Interventional procedure overview of percutaneous transluminal renal sympathetic denervation for resistant hypertension

Radiofrequency RDN

The mortality rate was less than 1% (10/2,237) at 6 months, 1% (28/2,112) at 1 year, 3% (54/1,917) at 2 years, and 4% (59/1,345) at 3 years after the procedure in the case series of 2,237 patients. The cardiovascular death rate was 0.3% at 6 months, 0.8% at 1 year, 1.5% at 2 years and 2.0% at 3 years, and the non-cardiovascular death rate was 0.1% at 6 months, 0.3% at 1 year, 1.0% at 2 years and 1.6% at 3 years (Mahfoud 2019).

All-cause mortality was reported in 2 patients who had RDN and 1 patient who had a sham procedure (SYMPLICITY HTN-3 2014) in the Cochrane review of 15 studies (Pisano 2021).

Death because of acute aortic dissection was reported in 1 patient at 2 months after the procedure in the RFM-RDN group in the 3-arm randomised trial of 117 patients (Fengler 2019).

Ultrasound RDN

All-cause mortality was described in 1 patient in the RDN group in the RCT of 136 patients (Azizi 2021).

Radiofrequency and ultrasound RDN

Death was reported in 10% (29/296) of patients during a median follow up of 48 months in the case series of 296 patients. Cardiovascular death was described in 5% (16/296) of patients. When considering response status, death was reported in 11% (19/180) of patients who responded to RDN and 9% (10/116) of patients who did not (hazard ratio [HR] 1.22, 95% CI 0.58 to 2.57, p=0.69; Fengler 2021).

Radiofrequency and ultrasound RDN

Major adverse cardiovascular events (cardiovascular death, ischaemic stroke or intracranial bleeding, acute myocardial infarction, critical limb ischaemia and acute renal failure) were reported in 15% (45/296) of patients during a median follow up of 48 months in the case series of 296 patients. When considering response status, major adverse cardiovascular events occurred less frequently in patients who responded to RDN than patients who did not, and the effect was statistically significant (12% [22/180] compared with 20% [23/116], HR 0.53, 95% CI 0.28 to 0.97, p=0.041). This statistically significant effect remained after adjustment for relevant covariates (p=0.041) and a propensity matched analysis (p=0.043). A proportional relationship was found between BP reduction after 3 months and frequency of major adverse cardiovascular events (HR 0.75 [95% CI 0.58 to 0.97] per 10 mmHg 24-hour systolic ambulatory BP reduction, p=0.031; Fengler 2021).

Ischaemic events (ischaemic stroke, acute myocardial infarction, peripheral artery disease needing intervention, and critical limb ischaemia) were reported in 11% (34/296) of patients during a median follow up of 48 months in the case series of 296 patients. When considering response status, ischaemic events happened less frequently in patients who responded to RDN than patients who did not, and the effect was statistically significant (8% [15/180] compared with 16% [19/116], HR 0.44, 95% CI 0.22 to 0.89, p=0.022). This statistically significant effect remained after a propensity matched analysis (p=0.08; Fengler 2021).

Radiofrequency RDN

RDN was associated with a higher risk of myocardial infarction compared with control, but the effect was not statistically significant (RR 1.31, 95% CI 0.45 to 3.84, p=0.62; I²=0%; 4 studies, n=742; GRADE, low quality) in the Cochrane review of 15 studies (Pisano 2021).

The rate of myocardial infarction was less than 1% (16/2,237) at 6 months, 1% (23/2,112) at 1 year, 2% (31/1,917) at 2 years, and 2% (33/1,345) at 3 years after the procedure in the case series of 2,237 patients (Mahfoud 2019).

Ultrasound RDN

Acute myocardial infarction (STEMI or non-STEMI) was reported in 1 patient in the RDN group in the RCT of 136 patients (Azizi 2021).

Radiofrequency RDN

Hospital admission for new onset heart failure was described in 9 patients in the RDN group and 3 patients in the sham group (SYMPLICITY HTN-3 2014) in the Cochrane review of 15 studies (Pisano 2021).

The rate of hospitalisation for new onset heart failure was less than 1% (16/2,237) at 6 months, 1% (24/2,112) at 1 year, 2% (38/1,917) at 2 years and 3% (46/1,345) at 3 years after the procedure in the case series of 2,237 patients (Mahfoud 2019).

Hospitalisation for acute decompensated heart failure was reported in 1 patient in the RFB-RDN group in the 3-arm randomised trial of 117 patients (Fengler 2019).

Radiofrequency and ultrasound RDN

Heart failure hospitalisation was reported in 7% (20/296) of patients during a median follow up of 48 months in the case series of 296 patients. When considering response status, heart failure hospitalisation was described in 7% (13/180) of patients who responded to RDN and 6% (7/116) of patients who did not (HR 1.27, 95% CI 0.52 to 3.11, p=0.59; Fengler 2021).

Radiofrequency RDN

RDN might have little or no effect on the risk of ischaemic stroke compared with control (RR 0.98, 95% CI 0.33 to 2.95, p=0.97; I² =0%; 5 studies, n=892; GRADE, low quality) in the Cochrane review of 15 studies (Pisano 2021).

The rate of stroke was less than 1% (15/2,237) at 6 months, 1% (27/2,112) at 1 year, 2% (41/1,917) at 2 years, and 3% (47/1,345) at 3 years after the procedure in the case series of 2,237 patients (Mahfoud 2019).

Radiofrequency RDN

RDN had a lower risk of unstable angina compared with control, but the effect was not statistically significant (RR 0.51, 95% CI 0.09 to 2.89, p=0.45; I² =0%; 3 studies, n=270; GRADE, low quality) in the Cochrane review of 15 studies (Pisano 2021).

Ultrasound RDN

Vasospastic angina was reported in 1 patient during the RDN procedure in the RCT of 136 patients (Kario 2022).

Radiofrequency RDN

The rate of hospitalisation for atrial fibrillation was less than 1% (15/2,237) at 6 months, 2% (32/2,112) at 1 year, 2% (46/1,917) at 2 years, and 3% (45/1,345) at 3 years after the procedure in the case series of 2,237 patients (Mahfoud 2019).

Hospitalisation for atrial fibrillation episodes was reported in 5 patients in the RDN group and 1 patient in the sham group (SYMPLICITY HTN-3 2014) in the Cochrane review of 15 studies (Pisano 2021).

Radiofrequency RDN

There were no statistically significant differences in the changes in serum creatinine levels (MD 0.03 mg/dL, 95% CI -0.06 to 0.13, p=0.50; I²=68%; 5 studies, n=721; GRADE, moderate quality) and in eGFR or creatinine clearance (MD -2.56 mL/min/1.73m², 95% CI -7.53 to 2.42, p=0.31; I²=50%; 6 studies, n=822; GRADE, moderate quality) between RDN and control in the Cochrane review of 15 studies (Pisano 2021).

The rate of new onset end-stage renal disease was 0.2% (4/2,237) at 6 months, 0.4% (9/2,112) at 1 year, 1.0% (19/1,917) at 2 years, and 1.6% (23/1,345) at 3 years after the procedure in the case series of 2,237 patients. The rates of serum creatinine elevation of more than 50% mg/dL were 0.4% (9/2,237) at 6 months, 0.9% (1.9/2,112) at 1 year, 1.2% (24/1,917) at 2 years and 1.5% (24/1,345) at 3 years (Mahfoud 2019).

There was a statistically significant decrease in renal function at 12 months (-2 mL/min/1.73 m²; p<0.05) in the case series of 407 patients (Zweiker 2016).

Ultrasound RDN

Doubling of plasma creatinine was reported in 1 patient in the RDN group in the RCT of 136 patients (Azizi 2021).

Radiofrequency RDN

RDN was associated with a higher risk of hypotensive episodes compared with control, but the effect was not statistically significant (RR 1.60, 95% CI 0.20 to 12.63, p=0.66; I²=58%; 3 studies, n=143) in the Cochrane review of 15 studies (Pisano 2021).

Symptomatic hypotension was reported in 2 patients in the RFB-RDN group in the 3-arm randomised trial of 117 patients (Fengler 2019).

Therapy-resistant hypotension was reported in 1 patient in the case series of 407 patients (Zweiker 2016).

Ultrasound RDN

Decreased BP was described in 1 patient within 3 months after RDN in the RCT of 136 patients (Kario 2022).

Radiofrequency RDN

RDN was associated with a lower risk of hypertensive crisis compared with control, but the effect was not statistically significant (RR 0.71, 95% CI 0.35 to 1.45, p=0.34; I²=0%; 3 studies, n=722) in the Cochrane review of 15 studies (Pisano 2021).

Symptomatic hypertension needing medical treatment was described in 1 patient in the RFM-RDN group and 2 patients in the RFB-RDN group in the 3-arm randomised trial of 117 patients (Fengler 2019).

The rate of hospitalisation for hypertensive crisis or emergency was less than 1% (17/2,237) at 6 months, 1% (24/2,112) at 1 year, 2% (36/1,917) at 2 years, and 3% (40/1,345) at 3 years after the procedure in the case series of 2,237 patients (Mahfoud 2019).

Ultrasound RDN

Increased BP was reported in 1 patient within 3 months after RDN in the RCT of 136 patients (Kario 2022).

Renal artery dissection or stenosis

Radiofrequency RDN

Renal artery damage after RDN (using the single-electrode denervation system) was reported in 0.45% (26/5,769) of patients (stenosis [more than 50% diameter stenosis], n=19, 0.33%; dissection, n=7, 0.12%) within a median follow up of 6 months (range 1 to 36 months) in a meta-analysis of 50 studies (5,769 patients). Of the 26 patients with renal artery damage, 24 patients needed stent implantation. Time to reported stenting ranged from 0 to 33 months with most events occurring within 6 months after the procedure. An annual incidence rate of renal artery stenting following RDN was 0.20% per year (95% CI 0.12 to 0.29%, I²=0%; Townsend 2020).

Renal artery dissection was reported in 1 patient who had RDN (Prague-15 2016) in the Cochrane review of 15 studies (Pisano 2021). Renal arterial dissection was reported in 1 patient in the case series of 407 patients and this patient needed stent implantation (Zweiker 2016).

The rate of new artery stenosis (more than 70% diameter stenosis) was 0.05% (1/2,237) at 6 months, 0.1% (3/2,112) at 1 year, 0.2% (4/1,917) at 2 years and 0.3% (4/1,345) at 3 years after the procedure in the case series of 2,237 patients (Mahfoud 2019). Re-stenosis(new renal artery stenosis more than 70%) was reported in 1 patient within the 6-month follow up (SYMPLICITY HTN-3 2014) in the Cochrane review of 15 studies (Pisano 2021). Renal artery stenosiswas reported in 2 patients at 72 days and 452 days after the procedure in the case series of 407 patients, and both patients needed percutaneous transluminal renal angioplasty (Zweiker 2016).

Renal artery spasm

Radiofrequency RDN

Renal artery vasospasm was reported in 4 patients who had RDN (Prague-15) and transient renal artery spasm in 1 patient after radiofrequency application (Warchol 2014) in the Cochrane review of 15 studies (Pisano 2021).

Renal artery spasm was described in 1 patient in the case series of 407 patients (Zweiker 2016).

Ultrasound RDN

Transient renal artery spasm was reported in 1 patient in the USM-RDN group in the 3-arm randomised trial of 117 patients (Fengler 2019).

Vasospasm of renal artery was observed in 6% (4/72) of patients who had RDN within 30 days in the RCT of 136 patients. All events resolved quickly during the procedure with intra-arterial injection of nitrates (Kario 2022).

Renal artery reintervention

Radiofrequency RDN

The rate of renal artery reintervention was 0.2% (5/2,237) at 6 months, 0.4% (8/2,112) at 1 year, 0.4% (9/1,917) at 2 years and 0.6% (10/1,345) at 3 years after the procedure in the case series of 2,237 patients (Mahfoud 2019).

Pain

Procedure access site complications

Radiofrequency RDN

RDN statistically significantly increased the risk of bradycardia symptoms compared with control (RR 6.63, 95% CI 1.19 to 36.84, p=0.03; I² =0%; 3 studies, n=220) in the Cochrane review of 15 studies (Pisano 2021).

RDN was associated with a lower risk of hyperkalaemia compared with control, but the effect was not statistically significant (RR 0.43, 95% CI 0.05 to 3.89, p=0.45; I²=37%; 3 studies, n=224) in the Cochrane review of 15 studies (Pisano 2021).

Dissection of the abdominal aorta was reported in 1 patient in the case series of 407 patients (Zweiker 2016).

Embolic event resulting in end-organ damage was reported in 1 patient and pitting oedema needing hospital admission in 1 patient who had RDN (SYMPLICITY HTN-3 2014) in the Cochrane review of 15 studies (Pisano 2021).

Ultrasound RDN

Cellulitis was described in 1 patient and postural dizziness in 1 patient in the RDN group in the RCT of 136 patients (Kario 2022).

Transient non-invasive ventilation was needed in 1 patient in the USM-RDN group after conscious sedation in the RCT of 117 patients (Fengler 2019).