Safety Of Renal Sympathetic Denervation Using An Saline-Irrigated Radiofrequency Ablation Catheter In111Patients

Objective:To evaluate the safety of renal sympathetic denervation(RSD) using a saline-irrigated radiofrequency ablation catheter in111patients.Methods:Acute adverse events were recorded during bilateral RSD procedure with a saline-irrigated catheter. To evaluate renal function and renal artery structure, Serum creatinine(Scr), urea nitrogen(BUN), cystatin C and renal artery CTA were obtained in55patients from baseline to6month after RSD. To evaluate the safety of the procedure, blood pressure were obtained in patients with Heart Failure from baseline to3month and6month after RSD. To assess the effectiveness of the procedure, blood pressure were obtained in patients with Hypertension from baseline to6month after RSD.Results:111patients (79males and32females, aged53.7±13.1years old) with hypertension, atrial fibrillation(AF) and/or heart failure(HF) etc underwent RSD procedure. The number of lesions, average lesion duration, total duration, ablation power, ablation temperature, start impedance, mean impedance decreasing was16.1±2.5points,71.6±19.5S,1144.6±338.3S,9.2±1.5W,39.3±1.2℃,173.7±27.2Ω and10.86±11.3Ω, respectively. Acute adverse events included lesion area pain (110cases,99%), vasovagal reflex (25cases,22.5%), right renal artery dissection(one c ase,0.9%), vasospasm(one case,0.9%) and hematoma at the femoral access site(one case,0.9%) during procedure. The pain and vasovagal reflex disappeared after RSD procedure. The Renal artery dissection was treated with a stent without any subsequent complication.55patients have completed6-month follow-up. Scr, BUN and cystatin C concentrations had no significant change from baseline to6months follow-up(77.4±19.5vs79.0±21.7μmol/L, P>0.05,5.9±1.7vs6.0±1.7mmol/L, P>0.05,1.07±0.25vs1.1±0.26mg/L, P>0.05, respectively). Renal artery CTA scan showed that two renal arteries had serious stenosis in2individuals.90%stenosis in the proximal portion of the right renal artery was observed with one patient, and right upper branch of renal artery had completely closed in another patient. The rest of renal arteries were normal at6-month after RSD. Office blood pressure after procedure in patients with Chronic Heart Failure were115.20±11.95/77.80±13.9mmHg,121.67±16.23/83±10.16mmHg at3and6months, respectively. In patients with Hypertension, office blood pressure after procedure were reduced by-13/-9mmHg at6months.Conclusion:Renal sympathetic denervation with irrigation catheter is relative safety. The rate of acute renal artery dissection was0.9%(1/111). Renal function had no significant change and serious renal stenosis occurred in two patients(3.6%,2/55) at6months follow-up. There was no orthostatic hypotension, atelectasis, bowel dysfunction or sweat off happening at6months follow-up. There were no hypotension occurring in patients with Chronic Heart Failure.