Early blood pressure outcomes after SPYRAL™ renal denervation: an exploratory small cohort analysis

Catheter-based renal denervation (RDN) is an interventional therapy for patients with resistant or uncontrolled arterial hypertension after the exclusion of secondary causes. This study aimed to evaluate the effects of the SPYRAL™ catheter system on systolic (SBP) and diastolic blood pressure (DBP) in a real-world clinical setting. Additionally, we explored whether the number of ablation points was associated with the magnitude of blood pressure (BP) reduction.

We conducted a retrospective, single-center study including patients aged ≥18 years with predominantly resistant hypertension with preserved renal function (eGFR ≥40 mL/min/1.73 m2) and no evidence of secondary hypertension. Ambulatory blood pressure monitoring (ABPM) and renal function were assessed at baseline and three months after RDN. Patients were stratified into subgroups based on the number of ablation points (≤20 vs. >20). A two-tailed p-value <0.05 was considered statistically significant.

Data from eleven patients (mean age 64.4 ± 8.1, 45.5% were male) were analyzed. At three months, eGFR remained stable (mean decrease -4.6 mL/min/1.73 m², CI 95% -15.8-6.6, p = 0.37). Mean ambulatory SBP and DBP decreased significantly following RDN (Δ -19.4mmHg, CI 95% -9.2 to -29.7, p = 0.002; Δ -8.6 mmHg, CI 95% -3.9 to -13.3, p = 0.002; for SBP and DBP respectively). Subgroup analysis revealed that patients with more ablation points experienced a greater reduction in SBP (Δ -17.7 mmHg, CI 95% 0.1-35.3, p = 0.04) and a numerically greater reduction in DBP (Δ -4.8 mmHg, CI 95% 4.5-12, p = 0.27) than those with fewer abation points.

In this small retrospective cohort, reductions in SBP and DBP were observed following RDN using the SPYRAL™ multi-electrode system, with no excess of adverse renal events. These preliminary findings require confirmation in larger, adequately powered patient cohorts before firm conclusions can be established.