Schirdewan Alexander, Herm Juliane, Roser Mattias, Landmesser Ulf, Endres Matthias, Koch Lydia, Haeusler Karl Georg
Department of Cardiology, Sana Clinic Lichtenberg , Berlin , Germany.
Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany; Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Front Cardiovasc Med. 2017 Feb 13;4:4. doi: 10.3389/fcvm.2017.00004. eCollection 2017.
Pulmonary vein isolation (PVI) is an established approach to treat symptomatic non-permanent atrial fibrillation (AF). Detecting AF recurrence after PVI is important, if discontinuation of oral anticoagulation after ablation is considered.
Patients with symptomatic paroxysmal AF were enrolled in the prospective randomized mesh ablator vs. cryoballoon pulmonary vein (PV) ablation of symptomatic paroxysmal AF study, comparing efficacy and safety of the HD Mesh Ablator (C.R. Bard, Lowell, MA, USA) and the Arctic Front (Medtronic, Minneapolis, MN, USA) catheter. Rhythm status post-PVI was closely monitored for 1 year using the implantable loop recorder (ILR) Reveal XT (Medtronic Minneapolis, MN, USA).
The study was terminated after the first interim analysis due to the inability of the HD Mesh Ablator to achieve the predefined primary study endpoint, an exit block of all PVs. After a 90-day blanking period, 23 (62.2%) out of 37 study patients (median 63.0 years; 41% females) had at least one episode of AF. AF recurrence was associated with AF episodes during the blanking period {hazard ratios (HR) 5.10 [95% confidence interval (CI) 1.21-21.4]; = 0.038}, and a common left-sided PV ostium [HR 4.17 (95%CI 1.48-11.8); = 0.039] but not with catheter type, age, gender, cardiovascular risk profile, or left atrial volume. There was a trend toward AF recurrence in patients without complete PVI of all PV ( = 0.095). Overall, 337 (59.4%) out of 566 ILR-detected episodes represented AF. Comparing patients with AF recurrence to those without, there was no difference in cognitive performance 6 months post-ablation.
Using an ILR, in more than 60% of all patients with paroxysmal AF, a recurrence of AF was detected within 12 months after ablation. In patients with a common PV ostium, the first generation balloon-based catheter is obviously less effective.
http://Clinicaltrials.gov NCT01061931.
肺静脉隔离术（PVI）是治疗有症状的非永久性心房颤动（AF）的既定方法。如果考虑在消融术后停用口服抗凝药，那么检测PVI术后AF复发情况就很重要。
有症状的阵发性AF患者被纳入前瞻性随机网状消融器与冷冻球囊肺静脉（PV）消融治疗有症状阵发性AF的研究，比较HD网状消融器（美国马萨诸塞州洛厄尔市C.R. Bard公司）和北极锋导管（美国明尼阿波利斯市美敦力公司）的疗效和安全性。使用植入式环形记录仪（ILR）Reveal XT（美国明尼阿波利斯市美敦力公司）对PVI术后的心律状态进行为期1年的密切监测。
由于HD网状消融器未能达到预定的主要研究终点，即所有PV的出口阻滞，该研究在首次中期分析后终止。在90天的空白期后，37例研究患者（中位年龄63.0岁；41%为女性）中有23例（62.2%）至少发生过一次AF。AF复发与空白期内的AF发作有关（风险比[HR]5.10[95%置信区间（CI）1.21 - 21.4]；P = 0.038），以及与常见的左侧PV口有关[HR 4.17（95%CI 1.48 - 11.8）；P = 0.039]，但与导管类型、年龄、性别、心血管风险状况或左心房容积无关。所有PV未完全进行PVI的患者有AF复发的趋势（P = 0.095）。总体而言，在ILR检测到的566次发作中，337次（59.4%）为AF。将有AF复发的患者与无复发的患者进行比较，消融术后6个月认知功能无差异。
使用ILR，超过60%的阵发性AF患者在消融术后12个月内检测到AF复发。对于有常见PV口的患者，第一代基于球囊的导管明显效果较差。
http://Clinicaltrials.gov NCT01061931
