FOR IMMEDIATE RELEASE
Ann Miller, Media Relations
BERLIN HEART BEATS FOR CHILD UNTIL TRANSPLANT
All Children’s Hospital First on Florida’s West Coast To Offer Mechanical “Bridge to Transplant”
May 21, 2007 (St. Petersburg, FL) – When sixteen-month old Alyssa Thomas was admitted to the Cardiovascular Intensive Care Unit at All Children’s Hospital in February of 2007, her heart muscle was literally dying and no one could tell why.
One thing was clear – she needed a new heart. But she was so sick she probably wouldn’t survive the wait for a donor heart to become available.
That’s when All Children’s began the process of obtaining a mechanical “bridge to transplant” called the Berlin Heart. This German-made device is the only one of its kind worldwide that is designed for use in pediatric patients as small as infants. In the United States, more than 50 of these devices have been implanted on a compassionate-use basis and the Berlin Heart is now poised to enter formal pre-clinical testing.
Though the Food and Drug Administration has not yet approved the Berlin Heart, it allowed All Children’s surgeons to implant the device on a one-time compassionate use basis. Several crates of equipment were shipped from Germany and specially trained support staff flew in to assist during and after the surgery.
On February 12, 2007, Alyssa became the second child in Florida to be implanted with the device. Special medical silicone tubing or cannulas were stitched into her diseased heart and connected to the EXCOR Pediatric biventricular assist device, which then pumped blood from her heart to her body for the next 75 days until a donor heart became available.
Alyssa was able to play and be held and fed in her CV-ICU room while waiting for transplant. Her successful heart transplant took place at the end of April. Alyssa’s post-transplant recovery has proceeded well, and she is now ready to be transferred to a pediatric in-patient rehabilitation program at Tampa General Hospital before ultimately returning to her home in Orlando.
“The Berlin Heart has revolutionized our ability to support children and infants with failing hearts while awaiting cardiac transplantation,” stated Jeff Jacobs, MD, pediatric heart and transplant surgeon at All Children’s Hospital. “Without this device, children like Alyssa face a much more complex and risky pathway to transplantation.”
"As has been the tradition of All Children's Hospital for more than eighty years, we are committed to progressive, quality care for all children,” noted Gary Carnes, President & CEO of All Children’s Health System. “In this particular case, we needed to commit to acquire and use new technology, the Berlin Heart, to meet the care requirements for Alyssa. This is another example of our ongoing commitment to be the choice of parents who seek care for their children.
“We are proud All Children's physicians and clinical staff were able to provide this new care modality for Alyssa. And, we are gratified that Orlando Regional Medical Center referred this young lady to All Children's. The talented and caring professionals at All Children's have worked a ‘miracle’ for this child."
ABOUT BERLIN HEART (http://www.berlinheart.com/):
Berlin Heart develops, produces and trades innovative devices for the mechanical support of the heart. The ventricular assist device EXCOR® Pediatric was developed specifically for the use for children, toddlers and even babies. This is possible due to the variety of blood pumps (10 – 60 ml volume) and the wide range of cannulas.
EXCOR® Pediatric offers blood pumps of 10 ml, 25 ml, 30 ml, 50 ml and 60 ml volume. The selection of the pump size depends on weight or body surface of the young patient.
Every EXCOR® Pediatric blood pump consists of a transparent polyurethane housing that is divided into one air chamber and one blood chamber by a three-layer membrane. Graphite between the membranes helps to minimize friction. The membrane on the blood side merges without a seam into the surface of the housing. A specially produced CARMEDA® coating is plated on the slick, flow-optimized blood contact surface. In- and outflow sockets, which are made of polyurethane and bear titanium connectors for the connection of the cannulas, lead from the blood chamber to the inlet or outlet cannulas. On the air side of the membrane lays the connection for the pneumatic driving tube.
EXCOR® and EXCOR® Pediatric blood pumps are driven and monitored through a mobile unit called the Ikus. Ikus meets all requirements regarding frequency of the pump, synchronous and alternate modes as well as varying driving pressure. While operating biventricular, both blood pumps can be controlled separately.
A laptop with an installed monitor program is integrated into the Ikus housing and all parameters can be adjusted and viewed.
The pneumatic system of the driving unit is based on a triple developed construction, so that in case of malfunction it is automatically switched to the next back-up system without interruption. In case of a breakdown of the supply voltage, an installed charging unit takes over the power supply.
ABOUT ALL CHILDREN’S HOSPITAL(http://www.allkids.org/):
All Children's Hospital is the only freestanding children’s hospital on Florida’s West Coast and a leader in pediatric treatment, education, research and advocacy. It has consistently ranked among America’s top 25 children’s hospitals in comparative studies done by Child Magazine, which rated All Children's Hospital as the best in Florida in 2007. All Children's has also garnered Most Outstanding Business awards from the Tampa Bay Business Journal and the Greater St. Petersburg Chamber of Commerce.
The mission of this private, not-for-profit hospital is rooted in its beginnings as Florida’s first Crippled Children’s Hospital for polio victims. All Children’s understands that it’s not enough to treat disease -- that true progress comes from teaching and research to cure disease. All Children’s shares its pediatric expertise through research and education affiliations with the University of South Florida (USF Health) as well as the H. Lee Moffitt Cancer Center & Research Institute.
As a regional referral center for children with some of the most challenging medical problems, All Children’s draws patients from throughout Florida, all 50 states and 36 foreign countries. Growing regional demand is such that construction is now underway on a new hospital and outpatient center to replace the current 40-year old facility. When this $300-million project is completed in 2009, it will represent nearly a million square feet of space dedicated to state-of-the-art pediatric healthcare.
NOTE TO NEWS MEDIA:
Video b-roll and still photographs from the Berlin Heart implantation surgery are available through All Children’s Media Relations (727) 767-8592. Still photos suitable for publication/broadcast with attribution to All Children’s Hospital are also available on the hospital’s website: www.allkids.org/BerlinHeartPhotos