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Erschienen in: CardioVascular and Interventional Radiology 2/2016

01.02.2016 | Clinical Investigation

Renal Sympathetic Denervation by CT-Guided Ethanol Injection: A Phase II Pilot Trial of a Novel Technique

verfasst von: J. Ricke, M. Seidensticker, S. Becker, J. Schiefer, I. Adamchic, K. Lohfink, M. Kandulski, A. Heller, P. R. Mertens

Erschienen in: CardioVascular and Interventional Radiology | Ausgabe 2/2016

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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.
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Metadaten
Titel
Renal Sympathetic Denervation by CT-Guided Ethanol Injection: A Phase II Pilot Trial of a Novel Technique
verfasst von
J. Ricke
M. Seidensticker
S. Becker
J. Schiefer
I. Adamchic
K. Lohfink
M. Kandulski
A. Heller
P. R. Mertens
Publikationsdatum
01.02.2016
Verlag
Springer US
Erschienen in
CardioVascular and Interventional Radiology / Ausgabe 2/2016
Print ISSN: 0174-1551
Elektronische ISSN: 1432-086X
DOI
https://doi.org/10.1007/s00270-015-1261-6

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