This Clinician's View is written by Usman Bhatti, MD, AdventHealth Cardiac Electrophysiologist.
Every year, approximately 1.5 million surgical heart procedures require access to the left side of the heart for catheter-based treatments like atrial fibrillation (AF) ablation, left atrial appendage (LAA) closure, and mitral valve repair/replacement (TVMR or TEER). This number is rising, partly due to the growing incidence of AF in the U.S. and the increase in ablation therapies. To meet this demand, new tools have been developed to improve the safety and precision of transseptal puncture, which is necessary to access the left atrium.
Evolution of Transseptal Access
Traditional catheterization techniques cannot directly access the left side of the heart. Instead, transseptal puncture involves passing a thin wire or needle from the right atrium through the interatrial septum (specifically the fossa ovalis) into the left atrium.
For over 60 years, the Brockenbrough (BRK) needle was the standard for this procedure. While effective, it was complex and posed risks, such as perforating the heart wall. In the last decade, radiofrequency (RF)-energized needles and guidewires have emerged, offering a more controlled and safer approach.
Zero-Exchange: A New Approach to Left-Heart Access
The latest innovation is the development of "zero-exchange" tools and systems that streamline the procedure. Traditionally, transseptal puncture required frequent changes of sheaths and catheters during the process. This created inefficiencies and increased the risk of complications like stroke (from air bubbles or clots) or cardiac tamponade (from cardiac perforation).
Zero-exchange systems, such as the HOTWIRE™ RF Guidewire, FlexCath Cross™, and VersaCross Access Solution, allow physicians to access the left atrium without switching out the guiding catheter or sheath multiple times. This reduces procedure time, minimizes anesthesia exposure, and lowers the risk of complications, ultimately improving patient outcomes.
Key Zero-Exchange Transseptal Access Systems
There are several systems available, each tailored to specific procedures, patient anatomy, and procedural workflows. While the HOTWIRE™, FlexCath Cross™, and VersaCross Access Solution all offer zero-exchange functionality, they have unique features:
- HOTWIRE™ RF Guidewire
- FDA Clearance: 2024. On August 1, AdventHealth Celebration became the first in Florida and second in the U.S. to use it.
- Features: This device is compatible with any delivery sheath and dilator, allowing flexibility in device choice. It is available in both J-tip and pigtail form in either 0.032” or 0.035.” It offers excellent echogenicity, making it easy to visualize using intra-cardiac echocardiography (ICE), ideal for electrophysiologists who prefer not to use fluoroscopy. The wire has high tensile strength to provide secure rail while advancing the sheath, and the soft tip minimizes the risk of perforation, making it especially useful in challenging cases like thick septum or prior septal closures.
- FlexCath Cross™
- FDA Clearance: 2023
- Features: This system combines a needle and dilator into one device. It is the only transseptal access system cleared for both mechanical (needle) and RF crossing, providing flexibility and compatibility with nearly all commercially available sheaths for zero-exchange access.
- VersaCross Connect™
- FDA Clearance: 2024
- Features: This system includes a 13 French dilator and RF guidewire. Its bigger size is ideal for larger transseptal access. Another unique feature is the ability to reshape the tip of the dilator for precise control in challenging anatomy.
Ongoing Innovation to Improve Patient Safety and Outcomes
As the population ages, the demand for effective and efficient cardiac care continues to grow. At AdventHealth, we are excited to incorporate these new zero-exchange technologies into our procedures, enhancing both safety and outcomes for patients undergoing structural and electrophysiological heart procedures. Our commitment to offering cutting-edge innovations aims to advance care for patients across the communities we serve.
