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Heartwise 2014 Remembering the ‘Vascular’ in Cardiovascular April 11th, 2014 Todd Wood, MD RPVI Interventional Cardiology Vascular & Endovascular Medicine The Heart Group of Lancaster General Health Objective At the conclusion of this presentation, participants should be able to: 1) Understand the impact of peripheral vascular disease on overall cardiovascular risk. 2) Identify the roles of screening and surveillance studies in identifying and monitoring PAD. 3) Gain an awareness of the therapeutic options available for symptomatic claudication. Disclosures I have no conflict of interest disclosures as pertaining to this talk Off label use of some medical devices will be discussed in the course of this talk

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Heartwise 2014

Remembering the ‘Vascular’ in Cardiovascular

!April 11th, 2014

!

Todd Wood, MD RPVI Interventional Cardiology

Vascular & Endovascular Medicine The Heart Group of Lancaster General Health

Objective

At the conclusion of this presentation, participants should be able to: !1) Understand the impact of peripheral vascular disease on overall cardiovascular risk.!2) Identify the roles of screening and surveillance studies in identifying and monitoring PAD.!3) Gain an awareness of the therapeutic options available for symptomatic claudication.

Disclosures

• I have no conflict of interest disclosures as pertaining to this talk

• Off label use of some medical devices will be discussed in the course of this talk

Disclosures Part II - About the Speaker

• vascular disease management continues to have extensive heterogeneity by specialty, training, and experience; my perspective comes from the following:

• Internal Medicine residency / board certified

• Cardiovascular Disease fellowship / board certified

• Interventional Cardiology fellowship / board certified

• Vascular Medicine / Endovascular Medicine fellowship / board certified

• Non-Invasive Vascular Ultrasound board certified

What is Vascular Disease?

• Vascular disease is NOT just blockages in the leg arteries

• Vascular disease incorporates both arterial and venous disease process

• It is most often a part of a systemic process and as such is a marker of the global health and risk for an individual

What is Vascular Disease?

Vascular Disease

• Arterial - occlusive

• Cerebrovascular

• Upper extremities

• Renovascular

• Mesenteric

• Aorto-iliac

• Lower Extremities

!

!

• Arterial - aneurysm

• Thoracic Aortic Aneurysm

• Abdominal Ao Aneurysm

• Cerebrovascular

• Visceral

• Lower Extremity

!

• Venous

• Venous Insufficiency

• DVT

• Pulmonary Embolism

Processes Behind Vascular Disease• Atherosclerosis

• Giant Cell Arteritis

• Takayasu Arteritis

• Kawasaki’s Disease

• Cogan Syndrome

• Polyarteritis Nodosa

• Microscopic polyarteritis Nodosa

• Thromboangitis Obliterans

• Wegner’s

• Marfan’s Syndrome

• Ehler’s Danlos Syndrome Type IV

• Fibromuscular Dysplasia

• Raynaud’s Disease

• Scleroderma

• Lupus

• May-Thurner Syndrome

• Hypercoaguable Conditions & States

• Antithrombin III Def.

• Factor V Leiden

• Lupus Anticoagulant

• Protein C Deficiency

• Protein S Deficiency

• Prothrombin Gene Mutation

• Requires addressing the full spectrum of PVD management:

• Prevention

• Detection / Diagnosis

• Medical Management / Lifestyle Modification

• Intervention (endovascular and surgical)

• Post-intervention surveillance and risk factor modification

Modern Vascular Medicine

Modern Vascular Medicine• Accomplishing this requires

• identifying at risk populations and providing screening where appropriate

• clinically diagnosing and utilizing appropriate diagnostic tools in suspected vascular disease

• providing the full Inpatient and Outpatient spectrum care

• Continuity of care before, during, and after any indicated interventions

• having an accredited Non-Invasive Lab

• actively addressing/treating underlying risk factors and disease processes throughout this entire process

Disease management beyond just procedures

Peripheral Arterial Disease (PAD)

PAD• Under-recognized

• Under-treated

• Under-appreciated

!

• Partly due to disjointed care:

•Primary Doctor •Cardiology •Vascular Surgery •Interventional Radiology

•Podiatry •Endocrinology •Cardiothoracic Surgery •Plastic Surgery •Wound care center

doi:10.1016/j.jacc.2012.02.009 published online Jun 11, 2012; J. Am. Coll. Cardiol.

Jeffrey W. Olin, and R. Eugene Zierler Emile R. Mohler, III, Heather L. Gornik, Marie Gerhard-Herman, Sanjay Misra,

Society for Cardiovascular Magnetic Resonance, Society for Vascular Ultrasound, American Podiatric Medical Association, Society for Clinical Vascular Surgery,

Medicine, Society for Vascular Surgery, American Academy of Neurology, Computed Tomography, Society for Interventional Radiology, Society for Vascular

Cardiovascular Angiography and Interventions, Society of Cardiovascular forIntersocietal Commission for the Accreditation of Vascular Laboratories, Society

American Society of Echocardiography, American Society of Nephrology,American College of Radiology, American Institute of Ultrasound in Medicine,

American College of Cardiology Foundation Appropriate Use Criteria Task Force, Physiological Testing Part I: Arterial Ultrasound and Physiological Testing

Appropriate Use Criteria for Peripheral Vascular Ultrasound and ACCF/ACR/AIUM/ASE/ASN/ICAVL/SCAI/SCCT/SIR/SVM/SVS 2012

This information is current as of June 15, 2012

http://content.onlinejacc.org/cgi/content/full/j.jacc.2012.02.009v1located on the World Wide Web at:

The online version of this article, along with updated information and services, is

by on June 15, 2012 content.onlinejacc.orgDownloaded from

• Partly due to top down Medicare edicts:

AUC Guidelines AAA Screening 1. M >60 w/ a 1st degree relative with AAA 2. F >60 w/ a 1st degree relative with AAA 3. M >65 current or former smoker 4. F >65 current or former smoker !Medicare Reimburseable Screening 1. M 65-75 w/ a 1st degree relative with AAA 2. M 65-75 current or former smoker !NO OTHER PAD SCREENING COVERED BY MEDICARE

• Partly due to top down Medicare edicts:

Clinical Impact of PAD

5 Year Mortality by Diagnosis

Armstrong DG, Int Wound J, 2007; 4(4) 287-288.

TextText

Pts with PAD have a higher mortality than with a diagnosis of CAD!

PAD: A Disease Process Requiring More Than Just Revascularization

Steg G et.al., JAMA. 2007;297(11):1197-1206

Identifying the At-Risk Population

RF’s for PAD

• Tobacco abuse

• Smoking increases the risk for PAD by 2 - 25 times, with a possible higher potentiation of the risk in the presence of other risk factors.

• Between 80 - 90% of patients with PAD are current or former smokers.

• Progression is more likely for patients who continue to smoke

RF’s for PAD

• Diabetes

• T2DM increases the risk for PAD by 3-4 times

• T2DM leads to an earlier average age of development and higher classification severity of symptoms.

• Poor glycemic control increases likelihood of progression

T2DM Tsunami• Diabetes

• 25.8 million Americans with diabetes (11.3% of population greater than 20 years old and 26.9% of the population over 65 years old)

• Estimation that over 1/3 of the population will be diabetic by 2050 (prevalence increased 128% from 1988-2008)

• 60% of non-traumatic limb amputations are associated with diabetes (65,700 annually)

• Clinician familiarity with PAD will be an absolute necessity

RF’s for PAD• Cholesterol

• Risk of PAD increases 5-10% for every 10mg/dL increase in LDL

• HDL <40 has independent increase in risk of PAD

• elevated TG has independent increase in risk of PAD

• HTN

• in presence of other RF’s; HTN further increases risk of PAD

RF’s for PAD

• References:

• Aboyans V, Criqui MH, Denenberg JO, Knoke JD, Ridker PM, Fronek A. Risk factors for progression of peripheral arterial disease in large and small vessels. Circulation. 2006 Jun 6;113(22):2623-9.

• Aung PP, Maxwell HG, Jepson RG, Price JF, Leng GC. Lipid-lowering for peripheral arterial disease of the lower limb. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000123.

• Steg PG, Bhatt DL, Wilson PWF, D’Agostino R, Ohman EM, Rother, J. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. Mar 21 2007;29(11)7:1197-1206.

• American Diabetes Association; 2013 Fast Facts Sheet

Diagnosis and Management

Primary Care & PAD• Opportunities for Care

• “Welcome to Medicare”

• Previously only time CMS allows for screening for AAA in appropriate demographics

• NEW as of January 2014 - CMS now allows screening at any visit in appropriate demographics

• Test for symptoms or exam findings... or refer for testing

• ultrasound for bruits or pulsatile abdominal mass

• rest and exercise ABI for claudication

• Making the diagnosis is the first step: RF modification, symptom treatment, revascularization when appropriate

Diagnosis Pearls• New Dx PAD

• localizing claudication symptoms by history

• Buttock/Hips - Pelvic inflow/Hypogastric

• Isolated Thigh - profunda +/- inflow

• Calves - inflow, SFA, pop/infrapop

• Physical Exam

• Bruits

• diminished Pulses

• BP differential between extremities

• Critical Limb Ischemia - dependent rubor / elevation pallor

• physiologic studies to make the diagnosis - CANNOT USE THESE TO “SCREEN” PATIENTS; NEED A CLINICAL OR PE FINDING

• imaging studies to localize disease (CTA better for pelvis, duplex better with calcified vessels and infrapopliteal vessels)

• When unclear - physiologic testing

• rest and stress ABI/PVR

• ABI = ankle brachial index, simultaneous BP cuff measurements demonstrating any drop-off in BP using the higher brachial pressure as a ‘normal control’

• PVR = pulse volume recording, the volume of blood flow with each pulse wave will change in pattern and amplitude if there is a blockage impeding flow

• Abnormal = low ABI at rest, drop in ABI with exercise, nl ABI but blunted PVR waveforms throughout suggesting inflow disease (can be symptomatic despite a normal ABI)

• Anatomic Identification of the problem

• arterial duplex ultrasound - no radiation; better in calcified vessels and infrapopliteal distribution

• CTA - better at aorto/iliac distribution, cannot discern Ca++ from contrast well

• Angiogram - gold standard but invasive with <0.5% procedural risk

Diagnostic Testing

Treating the whole disease process

• Risk Factor Modification / Lifestyle change

• tobacco cessation

• DM control

• statin / lipid control (LDL<100, possibly <70)1

• HTN: ACE/ARB (ramapril most studied; improved walking times)2

• ASA or Plavix 3

• WALK, WALK, WALK - unsupervised hasn’t shown efficacy but CMS doesn’t reimburse for PAD rehab despite consistent demonstration of efficacy of supervised programs4,5

!1. Aung PP, Maxwell HG, Jepson RG, Price JF, Leng GC. Lipid-lowering for peripheral arterial disease of the lower limb. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000123

2. Ahimastos AA, et. al. Effect of ramipril on walking times and quality of life among patients with peripheral artery disease and intermittent claudication: a randomized controlled trial.JAMA. 2013 Feb 6;309(5):453-60. doi: 10.1001/jama.2012.216237.

3. Kikano GE, Brown MT. Antiplatelet therapy for atherothrombotic disease: an update for the primary care physician. Mayo Clin Proc. 2007 May;82(5):583-93

4. Stewart KJ, Hiatt WR, Regensteiner JG, Hirsch AT. Exercise training for claudication. N Engl J Med. 2002;347:1941–1951.

5. Leng GC, Fowler B, Ernst E. Exercise for intermittent claudication. Cochrane Database Syst Rev. 2000:CD000990.

Routine Surveillance Studies

• Lower Extrem

• initial diagnostic studies in making diagnosis/determining therapy

• no role for routine f/u studies unless clinical change or pt underwent revasc.

Routine Surveilance Studies• AAA

• routine studies indicated to follow size and determine rate of growth if initial study didn’t meet size criteria for repair

• first two studies 6 mos apart

• subsequent studies based on size/rate of expansion

• M 5.5cm, F 5.0cm, or >0.5cm/year expansion = criteria for repair

• How might we help you with this? Vascular Health Pathway AAA Protocol

Routine Surveilance Studies• Carotid

• routine studies indicated to follow percentage stenosis if there is at least moderate narrowing on initial study

• initial study <50% stenosis - no repeat required

• 50-69% (or 50-79% depending on reporting system used) - repeat 6-12 months

• 70-99% (80-99%) - referral for revasc., if declining revasc. repeat studies may be indicated but should not be routinely ordered

• How might we help you with this? Vascular Health Pathway Carotid Protocol

Treating the whole disease process - Lower Extremity PAD

• Rx for symptoms

• Cilostazol - contraindicated if concomitant CHF; start 50mg twice daily, maximum 100mg twice daily; warn patients not to expect a symptomatic effect for weeks.

• ACE Inhibitor

• Revascularization

• endovascular

• surgical

• Surveilance (lesion specific modalities)

• Wound Management

• wound care centers

• debridement

• hyperbaric O2

• amputation: limit the extent as much as possible

Revascularization

Endovascular Interventions

• Carotid Artery Stenting

• proximal and distal protection options

• Endovascular AAA Repair

• Renal Artery Stenting

• Mesenteric Artery Stenting

• Aortic Stenting

• Subclavian Artery Stenting

• Iliac / SFA stenting

• CTO Devices

• Plaque Excision Atherectomy

• Drug Coated Balloons

• Bioabsorbable Stents

• Laser Atherectomy

• Orbital Atherectomy

• IVC Filter placement/retreival

• Arterial Thrombectomy (graft & native vessels)

• DVT Thrombectomy / Venous Stenting

• PE lysis

Lower Extremity Endovascular Revasc.

Endovascular Interventions in PAD/Critical Limb Ischemia (CLI)• Endovascular = less invasive

• Veins - the precious commodity

• pts usually also have CAD, prior/future bypass

• even vein grafts don’t last forever

• limited total natural conduit available

• Angiosome Concept - need in line flow to a non-healing wound, indirect bypass to a different artery isn’t as effective

!

• Endovascular: Is it the new 1st line therapy?

CLI• rest claudication

• non healing wounds (sometimes - not all ulcers are ischemic)

• arterial ulcer

• venous ulcer

• neurotrophic ulcer

• Elevation pallor, dependent rubor

• Often correlates to an ABI of 0.3 or less

UlcersCA

B

CLI• When suspected in a patient without known PAD,

resting ABI’s sufficient in making diagnosis

• ABI/TBI has to be severely depressed to lead to necrosis

• Wound management critical, but may therapies (like abx) plus the immune system, has difficulty in achieving tissue penetration due to lack of perfusion

• Expeditious evaluation for revascularization is indicated

• anatomic imaging study

• endovascular or surgical revascularization

CLI One Year Outcomes• 25% CLI resolves

• 25% unchanged

• 25% are dead

• 25% have undergone amputation

• following amputation:

• periop mortality 5-10% BKA, 10-15% AKA

• periop morbidity 20-30%

• 1 year mortality up to 45%

• 2nd amputation required in 30%

• full mobility achieved in only 50% of BKA and 25% of AKA patients

1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33(suppl 1):S1-S75.!2. Allie DE, Hebert CJ, Lirtzman MD, et al. Critical limb ischemia: a global epidemic. A critical analysis of current treatment unmasks the clinical and economic costs of CLI. EuroIntervention. 2005;1:75-84 3. Ouriel K. Peripheral arterial disease. Lancet. 2001;358:1257-1264. 4. Second European consensus document on chronic critical leg ischemia. Circulation. 1991;84:(4 suppl):1-26.

Amputation vs. Revascularization - Current State of Affairs

• Cost Effectiveness Analysis of US Medicare patients revealed

• 67% of CLI pts underwent primary amputation as first line therapy

• 23% underwent surgical revasc.

• 10% underwent endovascular revasc.

• 80% of wound complications, strokes, MI’s occurred in the amputation population

• Separate revascularization studies have shown a 34% absolute increase in 5 year survival over primary amputation

• primary amputation was 3x more costly than surgical revasc.

• endovascular intervention further reduced cost 30-50% in terms of procedural cost and cost per leg-year saved

.1. Allie DE, Hebert CJ, Lirtzman MD, et al. Critical limb ischemia: a global epidemic. A critical analysis of current treatment unmasks the clinical and economic costs of CLI. EuroIntervention. 2005;1:75-84. .2. Kalra M, Gloviczki P, Bower TC, et al. Limb salvage after successful pedal bypass grafting is associated with improved long term survival. J Vasc Surg. 2001;33:6-16. .3. Panayiotopoulos YP, Tyrrell MR, Arnold FJ, et al. Results and cost analysis of distal [crural/pedal] arterial revascularisation for limb salvage in diabetic and non-diabetic patients. Diabet Med.

1997;14:214-220. .4. Hunink MG, Cullen KA, Donaldson MC. Hospital costs of revascularization procedures for femoropopliteal arterial disease. J Vasc Surg. 1994;19:632-641. .5. Jansen RM, de Vries SO, Cullen KA, et al. Cost-identification analysis of revascularization procedures on patients with peripheral arterial occlusive disease. J Vasc Surg. 1998;28:617-623. .6. Laurila J, Brommels M, Standertskjold-Nordenstam CG, et al. Cost-effectiveness of percutaneous transluminal angioplasty (PTA) versus vascular surgery in limb-threatening ischaemia. Int J Angiol.

2000;9:214-219.

Angiosome Concept

• Previous approaches to revascularization was to get blood flow to the foot “any way possible” and let the foot collaterals take over

• path of least resistance for endovascular

• “juiciest target” for a bypass graft

• Angiosome concept is that direct in-line flow to the area of the wound/necrosis is more likely to heal the wound; revascularization should not be defined by most receptive anatomy but most direct blood flow

CLI Revasc.• different goals compared with revascularization

in the stable claudicant population

• importance is to heal the wound or limit the degree of amputation

• long term patency of the procedure is a secondary goal for treatment of their concomitant claudication

• In this regard, CLI revascularization choices are more influenced by risk/morbidity of procedure and possibly the ability to achieve direct in-line flow and less by long term patency rates.

RESERVED FOR IMAGES OF CLI CASE

Stable Claudicant Revasc.

• Revasc. does not impact mortality

• Goal is improved quality of life and ability to perform ADL’s & reduce/prevent disability

• Patency becomes a more central concern weighted against risk of procedures

The Tools• Surgical bypass

• in situ vein

• harvested vein

• endograft

• Surgical endarterectomy

• angioplasty

• stent

• covered

• self-expanding

• balloon expandable

• drug coated balloons

• drug coated stents

• directional atherectomy (scraping plaque)

• rotational/orbital atherectomy (drilling/sanding plaque)

• laser atherectomy

• bioabsorbable stents

Lower Extremity Intervention

Non-Stent Techniques

Plaque Excision Atherectomy•Frequently used CFA, Profunda, Pop (flexion points) where we want a stand alone result •Done with distal embolic protection

Laser Atherectomy•Debulking in-stent restenosis •standalone therapy for infrapopliteal vessels •thrombectomy device

Laser Atherectomy

Orbital Atherectomy•Debulking heavily calcified vessels for better stent apposition •standalone therapy for short segment SFA/Pop or infrapop •Done with distal embolic protection

Orbital Atherectomy

Non-Stent technique PLUS

• Debulking with an atherectomy device expands lumen capacity

• Stents can prevent elastic recoil, but like we learned in coronaries, intimal hyperplasia causes restenosis

• Drug coated stents, Drug coated balloons, biodegradable stents are all trying to address this with favorable early results but in need of more robust studies in real world patient populations.

Revascularization: What is the Best Tool for the Job

Revascularization by Arterial Bed

• Common and External Iliac Arteries

• Stenting - now largely first line therapy

• 1 year patency routinely 93-98% depending on study; 5y over 80% in the Bravissimo study of TASC A-D lesions (all complexities)

• much lower risk than Aorto-femoral bypass - now more reserved for CTO’s that cannot be crossed or unsalvageable restenosis after stenting

Revascularization by Arterial Bed

• Common Femoral Artery

• CFA Endarterectomy remains gold standard

• highly effective; short LOS; risk of groin infection; usually done under general anesthesia but spinal as well

• Stenting is not an option - flexion point, needed as an access point for catheterization/angiography, stent would “jail” the profunda

• Atherectomy - less invasive for higher risk patients but patency hasn’t held up as well when used as stand alone therapy in the CFA

• Studies now being performed using atherectomy followed by drug coated balloons (paclitaxel)

Revascularization by Arterial Bed• Superficial Femoral Artery

• Bypass

• Patency tied to conduit and touchdown (the more proximal the distal anastamosis and the more natural the conduit, the better the patency)

• Fem-above knee pop: Vein 1 Y primary patency 84%, 4 Y 69%; Endograft 1 Y 79%; 4 Y 60%

• Fem - below knee: Vein 1 Y prim pat 77%, 4Y 62%; Endo 1Y Secondary patency 68%, 4Y 40% (primary patecy as low as 12%)

• limited amount of vein conduit, especially considering many will have had or will need CABG

• longer hospitalization and more morbidity / mortality to procedure

Revascularization by Arterial Bed• Superficial Femoral Artery

• Stenting

• number of studies showing one year patency rates around 70-80%

• most studies done in shorter lesion lengths (<10 cm)

• 1 year primary patency in >10cm closer to 70%

• covered stents show patency irrespective of length but had more edge re-narrowing

• drug coated stents show 1 Y primary patency of 90%, 2 Y 83%

• same day discharge; limited morbidity,; DAPT for 1 month (bare metal), 2 months (drug coated), or one year (covered stents)

• when placed selectively they do not preclude future bypass and restenosis can often be addressed by re-intervention

Revascularization by Arterial Bed

• Superficial Femoral Artery

• Atherectomy

• Definitive LE showed 1 Y patency similar to stents in lesions <10 and >10 cm

• Studies now being performed using atherectomy followed by drug coated balloons (paclitaxel) Definitive AR

• Similar studies being performed for orbital and rotational atherectomy followed by DCB’s

• Bioabsorbable Stents

• strut support there initially to prevent elastic recoil but then resorbs over 4-6 wks - Will it translate into lower restenosis??? multiple trials ongoing

Revascularization by Arterial Bed

• Popliteal Artery

• No Good Solution!!!

• bypass - patency rates drop as we enter infrapopliteal distribution

• stents - lots of mechanical forces of torque and flexion; several stents with adequate radial strength to not fracture but restenosis rates appear to be higher; stent then may limit bypass anastamosis sites

• atherectomy - no dedicated trials for this bed; used by self or with DCB; does not eliminate other options by not eliminating anastamosis sites

• DCB angioplasty - no trials, used due to low risk and no burnt bridges

Revascularization by Arterial Bed

• tibial arteries

• No Good Solution!!!

• bypass - patency rates drop as we enter infrapopliteal distribution

• stents - coronary stents can be used in first 1/3 of tibias; crushed lower than that

• atherectomy - poor patency as standalone; now trials with DCB ongoing

• DCB angioplasty - best endovascular solution to date but studies still are gauging success by 6 month patency rates - 65%

Revascularization by Arterial Bed

• General Mantra - the bigger the arteries, the better the patency

• There should be no hesitation in treating inflow disease (iliac through CFA)

• There are growing options but no clear winner for SFA disease; a tailored approach is indicated for the claudicant who has failed medical therapy

• pop/infrapopliteal disease likely remains best managed conservatively unless CLI develops

Post Intervention Management

• Regardless of bypass or stents, close f/u required

• BLE Arterial Duplex in f/u after interventions

• For BMS or non-stent technique interventions: @ 1 month, Q6 mos. thereafter

• For Grafts and Covered Stents: @ 1mo. 4mos, 8mos, 12mos, Q6mos. thereafter

• Early reintervention on endograft bypass or covered (Gore Viabahn) for restenosis to prevent thrombosis

How are we addressing these complex patients?

• LGH forming multi-disciplinary vascular clinic - likely open before year is out.

• Vascular sugery, interventional radiology, vascular medicine, interventional cardiology, cardiology risk factor clinic, non-invasive vascular imaging… all in one office

• Cohesive multi-disciplinary efforts are the future of this field

Venous Thrombo-Embolic (VTE) Disease

PE• Massive PE: pt is hypotensive and hypoxic

• Give systemic lytics

• Minor PE: small subsegmental branch with no evidence of intolerance

• Anticoagulate

!

• Submassive PE - BP stable but RV stain by echo and positive BNP/CE’s

• ??????????

An echocardiographic RV/LV ratio > 0.9 was shown to be an independent predictive factor for hospital mortality.

Fremont B, Pacouret G, Jacobi D. CHEST 2008;133:358-362

Mortality rate: 1.9% if RV/LV ratio < 0.9

6.6% if RV/LV ratio ≥ 0.9

Mortality risk increases 11-fold for PE patients with an obstructive index > 40% amongst pts treated solely with

anticoagulant therapy Van der Meer R, Pattynama P, Van Strijen M, Van den Berg-Huijsmans A, Hartmann I, Putter H, De Roos A, Husman M, Radiology 2005; 235: 798-803

At 3 months: !PE-related mortality

!17% if RV/LV ≥ 1.5 !8% if 1.0 ≤ RV/LV < 1.5

!0% if RV/LV < 1.0

!11.2-fold increased risk with an obstruction index of 40% or greater

Right-ventricular hypokinesis on baseline echo was associated with ~40% higher mortality rate at 3 months.

Goldhaber S, Visani L, DeRosa M. The Lancet; Apr 24,1999; 353,9162; Health Module pg. 1386

15% no RV hypokinesis

21% with RV hypokinesisMortality rate:

Right-ventricular hypokinesis on baseline echo was associated with ~40% higher mortality rate at 3 months.

Goldhaber S, Visani L, DeRosa M. The Lancet; Apr 24,1999; 353,9162; Health Module pg. 1386

PE patients with Right Ventricle Dysfunction (RVD) unresolved prior to discharge were 8-times more likely to have a recurrent PE and suffered more than 4-times the mortality rate than patients whose

RVD was resolved Grifoni S, Vanni S, Magazzini S, et al. Arch Intern Med 2006; 166:2151-2156

Mortality rate at 4 years: !10.2% if RVD unresolved at discharge

!2.3% if RVD resolved at discharge

44% of PE patients with right heart dysfunction at time of diagnosis had chronic pulmonary hypertension at 1-year

follow-up. Ribeiro A, Lindmarker P, Johnsson H, et al. Circ 1999;99:1352-1330

If PAP(systolic) > 50mmHg at diagnosis: !

! 44% of PE patients with RVD had pulmonary hypertension at 1-year follow-up

! Risk for persistent pulmonary hypertension increases 3X

Patients treated with IV thrombolytics had lower PA pressures and pulmonary vascular resistance than PE patients

treated with heparin Sharma G, Folland E, McIntyre K, et al. Vascular Medicine 2000; 5:91-95

Key findings: ! Short-term f/u: Lytic group showed reduction of PAP and PVR at

rest, but heparin group did not ! Long-term f/u (mean 7.4 years), during exercise the lytic group did

not show changes in PAP and PVR, but the heparin group showed increased measurements

PE Interventions•for submassive PE, improved RV function which has good prognostic significance for short and longterm mortality as well as chronic pHTN

92% pre-Tx RV/LV ratios

were > 1.0

PE Interventions•for submassive PE, improved RV function which has good prognostic significance for short and longterm mortality as well as chronic pHTN

58% of post Tx RV/LV ratios were ≤ 1.0

RESERVED FOR LATE BREAKING RESULTS

SEATTLE PE STUDY

How are we addressing these massive/sub-massive PE patients?• LGH forming Pulmonary Embolus Response

Team. (Target start date is currently 7/1/14)

• Pulmonary coordinates / primary responder

• rapid CT/echo services

• CT Surgery / invasive angiographers (IR,IC) available to perform range of therapies

• ECMO, surgical embolectomy, large bore mechanical aspiration, pharmacomechanical lysis, etc.

• Modeled after similar efforts at Mass General

Summary• PAD

• underdiagnosed

• RF management should be a priority

• Best tool depends on the distribution

• increasing range of therapeutic options are allowing less invasive initial approaches while preserving/extending surgical options

• Non-stent therapies may be the future

• DVT and PE

• endovascular intervention can reduce morbidity without the cost of big bleeding risks

Thank You!