Key result
Renal denervation using the Vessix system reduced systolic blood pressure by 30 mmHg in a patient with a pacemaker, without affecting normal pacemaker function over 4 months of follow-up.
Why the study?
Does renal denervation using the Vessix system safely reduce blood pressure without affecting pacemaker function in a patient with resistant hypertension and a pacemaker?
Case Report (n=1)
Does renal denervation using the Vessix system safely reduce blood pressure without affecting pacemaker function in a patient with resistant hypertension and a pacemaker?
Renal denervation using a balloon-mounted bipolar electrode system effectively reduced blood pressure without interfering with pacemaker function in a single patient.
Hypothesis-generating for renal denervation in pacemaker patients; should not yet change practice pending larger studies.
Aims: Renal denervation using the point-by-point application of radiofrequency (RF) energy delivered by the firstgeneration Symplicity system is effective in lowering office blood pressure however it is time-consuming. The Vessix Renal Denervation System with eight balloon-mounted bipolar electrodes shortens and simplifies the procedure. This has been the first in-human case examining the efficiency of reducing blood pressure and also the effect of RF energy in case of renal denervation on the normal functioning of pacemaker and the tolerability of the procedure in case of a patient living with pacemaker. Materials and methods: The diabetic patient with a coronary artery disease had a baseline office systolic blood pressure ≥ 150 mmHg and took four antihypertensive medications. She had a Biotronik Talos S pacemaker with a unipolar Biotronik PX 60 UP lead because of sick sinus syndrome however she was not dependent on pacemaker. We applied 30 sec. long RF treatments in the renal artery two times. Results: The patients baseline systolic BP was 185 mmHg which reduced by 30 mmHg immediately after the denervation. The lowering of blood pressure was permanent during the 24-hour and four-months supervisions, despite the fact that we carried out the intervention only on one side. The radiofrequency energy did not have an impact on the normal functioning of the pacemaker during and after the intervention. It did cause less physical and psychological burden for the patient than a longer procedure.
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Csaba András Dézsi (2013) conducted a case report in Resistant hypertension (n=1). Renal denervation using the Vessix Renal Denervation System was evaluated on Reduction in systolic blood pressure and normal functioning of pacemaker. Renal denervation using the Vessix system reduced systolic blood pressure by 30 mmHg in a patient with a pacemaker, without affecting normal pacemaker function over 4 months of follow-up.
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