Abstract
BACKGROUND: The Alterra Adaptive Pre-Stent, used with the Edwards SAPIEN 3 valve, offers a novel transcatheter option for patients with severely dilated right ventricular outflow tracts (RVOTs) previously unsuitable for conventional transcatheter pulmonary valve replacement (TPVR). No prior experience with this system has been reported from the Middle East. METHODS: We report the first Middle Eastern experience with the Alterra Adaptive Pre-Stent from a high-volume congenital heart center. A retrospective, single-center analysis was performed at Prince Sultan Cardiac Center (Riyadh, Saudi Arabia). Between April and July 2025, a total of 10 patients with native (after balloon valvuloplasty) or surgically patched RVOTs underwent TPVR using the Alterra Pre-Stent and Edwards SAPIEN 3 valve. Patient selection, procedural data, and early clinical outcomes were reviewed. RESULTS: All 10 patients (mean age: 30 ± 7.1 years; range: 15-40 years) underwent successful implantation. The mean weight was 66.4 ± 22.7 kg (range: 35-103 kg), and 30% (n = 3) were male. Procedural success was 100%, with accurate device positioning and no significant residual gradient or pulmonary regurgitation. No major complications-including valve embolization, coronary compression, or surgical conversion-occurred. At a median follow-up of 31 days (range: 10-43 days), all patients remained clinically stable with improved functional status. CONCLUSIONS: This is the first reported experience of the Alterra Adaptive Pre-Stent in the Middle East. Early results demonstrate that the device is safe, technically feasible, and effective in selected patients with complex RVOT anatomies, potentially broadening TPVR applicability in the region.