Calkins H, Hall J, Ellenbogen K, Walcott G, Sherman M, Bowe W, Simpson J, Castellano T, Kay G N
Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-6568, USA.
Am J Cardiol. 1999 Mar 11;83(5B):227D-236D. doi: 10.1016/s0002-9149(98)01034-0.
Increased attention is now being focused on developing new technologies to cure atrial fibrillation using catheter ablation techniques. The performance of a MAZE-type procedure using standard catheter ablation technologies is arduous and is associated with an unacceptable risk of complications. The Guidant Heart Rhythm Technologies Linear Ablation System was developed to create long transmural linear lesions. Unique features of this system include the availability of different preshaped multi-electrode steerable ablation catheters, the use of phased radiofrequency (RF) energy, and the control of RF output by varying the duty cycle. A prospective multicenter clinical trial to evaluate the safety and efficacy of a right atrial ablation procedure using this technology to treat atrial fibrillation is currently underway. To date, 15 patients have been enrolled and the procedure was acutely effective in 14 of 15 patients with no complications. Atrial fibrillation has recurred during short-term follow-up in 12 of 15 patients, a not surprising result, because this initial phase of testing involved only right-sided ablation. The early results of the phase I clinical trial confirm the findings of others that successful ablation of chronic atrial fibrillation is likely to require a left atrial approach. This clinical trial, as well as others that are currently underway, will be invaluable in the continuing development of catheter ablation of atrial fibrillation and, ultimately, in determining if the routine use of this therapeutic tool can become a reality.
目前，越来越多的注意力集中在开发利用导管消融技术治疗心房颤动的新技术上。使用标准导管消融技术进行迷宫式手术操作艰巨，且伴有不可接受的并发症风险。Guidant心脏节律技术线性消融系统的研发目的是制造长的透壁线性损伤。该系统的独特之处包括可提供不同预塑形的多电极可操纵消融导管、使用相控射频（RF）能量以及通过改变占空比来控制RF输出。一项前瞻性多中心临床试验正在进行，以评估使用该技术治疗心房颤动的右心房消融手术的安全性和有效性。迄今为止，已招募了15名患者，该手术在15名患者中的14名中取得了即刻疗效，且无并发症。15名患者中有12名在短期随访期间出现房颤复发，这一结果并不意外，因为该测试的初始阶段仅涉及右侧消融。I期临床试验的早期结果证实了其他人的发现，即成功消融慢性房颤可能需要采用左心房入路。这项临床试验以及目前正在进行的其他试验，对于心房颤动导管消融技术的持续发展，以及最终确定这种治疗工具能否常规使用成为现实，将具有不可估量的价值。
