Andrea Bruno Rustum, Atié Jacob, Desh Steffen, Lurz Phillip, Hindricks Gerhard
Electrophysiology Department, Heart Center Leipzig, Leipzig, Sachsen, Germany.
Electrophysiology Department, Clementino Fraga Filho University Hospital - UFRJ, Rio de Janeiro, RJ, Brazil.
Int J Cardiol Heart Vasc. 2016 Mar 17;11:35-42. doi: 10.1016/j.ijcha.2016.03.008. eCollection 2016 Jun.
To evaluate in vivo the feasibility and safety of renal sympathetic denervation (RSD) with different catheters and various radiofrequency protocols.
Twenty-two pigs were included. First 2 pigs were enrolled in a feasibility protocol using one catheter and power from 5 W to 20 W. The next 10 pigs underwent RSD with three different catheters and four different RF-power settings of 5 W, 8 W, 10 W and 12 W in one minute per lesion (Protocol 1). The following 10 (Pigs 13 to 22) underwent RSD with five types of catheters (including the Symplicity® catheter), powers of 8 W and 10 W and two minutes RF-application (Protocol 2). Angiographic data were obtained at baseline, during and after RSD. At last, renal arteries were excised and analyzed macroscopically. The first pig developed severe renal stenoses with lesions of 15 to 20 W correlated with macroscopic alterations. The second feasibility pig did not develop renal stenosis with 5 and 8 W. In Protocol 1 from 60 RF-lesions, we observed 7 stenoses (≥ 30%). Three were severe (one of 80% with 10 W and two of 80% with 12 W). In Protocol 2 from 57 lesions we observed only 1 stenosis of 50% with 8 W with Symplicity® catheter. Severe stenosis was not observed.
In this study, renal sympathetic denervation showed safety using five types of catheters when applying RF-energy less than 10 W, within main stems of arteries larger than 3.0 mm diameter and a distance between lesions of at least 1 time catheter tip length.
在体内评估使用不同导管和各种射频方案进行肾交感神经消融术（RSD）的可行性和安全性。
纳入22头猪。首先2头猪参与使用一种导管且功率从5W至20W的可行性方案。接下来10头猪使用三种不同导管及5W、8W、10W和12W四种不同射频功率设置进行RSD，每个病灶持续一分钟（方案1）。随后的10头猪（第13至22号猪）使用五种类型的导管（包括Symplicity®导管）、8W和10W的功率以及两分钟的射频施加进行RSD（方案2）。在RSD前、期间和之后获取血管造影数据。最后，切除肾动脉并进行宏观分析。第一头猪出现严重肾狭窄，15至20W的病灶与宏观改变相关。第二头可行性研究猪在5W和8W时未出现肾狭窄。在方案1的60个射频病灶中，观察到7处狭窄（≥30%）。3处严重狭窄（一处10W时为80%，两处12W时为80%）。在方案2的57个病灶中，仅观察到使用Symplicity®导管8W时出现一处50%的狭窄。未观察到严重狭窄。
在本研究中，当在直径大于3.0mm的动脉主干内且病灶间距离至少为导管尖端长度的1倍时，使用五种类型的导管施加小于10W的射频能量，肾交感神经消融术显示出安全性。
