4/30/2016

Charles B. Ross, M.D., F.A.C.S.

Chief, Vascular and Endovascular Services

Piedmont Heart Institute; Piedmont Atlanta Hospital

Atlanta, Georgia

Florida Vascular Society

2016 Annual Meeting

Orlando, Florida

Inclusion of Pulmonary Embolism ResponseIn a

Level I Vascular Emergency Program

FVS: PE 2016

Objectives

1. What is a Level I Vascular Emergency Program?How does PE fit in?

2. Management of Pulmonary Embolism has changed. What’s the rationale?3. How do we intervene for PE? 4. Process and outcomes of PE management in the Piedmont Level I program

FVS: PE 2016

Disclosures

Financial Conflicts: None

Competition of Interest: Clinical Trial Participation

OPTALYSE – PE EKOS – BTG Site Principal Investigator, Piedmont Heart Institute

Potential Mention of Devices Not In Possession of Specific PE Indication/Off-label Use- Inari Flowtriever- 8F Penumbra Indigo System- Angiodynamics AngioVac

Piedmont HealthcarePiedmont Heart InstitutePiedmont Atlanta HospitalPiedmont Healthcare

2015 Volume Indicators

455 beds50,211 ED visits1157 CV pump cases1543 PCI cath cases

116 TAVR43 VAD implants77 ECMO cases

160 kidney transplants90 liver transplants12 heart transplants

24/7/365 MD critical careEmory Gen Surg ResidentsMercer PA StudentsPA and Nursing Residents

slide 5

Geographic Reach

FY15 PHI Patient Origin (white to dark green 1- 3,000+ patients per zip code)

Piedmont Healthcare and PHI in particular have broad geographic reach with advanced services focused at Piedmont Atlanta

Affiliate Hospital Locations

Piedmont Atlanta with Advanced Heart and Vascular Services Including SurgeryPiedmont & Affiliate Hospitals Piedmont Heart ClinicsPiedmont Primary Care ClinicsPiedmont Specialty ClinicsPiedmont Transplant Clinics

Level I Vascular Emergency ProgramA natural evolution in emergency cardiovascular care

FVS: PE 2016

Level I Vascular Emergency Programs

Level I Vascular Emergency Programs

- Natural evolution in cardiovascular emergency care- vascular emergency care is process driven and time dependent- vascular emergency care is resource dependent

- logistical expertise (CARELINK Call Center)- professional expertise, capability, availability- advanced imaging (CTA, MRA ,ECHO, Vasc Lab and Operating Hybrids)- rapid, precise diagnosis and management- extensive, redundant inventory requirement- critical care required 24/7/365

- vascular emergency care may benefit from “economy of scale”

FVS: PE 2016

Level I Vascular Emergency Programs

- same logistics- similar processes of care- same physicians and teams- same care venues- same coordinator- same outreach and marketing

Acute Aortic Syndromes Acute Limb Ischemia Catastrophic VTE

Vascular Emergency Program

FVS: PE 2016

Level I Vascular Emergency Programs

Level I Vascular Emergency Programs

Drs. Mark Davies and Alan Lumsden – Methodist DeBakey, Houston, Texas- Acute Aortic Treatment Center- “Door to intervention time of 90 minutes”

Dr. Michael Dalsing at Indiana University - Methodist Hospital in Indianapolis 2009- model statewide referral system for vascular emergencies- Tera Recon system for transfer of imaging data prior to patient arrival- extended the AATC concept to all vascular emergencies

Piedmont Atlanta Hospital- program build-out: August 2012-June 2014- sites visits IU-Methodist; Mehta-Albany- program “live” July 2014- multidisciplinary- our program incorporates PE rapid response

INNOVATIONCare plans and transfer protocols

Remote image transmittalahead of the patientRapid definitive plan

Level I Vascular Emergency Program

M.D. Groups Impacted by the Level I Program

Cardiothoracic SurgeryVascular Surgery

CV Anesthesiology

CTS Critical Care

GLA Critical Care

Fuqua CV/Radiology Imaging

PHI Cardiology Critical Care

Emergency Department

Hospitalists

FVS: PE 2016

CTA-PE Protocol

CTA Large Thrombus Burden PE

Hemodynamically Unstable

Massive PE

Hemodynamically Stable

Submassive PE

Institute hemodynamic and respiratory

support

Check BNP and troponin

Evaluate echocardiogram

LE Venous Duplex to identify source

Immediate consultation through Carelink:

Cardiothoracic Surgery

Vascular Surgery

Shock Team

Vascular Surgery Consult

No

contraindications

to lytic therapy

Anticoagulation

Consider IVC Filter

Catheter-directed

thrombolysis

Consider IVC Filter

Contraindications

to lytic therapy

Piedmont Healthcare Clinical PathwayAcute Venous Thromboembolism: Large Thrombus Burden PE Treatment Pathway

(+) Right heart

dysfunction

(-) Right heart

dysfunction

Anticoagulation

Piedmont Heart Venous ProgramNovember 2013

*Clinical pathways and guidelines are evidence-based tools that have been developed by a multidisciplinary team to assist clinicians in making appropriate health care decisions. They are not intended to replace individual clinician’s judgment.

GLA Pulmonary Critical Care Consult

FVS: PE 2016

Level I Vascular Emergency Program

Level I Activity: July 2014 – March 2016

PE- Contributes 33% of Level I volume

Downstream intangibles…….- Maintains vascular surgical leadership

in major venous interventions- iliofemoral venous thrombosis- vena cava thrombosis- filter decision-making

- Maintains high-profile vascular visibilityin the critical care units

- Platform for collaboration

FVS: PE 2016

FVS: PE 2016

900,000 cases annually 7.9 – 39 billion dollars U.S. Healthcare Costs

Incidence 133/100,000 people/yr increases with age

PE - 3rd leading cause of cardiovascular mortalityLeading cause of preventable in-hospital death in the United States100,000 to 180,000 deaths/year 25-33% present as sudden death

4 % incidence of CTPH

DVT – at least 350,000 cases annually 29 – 79% Post-thrombotic Syndrome- develops slowly- progressively debilitating- 6 to 7 million patients today- 400,000 – 500,000 venous ulcers

All practicing physicians interface with patients with or at risk for VTE

Venous Thromboembolism – Scope of the problem

FVS: PE 2016

Venous Thromboembolism – Scope of the problem

VTE – PE- different population compared to traditional VS- unmet need for interventional care- incredibly rewarding

FVS: PE 2016

Level I Vascular Emergency Programs

PE and the evolution from relative noninterventional care to safe intervention ……

…… it’s all about the RV

…… it’s all about the RV

…… it’s all about the RV

Pulmonary Embolism – Pathophysiology

Thrombus travels from legs to the right heart and lungs

Acutely obstructs pulmonary arteriesIncreases PVR

Right ventricular strain and failure

Hypotension, HypoxemiaDecreased coronary artery

perfusion

Cardiac output/shock DEATH

FVS: PE 2016

1. Stratify Risk for Adverse Outcome- identify RV strain

2. Relieve PA Obstruction- facilitate rapid RV recovery- Possibly prevent late CTePH

FVS: PE 2016

PE Management 2016 and Beyond: In a nutshell

PE in 2016 (and beyond) : Focus on the Right Ventricle

Poor Outcome Associated with Right Ventricular Dysfunction

1. ICOPER Registry + RV hypokinesis 18% in-hospital mortality57% higher mortality at 3 months (compared to normal RV function)

2. RV:LV ratio > 0.9 by CTA independent risk factor for mortality3. Risk of mortality increases stepwise with increasing RV:LV ratio4. RV dysfunction increased risk of recurrent PE and death5. Elevated biomarkers risk factor for mortality

FVS: PE 2016

IntermediateRisk - 25 to 40%

HIGH5%

Low Risk55 to 70%

PE 2016: Risk Stratification and Management Implications

Standard VTE management

Paradigm Shiftfavoring

Intervention

FVS: PE 2016

Low Risk PE

55 to 70% of all PEsNo hypotension or hemodynamic instabilityNo evidence for right heart strainLess than 3% risk for 30 – and 90 – day PE related mortality

FVS: PE 2016

Intermediate Risk PE

25 to 40% of all PEs

No hypotension

RV dilatation on CT (RV:LV > than 0.9)

RV dysfunction on ECHOandNonspecific EKG changesElevated troponin and BNP

90-day PE related mortality – 3 to 21%

FVS: PE 2016

High Risk PE

5% of all PEs

+ hypotension

Syncope or cardiac arrestSBP < than 90 mmHG for more than 15 minutes

(or drop in SBP > 40 mmHg below patient’s normal BP)Requires vasopressor support to maintain an SBP > 90 mmHg

Instability is not due to cause other than PE

90-day PE related mortality – > 15% and up to 50%

FVS: PE 2016

Large Burden PE Clinical Continuum

Intermediate Risk High Risk

Normal BPRV:LV > 0.9Stable Patient

Hypotensive, DyingPatient

TachycardiaHypoxemia

ArrhythmiaAnxiousness

Pathophysiology: Acute right ventricular failure

elevated troponinelevated BNP

Miller score

FVS: PE 2016

FVS: PE 2016

PE Risk Stratification

1. Systemic Thrombolysis- (generally) safe and effective – reduces risk of death- concern for increased risk of major bleeding, including ICH- PEITHO trial (6.3% major bleeding; 2% hemorrhagic stroke)- Clinical practice 19% major bleeding comps and 5% risk of ICH

2. Transcatheter thrombus fragmentation/catheter-directed thrombolysis- PERFECT Trial

3. Surgical Pulmonary Thrombectomy (on cardiopulmonary bypass)- safe and effective with proper patient selection- lack of uniform availability- lack of agreement/decisiveness

- often used only if systemic thrombolysis failedor thrombolysis was contraindicated

- late decisions with sicker patients yield less favorable results- 10% mortality if unstable; 3.6% if stable

Traditional Methods to Rapidly Relieve the RV

FVS: PE 2016

Immediate availability in any cath lab environment

Delivery of thrombolytic agent directly into the pulmonary arterial bed and effective treatment with far lower doses than systemic thrombolysis

For mechanical devices, safe and efficient removal of pulmonary arterial thrombus

Rescue availability -Immediate availability to convert to extracorporeal life support

- Patient selection and early transfer remains very important for sicker patients

Interventional Techniques for PE Management - 2016 Ideal Principles

FVS: PE 2016

- Ultrasound-accelerated (assisted), catheter-directed thrombolysis- 6F system with catheters (5.4 F) placed in one or both pulmonary arteries- Dual sheath access in either the femoral or internal jugular veins- 12 to 24 hour infusion of TPA with patient in ICU- Well-tolerated; patient’s do not discern/feel treatment (stay in bed)

Infusion Catheter

Ultrasonic Core

Acoustic Pulse Thrombolysis: The EKOS System

FVS: PE 2016

APT: The EKOS System- Ultrasound-accelerated (assisted), catheter-directed thrombolysis- Delivers low doses of TPA directly to the thrombus- Employs ultrasound pressure waves to facilitate thrombolysis

- Produces disaggregation of fibrin and increases binding sites for TPA- Produces acoustic streaming which increases penetration of TPA

APT: Ultrasound-Accelerated, Catheter-Directed Thrombolysis

FVS: PE 2016

Evidence supporting APT for intermediate-risk and high-risk PE

1. Multiple single-center, case series 2008 – 2013- rapid reduction in pulmonary artery pressure and recovery of RV function- significant lysis with low-doses of TPA (12 to 40 mg total doses)- marked reduction in major bleeding complications and no ICH

2. ULTIMA Trial (European, multiple centers, 59 patients)- prospective, randomized trial comparing APT with standard anticoagulation- RV:LV ratio was significantly reduced with APT at 24 hours- RV systolic function was significantly better with APT at 24 hours and 90 days- no major bleeding complications or ICH

3. SEATTLE II Trial (22 US centers, 150 patients)- prospective single arm trial; primary endpoint RV:LV ratio at 48 hours- primary safety endpoint was absence of major bleeding complications- mean TPA dose was 23.4 +/- 2.9 mg- 25% reduction in RV:LV ratio at 24 hours- Significant reduction in PA pressures at end of treatment- no hemodynamic collapse, no intracranial hemorrhage, 10% bleeding comps

4. FDA Approval – EKOS approved for interventional management of PE – May 2014

FVS: PE 2016

1. Medical Stabilization (Georgia Lung Critical Care)2. Review of data and “agreement among doctors” to use APT 3. Consent from patient to treat invasively4. Cath Lab Procedure

- team briefing; checklist of emergency meds- ultrasound-guided dual femoral or jugular access- vena cavagram- selective pa catheterization- measure PAP, RVP, RAP- PA’gram (optional)- selective bilateral EKOS 106x12 pa catheter placement- secure the system

5. Transport to ICU6. Initiate Therapy (Most commonly 1 mg/lung/hour – 10 mg/lung)7. Follow clinical response and PA pressures

Intermediate Risk PE: Treatment Process at PAH

FVS: PE 2016

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2015 Piedmont Level I PE Experience

42 Level I Activations for Large Thrombus Burden PEs27 M:15F; mean age 57 , range 22-85 yrs

- 4 low-risk, managed medically- 28 submassive (No deaths)

- 6 managed medically- 22 managed by APT (No ICH; 1 major bleeding complication)

- 10 massive- 2 ECMO + APT (1 death – withdrawal of support)- 2 surgical thromboembolectomy on cardiopulmonary bypass- 5 APT with ECMO standby (1 major bleeding comp)- 1 CPR in-progress treated by systemic thrombolysis (death)

FVS: PE 2016

Level I Vascular Emergency Program

Vascular Emergency Contribution Margin ($)

PE – low risk (n=4)

PE – submassive (n=28) 5.4%

PE – massive (n=10)

Aortic Dissection (n=32) 60%

Aortic Aneurysm (n=26) 28.6%

Acute Limb Ischemia (n=14) 2.6%

Other Vasc. Emergency (n=6) 3.3%

Total for all cases (n=120) 100%

Program Contribution Margin 2015

FVS: 2016

Level I Vascular Emergency Programs

Conclusions1. Safe PE intervention may provide short and long-term benefit

for patients with intermediate and high risk PE- unload the RV for better short and long-term outcomes

2. PE Rapid Response is a good fit in a Vascular Emergency Program3. PE intervention represents an opportunity for vascular surgeons

- VTE service-line opportunity (growth or defensive)- perfect opportunity to participate in collaborative care

FVS: 2016

Level I Vascular Emergency Programs

END