Transcatheter renal denervation in patients with resistant arterial hypertension: follow-up study of efficiency and safety

Objective. To evaluate the efficacy and safety of transcatheter renal denervation (TRD) in drug-resistant hypertension in a single-institution study (NCT01499810). Design and methods. Subjects with essential hypertension aged 18-80 years with blood pressure (BP) > 160/100 mmHg despite three or more antihypertensive drugs who signed written informed consent were included in the study. Exclusion criteria were: mean 24-h systolic BP < 135 mmHg (a^mbulatory blood pressure ^monitoring), esti^mated glo^merular filtration rate (e^jFR.) < 30 ml/ min/m², severe concomitant diseases. TRD was performed as 4-8 point radiofrequency (RF) ablations in each renal artery using standard EP catheter 5F. Efficacy endpoints: changes in office and ambulatory BP at 6 and 12 months after TRD. Safety endpoints: adverse events, changes in renal blood flow (ultrasound dopplerography) and renal function (proteinuria, serum creatinine, eGFR) at 1^st week, 6 and 12 months after TRD. Results. Interim analysis was done to monitor safety of TRD. The intervention was performed in 45 patients (aged 52,9 ± 12,2 years, 22 male), 29 patients were examined at 6 months and 16 patients — at 12 months after TRD. Intraoperative angiography showed no damage of renal arteries due to RF ablation. There were 5 minor periprocedural complications: small subcapsular kidney hematoma (80 ml by magnet-resonance tomography), contrast nephropathy, 2 access site pseudoaneurysms, allergy to dye. No additional events, significant changes in renal blood flow or renal function were found at 6 and 12 months of follow-up. Office BP fell by -34,8/-17,2 mmHg (p < 0,00001/0,00001) at 6 months and -41,0/-24,1 mmHg (p < 0,0001/0,0001) at 12 months after TRD (systolic/diastolic, respectively). Mean 24-h BP decreased by -11,1/-7,1 (p < 0,001/0,001) and 20,8/-13,1 mmHg (p < 0,0001/0,0001), respectively. Conclusions. TRD is safe in patients with resistant hypertension and causes significant long-term reduction of both office and ambulatory BP.

hypertension, radiofrequency ablation, percutaneous intervention

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