Friedman Peter L, Dubuc Marc, Green Martin S, Jackman Warren M, Keane David T J, Marinchak Roger A, Nazari Jose, Packer Douglas L, Skanes Allan, Steinberg Jonathan S, Stevenson William G, Tchou Patrick J, Wilber David J, Worley Seth J
Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Heart Rhythm. 2004 Jul;1(2):129-38. doi: 10.1016/j.hrthm.2004.02.022.
To study the safety, efficacy, and mapping utility of a new cryoablation catheter.
The CryoCath Technologies Freezor catheter has been used successfully for cryoablation of supraventricular tachycardia (SVT), but has not been evaluated in a large clinical trial.
A multicenter clinical trial to evaluate the safety, efficacy, and cryomapping utility of this cryoablation catheter was conducted in 166 subjects. The target of ablation was the slow pathway in patients with SVT due to AV nodal reentry (AVNRT, n = 103), an accessory pathway in patients with AV reentrant SVT (AVRT, n = 51) and the AV junction in patients with atrial fibrillation (AF, n = 12).
Acute procedural success (APS) was achieved in 83% of the overall group (95% CI, 76% to 88%). APS in the AVNRT group was 91% (98.3% CI, 82% to 97%), compared to 69% for AVRT (98.3% CI, 51% to 84%) and 67% for AF (98.3% CI, 29% to 93%), a highly significant difference (P < .001 by stepwise logistic regression). In patients with APS, long-term success after 6 months was 91% overall (95% CI, 86% to 96%) and 94% for AVNRT subjects (98.3% CI, 87% to 100%). None of the AVNRT or AVRT subjects required a permanent pacemaker. Cryomapping successfully identified ablation targets in 64% of patients in whom it was attempted. The electrophysiologic effects of cryomapping were completely reversible within minutes in 94% of such attempts.
Catheter cryoablation of SVT is a safe alternative to RF ablation and is clinically effective in patients with AVNRT. Cryomapping can reversibly identify targets for ablation and can help minimize the risk of inadvertent AV block during ablation.
研究一种新型冷冻消融导管的安全性、有效性及标测实用性。
CryoCath Technologies Freezor导管已成功用于室上性心动过速（SVT）的冷冻消融，但尚未在大型临床试验中进行评估。
在166名受试者中开展了一项多中心临床试验，以评估这种冷冻消融导管的安全性、有效性及冷冻标测实用性。消融靶点为房室结折返性心动过速（AVNRT，n = 103）患者的慢径路、房室折返性室上性心动过速（AVRT，n = 51）患者的旁道以及心房颤动（AF，n = 12）患者的房室交界区。
总体人群中83%（95%置信区间，76%至88%）实现了急性手术成功（APS）。AVNRT组的APS为91%（98.3%置信区间，82%至97%），而AVRT组为69%（98.3%置信区间，51%至84%），AF组为67%（98.3%置信区间，29%至93%），差异具有高度显著性（通过逐步逻辑回归分析，P <.001）。在实现APS的患者中，6个月后的长期成功率总体为91%（95%置信区间，86%至96%），AVNRT受试者为94%（98.3%置信区间，87%至100%）。AVNRT或AVRT受试者均无需植入永久性起搏器。冷冻标测在64%尝试该方法的患者中成功识别出消融靶点。在94%的此类尝试中，冷冻标测的电生理效应在数分钟内完全可逆。
SVT的导管冷冻消融是射频消融的一种安全替代方法，对AVNRT患者具有临床疗效。冷冻标测可可逆地识别消融靶点，并有助于将消融过程中意外发生房室传导阻滞的风险降至最低。
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