- Email: [email protected]
Development and Implementation of a Comprehensive, Multidisciplinary Emergency Department Extracorporeal Membrane Oxygenation Program
CARDIOLOGY/CONCEPTS
Development and Implementation of a Comprehensive, Multidisciplinary Emergency Department Extracorporeal Membrane Oxygenation Program Joseph E. Tonna, MD*; Craig H. Selzman, MD, FACS; Michael P. Mallin, MD; Brigham R. Smith, MD; Scott T. Youngquist, MD, MSc; Antigoni Koliopoulou, MD; Frederick Welt, MD; Kathleen Diane Stoddard, RN, BSN, CCRN; Ram Nirula, MD, MPH, FACS; Richard Barton, MD; James Franklin Fair III, MD; James C. Fang, MD, FACC, FAHA; Stephen McKellar, MD, MSc *Corresponding Author. E-mail: [email protected], Twitter: @JoeTonnaMD.
Despite advances in the medical and surgical management of cardiovascular disease, greater than 350,000 patients experience out-of-hospital cardiac arrest in the United States annually, with only a 12% neurologically favorable survival rate. Of these patients, 23% have an initial shockable rhythm of ventricular fibrillation/pulseless ventricular tachycardia (VF/VT), a marker of high probability of acute coronary ischemia (80%) as the precipitating factor. However, few patients (22%) will experience return of spontaneous circulation and sufficient hemodynamic stability to undergo cardiac catheterization and revascularization. Previous case series and observational studies have demonstrated the successful application of intra-arrest extracorporeal life support, including to out-of-hospital cardiac arrest victims, with a neurologically favorable survival rate of up to 53%. For patients with refractory cardiac arrest, strategies are needed to bridge them from out-of-hospital cardiac arrest to the catheterization laboratory and revascularization. To address this gap, we expanded our ICU and perioperative extracorporeal membrane oxygenation (ECMO) program to the emergency department (ED) to reach this cohort of patients to improve survival. In this report, we illustrate our process and initial experience of developing a multidisciplinary team for rapid deployment of ED ECMO as a template for institutions interested in building their own ED ECMO programs. [Ann Emerg Med. 2016;-:1-9.] 0196-0644/$-see front matter Copyright © 2016 by the American College of Emergency Physicians. http://dx.doi.org/10.1016/j.annemergmed.2016.10.001
INTRODUCTION Out-of-hospital cardiac arrest occurs in greater than 350,000 people annually in the United States; overall, neurologically intact survival occurs in only 12%.1,2 Ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) accounts for the initial rhythm in a significant percentage of patients (23%).1,3,4 Despite VF/VT alone being a strong independent predictor of survival (14.8% to 23%)5 compared with that for the overall population, the majority of patients with VF/VT out-of-hospital cardiac arrest do not survive. Among this group, approximately 80% of cases are due to acute cardiac ischemia.6 Furthermore, among the group of out-of-hospital cardiac arrest patients with VF/VT who achieve return of spontaneous circulation, coronary revascularization is associated with survival and a favorable neurologic outcome.7 Although the rate of survival to hospital discharge is highest in patients with bystanderwitnessed cardiac arrest (38.6%), only 6% of out-of-hospital cardiac arrests are witnessed.1 Thus, for patients in refractory cardiac arrest, despite favorable initial rhythm or bystander Volume
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cardiopulmonary resuscitation (CPR), survival remains poor (20%)8; patients require ongoing CPR, which often excludes them from mechanical revascularization or advanced therapies. These data strongly suggest that for patients with initial VF/VT who cannot be resuscitated with standard CPR, the addition of extracorporeal sustained perfusion bundled with percutaneous coronary intervention may result in a higher neurologically intact survival rate. The role of intra-arrest extracorporeal life support and extracorporeal membrane oxygenation (ECMO) for cardiac arrest has been previously described for out-ofhospital cardiac arrest.9-12 Among these published reports, causes of cardiac arrest vary from hypothermia to myocardial infarction, and the survival rate in these series ranges greatly (13% to 50%). Yet in the most recent study incorporating ECMO and protocoled interventions for refractory out-of-hospital cardiac arrest, the neurologically intact survival rate was 54%,12 suggesting improved outcomes with specific post-ECMO interventions. Annals of Emergency Medicine 1
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Given the improved outcomes associated with VF/VT out-of-hospital cardiac arrest and the high incidence of causal coronary lesions, we aimed to develop a program that would help bridge out-of-hospital cardiac arrest patients to coronary revascularization and improve outcomes. A primary goal of this program was the development of a multidisciplinary system to coordinate patient care across multiple silos within our medical system, ranging from emergency medical services (EMS), emergency department (ED), cardiac catheterization laboratory, cardiothoracic surgery, and ICU. Because we strongly believe that multidisciplinary support is essential for good outcomes, and we observed that our multidisciplinary program resulted in a high rate of successful initiation of ECMO during cardiac arrest in the ED, we describe our experience of design and implementation of a comprehensive and multidisciplinary program of ED ECMO as a template for institutions interested in building their own ED ECMO programs.
identification and correction (cardiac catheterization), myocardial recovery (ECMO, serial echocardiography, and left ventricular unloading), and post–cardiac arrest care.
PROGRAM DESIGN Before initiation of an ED ECMO program, the program leadership first had to identify the therapeutic goals and patient population for our program. The leadership identified refractory cardiac arrest patients with the potential for intact neurologic outcome as the ideal population (Figure 1). The goals included rapid establishment of sustained perfusion (ECMO), arrest cause
OUT-OF-HOSPITAL EMS There is wide variability across communities in regard to EMS out-of-hospital care of out-of-hospital cardiac arrest patients and hospital routing processes. In our community, EMS providers generally communicate with the closest ED to coordinate care. Specifically, EMS often complete resuscitations—including pronouncing death—in the field. The main thrust of our program development with EMS
THE OVERALL INSTITUTIONAL ECMO INFRASTRUCTURE AND STAKEHOLDER IDENTIFICATION This ED EMCO program was not created de novo, but rather as an extension of a well-established inhospital ECMO program that deployed venoarterial and venovenous ECMO in the operating room, catheterization laboratory, and ICU, with full support from hospital leadership. From that infrastructure, we incorporated new collaborators from the ED and previous stakeholders. Our working group for ED ECMO included physician and nursing leadership from the ED and ICU, EMS, cardiothoracic surgery, cardiac catheterization laboratory, and perfusion services.
Figure 1. Inclusion criteria for ED ECMO for out-of-hospital cardiac arrest. COPD, Chronic obstructive pulmonary disease; GI, gastrointestinal; CHF, congestive heart failure; VAD, ventricular assist device.
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consisted of education about our ED ECMO protocol’s inclusion and exclusion criteria and the need for highquality CPR both at the scene and during transport to the ED. To assist with the latter, EMS and ED stakeholders prioritized the purchase of mechanical CPR devices (LUCAS 2; Physio-Control Inc, Redmond, WA). EMERGENCY DEPARTMENT We identified a physician champion for the ED ECMO program in addition to support from nursing leadership. These champions were tasked with staff education, EMS communication and liaison, defining ED staff roles during ECMO placement, and development of the ED ECMO paging system and a modified and nurse-led resuscitation protocol during ECMO placement. The modifications to standard advanced cardiac life support included a continuous epinephrine infusion at a fixed dose of 0.7 mg/ kg per minute and minimization of pulse checks by using intra-arrest transesophageal echocardiography. Although we identified no data to support epinephrine infusions for resuscitation, we observed that the modification minimized interruptions during resuscitation while theoretically achieving the intention of increasing coronary perfusion. The use of continuous transesophageal echocardiography intra-arrest and during cannulation has been described.13-15 We have 3 emergency physicians who perform transesophageal echocardiography, all of whom have completed a fellowship in ultrasonography and undergone dedicated training on transesophageal echocardiography, including time spent performing examinations in the operating room with cardiac anesthesia. Endpoints of certification included the Examination of Special Competence in Adult Echocardiography (ASCeXAM). No new stakeholders from cardiothoracic surgery were needed for this ED EMCO collaborative effort. The greatest change was to identify how ED ECMO would fit into the division call schedule because cardiothoracic surgery was not in house. The second major change for cardiothoracic surgery to the established ECMO program was to work with emergency physicians for ECMO cannulation, whereas surgeons had been involved in all aspects of cannulation in other areas. CARDIOLOGY Because the goal of the ED ECMO program is to bridge patients with refractory out-of-hospital cardiac arrest to potentially lifesaving percutaneous coronary interventions, commitment from cardiology and the cardiac catheterization laboratory is essential. Just as with any percutaneous coronary intervention for ST-segment Volume
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elevation myocardial infarction, we sought to minimize the door-to-balloon time. Cardiology and catheterization laboratory stakeholders were included in our earliest discussions of expanding ECMO services into the ED. Cardiology leadership was fully supportive of being involved in ED ECMO activation pages and early mobilization of the catheterization laboratory, just as they would be during an ST-segment elevation myocardial infarction activation. ED ECMO patients use more laboratory time because, in addition to percutaneous coronary intervention, some work may be required for either establishing distal limb perfusion to the leg with the ECMO arterial cannula or decompressing the left ventricle. Quality metrics for the catheterization laboratory must be addressed because periprocedural outcomes, specifically mortality, are widely available data. The literature standard for best-case survival is 45% to 50% for refractory out-ofhospital cardiac arrest patients; cardiology leadership must be comfortable with accepting these high-risk patients who may alter overall quality metrics. NURSING After the coronary catheterization laboratory procedures, ED ECMO patients go directly to the cardiovascular ICU to be cared for by the ICU attending physicians (in house continuously) and nursing staff. From the outset of the program, we identified an ICU nurse champion who took a leading role in training, continuing education, and ensuring crash bed availability. Before initiating the program, we needed support from our ICU nurses to care for these critically ill patients. Concerns were raised that patients would be receiving ECMO for weeks, which can take a toll on morale. When presented with data that most patients are either decannulated successfully or die within a few days, nursing staff expressed full support. PERFUSION SERVICES Our perfusionists have always played a key role in our ECMO program and continued as such. They were tasked largely with equipment (durable and disposables) and assisting with pump priming, console turnover, and supporting our ICU teams, although they are not strictly required for initiation of support. CONSULTING SERVICES Post–cardiac arrest care involves temperature management, neuroimaging, seizure monitoring, and treatment. We sought engagement from neurology and neurocritical care, with agreements or protocols for temperature management and rewarming, timing of Annals of Emergency Medicine 3
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prognostication, neuroimaging or neuromonitoring, and family discussions. Although neuroprognostication has not been clearly developed for the out-of-hospital cardiac arrest victim undergoing ECMO support, we adapted existing clinical guidelines and describe our protocol under “Process.” We discussed with vascular and endovascular surgery the potential need to assist with peripheral vascular complications. We also engaged our echocardiography colleagues (emergency, cardiology, and anesthesia physicians) and have found their contributions in the ED, catheterization laboratory, and ICU invaluable.
In accordance with our experience, we strongly advise against attempted de novo creation of a stand-alone ED ECMO program because the postcannulation care systems (including cardiac catheterization, ICU management, neuroprognostication, and post decannulation management) are critical to a successful program. Additionally, a description of the costs associated with a full de novo ECMO program creation is beyond the scope of this article. After discussions about expected outcomes and resource use, hospital administration was supportive of this application of ECMO.
EXTRACORPOREAL LIFE SUPPORT SYSTEMS AND CONFIGURATION The basic design of an extracorporeal life support system includes the following components in series: patient outflow cannula (typically 17 to 27 F), centrifugal pump, oxygenator (which serves to oxygenate and remove carbon dioxide), and patient inflow cannula (typically 15 to 19 F). This basic configuration can withdraw and return blood to the venous system (venovenous ECMO) for lung-only support, or from the venous to the arterial system (venoarterial ECMO) for heart and lung support. This latter configuration is used for ED ECMO and extracorporeal CPR. For extracorporeal CPR or ED ECMO, the venous and arterial cannulas are placed percutaneously into the femoral vessels; the patient inflow cannula (placed in the patient’s artery) introduces oxygenated blood under pressure to the femoral artery and distal aorta, which flows retrogradely up the aorta. For planned cardiac support cases in which the patient is not in extremis, central cannulation may occur, in which cannulas are placed surgically into the great vessels, involving a thoracotomy or sternotomy. Axillary surgical approaches for venoarterial ECMO have been described.16
CAPITAL EXPENSES If an additional ECMO console is allocated to ED ECMO cases, this becomes the initial capital expense. There are 4 consoles in routine ICU use in the United States (Maquet Rotaflow [Maquet Cardiovascular, LLC, Wayne, NJ], Maquet Cardiohelp [Maquet Cardiovascular, LLC], Thoratec Centrimag [Thoratec Corporation, Pleasanton, CA], and Sorin Revolution [Sorin Group USA Inc, Arvada, CO]). We ultimately chose the Rotaflow console because of its comparative cost (manufacturer list prices: Rotaflow $42,000; Cardiohelp $110,250; and Centrimag $43,36017), because our institution had extensive experience with it, and because of its lower consumable component cost (see “Consumable Expenses”). A secondary capital expense is the consideration of mechanical CPR devices ($14,495).18 The superiority of mechanical CPR in out-of-hospital cardiac arrest is not clear,19 but we found that on a patient’s arrival to the ED, immediate application facilitated a more calm and quiet environment, facilitated continuous quality compressions, provided less movement of the patient for easier cannulation, and provided more working space.
EQUIPMENT AND FINANCIALS Costs associated with ED ECMO comprise capital and consumable expenses (ECMO console and components), physical space (for storing the console and supplies), staff resources (bed use, angiography laboratory, auxiliary therapies, and tests), multiple services, and the effort of iterative process analysis, improvement, and education. In our experience, a successful ED ECMO program grows from an established inpatient ECMO program, and as such, the additional equipment costs are consumable costs per additional patient,17 along with use of existing auxiliary services. Physical space in the ED was allocated for consumable resources such as vascular access lines and sterile gowns. 4 Annals of Emergency Medicine
CONSUMABLE EXPENSES The consumable costs for an ECMO circuit include the oxygenator, pump head, priming fluid, tubing, and the staff cost to maintain. The most widely used oxygenator approved for use in the United States for ICU ECMO is the Maquet Quadrox [Maquet Cardiovascular, LLC], which can be used for either the Maquet Rotaflow or Thoratec Centrimag console. The pump heads for each of these circuits are structurally distinct, with a significant cost differential ($447 versus $12,000, respectively).17 The Maquet Cardiohelp console uses an integrated pump head and oxygenator ($13,781)17 and is designed for transport. Our protocol is to keep a Rotaflow console primed and ready for any ECMO services (ED or otherwise). Our cardiothoracic surgeons already had a full array of arterial Volume
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and venous cannulas for their ECMO program. The only changes made were in placing the most commonly used cannulas on the portable ECMO cart rather than storing them in the operating room. Additionally, catheters for distal limb perfusion were also added to the portable cart. For institutions with established ECMO programs, the per-patient consumable costs (tubing, pump head, oxygenator, etc) vary from $2,447 to $14,000.17 The degree of involvement of cardiothoracic surgery, perfusion, and nursing, along with observed length of stay, will determine staffing and hospital costs, for which there are no published data on ED ECMO. As we articulated above, for programs without established ECMO programs, the cost of a new console ($42,000 to $110,250) is minimal, and the equipment alone inadequate, compared with the cost required for the personnel and structure necessary to sustain a successful ECMO program.
EDUCATION AND TRAINING The process of staff education includes components targeting physicians and providers, nursing and perfusion, and support staff. For our cardiothoracic surgeons, the application of emergency salvage ECMO was not new because they had already performed ECMO placement percutaneously and by cut down. For our emergency physicians, to focus on the cannulation process, they adopted a protocol- and nurse-run resuscitation. For our emergency support staff, establishing a sterile field in the midst of a resuscitation required adopting hats and masks and behavior modification. For our cardiologists, performing cardiac angiography during full ECMO support required acceptance of new staff and equipment in the angiography suite. EMS providers were trained by didactic sessions incorporated into their biannual cardiac arrest resuscitation training. A checklist with selection criteria was also provided to out-of-hospital personnel.
ICU MANAGEMENT The management of ECMO patients in the ICU requires specialty training around ECMO console operation. We found that best practice for the ECMO patient included both subtle and frank modifications to “routine” critical care. Anticoagulation, sedation, analgesia, ventilator management, nutrition, and hemodynamic support are all different. For example, the adsorption of drugs in the circuit alters patients’ plasma levels; we use ultralung protective settings for our ECMO patients; inotropic support is almost always needed to ensure left ventricular contraction and aortic valve opening. In general, Volume
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the print resources, educational courses, conferences, and expertise offered through the Extracorporeal Life Support Organization are highly recommended. BARRIERS TO PROGRAM IMPLEMENTATION The recognition that as an institution we had a multiyear history of successful ICU-based ECMO management predicated our actions to develop an ED ECMO program. Communication with EMS and the ED streamlined the transition of care from the field with ongoing CPR. The ICU components of an ECMO run compose the bulk of the time and management. Whether they include continuous bedside perfusionist staffing, ECMO-trained nurses, 2:1 nursing:patient ratios, or inhouse intensivists, these details are less important than the institutional and staff comfort with managing ECMO patients and a history of successful outcomes. Additionally, our institution had experience with salvage (performed during cardiac arrest) ECMO, and so the extension to the ED was not burdened by learning the cannulation procedure during cardiac arrest itself. Finally, it was important to see the published patient outcomes10,12,20 of extracorporeal CPR for in-house and out-of-hospital cardiac arrest to demonstrate to stakeholders that as a clinical initiative, our program had predicate models across the country, with acceptable outcomes.
OUTCOME TRACKING ED ECMO, as a subset of ICU-based venoarterial ECMO, or even of salvage venoarterial ECMO, is a yet immature application. We have found the learning curve to be steep and the acquisition of best practice lessons important to process improvement, facilitated by regular analysis. The Extracorporeal Life Support Organization maintains an international registry for all ECMO patients to which member programs submit data. Additionally, in an effort to share best practices around ED ECMO, provide a supportive community for clinicians, gather ED ECMO–specific data, and conduct multi-institutional research,21 the Extracorporeal Resuscitation Consortium (http://www.erectcollaborative.org) group maintains an “Extracorporeal Life Support Organization–compatible” patient data registry, has quarterly conference call Webinars among member programs, and aims to establish best practice standards for ED ECMO. To increase knowledge around appropriate evidence-based application of extracorporeal CPR or ED ECMO, we advocate that all ED ECMO programs participate in these 2 organizations and submit data. Annals of Emergency Medicine 5
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PROCESS ED ECMO Protocol Offered Online The University of Utah ED ECMO (Appendix S1, available online at http://www.annemergmed.com) program has evaluation and activation levels with associated page groups. The “EVAL” page is initiated by the ED charge nurse in conjunction with the ED attending physician; they receive base calls from EMS and identify any patients who meet the inclusion criteria (Figure 2). The EVAL page goes out before patient arrival and includes the cardiothoracic surgeon on call, the inhouse cardiovascular ICU intensivist, the interventional cardiologist, the cardiovascular ICU charge nurse or ECMO charge nurse, the house supervisor, and the ED echocardiography group. Meanwhile, the room is prepared with 2 sets of 6-F sheaths, PIK Kits (Percutaneous Insertion Kit—Venous [Edwards Lifesciences, Irvine, CA]), with sterile gowns and gloves, plus hats and masks for all room occupants. The mechanical CPR device is placed on the patient in the ambulance bay, before being transferred to the ED resuscitation room to facilitate quality compressions during transitions and gurney transport. Both groins are prepped and draped to allow 2 already sterile-gowned emergency physicians to begin obtaining bilateral femoral
vascular access. Once it is obtained, the sheaths and long PIK wires are advanced. The venous wire is visualized in the right atrial superior vena cava junction with transesophageal echocardiography. This entire process can happen without necessarily proceeding with activation or the presence of other team members, including cardiothoracic surgery, the ECMO charge nurse, or cardiology. For the process to move from evaluation to activation, confirmation of the availability of a cardiovascular ICU charge nurse or ECMO charge nurse (both bed and staffing availability), a catheterization laboratory by the interventional cardiologist, and a cardiothoracic surgeon for initial cannulation should be made. All 3 individuals must agree on the appropriateness of the patient for ECMO. The previously primed ECMO circuit and a cart with cannulas and extra supplies are brought to the resuscitation room by the cardiovascular ICU charge nurse or ECMO charge nurse. Once determination of candidate appropriateness is made, the second-tier activation process activates the catheterization laboratory and anesthesia. Bilateral cannulation is initiated by cardiothoracic surgery, emergency medicine, or the intensivist. Venous and arterial cannulation is confirmed by transesophageal echocardiography15 or transabdominal
Figure 2. ED ECMO process map.
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ultrasonography. In general, we use the smallest arterial and venous cannula, working under the assumption that early initiation of ECMO is important and smaller cannulas are quicker to insert. The ECMO charge nurse assists in connecting the circuit and manages the console. Once flow is adequate, vasopressors and inotropes are adjusted and the patient is transported to the catheterization laboratory for angiography, assessment of left ventricular function with decompression (as needed), and establishment of distal limb perfusion (as needed).21 For patients with little to no left ventricular function after initiation of ECMO (demonstrated by lack of ejection through the aortic valve), a vent to decompress the left ventricle and facilitate recovery is indicated. Left ventricular decompression can be performed, among other ways,21,22 with either an Impella percutaneous left ventricular assist device or with a left ventricular vent through the right superior pulmonary vein approached by a mini–right thoracotomy. On arrival in the cardiovascular ICU, patients are managed at the bedside by an ECMO-trained charge nurse, with direction from the ICU intensivist and cardiothoracic surgeon. Patients who are not following commands or are comatose undergo electroencephalogram (EEG), computed tomography, and targeted temperature management (at 36 C [96.8 F]) for 24 hours. After 24 hours, patients are warmed to 37 C [98.6 F]. We attempt to wean ECMO during 3 to 7 days, or as rapidly as possible, to achieve an “ECMO-free” assessment of patients’ postarrest cardiac and neurologic function. Neurology and neurocritical care consultants provide neuroprognostication, which, for patients not waking up spontaneously, is generally accomplished with serial detailed clinical examination, neuroimaging, continuous EEG, and biomarkers (neuron-specific enolase). Our discussions with families are transparent and direct, and have been well received. Management of patients treated with ED ECMO for out-of-hospital cardiac arrest primarily differs from standard venoarterial ECMO in only 3 additional ways: environment (patients are cannulated in the ED during full cardiac arrest), postcannulation angiography (patients undergo protocoled coronary angiography [echocardiography, distal perfusion catheter placement, and left ventricular unloading are standard venoarterial ECMO components]), and neuroprognostication and targeted temperature management. Vascular complications are higher with intra-arrest percutaneous approaches, although we have found that the primary complication is failure to obtain access and initiate ECMO rather than need for repair. Volume
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TEAM PERFORMANCE Before program launch, dry runs of the entire process were carried out to physically wheel a “patient” on a bed from the ambulance bay through the catheterization laboratory and then ICU, test the paging process, ensure all components were present for cannulation, and test the roles and behavior of team members. The dry runs served to introduce staff who did not help design the program to the process. CASES AND OUTCOMES After the official initiation of our ED ECMO program in April 2015, there was a 3-month delay until the first patient, which we attributed in part to lack of program awareness among EMS because we did not reroute patients from their standard hospital destinations and did not broadly advertise among out-of-hospital providers. During the subsequent 6 months, the program had 15 patient alerts for possible ECMO, of which we activated for ECMO in 8 patients. The most common reasons for failure to progress to activation were morbid obesity and changes on EMS arrival in witnessed arrest and time without CPR. Six of 8 patients were successfully placed on ECMO; morbid obesity was a barrier to successful cannulation in 2 cases. Four of 6 patients were cannulated in the ED; the remaining 2 achieved return of spontaneous circulation in the ED but rearrested in the cardiac catheterization laboratory and then were placed on ECMO. Among the 4 patients cannulated in the ED, specialties of physicians placing the cannulas variously included emergency medicine, critical care, and cardiothoracic surgery, with each case using more than 1 provider. Emergency medicine and cardiothoracic surgery were involved in all cases. As stated in the “Process” section, the cardiothoracic surgeon must be available for cannulations and is ultimately privileged to initiate ECMO, but as can be seen, with collaboration, the decision or “privilege” to administer ECMO to a patient becomes a discussion, with the process initiated by emergency physicians and the cannulation performed most often by emergency medicine and cardiothoracic surgery together. Three of 6 patients successfully cannulated for ECMO survived to hospital discharge. ITERATIVE REASSESSMENTS After each of the first few cases, feedback was solicited from key representatives at each stage (ED, catheterization laboratory, and ICU). We make an explicit ongoing effort among programmatic leadership to solicit feedback, offering opportunities for stakeholders to take ownership of Annals of Emergency Medicine 7
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certain processes. We identified improvements for equipment storage locations, drug dosing, and protocol refinement, along with team makeup. We began tracking quality metrics, including time to vascular access, time to ECMO, and door-to-balloon time. CONCLUSION In accordance with our experience, we advise that ED ECMO programs be developed within the context of an existing and mature ICU or perioperative ECMO program and have multidisciplinary collaboration from out-of-hospital through the entire ICU course. The value of an ED ECMO program lies in the ability to temporally bridge the patient with adequate organ perfusion to a therapeutic intervention, such as percutaneous coronary intervention. Without a clear therapeutic goal and interventions to achieve it, the application of ED ECMO adds only cost and prolongation of the end of life. Conversely, the appropriate measured application of ED ECMO to select victims of out-of-hospital cardiac arrest in conjunction with practiced efforts to reverse the inciting cause of arrest may offer one of greatest possible increases in survival of any bundled medical therapy. The authors acknowledge the nurses, support staff, physicians, and leadership at the University of Utah who, through their enthusiastic effort and belief in our mission, enabled the creation of a robust extracorporeal resuscitation program and exceptional patient outcomes. Supervising editor: Keith A. Marill, MD Author affiliations: From the Division of Cardiothoracic Surgery (Tonna, Selzman, Koliopoulou, McKellar), the Division of Emergency Medicine (Tonna, Youngquist, Fair, Mallin), and the Division of General Surgery (Nirula, Barton), the Department of Surgery, University of Utah School of Medicine, Salt Lake City, UT; the Division of Cardiovascular Medicine, Interventional Cardiology Section, Department of Medicine (Smith, Welt), and the Cardiovascular Intensive Care Unit, Staff Nurse Operating Room (Stoddard), University of Utah, Salt Lake City, UT; and the Division of Cardiovascular Medicine, the Department of Medicine (Fang), University of Utah Health Sciences Center, Salt Lake City, UT. Author contributions: All authors made substantial contributions to all of the following: concept and design of the study, acquisition of data, and analysis and interpretation of data; drafting the article or revising it critically for important intellectual content; and final approval of the version to be submitted. Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. Dr. Welt reports receiving consulting fees from Medtronic Advisory Board outside the scope of the submitted work.
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Publication dates: Received for publication July 22, 2016. Revision received September 30, 2016. Accepted for publication October 3, 2016.
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20. Sakamoto T, Morimura N, Nagao K, et al. Extracorporeal cardiopulmonary resuscitation versus conventional cardiopulmonary resuscitation in adults with out-of-hospital cardiac arrest: a prospective observational study. Resuscitation. 2014;85:762-768. 21. Tonna JE, Johnson NJ, Greenwood J, et al. Practice characteristics of emergency department extracorporeal cardiopulmonary resuscitation (eCPR) programs in the United States: the current state of the art of emergency department extracorporeal membrane oxygenation (ED ECMO). Resuscitation. 2016;107: 38-46. 22. Aiyagari RM, Rocchini AP, Remenapp RT, et al. Decompression of the left atrium during extracorporeal membrane oxygenation using a transseptal cannula incorporated into the circuit. Crit Care Med. 2006;34:2603-2606.
Annals of Emergency Medicine 9
Development and Implementation of a Comprehensive, Multidisciplinary Emergency Department Extracorporeal Membrane Oxygenation Program Joseph E. Tonna, MD*; Craig H. Selzman, MD, FACS; Michael P. Mallin, MD; Brigham R. Smith, MD; Scott T. Youngquist, MD, MSc; Antigoni Koliopoulou, MD; Frederick Welt, MD; Kathleen Diane Stoddard, RN, BSN, CCRN; Ram Nirula, MD, MPH, FACS; Richard Barton, MD; James Franklin Fair III, MD; James C. Fang, MD, FACC, FAHA; Stephen McKellar, MD, MSc *Corresponding Author. E-mail: [email protected], Twitter: @JoeTonnaMD.
Despite advances in the medical and surgical management of cardiovascular disease, greater than 350,000 patients experience out-of-hospital cardiac arrest in the United States annually, with only a 12% neurologically favorable survival rate. Of these patients, 23% have an initial shockable rhythm of ventricular fibrillation/pulseless ventricular tachycardia (VF/VT), a marker of high probability of acute coronary ischemia (80%) as the precipitating factor. However, few patients (22%) will experience return of spontaneous circulation and sufficient hemodynamic stability to undergo cardiac catheterization and revascularization. Previous case series and observational studies have demonstrated the successful application of intra-arrest extracorporeal life support, including to out-of-hospital cardiac arrest victims, with a neurologically favorable survival rate of up to 53%. For patients with refractory cardiac arrest, strategies are needed to bridge them from out-of-hospital cardiac arrest to the catheterization laboratory and revascularization. To address this gap, we expanded our ICU and perioperative extracorporeal membrane oxygenation (ECMO) program to the emergency department (ED) to reach this cohort of patients to improve survival. In this report, we illustrate our process and initial experience of developing a multidisciplinary team for rapid deployment of ED ECMO as a template for institutions interested in building their own ED ECMO programs. [Ann Emerg Med. 2016;-:1-9.] 0196-0644/$-see front matter Copyright © 2016 by the American College of Emergency Physicians. http://dx.doi.org/10.1016/j.annemergmed.2016.10.001
INTRODUCTION Out-of-hospital cardiac arrest occurs in greater than 350,000 people annually in the United States; overall, neurologically intact survival occurs in only 12%.1,2 Ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) accounts for the initial rhythm in a significant percentage of patients (23%).1,3,4 Despite VF/VT alone being a strong independent predictor of survival (14.8% to 23%)5 compared with that for the overall population, the majority of patients with VF/VT out-of-hospital cardiac arrest do not survive. Among this group, approximately 80% of cases are due to acute cardiac ischemia.6 Furthermore, among the group of out-of-hospital cardiac arrest patients with VF/VT who achieve return of spontaneous circulation, coronary revascularization is associated with survival and a favorable neurologic outcome.7 Although the rate of survival to hospital discharge is highest in patients with bystanderwitnessed cardiac arrest (38.6%), only 6% of out-of-hospital cardiac arrests are witnessed.1 Thus, for patients in refractory cardiac arrest, despite favorable initial rhythm or bystander Volume
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cardiopulmonary resuscitation (CPR), survival remains poor (20%)8; patients require ongoing CPR, which often excludes them from mechanical revascularization or advanced therapies. These data strongly suggest that for patients with initial VF/VT who cannot be resuscitated with standard CPR, the addition of extracorporeal sustained perfusion bundled with percutaneous coronary intervention may result in a higher neurologically intact survival rate. The role of intra-arrest extracorporeal life support and extracorporeal membrane oxygenation (ECMO) for cardiac arrest has been previously described for out-ofhospital cardiac arrest.9-12 Among these published reports, causes of cardiac arrest vary from hypothermia to myocardial infarction, and the survival rate in these series ranges greatly (13% to 50%). Yet in the most recent study incorporating ECMO and protocoled interventions for refractory out-of-hospital cardiac arrest, the neurologically intact survival rate was 54%,12 suggesting improved outcomes with specific post-ECMO interventions. Annals of Emergency Medicine 1
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Given the improved outcomes associated with VF/VT out-of-hospital cardiac arrest and the high incidence of causal coronary lesions, we aimed to develop a program that would help bridge out-of-hospital cardiac arrest patients to coronary revascularization and improve outcomes. A primary goal of this program was the development of a multidisciplinary system to coordinate patient care across multiple silos within our medical system, ranging from emergency medical services (EMS), emergency department (ED), cardiac catheterization laboratory, cardiothoracic surgery, and ICU. Because we strongly believe that multidisciplinary support is essential for good outcomes, and we observed that our multidisciplinary program resulted in a high rate of successful initiation of ECMO during cardiac arrest in the ED, we describe our experience of design and implementation of a comprehensive and multidisciplinary program of ED ECMO as a template for institutions interested in building their own ED ECMO programs.
identification and correction (cardiac catheterization), myocardial recovery (ECMO, serial echocardiography, and left ventricular unloading), and post–cardiac arrest care.
PROGRAM DESIGN Before initiation of an ED ECMO program, the program leadership first had to identify the therapeutic goals and patient population for our program. The leadership identified refractory cardiac arrest patients with the potential for intact neurologic outcome as the ideal population (Figure 1). The goals included rapid establishment of sustained perfusion (ECMO), arrest cause
OUT-OF-HOSPITAL EMS There is wide variability across communities in regard to EMS out-of-hospital care of out-of-hospital cardiac arrest patients and hospital routing processes. In our community, EMS providers generally communicate with the closest ED to coordinate care. Specifically, EMS often complete resuscitations—including pronouncing death—in the field. The main thrust of our program development with EMS
THE OVERALL INSTITUTIONAL ECMO INFRASTRUCTURE AND STAKEHOLDER IDENTIFICATION This ED EMCO program was not created de novo, but rather as an extension of a well-established inhospital ECMO program that deployed venoarterial and venovenous ECMO in the operating room, catheterization laboratory, and ICU, with full support from hospital leadership. From that infrastructure, we incorporated new collaborators from the ED and previous stakeholders. Our working group for ED ECMO included physician and nursing leadership from the ED and ICU, EMS, cardiothoracic surgery, cardiac catheterization laboratory, and perfusion services.
Figure 1. Inclusion criteria for ED ECMO for out-of-hospital cardiac arrest. COPD, Chronic obstructive pulmonary disease; GI, gastrointestinal; CHF, congestive heart failure; VAD, ventricular assist device.
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consisted of education about our ED ECMO protocol’s inclusion and exclusion criteria and the need for highquality CPR both at the scene and during transport to the ED. To assist with the latter, EMS and ED stakeholders prioritized the purchase of mechanical CPR devices (LUCAS 2; Physio-Control Inc, Redmond, WA). EMERGENCY DEPARTMENT We identified a physician champion for the ED ECMO program in addition to support from nursing leadership. These champions were tasked with staff education, EMS communication and liaison, defining ED staff roles during ECMO placement, and development of the ED ECMO paging system and a modified and nurse-led resuscitation protocol during ECMO placement. The modifications to standard advanced cardiac life support included a continuous epinephrine infusion at a fixed dose of 0.7 mg/ kg per minute and minimization of pulse checks by using intra-arrest transesophageal echocardiography. Although we identified no data to support epinephrine infusions for resuscitation, we observed that the modification minimized interruptions during resuscitation while theoretically achieving the intention of increasing coronary perfusion. The use of continuous transesophageal echocardiography intra-arrest and during cannulation has been described.13-15 We have 3 emergency physicians who perform transesophageal echocardiography, all of whom have completed a fellowship in ultrasonography and undergone dedicated training on transesophageal echocardiography, including time spent performing examinations in the operating room with cardiac anesthesia. Endpoints of certification included the Examination of Special Competence in Adult Echocardiography (ASCeXAM). No new stakeholders from cardiothoracic surgery were needed for this ED EMCO collaborative effort. The greatest change was to identify how ED ECMO would fit into the division call schedule because cardiothoracic surgery was not in house. The second major change for cardiothoracic surgery to the established ECMO program was to work with emergency physicians for ECMO cannulation, whereas surgeons had been involved in all aspects of cannulation in other areas. CARDIOLOGY Because the goal of the ED ECMO program is to bridge patients with refractory out-of-hospital cardiac arrest to potentially lifesaving percutaneous coronary interventions, commitment from cardiology and the cardiac catheterization laboratory is essential. Just as with any percutaneous coronary intervention for ST-segment Volume
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elevation myocardial infarction, we sought to minimize the door-to-balloon time. Cardiology and catheterization laboratory stakeholders were included in our earliest discussions of expanding ECMO services into the ED. Cardiology leadership was fully supportive of being involved in ED ECMO activation pages and early mobilization of the catheterization laboratory, just as they would be during an ST-segment elevation myocardial infarction activation. ED ECMO patients use more laboratory time because, in addition to percutaneous coronary intervention, some work may be required for either establishing distal limb perfusion to the leg with the ECMO arterial cannula or decompressing the left ventricle. Quality metrics for the catheterization laboratory must be addressed because periprocedural outcomes, specifically mortality, are widely available data. The literature standard for best-case survival is 45% to 50% for refractory out-ofhospital cardiac arrest patients; cardiology leadership must be comfortable with accepting these high-risk patients who may alter overall quality metrics. NURSING After the coronary catheterization laboratory procedures, ED ECMO patients go directly to the cardiovascular ICU to be cared for by the ICU attending physicians (in house continuously) and nursing staff. From the outset of the program, we identified an ICU nurse champion who took a leading role in training, continuing education, and ensuring crash bed availability. Before initiating the program, we needed support from our ICU nurses to care for these critically ill patients. Concerns were raised that patients would be receiving ECMO for weeks, which can take a toll on morale. When presented with data that most patients are either decannulated successfully or die within a few days, nursing staff expressed full support. PERFUSION SERVICES Our perfusionists have always played a key role in our ECMO program and continued as such. They were tasked largely with equipment (durable and disposables) and assisting with pump priming, console turnover, and supporting our ICU teams, although they are not strictly required for initiation of support. CONSULTING SERVICES Post–cardiac arrest care involves temperature management, neuroimaging, seizure monitoring, and treatment. We sought engagement from neurology and neurocritical care, with agreements or protocols for temperature management and rewarming, timing of Annals of Emergency Medicine 3
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prognostication, neuroimaging or neuromonitoring, and family discussions. Although neuroprognostication has not been clearly developed for the out-of-hospital cardiac arrest victim undergoing ECMO support, we adapted existing clinical guidelines and describe our protocol under “Process.” We discussed with vascular and endovascular surgery the potential need to assist with peripheral vascular complications. We also engaged our echocardiography colleagues (emergency, cardiology, and anesthesia physicians) and have found their contributions in the ED, catheterization laboratory, and ICU invaluable.
In accordance with our experience, we strongly advise against attempted de novo creation of a stand-alone ED ECMO program because the postcannulation care systems (including cardiac catheterization, ICU management, neuroprognostication, and post decannulation management) are critical to a successful program. Additionally, a description of the costs associated with a full de novo ECMO program creation is beyond the scope of this article. After discussions about expected outcomes and resource use, hospital administration was supportive of this application of ECMO.
EXTRACORPOREAL LIFE SUPPORT SYSTEMS AND CONFIGURATION The basic design of an extracorporeal life support system includes the following components in series: patient outflow cannula (typically 17 to 27 F), centrifugal pump, oxygenator (which serves to oxygenate and remove carbon dioxide), and patient inflow cannula (typically 15 to 19 F). This basic configuration can withdraw and return blood to the venous system (venovenous ECMO) for lung-only support, or from the venous to the arterial system (venoarterial ECMO) for heart and lung support. This latter configuration is used for ED ECMO and extracorporeal CPR. For extracorporeal CPR or ED ECMO, the venous and arterial cannulas are placed percutaneously into the femoral vessels; the patient inflow cannula (placed in the patient’s artery) introduces oxygenated blood under pressure to the femoral artery and distal aorta, which flows retrogradely up the aorta. For planned cardiac support cases in which the patient is not in extremis, central cannulation may occur, in which cannulas are placed surgically into the great vessels, involving a thoracotomy or sternotomy. Axillary surgical approaches for venoarterial ECMO have been described.16
CAPITAL EXPENSES If an additional ECMO console is allocated to ED ECMO cases, this becomes the initial capital expense. There are 4 consoles in routine ICU use in the United States (Maquet Rotaflow [Maquet Cardiovascular, LLC, Wayne, NJ], Maquet Cardiohelp [Maquet Cardiovascular, LLC], Thoratec Centrimag [Thoratec Corporation, Pleasanton, CA], and Sorin Revolution [Sorin Group USA Inc, Arvada, CO]). We ultimately chose the Rotaflow console because of its comparative cost (manufacturer list prices: Rotaflow $42,000; Cardiohelp $110,250; and Centrimag $43,36017), because our institution had extensive experience with it, and because of its lower consumable component cost (see “Consumable Expenses”). A secondary capital expense is the consideration of mechanical CPR devices ($14,495).18 The superiority of mechanical CPR in out-of-hospital cardiac arrest is not clear,19 but we found that on a patient’s arrival to the ED, immediate application facilitated a more calm and quiet environment, facilitated continuous quality compressions, provided less movement of the patient for easier cannulation, and provided more working space.
EQUIPMENT AND FINANCIALS Costs associated with ED ECMO comprise capital and consumable expenses (ECMO console and components), physical space (for storing the console and supplies), staff resources (bed use, angiography laboratory, auxiliary therapies, and tests), multiple services, and the effort of iterative process analysis, improvement, and education. In our experience, a successful ED ECMO program grows from an established inpatient ECMO program, and as such, the additional equipment costs are consumable costs per additional patient,17 along with use of existing auxiliary services. Physical space in the ED was allocated for consumable resources such as vascular access lines and sterile gowns. 4 Annals of Emergency Medicine
CONSUMABLE EXPENSES The consumable costs for an ECMO circuit include the oxygenator, pump head, priming fluid, tubing, and the staff cost to maintain. The most widely used oxygenator approved for use in the United States for ICU ECMO is the Maquet Quadrox [Maquet Cardiovascular, LLC], which can be used for either the Maquet Rotaflow or Thoratec Centrimag console. The pump heads for each of these circuits are structurally distinct, with a significant cost differential ($447 versus $12,000, respectively).17 The Maquet Cardiohelp console uses an integrated pump head and oxygenator ($13,781)17 and is designed for transport. Our protocol is to keep a Rotaflow console primed and ready for any ECMO services (ED or otherwise). Our cardiothoracic surgeons already had a full array of arterial Volume
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and venous cannulas for their ECMO program. The only changes made were in placing the most commonly used cannulas on the portable ECMO cart rather than storing them in the operating room. Additionally, catheters for distal limb perfusion were also added to the portable cart. For institutions with established ECMO programs, the per-patient consumable costs (tubing, pump head, oxygenator, etc) vary from $2,447 to $14,000.17 The degree of involvement of cardiothoracic surgery, perfusion, and nursing, along with observed length of stay, will determine staffing and hospital costs, for which there are no published data on ED ECMO. As we articulated above, for programs without established ECMO programs, the cost of a new console ($42,000 to $110,250) is minimal, and the equipment alone inadequate, compared with the cost required for the personnel and structure necessary to sustain a successful ECMO program.
EDUCATION AND TRAINING The process of staff education includes components targeting physicians and providers, nursing and perfusion, and support staff. For our cardiothoracic surgeons, the application of emergency salvage ECMO was not new because they had already performed ECMO placement percutaneously and by cut down. For our emergency physicians, to focus on the cannulation process, they adopted a protocol- and nurse-run resuscitation. For our emergency support staff, establishing a sterile field in the midst of a resuscitation required adopting hats and masks and behavior modification. For our cardiologists, performing cardiac angiography during full ECMO support required acceptance of new staff and equipment in the angiography suite. EMS providers were trained by didactic sessions incorporated into their biannual cardiac arrest resuscitation training. A checklist with selection criteria was also provided to out-of-hospital personnel.
ICU MANAGEMENT The management of ECMO patients in the ICU requires specialty training around ECMO console operation. We found that best practice for the ECMO patient included both subtle and frank modifications to “routine” critical care. Anticoagulation, sedation, analgesia, ventilator management, nutrition, and hemodynamic support are all different. For example, the adsorption of drugs in the circuit alters patients’ plasma levels; we use ultralung protective settings for our ECMO patients; inotropic support is almost always needed to ensure left ventricular contraction and aortic valve opening. In general, Volume
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the print resources, educational courses, conferences, and expertise offered through the Extracorporeal Life Support Organization are highly recommended. BARRIERS TO PROGRAM IMPLEMENTATION The recognition that as an institution we had a multiyear history of successful ICU-based ECMO management predicated our actions to develop an ED ECMO program. Communication with EMS and the ED streamlined the transition of care from the field with ongoing CPR. The ICU components of an ECMO run compose the bulk of the time and management. Whether they include continuous bedside perfusionist staffing, ECMO-trained nurses, 2:1 nursing:patient ratios, or inhouse intensivists, these details are less important than the institutional and staff comfort with managing ECMO patients and a history of successful outcomes. Additionally, our institution had experience with salvage (performed during cardiac arrest) ECMO, and so the extension to the ED was not burdened by learning the cannulation procedure during cardiac arrest itself. Finally, it was important to see the published patient outcomes10,12,20 of extracorporeal CPR for in-house and out-of-hospital cardiac arrest to demonstrate to stakeholders that as a clinical initiative, our program had predicate models across the country, with acceptable outcomes.
OUTCOME TRACKING ED ECMO, as a subset of ICU-based venoarterial ECMO, or even of salvage venoarterial ECMO, is a yet immature application. We have found the learning curve to be steep and the acquisition of best practice lessons important to process improvement, facilitated by regular analysis. The Extracorporeal Life Support Organization maintains an international registry for all ECMO patients to which member programs submit data. Additionally, in an effort to share best practices around ED ECMO, provide a supportive community for clinicians, gather ED ECMO–specific data, and conduct multi-institutional research,21 the Extracorporeal Resuscitation Consortium (http://www.erectcollaborative.org) group maintains an “Extracorporeal Life Support Organization–compatible” patient data registry, has quarterly conference call Webinars among member programs, and aims to establish best practice standards for ED ECMO. To increase knowledge around appropriate evidence-based application of extracorporeal CPR or ED ECMO, we advocate that all ED ECMO programs participate in these 2 organizations and submit data. Annals of Emergency Medicine 5
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PROCESS ED ECMO Protocol Offered Online The University of Utah ED ECMO (Appendix S1, available online at http://www.annemergmed.com) program has evaluation and activation levels with associated page groups. The “EVAL” page is initiated by the ED charge nurse in conjunction with the ED attending physician; they receive base calls from EMS and identify any patients who meet the inclusion criteria (Figure 2). The EVAL page goes out before patient arrival and includes the cardiothoracic surgeon on call, the inhouse cardiovascular ICU intensivist, the interventional cardiologist, the cardiovascular ICU charge nurse or ECMO charge nurse, the house supervisor, and the ED echocardiography group. Meanwhile, the room is prepared with 2 sets of 6-F sheaths, PIK Kits (Percutaneous Insertion Kit—Venous [Edwards Lifesciences, Irvine, CA]), with sterile gowns and gloves, plus hats and masks for all room occupants. The mechanical CPR device is placed on the patient in the ambulance bay, before being transferred to the ED resuscitation room to facilitate quality compressions during transitions and gurney transport. Both groins are prepped and draped to allow 2 already sterile-gowned emergency physicians to begin obtaining bilateral femoral
vascular access. Once it is obtained, the sheaths and long PIK wires are advanced. The venous wire is visualized in the right atrial superior vena cava junction with transesophageal echocardiography. This entire process can happen without necessarily proceeding with activation or the presence of other team members, including cardiothoracic surgery, the ECMO charge nurse, or cardiology. For the process to move from evaluation to activation, confirmation of the availability of a cardiovascular ICU charge nurse or ECMO charge nurse (both bed and staffing availability), a catheterization laboratory by the interventional cardiologist, and a cardiothoracic surgeon for initial cannulation should be made. All 3 individuals must agree on the appropriateness of the patient for ECMO. The previously primed ECMO circuit and a cart with cannulas and extra supplies are brought to the resuscitation room by the cardiovascular ICU charge nurse or ECMO charge nurse. Once determination of candidate appropriateness is made, the second-tier activation process activates the catheterization laboratory and anesthesia. Bilateral cannulation is initiated by cardiothoracic surgery, emergency medicine, or the intensivist. Venous and arterial cannulation is confirmed by transesophageal echocardiography15 or transabdominal
Figure 2. ED ECMO process map.
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ultrasonography. In general, we use the smallest arterial and venous cannula, working under the assumption that early initiation of ECMO is important and smaller cannulas are quicker to insert. The ECMO charge nurse assists in connecting the circuit and manages the console. Once flow is adequate, vasopressors and inotropes are adjusted and the patient is transported to the catheterization laboratory for angiography, assessment of left ventricular function with decompression (as needed), and establishment of distal limb perfusion (as needed).21 For patients with little to no left ventricular function after initiation of ECMO (demonstrated by lack of ejection through the aortic valve), a vent to decompress the left ventricle and facilitate recovery is indicated. Left ventricular decompression can be performed, among other ways,21,22 with either an Impella percutaneous left ventricular assist device or with a left ventricular vent through the right superior pulmonary vein approached by a mini–right thoracotomy. On arrival in the cardiovascular ICU, patients are managed at the bedside by an ECMO-trained charge nurse, with direction from the ICU intensivist and cardiothoracic surgeon. Patients who are not following commands or are comatose undergo electroencephalogram (EEG), computed tomography, and targeted temperature management (at 36 C [96.8 F]) for 24 hours. After 24 hours, patients are warmed to 37 C [98.6 F]. We attempt to wean ECMO during 3 to 7 days, or as rapidly as possible, to achieve an “ECMO-free” assessment of patients’ postarrest cardiac and neurologic function. Neurology and neurocritical care consultants provide neuroprognostication, which, for patients not waking up spontaneously, is generally accomplished with serial detailed clinical examination, neuroimaging, continuous EEG, and biomarkers (neuron-specific enolase). Our discussions with families are transparent and direct, and have been well received. Management of patients treated with ED ECMO for out-of-hospital cardiac arrest primarily differs from standard venoarterial ECMO in only 3 additional ways: environment (patients are cannulated in the ED during full cardiac arrest), postcannulation angiography (patients undergo protocoled coronary angiography [echocardiography, distal perfusion catheter placement, and left ventricular unloading are standard venoarterial ECMO components]), and neuroprognostication and targeted temperature management. Vascular complications are higher with intra-arrest percutaneous approaches, although we have found that the primary complication is failure to obtain access and initiate ECMO rather than need for repair. Volume
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TEAM PERFORMANCE Before program launch, dry runs of the entire process were carried out to physically wheel a “patient” on a bed from the ambulance bay through the catheterization laboratory and then ICU, test the paging process, ensure all components were present for cannulation, and test the roles and behavior of team members. The dry runs served to introduce staff who did not help design the program to the process. CASES AND OUTCOMES After the official initiation of our ED ECMO program in April 2015, there was a 3-month delay until the first patient, which we attributed in part to lack of program awareness among EMS because we did not reroute patients from their standard hospital destinations and did not broadly advertise among out-of-hospital providers. During the subsequent 6 months, the program had 15 patient alerts for possible ECMO, of which we activated for ECMO in 8 patients. The most common reasons for failure to progress to activation were morbid obesity and changes on EMS arrival in witnessed arrest and time without CPR. Six of 8 patients were successfully placed on ECMO; morbid obesity was a barrier to successful cannulation in 2 cases. Four of 6 patients were cannulated in the ED; the remaining 2 achieved return of spontaneous circulation in the ED but rearrested in the cardiac catheterization laboratory and then were placed on ECMO. Among the 4 patients cannulated in the ED, specialties of physicians placing the cannulas variously included emergency medicine, critical care, and cardiothoracic surgery, with each case using more than 1 provider. Emergency medicine and cardiothoracic surgery were involved in all cases. As stated in the “Process” section, the cardiothoracic surgeon must be available for cannulations and is ultimately privileged to initiate ECMO, but as can be seen, with collaboration, the decision or “privilege” to administer ECMO to a patient becomes a discussion, with the process initiated by emergency physicians and the cannulation performed most often by emergency medicine and cardiothoracic surgery together. Three of 6 patients successfully cannulated for ECMO survived to hospital discharge. ITERATIVE REASSESSMENTS After each of the first few cases, feedback was solicited from key representatives at each stage (ED, catheterization laboratory, and ICU). We make an explicit ongoing effort among programmatic leadership to solicit feedback, offering opportunities for stakeholders to take ownership of Annals of Emergency Medicine 7
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certain processes. We identified improvements for equipment storage locations, drug dosing, and protocol refinement, along with team makeup. We began tracking quality metrics, including time to vascular access, time to ECMO, and door-to-balloon time. CONCLUSION In accordance with our experience, we advise that ED ECMO programs be developed within the context of an existing and mature ICU or perioperative ECMO program and have multidisciplinary collaboration from out-of-hospital through the entire ICU course. The value of an ED ECMO program lies in the ability to temporally bridge the patient with adequate organ perfusion to a therapeutic intervention, such as percutaneous coronary intervention. Without a clear therapeutic goal and interventions to achieve it, the application of ED ECMO adds only cost and prolongation of the end of life. Conversely, the appropriate measured application of ED ECMO to select victims of out-of-hospital cardiac arrest in conjunction with practiced efforts to reverse the inciting cause of arrest may offer one of greatest possible increases in survival of any bundled medical therapy. The authors acknowledge the nurses, support staff, physicians, and leadership at the University of Utah who, through their enthusiastic effort and belief in our mission, enabled the creation of a robust extracorporeal resuscitation program and exceptional patient outcomes. Supervising editor: Keith A. Marill, MD Author affiliations: From the Division of Cardiothoracic Surgery (Tonna, Selzman, Koliopoulou, McKellar), the Division of Emergency Medicine (Tonna, Youngquist, Fair, Mallin), and the Division of General Surgery (Nirula, Barton), the Department of Surgery, University of Utah School of Medicine, Salt Lake City, UT; the Division of Cardiovascular Medicine, Interventional Cardiology Section, Department of Medicine (Smith, Welt), and the Cardiovascular Intensive Care Unit, Staff Nurse Operating Room (Stoddard), University of Utah, Salt Lake City, UT; and the Division of Cardiovascular Medicine, the Department of Medicine (Fang), University of Utah Health Sciences Center, Salt Lake City, UT. Author contributions: All authors made substantial contributions to all of the following: concept and design of the study, acquisition of data, and analysis and interpretation of data; drafting the article or revising it critically for important intellectual content; and final approval of the version to be submitted. Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. Dr. Welt reports receiving consulting fees from Medtronic Advisory Board outside the scope of the submitted work.
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Publication dates: Received for publication July 22, 2016. Revision received September 30, 2016. Accepted for publication October 3, 2016.
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