Supplementary Material for: Ten-Year Results of Therapeutic Intra-Vascular Ultrasound (TIVUS) Renal Denervation in Resistant Hypertension: A Prospective Single-Center Study

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.