St Louis, MO - 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.

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.

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.