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

https://doi.org/10.1016/j.jcin.2019.10.048Get rights and content
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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 high. 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.

Key Words

alcohol
catheter
hypertension
neurolysis
renal denervation

Abbreviations and Acronyms

ABPM
ambulatory blood pressure monitoring
AE
adverse event
BP
blood pressure
CI
confidence interval
CTA
computed tomographic angiography
eGFR
estimated glomerular filtration rate
RDN
renal denervation
RDUS
renal duplex ultrasound
TML
transient microleak

Cited by (0)

This work was supported by Ablative Solutions. Dr. Mahfoud has received speaking honoraria from Medtronic and Recor; and is supported by Deutsche Hochdruckliga, Deutsche Gesellschaft für Kardiologie, and Deutsche Forschungsgemeinschaft. Dr. Böhm has received honoraria from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cytokinetics, Servier, Medtronic, Novartis, and Vifor; and is supported by the Deutsche Forschungsgemeinschaft (DFG, TTR SFB- 219, S-01, M-03, M-05). Dr. Schmieder has received grants and personal fees from Ablative Solutions, Medtronic, ReCor, and ROX. Dr. van der Giet has received honoraria from CVRX. Ms. Haratani is an employee of Ablative Solutions. Dr. Pathak has received speaking honoraria from Medtronic and Recor; and is an investigator for trials sponsored by Medtronic, Recor, and Ablative Solutions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.