Assistant Professor Johns Hopkins University School of Medicine Baltimore, Maryland, United States
Disclosure(s): No financial relationships to disclose
Disclosure(s):
Rachael Quinn, PhD: No financial relationships to disclose
Purpose: The rapid growth of left-heart interventions necessitates safe and precise transseptal puncture. However, current technology is limited by steep learning curves, suboptimal crossing locations, and procedural risks and is a barrier to entry for surgeons performing catheter-based interventions. We report the first-in-human experience with a novel transseptal system. Methods: We designed and developed a novel catheter system designed to improve the safety, accuracy, and ease of performance of transseptal puncture (Protaryx Medical, Baltimore, MD). Key attributes include an atraumatic and highly echogenic retractable nitinol mesh, an extendable distal catheter, and a radiofrequency-powered guidewire. This first-in-human study was conducted at a single center. The primary efficacy endpoint was successful puncture of the fossa ovalis at a targeted location, and the primary safety endpoint was freedom from adverse events. Secondary endpoints included time from venous access to crossing and fluoroscopy duration. All events were adjudicated by an independent clinical review committee. Results: Five consecutive patients underwent transseptal puncture followed by therapeutic interventions: percutaneous balloon mitral valvuloplasty (BMV, n = 2) or Amplatzer occluder placement for PFO (n = 3). The median age was 46 years (range 23–60) and 80 % were female. Transesophageal echocardiography (TEE) guidance was utilized in the two BMV patients, while intracardiac echocardiography (ICE) was used in the other three. All transseptal punctures were successful at the targeted locations without adverse events. The echogenic atraumatic nitinol mesh on the distal end of the catheter enabled excellent visualization by both TEE and ICE (Figure, yellow arrow), while the extendable catheter (Figure, red arrow) facilitated superior maneuverability in all planes. Median transseptal puncture time was 10 minutes (range 6 – 18 minutes), and median fluoroscopy time was 9 seconds (range 9–16 seconds). All patients were discharged within 12 hours in good condition. Conclusion: This first clinical experience with a novel transseptal puncture catheter demonstrated excellent ease of use, precise targeting, superior echocardiographic and fluoroscopic visibility, and no safety concerns. Further studies are needed to evaluate the broader clinical utility of this technology.
