Title 54 pt Arial, Two Line Maximum

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Approach to Interventional Management of
Pulmonary Embolism and the Role of the
Multidisciplinary Team Approach
Kenneth Rosenfield, MD, MHCDS
on behalf of MGH PERT collaborators
With credits also to:
Richard N. Channick, M.D.
Michael R. Jaff, M.D.
Christopher Kabrhel, M.D.
The MGH PERT Team
Kenneth Rosenfield, MD, MHCDS
Conflicts of Interest
•
•
Consultant
– Abbott Vascular
– Capture Vascular
– Cardinal Health
– Contego
– CRUZAR Systems
– Endospan
– Eximo
– InspireMD
– MD Insider
– Micell
– Shockwave
– Silk Road
– Surmodics
– Valcare
Equity
– CardioMEMs
– Contego
– Embolitech
– Icon
– Janacare
– MD Insider
– Micell
– PQ Bypass
– Primacea
– Shockwave
– Vortex
•
Research or Fellowship
Support
– Abbott Vascular
– Atrium
– NIH
– InspireMD
– Lutonix-Bard
•
Board Member
– VIVA Physicians (Not For
Profit 501(c) 3
Organization)
• www.vivapvd.com
PE (and DVT): A national crisis!
• Severely under-recognized and
undertreated
• Significant immediate and long-term
sequelae
• High recurrence rate
• Treatments available that reduce mortality,
morbidity and sequelae
Kearon C et al. Chest 2008; 133: 454S-545S.
Pulmonary Embolus: Why Worry??
Consequences By Clinical Presentation
mortality
• Cardiac Arrest: 10-20%
66-95%
How many other diseases have such
• Massive PE (SBP <90 mmHg): 4-6% 22-53%
terrible implications???
• Submassive PE (stable
hemodynamics with RV dysfunction): 8-13%
23-40%
• Submassive PE (stable
1-4%
hemodynamics w/o RV dysfunction)
• Recurrent PE
25%
• Untreated
30%
Adapted from Fengler
Am J of Emergency Medicine, 2009 27,84-95
Have we made much progress since 1969?
5
Massive vs. Submassive PE
Massive PE
Submassive PE
•SBP<90mmHg or decrease
•SBP≥90mmHg
> 40 mmHg from baseline
for > 15 min
•Inotropic support
•Pulselessness
•Persistent bradycardia (HR
< 40 bpm)
•RV dysfunction
•RV dilatation ECHO or CT
(RV/LV diameter > 0.9)
• BNP > 90 pg/mL
• EKG changes
• Myocardial necrosis:
Troponin I > 0.4 ng/mL
Troponin T > 0.1 ng/mL
Jaff et al, Circulation 2011;123:1788
PE Outcomes – Massive and Submassive
“…good justification to treat!”
Kucher et al, Circulation 2006 –
ICOPER Registry
Mortality
52.4%*
• 2454 consecutive patients
with PE
• 108 patients with massive PE
14.7%
(SBP<90)
• Recurrent PE at 90 days
– Submassive PE: 7.6%
– Massive PE: 12.6%
*2/3 from recurrent PE
REMARKABLY LITTLE PROGRESS IN 30
YEARS
ICOPER Study - Kucher et al Massive PE Circulation 2006.
“Treatment gap” in PE
• <5% of patients with PE receive “advanced
therapy”, including those with clear indications
(hypotension, RV dysfunction, biomarkers, etc.)
• Many more are eligible than receive
• Reasons
• Failure to recognize potential benefit and
integrate data in “real-time”
• Fear of complications
• Inability to respond rapidly (“systems” issues)
• “Paralysis” in decision-making
8
Real World Case #1
•
66 year-old man with no signif past medical history noted
dyspnea on exertion 5-6 days prior to presentation.
•
Symptoms progressed – shortness of breath walking 20 feet
•
Outside hospital  PE-protocol CT  extensive bilateral saddle
PE
•
Started on heparin and transferred to a tertiary referral hospital
•
TTE at second hospital: large clot in right atrium  confusion
about best therapy
•
Patient transferred to MGH
Troponin-T: 0.4 ng/ml
NT-proBNP: 1975 pg/ml
PE-Protocol CT:
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Transthoracic Echocardiogram: Still Images
Thrombus Across Pulmonic Valve
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Management Alternatives
Acute PE
MCS
How do we decide which
therapy to apply in a given
patient ???
Anticoagulant
IVC Filter
Thrombolytic
Therapy
Systemic
Mechanical
Catheter
Directed
Percutaneous
Fragmentation
&
Aspiration
UltrasoundAssisted
Pharmacomechanical
Surgical
Embolectomy
~More likely with  severity
Therapeutic Alternatives in
Acute PE
•
•
– Systemic (full or half-dose)
Anticoagulation
– Catheter Directed (CDT)
– Unfractionated Heparin
– Pharmacomechanical
• Continuous Intravenous
Catheter-Directed
Thrombolysis (P-CDT)
• Full-Dose Subcutaneous
– Low-Molecular-Weight
Heparin
– Direct Thrombin Inhibitors
– Synthetic Pentasaccharide
Xa Antagonist
– Warfarin
Thrombolytic Therapy
•
Mechanical
– Surgical Thrombectomy
– Thrombo-aspiration
•
Adjunct Rx
– Extracorporeal support (ECMO)
– RVAD
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– IVC Filter
Available Guidelines
“Management of
submassive PE
crosses the zone of
equipoise, requiring
clinician to use clinical
judgment.”
“In most situations of uncertain
benefit of a treatment…we took the
position of primum non
nocere….given the certain risks of
bleeding and less-certain benefits,
thrombolysis is likely to be harmful.
Selected patients without
hypotension may benefit…”
Circulation 2011;123:1788.
Chest 2012;141:419S.
Decision-making Beyond the Guidelines
• Guidelines offer few class I recommendations and do not
cover all scenarios
– Paucity of data available for highest-risk patients
– Novel devices and approaches now available
• Expert multidisciplinary consultation essential (STEMI,
Stroke,TAVR teams)
• Timely decision-making and intervention crucial
Circulation 2010;122:1124.
Tex Heart Inst J 2013;40:5.
Which therapy to use???
• Best treatment unknown
– No “standard approach”
– No “Appropriate Use Criteria” for intervention
• Strategies “all over the map”… MGH experience as example:
– Practice variation by medical service, location, size and
threat to patient, etc.
– No standard algorithm or consistency in decision-making
– No single “team” or “clearing-house”
– No centralized locations for care or “centers of excellence”
– No systematic evaluation of results
How do we decide whether to “intervene” and by what
modality? Who decides? What is the endpoint?
Pulmonary Embolism Response Team
A Multidisciplinary Effort to Improve Care and
Outcomes in Patients with PE
17
PERT: Pulmonary Embolism Response Team
• Goals: Improve patient outcomes with a
collaborative, multidisciplinary team-based urgent
consult to treat massive and submassive PE
• Functionality
– Modeled on rapid-response concept
– Multidisciplinary team of experts: convened via
electronic meeting
– Evaluate and offer full range of available
treatments
Chest 2013;144:1738
Pulmonary Embolism – previous paradigm
…Chaos
ED / ICU / Floor Team
Pulmonary
Vascular Medicine/Cardiology
Cardiac Surgery
20
Pulmonary Embolism Response Team (PERT)
Objectives
•
Respond expeditiously to treat patients with massive and
submassive PE
•
Provide best therapeutic option(s) available for each patient
•
Leverage the input of a multidisciplinary team of experts
•
Coordinate care among services involved in care of PE
•
Develop protocols for the full range of therapies available
•
Collect data on clinical presentation, treatment efficacy, and
outcomes (short and long-term)
…Fill unmet need and gap in knowledge base…
21
PERT Program Flow Map
Expeditious input and clinical judgment from
multiple specialties to optimize therapy
ED
MGH
floor
OSH
PERT fellow:
History
Physical
Labs
EKG
Echo
CT-PE
Low Risk
Submassive
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A/C
Attending
Lytic
CDT
Massive
ACTIVATE PERT
MULTIDISCIPLINARY
TEAM
Handoff to
therapeutic site
Vortex
Electronic Meeting
Vascular Medicine
Cardiac Surgery
ICU/Pulmonary
Hematology
Rad,Echo
ECMO
Surgery
Multidisciplinary Virtual Consultation
•
Leverage low- and no-cost
internal and commercially
available tools
‒ Citrix® GoToMeeting
web-based HD
videoconferencing
‒ Allows exchange of
screen control
‒ Tracks meeting date,
time and length
Gotomeeting.com
‒ Group email distribution lists
‒ Group paging
Back to our 66 y.o. man with Submassive PE
and ?clot in transit…what to do?
• Multidisciplinary “gotomeeting”
– CT surgery, cardiology, vascular med, pulm critical
care, hematology, ED, and anesthesiology
 Decision made to proceed to catheterization laboratory
for Vortex Angiovac
• Procedure under general anesthesia with TEE guidance
• Access: Percutaneous
– Subclavian vein – triple lumen
– Right femoral vein – 26 F Dry-seal sheath
– Left femoral vein – 17 F Venous Return
– Left femoral artery (in case ECMO required)
25
Transesophageal Echocardiogram
26
AngioVac“VORTEX”
• 18 F Suction Catheter
• 17 F Return
• Pump/Filter
Thrombus Extracted by Vortex AngioVac
28
Transesophageal Echocardiogram: Post
Extraction
29
Pulmonary Angiography: Still Image
30
Post-VORTEX
• Plan to send to SICU for monitoring
• Sudden drop in BP to 60, requiring additional pressors
• Decision for thrombolysis of saddle PE’s
• Re-prepped and EKOS catheters placed bilaterally
31
EKOS Catheter Placement
32
Post-procedure
• Initial 12 hours
– 2mg bolus tPA, then 1mg/hr via each EKOS x 4 hrs,
then 0.5mg/hr x 6 hours
– Total dose 21mg
– Remained hypotensive/shocky requiring Epi @ 2-5,
Phenylephrine @ 5-15, +/-Vasopressin
– RV function poor
• 14 hours post-procedure – Prop. d/c’ed and awoke,
extubated, pressors stopped. BP 140, HR 80, O2 sat
100% on 2 L
• Home day 4
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Emerging Technologies - “game-changers”?
• Ultrasound facilitated lysis
– More rapid clot dissolution with lower dose of lytic agent?
• VORTEX Angiovac - En bloc thrombus aspiration
– Rapid removal of offending clot percutaneously
– Requires perfusionist & addl resources
• ECMO
– Ability to support patient hemodynamically
– “bridge” to definitive Rx
Will these change the paradigm completely?
How do we integrate these into existing treatments?
Underscores need for integrated, TEAM approach to PE
…with multi-disciplinary decision-making
PERT Activations
October 2012 Launch through November 2015
333 Activations in 25 Months
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OCT
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FY13
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FEB
MAR
APR
FY14
MAY
JUNE
JULY
FY15
AUG
SEPT
PERT Activations
October 2012 Launch to Present
• Male: 56% Female: 45%
• Age range: 10 – 98 yrs
‒ Median age: 62 yrs.
• Survival to discharge: 85%
AC Only
IVCF
IV Lysis
• Interventions:
36
CDT
59.8%
Anticoagulation only
9.1%
Catheter-direct thrombolysis
4.2%
Surgery
ECMO
2.8%
IV systemic lysis
Surgery
2.4%
Mechanical support/ECMO
21.0%
IVC filters
0.7%
Vortex
Vortex
PERT Consortium- Launch Meeting
Boston, MA
May 21, 2015
25+ Interested Centers
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Future of Vascular Intervention
Pulmonary Embolus Management
• Summary
– PE still poorly understood; much to learn
– New era: heightened awareness and
coordinated institutional approach to a complex,
life-threatening problem
– OPTIMAL CARE WITH TEAM APPROACH!!
PERT: a “model” program, demonstrating the
power of interdisciplinary collaboration to
streamline care, optimize outcomes for our
patients, and enable development of better
treatment paradigms for patients with PE
– PERT Consortium …Contact us if interested!!
• [email protected]
THANK YOU
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