Valvular & structural heart diseaseResearch article
Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation
- Single-arm pivotal trial
- multicentre
- 1 staged procedure
Authors' conclusion
The Alterra prestent in combination with the SAPIEN 3 THV has excellent outcomes at 2 years, with no significant valve dysfunction in the main pivotal cohort.
Study context
- Population
- Patients with dilated native right ventricular outflow tract (RVOT) and moderate or greater pulmonary regurgitation97 screened
- Participants
- 60 patients
- Comparison
- Alterra Adaptive Prestent with 29 mm SAPIEN 3 Transcatheter Heart Valve (THV)
- Alterra prestent + SAPIEN 3 THVn = 60
- Outcome
- THV dysfunction: composite of RVOT/pulmonary valve reintervention, moderate or greater total PR, or mean RVOT/pulmonary valve gradient ≥35 mm Hg on transthoracic echocardiography
- Follow-up
- 6 months
Main finding
As reported in the abstract
THV dysfunction
- No patients had THV dysfunction at 6 months
Further findings
Mild or less PR · 2 years
- Patients with mild or less PR
- 92.5%
- No coronary compression, stent fractures warranting reintervention or endocarditis
Safety
Early (days 0-1) arrhythmias
- Patients with early arrhythmias
- 21 (34.4%)
- Nonsustained VT that resolved with medication
- 12
Reintervention, death, explantation · 2 years
- Reintervention secondary to iatrogenic RVOT obstruction
- 1
- Deaths or explantations
- 0
Original publication
Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation. JACC Cardiovasc Interv. Published 14 October 2024. doi:10.1016/j.jcin.2024.07.036
Summarised from the published abstract; every number is checked against it