Self-Expanding Supra-Annular Transcatheter Valve for Pure Native Aortic Insufficiency

Q: What is the clinical evidence from this study?

Study design: Case Report. Population: Severe pure native aortic insufficiency (n=2). Intervention: Navitor self-expanding transcatheter aortic valve replacement (TAVR). Primary outcome: Acute procedural success, hemodynamic valve function, and clinical improvement.

Q: What does this research mean for the field?

Off-label transcatheter aortic valve replacement using the self-expanding Navitor valve is feasible and achieves acute hemodynamic success without significant paravalvular leak in selected high-risk patients with pure native aortic insufficiency. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Travis M. Howard; Nguyen T. Nguyen; Laura Muller; Luis H. Paz Rios; Mazen Saadi Albaghdadi; Brian J. Solomon; Thomas G. Caranasos; Dee Dee Wang; Robert J. Cubeddu

doi:10.1016/j.jaccas.2026.110036

September 1, 2026JACC Case ReportsOpen Access

Self-Expanding Supra-Annular Transcatheter Valve for Pure Native Aortic Insufficiency

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Key result

Off-label Navitor TAVR achieves 100% acute success with minimal gradients in high-risk native AI.

n=2

Figures

Graphical abstract published by JACC Case Reports — Graphical abstract · Published by JACC Case Reports · CC BY-NC-ND

Why the study?

The feasibility and safety of the Navitor self-expanding transcatheter aortic valve for off-label treatment of pure native aortic insufficiency in high surgical risk patients was not established.

Is off-label transcatheter aortic valve replacement using the self-expanding Navitor valve feasible and safe in high surgical risk patients with severe pure native aortic insufficiency?

Study Design

Type

Case Report (n=2)

Multicenter

No

Structured PICO

Is off-label transcatheter aortic valve replacement using the self-expanding Navitor valve feasible and safe in high surgical risk patients with severe pure native aortic insufficiency?

P

Population

2 elderly female patients (aged 87 and 89 years) with NYHA class III severe pure native aortic insufficiency at prohibitive surgical risk, followed for 1 month.

I

Intervention

Off-label transcatheter aortic valve replacement (TAVR) using the self-expanding intra-annular Navitor Vision valve (29 mm and 35 mm via FlexNav delivery system) with 10% to 30% oversizing relative to CT-derived annular area, deployed via transfemoral retrograde approach under general anesthesia and controlled ventricular pacing at 120 beats/min.

O

Outcome

Procedural feasibility, safety, and acute hemodynamic results (valve position and stability, paravalvular leak, final mean transvalvular gradient, and NYHA functional class improvement)

Off-label TAVR with the self-expanding Navitor valve is a feasible bridge therapy for carefully selected, prohibitive-surgical-risk patients with severe pure native aortic insufficiency, leveraging its wide outflow flare for ascending aortic anchoring.

Limitations

Strategy has not been widely tested
Unreliable anchoring due to absence of leaflet or LVOT calcification
Need for aggressive oversizing which increases risks of conduction disturbances and annular trauma
Flared outflow section cannot provide mechanical stabilization until completely expanded, leaving the valve vulnerable to ventricular embolization during final release
This strategy has not been widely tested
Device anchoring may be compromised by a lack of calcification, increasing the risk of migration, embolization, and malposition
Oversizing increases the risk of conduction disturbances and annular injuries
The flared outflow section of the self-expanding frame cannot provide mechanical stabilization until it is completely expanded, leaving the valve vulnerable to instantaneous ventricular embolization during the final release phase

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Implication

May offer temporizing bridge in select prohibitive-risk native AI; leaves open dedicated device trials before practice change.

Abstract

OBJECTIVE: The objective was to underscore the feasibility and safety of the Navitor self-expanding transcatheter aortic valve for off-label treatment of pure native aortic insufficiency (AI) in high surgical risk patients and provide a step-by-step procedural guide. KEY STEPS: Steps included: 1) analysis of computed tomography scans for ideal patient selection; 2) deployment of the Navitor transcatheter aortic valve; and 3) assessment of valve function using aortography and echocardiography. POTENTIAL PITFALLS: Device anchoring may be compromised by a lack of calcification, increasing the risk of migration, embolization, and malposition. Oversizing is crucial, but it also increases the risk of conduction disturbances and annular injuries. TAKE-HOME MESSAGES: The Navitor transcatheter aortic valve offers an innovative approach for high-surgical-risk pure native AI. While the procedural success depends on patient selection, careful sizing, and mitigation of anatomic and technical limitations, the Navitor transcatheter aortic valve can be a reasonable bridge therapy until dedicated transcatheter valves for severe AI are commercially approved and widely available.

Discussion

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Cite This Study

Howard et al. (2026) conducted a case report in Severe pure native aortic insufficiency (n=2). Navitor self-expanding transcatheter aortic valve replacement (TAVR) was evaluated on Acute procedural success, hemodynamic valve function, and clinical improvement. Off-label Navitor TAVR achieved 100% acute success with no paravalvular leak, low mean gradients, and functional class I-II improvement in 2 high-risk native AI patients.

synapsesocial.com/papers/6ac19d70aeea5716e8c6c694 https://doi.org/10.1016/j.jaccas.2026.110036

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Self-Expanding Supra-Annular Transcatheter Valve for Pure Native Aortic Insufficiency

Figures

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Self-Expanding Supra-Annular Transcatheter Valve for Pure Native Aortic Insufficiency

Figures

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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