(VP083) POOLED, 6-MONTH SAFETY AND EFFICACY RESULTS USING THE SYMPLICITY SPYRAL RADIOFREQUENCY RENAL DENERVATION CATHETER

Background: Over 1,200 hypertensive patients received renal denervation (RDN) to reduce high blood pressure (BP) using the current generation, multi-electrode, radiofrequency (RF) Symplicity SpyralTM catheter (herein referred to the Spyral catheter). A broad spectrum of patients was enrolled into feasibility and real-world evidence studies as well as pilot and pivotal trials. 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. GSR is an all-comer, global, single-arm study assessing safety and efficacy of RDN in a real-world setting. Here, we present the pooled, 6-month efficacy and safety results of RDN using the Spyral catheter.

METHODS AND RESULTS: All patients were treated with the Symplicity RDN system using the Spyral catheter. At each follow-up through 6 months office and 24-h ambulatory BP 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. OFF MED patients were required to have a medication washout period prior to treatment without taking medications for the first 3 months, whereas ON MED patients were required to be on a stable regimen of 1-3 antihypertensive medications.

As of December 19, 2022, 1,298 patients have received RDN therapy using the Spyral catheter. Patients had significant and clinically meaningful reductions in office and 24-h ambulatory systolic and diastolic BP through 6 months compared with baseline BP (Figure), with minimal changes in antihypertensive medications (0.1 ± 1.0). 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.

Conclusion: In a large, pooled population of over 1,200 subjects receiving RDN therapy using the multielectrode Spyral catheter, patients had significant and consistent reductions in 24-h ambulatory and office systolic and diastolic blood pressures through 6 months compared to baseline measures. There have been no incidences of renal artery stenosis and observed reductions in eGFR are consistent with the natural progression of the population. These results highlight the efficacy and safety of RF RDN using the current generation, Spyral catheter as an adjunctive therapy to antihypertensive medications to treat patients with HTN.