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. 2021 Jun 1;97(7):E982-E991.
doi: 10.1002/ccd.29281. Epub 2020 Sep 23.

Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry

Noriaki Moriyama  1   2 , Heidi Lehtola  3 , Hirokazu Miyashita  1 , Jarkko Piuhola  3 , Matti Niemelä  3 , Mika Laine  1
Affiliations

Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry

Noriaki Moriyama et al. Catheter Cardiovasc Interv. .

Abstract

Objectives: The study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR).

Background: The new balloon-expandable S3-Ultra system incorporates new features to reduce paravalvular leakage (PVL). However, the data after the S3-Ultra implantation is very limited.

Methods: A total of 282 consecutive patients who underwent TF-TAVR with the S3-Ultra and the S3 were evaluated. The primary outcome of this study was to compare the incidence of ≥mild PVL after the S3-Ultra and S3 implantation.

Results: Between June 2017 and November 2019, 141 patients with the S3-Ultra and 141 patients with the S3 were identified with similar baseline and preprocedural imaging characteristics (mean age: 79.6 ± 6.7 years and mean aortic annulus area: 492.5 ± 91.2 mm2 ). In total, 83 patients (29.4%) were treated with 29-mm valve. Predischarge echocardiography demonstrated a significantly lower incidence of ≥mild PVL (the total cohort: 7.2 vs. 22.3%, p < .001, and the cohort excluding 29-mm valve: 4.0 vs. 21.4%, p = .03) for the S3-Ultra. The S3-Ultra system, especially 20-, 23-, and 26-mm valve, was associated with significantly lower risk of ≥mild PVL compared with the S3 system in multivariate analysis. There were no significant differences in clinical outcomes at 30-day between these groups, except for the lower incidence of major vascular complication (4.5 vs. 11.4%, p = .05) in patients with the S3-Ultra.

Conclusions: In this registry, the S3-Ultra system performed superiorly to the S3, as demonstrated by reduced ≥mild PVL, with comparable safety.

Keywords: paravalvular leakage (PVL); transcatheter aortic valve replacement (TAVR); transcatheter heart valve (THV); transfemoral (TF).

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Conflict of interest statement

N.M. reports receiving consultant fee from Teleflex and is a clinical proctor of Boston Scientific (LOTUS Edge and ACURATE neo) and Edwards Lifesciences (SAPIEN 3 series). M.L. reports receiving non‐regulatory research grants from Teleflex and consultant fee from Boston Scientific, Edwards Lifesciences and Medtronic, and is a clinical proctor of Boston Scientific (LOTUS Edge and ACURATE neo) and Edwards Lifesciences (SAPIEN 3 series). H.L., H.M., J.P., and M.N. report no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Study flow. The hemodynamic and clinical outcomes were compared between patients who underwent TF‐TAVR with the SAPIEN 3 Ultra or SAPIEN 3. TF‐TAVR, transfemoral transcatheter aortic valve; THV, transcatheter heart valve
FIGURE 2
FIGURE 2
The SAPIEN 3 Ultra system. The SAPIEN 3 Ultra system (Edwards Lifesciences, Irvine, California) consists the SAPIEN 3 Ultra THVs 20‐, 23‐, and 26‐mm including an improved outer sealing skirt and the SAPIEN 3 29‐mm THV. Abbreviation as in Figure 1
FIGURE 3
FIGURE 3
Paravalvular leakage evaluated by transthoracic echocardiography at discharge. (a) THV with 20‐, 23‐, 26‐, and 29‐mm; (b) THV with 20‐, 23‐, and 26‐mm; and (c) THV with 29‐mm. PVL, paravalvular leakage
FIGURE 4
FIGURE 4
Comparative risk for ≥mild paravalvular leakage with the SAPIEN 3 Ultra and SAPIEN 3. The SAPIEN 3 Ultra system is associated with significantly lower risk of ≥mild PVL in comparison to the SAPIEN 3 system, which is derived from the performance of the SAPIEN 3 Ultra 20‐, 23‐, and 26‐mm THV. PVL, paravalvular leakage. Other abbreviations as in Figure 1
See this image and copyright information in PMC

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