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VAD Coordinator Series

Home Is Where the HeartWare Is: Preparing Pediatric Patients and Caregivers for Discharge to Home and Integration Into the Community

DiFusco, Leigh Ann; Patton, Ashley M.; White, Rachel M.; Bober, Carley M.; Miller, Kelley D.

Author Information
doi: 10.1097/MAT.0000000000000846

Abstract

Pulsatile (paracorporeal) ventricular assist devices (VADs) have long been the support of choice for pediatric patients, largely because of size constraints. The various types, basis for selection, complications, and expected outcomes are well described in scholarly literature.1–3 Although a stable VAD patient may be safely transitioned to a step-down unit while awaiting transplant, large external drivers and the paracorporeal design have been limiting factors for discharge to home. Continuous-flow devices have further shifted the paradigm of pediatric mechanical circulatory support (MCS).4,5 Although the HeartWare (HVAD) is not approved by the Food and Drug Administration for use in the pediatric population, its smaller size has allowed for successful implantation of an intracorporeal device into the pediatric patient.6,7

In 2014, cardiothoracic surgeons at the Children’s Hospital of Philadelphia (CHOP) implanted the first HVAD as a bridge to transplant and with the intent to discharge the patient to home. Fifteen patients have undergone implantation of the HVAD at CHOP between 2014 and 2017, and eight (53%) have been successfully discharged home on MCS to await heart transplantation. This article describes our early experiences, highlighting outcomes, strategies, and lessons learned in order to support HVAD patients and their caregivers in the hospital and community setting.

Increasing Pediatric MCS Options With HeartWare HVAD

The first HeartWare HVAD implant at CHOP took place in March 2014. An example of the timeline from preimplant through discharge is depicted in Figure 1. As with any new option for MCS, the team must receive extensive training to care for the VAD patient throughout their admission. Although the VAD program is highly specialized, low patient volumes currently do not support a full-time VAD coordinator position. Instead, the role of VAD coordinator is shared by members of a multidisciplinary team whose roles and responsibilities are detailed in Table 1. In addition to creating policies, procedures, standards of care, and staff resources specific to the HVAD, the team conducted rapid benchmarking with adult and pediatric VAD institutions to design and implement an education program for patients, caregivers, and communities that prepared them for discharge.

Table 1.
Table 1.:
Responsibilities for Coordination of Care
Figure 1.
Figure 1.:
Timeline from Pre-Implantation to Discharge to Home with a HeartWare HVAD®.

Preparing the Pediatric HVAD Patient and Caregivers for Discharge

Caregiver education is initiated once the patient is clinically stable in the Cardiac Intensive Care Unit (CICU). The parent or legal guardian is asked to identify a minimum of two individuals (typically the patient’s parents) who will receive training on the device. Unlike adult patients with HVAD, pediatric patients must have a trained adult caregiver with them at all times. The primary caregivers are ultimately responsible for care and oversight of the patient with HVAD once discharged; however, they are strongly encouraged to identify other individuals to receive training. This provides primary caregivers with respite care and support to resume employment and other activities as needed. A Child Life Specialist is present to support and help facilitate developmentally appropriate training for any patient under 14 years of age and older patients by request.

Competency is formally validated through discussion, practice, and return demonstration and must be demonstrated before discharge (see Supplement Table 1, Supplemental Digital Content, http://links.lww.com/ASAIO/A304). Primary caregivers attended a minimum of five progressive VAD education sessions lasting in length from 30 to 60 minutes each. They are provided with an HVAD patient manual and discharge binder that includes emergency contact information, current controller settings, and specific instructions for dressing changes, wound care, anticoagulation management, activity guidelines and restrictions, diet and nutrition, and steps to prepare for clinic visits. Primary caregivers are also required to receive cardiopulmonary resuscitation (CPR) training, attend medication administration classes, and verify that the patient’s home meets the safety requirements for safe operation of the HVAD.

The most important indicators of patient and parent discharge readiness are the ability to demonstrate competence in managing device power, driveline site assessment and dressing care, completing 24 hours of care during admission and participating in two excursions to help support acclimation to life outside of the hospital with an HVAD. When completing 24 hours of care, primary caregivers are required to assume complete responsibility for all aspects of care, including medication administration, handling, and troubleshooting the HVAD under the supervision of the multidisciplinary team. Several days before discharge, the patient and primary caregivers complete an unsupervised internal and external excursion (Table 2). During this time, the patient and caregivers maintain sole accountability for the HVAD and are expected to use resources as they would if they were officially discharged to home.

Table 2.
Table 2.:
Unsupervised Excursions

Discharge Readiness and Planning

Key factors in determining discharge readiness from a clinical standpoint include recovery from surgery, optimization of nutrition (including fluid balance), and the ability to maintain a stable anticoagulation regimen. Optimization of the anticoagulation regimen in children can be challenging in respect to developmental differences in hemostasis.1 Devices for monitoring coagulation/international normalized ratio (INR) status are rarely covered by insurance in our population. Moreover, children who have been able to use these devices in the home setting have experienced challenges with correlation of values. As an alternative, patients are required to establish a relationship with an outpatient laboratory that is close to home so that test results can be obtained within the same day. The frequency of lab draws are contingent on therapeutic levels, which can vary based on medication administration, diet, and other factors, although most visit an outpatient laboratory at least once weekly until therapeutic levels are achieved. Once a child demonstrates therapeutic coagulation levels, anticoagulation labs are collected on a monthly basis with clinic visits. Additional challenges that impact pediatric anticoagulation regimens include genetic factors, such as known gene mutations, that are present with or without a congenital heart defect. Adult patients may experience similar challenges but can be monitored closely in the outpatient setting.

Discharge planning and case management begins once the decision is made to implant an HVAD, with two key stakeholders being social work and case management team members. Social work colleagues identify and correct nonclinical barriers to discharge and assist the primary caregivers with adjusting their personal and family routines to care for a pediatric HVAD patient at home. A team of psychologists are also available to manage complex psychosocial needs for patients and caregivers as they arise.

The case management team identifies the patient’s type of insurance coverage and scope of home care services that will be available on an outpatient basis to assure that the necessary supplies and equipment are available for each patient; however, some items (automated external defibrillator [AED] and INR-monitoring devices) may not be covered by every insurance provider. The case managers communicate with the team on a daily basis to address changes in the plan of care or challenges with obtaining equipment and supplies in order to assure that the patient will have appropriate inventory available at home or through community resources. When challenges are identified, the case management team will collaborate with providers and insurance carriers in attempt to advocate for specialized equipment and supplies in the home setting.

We have been successful when advocating for patient- specific dressing change supplies, but still experience challenges with obtaining AEDs for every patient. Although having an AED at home is preferred, our team is willing to forego one if it is not covered by insurance because caregivers receive CPR training and have an emergency plan in place at all times. Some insurance providers may authorize home nursing visits in instances where caregivers are limited in their support and resources. Home nurses assigned to an HVAD patient receive training from the VAD team.

Patients who are discharged to home must reside within 2.5 hours from the implanting institution, so long as there is access to a local hospital with experience in caring for children with an HVAD. The majority of our patients have resided in close proximity to CHOP. Once discharged to home, patients are seen at weekly intervals, progressing to monthly as their clinical condition permits. Education regarding the HVAD is reinforced at each clinic visit. In addition to follow-up visits, patients and caregivers are provided with 24 hour direct telephone access to an attending physician or nurse practitioner on their primary team and asked to document once-daily flows, watts, and speed on a flowsheet specifically designed for home use.

HVAD Outcomes

Between March 2014 and June 2017, 15 patients between the ages of 3 and 17 years (median 11 years) underwent HVAD implementation at CHOP (Table 3). The smallest child to receive an HVAD was 12.0 kg (body surface area (BSA) 0.55 m2). The median weight of patients was 45.8 kg (range: 12.0–85.6 kg). Eleven patients had biventricular circulation (74%) with cardiomyopathy being the most common diagnosis in 7 out of 15 (47%). Three patients (10%) underwent atrial cannulation and 2 (13%) patients underwent biventricular cannulation. One patient (7%) died in the CICU after implantation.

Table 3.
Table 3.:
Demographics for HVAD Patients at The Children’s Hospital of Philadelphia Between March 2014 and June 2017 (n = 15)

The median time from HVAD implant to discharge was 40 days (range: 21–423 days). Patients spent a median of 131 days (range: 30–372 days) on VAD support, and the median number of days between implant and transplant was 118 (range: 27–356 days). Ten patients (67%) met criteria for discharge and 8 (53%) were discharged to home with a HVAD in place. Discharge to home was not appropriate for four (27%) patients.

Our team maintains a conservative approach to managing pediatric patient complications in the outpatient setting when compared with adults. Patients and caregivers are prepared for the probability of readmission during their course of therapy. Of the eight patients who were discharged to home, 7 (88%) have experienced at least one readmission. Three patients have been readmitted three times or more, accounting for 12 (67%) of our total readmissions. The most common cause for readmission is low-flow alarms/dehydration and laboratory abnormalities (49%). Table 4 provides further insight into our patterns of hospital readmission.

Table 4.
Table 4.:
Readmission Data for Patients Discharged With an HVAD Between March 2014 and June 2017 (n = 8)

Our criteria for readmission to the hospital have evolved over time as our experience with the HVAD has increased. We take a more collaborative approach for managing low-flow alarms or equipment malfunctions in the home or outpatient setting and as opposed to our prior conservative approach of inpatient admission. Families are often instructed to encourage fluid intake and monitor the child at home to see whether alarms resolve before visiting the Emergency Department (ED), with exception to situations where a child is symptomatic. In these cases, they are instructed to notify Emergency Medical Services and go to the nearest ED. Controller changes are often completed under medical observation, allowing HVAD patients to return home on the same day.

Return to School

Two HVAD patients (13%) have returned to school after discharge. The majority of adolescent/teenage patients received medical clearance to return to school but opted for in-home schooling because of perceptions of differing body image as a result of the HVAD. Support for children with an HVAD in the school setting can be variable and may require the presence of a trained caregiver.

Ventricular assist device team members facilitated sessions in schools to prepare the students and faculty to support the student with an HVAD. Faculty participated in hands-on and return demonstration, received access to online modules, HeartWare On Demand Training Link, and were provided with contact information for the designated provider team. Major topics of reinforcement included presence of a back-up controller and power sources, responding to alarms, changing the controller, parameters for initiating emergency services, and environmental safety in the school setting (Table 5). Revalidation of skills was provided on a quarterly basis while the student remained in school with the device.

Table 5.
Table 5.:
Safe Practices in the School and Community Environment

Lessons Learned and Next Steps

With each discharge of an HVAD patient, valuable lessons are learned. Insurance plans are variable and may result in inconsistent eligibility for services and supplies that are deemed necessary for support of the HVAD patient at home. In these instances, the VAD team has collaborated with case management to identify suitable alternatives or adapt plans of care to avoid out-of-pocket costs for caregivers.

Smaller children may mistake the device for a toy. When inappropriate handling becomes a concern, we have protected cables, cords, and device connections with heavy-duty plastic tubing (such as extracorporeal membrane oxygenation tubing) from undue damage. If unintentional disconnects are a concern, the child is categorized as a single patient assignment or designated as a safety observation where an individual is present within an arms-length to further prevent harm or injury.

Additionally, small children struggle to carry the standard-size HVAD controller bags and require small backpacks that are modified with pockets and straps to evenly distribute the weight of their equipment. Caregivers have partnered with local crafters and seamstresses in order to reconfigure retail backpacks and tote bags with mesh pockets and Velcro straps in order to secure the controller and power sources. We continue to explore development options locally and nationally in hopes of being able to mass-produce a customized product in the future. Similarly, vehicle travel using age- and size-appropriate car seats require added steps and creativity to secure the controller, such as using a foot-stool or item akin to a shelf that can be positioned near the child in order to hold the device and then securing it further with flexible straps.

Standard educational materials are written from the perspective of adult heart failure patients may do not adequately address risks specific to children with an HVAD. Through our experience, we have identified many normal childhood activities, board games, toys, and playground equipment that can pose risk to the pediatric HVAD patient. Because our population of HVAD patients is small in number, we have created institution-specific educational materials that address these unique risks and continue to keep them updated as we identify additional content. As HVAD use becomes more prevalent in the pediatric population, we hope to collaborate with HeartWare to create resources for children with an HVAD.

The future of the VAD program at CHOP is bright with possibility. Many pediatric centers do not offer the same level of rehabilitative services as adult centers,6 yet HVAD patients are at high risk for deconditioning. The Cardiac Center and inpatient rehabilitative unit are in the early stages of exploring collaborative relationships that may result in an ability to provide services to HVAD patients who meet eligibility criteria in the future.

A prototype for a custom dressing change kit is being tested in the hopes of standardizing the availability of supplies in the hospital and home setting and streamlining the process for changing VAD dressings. A dressing change video is in development and will be posted online for use in both the inpatient and outpatient setting. Lastly, opportunity exists to create age-specific and child-friendly educational material and standards for the HVAD to better meet the needs of the pediatric VAD population and their caregivers.

Conclusions

Ventricular assist devices are an excellent treatment option for many pediatric patients with advanced heart failure. The majority of patients see resolution of their heart failure, subsequently meeting and surpassing growth and development milestones that were previously unattainable. Overall, an average of 1.2 million dollars of inpatient care per child is saved at CHOP thanks to the ability to sustain pediatric HVAD patients in the outpatient setting. Additional benefits include the ability to be discharged from the hospital and return to activities of daily living,4 which enhances quality of life and their transplant candidacy.8

The Children's Hospital of Philadelphia implanted its first HVAD in 2014. Since then, the HVAD has been implanted it in children as small as 12 kg with diagnoses ranging from cardiomyopathy to complex single ventricle physiology. Clinical management is guided by patient size, diagnosis, and device placement. Single ventricle patients present the most challenges, yet continuous-flow devices may still promote better outcomes in this population. Eight patients have been discharged to home, and one patient has remained at home on the HVAD for nearly 15 months. These outcomes are testament to the systems that are in place at CHOP to support patients with VAD and those who care for them in the hospital, home, and community settings.

References

1. Burki S, Adachi I. Pediatric ventricular assist devices: Current challenges and future prospects. Vasc Health Risk Manag 2017.13: 177185.
2. O’Connor MJ, Rossano JW. Ventricular assist devices in children. Curr Opin Cardiol 2014.29: 113121.
3. Hsu KH, Huang NH, Chi CI, et al. Ventricular assist device application as a bridge to pediatric heart transplantation: A single center’s experience. Transplant Proc 2012.44: 883885.
4. D’Alessandro D, Forest SJ, Lamour J, Hsu D, Weinstein S, Goldstein D. First reported use of the heartware HVAD in the US as bridge to transplant in an adolescent. Pediatr Transplant 2012.16: E356E359.
5. Stein ML, Yeh J, Reinhartz O, et al. HeartWare HVAD® for biventricular support in children and adolescents: The Stanford experience. ASAIO J 2016.62, e48e51.
6. Crews KA, Kaiser SL, Walczak RJ, Jaquiss RD, Lodge AJ. Bridge to transplant with extracorporeal membrane oxygenation followed by HeartWare ventricular assist device in a child. Ann Thorac Surg 2013.95: 17801782.
7. Miera O, Potapov EV, Redlin M, et al. First experiences with the HeartWare ventricular assist system in children. Ann Thorac Surg 2011.91: 12561260.
8. Hawkins B, Fynn-Thompson F, Daly KP, et al. The evolution of a pediatric ventricular assist device program: The Boston Children’s Hospital experience. Pediatr Cardiol 2017.38: 10321041.
Keywords:

pediatric; ventricular assist device; HeartWare; discharge planning; education

Supplemental Digital Content

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