F-5 | Long-term Outcomes Following Radiofrequency Renal Denervation: Meta-analysis of 18 Reports with Patient Level Data from the Global Symplicity Registry DEFINE

Radiofrequency renal denervation (RF RDN) safely reduces office and 24-hour blood pressure (BP) in patients with uncontrolled hypertension. We performed a meta-analysis to assess long-term durability of RF RDN to at least 3 years based on published reports of outcomes including the Symplicity Flex and Spyral catheters, inclusive of the largest RF RDN registry to date: Global Symplicity Registry (GSR) DEFINE. A PRISMA guided search was performed to identify clinical reports of RF RDN using the Symplicity Flex or Spyral device in patients with uncontrolled hypertension with a minimum of 3 years follow up. Data from the GSR DEFINE registry were updated from the trial database. Key outcomes included office and 24-hour BP change from baseline as well as changes in antihypertensive drugs. A random effects meta-analysis was conducted at 3 years, or the last reported follow-up beyond 3 years and effect size was weighted by the inverse variance. Following screening of 217 records, 18 reports were included in the meta-analysis. Mean time of follow up was 4.3 years (range: 3-9.4). The long-term reduction in office systolic (S)BP from baseline in 13 reports (n=1779) was -22.8 mmHg (95%CI: -27.5, -18.1 p<0.001; Figure). 24-hour SBP was available in 10 reports (n=912) and also decreased significantly (-13.3 mmHg; 95%CI: -17.4, -9.2 p<0.001). Diastolic BP data and safety event rates will also be reported. Number of antihypertensive drugs changed by +0.29 (95%: -0.2, 0.8) through final follow-up. Meta-analysis of 18 reports indicates substantial BP reduction following RF RDN sustained to at least 3 years.