Cardiovascular Report - No Cutting, No Surgery With Catheter-Delivered Heart Valve Repair
No Cutting, No Surgery With Catheter-Delivered Heart Valve Repair
Date: September 17, 2010
Open-heart surgery is no stranger to patients like Maryland’s 17-year-old Alex Compton. Born with tetralogy of Fallot, Compton has endured several invasive surgeries with long hospitalizations and recoveries, most recently when he was 8 and needed his pulmonary valve repaired. It meant 10 days in the hospital.
Time and technology, however, heal some wounds. This past May, Compton needed another pulmonary valve procedure. But this time, a minimally invasive catheter approach required only a one-night stay. Two days later, Compton attended rehearsal for his high school graduation.
The new catheter procedure is called percutaneous pulmonary valve replacement, and Johns Hopkins pediatric cardiologist Richard Ringel is one of a handful of interventionalists nationwide who perform it. “There is no surgery, no cutting of anything,” he says. “It’s just a puncture in the vein of the leg.”
For the novel procedure, which is performed with the patient under general anesthesia, Ringel places a stent-mounted bioprosthetic valve onto a balloon-tipped catheter and threads it through the femoral vein and up to the pulmonary valve. He then expands the bioprosthetic valve to prop open the poorly functioning existing valve.
“When the surgeon puts in a conduit or an animal valve,” says Ringel, “we hope that it will last 15 or 20 years. But too often it lasts only a few years, and those patients may require multiple replacements and operations. So we insert this valve in the hope of giving that conduit the years it was designed to get and to reduce the number of open-heart surgeries patients need over a lifetime.”
This new catheter approach, says Ringel, is not always designed to replace open heart surgery but rather to delay it by extending the life of the conduit.
The procedure, says Ringel, has proved successful enough in U.S. and European trials for the FDA to approve the valve as a humanitarian-use device for patients like Compton.
Pulmonary valve dysfunction trial
Richard Ringel is the only Maryland practitioner authorized to implant the first catheter-delivered, FDA-approved heart valve—the Medtronic Melody Transcutaneous Pulmonary Valve. The Melody valve has received humanitarian device exemption (HDE) approval from the FDA for implant in patients who have severe pulmonary valve stenosis or insufficiency due to a failed surgical implant. According to FDA requirements, all patients are enrolled into local IRB-approved follow-up programs. Info: Richard Ringel, 410-614-6745, firstname.lastname@example.org