POOLED, 6-MONTH SAFETY AND EFFICACY RESULTS USING THE SYMPLICITY SPYRAL RADIOFREQUENCY RENAL DENERVATION CATHETER

Abstract

Objective: Over 1,200 patients received renal denervation (RDN) to reduce high blood pressure using the current generation, multi-electrode, radiofrequency Symplicity SpyralTM catheter as part of the SPYRAL HTN Global Clinical Program. The Spyral FIM was a prospective, single-arm study to assess feasibility. The SPYRAL HTN-OFF MED and -ON MED studies were randomized, sham controlled, blinded trials assessing the safety and efficacy of RDN in the absence and presence of antihypertensive medications, respectively. The Global SYMPLICITY Registry is an all-comer, global, single-arm study assessing safety and efficacy of RDN in a real-world setting with patients on various medication regimens. Here, we present the pooled, 6-month efficacy and safety results of RDN using the Spyral catheter. Design and method: At each follow-up, including at 6 months, office systolic and diastolic blood pressures and 24-h ambulatory systolic and diastolic were collected. Adverse safety events and other indicators including estimated glomerular filtration rate (eGFR) and incidence of renal artery stenosis were recorded. GSR was an all-comer registry for patients with uncontrolled hypertension, whereas patients in the SPYRAL HTN-OFF and ON MED trials were required to have an OSBP > = 150 and <180 mmHg and ODBP > = 90 mmHg. Results: As of December 19, 2022, 1,298 patients have received RDN therapy using the Spyral catheter, including eligible control patients from the randomized trials who elected to cross over to receive RDN after unblinding. Mean, 6-month reductions in office and 24-h ambulatory BP from baseline are shown in the Figure. Patients had similar, significant reductions in diastolic blood pressure from baseline through 6 months. Including crossover patients, eGFR decreased by 1.5 mL/min/1.73 m2 through 6 months in RDN patients using the SPYRAL catheter (n = 962; 95% CI: -2.27,-0.74; p < 0.001). There have been no recorded instances of renal artery stenosis >70% through 6 months. Conclusions: Patients receiving RDN had significant and consistent 6-month reductions in BP compared to baseline measures. There have been no incidences of renal artery stenosis, and reductions in eGFR are consistent with natural progression with age. These results highlight the efficacy and safety of RDN using the current generation Spyral catheter.