Long-term follow-up of patients undergoing renal sympathetic denervation

Abstract

Objectives Renal denervation (RDN) proved to significantly lower blood pressure (BP) at 2–6 months in patients on and off antihypertensive drugs. Given a lack of longer-term follow-up data, our aim was to assess the safety and efficacy of RDN up to five years taking into account antihypertensive drug regimen changes over time. Methods In the present single-center study, patients underwent RDN for (therapy resistant) hypertension. Patients underwent protocolized yearly follow-up out to five years. Data were collected on 24-h ambulatory BP and office BP monitoring, renal function, antihypertensive drug regimen, and safety events, including non-invasive renal artery imaging at 6/12 months. Efficacy analyses were performed using linear mixed-effects models. Results Seventy-two patients with mean age 63.3 ± 9.5 (SD) years (51% female) were included. Median follow-up time was 3.5 years and Clark’s Completeness Index was 72%. Baseline ambulatory daytime BP was 146.1/83.7 ± 17.4/12.2 mmHg under a mean number of 4.9 ± 2.7 defined daily doses (DDD). At five years, ambulatory daytime systolic BP as calculated from the mixed model was 120.8 (95% CI 114.2–127.5) mmHg and diastolic BP was 73.3 (95% CI 69.4–77.3) mmHg, implying a reduction of -20.9/-8.3 mmHg as compared to baseline estimates (p < 0.0001). The number of DDDs remained stable over time (p = 0.87). No procedure-related major adverse events resulting in long-term consequences were observed. Conclusions The BP-lowering effect of RDN was safely maintained at least five years post-procedure as reflected by a significant decrease in ambulatory daytime BP in the absence of escalating antihypertensive drug therapy over time. Graphical abstract

Long-term reduction in morning and nighttime blood pressure after renal denervation: 36-month results from SPYRAL HTN-ON MED trial

“…The present results supporting RDN efficacy to at least 3 years of follow-up confirm and extend recent pre-clinical [32,33] and clinical trial [25,[34][35][36][37] reports of long-term safety and efficacy of radiofrequency RDN. Note that no repeat procedures have been performed to date in the SPYRAL HTN trials.…”

Catheter-Based Renal Denervation: 9-Year Follow-Up Data on Safety and Blood Pressure Reduction in Patients With Resistant Hypertension

“…Our data, therefore, provide important information on both the safety and efficacy of catheter-based RDN with radiofrequency ablation and are in line with 3-year FU data from randomized sham-controlled 3,4 and other single-center extended FU investigations. 16 BP across the sleep-wake cycle was significantly reduced from baseline. While overall BP reduction is the key pillar in reducing cardiovascular morbidity and mortality, nighttime BP remains the best predictor of cardiovascular outcomes.…”

“…Our data, therefore, provide important information on both the safety and efficacy of catheter-based RDN with radiofrequency ablation and are in line with 3-year FU data from randomized sham-controlled 3,4 and other single-center extended FU investigations. 16…”

The position of renal denervation in treatment of hypertension: an expert consensus statement

“…However, renal hormone excretion was only partially restored [ 47 ]. Whereas evidence on this phenomenon lacks in humans, registry studies confirmed a durable sABP-lowering effect of −8.0 and −20.9 mm Hg up until three and five years after RDN respectively [ 46 , 49 ]. In the RADIANCE HTN SOLO study, sOBP was lower in the RDN group (−5.9 vs. −4.3 mm Hg) while on less medication compared with the control group 12 months post randomisation [ 50 ].…”