Melody Valve–A Medical God-send
This is Dr. James Locke. He is a cardiologist at Boston Children’s Medical. At this time I stand in awe of the extensive research work and clinical work this man has done in behalf of heart children. He, and many others like him, are advancing treatment of congenital heart defects. According to his research website, he “has developed and provided the initial descriptions of nearly a dozen new techniques in interventional cardiology.” He was one of the iventors of the cardioseal, a device inserted through a catheter to correct ventricular septal defects, Fontan fenestration, and patent foramen ovale. Did you miss it? Did you miss that the cardioseal is inserted through a catheter? For those of you who have undergone open-heart surgery you know what great news this is. No more bypass machines, stopping the heart, cutting the chest open, swelling of the heart, drainage, pressure, compression. Certainly a cath procedure is not without possibility of complications, however; in comparison to open heart surgery, those risks are fewer and less serious.
I recently contacted Dr. Locke when I heard about an investigational new procedure for pulmonary valve replacement. My daughter had severe pulmonary stenosis with her Tetralogy of Fallot. During surgery, the only way to correct extreme high pressures in one side of the heart was to cut into the pulmonary valve, resulting in severe regurgitation through that valve. This leads to an enlarged right ventricle, exercise intolerance, abnormal arrhythmia, and sudden death in later years if left uncorrected. Now, ten years later, we are facing the first of her pulmonary valve replacements. This road down pulmonary valve replacement is a road that seems long. As Abby outgrows the valve–open heart surgery. As the valve wears out–open heart surgery. In essence, Abby is among the unlucky with Tetralogy of Fallot who need subsequent surgeries due to the pulmonary valve regurgitation.
In preparing for this surgery, I came across an article describing the new procedure Dr. Locke was investigating called the Melody valve. This procedure, being tested in Europe and Canada for some time, was being tested in 30 patients here in America.
This is the catheter containing the Melody valve. The catheter is inserted through the groin, through the blood stream and put in place with the use of cameras and the balloon (as can be seen in the picture). This is similar to angiograms or other cath procedures. After effective results in the 30 initial patients, the trial was enlarged to 99. Last month, the FDA announced its approval of the Melody valve for an enlarged research group of 4,000 children. The valve and procedure had received the European CE Mark approval and the Canadian approval before trials began here in America.
Medtronic, the company who makes the valve, announced that the valve is
“Delivered through a catheter requiring only a small incision, the Melody valve will benefit children and adults who are born with a malformation of their pulmonary valve, which is the valve between the heart and lungs. These patients often require open-heart surgery to restore effective blood flow to their lungs. Previously, the only way to repair or replace a failed pulmonary valve conduit was through additional surgeries. To date, more than 1,100 patients worldwide have received a Melody valve.
“The Melody Transcatheter Pulmonary Valve is a significant technological breakthrough and offers a reprieve for many patients with congenital heart disease – many of whom are young and will require several heart surgeries over their lifetime,” said pediatric cardiologist Dr. William E. Hellenbrand of the NewYork-Presbyterian Morgan Stanley Children’s Hospital and Columbia University Medical Center.
“The Melody valve gives patients with congenital heart disease a new, non-surgical approach to managing their disease.”
“This novel technology will improve the lives of thousands of patients in the United States,” said Dr. John Liddicoat, vice president and general manager of the Structural Heart division, part of the CardioVascular business, at Medtronic. “Medtronic is leading the development of transcatheter therapies for heart valve disease. FDA approval of the Melody Transcatheter Pulmonary Valve is evidence of that leadership.” (brown text quoted from linked website)
The Melody valve requires a short 2-4 day hospital stay after implantation, without any ICU time and patients are not faced with the discomforts and pain associated with open-heart surgery.
Dr. Locke performed the first successful American trial at Boston Children’s Hospital in 2007 on a four-year-old boy with Tetralogy of Fallot who had severe complications from H1N1, resulting in the breakdown of his valve.
This valve is more than a novel medical advance. For those of us who face the future of pulmonary valve replacement surgery, again and again, this little conduit is a god-send. My daughter, having her pulmonary valve replaced this summer, is not a candidate for the Melody valve this time around. Her pulmonary valve is virtually non-existent, as they had to cut into it deeply to overcome the effects of the stenosis. After contacting Dr. Locke, and sending him her records, he informed us that in the future, she would be a candidate for the surgery once a valve was replaced that was functioning. So, while we missed the Melody valve this round, future replacements can be done without open-heart surgery.
Thanks to the organizations who raise money for research and funding, Dr. Locke can continue to pioneer new methods and procedures to reduce open-heart surgeries. Thanks to all those who pioneer for my daughter and the thousands of other children like her. You work and dedication is appreciated.
Entry filed under: CHD Research, Congenital Heart Defect, Open Heart Surgery, tetralogy of fallot. Tags: Boston Children's, CHD Research and Funding, Dr. John Locke, FDA, Medtronic, Melody valve, Open Heart Surgery, pulmonary stenosis, Pulmonary Valve, tetralogy of fallot.