Felix Mahfoud1, Jean Renkin2, Horst Sievert3, Stefan Bertog4, Sebastian Ewen5, Michael Böhm5, Jean-Philippe Lengelé2, Wojciech Wojakowski6, Roland Schmieder7, Markus van der Giet8, Helen Parise9, Nicole Haratani10, Atul Pathak11, Alexandre Persu2. 1. Department of Internal Medicine III, Cardiology, Angiology, Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany. Electronic address: felix.mahfoud@uks.eu. 2. Division of Cardiology, Department of Cardiovascular Diseases, Cliniques Universitaires Saint-Luc and Pole of Cardiovascular Research, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium. 3. CardioVascular Center Frankfurt, Frankfurt, Germany; Anglia Ruskin University, Chelmsford, United Kingdom; University California, San Francisco, San Francisco, California; Yunnan Hospital Fuwai, Kunming, China. 4. CardioVascular Center Frankfurt, Frankfurt, Germany. 5. Department of Internal Medicine III, Cardiology, Angiology, Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany. 6. Medical University of Silesia, Katowice, Poland. 7. University Hospital Erlangen, Friedrich-Alexander University Erlangen, Erlangen, Germany. 8. Department of Nephrology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Germany. 9. Las Vegas, Nevada. 10. Ablative Solutions, San Jose, California. 11. Department of Cardiovascular Medicine, Hypertension and Heart Failure Unit, INSERM 1048, Clinique Pasteur, Toulouse, France.
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.
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 hypertensivepatients 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: Anna Pisano; Luigi Francesco Iannone; Antonio Leo; Emilio Russo; Giuseppe Coppolino; Davide Bolignano Journal: Cochrane Database Syst Rev Date: 2021-11-22
Authors: V J M Zeijen; A A Kroon; B H van den Born; P J Blankestijn; S C A Meijvis; A Nap; E Lipsic; A Elvan; J Versmissen; R J van Geuns; M Voskuil; P A L Tonino; W Spiering; J Deinum; J Daemen Journal: Neth Heart J Date: 2022-08-24 Impact factor: 2.854
Authors: Felix Mahfoud; Michel Azizi; Sebastian Ewen; Atul Pathak; Christian Ukena; Peter J Blankestijn; Michael Böhm; Michel Burnier; Gilles Chatellier; Isabelle Durand Zaleski; Guido Grassi; Michael Joner; David E Kandzari; Ajay Kirtane; Sverre E Kjeldsen; Melvin D Lobo; Thomas F Lüscher; John William McEvoy; Gianfranco Parati; Patrick Rossignol; Luis Ruilope; Markus P Schlaich; Atif Shahzad; Faisal Sharif; Andrew S P Sharp; Horst Sievert; Massimo Volpe; Michael A Weber; Roland E Schmieder; Costas Tsioufis; William Wijns Journal: Eur Heart J Date: 2020-04-21 Impact factor: 29.983