Mary Mehegan

Outpatient management of intra-corporeal left ventricular assist device system in children: a multi-center experience.

Little is known about the outcomes of children supported on intracorporeal left ventricular assist device (HVAD), and the feasibility of outpatient management. All centers with pediatric patients discharged from the hospital on the device were identified using company database. A total of 14 centers were contacted, with 9 centers, contributing data retrospectively. From 2011 to 2013, 12 pediatric patients (7 females), mean aged 11.9 ± 2.3 years (range 8–15), mean weight 43 ± 19 kg (range 18–81), mean body surface area 1.3 ± 0.3 m2 (range 0.76–1.96) were identified. Diagnosis included: dilated cardiomyopathy (CMP) (n = 5), noncompaction CMP (n = 4), toxic CMP (n = 2) and viral CMP (n = 1). Indications for support were permanent support (n = 1), bridge to recovery (n = 1) and bridge to transplantation (n = 10). Prior to HVAD implantation, all patients received intravenous inotropes and two patients were on temporary mechanical support. Overall mortality was 0%. Mean duration of inpatient and outpatient support were 56 (range: 19–95 days) and 290 days (range: 42–790), respectively. Mean readmission rate was 0.02 per patient month (2.1 per patient). No adverse events involving emergency department occurred. Eight children resumed local schooling. Home discharge of children supported on HVAD is feasible and safe. School integration can be achieved. There is wide center variability to discharge practice for children.

Continuous Flow Device Support in Children Using the HeartWare HVAD: 1,000 Days of Lessons Learned From a Single Center Experience.

The purpose of this study is to provide a single center experience with a continuous flow device in adolescents with end-stage heart failure. A retrospective single center analysis of patients aged 18 years or younger implanted with HVAD (HeartWare Inc, Framingham, MA) between October 2012 and March 2014 was performed. Demographics, preimplant and postimplant clinical data, survival, and adverse events (AEs) were recorded. A matched group of adults based on diagnosis, body surface area (BSA), and time period were used for outcome comparisons. Six adolescents with dilated cardiomyopathy were implanted with the HVAD. Median age and BSA were 13.4 years and 1.45 m2, respectively. All were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile-1 or profile-2. Median days on device were 108 with total patient-days on device of 1,017. Four adolescents were discharged home on device all in New York Heart Association 1. Five underwent transplantation with 100% survival. There were 18 AEs with one AE per 170 days on device. Compared with the adult cohort (n = 5), there was no difference in 1 year survival (p = 0.32). HVAD support in adolescents is highly successful as a bridge to transplantation. It provides early rehabilitation and improvement in quality of life. Morbidity is not negligible but appears comparable with that seen in adults.

Simulation-Based Assessment of ECMO Clinical Specialists.

Objective The aims of the study were (1) to create multiple scenarios that simulate a range of urgent and emergent extracorporeal membrane oxygenation (ECMO) events and (2) to determine whether these scenarios can provide reliable and valid measures of a specialist’s advanced skill in managing ECMO emergencies. Design Multiscenario simulation-based performance assessment was performed. Setting The study was conducted in the Saigh Pediatric Simulation Center at St. Louis Children’s Hospital. Subjects ECMO clinical specialists participated in the study. Measurements and Main Results Twenty-five ECMO specialists completed 8 scenarios presenting acute events in simulated ECMO patients. Participants were evaluated by 2 separate reviewers for completion of key actions and for global performance. The scores were highest for the hemodilution scenario, whereas the air entrainment scenario had the lowest scores. Psychometric analysis demonstrated that ECMO specialists with more than 1 year of experience outperformed the specialists with less than 1 year of experience. Participants endorsed these sessions as important and representative of events that might be encountered in practice. Conclusions The scenarios could serve as a component of an ECMO education curriculum and be used to assess clinical specialists’ readiness to manage ECMO emergencies.

Recommendations for utilization of the paracorporeal lung assist device in neonates and young children with pulmonary hypertension.

The management of decompensating critically ill children with severe PH is extremely challenging and requires a multidisciplinary approach. Unfortunately, even with optimal care, these children might continue to deteriorate and develop inadequate systemic perfusion and at times cardiac arrest secondary to a pulmonary hypertensive crisis. Tools to support these children are limited, and at times, the team should proceed with offering extracorporeal support, especially in newly diagnosed patients who have not benefitted from medical therapy prior to their acute deterioration, in patients with severe pulmonary venous disease and in patients with alveolar capillary dysplasia. Currently, the only approved mode for extracorporeal support in pediatric patients with PH eligible for lung transplantation is ECMO. To decrease the risks associated with ECMO, and offer potential for increased duration of support, extubation, and rehabilitation, we transitioned four small children with refractory PH from ECMO to a device comprising an oxygenator interposed between the PA and LA. This work describes in great detail our experience with this mode of support with emphasis on exclusion criteria, the implantation procedure, and the post‐implantation management.

Board 330 - Research Abstract Simulation-Based Assessment of ECMO Clinical Specialists (Submission #442)

Introduction/Background Extracorporeal Membrane Oxygenation [ECMO] is a life-saving measure with significant risks of morbidity and mortality for critically ill patients in cardiac or pulmonary failure. Clinical specialists in the management of ECMO patients provide continuous bedside monitoring and are the first line of defense in recognizing and responding to acute and potentially catastrophic events. However, since such events are infrequent and unpredictable, an ECMO specialist with many years of experience may never have encountered one. The purpose of this study was to create simulated scenarios of critical events to enhance the training of ECMO specialists. A second goal was to assess their performance in recognizing and responding to the simulated events. The hypothesis was that more experienced individuals would outperform the less experienced. The simulations provided a hands-on, real-time approach to the challenging and complex nature of bedside ECMO emergencies. Methods Eight scenarios, designed to reflect acute events an ECMO specialist would be expected to manage included hyperventilation, air entrainment, ventricular tachycardia, hypovolemia causing venous occlusion, agitation with arterial occlusion, pneumothorax, bleeding and hemodilution. The scenarios were created and piloted by perfusionists, critical care physicians and the ECMO nurse coordinator. These scenarios represent events that have occurred while a patient was on ECMO support. Twenty five ECMO clinical specialists consented to participate in this IRB-approved study. The subjects were oriented to the manikin and the study format and participated individually. They had five minutes to complete each scenario and an in-depth debriefing was held at the Conclusion of the session. The sessions were captured on an audiovisual system. Two trained raters scored for completion of key actions and assessed a global score. Results All twenty five participants completed the scenarios. Thirteen (52%) had less than one year of experience on the ECMO team. The generalizability coefficients were moderate for both the checklist (0.41) and global scores (0.43). Large proportions of variance were attributable to the Person x Task (P x T) interaction, suggesting that performance in one scenario was poorly predicted by performance in another. Relatively little variance was attributable to the rater, or associated interactions, indicating the raters were reasonably consistent in the assignment of scores. The standardized inter-rater reliability coefficient were comparable for the checklist scores (r=0.72) and the global scores (r=0.70). For the ANOVA of both the checklist and global scoring, the group (experience) by scenario interaction was not significant indicating that any performance differences between ECMO groups were reasonably consistent across scenarios. There was a main effect attributable to group by checklist (F=4.3, p<0.05) and global score (F=8.4, p<0.015) indicating that the more experienced ECMO group outperformed the less experienced group. Participants with >1 year experience (mean=77.5, SD=17.9) outperformed those with <=1 year experience (mean=73.1, SD=14.1) by checklist scoring as well as in their global score [>1 year: (mean=7.2, SD=1.5) versus <=1 year: (mean=6.6, SD=1.4)]. There was also a main effect attributable to scenario based on checklist scores (F=6.9, p<0.01), as well as the global rating (F=4.1, p<0.01) indicating that the scenarios were not of equal difficulty. Conclusion ECMO simulation scenarios were created for acute skills training and evaluation of ECMO clinical specialists. Regarding reliability, the study revealed a great deal of task specificity, which is not unexpected with a heterogeneous group of tasks to be accomplished. Construct validity was supported by the experienced specialists outperforming the less experienced. It was also supported by participant feedback following the sessions. In their evaluations, the participants felt that the simulation scenarios were realistic, represented events that could occur in practice and were appropriate for training. These preliminary data support the simulation of ECMO critical events for training and evaluation of clinical specialists. References 1. Alpard SK, Zwischenberger JB. Extracorporeal Membrane Oxygenation for Respiratory or Cardiac Support pp 662-695, in Cardiopulmonary Bypass: Principles and Practice, 2nd ed, Gravlee et al, 2000. 2. Anderson JM, Boyle KB, Murphy AA et. al. Simulating Extracorporeal Membrane Oxygenation Emergencies to Improve Human Performance. Part I: Methodologic and Technologic Innovations, Simul Healthcare 2006;1: 220–227. 3. Anderson JM, Boyle KB, Murphy AA et. al. Simulating Extracorporeal Membrane Oxygenation Emergencies to Improve Human Performance. Part II:Assessment of Technical and Behavioral Skills, Simul Healthcare 2006;1: 228–232. 4. Burton KS, Pendergrass TL, Byczkowski TL et. al. Impact of Simulation-Based Extracorporeal Membrane Oxygenation Training in the Simulation Laboratory and Clinical Environment Sim Healthcare 6:284–291, 2011. 5. Chan S, Figueroa M, Spentzas T et. al. Prospective Assessment of Novice Learners in a Simulation-Based Extracorporeal Membrane Oxygenation (ECMO) Education Program Pediatr Cardiol2013 Mar; 34(3):543-52. Disclosures AHRQ R-18 Simulation Project Grant.