Pediatrics is moving away from an ICU default decision for patients on continuous-flow ventricular assist devices (VADs). Increasing numbers of young patients awaiting transplant are being transferred to the cardiac floor, or home.
This trend is driven by the effort of specialists from more than 40 centers collaborating in the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to make the bridge to transplant more closely resemble “normal life.” The prevailing view is that patients are benefiting physically and psychologically, both before and after transplant.
In late 2019, David Bearl, M.D., medical director of the pediatric VAD program at Monroe Carell Jr. Children’s Hospital at Vanderbilt, and his team were able to send a two-year-old VAD patient to the cardiac care floor, where she could practice appropriate developmental tasks. They also discharged a teenage VAD patient for the first time, to return home and receive outpatient cardiac care. Both patients later received successful transplantation surgeries and rehabilitation therapy.
“Historically, it was thought that with mechanical support, patients were too fragile to wait for heart transplant anywhere but in the ICU,” Bearl said. “But the research on pediatric patients is mimicking what we know about adult patients. If they meet certain criteria, we think they are better off without the sedation, immobilization and breathing tubes that are part and parcel of the ICU.”
“If they meet certain criteria, we think they are better off without the sedation, immobilization and breathing tubes that are part and parcel of the ICU.”
Studies on Discharged Patients
While anecdotal evidence supports the shift away from ICU, robust data have been lacking. To help fill this gap, Bearl and colleagues studied 144 VAD-implanted patients, ages 10 to 21, who were discharged from 25 centers. While over half of the patients (66.7 percent) were readmitted over the bridge period, the median time to readmission was long (45 days), median length of stay was six days, and in-hospital mortality was low (1.8 percent).
A smaller study found a shorter median time to readmission of 14 days, but with 89 percent of post-implant days spent out of the hospital. The authors concluded that “children with CF-VADs can be discharged with acceptable readmission rates and significant time spent out of hospital.”
“This is far from a settled issue, but more centers are confident enough in their staff, protocols and devices to push this trend along,” Bearl says. In fact, the frequency of discharge across the 25 centers in Bearl’s study increased from 36.9 percent (between 2009 to 2012) to 59.7 percent (between 2013 and 2018).
Criteria for Leaving the ICU
Bearl says that four main shifts in the VAD landscape have enabled discharge from the ICU: the presence of VAD-dedicated teams, new medication management strategies, standardized criteria for patient selection and improvements in the devices themselves.
At Children’s Hospital, Bearl led his team in establishing criteria and creating the safety net that enabled the two patients to move from ICU last year. First, the patient must be stable on their anticoagulation and antiplatelet regimen and in their VAD settings for at least two days. “Fortunately, this has been helped by replacing heparin with bivalirudin, which is a direct thrombin inhibitor,” Bearl said. “Particularly for paracorporeal VADs, this medication has allowed us to avoid wild fluctuations in over- or under-coagulating. It’s also helping to modulate the impact of inflammation.”
Next is the educational component. The caregiver is trained and must demonstrate by written exam that they understand the device, know how to recognize a problem and know what to do when settings change or symptoms signal a change in patient status.
The devices themselves are following an expected improvement curve, demonstrating lower pump malfunction, bleeding risks and stroke risks, and offering these improvements in smaller packages. If equipment malfunctions or tubing becomes occluded, Bearl assures quick response through teaming up with a nurse practitioner specializing in VAD. One of the two of them is always available by phone for emergent and non-emergent calls from a provider, parent or caregiver.
“One of our top priorities now is to compare these outcomes with those of patients who remain in ICU so we have a true handle on the risks and benefits.”
Bearl and members of ACTION meet by phone at least monthly as well as multiple times a year at pediatric heart transplantation conferences. “We have shared data on what happens with these patients following discharge. One of our top priorities now is to compare these outcomes with those of patients who remain in ICU so we have a true handle on the risks and benefits.”