Key result
Transcatheter aortic valve replacement with SAPIEN 3 Ultra was associated with a similar 1-year risk of death compared to SAPIEN 3 (5.8% vs. 5.5%; HR 1.07, 95% CI 0.81-1.90).
Why the study?
Literature comparing SAPIEN 3 Ultra with SAPIEN 3 was limited to short-term follow-up.
Does transcatheter aortic valve replacement with SAPIEN 3 Ultra improve 1-year clinical and echocardiographic outcomes compared to SAPIEN 3 in patients undergoing TAVR?
Cohort (n=1,155)
No
Does transcatheter aortic valve replacement with SAPIEN 3 Ultra improve 1-year clinical and echocardiographic outcomes compared to SAPIEN 3 in patients undergoing TAVR?
Hazard Ratio: 1.07 (95% CI 0.81–1.9)
Absolute Event Rate: 5.8% vs 5.5%
The SAPIEN 3 Ultra valve provides similar 1-year clinical outcomes to the SAPIEN 3 valve, with reduced mild paravalvular leak but a greater increase in transprosthetic gradient over time.
S3U shows similar 1-year clinical safety to S3 with less mild PVL but greater gradient rise; leaves open long-term hemodynamic implications for TAVR valve choice.
BACKGROUND: The newest-generation balloon-expandable valve, SAPIEN 3 Ultra (S3U), is expected to function well with the enhanced sealing skirt compared with SAPIEN 3 (S3). However, current literature on the comparison between these two valves is limited to short-term follow-ups. Therefore, we aimed to evaluate the 1-year outcomes and echocardiographic changes of S3U compared with S3. METHODS: We retrospectively identified patients who underwent transfemoral-transcatheter aortic valve replacement with S3U or S3 (20/23/26 mm) at our institution in 2018-2020. Outcomes were 1-year clinical events and echocardiographic parameters, and were compared between S3U and S3 after adjustment with inverse probability of treatment weighting. RESULTS: The S3U and S3 groups included 297 (25.7%) and 858 (74.3%) patients, respectively. There were no significant differences between the two groups in clinical events (death 5.8% vs. 5.5%, hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.81-1.90; death or heart failure hospitalization 10.3% vs. 10.1%, HR 1.04, 95% CI 0.67-1.62). The S3U group had a lower prevalence of mild paravalvular leakage (PVL) (13.7% vs. 22.3%, p = 0.044), with similar moderate PVL (0.7% vs. 1.2%, p > 0.99). No significant differences were observed in aortic valve mean gradient and Doppler velocity index at 1 year. However, the S3U group had a larger increase in mean gradient from implantation to 1 year (median +4.70 vs. +1.63 mmHg, p < 0.001). CONCLUSIONS: S3U and S3 carried similarly favorable clinical event risks. Nonetheless, S3U was associated with less frequent mild PVL but a larger increase in transprosthetic gradient. Further studies are needed to determine the prognostic impact of these hemodynamic differences.
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Isogai et al. (2022) conducted a cohort in Aortic valve replacement (n=1,155). SAPIEN 3 Ultra vs. SAPIEN 3 was evaluated on death (HR 1.07, 95% CI 0.81-1.90). Transcatheter aortic valve replacement with SAPIEN 3 Ultra was associated with a similar 1-year risk of death compared to SAPIEN 3 (5.8% vs. 5.5%; HR 1.07, 95% CI 0.81-1.90).
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