Key result
Transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve achieved a 96.4% procedural success rate and reduced moderate-to-severe pulmonary regurgitation to 0%.
Why the study?
Following encouraging results with Edwards Sapien and XT valves, procedural data and early outcomes for Sapien 3 valves in transcatheter pulmonary valve replacement needed review.
Does transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve safely improve hemodynamics in patients requiring pulmonary valve replacement?
Observational (n=56)
Yes
Does transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve safely improve hemodynamics in patients requiring pulmonary valve replacement?
TPVR with the Edwards Sapien 3 valve demonstrates high procedural success and excellent early hemodynamic outcomes, potentially extending the eligible patient pool for transcatheter interventions.
High procedural success supports Sapien 3 TPVR feasibility; leaves open durability and randomized comparisons.
Background: After encouraging results with the Edwards Sapien and XT valves, this study aimed to review procedural data and early outcomes for the Sapien 3 valves for transcatheter pulmonary valve replacement (TPVR).Methods: We performed a multicenter, retrospective analysis of cases who underwent a Sapien 3 TPVR between 2015 and 2017 in 7 centers in Germany with a follow-up of up to 2 years.Results: 56 patients could be enrolled (weight 58,5 ± 25,0 kg; 53% Tetralogy of Fallot, 45% native RVOT). Most procedures were two-stage procedures (82,1%) with 100% prestenting. Valve sizes were 20 mm (n = 1), 23 mm (n = 15), 26 mm (n = 27), 29 mm (n = 13). Procedural success rate was 96.4%. Two patients underwent surgical valve implantation after balloon rupture during TPVR. Follow-up data were available up to 24-month post TPVR. The rate of patients with ? moderate and severe pulmonary regurgitation decreased to 0% after TPVR, peak systolic gradient decreased from 24,2 (SD±20,9) mmHg to 7,1 mmHg (SD±5,0). There were no endocarditis, severe tricuspid valve impairment or stent fractures.Conclusions: With the Edwards Sapien 3 valve, the patient pool for TPVR can be substantially extended. Continued data collection is necessary to verify long-term results.
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Lehner et al. (2019) conducted an observational in Transcatheter pulmonary valve replacement (n=56). Edwards Sapien 3 valve for transcatheter pulmonary valve replacement was evaluated on Procedural success rate. Transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve achieved a 96.4% procedural success rate and reduced moderate-to-severe pulmonary regurgitation to 0%.
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