New data, new studies, new hopes for renal denervation in patients with uncontrolled hypertension

following the publication of SYMPLICITY HTN-3 the field of renal of denervation was put on hold. Although SYMPLICITY HTN-3 was well-designed and sham-controlled trial it failed to show any meaningful reduction in office or 24 h ambulatory blood pressure. The procedure was however safe and allowed research to continue. Although several pitfalls of the study have been pointed out, incomplete renal denervation was also implicated. Since then, a great deal of basic and clinical research took place and will be briefly commented on in this article.

Before and after SYMPLICITY-HTN-3, numerous uncontrolled, single or unblinded studies have shown substantial office BP reduction ranging from -7.7 to -32 mmHg and ambulatory BP ranging from -2.2 to 10.2 mmHg. Average weighted office systolic BP reduction was -20.8 mmHg and weighted average 24 h ambulatory BPM reduction was -7.8 mmHg. National and international registries have shown similar BP reductions, but results remained unconvincing due to lack of reliable sham controls. In recent years, 5 well-designed sham - controlled studies (beyond, SYMPLICITY-HTN-3) have been published. Of those studies two were single center and three were multicenter international studies. Four studies used single tip or multi-electrode, radiofrequency catheters and one used focused ultrasound. The three multicenter studies reported positive-placebo subtracted results and established BP reductions measured both in the office and by ambulatory monitoring. No serious adverse events were reported.

It can therefore be concluded that the latest sham controlled studies established efficacy and safety of renal denervation.