Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea)

Abstract

Reports detailing the response of hypertensive patients to renal denervation (RDN) in Asian patients are limited. We evaluated 6- and 12-month outcomes after RDN in an Asian population and compared outcomes to a primarily Caucasian population. The Global SYMPLICITY Registry (GSR) is a prospective, all-comer, worldwide registry that evaluates the safety and effectiveness of RDN and includes the Korean registry substudy (GSR Korea) and a Caucasian subset (GSR Caucasian). Given differences in baseline characteristics among GSR Korea (n=93) as compared with GSR Caucasian (n=169) patients, including lower baseline office systolic blood pressure (SBP), lower body mass index and differences in medications, propensity score adjustment was performed when comparing the change in SBP between subsets. The 6- and 12-month change in SBP in GSR Korea was -19.4±17.2 and -27.2±18.1 mm Hg, respectively (P<0.001 for both vs baseline). GSR Caucasian had a SBP change similar to GSR Korea at 6 months (-20.9±21.4 mm Hg, unadjusted P=0.547, adjusted P=0.998), whereas at 12 months the change was significantly less pronounced (-20.1±23.9 mm Hg, unadjusted P=0.004, adjusted P=0.002). There were no protocol-defined procedure-related adverse events and no chronic adverse events associated with the device in an Asian population. RDN provided a significant reduction in 6- and 12-month office SBP among Asian patients, with a favorable safety profile. The 12-month SBP reduction was larger than that observed in Caucasian patients.

Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry

“…These results are supported as well by multivariable analyses, in which higher baseline SBP was consistently associated with a greater reduction in both office and 24-h ambulatory SBP at all timepoints. Although this is the first multivariable analysis to our knowledge to examine predictors of BP change at 3 years, this finding is consistent with previous multivariable analyses of predictors of BP at 6 or 12 months after RDN 10 , 27 , 28 …”

Individualised renal artery denervation improves blood pressure control in Kazakhstani patients with resistant hypertension

“…Our observations are consistent with some of the other non-controlled studies that have been performed [6,8]. A recent analysis of the Global SYMPLICITY Registry in South Korea suggested that some Asian populations may have a greater response to RAD, compared to Caucasian patients [26]. The effect size we observed in BP reduction was similar to that observed in the Asian patients in their study.…”

Renal Artery Vasodilation May Be An Indicator of Successful Sympathetic Nerve Damage During Renal Denervation Procedure

“…Renal sympathetic activation leads to volume retention via increased sodium reabsorption, reduction of renal blood flow, and activation of the renin-angiotensin-aldosterone system via increased renin release from the juxta-glomerular apparatus, which are important for BP regulation293031. Theoretically speaking, sufficient disruption of sympathetic fibers via RDN is an effective non-pharmacological method to lower BP, which has been revealed by previous clinical researches781011. Meanwhile, our previous published basic study had shown that catheter-based RDN, no matter conducted by TC catheter or saline-irrigated catheter, could induce the significant damage to renal nerves28.…”

“…A series of clinical studies7891011 indicated that RDN could lead to significant blood pressure (BP) reduction in patients with resistant hypertension until to the Simplicity HTN-312 failed to demonstrate the superiority of RDN over pharmacological management of hypertension no matter for office BP or 24-hour ambulatory BP measurements. However, further evaluation of the Simplicity HTN-3 trial identified several potential confounding factors that may contribute to the negative results, including over-proportion of Afro-American participants, short of operative experience for RDN, insufficient 4-quadrant ablations, and antihypertensive medication changes1314.…”