August 2013


Blood pressure reductions with OneShot renal denervation device sustained at 12 months


John A Ormiston (Mercy Angiography, New Market, New Zealand) and others reported the 12-month results of the Renal Hypertension Ablation System (RHAS) trial in EuroIntervention, which showed that reduction in office blood pressure with the OneShot renal denervation device (Covidien) were sustained at 12 months. The study was also presented as an abstract at EuroPCR (21–24 May, Paris, France)


O


rmiston et al re- ported that unlike the first-generation


renal denervation devices, which use radiofrequency energy to ablate the sympathetic nerves in the renal artery adventitia in a distal-to-proximal, point- by-point pattern, the One- Shot device is designed to achieve renal denervation “using a single two-minute ablation to each renal artery.” They added that the RHAS study was a first-in-man, hypothesis- generating study that aimed to provide safety and feasibility data for the device. The primary endpoint was the ability to insert the OneShot balloon into each renal artery and


to deliver low-level radi- ofrequency energy. The authors com- mented, as has been previously reported, that the primary endpoint was achieved in eight of the nine patients in the study (89%). Mean systolic office blood pressure was significantly reduced from 185.67±18.7mmHg at baseline to


155.58±58±18.84mmHg at one month (p=0.0004), to 151.46±19.93mmHg at three months (p=0.002), and to 152.08±22.27mmHg at six months (p=0.021). Ormiston et al said that at 12 months, mean systolic office blood pressure was significantly reduced to


minor adverse events at 12 months and with no change in renal function and no appearance of renal artery stenosis.


John A Ormiston


155.89±27.27mmHg (p=0.019). They noted: “In the current trial, the reduction in office blood pressure compared with baseline is sustained at 12 months.” Furthermore, renal denervation with the OneShot device was found to be safe with


However although reductions in ambula- tory blood pressure were observed at one, three, six, and 12 months, they were of a lesser magnitude than those observed with office systolic blood pressure. Ormiston et al comment- ed: “Office blood pressure measurement is widely used in hypertension stud- ies and is of prognostic importance. The relatively small change in 24-hour ambulatory blood pressure could be because some of the patients had ‘white- coat’ hypertension.”


Renal denervation


Significant and sustained blood


pressure reduction with Vessix renal


denervation system I


nterim data from the REDUCE-HTN clinical pro- gramme, presented at EuroPCR (21–24 May, Paris, France) by Joachim Schofer (Hamburg University Cardiovascular Center, Hamburg, Germany), indi- cates that the Vessix renal denervation system (Boston Scientific) is associated with a significant and sustained reduction in blood pressure.


The aim of the REDUCE-HTN is to evaluate the ability of the Vessix system to reduce blood pressure in patients with resistant hypertension. Investigators are comparing patients’ blood pressure levels at six months after receiving treatment with the renal denervation system with their pre-treatment levels. All patients underwent successful bilateral renal denervation treatment and there were no reports of device-related adverse events or procedural renal artery complications. The investigators also noted that at six months, patients experienced a significant 27.6mmHg reduction in systolic blood pressure (p<0.0001). Furthermore, long-term efficacy was demonstrated, with a sustained 28.4mmHg reduction in systolic blood pressure in the subset of patients for whom 12-month data are available.


Horst Sievert, CardioVascular Center Frankfurt, Sankt Katharinen Hospital, in Frankfurt, Germany, and principal investigator in the REDUCE-HTN clinical programme, said: “The interim data from REDUCE- HTN demonstrate that renal denervation with the Vessix System offers a significant and sustained blood pressure reduction in patients with uncontrolled hypertension.


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