Interventional procedure overview of alcohol-mediated perivascular renal sympathetic denervation for resistant hypertension
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Appendix B: Other relevant studies
Other potentially relevant studies that were not included in the main evidence summary (tables 2 and 3) are listed in table 5 below.
Article | Number of people and follow up | Direction of conclusions | Reason study was not included in main evidence summary |
|---|---|---|---|
Fischell TA, Fischell DR, Ghazarossian VE, et al. (2015) Next generation renal denervation: chemical "perivascular" renal denervation with alcohol using a novel drug infusion catheter. Cardiovascular Revascularization Medicine 16: 221-7. | Case series N=18 Follow up: 6 months | Perivascular RDN using micro-doses of alcohol is a promising alternative to energy-based systems to achieve dose-dependent, predictable, safe and essentially painless renal denervation. Further clinical evaluation is warranted. | More recent studies with larger samples or better design were included in the main evidence. |
Gunes-Altan M, Schmid A, Ott C et al. (2024) Blood pressure reduction after renal degermation in patients with or without chronic kidney disease. Clinical Kidney Journal, 17: 1-11 | Non-randomised comparative study N=174 (47 people with CKD and 124 people without CKD) Follow up: 12 months | Authors observed a similar reduction in 24-hour, day and night-time ambulatory BP as well as in-office BP in people with and without CKD at any time point up to 12 months. Authors conclude that RDN is an effective and safe treatment option for patients with hypertension and CKD. | Intervention included radiofrequency-, ultrasound- or alcohol-infusion-based RDN, the outcomes for alcohol-mediated RDN not reported separately |
Hearon CMJ, Howden EJ, Fu Q et al. (2021) Evidence of reduced efferent renal sympathetic innervation after chemical renal denervation in humans. American journal of hypertension 34(7): 744-52 | Pilot study n=7 | These results are the first to show efferent sympathetic denervation of the renal cortex following RDN in humans. Further studies of mechanisms underlying variable blood pressure lowering in the setting of documented RDN may provide insights into inconsistencies in clinical trial outcomes. | Small sample with limited efficacy data reported. |
Luo G, Zhu JJ, Yao M et al. (2021) Computed tomography-guided chemical renal sympathetic nerve modulation in the treatment of resistant hypertension: A case report. World Journal of Clinical Cases 9(32): 9970-6 | Case report n=1 Follow up: 1 year | Computed tomography-guided chemical renal sympathetic modulation may be a feasible method for the treatment of resistant hypertension. | Small sample |
Mahfoud F, Bertog S, Lauder L et al. (2021) Blood pressure lowering with alcohol-mediated renal denervation using the Peregrine infusion Catheter is independent of injection site location. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions 98(6): e832-38 | Post-hoc analysis of a feasibility study (Mahfoud 2020) n=45 Follow up: 6 months | In this post-hoc analysis, the location of alcohol infusion within the main renal artery using the Peregrine system, with alcohol as the neurolytic agent for chemical RDN, did not affect the magnitude of BP changes at 6 months. | Mahfoud (2020) is included in the main evidence. |
Persu A, Maes F, Toennes SW et al. (2022) Impact of drug adherence on blood pressure response to alcohol-mediated renal denervation. Blood Pressure 31(1): 109-17 | Sub-analysis of drug adherence of a feasibility study (Mahfoud 2020, 2021) n=45 Follow up: 12 months | About 40% of patients with apparently treatment-resistant hypertension were not fully adherent at baseline, and adherence decreased further in 30%. Nevertheless, mean blood pressure changes after renal denervation were similar irrespective of drug adherence. Our results suggest that such patients may benefit from alcohol-mediated renal denervation, irrespective of drug adherence. These findings are hypothesis-generating and need to be confirmed in ongoing sham-controlled trials. | The feasibility study is included in the main evidence. |
Ricke J, Seidensticker M, Becker S et al. (2016) Renal sympathetic denervation by CT-guided ethanol injection: a phase ii pilot trial of a novel technique. Cardiovascular and interventional radiology 39(2): 251-60 | Case series N=11 Follow up: 6 months | CT-guided sympathetic denervation proved to be safe and applicable under various anatomical conditions with more renal arteries and such of small diameter. | More recent studies with larger samples or better design were included in the main evidence. |
Streitparth F, Gebauer B, Nickel P et al. (2014) Percutaneous computer tomography-guided ethanol sympathicolysis for the treatment of resistant arterial hypertension. Cardiovascular and interventional radiology 37(2): 513-8 | Case report n=1 Follow up: 1 month | Image-guided periarterial ethanol injection for renal sympathetic denervation in a patient with drug-resistant hypertension is feasible. Authors provide a detailed description of this new interventional procedure and discuss its potential advantages compared with catheter-based radiofrequency ablation. | Small sample |
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