Safety and feasibility of transcatheter renal sympathetic denervation using different types of catheter and various...

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.