Safety and performance of diagnostic electrical mapping of renal nerves in hypertensive patients.

Abstract

The aim of this study was to evaluate the safety and performance of renal nerve stimulation (RNS) for diagnostic mapping of the renal nerves. In this first-in-man study, twenty hypertensive patients underwent RNS using the ConfidenHT system. Bilateral stimulations were performed at three to four sites per artery at 2 and 4 mA. The primary endpoint was change in systolic blood pressure (SBP). Mean office blood pressure was 156/89 mmHg. No periprocedural adverse events occurred. Stimulation with 2 mA resulted in a maximum change of 8.3±6.3 mmHg in SBP (based on 119 stimulations; p<0.001), while stimulating with 4 mA resulted in a maximum change of 10.1±7.8 mmHg (based on 61 stimulations; p<0.001). The mean change in SBP did not vary between mid, distal or branch sites when stimulating at 2 mA but was significantly higher at ostial (23±14 mmHg) than at non-ostial locations (9±7 mmHg) when stimulating at 4 mA (p=0.003). RNS can be performed safely and effectively along the renal artery and results in a large variation in temporary BP changes per patient and per anatomic location. RNS might help in optimising treatment effect and selecting potential responders to renal sympathetic denervation.