Chronic Illness • Dec 21, 2011

Building Bridges – The Berlin Heart

 At St. Louis at Children’s Hospital we have one of the largest pediatric heart transplant programs in the country. As a result, we are a large volume user of the Berlin Heart Excor, which is a pumping device that works in place of a child’s failing heart and buys time until a donor heart is available.

When we first heard about the Berlin Heart back in 2005 we were pretty excited about it and we still are. I’ve seen too many babies and children die since I started in the heart transplant business 20 years ago, babies who we couldn’t support for very long with just medicines and a mechanical ventilator. We’ve had all too many people go on ECMO (bypass) and die because a child can only survive on ECMO for about 14 days before his body starts to shut down. Now, the Berlin heart allows us time.

We started using it right away after it was made available by compassionate use by the FDA. 
We had actually used it about 8-12 times even before any clinical trial had begun.

Getting a donor heart is often like the lottery.  It can come hours after you list a patient, or it can take months.  Some kids don’t have months.

Some people are lucky enough to get their organs quickly, but for the ones who aren’t, we knew if our last option was ECMO, then basically the child only had about 14 days to live. It led us to accept donor hearts that really weren’t the best organs. We had to take chances because the risk of otherwise losing the child while waiting was too severe.  Having the Berlin, we don’t have to take those risks.

And, the patients are in such better shape than they used to be before the device was available – especially after the transplant. One of the things that will come out over time is not just the ability to bridge children to getting an organ but how much healthier they are on the Berlin than without it. Before we used it routinely, those patients would require a ventilator, be immobilized, often paralyzed in an ICU for weeks at a time so when they finally got the heart transplant, the heart worked great but the muscles were so weak the patients could hardly even move or walk. Very often after a very successful surgical procedure the child needed to stay in the hospital for another 4-6 weeks just to get strong enough to walk out of the hospital. Now, at St. Louis Children’s Hospital, we have patients walking and eating with the Berlin heart in place.  After they receive their transplant, they’ll leave the hospital in 7-10 days.

It’s not just amazing that we can salvage these children who would otherwise die, but after they have the transplant they feel so much better so quickly and go back to their normal lives so much sooner than before the  device.

I was able to present my experiences with the Berlin Heart to the FDA panel reviewing the trial over the summer. As I concluded my statement I told them ‘you all will vote on this device today, but the pediatric heart transplant community in North America has already voted on the device before we presented it to the panel and they unanimously feel it is critical to optimize results in children in end-stage heart failure listed for transplantation.’


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