Advanced Cardiac Therapies Improving Outcomes Network Research Articles

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.

Ventricular Assist Device Use in Pediatric Restrictive and Hypertrophic Cardiomyopathy: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Analysis

<h3>Purpose</h3> Use of ventricular assist devices (VAD) in patients with restrictive (RCM) and hypertrophic cardiomyopathy (HCM) remains low compared to use in dilated cardiomyopathy. We describe the outcomes of patients with RCM and HCM supported by VAD and characteristics associated with successful VAD support. <h3>Methods</h3> We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of patients with RCM, HCM and mixed HCM/RCM who underwent VAD implantation from March 2012 - July 2021, including major adverse events, and survival. <h3>Results</h3> Fourteen patients were identified and represent 2.2% of the ACTION registry at data collection. There were 9 initial LVAD (with 2 subsequent RVAD) and 5 initial BIVAD (1 total artificial heart). Of 12 LVAD patients with data, 4 had LA and 8 had LV cannulation. Median age was 3.4 years (range 0.3-16.9), weight 15 kg (5.2-57.2), and BSA 0.64 m2 (0.29-1.67). Diagnoses included RCM (50%), HCM (35.7%), and mixed RCM/HCM (14.3%). Illness severity at implant was high with 29% Intermacs profile 1, 50% on ECMO, 57.1% on ventilator support, 85.7% on 1 or more inotrope, and 64.3% on TPN. Twenty devices were used in 14 patients: 10 (50%) paracorporeal pulsatile, 6 (30%) paracorporeal continuous, 3 (15%) implantable continuous, and 1 (5%) intracorporeal pulsatile. Median duration of support was 80 days (8-412). Four patients died on device, 9 transplanted and 1 alive on device. Though not statistically significant, patients who died had higher incidence of pre-VAD: ECMO, TPN, Intermacs profile 1, HCM, initial BIVAD and major VAD-related adverse events. Cause of death was inadequate support (1, HCM with Rotaflow BiVAD), infection (2), and multi-organ failure (1). <h3>Conclusion</h3> Patients with restrictive and hypertrophic cardiomyopathy have high pre-implant illness severity, however, most patients had successful VAD outcomes. VAD support is a reasonable strategy for select RCM and HCM patients.

Patient and Device Selection in Pediatric MCS: A Review of Current Consensus and Unsettled Questions.

The field of pediatric ventricular assist device (VAD) support has expanded significantly over the past 20years, with one third of pediatric heart transplant recipients currently being bridged to transplant with a VAD. Despite increased pediatric VAD utilization, however, there remains little formalized guidance for patient or device selection. The population of children with advanced heart failure is quite heterogeneous, and the available data suggest that VAD outcomes vary significantly based upon patient size, anatomy, level of illness, and type of device implanted. In an effort to better understand current practice patterns and identify populations for whom there does not appear to be a consensus approach to achieving optimal VAD outcomes, the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) has surveyed clinical decision-making among member sites and conducted a review of the available literature regarding patient population-specific VAD outcomes and center-specific practices related to patient and device selection. Rather than aiming to provide clinical guidelines, this document offers an overview of contemporary approaches to patient and device selection, highlighting specific populations for whom there is not a consensus approach to achieving reliably good VAD outcomes, as these populations may benefit most from future research and quality improvement efforts directed toward identifying best practice.

Mechanical support for the failing single ventricle after Fontan

Mechanical support for the failing single ventricle after Fontan

Abstract 11259: Promoting Discharges in Pediatric Patients with Congenital Heart Disease on Ventricular Assist Device Support: An ACTION Quality Improvement Project

Introduction: Discharge of pediatric ventricular assist device (VAD) patients is lagging behind adults, especially pediatric patients with concurrent congenital heart disease (CHD). This quality improvement project aimed to increase discharge rates and decrease time to discharge for pediatric patients with CHD on VAD support. Methods: Patients with CHD implanted with HeartWare HVAD or HeartMate 3 at participating Advanced Cardiac Therapies Improving Outcomes Network (ACTION) centers were included. Baseline demographics and outcomes including explant, transplant, or death, and time to outcome was collected from April 2018 until October 2019. QI interventions (VAD Flight Plan and Discharge Journey Map) were initiated in November 2019. Percentage discharged on VAD as well as time to outcome were compared before and after intervention. Results: Twenty-six patients with CHD (18 single ventricle physiology) were identified (14 pre-intervention and 12-post). The mean age was 16 years old with 27% implanted as Intermacs profile 1. Mortality on device was high at 38%. There were 77% (n=20) considered discharge eligible (alive on device &gt; 30 days) while 42% (n=11) achieved discharge (Table 1). Mean length of stay post-implant for discharged patients was 33 days. A higher percentage of biventricular physiology were discharged (63%) compared to univentricular (33%). QI interventions did not change discharge rate (43% vs 42%), mean time to discharge (46.3 vs 43.4 days), transplant before discharge (17% vs 21%), or death before discharge (42% vs 43%) in the post-intervention group. Conclusion: Discharging CHD patients on VAD support from the hospital remains a challenge largely due to the complex and heterogenous nature of this population at the time of implant. Interventions to address optimal timing of VAD implantation and patient selection could impact outcomes.

Abstract 11384: Discharge and De-Escalation After VAD Implant in Children with Dilated Cardiomyopathy: A Multi-Center Quality Improvement Initiative

Introduction: Children with dilated cardiomyopathy (DCM) are increasingly bridged to heart transplant (Tx) with intracorporeal continuous flow ventricular assist devices (VADs), but there continues to be variability in hospital discharge. We sought to assess the impact of a quality improvement (QI) project promoting hospital discharge in pediatric VAD patients with DCM. Methods: Patients enrolled at sites participating in the Discharge and De-Escalation QI project of the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry were eligible. Patients with a HeartWare (HVAD) or HeartMate3 (HM3) VAD, implanted between April 2018 and February 2021, were included. Patient characteristics and outcomes were compared before and after the QI initiative, which targeted team and family expectations, was implemented in November 2019. Results: There were 85 patients (75%) with DCM and/or myocarditis who were included in this study (median age 14 years; median weight 57.1 kg; 67% male). Among 57 patients in the baseline group, 56% (n=32) were discharged with a mean post-implant hospital length of stay (LOS) of 36 days and 44% (n=25) underwent Tx during index VAD admission, with a mean of 52 days on device. There were 28 patients in the intervention group; 64% (n=18) were discharged with a mean LOS of 45 days, while 29% (n=8) patients underwent Tx during index VAD admission, with a mean of 44 hospital days on device. There was no significant difference in the frequency of hospital discharge or in hospital LOS between groups. Conclusions: Pediatric centers discharged just over half of DCM patients supported on an HVAD or HM3, with nearly one third of patients undergoing transplant during the index VAD admission. The QI intervention did not significantly alter the discharge rate. Further work is required to understand practice variation between centers with respect to Tx listing and organ acceptance for children on intracorporeal continuous flow VADs.

Learning networks in pediatric heart failure and transplantation.

Learning networks have emerged in medicine as a novel organizational structure that contains elements of quality improvement, education, and research with the goal of effecting rapid improvements in clinical care. In this article, the concept of a learning network is defined and highlighted in the field of pediatric heart failure and transplantation. Learning networks are defined, with particular attention paid to the recent creation of the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) for children with heart failure and those being supported with ventricular assist devices (VAD). The mission, goals, and organizational structure of ACTION are described, and recent initiatives promoted by ACTION are highlighted, such as stroke reduction initiatives, practice harmonization protocols, and use of ACTION data to support the recent US Food and Drug Administration approval of newer VAD for pediatric patients. The learning network, exemplified by ACTION, is distinguished from traditional clinical research collaboratives by contributions in research, quality improvement, patient-reported outcomes, and education, and serves as an effective vehicle to drive clinical improvement in the care of children with advanced heart failure.

Multisystem Inflammatory Syndrome Associated with COVID-19 Anti-thrombosis Guideline of Care for Children by Action.

With growing number of pediatric cases of COVID-19, a unique hyper-inflammatory syndrome, linked to SARS-CoV-2 infection, has emerged in children referred to as multisystem inflammatory syndrome in children (MIS-C). This Kawasaki Disease (KD)-like illness has been described across the world. This syndrome shares features of KD, toxic shock syndrome, and macrophage activation syndrome and is associated with significantly elevated inflammatory markers. Everyday there are new data emerging improving the care of these patients. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is a collaborative network designed to improve the outcomes of pediatric patients with end-stage heart failure and involves centers from across North America. The committee gathered information concerning COVID-19 anticoagulation practices at various centers and harmonized the data to formulate a set of recommendations.

Pediatric ventricular assist device registries: update and perspectives in the era of miniaturized continuous-flow pumps.

The success of ventricular assist devices (VADs) in the treatment of end-stage heart failure in the adult population has led to industrial innovation in VAD design, focusing on miniaturization and the reduction of complications. A byproduct of these innovations was that newer generation devices could have clinical applications in the pediatric population. Over the last decade, VAD usage in the pediatric population has increased dramatically, and the newer generation continuous flow (CF) devices have begun to supplant the older, pulsatile flow (PF) devices, formerly the sole option for ventricular assist in the pediatric population. However, despite the increase in VAD implants in the pediatric population, patient numbers remain low, and the need to share data between pediatric VAD centers has become that much more important for the continued growth of VAD programs worldwide. The creation of pediatric VAD registries, such as the Pediatric Registry for Mechanical Circulatory Support (PediMACS), the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) and the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) has enabled the collection of aggregate data from VAD centers worldwide, and provides a valuable resource for clinicians and programs, as more and more pediatric heart failure patients are considered candidates for VAD therapy.

The ACTION Quality Improvement Collaborative: 2020 Annual Report

Purpose ACTION (Advanced Cardiac Therapies Improving Outcomes Network) is a multi-faceted quality improvement (QI) and research network with the goal of improving pediatric and congenital heart disease VAD and heart failure (HF) outcomes. This report describes ACTION initiatives. Methods ACTION includes QI, educational activities, and a data registry. Stakeholders include providers, patients and families, and industry partners. The core values of ACTION include collaboration and transparency. ACTION started in 2017, with data collection beginning in April 2018. This report utilizes ACTION data and describes selected completed and ongoing initiatives. Results The ACTION registry report is shared with sites as an interactive dashboard (refreshed monthly). A comprehensive data quality strategy includes data queries and adjudication of critical events. There are 50 US/Canadian sites in the network and 34 of the sites contribute data. There are additional international sites that participate in all activities except patient-level data collection. The registry includes 388 patients implanted with 511 devices with 51,411 device days. DCM (203) and CHD (143) are the major underlying diagnoses. EXCOR (148), HVAD (97), and HM3 (70), are the most common end devices. Survival is 91% (including ongoing support, transplant and wean). AE rates are: stroke 11%, bleeding 21%, and infection 26%. The dashboard allows intuitive examination of subgroups, e.g., stroke/bleeding rate in patients less than 10 kg/on a specific device. Initial QI projects include an initiative (ABC of stroke), that used a bundle of interventions to reduce stroke during VAD support; a discharge planning project; a telehealth support project; and a harmonization initiative to reduce burden of protocol development for sites. Additionally, a patient-facing education website about VAD/HF care is being deployed and a HF project is collecting baseline data for acute decompensated HF. ACTION data have been used to support regulatory (FDA) approval of selected devices. Conclusion ACTION, a collaborative, multi-stakeholder network, has undertaken numerous approaches to improve outcomes for children with HF and VADs. In keeping with the values of transparency and collaboration, the ACTION annual reports will be made available in their entirety in a patient-facing version, via the ACTION website.

The ABC's of Stroke Prevention: Reduction in Stroke Frequency Following a Quality Improvement Intervention by the Action Learning Network

<h3>Purpose</h3> To assess the frequency of stroke among ventricular assist device patients following a quality improvement bundled intervention (the "ABCs of Stroke Prevention" [ABCs] which focused on Anticoagulation, Blood pressure, and Communication) within the Advanced Cardiac Therapies Improving Outcomes Network (ACTION). The bundle intervention comprised 3 interventions. These were: a document harmonizing how to implement and maintain bivalirudin infusion, a blood pressure management protocol and a daily stroke prevention checklist. <h3>Methods</h3> Baseline stroke outcomes prior to the formation of ACTION (Q3 2014 - Q2 2017) were obtained from Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs). The CVA adverse event definition was used to assess stroke from Pedimacs. Stroke outcomes following implementation of the ABCs were obtained from the ACTION Outcome Registry Q1 2018-9/18/2020. <h3>Results</h3> A total of 693 patients (350 Pedimacs, 343 ACTION) and 887 devices (472 Pedimacs, 415 ACTION) were included. The overall stroke rate decreased following implementation of the ABCs from 14.6% to 10.4% (p=0.03) (Figure 1). The paracorporeal pulsatile pump stroke rate decreased from 30.1% to 8.2% (p<0.001) (Figure 2). <h3>Conclusion</h3> Stroke frequency has decreased following implementation of the ABCs. The most notable reduction has occurred in pulsatile paracorporeal pump patients where the stroke frequency has decreased more than 20%. Follow-up interventions are focused on further improving other device specific stroke outcomes and understanding patient specific risk factors.

The Adjudication Process at ACTION - Providing Real-World High-Quality Data

Purpose Lack of both relevant clinical trials and real-world data (RWD) make it difficult to assess the effectiveness of any intervention in pediatric ventricular assist devices (VADs) population. Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry offers a means to capture RWD outside of traditional clinical trials. ACTION registry has introduced a standardized blinded adjudication process to provide VAD related adverse events (AEs) data with improved consistency and reliability. This study reviews the outcomes of the process at the end of its first year. Methods The ACTION adjudication committee, comprised of experts in the field, reviews all critical adverse events, including neurological dysfunction (ND), device malfunctions (DM) and events that lead to death, on a quarterly basis. The committee also reviews a randomly selected subset (15%) of major bleeding (MB) and major infection (MI). Pre-adjudication reports are sent to the centers to upload source documents to a secure portal. Documents are de-identified by the Data Coordinating Center (DCC) and are shared with the chair and two assigned adjudication reviewers. Each AE is presented by the assigned reviewers at a virtual meeting followed by a period of discussion and final adjudication. Committee recommendations are sent as post-adjudication reports to make necessary changes to the AE data entered in registry. Results Total of 658 AEs were reported in the registry through June 2020. Thus far, 182 (28%) AEs were adjudicated (59 Neuro AE, 48 events leading to death, 37 DM, and 38 randomly selected from other AEs). Majority of AEs [150 (82%)] were adjudicated as classified, however, 25 (14%) were classified as non-AEs (DMs = 22, MB = 2, ND = 1). Eight (4.5%) reported events were reclassified in different categories (MI = 2, ND = 4, Events leading to cause of death = 2). As a result of this process, 34 additional events (Events leading to cause of death = 21; Stroke = 4; Other neurological events = 3; Bleeding = 4; Infection = 1; Device malfunction = 1) were identified by the committee that were not originally reported to the registry. Conclusion ACTION adjudication process identified 18% misclassified and ∼5% unreported events, highlighting limitations of any registry data. However, an expert-led adjudication process with a follow-up DCC to site communications and training has the potential to improve the quality of RWD.

Characterization of Strokes in Children on Ventricular Assist Devices: An Action Collaborative Analysis

Purpose We sought to characterize strokes in children supported with ventricular assist devices (VADs) in the Advanced Cardiac Therapies Improving Outcomes Network (ACTION). Methods All patients entered in the ACTION registry (4/1/2018-6/8/2020) were included. Stroke was defined by pre-specified criteria and categorized as hemorrhagic or ischemic in etiology. All strokes were adjudicated by the data coordinating center and the adjudication committee which is comprised of members from multiple sites. Results Of 270 patients in the ACTION registry, 26 patients (9.6%) experienced 28 strokes (25 ischemic and 3 hemorrhagic). Of these 26 patients, 12 (46%) were ≤1yo, 12 (46%) had congenital heart disease, 8 (26%) had preimplant ECMO use, 23 (88%) were on paracorporeal VADs and 3 (15%) had intracorporeal VADs. The median time to stroke was 17.5 days. There were 11 (39%) and 17 (60%) strokes that occurred within 7 and 30 days, respectively, and all strokes occurring ≤30 days post-implant were ischemic. On paracorporeal VADs, there were 23 ischemic (EXCOR=9, Centrimag=6, Pedimag=6, Rotaflow=2) and 2 hemorrhagic (EXCOR=1, Centrimag=1) strokes. With intracorporeal support there were 2 ischemic (HVAD=1, HM3=1) and 1 hemorrhagic (HVAD=1) strokes. The overall stroke rate was 145.4 per 10,000 patient-days. Mortality rates were significantly higher for patients who did (10/26; 38.5%) vs. those who did not (32/144; 13.1%) experience a stroke (p Conclusion Although the stroke rate in children on VADs has decreased over time, strokes still occur in 1/10 patients and are associated with significantly increased mortality. The large majority of strokes are ischemic in nature, associated with paracorporeal VADs, and occur within the first 30 days after implant. About half of the children experiencing strokes on a VAD are ≤1yo and/or have congenital heart disease. Based on these data, ACTION is focusing ongoing quality improvement projects on decreasing strokes for children on paracorporeal devices with particular attention to the early post-implant period.

Outcomes of Infants and Children with Stage 1 Single Ventricle Implanted with Ventricular Assist Devices: An Analysis of the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry

<h3>Purpose</h3> Ventricular assist device (VAD) use in patients with congenital heart disease is increasing. Data on VAD outcomes in infants/children with stage 1 single ventricle (SV) are limited. Our study aims to characterize the outcomes of this population using multi-center registry data. <h3>Methods</h3> We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of stage 1 SV patients undergoing VAD implantation between March 2018 - June 2020. ACTION data are collected from 30 centers, and major adverse events undergo central adjudication using pre-specified event definitions. Clinical characteristics, major adverse events, and survival are reported. <h3>Results</h3> During the study period, 27 stage 1 SV patients underwent VAD implant with median age of 1 month (range 0.1-44), weight 3.7kg (2.4-17), and BSA 0.24 m² (0.18-0.65). Pre-implant comorbidities were frequent: ventilator support (85%), ECMO (37%), history of cerebral vascular accident (CVA, 30%), and pre-implant dialysis (18.5%). Device strategy included paracorporeal continuous-flow VAD in 11 patients, paracorporeal pulsatile VAD (12), and multiple devices (4). Concomitant surgical procedure was performed in 4 patients. Median support duration was 56 days (2-271). A positive clinical outcome, defined as transplant, weaned, or alive on device was obtained in 59%, with 12 patients transplanted while 11 died on device (Fig 1). Adverse events on VAD support included neurologic dysfunction (18.5%, with n=2 CVA), bleeding (22%), infection (48%), renal dysfunction (15%), and device malfunction (4%). <h3>Conclusion</h3> Stage 1 SV patients undergoing VAD support have frequent and severe pre-implant comorbidities, which likely contributed to the significant morbidity and mortality post-implant. A variety of device types and surgical strategies are employed by centers to support this challenging physiology.

Atrial Cannulation in Pediatric Mechanical Circulatory Support

Purpose Several centers have considered the potential benefits of atrial inflow cannulation to provide mechanical circulatory support (MCS) among pediatric patients with small or restrictive ventricles particularly in those with potential for myocardial recovery. Limited pediatric data are available on contemporary outcomes of atrial cannulation. We sought to describe the characteristics, complications, and outcomes of children supported with atrial cannulation using the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) ventricular assist device (VAD) database. Methods Data were collected from the ACTION VAD database for all patients who underwent VAD implantation via atrial cannulation from 8/16/2012 to 9/8/2020. Patient characteristics, VAD types, complications, and outcomes were analyzed. Results Forty-one patients met the study criteria with 52 implants. Median age was 3.6 years (range 0.02 - 25.32), weight 13.6 kg (2.7-106), and BSA 0.6 (0.15 - 2.2). Diagnoses included dilated cardiomyopathy (42%), congenital heart disease (37%), transplant graft dysfunction (7%), restrictive and hypertrophic cardiomyopathies (5% each). VAD indications were bridge to decision (42%), bridge to transplant (42%), and bridge to recovery (17%). Eighty-four percent of patients were INTERMACS 1 or 2, 44% were on ECMO, and 63% were mechanically ventilated. Devices utilized included Berlin Heart Excor (40%), paracorporeal continuous flow devices (38%), Heartware (19%) and one Heartmate 3. Median support duration was 43.5 days (range 0-307). Overall mortality was 22%. Twenty patients (49%) were successfully transplanted, 7 (17%) recovered, and 5 (12%) are still alive on the device. Adverse events included major bleeding (24%), stroke (12%), sepsis (10%), right heart failure requiring RVAD (5%), and one instance of pump thrombosis. Conclusion Atrial cannulation in pediatric MCS can be performed across a variety of anatomic substrates and age ranges with outcomes and complication rates that are comparable to left ventricular cannulation strategies. This method may be advantageous in certain circumstances including patients with small or restrictive ventricles, potential for myocardial recovery, or multiple prior sternotomies to minimize surgical dissection. Further studies are needed to delineate the ideal patient population and benefits of varying atrial cannulation techniques.

Right heart failure considerations in pediatric ventricular assist devices.

Right heart failure (RHF) is a vexing problem in children after left ventricular assist device (LVAD) implantation that can negatively impact transplant candidacy and survival. Anticipation, prevention, early identification and appropriate medical and device management of RHF are important to successful LVAD outcomes. However, there is limited pediatric evidence to guide practice. This pediatric-focused review summarizes the relevant literature and describes the harmonized approach to RHF from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION). This review seeks to improve RHF outcomes through the sharing of best practices and experience across the pediatric VAD community.

Variation in Cardiac Rehabilitation for Pediatric Ventricular Assist Device Recipients Across North America.

Despite increasing utilization of continuous-flow pediatric ventricular assist devices (VAD) in children, data on exercise testing and cardiac rehabilitation (CR) are unknown. We described variation in CR practices and identified barriers to exercise testing and CR. A survey was performed through the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) representing pediatric VAD centers across North America. Descriptive statistics were performed. A multidisciplinary cohort of 52 respondents from 28 pediatric VAD centers responded. Although 38% reported performing exercise testing, most (65%) used 6 minute walk tests rather than formal cycle or treadmill exercise testing. While all respondents refer to physical therapy during the initial inpatient stay for VAD placement, only 52% refer to a CR program. When performed, CR was performed at an ACTION center (84%), a local specialized center (21%), or a home-based CR program (26%). Commonly cited barriers to either CR or exercise testing were inadequate resources, inadequate implementation logistics knowledge, concerns about safety, inability of patients to travel to a CR facility, and concern about utility of exercise testing or CR. Over 90% of centers were interested in implementing a standardized pediatric VAD CR program. Utilization of exercise testing and CR after VAD placement is variable. Despite perceived barriers, most pediatric VAD centers are interested in implementing a standardized CR program for recipients. In response to this interest, we plan to implement a standardized CR protocol to all ACTION pediatric VAD centers in an effort to improve pretransplant waitlist rehabilitation and post-transplant outcomes.

HVAD Usage and Outcomes in the Current Pediatric Ventricular Assist Device Field: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Analysis.

Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is the first pediatric ventricular assist device (VAD) quality improvement network (46 centers). We aimed to describe outcomes with the HeartWare HVAD from ACTION centers. Patients with an HVAD implant in the ACTION registry (April 2018-April 2020) were analyzed. Baseline characteristics, adverse events, and survival were described. There were 50 patients implanted with a HVAD during the study period [36 cardiomyopathy, 8 congenital heart disease (CHD), and 6 other] and 21 (42%) had a prior sternotomy. Median age (range) was 12.9 years (3.4-19.1), body surface area was 1.3 m2 (0.56-2.62), and weight was 41.8 kg (12.8-135.3). Most were INTERMACS profile 2 (n = 26, 52%). Mechanical ventilation and ECMO were used pre-HVAD in 13 (26%) and 6 (12%), respectively. Median time on VAD was 71 (5-602) days. Survival was 96% at 1 year; 3 deaths were recorded, all of whom had CHD (p = 0.001). Neither ECMO nor mechanical ventilation were associated with death (p > 0.29). Most frequent AEs were bleeding (n = 7, 14%) and infection (n = 7, 14%). Stroke was rare (n = 2, 4%). ACTION Network HVAD outcomes were excellent, with 96% survival at 1 year and only 4% occurrence of stroke. Major bleeding and infection were the most common adverse events.

Berlin Heart EXCOR and ACTION post-approval surveillance study report

The Berlin Heart EXCOR Pediatric (EXCOR) ventricular assist device (VAD) was introduced in North America nearly 2 decades ago. The EXCOR was approved under Humanitarian Device Exemption status in 2011 and received post-market approval (PMA) in 2017 from Food and Drug Administration. Since the initial approval, the field of pediatric mechanical circulatory support has changed, specifically with regard to available devices, anticoagulation strategies, and the types of patients supported. This report summarizes the outcomes of patients supported with EXCOR from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry. These data were part of the PMA surveillance study (PSS) required by the Food and Drug Administration. ACTION is a learning collaborative of over 40 pediatric heart failure programs worldwide, which collects data for all VAD implantations as one of its initiatives. All patients in North America with EXCOR implants reported to ACTION from 2018 to 2020 (n = 72) who had met an outcome were included in the EXCOR PSS group. This was compared with a historical, previously reported Berlin Heart EXCOR study group (Berlin Heart study [BHS] group, n = 320, 2007‒2014). Patients in the PSS group were younger, were smaller in weight/body surface area, were more likely to have congenital heart disease, and were less likely to receive a bi-VAD than those in the BHS group. Patients in the PSS group were less likely to be in Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 and were supported for a longer duration. The primary anticoagulation therapy for 92% of patients in the PSS group was bivalirudin. Success, defined as being transplanted, being weaned for recovery, or being alive on a device at 180 days after implantation, was 86% in the PSS group compared with 76% in the BHS group. Incidence of stroke was reduced by 44% and the frequency of pump exchange by 40% in the PSS group compared with those in the BHS group. Similarly, all other adverse events, including major bleeding, were reduced in the PSS group. The PSS data, collected through ACTION, highlight the improvement in outcomes for patients supported with EXCOR compared with the outcomes in a historical cohort. These findings may be the result of changes in patient care practices over time and collaborative learning.

Heart failure in children: Priorities and approach of the ACTION collaborative

Despite significant advances in the medical field, pediatric heart failure continues to have a significant health burden. ACTION (Advanced Cardiac Therapies Improving Outcomes Network) was formed to bring the benefits of a learning health system to the problems of pediatric heart failure and VAD care. The ACTION learning collaborative network has expanded its focus to incorporate quality improvement initiatives aimed at improving outcomes in pediatric heart failure. The multiple initiatives include a collaboration with the Pediatric Health Information System (PHIS) database, timely referral for heart failure management in Fontan patients, formation of a waitlist outcomes committee, and a heart failure management committee with numerous parent and provider education initiatives.