Effect of applied energy in renal sympathetic denervation with magnetic resonance guided focused ultrasound in a porcine model.

BACKGROUND: Past catheter-based and focused ultrasound renal denervation studies have indicated that procedure efficacy is related to the number of ablations performed or the amount of energy used for the ablation. This study extends those prior results and investigates energy level effects on the efficacy of MR guided focused ultrasound renal denervation performed in a porcine model.

METHODS: Twenty-four normotensive pigs underwent unilateral denervation at three intensity levels. The applied intensity level was retrospectively de-rated to account for variability in animal size. Efficacy was assessed through evaluating the norepinephrine present in the kidney medulla and through histological analysis. The treatment was performed under MRI guidance including pre- and post-procedure T1-weighted and quantitative T1 and T2 imaging. During treatment, the temperature in the near field of the ultrasound beam was monitored in real time with MR temperature imaging. Energy delivery in the regions surrounding the renal artery was independently confirmed through an invasive fiberoptic temperature probe placed in the right renal artery.

RESULTS: Animals that underwent denervation at a de-rated acoustic intensity of greater than 1.2 kW/cm(2) had a significantly lower norepinephrine concentration in the kidney indicating successful denervation. Images obtained during the treatment indicated no tissue changes in the kidneys as a function of the procedure but there were significant T1 changes present in the right lumbar muscles, although only one animal had indication of muscle damage at the time of necropsy.

CONCLUSIONS: While MR guided focused ultrasound renal denervation was found to be safe and effective in this normotensive animal model, the results indicated the need to incorporate patient-specific details in the treatment planning of MRgFUS renal denervation procedure.