Steerable versus nonsteerable sheath technology in atrial fibrillation ablation: a prospective, randomized study.
BACKGROUND
Steerable sheath technology is designed to facilitate catheter access, stability, and tissue contact in target sites of atrial fibrillation (AF) catheter ablation. We hypothesized that rhythm control after interventional AF treatment is more successful using a steerable as compared with a nonsteerable sheath access.


RESULTS
One hundred thirty patients with paroxysmal or persistent drug-refractory AF undergoing their first ablation procedure were prospectively included in a randomized fashion in 2 centers. Ablation was performed by 10 operators with different levels of clinical experience. Treatment outcome was measured with serial 7-day Holter ECGs and additional symptom-based arrhythmia documentation. Single procedure success (freedom from AF and/or atrial macroreentrant tachycardia) was significantly higher in patients ablated with a steerable sheath (78% versus 55% after 3 months, P=0.005; 76% versus 53% after 6 months, P=0.008). Rate of pulmonary vein isolation, procedure duration, and radiofrequency application time did not differ significantly, whereas fluoroscopy time was lower in the steerable sheath group (33±14 minutes versus 45±17 minutes, P<0.001). Complication rates showed no significant difference (3.2% versus 5%, P=0.608). On multivariable analysis, steerable sheath usage remained the only powerful predictor for rhythm outcome after 6 months of follow-up (hazard ratio, 2.837 [1.197 to 6.723]).


CONCLUSIONS
AF catheter ablation using a manually controlled, steerable sheath for catheter navigation resulted in a significantly higher clinical success rate, with comparable complication rates and with a reduction in periprocedural fluoroscopy time.


BACKGROUND
URL: http://clinicaltrials.gov. Unique identifier: NCT00469638.
Department of Electrophysiology, Heart Center, University of Leipzig, Germany. piorkowskic@yahoo.de
Christopher
C
Piorkowski
Charlotte
C
Eitel
Sascha
S
Rolf
Kerstin
K
Bode
Philipp
P
Sommer
Thomas
T
Gaspar
Simon
S
Kircher
Ulrike
U
Wetzel
Abdul Shokor
AS
Parwani
Leif-Hendrik
LH
Boldt
Meinhard
M
Mende
Andreas
A
Bollmann
Daniela
D
Husser
Nikolaos
N
Dagres
Masahiro
M
Esato
Arash
A
Arya
Wilhelm
W
Haverkamp
Gerhard
G
Hindricks
D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation*; D057785:Catheters; D016009:Chi-Square Distribution; D015716:Electrocardiography, Ambulatory; D004867:Equipment Design; D005260:Female; D005471:Fluoroscopy; D005858:Germany; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015641:Radiography, Interventional; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
D000889:Anti-Arrhythmia Agents