Department of Electrophysiology, Heart Center, University of Leipzig, Germany.
Circ Arrhythm Electrophysiol. 2011 Apr;4(2):157-65. doi: 10.1161/CIRCEP.110.957761. Epub 2011 Jan 19.
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.
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]).
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.
URL: http://clinicaltrials.gov. Unique identifier: NCT00469638.
可操控鞘管技术旨在促进房颤（AF）导管消融的靶部位的导管进入、稳定性和组织接触。我们假设，与非可操控鞘管通路相比，在介入性 AF 治疗后，使用可操控鞘管通路进行节律控制的成功率更高。
在 2 个中心，前瞻性地以随机方式纳入了 130 例患有阵发性或持续性药物难治性 AF 且正在接受首次消融治疗的患者。消融由 10 位具有不同临床经验水平的术者进行。通过连续 7 天的 Holter ECG 和额外的基于症状的心律失常记录来测量治疗结果。在可操控鞘管消融的患者中，单步治疗成功率（无 AF 和/或心房大折返性心动过速）显著更高（3 个月时分别为 78%和 55%，P=0.005；6 个月时分别为 76%和 53%，P=0.008）。肺静脉隔离率、手术持续时间和射频应用时间无显著差异，而可操控鞘管组的透视时间较低（33±14 分钟比 45±17 分钟，P<0.001）。并发症发生率无显著差异（3.2%比 5%，P=0.608）。多变量分析显示，可操控鞘管使用是 6 个月随访后节律结果的唯一有力预测因素（危险比，2.837[1.197 至 6.723]）。
使用手动控制的可操控鞘管进行导管导航的 AF 导管消融可显著提高临床成功率，且并发症发生率相当，且透视时间减少。
