1. 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

2. Kenneth Rosenfield, MD, MHCDS Conflicts of Interest
Research or Fellowship Support
Abbott Vascular
Atrium
NIH
InspireMD
Lutonix-Bard
Board Member
VIVA Physicians (Not For Profit 501(c) 3 Organization)
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

3. 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.

4. Pulmonary Embolus: Why Worry?? Consequences By Clinical Presentation
mortality
66-95%
22-53%
8-13%
1-4%
25%
30%
Cardiac Arrest: %
Massive PE (SBP <90 mmHg): 4-6%
Submassive PE (stable hemodynamics with RV dysfunction): %
Submassive PE (stable hemodynamics w/o RV dysfunction)
Recurrent PE
Untreated
How many other diseases have such terrible implications???
Adapted from Fengler
Am J of Emergency Medicine, ,84-95

5. Have we made much progress since 1969?

6. Massive vs. Submassive PE
SBP<90mmHg or decrease > 40 mmHg from baseline for > 15 min
Inotropic support
Pulselessness
Persistent bradycardia (HR < 40 bpm)
Submassive PE
SBP≥90mmHg
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

7. REMARKABLY LITTLE PROGRESS IN 30 YEARS
PE Outcomes – Massive and Submassive
“…good justification to treat!”
Kucher et al, Circulation 2006 – ICOPER Registry
2454 consecutive patients with PE
108 patients with massive PE (SBP<90)
Recurrent PE at 90 days
Submassive PE: 7.6%
Massive PE: 12.6%
Mortality
52.4%*
14.7%
*2/3 from recurrent PE
REMARKABLY LITTLE PROGRESS IN 30 YEARS
ICOPER Study - Kucher et al Massive PE Circulation 2006.

8. “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

9. 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
66 year-old male with no significant past medical history who presents with a pulmonary embolism and clot in transit. He reports developing shortness of breath and DOE 5-6 days prior to presentations. Because of symptoms progression, he went to Winchester Hospital ED where a PE protocol CT showed bilateral PEs extendings to segmental and subsegmental branches of all lobes. He was started on heparin gtt and transferred to Tufts medical center. A TTE there showed RV dilated and hypokinetic, septal flattening, reduced LVEF of 35% and a clot in the RA passing across the TV.
Troponin-T: 0.4 ng/ml
NT-proBNP: 1975 pg/ml

10. PE-Protocol CT:

11. Who makes the decision and on what basis?
Transthoracic Echocardiogram: Still Images Thrombus Across Pulmonic Valve
What would you do next?
Who makes the decision and on what basis?

12. Management Alternatives
Acute PE
Anticoagulant
Mechanical
Thrombolytic
Therapy
Systemic
Catheter
Directed
IVC Filter
MCS
How do we decide which therapy to apply in a given patient ???
Percutaneous
Fragmentation
&
Aspiration
Surgical
Embolectomy
Ultrasound-
Assisted
Pharmaco-
mechanical
~More likely with  severity

13. Therapeutic Alternatives in Acute PE
Thrombolytic Therapy
Systemic (full or half-dose)
Catheter Directed (CDT)
Pharmacomechanical Catheter-Directed Thrombolysis (P-CDT)
Mechanical
Surgical Thrombectomy
Thrombo-aspiration
Adjunct Rx
Extracorporeal support (ECMO)
RVAD
IVC Filter
Anticoagulation
Unfractionated Heparin
Continuous Intravenous
Full-Dose Subcutaneous
Low-Molecular-Weight Heparin
Direct Thrombin Inhibitors
Synthetic Pentasaccharide Xa Antagonist
Warfarin

14. Available Guidelines
“Management of submassive PE crosses the zone of equipoise, requiring the 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…”
No lytics:
A: prior ICH, AVM, malignant intracranial, CVA in 3 months, aortic dissection, active bleeding, recent surgery (spine), closed head or facial trauma
R: > 75, anticoag, pregnancy, noncompressible puncture, CPR > 10, bleed 2-4 weeks, HTN 180/110/uncontrolled, dementia, CVA > 3 months, major surgery 3 weeks
2C: Very weak recommendations; other alternatives may be equally reasonable
Jaff: ACCP took a step back. Unclear why --- waiting for definitive trial, and “time was up”
Circulation 2011;123:1788.
Chest 2012;141:419S.

15. 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.

16. 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?

17. Pulmonary Embolism Response Team A Multidisciplinary Effort to Improve Care and Outcomes in Patients with PE

18. 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

20. Pulmonary Embolism – previous paradigm …Chaos
ED / ICU / Floor Team Pulmonary
Vascular Medicine/Cardiology
Cardiac Surgery

21. 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…

22. PERT Program Flow Map
Expeditious input and clinical judgment from multiple specialties to optimize therapy
Handoff to therapeutic site ED
PERT fellow:
History
Physical
Labs
EKG
Echo
CT-PE
Low Risk
A/C
MGH floor
Lytic
Submassive
Attending
CDT
OSH
Massive
Vortex
ECMO
Electronic Meeting
Vascular Medicine
Cardiac Surgery
ICU/Pulmonary
Hematology
Rad,Echo
ACTIVATE PERT MULTIDISCIPLINARY TEAM
Surgery 22

23. Gotomeeting.com 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
Group distribution lists
Group paging
11/14/13
61F China, HTN, thrombocytopenia
Tachycardia to 130s before fluid now 108, SBP 94 (home 140s) -> 124, rr 32, SaO2 97 2L
CT with bilateral thrombus burden R main-RUL, RLL, L main-LUL, LLL
PERT due to VS, EKG with anterior TWI, PLT 90, and RLL ? infarct.
Echo in real time while on call: RVSP 43, RV sl dilated 45, McConnell, no TIT
She has relatively large thrombus burden and is still tachyneic and modeately tachycardic. THere is no firm rule or guideline, nor clinical indicator to tell us whether she will ultimately do better with lysis versus heparin alone. I do believe she could potentially benefit from low dose, limited infusion of tPA via EKOS into Rt main pulm artery. On other hand, she is slightly improved over past 12 hours. D/w DR. O'Donnell...we agree her usual BP is much higher and she is very dyspneic/tachypneic with almost any motion. If we can help her along by lysing some of her thrombus with very low dose lytic, we likely can minimize risk of bleeding while still giving her a "head start" with CDT
Got EkOS – large mobile burden in bilateral segmental arteries.
After 24h UFH switched to Coumadin and UFH. R popliteal DVT
98 BP: 140/97 : RR: O2: 95% RA ‎ ‎‎‎‎
Gotomeeting.com

24. Multidisciplinary Collaboration
PERT
Vascular Medicine and Intervention
Pulmonary/ Critical Care
Cardiac Surgery
Cardiac and Thoracic Imaging
Nursing
Quality & Safety
Vascular Surgery
Echocardiography
Cardiology
Hematology/ Oncology
Emergency Medicine

25. Back to our 66 y. o. man with Submassive PE and
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)

26. Transesophageal Echocardiogram

27. AngioVac“VORTEX”
18 F Suction Catheter
17 F Return
Pump/Filter

28. Thrombus Extracted by Vortex AngioVac

29. Transesophageal Echocardiogram: Post Extraction

30. Pulmonary Angiography: Still Image

31. 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

32. EKOS Catheter Placement

33. 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 2-5, 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

34. 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

35. PERT Activations October 2012 Launch through November 2015
333 Activations in 25 Months

36. PERT Activations October 2012 Launch to Present
Male: 56% Female: 45%
Age range: 10 – 98 yrs
Median age: 62 yrs.
Survival to discharge: 85%
Interventions:
59.8% Anticoagulation only
9.1% Catheter-direct thrombolysis
4.2% Surgery
2.8% IV systemic lysis
2.4% Mechanical support/ECMO
21.0% IVC filters
0.7% Vortex

37. PERT Consortium- Launch Meeting Boston, MA May 21, 2015
25+ Interested Centers

39. 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!! 39

40.
THANK YOU