1 S E P T E M B E R 2 0 1 4 • VA S C U L A R S P E C I A L I S TNEWS FROM SVS

S V S R E S E A R C H N E W S L E T T E R

Introduction:FosteringResearch andInnovation

The vascular community has a lot to beproud of. Thanks to what we do, our pa-tients enjoy a better quality of life than

ever before. Progress in our field has trans-formed expectations about aging and recover-

ing from illness at anystage in life.

But the full promise ofour field cannot be ful-filled without researchmoving us forward. Sup-port for vascular researchis critical to developingbetter treatments for ourpatients, and maintaininga prominent role for ourspecialty in defining vas-cular care.

Or, as Michael Conte writes succinctly in thesepages, “Research is important to SVS because itis important to our patients.”

I am pleased to introduce the first-ever SVSresearch newsletter. In this issue you will learnmore about the vascular surgeon scientists whoare hungry for answers that will lead to betterpatient care, the society’s commitment to re-search and multispecialty collaboration, and theopportunities available to all members of ourcommunity to share their research.

My heartfelt appreciation to our communityof scientists and the SVS members serving onthe Research Council and its committees. To-gether, we are fostering research and innova-tion with the highest levels of scientificintegrity.

Peter F. Lawrence, MD

President, Society for Vascular Surgery

DR. LAWRENCE

SVS Research Leadership ReportB Y M I C H A E L S. C O N T E , M D

O N B E H A L F O F T H E S V S R E S E A R C H

C O U N C I L

Thank you, SVS colleagues, for the opportunityto help fulfill our collective commitment toscientific leadership. Those of us

who serve on the Research Council andits three committees – Clinical andComparative Effectiveness Research,Outcomes and Technology Assessment,and Research and Education – arepleased to confirm the vibrant state ofour society’s scientific initiatives.

Research is important to SVS be-cause it is important to our patients.Our field has made dramatic advancesbut the burden of vascular disease re-mains great, and we still have many unmet scien-tific needs – spanning from discovery sciencethrough translation and clinical investigation. Re-search also propels our specialty forward in everyrelevant domain, giving us an authoritative andpersuasive voice with public policy makers, indus-try, regulatory bodies, or-ganizations like the AHA,and the NIH.

SVS has made impor-tant contributions to sci-entific advances – inbasic/translational, clini-cal, and outcomes re-search. Here are somekey examples: P The SVS Foundation/ NHLBI Mentored Ca-reer Development Award Program has proven ef-fective in sustaining the pipeline ofbasic/translational vascular research. Our recent-ly completed 15-year assessment shows that with$9.4 million in supplemental support from SVS,29 K Award recipients went on to secure $45.1million in additional NIH and VA funding, a 4.8return on investment. Further positive results in-clude prodigious scientific output and a signifi-cant amplification of knowledge and skillsthrough mentorship. Still, the report does not tell

the whole story. The profile of Scott Berceli of-fered here provides ample evidence of the incal-culable value of our K Program.P Endorsing the BEST-CLI Trial is a prime ex-ample of how SVS contributes to advancing clin-ical research for our field. Following the process

developed by the council, the BEST-CLITrial was the first study to obtain anSVS endorsement. As Alik Farber andMatt Menard attest further in this re-port, they believe the endorsement wasinstrumental in convincing the NIH toapprove $25 million to fund the BEST-CLI Trial, by any measure a monumen-tal study.P For nearly 30 years, the Vascular Re-search Initiatives Conference has en-couraged interaction and collaboration

among new and established vascular surgeon in-vestigators and scientists from other vascular bi-ology-related disciplines. Katherine Gallagher’stop-rated presentation from the 2014 VRIC, sum-marized here, demonstrates the compelling workour members are doing in translational research.

Finally, we aremindful of the pio-neering vascularsurgeon-scientistswho have con-tributed so much tothe science andpractice of vascularmedicine, and have

distinguished themselves by the volume, breadthand depth of their work. For his lifetime ofachievements as a vascular biologist, his decadesof leadership, and most importantly his mentor-ship and inspiration to so many of us, I saluteAlec Clowes. His insightful remarks in our firstResearch Newsletter reflect a unique perspectiveon where we are in vascular research and wherewe are going.

On behalf of all my Research Council col-leagues, thank you for your ongoing support ofthis work. We welcome any comments you mayhave on this report.

DR. CONTE

Astride Science and Clinical PracticeB Y A L E X A N D E R W.

C L O W E S, M D

An invitation arrived fromMike Conte and JulieAnne Freischlag to share

my thoughts on what I see onthe horizon for vascular sur-geons. How could I resist?As context, I speak as a ca-reer academic surgeon work-ing at the interface betweenvascular biology and clinicalpractice, focused on what Iwould call the response to

injury, intimal hyperplasia,and stenosis/restenosis. It’s abig problem and it is themain reason for luminal nar-rowing in 1 in 3 reconstruc-tions. With that in mind,here are five thoughts.

One: Peripheral vascularsurgery isn’t going away.Peripheral vascular disease isnot on the decline. Risk fac-tors have not diminished.First, diabetes has gottenworse; we don’t have an effec-

tive way of countering thetoxic effects of diabetes onthe build-up of plaque. Sec-ond, with an aging baby-boom generation, there’sgoing to be a lot moreaneurysmal disease. There areother kinds of diseases thatneed attention, but these twoprobably transcend every-thing else in magnitude andin importance for the future.

Two: We have gaps to fill.We have a variety of tools for

opening blocked arteries andrestoring circulation. What ismissing are strategies that aresufficiently robust to guaran-tee that the repair of anartery is long-lasting. We’vehad some progress here, butneed a lot more.

Part of the answer is moreclinical trials. Vascular sur-geons have come late to thisresearch method, but it isvery important and SVSshould champion this ap-proach. We have also come

to recognize the importanceof “bedside to bench” –carefully studying the dis-ease and responses in hu-mans because our animalmodels have many limita-tions. This is a unique op-portunity forsurgeon-scientists.

Three: Researchers willneed new tools andexpertise.If I were starting today, I

Continued on following page

Research propels our specialty forward in

every relevant domain, giving us an

authoritative and persuasive voice with

policy makers, industry, regulatory bodies,

organizations like the AHA, and the NIH.

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would train myself in twoareas: genetics, because Ireally do think there is a ge-netic underpinning for vas-cular disease; and novelimaging devices that willlet us go beyond death andlimb loss, and look at natur-al history and outcomes ofpharmacological interven-tions.

Research teams of the fu-ture will need to include notonly vascular surgeons, butalso people who are skilled

at defining the progressionand regression of disease;who understand the under-lying biology; who are ex-perts in endocrinology,cholesterol metabolism, dia-betes, and other areas.

Four: SVS is on the rightpath; keep going.SVS and its members are well situated to improvevascular care because wetreat all aspects of occlusiveand dilating diseases, andthat makes us unique. Italso makes us responsible.

Some of our colleagueshave a huge desire to do thescience needed to advanceour field.

The SVS should continueto select, train and supportyoung academic investigatorswho are capable of being thebridge between the scienceand the clinical care.

We need more transla-tional research, yes, but wealso need to encouragethose few brave souls will-ing to go straight after basicscience. And we certainlyneed to expand the cadre of

highly qualified and creativeclinical investigators.

Our K Award programsare doing just that.

Five: Tune in to theenthusiasm of vascularinvestigators.I don’t think the SVS shouldbe in the business of tellingpeople what to research. In-vestigators should have theirown ideas because there isno substitute for enthusias-tic investigators driven heartand soul to dig into some-thing they care about.

Dr. Clowes has been associatedwith the University of Wash-ington School of Medicinesince 1980. He was Chief ofthe Division of VascularSurgery from 1995 to 2007. Hehas been funded for more than30 years by the NIH and cur-rently is investigating the roleof a single nucleotide polymor-phism (SNP) in the promoter ofa critical cell cycle regulator,p27 Kip1. Nothing has givenhim more professional satisfac-tion than witnessing the suc-cess of his colleagues as theybuild their careers.

Continued from previous page

Vascular Surgery Leads in Definitive Guidance for CLI

In October 2007, SVS membersAlik Farber, MD, Boston MedicalCenter, and Matthew Menard,

MD, Brigham and Women’s Hospital,Boston, decided to collaborate on alarge-scale study to provide definitiveguidance on how to best treat pa-tients with CLI. They expected a longpath. They were right.

Countless conversations, hundredsof documents, dozens of consulta-tions with researchers and cliniciansin vascular surgery and other disci-plines, two NIH grant cycles, andseven years later, their application fora $25 million R01 grant to supportthe BEST-CLI Trial was approved.

Now the work begins.

Defining practice for CLIThe Best Endovascular versus BestSurgical Therapy in Patients withCritical Limb Ischemia (BEST-CLI)Trial will compare treatment efficacy,functional outcomes, and costs for2,100 patients age 35+ undergoingbest open surgical or best endovascu-lar revascularization.

“It won’t be easy,” Dr. Farber said,“but the prospect of giving cliniciansbetter guidance on how to effectivelytreat CLI, and offer patients optimaloutcomes has been an ongoing moti-vator.”

Dr. Menard agreed. “We under-stand the challenges of such an ambi-tious trial, but the support andenthusiasm we have seen from thosewho understand CLI and who shareour desire for substantive progressgiven the current lack of data hasbeen compelling.”

CLI: A top-three clinical researchpriorityIn 2010, the SVS named CLI one ofthe top-three unmet clinical researchneeds. Known to affect 500 to 1,000per million U.S. patients every year,

the CLI rate is expected to continueto escalate. Currently, unless affectedlimbs can be successfully revascular-ized, as many as 40% will be ampu-tated, and the associated annualmortality rate exceeds 20%.*

“The CLI population is an excep-tionally complex and challenginggroup of patients to treat. By lookingat both functional outcomes and thecost-effectiveness of open and en-dovascular treatment options, wehope to provide the evidence-basedguidelines that are currently needed,”Dr. Menard said.

Unique on many levelsThe study is unique in several impor-tant ways, among them its pragmatictrial design, its use of novel end-points, the inclusion of a robust cost-effectiveness component, and itscollaborative approach.

The BEST-CLI Trial is also one ofthe few large-scale, multispecialty

clinical trials with vascular surgeryroots and leadership. In addition toprincipal investigators Drs. Menardand Farber, who serve as two of thethree trial chairs, vascular surgeonsDr. Michael S. Conte and Dr. RichardJ. Powell serve on the seven-memberexecutive committee. Dr. Conte co-chairs the executive committee withDr. Chris White, an interventionalcardiologist.

At the same time, the BEST-CLITrial includes all specialists who treatpatients with CLI: vascular surgeons,interventional cardiologists, inter-ventional radiologists, and vascularmedicine physicians. Drs. Farber andMenard acknowledge there has notalways been perfect harmony amongspecialists treating CLI, but theyhave been encouraged by the extentto which those involved have workedto move beyond those differences toachieve the goals of the trial.

“The BEST-CLI Trial is an opportu-nity for everyone treating patientswith CLI to get away from bias andconvictions that are not validated byscience,” Dr. Farber said. “If we’regoing to define practice, we have toinvolve everyone.”

“The trial will provide a unique op-portunity for interdisciplinary collab-oration between all of thesubspecialties providing care to CLIpatients,” Dr. Menard added. “Dr.Ken Rosenfield, who represents theinterventionalist community on thePI team, and his colleagues on the ex-ecutive committee have been instru-mental in involving a diversity ofendovascular clinicians.”

Endorsed by the SVS, othersocieties and the FDADrs. Menard and Farber acknowledgethe support provided to them and the

trial by the SVS. The society leader-ship at the time, including Drs.Richard P. Cambria, Anton Sidawyand Robert M. Zwolak, and RonaldL. Dalman provided a key endorse-ment at a critical early juncture. Theendorsement cited the promise ofthe bringing “transformative power”to CLI care, and described trial re-sults as being “of critical importanceto patients and their vascular surgeonspecialists.”

“Strong endorsement from our na-tional vascular surgery society, andthe signal this sends to the NIH, wasa very important component of ourgrant application,” Dr. Menard said.“We remain grateful for the ongoinginvestment in and support of the trialby the current SVS leadership, whohave, throughout, shared our beliefin the value of this effort to our col-lective patients.”

Attesting to its broad multi-discipli-nary backing, the BEST-CLI Trial isalso endorsed by the FDA, the Soci-ety for Cardiovascular Angiography& Interventions (SCAI), the Societyof Interventional Radiology (SIR),the Society of Vascular Medicine(SVM), the Vascular Disease Founda-tion (VDF), and Vascular InterVen-tional Advances (VIVA).

Reflects realities of the careenvironmentUnlike previous trials, the BEST-CLITrial leaves the definition of “besttherapy” to the individual investiga-tor and allows use of all commercial-ly available endovascular therapies,all surgical bypass techniques, and alltypes of conduit to be used. New andevolving therapies will be criticallyreviewed as the trial progresses;those found suitable will be added to

DR. FARBER DR. MENARD

Continued on following page

BEST-CLI Trial: 2,100 patients, 120 centers,

4 years, 26-month minimum follow-up, $25 million

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the list of options.The dedicated focus of the trial on

comparative effectiveness also re-flects today’s economic realities. Dr.Farber described this aspect of thestudy as central to securing supportfrom the NHLBI, the funding insti-tute within the NIH.

“Everyone recognizes the need toallocate the scarce resources of to-day’s tightened budgets as wisely aspossible. We hope to provide a moreobjective, evidence-supported basison which to do so,” he said.

More than a conventional RCTPrincipal Investigators Dr. Menard,

Dr. Farber, and cardiologist KenRosenfield, MD, MassachusettsGeneral Hospital, Boston, have always been interested in tappingthe expertise offered at each ofthe 120 participating trial centers in the United States and inCanada.

To do so, the investigators havechampioned a “CLI team” approachthrough which local site teams willcollaborate over the course of the trial.

Sites are on target to complete the first of several webinars sched-uled this fall to orient investigatorsto the specific rules of the trial.This month, they hope to welcomethe first of 2,100 randomized patients.

Bright outlookDrs. Farber and Menard say theirSVS colleagues have beennothing but supportive.from day one. “People understand the inherentchallenges, but are moti-vated by the potential forthe level of data only arandomized trial of thiskind can provide,” Dr.Menard said.

At the 2014 Vascular An-nual Meeting, they de-scribed the investigators meeting to orient first-wave participants and others still considering partici-pation as “high attendance and highenergy.”

Asked how colleagues can help theBEST-CLI Trial as it moves forward,

Dr. Farber said, “by join-ing in the effort to recruitpatients.”

Enrollment starts thismonth. For more informa-tion visit http://vsweb.org/BESTCLI.

If interested in partici-pating, please contact Dr.Menard (mmenard@part-ners.org ) or Dr. Farber(Alik.Farber@bmc.org).

*Norgren, L., et al., Inter-Society Con-sensus for the Management of Periph-eral Arterial Disease (TASC II). J.Vasc. Surg. 2007. 45 Suppl S: p. S5-67.

Continued from previous page

DR. ROSENFIELD

The Best From 2014 VRIC: Highest-Rated Abstract Presentation

More than 100 investi-gators, students andtrainees with an inter-

est in science and cutting-edge translational researchattended the April 30, 2014Vascular Research InitiativesConference in Toronto. Theresearch abstract presentedby Katherine A. Gallagher,MD, summarized below, wasthe highest-rated.

Co-moderator for theVRIC session devoted tostem cells and tissue engi-

neering abstracts, Dr. Gal-lagher is a member of theSVS Research and EducationCommittee and an assistantprofessor of vascular surgery,University of Michigan, AnnArbor, Michigan.

ABSTRACT SUMMARY

Bone-Marrow ChimerasDemonstrate That the Epi-genetic Signature in theBone Marrow Myeloid CellsInfluences the PeripheralWound M1-Dominant

Macrophage PhenotypeKatherine A. Gallagher, AmritaJoshi, Emily Hogikyan, DawnColeman, William Carson,Steven Kunkel, University ofMichigan, Ann Arbor, Michigan.Within the broad field of epi-genetics, this work focusedon the role of immune cellsin Type 2 diabetic woundhealing. Specifically, this re-search examined histonemethylation changes in bonemarrow stem cells and the as-sociated transfer of informa-tion into more differentiatedmonocytes and macrophagesat the wound level.

The study hypothesized

that the diabetic milieu inType 2 diabetes generates cy-tokines and other growthfactors that induce methyla-tion changes at the bonemarrow cell level, resultingin monocytes and peripheralmacrophages which go to thewound “preprogrammed” toact as an M1 (pro-inflamma-tory) macrophage, and havetrouble switching to an M2(anti-inflammatory) pheno-type for tissue repair.

We found previously that adecreased level of H3K27 inmature macrophages at theIL12 promoter results in in-creased expression of thepro-inflammatory cytokinein wounds. In this study, wewanted to determine whichepigenetic enzyme plays arole in driving this K27methylation mark.

We took macrophagesfrom diabetic versus controlwounds and found that oneenzyme, Jmjd3, showed a23-fold increase in diabeticmacrophages versus controlcells. That result did not sur-prise us, because Jmjd3specifically demethylates forH3K27; it removes themethyl group, decreasingthe level of H3K27.

To assess whether this newresult is functionally and bio-logically important, we ex-posed the diabeticmacrophages to GSK-J4, anew dimethyl inhibitor spe-cific for Jmjd3, and observedincreased levels of H3K27 on

the IL12 promoter.Perhaps more importantly,

when we looked at IL12 pro-duction, we saw a dose-depen-dent decrease correspondingwith the inhibitor for Jmjd3.When we inhibit this epige-netic enzyme, we can controlthe levels of cytokine produc-tion coming from these dia-betic macrophages, which isimportant from a therapeuticperspective.

To look at our second goal,to assess the role of bonemarrow in this process, wecreated chimeric mice. Wetook bone marrow from dia-betic and non-diabetic miceand injected it into both irra-diated diabetic and non-dia-betic animals. We observedimpaired wound healing innon-diabetic mice that re-ceived diabetic bone marrow.More importantly, theirmacrophages showed in-creased levels of Jmjd3 andIL12—as a result of diabeticbone marrow being injectedinto normal-diet mice.

In summary, this studyshowed that bone marrowfrom diabetic mice can impairperipheral macrophages andnegatively impair wound heal-ing. Histone methylationchanges in the cells appear toinfluence peripheral macro-phage functions. Potentially,modulation of these enzymesmay offer therapeutic benefitsby modulating cytokine levelsand perhaps dictating macro-phage function.

Marrow-based epigenetic signatures

and type 2 diabetic wounds

Submit abstracts for meetings

2015 Vascular Research Initiatives

Conference (San Francisco, CA)

2015 Vascular Annual Meeting (Chicago, IL)

Apply for SVS Foundation Awards

Mentored Clinical Scientist Research Career

Development Award (K08)

Mentored Patient-Oriented Research Career

Development Award (K23)

Clinical Research Seed Grant

VRIC Trainee Travel Scholarship

Resident Research Prize

Student Research Fellowship

EJ Wylie Traveling Fellowship

SVS Foundation and Vascular Cures

Wylie Scholar Award

Submit manuscripts and articles for publication

Journal for Vascular Surgery

Journal of Vascular Surgery: Venous and

Lymphatic Disorder

Vascular Specialist

Deadline

January 23, 2015

February 10, 2015

Deadline

October 12, 2014

October 12, 2014

Fall 2014

January 23, 2015

February 10, 2015

March 2, 2015

March 2, 2015

March 27, 2015

Deadline

Ongoing, published monthly

Ongoing, published quarterly

Ongoing, published monthly

For more information

vsweb.org/VRIC

VascularAnnualMeeting.org

For more information

vsweb.org/MentoredClinical

vsweb.org/MentoredPatient

vsweb.org/SeedGrant

vsweb.org/VRICscholarship

vsweb.org/ResidentResearch

vsweb.org/StudentResearch

vsweb.org/WylieTravel

vsweb.org/WylieScholar

For more information

jvascsurg.org

jvsvenous.org

VascularSpecialistOnline.com

Research and Publication Opportunities for Vascular Specialists

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development, not only as a sur-geon-scientist but as a person, thanDr. Frank LoGerfo and Dr. AlecClowes, both giants in vascular re-

search,” Dr. Berceli said.As to the 30-plus lab trainees and

vascular surgeons Dr. Berceli hasmentored, “I’ve tried to create an en-vironment where engineering gradstudents and surgery residents cancross-pollinate, flourish and move on,”he said.

“I also mentor more senior people,like Dr. Salvatore Scali, our junior fac-ulty member. Helping him plant goodroots and succeed with his own Kgrant and SVS Foundation Award hasbeen very rewarding.”

More broadly, Dr. Berceli is con-cerned that research opportunitiesfor vascular surgeons in traininghave all but disappeared. “It’s criticalthat we preserve opportunities forthe motivated people who we thinkwill lead the specialty going for-ward,” he said. “We need more in-vestigative experiences, not just atthe faculty level, but during training,when we can inspire people tochoose a career that includes re-search.”

has not only a new look,

but new features, with the goal of providing you

the latest in vascular and medical

news beyond the print edition.

S V S R E S E A R C H N E W S L E T T E R

Dr. Scott Berceli Reflects on the Research and CareerValue of the SVS Foundation K Award Program

Each year, vascular surgeon-scien-tists awarded K08 or K23 careerdevelopment grants compete for

an SVS Foundation/NHLBI Men-tored Career Development Award. In2004, Scott Berceli, MD, PhD, suc-ceeded, and received mentorshipfrom a senior investigator and $75,000per year in addition to NIH funding.

Dr. Berceli said the supplementalfunding is equally, if not more impor-tant than the K award itself. “My K08award, allowed only $25,000 for sup-plies and other expenses—not enoughif you want to innovate and move yourresearch into a novel area,” he said.

As it turned out, the SVS Founda-tion was crucial for Dr. Berceli.

Understanding the biology of veingraft remodelingGoing into his 2004-2009 K08 award,Dr. Berceli believed he would findone or two molecules that could bereprogrammed through drug therapyor some other means to help slowthe progress of intimal hyperplasia sografts would last longer.

“Experiments showed that a vari-ety of factors are involved, and a lotof interconnectedness. I needed totake my research in a completelynew direction,” Dr. Berceli said.

His background as a chemical engi-neer helped Dr. Berceli regroup un-der a systems biology approach. Thenew goal was a comprehensive under-standing of the cell-to-cell signalingset off by the act of inserting a bypassgraft into the arterial circulation.

Following completion of work un-der the K award, Dr. Berceli secureda five-year R01 grant to keep theteam intact and take the investigationfurther.

The power of mathematical modelsMathematical models revealed howspecific genes signal cells to divideor die and reassemble to form scars,narrowing the vessel and changingthe way the blood flows through thebypass. The team saw how genescould be turned on or off to changethe vein remodeling cycle. Theywere able to quickly perform exten-sive experiments with various setsof genes and predict associatedchanges in vein graft geometry.

Circling back to in vivo modelsToday, one of three NIH studies thatDr. Berceli is leading is under the aus-

pices of the MultiScale ModelingConsortium. Funded by a $3.5 mil-lion U01 NIH grant, a multi-institu-tional research team is working withscientists at the NIH, National Sci-ence Foundation, Department of En-ergy, and Department of Defense.

“Multiscale modeling says if we canpredict how things will occur on asecond-by-second basis at a molecularlevel, we can eventually understandhow the whole hyperplastic processworks,” Dr. Berceli explained.

The team will define perhaps fivegenes with potential to improve by-pass graft biology.

Using high-throughput cell culture,they will run experiments on tens ofthousands of different combinationsof the target genes to validate previ-ously developed predictions.

Findings will be tested in the rabbitvein graft model that Dr. Berceli de-veloped for his K Award study, afterwhich the team can move on to testsin humans.

When asked how novel this workis, Dr. Berceli said, “About a year ago,the head of the Bioengineering Di-rectorate at the NIH asked me to pre-sent at a monthly seminar he hostsfor his branch. He told me no oneelse he knows of is on our samepath, linking engineering work andbiology through multiscale modelingto develop a therapy.”

Changing lives through mentoring“No one outside my family has hada more profound influence on my

Dr. Scott Berceli (right), shown with his colleague and mentee, Dr. Salvatore

Scali, is a prime example of the value of the SVS Foundation K Award Program.

SV

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