Interventional procedure overview of percutaneous transluminal renal sympathetic denervation for resistant hypertension
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Appendix
The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. Because of the size of the evidence base, the following studies are not listed in the appendix: review articles, case reports, non-randomised comparative studies and case series with less than 50 patients. and studies in which RDN combined with other treatments other than antihypertensive medications. It is by no means an exhaustive list of potentially relevant studies.
Article | Number of patients/follow up | Direction of conclusions | Reasons for non-inclusion in summary of key evidence section |
|---|---|---|---|
Agasthi P, Shipman J, Arsanjani R et al. (2019) Renal denervation for resistant hypertension in the contemporary era: a systematic review and meta-analysis. Scientific reports 9(1): 6200 | Systematic review and meta-analysis n=15 studies (1,473 patients) follow up: 6 months | Based on the current evidence, patients with resistant hypertension and no identifiable secondary cause (renovascular or renal parenchymal disease, etc.), maximised on lifestyle interventions and medical therapy by a hypertension specialist may benefit from renal denervation with an experienced operator. | All relevant studies of percutaneous transluminal RDN for resistant hypertension included in this systematic review were included in Pisano (2021). |
Ahmad Y, Francis DP, Bhatt DL et al. (2021) Renal denervation for hypertension: a systematic review and meta-analysis of randomized, blinded, placebo-controlled trials. JACC: Cardiovascular Interventions 14(23): 2614-24 | Systematic review and meta-analysis n=7 studies (1,368 patients) | The randomised placebo-controlled trials show consistently that renal denervation provides significant reduction in ambulatory and office blood pressure. Although the magnitude of benefit, about 4/2 mmHg, is modest, it is similar between patients on background antihypertensive medications and those who are not. Denervation could therefore be a useful strategy at various points for patients who are not willing to add antihypertensive agents. Whether the effect changes with time is currently unknown. | All studies in this study were included in Pisano (2021) and the outcomes for resistant hypertension were not reported separately. |
Ahmad Y, Kane C, Arnold AD et al. (2022) Randomized blinded placebo-controlled trials of renal sympathetic denervation for hypertension: a meta-analysis. Cardiovascular Revascularization Medicine 34: 112-8 | Meta-analysis n=6 studies follow up: 6 months | The totality of blinded, randomized placebo-controlled data shows that renal denervation is safe and provides genuine reduction in blood pressure for at least 6 months post-procedure. If this effect continues in the long term, renal denervation might provide a life-long 10% relative risk reduction in major adverse cardiac events and 7.5% relative risk reduction in all-cause mortality. | All relevant studies of percutaneous transluminal RDN for resistant hypertension in this meta-analysis were included in Pisano (2021) and the outcomes for resistant hypertension were not reported separately. |
Aripov M, Mussayev A, Alimbayev S et al. (2017) Individualised renal artery denervation improves blood pressure control in Kazakhstani patients with resistant hypertension. Kardiologia polska 75(2): 101-7 | Case series (Kazakhstani Registry) n=63 follow up: 12 months | In this population renal artery denervation resulted in statistically and clinically significant blood pressure reduction at 12 months with minimal adverse events. | Studies with larger samples and better designs are included in the key evidence. |
Azizi M, Pereira H, Hamdidouche I et al. (2016) Adherence to antihypertensive treatment and the blood pressure-lowering effects of renal denervation in the renal denervation for hypertension (DENERHTN) trial. Circulation 134(12): 847-57 | RCT n=106 (RDN, n=53; control, n=53) follow up: 6 months | In the DENERHTN trial, the prevalence of nonadherence to antihypertensive drugs at 6 months was high (≈50%) but not different in the renal denervation and control groups. Regardless of adherence to treatment, renal denervation plus standardised stepped-care antihypertensive treatment resulted in a greater decrease in blood pressure than standardised stepped-care antihypertensive treatment alone. | DENERHTN was included in Pisano (2021). |
Azizi M, Sapoval M, Gosse P et al. (2015) Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet (London, England) 385(9981): 1957-65 | RCT n=106 (RDN, n=53; control, n=53) follow up: 6 months | In patients with well-defined resistant hypertension, renal denervation plus a standardised stepped-care antihypertensive treatment (SSAHT) decreases ambulatory blood pressure more than the same SSAHT alone at 6 months. This additional blood pressure lowering effect may contribute to a reduction in cardiovascular morbidity if maintained in the long term after renal denervation. | This study was included in Pisano (2021). |
Azretovich YA, Dzhoshibaev S, Baymagambetov AK et al. (2016) Experience of one-electrode symplicity flex catheter and multi-electrode symplicity spyral catheter in Kazakhstan. Research Journal of Pharmaceutical, Biological and Chemical Sciences 7(4): 2698-704 | Non-randomised comparative study n=58 (one-electrode Symplicity Flex catheter, n=44; multi-electrode Symplicity Spyral catheter, n=14) follow up: 6 months | Application of multi-electrode catheter in clinical practice helps to significantly reduce the total duration of intervention and improve efficiency. | Small sample |
Bakris GL, Townsend RR, Liu M et al. (2014) Impact of renal denervation on 24-hour ambulatory blood pressure: results from SYMPLICITY HTN-3. Journal of the American College of Cardiology 64(11): 1071-8 | RCT n=535 (RDN, n=364; sham, n=171) follow up: 6 months | The current trial confirms the safety of renal denervation with the Symplicity catheter; however, a significant BP-lowering effect on 24-h ambulatory BP was not observed. Further clinical research using rigorous trial design will be required to understand whether renal denervation has any role in the treatment of resistant hypertension. | SYMPLICITY HTN-3 was included in Pisano (2021). |
Bakris GL, Townsend RR, Flack J M et al. (2015) 12-month blood pressure results of catheter-based renal artery denervation for resistant hypertension: the SYMPLICITY HTN-3 trial. Journal of the American College of Cardiology 65(13): 1314-21 | RCT n=535 (RDN, n=364; crossover, n=101; non-crossover, n=70) Follow up: 12 months | The data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. | SYMPLICITY HTN-3 was included in Pisano (2021). |
Beeftink MMA, Spiering W, De Jong MR et al. (2017) Renal denervation beyond the bifurcation: The effect of distal ablation placement on safety and blood pressure. Journal of clinical hypertension (Greenwich, Conn.) 19(4): 371-8 | Case series (registry) n=97 follow up: 12 months | Authors found no reason to believe that renal denervation distal to the bifurcation poses additional risks over the currently advised approach of proximal denervation, but improved efficacy remains to be conclusively established. | Studies with larger samples and better designs are included in the key evidence. |
Bergland OU, Soraas CL, Larstorp ACK et al. (2021) The randomised Oslo study of renal denervation vs. antihypertensive drug adjustments: efficacy and safety through 7 years of follow-up. Blood pressure 30(1): 41-50 | RCT n=19 (RDN, n=9; drug adjustment, n=10) follow up: 7 years | Blood pressure changes up to 7 years show a tendency towards a smaller difference in BPs between the RDN and drug adjustment patients. The data support RDN as a safe procedure, but it remains non-superior to intensive drug adjustment 7 years after the intervention. | Oslo RDN was included in Pisano (2021). |
Bergland OU, Larstorp ACK, Lund Soraas C et al. (2021) Changes in sympathetic nervous system activity after renal denervation: results from the randomised Oslo RDN study. Blood pressure 30(3): 154-64 | RCT n=19 (RDN, n=9; drug adjustment, n=10) follow up: 6 months | The data suggest that RDN reduces SNS activity after 6 months. The finding warrants investigation in a larger study. | Oslo RDN was included in Pisano (2021). |
Bhatt DL, Kandzari DE, O'Neill WW et al. (2014) A controlled trial of renal denervation for resistant hypertension. The New England journal of medicine 370(15): 1393-401 | RCT n=535 (RDN, n=364; sham, n=171) follow up: 6 months | This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. | This study was included in Pisano (2021). |
Bohm M, Mahfoud F, Ukena C et al. (2015) First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension. Hypertension (Dallas, Tex.: 1979) 65(4): 766-74 | Case series (Global SYMPLICITY Registry) n=998 follow up: 6 months | Renal denervation was associated with low rates of adverse events. After the procedure through 6 months, there was 1 new renal artery stenosis >70% and 5 cases of hospitalisation for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favourable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures. | Analysis of this registry with a larger sample (Mahfoud 2019) is included in the key evidence. |
Bohm M, Ukena C, Ewen S et al. (2016) Renal denervation reduces office and ambulatory heart rate in patients with uncontrolled hypertension: 12-month outcomes from the global SYMPLICITY registry. Journal of hypertension 34(12): 2480-6 | Case series (registry) n=846 follow up: 12 months | RDN reduces BP independent from HR. A HR reduction is dependent on baseline HR and unchanged by b-blocker treatment. The effects of RDN on SBP and HR are durable up to 1 year. HR reduction might be a target for RDN in patients with high HR at baseline, which needs to be scrutinized in prospective trials | Analysis of this registry with a larger sample (Mahfoud 2019) is included in the key evidence. |
Brandt MC, Reda S, Mahfoud F et al. (2012) Effects of renal sympathetic denervation on arterial stiffness and central hemodynamics in patients with resistant hypertension. J Am Coll Cardiol. 60(19): 1956-65 | Non-randomised comparative study n=120 (RDN, n=110; control, n=10) follow up: 6 months | Besides the known effect of RD on brachial blood pressure, the study showed for the first time that this novel approach significantly improves arterial stiffness and central hemodynamics, which might have important prognostic implications in patients with resistant hypertension at high cardiovascular risk. | Studies with larger samples or better designs are included in the key evidence. |
Chen S, Kiuchi MG, Schmidt B et al. (2019) Renal denervation for mild-moderate treatment-resistant hypertension: A timely intervention? Herz 44(5): 412-8 | Meta-analysis n=4 studies (185 patients) follow up: 6 months | New antihypertensive strategies to achieve better BP control even in less severe forms of RH are needed and should be carefully evaluated. RDN appears to be an effective and safe therapeutic option for patients with MMRH. However, the data from this patient group remain preliminary and need to be validated in large randomised studies with long-term follow up. | Meta-analysis with a larger sample is included in the key evidence. Of the 4 studies, 1 RCT was included in Pisano (2021) and 3 studies were case series with small samples. |
Chen S, Kiuchi MG, Acou WJ et al. (2017) Feasibility of catheter ablation renal denervation in "mild" resistant hypertension. Journal of clinical hypertension (Greenwich, Conn.) 19(4): 361-8 | Meta-analysis n=3 studies follow up: 6 months | The present study suggests that RDN seems feasible to treat mild RH. Further research of RDN in this patient group is needed. | Meta-analysis with a larger sample is included in the key evidence. Of the 3 studies, 1 RCT was included in Pisano (2021), and 2 studies were case series with small samples. |
Chen W, Ling Z, Du H et al. (2016) The effect of two different renal denervation strategies on blood pressure in resistant hypertension: Comparison of full-length versus proximal renal artery ablation. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions 88(5): 786-95 | RCT n=47 (full-length ablation, n=23; proximal ablation, n=24) follow up: 12 months | The results indicate that proximal RDN has a similar efficacy and safety profile compared with full-length RDN, and propose the proximal artery as the key portion for RDN. | RCTs with larger samples are included in the key evidence. |
Cheng XCh, Zhang DY, Luo SX et al. (2019) Effect of catheter-based renal denervation on uncontrolled hypertension: a systematic review and meta-analysis. Mayo Clinic proceedings 94(9): 1695-706 | Systematic review and meta-analysis n=12 studies | Catheter-based RDN was associated with a significant BP-lowering benefit without increasing major adverse events. | All relevant studies of percutaneous transluminal RDN for resistant hypertension in this systematic review were included in Pisano (2021) and the outcomes for resistant hypertension were not reported separately. |
Coppolino G, Pisano A, Rivoli L et al. (2017) Renal denervation for resistant hypertension. The Cochrane database of systematic reviews 2: cd011499 | Cochrane review n=12 RCTs | In patients with resistant hypertension, there is low quality evidence that renal denervation does not change major cardiovascular events, and renal function. There was moderate quality evidence that it does not change blood pressure and low-quality evidence that it caused an increase of bradycardia episodes. Future trials measuring patient-centred instead of surrogate outcomes, with longer follow-up periods, larger sample size and more standardised procedural methods are necessary to clarify the utility of this procedure in this population. | The updated review (Pisano 2021) is included in the key evidence. |
Daemen J, Mahfoud F, Kuck KH et al. (2019) Safety and efficacy of endovascular ultrasound renal denervation in resistant hypertension: 12-month results from the ACHIEVE study. Journal of hypertension 37(9): 1906-12 | Case series n=96 follow up: 12 months | The therapy appeared safe and resulted in sustained reductions in both office BP and 24-h ambulatory BP through 12 months | Small sample |
Dahal, K., Khan, M., Siddiqui, N. et al. (2020) Renal denervation in the management of hypertension: a meta-analysis of sham-controlled trials. Cardiovascular Revascularization Medicine 21(4): 532-537 | Meta-analysis n=7 sham-controlled trials | Current meta-analysis shows that RD reduces ambulatory BP and office DBP in patients with hypertension. Future trials with longer follow-up should confirm these findings | All relevant studies of percutaneous transluminal RDN for resistant hypertension in this meta-analysis were included in Pisano (2021). The outcomes for resistant hypertension were not reported separately. |
de Jager RL, van Maarseveen EM, Bots ML et al. (2018) Medication adherence in patients with apparent resistant hypertension: findings from the SYMPATHY trial. British journal of clinical pharmacology 84(1): 18-24 | Substudy of SYMPATHY n=98 Follow up: 6 months | Objective methodology, using a bioanalytical screening assay, to assess adherence to BP lowering drugs, provides a valuable tool to define true resistant hypertension and, when applicable, refine a treatment plan in consultation with the patient. | SYMPATHY was included in Pisano (2021). |
de Sousa Almeida M, de Araujo Goncalves P, Branco P et al. (2016) Impact of renal sympathetic denervation on left ventricular structure and function at 1-year follow-up. PloS one 11(3): e0149855 | Case series n=57 follow up: 12 months | In this study, renal denervation was associated with significant reduction in both office and ABPM blood pressure and a significant decrease in left ventricle mass evaluated by transthoracic echocardiogram at 1 year follow-up. | Studies with larger samples and better designs are included in the key evidence. |
Denegri A, Naduvathumuriyil T, Luscher TF et al. (2018) Renal nerve ablation reduces blood pressure in resistant hypertension: Long-term clinical outcomes in a single-center experience. Journal of clinical hypertension (Greenwich, Conn.) 20(4): 627-33 | Case series n=57 follow up: 24 months | In this study, in all patients with resistant hypertension, RNA, if performed adequately in the number of ablations and energy delivery, is an efficient and safe treatment option to lower office and 24-hour blood pressure. Whether these blood pressure–lowering effects will lead to a reduction of cardiovascular morbidity and mortality will require further studies. | Studies with larger samples or better designs are included in the key evidence. |
Desch S, Okon T, Heinemann D et al. (2015) Randomized sham-controlled trial of renal sympathetic denervation in mild resistant hypertension. Hypertension (Dallas, Tex.: 1979) 65(6): 1202-8 | RCT n=71 (RDN, n=35; sham, n=36) follow up: 6 months | In patients with mild resistant hypertension, renal sympathetic denervation failed to show a significant reduction in the primary end point of 24-hour systolic BP at 6 months between groups in the intention to treat analysis. | This study was included in Pisano (2021). |
Dorr O, Liebetrau C, Mollmann H et al. (2016) Long-term verification of functional and structural renal damage after renal sympathetic denervation. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions 87(7): 1298-303 | Case series n=62 Follow up: 36.9 months | The results of the present study show a sustained effect of RSD on BP reduction after a three-year follow-up, and there was no evidence of renal failure. These results provide verification of the long-term safety and effectiveness of RSD, even in patients with impaired renal function. | Small sample |
Fadl Elmula FEM, Jin Y, Yang WY et al. (2015) Meta-analysis of randomized controlled trials of renal denervation in treatment-resistant hypertension. Blood pressure 24(5): 263-74 | Meta-analysis n=7 studies follow up: 6 months | In selected rHT patients maintained on antihypertensive drugs, RDN with the SYMPLICITY systems does not significantly decrease BP but is safe. Future trials with next-generation catheters should aim at identifying responders in patients with evidence of sympathetic nervous overactivity. | All studies were included in Pisano (2021). |
Esler MD, Bohm M, Sievert H et al. (2014) Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension: 36 month results from the SYMPLICITY HTN-2 randomized clinical trial. European heart journal 35(26): 1752-9 | RCT n=106 (RDN, n=52; control, n=54) follow up: 36 months | Renal denervation resulted in sustained lowering of blood pressure at 3 years in a selected population of subjects with severe, treatment-resistant hypertension without serious safety concerns. | This study was included in Pisano (2021). |
Ewen S, Dorr O, Ukena C et al. (2015) Blood pressure variability after catheter-based renal sympathetic denervation in patients with resistant hypertension. Journal of hypertension 33(12): 2512-8 | Case series n=84 follow up: 6 months | RDN reduces office and ambulatory BP and BP variability in patients with resistant hypertension. Improvement in BP variability was also documented in patients characterized as office BP non-responders after 6 months. | Studies with larger samples or better designs are included in the key evidence. |
Ewen S, Mahfoud F, Linz D et al. (2014) Effects of renal sympathetic denervation on exercise blood pressure, heart rate, and capacity in patients with resistant hypertension. Hypertension 63(4): 839-45 | Non-randomised comparative study n=60 (RDN, n=50; control, n=10) follow up: 12 months | Renal denervation reduced blood pressure and heart rate during exercise, improved mean workload, and increased exercise time without impairing chronotropic competence. | Small sample |
Ewen S, Meyer MR, Cremers B et al. (2015) Blood pressure reductions following catheter-based renal denervation are not related to improvements in adherence to antihypertensive drugs measured by urine/plasma toxicological analysis. Clinical research in cardiology: official journal of the German Cardiac Society 104(12): 1097-105 | Non-randomised comparative studies n=100 (adherent, n=52; non-adherent, n=48) follow up: 6 months | Renal denervation can reduce office and ambulatory blood pressure in patients with resistant hypertension despite a significant reduction in adherence to antihypertensive treatment after 6 months. | Studies with larger samples or better designs are included in the key evidence. |
Fadl Elmula FEM, Feng YM, Jacobs L et al. (2017) Sham or no sham control: that is the question in trials of renal denervation for resistant hypertension. A systematic meta-analysis. Blood pressure 26(4): 195-203 | Meta-analysis n=10 studies follow up: 6 months | The overall meta-analysis of 10 randomized and controlled studies showed no significant effect on BP of RDN in resistant hypertension. Moreover, the analysis does not support the use of sham control but rather suggests extensive use of 24-hour ambulatory BP in studies of RDN in resistant hypertension. | All studies in this meta-analysis were included in Pisano (2021). |
Fengler, Karl, Ewen, Sebastian, Hollriegel, Robert et al. (2017) Blood pressure response to main renal artery and combined main renal artery plus branch renal denervation in patients with resistant hypertension. Journal of the American Heart Association 6(8) | Non-randomised comparative studies n=50 (combined ablation, n=25; main artery ablation, n=25) follow up: 3 months | Combined ablation of the main renal artery and branches appears to improve BP-lowering efficacy and should be further investigated. | Studies with larger samples or better designs are included in the key evidence. |
Fengler K, Rommel KP, Blazek S et al. (2018) Predictors for profound blood pressure response in patients undergoing renal sympathetic denervation. Journal of hypertension 36(7): 1578-84 | Non-randomised comparative studies n=190 (profound BP response, n=33; no or regular BP response, n=157) follow up: 3 months | Younger vascular age, higher baseline BP, treatment with ultrasound RDN and combined diuretic therapy were found as predictors for a pronounced BP reduction following RDN, improving BP control at follow-up. | Studies with larger samples or better designs are included in the key evidence. |
Fengler K, Rommel KP, Lapusca R et al. (2019) Renal denervation in isolated systolic hypertension using different catheter techniques and technologies: insights from a randomized trial. Hypertension 74(2): 341-348 | Post-hoc analysis of RCT n=120 follow up: 3 months | Using adjusted BP values, RDN seems to be equally effective in patients with ISH and CH, irrespective of the RDN technology and technique used. The role and potential of RDN in ISH patients should be evaluated in appropriately designed trials. In the meantime, the quest for the ideal candidate for RDN continues. | RADIOSOUND-HTN is included in the key evidence (Fengler 2019) |
Fengler K, Hollriegel R, Okon T et al. (2017) Ultrasound-based renal sympathetic denervation for the treatment of therapy-resistant hypertension: a single-center experience. Journal of hypertension 35(6): 1310-7 | Non-randomised comparative studies n=50 (responder, n=31; non-responder, n=19) follow up: 6 months | Ultrasound-based RDN seems to be well tolerated and effective for the treatment of patients with therapy-resistant hypertension. | Studies with larger samples or better designs are included in the key evidence. |
Fengler K, Rommel KP, Lapusca R et al. (2019) Renal denervation in isolated systolic hypertension using different catheter techniques and technologies: insights from a randomized trial. Hypertension 74(2): 341-8 | Post-hoc analysis of RADIOSOUND-HTN n=120 (USM-RDN, n=42; RFM-RDN, n=39; RFB-RDN, n=39) follow up: 3 months | Using adjusted BP values, RDN seems to be equally effective in patients with ISH and CH, irrespective of the RDN technology and technique used. The role and potential of RDN in ISH patients should be evaluated in appropriately designed trials. In the meantime, the quest for the ideal candidate for RDN continues. | RADIOSOUND-HTN is included in the key evidence (Fengler 2019) |
Fengler K, Rommel KP, Hoellriegel R et al. (2017) Pulse wave velocity predicts response to renal denervation in isolated systolic hypertension. Journal of the American Heart Association 6(5) | Non-randomised comparative study n=109 (combined hypertension, n=69; isolated systolic hypertensin, n=40) follow up: 3 months | Extended assessment of arterial stiffness can help improve patient preselection for renal sympathetic denervation and identify a subgroup of isolated systolic hypertension patients who benefit from sympathetic modulation. | Studies with larger samples or better designs are included in the key evidence. |
Flack JM, Bhatt DL, Kandzari DE et al. (2015) An analysis of the blood pressure and safety outcomes to renal denervation in African Americans and Non-African Americans in the SYMPLICITY HTN-3 trial. Journal of the American Society of Hypertension: JASH 9(10): 769-79 | Subgroup analysis of SYMPLICITY HTN-3 trial n=140 (RSN, n=90; sham, n=50) follow up: 6 months | AA race did not independently predict SBP response in either sham or RDN. There appears to be effect modification by race with individual-level patient characteristics in both treatment arms that affect the observed pattern of SBP responses. | SYMPLICITY HTN-3 trial was included in Pisano (2021). |
Gao JQ, Zhang H, Li LY et al. (2021) Comparison of a 5 F microtube-irrigated ablation catheter and a general ablation catheter in the treatment of resistant hypertension with renal denervation. Cardiovascular Innovations and Applications 6(2): 81-89 | Non-randomised comparative study n=65 follow up: 12 months | The microtube-irrigated ablation catheter is more effective in treating hypertension than the general ablation catheter at the 6-month follow up and thus fewer antihypertensive drugs were used in the microtube-irrigated ablation catheter group than in the general ablation catheter group. | Studies with larger samples or better designs are included in the key evidence. |
Gosain P, Garimella PS, Hart PD et al. (2013) Renal sympathetic denervation for treatment of resistant hypertension: a systematic review. Journal of clinical hypertension (Greenwich, Conn.) 15(1): 75-84 | Systematic review n=19 studies (2 RCTs, 4 case-control studies, and 13 case series published between 2009 and 2012) | Data from short-term studies suggest that RSD is a safe and effective therapeutic option in carefully selected patients with resistant hypertension. Long-term studies with large patient populations are needed to study whether this benefit is sustained with a demonstrable difference in cardiovascular disease event rates. | Both RCTs referred to SYMPLICITY HTN-2 and were included in Pisano (2021). No meta-analyses were performed. More recent RCTs were included in Pisano (2021). |
Gosse P, Cremer A, Pereira H et al. (2017) Twenty-four-hour blood pressure monitoring to predict and assess impact of renal denervation: the DENERHTN study (renal denervation for hypertension). Hypertension (Dallas, Tex.: 1979) 69(3): 494-500 | Analysis of DENERHTN n=97 (RDN, n=44; control, n=53) follow up: 6 months | This detailed analysis of ABPM data in the DENERHTN trial confirms the efficacy of RD with the Simplicity flex catheter in addition to a SSAHT in lowering BP in patients with RH, with a homogenous effect over 24 hours. Nighttime SBP and its variability in patients being treated with a renin angiotensin system blocker, a thiazide, and a calcium channel blocker seem as the best candidates that can be derived from ABPM recordings to predict responders to RD. Therefore, 24-hour ABPM should systematically precede any decision of RD as recommended by consensus guidelines. | DENERHTN was included in Pisano (2021). |
Hamdidouche I, Gosse P, Cremer A et al. (2019) Clinic versus ambulatory blood pressure in resistant hypertension: impact of antihypertensive medication nonadherence: a post hoc analysis the DENERHTN study. Hypertension (Dallas, Tex.: 1979) 74(5): 1096-1103 | Post-hoc analysis of DENERHTN n=97 follow up: 6 months | This analysis indicates that antihypertensive medication nonadherence impacts greatly the clinic-SBP–day-SBP difference in patients with apparent resistant hypertension. Medication nonadherence should be considered in resistant hypertensive patients who have substantially higher clinic SBP recordings than ambulatory or home SBP recordings. | DENERHTN was included in Pisano (2021). |
Hamza M and Khamis H (2014) Renal sympathetic denervation for treatment of resistant hypertension: Egyptian experience. J Interven Cardiol 27: 423-7 | Case series n=55 follow up: 6 months | In this observational study, catheter-based renal denervation causes sustained blood pressure reduction in patients with resistant hypertension, without serious adverse events. | Small sample |
Hering D, Lambert EA, Marusic P et al. (2013) Renal nerve ablation reduces augmentation index in patients with resistant hypertension. Journal of hypertension 31(9): 1893-900 | Non-randomised comparative studies n=50 (RDN, n=40; control, n=10) | RDN results in a substantial and rapid reduction in augmentation index, which appears to be independent of BP and muscle sympathetic nerve activity changes. These findings are indicative of a beneficial effect of RDN on arterial stiffness in patients with resistant hypertension and may contribute to the sustained BP-lowering effect of RDN. | Small sample |
Hering, Dagmara, Marusic, Petra, Walton, Antony S et al. (2016) Renal artery anatomy affects the blood pressure response to renal denervation in patients with resistant hypertension. International journal of cardiology 202: 388-93 | Non-randomised comparative studies n=91 (65 patients with single renal arteries bilaterally, 16 patients with dual renal arteries on either one or both sides, and 10 patients with other anatomical constellations or structural abnormalities) follow up: 6 months | While RDN can be performed safely irrespective of the underlying renal anatomy, the presence of single renal arteries with or without structural abnormalities is associated with a more pronounced BP and muscle sympathetic nerve activity lowering effect than the presence of dual renal arteries in patients with RH. However, when patients with dual renal arteries received renal nerve ablation in all arteries there was trend towards a greater BP reduction. Insufficient renal sympathetic nerve ablation may account for these differences. | Studies with larger samples or better designs are included in the key evidence. |
Id D, Bertog SC, Ziegler AK et al. (2016) Predictors of blood pressure response: Obesity is associated with a less pronounced treatment response after renal denervation. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions 87(1): e30-8 | Case series n=101 follow up: 6 months | Blood pressure reductions after RDN were more pronounced in patients with higher baseline blood pressure and lower BMI. These findings may have implications regarding patient selection for renal denervation. | Studies with larger samples and better designs are included in the key evidence. |
Id D, Kaltenbach B, Bertog S C et al. (2013) Does the presence of accessory renal arteries affect the efficacy of renal denervation? JACC. Cardiovascular interventions 6(10): 1085-91 | Non-randomised comparative study n=74 (bilateral single renal arteries, n=54; accessory renal arteries, n=20) follow up: 6 months | BP reduction achieved after renal denervation in patients with accessory renal arteries is less pronounced than in patients with bilateral single renal arteries. | Studies with larger samples and better designs are included in the key evidence. |
Jacobs L, Persu A, Huang QF et al. (2017) Results of a randomized controlled pilot trial of intravascular renal denervation for management of treatment-resistant hypertension. Blood pressure 26(6): 321-31 | RCT (INSPiRED pilot trial) n=18 follow up: 6 months | The INSPiRED pilot suggests that RDN with the EnligHTNTM system is effective and safe and generated insights useful for the design of future RDN trials. | INSPiRED was included in Pisano (2021). |
Juknevicius V, Berukstis A, Jukneviciene R et al. (2021) Long-term effects of renal artery denervation. Medicina (Kaunas, Lithuania) 57(7) | Case series n=73 follow up: 48 months | Antihypertensive effect after renal denervation lasts up to 48 months with no worsening of arterial stiffness compared to baseline. In this study, polypharmacy was associated with increased arterial stiffness 48 months after the procedure. | Studies with larger samples and better designs are included in the key evidence. |
Kaiser L, Beister T, Wiese A et al. (2014) Results of the ALSTER BP real-world registry on renal denervation employing the Symplicity system. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 10(1): 157-65 | Case series (ALSTER BP Registry) n=93 follow up: 6 months | This real-world analysis of renal sympathetic denervation confirms the procedure to be safe and efficient in most patients. Non-responders may profit from a second ablation, arguing in favour of the hypothesis that the procedure did not destroy sufficient amounts of sympathetic innervation in these patients. However, repeated denervations may also increase side effects. | Studies with larger samples and better designs are included in the key evidence. |
Kandzari DE, Hickey GL, Pocock SJ et al. (2021) Prioritised endpoints for device-based hypertension trials: the win ratio methodology. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 16(18): e1496-e1502 | Win ratio analysis of the data from SPYRAL HTN-ON MED pilot study n=80 (RDN, n=38; sham control, n=42) | The win ratio method addresses prior limitations by enabling inclusion of more patient-oriented results while prioritising those endpoints considered most clinically important. Applying these methods to the SPYRAL HTN-ON MED pilot study, RDN was determined to be superior regarding a hierarchical endpoint and a "winner" compared with sham control patients. | Outcomes for resistant hypertension were not reported separately. |
Kandzari DE, Bohm M, Mahfoud F et al. (2018) Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet 391(10137): 2346-55 | RCT n=80 (RDN, n=38; sham, n=42) follow up: 6 months | Renal denervation in the main renal arteries and branches significantly reduced blood pressure compared with sham control with no major safety events. Incomplete medication adherence was common. | Outcomes for resistant hypertension were not reported separately. |
Karbasi-Afshar R, Noroozian R, Shahmari A et al. (2013) The effect of renal arterial sympathectomy on refractory hypertension. Tehran University Medical Journal 71(3): 179-84 | Non-randomised comparative study n=212 (RDN, n=117; control, n=95) follow up: 6 months | It seems that the sympathetic renal denervation can be an effective and safe method for treatment of refractory hypertensive patients indeed of routine medications although further studies with longer follow up duration and more cases are suggested for confirming this issue. | Studies with larger samples and better designs are included in the key evidence. |
Kario K, Ogawa H, Okumura K et al. (2015) SYMPLICITY HTN-Japan - first randomized controlled trial of catheter-based renal denervation in Asian patients. Circulation journal: official journal of the Japanese Circulation Society 79(6): 1222-9 | RCT n=41 (RDN, n=22; control, n=19) follow up: 6 months | SYMPLICITY HTN-Japan, the first randomized controlled trial of RDN in an Asian population, was underpowered for the primary endpoint analysis and did not demonstrate a significant difference in 6-month BP change between RDN and control subjects. | SYMPLICITY HTN-Japan was included in Pisano (2021). |
Kario K, Bhatt DL, Brar S et al. (2015) Effect of catheter-based renal denervation on morning and nocturnal blood pressure: Insights from SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan. Hypertension (Dallas, Tex.: 1979) 66(6): 1130-7 | Pooled analysis n=2 studies (576 patients) follow up: 6 months | In SYMPLICITY HTN-3, compared with controls (n=159), patients treated with renal denervation (n=325) experienced a significantly greater change in morning (−7.3±19.8 mm Hg, P<0.001) and night-time (−6.1±18.2 versus −1.6±19.7 mm Hg, P=0.02) but not daytime systolic BP (−7.2±16.2 versus −6.4±18.6 mm Hg, P=0.67). This same trend was observed in the pooled analysis with HTN-Japan. | SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan were included in Pisano (2021). |
Kario K, Bhatt DL, Kandzari DE et al. (2016) Impact of renal denervation on patients with obstructive sleep apnea and resistant hypertension - insights from the SYMPLICITY HTN-3 Trial. Circulation journal: official journal of the Japanese Circulation Society 80(6): 1404-12 | Post-hoc analysis of SYMPLICITY HTN-3 trial n=535 follow up: 6 months | Obstructive sleep apnoea patients appeared to be responsive to renal denervation therapy. However, this hypothesis requires prospective testing. | SYMPLICITY HTN-3 was included in Pisano (2021). |
Kario K, Yamamoto E, Tomita H et al. (2019) Sufficient and persistent blood pressure reduction in the final long-term results from SYMPLICITY HTN-Japan - safety and efficacy of renal denervation at 3 years. Circulation journal: official journal of the Japanese Circulation Society 83(3): 622-9 | RCT n=41 (RDN, n=22; control, n=19) follow up: 36 months | SYMPLICITY HTN-Japan is the first randomised controlled trial to evaluate RDN in an Asian population. Despite the small number of enrolments, results show patients who received RDN therapy maintained SBP reduction out to 36 months. | SYMPLICITY HTN-Japan was included in Pisano (2021). |
Kim BK, Bohm M, Mahfoud F et al. (2016) Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea). Journal of human hypertension 30(5): 315-21 | Case series (GSR-Korea registry) n=262 follow up: 12 months | RDN provided a significant reduction in 6- and 12-month office SBP among Asian patients, with a favourable safety profile. The 12-month SBP reduction was larger than that observed in Caucasian patients. | Analysis of this registry with a larger sample was presented in Mahfoud (2019). |
Kindermann I, Wedegartner SM, Mahfoud F et al. (2017) Improvement in health-related quality of life after renal sympathetic denervation in real-world hypertensive patients: 12-month outcomes in the Global SYMPLICITY Registry. Journal of clinical hypertension (Greenwich, Conn.) 19(9): 833-839 | Case series (registry) n=934 follow up: 12 months | Renal denervation was associated with a significant improvement in health-related quality of life, particularly anxiety/ depression. | Analysis of this registry with a larger sample was presented in Mahfoud (2019). |
Kiuchi MG, Chen S, Rodrigues PLM et al. (2018) Number of ablated spots in the course of renal sympathetic denervation in CKD patients with uncontrolled hypertension: EnligHTN vs. Standard irrigated cardiac ablation catheter. Hipertension y riesgo vascular 35(2): 54-63 | Non-randomised comparative studies n=112 (EnligHTN, n=56; Flexability, n=56) follow up: 6 months | The RSD reduced the mean 24-h ABPM in subjects with CKD and uncontrolled hypertension and improved the renal function in both groups. These effects were more marked and important in subgroups underwent a great number of ablated spots using the SICAC. | Outcomes for resistant hypertension were not reported separately. |
Krum H, Schlaich MP, Sobotka PA et al. (2014) Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet (London, England) 383(9917): 622-9 | Case series (Symplicity HTN-1) n=88 follow up: 3 years | Changes in blood pressure after RDN persist long term in patients with treatment-resistant hypertension, with good safety. | Studies with larger samples and better designs are included in the key evidence. |
Krum HK, Schlaich M, Whitbourn R et al. (2009) Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 373:1275-81 | Case series n=50 follow up: up to 1 year | Catheter-based RDN causes substantial and sustained BP reduction, without serious adverse events, in patients with resistant hypertension. Prospective randomised clinical trials are needed to investigate the usefulness of this procedure in the management of this condition. | Small sample |
Kwok CS, Loke YK, Pradhan S et al. (2014) Renal denervation and blood pressure reduction in resistant hypertension: A systematic review and meta-analysis. Open Heart 1(1): e000092 | Systematic review and meta-analysis n=12 studies (3 RCTs, 8 prospective observational studies and 1 observational study with matched controls) follow up: 3 months | Evidence for the efficacy of renal denervation using catheter-based systems in reducing blood pressure in resistant hypertension is derived from unblinded studies that are at risk of bias. The highest quality single blinded randomised controlled trial did not show efficacy in office blood pressure reduction, although it did meet its safety end point. Future studies investigating the efficacy of renal denervation in the treatment of drug-resistant hypertension should be undertaken in a blinded manner, with sham procedures in the control group and ambulatory monitoring to reduce the potential for bias. | Of the 3 RCTs included in this study, 2 RCTs were included in Pisano (2021) and 1 RCT compared pulmonary vein isolation with RDN with pulmonary vein isolation alone in patients with refractory symptomatic atrial fibrillation and resistant hypertension. Other studies were observational studies with small samples. |
Lambert GW, Hering D, Marusic P et al. (2015) Health-related quality of life and blood pressure 12 months after renal denervation. Journal of hypertension 33(11): 2350-8 | Non-randomised comparative studies n=97 (resistant hypertension, n=69; pseudoresistent, n=11; masked uncontrolled hypertension, n=17) follow up: 12 months | These results indicate that in patients with confirmed resistant hypertension, RDN is associated with a reduction in BP and a sustained improvement in mental health-related aspects of QoL. | Studies with larger samples and better designs are included in the key evidence. |
Lambert T, Nahler A, Reiter C et al. (2015) Influence of pseudo-resistance on the effect of renal denervation on 24-hour ambulatory blood pressure levels. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions 86(3): e126-30 | Case series n=106 follow up: 6 months | There was a significant BP reduction in almost 60% of patients with true-resistant hypertension, but only in 10% in patients with pseudoresistant hypertension. According to our results, patient selection seems to be crucial for acceptable response rates after RDN. | Studies with larger samples and better designs are included in the key evidence. |
Lambert T, Blessberger H, Gammer V et al. (2014) Effects of renal denervation on ambulatory blood pressure measurements in patients with resistant arterial hypertension. Clinical cardiology 37(5): 307-11 | Case series n=86 follow up: 6 months | Office BP and AMBP levels can be significantly lowered by RDN in patients with resistant hypertension. | Studies with larger samples and better designs are included in the key evidence. |
Lambert T, Nahler A, Reiter C et al. (2015) Frequency of renal artery stenosis after renal denervation in patients with resistant arterial hypertension. The American journal of cardiology 115(11): 1545-8 | Case series n=76 follow up: 6 months | The incidence of significant renal artery stenosis 6 months after RAD seems to be very low. However, late-onset development of nonsignificant renal artery narrowing cannot be excluded in some patients and should be anticipated in the case of RAH relapse or worsening of renal function after successful RAD. | Studies with larger samples and better designs are included in the key evidence. |
Lauder L, Ewen S, Tzafriri AR et al. (2018) Anatomical and procedural determinants of ambulatory blood pressure lowering following catheter-based renal denervation using radiofrequency. Cardiovascular revascularization medicine: including molecular interventions 19(7ptb): 845-851 | Non-randomised comparative study n=150 follow up: 6 months | 24h-ambulatory BP lowering was most pronounced in patients with smaller renal artery diameter but not related to renal artery length, accessory arteries or renal artery disease. Further, there was no dose-response relationship observed with increasing number of ablations. | Studies with larger samples and better designs are included in the key evidence. |
Lenski D, Kindermann I, Lenski M et al. (2013) Anxiety, depression, quality of life and stress in patients with resistant hypertension before and after catheter-based renal sympathetic denervation. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 9(6): 700-8 | Case series n=119 follow up: 6 months | RDN is associated with reduced anxiety and depression, intensity of headache and with improved QOL and stress tolerance in patients with resistant hypertension. | Studies with larger samples and better designs are included in the key evidence. |
Linz D, Mancia G, Mahfoud F et al. (2017) Renal artery denervation for treatment of patients with self-reported obstructive sleep apnea and resistant hypertension: results from the Global SYMPLICITY Registry. Journal of hypertension 35(1): 148-53 | Non-randomised comparative study (Registry) n=1,868 (non-OSA, n=1,663; OSA, n=205) follow up: 6 months | RDN resulted in significant BP reductions at 6 months in hypertensive patients with and without OSA, and regardless of continuous positive airway pressure usage in OSA patients. | Analysis of this registry with a larger sample was presented in Mahfoud (2019). |
Mahfoud F, Ukena C, Schmieder RE et al. (2013) Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension. Circulation 128(2): 132-40 | Non-randomised comparative study n=346 (true resistant, n=303; pseudoresistant, n=43) follow up: 12 months | RDN reduced office BP and improved relevant aspects of ambulatory BP monitoring, commonly linked to high cardiovascular risk, in patients with true-treatment resistant hypertension, whereas it only affected office BP in pseudoresistant hypertension. | Studies with larger samples and better designs are included in the key evidence |
Mahfoud F, Bakris G, Bhatt DL et al. (2017) Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. European heart journal 38(2): 93-100 | Non-randomised comparative study n=1,103 (isolated systolic hypertension, n=429; combined systolic-diastolic hypertension, n=674) follow up: 6 months | In the hitherto largest analysed population of patients with uncontrolled hypertension considered for RDN therapy, patients with ISH and CH appear to exhibit a reduction in SBP after RDN. However, patients with ISH who underwent RDN in SYMPLICITY HTN-3 and GSR had a significantly smaller reduction in office and ambulatory BPs after RDN than patients with CH. There was no difference in response to RDN between the patients with ISH who were younger than or older than 65 years of age. Patients with CH may represent good candidates for testing this procedure. | SYMPLICITY HTN-3 was included in Pisano (2021), and data from the registry were included in Mahfoud (2019). |
Mahfoud F, Kandzari DE, Kario K et al. (2022) Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. | RCT n=80 (RDN, n=38; control, n=42) follow up: 36 months | Radiofrequency RDN compared with sham control produced a clinically meaningful and lasting blood pressure reduction up to 36 months of follow-up, independent of concomitant antihypertensive medications and without major safety events. RDN could provide an adjunctive treatment modality in the management of patients with hypertension. | Outcomes for patients with resistant hypertension were not reported separately. |
Makai P, IntHout J, Deinum J et al. (2017) A network meta-analysis of clinical management strategies for treatment-resistant hypertension: making optimal use of the evidence. Journal of general internal medicine 32(8): 921-930 | Network meta-analysis n=20 studies (RDN, n=8 studies) follow up: 8 to 24 weeks | When compared to MRA as anchor, darusentan, CAA and RDN are not more effective in achieving a clinically significant reduction in ambulatory blood pressure in individuals with apparent treatment resistant hypertension. | All 8 studies on the effect of RDN for resistant hypertension were included in Pisano (2021). |
Mathiassen ON, Vase H, Bech JN et al. (2016) Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial. Journal of hypertension 34(8): 1639-47 | RCT (ReSET) n=69 (RDN, n=36; sham, n=33) follow up: 6 months | Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques. | This study was included in Pisano (2021). |
Naduvathumuriyil T, Held U, Steigmiller K et al. (2020) Clinical benefits and safety of renal denervation in severe arterial hypertension: A long-term follow-up study. Journal of Clinical Hypertension | Case series n=50 follow up: 36 months | Renal denervation is a safe and effective procedure for patients with treatment-resistant hypertension with a clinically significant antihypertensive effect. Further randomized trials are needed to determine the specific context within which renal denervation should be considered a therapeutic option in antihypertensive care. | Small sample |
Neumann JT, Ewen S, Mortensen K et al. (2016) Effects of renal denervation on heart failure biomarkers and blood pressure in patients with resistant hypertension. Biomarkers in medicine 10(8): 841-51 | Case series n=157 follow up: 6 months | In this multicentre analysis RDN did significantly reduce systolic BP. However, NT-proBNP, ST-2, galectin-3 and hs-TnI did not correspond to BP reduction 6 months after RDN. | Studies with larger samples and better designs are included in the key evidence. |
Ogoyama Y, Tada K, Abe M et al. (2022) Effects of renal denervation on blood pressures in patients with hypertension: a systematic review and meta-analysis of randomized sham-controlled trials. Hypertension research: official journal of the Japanese Society of Hypertension 45(2): 210-20 | Systematic review and meta-analysis n=9 studies (1,555 patients) | These data from randomised sham-controlled trials showed that renal denervation significantly reduced all BP metrics in medicated or unmedicated patients with hypertension, including resistant/uncontrolled hypertension. Future trials should investigate the long-term efficacy and safety of renal denervation. | Outcome for resistant hypertension were not reported separately. All relevant studies in this systematic review are included in the key evidence (Pisano 2021; Azizi 2021; Kario 2022). |
Oliveras A, Armario P, Clara A et al. (2016) Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study - a randomized controlled trial. Journal of hypertension 34(9): 1863-71 | RCT n=24 (RDN, n=11; spironolactone, n=13) follow up: 6 months | Authors conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated' in all patients with resistant hypertension before considering RDN. | DENERVHTA was included in Pisano (2021). |
Oliveras A, Armario P, Sans L et al. (2018) Organ damage changes in patients with resistant hypertension randomized to renal denervation or spironolactone: The DENERVHTA (Denervacion en Hipertension Arterial) study. Journal of clinical hypertension 20(1): 69-75 | RCT n=24 (RDN, n=11; spironolactone, n=13) follow up: 6 months | At 6 months there was a reduction in albuminuria in patients with resistant hypertension treated with spironolactone as compared with renal denervation. | DENERVHTA was included in Pisano (2021). |
Ott C, Mahfoud F, Mancia G et al. (2022) Renal denervation in patients with versus without chronic kidney disease: results from the Global SYMPLICITY Registry with follow-up data of 3 years. Nephrology, dialysis, transplantation: official publication of the European Dialysis and Transplant Association - European Renal Association 37(2): 304-10 | Case series (registry) n=1,980 follow up: 3 years | After adjusting for baseline data, 24-h systolic and diastolic ABP reduction were similar in patients with and without CKD after RDN, whereas office systolic but not diastolic BP was reduced less in patients with CKD. Authors conclude that RDN is an effective antihypertensive treatment option in CKD patients. | Mahfoud (2019) included a larger sample (n=2,237) from the Global SYMPLICITY Registry. |
Ott C, Mahfoud F, Schmid A et al. (2013) Renal denervation in moderate treatment-resistant hypertension. Journal of the American College of Cardiology 62(20): 1880-6 | Case series n=54 follow up: 6 months | The data indicate that RDN may reduce office and 24-h ambulatory BP substantially in patients with moderate treatment-resistant hypertension. | Small sample |
Ott C, Franzen KF, Graf T et al. (2018) Renal denervation improves 24-hour central and peripheral blood pressures, arterial stiffness, and peripheral resistance. Journal of clinical hypertension (Greenwich, Conn.) 20(2): 366-72 | Case series n=94 follow up: 12 months | The results suggest that RDN improves both peripheral and central BP, as well as aortic stiffness and total vascular resistance in 24-hour measurements under ambulatory conditions. Hence, RDN may improve CV prognosis of patients with true treatment resistant hypertension. | Studies with larger samples and better designs are included in the key evidence. |
Ott C, Schmid A, Toennes SW et al. (2015) Central pulse pressure predicts BP reduction after renal denervation in patients with treatment-resistant hypertension. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 11(1): 110-6 | Case series n=63 follow up: 6 months | The data suggest that cPP, indicative of the degree of large arterial stiffening, may be helpful to identify responders to RDN | Studies with larger samples and better designs are included in the key evidence. |
Pancholy SB, Shantha GPS, Patel TM et al. (2014) Meta-analysis of the effect of renal denervation on blood pressure and pulse pressure in patients with resistant systemic hypertension. The American journal of cardiology 114(6): 856-61 | Meta-analysis n=5 studies follow up: 6 months | This meta-analysis shows that RD is superior to MMT in lowering BP, but heterogeneity among study populations in this pooled sample is high, and further data are needed to better compare these treatment strategies. | Of the 3 RCTs, 2 RCTs were included in Pisano (2021) and 1 RCT compared pulmonary vein isolation with RDN with pulmonary vein isolation alone in patients with refractory symptomatic atrial fibrillation and resistant hypertension. Two studies were non-randomised comparative studies with small samples. |
Pappaccogli M, Covella M, Berra E et al. (2018) Effectiveness of renal denervation in resistant hypertension: a meta-analysis of 11 controlled studies. High blood pressure & cardiovascular prevention: the official journal of the Italian Society of Hypertension 25(2): 167-76 | Meta-analysis n=11 studies (1,236 patients) follow up: 6 months | In spite of promising results in early reports, renal denervation fails to show superiority to a sham procedure or to medical therapy in recently published controlled studies. Lack of a sham control in most publications and heterogeneity in assessment of treatment adherence may account for part the variability reported in the studies. | Ten of the 11 studies were included in Pisano (2021) and 1 study with a small sample and being stopped early for ethical reasons because RDN had uncertain BP-lowering effect. |
Pekarskiy, Stanislav E, Baev, Andrei E, Mordovin, Victor F et al. (2017) Denervation of the distal renal arterial branches vs. conventional main renal artery treatment: a randomized controlled trial for treatment of resistant hypertension. Journal of hypertension 35(2): 369-375 | RCT n=51 (main renal artery, n=26; distal branches, n=25) follow up: 6 months | Percutaneous renal denervation treatment was significantly less effective at lowering 24-h blood pressure in treatment-resistant hypertensive patients when therapy was applied conventionally in the trunk of renal artery as compared with when applied to distal segmental branches. This observation is in accordance with previous surgical and anatomical findings showing that most renal nerve fibres are distant from the lumen proximally and become available for endovascular treatment mainly in the distal portion of the vessel. | RCTs with larger samples are included in the key evidence. |
Persu A, Jin Y, Azizi M et al. (2014) Blood pressure changes after renal denervation at 10 European expert centers. Journal of human hypertension 28(3): 150-6 | Case series n=109 follow up: 6 months | The key findings were that the BP responses to RDN were: (i) highly variable in individual patients; (ii) on average considerably smaller on ambulatory than office measurement (iii) and smaller than reported in previous studies. | Small sample |
Persu A, Azizi M, Jin Y et al. (2014) Hyperresponders vs. nonresponder patients after renal denervation: do they differ? Journal of hypertension 32(12): 2422-7 | Case series n=109 follow up: 6 months | This study suggests a major overestimation of BP response after RDN in extreme responders defined according to office, but not ambulatory BP. The association of lower eGFR with poor response to RDN is consistent with our previous analysis. The increased proportion of women in extreme responders may reflect sex differences in drug adherence. | Small sample |
Persu A, Gordin D, Jacobs L et al. (2018) Blood pressure response to renal denervation is correlated with baseline blood pressure variability: a patient-level meta-analysis. Journal of hypertension 36(2): 221-9 | Case series n=167 follow up: 6 months | RDN was associated with a decrease in BP variability independent of the BP level, suggesting that responders may derive benefits from the reduction in BP variability as well. Furthermore, baseline DBP variability estimates significantly correlated with mean DBP decrease after RDN. If confirmed in younger patients with less arterial damage, in the absence of the confounding effect of drugs and drug adherence, baseline BP variability may prove a good predictor of BP response to RDN. | Studies with larger samples and better designs are included in the key evidence. |
Peters CD, Mathiassen ON, Vase H et al. (2017) The effect of renal denervation on arterial stiffness, central blood pressure and heart rate variability in treatment resistant essential hypertension: a substudy of a randomized sham-controlled double-blinded trial (the ReSET trial). Blood pressure 26(6): 366-80 | RCT n=58 follow up: 6 months | In a sham-controlled setting, there were no significant effects of RDN on arterial stiffness, C-BP and HRV. Thus, the idea of BP-independent effects of RDN on large arteries and cardiac autonomic activity is not supported. | ReSET trial was included in Pisano (2021) |
Petrov I, Tasheva I, Garvanski I et al. (2019) Comparison of standard renal denervation procedure versus novel distal and branch vessel ablation with brachial arterial access. Cardiovascular Revascularization Medicine 20: 38-42 | Non-randomised comparative study n=119 (standard ablation, n=80; Y-patten ablation, n=39) follow up: 6 months | Renal denervation using a Y-pattern ablation strategy combined with a greater number of lesions is safe and resulted in significant greater decreases in mean 24-hour ambulatory systolic and diastolic blood pressure compared to the conventional approach in this single-centre matched cohort study. Brachial artery access was shown to be feasible and safe for renal denervation. | Studies with larger samples and better designs are included in the key evidence. |
Prochnau D, Otto S, Figulla HR et al. (2016) Renal denervation with standard radiofrequency ablation catheter is effective in 24-hour ambulatory blood pressure reduction - Follow-up at 1/3/6/12 months. Netherlands Heart Journal 24(78): 449-55 | Case series n=70 follow up: 12 months | RDN with a standard RF catheter can be used safely to reduce mean ABP in resistant hypertension as shown in long-term follow-up. | Studies with larger samples or better designs are included in the key evidence. |
Beeftink MMA, Spiering W, Bots ML et al. (2016) Renal denervation in a real life setting: a gradual decrease in home blood pressure. PloS one 11(9): e0162251 | Case series n=70 follow up: 12 months | Blood pressure reduction after renal denervation occurs as a gradual decrease that extends to at least 1-year follow-up. Home monitoring seems a suitable alternative for ambulatory blood pressure monitoring after renal denervation. | Small sample |
Qi X-Y, Cheng B, Li Y-L et al. (2016) Renal denervation, adjusted drugs, or combined therapy for resistant hypertension: A meta-regression. Medicine 95(30): e3939 | Meta-analysis n=13 studies (6 RCTs and 7 cohort studies) follow up: 6 months | Compared with control, the meta-analysis showed that RDN significantly reduced office-based BP and ambulatory BP in 6 months in the unblinded studies, while no significant difference was found in the blinded studies. Meta-regression showed the significant influence of blinding method on BP reduction, and further analysis revealed a significant BP reduction compared with baseline even in the control arm of blinded studies. RDN had similar effects compared with adjusted drugs, and combined therapy seemed to further reduce the level of BP. | Five of the 6 RCTs were included in Pisano (2021), and 1 with a small sample and being stopped early for ethical reasons because RDN had uncertain BP-lowering effect. Seven studies were cohort studies with small samples. |
Ripp TM, Mordovin VF, Pekarskiy SE et al. (2015) Predictors of renal denervation efficacy in the treatment of resistant hypertension. Current hypertension reports 17(12): 90 | Non-randomised comparative study n=60 follow up: 24 weeks | The study found the associations between the initial LV wall dimensions and LV MM changes. Unlike LV EDD, arterial blood pressure, or heart rate, the initial values of LV wall thickness predicted LV MM regress. | Studies with larger samples or better designs are included in the key evidence. |
Rodriguez-Leor O, Segura J, Donaire JAG et al. (2020) Renal denervation for the treatment of resistant hypertension in Spain. The Flex-Spyral registry. Rev Esp Cardiol. | Case series (FLEX-SPYRAL Registry) n=125 follow up: 12 months | In patients with resistant hypertension, treatment with renal denervation was related to a decrease in office blood pressure and, more importantly, in ambulatory blood pressure monitoring, with a significant reduction in pharmacological treatment. | Studies with larger samples or better designs are included in the key evidence. |
Rohla M, Nahler A, Lambert T et al. (2016) Predictors of response to renal denervation for resistant arterial hypertension: a single center experience. Journal of hypertension 34(1): 123-9 | Case series n=103 follow up: 12 months | Out of a wide range of baseline variables, elevated systolic ABPM values, BMI and the number of antihypertensive drugs used were associated with response. One has to consider the Hawthorne effect, the regression to the mean phenomenon, the actual effect of sympathetic denervation and the interaction of therapy modification when interpreting data from RDN registries without a control arm. | Studies with larger samples or better designs are included in the key evidence. |
Rosa J, Widimsky P, Waldauf P et al. (2016) Role of adding spironolactone and renal denervation in true resistant hypertension: one-year outcomes of randomized PRAGUE-15 study. Hypertension (Dallas, Tex.: 1979) 67(2): 397-403 | RCT (PRAGUE-15) n=106 (RDN, n=52; PHAR, n=54) follow up: 12 months | This study shows that over a period of 12 months, RDN is safe, with no serious side effects and no major changes in the renal arteries. RDN in the settings of true resistant hypertension with confirmed compliance is not superior to intensified pharmacological treatment. Spironolactone addition (if tolerated) seems to be more effective in blood pressure reduction. | PRAGUE-15 was included in Pisano (2021). |
Rosa J, Widimsky P, Tousek P et al. (2015) Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study. Hypertension 65(2): 407-13 | RCT (PRAGUE-15) n=106 (RDN, n=52; PHAR, n=54) follow up: 6 months | The 6-month results of this study confirmed the safety of renal denervation. In conclusion, renal denervation achieved reduction of blood pressure comparable with intensified pharmacotherapy. | PRAGUE-15 was included in Pisano (2021). |
Rosa J, Widimsky P, Waldauf P et al. (2017) Renal denervation in comparison with intensified pharmacotherapy in true resistant hypertension: 2-year outcomes of randomized PRAGUE-15 study. Journal of hypertension 35(5): 1093-9 | RCT n=106 (RDN, n=52; PHAR, n=54) follow up: 24 months | In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in BP reduction over a period of 24 months. However, by contrast to the 12-month results, BP changes were not significantly greater. | PRAGUE-15 was included in Pisano (2021). |
Sardar P, Bhatt DL, Kirtane AJ et al. (2019) Sham-controlled randomized trials of catheter-based renal denervation in patients with hypertension. Journal of the American College of Cardiology 73(13): 1633-1642 | Meta-analysis n=6 studies (977 patients) follow up: 2 to 6 months | RSD significantly reduced blood pressure compared with sham control. Results of this meta-analysis should inform the design of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with hypertension. | This review included patients with hypotension and outcomes for resistant hypertension were not reported separately. |
Sanders MF, Reitsma JB, Morpey M et al. (2017) Renal safety of catheter-based renal denervation: systematic review and meta-analysis. Nephrology, dialysis, transplantation: official publication of the European Dialysis and Transplant Association - European Renal Association 32(9): 1440-7 | Systematic review and meta-analysis n=66 studies follow up: 9 months | The results show that renal function does not significantly change up to at least 9 months after RDN. | This study assessed the change in renal function after RDN and outcomes for resistant hypertension were not reported separately. |
Sata Y, Hering D, Head G A et al. (2018) Ambulatory arterial stiffness index as a predictor of blood pressure response to renal denervation. Journal of hypertension 36(6): 1414-22 | Case series n=111 follow up: 12 months | We conclude that in patients with resistant hypertension, a lower AASI is an independent predictor of the BP response to RDN, possibly explained by a more pronounced neurogenic rather than biomechanical contribution to their BP elevation. | Studies with larger samples and better designs are included in the key evidence. |
Schirmer SH, Sayed MMYA, Reil JC et al. (2014) Improvements in left ventricular hypertrophy and diastolic function following renal denervation: effects beyond blood pressure and heart rate reduction. Journal of the American College of Cardiology 63(18): 1916-23 | Case series n=66 follow up: 6 months | In patients with resistant hypertension, LV hypertrophy and diastolic function improved 6 months after RDN, without significant relation to SBP and HR. These findings suggest a direct effect of altered sympathetic activity in addition to unloading on cardiac hypertrophy and function. | Studies with larger samples or better designs are included in the key evidence. |
Schmid A, Schmieder R, Lell M et al. (2016) Mid-term vascular safety of renal denervation assessed by follow-up MR imaging. Cardiovascular and interventional radiology 39(3): 426-32 | Case series n=51 follow up: 11 months | No vascular or parenchymal complications after radiofrequency based RDN were detected in 51 patients followed up by MRI. | Studies with larger samples or better designs are included in the key evidence. |
Schmid A, Ditting T, Sobotka P A et al. (2013) Does renal artery supply indicate treatment success of renal denervation? Cardiovascular and interventional radiology 36(4): 987-91 | Non-randomised comparative studies n=53 (one-vessel, n=32; multivessel, n=21) follow up: 6 months | In patients with multiple renal arteries, RDN of one renal artery - namely, the dominant one - is sufficient to induce BP reduction in treatment-resistant hypertension. | Studies with larger samples or better designs are included in the key evidence. |
Schmieder RE, Ott C, Schmid A et al. (2016) Adherence to antihypertensive medication in treatment-resistant hypertension undergoing renal denervation. Journal of the American Heart Association 5(2) | Non-randomised comparative studies n=79 (adherent, n=44; partially adherent, n=22; non-adherent, n=13) follow up: 6 months | Nonadherence to medication among patients with TRH was relatively low: about 1 of 6 patients with TRH did not take ≥2 of the prescribed drugs. Adherence pattern did not change significantly after renal denervation and had no impact on the overall observed BP changes, supporting the concept that renal denervation is an effective treatment in patients with TRH. | Studies with larger samples or better designs are included in the key evidence. |
Schneider S, Promny D, Sinnecker D et al. (2015) Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve). Nephrology, dialysis, transplantation: official publication of the European Dialysis and Transplant Association - European Renal Association 30(11): 1928-36 | RCT n=18 follow up: 6 months | RDN is feasible and safe in renal transplant recipients. However, larger sham-controlled studies will be necessary to clarify the potential role of RDN in this population. | Small sample and focusing on RDN in patients with post-transplant hypertension. |
Sievert H, Schofer J, Ormiston J et al. (2015) Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 10(10): 1213-20 | Single-arm trial n=146 follow up: 6 months | Renal artery denervation with the Vessix system reduced both office and ambulatory BP at 6 months in patients with resistant hypertension. Renal artery safety and renal function results are favourable. | Studies with larger samples or better designs are included in the key evidence. |
Silverwatch J, Marti KE, Phan MT et al. (2021) Renal denervation for uncontrolled and resistant hypertension: Systematic review and network meta-analysis of randomized trials. Journal of Clinical Medicine 10(4): 1-14 | Systematic review and network meta-analysis n=20 studies (resistant hypertension, n=15 studies; uncontrolled hypertension, n=5) follow up: | Radiofrequency in main renal artery (MRA) and branches ranked as the best treatment to reduce 24-h ambulatory, daytime, and nighttime SBP and DBP versus other interventions (p-scores: 0.83 to 0.97); significant blood pressure effects were found versus sham or antihypertensive therapy (AHT). Radiofrequency in MRA+AHT was the best treatment to reduce office SBP and DBP (p-scores: 0.84 and 0.90, respectively). Radiofrequency in MRA and branches was the most efficacious versus other interventions to reduce 24-h ambulatory SBP and DBP in uncontrolled or resistant hypertension. | Most of the relevant studies are included in the key evidence (Pisano 2021; Fengler 2019). Limited efficacy outcomes for resistant hypertension were reported via sensitive analyses. |
Skowerski M, Roleder T, Banska-Kisiel K et al. (2016) Long-term follow-up after radio-frequency catheter-based denervation in patients with resistant hypertension. International journal of cardiology 215: 472-5 | Case series n=86 follow up: 24 months | Authors regard RND as a safe and effective procedure in resistant hypertension, although more studies and trials are needed to find the most adequate model of a patient that would be a good responder to RND. | Small sample |
Stavropoulos K, Patoulias D, Imprialos K et al. (2020) Efficacy and safety of renal denervation for the management of arterial hypertension: A systematic review and meta-analysis of randomized, sham-controlled, catheter-based trials. Journal of Clinical Hypertension 22(4): 572-84 | Systematic review and meta-analysis n=6 studies | The results suggest that renal denervation works in the short term and may contribute to better management and control of uncontrolled hypertension. Nonetheless, the effect is relatively small and most likely diluted by non-responders. Further, well-designed studies are needed to better define the role of renal denervation in the treatment of hypertension in the general population. | All relevant studies of percutaneous transluminal RDN for resistant hypertension were included in Pisano (2021). |
Stoiber L, Mahfoud F, Zamani SM et al. (2018) Renal sympathetic denervation restores aortic distensibility in patients with resistant hypertension: data from a multi-center trial. Clinical research in cardiology: official journal of the German Cardiac Society 107(8): 642-52 | Case series n=65 follow up: 6 months | The results underline the direct neurohormonal influence of RDN on vascular tone and aortic stiffness and propose that CMR determined AD may be most suitable in the evaluation of aortic compliance in invasive BP therapy. Indeed, other parameters considered to integrate alterations of vascular compliance and arterial stiffness such as isolated systolic hypertension, augmentation index, and pulse wave velocity have been demonstrated to improve with RDN. | Studies with larger samples and better designs are included in the key evidence. |
Sun D, Li C, Li M et al. (2016) Renal denervation vs pharmacotherapy for resistant hypertension: a meta-analysis. Journal of clinical hypertension (Greenwich, Conn.) 18(8): 733-40 | Meta-analysis n=9 studies (1,096 patients) follow up: 6 months | This pooled analysis shows that for patients with resistant hypertension, RD is more effective in reducing SBP and DBP than PHAR. RD may be more effective in special subgroups of patients, which needs to be identified in future investigations. | Most relevant RCTs of percutaneous transluminal RDN for resistant hypertension were included in Pisano (2021). |
Syed M, Osman M, Alhamoud H et al. (2021) The state of renal sympathetic denervation for the management of patients with hypertension: A systematic review and meta-analysis. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions 97(4): e438-e445 | Systematic review and meta-analysis n=8 studies | The use of RSD for the management of hypertension resulted in effective reduction in the ambulatory and office blood pressure compared to sham procedure. Adequately powered RCTs of RSD are needed to confirm safety, reproducibility and assess the impact on clinical outcomes. | Most studies for resistant hypertension were included in Pisano (2021). |
Symplicity HTN-1 Investigators. (2011) Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension 57(5): 911-7 | Case series n=153 follow up: up to 24 months | In patients with resistant hypertension, catheter-based RDN results in a substantial reduction in BP sustained out to ≥2 years of follow-up, without significant adverse events. | Studies with larger samples and better designs are included in the key evidence. |
Tsioufis C, Ziakas A, Dimitriadis K et al. (2017) Blood pressure response to catheter-based renal sympathetic denervation in severe resistant hypertension: data from the Greek Renal Denervation Registry. Clinical research in cardiology: official journal of the German Cardiac Society 106(5): 322-30 | Case series (Greek registry) n=79 follow up: 12 months | In our ''real-world'' multicenter national registry, the efficacy of renal denervation in reducing BP as well as safety is confirmed during a 12-month follow-up. Moreover, younger age, obesity, and higher levels of baseline systolic BP are independently related to better BP response to RDN. | Studies with larger samples and better designs are included in the key evidence. |
Ukena C, Seidel T, Rizas K et al. (2020) Effects of renal denervation on 24-h heart rate and heart rate variability in resistant hypertension. Clinical Research in Cardiology 109(5): 581-588 | Case series n=105 follow up: 6 months | In patients with resistant hypertension and elevated heart rate or high burden of PACs, RDN was associated with a reduction of HR and number of PAC. Parameters of HRV were not changed after RDN nor were predictive of response to RDN. | Studies with larger samples and better designs are included in the key evidence. |
Verheye S, Ormiston J, Bergmann MW et al. (2015) Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 10(10): 1221-9 | Case series (RAPID) n=50 follow up: 12 months | The results showed safety delivery of RF energy by the OneShot Renal Denervation System for renal sympathetic denervation and sustained efficacy, as evidenced by a significant reduction in office and 4-hour ABPM for 6 months, which was sustained up to 12 months. | Studies with larger samples and better designs are included in the key evidence. |
Verloop WL, Vink EE, Spiering W et al. (2014) Renal denervation in multiple renal arteries. European journal of clinical investigation 44(8): 728-35 | Case series n=69 follow up: 6 months | Based on our results and the high prevalence of multiple arteries, it seems reasonable not to exclude patients with multiple renal arteries from RDN. Current analysis suggests that BP reduction may be less pronounced in patients with multiple renal arteries of whom not all arteries were treated | Small sample |
Verloop WL, Vink EE, Spiering W et al. (2015) Effects of renal denervation on end organ damage in hypertensive patients. European journal of preventive cardiology 22(5): 558-67 | Case series n=54 follow up: 12 months | In the current study, authors observed a modest effect from renal denervation. Moreover, RDN did not result in a statistically significant effect on end organ damage 12 months after treatment. | Small sample |
Vink EE, Verloop WL, Bost RBC et al. (2014) The blood pressure-lowering effect of renal denervation is inversely related to kidney function. Journal of hypertension 32(10): 2045-53 | Case series n=67 follow up: 6 months | The present study shows an inverse relation between the BP-lowering effect of RDN and eGFR. Second, authors found relations between variables of the RAAS and SNS with the BP-lowering effect of RDN. The data complement current concepts on pathophysiology of sympathetic hyperactivity and hypertension and may give some insight in the wide range of the effect of RDN. | Limited efficacy reported and small sample. |
Vogel B, Kirchberger M, Zeier M et al. (2014) Renal sympathetic denervation therapy in the real world: results from the Heidelberg registry. Clinical research in cardiology: official journal of the German Cardiac Society 103(2): 117-24 | Case series (Heidelberg registry) n=63 follow up: 12 months | RDN with the SymplicityTM system is safe and effective in patients with treatment-resistant hypertension also in a real-world setting. | Studies with larger samples and better designs are included in the key evidence. |
Vogiatzakis N, Tsioufis C, Georgiopoulos G et al. (2017) Effect of renal sympathetic denervation on short-term blood pressure variability in resistant hypertension: a meta-analysis. Journal of hypertension 35(9): 1750-7 | Meta-analysis n=6 studies (2 RCTs and 4 non-randomised comparative studies) | Catheter-based RDN in resistant hypertensive patients can favourably affect short-term BPV, independent of the level of BP reduction. Further investigation of the effect of RDN on BPV is needed with large, randomised trials. | 3 studies in this meta-analysis were included in Townsend (2020) and both RCTs were included in Pisano (2021). |
Volz S, Spaak J, Elf J et al. (2018) Renal sympathetic denervation in Sweden: a report from the Swedish registry for renal denervation. Journal of hypertension 36(1): 151-8 | Case series (Swedish registry) n=252 follow up: 24 months | In this complete national cohort, RDN was associated with a sustained reduction in office and ambulatory BP in patients with resistant hypertension. The procedure proved to be feasible and associated with a low-complication rate, including long-term adverse events. | This study was included in Townsend (2020). |
Warchol-Celinska E, Prejbisz A, Kadziela J et al. (2018) Renal denervation in resistant hypertension and obstructive sleep apnea: randomized proof-of-concept phase ii trial. Hypertension (Dallas, Tex.: 1979) 72(2): 381-90 | RCT n=60 (RDN, n=30; control, n=30) follow up: 6 months | This study shows that catheter-based renal sympathetic denervation may lower BP in resistant hypertensive patients with sleep-disordered breathing. This was accompanied by improvement of the clinical course of sleep apnoea. Our data are in concordance with the post hoc analyses from Symplicity-HTN-3 and global registry studies suggesting that patients with OSA may be particularly responsive to RDN therapy. Further studies are warranted to assess the impact of RDN on sleep apnoea and its relation to BP decline and cardiovascular risk. | This RCT was included in Pisano (2021). |
Xia M, Liu T, Chen D et al. (2021) Efficacy and safety of renal denervation for hypertension in patients with chronic kidney disease: a meta-analysis. International journal of hyperthermia: the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group 38(1): 732-42 | Meta-analysis n=11 studies (238 patients with hypertension and CKD) follow up: 24 months | The meta-analysis showed that RDN may be effective and safe for treating CKD patients with hypertension. Well-designed randomized controlled trials of RDN are urgently needed to confirm the safety and reproducibility of RDN and to assess its impact on clinical outcomes. | This study evaluated the efficacy and safety of RDN for hypertension in patients with CKD, and the outcomes for resistant hypertension were not reported separately. |
Xu Y, Xiao P, Fan J et al. (2018) Blood pressure elevation response to radiofrequency energy delivery: one novel predictive marker to long-term success of renal denervation. Journal of hypertension 36(12): 2460-70 | Case series n=57 follow up: 12 months | Baseline SBP and BP-elevation response during radiofrequency ablation, as well as larger positive response points to radiofrequency energy delivery could be an effective intraprocedural predictive markers to long-term procedural success of RDN. | Studies with larger samples or better designs are included in the key evidence. |
Yang X, Liu H, Chen S et al. (2022) Intravascular renal denervation reduces ambulatory and office blood pressure in patients with essential hypertension: a meta-analysis of randomized sham-controlled trials. Kidney Blood Press Res 47: 363–74 | Meta-analysis n=8 studies | Intravascular RDN using second-generation catheters reduces ambulatory and office BP in patients with essential hypertension. The selection of appropriate hypertensive patients may be the major challenge for the performance of intravascular RDN in routine clinical practice. | Most relevant studies of percutaneous transluminal RDN for resistant hypertension are included in the key evidence (Pisano 2021; Azizi, 2021). Outcomes for resistant hypertension were not reported separately. |
Yao Y, Zhang D, Qian J et al. (2016) The effect of renal denervation on resistant hypertension: Meta-analysis of randomized controlled clinical trials. Clinical and experimental hypertension (New York, N.Y.: 1993) 38(3): 278-86 | Meta-analysis n=9 studies follow up: 6 months | Radiofrequency RDN in a randomised manner did not have superiority compared with medical treatment at 6-month follow-up in general population. Current evidence provides insufficient evidence to support the use of such RDN strategy in the treatment of resistant hypertension. The result could not be used to extrapolate other strategies' effect. | Most studies in this meta-analysis were included in Pisano (2021). |
Zhang X, Wu N, Yan W et al. (2016) The effects of renal denervation on resistant hypertension patients: a meta-analysis. Blood pressure monitoring 21(4): 206-14 | Meta-analysis n=11 studies follow up: 6 months | This meta-analysis shows that RDN is superior to the control group in lowering office blood pressure rather than ambulatory SBP and might have other potential benefits to protect heart and renal function. | Most relevant RCTs were included in Pisano (2021) and non-randomised comparative studies had small samples. |
Zhang ZH, Yang K, Jiang FL et al. (2014) The effects of catheter-based radiofrequency renal denervation on renal function and renal artery structure in patients with resistant hypertension. Journal of clinical hypertension (Greenwich, Conn.) 16(8): 599-605 | Non-randomised comparative studies n=77 (RDN, n=39; control, n=38) follow up: 12 months | RDN significantly and persistently reduced blood pressure and decreased urinary protein excretion rate in patients with resistant hypertension and did not exhibit any adverse effect on renal function and renal artery structure | Studies with larger samples or better designs are included in the key evidence. |
Zweiker D, Lambert T, Steinwender C et al. (2019) Blood pressure changes after renal denervation are more pronounced in women and nondiabetic patients: findings from the Austrian Transcatheter Renal Denervation Registry. Journal of hypertension 37(11): 2290-7 | Case series (Registry) n=291 follow up: 12 months | Ambulatory BP reductions after RDN were substantially more pronounced in female and in nondiabetic patients despite lower baseline BP. It is concluded that in terms of efficacy female patients and nondiabetic patients might benefit more from RDN. | Studies with larger samples or better designs are included in the key evidence. |
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