A valve inside a valve: A new heart valve can be implanted in people suffering with adult congenital heart disease without open heart surgery

June 24, 2013 — Many adult congenital heart patients have undergone multiple heart surgeries by the time they reach their 20s. Each time surgeons operate on the heart, the risk of complications increases. A new valve recently approved by the Food and Drug Administration, now gives these patients a new way to manage their disease without having to undergo open heart surgery.Many adults with congenital heart disease are born with a malformation of the pulmonary valve, which sits between the heart and lungs. Most have undergone open heart surgery during childhood to restore blood flow to the lungs, and often require a second and third open heart surgery to replace this valve. Because of advancements in heart surgery over the past 50 years, more and more of these patients are making it to the adulthood for the first time in history.The new Melody Transcatheter Pulmonary Valve, which is delivered through a catheter and requires only a small incision, is a new technique that is bringing new hope to these patients.The first Melody Valve at Methodist DeBakey Heart & Vascular Center in Houston was recently implanted by Dr. C. Huie Lin, an adult congenital heart disease specialist, in a young man who had already had three open heart surgeries for congenital heart disease.”More than a million people live with adult congenital heart disease in the U.S., and we expect that number to grow by 5 percent each year,” Lin said. “I believe this new Melody Valve is a great new option for people who were no longer candidates for surgery.”Lin said the Melody Valve helps patients who have already had an open heart surgery for congenital heart disease and have developed problems with the valve leaking or becoming blocked.The valve, made for the right side of the heart, is designed to be implanted inside of the existing valve. Made from the internal jugular vein of a cow, the valve is sewn onto a stent and the stent is then put onto a balloon catheter. The catheter is then placed through the femoral vein and advanced to the pulmonary valve position. …

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Study on fragile newborns challenges current practices

June 20, 2013 — One of the largest clinical trials done in infants with congenital (present at birth) heart diseases, published in the New England Journal of Medicine, shows that the increasingly common practice of using the drug clopidogrel (Plavix®) to reduce shunt-related blood flow issues is not effective in the dose studied.”Once again, pediatric-specific research shows that newborns and infants are not little adults,” said David Wessel, MD, Chief Medical Officer, Children’s National Medical Center, and lead author on the international study published in the June 20, 2013 issue of the New England Journal of Medicine. “The take away message for pediatric cardiac care providers is to reconsider use of Plavix® in certain cases. In pediatric medicine, the assumption is that smaller doses of a drug that works in adults will work in infants, but our study shows that this is not true for these young patients. For the parents of these fragile newborns, it is important to understand that research informs best practices, and they need to be informed advocates for their children.”The objective of this international trial, which included more than 900 patients seen across 134 centers in 33 countries, was to evaluate the efficacy of Plavix® compared with placebo for the reduction of all-cause mortality and shunt-related morbidity in neonates and infants with cyanotic congenital heart disease palliated with systemic-to-pulmonary artery shunts. Many forms of congenital heart disease can be repaired in early infancy, and pulmonary blood flow with shunts is an important consideration during initial treatment that may include reconstructive heart surgery for defects in heart ventricles.As the authors note, effective prevention for thrombosis (blood clots) in neonates and infants with these heart conditions had not been previously tested, although aspirin treatment was associated with significantly lower risk of mortality and shunt thrombosis in a separate registry developed before this trial. Preventive treatment in adult patients who develop clots in coronary arteries often combines aspirin and Plavix®. As happens with many drugs approved for use in adults, Plavix® use is spreading into pediatric practice without sound evidence, according to study authors. In fact, they continue, use of this drug has increased 15-fold from 2001 to 2009 in children’s hospitals in the US.This study showed no benefit from adding Plavix® to current treatment, which often includes aspirin. As noted in the study, the use of Plavix® to address thrombosis in newborns and infants being palliated with systemic-to-pulmonary artery shunts does not reduce all-cause mortality or shunt-related morbidity.Further analysis (not part of the original trial design) supports the notion that aspirin alone may be effective at reducing the risk of clot formation in these infants. The study authors point out that the trial suggests that switching from aspirin alone to Plavix® alone at the dose studied is not a good idea.”This is a good illustration of the successful collaboration between industry and academia to conduct clinical research in children under the written request process of FDA’s Best Pharmaceuticals for Children Act (BPCA), noted Edward Connor, MD, MBE, Director of Innovation Development at Children’s National and internationally recognized expert on drug development. …

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