Our Summary

The Harmony™ Transcatheter Pulmonary Valve, a device made by Medtronic, was recently approved by the FDA for a procedure to replace the pulmonary valve in the heart without needing open-heart surgery. However, some patients have a condition where the main arteries in their lungs are severely enlarged, and they still need traditional surgical valve replacement.

This research paper reports on a new mixed or “hybrid” approach for these patients. This method involves a surgical step to create a “landing zone” for the valve, then the Harmony™ valve is implanted using the non-surgical method, and finally, the valve is secured in place with stitches.

The researchers share their first use of this hybrid method for replacing the pulmonary valve with the Harmony™ device. They discuss two cases where this approach was successful, even though the surgical steps to create the landing zone were slightly different for each case.

FAQs

  1. What is the Harmony™ Transcatheter Pulmonary Valve?
  2. Who is eligible for the Harmony™ Transcatheter Pulmonary Valve replacement?
  3. What is the hybrid approach for Harmony™ transcatheter pulmonary valve replacement?

Doctor’s Tip

One helpful tip a doctor might tell a patient about pulmonary valve replacement is to follow a healthy lifestyle to support the success of the procedure. This can include maintaining a balanced diet, staying physically active, quitting smoking, and managing any underlying medical conditions such as high blood pressure or diabetes. By taking care of your overall health, you can improve the outcome of the pulmonary valve replacement surgery and reduce the risk of complications.

Suitable For

Patients who are typically recommended for pulmonary valve replacement include those with congenital heart disease, particularly those with pulmonary valve disease (PVD). These patients may have severe pulmonary regurgitation or stenosis, leading to symptoms such as shortness of breath, fatigue, and exercise intolerance. Patients with dilated main pulmonary arteries may also be candidates for pulmonary valve replacement. Additionally, patients who have previously undergone surgical repair of their congenital heart defect and now require a re-intervention may be recommended for pulmonary valve replacement. The Harmony™ Transcatheter Pulmonary Valve may be a suitable option for some patients, particularly those with a native right ventricular outflow tract.

Timeline

Before pulmonary valve replacement:

  1. Patient is diagnosed with pulmonary valve disease, which may be a result of congenital heart defects or other conditions.
  2. Patient undergoes various diagnostic tests such as echocardiogram, MRI, and cardiac catheterization to assess the severity of the pulmonary valve disease.
  3. Treatment options are discussed with the patient, including the possibility of pulmonary valve replacement.
  4. Patient may undergo pre-operative testing and preparation for the surgical or transcatheter procedure.

After pulmonary valve replacement:

  1. Patient undergoes the pulmonary valve replacement procedure, either through surgical or transcatheter means.
  2. Recovery period begins, with the patient monitored closely for any complications or signs of improvement.
  3. Patient may need to participate in cardiac rehabilitation and follow-up appointments to monitor their progress.
  4. Over time, the patient’s symptoms of pulmonary valve disease improve, leading to a better quality of life and improved cardiac function.
  5. Patient may need to continue follow-up appointments and monitoring to ensure the long-term success of the pulmonary valve replacement.

What to Ask Your Doctor

  1. What is the reason for recommending a pulmonary valve replacement?
  2. Are there any alternative treatment options available?
  3. What are the potential risks and complications associated with the procedure?
  4. What is the expected outcome and recovery time after the procedure?
  5. Will I need to take any medications or follow-up treatments post-surgery?
  6. How long will the replacement valve last and will I need further interventions in the future?
  7. What should I expect during the procedure and how long will it take?
  8. What type of anesthesia will be used during the surgery?
  9. Will I need to make any lifestyle changes or modifications after the surgery?
  10. Are there any specific instructions or precautions I should follow before and after the surgery?

Reference

Authors: Shibbani K, Aboulhosn J, Levi D, Mohammad Nijres B, Blais B, Karimi M, Van Arsdell G, Aldoss O. Journal: Catheter Cardiovasc Interv. 2023 Jan;101(1):135-139. doi: 10.1002/ccd.30504. Epub 2022 Nov 26. PMID: 36434791