Transcatheter Pulmonary Valve Implantation Using Self-Expandable Percutaneous Pulmonary Valve System: 3-Year CE Study...

Pulmonary regurgitation is common during follow-up of patients after surgical repair of tetralogy of Fallot and other right ventricular outflow tracts (RVOTs). Many percutaneous pulmonary valves have been used but are limited to smaller RVOTs.

Since August 2016, a multicenter CE (Conformité Européenne) study was initiated to evaluate a self-expandable VenusP-valve. We aimed to report the acute and 3-year follow-up results.

A total of 81 patients with pulmonary regurgitation were recruited for VenusP-valve implantation and assessed for a 3-year period.

In all patients, VenusP-valves were successfully implanted. The mean age was 26.5 ± 13.3 years and the mean weight 59.5 ± 15.6 kg. There was no early procedure-related or late mortality. One patient experienced guidewire perforation of a branch pulmonary artery, causing hemoptysis, and 1 had ventricular tachycardia, at the end of the procedure. During follow-up, 1 patient developed runs of ventricular tachycardia and needed an implantable cardioverter-defibrillator and ablation of the RVOT 5 months after valve implantation. One developed endocarditis 11 months after implantation. After medical treatment, the valve has continued to function normally. One patient developed thrombus on the distal flare 3 years after implantation and was treated with anticoagulants. During 3-year follow-up, valve function has remained satisfactory and right ventricular remodeling has occurred in all patients.

We report the 3-year CE study results of percutaneous pulmonary valve implantation in patients with severe pulmonary regurgitation. The valve has shown promising safety and durability. Long-term evaluation is warranted.