Medtronic, Minneapolis, MN (B.H., N.K., N.B., B.O., M.T.S., D.C.S.).
Beaumont, Royal Oaks, MI (D.E.H.).
Circ Arrhythm Electrophysiol. 2022 Jun;15(6):e010127. doi: 10.1161/CIRCEP.121.010127. Epub 2022 Jun 1.
Phrenic nerve palsy is a well-known complication of cardiac ablation, resulting from the application of direct thermal energy. Emerging pulsed field ablation (PFA) may reduce the risk of phrenic nerve injury but has not been well characterized.
Accelerometers and continuous pacing were used during PFA deliveries in a porcine model. Acute dose response was established in a first experimental phase with ascending PFA intensity delivered to the phrenic nerve (n=12). In a second phase, nerves were targeted with a single ablation level to observe the effect of repetitive ablations on nerve function (n=4). A third chronic phase characterized assessed histopathology of nerves adjacent to ablated cardiac tissue (n=6).
Acutely, we observed a dose-dependent response in phrenic nerve function including reversible stunning (R=0.965, <0.001). Furthermore, acute results demonstrated that phrenic nerve function responded to varying levels of PFA and catheter proximity placements, resulting in either: no effect, effect, or stunning. In the chronic study phase, successful isolation of superior vena cava at a dose not predicted to cause phrenic nerve dysfunction was associated with normal phrenic nerve function and normal phrenic nerve histopathology at 4 weeks.
Proximity of the catheter to the phrenic nerve and the PFA dose level were critical for phrenic nerve response. Gross and histopathologic evaluation of phrenic nerves and diaphragms at a chronic time point yielded no injury. These results provide a basis for understanding the susceptibility and recovery of phrenic nerves in response to PFA and a need for appropriate caution in moving beyond animal models.
膈神经麻痹是心脏消融的一种已知并发症,是由直接热能应用引起的。新兴的脉冲场消融(PFA)可能会降低膈神经损伤的风险,但尚未得到很好的描述。
在猪模型中,在进行 PFA 时使用加速度计和连续起搏。在第一个实验阶段,使用递增的 PFA 强度将其递送至膈神经,确定了膈神经的急性剂量反应(n=12)。在第二个阶段,使用单一消融水平靶向神经,观察重复消融对神经功能的影响(n=4)。第三个慢性阶段的特点是评估与消融心脏组织相邻的神经的组织病理学(n=6)。
我们观察到膈神经功能的剂量依赖性反应,包括可逆性失活(R=0.965,<0.001)。此外,急性结果表明膈神经功能对不同水平的 PFA 和导管接近位置的反应不同,结果为:无影响、有影响或失活。在慢性研究阶段,在不预测会导致膈神经功能障碍的剂量下成功分离上腔静脉与膈神经功能正常和膈神经组织病理学正常相关在 4 周时。
导管与膈神经的接近程度和 PFA 剂量水平对膈神经反应至关重要。在慢性时间点对膈神经和膈肌进行大体和组织病理学评估,没有发现损伤。这些结果为理解膈神经对 PFA 的敏感性和恢复提供了基础,并需要在超越动物模型时适当谨慎。