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A new transseptal solution for enabling left atrial access of large delivery sheaths
Author(s) -
Inohara Taku,
Gilhofer Thomas,
AlDujaili Saja,
Leung Linus,
Yeung Darwin,
Tsang Michael,
Saw Jacqueline
Publication year - 2021
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/jce.14903
Subject(s) - dilator , medicine , interatrial septum , cardiology , heart septum , atrial fibrillation , left atrium
Background Transseptal access for large sheaths may be encumbered by tissue resistance against the sheath–dilator stepped interface. The ExpanSure Large Access Transseptal Dilator (Baylis Medical) is designed as a single introducer and dilation device with a smooth sheath–dilator transition to support transseptal puncture. It may facilitate ease and efficiency of interatrial crossing. Methods This study experimentally evaluated the crossing force of ExpanSure relative to a conventional 8.5 F Swartz SL1 transseptal sheath and dilator in a benchtop septum model. Its ability to reduce the subsequent crossing force of a 14 F WATCHMAN delivery sheath was also tested. The clinical use of ExpanSure, including procedure time, was then validated in a series of left atrial appendage closure (LAAC) procedures. Results In a benchtop septum model ( N = 12), less peak force (1.90 ± 0.08 N vs. 2.36 ± 0.09 N; p < .001) and overall work (17.3 ± 1.2 mJ vs. 28.0 ± 1.9 mJ; p < .001) were required to advance ExpanSure relative to a conventional SL1 transseptal sheath and dilator system. Peak force (2.34 ± 0.24 N vs. 2.65 ± 0.21 N; p < .003) and overall work (28.5 ± 3.9 mJ vs. 35.4 ± 2.1 mJ; p < .001) to advance a WATCHMAN sheath were also significantly lower after using ExpanSure than after using a conventional transseptal system. In 19 LAAC procedures, ExpanSure crossed the septum smoothly and integrated readily, which enabled efficient procedure completion (mean total procedure time 37.6 ± 13.5 min), with 100% success and no procedure‐related complications. Conclusion Experimental force measurements, combined with early clinical experience using ExpanSure, suggest that the tapered design with smooth transition without dilator–sheath step‐up and the larger diameter, both facilitated ease and efficiency of interatrial crossing.