What does this research mean for the field?

The intra-annular Navitor transcatheter heart valve demonstrates a similar safety profile and comparable mid-term mortality to the supra-annular Evolut valve in patients with severe aortic stenosis, but with a lower risk of moderate or severe paravalvular leak. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This research evaluates the safety and efficacy of two types of transcatheter heart valves: intra-annular Navitor and supra-annular Evolut PRO.

April 10, 2026Open Access

Early safety and efficacy of intra-annular versus supra-annular self-expanding transcatheter heart valves

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Severe aortic stenosis (n=541). Intervention: Intra-annular Navitor THV vs. Supra-annular Evolut THV. Primary outcome: Primary composite safety endpoint (all-cause mortality, myocardial infarction, disabling stroke, life-threatening bleeding, major vascular complication, or acute kidney injury requiring dialysis until discharge) (OR 0.97, 95% CI 0.50-1.89, p=0.224).

Key Result

The intra-annular Navitor THV demonstrated a similar rate of the primary composite safety endpoint compared to the supra-annular Evolut THV (adjusted OR 0.97) in patients with severe aortic stenosis.

Key Points

This research evaluates the safety and efficacy of two types of transcatheter heart valves: intra-annular Navitor and supra-annular Evolut PRO.
Compared adverse event rates in patients receiving Navitor and Evolut PRO valves.
Monitored moderate and severe paravalvular leak (PVL) incidences.
Assessed mid-term mortality in both groups.
Severe adverse events occurred at similar rates for both valve types until discharge.
Navitor showed a lower risk of moderate or severe PVL compared to Evolut PRO.
Mid-term mortality rates were comparable between both groups.

Study Design

Type

Observational (n=541)

Multicenter

Yes

Structured PICO

Does the intra-annular Navitor valve improve safety and efficacy compared to the supra-annular Evolut PRO valve in patients undergoing transcatheter heart valve implantation?

Population

Patients undergoing transcatheter heart valve implantation

Intervention

Intra-annular self-expanding transcatheter heart valve (Navitor)

Comparator

Supra-annular self-expanding transcatheter heart valve (Evolut PRO)

Outcome

Severe adverse events until discharge, moderate or severe paravalvular leak (PVL), and mid-term mortalitysafety

The intra-annular Navitor valve demonstrated a lower risk of moderate or severe paravalvular leak compared to the supra-annular Evolut PRO, with comparable early safety and mid-term mortality.

Main Result

Effect estimate: OR 0.97 (95% CI 0.50-1.89)

Absolute Event Rate: 10.8% vs 7.7%

p-value: p=0.224

Limitations

Retrospective design
Data were not blinded
Patients were not randomized
Prospective long-term data were not available for all patients

Abstract

The implantation of the intra-annular Navitor and the supra-annular Evolut PRO was safe, with severe adverse events occurring at similar rates until discharge. The risk of moderate or severe PVL was lower with Navitor; mid-term mortality was comparable in both groups.

Bookmark

View Full Paper

Bookmark

View Full Paper

Cite This Study

Mattig et al. (Wed,) conducted a observational in Severe aortic stenosis (n=541). Intra-annular Navitor THV vs. Supra-annular Evolut THV was evaluated on Primary composite safety endpoint (all-cause mortality, myocardial infarction, disabling stroke, life-threatening bleeding, major vascular complication, or acute kidney injury requiring dialysis until discharge) (OR 0.97, 95% CI 0.50-1.89, p=0.224). The intra-annular Navitor THV demonstrated a similar rate of the primary composite safety endpoint compared to the supra-annular Evolut THV (adjusted OR 0.97) in patients with severe aortic stenosis.

synapsesocial.com/papers/69d895be6c1944d70ce06e1a https://doi.org/https://doi.org/10.1007/s00392-026-02910-w

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: