Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry.
EuroIntervention
; 20(9): 579-590, 2024 May 10.
Article
em En
| MEDLINE
| ID: mdl-38726714
ABSTRACT
BACKGROUND:
Data on the performance of the latest-generation SAPIEN 3 Ultra RESILIA (S3UR) valve in patients who undergo transcatheter aortic valve replacement (TAVR) are scarce.AIMS:
We aimed to assess the clinical outcomes, including valve performance, of the S3UR.METHODS:
Registry data of 618 consecutive patients with S3UR and of a historical pooled cohort of 8,750 patients who had a SAPIEN 3 (S3) valve and underwent TAVR were collected. The clinical outcomes and haemodynamics, including patient-prosthesis mismatch (PPM), were compared between the 2 groups and in a propensity-matched cohort.RESULTS:
The incidence of in-hospital death, vascular complications, and new pacemaker implantation was similar between the S3UR and the S3 groups (allp>0.05). However, both groups showed significant differences in the degrees of paravalvular leakage (PVL) (none-trivial 87.0% vs 78.5%, mild 12.5% vs 20.5%, ≥moderate 0.5% vs 1.1%; p<0.001) and the incidence of PPM (none 94.3% vs 85.1%, moderate 5.2% vs 12.8%, severe 0.5% vs 2.0%; p<0.001). The prevalence of a mean pressure gradient ≥20 mmHg was significantly lower in the S3UR group (1.6% vs 6.2%; p<0.001). Better haemodynamics were observed with the smaller 20 mm and 23 mm S3UR valves. The results were consistent in a matched cohort of patients with S3UR and with S3 (n=618 patients/group).CONCLUSIONS:
The S3UR has equivalent procedural complications to the S3 but with lower rates of PVL and significantly better valve performance. The better valve performance of the S3UR, particularly in smaller valve sizes, overcomes the remaining issue of balloon-expandable valves after TAVR.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Valva Aórtica
/
Estenose da Valva Aórtica
/
Próteses Valvulares Cardíacas
/
Sistema de Registros
/
Substituição da Valva Aórtica Transcateter
Limite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
EuroIntervention
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
/
TERAPEUTICA
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Japão