Long‐Term Safety and Efficacy of Transcatheter Microwave and Radiofrequency Denervation in a Chronic Ovine Model

Abstract

Background Transcatheter renal denervation (RDN) has had inconsistent efficacy and concerns for durability of denervation. We aimed to investigate long‐term safety and efficacy of transcatheter microwave RDN in vivo in normotensive sheep in comparison to conventional radiofrequency ablation. Methods and Results Sheep underwent bilateral RDN, receiving 1 to 2 microwave ablations (maximum power of 80–120 W for 240 s–480 s) and 12 to 16 radiofrequency ablations (180 s–240 s) in the main renal artery in a paired fashion, alternating the side of treatment, euthanized at 2 weeks (acute N=15) or 5.5 months (chronic N=15), and compared with undenervated controls (N=4). Microwave RDN produced substantial circumferential perivascular injury compared with radiofrequency at both 2 weeks [area 239.8 (interquartile range [IQR] 152.0–343.4) mm 2 versus 50.1 (IQR, 32.0–74.6) mm 2 , P <0.001; depth 16.4 (IQR, 13.9–18.9) mm versus 7.5 (IQR, 6.0–8.9) mm P <0.001] and 5.5 months [area 20.0 (IQR, 3.4–31.8) mm 2 versus 5.0 (IQR, 1.4–7.3) mm 2 , P =0.025; depth 5.9 (IQR, 1.9–8.8) mm versus 3.1 (IQR, 1.2–4.1) mm, P =0.005] using mixed models. Renal denervation resulted in significant long‐term reductions in viability of renal sympathetic nerves [58.9% reduction with microwave ( P =0.01) and 45% reduction with radiofrequency ( P =0.017)] and median cortical norepinephrine levels [71% reduction with microwave ( P <0.001) and 72.9% reduction with radiofrequency ( P <0.001)] at 5.5 months compared with undenervated controls. Conclusions Transcatheter microwave RDN produces deep circumferential perivascular ablations without significant arterial injury to provide effective and durable RDN at 5.5 months compared with radiofrequency RDN.