Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study

Area of Science:

• Cardiovascular Surgery
• Interventional Cardiology
• Biomedical Engineering

Background:

• The Harmony transcatheter pulmonary valve (TPV) is designed to treat pulmonary valve regurgitation in patients with repaired right ventricular outflow tracts.
• Postoperative pulmonary valve regurgitation is a common complication following surgical repair of right ventricular outflow tracts.

Purpose of the Study:

• To evaluate the three-year outcomes of the Harmony transcatheter pulmonary valve (TPV) in patients with repaired right ventricular outflow tracts.
• To assess the safety and efficacy of the Harmony TPV for treating pulmonary valve regurgitation.

Main Methods:

• A prospective, multicenter, nonrandomized feasibility study (Native TPV EFS) involving 20 patients implanted with the Harmony TPV.
• Three-year follow-up data, including echocardiography and computed tomography scans, were collected and analyzed.

Main Results:

• Seventeen patients completed 3-year follow-up; no deaths occurred. Most patients demonstrated good valve function with no/trace pulmonary valve regurgitation and no moderate/severe paravalvular leak.
• Two patients developed neointimal proliferation requiring successful transcatheter valve-in-valve treatment. Mean RVOT gradient at 3 years was 15.7±5.5 mm Hg.
• No significant late frame fractures or erosions were identified radiographically. Luminal tissue thickening was observed in some patients but did not significantly alter valve housing.

Conclusions:

• The Harmony TPV demonstrated stable device position and good valve function in most patients at three years.
• The study confirmed the absence of moderate/severe paravalvular leak and significant late frame fractures.
• While two patients required reintervention for neointimal proliferation, the overall results support the Harmony TPV as a viable treatment option.