Author + information
- Jason Andrade1,
- Jean Champagne2,
- Marc Deyell1,
- Vidal Essebag3,
- Carlos Morillo4,
- John Sapp5,
- Patricia Theoret-Patrick6,
- George Wells7 and
- Atul Verma8
- 1UBC, Vancouver, British Columbia, Canada
- 2IUPCQ, Quebec City, Quebec, Canada
- 3McGill, Montreal, Quebec, Canada
- 4Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada
- 5Dalhousie, Halifax, Nova Scotia, Canada
- 6Ottawa, Ottawa, Ontario, Canada
- 7Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- 8Southlake Regional Health Centre, Newmarket, Ontario, Canada
Transseptal puncture is a critical step in achieving left atrial (LA) access for many cardiac procedures. More recently, there has been an increasing need for LA access using large caliber sheaths, which presents a unique risk of perforation associated with the initial advancement into the LA due to the larger diameter and shouldering. This study sought to investigate the comparative effectiveness of a Baylis transseptal system (RF needle, TorFlex sheath, and specialized ProTrack guidewire) compared with a conventional transseptal (conventional sheath, Brockenbrough needle, and standard guidewire) for transseptal LA access during cryoballoon ablation procedures, which require the use of a 15-F guiding sheath.
In this prospective, single-blinded, controlled trial, 135 patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the Arctic Front Cryoballoon system were randomized to transseptal access with the conventional transseptal versus the Baylis transseptal system. The primary outcome was time required for transseptal LA access. Secondary outcomes included failure of the assigned transseptal system and radiation exposure.
The median transseptal puncture time was significantly shorter using the Baylis transseptal system compared with the conventional transseptal (80 s [interquartile range (IQR): 51 to 131] vs. 119 s [IQR: 61 to 225]; p = 0.016). Fewer transseptal attempts were noted with the Baylis transseptal system compared with the conventional transseptal (1 [range 0 to 3] vs. 1 [range 0 to 6]; p = 0.023). There was a trend to less radiation exposure with the Baylis transseptal system compared with the conventional transseptal (27 s [IQR: 12 to 60] vs. 54 s [IQR: 18 to 96]; p = 0.066). Failure to achieve transseptal LA access with the assigned system was rarely observed (1 patient in each group).
Use of the Baylis transseptal system resulted in shorter time to LA access and reduced radiation exposure compared with LA access using conventional transseptal equipment.