First mid- to long-term study of the Harmony Transcatheter Pulmonary Valve System validates its safety and efficacy

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May 19, 2022 — A 1-year outcome study in the largest cohort to date of Harmony transcatheter pulmonary valve (TPV) patients with congenital heart disease (CHD) and severe pulmonary regurgitation (RP) was presented today. today as last-minute clinical research at the Society of Angiography and Cardiovascular Procedures (SCAI) Scientific Sessions 2022. Results show that Harmony TPV patients had favorable clinical and hemodynamic outcomes, confirming previous results and demonstrating continued safety and efficacy of the device across studies and valve types at 1 year .

About one in five coronary patients has an abnormality in their right ventricular outflow tract (RVOT) (NLM). Prior to TPV technology, coronary patients were treated with invasive procedures such as open-heart surgery or opted for surgical valve replacement later in life. The Harmony TPV is designed to be a non-invasive, non-surgical treatment option for many of those adolescent and adult coronary patients who could not previously be treated with TPVs.

The data was aggregated from the Harmony Native Outflow Tract Preliminary Feasibility Study, Harmony TPV Pivotal Trial and Continuous Access Study. Eligible patients had severe RA by echocardiography or a PR fraction ≥ 30% by cardiac magnetic resonance imaging and a clinical indication for pulmonary valve replacement. Forty-two patients received the TPV22 device and 45 received the modified TPV25 device. Additionally, 19 patients received an early iteration of the 25mm valve (clinical TPV25) which was later found to have less predictable deployment and was discontinued. The primary safety endpoint was the absence of procedure- or device-related mortality at 30 days. Efficacy was assessed by freedom from RA, stenosis, and interventions (≥ moderate RA, mean RVOT gradient > 40 mmHg, device-related RVOT reoperation, and catheter reoperation) over 1 year. Adverse events were assessed by a clinical events committee.

A total of 108 patients were catheterized, 106 underwent TPV implants, and 104 remained implanted for more than 24 hours. The 2 patients who had surgical explantation within 24 hours had received a clinical TPV25 valve. The mean (SD) age of patients at baseline was 29.0 (12.7) years; 62.0% were men and 86.1% had an initial diagnosis of tetralogy of Fallot. At 1 year, there were no deaths, and 95.1% of TPV22 patients and 89.7% of mTPV25 patients were free of RA, stenosis, and interventions. Eighty-five percent or more of patients had no/trace of PsA and ≥90% had no/trace of paravalvular leakage at all follow-up visits.

“We knew that Harmony TPV patients did well in the acute phase, but these data now validate these mid-term results.” said Daniel S. Levi, MD, FSCAI, Mattel Children’s Hospital at UCLA, Los Angeles, CA. “Even a year after implantation, the valve continues to function well without major interventions, obstruction or regurgitation. This gives us confidence that we are on the right course of treatment with this pulmonary valve. Researchers will continue to follow this cohort of patients and further demonstrate that Harmony TPV remains safe and effective over the long term.

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