J Ricke1,2, M Seidensticker3,4, S Becker3,5, J Schiefer5, I Adamchic3, K Lohfink3, M Kandulski5, A Heller5, P R Mertens5. 1. Department of Radiology and Nuclear Medicine, Universitätsklinikum Magdeburg AöR, Otto-von-Guericke University Magdeburg, Leipziger Straße 44, 39120, Magdeburg, Germany. jens.ricke@med.ovgu.de. 2. Deutsche Akademie für Mikrotherapie, Magdeburg, Germany. jens.ricke@med.ovgu.de. 3. Department of Radiology and Nuclear Medicine, Universitätsklinikum Magdeburg AöR, Otto-von-Guericke University Magdeburg, Leipziger Straße 44, 39120, Magdeburg, Germany. 4. Deutsche Akademie für Mikrotherapie, Magdeburg, Germany. 5. Department of Nephrology and Hypertension, Diabetes and Endocrinology, Universitätsklinikum Magdeburg AöR, Magdeburg, Germany.
Abstract
OBJECTIVES:CT-guided ethanol-mediated renal sympathetic denervation in treatment of therapy-resistant hypertension was performed to assess patient safety and collect preliminary data on treatment efficacy. MATERIALS AND METHODS:Eleven patients with therapy-resistant hypertension (blood pressure of >160 mmHg despite three different antihypertensive drugs including a diuretic) and following screening for secondary causes were enrolled in a phase II single arm open label pilot trial of CT-guided neurolysis of sympathetic renal innervation. Primary endpoint was safety, and secondary endpoint was a decrease of the mean office as well as 24-h systolic blood pressure in follow-up. Follow-up visits at 4 weeks, 3, and 6 months included 24-h blood pressure assessments, office blood pressure, laboratory values, as well as full clinical and quality of life assessments. RESULTS: No toxicities ≥3° occurred. Three patients exhibited worsened kidney function in follow-up analyses. When accounting all patients, office systolic blood pressure decreased significantly at all follow-up visits (maximal mean decrease -41.2 mmHg at 3 months). The mean 24-h systolic blood pressure values decreased significantly at 3 months, but not at 6 months (mean: -9.7 and -6.3 mmHg, respectively). Exclusion of five patients who had failed catheter-based endovascular denervation and/or were incompliant for antihypertensive drug intake revealed a more pronounced decrease of 24-h systolic blood pressure (mean: -18.3 and -15.2 mmHg at 3 and 6 months, p = 0.03 and 0.06). CONCLUSION:CT-guided sympathetic denervation proved to be safe and applicable under various anatomical conditions with more renal arteries and such of small diameter.
RCT Entities:
OBJECTIVES: CT-guided ethanol-mediated renal sympathetic denervation in treatment of therapy-resistant hypertension was performed to assess patient safety and collect preliminary data on treatment efficacy. MATERIALS AND METHODS: Eleven patients with therapy-resistant hypertension (blood pressure of >160 mmHg despite three different antihypertensive drugs including a diuretic) and following screening for secondary causes were enrolled in a phase II single arm open label pilot trial of CT-guided neurolysis of sympathetic renal innervation. Primary endpoint was safety, and secondary endpoint was a decrease of the mean office as well as 24-h systolic blood pressure in follow-up. Follow-up visits at 4 weeks, 3, and 6 months included 24-h blood pressure assessments, office blood pressure, laboratory values, as well as full clinical and quality of life assessments. RESULTS: No toxicities ≥3° occurred. Three patients exhibited worsened kidney function in follow-up analyses. When accounting all patients, office systolic blood pressure decreased significantly at all follow-up visits (maximal mean decrease -41.2 mmHg at 3 months). The mean 24-h systolic blood pressure values decreased significantly at 3 months, but not at 6 months (mean: -9.7 and -6.3 mmHg, respectively). Exclusion of five patients who had failed catheter-based endovascular denervation and/or were incompliant for antihypertensive drug intake revealed a more pronounced decrease of 24-h systolic blood pressure (mean: -18.3 and -15.2 mmHg at 3 and 6 months, p = 0.03 and 0.06). CONCLUSION: CT-guided sympathetic denervation proved to be safe and applicable under various anatomical conditions with more renal arteries and such of small diameter.