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

Garrett A. Welle, Bassim El-Sabawi, Jeremy J. Thaden, Kevin L. Greason, Kyle W. Klarich, Vuyisile T Nkomo, Mohamad A. Alkhouli, Mayra E. Guerrero, Juan A. Crestanello, David R. Holmes, Charanjit S. Rihal, Mackram Eleid

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
JournalCatheterization and Cardiovascular Interventions
StateAccepted/In press - 2020


  • aortic valve disease
  • interventional devices/innovation
  • transcatheter valve implantation

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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