Clinical outcomes of laparoscopic‐based renal denervation plus adrenalectomy vs adrenalectomy alone for treating resistant hypertension caused by unilateral aldosterone‐producing adenoma

Abstract

Previous studies describing renal denervation (RDN) from the intima of the renal artery for the treatment of resistant hypertension have reported variable efficacies, and RDN triggers renal intimal injury and atherosclerosis. This study aimed to evaluate the efficacy and safety of RDN from the adventitia of renal artery plus unilateral laparoscopic adrenalectomy to treat patients with resistant hypertension caused by unilateral aldosterone-producing adenoma (APA). A total of 60 consecutive patients with resistant hypertension caused by unilateral APA were enrolled in this study. Patients were randomly assigned to undergo RDN from the adventitia of the renal artery plus adrenalectomy (RDN group, n = 30) or adrenalectomy alone (control group, n = 30) and were followed up for 12 months. The primary efficacy end point was the change in 24-hours mean ambulatory systolic blood pressure (SBP) from baseline to 12 months. At the 12-month follow-up, the mean reduction of 24-hours average SBP and office SBP in the RDN group was 20.7 ± 15.2 and 37.1 ± 26.0 mm Hg, respectively, which was significantly higher than the mean reduction of 24-hours average SBP (11.9 ± 11.1 mm Hg, P = .017) and the office SBP (25.9 ± 16.8 mm Hg, P = .035) in the control group. Serum potassium levels returned to normal 12 months post-procedure. Patients in the RDN group had higher proportion of cured clinical and biochemical outcomes than those in the control group (35.7% vs 17.9% in clinical outcome; 96.4% vs 89.3% in biochemical outcome, respectively). There were no procedural-, device-, or treatment-related safety events during the 12-month followup period between the groups. In conclusion, RDN from the adventitia of the renal artery plus unilateral laparoscopic adrenalectomy is more effective than adrenalectomy alone for treating resistant hypertension caused by unilateral APA.

Thirty‐six‐month results of laparoscopic‐based renal denervation plus unilateral laparoscopic adrenalectomy for the treatment of patients with resistant hypertension caused by unilateral aldosterone‐producing adenoma

“…From the results of previous studies, the ambulatory BP and office BP of the RDN group decreased more significantly than those of the control group, and combined laparoscopic adrenalectomy with adventitia‐RDN was equally safe at one year postprocedure. 16 This report also carried out a 3‐year long‐term follow‐up of the clinical study. From the results of our study, it can be seen that both laparoscopic adrenalectomy on the affected side alone and laparoscopic adrenalectomy combined with adventitia‐RDN can safely and effectively reduce BP in patients with resistant hypertension caused by APA.…”

Consensus and inconsistency between different consensus documents on renal denervation worldwide: the way forward

“…Although there are currently no published RDN registries in Chinese mainland, two RDN clinical trials have been conducted. RDN was performed using a saline-irrigated ablation catheter in one of the trials, [57] and by adventitia ablation using a radiofrequency catheter following laparoscopic adrenalectomy in the other trial [58] . Although no sham-controlled groups were included, both randomized trials demonstrated the efficacy of RDN in reducing office and ambulatory BP for up to 12 months.…”

“…If the BP is not controlled following definitive treatment for the secondary causes it is reasonable to recommend RDN, since hypertension is inherently a multifactorial disease. [ 58 ] In the ARDeC consensus, patients with suspected higher sympathetic tone, including Asian hypertensive patients, [ 70 ] patients with obstructive sleep apnea, and patients with increased 24-h ambulatory heart rate (>74/min), [ 43 , 71 ] and features of salt sensitivity such as asleep hypertension and morning hypertension [ 59 , 70 ] are considered to be ideal candidates for RDN. The ARDeC consensus also recommends that patients with resistant hypertension, those with established cardiovascular disease, and those who are either intolerant or do not adhere to antihypertensive medications are ideal candidates.…”

“…The “2” stands for “treatment-resistant secondary ( 2 ndary) hypertension.” The presence of secondary causes of hypertension does not guarantee that the identified secondary causes are the only causes of hypertension. If the BP is not controlled following definitive treatment for the secondary causes it is reasonable to recommend RDN, since hypertension is inherently a multifactorial disease [58] . In the ARDeC consensus, patients with suspected higher sympathetic tone, including Asian hypertensive patients, [70] patients with obstructive sleep apnea, and patients with increased 24-h ambulatory heart rate (>74/min), [43,71] and features of salt sensitivity such as asleep hypertension and morning hypertension [59,70] are considered to be ideal candidates for RDN.…”

Device-Based Treatment in Hypertension: At the Forefront of Renal Denervation

“…Various other modalities, including microwave, [65] ionizing radiation, [66] cryo-ablation [67,68] and modified laparoscopic techniques [69,70] have been studied for RDN application, each with specific potential clinical advantages. However, these technologies have not yet progressed beyond the pre-clinical or early first in man phase of research.…”