A radiofrequency transseptal needle: initial animal studies
Matthew A Crystal1, Mahmood A Mirza, Lee N Benson
1Department of Pediatrics, The University of Toronto School of Medicine, Toronto, Ontario, Canada.
Summary
This study shows a new radiofrequency (RF) transseptal needle is safe and effective for accessing the left heart. The RF needle design simplifies transseptal puncture for complex cardiac procedures.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Electrophysiology
Background:
- Radiofrequency (RF) transseptal puncture is a recognized method for left heart access.
- Existing techniques using RF wire-catheters are effective for complex cases.
- A standard transseptal needle is commonly used for this procedure.
Purpose of the Study:
- To evaluate the safety and efficacy of a novel transseptal needle.
- To assess a new needle design featuring a radiofrequency (RF) tip.
- To determine the ease of use of the new needle configuration for transseptal access.
Main Methods:
- The NRG™ Transseptal Needle, designed for RF percutaneous transseptal access, was utilized.
- Eight pigs underwent transvenous cardiac catheterization.
- Transseptal RF puncture was performed, followed by left atrial pressure waveform monitoring.
Main Results:
- Intracardiac electrograms confirmed needle placement during transit across the atrial septum.
- RF septal puncture was successful in all animals, with contrast staining.
- Dielectric breakdown, tissue vaporization, and perforation occurred within seconds, confirmed by impedance and voltage changes.
- Left atrial entry was verified by pressure waveforms and contrast injection.
- The NRG™ needle demonstrated compatibility with various transseptal sheaths.
Conclusions:
- Radiofrequency (RF) puncture of the interatrial septum using the NRG™ Transseptal Needle offers an effective alternative method for left atrial entry.
- The study demonstrates the feasibility of this new device for transseptal procedures.
