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Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension
BACKGROUND: Primary results of this prospective, open-label, multicenter trial suggested that alcohol-mediated renal denervation with perivascular injection of dehydrated alcohol using the Peregrine System Infusion Catheter safely reduces blood pressure (BP) in patients with resistant hypertension....
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452324/ https://www.ncbi.nlm.nih.gov/pubmed/34470501 http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.010075 |
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author | Mahfoud, Felix Sievert, Horst Bertog, Stefan Lauder, Lucas Ewen, Sebastian Lengelé, Jean-Philippe Wojakowski, Wojciech Schmieder, Roland van der Giet, Markus Weber, Michael A. Kandzari, David E. Parise, Helen Fischell, Tim A. Pathak, Atul Persu, Alexandre |
author_facet | Mahfoud, Felix Sievert, Horst Bertog, Stefan Lauder, Lucas Ewen, Sebastian Lengelé, Jean-Philippe Wojakowski, Wojciech Schmieder, Roland van der Giet, Markus Weber, Michael A. Kandzari, David E. Parise, Helen Fischell, Tim A. Pathak, Atul Persu, Alexandre |
author_sort | Mahfoud, Felix |
collection | PubMed |
description | BACKGROUND: Primary results of this prospective, open-label, multicenter trial suggested that alcohol-mediated renal denervation with perivascular injection of dehydrated alcohol using the Peregrine System Infusion Catheter safely reduces blood pressure (BP) in patients with resistant hypertension. To date, maintenance of the BP-lowering effect beyond 6 months using this novel technology has not been reported. This article describes the final, 12-month follow-up data on the safety and efficacy of alcohol-mediated renal denervation in these patients. METHODS: Forty-five patients with resistant hypertension on a stable regimen of on average 5.1±1.5 antihypertensive medications underwent successful bilateral renal denervation using the Peregrine Catheter with alcohol as the neurolytic agent (0.6 mL per renal artery). Apart from 2 vascular access pseudoaneurysms (both without sequelae), no major procedural complications occurred. RESULTS: At 12 months post-procedure, mean 24-hour ambulatory systolic and diastolic BP were reduced by 10 mm Hg (95% CI, −16 to −5) and 7 mm Hg (−10 to −3), respectively (P<0.001). Office systolic/diastolic BP was reduced by 20/10 mm Hg (−27, −13/−14, −6; <0.001). Compared with baseline, the number of antihypertensive medications was reduced in 21% of patients, while it was increased in 19%. From baseline to 12 months, serum creatinine, urea, cystatin C, and spot urine albumin levels remained unchanged. The change in estimated glomerular filtration rates (−3.9±10.3 mL/minute per 1.73 m(2) [95% CI, −7.1 to −0.75]; P=0.02) was within the expected range. There were no cases of renal artery stenosis up to 12-month follow-up. CONCLUSIONS: Catheter-based chemical renal denervation with dehydrated alcohol using the Peregrine Catheter seems to safely reduce BP at follow-up of up to 12 months. Further randomized and sham controlled studies are underway to further validate these findings. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02570113. |
format | Online Article Text |
id | pubmed-8452324 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-84523242021-09-28 Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension Mahfoud, Felix Sievert, Horst Bertog, Stefan Lauder, Lucas Ewen, Sebastian Lengelé, Jean-Philippe Wojakowski, Wojciech Schmieder, Roland van der Giet, Markus Weber, Michael A. Kandzari, David E. Parise, Helen Fischell, Tim A. Pathak, Atul Persu, Alexandre Circ Cardiovasc Interv Original Article BACKGROUND: Primary results of this prospective, open-label, multicenter trial suggested that alcohol-mediated renal denervation with perivascular injection of dehydrated alcohol using the Peregrine System Infusion Catheter safely reduces blood pressure (BP) in patients with resistant hypertension. To date, maintenance of the BP-lowering effect beyond 6 months using this novel technology has not been reported. This article describes the final, 12-month follow-up data on the safety and efficacy of alcohol-mediated renal denervation in these patients. METHODS: Forty-five patients with resistant hypertension on a stable regimen of on average 5.1±1.5 antihypertensive medications underwent successful bilateral renal denervation using the Peregrine Catheter with alcohol as the neurolytic agent (0.6 mL per renal artery). Apart from 2 vascular access pseudoaneurysms (both without sequelae), no major procedural complications occurred. RESULTS: At 12 months post-procedure, mean 24-hour ambulatory systolic and diastolic BP were reduced by 10 mm Hg (95% CI, −16 to −5) and 7 mm Hg (−10 to −3), respectively (P<0.001). Office systolic/diastolic BP was reduced by 20/10 mm Hg (−27, −13/−14, −6; <0.001). Compared with baseline, the number of antihypertensive medications was reduced in 21% of patients, while it was increased in 19%. From baseline to 12 months, serum creatinine, urea, cystatin C, and spot urine albumin levels remained unchanged. The change in estimated glomerular filtration rates (−3.9±10.3 mL/minute per 1.73 m(2) [95% CI, −7.1 to −0.75]; P=0.02) was within the expected range. There were no cases of renal artery stenosis up to 12-month follow-up. CONCLUSIONS: Catheter-based chemical renal denervation with dehydrated alcohol using the Peregrine Catheter seems to safely reduce BP at follow-up of up to 12 months. Further randomized and sham controlled studies are underway to further validate these findings. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02570113. Lippincott Williams & Wilkins 2021-09-02 /pmc/articles/PMC8452324/ /pubmed/34470501 http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.010075 Text en © 2021 The Authors. https://creativecommons.org/licenses/by-nc-nd/4.0/Circulation: Cardiovascular Interventions is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made. |
spellingShingle | Original Article Mahfoud, Felix Sievert, Horst Bertog, Stefan Lauder, Lucas Ewen, Sebastian Lengelé, Jean-Philippe Wojakowski, Wojciech Schmieder, Roland van der Giet, Markus Weber, Michael A. Kandzari, David E. Parise, Helen Fischell, Tim A. Pathak, Atul Persu, Alexandre Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension |
title | Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension |
title_full | Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension |
title_fullStr | Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension |
title_full_unstemmed | Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension |
title_short | Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension |
title_sort | long-term results up to 12 months after catheter-based alcohol-mediated renal denervation for treatment of resistant hypertension |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452324/ https://www.ncbi.nlm.nih.gov/pubmed/34470501 http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.010075 |
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