A Minimally Invasive Option for Pulmonary Regurgitation

Wayne Batchelor, MD ,MHS is Associate Director of Inova Schar Heart and Vascular, System Director of Interventional Cardiology, and Director of Interventional Cardiology Research and Education at Inova Health System. Dr. Batchelor is board certified in cardiology with added qualifications in interventional cardiology.

Catherine Tomasulo, MD, is Director of Pediatric and Congenital Interventional Cardiology at Inova. She is board certified in pediatric cardiology and pediatrics and completed additional fellowships in interventional cardiology and lymphatic imaging and interventions.

Thanks to interventional cardiology, many procedures that used to require open heart surgery can now be done with minimally invasive methods. We can place valves, stents and even pacemakers using catheters (thin tubes) that travel through a vein. You don’t need a chest incision, and your recovery is much shorter.

This technology is exciting, but those who have severe pulmonary regurgitation haven’t been eligible for a minimally invasive option – until now.

Challenges with Severe Pulmonary Regurgitation

Pulmonary arteries are the blood vessels that carry oxygen-poor blood from your heart to your lungs. When someone has pulmonary regurgitation, a valve within the pulmonary artery in their heart doesn’t close properly. The leaky valve causes some blood to flow backward, and the heart must work harder to push that blood out.

In most cases, people with pulmonary regurgitation have a dilated (widened) right ventricular outflow tract (RVOT). The RVOT is the part of the heart that directs blood to the lungs. People might have a dilated RVOT if they have tetralogy of Fallot or another congenital (present at birth) heart defect.

Previous minimally invasive devices couldn’t expand enough to properly fit dilated RVOTs. These devices are made with tiny balloons that are designed to treat narrowed valves, not widened ones.

An Alternative to Open Heart Surgery

At Inova, we were among the first five teams in the United States selected to use the Medtronic Harmony™ Transcatheter Pulmonary Valve (TPV) System as part of the relaunch earlier this year. This device is FDA-approved and designed specifically for severe pulmonary regurgitation.

The Harmony TPV uses a tiny wire frame, rather than a balloon. The structure is designed especially for pulmonary regurgitation and fits larger RVOTs. Our team at Inova has successfully implanted the Harmony TPV in three people with severe pulmonary regurgitation. They ranged in age from 16 to 60.

All three procedures went smoothly with no complications. These three patients came back to us for follow-ups at three months, and they continue to have positive results. Tests revealed their hearts were pumping well. All three are enjoying an improvement in pulmonary regurgitation symptoms like fatigue and dizziness.

How It Works

The Harmony TPV uses a common and proven valve material made from a pig’s heart. A protective layer of polyester fabric surrounds the valve and attaches to the wire frame. The valve and frame collapse down into a slim case that is small enough to fit through a vein.

Placing the Harmony TPV takes two to three hours. You will be fully asleep and will not feel any pain. During your procedure, your interventional cardiology team:

  1. Loads the Harmony TPV device into a catheter
  2. Makes a small incision in a vein, usually in your upper leg
  3. Uses imaging to view your veins and heart in real time
  4. Guides the catheter through your vein and into your heart
  5. Deploys the valve in your RVOT, where it opens and begins to work immediately
  6. Removes the catheter and uses imaging to ensure your new valve is working properly
  7. Closes your leg incision and takes you to a recovery room

Am I a Candidate for Harmony TPV?

A cardiologist who is familiar with the TPV procedure can determine whether the Harmony TPV could treat your pulmonary regurgitation. To make that determination, we usually perform an MRI to check the function of your current pulmonary valve and the size of your right ventricle. If pulmonary valve replacement is indicated, we will order a CT scan to take measurements of your heart.

We send those measurements to Medtronic. They analyze the data and let us know if the Harmony TPV could work for you. With this process, we can be confident that the device is a good fit without using more invasive tests.

More Time for Enjoying Life

The Harmony TPV cannot usually eliminate all open heart surgeries. When the device wears out (anticipated in about 10 years), your cardiologist may be able to place a new device inside the first. We expect that after two or three Harmony TPV procedures, you will need surgery to remove them and start fresh. But a transcatheter valve allows you to have fewer heart surgeries in your lifetime.

Whether we can delay one surgery or several, the benefits are powerful. Fewer chest incisions mean you will likely have less scar tissue. When you do need an open heart surgery, you may have fewer complications. A transcatheter device can also get you back to your life sooner. Rather than several weeks of recovery, you can resume normal activities within a few days.

Looking to the Future

Catheter-based procedures continue to improve and evolve, making them an option for more and more people. We remain hopeful that, one day, all patients with pulmonary regurgitation will have a minimally invasive treatment option.

If you have heart disease, you’re in expert hands with our specialists. Our structural heart program offers a team of interventional cardiologists who provide leading-edge care with a compassionate approach. Learn more about Inova’s nationally recognized structural heart/valve disease program.

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