Pulmonary Embolism Response Teams PERTs and Interventional Cardiology

Pulmonary Embolism Response Teams (PERTs) and Interventional Cardiology: A New Approach to an Old Disease • Institutional Logo Kenneth Rosenfield, MD, MHCDS, MSCAI Massachusetts General Hospital …on behalf of the PERT Consortium TM, a 501 c 3 organization

• Institutional Logo Kenneth Rosenfield, MD • Consultant – Abbott Vascular – Access Vascular – Capture Vascular – Cardinal Health – CRUZAR Systems – Endospan – Inspire. MD – MD Insider – Micell – Shockwave – Silk Road – Surmodics – Valcare • • Financial Disclosures Equity • Research or Fellowship Support – Access Vascular – NIH – Contego – Atrium – Embolitech – MDInsider – Janacare – PQ Bypass – Primacea – Vortex Board Member – VIVA Physicians (Not For Profit 501(c) 3 Organization) • www. vivapvd. com

• Institutional Logo How much progress have we made since 1969?

• Institutional Logo The International crisis of PE! • High incidence; ubiquitous • Public awareness of impact low • Under-recognized & undertreated by clinicians • Significant immediate morbidity/mortality and long-term sequelae • Most patients do not receive advanced therapies • Little consensus regarding how to treat Kearon C et al. Chest 2008; 133: 454 S-545 S.

• Institutional Logo GLOBAL PUBLIC AWARENESS: DVT/PE (J Thromb Haemostasis 2015; 13: 1365 -71)

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• Institutional Logo Challenges in PE – Who is in jeopardy? Becattini C, Agnelli G. Predictors of mortality from pulmonary embolism and their influence on clinical management. Thromb Haemost. 2008; 100(5): 747– 751 Abrahams van-Doorn P. and Hartmann IJC. Imaging Insights. 2011; 2: 705 -715 Dalen JE. Chest. 2002; 122: 1801 -17

• Pathophysiology of Pulmonary Embolism…Importance of the RV Institutional Logo Abrahams van-Doorn P. and Hartmann IJC. Imaging Insights. 2011; 2: 705 -715 Eur Heart J. 2014 Nov 14; 35(43): 3033 -69, 3069 a-3069 k 8

• Institutional Logo Therapeutic Alternatives in Acute PE • Anticoagulation • Thrombolytic Therapy • Systemic (full or half-dose) • Catheter Directed (CDT) • Pharmacomechanical Catheter-Directed Thrombolysis (P-CDT) • Unfractionated Heparin How do we currently decide • Continuous Intravenous • Full-Dose Subcutaneous which therapy to apply in a • Low-Molecular-Weight Heparin • given Direct Thrombin Inhibitors patient ? ? ? • Mechanical • Synthetic Pentasaccharide Xa Antagonist • Warfarin • Surgical Thrombectomy • Thrombo-aspiration • Clot maceration • Adjunct Rx • Extracorporeal support (ECMO) • RVAD • IVC Filter

• Institutional Logo “Treatment gap” in PE • <5% of patients with PE receive “advanced therapy”, including those with clear indications (hypotension, RV dysfunction, biomarkers, etc. ) • Impediments • Inability to respond rapidly (“systems” issues) • Failure to recognize potential benefit • Absence of data to support Rx • Fear of complications “Paralysis” in decision-making

• Institutional Logo Is PE like STEMI? Yes • Life-threatening • Requires urgent response and immediate therapy • Pts often benefit from “intervention” • Prerequisite…ability to rapidly assemble a team …at the same time, NO!

• Institutional Logo PE: More Challenging than STEMI • Best treatment unknown • Evidence base incomplete – “data-free zone” – Guidelines all “Level C” • No “standard approach” or “Appropriate Use Criteria” for intervention • Strategies “all over the map”… MGH experience as example: • • Practice variation by medical service, location, size, threat to patient, etc. No standard algorithm or consistency in decision-making No single “team” or “clearing-house”; no centralized location for care No systematic evaluation of results How do we decide whether to “intervene”? What modality is best? Who decides? What is the endpoint?

• Institutional Logo AHA Moment!

• Institutional Logo MGH Pulmonary Embolism Response Team (aka “PERT”) – circa 2013

• Institutional Logo 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 management 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 clinical need and provide data to close gap in evidence base…

• Institutional Logo Pulmonary Embolism – previous paradigm …Chaos

Pulmonary Embolism – new paradigm • Institutional Logo ED / ICU / Floor Team/ Pulmonary Vascular Medicine/Cardiology Cardiac Surgery

• Institutional Logo Multidisciplinary Collaboration Pulmonary/ Critical Care Emergency Medicine Vascular Medicine and Intervention Hematology/ Oncology Cardiac Surgery PERT Cardiology/Echo Cardiac and Thoracic Imaging Interventional Radiology Nursing Vascular Surgery Quality & Safety

• Institutional Logo PERT 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 Handoff to therapeutic site A/C Attending Lytic CDT Massive ACTIVATE PERT MULTIDISCIPLINARY TEAM Vortex Electronic Meeting Vascular Medicine Cardiac Surgery ICU/Pulmonary Hematology Rad, Echo ECMO Surgery

• Institutional Logo Gotomeeting. com Multidisciplinary Virtual Consultation ‒ Group email distribution lists ‒ Group paging

• Institutional Logo October, 2017 >900 total PERT Activations!!! 23

• Institutional Logo 3 rd Annual Meeting June 22, 2017 >175 member participants

• Institutional Logo What is a PERT? Bylaws. Definition An institutionally based multidisciplinary team that can: • rapidly assess and provide treatment for patients with acute PE • exercise a full range of medical, surgical, and endovascular therapies • Provide multidisciplinary follow-up of patients • collect, evaluate and share data regarding the effectiveness of treatment rendered

• Institutional Logo Membership 2017 • >60 Member Institutions (40 Founding) • 50+ “Transitional” Member Institutions • 500+ Professional Members • PERT International… • “PERT fever” spreading around the globe • “PERT champions” from China, Brazil, Uganda, Turkey, Canada, Netherlands, India

• Institutional Logo PERT Consortium Activities • • PAID MEMBER INSTITUTIONS: 40 FOUNDING. 60+ now; >100 involved • • Annual Scientific PE Meeting • • Satellite symposia at national meetings • • Webinars • • “PERT-inent Updates” • • On-line library of references for PE • • Multicenter registry/database Published manuscripts Partner in clinical trials – PE TRACT Developing standardized clinical practice protocols Established governance structure Election proceedings Constituted Board of Directors Corporate Committee of nearly 20 industry partners

• Institutional Logo “The PERT Consortium is at the center of the PE universe, and is the most important opportunity to date for improvement in care and outcomes for patients with PE. ” -Michael Jaff

• Institutional Logo Future of PE Management • PE still poorly understood; much to learn…State of Art yet to be defined • New era: heightened awareness about need for coordinated institutional approach to a complex, life-threatening problem • OPTIMAL CARE WITH TEAM APPROACH! • PERT: a “model” program of interdisciplinary collaboration to streamline care, optimize outcomes, and develop better treatment paradigms • PERTTM Consortium • fills important unmet need • power of team-based care and collaboration across institutions • opportunity to expand knowledge base, educate providers & community, increase awareness, improve clinical practice & outcomes for patients

• Institutional Logo Get involved! …attend the annual PERT Business and PE CME Meetings in Nashville! June 21 PERT Consortium June 22 -23 CME Meeting