Renal Sympathetic Denervation by CT-Guided Ethanol Injection: A Phase II Pilot Trial of a Novel Technique
- 354 Downloads
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.
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).
CT-guided sympathetic denervation proved to be safe and applicable under various anatomical conditions with more renal arteries and such of small diameter.
KeywordsTherapy-resistant arterial hypertension Sympathetic nerves Vasotonus CT-guided ablation
Compliance with Ethical Standards
Conflict of Interest
All authors declare they have no conflict of interest.
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The institutional review board approved the study. All patients provided written informed consent prior to inclusion. The study was registered as EudraCT 2012-002978-31.
Informed consent was obtained from all individual participants included in this study.
- 1.Lim SS, Vos T, Flaxman AD, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the global Burden of disease study 2010. Lancet. 2012;380:2224–60.PubMedCentralCrossRefPubMedGoogle Scholar
- 31.Wang S, Zhuang L, Meng Z. Hepatocellular carcinoma more than 3 cm in diameter: a systematic review of transcatheter arterial chemoembolization plus percutaneous ethanol injection versus transcatheter arterial chemoembolization alone. ISRN Gastroenterol. 2013;2013:526024.PubMedCentralPubMedGoogle Scholar