title: Randomized trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA study).
abstract: BACKGROUND
  Transseptal puncture is a critical step in achieving left atrial (LA) access for a variety of cardiac procedures. Although the mechanical Brockenbrough needle has historically been used for this procedure, a needle employing radiofrequency (RF) energy has more recently been approved for clinical use. We sought to investigate the comparative effectiveness of an RF versus conventional needle for transseptal LA access.
  
  
  RESULTS
  In this prospective, single-blinded, controlled trial, 72 patients were randomized in a 1:1 fashion to an RF versus conventional (BRK-1) transseptal needle. In an intention-to-treat analysis, the primary outcome was time required for transseptal LA access. Secondary outcomes included failure of the assigned needle, visible plastic dilator shavings from needle introduction, and any procedural complication. The median transseptal puncture time was 68% shorter using the RF needle compared with the conventional needle (2.3 minutes [interquartile range {IQR}, 1.7 to 3.8 minutes] versus 7.3 minutes [IQR, 2.7 to 14.1 minutes], P = 0.005). Failure to achieve transseptal LA access with the assigned needle was less common using the RF versus conventional needle (0/36 [0%] versus 10/36 [27.8%], P < 0.001). Plastic shavings were grossly visible after needle advancement through the dilator and sheath in 0 (0%) RF needle cases and 12 (33.3%) conventional needle cases (P < 0.001). There were no differences in procedural complications (1/36 [2.8%] versus 1/36 [2.8%]).
  
  
  CONCLUSIONS
  Use of an RF needle resulted in shorter time to transseptal LA access, less failure in achieving transseptal LA access, and fewer visible plastic shavings.
authors.affiliation: Section of Cardiac Electrophysiology, Division of Cardiology, Department of Medicine, University of California, San Francisco, San Francisco, CA.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Hsu
authors.forename: Nitish
authors.initials: N
authors.lastname: Badhwar
authors.forename: Edward P
authors.initials: EP
authors.lastname: Gerstenfeld
authors.forename: Randall J
authors.initials: RJ
authors.lastname: Lee
authors.forename: Mala C
authors.initials: MC
authors.lastname: Mandyam
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Dewland
authors.forename: Kourtney E
authors.initials: KE
authors.lastname: Imburgia
authors.forename: Kurt S
authors.initials: KS
authors.lastname: Hoffmayer
authors.forename: Vasanth
authors.initials: V
authors.lastname: Vedantham
authors.forename: Byron K
authors.initials: BK
authors.lastname: Lee
authors.forename: Zian H
authors.initials: ZH
authors.lastname: Tseng
authors.forename: Melvin M
authors.initials: MM
authors.lastname: Scheinman
authors.forename: Jeffrey E
authors.initials: JE
authors.lastname: Olgin
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Marcus
mesh_terms: D017115:Catheter Ablation / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006325:Heart Atria / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009339:Needles; D011446:Prospective Studies; D011677:Punctures / Q000295:instrumentation*; D011846:Radio Waves; D016037:Single-Blind Method
keywords: Brockenbrough needle; comparative effectiveness; left atrial access; radiofrequency energy needle; randomized controlled trial; transseptal puncture
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