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

@entity1 @entity137 @entity1068 @entity101
OBJECTIVES: CT-guided @entity1068 -mediated renal sympathetic denervation in treatment of therapy-resistant @entity101 was performed to assess @entity1 safety and collect preliminary data on treatment efficacy. MATERIALS AND METHODS: Eleven @entity1 with therapy-resistant @entity101 (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 @entity137 >= 3   occurred. Three @entity1 exhibited worsened kidney function in follow-up analyses. When accounting all @entity1 , 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 @entity1 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.
