Long-term safety and efficacy of endovascular ultrasound renal denervation in resistant hypertension: 8-year results from the ACHIEVE study

Abstract Background Ultrasound renal sympathetic denervation (uRDN) reduces blood pressure (BP) in the absence and presence of antihypertensive treatment at 2 months. Beyond 3 years, there is a lack of follow-up data. This study investigated the long-term safety and efficacy of uRDN. Methods This prospective observational study recruited patients previously included in the international multicenter ACHIEVE study, with office systolic blood pressure (SBP) ≥160 mmHg, 24 h ambulatory SBP ≥130 mmHg, ≥3 antihypertensive drugs and estimated Glomerular Filtration Rate (eGFR) ≥45 ml/min/1.73m 2 undergoing uRDN. The primary efficacy outcome was 24 h ambulatory SBP, adjusted for the number of defined daily dosages (DDD) of antihypertensive drugs. Statistical analyses were performed using linear mixed-effects models and inverse probability weighting. Results A total of 27 out of the initially enrolled 96 patients underwent prospective follow-up at a median of 8.2 7.6−8.9 years. Mean age was 62.6±9.3 years (37.0% female). Preprocedural 24 h ambulatory BP was 151.9/84.1±11.5/11.1 mmHg and the median number of DDDs was 5.0 4.3−7.0. At 8 years after uRDN, the change in 24 h ambulatory SBP was −19.5 95%CI −26.7,−12.4 mmHg ( p <0.001). The 8-year change in the number of DDDs was −1.7 −2.8,−0.6 ( p = 0.003). The 8-year decline in eGFR was −8.9 −13.2,−4.7 ml/min/1.73m 2 ( p <0.001). Clinical event data were available for all 96 patients (median follow-up 3.5 1.0–8.0 years). Renal failure occurred in one patient and no cases of renal artery stenosis were detected. Conclusions A significant BP reduction was observed up until 8 years following uRDN in parallel to a decrease in drug burden over time, in the absence of procedure-related adverse events.