MIAMI – A surgeon at Miami Children’s Hospital’s Congenital Heart Institute has performed the nation’s first heart valve replacement on a premature infant with a severe heart defect by using CorMatrix extracellular matrix material – an innovation that saved one-year-old Analiah Duarte Escorcia’s life and may make it possible for her to avoid future valve replacements common when mechanical or biological valves are used.

Dr. Redmond P. Burke, Director of Cardiovascular Surgery at Miami Children’s Hospital, performed the operation in February 2012. “Analiah was born with two defective heart valves and had very limited options,” said Dr. Burke. “Her heart was massively enlarged and had compressed both of her lungs severely. The mortality rate for this defect is among the highest for any congenital heart problem.”

New options, new hope
Current treatment options are limited for patients with these challenges. One prevalent approach is to close the valve completely with a patch and turn the child's heart into a rudimentary single ventricle, requiring multiple subsequent operations. However, no available mechanical or biological valve would safely fit within the child’s heart.
 
Dr. Burke used extracellular matrix (ECM) material, developed from porcine intestines by biotechnology leader CorMatrix Cardiovascular, to craft the new valve in the operating room. The valve was then implanted, with sutures anchoring it to the support structures in the child’s right ventricle.

Analiah, now at home with her family, has had a remarkable recovery, with a gradual decrease in her heart's size, and expansion of her lungs to near normal dimensions. The valve also shows near normal function. The ultimate test of the technology will be the demonstration of growth over time. At a year follow up, the valve continues to function well and she is on minimal medication.

Dr. Burke noted that the ECM shows great promise for babies requiring valve repairs and replacements, as the material stimulates the patient’s natural wound-healing mechanisms, allowing the patient to regrow healthy tissue, effectively becoming an integrated part of the patient’s body.

“This is the holy grail of heart valve reconstruction,” he said. “Our hope is that this revolutionary extracellular matrix technology will allow stem cells to be attached to the valve and become normal valve tissue, capable of growth, so that the child’s tricuspid valve will not have to be replaced in the future.”

Children receiving transplants with current biological or mechanical valves typically must undergo reoperations for valve replacement procedures every 10 years or so, or as the valve wears out or the child outgrows it. 

"We are hopeful that this technology will prove to be a new standard of care in congenital heart surgery, allowing us to create heart valves that will grow with our smallest, newborn into functioning adult valves,” Dr. Burke said.

About Miami Children’s Hospital
Founded in 1950 by Variety Clubs International, Miami Children's Hospital® is South Florida’s only licensed specialty hospital exclusively for children, with more than 650 attending physicians and over 130 pediatric subspecialists. The 289-bed hospital is renowned for excellence in all aspects of pediatric medicine with specialty programs ranked among the best in the nation in 2008, 2009, 2010, 2011 and 2012 by U.S. News & World Report. The hospital is also home to the largest pediatric teaching program in the southeastern United States and has been designated an American Nurses Credentialing Center (ANCC) Magnet facility, the nursing profession’s most prestigious institutional honor

About CorMatrix ECM® Technology     
CorMatrix Cardiovascular holds an exclusive license from Purdue University to research, develop, manufacture and market naturally occurring ECM® products for cardiovascular applications. The company currently has U.S. clearance and European approval with a CE Mark for its ECM Technology as an implant for pericardial closure, and clearance in the U.S. for use in cardiac tissue repair. For more information, visit www.cormatrix.com.