A randomized trial to compare atrial fibrillation ablation using a steerable vs. a non-steerable sheath

Europace. 2009 May;11(5):571-5. doi: 10.1093/europace/eup069. Epub 2009 Apr 7.

Abstract

Aims: Catheter positioning and stability are recognized challenges in catheter ablation of atrial fibrillation (AF). This prospective randomized study assessed whether routinely using a steerable sheath affects procedure outcomes.

Methods and results: Fifty-six AF patients were randomized to ablation using either an Agilis NXT (St Jude Medical, St Paul, MN, USA) steerable sheath or a fixed-curve Mullins sheath (Cook Medical Inc., Bloomington, IN, USA) for the ablation catheter. A mapping system with CT integration was used to isolate the pulmonary veins (PVs) in pairs and further ablation performed if AF persisted. There was no significant difference in time to gain trans-septal access, CT registration time, time to isolate PVs, fluoroscopy time for PV isolation, total procedure time, or total fluoroscopy time. A learning curve was seen for the steerable sheath, and after correcting for this, CT registration time and right PV isolation were quicker in this group. One patient crossed over from fixed-curve to steerable. Acute, 3-, and 6-month single procedure success were similar in both groups.

Conclusion: Allowing for the usage learning curve, a steerable sheath reduced time for some elements of AF ablation. Although this did not result in improved success, it may be useful for inexperienced operators, but at increased procedure cost.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Atrial Fibrillation / surgery*
  • Catheter Ablation / economics
  • Catheter Ablation / instrumentation*
  • Catheter Ablation / methods*
  • Cost-Benefit Analysis
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pulmonary Veins / surgery
  • Time Factors
  • Treatment Outcome