Valvular & structural heart disease
Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry
Authors' conclusion
The S3UR has equivalent procedural complications to the S3 but with lower rates of PVL and significantly better valve performance.
Study context
- Population
- Patients undergoing transcatheter aortic valve replacement (TAVR) in the OCEAN-TAVI registrymatched cohort n=618/group
- Participants
- 618 vs 8,750
- Exposure
- SAPIEN 3 Ultra RESILIA vs SAPIEN 3 valve in TAVR
- S3URn = 618
- S3n = 8,750reference
- Outcome
- Clinical outcomes, incl. valve performance (haemodynamics, patient-prosthesis mismatch (PPM))
Methodological detailsconsecutive patients, historical comparison cohort, propensity-matched cohort
- Consecutive patients
- Historical comparison cohort
- Propensity-matched cohort
Main finding
As reported in the abstract
- In-hospital death, vascular complications and new pacemaker implantation similar between S3UR and S3
- allp>0.05
Observational data: associations, not effects.
Further findings
Paravalvular leakage (PVL)
P < 0.001
None-trivial
Mild
≥moderate
Patient-prosthesis mismatch (PPM)
P < 0.001
None
Moderate
Severe
Mean pressure gradient ≥20 mmHg
P < 0.001
Haemodynamics by S3UR valve size
- Better haemodynamics with smaller 20 mm and 23 mm S3UR valves
Matched cohort
- Results consistent in matched cohort (n=618 patients/group)
Original publication
Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry. EuroIntervention. Published 10 May 2024. doi:10.
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