Korean Circ J.  2020 Oct;50(10):907-922. 10.4070/kcj.2020.0061.

Comparing the Procedural and Clinical Outcomes of Sapien XT and Sapien 3 Valves in Transcatheter Aortic Valve Replacement in Korean Patients

• Kook H
• Jang DH
• Yang KS
• Joo HJ
• Park JH
• Hong SJ
• Lim DS
• Choi SH
• Choi YJ
• Chang K
• Yu CW

• KMID: 2507008
• DOI: http://doi.org/10.4070/kcj.2020.0061

Abstract

Background and Objectives
The Sapien 3 (S3) valve has not been compared to the Sapien XT (SXT) valve in Korea. We compared procedural and clinical outcomes between the 2 devices.
Methods
A total of 189 patients who underwent transcatheter aortic valve replacement (TAVR) with S3 (n=95) or SXT (n=94) valve was analyzed. The primary endpoint was cardiovascular mortality at 1 year. The median follow-up duration was 438 days.
Results
The Society of Thoracic Surgeons score was similar between the 2 groups. The device success rate (90.4% vs. 97.9%; p=0.028) was higher in the S3 than in the SXT. The S3 showed significantly fewer cases of moderate or severe paravalvular leakage (PVL) (16.7% vs. 0.0%; p=0.001) than the SXT. However, effective orifice area (EOA) (2.07±0.61 vs. 1.70±0.49 cm² ; p<0.001) was smaller in the S3. Multivariable Cox regression analysis showed the S3 was associated with significantly fewer cardiovascular mortality at 1 year compared to the SXT (5.4% vs. 1.1%; hazard ratio, 0.031; 95% confidence interval, 0.001–0.951; p=0.047). Periprocedural complication rates, composite of disabling stroke or all-cause mortality, allcause mortality, and disabling stroke at 1 year were similar between the 2 groups.
Conclusions
Cardiovascular mortality was lower in the S3 group than in the SXT group over 1 year of follow-up. The reduction in PVL was attributed to the higher device success rate of TAVR with the S3 valve. However, the benefit of S3 obtained at the expense of reduced EOA should be meticulously re-evaluated in larger studies during long-term follow-up.

Keyword

Transcatheter aortic valve replacement; Aortic valve stenosis

Figure

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  Figure 1 Flow chart of TAVR patient stratification according to balloon-expandable TAVR generation from a multicenter registry.TAVR = transcatheter aortic valve replacement; VARC = Valve Academic Research Consortium.

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  Figure 2 Kaplan-Meier analysis of the cumulative incidence of clinical outcomes according to balloon-expandable TAVR valve generation. (A) The time-to-event Kaplan-Meier curves for the cumulative incidence of cardiovascular mortality. (B) The cumulative incidence of a composite of disabling stroke or all-cause mortality. (C) The cumulative incidence of all-cause mortality. (D) The cumulative incidence of disabling stroke.TAVR = transcatheter aortic valve replacement.

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  Figure 3 Echocardiographic findings regarding the EOA and mean PG in the SXT group and the S3 group.EOA = effective orifice area; NS = not significant; SXT = Sapien XT; S3 = Sapien 3; PG = pressure gradient.

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