Print 13 comment(s) - last by eldakka.. on Feb 7 at 2:08 AM

Device was commercially approved in Europe in 2006, and now, the FDA has approved its use in the United States

An Oregon Health & Science University (OHSU) Doernbecher Children's Hospital pediatric cardiac team has made a successful breakthrough in the treatment of heart disease/defects. 

Dr. Grant Burch, M.D., associate professor of pediatric cardiology at OHSU Doernbecher Children's Hospital and director of the OHSU Pediatric and Adult Congenital Cardiac Catheterization Lab, and Laurie Armsby, M.D., Burch's partner in the OHSU Pediatric and Adult Congenital Cardiac Catheterization Lab and associate professor of pediatric cardiology at OHSU Doernbecher Children's Hospital, have used a device to implant a pulmonary heart valve without the use of open-heart surgery.  

The device is called the Medtronic Melody Transcatheter Pulmonary Valve, and it is used to replace a leaky or narrow pulmonary valve conduit in adults and children that have already had surgery to fix a congenital heart defect. This tool was recently approved by the Food and Drug Administration (FDA), and does not require open-heart surgery. It was first approved for commercial use in Europe in 2006, and since then, over 1,700 patients have been implanted with the pulmonary valve. Now, according to the FDA, 1,000 U.S. citizens with congenital heart disease will qualify for the Melody valve each year.

"Children born with blocked or leaky heart valves can undergo as many as four open-heart surgeries before reaching adulthood to replace conduits that have worn out or that they've outgrown, and each time the risk of surgery goes up," said Burch. "The Melody extends the useful life of an implanted valve conduit and is very likely to reduce the number of open-heart operations a patient might require over a lifetime."

The Melody is placed into a small opening in a patient's leg and is led by a catheter through blood vessels into the heart. A balloon on the end of the catheter is inflated once the valve is positioned in place, which delivers the valve and corrects blood flow

"The remarkable thing about this procedure is that the valve is placed into the beating heart through a vein in the patient's leg," said Armsby. "After the procedure, patients spend a night on the hospital ward and are discharged home the following morning. This device brings us closer to the goal of providing children less invasive alternatives to surgery for the treatment of congenital heart disease." 

Burch noted that the Melody valve cannot eliminate the need for open-heart surgery entirely, but it can be used as a safe alternative for those with congenital heart disease. 

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As someone...
By MrBlastman on 2/4/2011 1:42:28 PM , Rating: 5
Who has endured open-heart surgery, I am glad that this device is _finally_ here in the United States. Technologies like these give hope to those who may face, are facing or will face again potential heart surgeries that they may not need to have their chest cracked open to have it done.

Having your sternum sawed in half is not fun, believe me. However, if you survive the surgery, the pain really is meaningless as waking up alive far outweighs any recovery you might have to go through. The recovery though, can take several months and the reality is, with conventional OHS, the recovery takes about a full year to complete. Yes, a full year.

The thing most people don't realize is that in order to have OHS, someone is under anesthesia for at least six to eight hours and depending on the gravity of the surgery, they may need to be chilled down to 50 or 60 degrees fahrenheit while hooked up to a cardio-pulmonary system that filters and oxygenates the blood (as in my case). In some extreme cases, their brains are even completely unhooked for a short while. The surgery itself might only take thirty minutes to an hour, but the preparation takes at least an hour to two hours and the warming can take far longer. This is primarily due to avoiding bubbles building up in the blood which can cause stroke. The risks in OHS are much more than you'd think.

I welcome technologies such as these. They offer to prevent many (seemingly exotic) surgical neccesities from being used in the future and afford the patient a quicker process, shorter hospital stay (try outpatient eventually) and let them get on with their life far more quickly than in the past. When I said a full year, I meant it. It truly takes that long and it isn't just the sternum healing. Your body being put into a deep chill like that, along with the oxygenation of the blood, really takes its toll on a person.

This isn't the only device or procedure I have read about here in the states though involving this. I think about two years ago I read about a nun who at the age of 91, received an aortic valve transplant and was up and running down the halls of the hospital later on that night. Yes, running is incredibly risky for someone who is 91, but, she was doing it. Nobody who has had their sternum cracked will be running for weeks after surgery.

RE: As someone...
By Schrag4 on 2/4/2011 3:18:39 PM , Rating: 2
My middle child may someday benefit from this. He was born with a narrowing of the aorta (which was corrected just after his first birthday) and he has malformed valves. While the vales are functioning, someday they will need to be replaced. Maybe 10 years from now, maybe 50 years from now. At any rate, it's always good to hear about progress like this, especially when it hits home for you or your family!

RE: As someone...
By HyperTension on 2/6/2011 10:45:09 AM , Rating: 1
Active OH Recovery ICU/CCU RN here. Interesting procedure, need to read up on it regarding benefits, technique, and overall prognosis.

Blast, you hit that pretty close to center with your description of what its like as an OH recovery patient. I have had patients walk around the unit 6-7 hours after closure, (about 3 hours post extubation) but it's a rarity.

Just a couple of small corrections: The brain is never "unhooked", however the level of anesthesia just about makes it so. If you have any repair to the aorta / aortic valve, a "circulation arrest" is performed where the patients head is wrapped in ice, massive doses of steroids and benzo / phenobarbs given and there is literally no flow going to the brain for "x" period of time. The standard is less than 15 - 18 minutes, however had a few patients with >45 minutes recover without impairment, but the risk of adverse events exponentially increases the longer the patient goes without adequate perfusion / oxygen saturation.

Actual "hard" anesthesia is variable between 2-4 hours, length of procedure between 3-6 hours (rough average).

The FDA does and will test devices, sometimes to the point of nausea for the clinicians and the patients where said treatment may be viable. It's just what is. Average time seems to be about 7-10 years for full approval. And even with this we have seen medical devices / medications recalled, sometimes long after the patent for original formulation expires (Darvocet). There are obviously pros / cons to this approach.

Either way, I'm pretty excited to see this treatment finally get a bit more "head room" and attention. I hope this provides an improvement over previous procedures for the patient and their family.

Nice to see you recovered well :)

