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Patient Selection Process for the Harmony Transcatheter Pulmonary Valve Early Feasibility Study
Matthew J Gillespie1, Lee N Benson2, Lisa Bergersen3
1Division of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
The American Journal of Cardiology
|August 22, 2017
Summary
The Medtronic Harmony transcatheter pulmonary valve (TPV) shows promise for non-surgical pulmonary valve replacement. Rigorous patient screening ensured successful implantation in patients with complex right ventricular outflow tract issues.
Area of Science:
- Cardiology
- Biomedical Engineering
- Interventional Cardiology
Background:
- Transcatheter pulmonary valve (TPV) replacement is an emerging alternative to surgery.
- The Medtronic Harmony TPV is designed for patients with specific right ventricle-pulmonary artery conduit issues.
- Early feasibility studies are crucial for evaluating novel device performance and safety.
Purpose of the Study:
- To gather in vivo data on device loading conditions for the Medtronic Harmony TPV.
- To assess the procedural feasibility, safety, and performance of the Harmony TPV.
- To evaluate the suitability of the Harmony TPV in patients not suitable for surgical pulmonary valve replacement.
Main Methods:
- Prospective, nonrandomized early feasibility study at 3 sites.
- Rigorous patient selection based on precise anatomical matching to a single-size Harmony TPV.
- 270 patients prescreened, 66 enrolled, 20 underwent TPV implantation.
Main Results:
- Nineteen out of 20 implanted devices (95%) met criteria for implant success.
- The study confirmed assumptions on device loading conditions.
- Procedural feasibility and safety were demonstrated.
Conclusions:
- The Medtronic Harmony TPV is a viable therapeutic option for complex right ventricular outflow tract failure.
- Careful patient screening is essential due to anatomical variability.
- This early feasibility study provides valuable initial clinical data for the Harmony TPV.
