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Sioux Falls Heart Surgeon First in the Nation to Use Newly-Approved Occlusion Device

Michael Bacharach, MD, a vascular medicine specialist with Avera Heart Hospital in Sioux Falls, recently became the first doctor in the country to use a new minimally invasive device for large atrial septal defects commercially. 

“An ASD is a hole between the right and left atriums of the heart,” explains Bacharach. “What happens is the blood goes from left to right. Over time it causes the right ventricle to become dilated and raises the risk for right-sided heart failure. It is one of the more common congenital anomalies.”

The Gore Cardioform ASD occluder is a is an implantable fabric-based device for trancatheter closure of ostium secundum ASDs. These larger ASDs typically carry a greater risk for complications like pulmonary hypertension, right heart enlargement, or atrial fibrillation. For years, ostium secundum ASDs were only treatable with open surgery. Then came the Jude Amplatzer Atrial Septal Occluder.

“It is essentially a metal screen with big discs on either side,” says Bacharach. “Sometimes, when you sized it, the wings took up too much space in the atrium. There were also some migrations and erosions with that device.”

The new Gore device is predominantly fabric with much less metallic framework. Its conical shape allows for a wider range of sizes. Eventually, it becomes incorporated into the heart wall.

“It basically allows you to occlude the hole without having a huge rim on each side,” says Bacharach. “There will still be some who require surgical intervention, but it will be much less.”

Dr. Bacharach has used a similar device to close patent foramen ovales, a smaller type of congenital hole in the heart that can raise the risk for stroke. “We have never had an errosion with the Gore device that we’ve used for PFOs,” he says.

Implantation of the Cardioform ASD occluder takes about an hour and patients go home the next day. The first two patients treated with the new device were not good candidates for the Amplatzer device. In one case, the only alternative would have been a much riskier open operation. 

“The new device worked very well and it was nice to have the opportunity to do it endovascularly rather than surgically,” says Dr. Bacharach. “Both operations went smoothly and both patients went home the following day.”


Check out this video of the new occlusion device being deployed.

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