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
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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