Our Summary

This research paper is about a study conducted on 22 patients who were fitted with a Harmony TPV25 device, a type of heart valve, despite predictions that it would not fit properly. The Harmony valve is used to replace the pulmonary valve, which is in the right side of the heart. The prediction of whether the valve will fit properly is usually done through a method called a perimeter plot (PP).

The study found that despite the PP predicting that the valve would not fit, there were no unsuccessful implants or any problems related to the valve. The patients’ heart anatomies varied, but all could be categorized into one of three types based on the shape and size of their right ventricular outflow tract (RVOT - the passage through which blood leaves the heart and enters the lungs).

The first type of patient had a long RVOT with a choke point (a narrow section) and a wide main pulmonary artery (the vessel carrying blood from the heart to the lungs). The second type of patient had a short, pyramid-shaped RVOT with no choke point, and a main pulmonary artery that lengthened and expanded during the heart’s pumping phase. The third type of patient had a short, bulbous main pulmonary artery with a choke point and an open branch of the pulmonary artery.

The study concludes that the Harmony valve can be successfully implanted in some patients even when the PP predicts it won’t fit. The researchers note that the three anatomic patterns they identified are not considered in the current screening report. They suggest that doctors should review each case individually to decide if the implant is feasible.

FAQs

  1. What is the purpose of the perimeter plot (PP) in determining the suitability of a Harmony valve implant?
  2. What are the different anatomic types identified in the study for patients undergoing transcatheter pulmonary valve replacement with the Harmony TPV25 device?
  3. Can a transcatheter pulmonary valve replacement with the Harmony valve be performed if a PP predicts inadequate oversizing?

Doctor’s Tip

One helpful tip a doctor might tell a patient about pulmonary valve replacement is to trust the expertise of the medical team and understand that individualized assessment is key in determining the feasibility of the implant. In some cases, patients may still be suitable candidates for the procedure even if the perimeter plot predicts inadequate oversizing. It is important to discuss any concerns or questions with your healthcare provider to ensure the best possible outcome.

Suitable For

Patients who are typically recommended for pulmonary valve replacement include those with congenital heart defects such as tetralogy of Fallot, pulmonary atresia, and other complex forms of congenital heart disease. These patients may have pulmonary valve stenosis, regurgitation, or a combination of both, leading to symptoms such as cyanosis, exercise intolerance, and right heart failure. In some cases, patients may have undergone previous surgical repair or placement of a prosthetic pulmonary valve that requires replacement due to dysfunction or deterioration. The decision to recommend pulmonary valve replacement is based on a thorough evaluation of the patient’s symptoms, imaging studies, and overall cardiac function.

Timeline

Before pulmonary valve replacement:

  1. Patient undergoes evaluation to determine the need for a pulmonary valve replacement.
  2. Anatomic features and measurements are assessed, including the RVOT dimensions.
  3. Screening report and perimeter plot are used to determine suitability for Harmony valve implant.
  4. In some cases, the PP may predict inadequate oversizing, but the implant may still proceed depending on individual patient factors.

After pulmonary valve replacement:

  1. The Harmony TPV25 device is implanted in the patient’s RVOT.
  2. Anatomic features are reviewed post-implantation, revealing variations in RVOT dimensions.
  3. Patients are categorized into 3 anatomic types based on RVOT characteristics.
  4. Despite the PP predicting inadequate oversizing, successful implantation occurs without adverse valve-related events.
  5. Implanters must assess each case individually to determine the feasibility of the implant based on anatomic features.

What to Ask Your Doctor

  1. Can you explain why the perimeter plot (PP) predicted inadequate oversizing for my Harmony valve implant?
  2. Are there any specific risks or complications associated with undergoing a Harmony TPV25 implant despite inadequate oversizing?
  3. How will you ensure the proper fit and function of the Harmony valve in my specific anatomy?
  4. What alternative treatment options are available if the Harmony valve implant is not suitable for me based on the PP analysis?
  5. What is your experience with performing Harmony valve implants in patients with similar anatomical features to mine?
  6. How will my post-operative recovery and long-term outcomes be affected by undergoing a Harmony valve implant despite the PP predicting inadequate oversizing?
  7. Will I need any additional monitoring or follow-up care due to the unique anatomical considerations of my RVOT and main pulmonary artery?
  8. Can you provide information on the success rates and potential complications associated with Harmony valve implants in patients with similar anatomical characteristics as mine?
  9. How will the Harmony valve improve my overall heart function and quality of life compared to other treatment options for pulmonary valve replacement?
  10. Are there any specific lifestyle modifications or restrictions I should be aware of after undergoing a Harmony valve implant with inadequate oversizing predicted by the PP analysis?

Reference

Authors: McElhinney DB, Gillespie MJ, Aboulhosn JA, Cabalka AK, Morray BH, Balzer DT, Qureshi AM, Hoskoppal AK, Goldstein BH. Journal: Circ Cardiovasc Interv. 2024 May;17(5):e013889. doi: 10.1161/CIRCINTERVENTIONS.123.013889. Epub 2024 Apr 12. PMID: 38606564