Helmsley Electrophysiology Center, Department of Cardiology, Icahn School of Medicine at Mount Sinai, NY (S.R.D., C.O., T.S., W.W., J.S.K., S.C., V.Y.R.).
Cardiovascular Division, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee (T.N., I.N., R.N., W.G.S.).
Circ Arrhythm Electrophysiol. 2022 May;15(5):e010020. doi: 10.1161/CIRCEP.121.010020. Epub 2022 Apr 27.
Frequent premature ventricular contractions (PVCs) are often amenable to catheter ablation. However, a deep intramural focus may lead to failure due to inability of standard ablation techniques to penetrate the focus. We sought to assess the efficacy and safety of infusion needle ablation (INA) for PVCs that are refractory to standard radiofrequency ablation.
Under 2 Food and Drug Administration approved protocols, INA was evaluated in patients with frequent PVCs that were refractory to standard ablation. Initial targets for ablation were selected by standard mapping techniques. INA was performed with a deflectable catheter equipped with an extendable/retractable needle at the tip that can be extended up to 12 mm into the myocardium and is capable of pacing and recording. After contrast injection for location assessment, radiofrequency ablation was performed with the needle tip using a temperature-controlled mode (maximum temperature 60 °C) with saline infusion from the needle. The primary end point was a decrease in PVC burden to <5000/24 hours at 6 months. The primary safety end point was incidence of procedure- or device-related serious adverse events.
At 4 centers, 35 patients (age 55.3±16.9 years, 74.2% male) underwent INA. The baseline median PVC burden was 25.4% (interquartile range, 18.4%-33.9%) and mean left ventricular ejection fraction was 37.7±12.3%. Delivering 10.3±8.0 INA lesions/patient (91% had adjunctive standard radiofrequency ablation also) resulted in acute PVC elimination in 71.4%. After a mean follow-up of 156±109 days, the primary efficacy end point was met in 73.3%. The median PVC burden decreased to 0.8% (interquartile range, 0.1%-6.0%; <0.001). The primary safety end point occurred in 14.3% consisting of 1 (2.9%) heart block, 1 (2.9%) femoral artery dissection, and 3 (8.6%) pericardial effusions (all treated percutaneously).
INA is effective for the elimination of frequent PVCs that are refractory to conventional ablation and is associated with an acceptable safety profile.
URL: https://www.
gov; Unique identifier: NCT01791543 and NCT03204981.
频发室性早搏（PVCs）通常可通过导管消融治疗。然而，由于标准消融技术无法穿透病灶，深部心内膜病灶可能导致消融失败。我们旨在评估针对标准射频消融治疗无效的 PVCs 的针吸消融（INA）的疗效和安全性。
在两项经美国食品药品监督管理局批准的方案下，我们评估了 INA 在频发 PVCs 患者中的应用，这些患者对标准消融治疗有抵抗。初始消融靶点通过标准标测技术选择。INA 采用带有可弯曲导管的设备进行，导管尖端带有可伸出/缩回的针，可伸出至心肌 12mm 并具有起搏和记录功能。在对比剂注射定位后，使用温度控制模式（最高温度 60°C）和从针内输注盐水进行针尖端射频消融。主要终点为 6 个月时 PVC 负荷减少至＜5000/24 小时。主要安全性终点为与操作或器械相关的严重不良事件发生率。
在 4 家中心，35 名患者（年龄 55.3±16.9 岁，74.2%为男性）接受了 INA。基线时的 PVC 负荷中位数为 25.4%（四分位距，18.4%-33.9%），平均左心室射血分数为 37.7±12.3%。每个患者进行 10.3±8.0 个 INA 消融灶（91%的患者还进行了辅助标准射频消融），71.4%的患者即刻消除了 PVC。平均随访 156±109 天后，主要疗效终点达到 73.3%。PVC 负荷中位数降至 0.8%（四分位距，0.1%-6.0%；＜0.001）。主要安全性终点发生率为 14.3%，包括 1 例（2.9%）心脏传导阻滞、1 例（2.9%）股动脉夹层和 3 例（8.6%）心包积液（均经皮治疗）。
INA 对于消除常规消融治疗无效的频发 PVCs 是有效的，且安全性良好。
网址：https://www.
gov；独特标识符：NCT01791543 和 NCT03204981。
