Cardiac Closure Devices

What is an ASD closure device?

An atrial septal defect (ASD) closure device plugs an opening in the wall that separates the left and right upper chambers of your heart (atria) called the interatrial septum. ASDs are holes that are present at birth but shouldn’t be.

You may also need a cardiac closure device for a patent foramen ovale (PFO). A PFO isn’t a true opening like an ASD, but instead a potential space in the interatrial septum that a fetus uses in normal fetal circulation. Only a fetus uses the foramen ovale. It should normally close after birth. If the foramen ovale remains open, it’s referred to as being “patent”, hence the term patent foramen ovale.

These openings may close on their own or be small enough that they don’t cause issues. But people who have shortness of breath, fatigue or heart palpitations may need a cardiac closure device.

Types of ASD closure devices

ASD closure devices and PFO closure devices include:

• Amplatzer™ Septal Occluder.
• Amplatzer™ PFO Occluder.
• Amplatzer™ Cribriform (for a septum with more than one hole).
• Gore® Cardioform Septal Occluder.
• Gore® Cardioform ASD Occluder (for larger ASDs).
• STARFlex® Septal Closure System.

Why is a cardiac closure device used?

You may need a cardiac closure device if you have a hole in the wall between your left and right atria. Closing this opening keeps blood in your left atrium separate from the blood in your right atrium. This is important because there’s oxygen in the blood in your left atrium, but not in your right atrium.

If blood from your atria mix, it doesn’t allow your heart to send enough oxygen to your body. All of the blood in your left atrium is supposed to have oxygen in it before it goes to your body’s cells.

Providers also use ASD closure devices to prevent a stroke in people who have a patent foramen ovale (PFO). Like an ASD, this type of opening allows blood to go the wrong way inside your heart.

How common are cardiac closure devices?

About 6 to 10 babies out of 10,000 have an atrial septal defect at birth. People of all ages receive cardiac closure devices.

How will a provider put a cardiac closure device into my heart?

Surgeons place ASD closure devices during open-heart surgery or cardiologists place devices with a catheter. Using a catheter allows providers to fix the issue during cardiac catheterization instead of open-heart surgery. Today, providers use cardiac catheterization to repair more than 80% of ASDs.

ASD closure devices can range from 4 mm (millimeters) to 40 mm in size. The size of the tool providers use to place the device varies as well. They can choose the appropriate size for the device they’re placing. They use a balloon put through a catheter to measure the size of the opening the device will need to fill.

To close a PFO or ASD using a catheter, a provider puts a special catheter into your heart by way of a leg vein. They slowly push the device out of the catheter, allowing each side of the device to open up and cover each side of the hole. With X-ray used during the procedure and ultrasound guidance, they release the device when it’s in the right position.

What are the advantages of an ASD closure device?

Success rates for placing ASD closure devices exceed 93% in various studies.

Researchers found that transcatheter ASD closure devices work as well as and are as safe as devices surgeons put in during open-heart surgery. However, if you get an ASD closure device during a cardiac catheterization, you can expect less discomfort and a shorter hospital stay.

Research also suggests that using a catheter to place a cardiac closure device to fix a PFO is better than medicine for preventing a stroke.

What are the side effects of an ASD closure device?

Side effects or complications of a PFO or ASD closure device may include:

• Aortic insufficiency (blood flowing backward from your aortic valve).
• Blood clots.
• Abnormal heart rhythms.
• The device moving out of place.
• Endocarditis from dental procedures.
• ASD closure device leak. (Most stop leaking during the first year.)
• Difficulty accessing your left atrium in the future.
• Device erosion. (This is rare. There’s an estimated .04% to 0.3% chance.)

How can a provider prevent side effects or complications?

Researchers have found ways to minimize some complications of cardiac closure devices. Here are some ways providers help prevent complications:

• To prevent blood clots, your provider will recommend that you take an anticoagulant for six months after receiving an ASD closure device.
• Providers can use newer devices that allow them to pass catheters through. Even though the closure device seals a hole to completely separate the left and right atrium, these newer devices will still allow catheters to pass through them to access the left atrium for procedures like ablation for atrial fibrillation. Older devices don’t have this feature.
• To prevent device erosion, providers need to be careful to choose the right device and the right size device for each person.

To protect yourself from endocarditis for the first six months after receiving an ASD closure device:

• Tell all of your healthcare providers and dentists that you have a cardiac closure device. You may want to carry a card with this information.
• Contact your provider if you have symptoms of an infection (sore throat, general body aches and fever).
• Take good care of your teeth and gums to prevent infections.
• See your dentist regularly.
• Take antibiotics before you undergo any procedure that may cause bleeding, such as any dental work (even a basic teeth cleaning), invasive tests and most major or minor surgeries.
• Check with your provider about the type and amount of antibiotics you should take.

What is the recovery time?

You’ll need an overnight stay after your provider uses a catheter to implant an ASD closure device. After that, you may need to take it easy for two weeks. You can do nonstrenuous activities a day or two after your procedure. Recovery from open-heart surgery takes longer.

Is an ASD closure device safe?

Yes, this procedure is generally safe. Complications happen more often with device placement during open-heart surgery, which leads to longer hospital stays. Still, the risk of dying in the hospital from this type of surgery is very low (0.3% to 0.9%).

When should I see my healthcare provider?

Contact your provider if you faint or have chest pain after receiving an ASD closure device. You’ll also need regular checkups to make sure your cardiac closure device is staying in place and working correctly.

Is an ASD closure device safe in an MRI?

You may be able to have a magnetic resonance imaging (MRI) scan after receiving an ASD closure device. However, you may have certain restrictions, such as getting a scan in a machine with a less powerful magnetic field. Talk with your provider about the MRI safety of the specific device you have.

What is an ASD closure device made of?

ASD closure devices have a wireframe of nitinol (nickel and titanium) with a polyester fabric covering. Some devices may include platinum, as well. Cardiac closure devices often have two round disks with a narrow mesh “waist” between them. One disk stays on each side of the opening in your heart wall. The waist sits in the hole.

With time, your body’s tissue grows over the ASD closure device material and it becomes part of your heart.

What if a closure device isn’t an option?

People who aren’t candidates for catheter-based closure devices may require surgery to close their septal defect. Providers can do these operations with minimally invasive and robotically assisted approaches.