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

BACKGROUND: Transcatheter pulmonary valve replacement (tPVR) has emerged as a promising management strategy for dysfunctional right ventricular outflow tract (RVOT). However, the management of chronic pulmonary regurgitation (PR) in native or patched RVOT remains challenging with the vast variation in morphology, leading to the demand for novel self-expandable valves.

OBJECTIVE: To report procedural performance and medium-term follow-up data of the Med Zenith PT-Valve for tPVR in native or patched RVOT from a single-center feasibility trial.

METHODS: Fifteen patients with PR were recruited for candidacy assessment, with 12 tPVR procedures performed with per-protocol follow-up.

RESULTS: Amongst patients recruited, one with concomitant aortic pathology was diverted to surgery; there was one screen failure (7.1%) and one patient withdrew consent. Twelve patients underwent tPVR with the study valve with 100% success rate. Complications included one wire-related pulmonary hemorrhage, one transient brachial neuropraxia, one femoral pseudoaneurysm, and two patients with non-sustained ventricular tachycardia Day 1 post-tPVR. Both patients received a short course of a beta-blocker without recurrence of arrhythmia. There were no deaths or valve-related reinterventions with a median follow-up of 28.5 months (range 17.9-40.0 months). One episode of infective endocarditis was managed conservatively with antibiotics with no sequelae. There were otherwise no late complications. Significant improvement in biventricular volume and PR fraction was observed.

CONCLUSION: The Med Zenith PT-Valve has performed well over short to mid-term follow-up in patients with significant PR in native or patched RVOT. Future studies are required to elucidate the longevity of the valve.