Transseptal Access Dilator Facilitates LAA Closure

A new dilation system with a larger diameter optimizes left-heart procedures that require a large sheath to cross the heart's septum from the right atrium.

The Baylis Medical (Montreal, Canada) ExpanSure Transseptal Dilation System combines a sheath and dilator into a single braided composite tool, eliminating the traditional dilator-sheath transition that demands the use of added force to achieve crossing and allowing larger dilations, when compared to the standard fixed curve sheath. The system is intended for procedures such as left-atrial appendage (LAA) closure and balloon ablation for atrial fibrillation (AF). Features include a 12.5 Fr outer diameter, which pre-dilates the transseptal puncture, and a 0.035" inner diameter that allows physicians to engage their preferred wire without having to exchange for a compatible dilator.

“Crossing a 14 F sheath across the septum is often challenging, and, in certain cases, additional devices are needed to facilitate left-atrial access. Research has shown that introducing additional dilation devices may result in adverse events to the patient,” said Oussama Wazni, MD, section head of electrophysiology at the Cleveland Clinic (CC; OH, USA), who performed the first ExpanSure clinical case in the US. “Clinical evidence has shown that the dilator-sheath transition found in typically-used devices can cause septal tissue to get caught, resulting in difficulty crossing the septum.”

“Baylis is proud to offer a device uniquely designed to optimize transseptal access, allowing the physician's primary focus to remain on delivering the necessary therapy to the patient,” said Robert Harrison, director of research and development in cardiology at Baylis Medical. “We are delighted to have partnered with Dr. Wazni and the Cleveland Clinic for this successful first clinical use.”

Access to the left side of the heart is required for various therapies, including pulmonary vein isolation (PVI), mitral valve repair, and LAA closure. These procedures are typically performed through an atrial septal puncture. Once access to the left atrium is achieved, the role of a transseptal sheath and dilator set differs depending on the therapy being performed. Although the use of the sheath may vary, the ability to precisely control the distal end of the sheath during the atrial septal puncture is a common requirement.

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