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目的通过实验猪探讨自主研制Magi Cath导管消融系统行经导管肾去交感神经术(renal sympathetic denervation,RDN)的安全性及有效性。方法将12只约克猪随机分为4组:双侧消融组-1(随访7天)、双侧消融组-2(随访14天)、双侧消融组-3(随访30天)和假手术组(随访30天)。于RDN术前、术后分别抽血、验尿及双侧肾动脉造影,监测动脉血压、心率及评估肾动脉形态,随访结束后分别取出实验猪的肾动脉,经苏木精-伊红染色法染色后观察肾动脉内膜及肾动脉周围交感神经的形态学变化,并检测肾组织中去甲肾上腺素的含量。结果经病理学及造影检查,Magi Cath消融系统行RDN术对实验猪的肾动脉内膜未造成严重并发症。随访30天后动脉收缩压为(110±2.0)mm Hg,较术前基础收缩压[(142.5±2.3)mm Hg]明显下降,舒张压未见明显下降。该系统可导致肾动脉周围神经明显变性坏死、纤维化及空泡化,并且较假手术组能够明显降低肾组织内去甲肾上腺素的含量,差异具有显著性(P<0.01)。结论应用Magi Cath消融系统行RDN术是安全的。在30天随访中,该系统行RDN术的疗效是肯定的。
Objective To explore the safety and efficacy of self-developed Magi Cath catheter ablation system for renal sympathetic denervation (RDN) via experimental pigs. Methods Twelve Yorkshire pigs were randomly divided into 4 groups: bilateral ablation group -1 (followed up for 7 days), bilateral ablation group -2 (followed up for 14 days), bilateral ablation group -3 (followed up for 30 days) and sham operation Group (followed up for 30 days). Before RDN, blood samples, urine tests and bilateral renal artery angiography were performed before and after RDN respectively. Arterial blood pressure and heart rate were measured and renal artery morphology was assessed. After the follow-up, the renal arteries were removed and stained with hematoxylin-eosin The morphological changes of sympathetic nerves around the intima of the renal artery and the renal artery were observed after the method of staining, and the content of norepinephrine in the kidney tissue was detected. Results By pathology and radiography, RDN operated by Magi Cath ablation system did not cause serious complications in the intima of renal arteries in experimental pigs. Arterial systolic pressure was (110 ± 2.0) mm Hg after 30 days of follow-up, which was significantly lower than preoperative basal systolic pressure (142.5 ± 2.3 mm Hg) and no significant decrease of diastolic pressure. The system can cause significant degeneration and necrosis, fibrosis and vacuolization of the peripheral nerve of renal artery, and can significantly reduce the content of norepinephrine in renal tissue compared with sham operation group, the difference was significant (P <0.01). Conclusion It is safe to use the Magi Cath ablation system to perform RDN. In the 30-day follow-up, the system line RDN surgery is positive.