Department of Medicine I, University Hospital Munich, Ludwig-Maximilians University, Munich, Germany.
German Cardiovascular Research Centre (DZHK), Partner Site: Munich Heart Alliance, Munich, Germany.
Biomed Res Int. 2018 Sep 18;2018:9784259. doi: 10.1155/2018/9784259. eCollection 2018.
The value of contact force information for ablation of LA anterior line is unknown. In a prospective randomized clinical trial, we investigated if information on contact force during left atrial (LA) anterior line ablation reduces total radiofrequency time and results in higher rates of bidirectional line block in patients undergoing pulmonary vein isolation (PVI) plus substrate modification.
We included patients with indication for pulmonary vein isolation (PVI) and additional substrate modification. For LA anterior line ablation, patients were randomized to contact force information visible (n=35) or blinded (n=37). Patients received contrast enhanced cardiac magnetic resonance imaging (cMRI) before and 3-6 months after ablation to visualize the LA anterior line. Primary endpoint was radiofrequency time to achieve bidirectional line block. Secondary endpoints were completeness of the LA anterior line on cMRI, distribution of contact force, procedural data, adverse events, and 12 months success rate.
In 72 patients (64±9 years, 68% male), bidirectional LA anterior line block was achieved in 70 (97%) patients. Radiofrequency time to bidirectional block did not differ significantly across groups (contact force information visible 23±18min versus contact force information blinded 21±15min, p=0.50). The LA anterior line was discernable on cMRI in 40 patients (82%) without significant differences across randomization groups (p=0.46). No difference in applied contact force was found depending on cMRI line visibility. Twelve-month success and adverse event rates were comparable across groups.
Information on contact force does not significantly improve the ablation of LA anterior lines.
The trial was registered at http://www.clinicaltrials.gov by identifier: NCT02217657.
接触力信息在左心房（LA）前壁消融中的价值尚不清楚。在一项前瞻性、随机临床试验中，我们研究了在接受肺静脉隔离（PVI）加基质改良的患者中，LA 前壁消融过程中接触力信息是否可以减少总射频时间，并提高双向线阻滞的成功率。
我们纳入了有肺静脉隔离（PVI）和附加基质改良适应证的患者。对于 LA 前壁消融，患者被随机分为接触力信息可见（n=35）或不可见（n=37）组。所有患者在消融前和消融后 3-6 个月均行心脏对比增强磁共振成像（cMRI），以显示 LA 前壁。主要终点是达到双向线阻滞的射频时间。次要终点是 cMRI 上 LA 前壁的完整性、接触力分布、手术数据、不良事件和 12 个月成功率。
在 72 例患者（64±9 岁，68%为男性）中，70 例（97%）患者实现了双向 LA 前壁阻滞。两组之间达到双向阻滞的射频时间无显著差异（接触力信息可见组 23±18min 与接触力信息不可见组 21±15min，p=0.50）。在 40 例患者（82%）中，cMRI 上可识别 LA 前壁，两组之间无显著差异（p=0.46）。根据 cMRI 线可见性，应用的接触力无差异。两组之间 12 个月成功率和不良事件发生率无差异。
接触力信息并不能显著改善 LA 前壁的消融效果。
该试验在 http://www.clinicaltrials.gov 上注册，标识符为：NCT02217657。
