establishing a pe response team - ilacc.org · pe response team daniel schimmel, md ms assistant...
TRANSCRIPT
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Establishing a
PE Response Team
Daniel Schimmel, MD MSAssistant Professor of Medicine
Northwestern Medicine
November 3, 2018
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Pulmonary Embolism Management
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Pulmonary Embolism Management
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Pulmonary Embolism Management
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Pulmonary Embolism Management
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Pulmonary Embolism Management
PERT
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Pulmonary Embolism Management
PERT
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What is a PERT?
• A multidisciplinary response team
available to triage and treat patients with
submassive or massive pulmonary
embolism
• First publicly described in 2013 by
colleagues at the MGH
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Why do we need a PERT?
• 3rd most common CV death in US
• Lack of robust clinical trial evidence
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Why do we need PERT?
• 3rd most common CV death in US
• Lack of robust clinical trial evidence
• Differing practice guidelines for risk
stratification AND treatment
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Becattini C, Agnelli G. Thromb Haemost. 2008; 100(5): 747–751Abrahams van-Doorn P. and Hartmann IJC. Imaging Insights. 2011; 2: 705-715Dalen JE. Chest. 2002; 122: 1801-17
Shock
High-intermediate
risk PE
Low-intermediate risk PE
Low risk PE
Asymptomatic
5
10
20
25
40
Estimated Prevalence (%) Mortality 13-30%
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• In clinical practice, systemic thrombolysis is
withheld in up to two thirds of patients with
high-risk (massive) PE
Eur Heart J 2008: 29:2276-2315Am J Cardiol. 2006;97:127-9Circulation 2006;113:577-82
12
Massive PE and hesitation to treat
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Systemic Thrombolysis Trials
• 2004 Meta-analysis of RCTs:
– 748 unselected patients showed no benefit
– subgroup 128 patients unstable
• combined endpoint, death and recurrent PE
• 9.4% vs 19% OR 0.45 95% CI 0.22-0.92
• NNT=10
Circulation. 2004 Aug 10;110(6):744-9
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Thrombolytics and Mortality
Chatterjee et al; JAMA. 2014;311(23):2414-2421
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• In randomized trials, systemic lytics
• 13% risk of major bleeding
• 1-2% risk of intracranial hemorrhage
• In practice, systemic lytics
• 20% risk of major bleeding
• 3-4% risk of intracranial hemorrhage
Massive PE and hesitation to treat
Eur Heart J 2008: 29:2276-2315Am J Cardiol. 2006;97:127-9Circulation 2006;113:577-82
15
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To lyse or not to lyse…
Chatterjee et al; JAMA. 2014;311(23):2414-2421
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When will I give systemic thrombolysis?
• Persistent hypotension or shock are only widely accepted indication1
– SBP < 90 mmHg or 40 mmHg from baseline
–Normotensive shock
– Low bleeding risk
1Chest. 2016;149(2):315-3522Circulation. 2000 Jun 20;101(24):2817-22.
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Contemporary Trials
intermediate risk PE (submassive)
• Systemic lytic trials - ?expanded use
– PEITHO
– MOPPET
– TOPCOAT
• Catheter trials
– ULTIMA
– SEATTLE
– PERFECT
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PEITHO Trial
• PEITHO trial
• Tenecteplase + heparin VS placebo + heparin
• Normotensive patients with RV dysfunction and biomarker elevation
• 1005 patients enrolled
N Engl J Med. 2014 Apr 10;370(15):1402-11
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PEITHO Trial
N Engl J Med. 2014 Apr 10;370(15):1402-11
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PEITHO Trial
N Engl J Med. 2014 Apr 10;370(15):1402-11
Stroke risk 2.4% vs 0.2%
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Contemporary Trials
intermediate risk PE (submassive)
• Systemic lytic trials
– PEITHO
– MOPPET
– TOPCOAT
• Catheter trials
– ULTIMA
– SEATTLE
– PERFECT
No mortality benefit
More complete and rapid
RV and PASP improvement
Possible improved QOL
Expense of more bleeding,
including ICH
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Who are the key stakeholders?
• Non-interventional colleagues
– ED, intensivists/pulmonology
– Internal medicine, hematology
• Interventional colleagues
– Cardiology, IR, vascular, CT surgery
– Interventional cardiology partners
• Administrative
– Infrastructure, cohesiveness of above
– Bed assignment, transfer coordinator
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Why cardiology?
• BNP and Troponin
• Echo
• Anticoagulation
• Thrombolytic therapy
• Time sensitive endovascular procedures
• Mechanical support
• ECMO
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Why pulmonology?
• Historic familiarity
• Interpretation of imaging and
parenchymal changes
• Evaluation for chronic forms of
pulmonary hypertension
• Strategies for managing acute hypoxic
respiratory failure
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Why hematology?
• Complicating coagulopathies
• Heparin induced thrombocytopenia
• Role for hypercoaguable testing
• Duration of anticoagulation
• Family screening
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Why interventionalist?
• Reperfusion is key in patients who are
unstable
• Need at least one champion in the space
who knows the data well and is
experienced
• Operator volume correlates with
avoidance of bad outcomes
• Interventional Cardiology, Interventional
Radiology or Vascular
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Extra credit: Cardiac surgeon
• Extra corporeal membrane oxygenation
(ECMO) may be required
• Surgical embolectomy for those
unresponsive to thrombolytics or with
lytic contraindications
• May not be at your hospital
– Establish a relationship with a referral center
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What is your capacity?
• Fellows and advanced practice providers
• 24 hour coverage (Echo? Intervention?)
• Consult-> dx VS decision VS activate
• All PE vs intermediate to high risk
• Interventional partners
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What infrastructure needed?
• Call system/IT
• Infusion catheters +/- ultrasound facilitated
• Fragmentation and Suction embolectomy
devices
• ECMO and mechanical support
• IVC filter responsibility
• Quality review and education
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Low Risk
Intermediate Risk
High Risk
Obs vs D/C
Telemetry
ICU/TX Decisions
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Pulmonary Embolism Risk Stratification
Yes NosPESI = 0 and no RV dysfxn
sPESI>0 or RV dysfxn
Anticoagulate. Consider early transition to
outpt therapyMortality <1%
SBP<90
sPESI ScoreRisk Stratify*:
Troponin, BNP, Echo
Reperfusion therapy +/-
support Mortality >15%
Anticoagulate, Strongly consider
reperfusion therapy
30 day PE related mortality 10-15%
Anticoagulate. Consider
reperfusion therapy
30 day PE related
mortality ~ 5-7%
Anticoagulate.30 day PE
related mortality ~2-3%
High Risk PEScore 5+
Interm-high risk acute PE
Score 0-2Low-intermed
risk PEVery low risk PE
*risk stratification modified from ESC 2014 Guidelines, BOVA score and modified FAST scores**If HR less than 100 and biomarkers negative, consider chronic thromboembolic HTN
ICU Admit
sPESI calculation (each 1 pt)
Age>80CancerChronic heart failureChronic lung diseaseHR>110SBP<100RA SpO2<90%
Heart rate >110 1 point(HR>SBP) 2 points
Syncope hx 1 pointSys BP 90-100 2 pointsBiomarker + 1 point2nd Biomarker 1 pointSevere RV dysfxn 2 points
(by CT or echo)
Score 3-4 Intermediate risk acute PE
ICU ICU Obs vs D/C
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Shared
Decision
Treatment Potential
Harm
PE Risk
Treatment Potential
Gain
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Catheter-directed lysis
Chen R. Endovascular Today July 2014
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Unifuse sidehole catheter AngioJet - Powerpulse
Angiovac – large volume suction embolectomy EKOs - Ultrasound facilitated
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Ultrasound facilitated lysis
Fibrin separation₸
Fibrin without Ultrasound
Fibrin With Ultrasound
Active drug deliveryby acoustic streaming
Mechanism of Action
Braaten et al. Thromb Haemost 1997; 78:1063-8.
Ultrasound delivered in:High frequency (2.2 Mhz)Low power (0.5 W per element)Pulses of varying waveforms
Ultrasound pulses
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ULTIMA trial Systolic RV
dysfunction
37
0%
20%
40%
60%
80%
100%
Baseline 24 hrs 90 days
Syst
olic
RV
Dys
fun
ctio
n
Baseline 24 hrs 90 days
Severe
Moderate
Mild
Normal
USAT + Heparin Heparin
P<0.0001P<0.0001
P=0.003**
Kucher et al. Circulation 2013
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ULTIMA Secondary endpoint analysis
Clinical outcomes at 90 days
EKOS + Heparin Heparin
p-valueN = 30 N = 29
Death 0 0% 1* 3% 0.49
Recurrent venous thromboembolism 0 0% 0 0% 1.00
Major bleeding 0 0% 0 0% 1.00
Minor bleeding 3** 10% 1§ 3% 0.61
* rehospitalization and death from advanced pancreatic cancer** two patients with transient mild hemoptysis without medical intervention,
one patient with groin hematoma requiring manual compression§ one patient with transient anal bleeding following endoscopic removal of colon polyp
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Catheter-directed Studies• SEATTLE: single arm, prospective 150 patients high and
intermediate risk
– Mean ratio reduction of 0.42, mean PA pressure reduction 14.5 mmHg (p<0.0001)
• PERFECT: 101 patients prospective registry high and intermediate
– Success in 85.7% massive PE pts, 97.3 submassive PE pts, 89.1% showed improvement in RV strain on echo (p<0.0001)
• OPTALYSE PE: 4 arms comparing lytic dose and duration of ultrasound facilitated lytics – no significant difference Circulation. 2014 Jan;129(4):479-86
JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-92Chest. 2015 Sep;148(3):667-73
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Contemporary Trials
intermediate risk PE (submassive)
• Systemic lytic trials
– PEITHO
– MOPPET
– TOPCOAT
• Catheter trials
– ULTIMA
– SEATTLE
– PERFECT
– OPTALYSE PE
– FLARE
No mortality data
More complete and rapid RV
and PASP improvement
More bleeding than heparin
Less major bleeding than
systemic lysis (however no direct comparison)
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Contemporary Trials
intermediate risk PE (submassive)
• Systemic lytic trials
– PEITHO
– MOPPET
– TOPCOAT
• Catheter trials
– ULTIMA
– SEATTLE
– PERFECT
No mortality data
More complete and rapid RV
and PASP improvement
More bleeding than heparin,
but no ICH in recent data
No comparison systemic lysis
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Contemporary Trials
intermediate risk PE (submassive)
• Systemic lytic trials
– PEITHO
– MOPPET
– TOPCOAT
• Catheter trials
– ULTIMA
– SEATTLE
– PERFECT
No mortality data
More complete and rapid RV
and PASP improvement
More bleeding than heparin,
but no ICH in recent data
No comparison systemic lysis
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Submassive and massive PELanes of care
Hemodynamics
• ECMO
• Pressor/Inotrope
• RP Impella?
• None required
Reperfusion
• Systemic tPA
• Catheter directed lysis
• Suction embolectomy
• Surgical embolectomy
• Endogenous lysis
Prevention
• Anticoagulation
• IVC Filter
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NMH PE Response Team
• ~ 4 years experience
• ~ 350 consults
• systemic and catheter directed cases
• Suction embolectomy
• emergent ECMO and surgical embolectomies
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PERTCONSORTIUM.ORG
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Life after acute PE
All PE patients
Reduced functional status 50%
Persistent thrombi 15-33%
Measurable limitation
10-30%
CTEPH
0.1-4%
Klok Blood Reviews 2014Matthews Pulm Circulation 2016
Web image from Quizlet.com
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PE Response Team Follow-up
• Pulmonary HTN advanced practice nurse follows in hospital
• Standard discharge follow-up for submassive and massive PE to Pulmonary HTN/CLOT Clinic
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PE Response Team Follow-up
• Pulmonary HTN advanced practice nurse follows in hospital
• Standard discharge follow-up for submassive and massive PE to Pulmonary HTN/CLOT Clinic
CTED and CTEPH
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Chronic thromboembolic disease
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CTEPH/Acute PE imitators• Syncope but otherwise looks well
• No troponin rise with large RV
• Elevated PASP above 50
• RV hypertrophy
• High residual burden after lysis
Becattini Chest 2006Klok Blood Reviews 2014
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Things to look for on Angiography
1) Pouch defects
2) Pulmonary artery webs or bands
3) Abrupt narrowings
4) Complete obstruction at origin of vessel
5) Intimal irregularities
Fedullo et al. 2011 American Thoracic Society Journal
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Things to look for on Angiography
1) Pouch defects
2) Pulmonary artery webs or bands
3) Abrupt narrowing
4) Complete obstruction at origin of vessel
5) Intimal irregularities
Fedullo et al. 2011 American Thoracic Society Journal
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Things to look for on Angiography
1) Pouch defects
2) Pulmonary artery webs or bands
3) Abrupt narrowing
4) Complete obstruction at origin of vessel
5) Intimal irregularities
Fedullo et al. 2011 American Thoracic Society Journal
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Hiroki Mizoguchi et al. Circ Cardiovasc
Interv. 2012;5:748-755
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Controversies in
acute care and f/u
• How do we risk stratify?
• Does CDT add anything meaningful?
• When to recommend surgery?
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Controversies in
acute care and f/u
• How do we risk stratify?
• Does CDT add anything meaningful?
• When to recommend surgery?
• How do we follow-up?
• Duration anticoagulation?
• Activity recommendations?
• CTEPH Evaluation?
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Homework
• ESC guidelines 2014
• JACC March 2016; 67 –Management of PE
• JACC March 2016; 67 –Acute PE Interventional Approach
• Circulation 2016;133 – Multidisciplinary PERT
• CHEST Feb 2016;149 – Antithrombotic therapyfor VTE
• www.pertconsortium.org Dan [email protected]