title: Renal Sympathetic Denervation by CT-Guided Ethanol Injection: A Phase II Pilot Trial of a Novel Technique.
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  CT-guided sympathetic denervation proved to be safe and applicable under various anatomical conditions with more renal arteries and such of small diameter.
authors.affiliation: 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.|Deutsche Akademie für Mikrotherapie, Magdeburg, Germany. jens.ricke@med.ovgu.de.
authors.forename: J
authors.initials: J
authors.lastname: Ricke
authors.affiliation: Department of Radiology and Nuclear Medicine, Universitätsklinikum Magdeburg AöR, Otto-von-Guericke University Magdeburg, Leipziger Straße 44, 39120, Magdeburg, Germany.|Deutsche Akademie für Mikrotherapie, Magdeburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Seidensticker
authors.affiliation: Department of Radiology and Nuclear Medicine, Universitätsklinikum Magdeburg AöR, Otto-von-Guericke University Magdeburg, Leipziger Straße 44, 39120, Magdeburg, Germany.|Department of Nephrology and Hypertension, Diabetes and Endocrinology, Universitätsklinikum Magdeburg AöR, Magdeburg, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Becker
authors.affiliation: Department of Nephrology and Hypertension, Diabetes and Endocrinology, Universitätsklinikum Magdeburg AöR, Magdeburg, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Schiefer
authors.affiliation: Department of Radiology and Nuclear Medicine, Universitätsklinikum Magdeburg AöR, Otto-von-Guericke University Magdeburg, Leipziger Straße 44, 39120, Magdeburg, Germany.
authors.forename: I
authors.initials: I
authors.lastname: Adamchic
authors.affiliation: Department of Radiology and Nuclear Medicine, Universitätsklinikum Magdeburg AöR, Otto-von-Guericke University Magdeburg, Leipziger Straße 44, 39120, Magdeburg, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Lohfink
authors.affiliation: Department of Nephrology and Hypertension, Diabetes and Endocrinology, Universitätsklinikum Magdeburg AöR, Magdeburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Kandulski
authors.affiliation: Department of Nephrology and Hypertension, Diabetes and Endocrinology, Universitätsklinikum Magdeburg AöR, Magdeburg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Heller
authors.affiliation: Department of Nephrology and Hypertension, Diabetes and Endocrinology, Universitätsklinikum Magdeburg AöR, Magdeburg, Germany.
authors.forename: P R
authors.initials: PR
authors.lastname: Mertens
mesh_terms: D000328:Adult; D000368:Aged; D000431:Ethanol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007267:Injections; D007668:Kidney / Q000294:innervation*; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D010865:Pilot Projects; D015641:Radiography, Interventional; D013562:Sympathectomy / Q000379:methods*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000431:Ethanol
keywords: CT-guided ablation; Sympathetic nerves; Therapy-resistant arterial hypertension; Vasotonus