What question did this study set out to answer?

To assess the long-term outcomes of renal denervation using the TIVUS system in resistant hypertension over ten years.

April 1, 2026

Ten-year results of therapeutic intra-vascular ultrasound (TIVUS) renal denervation in resistant hypertension: a prospective single-center study

Resultado clave

TIVUS-based ultrasound renal denervation in resistant hypertension safely reduced 10-year mean office blood pressure by 38.7/14.3 mmHg and 24-hour ambulatory systolic blood pressure by 20 mmHg.

Puntos clave

To assess the long-term outcomes of renal denervation using the TIVUS system in resistant hypertension over ten years.
Prospective follow-up of 12 patients with resistant hypertension in a single center.
Underwent bilateral renal denervation using the TIVUS system.
Blood pressure was measured at multiple intervals (baseline, 1, 3, 6, 12 months, and 10 years).
Estimated glomerular filtration rate and adverse events were monitored throughout the study.
Data analyzed using mixed-effects models adjusted for baseline covariates.
Systolic blood pressure decreased by 22 mmHg at one month and 37.6 mmHg at 12 months (p<0.001).
At 10 years, mean office BP reductions of –38.7 mmHg systolic and –14.3 mmHg diastolic were observed (p<0.001).
Significant reductions in 24-hour ambulatory blood pressure were noted over ten years.
Renal function declined modestly, from 68.6 to 60.2 mL/min/1.73 m², without procedure-related adverse events.

PICO estructurado

Does bilateral ultrasound catheter renal denervation using the TIVUS system reduce blood pressure in patients with severe resistant hypertension?

Población

12 patients with severe resistant hypertension, mean age 65±8 years, 75% with diabetes, from a single center.

Intervención

Bilateral ultrasound catheter renal denervation (RDN) using the Therapeutic Intravascular Ultrasound (TIVUS) system.

Resultado

Office BP, 24-hour ambulatory BP, estimated glomerular filtration rate (eGFR), and adverse events at 10 years.surrogate

Ultrasound-based renal denervation using the TIVUS system provides sustained blood pressure reductions and appears safe over a 10-year follow-up in patients with resistant hypertension.

Resultado numérico

Tasa de eventos absoluta: 0% vs 0%

Resumen

Abstract Background Catheter-based renal denervation (RDN) is a promising therapy for resistant hypertension via ablation of renal sympathetic nerves. The Therapeutic Intravascular Ultrasound (TIVUS) system, a non-occlusive, multi-directional catheter, has shown safe BP reduction; however, its long-term efficacy and safety remain uncertain. Purpose To evaluate 10-year outcomes following RDN using the TIVUS system in patients with severe resistant hypertension. Methods We prospectively followed 12 single-center patients with resistant hypertension who underwent bilateral ultrasound catheter RDN as part of the TIVUS trial. Office BP was measured at baseline and one, three, six, and 12 months, then; ambulatory 24 hours BP was assessed at year 1, and 2, 5 and 10 years. Estimated glomerular filtration rate (eGFR) and adverse events were monitored. 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 was 176/84 mmHg. The RDN procedure was completed in all patients without any acute complications. Systolic office BP decreased by 22 mmHg at one month (p0.001) and 37.6 mmHg at 12 months (p0.001). At 10 years, the mean office BP monitoring reflected reductions of –38.7 mmHg systolic (p0.001) and –14.3 mmHg diastolic (p0.001). Consistent with office readings, 24-hour ambulatory BP also decreased over the decade: mean ASBP fell 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) at 10 years. The 10-year net change in the number of defined daily doses (DDDs) of antihypertensive therapy was −1.60 (−2.70, −0.40) (p = 0.002). Renal function declined modestly (eGFR: 68.6 to 60.2 mL/min/1.73 m²), consistent with aging. No procedure-related adverse events were identified at the 10-year follow-up. Conclusions TIVUS-based ultrasound RDN yielded sustained BP reductions and preserved renal function over 10 years, supporting its long-term safety and therapeutic durability in resistant hypertension.Longitudinal 24-hour ambulatory BPFor image description, please refer to the figure legend and surrounding text. Distribution GFR over 10years after RDNFor image description, please refer to the figure legend and surrounding text.

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