Ospedale Generale Regionale "F. Miulli," Dipartimento di Cardiologia, Acquaviva delle Fonti, Bari, Italy (M.G., A.D.M.).
Biosense Webster, Inc, Irvine, CA (T.G., D.B., K.D., T.S., A.G., A.A.).
Circ Arrhythm Electrophysiol. 2022 Jul;15(7):e010661. doi: 10.1161/CIRCEP.121.010661. Epub 2022 Jun 28.
Pulsed-field ablation (PFA) is a tissue-selective, nonthermal cardiac ablation modality. A novel PFA ablation system consisted of a multichannel irreversible electroporation generator system and a multielectrode circular irreversible electroporation catheter has been developed for catheter ablation. To understand the progression and immediate impacts of PFA, this study evaluated the subchronic (7±3 day) and chronic (30±3 day) safety and performance of the novel PFA system when simulating pulmonary vein and superior vena cava isolation in a porcine beating heart model.
Ten swine models were divided into subchronic (n=6) and chronic cohorts (n=4). Lesions were performed within the right and left atrium to conduct right pulmonary veins and superior vena cava isolations, in addition to creating stacked lesions in the left atrium roof and right atrium posterior wall.
Acute pulmonary vein and superior vena cava isolation were achieved in 10 out of 10 swine and demonstrated 100% lesion durability in both cohorts, including sustained elimination of electrical activity at the left atrium roof and right atrium posterior wall. Histology demonstrated that all the cardiac sites ablated showed discrete zones of loss of myocardial fibers or smooth muscle cells with preservation of the tissue architecture with resultant fibrocellular replacement, neovascularization, and neocollagen deposition. Mineralization findings were present in association with residual necrotic muscle fibers. Only in 7 days group, areas of mineralization were frequently associated with inflammation. There were no treatment-related changes in other tissues, including complete sparing of the phrenic nerve.
Pulsed-field ablation for pulmonary vein and superior vena cava isolation with the novel PFA system was feasible, safe with myocardial-specific ablative effect. Durable lesions were observed at the target areas. with inflammation phenomena mainly documented at 7 days.
脉冲场消融（PFA）是一种组织选择性、非热心脏消融方式。一种新型的 PFA 消融系统由多通道不可逆电穿孔发生器系统和多电极圆形不可逆电穿孔导管组成，用于导管消融。为了了解 PFA 的进展和即时影响，本研究在猪心搏动模型中模拟肺静脉和上腔静脉隔离，评估了新型 PFA 系统的亚慢性（7±3 天）和慢性（30±3 天）安全性和性能。
将 10 头猪模型分为亚慢性（n=6）和慢性组（n=4）。在右心房和左心房内进行病变，以进行右肺静脉和上腔静脉隔离，此外还在左心房房顶和右心房后壁创建堆叠病变。
10 头猪中的 10 头均成功实现了急性肺静脉和上腔静脉隔离，在两个队列中均实现了 100%的病变耐久性，包括左心房房顶和右心房后壁电活动的持续消除。组织学显示，所有消融的心脏部位均显示出心肌纤维或平滑肌细胞离散区域丧失，同时保留了组织结构，导致纤维细胞替代、新生血管形成和新胶原蛋白沉积。与残留的坏死肌纤维相关存在矿化发现。仅在 7 天组中，矿化区域常与炎症相关。其他组织无治疗相关变化，包括膈神经完全保留。
新型 PFA 系统进行肺静脉和上腔静脉隔离的脉冲场消融是可行的、安全的，具有心肌特异性消融效果。在目标区域观察到持久的病变，主要在 7 天记录到炎症现象。
