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


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, all-cause 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.

SUBMITTER: Kook H 

PROVIDER: S-EPMC7515760 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Kook Hyungdon H   Jang Duck Hyun DH   Yang Kyung Sook KS   Joo Hyung Joon HJ   Park Jae Hyoung JH   Hong Soon Jun SJ   Hong Soon Jun SJ   Lim Do Sun DS   Choi Seung Hyuk SH   Choi Young Jin YJ   Chang Kiyuk K   Yu Cheol Woong CW  

Korean circulation journal 20200728 10


<h4>Background and objectives</h4>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.<h4>Methods</h4>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.<h4>Results</h4>The Society of Thoracic Surgeons score was si  ...[more]

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