Outcomes Before and After Implementation of a Pediatric Rapid-Response Extracorporeal Membrane Oxygenation Program

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1 Outcomes Before and After Imlementation of a Pediatric Raid-Resonse Extracororeal Membrane Oxygenation Program Joseh W. Turek, MD, PhD,* Nicholas D. Andersen, MD,* D. Scott Lawson, BS, CCP, Desiree Bonadonna, BSE, CCP, Ryan S. Turley, MD, Michelle A. Peters, BS, RCP, James Jaggers, MD, and Andrew J. Lodge, MD Division of Pediatric Cardiac Surgery, Deartment of Cardiothoracic Surgery, University of Iowa Children s Hosital, Iowa City, Iowa, Divisions of Cardiovascular and Thoracic Surgery, Perfusion Services, and Resiratory Care, Duke University Medical Center, Durham, North Carolina, and Deartment of Pediatric Cardiothoracic Surgery, Children s Hosital Colorado, University of Colorado, Aurora, Colorado Background. Raid-resonse extracororeal membrane oxygenation () has been imlemented at select centers to exedite cannulation for atients laced on ECMO during extracororeal cardioulmonary resuscitation (ECPR). In 2008, we established such a rogram and used it for all ediatric venoarterial ECMO initiations. This study was designed to comare outcomes before and after rogram imlementation. Methods. Between 2003 and 2011, 144 ediatric atients were laced on venoarterial ECMO. Records of atients laced on ECMO before (17 ECPR and 62 non-ecpr) or after (14 ECPR and 51 non-ecpr) rogram imlementation were retrosectively comared. Results. The eak erformance of the ECMO team was assessed by measuring ECMO initiation times for the ECPR atient subgrou (n 31). There was a shift toward more ECPR initiations achieved in less than 40 minutes (24% re- versus 43% ; 0.25) and fewer requiring more than 60 minutes (47% re- versus 21% ; 0.14) after rogram imlementation, although these changes did not reach statistical significance. After multivariable risk adjustment, was associated with a 52% reduction in neurologic comlications for all atients (adjusted odds ratio, 0.48; 95% confidence interval, 0.23 to 0.98; 0.04), but the risk of in-hosital death remained unchanged (adjusted odds ratio, 0.99; 95% confidence interval, 0.50 to 1.99; 0.99). Conclusions. Imlementation of a ediatric rogram for venoarterial ECMO initiation was associated with reduced neurologic comlications but not imroved survival during the first 3 years of rogram imlementation. These data suggest that develoment of a coordinated system for raid ECMO deloyment may benefit both ECPR and non-ecpr atients, but further efforts are required to imrove survival. (Ann Thorac Surg 2013;95:2140 7) 2013 by The Society of Thoracic Surgeons Extracororeal membrane oxygenation (ECMO) remains the rimary theray for ediatric atients acutely requiring mechanical circulatory suort for cardiac or resiratory failure [1]. Extracororeal membrane oxygenation is usually initiated emergently in the intensive care unit (ICU) for severe resiratory or circulatory failure, sometimes during or in anticiation of cardioulmonary arrest. When ECMO is used in the setting of active cardioulmonary resuscitation (ECPR), longer deloyment times have been associated with increased mortality [2]. As a result, raid-resonse ECMO services for ECPR have been imlemented at a small number of Acceted for ublication Jan 27, *These authors contributed equally to this work. Presented at the Fifty-ninth Annual Meeting of the Southern Thoracic Surgical Association, Nales, FL, Nov 7 10, Address corresondence to Dr Lodge, Division of Cardiovascular and Thoracic Surgery, Duke University Medical Center, Box 3340, Durham, NC 27710; andrew.lodge@duke.edu. hositals in an attemt to imrove atient outcomes through shortened ECMO initiation times [3 7]. Beginning in May 2008, a formal ediatric raidresonse ECMO () rogram was imlemented at our institution with the similar goal of imroving atient outcomes through shortened ECMO initiation times and streamlined ECMO team functioning. However, at our center the service was alied broadly to all ediatric atients requiring emergent venoarterial (VA) ECMO and was not restricted to atients requiring ECPR. This reort comares atient outcomes before and after imlementation of the ediatric rogram at our institution. Material and Methods Patient Poulation This study was aroved by the Institutional Review Board of Duke University, and the need for individual atient consent was waived. We retrosectively reviewed 2013 by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc htt://dx.doi.org/ /j.athoracsur

2 Ann Thorac Surg TUREK ET AL 2013;95: OUTCOMES OF PEDIATRIC RAPID-RESPONSE ECMO 2141 the records of all ediatric atients (age 18 years) laced on VA ECMO 5 years before (Aril 30, 2003 to May 1, 2008) and 3 years after (May 1, 2008 to March 1, 2011) imlementation of the rogram. Patients laced on ECMO in the oerating room after failure to wean from cardioulmonary byass were excluded. Raid-Resonse Extracororeal Membrane Oxygenation Program Key features of the rogram included (1) introduction of a batch aging system for notification of ECMO team members, (2) training of resiratory theraists to initiate ECMO without a erfusionist, (3) lacement of surgical cannulation carts in all ediatric ICUs, and (4) maintenance of crystalloid-rimed ECMO circuits dedicated to raid deloyment. The decision to initiate the batch aging system is tyically made by the in-house cardiac, ediatric, or neonatal intensive care hysician. Reciients of the batch age are the on-call attending cardiothoracic surgeon, ediatric erfusionist, ediatric resiratory theraist, oerating room charge nurse, ICU charge nurse, attending intensive care hysician, and cardiothoracic surgical resident. Although the on-call ediatric erfusionist and oerating room team are included in the notification, the system has been designed to allow for ECMO deloyment in their absence. At our institution, on-call erfusionists do not remain in-house after regular work hours. However, ECMOtrained resiratory theraists maintain active ECMO circuits 24 hours a day. A subset of these ECMO-trained resiratory theraists underwent additional training to erform asanguinous ECMO circuit riming and initiation of ECMO without a erfusionist. Identical surgical suly carts with all sulies necessary for intrathoracic, cervical, or femoral cannulation were laced in the ediatric ICUs. The ediatric cardiothoracic surgeons erform all ediatric ECMO cannulations at our institution. The general cannulation strategy involves an intrathoracic aroach in atients with a recent median sternotomy and cervical (infants and small children) or femoral or iliac (larger children) access in all other children. The ECMO circuits consist of a Maquet (Maquet Inc, Wayne, NJ) Bioline coated Quadrox D oxygenator, a BB14 Better Bladder (Circulatory Technology, Inc, Oyster Bay, NY) venous reservoir, A SMARxT coated Sorin (Sorin Grou USA, Arvada, CO) Revolution centrifugal um, and 0.25-inch Carmeda (Medtronic, Inc, Minneaolis, MN) coated tubing. For atients weighing more than 10 kg, the circuit tubing was usized to three-eighths inch. The length of the tubing is minimized to decrease the rime volume. These circuits were rimed in a sterile fashion with Normosol R (Hosira, Inc, Lake Forest, IL), had all air bubbles removed, and were covered for a maximum of 30 days [8]. If blood roducts are not immediately available, the circuits are reared for asanguinous ECMO deloyment by adding 25 meq of sodium bicarbonate, 200 units of hearin, and 300 mg of calcium gluconate to the circuit. Immediately after ECMO initiation, equal volumes of banked red blood cells and ultrafiltrate are exchanged to increase the hematocrit of the atient. Identical um consoles and circuits are used in all ediatric ICUs to maximize familiarity for the ECMO secialists. Extracororeal membrane oxygenation team members are routinely debriefed after ECMO deloyment, and ercetion surveys are eriodically administered to ICU nurses, resiratory theraists, and erfusionists to allow for anonymous feedback and an additional mechanism for identifying weaknesses of the rogram that can be targeted for quality imrovement. Data Collection Diagnostic categories included reoerative or nonoerative heart disease (structural congenital heart disease without oeration before ECMO, cardiomyoathy, myocarditis), ostoerative congenital heart surgery (cardiac oeration during the same admission before ECMO), and resiratory (meconium asiration, rimary ulmonary hyertension of the newborn, sesis, viral or bacterial neumonia, congenital diahragmatic hernia). Noncardiac structural malformations or chromosomal abnormalities were defined as reviously described by Kane and colleagues [6]. Indications for ECMO included rimary resiratory failure (hyoxemia or ulmonary hyertension), arrhythmia, or cardiogenic shock. Extracororeal cardioulmonary resuscitation atients were defined as those laced on ECMO during cardioulmonary resuscitation (CPR) with chest comressions. Extracororeal membrane oxygenation initiation times for ECPR atients were determined by the interval between the onset of CPR and the initiation of ECMO flow. Extracororeal membrane oxygenation initiation times for non-ecpr atients were not comared given the lack of a documented start time for the ECMO initiation rocess in the re- era. Pre-ECMO acid-base status was determined from the most recent blood gas immediately before lacement on the ECMO circuit. The eak lactate level before or within 24 hours of ECMO initiation was recorded. Comlications were defined as reviously described by Kane and colleagues [6]. Circuit comlications included thrombus formation in the circuit, circuit failure, and circuit or oxygenator change. Bleeding was defined as surgical or cannulation site hemorrhage requiring surgical exloration. Anticoagulation rotocols during ECMO were reviewed and were not found to have changed during the study eriod. Resiratory comlications included neumonia, acute resiratory distress syndrome, neumothorax requiring tube thoracostomy, and ulmonary hemorrhage. Sesis was defined as a ositive blood culture while on ECMO. Central nervous system (CNS) injury was defined as any radiologic evidence of brain injury temorally related to the time of ECMO suort, seizures documented by electroencehalograhy, or ronouncement of brain death. Protocols for neurologic assessment and imaging surveillance were reviewed and were not found to have changed during the study eriod. The rate of neurologic imaging by ultra-

3 Table 1. Patient and Extracororeal Membrane Oxygenation Characteristics a Variable Pre- (n 79) All Patients ECPR Non-ECPR (n 65) Pre- (n 17) (n 14) Pre- (n 62) (n 51) Demograhics Age (mo) 0.13 ( ) 0.36 ( ) ( ) 1.50 ( ) ( ) 0.20 ( ) 0.20 Weight (kg) 3.3 ( ) 3.5 ( ) ( ) 3.9 ( ) ( ) 3.5 ( ) 0.11 Female 32 (41%) 28 (43%) (41%) 7 (50%) (40%) 21 (41%) 0.93 Diagnosis Preoerative or 16 (20%) 19 (29%) 3 (18%) 5 (36%) 13 (21%) 14 (27%) nonoerative heart disease Postoerative 27 (34%) 16 (25%) 14 (82%) 6 (43%) 13 (21%) 10 (20%) congenital heart surgery Resiratory 36 (46%) 30 (46%) 0 3 (21%) 36 (58%) 27 (53%) Noncardiac structural 24 (30%) 17 (26%) (35%) 4 (29%) (29%) 13 (25%) 0.68 or chromosomal abnormality Indication Resiratory 46 (58%) 35 (54%) 3 (18%) 3 (21%) 43 (69%) 32 (63%) Arrhythmia 11 (14%) 6 (9%) 10 (59%) 3 (21%) 1 (2%) 3 (6%) Cardiogenic shock 22 (28%) 24 (37%) 4 (24%) 8 (57%) 18 (29%) 16 (31%) ECPR 17 (22%) 14 (22%) 1 17 (100%) 14 (100%) Duration of CPR (31 187) (30 99) 0.32 (min) CPR duration 60 9 (53%) 11 (79%) 0.14 minutes Cannulation site Neck 51 (65%) 43 (66%) 5 (29%) 5 (36%) 46 (74%) 38 (75%) Chest 26 (33%) 17 (26%) 12 (71%) 6 (43%) 14 (23%) 11 (22%) Groin 2 (3%) 5 (8%) 0 3 (21%) 2 (3%) 2 (4%) Pre-ECMO acidosis Arterial H ( ) ( ) ( ) ( ) ( ) ( ) 0.02 Base excess ( 25, 29) ( 30, 14) ( 25, 29) ( 28, 11) ( 22, 9) ( 30, 14) 0.12 Peak lactate (mmol/l) (0.9 27) (1.9 36) (5.3 27) (10 36) (0.9 25) (1.9 23) 0.59 Duration of ECMO (days) ( ) ( ) ( ) ( ) ( ) ( ) 0.37 a s exressed as median (interquartile range), mean standard deviation (range), or number (ercent). CPR cardioulmonary resuscitation; ECMO extracororeal membrane oxygenation; ECPR extracororeal cardioulmonary resuscitation; raid-resonse extracororeal membrane oxygenation TUREK ET AL Ann Thorac Surg OUTCOMES OF PEDIATRIC RAPID-RESPONSE ECMO 2013;95:2140 7

4 Ann Thorac Surg TUREK ET AL 2013;95: OUTCOMES OF PEDIATRIC RAPID-RESPONSE ECMO 2143 sound, comuted tomograhy, or magnetic resonance imaging during ECMO suort or before hosital discharge was 96% and did not differ between eras (97% re- versus 94% ; 0.28) Post- ECMO neurologic status was assessed for survivors using ediatric cerebral erformance category scores as reviously described [5 7, 9]. Pediatric cerebral erformance category scores were assigned at latest follow-u if adequate neurologic information was available in the medical record. Statistical Analysis Variables were comared between atients treated before (re-) and after () imlementation of the rogram. Continuous and categorical variables were comared using the Mann-Whitney rank sum test or 2 test, resectively. For outcomes with greater than ten events er grou (CNS injury, renal failure, liver injury, death), the association between RR- ECMO and outcome was assessed using logistic regression models to adjust for differences in atient demograhics and disease severity between grous. In multivariable models, odds ratios were adjusted for all variables with a robability value of less than 0.20 on univariate analysis (age, weight, and re-ecmo arterial H). Calculations were erformed using STATA 11.1 (StataCor, College Station, TX). Results Patient and Extracororeal Membrane Oxygenation Characteristics Between Aril 2003 and March 2011, 144 ediatric atients were laced on emergent VA ECMO, including 31 (22%) ECPR initiations. Of these, 79 (55%) were laced on ECMO before and 65 (45%) were laced on ECMO after imlementation of the rogram. Patient demograhics, baseline variables, and ECMO characteristics are shown in Table 1. Raid-resonse ECMO atients demonstrated more severe re-ecmo acidosis when comared with re- atients. Extracororeal Cardioulmonary Resuscitation Resonse Times The coordinated erformance and eak seed of the ECMO team was assessed by measuring the duration of CPR with chest comressions before ECMO initiation in ECPR atients. The mean duration of CPR before and after imlementation of the rogram shifted from 68 to 51 minutes ( 0.32). When viewed as categorical data, there was also a shift toward more ECPR initiations achieved in less than 40 minutes (24% re-rr- ECMO versus 43% ; 0.25) and fewer ECPR initiations requiring more than 60 minutes (47% re-rr- ECMO versus 21% ; 0.14) with, although these changes did not reach statistical significance (Fig 1). Eleven of 31 (35%) ECPR atients survived to hosital discharge, and mean ECPR initiation time was Fig 1. Duration of cardioulmonary resuscitation (CPR) with chest comressions for extracororeal cardioulmonary resuscitation atients before (Pre-, n 17) and after (, n 14) raid-resonse extracororeal membrane oxygenation rogram imlementation. similar between survivors and nonsurvivors (56 41 minutes versus minutes; 0.32). Comlications and Outcomes Unadjusted rates of ECMO comlications and atient outcomes before and after imlementation are shown in Table 2. Overall, 65 (45%) atients exerienced CNS injury, 50 (35%) exerienced renal failure, and 28 (19%) exerienced liver injury. One hundred five (73%) atients were successfully weaned from ECMO suort, and 73 (51%) survived to hosital discharge. Survival by diagnostic category was 46% (16 of 35) for reoerative or nonoerative heart disease atients, 42% (18 of 43) for ostoerative congenital heart surgery atients, and 59% (39 of 66) for resiratory atients. Pediatric cerebral erformance category scores were assigned to 71 of 73 survivors, of which 53 (75%) had no or mild neurologic injury (ediatric cerebral erformance category score 2). After multivariable risk adjustment, was associated with a 52% reduced risk of CNS injury relative to the immediate re- era, but the risks of renal failure, liver injury, and in-hosital death were unchanged (Table 3). Comment We retrosectively comared ECPR initiation times, comlications, and outcomes before and after imlementation of a ediatric rogram that was alied broadly to a heterogeneous grou of ediatric atients laced on VA ECMO for cardioulmonary arrest or near arrest. Our findings demonstrated a trend toward shortened ECPR initiation times and a reduced risk of CNS injury after rogram imlementation. However, other comlications and survival to hosital discharge remained unchanged. The goal of reducing ECMO initiation time for atients exeriencing cardiac arrest aears self-evident, as the

5 2144 TUREK ET AL Ann Thorac Surg OUTCOMES OF PEDIATRIC RAPID-RESPONSE ECMO 2013;95: Table 2. Comlications and Outcomes a All Patients ECPR Non-ECPR Variable Pre-RR- ECMO (n 79) (n 65) Pre-RR- ECMO (n 17) (n 14) Pre-RR- ECMO (n 62) (n 51) Circuit comlication 6 (8%) 9 (14%) (6%) (8%) 9 (18%) 0.12 Bleeding 12 (15%) 4 (6%) (18%) (15%) 4 (8%) 0.27 Resiratory 5 (6%) 9 (14%) (6%) 1 (7%) (6%) 8 (16%) 0.11 comlication Sesis 9 (11%) 6 (9%) (12%) 2 (14%) (11%) 4 (8%) 0.54 CNS injury 40 (51%) 25 (38%) (53%) 6 (43%) (50%) 19 (37%) 0.18 Seizures 5 (6%) 1 (2%) 1 (6%) 0 4 (6%) 1 (2%) Radiologic 34 (43%) 21 (32%) 8 (47%) 5 (36%) 26 (42%) 16 (31%) evidence of CNS injury Brain death 6 (8%) 3 (5%) 2 (12%) 1 (7%) 4 (6%) 2 (4%) Renal failure 27 (34%) 23 (35%) (35%) 6 (43%) (34%) 17 (33%) 0.95 Serum creatinine 26 (33%) 23 (35%) 6 (35%) 6 (43%) 20 (32%) 17 (33%) mg/dl Dialysis use (PD 7 (9%) 5 (8%) 3 (18%) 0 4 (6%) 5 (10%) 0.51 or CVVHD) Liver injury (ALT 13 (16%) 15 (23%) (29%) 7 (50%) (13%) 8 (16%) 0.67 or AST 500 IU/dL) ECMO weaned 62 (78%) 43 (66%) (71%) 6 (43%) (81%) 37 (73%) 0.31 Survival to hosital 41 (52%) 32 (49%) (41%) 4 (29%) (55%) 28 (55%) 0.99 discharge Length of stay 28 (16 64) 34 (15 70) (15 52) 23 (4 46) (16 64) 36 (15 74) 0.55 (days) PCPC score 2 32/40 (80%) 21/31 (68%) /7 (57%) 2/4 (50%) /33 (85%) 19/27 (70%) 0.18 a s exressed as median (interquartile range) or number (ercent). ALT alanine aminotransferase; AST asartate aminotransferase; CNS central nervous system; CVVHD continuous venovenous hemodialysis; ECMO extracororeal membrane oxygenation; ECPR extracororeal cardioulmonary resuscitation; PCPC ediatric cerebral erformance category; PD eritoneal dialysis; raid-resonse extracororeal membrane oxygenation. duration of conventional CPR directly correlates with mortality and adverse neurologic outcomes [10]. In addition, a recent single-institution study of 37 ECPR atients [7], as well as a meta-analysis of 288 ECPR atients [2], reorted CPR duration greater than 30 minutes was an indeendent risk factor for mortality [2]. In our study, an encouraging trend was observed toward reduced mean ECPR initiation time and fewer ECPR initiations requiring greater than 60 minutes with. In addition, our mean ECPR initiation time of 51 minutes is comarable to ECPR initiation times achieved by other centers shortly after rogram imlementation [3, 5, 11]. However, further imrovement remains ossible, as the Boston grou has shown median ECPR initiation times fell steadily from 50 to 25 minutes during the 13-year interval after imlementation of their rogram [6]. One major area for further rocess imrovement identified by ercetion surveys (data not shown) was the lack of oerating room staff availability, often requiring other ersonnel to fulfill circulating and scrub nurse duties while awaiting arrival of the full oerating room team. This aears to be a rate-limiting ste to ECMO initiation at our institution, and in resonse we have roosed training a select grou of ICU charge nurses or hysician extenders to erform oerating room staff duties to allow for streamlined ECMO initiation in their absence. At resent, we view our current ECPR initiation times as a work in rogress, and ideally ECPR initiation times less than 30 minutes can routinely be achieved with further team training and rocess refinements. In addition, an emhasis on erformance of high-quality CPR is necessary, as our study and others have not shown a survival benefit from reduced CPR duration [6, 11, 12], suggesting the quality of re-ecmo CPR may be as imortant as the duration of CPR. The 45% incidence of CNS injury in our study was similar to the 52% incidence of CNS injury reorted in the Boston ECPR exerience, from which we used the same broad clinical and radiograhic definitions to cature neurologic insults [6]. In addition, follow-u ediatric cerebral erformance category scores aeared favorable, with 75% of survivors demonstrating no or mild neurologic injury [5, 6]. Perhas the most encouraging finding of our study was a 52% reduced risk of CNS injury after imlementation relative to the immediate re- era, after multivariable risk adjustment. Although shortened ECMO initiation time should reduce neurologic events in ECPR atients exe-

6 Ann Thorac Surg TUREK ET AL 2013;95: OUTCOMES OF PEDIATRIC RAPID-RESPONSE ECMO 2145 Table 3. Risk-Adjusted Associations Between Raid- Resonse Extracororeal Membrane Oxygenation and Select Outcomes Versus Pre- OR 95% CI CNS injury Renal failure Liver injury In-hosital death CI confidence interval; CNS central nervous system; OR odds ratio; raid-resonse extracororeal membrane oxygenation. riencing fulminant cardioulmonary arrest [13], the majority of atients in our study were not laced on ECMO during CPR and were resumably less suscetible to neurologic injury as a result of delayed ECMO deloyment. We therefore susect other comonents of the rogram besides initiation time may have contributed to the reduced risk of CNS injury, such as a more controlled transition to extracororeal circulation or an increased willingness to use ECMO before cardiac arrest. It is also ossible that ractice changes unrelated to ECMO initiation contributed to reduced CNS injury, such as use of controlled hyothermia or changes in the management of the ECMO circuit. Nonetheless, the significant ositive association between reduced CNS injury and imlementation of the rogram suggests some facet of the streamlined ECMO initiation rocess may lead to reduced neurologic injury, and further study to identify the recise contributors is warranted. The overall survival rate of 51% in our study was comarable to the ediatric ECMO survival rates of 38% to 52% reorted to the Extracororeal Life Suort Organization database [13]. Survival by diagnostic category also aeared consistent with ublished reorts, with the highest and lowest survival observed for resiratory atients (59%) and ECPR atients (35%), resectively [14]. When interreting our survival numbers it is imortant to emhasize that venovenous ECMO atients, in whom the best outcomes are usually observed, were excluded [14]. Although our survival rates were accetable, was not associated with imroved survival. For ECPR atients, it may be that initiation times less than 30 minutes are required to ositively affect survival, as shown by Tajik and colleagues [2], a threshold our rogram has yet to consistently achieve. For non-ecpr atients, the largest determinants of survival are likely the severity and reversibility of the underlying disease rocess, and raid ECMO deloyment may be less influential. However, the atients in our study were at a higher risk of ECMO comlications and death as a result of more severe acidosis at the time of ECMO initiation [6, 13, 15, 16], and risk adjustment may not have fully accounted for the baseline differences in disease severity between the two atient cohorts. Although it initially seems aradoxical that the recent atients demonstrated worse acidosis before ECMO initiation desite raid ECMO deloyment, we seculate that the more recent atients may have been a higher risk cohort owing to more liberal use of ECMO in atients who reviously would not have been considered candidates for ECMO. In suort of this ossibility, rior studies have shown trends toward the use of ECMO in more atients and sicker atients with time [14, 17]. Limitations Raid-resonse ECMO atients were comared with historical controls from the era immediately receding rogram imlementation. Unmeasured confounders related to atient selection and ECMO management may influence the comarison of outcomes between eras. Retrosective risk adjustment models are also unable to fully account for differences in atient grous in the absence of randomization. The study is rone to tye II error and is underowered to detect small differences in outcomes between grous. Retrosective assignment of ediatric cerebral erformance category scores from follow-u notes reresents a crude and imerfect tool for assessing neurologic status, although this method has been used in revious ECMO reorts [5 7]. Conclusions Imlementation of a ediatric rogram for VA ECMO initiation was associated with reduced neurologic comlications but did not imrove survival or reduce other comlications during the first 3 years of rogram imlementation. These data suggest that develoment of a coordinated system for raid ECMO deloyment may benefit both ECPR and non-ecpr atients, but additional research and continued attention to rocess imrovements are needed to imrove survival after emergent ECMO deloyment. Suort was received by a Thoracic Surgery Foundation for Research and Education Research Fellowshi to Dr Andersen. References 1. Duncan BW. Mechanical circulatory suort for infants and children with cardiac disease. Ann Thorac Surg 2002;73: Tajik M, Cardarelli MG. Extracororeal membrane oxygenation after cardiac arrest in children: what do we know? Eur J Cardiothorac Surg 2008;33: Duncan BW, Ibrahim AE, Hraska V, et al. Use of raiddeloyment extracororeal membrane oxygenation for the resuscitation of ediatric atients with heart disease after cardiac arrest. J Thorac Cardiovasc Surg 1998;116: Jacobs JP, Ojito JW, McConaghey TW, et al. Raid cardioulmonary suort for children with comlex congenital heart disease. Ann Thorac Surg 2000;70: Huang SC, Wu ET, Chen YS, et al. Extracororeal membrane oxygenation rescue for cardioulmonary resuscitation in ediatric atients. Crit Care Med 2008;36: Kane DA, Thiagarajan RR, Wyij D, et al. Raid-resonse extracororeal membrane oxygenation to suort cardioulmonary resuscitation in children with cardiac disease. Circulation 2010;122(11 Sul):S Sivarajan VB, Best D, Brizard CP, Shekerdemian LS, d Udekem Y, Butt W. Duration of resuscitation rior to

7 2146 TUREK ET AL Ann Thorac Surg OUTCOMES OF PEDIATRIC RAPID-RESPONSE ECMO 2013;95: rescue extracororeal membrane oxygenation imacts outcome in children with heart disease. Intensive Care Med 2011;37: Walczak R, Lawson DS, Kaemmer D, et al. Evaluation of a rerimed microorous hollow-fiber membrane for raid resonse neonatal extracororeal membrane oxygenation. Perfusion 2005;20: Fiser DH, Long N, Roberson PK, Hefley G, Zolten K, Brodie- Fowler M. Relationshi of ediatric overall erformance category and ediatric cerebral erformance category scores at ediatric intensive care unit discharge with outcome measures collected at hosital discharge and 1- and 6-month follow-u assessments. Crit Care Med 2000;28: Slonim AD, Patel KM, Ruttimann UE, Pollack MM. Cardioulmonary resuscitation in ediatric intensive care units. Crit Care Med 1997;25: Huang SC, Wu ET, Wang CC, et al. Eleven years of exerience with extracororeal cardioulmonary resuscitation for aediatric atients with in-hosital cardiac arrest. Resuscitation 2012;83: Morris MC, Wernovsky G, Nadkarni VM. Survival outcomes after extracororeal cardioulmonary resuscitation instituted during active chest comressions following refractory in-hosital ediatric cardiac arrest. Pediatr Crit Care Med 2004;5: Cengiz P, Seidel K, Rycus PT, Brogan TV, Roberts JS. Central nervous system comlications during ediatric extracororeal life suort: Incidence and risk factors. Crit Care Med 2005;33: Laussen PC, Fynn-Thomson F. Surgical aroaches, cardioulmonary byass, and mechanical circulatory suort in children. In: Sellke FW, del Nido PJ, Swanson SJ, eds. Sabiston & Sencer surgery of the chest. 8th ed. Philadelhia, PA: Saunders Elsevier; 2010: Barrett CS, Bratton SL, Salvin JW, Laussen PC, Rycus PT, Thiagarajan RR. Neurological injury after extracororeal membrane oxygenation use to aid ediatric cardioulmonary resuscitation. Pediatr Crit Care Med 2009;10: Thiagarajan RR, Laussen PC, Rycus PT, Bartlett RH, Bratton SL. Extracororeal membrane oxygenation to aid cardioulmonary resuscitation in infants and children. Circulation 2007;116: Schaible T, Hermle D, Loersch F, Demirakca S, Reinshagen K, Varnholt V. A 20-year exerience on neonatal extracororeal membrane oxygenation in a referral center. Intensive Care Med 2010;36: DISCUSSION DR BRIAN KOGON (Atlanta, GA): A huge congratulations to you and your rogram. Obviously it s very difficult to resurrect an ECMO (extracororeal membrane oxygenation) rogram and get all of the intensive care units (NICU, PICU, and CICU), as well as the hysicians, nurses, and resiratory theraists, on board to make such a transition. The one thing that I noticed is that although your times are better, they are not significantly better. In your manuscrit you mention that the Boston rogram has ublished times down to 25 minutes, so you know those times are achievable. As time goes on, are you going to, let me say, cross your fingers and hoe that your ECMO initiation times come down into that range or are you going to actively tweak the system? DR ANDERSEN: Yes, we certainly lan to continue with an active quality imrovement rocess. In general, we hoe to use feedback mechanisms, such as the ercetion surveys, to identify areas for imrovement and make targeted adjustments to the rogram to imrove efficiency. One area we are currently working on based on the ercetion survey is to train different eole to fulfill the OR (oerating room) resonsibilities so we can deloy ECMO without relying uon OR staff. DR MUHAMMAD MUMTAZ (Norfolk, VA): I wish to thank you. You have taken a very difficult task, it s a very large team, there are a lot of factors to control, but I think at the end of the day the erson who is utting the kid on ECMO has a much more in-deth look at this than somebody just looking at the data. And so my question is more to Dr Lodge and eole at Duke who are intricately involved with ECMO. What are the time-limiting stes? Is it cannulation? Is it the OR staff showing u? You have a ventricular assist device system; you have RTs (resiratory theraists) that are at the beside who can ut the kid on ECMO; there is a circuit ready. I struggle with the same roblems, and each time it s a different reason. So I understand that for every case there is going to be a different story. But in this samle size you should be able to come u with one or two major time-limiting factors, so that when we go back to our institutions we can look at a major area of imrovement. DR ANDERSEN: Absolutely. I will let Dr Lodge seak to that question. DR LODGE: I think Nick did a good job at covering some of the limitations that we identified, and as he said, I think the ercetion surveys have been fairly indicative of what the major limitations are. And, as you said, these are all different situations and there is a lot of heterogeneity in the atient oulation. But a fairly common thread has been either the OR staff or some surrogate for the OR staff being available and having the equiment. A lot of it has to do with the time of day, whether it s a weekend or not. But I have sent the last 8 or 9 years gradually making imrovements, or what I think are imrovements, to the rocess, and some of it has included having all the equiment available in the setting where it is used. Initially when I started, it used to be that we had to have somebody coming in and dragging the equiment u from the oerating room to the fifth floor, which is where our ICUs are, and that took a long time. So we ut all the equiment in the ICUs where the atients are. So all the equiment is there, but the eole that are there are not familiar with it, and they are very uncomfortable heling us with ECMO. So you have to do it yourself. Another idea that we have had is to try and cross-train some other grou, because it s inevitable that the OR staff will show u last. The erfusionist will be there, the resiratory theraist will be there, we will be there, but we don t have somebody who is familiar with the instruments and things like that. So one idea that I had was that a constant oulation there is the midlevel roviders. They are a relatively small grou. They are highly educated, they are motivated, and they would seem to be a logical choice. Unfortunately getting that grou on board has met with some resistance, but I think that would be one otion. Another otion would be a subset of the nurses. In our grou it s the charge nurses. There is a fairly small, identified grou of eole who have charge nurse resonsibilities. That would be a grou of eole that could otentially be trained. So I think that s the next ste, and I think that will lead to a significant decrease in the time.

8 Ann Thorac Surg TUREK ET AL 2013;95: OUTCOMES OF PEDIATRIC RAPID-RESPONSE ECMO 2147 DR ANASTASIOS POLIMENAKOS (Danville, PA): If I may, Andrew, in the last few years there are more and more data coming out that actually it s not the duration of redeloyment of ECMO CPR (cardioulmonary resuscitation) but the quality of CPR going into ECMO. That s one. Second is the fact some of the institutions have some reemtive aroach, meaning they title some of their cases as high risk. So the threshold for ECMO is a lot lower for this subset of atients. Do you think that this, too, can romote better outcomes in your center or its irrelevant? DR LODGE: I do. And Nick has also addressed this in the manuscrit. But there are other confounding things that have occurred. For examle, robably the quality of CPR and the monitoring of that have imroved over the course of this study. The use of hyothermia after a cardiac arrest has also been added, and it s much more common now and that may have an imact on the neurologic outcome. So there are a number of things like that that contribute. DR ERLE AUSTIN (Louisville, KY): Nicely resented and a difficult roblem and we have wrestled with it, too. How much does the factor of time of day lay into this? Do you have that information? Did you look and see when these cardiac arrests occurred and how that affected the resonse times? DR ANDERSEN: Good question. One thing I want to first reiterate is that most of our atients did not exerience cardiac arrest. Only 22% of our cases were ECPR (extracororeal cardioulmonary resuscitation) initiations, and this reresents one major difference between our raid-resonse rogram and others in that we use the raid-resonse mechanism to initiate ECMO even in children who are not exeriencing cardiac arrest. But to answer your question, we did not look for a correlation between the time of day that the initiations occurred and the ECMO resonse times. We certainly could take a look at that and see if we can identify some general atterns, although the samle size for the atients with objectively documented resonse times is small and is limited only to the ECPR cohort.