A leading pediatric heart surgeon is hoping that a ventricular
assist device (VAD) for use in small children that is widely
available in Europe will soon be approved in the US [1]. Dr Sanjiv K
Gandhi (St Louis Children's Hospital, MO), who has just published
the results of his own initial experiences with the miniaturized
heart pump (Excor Pediatric, Berlin Heart, Berlin, Germany) in the
September 30, 2008 supplement of Circulation, told heartwire: "These
devices really are the difference between life and death."

Gandhi and his team describe the implantation of the VAD in nine
pediatric heart-transplant candidates and conclude that the
device "can effectively be used in small children as a bridge to
heart transplantation, and [this] can be accomplished with low
mortality and morbidity."

Gandhi added: "Our results were quite favorable. The majority (eight
of nine) of the kids survived the period of ventricular assist
support to heart transplantation." His team has now used the VAD in
13 children, 12 of whom have survived, and he notes that an FDA-
sponsored investigational device exemption (IDE) trial is ongoing,
which has seen the devices implanted in around 160 children in the
US and Canada, with around a 70% to 75% survival rate. This
is "still a hell of a lot better than zero," he maintains,
explaining that most of these children would have died without the
support of the device.

Despite Ongoing IDE Study, Equipment Not Easy to Procure

Gandhi explains that the main problem obstructing surgical teams has
been the bureaucratic nightmare required to obtain and use the
device and associated equipment in the US. "The whole process of
getting the equipment used to take a week, and when you've got a kid
dying in the hospital, waiting for a heart transplant, that week can
be a very critical period of time."

Even now, with the IDE trial ongoing, "it's still not
instantaneous," he says. The irony is, "there are a million VADs on
the market readily available for adults, and if I want to put one in
you tomorrow, I can do it, no questions asked. But if I want to put
one in your child tomorrow, it's still going to take a few days."

He is hopeful, however, that the IDE trial will be successfully
completed "and the FDA will buy into the data, because then we'll be
able to purchase equipment and have it on-site as we would if we
were implanting a heart valve. And then we could do it when we want
to.

"This really is the difference between life and death. In our paper,
a lot of those kids would be dead kids, literally, were it not for
the VAD. There is no way they would have lived the period of time
they were supported on the device if they didn't have that device
while they were waiting for a heart."

Linda Buerk (marketing manager, Berlin Heart) told heartwire that
the Berlin Heart Excor Pediatric VAD has been used in 248 pediatric
patients so far in Europe (115 biVADs, 131 left VADs, two right
VADs). The device was first used in 1990 and so has been available
for 18 years.

Study Details

In this study, Gandhi and colleagues explain that is not unusual for
a child listed as a status 1A heart-transplant candidate to wait
several months before an organ becomes available. Extracorporeal
membrane oxygenation (ECMO) has remained the most common form of
mechanical support available prior to ventricular assist devices,
but the incidence of medium- and long-term bleeding and infectious
complications is exceedingly high with ECMO, and neurological
impairment is also common. ECMO also restricts patient mobility,
impairing physical rehabilitation, they note.

They present the details of their initial experience in nine
children, with an average age of 1.7 years and a median weight of
9.4 kg. All children had significant right ventricular dysfunction
and were supported with multiple intravenous inotropes and/or
mechanical ventilation or ECMO before receiving biVAD implantation.

Eight of the patients were successfully bridged to heart
transplantation after a median duration of support of 35 days with
the Berlin Excor Pediatric biVAD. One death occurred after 10 days
of support from perioperative renal failure in a 3-kg infant. There
were no acute neurological complications, no thromboembolic events,
and no bleeding complications. The eight remaining patients
underwent successful heart transplantation, with one episode of
rejection, and there have been no deaths after transplant with a
median follow-up of 19 months.

Gandhi reported no disclosures. Disclosures for the coauthors are
listed in the paper.


Gandhi SK, Huddleston CB, Balzer DT, et al. Biventricular assist
devices as a bridge to heart transplantation in small children.
Circulation 2008; 118:S89-S93.