management of intermediate high-risk pulmonary …...congestive heart failure, and chronic pulmonary...
TRANSCRIPT
8/2/2019
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MANAGEMENT OF INTERMEDIATE &
HIGH-RISK PULMONARY EMBOLUS: THE UVA EXPERIENCE
Department of Medicine Grand RoundsAugust 2, 2019
Andrew D. Mihalek, MDAssistant Professor of Medicine
Division of Pulmonary & CC Medicine
Aditya Sharma, MDAssociate Professor of Medicine
Division of Cardiovascular Medicine
Financial Disclosure(s)
Dr. Andrew Mihalek participates in industry-sponsored clinical trials
Complexa, Inc
Corvia Medical, Inc
United Therapeutics
(None of these hold relevance to today’s conversation)
Dr. Aditya Sharma participates in industry-sponsored medical device trials
Portola, Inc
Vascular Medcure, Inc
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Session Objectives
Distinguish high-risk pulmonary embolus from intermediate-risk and low-risk pulmonary embolus
Review various treatment options for high and intermediate-high risk pulmonary embolus
Review, discuss, and dissect in-house data generated from the initiation of the Pulmonary Embolism Response Team at UVA
Our Personal Disclosures
Cardiovascular Disease Emergency Medicine
Pulmonary & CCMInterventional Radiology
Cardiovascular Surgery
PharmacologyHematology
Diagnostic Radiology
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Clot Propagation Equates to Propagation of Fear
“Clot Burden” Not Supported by Real World Clinical Experience
Jain et al. Am J Cardiol. 2017: Nonsaddle PE more likely to present with hypotension (46% vs. 33%, p = 0.02)
Nonsaddle had a higher 90 day mortality (26% vs. 13%, p = 0.02)
Conclusion: “Clot location not associated with patient outcomes”
Alkinj et al. Mayo Clin Proc. 2017: Saddle PE more likely to present with hypotension (31% vs. 21%, p = 0.01)
No difference in length of stay (5 vs. 4 days, p = 0.09)
No difference in hospital mortality (4 vs. 5 %, p = 0.81)
Conclusion: “No difference in short term outcomes”
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PE Risk Stratification
ESC/ERS Consensus. European Heart J 2014
2014 ESC PE Risk Stratification Guidelines
ESC/ERS Consensus. European Heart J 2014
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Techniques for PE Risk Stratification
Jaff et al. Circ 2011Quiroz et al. Circ 2004
“Massive” PE “Submassive” PE “Minor” PE
• Sustained Hypotension• Systolic BP < 90mmHg• 40mm Hg from baseline
• Inotropic Support
• Pulselessness
• Bradycardia• HR < 40bpm
• Normotensive
• Right Ventricle Dysfunction
• Myocardial Necrosis
• Normotensive
• No RV Dysfunction
• No myocardial necrosis
High-Risk PE Intermediate-Risk PE Low-RiskPE
Do Intermediate-Risk Patients Warrant Aggressive Care?
Konstantinides et al. NEJM. 2002Meyer et al. NEJM. 2014
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Are There Better Treatment Options for Intermediate-Risk Patients?
Diversity of Therapeutic Options for Pulmonary Embolus in 2019
Intermediate Risk
Pulmonary Embolism
IVC Filter
Systemic Lysis
Catheter-Directed
lysis
Mechanical Thrombectomy
ECMO
Surgical Therapies
• No clear recommendations from professional groups
• No strong RCTs
• High mortality in this group despite anticoagulation
• Complex clinical scenarios
Real-Life Conundrums
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Mission for PE Response Team program
Improve mortality and morbidity associated with intermediate and high-risk PE
Provide “state of the art” care utilizing multidisciplinary team approach in a rapid fashion
Rapid Response Team
(STEMI)
Multidisciplinary approach (Tumor board)
PERT
Who do you need in a PE Response Team?
CORE CLINICAL GROUP
Urgent evaluation: 24 / 7 x 365 days
Potential Benefits: Rapid multi-disciplinary medical decision making in complex scenarios in light of limited robust data and vague guideline recommendations Increase possibility of hybrid process requiring multidisciplinary team approach Increases accountability among specialties
Medical teamVascular MedicineCardiology
Pulmonary Critical Care
Interventional teamInterventional cardiologyInterventional radiology
Vascular surgery
Surgical teamCardiothoracic surgery
Vascular surgery.
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PERT team: It Takes a Village to Treat a PE Patient
PERTCore clinical group
1. Medical Team
2. Interventional Team
3. Surgical Team
Clinical Members
Direct Patient Care
1. Emergency Medicine
2. Internal Medicine3. Pharmacy
4. Hematology
5. Nursing
Monitoring
1. QI Management
2. Research & Outcomes
3. Safety Reporting
A champion invested in PERT in each group is vital
Acute Massive or Submassive Patient in the Emergency Department, on Inpatient Service, or in Intensive Care
Acute PE ALERT Activation
x42012
PE ALERT Evaluation by On‐Call Physician
Multidisciplinary Conference
Discussion and Consensus
Vascular Medicine
Interventional Radiology
PulmonaryCritical Care
Echocardiography
Cardiothoracic Surgery
Cardiology
Options and Recommendations Presented to the Patient, Family, and Care Team
ACTION
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ICU available with systemic lysis
No interventional or surgical programs
Academic Tertiary Center with all members of the PE Response Team
PERT Center of ExcellenceAll clinical teams with 24 x 7 coverage with all procedures available as well as research and quality improvement programs IVC filter
Catheter directed therapySurgical embolectomy
ICU available with systemic lysis and catheter directed therapies
No surgical programs or advanced mechanical thrombectomy procedures
Mechanical thrombectomySurgical embolectomy
High Risk PECardiac ArrestIntermediate
Risk PE
Intermediate Risk PE
Low Risk PE
Systemic Lysisor
ECMO orRV Assist Device
Contraindicationto Systemic Lysis
Systemic Lysis
Surgical Thrombectomy
Catheter Directed Therapy +/- ECMO
Vs.Anticoagulation Alone
Anti-Coagulation +/-IVC Filter
Catheter Directed Lysis
Contra-Indications to Catheter
Directed Therapy
Intermediate-High
Risk PE
Acute PE
Surgical Candidate
YES
YES NO
NO
YES NO
YES NO
YES NO
Anticoagulation
Intermediate-Low
Risk PE
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• PE on call• Vascular
Medicine • Pulmonary • Cardiology
• Interventionaliston call
• Surgeon on call
• PESI• Echocardiogram• Cardiac
biomarkers • Lactate • PE stratification-
• Anticoagulation• Endovascular • Surgical • RV support
devices
• Hematology• High risk OB• Neurosurgery • Oncology
• Clinics• Vascular Medicine • Hematology• Pulmonary
Hypertension clinic
• IVC filter removal• CTEPH evaluation • Duration and choice of
anticoagulation
PERT Program Process
PE Diagnosis Practice Bias Treatment
Involvement of
Consultants
Discharge to Home
Has it changed outcomes?
Department of Medicine Grand RoundsAugust 2, 2019
PATIENT CARE UNDER THE PE RESPONSE TEAM AT UVA
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“Demographics” of Our Program at UVA
Lukasz Myc, MD
Alex Kadl, MD
“Go live” date: April 1, 2017
120 calls from Apr 2017- Oct 2018 Intermediate-High Risk Calls: 40
High-Risk Calls: 26
CDT hrombolysis/Thrombectomy: 22
Systemic Lysis: 5
ECMO/Surgical Thrombectomy: 5
Institutionalization of PE Response Team Has Improved Mortality at UVA
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PE Alert Team at UVA Services Very Critically Ill Patient Population
Therapeutic Results from UVA PE Response Team
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Use of a PE Response Team for High & Intermediate-Risk Patients Does Not Effect the Bottom Line
Benefits of a PE Response Team at UVA
Sicker patients serviced with better outcomes
Intermediate & high-risk PE patients are serviced without increased in hospital stay or cost
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Benefits of a PE Response Team at UVA(Extends Past the Data)
Customer Satisfaction (Providers): Program is an extraordinary resource for all service lines
Customer Satisfaction (Patients): Provides confidence in delivery of complicated quality care Protocolized out patient follow-up program
Customer Satisfaction (Outside Institutions): Established UVA as a clear leader in providing quaternary care for the region
Customer Satisfaction (Ancillary Staff): Open communication between service lines Standardization of bedside patient care needs
Customer Satisfaction (Hospital Leadership): Utilizing resources that already exist to promote care at UVA on a national stage Providing mentorship and research opportunities to trainees
Future Directions for the UVA Program
System-based approach to guideline-based risk stratification of pulmonary embolism
Large research & quality improvement opportunities: Standardization of RV strain grading
Identifying better risk stratification process Specific patient population needs?
Developing blood biorepository database
Developing Quality and Outcome Markers for PE similar to STEMI & ACS programs
Identifying safer therapeutic options & processes
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Emerging Therapies: RV Support Devices
A general indication for ECMO : any respiratory or cardiac failure that is potentially reversible, has failed conventional therapies, and is associated with an otherwise high mortality
VA ECMO Hemodynamic support (generally considered for PE)
Semin Respir Crit Care Med 2017;38:66–72.
National trends and outcomes for extra-corporeal membrane oxygenation use in high-risk pulmonary embolism
Elbadawi, A. Vascular Medicine, 2019: 24(3), 230–233.
AHA Scientific Statement on management of PE published in 2011 did not include the use of ECMO, citing a lack of data.
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National Inpatient Sample Database
2005-2013: 77,809 hospitalizations with high risk PE
In-hospital mortality with ECMO use: 61.6%
Lower in-hospital mortality with ECMO use (OR = 0.34; 95% CI = 0.25 to 0.45, p < 0.001).
Independent predictors of increased mortality: age, female sex, obesity, congestive heart failure, and chronic pulmonary disease
Advanced therapies in conjunction with ECMO: 45 cases (20.4%) with surgical embolectomy
54 cases (24.9%) with thrombolysis
69 cases (31.7%) with IVC filter placementElbadawi, A. Vascular Medicine, 2019
ECMO as 1st line therapy in High-Risk PE
In ECMO group14/29 were only anticoagulatedSurvival better in ECMO group: (73% vs 96%; P =.02)
J Thorac Cardiovasc Surg 2018;156:672-81
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ECMO in High-Risk PE: Systematic Review & Meta-analysis Literature Search Strategy
Literature review until Feb 2019
Total 944 patients with high risk PE and ECMO
Mean age was 52.7 years old (18-86)
295 males (295/791), 37.3%
Mean duration of ECMO support was 4.41 (0.2-18) days
Results:
Survived index hospitalization: 517 patients
Pooled IV estimate survival to hospital discharge was 60% (95%CI =57% - 63%)
Pre- ECMO cardiac arrest (CA): 281 patients (reported in 19 studies)
Mortality for Patients with High-Risk PE Who Undergo ECMO vs. Patients Without ECMO
ECMO group: 34% more patients had pre-ECMO cardiac arrest compared to no ECMO group
Kaso et al. Unpublished
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Mortality Increased in Patients with Pre-ECMO CA
Outcomes may be better if ECMO considered sooner in high-risk PE patients rather than after cardiac arrest
Kaso et al. Unpublished
System-Based Improvement of Risk Stratification of Acute PE
Better Risk Stratification !!!UVA PE Research Data
45
31
44
16
81
64
51
39
99 99
82 81
Troponin BNP RV strain All three
Risk Stratification of PEPre-PERT Non-PERT PERT
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System-Based Improvement of Risk Stratification of Acute PE
Better Risk Stratification !!!UVA PE Research Data
Salient Points
Distinguish high-risk pulmonary embolus from intermediate-risk and low-risk pulmonary embolus Cardiovascular and hemodynamic effects of an acute pulmonary
embolus are the main determinant of patient outcomes from a PE Risk stratify all your PE patients
Review treatment options for intermediate-risk pulmonary embolus Liberal consideration for activating the Acute PE consult service
Discuss data generated from the initiation of the Acute Pulmonary Embolus service at UVA The UVA Acute Pulmonary Embolus is currently providing up-to-date
quality care some of the sickest patients in the hospital
Call x42012
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UVA
PE
Resp
onse
Tea
m: T
RULY
A T
EAM
EFF
ORT PE Officers:
Taison Bell
Michael Bergman
Kyle Enfield
Alexandra Kadl
Sarah Kilbourne
Younghoon Kwon
Numaan Malik
Sula Mazimba
Tessy Paul
Randy Ramcharitar
Diagnostic Radiology: Klaus Hagspiel
Patrick Norton
Vascular Medicine & Pulm/CCM Fellows
Echocardiography and Imaging Services
Emergency Operator Services
Cardiacthoracic Surgery: John Kern
Gorav Ailawadi
Nicholas Teman
Leora Yarboro
Interventional Radiology: Alan Matsumoto
John Angle
Ziv Haskal
Auh Whan Park
Daniel Sheeran
James Stone
Luke Wilkins
Emergency Medicine: David Burt
Hematology: Louise Man
Pharmacology: Angela Holian
Surabhi Palkimas