Initial clinical experience with the FlexPoint Steerable Transseptal Needle in left-sided structural heart procedures

Area of Science:

• Cardiovascular interventions
• Medical device technology
• Interventional cardiology

Background:

• Targeted transseptal puncture is crucial for numerous structural heart interventions.
• The clinical application of a steerable needle for this purpose has not been previously documented.

Purpose of the Study:

• To evaluate the initial clinical experience and feasibility of using a novel steerable transseptal needle (STSN).
• To assess the STSN's efficacy in left-sided structural heart procedures requiring transseptal puncture.

Main Methods:

• The study included consecutive patients undergoing structural heart interventions requiring transseptal puncture.
• The steerable transseptal needle (STSN) was utilized with a standard transseptal sheath under real-time TEE and fluoroscopic guidance.
• Needle deflection was adjusted dynamically to precisely localize the puncture site.

Main Results:

• The STSN was successfully employed in 27 patients for interatrial septum puncture.
• The needle's steerability allowed for optimal tenting and localization without removal or reshaping across various atrial dimensions.
• Assisted crossing techniques were used in two cases with fibrotic septa, and no procedural complications occurred.
• All procedures were successfully completed.

Conclusions:

• The steerable transseptal needle (STSN) offers real-time, adjustable deflection for accurate targeting of the interatrial septum.
• The STSN facilitates successful transseptal crossing without complications, demonstrating its utility in structural heart interventions.