Cardiac Therapies Improving Outcomes Network Research Articles

Collaboration and new data in ACTION: a learning health care system to improve pediatric heart failure and ventricular assist device outcomes

Outcomes in pediatric heart failure and ventricular assist devices (VADs) remain suboptimal. Given the complexity and limited numbers, centers cannot be expected to acquire mastery and generalizable knowledge independently. Recognizing this problem, the community has formed Advanced Cardiac Therapies Improving Outcomes Network (ACTION), a collaborative learning health care system committed to unrelenting collaboration and continuous learning to improve critical outcomes in pediatric heart failure. ACTION is inclusive of all interested parties and believes the fastest and most effective way to make progress is through working together. ACTION's approaches to collaboration and data sharing will be highlighted.

It Takes a Village: Pediatric Ventricular Assist Device Training and Education Practices among ACTION Centers

Purpose The last decade has seen a dramatic increase in the number of ventricular assist devices (VADs) implanted in children. Despite the increases, the procedure remains uncommon at individual centers making patient, family and staff education challenging. ACTION ( Advanced Cardiac Therapies Improving Outcomes Network) is the first pediatric VAD quality improvement network. The initial goal of ACTION is stroke reduction. We sought to describe the education and care delivery structure among members of the ACTION pediatric VAD quality improvement collaborative. Methods A 26 question electronic survey assessing education infrastructure, resource use, methods and gaps in knowledge was distributed among the primary VAD education providers (VEPs) at ACTION sites. Results Seventeen centers replied, the majority of respondents were VAD coordinators (71%). The majority of VEPs train >100 providers/staff yearly (53%) and devote >6 hours/month on education (75%). There was significant variability in the effectiveness of VAD education programs, competence of care providers, patient/family discharge preparation and ongoing competence assessment among centers. The majority of respondents felt that the existing, educational materials and resources were insufficient for pediatric VAD patients/families and care providers, leading centers to center specific VAD education resources (figure). Conclusion Pediatric VEPs currently spend a significant amount of time educating patients and patient care providers on VAD management and care. The existing VAD educational materials and resources are insufficient and have led programs to create highly variable education/discharge protocols and center specific educational materials. The rapid growth of the field of pediatric VAD has created the urgent need for pediatric specific, high quality VAD educational materials and protocols.

Real World Data from the ACTION Quality Improvement Network - Preliminary Experience with a Magnetically Levitated Ventricular Assist Device in US Pediatric Centers

Purpose We sought to describe the off-label use to date of an intracorporeal, centrifugal, continuous flow ventricular assist device (cfVAD) characterized by a magnetically levitated impeller in US pediatric cardiac centers, in order to further inform device selection quality improvement initiatives. Methods Members of the ACTION (Advanced Cardiac Therapies Improving Outcomes Network) collaborative whose centers implanted ≥1 intracorporeal magnetically levitated cfVAD were identified. Centers submitted de-identified data on each implant through 10/21/18. Results are reported as count (percentage) or median (range) for summary statistics. Results Fourteen implants occurred at 6 centers; the number of implants per center was 1 - 4. Thirteen patients (93%) had dilated cardiomyopathy (DCM); one patient (7%) had congenital heart disease (CHD) with a Fontan circulation. Of the DCM patients, 3 had neuromuscular disease (2 with Duchenne and 1 with Becker muscular dystrophy). Device strategy included bridge to transplant in 8/14 (57%), bridge to candidacy in 4/14 (29%), and destination therapy in 2/14 (14%). Median age at implant was 15 y (12 y - 24 y), with median weight 70 kg (31 kg - 118 kg) and median body surface area (BSA) 1.8 m2 (1.3 m2 - 2.4 m2). Most patients (10/14, 71%) were INTERMACS category 2 at implant; 3/14 (21%) were category 3 and 1/14 (7%) was category 4. No biVADs were placed. Median support time was 32 d (5 d - 315 d). To date, 5/14 (36%) patients were discharged, 1/14 (7%) underwent heart transplantation, and 1/14 (7%) died on VAD support; the remainder are hospitalized with the device in place. For discharged patients, median hospital length of stay after implant was 26 d (12 d - 37 d). There were no episodes of stroke or pump thrombosis. Conclusion The intracorporeal, centrifugal, magnetically levitated cfVAD is a newer device being used with increasing frequency in the pediatric and CHD population. Utilization of the device has largely been limited to older, larger children with DCM. This preliminary data will contribute to our understanding of device selection in order to improve outcomes.

Speaking the Same Language? Assessing Blood Pressure Measurement and Effectiveness in Pediatric VAD Patients

Purpose Elevated blood pressure (BP) is a risk factor for stroke in adult ventricular assist device (VAD) patients. There are currently no data or BP management guidelines for pediatric VAD patients. ACTION ( Advanced Cardiac Therapies Improving Outcomes Network) is the first pediatric VAD quality improvement network. The initial goal of ACTION is stroke reduction. This report describes the methods used to obtain BP and effectiveness of BP control among ACTION members. We also describe the development of a BP clinical decision support (CDS) tool to standardize BP reporting and goals. Methods The BP protocols among ACTION members were assessed. Process measures that may impact stroke rates were identified via anonymous surveys beginning June 2018. Statistical process control charts were used to assess baseline metrics. Results A total of 28 patients from 11 centers were identified with BP data. Including 12 Heartware, 10 Berlin, 2 Heartmate3, and 4 paracorporeal continuous flow (CF) devices. Height/age BP %iles were used to guide BP goal in 19 (68%) patients. Among CFVAD patients, BP measurement method (outside the perioperative period) and BP goal value varied, especially among the 11 patients (55%) with a palpable pulse (Figure 1). Patients had well controlled BP on 69% of support days (Figure 2). Conclusion The BP measurement methods and goals varied across ACTION, especially among patients on a CF-VAD with a pulse. A CDS tool has been developed to standardize BP measurement and management among ACTION members and will guide subsequent collaborative studies to assess the role of BP in stroke among pediatric VAD patients.

Anti-Coagulation Management in Pediatric Ventricular Assist Device: A Quality Improvement Target

Purpose Pediatric Ventricular Assist Device (VAD) therapy is associated with high rates of stroke and bleeding. There have been limited efforts to date, to define and implement optimal anticoagulation (AC) strategies in this population. ACTION (Advanced Cardiac Therapies Improving Outcomes Network) is the first pediatric VAD quality improvement network, with an initial goal of stroke reduction. This report describes baseline AC data from ACTION centers, including agents used and aggregate levels of performance, to inform development of specific interventions. Methods The AC practices of ACTION centers were assessed. Data collected included VAD type, weekly data characterizing AC agents used; time to achieve desired levels; and percentage of levels within the desired range. Results Data were collected from 11 centers, with a total of 30 patients. AC data were collected from 6/1-9/1/18, while strokes were collected retrospectively for the entire VAD support interval. Devices included: HVAD (12); EXCOR (10); Heartmate 3 (3); and 5 paracorporeal continuous flow devices. There were 5 strokes (16.7%). Intravenous AC included unfractionated heparin (36%), and bivalirudin (64%). There was wide variability between patients in the time to achieve first therapeutic AC level (Figure 1), with 15 patients at goal within 20 hours, while others required up to 170 hours. Heparin levels varied widely, with the percent of labs within range falling below 50%, in 50% of the weeks reported. For bivalirudin, levels were less variable, with percent of labs within range falling below 50% in only 14% of weeks reported. Conclusion At baseline, stroke rates remain high in the ACTION centers. Intravenous AC includes both heparin and bivalirudin, with high variability in time until therapeutic levels are achieved, and with high variability in subsequent levels, particularly for heparin. These data will inform interventions designed to reduce variability in AC performance as a basis for stroke reduction.