Advanced Cardiac Therapies Improving Outcomes Network Research Articles

Mechanical Ventilation and Outcomes of Children Who Undergo Ventricular Assist Device Placement: 2014-2020 Linked Analysis From the Advanced Cardiac Therapies Improving Outcomes Network and Pediatric Cardiac Critical Care Consortium Registries.

Placement of a ventricular assist device (VAD) improves outcomes in children with advanced heart failure, but adverse events remain important consequences. Preoperative mechanical ventilation (MV) increases mortality, but it is unknown what impact prolonged postoperative MV has. Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and Pediatric Cardiac Critical Care Consortium (PC4) registries were used to identify and link children with initial VAD placement admitted to the cardiac ICU (CICU) from August 2014 to July 2020. Demographics, cardiac diagnosis, preoperative and postoperative CICU courses, and outcomes were compiled. Univariable and multivariable statistics assessed association of patient factors with prolonged postoperative MV. Multivariable logistic regression sought independent associations with outcomes. Thirty-five pediatric CICUs across the United States and Canada. Children on VADs included in both registries. None. Two hundred forty-eight ACTION subjects were linked to a matching patient in PC4. Median (interquartile) age 7.7 years (1.5-15.5 yr), weight 21.3 kg (9.1-58 kg), and 56% male. Primary diagnosis was congenital heart disease (CHD) in 35%. Pre-VAD explanatory variables independently associated with prolonged postoperative MV included: age (incidence rate ratio [IRR], 0.95; 95% CI, 0.93-0.96; p < 0.01); preoperative MV within 48 hours (IRR, 2.76; 95% CI, 1.59-4.79; p < 0.01), 2-7 days (IRR, 1.82; 95% CI, 1.15-2.89; p = 0.011), and greater than 7 days before VAD implant (IRR, 2.35; 95% CI, 1.62-3.4; p < 0.01); and CHD (IRR, 1.96; 95% CI, 1.48-2.59; p < 0.01). Each additional day of postoperative MV was associated with greater odds of mortality (odds ratio [OR], 1.09 per day; p < 0.01) in the full cohort. We identified an associated greater odds of mortality in the 102 patients with intracorporeal devices (OR, 1.24; 95% CI, 1.04-1.48; p = 0.014), but not paracorporeal devices (77 patients; OR, 1.04; 95% CI, 0.99-1.09; p = 0.115). Prolonged MV after VAD placement is associated with greater odds of mortality in intracorporeal devices, which may indicate inadequacy of cardiopulmonary support in this group. This linkage provides a platform for future analyses in this population.

Outcomes of Intracorporeal Continuous and Paracorporeal Pulsatile Ventricular Assist Devices in Pediatric Patients 10-30 kg.

Ventricular assist devices (VADs) have been increasingly implanted in pediatric patients. Paracorporeal VADs are generally chosen when intracorporeal continuous (IC) devices are too large. Superiority between IC and paracorporeal pulsatile (PP) devices remains unclear in smaller pediatric patients. Our study analyzes outcomes of IC and PP VADs in pediatric patients who could be considered for either of these options. Using the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) database, we identified children between 10 and 30 kg who received a VAD between June 2018 and September 2021. Survival and stroke outcomes were analyzed based on VAD type. There were 41 patients in the IC group and 54 patients in the PP group. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile at the time of implant was higher in the PP cohort (p < 0.02). The PP cohort was younger (p < 0.001) and smaller (p < 0.001) than the IC cohort. The diagnosis was similar between cohorts. Overall survival was similar between groups. Stroke was more common in the PP cohort, but did not reach statistical significance (p = 0.07). Discharge was possible only in the IC group, but the discharge rate was low (9.5%). Direct comparisons remain challenging given differences in INTERMACS profiles, age, and size.

Impact of HeartWare ventricular assist device discontinuation on the pediatric population: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry analysis

BackgroundThe HeartWare ventricular assist device (HVAD) was discontinued in July 2021. The aim of this study is to describe the impact the discontinuation the HVAD had on pediatric ventricular assist device utilization and outcomes. MethodsThe Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry was queried for type of VAD utilization and outcomes/adverse event rates in patients with a body surface area of 0.7-1.4 m2. Results were compared from before and after July 2021. All patients in the registry implanted with a HVAD were reported to determine overall outcomes of these patients and define who remains on the device. ResultsThe HeartMate 3 (HM3) primarily replaced the HVAD in pediatric patients increasing from 29 of 258 (11%) of implants before July 2021 to 31 of 109 (29%) of implants after. A small increase in the use of the Berlin Heart EXCOR (40 of 258, 16% before to 20 of 109, 18% after) and paracorporeal continuous flow devices (116 of 258, 45% before to 58 of 109, 53% after) was also observed. The rate of ischemic stroke increased in the overall population and a decrease in bleeding complications in the EXCOR group was observed. Of the 187 pediatric patients implanted with a HVAD in the registry, 7 patients remain supported, one patient transitioned from the HVAD to a HM3, and 6 patients were lost to follow-up. ConclusionThe HM3 has been the primary replacement for the HVAD in the medium sized pediatric population. The rate of ischemic stroke was higher after July 2021.

Clinical Outcomes of SARS-CoV-2 Infection in Pediatric Patients on Ventricular Assist Device Support: An ACTION Registry Analysis.

Adult patients on left ventricular assist device (LVAD) support have increased morbidity and mortality after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. There are no reported clinical data describing outcomes among pediatric patients on ventricular assist device (VAD) support infected with SARS-CoV-2. We conducted a retrospective study using the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry to evaluate patient characteristics and clinical outcomes after SARS-CoV-2 infection. A total of 22 children on VAD support (median age at infection 10.6 years) from 16 centers tested positive for SARS-CoV-2. Cardiomyopathy (59.1%) and congenital heart disease (40.9%) were the most common primary diagnoses. The type of support included LVAD in 19 (86.4%), biventricular assist device (BIVAD) in one (4.5%), and single ventricle VAD in two (9%) patients. At the time of infection, 50% were outpatients, 23% were inpatients on a general cardiology floor, and 27% were in the cardiac intensive care unit (CICU). Most patients (82%) were symptomatic at time of diagnosis, but only 13% required escalation of respiratory support, and 31% received SARS-CoV-2 therapies. Notably, no mortality occurred, and significant morbidity was rare after SARS-CoV-2 infection in pediatric patients on VAD support.

Successful implementation of telehealth visits in the paediatric heart failure and heart transplant population.

The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and Pediatric Heart Transplant Society (PHTS) convened a working group at the beginning of 2020 during the COVID-19 pandemic, with the aim of using telehealth as an alternative medium to provide quality care to a high-acuity paediatric population receiving advanced cardiac therapies. An algorithm was developed to determine appropriateness, educational handouts were developed for both patients and providers, and post-visit surveys were collected. Telehealth was found to be a viable modality for health care delivery in the paediatric heart failure and transplant population and has promising application in the continuity of follow-up, medication titration, and patient education/counselling domains.

Expanding use of the HeartMate 3 ventricular assist device in pediatric and adult patients within the Advanced Cardiac Therapies Improving Outcomes Network (ACTION)

We report current outcomes in patients supported with the HeartMate 3 (HM3) ventricular assist device in a multicenter learning network. The Advanced Cardiac Therapies Improving Outcomes Network database was queried for HM3 implants between 12/2017 and 5/2022. Clinical characteristics, postimplant course, and adverse events were collected. Patients were stratified according to body surface area (BSA) (<1.4m2, 1.4-1.8m2, and >1.8m2) at device implantation. During the study period, 170 patients were implanted with the HM3 at participating network centers, with median age 15.3years; 27.1% were female. Median BSA was 1.68m2; the smallest patient was 0.73m2 (17.7kg). Most (71.8%) had a diagnosis of dilated cardiomyopathy. With a median support time of 102.5days, 61.2% underwent transplantation, 22.9% remained supported on device, 7.6% died, and 2.4% underwent device explantation for recovery; the remainder had transferred to another institution or transitioned to a different device type. The most common adverse events included major bleeding (20.8%) and driveline infection (12.9%); ischemic and hemorrhagic stroke were encountered in 6.5% and 1.2% of patients, respectively. Patients with BSA <1.4m2 had a higher incidence of infection, renal dysfunction, and ischemic stroke. In this updated cohort of predominantly pediatric patients supported with the HM3 ventricular assist device, outcomes are excellent with <8% mortality on device. Device-related adverse events including stroke, infection, and renal dysfunction were more commonly seen in smaller patients, highlighting opportunities for improvements in care.

PEDS2: Impact of Mechanical Ventilation Duration on Outcomes in Children after Ventricular Assist Device Placement: A linked analysis from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and Pediatric Cardiac Critical Care Consortium (PC4) Registries.

Background: Placement of a ventricular assist device (VAD) has improved outcomes in children with advanced heart failure (HF), but adverse events, such as stroke and mortality, remain important consequences. It is unknown what impact prolonged post-operative mechanical ventilation (MV) has on these outcomes. Methods: ACTION and PC4 are audited, comprehensive, encounter-based registries of patient course and outcomes for pediatric HF and pediatric cardiac critical care, respectively. Data from initial VAD placement in each registry from 8/2014-7/2020 were linked using indirect patient identifiers with 98% match concordance. Patient demographics, heart disease, pre- and post-op ICU courses and outcomes were compiled. Descriptive and univariate statistics assessed association of patient factors with prolonged post-op MV. Multivariable logistic regression sought independent associations with outcomes. Results: Overall, 248 ACTION subjects were linked to a matching patient in PC4. Median age was 7.7 years (1.5-15.5), weight 21.3kg (9.1-58), 56% male. Primary diagnosis was congenital heart disease (CHD) in 35%. Pre-VAD variables that independently predicted prolonged post-op MV included age (IRR=0.95 [95%CI: 0.93-0.96], p<0.01); renal dysfunction: eGFR 30-60 (IRR=3.28 [95%CI: 1.11-9.68], p=0.032), eGFR 60-90 (IRR=3.87 [95%CI: 1.35-11.07], p=0.012); pre-op MV within 48 hours (IRR=2.76 [95%CI: 1.59-4.79], p<0.01), 2-7 days (IRR=1.82 [95%CI: 1.15-2.89], p=0.011), and >7days before implant (IRR=2.35 [95%CI: 1.62-3.4], p<0.01); and CHD (IRR=1.96 [95%CI: 1.48-2.59], p<0.01). Each additional day of post-op MV was associated with increased risk of death (OR 1.09 per day, p<0.01) in the full cohort. Association of post-operative MV duration with mortality is presented in Figure 1. By device type, duration of post-op MV had no association with outcomes in extracorporeal devices (n=77), but remained strongly associated with risk of death in intracorporeal devices (n=102) (OR=1.24 [95%CI: 1.04-1.48], p=0.014). Conclusion: There is increased risk of death per day of MV after VAD placement, however, this did not hold true with extracorporeal devices. Further studies are warranted.

PEDS5: VAD Discharge at Pediatric Centers- Why can’t we get home?

Background: The use of intra-corporeal continuous flow ventricular assist devices (CF-VAD) has allowed patients with advanced heart failure to be discharged home. Moreover, it has been shown that heart transplant (HTx)>30 days after VAD implant offers some survival benefit. Despite this, only about 50% of patients at pediatric centers are discharged, while others remain in hospital until HTx. We sought to characterize the cohort of patients who are transplanted during their index VAD admission as a means to identify potential barriers to discharge. Methods: Using the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry, individuals who underwent implant with a dischargeable VAD (HVAD and HM3) at a pediatric center were included. Data including patient demographics, characteristics and clinical course were compared between the discharged versus hospitalized cohorts. Patients who recovered or died during their VAD admission were excluded. Results: From December 2012 to June 2022, 220 patients underwent implant with HM3 (n=108) or HVAD (n=111) across 32 pediatric centers. Overall, 28% (62/220) of patients remained hospitalized until HTx. There was no significant difference in age, underlying diagnosis, days to extubation, INTERMACS profile, or history of ECMO in those who were discharged versus hospitalized. There was also no significant difference in adverse events including stroke, bleeding, infection, hepatic or renal dysfunction, or right heart failure between the two groups (See Table 1). Patients with HM3 were less likely to be discharged if lower BSA (p=0.05) or on BiVAD support (p=0.04). Conclusion: Although discharge in VAD patients at pediatric centers is improving, nearly one-third of patients undergoing implant with dischargeable VADs remain hospitalized until transplant. There was no significant difference in markers of severity of illness or adverse events in those who remain hospitalized versus discharged. Thus, perceived non-medical barriers by providers or families may be limiting discharge at pediatric centers and may be a potential target for further education.

TOP3: Over 100 Fontan Patients on Ventricular Assist Device Support: An ACTION Update

Background: Many Fontan patients will require end-stage heart failure therapy, and an increasing number are requiring systemic ventricular assist device (VAD) support. This report describes the pre-implant characteristics and clinical outcomes of the largest cohort of Fontan VAD patients. Methods: Fontan patients with systemic VAD support were identified from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry. Patient characteristics and outcomes are described (median, interquartile range). Results: Between 1/2012-12/2022, 107 Fontan patients had VAD implanted (age 10, IQR 5-16 years; 27% female), with 69% as bridge to transplant. Implantable continuous devices (IC-VADs) were most common, with Medtronic Heartware HVAD (31%) and Abbott Heartmate 3 (20%), followed by Berlin EXCOR (22%) and paracorporeal continuous devices (20%). At implant, 58% were on >≥2 inotropes, 26% on extracorporeal membrane oxygenation, 41% were intubated, 48% on total parenteral nutrition, and 8% on dialysis; 28% were INTERMACS Profile 1. Over a median 113 (IQR 43-266) days of support, 75% experienced >≥1 adverse event, with infection most common (10.5 per 100 patient-months) followed by bleeding (8.7 per 100 patient-months) and neurologic dysfunction (5.5 per 100 patient-months). Of patients on IC-VADs, 49% were discharged. At 1 year post-VAD implant, 54% were transplanted, 18% died, and 26% were still on support. Conclusion: Despite requiring high level of support (ECMO, intubation, multiple inotropes) at time of implant, an increasing number of Fontan patients are being successfully supported with VADs, with almost half of patients with IC-VADs discharged on support. Though the majority are alive at 1-year post-implant, adverse events remain common.

Taking ACTION: A Prognostic Tool for Pediatric Ventricular Assist Device Mortality.

We sought to develop a contemporary risk assessment tool for use in pediatric ventricular assist device (VAD) candidates to estimate risk for mortality on the device using readily available preimplantation clinical data. Training and testing datasets were created from Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry data on patients supported with a VAD from 2012 to 2021. Potential risk factors for mortality were assessed and incorporated into a simplified risk prediction model utilizing an open-source, gradient-boosted decision tree machine learning library, known as random forest. Predictive performance was assessed by the area under the receiver operating characteristic curve in the testing dataset. Nine significant risk factors were included in the final predictive model which demonstrated excellent discrimination with an area under the curve of 0.95. In addition to providing a framework for establishing pediatric-specific risk profiles, our model can help inform team expectations, guide optimal patient selection, and ultimately improve patient outcomes.

Impact of Weight on Ventricular Assist Device Outcomes in Dilated Cardiomyopathy Patients in Pediatric Centers: An ACTION Registry Study.

Ventricular assist device (VAD) options vary for children in different weight groups. This study evaluates contemporary device usage and outcomes for children based on weight. Data from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry were examined for patients with dilated cardiomyopathy (DCM) in 4 weight cohorts: <8 kg, 8-20 kg, 21-40 kg, and >40 kg, for devices implanted 3/2013-10/2020. Adverse event rates and ultimate outcome (deceased, alive on device, transplanted, or ventricular recovery) were analyzed. 222 DCM patients were identified with 24% in cohort 1, 23% in cohort 2, 15% in cohort 3, and 38% in cohort 4. Of 272 total implants, paracorporeal pulsatile devices were most common (95%) in cohorts 1 and 2 and intracorporeal continuous devices (81%) in cohorts 3 and 4. Stroke was noted in 17%, 12%, 6%, and 4% of cohorts, respectively (Cohort 1 vs. 4 and 2 vs. 4 - p = 0.01; other comparisons - not significant). Incidences of major bleeding, device malfunction, and infection was not different. All cohorts had >90% positive outcomes. Stroke incidence was higher in smaller cohorts, but other outcomes were similar. Positive outcomes were attained in over 90% across all weight groups, demonstrating excellent outcomes using current VADs in this DCM population.

Pediatric mechanical circulatory support - a review.

The history of mechanical circulatory support began in 1953, as the first heart-lung machine enabled surgeons to perform complex open heart surgery. Heart failure is more prevalent in adults than pediatric patients which has led to the development of devices for adults with end-stage heart failure at a faster pace. Pediatric mechanical circulatory support has been derived from adult durable devices and subsequently applied in the adolescent population. The application of adult devices in children is inherently problematic due to size mismatch, especially in smaller patients. There has been an increasing interest in developing durable pumps that are appropriate for children for several reasons, with the primary factor being the number of children with end-stage heart failure far exceeding the number of potential donors. Mechanical circulatory support (MCS) for children can be divided into short-term temporary support and long-term durable support. The goal of this review is to discuss the devices available for the pediatric population and review the options for support in complex patients including single-ventricle anatomy, biventricular support, and total artificial heart options. We will also briefly discuss the Pumps for Kids, Infants, and Neonates (PumpKIN) Trial and MCS registries, including the Advanced Cardiac Therapies Improving Outcomes Network (ACTION).

Considerations for Advanced Heart Failure Consultation in Individuals With Fontan Circulation: Recommendations From ACTION.

Individuals with Fontan circulation are at risk of late mortality from both cardiac and noncardiac causes. Despite the known risk of mortality, referral indications for advanced heart failure care vary between centers, and many individuals die from Fontan circulation-related complications either after late consideration for advanced heart failure therapies or having never seen a heart failure specialist. There is a critical need for guidelines to direct appropriately timed referral for advanced heart failure consultation. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Fontan Committee has developed recommended thresholds for advanced heart failure referral to guide primary cardiologists. These recommendations are divided into 4 categories of clinical Fontan circulatory dysfunction including (1) cardiac/systemic ventricular dysfunction, (2) Fontan pathway dysfunction, (3) lymphatic dysfunction, and (4) extracardiac dysfunction.

Patient and parent-reported outcomes in paediatric ventricular assist device support: a multi-center ACTION learning network feasibility and pilot experience.

Patient- and proxy-reported outcomes (PROs) are an important indicator of healthcare quality and can be used to inform treatment. Despite the widescale use of PROs in adult cardiology, they are underutilised in paediatric cardiac care. This study describes a six-center feasibility and pilot experience implementing PROs in the paediatric and young adult ventricular assist device population. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is a collaborative learning network comprised of 55 centres focused on improving clinical outcomes and the patient/family experience for children with heart failure and those supported by ventricular assist devices. The development of ACTION's PRO programme via engagement with patient and parent stakeholders is described. Pilot feasibility, patient/parent and clinician feedback, and initial PRO findings of patients and families receiving paediatric ventricular assist support across six centres are detailed. Thirty of the thirty-five eligible patients (85.7%) were enrolled in the PRO programme during the pilot study period. Clinicians and participating patients/parents reported positive experiences with the PRO pilot programme. The most common symptoms reported by patients/parents in the first month post-implant period included limitations in activities, dressing change distress, and post-operative pain. Poor sleep, dressing change distress, sadness, and fatigue were the most common symptoms endorsed >30 days post-implant. Parental sadness and worry were notable throughout the entirety of the post-implant experience. This multi-center ACTION learning network-based PRO programme demonstrated initial success in this six-center pilot study experience and yields important next steps for larger-scale PRO collection, research, and clinical intervention.

End-of-Life in Pediatric Patients Supported by Ventricular Assist Devices: A Network Database Cohort Study.

Most pediatric patients on ventricular assist device (VAD) survive to transplantation. Approximately 15% will die on VAD support, and the circumstances at the end-of-life are not well understood. We, therefore, sought to characterize patient location and invasive interventions used at the time of death. Retrospective database study of a cohort meeting inclusion criteria. Thirty-six centers participating in the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry. Children who died on VAD therapy in the period March 2012 to September 2021. None. Of the 117 of 721 patients (16%) who died on VAD, the median (interquartile range) age was 5 years (1-16 yr) at 43 days (17-91 d) postimplant. Initial goals of therapy were bridge to consideration for candidacy for transplantation in 60 of 117 (51%), bridge to transplantation in 44 of 117 (38%), bridge to recovery 11 of 117 (9%), or destination therapy (i.e., VAD as the endpoint) in two of 117 (2%). The most common cause of death was multiple organ failure in 35 of 117 (30%), followed by infection in 12 of 117 (10%). Eighty-five of 92 (92%) died with a functioning device in place. Most patients were receiving invasive interventions (mechanical ventilation, vasoactive infusions, etc.) at the end of life. Twelve patients (10%) died at home. One-in-six pediatric VAD patients die while receiving device support, with death occurring soon after implant and usually from noncardiac causes. Aggressive interventions are common at the end-of-life. The ACTION Registry data should inform future practices to promote informed patient/family and clinician decision-making to hopefully reduce suffering at the end-of-life.

Ventricular Assist Device Outcomes in Infants and Children With Stage 1 Single Ventricle Palliation.

Data on ventricular assist device (VAD) outcomes in infants with stage 1 single ventricle (SV) palliation are limited. We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of pre/poststage 1 SV patients undergoing VAD implantation between March 2018 and October 2020. Data are collected from 32 centers and major adverse events undergo central adjudication. During the study period, 30 stage 1 SV patients underwent VAD implant with median age of 0.9 months (range 0.1-25) and weight 3.7 kg (2.4-17). Preimplant illness severity was high: ventilator support (90%), ECMO (30%), prior cerebral vascular accident (CVA, 23%), and dialysis (13%). Devices used included paracorporeal pulsatile (50%), paracorporeal continuous-flow (37%), and multiple devices (13%). Median support duration was 56 days (range 3-246). A positive clinical outcome (transplanted or weaned) was attained in 63% (63% transplanted, 37% mortality, 0% weaned). VAD adverse events included: major infection (43%), neurologic dysfunction (any = 30%; CVA = 20%), major bleeding (17%), renal dysfunction (13%), and device malfunction (3%). In conclusion, stage 1 SV patients undergoing VAD support have high preimplant illness severity and complexity, as well as significant morbidity and mortality postimplant. A variety of devices and strategies are employed by centers to support this challenging population.

Feasibility of Implementation of a Heart Failure Communication Checklist in the Multi-Center Action Network

<h3>Purpose</h3> Children admitted for acute decompensated heart failure (HF) have significant morbidity and mortality. Improving communication about pediatric-specific HF symptoms and treatment goals among team members and families may help improve outcomes including length of stay (LOS) and hospital readmission rate. <h3>Methods</h3> A 13-item pediatric-specific HF communication checklist tool (HFcc) was developed by expert consensus covering key daily HF assessments and goals including weight trend, cardiac rhythm, pediatric-specific HF symptoms, fluid management, feeding tolerance, anticoagulation, HF medications and doses, HF severity score, and barriers to discharge. The HFcc was implemented across the multi-center Advanced Cardiac Therapies Improving Outcomes Network (ACTION). Each participating ACTION institution recorded daily use of the HFcc by scanning a QR code and reported HF admission outcomes including LOS, readmission rate, death, heart transplant (HT), and placement of a ventricular assist (VAD). <h3>Results</h3> Between 1/26/2021-10/5/2021, 16 ACTION institutions recorded use of the HFcc in 112 individual patients (a total of 1483 uses) with increased usage over time (Figure 1). Enrollment data were available for 73 patients (53% cardiomyopathy, 36% congenital heart disease, 5% HT, 6% other); 38 patients were discharged (3 with VAD), 19 were listed for HT (12 underwent HT during admission), and 4 deaths were reported at the time of data analysis. HFcc use was recorded in 23% of total hospital days (935/4121 days). The median LOS was 16.5 days. For 31 patients with 30-day follow-up data, 8 were readmitted (86% unplanned). <h3>Conclusion</h3> Adoption of a pediatric-specific HF communication checklist tool across pediatric multiple centers is feasible. Further work to improve daily HFcc usage and assess the impact of the HFcc tool on pediatric HF outcomes is planned.

Inter-Rater Reliability of Total Cardiac Volume Measurement for Heart Transplantation: An ACTION Collaborative Study

<h3>Purpose</h3> There is increasing evidence that size-matching pediatric donor hearts by direct measurement of total cardiac volume (TCV) is superior to traditional methods based on body size. Currently, there are no standardized protocols for assessing TCV or studies evaluating the inter-rater reliability of such measurements, both critical requirements to support a national TCV-based size-matching system. We sought to evaluate the inter-rater reliability of a standardized TCV measurement protocol across multiple pediatric transplant centers. <h3>Methods</h3> A total of nine pediatric transplant centers within the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) performed TCV assessments in 12 test subjects. TCV was assessed from computed tomography (CT) or magnetic resonance imaging (MRI) files using a standard TCV measurement protocol that was reviewed with each center. Interclass correlation coefficients (ICC) were calculated between all centers and each center in relation to the primary center. <h3>Results</h3> Of the 12 test subjects, the median age was 9.5 years (range 18 days to 30 years), the median weight was 28 (2.5 to 89) kg; 3 had no heart disease (donors), 3 had cardiomyopathy (CMP); 6 had congenital heart disease (CHD) including 4 single-ventricle CHD (1 shunted newborn, 2 Glenns, and 2 Fontans) and 2 biventricular CHD (aortic stenosis, tetralogy of Fallot/pulmonary atresia). Imaging modalities included 7 contrast CTs (CCT), 3 non-contrast CT (NCT), and 2 MRI. TCV was performed by 7 cardiologists, 1 radiologists, and 1 biomedical engineer. Overall compared to the primary center, the ICC across all 8 centers for all 12 scans was 0.99 (95% CI 0.98-0.99), including in normal hearts 0.98 (0.95-1.0), in CMP 0.99 (0.96-1.0), in CHD 0.99 (95% CI 0.99-0.99) and single ventricle CHD 0.99 (95% CI 0.97-0.99). By imaging modality, ICC for NCT was 0.98 (0.94-1.0), CCT 0.99 (0.99-0.99), and MRI 0.79 (0.32-1.0). By age, infants ICC was 0.99 (0.95-1.0), children 0.99 (0.98-0.99), and adults 0.97 (0.81-1.0). <h3>Conclusion</h3> The inter-rater reliability for total cardiac volume assessment in healthy and diseased hearts appears excellent across a variety of age groups and diagnoses. ICC for MRI was modest compared to CT imaging albeit the small sample size. Further validation of a standardized TCV measurement protocol among ACTION transplant centers is warranted.

Characteristics and Outcomes of Patients Supported with Impella Percutaneous VAD Device at Pediatric Institutions: Action Collaborative Experience

<h3>Purpose</h3> We describe Advanced Cardiac Therapies Improving Outcomes Network (ACTION) pediatric multicenter experience with Impella® percutaneous ventricular assist device (PVAD) support for management of cardiogenic shock. <h3>Methods</h3> Retrospective review of patients supported with a Impella PVAD 15 pediatric centers participating in ACTION Collaborative from 10/2014 to 09/2021. Only patients supported with Impella PVAD alone were included. Demographics, device, and outcomes data was reviewed and reported using descriptive statistics. <h3>Results</h3> Total of 47 patients met the inclusion criteria. Median age was 16.1 years (range 6.38,34.4), weight 65.0 kg (range 29.6,124), and BSA 1.75 m² (range 1.05,2.52). PVAD was used most often for transplant graft dysfunction (40.4%) followed by dilated cardiomyopathy/myocarditis (31.9%), end stage congenital heart disease (14.9%) and others (12.5%). INTERMACS Profile 1 was reported in 42.6%, Profile 2 in 42.6%, and Profile 3 in 10.6%. Strategies for support included bridge to recovery (55.3%), bridge to transplant (23.4%) and bridge to decision (19.1%). Ten patients (21.3%) were bridged to durable VAD support. Impella CP was used in 64% cases, 5.0 in 18% and 5.5 in 18%. Nine (19%) patients had >1 device implanted. Anticoagulation was achieved with unfractioned heparin in 91% and a direct thrombin inhibitors in 9%. Median duration of support was 5.5 days (range 1,116) on CP device, 27 days (range 6,64) on 5.5 device and 21.5 days (range 8,143) on 5.0 device. Most common device complications included hemolysis (39.0%), major bleeding (15.3%), device malfunction (13.6%), renal failure (8.5%), arterial non-CNS thrombus (5.1%), and cardiac arrhythmia (3.2%). There were no neurological events. A positive clinical outcome was achieved in 85% of patients (77% survived to explant; 8% alive on device). <h3>Conclusion</h3> This study reports the Impella PVAD pediatric multi center experience for support of cardiogenic shock, with overall low morbidity and satisfactory survival benefit for a high-risk population. This device should be considered as part of the mechanical support armamentarium used in management of cardiogenic shock. Further investigation into optimal patient selection and support environment is needed to optimize its use in pediatric institutions and minimize adverse events.

Outcomes of Intracorporeal Continuous, Paracorporeal Continuous, and Paracorporeal Pulsatile Ventricular Assist Devices in Pediatric Patients 10-30 kg

<h3>Purpose</h3> In the past decade, ventricular assist devices (VADs) have been increasingly implanted in pediatric patients. Although no definitive size standards exist, paracorporeal VADs are generally chosen when intracorporeal continuous (IC) devices are deemed too large for smaller patients. Superiority between IC, paracorporeal continuous (PC) and paracorporeal pulsatile (PP) devices remains unclear in smaller pediatric patients. Our study analyzes outcomes of IC, PC and PP VADs in pediatric patients who could be considered for any of these options. <h3>Methods</h3> Using the Advanced Cardiac Therapies Improving Outcomes Network(ACTION) database, we identified children between 10 and 30 kg who were supported on a VAD between June 2018 and September 2021. Survival and stroke outcomes were analyzed based on VAD type. <h3>Results</h3> Patient demographics, survival outcomes and stroke rates are displayed in Table 1. Patient diagnosis was similar amongst all three cohorts. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile at time of implant was similar in all groups except when comparing the IC vs PP cohorts (p = 0.03). The PP and PC cohorts were younger (p<0.001) and smaller (p<0.001) than the IC cohort. The number of device days was highest in the IC cohort. Overall survival was similar between groups. Stroke rate was higher in the PP group, but without statistical significance. Discharge was possible only in the IC group, but the discharge rate was low (9.5%). <h3>Conclusion</h3> There was difference in overall survival rates between the IC, PC and PP cohorts. Rates of stroke were highest in the PP cohort, but without statistical significance. Diagnosis and INTERMACS profile were similar with the exception of the IC vs PP cohorts, but direct comparisons remain challenging given differences in age and size. Future studies are needed to compare outcomes in these devices especially given size constraints in smaller pediatric patients.