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. 2023 Jun 12;12(12):3999.
doi: 10.3390/jcm12123999.

Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis

Clemens Enno Eckel  1   2 , Won-Keun Kim  3   4 , Christina Grothusen  1   5 , Vedat Tiyerili  1 , Albrecht Elsässer  2 , Dagmar Sötemann  1 , Judith Schlüter  1   2 , Yeong-Hoon Choi  3 , Efstratios I Charitos  3 , Matthias Renker  4   6 , Christian W Hamm  6   7 , Guido Dohmen  8 , Helge Möllmann  1 , Johannes Blumenstein  1   2
Affiliations

Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis

Clemens Enno Eckel et al. J Clin Med. .

Abstract

Background: Third-generation transcatheter heart valves (THVs) are designed to improve outcomes. Data on the new intra-annular self-expanding NAVITOR are scarce.

Aims: The aim of this analysis was to compare outcomes between the PORTICO and the NAVITOR systems.

Methods: Data from 782 patients with severe native aortic stenosis treated with PORTICO (n = 645) or NAVITOR (n = 137) from 05/2012 to 09/2022 were evaluated. The clinical and hemodynamic outcomes of 276 patients (PORTICO, n = 139; NAVITOR, n = 137) were evaluated according to VARC-3 recommendations.

Results: Rates of postprocedural more-than-mild paravalvular leakage (PVL) were significantly lower for NAVITOR than for PORTICO (7.2% vs. 1.5%, p = 0.041). In addition, severe bleeding rates (27.3% vs. 13.1%, p = 0.005) and major vascular complications (5.8% vs. 0.7%, p = 0.036) were lower in the NAVITOR group. The mean gradients (7 vs. 8 mmHg, p = 0.121) and calculated aortic valve areas (1.90 cm2 vs. 1.99 cm2, p = 0.235) were comparable. Rates of PPI were similarly high in both groups (15.3 vs. 21.6, p = 0.299).

Conclusions: The NAVITOR demonstrated favorable in-hospital procedural outcome data, with lower rates of relevant PVL, major vascular complications, and severe bleeding than its predecessor the PORTICO and preserved favorable hemodynamic outcomes.

Keywords: TAVI; TAVR; aortic stenosis; paravalvular leak; self-expanding prosthesis.

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Conflict of interest statement

H.M.: Proctor fees and or speaker honoraria from Boston Scientific. W.K.-K.: Proctor fees and or speaker honoraria from Boston. J.B.: Proctor fees and or speaker honoraria from Boston Scientific.

Figures

Figure 1
Figure 1
Study flowchart and procedural outcomes. Abbreviations: DS = delivery system; PVL = paravalvular leakage; compl. = complications. Bold outcomes for NAVITOR denote significant difference from values for PORTICO. 1 Excludes patients with permanent pacemaker at baseline.
Figure 2
Figure 2
Landing zone and implantation depth. Abbreviations: LCC = left coronary cusp; NCC = non-coronary cusp.
Figure 3
Figure 3
Kaplan–Meier curves for mortality up to 30 days 1. Annotation: 1 Lost to follow up at 30 days: n = 33 (12.0%); 8 patients deleted due to missing data.
See this image and copyright information in PMC

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