What does this research mean for the field?

Transseptal puncture using the novel Accusafe guidewire combined with a steerable sheath achieves a 100% first-pass success rate and significantly improves sheath-to-left atrial appendage coaxiality compared to conventional methods. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

September 3, 2026Frontiers in Cardiovascular MedicineOpen Access

Application of the combined technique of novel transseptal puncture guidewire and steerable sheath in left atrial appendage occlusion: a preliminary feasibility case series

Q: What is the clinical evidence from this study?

Study design: Case Series. Population: Non-valvular atrial fibrillation (n=20). Intervention: Accusafe transseptal puncture guidewire with Navigo steerable sheath vs. Conventional transseptal puncture. Primary outcome: First-pass puncture success rate (p=0.105).

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Key result

Accusafe guidewire with steerable sheath achieves 100% first-pass transseptal success and improves LAA coaxiality.

P=0.105
n=20

Why the study?

Conventional transseptal puncture needles cause unpredictable needle tip movement leading to suboptimal puncture sites and compromised sheath-LAA alignment during LAAO.

Does a novel transseptal puncture guidewire combined with a steerable sheath improve first-pass puncture success, reduce sheath displacement, and improve coaxiality compared to conventional transseptal puncture in patients undergoing left atrial appendage occlusion?

Study Design

Type

Case Series (n=20)

Multicenter

Structured PICO

Population

20 patients with non-valvular atrial fibrillation undergoing a one-stop procedure of AF ablation combined with left atrial appendage occlusion.

Intervention

Transseptal puncture using a novel transseptal puncture guidewire (Accusafe) combined with a steerable sheath (Navigo).

Comparator

Conventional transseptal puncture using standard puncture needles and a fixed-curve sheath (SL1, Swartz).

Outcome

First-pass puncture success rate, incidence of post-puncture site migration (sheath displacement), and coaxiality assessed by the angle between the delivery sheath and the central axis of the left atrial appendage on angiography.surrogate

Main Result

Absolute Event Rate: 100% vs 70%

p-value: p=0.105

A novel transseptal puncture guidewire combined with a steerable sheath is feasible and significantly improves procedural precision, coaxiality, and efficiency during left atrial appendage occlusion compared to conventional techniques.

Limitations

Limited sample size (n = 20)
Single-center design may introduce selection bias
Non-randomized allocation
Inability to distinguish independent contributions of the novel sheath versus the novel guidewire
Limited sample size (n=20)
Single-center design
Simultaneous adoption of novel steerable sheath and novel puncture guidewire prevents distinguishing independent contributions

Implication

May facilitate transseptal access; hypothesis-generating and requires prospective validation before practice change.

Abstract

Objective: Transseptal puncture (TSP) is a critical step in left atrial appendage occlusion (LAAO) but presents certain technical challenges. Conventional puncture needles, due to their inherent rigidity, often cause unpredictable needle tip "bouncing" or upward migration at the moment of septal puncture, resulting in a high or suboptimal puncture site, which subsequently compromises the coaxial alignment between the sheath and the left atrial appendage (LAA). This study aims to evaluate the safety and feasibility of the novel transseptal puncture guidewire Accusafe™ used in combination with a steerable sheath Navigo™. Methods: In this case series, 20 consecutive patients undergoing a one-stop procedure (LAAO combined with atrial fibrillation ablation) were enrolled. The first 10 patients underwent conventional transseptal puncture, while the latter 10 underwent transseptal puncture using Accusafe™. The primary endpoints included first-pass puncture success rate, incidence of post-puncture site migration, and coaxiality assessed by the angle between the delivery sheath and the central axis of the LAA on angiography. Results: Transseptal puncture was successfully performed in all patients. The application of Accusafe™ in combination with a steerable sheath significantly reduced sheath migration, achieving a first-pass puncture success rate of 100%. Furthermore, Accusafe™ significantly improved sheath-LAA coaxiality, effectively simplified the occluder delivery and deployment process, shortened procedure time, and ensured an ideal occlusion outcome. Conclusion: Transseptal puncture via the Accusafe™ guidewire with steerable sheath improves first-pass puncture success rate, enhances puncture site accuracy, and optimizes sheath-LAA central axis coaxiality, thereby improving procedural efficiency and occlusion efficacy. These findings support further validation of its clinical value in larger, randomized controlled studies.

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Published by Frontiers in Cardiovascular Medicine · CC BY

Cite This Study

Wang et al. (2026) conducted a case series in Non-valvular atrial fibrillation (n=20). Accusafe transseptal puncture guidewire with Navigo steerable sheath vs. Conventional transseptal puncture was evaluated on First-pass puncture success rate (p=0.105). The Accusafe transseptal puncture guidewire with a steerable sheath achieved a 100% first-pass success rate versus 70% with conventional methods, and significantly improved sheath-LAA coaxiality.

synapsesocial.com/papers/6ac19810d2b33a8deea23d29 https://doi.org/10.3389/fcvm.2026.1908230