Key result
Sapien XT PPVI yields ~86% five-year freedom from reintervention in native RVOT after ToF repair.
Why the study?
Data regarding the mid- and long-term results of balloon-expandable percutaneous valves in the native RVOT were limited.
Does percutaneous pulmonary valve implantation (PPVI) prevent the need for surgical or percutaneous reintervention in patients with native RVOT after Tetralogy of Fallot repair?
Cohort (n=42)
No
Does percutaneous pulmonary valve implantation (PPVI) prevent the need for surgical or percutaneous reintervention in patients with native RVOT after Tetralogy of Fallot repair?
PPVI in native RVOT after Tetralogy of Fallot repair shows excellent early freedom from reintervention, but this declines to 70.2% by 7 years, with emergent long-term tricuspid valve issues.
Should not yet change practice for native RVOT PPVI; leaves open durability and tricuspid questions for prospective trials.
Although the long-term outcomes of the surgical grafts are well defined and reported, the data regarding the mid-and long-term results of the balloon-expandable percutaneous valves in the native right ventricular outflow tract (RVOT) is limited. We retrospectively evaluated 42 patients who underwent PPVI (Sapien® XT valve) to native RVOT due to severe pulmonary regurgitation (PR) and/or moderate to severe pulmonary stenosis (PS) between August 2015 and November 2020. The median patient age at the time of PPVI was 13.4 years (6.1-36.5 years). The median body weight of the patients was 42 kg (15-110 kg). The rate of patients who were followed up without the need for percutaneous or surgical intervention was 97.4% at the end of year 1, 89.3% at the end of year 3, and 85.8% at the end of year 5. At the end of year 6, the proportion of patients requiring no procedure remained constant, with year 5 at 85.8%, but decreased to 70.2% at the end of year 7. Although the early results are very encouraging, it is seen that PPVI in patients with RVOT in the long term brings some problems. The most important of these is tricuspid valve problems, which were not considered before the procedure. Patients requiring reintervention due to pulmonary regurgitation show similar characteristics to surgical valves' long-term results.
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Ödemiş et al. (2025) conducted a cohort in Severe pulmonary regurgitation and/or moderate to severe pulmonary stenosis in native right ventricular outflow tract after Tetralogy of Fallot repair (n=42). Percutaneous pulmonary valve implantation (Sapien XT valve) was evaluated on Freedom from percutaneous or surgical reintervention at 5 years. Percutaneous pulmonary valve implantation with the Sapien XT valve in native right ventricular outflow tracts after Tetralogy of Fallot repair achieved an 85.8% rate of freedom from reintervention at 5 years.
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