The Berlin Heart EXCOR Pediatric is a paracorporeal, pulsatile ventricular assist device (VAD) (Berlin Heart). In other words, it is a device that helps the heart pump blood through the body, in which the blood pumps and driving unit are located outside the body. These blood pumps are still connected to the heart through tubes, called cannulas. The Berlin Heart EXCOR Pediatric was developed with Deutsches Herzzentrum, a specialized heart treatment center located in Berlin, Germany, in the early 1990's (Sponsor Executive 4). The device was approved relatively quickly, in 1996, by the European Union (Sponsor Executive 10). Four years later, the first EXCOR Pediatric device was implanted in the United States, despite not being FDA (Food and Drug Administration) approved (Sponsor Executive 10). In 2005, the FDA requested that Berlin Heart apply for an IDE (Investigational Device Exemption), which allows a device to be investigated in a clinical study, and in 2007 the IDE was conditionally approved, while in 2008 it was unconditionally approved (Sponsor Executive 10). The study, led by Dr. Charles D. Fraser Jr. of Texas Children's Hospital, involved 48 children and 17 different hospitals (Texas Children's Hospital). Of those 48 children 90% survived long enough to get a heart transplant, while using conventional methods only 40% to 60% live long enough for a transplant (Texas Children's Hospital). This study lead to the FDA approving the Berlin Heart EXCOR Pediatric in the U.S. in 2011 (Texas Children's Hospital). The only other place to approve of this device, besides the U.S. and Europe, is Canada, who approved it in 2009 (Sponsor Executive 10). The EXCOR Pediatric is specifically designed for children, aging from 6 days to 16 years, that are suffering from severe heart failure, which is when the heart can't pump enough blood to meet the body's needs (Sponsor Executive 4). This device can be used to support either ventricle (left or right), which are responsible for pumping blood through the body, independently or at the same time (Berlin Heart). The EXCOR Pediatric is used successfully as long-term cardiac support, and can be used as short and medium-term support (Berlin Heart). European studies have found that the EXPOR Pediatric can provide stable support for children as young as 6 days old for up to 1041 days (Sponsor Executive 4). This device is primarily used as a bridge until a heart transplantation is preformed (Berlin Heart). Sometimes, though, patients using this device retain full heart function and are able to be taken off the device, as the EXCOR Pediatric allows failing hearts to rest and try to recover (Berlin Heart). One such incident involved a 14 year old girl named Melissa Mills, she was told by doctors that she would need a heart transplant, so when she got too sick to wait for a donor she got the EXCOR Pediatric implanted to hopefully give her enough time for a donor heart to become available, but after 146 days her heart was deemed strong enough to work by itself and the device was removed (Budd).
This device has and will continue to make a big contribution to society. With the EXCOR Pediatric being the first cardiac assist device for children to be approved by the FDA, it will offer parents of children with heart failure a better treatment option (Kaiser). The EXCOR Pediatric will be the new standard in the U.S. as a pediatric bridge to transplantation as it tested much better than the previous standard, extracorporeal membrane oxygenation (ECMO) (National Center for Biotechnology Information). Now that EXCOR Pediatric is the new standard, after finding it has a survival rate of more than 30% higher than the previous conventional methods, including ECMO, it will have a very positive effect on society. To put the 30% into context, if 1000 children were treated with conventional methods, while 1000 other children were treated with the EXCOR Pediatric, at least 300 more children would survive long enough for transplantation using the EXCOR Pediatric. Since heart failure is one of the leading causes of death globally, the EXCOR Pediatric will go a long way in saving children that are unfairly dealt a weak heart (Lauscher). Survival rate is not the only reason that the EXCOR Pediatric is better than the previous standard treatment, though. According to Dr. Fraser, children on ECMO can't get up and move around, they can't do any physical therapy, and they don't get normal nutrition, while children on the EXCOR Pediatric are able to get out of bed, do physical therapy, and eat normally (Gordon). An important risk to understand about this device is it can cause infection, major bleeding, and strokes, but that is why this device is used for children with such severe heart failure that they likely will not live long enough for a transplant (Gordon). Also, this device could be the foundation of a future ventricular assist device that in some way is more efficient than this one. In the next century, this device will almost certainly be replaced by another device that is much more efficient, as technology continues its ascent. The replacement could be a completely artificial heart that is capable of lasting a lifetime, or just a more efficient VAD, it's really anyone's guess. The technological advances in the medical field are going to continue, and this will likely result in many advances in treating children with heart failure.
This device has and will continue to make a big contribution to society. With the EXCOR Pediatric being the first cardiac assist device for children to be approved by the FDA, it will offer parents of children with heart failure a better treatment option (Kaiser). The EXCOR Pediatric will be the new standard in the U.S. as a pediatric bridge to transplantation as it tested much better than the previous standard, extracorporeal membrane oxygenation (ECMO) (National Center for Biotechnology Information). Now that EXCOR Pediatric is the new standard, after finding it has a survival rate of more than 30% higher than the previous conventional methods, including ECMO, it will have a very positive effect on society. To put the 30% into context, if 1000 children were treated with conventional methods, while 1000 other children were treated with the EXCOR Pediatric, at least 300 more children would survive long enough for transplantation using the EXCOR Pediatric. Since heart failure is one of the leading causes of death globally, the EXCOR Pediatric will go a long way in saving children that are unfairly dealt a weak heart (Lauscher). Survival rate is not the only reason that the EXCOR Pediatric is better than the previous standard treatment, though. According to Dr. Fraser, children on ECMO can't get up and move around, they can't do any physical therapy, and they don't get normal nutrition, while children on the EXCOR Pediatric are able to get out of bed, do physical therapy, and eat normally (Gordon). An important risk to understand about this device is it can cause infection, major bleeding, and strokes, but that is why this device is used for children with such severe heart failure that they likely will not live long enough for a transplant (Gordon). Also, this device could be the foundation of a future ventricular assist device that in some way is more efficient than this one. In the next century, this device will almost certainly be replaced by another device that is much more efficient, as technology continues its ascent. The replacement could be a completely artificial heart that is capable of lasting a lifetime, or just a more efficient VAD, it's really anyone's guess. The technological advances in the medical field are going to continue, and this will likely result in many advances in treating children with heart failure.