多电极肺静脉隔离术与单尖端大面积导管消融术治疗阵发性心房颤动：一项多国多中心随机临床试验
Multielectrode Pulmonary Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation: A Multinational Multicenter Randomized Clinical Trial.
作者信息
Boersma Lucas V, van der Voort Pepijn, Debruyne Pilippe, Dekker Lukas, Simmers Tim, Rossenbacker Tom, Balt Jippe, Wijffels Maurits, Degreef Yves
机构信息
From the Cardiology Department, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands (L.V.B., J.B., M.W.); Cardiology Department, Catharina Ziekenhuis, Eindhoven, The Netherlands (P.v.d.V., L.D., T.S.); Cardiology Department, Imelda Ziekenhuis, Bonheiden, Belgium (P.D., T.R.); and Cardiology Department, AZ Middelheim, Antwerpen, Belgium (Y.D.).
出版信息
Circ Arrhythm Electrophysiol. 2016 Apr;9(4):e003151. doi: 10.1161/CIRCEP.115.003151.
BACKGROUND
Single-shot ablation techniques may facilitate safe and simple pulmonary vein isolation to treat paroxysmal atrial fibrillation. Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation-paroxysmal atrial fibrillation is the first multinational, multicenter, prospective, noninferiority randomized clinical trial comparing multielectrode-phased radiofrequency ablation (MEA) to standard focal irrigated radiofrequency ablation (STA) using 3-dimensional navigation.
METHODS AND RESULTS
Patients with paroxysmal atrial fibrillation were randomized to MEA (61 patients) or STA (59 patients). Preprocedure transesophageal echocardiogram and computed tomography/magnetic resonance imaging (also 6-month postprocedure) were performed. Mean age was 57 years, 25% female sex, BMI was 28, CHA2DS2-VASc score was 0 to 1 in 82%, 8% had previous right atrial ablation, whereas all had at least 1 antiarrhythmic drug failure. The MEA group had significantly shorter mean procedure time (96±36 versus 166±46 minutes, P<0.001) and fluoroscopy time (23±9 versus 27±9 minutes, P=0.023). The total radiofrequency energy duration was 22±8 minutes for MEA versus 36±13 minutes for STA (P<0.001) with confirmed pulmonary vein isolation in all patients. Hospital admission was 1 day in both groups, without major adverse events either during the procedure or during 30-day follow-up. Two patients in the STA group had 1 PV with asymptomatic narrowing >50%. Freedom of atrial fibrillation for MEA and STA was 86.4% and 89.7% at 6 months, dropping to 76.3% and 81.0% at 12 months.
CONCLUSIONS
In this multicenter, randomized clinical trial, MEA and STA had similar rates of single-procedure acute pulmonary vein isolation without serious adverse events in the first 30 days. MEA had slightly lower long-term arrhythmia freedom, but showed marked and significantly shorter procedure, fluoroscopy, and radiofrequency energy times.
CLINICAL TRIAL REGISTRATION
URL: www.clinicaltrials.gov; Unique identifier: NCT01696136.
背景
单次消融技术可能有助于安全、简便地进行肺静脉隔离以治疗阵发性心房颤动。多电极肺静脉隔离术与单尖端大面积导管消融术治疗阵发性心房颤动的研究是第一项跨国、多中心、前瞻性、非劣效性随机临床试验，该试验采用三维导航技术，将多电极分期射频消融术（MEA）与标准的局灶性灌注射频消融术（STA）进行比较。
方法与结果
阵发性心房颤动患者被随机分为MEA组（61例）或STA组（59例）。术前进行经食管超声心动图检查以及计算机断层扫描/磁共振成像检查（术后6个月也进行此项检查）。平均年龄为57岁，女性占25%，体重指数为28，82%的患者CHA2DS2-VASc评分为0至1分，8%的患者既往有右心房消融史，而所有患者至少有1种抗心律失常药物治疗失败。MEA组的平均手术时间显著更短（96±36分钟对166±46分钟，P<0.001），透视时间也更短（23±9分钟对27±9分钟，P=0.023）。MEA组的总射频能量持续时间为22±8分钟，STA组为36±13分钟（P<0.001），所有患者均实现了肺静脉隔离的确认。两组患者的住院时间均为1天，手术期间及30天随访期间均未发生重大不良事件。STA组有2例患者出现1条肺静脉无症状性狭窄>50%。MEA组和STA组在6个月时无房颤的比例分别为86.4%和89.7%，在12个月时降至76.3%和81.0%。
结论
在这项多中心随机临床试验中，MEA和STA在单次手术急性肺静脉隔离率方面相似，且在最初30天内均未发生严重不良事件。MEA的长期无心律失常比例略低，但手术、透视和射频能量时间明显更短。
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