Transcatheter Pulmonary Valve Replacement With a Novel Valve: Medium-Term Results From a Single Center Study

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Transcatheter pulmonary valve replacement (tPVR) is a key strategy for dysfunctional right ventricular outflow tracts (RVOT).
• Managing chronic pulmonary regurgitation (PR) in native or patched RVOT presents challenges due to anatomical variations.
• There is a need for novel self-expandable valves to address these challenges.

Purpose of the Study:

• To evaluate the procedural success and medium-term outcomes of the Med Zenith PT-Valve for tPVR.
• To assess the valve's performance in patients with PR in native or patched RVOT.
• To report data from a single-center feasibility trial.

Main Methods:

• A feasibility trial was conducted involving patients with PR.
• Fifteen patients were assessed for candidacy, and 12 underwent tPVR with the Med Zenith PT-Valve.
• Follow-up was performed per protocol.

Main Results:

• The tPVR procedure achieved a 100% success rate in the 12 patients treated.
• Complications included transient events like pulmonary hemorrhage and neuropraxia, with no deaths or valve-related reinterventions.
• Significant improvements in biventricular volume and PR fraction were observed at a median follow-up of 28.5 months.

Conclusions:

• The Med Zenith PT-Valve demonstrated effective performance in the short to mid-term for patients with significant PR in native or patched RVOT.
• Further research is necessary to determine the long-term durability of the valve.
• The valve represents a viable option for tPVR in challenging RVOT anatomies.