Velagić Vedran, de Asmundis Carlo, Mugnai Giacomo, Hünük Burak, Hacioğlu Ebru, Ströker Erwin, Moran Darragh, Ruggiero Diego, Poelaert Jan, Verborgh Christian, Umbrain Vincent, Paparella Gaetano, Beckers Stefan, Brugada Pedro, Chierchia Gian-Battista
aHeart Rhythm Management Centre bAnesthesiology Department, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium *Vedran Velagić and Carlo de Asmundis contributed equally as first authors.
J Cardiovasc Med (Hagerstown). 2017 Jul;18(7):518-527. doi: 10.2459/JCM.0000000000000493.
To study the learning curve with the second-generation cryoballoon technology focusing on safety, efficacy and procedural characteristics.
We included 300 patients (men 64.6%, mean age 58.3 ± 12.4 years), 240 of whom were treated by four operators without prior experience in atrial fibrillation ablation and compared them with 60 consecutive patients treated by senior operator. To study the learning curves, we divided the study period into two trimesters and analyzed procedure duration, fluoroscopy times, complications, characteristics of the freeze-thaw cycles and midterm outcomes.
Hands-on help from senior operators to achieve pulmonary vein isolation was needed only in the first study trimester (24.1%), most commonly to achieve right inferior pulmonary vein isolation (55.2%). The mean procedure duration shortened from 76.7 ± 17.4 to 65.1 ± 11.4 min (P < 0.0001), and fluoroscopy time decreased from 18.5 ± 7.3 to 12.1 ± 4.3 min (P < 0.0001) for first and second trimester, respectively, and approached senior operator's results (58.2 ± 12.8 and 8.7 ± 4.5 min). Most of the major complications (one stroke, four pseudoaneurysms and one retroperitoneal hematoma) occurred during the first study trimester. Most characteristics of the freeze cycles remained unchanged in both study periods. Compared with junior operators, the senior operator achieved lower nadir temperatures in both inferior veins. However, there was no significant difference in midterm outcomes between junior and senior operators (79.5 vs 83.3%, P = 0.589).
The learning curve with the second-generation cryoballoon is steep. Inexperienced operators, trained in high-volume centers, can achieve pulmonary vein isolation safely and efficiently with short procedure and fluoroscopy times after having performed 20-30 cases.
研究第二代冷冻球囊技术的学习曲线，重点关注安全性、有效性及操作特点。
我们纳入了300例患者（男性占64.6%，平均年龄58.3±12.4岁），其中240例由4名之前无房颤消融经验的术者进行治疗，并将他们与60例由资深术者连续治疗的患者进行比较。为研究学习曲线，我们将研究期分为两个阶段，并分析手术时长、透视时间、并发症、冻融周期特点及中期结果。
仅在第一个研究阶段（24.1%）需要资深术者的实际帮助以实现肺静脉隔离，最常见于实现右下肺静脉隔离（55.2%）。第一阶段和第二阶段的平均手术时长分别从76.7±17.4分钟缩短至65.1±11.4分钟（P<0.0001），透视时间分别从18.5±7.3分钟降至12.1±4.3分钟（P<0.0001），并接近资深术者的结果（58.2±12.8分钟和8.7±4.5分钟）。大多数主要并发症（1例卒中、4例假性动脉瘤和1例腹膜后血肿）发生在第一个研究阶段。两个研究阶段中大多数冷冻周期的特点保持不变。与初级术者相比，资深术者在两条下肺静脉中均实现了更低的最低温度。然而，初级术者和资深术者的中期结果无显著差异（79.5%对83.3%，P=0.589）。
第二代冷冻球囊的学习曲线很陡。在高容量中心接受培训的无经验术者，在完成20 - 30例手术后，能够安全有效地实现肺静脉隔离，且手术和透视时间较短。
