Melody Valve–A Medical God-send

February 6, 2010 at 4:31 pm 3 comments

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: , , , , , , , , , .

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3 Comments Add your own

  • 1. harpersmom  |  July 15, 2011 at 10:05 pm

    My daughter had TOF corrective surgery when she was 20 days old. The surgeon patched 2 septum holes with Gortex, and had to enlarge her pulmonary valve from 7mm to 10mm wide, so that enough blood could get to her lungs. By doing so, her pulmonary valve was damaged, causing regurgitation into her right ventricle. This added pressure enlarges her heart wall, while making the cardial wall thinner- which is very bad for heart health.

    She had one cardiac MRI at 1.5 yrs to measure the pressure. It was high, yet the Drs let us come back 6 months later for a 2nd cardiac MRI. This time, the pressure was so high, that the Drs will replace her pulmonary valve (PVR) with a bovine valve at 22 months of age. She will need future PVR surgeries since the valve does not grow with her heart. The Dr. will also put in a PV conduit (at least 16mm diameter) so that the next time she needs surgery, she MAY be able to do it via the Melody transcatheter valve. Google melody valve, for more information. The site even has a map of all the hospitals/Drs that do this throughout the nation. To tell you the truth, I am a little relieved that is is not a candidate this time around, because this is such a new procedure, just recently approved by the FDA, I would like to see more success statistics on it down the road. I remain thankful for medical technology and empathize with the parents of CHD children in the world who are not so fortunate.

    PS Abby, as a heart mom, I enjoyed your letter; I will have my daughter read it when she is old enough. I am an elementary school teacher, and hope you had a chance to read your letter to your classmates and/or friends. You are a smart, brave, and beautiful girl. By reading the letter, I can already tell that TOF has made you a strong soul, ready for all that your lovely life has to offer! You are my role model.

  • 2. Roxy  |  June 28, 2012 at 6:46 pm

    I hope that Im giving all the accurate information. My soon to be 7 year old Nephew has a homograft valve (which means he has had an open heart surgery and he also had a cardiac catheter) and it is dilated and to much pressure is going back to his heart. They are contemplating another open heart to replace the homograft that he has now. Or to insert a melody valve into the homograft through a cardiac cath procedure. Now if the melody valve is what they choose there is a chance that it can tear the graft and then he would be rushed into open heart surgery anyways. What would be the benefits and risk of him having the melody valve put in and or another open heart to replace the old graft? My sister-in-law is trying to make sure she is asking all the right questions to the doctors to come to the most acceptable procedure for her child. Can you think of any major questions she should be asking?


    • 3. Roxy  |  June 28, 2012 at 7:00 pm

      I forgot to had that he has had two metal stints placed inside his homograft valve. It is the right ventricle valve that was replaced with the homograft. I think thats everything.



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