Terry R. Bowers, MD, FACC, FSVM

Director, Vascular MedicineDirector, Vascular Medicine

Beaumont Health, Royal Oak

• None relevant to this topic• None relevant to this topic

• What it means• What it means

• How to get training/expertise

• Why we should do it– Patient benefits

– Physician benefits

• How to screen for and treat the vascular patients• How to screen for and treat the vascular patients

• What the expected “Market” will be

• Lessons learned over 20 years to help overcome the “politics”• Lessons learned over 20 years to help overcome the “politics”

• Recommendations on how to implement a cardiovascularprogram at the local hospital looking to enter the market

• Atherosclerotic disease experts VascularKnowledge

• Expertise in cardiovascularimaging, hemodynamicmonitoring

Knowledge

ClinicalSkills

• Access to patients

• Longitudinal follow up alreadyestablished

Skills

established

• Survival dependent on cardiacissues

• Cardiovascular training programs• Cardiovascular training programsinclude vascular disease didacticsto fulfill board requirements

• Interventional skill set

AngioSkills

• Interventional skill set

COCATS Level III (VascularCOCATS Level III (VascularMedicine Certified)

– Dedicated additionalVM year

COCATS Level I– All Cardiology fellows achieve

– Provide care for most PVD VM year– RPVI eligible– ABVM Board eligible– PVD Expert

– Provide care for most PVDpatients as consultant

– Not able to bill for PVDdiagnostic testing PVD Expert

Peripheral Vascular Intervention– Dedicated additional

interventional year beyondCoronary Intervention

COCATS Level II– Achieved in fellowship with

dedicated months Coronary Intervention– May be RPVI eligible if vascular lab

experience– ABVM Endovascular Intervention

eligible

dedicated months

– RPVI eligible

– Provide specialized PVD care

eligible

www.acc.org/membership/sections-and-councils/fellows-in-training-sectionReed and Gornik January 19, 2016

Vascular Medicine Endovascular Intervention

Certifying Examination

Vascular Medicine

• Training pathway onlyoption after 2015

Endovascular Intervention

• Interventional training inCardiology or VMoption after 2015

• Topics covered noted

• 50% of practice dedicatedto vascular disease

Cardiology or VM

• Focused on:– Patient selection

– Technical issuesto vascular disease

• Most have boardcertification in IM and

– Technical issues

– Complications

– Expected outcomes forarterial and venous disease

certification in IM andCardiology

• Don’t Dabble, get certified

arterial and venous disease

– Diagnostic studies

Vascular Disease States Managed by a

CardioVASCULAR Expert If you’re in, you’re inCardioVASCULAR Expert If you’re in, you’re in

• Peripheral arterial disease • Vasculitis and connectivetissue disease

Peripheral arterial disease• Cerebrovascular disease• Visceral artery disease• Aortic disease

Vasculitis and connectivetissue disease

• Leg ulcers• Congenital vascular• Aortic disease

• Vasospastic and thermaldisease

• Venous disease

• Congenital vascularanomalies

• Neurovascularcompression syndrome• Venous disease

• Thrombosis• Lymphatic disease

compression syndrome• Management of medical

issues around vascularsurgery• Lymphatic disease

• Risk factors andprevention

surgery• Vascular laboratory• Vascular biology• Vascular biology

Not all occlusive disease is atheroscleroticNot all occlusive disease is atherosclerotic

Takyasu’s TAO Popliteal Entrapment

Paget Schroeder’sCystic AdventitialFibromuscular Dysplasia

CoronaryArtery

Disease

CerebrovascularDisease

Disease

1/3 have PAD3/4 have CAD

PADPAD

Patients with one manifestation have coexistent disease in other vascular beds

3/4 have CAD

Patients with one manifestation have coexistent disease in other vascular beds

Aronow WS, Ahn C. AJC 1994;74:64

ABI

3.8CHD Events/year (%)

PAD

1.6

2

Framingham “High Risk”20% at 10 yearsPAD patients are VeryHigh Risk:

1.41.6 High Risk:

ABI 0.9-0.7 – 20%ABI <0.7 – 38%

>1.01 1.0-0.91 0.9-0.7 <0.7

Leng GC Brit Med J:1996;313:1440

5 YEAR OUTCOMES5 YEAR OUTCOMES

Age > 55yrs 8.9 Million PatientsAge > 55yrs

Claudication

8.9 Million PatientsWith PAD

Claudication5%

PVD CVDPVDOutcomes

CVDOutcomes

Pain25%

Revasc30%

Amp4%

MI / CVA20%

Mortality30%25% 30% 4% 20% 30%

Decrease CV Events and Death• Stop smoking

Improve symptoms and QOL

Walking program• Stop smoking– Chantix works best

• Walking program– Supervised ideally

• Walking program

• Cilostazol 100mg bid

• ? Ramipril (Always if Htn)– Supervised ideally– Pre and post revascularization

• Control BP to goal– ACEI

• ? Ramipril (Always if Htn)

• Foot care

• Revascularization– ACEI

• Treat LDL Cholesterol– <70mg/dl– or High Intensity Statin

• Revascularization– Lifestyle “Interfering” Sx

– Rest pain or ulceration

– Endovascular First– or High Intensity Statin

• Antiplatelet therapy– ECASA– Think Plavix (Caprie Trial)

– Endovascular First

– Proactive for AortoIliac Dz

– Think Plavix (Caprie Trial)

Terribly low for all but much lower for PAD population

Subherwal S et al. Circulation 2012;126:1345

50% Reduction in:50% Reduction in:MACCE (MI, CVA)DeathAmputationAmputation

Only 65% were placedon statin

Westin et al. JACC 2014;63:682-690

>90%>90%Compliance

BCBSM PVI Initiative, Grossman et al

Appropriate in Asx Patients

Carotid Duplex

Not Approved

• Drive by Carotid angiography• Carotid Duplex– Known or suspected carotid

stenosis in certified lab 1c

– Symptomatic PAD, CAD or AAA

• Drive by Carotid angiography

• Peripheral angiography at timeof cath in asx patients

– Symptomatic PAD, CAD or AAAIIb

– 2 or more RF (Htn, HLD, smoker,FH atherosclerosis or CVA <60

of cath in asx patients

• Repeat Aortic screens if initialstudy negative

• Routine Carotid duplex if no RFFH atherosclerosis or CVA <60IIb

• Aortic Duplex I– 65-75 yo men

• Routine Carotid duplex if no RF

• Repeat Carotid duplex ifremains asx and initial studynegative

– 65-75 yo men

– 65-75 yo women with FH/tob

– 50-65 yo men with FH/tob

negative

Circulation. 2011;124:489–532

• Age <50 with DM, and one additional RF• Age <50 with DM, and one additional RF

• Age 50-69 with h/o smoking or DM

• Age ≥70 for all• Age ≥70 for all

• Leg symptoms with exertion or ischemic rest pain

• Abnormal LE pulse examination• Abnormal LE pulse examination

• Known atherosclerotic coronary, carotid or renalarterial diseasearterial disease

• Identify disease that warrantsevidence based therapies that are

Recommendation for Serial DuplexScan Frequencyevidence based therapies that are

currently underutilized in PAD• Decrease Stroke in those with

significant carotid atheroscleroticdisease (>70%)

Scan Frequency• Carotid

– 50-70% every 6-12 months– 30-49% every 1-3 years

disease (>70%)– Prevalence 1-2%– Anticipated 2-3%/yr decrease if

revasc

• Decrease morbidity and mortality

– 30-49% every 1-3 years– <30% every 3-5 years

• Aortic– >5cm every 6 months– 4-5cm every 6-12 months

• Decrease morbidity and mortalityof aortic aneurysmal disease withearly detection– Prevalence 4-7.7%

– 4-5cm every 6-12 months– 3-4cm every 1-2 years

– Prevalence 4-7.7%– >5.5cm prevalence 0.6%– 50% reduction in mortality over

13yrs

Jonas DE et al, AHRQ:13-05178-EF-1;2014

Office Based Hospital BasedOffice Based

• Consultation (most common)– Claudication

Venous/lymphatic disease

Hospital Based• Consultation• Vascular Angiography/

Intervention– Venous/lymphatic disease

– Carotid disease

– Aneurysmal disease

– Vasospastic disease

Intervention– Aortoiliac– Femoropopliteal– Infrapopliteal– Vasospastic disease

• Vascular Duplex studies andinterpretation– 100/week (group of 20)

– Infrapopliteal– Subclavian– Carotid– Visceral

• PERT– 100/week (group of 20)

– Important to follow post revasc

• EVLT– 8/week (2 operators)

• PERT– PA EKOS placement– Venous thrombectomy

• IVC Filter placement/retrieval– 8/week (2 operators) • IVC Filter placement/retrieval

Arterial VenousArterial

• PTA with or without BMS orDES

Venous

• Endovenous Ablation

• Vena Cava filter placementDES

• Drug-coated balloon PTA

• Atherectomy

• Carotid Stenting with DEP

• Vena Cava filter placementand retrieval (big deal)

• Venous PTA and stenting

• Large bore aspiration• Carotid Stenting with DEP

• Covered Stents

• Thrombectomy

• Large bore aspirationthrombectomy

• Mechanical thrombectomy• Thrombectomy • Mechanical thrombectomy

By 20-30% by 2025By 20-30% by 2025

Projected Growth in Specialists Projected Growth in ChronicProjected Growth in Specialistsbased on need

Projected Growth in ChronicDisease States

Endovascular InterventionEndovascular Intervention

2013 Medicare Fees

2%

Vasc Surg Cardiology IR Other

43%

14%

43%

41%

Claudicators

Critical LimbIschemia

ClaudicatorsIschemia

Volume Trends for SelectCardioVASCULAR Interventions 2005-2013CardioVASCULAR Interventions 2005-2013

https://www.advisory.com/research/cardiovascular-roundtable/cardiovascular-rounds

EVLT and Venous InterventionArterial BMS, DES, DCB, andAtherectomyEVLT and Venous Intervention

In thousands

2016 2022

Atherectomy

1430

In thousands

2016 20222016 2022

1220

14302016 2022

355475 500

300355

140 190

EVLT Venous Stents

80 50 100190

300

EVLT Venous Stents

WWW.Meddeviceonline.com/doc/evaluating-the-global-markets,2017

Fastest growth rate internationallyup to 5.2 Million procedures annually inup to 5.2 Million procedures annually in2022

Expected to exceed2 Million cases annually2 Million cases annually

MedMarket Diligence, LLC; “Global Dynamics of Interventional CV Procedures, 2015-2022”

The Society for CardiovascularAngiography & Interventions 2013

The American College ofCardiology 2016Angiography & Interventions 2013 Cardiology 2016

The focus now is on appropriateness criteria for intervention

• Goal of revascularization differs– Limb salvage– Limb salvage– Claudication, improve QOL

• Higher restenosis rates infrainguinally• Extrinsic forces on the treatment zone• Extrinsic forces on the treatment zone

– Challenging compressive and torsional forces– Extensive calcification– Challenging tortuosity– Challenging tortuosity

• Procedures can be long and tedious• Critical limb ischemia is extremely complex with high stakes• New techniques, equipment, and devices need to be mastered• New techniques, equipment, and devices need to be mastered• Ultrasound and CTA should be mastered to guide intervention and

diligent surveillance of the treatment zone

Pre DEB Supera

75yo rest pain, post CABG 6 mo earlier, duplex and PVI skills necessary

Inflow, Disease Location, Lesion AssessmentInflow, Disease Location, Lesion Assessment

DES 4.0x28mmDES 4.0x28mm

Recanalization of R TPT occlusion with wire escalation then DES

• Ensure maximal medical therapy toreduce risk of MI, stroke and CVreduce risk of MI, stroke and CVdeath

• Always assess inflow (aortoiliac) andoutflow (runoff to the feet)outflow (runoff to the feet)

• Establish inline flow to the foot toallow for wound healing(“Angiosome”)(“Angiosome”)

• Never take away a surgical option

• Avoid stenting at surgical sites(flexion points)

• Avoid occlusive sheaths

• Avoid distal wire complication

• Manage your complications

• Collaborate with vascular surgery

Device Technology lead by CardiologistsDevice Technology lead by Cardiologists

• Improved PTA to avoid stenting• Improved PTA to avoid stenting• Cutting Balloon

• Drug Eluting Balloons

• Cryoplasty• Cryoplasty

• Atherectomy• Directional – Fox Hollow

• Rotational – Orbital, Rotablator• Rotational – Orbital, Rotablator

• Laser – Excimer

• Improved Stenting ConceptsActive Coatings – Drug Eluting• Active Coatings – Drug Eluting

• Better Stent Designs – flex/fracture

• Bioabsorbable stents

• Stent Grafts - Viabahn

Endovascular Privilege RequestFIT and Practice PathwaysFIT and Practice Pathways

• Extensive documentation with procedure logs• Extensive documentation with procedure logsand outcomes (Do as many cases as possible)

• Didactic lectures attended/delivered• Didactic lectures attended/delivered

• Courses completed (academic/industry)

• Attend or start a hospital Peripheral• Attend or start a hospital PeripheralConference to discuss complex cases

• Find the institutional need and meet it to getin the door (PERT, for instance)in the door (PERT, for instance)

100 Diagnostic50 Interventions50 Interventions

Successful Steps Initiating a CV PeripheralInterventional Program Where Vascular Surgery StrongInterventional Program Where Vascular Surgery Strong

• Develop Multidisciplinary Vascular Interventional LabDevelop Multidisciplinary Vascular Interventional Lab

– Inventory, staffing, protocols, training, colleague trainingsupport (IR, VS, IC working together)

– Focus on Quality– Focus on Quality

– Proper case selection

– Promote team approach

• Develop System Privileging Criteria for Vascular Intervention

• Initiated Vascular Screening Program

• Initiate a Quality Initiative program(BCBSM PVI)• Initiate a Quality Initiative program(BCBSM PVI)

• Create a multidisciplinary system peripheral VAT committee

• Develop multidisciplinary VTE initiative/PERT• Develop multidisciplinary VTE initiative/PERT

• CardioVASCULAR Medicine is a great job• CardioVASCULAR Medicine is a great job• Probably better than Cardiology alone• Provides opportunity for:

– Growth– Growth• Patients• Vascular Lab Volume• Interventional Volume• Interventional Volume

– Comprehensive care of the patient• Streamlining care• Improving outcomes of CV Death, amputation free survival• Improving outcomes of CV Death, amputation free survival

– Application of new imaging and technologies in patientcare

Benefits of Peripheral DiseaseManagementManagement

• Decrease in invasive surgical bypass by 45%• Decrease in invasive surgical bypass by 45%

• Reduction in lower limb amputations

– 9% fewer amputations (2005-2013)– 9% fewer amputations (2005-2013)

– 30% fewer major amputation (AKA, BKA)

• Lower all-cause mortality by 65% (HR 0.35,• Lower all-cause mortality by 65% (HR 0.35,p=0.02)

Due to medical therapy– Due to medical therapy

– Reducing MI, CVA, CV death

Pande RL et al. Circulation 2011;124:17-23

Durable Restoration of inflowDurable Restoration of inflow

TASC DTASC D

Bilat PTA – RCIA BES - short landing area, LCIA SES - ectasia

PTA: TASC A – It’s rarely this easyPTA: TASC A – It’s rarely this easy

• Short lesions

• Good runoff• Good runoff

• Vessel >4mm

• Nondiabetic

• Claudication• Claudication

Technical Success: 100%, Patency: 1yr 95%, 5yr 80%Technical Success: 100%, Patency: 1yr 95%, 5yr 80%

AdditionalCertificationsCertifications

• Venous Certification– Phlebology Boards

• Vascular Laboratory– RPVI (Registered Physician– Phlebology Boards

ABVLM

– 200 cases (PracticePathway)

– RPVI (Registered PhysicianVascular Interpretation)

– ARDMS Board exam– 200 cases (PracticePathway)

• Saphenous vein ablation

• Sclerotherapy, Phlebectomy

Compression tx CEAP C5-C6

– ARDMS Board exam

– Supervised interpretationof 500 studies (arterial andvenous)

• Compression tx CEAP C5-C6

• Management of deepdisease

– Thrombectomy

venous)

– COCATS II and III eligible

– Thrombectomy

– Thrombolysis

– IVC filter

– Venous stenting

Cutting Balloon then Drug Coated BalloonCutting Balloon then Drug Coated Balloon

Restenosis 6mo Recurrent Restenosis

Requires complex CTO wire escalation techniqueRequires complex CTO wire escalation technique

Plaque excision to avoid stenting of flexion point at knee

ATA Orbital Atherectomy with Emboshield DPATA Orbital Atherectomy with Emboshield DPToe Ulcer with 1v RO – PTA and peroneal occluded

ATA Orbital Atherectomy

Critical limb ischemia requires advanced technical expertise

Crosser Assisted Tibial Recanalization – toe ulcerCrosser Assisted Tibial Recanalization – toe ulcer

Crosser PTA Hibernating DPADistal ATAPeroneal A Crosser PTA Hibernating DPADistal ATAPeroneal A

Another example of advanced CTO revascularization

EKOS in Submassive PEIt’s all about the RVIt’s all about the RV

Fibrin SeparationUltrasound separates fibrin

without fragmentation of emboliwithout fragmentation of emboli

Cardiology and IR leading the charge

CDL with EKOS 8mg tPA over 2 hoursCDL with EKOS 8mg tPA over 2 hours

Baseline RV/LV 1.5 Post EKOS CDL RV/LV 0.8Baseline RV/LV 1.5 Post EKOS CDL RV/LV 0.8

ULTIMA and OPTALYSE Trials

Jaber et al. JACC. 2016; 67(8): 991-1002

Treatment StrategyTreatment Strategy

SMOKINGCESSATION EXERCISE

CILOSTAZOL

PROGRAMGOODFOOTCARE

ASO

CARE

Rx RISKFACTORS

EndovascularIntv First

ANTIPLATELETASA/PLAVIX

FACTORSLipids

HtnDiabetesIntv FirstASA/PLAVIX Diabetes

Balloon AloneBalloon AloneImproved flow to calcaneal branch PTA

Calcaneal UlcerCalcaneal Ulcer

PTA stenosisPTA stenosis Post PTAPost PTA

Calcaneal UlcerCalcaneal Ulcer

Fox Hollow AtherectomyFox Hollow AtherectomyHeel Ulcer served by calcaneal br of peroneal

PostPre PostPre

Short Infrapopliteal SegmentsShort Infrapopliteal Segments

Restenosis post FH atherectomyRestenosis post FH atherectomyRecurrent ischemic rest pain - 3 mo

Supported by:Supported by:

Scheinert et al., Eurointv 2005

10/5/2017 51

Cannulation CFV 24F Sheath Indications/BenefitsCannulation CFV 24F Sheath Indications/Benefits

• RV support after PEescalation strategiesescalation strategies

• Single Access site

• Up to 4 L/min flow

• CON: No oxygenation• CON: No oxygenationability

• Expensive• Expensive

• Unclear which PE patientsbenefitbenefit

Courtesy of ABIOMED