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. 2021 Apr 1;97(5):895-902.
doi: 10.1002/ccd.29317. Epub 2020 Oct 6.

Effect of a fourth-generation transcatheter valve enhanced skirt on paravalvular leak

Garrett A Welle  1 , Bassim El-Sabawi  1 , Jeremy J Thaden  2 , Kevin L Greason  2 , Kyle W Klarich  2 , Vuyisile T Nkomo  2 , Mohamad A Alkhouli  2 , Mayra E Guerrero  2 , Juan A Crestanello  2 , David R Holmes Jr  2 , Charanjit S Rihal  2 , Mackram F Eleid  2
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Effect of a fourth-generation transcatheter valve enhanced skirt on paravalvular leak

Garrett A Welle et al. Catheter Cardiovasc Interv. .

Abstract

Objectives: The aim of this study was to assess the 30 day incidence of paravalvular leak (PVL) and need for aortic valve reintervention of a fourth generation balloon expandable transcatheter valve with enhanced skirt (4G-BEV) (SAPIEN 3 Ultra) compared with a third generation balloon expandable transcatheter valve (3G-BEV) (SAPIEN 3).

Background: The incidence of PVL has steadily declined with iterative improvements in transcatheter aortic valve replacement (TAVR) technology and implantation strategies.

Methods: Patients who underwent TAVR at Mayo Clinic from 7/2018 to 7/2019 were included in a prospective institutional registry. 4G-BEV has been utilized since 2/2019, and, after this date, 3G-BEV and 4G-BEV were simultaneously used. 4G-BEV had three sizes (20, 23, and 26 mm) while 3G-BEV included four sizes (20, 23, 26, and 29 mm). Both cohorts were evaluated at 30 days post-TAVR with a transthoracic echocardiogram to assess for PVL.

Results: A total of 260 consecutive patients were included. Of these, 101 patients received a 4G-BEV and 159 patients received a 3G-BEV. There were more females (p = .0005) and a lower aortic valve calcium score (p = .02) in the 4G-BEV cohort at baseline. Age, STS risk score, NYHA Class, and aortic valve mean gradient did not differ between groups. 4G-BEV was associated with a lower incidence of mild PVL (10.8 vs. 36.5%; p < .0001) and moderate PVL (0 vs. 5.8%) compared to the 3G-BEV at 30 days. There was no association between PVL and valve size in either cohort.

Conclusions: Utilization of 4G-BEV is associated with reduced PVL at 30 days post-TAVR compared with 3G-BEV.

Keywords: aortic valve disease; interventional devices/innovation; transcatheter valve implantation.

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References

REFERENCES

    1. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 2017;135:1159-1195.
    1. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198.
    1. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609-1620.
    1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705.
    1. LLC EL. Edwards SAPIEN 3 transcatheter heart valve system and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System. 2019; P140031/S085:3.

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