Dr. Doff McElhinney of Stanford University shared findings at the CSI Frankfurt event in Germany today. According to a Medtronic spokesperson, McElhinney presented one of the longest follow-ups to date for a transcatheter treatment of native or surgically repaired right ventricular outflow tract (RVOT) in patients with severe pulmonary regurgitation.
Patients evaluated in the study received treatment with the commercially available Harmony TPV22 and TPV25 devices. Medtronic says findings provide insight into mid-term durability, safety and patient-reported outcomes.
Medtronic reports sustained valve performance at five years with the Harmony TPV system. Investigators saw none/trace or mild pulmonary regurgitation in approximately 93% of TPV22 patients and approximately 96% of TPV25 patients. They also reported low reintervention rates, with no new reinterventions reported between years four and five. Patients had 100% freedom from surgical reintervention in TPV25 patients.
Additionally, the study saw a stable safety profile, with no device- or procedure-related mortality and no new ventricular tachycardia (VT) events beyond 30 days. Pulmonary regurgitation remained minimal in the majority of patients at five years, demonstrating consistent hemodynamic benefit.
Medtronic said that data showed reductions in RV volumes and sustained improvements in patient-reported outcomes over time.
Harmony TPV is the first FDA-approved device for the treatment of severe pulmonary regurgitation in a native or surgically repaired RVOT. This patient population typically has the condition managed with repeat open-heart surgery.
The Harmony system first received FDA clearance in March 2021. However, an FDA Class I recall for the system in April 2022 saw it briefly leave the market. Medtronic relaunched Harmony in the U.S. in February 2023 and soon had positive two-year results to report for the system.
