Cardioangiologisches Centrum Bethanien, Medizinische Klinik III, Markus Krankenhaus, Wilhelm-Epstein-Street 4, D-60431 Frankfurt am Main, Germany
Cardioangiologisches Centrum Bethanien, Medizinische Klinik III, Markus Krankenhaus, Wilhelm-Epstein-Street 4, D-60431 Frankfurt am Main, Germany.
Europace. 2016 Dec;18(12):1795-1800. doi: 10.1093/europace/euw012. Epub 2016 Mar 2.
A novel third-generation cryoballoon (CB3) to perform pulmonary vein isolation (PVI) has recently been released, featuring a shortened distal balloon tip when compared with the second-generation (CB2), possibly allowing for enhanced intra-ablation pulmonary vein (PV) signal mapping. We aimed to investigate procedural efficacy and safety of the CB3 as compared to the CB2.
We studied 472 consecutive patients who underwent CB-PVI for paroxysmal or persistent atrial fibrillation (CB3: 49 patients; CB2: 423 patients). Detailed procedural data and in-hospital complications were registered in a prospective database. Complete PVI using the CB only was achieved in 98% of patients in each group. Single-freeze PVI was observed in 84/88% (CB2/CB3, P = n.s.) of the PVs. Time-to-PVI (TPVI) was 49 ± 32 (CB2) and 45 ± 27 s (CB3) (P = n.s.). Time-to-PVI determination rate was higher in the CB3 group (89.5 vs. 82.6%, P = 0.016). Signal noise due to ice formation on mapping electrodes occurred after 70 ± 46 s using CB3 and did not interfere with TPVI determination. Exchange of the spiral mapping catheter with a guide wire was more frequently required in the CB3 group (8.2 vs. 0.7% patients, P < 0.001). Balloon dislodgement during hockey stick manoeuvres occurred in 6.1% patients of the CB3 group only (P = 0.001). Complication rates were not different between the groups.
The CB3 offers a higher TPVI determination rate, facilitating dosing schemes based on TPVI, with equally high single-freeze efficacy compared with the CB2. The shortened distal tip of the CB3 requires adaptation of standard catheter manoeuvers to avoid balloon dislodgement.
一种新型的第三代冷冻球囊(CB3)已被用于实施肺静脉隔离(PVI),与第二代冷冻球囊(CB2)相比,其远端球囊尖端缩短,这可能使球囊内消融时的肺静脉(PV)信号标测更加准确。本研究旨在对比 CB3 和 CB2 的临床效果和安全性。
本研究纳入了 472 例行 CB-PVI 的阵发性或持续性房颤患者(CB3 组:49 例;CB2 组:423 例)。详细的手术数据和住院期间的并发症均被记录在一个前瞻性数据库中。每组患者均有 98%实现了仅用 CB 完成的完全 PVI。在每组患者中,单冷冻消融的 PV 比例分别为 84/88%(CB2/CB3,P = n.s.)。TPVI 时间(CB2:49 ± 32 s;CB3:45 ± 27 s)无统计学差异(P = n.s.)。CB3 组的 TPVI 确定率更高(89.5% vs. 82.6%,P = 0.016)。由于球囊上形成的冰导致的标测电极信号噪声在使用 CB3 时出现于 70 ± 46 s,并未影响 TPVI 的确定。CB3 组更常需要将螺旋标测导管更换为导丝(8.2% vs. 0.7%患者,P < 0.001)。仅在 CB3 组中观察到 hockey stick 操作时球囊移位(6.1%)(P = 0.001)。两组并发症发生率无差异。
CB3 可提供更高的 TPVI 确定率,有利于基于 TPVI 的剂量方案,且与 CB2 相比具有同等的单次冷冻消融效果。CB3 的短远端尖端需要调整标准的导管操作以避免球囊移位。