows that 42 percent of physicians were employed by hospitals in July 2016, compared to just one in four physicians in July 2012. The analysis, conducted by Avalere Health, shows that over the four-year period from July 2012 to July 2016, the nationwide trend of physicians leaving private practice to become employed by hospitals and health systems intensified significantly. “As payers and hospitals continue to drive consolidation across the healthcare system, it is becoming more and more difficult for a physician to maintain an independent practice,” Robert Seligson, MD, PAI president and CEO of the North Carolina Medical Society, said in an announcement. VT N AZAR
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that he said might inhibit collaboration among stakeholders. He said that he is confident of success because “the time has simply come – as costs continue to skyrocket, the current system simply cannot last.” Azar said the measures he outlined today will get the country part of the way: putting patients in charge of their own data; providing them with useful, transparent price and quality information; using Medicare and Medicaid to shift toward a value-based system; and getting the government out of the way of such a system. He said those who are interested in building a value-based system will have the opportunity to take advantage of a system that will serve patients first, but it will be fair for providers and payers, too. “I assure you: Change is possible, change is necessary, and change is coming.” VT N
APRIL/MAY 2018 < VEIN THERAPY NEWS
SECONDLOOK Survey: Only 19% open to AI replacing doctor in healthcare
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According to a survey released by Syneos Health Communications, fewer than 20 percent of patients perceive any value in artificial intelligence (AI) replacing physicians for diagnosis and treatment. In contrast, 64 percent showed comfort in the replacement of human nurses with an AI virtual nursing assistant. The survey found only 19 percent positive about the idea of an AI symptom checker calibrating diagnoses, and 16 percent about an AI assistant prescribing medications or treatments. “When you go to a doctor’s office, the nurse is doing the intake evaluation for the visit and then discusses with the doctor your opinion. Then hopefully the patient and the doctor decide together what the best treatment is,” A.J. Triano, senior vice president of engagement strategy at Syneos Health Communications and a contributor to the report, told Health Care Business News (HBN). The report is titled “Artificial Intelligence for Authentic Engagement: Patient Perspectives on Health Care’s Evolving AI Conversation.” “Patients don’t mind AI doing the legwork of gathering the data and doing the triage process,” Triano said. “It’s okay if, even in serving it up, it makes key recommendations to the doctor. “The interest for the patient is that on the other end of the process there’s a human being who’s evaluating and making key decisions. The doctor can’t be replaced in that respect.” Researchers issued the survey to 800 patients in Europe and America suffering from atrial fibrillation, Type 2 diabetes and breast cancer. They also interviewed 200 caregivers for patients with Parkinson’s disease. Participants indicated a lack of human oversight and the potential for machine errors as the main fears that put them off to the idea of relying on AI as a physician. In addition to diagnosis and treatment, only 24 percent said they would feel comfortable receiving medical testing or imaging results directly from an AI assistant with no review by a human physician. The survey also found that patients were more likely to trust physicians, pharmacists and hospitals as potential providers of AI-powered virtual nurses compared to technology companies and insurers.“That should serve as a message to any company that is currently not structured to engage a physician actively as a part of the development team or the strategy team for the product,” he said. “They really run the risk of having mistrust in the marketplace. Or to look at it another way, they’ll earn more trust far faster if they can point to the involvement of the physician in the product.” VT N
Solutions for Vision, Control, & Training
VEIN THERAPY NEWS < APRIL/MAY 2018
Redefining vascular visualization ■ ■ ■
Near infrared technology for IV access Wearable, hands-free vein visualization See approximately 7mm below the skin Made in USA
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SECONDLOOK
300,378 breast augmentations done in 2017
Number two procedure last year was liposuction
SURGERY PROCEDURES INCREASE
New ASPS data reveals the shape of plastic surgery in 2017 New data released by the American Society of Plastic Surgeons (ASPS) shows continued growth in cosmetic procedures over the last year. According to the annual plastic surgery procedural statistics, there were 17.5 million surgical and minimally-invasive cosmetic procedures performed in the United States in 2017, a 2 percent increase over 2016. The statistics released to the 7,000 members also reveal Americans are turning to new and innovative ways to shape their bodies, as minimally-invasive cosmetic procedures have increased nearly 200 percent since 2000.
TOP 5 PROCEDURES Minimally-invasive cosmetic procedures grew at a slightly higher rate than surgical procedures in 2017. While three of the topfive surgical procedures focused on the body, the top minimally-invasive procedures focused on the face. Of the nearly 1.8 million cosmetic surgical procedures performed in 2017, the top 5 were: 1. Breast augmentation (300,378 procedures, up 3 percent from 2016) 2. Liposuction (246,354 procedures, up 5 percent from 2016) 3. Nose reshaping (218,924 procedures, down 2 percent from 2016) 4. Eyelid surgery (209,571 procedures, approximately the same as 2016) 5. Tummy tuck (129,753 procedures, up 2 percent from 2016) Among the 15.7 million cosmetic minimally-invasive procedures performed in 2017, the top 5 were:
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218,354 nose jobs
Tummy tucks up 2%
1. Botulinum Toxin Type A (7.23 million procedures, up 2 percent from 2016) 2. Soft Tissue Fillers (2.69 million procedures, up 3 percent from 2016) 3. Chemical Peel (1.37 million procedures, up 1 percent since 2016) 4. Laser hair removal (1.1 million procedures, down 2 percent from 2016) 5. Microdermabrasion (740,287 procedures, down 4 percent from 2016)
TUMMY TUCKS
BREAST REDUCTIONS After a 4 percent decline in 2016, there was a dramatic spike in breast reduction surgeries in 2017, increasing by 11 percent. Breast reduction, also known as reduction mammaplasty, is a procedure to remove excess breast fat, glandular tissue and skin to achieve a breast size in proportion with your body. “Breast reductions are consistently reported as one of the highest patient satisfaction procedures because it positively affects a woman’s quality of life. It addresses both functional and aesthetic concerns,” said ASPS President Jeffrey E. Janis, MD.
Tummy tucks, which dropped from the top five most popular cosmetic surgical procedures in 2016, have rebounded their way back into the top five in 2017. There were more than 2,000 more tummy tuck procedures in 2017 than there were in 2016. “An improved abdominal contour is something that many of us strive for, but for some patients, that may not be attainable through diet and exercise alone,” Dr. Janis said. “Age, pregnancy and significant weight changes can impact both the skin and underlying muscle. Tummy tucks performed by a board-certified plastic surgeon remove excess fat and skin and, in most cases, restore weakened or separated muscles to create an improved abdominal profile.”
BODY SCULPTING, FAT PROCEDURES More people are choosing to shape different parts of their bodies using ultrasound, radio frequency, infrared light, vacuum massage and injectable medication to reduce fat cells.
Non-invasive procedures to eliminate fat and tighten the skin are gaining popularity, with the fastest growing procedure – cellulite treatments – up nearly 20 percent over last year. “Unwanted fat is something that affects so many Americans,” Dr. Janis said. “Plastic surgeons are able to give patients more options than ever before for fat elimination or redistribution. Patients appreciate having options, especially if they can act as maintenance steps while they decide if getting something more extensive down the line will be right for them.” Current non-invasive fat reduction and skin tightening procedures continue to gain popularity: • Non-invasive fat reduction procedures that use special technology to “freeze” away fat without surgery increased 7 percent. • Non-surgical cellulite treatments that use lasers to eliminate fat increased 19 percent (up 55 percent since 2000). • Non-invasive skin tightening procedures that target fat and tighten sagging areas increased 9 percent. ASPS members may report procedural information through the first online national database for plastic surgery procedures, Tracking Operations and Outcomes for Plastic Surgeons (TOPS). This data, combined with an annual survey sent to American Board of Medical Specialties’ certified physicians most likely to perform these procedures, results in the most comprehensive census on plastic surgery. VT N READ MORE: STATS REPORT: 2017 National Clearinghouse of Plastic Surgery
APRIL/MAY 2018 < VEIN THERAPY NEWS
SECONDLOOK ACP
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at the Gaylord Opryland Resort in Nashville, Nov. 8-11. Registration opens May 9 for ACP members and June 28 for non-members at acpcongress.org. The ACP 2018 Annual Congress concurrent sessions will deliver extensive educational opportunities for physician and non-physician healthcare participants across all aspects of venous and lymphatic medicine. These sessions will dedicate extensive time to relevant subjects, including 18 hours of deep venous and superficial venous disease. The program also will provide dedicated sessions on vascular medicine, lymphedema care, ultrasound imaging, venous aesthetics and the latest in chronic wound management. Each afternoon all attendees will join the general sessions showcasing the latest advancements in venous and lymphatic research. The general sessions will present new research opportunities and new investigations undertaken in the past year, and they will highlight efforts to influence healthcare policy through advocacy and demonstrate how each person can raise a voice as an advocate. “There will be special keynote sessions on our relationships with payors and policymakers and how the ACP and individual practitioners can influence those relationships to achieve better medical policies for our patients,” Dr. Stephen Daughtery, program chair for the ACP 2018 Annual Congress, said. To better serve Latin American attendees, a live Spanish translation service will be available during most sessions throughout the meeting. On Sunday morning, attendees will walk through the ACP Village’s themed neighborhoods, including: Sclerotherapy/ Small Veins, Compression and Wound Care, NTNT, Thrombosis, Superficial Vein Treatment, Chronic Venous Obstruction and Pelvic Venous Reflux. Each neighborhood will offer hands-on demonstrations, opportunities to ask questions and much more. The ACP Village will be open for three hours as a unique time for hands-on education in a relaxed atmosphere. This event is more than an opportunity to grow in knowledge and skill in venous and lymphatic medicine. It is a place to engage with fellow members and colleagues and to advance the field by being involved with focused committees that will be meeting throughout the Annual Congress. The 2018 Annual Congress will kick off with an informal Welcome Drop-In on Wednesday evening, Nov. 7. The Exhibit Hall will now be open each day during an APC
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VEIN THERAPY NEWS < APRIL/MAY 2018
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SECONDLOOK
FCARE KAVS CATHETER
Device touted as new NTNT procedure for treating superficial venous reflux FCare Systems USA LLC is promoting the KAVS catheter, a unique triple lumen catheter for treatment of the GSV and SSV, as the new non thermal non-tumescent (NTNT) procedure for superficial venous reflux. The KAVS device utilizes a silicon triple lumen catheter (distal port, balloon port, and sclerosing and/or analyzing agent port) that can be introduced via a percutaneous sheath method (9Fr) or open cut down. Patrick Danciu, president and CEO of FCare Systems U.S., said KAVS is the only guidewire-assisted NTNT solution. The KAVS catheter is latex free and 100cm long. “The device is guided through the vein under direct ultrasound visualization.,” Danciu explained. “Once in place, the distal balloon is inflated in order to exclude the sclerosing or embolize the agent from more proximal vessels, such as the common femoral vein at the saphenofemoral junction or the popliteal vein at the saphenous popliteal junction. “At this point, the sclerosing agent recommended to ablate the intended vessel should be of a foam variety, because liquid agents cannot be visualized on ultrasound. “Use a foam agent (FDA-approved, non-compounded foam Varithena); or CO2 physician-generated foam (off label); or in office made foam sclero (off label). Using a foam agent, one can visualize that there is no solution leaking proximal to the occlusion balloon, which ensures that high concentration sclerosing agents are not in contact with the deep system, thus avoiding the risk of deep vein thrombosis.” CIED
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special tools, with excellent success and low clinical complication rates.”
SCOPE OF PROBLEM The rate of major complications from TLE is estimated to be 1 to 2 percent. Among those complications is laceration of the central veins, which often can be fatal. While the low rate of major complications is welcome, it makes it difficult to identify predictors of complications and makes risk-benefit assessment a challenge. Dr. Tarakji and colleagues set out to define the incidence and extent of venous injuries after TLE on a microscopic level and compare them with the incidence of clinically documented venous lacerations. They did so by microscopically reviewing tissue samples from all patients undergoing TLE of pacemaker and implantable cardioverter-defibrillator leads at Cleveland Clinic during a 30-month period from 2013 to 2016. Leads that were more than 1-year-old or required additional tools for removal were included in the study, thereby meeting Heart Rhythm Society criteria for the definition of TLE.
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The KAVS catheter is latex free and 100cm long. The device is triple lumen: distal port, balloon port, and sclerosing and/or analyzing agent port. He said that unlike other methods depending on external compression of the junctional areas, and are thus userdependent with regards to safety, the balloon occlusion eliminates user variability. Danciu recommends that in the preoperative mapping of superficial venous system, perforator vessels particularly in the thigh be identified so as not to allow sclerosing agent long periods of contact time, and leakage into the deep system through these routes. “Should one identify perforators such as described, then avoidance of this technique to prevent the risk of deep vein
In all, 861 leads were extracted from 461 patients. A variety of extraction techniques were used, based on operator preference and the clinical situation. All operators were electrophysiologists experienced in TLE. The leads and surrounding tissue were sent to the pathology laboratory, where they were fixed in formalin. Pathologic examination was standardized to allow examination of areas covered by tissue cuffs along the length of the lead. “We believe this is the first study to characterize microscopic findings of extracted leads among a large patient cohort,” Dr. Tarakji said.
INJURIES COMMON Vein injury was defined as the presence of the intermediate layer (tunica media) or outer layer (tunica adventitia) of the venous wall around the extracted lead. The venous injury was considered transmural (see photo on page 1) if the adventitial layer was present. Despite a very low rate of clinical adverse events (1 percent), vein injury was seen at a microscopic level in 80 of the 861 extracted leads (9.3 percent) among 72 out of the total 461 patients (15.6 percent). The majority of these injuries were transmural. Only five patients (1.1 percent) experienced major complications requiring surgical
thrombosis should strongly be considered (as well as avoiding the use of other potentially damaging treatments such as Varithena, VenaSeal and MOCA, with consideration of a thermal tumescent technique). The foam agent is infused with a volume based on the size and length of the treated vessel, according to Danciu, and the concentration of sclerosing agent can vary based on the agent used (Sotradecol vs Polidocanol). “The agent is left in place for a period of two to four minutes, during time residual agent (mixed with blood) is aspirated, removing the chemical from the body and avoiding deep vein thrombosis (DVT). This is all performed while the balloon is inflated and the catheter remains stationary. At this point, after safe and effective delivery of the sclerosing and the radicalizing agent is completed, the balloon is completely deflated and the catheter is removed.” Danciu said outcomes of using this device 30,000 times worldwide has shown no evidence of DVT. Follow-up to, and including, six months has demonstrated no evidence of recapitalization of the treated vessels. The KAVS, which is FDA approved, is available in the United States from FCare Systems USA LLC for less than $500, including the 9F introducer. FCare is applying for its own current procedural terminology (CPT) code based on unique safety capabilities when the committee meets May 17-19. For more information, email Danciu at info@fcaresystems.us or call him at 786 288 0740. VT N
or percutaneous intervention. “Clearly, microscopic vein injuries are common with lead extraction but often not recognized clinically,” he said.
PREDICTING RISK Predictors of vein injury included older age of lead, defibrillator (vs. pacemaker) leads and the use of laser-powered sheaths. “We observed a correlation between vein injury and older lead age,” Dr. Tarakji said. “Injuries weren’t common with leads that were one to five years old, but they were significantly higher with both pacemaker and defibrillator leads after five years. This information can help with decision-making when clinicians weigh whether to remove or abandon a lead, especially in noninfectious indications for extraction.” Several observations may explain the absence of significant clinical complications in patients with vein injury, the researchers wrote: • In 20 percent of extracted leads with vein injury, the injury was located at or near the pocket access site. • In 18.8 percent of extracted leads with vein injury, the injury involved a partial wall thickness that may not have resulted in a perforation.
• A transmural vein injury detected microscopically will not always lead to perforation of the superior vena cava due to the presence of supportive tissue outside the vein proper.
PRACTICE EFFECTS “Venous injuries with lead extraction happen more frequently than we observe clinically, so we should be prepared,” Dr. Tarakji said. “A rate of 1 to 2 percent of clinical complications that could be life-threatening is 1 to 2 percent too many.” According to Dr. Tarakji, at Cleveland Clinic, the TLE is performed by experienced electrophysiologists in a hybrid OR with backup provided by their cardiothoracic surgical colleagues. He said these new findings can help guide further research comparing different lead designs and different extraction tools. “Clinical comparison is difficult when the incidence of clinical complications is 1 to 2 percent, because we need to study thousands of patients in order to show a difference in outcomes,” he explained. “With histopathology detecting 10 percent of CIED
continued on page 34
APRIL/MAY 2018 < VEIN THERAPY NEWS
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PRODUCTNEWS
THE DIGITAL STETHOSCOPE
New ‘smart’ products do more than amplify heart sounds A handful of digital stethoscopes that have secured FDA clearance are devices that seek to increase the clinical data physicians collect from their patients but also to make it easier to share that data for consults, second opinions and remote monitoring. M3DICINE (stethee.com) is the latest entry into the digital stethoscope landscape, following offerings from other companies such as Eko Devices (ekodevices.com), TytoCare (tytocare.com) and Rijuven (rijuven.com). M3DICINE’s Stethee device is designed to be used by clinicians, but also has settings designed for veterinary medicine and medical education. M3DICINE Founder and CEO Nayyar Hussain said the device and companion apps with a machine learning component were cleared in October last year. Stethee, according to Hussain, goes beyond the capabilities of a traditional stethoscope, such as reporting back systole and diastole duration as well as tagging geolocation and environmental data every time a sample is recorded. “We are focusing on much more than simply amplifying heart sounds. We aren’t playing the ‘better stethoscope game.’ We are changing the game,” he said. Stethee, which was cleared by the FDA late last year, filters and amplifies the sounds of a patient’s heart or lungs before sending the audio to a user’s connected headphones via Bluetooth. A copy is also made on the Stethee app, which can display the audio file as a continuous phonocardiograph or calculate heart rate. The device includes a “Beat Finder” feature to help determine the optimal location for it to be held, and collects the data needed to make its analyses within 20 seconds.
3D printed stethoscope saved lives during war A team of researchers have developed an open-source, clinically validated template for a 3D printed stethoscope for use in areas of the world with limited access to medical supplies – places where a stethoscope could mean the difference between life and death. “As far as we know this is the first opensource medical device that has been clinically validated and is widely available,” said Tarek Loubani, MD and associate professor at Western University’s Schulich School of Medicine & Dentistry; associate scientist at Lawson Health Research Institute; and an emergency room physician at London Health Sciences Centre in London, Ontario.
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Stethee believes changes the game.
new
product
The platform’s artificial intelligence engine, named “Aida,” automatically tags geolocation, patient position and environmental data – such as humidity, temperature or pollen count – when making its analyses. These data points are encrypted, anonymized and can be reported back or shared with practitioners as quantitative reports. The reports can be viewed remotely through an online analytics portal, which the company says will soon have an API for EHR integration. Alongside the app, Hussain said these features position the device as a potential tool for telemedicine. “The potential for Stethee to be used in remote and rural areas is enormous because it’s incredibly easy to use and the results can be shared and analyzed instantly by a medical specialist anywhere in the world,” he said. “The ability to record, share and compare samples is invaluable to improving Dr. Loubani spent time working as an ER physician in hospitals in Gaza during wartime when medical supplies were often scarce. “We wanted physicians and allied health care professionals to be able to have something that was high quality. This study found that the acoustic quality was the same in our stethoscope as in a premium brand stethoscope.” The idea to 3D print a stethoscope was born while playing with a toy stethoscope and noticing it performed its function quite well. That led Dr. Loubani and a team of engineers to design an open-access template for a 3D printed stethoscope that could be created using recycled plastic. Now, the team’s stethoscope has been clinically validated, and their results are published online today in the journal PLOS ONE. The stethoscope, called the Glia model, was made using free open source software to keep costs low and allow others to easily access the
patient care, especially for remote and rural clinics where access to screening services or a cardiologist is extremely difficult.” The Stethee line includes three products: Stethee Pro for use by medical and healthcare professionals, Stethee Vet for veterinarians, and Stethee Edu for educators and researchers. Preorders for the Stethee Pro and Stethee Vet are available now for $499, with the Stethee Edu is scheduled for summer. While the corresponding apps are available now on mobile marketplaces, the analytics platform will require a subscription to the Stethee Central web portal. M3DICINE has research agreements with Sinskey Labs at MIT, Queensland University of Technology, University of Malaysia and professors and researchers at Texas A&M, Australia Zoo Hospital, University of Sydney, Texas Heart and Mayo Clinic.
Eko Devices (kodevices.com)received 510 (k) clearance for its CORE digital stethoscope in 2015. The CORE digital stethoscope from Eko Devices, which received FDA clearance in 2015, wirelessly streams heart sounds to a smartphone app and integrates heart sounds directly into the patient’s electronic health record. In 2017, the company secured clearance for a second device, DUO, which is designed to be used by a patient to record heart sounds and do a remote EKG test from home. It could also be prescribed to heart disease patients by physicians to support remote
monitoring, not only to engage patients in their health but also to reduce readmissions. Among the clinical applications are calculating time intervals and pattern recognition to detect heart abnormalities such as arrhythmias, heart murmurs and valvular heart diseases. It could also help physicians assess the impact of certain drugs on patients’ cardiac conditions and has relevance for telemedicine. TytoCare developed a digital stethoscope in 2016 that was designed to support telemedicine with patient-facing product TytoHome and clinical-facing product TytoPro. Although the Israeli company’s initial target audience was pediatricians and parents, TytoCare has since broadened its customer base to include adult patients. It recently partnered with Miami Children’s Health System to support telehealth services for patients. Shortly after its device received FDA clearance, TytoCare signed a partnership with American Well to combine video telehealth visits with remote examinations. Rijuven (Rijuven.com) developed a device that was designed to convert traditional stethoscopes into digital ones through what it calls the CardioSleeve. The business later developed a digital cardiac program geared for patients being discharged from the hospital following a cardiac event. Vytelex is a way for patients to do daily heart failure assessments that can be remotely monitored by clinicians. VTN
code. With the Glia template, the stethoscope can be made in less than three hours and costs less than $3 to produce. Anyone with a 3D printer and access to ABS – a plastic used to make garden chairs and Lego – can create the device. The results of the study show it has the same acoustic quality as the best stethoscopes on the market. “Use of the open source approach in every aspect of this project contributes powerfully to the body of medical device research,” said Gabriella Coleman, PhD, noted scholar on technology and open source software. “This research gives a guide for others to create medical-grade open access devices that can reduce costs and ultimately save lives. The device is currently in clinical use by physicians and allied health professionals in Gaza and is also subject of a clinical trial at the London Health Sciences Centre, in London, Ontario.
Dr. Loubani says stethoscopes may not be seen as vital for diagnosis and treatment in places such as London, where physicians rely heavily on ultrasound, CT and other diagnostic technologies. However, in war torn and low-income communities, the stethoscope is a necessary tool. “Stethoscope utility goes up as other resources go down. In London, if someone gets shot, I can use an ultrasound to look inside and see if there is a life-threatening air pocket called a pneumothorax. In Gaza, ultrasounds are not available in emergency departments, or are dilapidated, so the stethoscope becomes an inexpensive tool that allows us to make lifesaving decisions.” The hope now is to create templates for other medical devices that can be made or improved on-site in locations with scarce resources. VTN
EARLIER DIGITAL STETHOSCOPES
APRIL/MAY 2018 < VEIN THERAPY NEWS
PRODUCTNEWS
SAVE THE DATE!!
Spring and Fall Residents & Fellows Courses 2018 Spring Residents and Fellows Course May 18-20, 2018
2018 Fall Residents and Fellows Course December 7-9, 2018
Englewood Hospital and Medical Center 350 Engle St, Englewood, NJ 07631
University of Texas San Antonio San Antonio, TX
OVERVIEW
MEETING ATTIRE
The Residents and Fellows Course in Venous Disease is presented for the benefit of Fellows and Residents within the specialty of vascular surgery, interventional radiology, cardiology, vascular medicine and associated programs.
Dress is casual including dinners.
The goal of the course is to educate and update the Fellows and Residents regarding the latest theories and developments in the clinical practice of vein disease management. Residents and Fellows will gain an overall understanding of vein disease to allow them to successfully incorporate venous knowledge, skills and techniques into their overall practice as they make the transition from training to the clinical practice.
FEES Residents and Fellows in an accredited training program, do not pay registration fees to attend. In addition, the AVF provides a travel stipend, hotel accommodations, and meals while at the Course. “Attendees must provide a credit card to hold their hotel reservation. If registration is not cancelled three weeks prior to the event, the credit card will be charged for one-night hotel”
ADDITIONAL BENEFITS OF ATTENDING By attending the 2018 Courses you will receive complimentary registration to AVF’s 2019 31st Annual Conference scheduled to take place at the Westin Mission Hills Golf Resort and Spa in Rancho Mirage, CA from February 19-22, 2019. You will also receive one-year complimentary Resident/Fellow membership to the American Venous Forum, and all of the membership benefits associated with an AVF membership. (Please note that the complimentary conference registration and membership are nontransferable or redeemable for cash).
FELLOWS GRANT - TRAVEL REIMBURSEMENT The courses are funded through a Grant Program that covers registration and travel expenses. To be eligible for the grant, all participants are required to attend the entire course. Each will receive two nights of lodging at the designated hotel, transportation to and from the airport, and food and beverage supplied during the course. AVF will reimburse travel expenses up to a total of $550. This includes travel to and from the course (i.e., coach airfare, gas mileage, train ticket, etc.), parking and nominal food and beverage purchases on days of travel. Please note that our policy is that all travel reimbursements must be submitted within 30 days of the completion of the course.
NOTE: Alcoholic beverages will not be reimbursed. A travel reimbursement form will be provided. Each Resident and Fellow must complete their own reimbursement form and forward it to the AVF office along with itemized receipts to receive reimbursement. Failure to provide completed form will delay reimbursement. NOTE: Failure to attend the entire course will result in forfeiture of any travel reimbursement.
http://www.veinforum.org VEIN THERAPY NEWS < APRIL/MAY For more information regarding 2018 the Spring and Fall Residents and Fellows Courses or anything AVF related please contact the AVF office at (727) 350-1580 or email us at info@veinforum.com, or www.veinforum.com, or check us out on social media.
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PRODUCTNEWS increased range of motion and improving their quality of life. The inner sleeve enables one-handed application and the padded skin-contacting material improves comfort over sensitive skin. COMPREFLEX ARM is patent pending. “We design all our products with the patient top-of-mind,” said Scot Dubé, president and CEO SIGVARIS North America. “We are excited to provide compression products that give patients the freedom to easily complete daily activities without thought to their medical garments – knowing that improving patient adherence will lead to better clinical outcomes.” VTN READ MORE: sigvarisusa.com
Imbed preparing launch of film to promote healing
SIGVARIS launches 3 new products for inelastic line SIGVARIS has introduced three new products to its inelastic compression line – COOLFLEX NF, COMPREFLEX REDUCE and COMPREFLEX ARM. The COOLFLEX NF is the first product of its kind, intended for venous disease and lymphedema. The inelastic wrap for the lower leg integrates SIGVARIS’ new EZ-Close Pressure System, featuring straps with built-in visual indicators that allow patients to consistently receive their prescribed compression. The one-handed closure eases donning for morbidly obese and arthritic patients. The COOLFLEX NF also features Spacer
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Fabric TR, which provides 60 percent more breathability versus traditional wrap material, improving patient comfort. The adjustable design accommodates irregular leg shapes that may otherwise require a custom product. In a four-week clinical evaluation, the COOLFLEX NF resulted in 100 percent patient adherence. The COMPREFLEX REDUCE uses six simple steps, making it the easiest cut-to-fit inelastic product for decongestive therapy in place of bandages for the foot, lower leg, knee and upper leg as needed. Tests show the self-adjustable tension tabs are 30 percent faster than bandage wrapping. The COMPREFLEX REDUCE fits patients with a calf circumference up to 90cm and a thigh circumference up to 125cm. The COMPREFLEX ARM is an inelastic arm wrap featuring a new 90° Flexi-Zone™ technology, providing patients with an
Imbed Biosciences, a young Fitchburg, Wisc., company that has developed an ultrathin film to heal wounds, is poised to launch its product this spring with the help of the latest injection of funds from investors. A “national wound care company” will partner with Imbed and will market Microlyte Ag, said Ankit Agarwal, Imbed CEO and co-founder. The partner company’s name is not being released yet. Microlyte Ag is a patented, ultrathin film coated with tiny silver particles that stick to the surface of the wound and kill bacteria. The U.S. Food and Drug Administration cleared it in August 2016 as a medical device, for prescription and over-the-counter use. Mission Health’s hospital in Asheville, North Carolina is applying Microlyte Ag to 100 patients in a clinical study; results will be presented this spring. In a separate pilot project, doctors in about 25 hospitals across the U.S. are treating patients with the microfilm, Agarwal said. It is aimed at treating surgical wounds, chronic skin ulcers, pressure sores and firstand second-degree burns. Agarwal said he is encouraged by some of the comments he’s hearing from the test sites. “Patients have called saying the product has healed wounds that had not healed for a year,” he said. “It feels very good just to know that.” Agarwal was part of a team that invented the technology while he was a post-doctoral research scientist at the University of Wisconsin-Madison in 2008. The team also included Jonathan McAnulty, chairman of the Department of Surgical Sciences at the UW-Madison School of Veterinary Medicine, and former UW surgeon Michael Schurr, MD, now a surgeon at Mission Hospitals. Imbed was formed in 2010 and has eight employees. The company recently finalized $1.6 million in funding – some of it new money and some
Microlyte Ag from converting debt to equity – all from past investors led by WISC Partners, which has offices in Madison and Silicon Valley. Imbed plans to raise up to $5 million more, later this year, Agarwal said, to help launch of Microlyte Ag and conduct more studies. VTN
Cynosure touts TempSure Envi to improve skin Cynosure, now a part of Hologic, is releasing a radiofrequency system for performing aesthetic procedure on the skin, including for reduction of wrinkles and other facial lines, tightening of skin by coagulating soft tissue, and making cellulite look more attractive than its natural self. The system is already FDA cleared. The TempSure Envi device generates heat in the deeper layers of the skin while simultaneously monitoring the temperature of the affected area. It features Therapeutic Logic Control, a technology that correlates the temperature of the therapy to how much time it is delivered to achieve optimal results without leading to discomfort. Spokesmen say that with a 300-watt generator, TempSure Envi offers best-in-class temperature sensing and response, with up to 100 times faster response than its competitor, based on an in-house study. Heating the lower layers of the skin leads to collagen production, makes cellulite look better, and smooths out wrinkles, frown lines, crow’s feet, and the like. The company touts it as being a safe, consistent and reliable RF skin tightening treatment. Procedures take between a half hour and an hour, depending on what is being treated, and are performed in continuous sessions requiring no downtime. VTN READ MORE: cynosure.com
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APRIL/MAY 2018 < VEIN THERAPY NEWS
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.
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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 BUSINESS SIDE
continued on page 19
to discuss.
PRODUCTNEWS Dermatologists offer opinions regarding Dermaroller usage Anti-aging skin care comes in many forms, Julie Ricevuto , digital beauty editor wrote in a January blog on newbeauty.com. Topicals, if you’re a believer in the miracle of skin creams. Dermatologist treatments, if you’re a fan of Botox and searing lasers. And finally, the sweet spot between these two options – at-home beauty tools. According to Pinterest’s 2018 trend predictions, this year will see a crazy spike in usage of a particularly popular at-home tool – the dermaroller. Last year, the website saw a 345-percent increase in saves for “dermaroller,” so we can only assume that number will continue to grow over the next 12 months, and for good reason. So, what exactly is this dermaroller that’s about to be in every household? Well, according to New York dermatologist, Heidi Waldorf, MD, it’s a “handheld device consisting of tiny spikes on a roller that’s moved along the skin with a handle.” The microneedling tool aids in the absorption of topical cosmeceuticals, ensuring
that all those pricey skin care products you buy can dive deeper into the skin and actually do their job. The tool also creates microinjuries to the surface of the skin in order to force it to heal itself and naturally boost collagen production, smooth the skin’s surface and tighten pores. While plenty of people already swear by dermarollers for enhancing their complexion, doctors are torn on whether or not people should be encouraged to use one at home. One of the biggest risks consumers are faced with when using this tool themselves is the possibility of infection. New York dermatologist Ellen Marmur, MD, said the danger with sharp instruments is that damage to the skin can lead to infection. “So, it’s important to clean the tool with alcohol after every single use and not to share it with anyone in order to prevent spreading contagious infections.” However, it’s not just the risk of infection that dermatologists warn users about: Dermarollers could potentially do more damage than good if used incorrectly, according to Dr. Waldorf. “I’m very concerned that the risk of injury with overuse or use of a poorly made version with irregular pins,” she said. “I don’t recommend buying one.”
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Double-paired gloves
Dermaroller Even though Dr. Waldorf advises people against using a dermaroller on themselves, it’s clear from the recent Pinterest stats that not many people are listening. So, if you have your heart set on snagging one of these at-home microneedling tools, Dr. Marmur says to be sure to do your research first. “Make sure [the dermaroller] is made by a good company and feels solid,” Dr. Marmur said. “Always follow the directions and only allow two passes [across the skin] per day.” Additionally, it’s vital to use the tool appropriately in order to ensure the best results. According to Dr. Marmur, you should hold the dermaroller on the skin with medium pressure and roll it up and down in strategic lines over the cheeks, forehead, jawline, neck and chest. The key to avoiding injury is to not roll the tool along your skin too forcefully, otherwise you risk scarring. Ultimately, dermarolling can give users incredible results, and even though dermatologists generally agree that microneedling should be left to the experts, it’s hard not to be intrigued by the tool. So, if you’re in the market for a safe dermarolling option, try one from a trusted retailer, like the Rodan + Fields Amp MD System ($220). Not only will you get the sought-after dermarolling tool, but you’ll also get a renewing serum to deliver smoother skin over time. Just be sure to proceed with caution when using. VTN READ MORE: rodanandfields. com/Shop/Product/AAAPSP1 or newbeauty.com
Donning two pairs of surgical gloves as fast as one pair Putting on two pairs of gloves is a common occurrence in medicine, particularly among surgeons who work with sharp instruments. It’s frustrating and feels like a waste of time, but that’s reality. Now there are gloves that come already doubled, while being easy to snap on. The GAMMEX PI Glove-in-Glove system from Ansell, a company with offices in Iselin, N.J., and Melbourne, Australia, comes as two pairs of two gloves whose fingers are comfortably pre-aligned and are as easy to put on as one pair. Each pair comes in its own package, in some cases potentially saving a
bit on the amount of packaging that’s thrown away over four separate gloves. The inner glove is bright green colored, while the exterior one is natural skin-like color. If the exterior glove is damaged by a scalpel, for example, the green from the glove below suddenly pops out – a safety feature for clinicians. VTN READ MORE: www.ansell.com APC
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extended lunch break and for the Exhibit Hall Opening Reception on Thursday evening. The ACP Foundation will host various events throughout the Annual Congress to support its mission to advance Advocacy, Research and Education (ARE), including a Sunset Celebration every evening, the Silent Auction and the Annual Fun Run. And, be sure to make plans to be a part of the closing celebration Saturday evening! VT N Amanda Godwin is the senior marketing coordinator at the American College of Phlebology. She can be contacted by email at agodwin@acpmail.org. CIED
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leads causing vascular injury, we can reach conclusions more rapidly and efficiently.”
AVOID THESE INJURIES
“The best strategy is to avoid the need for TLE to begin with,” Dr. Tarakji advises. “This can be accomplished by minimizing CIED infection, improving lead designs and expanding the battery longevity of these device to minimize the need for frequent procedures.” He said Cleveland Clinic is leading global clinical trials to assess new technologies to minimize CIED infections. “The technological advancements with the development of subcutaneous ICDs and leadless pacemakers are a major leap toward the future of the field of CIEDs,” Dr. Tarakji said. “In the next decade or two, endovascular leads may perhaps become obsolete.” VT N
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