Ventricular Assist Device Program Research Articles

(1315) - International Survey: Ventricular Assist Device Program Staffing Structure and the Role of VAD Coordinator

(1315) - International Survey: Ventricular Assist Device Program Staffing Structure and the Role of VAD Coordinator

Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study

Generic and heart failure-specific measures do not capture unique aspects of living with a ventricular assist device (VAD). Using state-of-the-science psychometric measurement methods, we developed a measurement system to assess post-ventricular assist deviceadjustment and health-related quality of life (HRQOL). Patients were recruited from 10/26/16-2/29/20 from 12 U.S. VAD programs. We created a dataset of participants (n=620) enrolled before left (L)VAD implantation, with data at 3- or 6- months post-implantation (group1 [n=154]), and participants enrolled after LVAD implantation, with data at one timepoint (group 2 [n=466]). We constructed 5item banks: 3 modified from existing measures and 2 new measures. Analyses included item response theory (IRT) modeling, differential item functioning tests for systematic measurement bias, and indicators of reliability and validity. Of 620 participants, 56% (n=345) were implanted as destination therapy, 51% (n=316) were <12 months post-implantation, mean age=57.3 years, 78% (n=485) male, 70% (n=433) White, 58% (n=353) married/partnered, and 58% (n=357) with >high school education. We developed 5 new VAD item banks/measures: 6-item VAD Team Communication; 12-item Self-efficacy Regarding VAD Self-care; 11-item Being Bothered by VAD Self-care and Limitations; 7-item Satisfaction with Treatment; and 11-item Stigma. Cronbach's alpha reliability ranged from good (≥0.80) to excellent (≥0.90) for item banks/measures. All measures, except VAD Team Communication, demonstrated at least moderate correlations (≥0.30) with construct validity indicators. These measures meet IRT modeling assumptions and requirements; scores demonstrate reliability and validity. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and guide post-VAD interventions.

Starting Pediatric VAD Program: Transforming Challenges into Opportunities; A Case Series of a Single Center

Background: The prevalence of heart failure is constantly increasing in both children and adults. End-stage heart failure in children unresponsive to medical therapy has limited treatment options. Surgical options include heart transplantation or implantation of durable ventricular assist devices (VADs). To start the VAD program, it was necessary to train core team members, invite experienced proctors and adjust the organizational approach. Methods: We present our first seven pediatric patients who underwent a VAD implantation with primary indication end-stage dilated cardiomyopathy. Results: The median age on implant was four and a half years and the median duration of VAD support was 39 days with long term survival achieved in three patients. The causes of death were multiorgan failure, thromboembolic events, sepsis, and low cardiac output syndrome. Ischemic stroke was the reason for successful neurointervention during VAD support in two patients. Conclusions: To establish a VAD program, numerous specialties must be included with adequate training and learning for all team members.

The Impact of Improving Nutrition Status, Pre-habilitation, Optimization of Cardiac Hemodynamics Including use of Temporary Mechanical Support When Indicated on the Reduction of Frailty in Patients Evaluated for Advanced Heart Failure Therapies

Background: Advanced frailty and age are associated with increased mortality, adverse surgical and transplant outcomes. Aside from bridge-to-transplant ventricular assist device (VAD) implant, minimal literature exists regarding reversing frailty. The aim of this study was to assess interventions used by Lutheran Heart Transplant (HTx) and VAD Program on reducing frailty and the impact on short-term operative outcomes.&#x0D; Methods: A retrospective chart review of 29 patients evaluated in the Lutheran HTx and VAD program was performed. Data collected included biomarker and demographic data for June 2020 to present. The study population was analyzed and then stratified by their modified Fried Frailty Phenotype (mFFP) score. Independent analysis was performed for HTx and VAD cohorts. Fisher’s exact and t-tests were used to analyze categorical and continuous variables, respectively (alpha = 0.05).&#x0D; Results: 18 out of 29 patients (62%) were classified as frail at initial assessment. Significant improvements were observed in bilirubin (p=0.017), creatinine (p=0.001), eGFR (p=0.001), lactic acid (p=0.002), and prealbumin (p=0.002) for the total study population. Frail patients experienced longer intubation (3 vs 4 days) and hospitalization (20 vs 23 days) times post-HTx. Due to limited sample size, we were unable to analyze the VAD cohort by mFFP score.&#x0D; Conclusions: Significant improvements were seen in kidney function and nutrition status as indicated by creatinine, eGFR, and prealbumin data. However, the available data was insufficient to examine the interventions impact on frailty as described by the Fried Frailty Phenotype. Similar to other studies, frailty was associated with increased intubation and hospitalization duration post-HTx.

Development of a non‐transplant left ventricular assist device program

Although the established long-term benefit of left ventricular assist device (LVAD) therapy has led to its proliferation as destination therapy (DT), few studies have evaluated LVAD outcomes at nontransplant centers. We undertook this study to better evaluate our experience in building a nontransplant, DT LVAD program. We conducted a retrospective review of all LVADs implanted from 2010 to 2021. Patient, operative, and outcome data were extracted from the electronic medical record. Secular trends were evaluated by organizing the data into eras of implant. Survival was assessed using the Kaplan-Meier method. Multivariable Cox proportional hazards regression models further evaluated outcomes. From 2010 to 2021, 100 primary LVAD implants were performed. Annual volume grew from 1 to 30 implants per year. The average age of our cohort was 65.7 years, most patients (80%) were male, 51% had an ischemic etiology, and 65 (65%) were INTERMACS profile 1 or 2. Our 1- and 2-year survival were 82% and 79%, respectively. Multivariable analysis of 1-year mortality demonstrated that decreasing renal function and increased cardiopulmonary bypass (CPB) time were associated with increased mortality while preoperative hemoglobin was protective. When stratified by era of implant, our most recent patients were more likely to be INTERMACS profile 1 or 2; had shorter CPB and aortic cross clamp times; required fewer reoperations for bleeding; and suffered less right ventricular failure requiring mechanical support. A single, nontransplant LVAD center can experience significant growth in volume in a high-acuity cohort while maintaining acceptable outcomes and quality of care.

Bereaved Caregiver Perspectives on Implantation and End of Life in Pediatric Ventricular Assist Device Patients

<h3>Purpose</h3> Ventricular assist devices (VADs) are increasingly used in pediatric patients with heart failure as a bridge to heart transplant, though approximately 3-12% will die on support. The patient and family perspectives of pediatric VAD implantation, deactivation, and end-of-life experience are not well described. <h3>Methods</h3> Semi-structured interviews were performed with caregivers of pediatric VAD patients who died from 2014-2020. Analysis was performed using a grounded theory framework: interviews were coded by two independent readers using Dedoose software, and themes derived from codes were discussed in iterative meetings using established qualitative analysis methods. Caregivers were screened for adverse psychological reactions by a psychologist during interviews and at one-week follow up. <h3>Results</h3> Six of 18 eligible families participated in interviews at a median 2.4 years after their child died. Four major themes emerged. Five of six families did not regret their decision for VAD implant despite the child's death. Caregiver-child accord (via verbal consent or cues from the child's physical state) at implant and end of life was associated with lack of regret. Perceived cues from the child about readiness to die were often more impactful in families' decisions for VAD deactivation than medical provider recommendation. Moreover, the development of a surrogate local "family" composed of the medical team (VAD providers, nurses, social workers) and other patient families provided powerful support to these families, equal or above that of the extended family or palliative care service. Though caregiver coping styles differed widely, they did not spontaneously report persistent symptoms of post-traumatic stress or depression. <h3>Conclusion</h3> This qualitative study of bereaved caregivers of pediatric VAD patients demonstrates that accord between the child and family is an important component of caregiver decision-making in VAD implantation and deactivation. Local surrogate support systems and longitudinal medical providers often play a meaningful role for caregivers at a child's end of life, sometimes more so than remote families or palliative care. A better understanding of the caregiver perspective should inform VAD programs' approach to implantation and end-of-life conversations to promote quality decision-making and bereavement.

Stress and Coping Among Family Caregivers of Patients With a Destination Therapy Left Ventricular Assist Device: A Multicenter Mixed Methods Study.

Family caregivers of patients with a destination therapy left ventricular assist device play a central and formalized role in postimplant care. We aimed to characterize longitudinal stress, predictors and correlates of stress, and coping processes among left ventricular assist device caregivers. We performed a sequential, exploratory, mixed-methods study from 6 diverse left ventricular assist device programs. The primary outcome for the quantitative analysis was the Perceived Stress Scale-10 at 6 months (0-40). Based on the quantitative findings and guided by the Transactional Model of Stress and Coping, semistructured interviews explored causes of stress and coping processes. Integration was performed during the qualitative and interpretation phase. A total of 96 caregivers met inclusion criteria for quantitative analysis. Mean (SD) Perceived Stress Scale score was 14.3 (5.5) preimplant and 11.8 (6.9) at 6 months. Preimplant, only decreased preparedness for caregiving was associated with higher Perceived Stress Scale score at 6 months. At 6 months, increased caregiver depressive symptoms, decreased caregiver preparedness for caregiving, and lower patient quality of life were associated with higher Perceived Stress Scale score. Qualitative analysis of 25 caregivers revealed the causes of stress coalesced around 3 themes: (1) lack of preparedness to be a caregiver, (2) uniqueness of stress for the caregiver and patient situation, and (3) caregiving responsibilities physically and emotionally impacting caregivers. To cope with stress, most caregivers employed emotion-focused coping. In family caregivers of patients with a left ventricular assist device, higher perceived stress was associated with lower caregiver preparedness, higher caregiver depressive symptoms, and lower patient quality of life. Emotion-focused coping strategies were common for caregivers. Future work should better prepare caregivers for this role and support them through the caregiving experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02344576.

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.

Value of psychosocial evaluation for left ventricular assist device candidates.

Left ventricular assist devices require a psychosocial assessment to determine candidacy despite limited data correlating with outcome. Our objective is to determine whether the Stanford Integrated Psychosocial Assessment for Transplant, a tool validated for transplant and widely used by left ventricular assist device programs, predicts left ventricular assist device program hospital readmissions and death. We performed a retrospective analysis of adults at the Cleveland Clinic with Stanford Integrated Psychosocial Assessment for Transplant scores before primary left ventricular assist device program implantation from April 1, 2013, to December 31, 2018. The primary outcome was unplanned hospital readmissions censored at death, transplantation, and transfer of care. The secondary outcome was death. There were 263 patients in the left ventricular assist device program with a median (Q1, Q3) Stanford Integrated Psychosocial Assessment for Transplant score of 16 (8, 28). During a median follow-up 1.2years, 56 died, 65 underwent transplantation, and 21 had transferred care. There were 640 unplanned hospital readmissions among 250 patients with at least 1 outpatient visit at our center. In a multivariable analysis, Stanford Integrated Psychosocial Assessment for Transplant components but not total Stanford Integrated Psychosocial Assessment for Transplant score was associated with readmissions. Psychopathology (Stanford Integrated Psychosocial Assessment for Transplant C-IX) was associated with hemocompatibility (coefficient 0.21±standard error 0.11, P=.040) and cardiac (0.15±0.065, P=.02) readmissions. Patient readiness was associated with noncardiac (Stanford Integrated Psychosocial Assessment for Transplant A-III, 0.24±0.099, P=.016) and cardiac (Stanford Integrated Psychosocial Assessment for Transplant A-low total, 0.037±0.014, P=.007) readmissions. Poor living environment (Stanford Integrated Psychosocial Assessment for Transplant B-VIII) was associated with device-related readmissions (0.83±0.34, P=.014). Death was associated with organic psychopathology or neurocognitive impairment (Stanford Integrated Psychosocial Assessment for Transplant C-X, 0.59±0.21, P=.006). Total Stanford Integrated Psychosocial Assessment for Transplant score was not associated with left ventricular assist device program readmission or mortality. However, we identified certain Stanford Integrated Psychosocial Assessment for Transplant components that were associated with outcome and could be used to create a left ventricular assist device program specific psychosocial tool.

Evaluation of Team-Based Learning to Increase Nurses' Knowledge of the Ventricular Assist Device.

Ventricular assist devices (VAD) are used to extend life expectancy for patients with advanced heart failure. Approximately 102 hospitals nationwide have a VAD program, but the majority implant only a small number of devices each year. This low-volume and high-acuity patient population can create concerns for maintaining nursing knowledge skill levels. Nursing staff from a step-down telemetry floor in a large urban hospital completed an Individual Readiness Assessment Test to assess their knowledge and accuracy in the care of mechanical circulatory support patients using the Immediate Feedback Assessment Technique. The nurses were then assigned to small groups and worked as a team to complete the same test known as the Group Readiness Assessment Test. Study results suggest that team-based learning was effective in increasing knowledge of mechanical circulatory support. [J Contin Educ Nurs. 2021;52(1):13-20.].

288 Characteristics and Outcomes of Patients with Ventricular Assist Devices Presenting to a Pediatric Emergency Department

Ventricular assist devices (VADs) are being used more frequently in pediatric patients with advanced heart failure. Outpatient management of children with VAD implantations also is becoming more common. However, no study exists that describes Emergency Department (ED) care of these patients. This study aims to identify patient characteristics and outcomes of children with VADs presenting to the ED. This is a retrospective descriptive study of all patients ages 0 to 18 years in the Stanford Children’s outpatient VAD program who presented to our pediatric ED between 2010 (year of first discharged VAD patient) and 2020. Patient data was abstracted from electronic medical records. Adverse events were defined according to the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry guidelines. Adverse events were included if they occurred during the ED visit or associated hospitalization. A total of 30 children with VAD implantations were transitioned to outpatient care in the study period. All were implanted with continuous flow devices. Among children in the outpatient VAD program, 20/30 (66.7%) had 38 visits to our pediatric ED over 141.5 patient-months. Median age of patients at time of ED visit was 12.5 (range 7.3-17.4) years. Median number of ED visits per discharged child was 1 (range 0-4). The most common complaints on arrival to ED included fever (7/38; 18.4%), abdominal pain or vomiting (7/38; 18.4%), headache (6/38; 15.8%), bleeding from any site (4/38; 10.5%), chest pain (4/38; 10.5%), device malfunction or alarm (3/38; 7.9%), dizziness (3/38; 7.9%), and dyspnea (3/38; 7.9%). Adverse events occurred during 14/38 (36.8%) ED visits or associated hospitalizations, including 3/38 (7.9%) instances each of hypertension, major infection, or right heart failure, 2/38 (5.3%) instances of major bleeding, and 1/38 (2.6%) instances each of hemolysis, renal dysfunction, or device malfunction. Hospital admission occurred in 27/38 (71.1%) of visits, including 10/27 (37.0%) to a cardiac intensive care unit. No patients died during an ED visit or associated hospitalization. Mortality of all children in the outpatient VAD program during the study period was 3/30 (10.0%) including one patient on destination therapy, one with hemorrhagic stroke, and one with multi-system organ failure due to cardiogenic shock. In a single outpatient pediatric VAD program, patients had high utilization of ED care and had a high rate of hospital admission following ED presentation. The youngest patient transitioned to outpatient VAD care was 7 years old. Fever, abdominal pain/vomiting, and headache were the most frequent initial complaints. The most common adverse events were hypertension, major infection, and right heart failure.

Amidst the CAUTI Metrics Hurley Burly, a Sustained SURly Success Adaptable for Reducing Other Nosocomial Infections

Background: Surveillance metrics for catheter-associated urinary tract infections (CAUTIs) are subject to ongoing debate and refinement to best capture infectious catheter-related harm (ICRH) and noninfectious catheter-related harm (NCRH). Indwelling urinary catheters cause 5 times more NCRH than ICRH. The commonly used standardized infection ratio (SIR) does not fully capture NCRH nor the impact of prevention efforts in all settings. Alternatively, device utilization rates and ratios (DUR) do not reflect differences in other factors that may describe levels of device use. DUR lose comparability over time and across settings and can mask truly effective interventions by selecting for a higher risk group of catheterized patients. Experts now advocate use of the standardized utilization ratio (SUR). We sought to implement a multidimensional intervention to reduce exposure risk, CAUTI, and NCRH across a 5-hospital healthcare system, totaling 1,692 acute-care beds. Methods: The intervention comprised the following elements: (1) an interactive educational campaign comprising one-on-one engagements between infection preventionists and frontline providers, encouraging the use of female external urinary collection devices and male custom-fitted condom catheters, rewarding overall participation, device utilization, hand hygiene, and CAUTI rates; (2) educational emails to all staff from top executives; (3) increasing the urinalysis reflex to culture threshold from &gt;5 to ≥10 WBCs; and (4) clinical decision support (CDS) for ordering urine cultures for patients with indwelling catheters and for encouraging Foley catheter alternatives and catheter removal. Monthly, quality department representatives discuss unit level DURs with managers, who then discuss patient-level device use at daily huddles with physicians and advanced practice providers. Significance was determined using the 2-tailed t test. The results are listed in Table 1. Discussion: One year after the intervention, use of device alternatives increased 5-fold, CDS-driven ordering predominated, and the SIR and SUR remained significantly decreased. These successes are especially notable because , a ventricular-assist device program was launched in the postintervention period. By the end of the study, the program became the second-busiest of its type in the United States, resulting in a group of patients at high risk of device use and infection in the postintervention period, but absent in the preintervention period. numerous reports of effective interventions for reducing CAUTI have been published, we found no large studies using the SUR as the main metric. The limitations of this study include the lack of a population SIR and data pertaining to catheter-related bacteriuria and antibiotic usage. However, this approach is easily customizable to any infection, device, and diagnostic test.Disclosures: NoneFunding: None

Evaluation of a Health Care Performance Improvement Initiative to Facilitate Optimal Clinical Outcomes in Patients Receiving Ventricular Assist Device Support

Ventricular assist device (VAD) patients are at high risk for morbidities and mortality. One potentially beneficial component of the Joint Commission VAD Certification process is the requirement that individual VAD programs select 4 performance measures to improve and optimize patients' clinical outcomes. Review of patient data after our program's first certification visit in 2008 showed that, compared to national recommendations and published reports, our patients had suboptimal outcomes in 4 areas after device implantation: length of hospital stay, receipt of early (<48 hours) postsurgical physical therapy, driveline infection incidence, and adequacy of nutritional status (prealbumin ≥18 mg/dL). Plan-Do-Study-Act processes were implemented to shorten length of stay, increase patient receipt of early physical therapy, decrease driveline infection incidence, and improve nutritional status. With 2008 as our baseline, we deployed interventions for each outcome area across 2009 to 2017. Performance improvement activities included staff, patient, and family didactic, one-on-one, and hands-on education; procedural changes; and outcomes monitoring with feedback to staff on progress. Descriptive and inferential statistics were examined to document change in the outcomes. Across the performance improvement period, length of stay decreased from 40 to 23 days; physical therapy consults increased from 87% to 100% of patients; 1-year driveline infection incidence went from 38% to 23.5%; and the percentage of patients with prealbumin within the normal range increased from 84% to 90%. Performance improvement interventions may enhance ventricular assist device patient outcomes. Interventions' sustainability should be evaluated to ensure that gains are not lost over time.

Outcomes with Ventricular Assist Device Therapy for Advanced Heart Failure in North Macedonia: First Annual Report

Mechanical circulatory support by a continuous-flow ventricular assist device (VAD) improves survival and quality of life in selected patients with advanced heart failure. Developing countries have been struggling to construct a contemporary and effective health care system to manage advanced heart failure. This observation represents the first annual report on clinical outcomes with VAD for patients with advanced heart failure in the Republic of North Macedonia. Data from all patients with VAD implantations between November 2018 and December 2019 were collected. The etiology of the heart failure was dilated cardiomyopathy in 4 patients (57%), ischemic cardiomyopathy in 2 (28%), and hypertrophic cardiomyopathy in 1 (14%). The primary outcome was survival; secondary outcomes included adverse events defined according to the Interagency Registry for Mechanically Assisted Circulatory Support. A total of 7 patients (85% males, median age 56 years) received a VAD; 5 of them received left VAD, and the remaining 2 received biventricular VAD. There were no deaths. Observed morbidity during a mean follow-up of 216 days included 3 bleeding events in 1 patient, 2 patients with superficial driveline infection, and 1 minor stroke and a pump thrombosis, which were treated with VAD exchange. Significant improvement in quality of life, as assessed by the Kansas City Cardiomyopathy Questionnaire and the Functional Independence Measure™ instrument, was seen with all patients. Our results demonstrate a successful initiation of the VAD program in the Republic of North Macedonia. Proper training of a dedicated HF team supports the reproducibility of this treatment in developing countries.

Decision Aid Implementation among Left Ventricular Assist Device Programs Participating in the DECIDE-LVAD Stepped-Wedge Trial.

Background. Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision-ideal for exploring implementation of a DA. Methods. We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study. Results. From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation. Conclusions. In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.

What Do VAD Coordinators Do?

While every program following patients on durable left ventricular assist devices (VADs) has VAD coordinators, their responsibilities are not unified. Although all of them take care of patients and provide education to patients, family, medical professionals, and public, their daily functions differ. The purpose of this descriptive study was to characterize daily functions of VAD coordinators in the USA-based programs. We surveyed representatives (heart failure cardiologists or cardiothoracic surgeons) of the programs implanting VADs and following VAD patients. Each representative answered a standardized block of questions. Programs which opened within one year of the study, programs following less than 20 patients, and programs where VAD coordinators also function as transplant coordinators were excluded. A total of 20 heart failure cardiologists and cardiothoracic surgeons representing VAD programs from various regions of the country, answered the questions of the survey.The number of patients with LVAD followed by individual programs ranged 50-200, median 100, and the number of coordinators in the program ranged 2-7, median 4. Number of patient per coordinator was 25 (median), ranging 10-65.They performed following functions:1. INR management 75% 2. Daily notes on in-patient service in patients with VADs 55%3. Notes on out-patients with VADs during clinic visits 73,7%4. Coming to the emergency room by default when patient with VAD is admitted 45%5. Home inspection in the process of evaluation for VAD 20%6. Weekend rounds on LVAD patient 25% CONCLUSION: There is wide variability in daily functions of VAD coordinators across the country, The median ratio is 25 patients with VADs per coordinator, with a very wide range 10-65. Programs with best workflow and outcomes should be studied in order to determine the optimal set of responsibilities for VAD coordinators.

Paving a Road Home: Developing Education for a Pediatric Home-Going VAD Program.

The objective was to create a multidisciplinary education plan for discharge home following implantation of a ventricular assist device (VAD) in pediatrics. Educational program was developed for the local community: emergency department, emergency medical services, medical transport team, as well as, the pediatric patient and their caregivers. Education geared to the individual learner included both lecture and hands-on training. A direct line for family and local providers to speak directly with a VAD-trained physician 24/7 was also created. Patient and caregivers required to 1) perform 10 supervised power exchanges; 2) qualify written quizzes on the controller, battery charger, alarms, and troubleshooting; 3) perform 10 supervised dressing changes; 4) pass simulation session responding correctly to alarm scenarios; and 5) take both an on-campus and off-campus field trip unaccompanied by support staff. Once the education plan is complete and the patient is medically stable, they are considered ready for discharge. From a mechanical support perspective, discharge home of a medically complex pediatric patient on a durable VAD can be accomplished safely, even in a low volume center, with attention to detail, creation of a robust education plan, and close partnership between the VAD team, the family, and the community.

Paving a Road Home: Developing Education for a Pediatric Home-Going VAD Program

The objective was to create a multidisciplinary education plan for discharge home following implantation of a ventricular assist device (VAD) in pediatrics. Educational program was developed for the local community: emergency department, emergency medical services, medical transport team, as well as, the pediatric patient and their caregivers. Education geared to the individual learner included both lecture and hands-on training. A direct line for family and local providers to speak directly with a VAD-trained physician 24/7 was also created. Patient and caregivers required to 1) perform 10 supervised power exchanges; 2) qualify written quizzes on the controller, battery charger, alarms, and troubleshooting; 3) perform 10 supervised dressing changes; 4) pass simulation session responding correctly to alarm scenarios; and 5) take both an on-campus and off-campus field trip unaccompanied by support staff. Once the education plan is complete and the patient is medically stable, they are considered ready for discharge. From a mechanical support perspective, discharge home of a medically complex pediatric patient on a durable VAD can be accomplished safely, even in a low volume center, with attention to detail, creation of a robust education plan, and close partnership between the VAD team, the family, and the community.

Marked Practice Variation in Antithrombotic Care with the Berlin Heart EXCOR Pediatric Ventricular Assist Device.

Management of antithrombotic therapy (ATT) for pediatric ventricular assist devices is challenging, and the Berlin EXCOR remains the only Food and Drug Administration (FDA)-approved option. Among those on the EXCOR, 28% have neurologic complications and major bleeding occurs in 50%. The Edmonton Protocol was developed to guide ATT, but the adverse event rate remains high, leading most centers to make modifications. The objective of this study is to characterize antithrombotic practice variation among North American pediatric ventricular assist device programs, in order to guide future research. In this descriptive cross-sectional study, a survey assessing antithrombotic (AT) practices was distributed by Berlin Heart Inc. to centers that implanted ≥1 EXCOR between January 2012 and January 2016. Practices were compared at high- versus low-volume centers. High volume was defined as ≥14 implants in this period. Seventeen of 38 centers (44.7%) participated; 4 were high volume. At half of all centers (9/17), ≤2 clinicians managed all AT decisions. Although 47.1% (8/17) followed the protocol "extremely/very closely," only 5.9% (1/17) felt it to be "very effective." Most centers (10/15; 66.7%) deviated in ≥2 protocol aspects. Over half modified either recommended antiplatelet agents (5/15) or anticoagulants (4/15). Adjunct medication use was highly variable. Most (11/17; 64.7%) deviated from protocol in either timing or type of AT lab monitoring. Despite widespread use of Thromboelastography (TEG)/Platelet Mapping (PM), concerns of inaccuracy were common. Most high-volume centers (3/4; 75%) abandoned TEG/PM as a primary tool. These practice variation analyses have identified areas in ATT that are amenable to care standardization and further research. Systematic study of optimal AT medication dosing and monitoring is needed.

The Intersection of Quality and Clinical Care: Approach to Improve Ventricular Assist Device Patient Care

Background Improving outcomes in the Ventricular Assist Device (VAD) patient population is an on-going challenge. Incorporating comprehensive quality into a VAD program ensures not only meeting accreditation standards, but helps improve patient care. We used performance measure data to identify deficiencies and garner stakeholder buy-in with the intended goal of improving care. Methods The quality specialist worked closely with the VAD team to identify the performance measures for the program as well as establish benchmarks using evidenced based best practices. Each performance measure was distinctly tied to a data point that would subsequently be abstracted from the chart for each patient. The quality specialist and VAD Coordinator then incorporated the quality measures and performance goals into a QAPI Plan and encouraged stakeholders to review and provide feedback. By engaging stakeholders to review and revise, we promoted buy-in to the QAPI elements of the VAD program. Performance measures were tracked monthly. Variance on the scorecard was presented to the VAD multidisciplinary team as well as Hospital Quality Council. If variance occurred, performance improvement activities were developed. Results A unique color-coded QAPI scorecard was created in which different colors represented different levels of compliance. The metrics were tracked using the Scorecard and presented at the monthly meetings. At baseline, driveline dressing change compliance was 63%. After implementation of our improvement measures, compliance increased to 81%. Similarly, performance of Daily Weights increased from 36% to 96%. Documentation of Nursing VAD Education increased from 57% to 97% and documentation of Pain Assessment increased from 64% to 97%. We maintained a zero percent rate of driveline infection. Conclusion Creating stakeholder awareness of gaps in performance increased commitment to performance improvement plans. Use of a unique color coded QAPI scorecard can be useful in improving quality metrics and subsequently patient care. This approach can be utilized beyond the VAD population to improve quality among all heart failure and transplant patients.