Abstract：
BACKGROUND: We investigated the preclinical safety and efficacy of ventricular pulsed field ablation (PFA) using a family of novel, 6-/8-Fr, linear, and spiral PFA/mapping catheters (CRC EP, Inc).
METHODS: QRS-gated, bipolar PFA (>2.0 kV) was performed in 10 healthy swine. Altogether, 20 endocardial and epicardial right and left ventricular applications were delivered. The catheters were inserted through an 8.5-Fr steerable introducer. The intensity of skeletal muscle activation was quantified using an accelerometer. Lesions were assessed by pre- versus post-PFA electrogram analysis, pacing threshold, 3D voltage mapping, necropsy, and histology. The swine rete mirabile, liver and kidneys were examined for embolic events.
RESULTS: All applications were single-shot (56 ± 18 s) without catheter repositioning. Minimal microbubbling was observed without significant skeletal muscle stimulation (mean acceleration 0.05 m/s2) or ventricular tachyarrhythmias. There was significant reduction in post- versus pre-PFA electrogram amplitude (0.5 ± 0.2 mV versus 3.2 ± 0.9 mV, P < 0.001) with a marked increase in pacing threshold (>20 mA versus 7.5 ± 2.9 mA, P < 0.001). All lesions were large and durable up to 28 days, measuring 32 ± 5 mm (length), 27 ± 8 mm (width), and 8 ± 3 mm (depth) using the spiral catheters and 43 ± 1 mm (length), 7 ± 1 mm (width), and 8 ± 1 mm (depth) using the linear catheters. Despite higher waveform voltages and prolonged applications, no thermal effects were detected at necropsy/histology. Moreover, gross and microscopic examinations revealed no evidence of thromboembolism, vascular or collateral injury.
CONCLUSIONS: A novel, QRS-gated PFA system using linear and spiral PFA catheters is capable of creating large and durable ventricular lesions in vivo without significant microbubbling, ventricular arrhythmias or thromboembolism.
METHODS: QRS-gated, bipolar PFA (>2.0 kV) was performed in 10 healthy swine. Altogether, 20 endocardial and epicardial right and left ventricular applications were delivered. The catheters were inserted through an 8.5-Fr steerable introducer. The intensity of skeletal muscle activation was quantified using an accelerometer. Lesions were assessed by pre- versus post-PFA electrogram analysis, pacing threshold, 3D voltage mapping, necropsy, and histology. The swine rete mirabile, liver and kidneys were examined for embolic events.
RESULTS: All applications were single-shot (56 ± 18 s) without catheter repositioning. Minimal microbubbling was observed without significant skeletal muscle stimulation (mean acceleration 0.05 m/s2) or ventricular tachyarrhythmias. There was significant reduction in post- versus pre-PFA electrogram amplitude (0.5 ± 0.2 mV versus 3.2 ± 0.9 mV, P < 0.001) with a marked increase in pacing threshold (>20 mA versus 7.5 ± 2.9 mA, P < 0.001). All lesions were large and durable up to 28 days, measuring 32 ± 5 mm (length), 27 ± 8 mm (width), and 8 ± 3 mm (depth) using the spiral catheters and 43 ± 1 mm (length), 7 ± 1 mm (width), and 8 ± 1 mm (depth) using the linear catheters. Despite higher waveform voltages and prolonged applications, no thermal effects were detected at necropsy/histology. Moreover, gross and microscopic examinations revealed no evidence of thromboembolism, vascular or collateral injury.
CONCLUSIONS: A novel, QRS-gated PFA system using linear and spiral PFA catheters is capable of creating large and durable ventricular lesions in vivo without significant microbubbling, ventricular arrhythmias or thromboembolism.
摘要：
背景：我们研究了心室脉冲场消融（PFA）的临床前安全性和有效性，6-/8-Fr,线性,和螺旋PFA/标测导管(CRCEP，公司）。
方法：QRS门控，在10只健康猪中进行双极PFA(>2.0kV)。总之,递送了20例心内膜和心外膜右心室和左心室应用。通过8.5-Fr可操纵的导引器插入导管。使用加速度计量化骨骼肌激活的强度。通过PFA前与后电描记图分析评估病变，起搏阈值,3D电压映射，尸检,和组织学。猪retemirabile，检查肝脏和肾脏的栓塞事件.
结果：所有应用均为单次注射（56±18s），无需重新定位导管。观察到最小的微泡，没有明显的骨骼肌刺激（平均加速度0.05m/s2）或室性快速性心律失常。PFA后与PFA前的电描记图幅度显着降低（0.5±0.2mV对3.2±0.9mV，P<0.001），起搏阈值显着增加（>20mA对7.5±2.9mA，P<0.001)。所有病变都很大，持续时间长达28天，测量32±5mm（长度），27±8mm(宽),使用螺旋导管的深度为8±3mm，长度为43±1mm，7±1mm(宽),使用线性导管和8±1mm(深度)。尽管较高的波形电压和延长的应用，在尸检/组织学检查中未检测到热效应.此外，大体和显微镜检查显示没有血栓栓塞的证据，血管或附带损伤。
结论：小说，使用线性和螺旋PFA导管的QRS门控PFA系统能够在体内产生大而持久的心室损伤，而不会产生明显的微泡。室性心律失常或血栓栓塞。
方法：QRS门控，在10只健康猪中进行双极PFA(>2.0kV)。总之,递送了20例心内膜和心外膜右心室和左心室应用。通过8.5-Fr可操纵的导引器插入导管。使用加速度计量化骨骼肌激活的强度。通过PFA前与后电描记图分析评估病变，起搏阈值,3D电压映射，尸检,和组织学。猪retemirabile，检查肝脏和肾脏的栓塞事件.
结果：所有应用均为单次注射（56±18s），无需重新定位导管。观察到最小的微泡，没有明显的骨骼肌刺激（平均加速度0.05m/s2）或室性快速性心律失常。PFA后与PFA前的电描记图幅度显着降低（0.5±0.2mV对3.2±0.9mV，P<0.001），起搏阈值显着增加（>20mA对7.5±2.9mA，P<0.001)。所有病变都很大，持续时间长达28天，测量32±5mm（长度），27±8mm(宽),使用螺旋导管的深度为8±3mm，长度为43±1mm，7±1mm(宽),使用线性导管和8±1mm(深度)。尽管较高的波形电压和延长的应用，在尸检/组织学检查中未检测到热效应.此外，大体和显微镜检查显示没有血栓栓塞的证据，血管或附带损伤。
结论：小说，使用线性和螺旋PFA导管的QRS门控PFA系统能够在体内产生大而持久的心室损伤，而不会产生明显的微泡。室性心律失常或血栓栓塞。
