Utility and safety of the SafeSept™ transseptal guidewire for electrophysiology studies with catheter ablation in pediatric and congenital heart disease

J Interv Card Electrophysiol. 2017 Apr;48(3):369-374. doi: 10.1007/s10840-017-0224-z. Epub 2017 Jan 14.


Purpose: The atrial transseptal procedure is used in catheter ablation of left-sided arrhythmias. Studies in adult patients have shown the SafeSept™ transseptal guidewire (SSTG) to be effective in atrial transseptal procedures. We analyzed our 5-year experience with SSTG use in pediatric and congenital heart disease patients undergoing catheter ablation.

Methods: This is a single-center retrospective analysis of patients undergoing catheter ablation from 2009 to 2014. We identified all procedures where SSTG was used for atrial transseptal or trans-baffle access. Success of transseptal access and complications were recorded and compared to the standard transseptal approach without the SSTG.

Results: One hundred twenty-seven patients underwent 132 attempted atrial transseptal or trans-baffle procedures using SSTG. Median age was 14 (1.2-38) years. Arrhythmia substrates included AV reentrant tachycardia (90.2%), atrial tachycardia (4.5%), ventricular tachycardia (2.3%), and AV nodal reentrant tachycardia (2.3%). Transseptal or trans-baffle access was successful in 96.2% of the SSTG cases compared to 98.9% in the standard transseptal group without SSTG (p = NS). The youngest patient with successful atrial transseptal procedure using SSTG was 4 years old. SSTG was used to successfully cross a surgically created atrial baffle in a patient who had undergone the Mustard procedure. There was one major complication in both groups, 0.8% in the SSTG group compared to the standard transseptal group without SSTG, 1.1% (p = NS). The major complication in the SSTG group occurred when the SSTG crossed the aorta into the coronary artery system and mimicked placement in the left atrial appendage, with subsequent placement of a transseptal sheath into the aorta, requiring sternotomy and surgical intervention.

Conclusions: SSTG is effective for use in atrial transseptal and surgical trans-baffle access in pediatric and congenital heart disease patients. Placement of the SSTG into the pulmonary vein is necessary to avoid major complications, and if not achieved requires additional methods to determine appropriate left atrial placement.

Keywords: Catheter ablation; Pediatric; SafeSept™ transseptal guidewire; Transseptal puncture.

MeSH terms

  • Adolescent
  • Adult
  • Atrial Septum / diagnostic imaging*
  • Atrial Septum / surgery*
  • Body Surface Potential Mapping / instrumentation*
  • Catheter Ablation / instrumentation*
  • Child
  • Child, Preschool
  • Equipment Design
  • Equipment Failure Analysis
  • Female
  • Fiducial Markers
  • Heart Defects, Congenital / diagnosis
  • Heart Defects, Congenital / epidemiology*
  • Heart Defects, Congenital / surgery*
  • Humans
  • Infant
  • Male
  • Ohio / epidemiology
  • Postoperative Complications / epidemiology*
  • Postoperative Complications / prevention & control
  • Prevalence
  • Retrospective Studies
  • Risk Factors
  • Surgery, Computer-Assisted / instrumentation
  • Treatment Outcome
  • Young Adult