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%

How many other diseases have such

Massive PE (SBP <90 mmHg): 4-6%

terrible implications???

Submassive PE (stable 22-53% hemodynamics with RV dysfunction): 8-13% 23-40% Submassive PE (stable hemodynamics w/o RV dysfunction) 1-4% Recurrent PE 25% Untreated 30% Adapted from Fengler Am J of Emergency Medicine, 2009 27,84-95

5 Have we made much progress since 1969?

Massive vs. Submassive PE

Massive 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

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.

“Treatment gap” in PE 8 • • • <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

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 PE-protocol CT  extensive bilateral saddle 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

10 PE-Protocol CT:

11 Transthoracic Echocardiogram: Still Images

Thrombus Across Pulmonic Valve

Management Alternatives

Acute PE

How do we decide which

MCS

therapy to apply in a given

IVC Filter Thrombolytic Therapy Mechanical Systemic Catheter Directed Ultrasound Assisted Percutaneous Fragmentation & Aspiration Pharmaco mechanical Surgical Embolectomy ~More likely with  severity

Therapeutic Alternatives in Acute PE •

Anticoagulation

– Unfractionated Heparin • • Continuous Intravenous Full-Dose Subcutaneous – Low-Molecular-Weight Heparin – – Direct Thrombin Inhibitors Synthetic Pentasaccharide Xa Antagonist – Warfarin •

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 13

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?

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Pulmonary Embolism Response Team

A Multidisciplinary Effort to Improve Care and Outcomes in Patients with PE

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…

PERT Program Flow Map 22

Expeditious input and clinical judgment from multiple specialties to optimize therapy

Handoff to therapeutic site ED MGH floor OSH PERT fellow: History Physical Labs EKG Echo CT-PE Low Risk Submassive Massive Attending A/C Lytic CDT Vortex ECMO ACTIVATE PERT MULTIDISCIPLINARY TEAM Electronic Meeting Vascular Medicine Cardiac Surgery ICU/Pulmonary Hematology Rad,Echo 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 Group email distribution lists ‒ Group paging

25 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

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 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

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

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17 15 14 10 10 5 0 OCT 4 NOV 6 DEC FY13 JAN 13 12 FEB 13 5 13 11 MAR APR FY14 12 10 MAY 8 6 14 10 17 17 JUNE JULY FY15 AUG 20 19 SEPT 17 13

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% 4.2% 2.8% 2.4% 21.0% 0.7% Catheter-direct thrombolysis Surgery IV systemic lysis Mechanical support/ECMO IVC filters Vortex AC Only IVCF IV Lysis CDT Vortex ECMO Surgery

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!!

40 • [email protected]

THANK YOU