Abstract

BACKGROUND

Renal denervation (RDN) is an emerging therapy for resistant hypertension. The Therapeutic Intravascular Ultrasound (TIVUS) system offers a non-occlusive, multi-directional approach, but its long-term efficacy and safety remain unknown.

PURPOSE

To evaluate 10-year outcomes following RDN using the TIVUS system in patients with severe resistant hypertension.

MATERIALS AND METHODS

We prospectively followed 12 patients who underwent bilateral ultrasound RDN as part of the TIVUS trial. Office BP was measured at baseline, 1, 3, 6, and 12 months; 24-hour ambulatory BP at years 1, 2, 5, and 10. Estimated glomerular filtration rate (eGFR) and adverse events were tracked. BP changes were analyzed using mixed-effects models adjusted for baseline covariates.

RESULTS

Mean age was 65 ± 8 years; 75 % had diabetes. Baseline office BP averaged 176/84 mmHg. The RDN procedure was completed in all patients without complications. Systolic office BP decreased by 22 mmHg at 1 month (p < 0.001) and 37.6 mmHg at 12 months (p < 0.001). At 10 years, office BP reductions were -38.7/-14.3 mmHg (p < 0.001). Ambulatory BP declined similarly: ASBP from 149.4 ± 9.8 to 128.4 ± 10.0 mmHg (Δ≈-20) and ADBP from 85.0 ± 8.5 to 74.4 ± 9.2 mmHg (Δ≈-10.6). The 10-year change in antihypertensive defined daily doses was -1.60 (95 % CI -2.70 to -0.40; p = 0.002). eGFR declined modestly (68.6 to 60.2 mL/min/1.73 m²), consistent with aging. No procedure-related adverse events occurred.

CONCLUSIONS

TIVUS ultrasound RDN achieved durable BP reduction with preserved renal function over 10 years.

MeSH

Kidney Diseases, Hypertension, Denervation, Blood Pressure, Kidney, Drug-Related Side Effects And Adverse Reactions, Therapeutics