Key result
Implantation of Edwards SAPIEN XT and S3 valves in patients with dilated native RVOT achieved a 98% procedural success rate with no deaths over a median 14-month follow-up.
Why the study?
Few PPVI options exist for patients with a dilated native RVOT, among which is the off-label use of Edwards SAPIEN valves.
Cohort (n=86)
Off-label use of Edwards SAPIEN XT and S3 valves for percutaneous pulmonary valve implantation in patients with dilated native RVOT is feasible, safe, and associated with excellent short-to-medium term valve function.
Supports feasibility of off-label SAPIEN PPVI in native RVOT; leaves open durability and need for RCTs.
OBJECTIVE: Percutaneous pulmonary valve implantation (PPVI) into right ventricle-to-pulmonary artery conduits is increasingly being performed, but a few options are available for patients with a dilated native right ventricular outflow tract (RVOT), among which is the off-label use of Ed-wards SAPIEN® valves. This study reviews the results of the SAPIEN XT and SAPIEN 3 (S3) valve implantations in the pulmonary position in patients with a dilated native RVOT. METHODS: Between January 2015 and March 2020, PPVI procedures were performed on 129 patients. Among them, 103 (80%) had dilated native RVOT, 86 of whom were eligible for PPVI prestenting and valve implantation. Retrospective analysis was performed on 84 patients who have undergone successful PPVI implantation using the SAPIEN XT or S3 valves with dilated native RVOT. RESULTS: The procedural success rate was 84/86 (98%). The median age was 18.7 years (8-46 years), and the median weight was 57 kg (22-102 kg). The primary underlying diagnosis was tetralogy of Fallot (n=77/84). Stenting was performed simultaneously with valve implantation in 50/84 (60%) cases-six of which were hybrid procedures-whereas prestenting was performed 3 to 14 weeks earlier in 34/84 cases. Before valve im-plantation, the median right anterior oblique and lateral diameters of the stents were 26 mm (20-32 mm) and 28 mm (21-32 mm). Valve sizes were 26 mm (n=13) and 29 mm (n=64) for XT and 29 mm (n=7) for S3. In 59 patients, an additional 1-5 ml (median 2 ml) volume was added to the valves' balloons for stabilization. In all hybrid procedures, the stent and valve were implanted in the same session. During follow-ups of 1 to 59 months (median 14 months), no deaths were reported, 3 patients developed tricuspid regurgitation secondary to the procedure, and valves continued to function in all patients. CONCLUSION: The Edwards SAPIEN XT and S3 valves may be an alternative to PPVI in patients with dilated native RVOT.
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Alper Güzeltaş (2020) conducted a cohort in Dilated native right ventricular outflow tract (n=86). Edwards SAPIEN XT and SAPIEN 3 valves was evaluated on Procedural success rate. Implantation of Edwards SAPIEN XT and S3 valves in patients with dilated native RVOT achieved a 98% procedural success rate with no deaths over a median 14-month follow-up.
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