Blood pressure lowering with alcohol-mediated renal denervation using the Peregrine infusion Catheter is independent of injection site location.
angiography
hypertension
renal artery
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
15 11 2021
15 11 2021
Historique:
revised:
09
08
2021
received:
29
06
2021
accepted:
21
08
2021
pubmed:
3
9
2021
medline:
15
12
2021
entrez:
2
9
2021
Statut:
ppublish
Résumé
The current analysis utilized core laboratory angiographic data from a prospective, single-arm, open-label, multi-center feasibility study to ascertain whether the location of alcohol infusion within main renal arteries during renal denervation (RDN) had an impact on the BP-lowering effect at 6 months. The influence of the location of alcohol infusion during RDN, within the main renal artery (proximal, middle, or distal), on the magnitude of the blood pressure (BP) lowering is unstudied. The Peregrine Catheter was used to perform alcohol-mediated RDN with an infusion of 0.6 mL of alcohol per artery as the neurolytic agent in 90 main arteries and four accessory arteries of 45 patients with hypertension. No relationship between the site of alcohol infusion and change from baseline in both office systolic and 24-hour systolic ambulatory BP (ABP) at 6 months was observed. When analyzed at the artery level, the least squares (LS) mean changes ± SEM from baseline to 6 months post-procedure in 24-hour systolic ABP when analyzed by renal arterial location were -11.9 ± 2.4 mmHg (distal), -10 ± 1.6 mmHg (middle), and -10.6 ± 1.3 mmHg (proximal) (all p < 0.0001 for change from baseline within groups). The results were similar for office systolic BP. There was no difference between treated locations (proximal is reference). 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.
Sections du résumé
OBJECTIVES
The current analysis utilized core laboratory angiographic data from a prospective, single-arm, open-label, multi-center feasibility study to ascertain whether the location of alcohol infusion within main renal arteries during renal denervation (RDN) had an impact on the BP-lowering effect at 6 months.
BACKGROUND
The influence of the location of alcohol infusion during RDN, within the main renal artery (proximal, middle, or distal), on the magnitude of the blood pressure (BP) lowering is unstudied.
METHODS
The Peregrine Catheter was used to perform alcohol-mediated RDN with an infusion of 0.6 mL of alcohol per artery as the neurolytic agent in 90 main arteries and four accessory arteries of 45 patients with hypertension.
RESULTS
No relationship between the site of alcohol infusion and change from baseline in both office systolic and 24-hour systolic ambulatory BP (ABP) at 6 months was observed. When analyzed at the artery level, the least squares (LS) mean changes ± SEM from baseline to 6 months post-procedure in 24-hour systolic ABP when analyzed by renal arterial location were -11.9 ± 2.4 mmHg (distal), -10 ± 1.6 mmHg (middle), and -10.6 ± 1.3 mmHg (proximal) (all p < 0.0001 for change from baseline within groups). The results were similar for office systolic BP. There was no difference between treated locations (proximal is reference).
CONCLUSION
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.
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
E832-E838Subventions
Organisme : This work was supported by Ablative Solutions, Inc.
Organisme : Ablative Solutions, Inc.
Informations de copyright
© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
Références
Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020;395(10234):1444-1451.
Azizi M, Schmieder RE, Mahfoud F, et al. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018;391(10137):2335-2345.
Mahfoud F, Renkin J, Sievert H, et al. Alcohol-mediated renal denervation using the Peregrine system infusion catheter for treatment of hypertension. J Am Coll Cardiol Intv. 2020;13(4):471-484.
Sakakura K, Ladich E, Cheng Q, et al. Anatomic assessment of sympathetic peri-arterial renal nerves in man. J Am Coll Cardiol. 2014;64(7):635-643. https://doi.org/10.1016/j.jacc.2014.03.059
Tzafriri AR, Mahfoud F, Keating JH, et al. Innervation patterns may limit response to endovascular renal denervation. J Am Coll Cardiol. 2014;64(11):1079-1087.
Mahfoud F, Bhatt DL. Catheter-based renal denervation: the black box procedure. Vol. 6. JACC: Cardiovascular Intervent. 2013;10:1092-1094.
García-Touchard A, Maranillo E, Mompeo B, Sañudo JR. Microdissection of the human renal nervous system: implications for performing renal denervation procedures. Hypertension. 2020;76(4):1240-1246.
Mahfoud F, Lüscher TF. Renal denervation: symply trapped by complexity? Eur Heart J. 2015;36:199-202.
Vink EE, Goldschmeding R, Vink A, Weggemans C, Bleijs RLAW, Blankestijn PJ. Limited destruction of renal nerves after catheter-based renal denervation: results of a human case study. Nephrol Dialys Transplant. 2014;29(8):1608-1610.
Henegar JR, Zhang Y, Hata C, Narciso I, Hall ME, Hall JE. Catheter-based radiofrequency renal denervation: location effects on renal norepinephrine. Am J Hypertens. 2015;28(7):909-914.
Mahfoud F, Tunev S, Ewen S, et al. Impact of lesion placement on efficacy and safety of catheter-based radiofrequency renal denervation. J Am Coll Cardiol 2015;66(16):1766-75.
Kandzari DE, Kario K, Mahfoud F, et al. The SPYRAL HTN global clinical trial program: rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016;171(1):82-91.
Bertog S, Fischell TA, Vega F, et al. Randomised, blinded and controlled comparative study of chemical and radiofrequency-based renal denervation in a porcine model. EuroIntervention. 2017;12(15):e1898-e1906.
Fischell TA, Vega F, Raju N, et al. Ethanol-mediated perivascular renal sympathetic denervation: preclinical validation of safety and efficacy in a porcine model. EuroIntervention. 2013;9(1):140-147.
Pekarskiy SE, Baev AE, Mordovin VF, et al. Denervation of the distal renal arterial branches vs. conventional main renal artery treatment: a randomized controlled trial for treatment of resistant hypertension. J Hypertens. 2017;35(2):369-375.
Tzafriri AR, Mahfoud F, Keating JH, et al. Procedural and anatomical determinants of multielectrode renal denervation efficacy: insights from preclinical models. Hypertension. 2019;74(3):546-554.
Rippy MK, Zarins D, Barman NC, Wu A, Duncan KL, Zarins CK. Catheter-based renal sympathetic denervation: chronic preclinical evidence for renal artery safety. Clin Res Cardiol. 2011;100(12):1095-1101.
Tzafriri AR, Keating JH, Markham PM, et al. Arterial microanatomy determines the success of energy-based renal denervation in controlling hypertension. Sci Transl med. 2015;29:7(285).
Fengler K, Rommel KP, Blazek S, et al. A three-arm randomized trial of different renal denervation devices and techniques in patients with resistant hypertension (RADIOSOUND-HTN). Circulation. 2019;139(5):590-600.