Medtronic’s Harmony TPV Demonstrates Safety and Efficacy at 1 Year

May 19, 2022—A study of 1-year outcomes in the largest cohort to date of patients with congenital heart disease and severe pulmonary regurgitation (PR) treated with Medtronic’s Harmony transcatheter pulmonary valve (TPV) was presented as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 scientific sessions held May 19-22 in Atlanta, Georgia.

According to the SCAI press release, the findings show Harmony TPV patients had favorable clinical and hemodynamic outcomes, confirming earlier results, and demonstrating continued device safety and effectiveness across studies and valve types at 1 year.

Data were pooled from the Harmony Native Outflow Tract Early Feasibility Study, Harmony TPV Pivotal Trial, and Continued Access Study. Eligible patients had severe PR by echocardiography or PR fraction ≥ 30% by cardiac MRI and a clinical indication for pulmonary valve replacement.

In the cohort, 42 patients received the TPV22 device and 45 received the modified TPV25 (mTPV25) device. Additionally, 19 patients received an early iteration of the 25-mm valve (clinical TPV25) that was later found to have less predictable deployment and discontinued.

The primary safety endpoint was freedom from procedure- or device-related mortality at 30 days. Efficacy was assessed as freedom from PR, stenosis, and interventions (≥ moderate PR; mean right ventricular outflow tract [RVOT] gradient > 40 mm Hg; device-related RVOT reoperation; and catheter reintervention) through 1 year. Adverse events were adjudicated by a Clinical Events Committee.

As summarized in the SCAI press release, a total of 108 patients were catheterized, 106 underwent TPV implants, and 104 remained implanted for > 24 hours. The two patients who had surgical explantation within 24 hours had received a clinical TPV25 valve. Mean (standard deviation) patient age at baseline was 29.0 (12.7) years; 62.0% were male; and 86.1% had an original diagnosis of tetralogy of Fallot.

The findings at 1 year showed the following:

• No deaths
• 95.1% of TPV22 and 89.7% of mTPV25 patients were free from PR, stenosis, and interventions
• ≥ 85% of patients had none/trace PR and ≥ 90% had none/trace paravalvular leak at all follow-up visits

Investigators will continue to follow this patient cohort to further demonstrate that Harmony TPV remains safe and effective in the long run, noted SCAI.

“We knew that Harmony TPV patients were doing well acutely, but this data now validates these findings in the intermediate term,” commented Daniel S. Levi, MD, in the SCAI press release. “Even a year after implant, the valve is continuing to function well without significant interventions, obstruction, or regurgitation. This gives us confidence that we are going down the right treatment path with this pulmonary valve.” Dr. Levi is with Mattel Children’s Hospital at UCLA in Los Angeles, California.