Alcohol-Mediated Renal Denervation Using the Peregrine System Infusion Catheter for Treatment of Hypertension

Mahfoud F, Renkin J, Sievert H, Bertog S, Ewen S, Böhm M, Lengelé JP, Wojakowski W, Schmieder R, van der Giet M, Parise H, Haratani N, Pathak A, Persu A (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Jacc-Cardiovascular Interventions Elsevier

Book Volume: 13

Pages Range: 471-484

Journal Issue: 4

DOI: 10.1016/j.jcin.2019.10.048

Abstract

Objectives: The aim of this multicenter, open-label trial was to evaluate the safety and efficacy of alcohol-mediated renal denervation using a novel catheter system (the Peregrine System Infusion Catheter) for the infusion of dehydrated alcohol as a neurolytic agent into the renal periarterial space. Background: The number of hypertensive patients with uncontrolled blood pressure (BP) remains unacceptably low. The renal sympathetic nervous system has been identified as an attractive therapeutic target. Methods: Forty-five patients with uncontrolled hypertension on ≥3 antihypertensive medications underwent bilateral renal denervation using the Peregrine Catheter with 0.6 ml alcohol infused per renal artery. Results: All patients were treated as intended. Mean 24-h ambulatory BP reduction at 6 months versus baseline was −11 mm Hg (95% confidence interval [CI]: −15 to −7 mm Hg) for systolic BP and −7 mm Hg (95% CI: −9 to −4 mm Hg) for diastolic BP (p < 0.001 for both). Office systolic BP was reduced by −18/−10 mm Hg (95% CI: −25 to −12/−13 to −6 mm Hg) at 6 months. Antihypertensive medications were reduced in 23% and increased in 5% of patients at 6 months. Adherence to the antihypertensive regimen remained stable over time. The primary safety endpoint, defined as the absence of periprocedural major vascular complications, major bleeding, acute kidney injury, or death within 1 month, was met in 96% of patients (95% CI: 85% to 99%). Two patients had major adverse events of periprocedural access-site pseudoaneurysms, with major bleeding in one. There were no deaths or instances of myocardial infarction, stroke, transient ischemic attack, or renal artery stenosis. Transient microleaks were noted in 42% and 49% of the left and right main renal arteries, respectively. There were 2 cases of minor vessel dissection that resolved without treatment. Conclusions: Primary results from this trial suggest that alcohol-mediated renal denervation using the Peregrine Catheter safely reduces blood pressure and as such may represent a novel approach for the treatment of hypertension.

Authors with CRIS profile

Roland Schmieder Professur für Innere Medizin (Nephrologie)

Involved external institutions

Cliniques universitaires Saint-Luc (CHU St-Luc) BE Belgium (BE) Ablative Solutions US United States (USA) (US) CardioVasculäres Centrum Frankfurt DE Germany (DE) Charité - Universitätsmedizin Berlin DE Germany (DE) Clinique Pasteur FR France (FR) Medical University of Silesia in Katowice / Śląski Uniwersytet Medyczny w Katowicach (SUM) PL Poland (PL) Universitätsklinikum des Saarlandes (UKS) DE Germany (DE)

How to cite

APA:

Mahfoud, F., Renkin, J., Sievert, H., Bertog, S., Ewen, S., Böhm, M.,... Persu, A. (2020). Alcohol-Mediated Renal Denervation Using the Peregrine System Infusion Catheter for Treatment of Hypertension. Jacc-Cardiovascular Interventions, 13(4), 471-484. https://doi.org/10.1016/j.jcin.2019.10.048

MLA:

Mahfoud, Felix, et al. "Alcohol-Mediated Renal Denervation Using the Peregrine System Infusion Catheter for Treatment of Hypertension." Jacc-Cardiovascular Interventions 13.4 (2020): 471-484.

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