Key result
The VersaCross RF transseptal wire system reduced time to final WATCHMAN device release compared to the standard RF needle-based workflow (24.6 vs 29.1 min, p=0.01).
Why the study?
This study aimed to investigate whether the VersaCross RF transseptal wire system improves procedural efficiency during left atrial appendage closure compared to the standard RF needle-based workflow.
Does a radiofrequency transseptal wire system improve time to device release in patients undergoing left atrial appendage closure compared to a standard radiofrequency needle?
Observational (n=81)
Does a radiofrequency transseptal wire system improve time to device release in patients undergoing left atrial appendage closure compared to a standard radiofrequency needle?
Using an RF transseptal wire system for LAAC significantly improves procedural efficiency by reducing time to device release, transseptal puncture time, and fluoroscopy exposure.
May support LAAC efficiency in observational data; leaves open randomized confirmation of net benefit.
OBJECTIVE: The radiofrequency (RF) needle has been shown to improve transseptal puncture efficiency and safety compared to mechanical needles. This study aimed to investigate the use of VersaCross RF transseptal wire system (Baylis Medical) to improve procedural efficiency of left atrial appendage closure (LAAC) compared to the standard RF needle-based workflow. METHODS: Eighty-one LAAC procedures using WATCHMAN FLX were retrospectively analyzed comparing the standard RF needle-based workflow to a RF wire-based workflow. Study primary endpoint was time to WATCHMAN device release, and secondary endpoints were transseptal puncture time, LAAC success, fluoroscopy use, and procedural complications. RESULTS: Twenty-five cases using standard RF needle-based workflow were compared to 56 cases using the RF wire-based workflow. Baseline patient characteristics were similar between both groups. LAAC was successful in all patients with no differences in intraprocedural complication rates (p = 0.40). Transseptal puncture time was 1.3 min faster using the RF wire-based workflow compared to the standard RF needle-based workflow (6.5 ± 2.3 vs. 7.8 ± 2.3 min, p = 0.02). Overall, time to final WATCHMAN device release was 4.5 min faster with the RF wire-based workflow compared to the RF needle-based workflow (24.6 ± 5.6 vs. 29.1 ± 9.6 min, p = 0.01). Fluoroscopy time was 21% lower using the RF wire-based workflow (7.6 ± 2.8 vs. 9.6 ± 4.4 min; p = 0.05) and fluoroscopy dose was 67% lower (47.1 ± 35.3 vs. 144.9 ± 156.9 mGy, p = 0.04) and more consistent (F-test, p ˂ 0.0001). CONCLUSIONS: The RF wire-based workflow streamlines LAAC procedures, improving LAAC efficiency and safety by reducing fluoroscopy, device exchanges, and delivery sheath manipulation.
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Whitler et al. (2023) conducted an observational in Left atrial appendage closure (LAAC) (n=81). VersaCross RF transseptal wire system (RF wire-based workflow) vs. Standard RF needle-based workflow was evaluated on Time to WATCHMAN device release (p=0.01). The VersaCross RF transseptal wire system reduced time to final WATCHMAN device release compared to the standard RF needle-based workflow (24.6 vs 29.1 min, p=0.01).
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