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3. Endovascular ultrasound renal denervation to lower blood pressure in young hypertensive women planning pregnancy: study protocol for a multicentre randomised, blinded and sham controlled proof of concept study

Author

Laurence Amar, Hélène Bouvaist, Anne Blanchard, Guillaume Lamirault, Didier Riethmuller, Loïc Sentilhes, Philippe Gosse, Louise Ghesquière, Pascal Delsart, Marc Sapoval, Patrice Guérin, Michel Azizi, Rosa Maria Bruno, Romain Boulestreau, Julien Doublet, Julie Gaudissard, Antoine Cremer, Vassilis Tsatsaris, Claire Mounier Vehier, Guillaume Ledieu, Benjamin Longere, Olivier Ormezzano, Charlotte Casser, Yannick Neuder, Mathieu Rodiere, Béatrice Duly-Bouhanick, Paul Guerby, Hervé Rousseau, and Robert Winer

Subjects
Medicine
Abstract

Introduction A major issue confronting clinicians treating hypertension in pregnancy is the limited number of pharmacological options. Endovascular catheter-based renal denervation (RDN) is a new method to lower blood pressure (BP) in patients with hypertension by reducing the activity of the renal sympathetic nervous system. Drugs that affect this system are safe in pregnant women. So there is reasonable evidence that RDN performed before pregnancy should not have deleterious effects for the fetus. Because the efficacy of RDN may be greater in younger patients and in women, we may expect a larger proportion of BP normalisation in young hypertensive women, but this remains to be proven. Our primary objective is to quantify the proportion of BP normalisation with RDN in this population.Methods and analysis WHY-RDN is a multicentre randomised sham-controlled trial conducted in six French hypertension centres that will include 80 women with essential hypertension treated or untreated, who are planning a pregnancy in the next 2 years and will be randomly assigned to RDN or classic renal arteriography and sham RDN in a ratio of 1:1. The primary outcome is the normalisation of 24-hour BP (

Published
2023
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4. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial

Author

Michel Azizi, Kintur Sanghvi, Manish Saxena, Philippe Gosse, John P Reilly, Terry Levy, Lars C Rump, Alexandre Persu, Jan Basile, Michael J Bloch, Joost Daemen, Melvin D Lobo, Felix Mahfoud, Roland E Schmieder, Andrew S P Sharp, Michael A Weber, Marc Sapoval, Pete Fong, Atul Pathak, Pierre Lantelme, David Hsi, Sripal Bangalore, Adam Witkowski, Joachim Weil, Benjamin Kably, Neil C Barman, Helen Reeve-Stoffer, Leslie Coleman, Candace K McClure, Ajay J Kirtane, Josh Costello, Courtney Krathan, Luot Lewis, Andrew McElvarr, John Reilly, Stephen Jenkins, Michael Cash, Shannon Williams, Maria Jarvis, Cheryl Laffer, James Gainer, Mark Robbins, Sherron Crook, Sarita Maddel, Scott Martin, Edward Portnay, Maryanne Ducey, Suzanne Rose, Elizabeth DelMastro, Stephen Williams, Stanley Cabos, Carolina Rodriguez Alvarez, Thomas Todoran, Eric Powers, Emily Hodskins, Vijay Paladugu, Anna Tecklenburg, Chandan Devireddy, Janice Lea, Bryan Wells, Amanda Fiebach, Claudia Merlin, Florian Rader, Suhail Dohad, Hyun-Min Kim, Mohammad Rashid, Josephine Abraham, Theophilus Owan, Anu Abraham, Iran Lavasani, Hailey Neilson, David Calhoun, Thomas McElderry, William Maddox, Suzanne Oparil, Sheila Kinder, Jai Radhakrishnan, Candido Batres, Suzanne Edwards, Joseph Garasic, Doug Drachman, Randy Zusman, Kenneth Rosenfield, Danny Do, Matheen Khuddus, Suzanne Zentko, James O'Meara, Ilie Barb, Abby Foster, Alice Boyette, Yale Wang, Desmond Jay, Nedaa Skeik, Robert Schwartz, Rose Peterson, Jo Anne Goldman, Jessie Goldman, Gary Ledley, Nancy Katof, Srinivasa Potluri, Scott Biedermann, Jacquelyn Ward, Megan White, Naomi DL Fisher, Laura Mauri, Piotr Sobieszczky, Alex Smith, Laura Aseltine, Rick Stouffer, Alan Hinderliter, Eric Pauley, Tyrone Wade, David Zidar, Mehdi Shishehbor, Barry Effron, Marco Costa, Terence Semenec, Chanwit Roongsritong, Priscilla Nelson, Bridget Neumann, Debbie Cohen, Jay Giri, Robin Neubauer, Thu Vo, Atul R Chugh, Pei-Hsiu Huang, Powell Jose, John Flack, Robert Fishman, Michael Jones, Todd Adams, Christopher Bajzer, Anthony Mathur, Ajay Jain, Armida Balawon, Olivier Zongo, Clare Bent, David Beckett, Nicki Lakeman, Sarah Kennard, Andrew Sharp, Richard J D'Souza, Sarah Statton, Lindsay Wilkes, Christine Anning, Jeremy Sayer, Sudha Ganesh Iyer, Nicholas Robinson, Annaliza Sevillano, Madelaine Ocampo, Robert Gerber, Mohamad Faris, Andrew John Marshall, Janet Sinclair, Hayley Pepper, Justin Davies, Neil Chapman, Paula Burak, Paula Carvelli, Sachin Jadhav, Jane Quinn, Lars Christian Rump, Johannes Stegbauer, Lars Schimmöller, Sebastian Potthoff, Claudia Schmid, Sylvia Roeder, Lukas Hafer, Tolga Agdirlioglu, Tanja Köllner, Michael Böhm, Sebastian Ewen, Saarraaken Kulenthiran, Angelika Wachter, Christina Koch, Philipp Lurz, Karl Fengler, Karl-Philipp Rommel, Kai Trautmann, Martin Petzold, Christian Ott, Axel Schmid, Michael Uder, Ulrike Heinritz, Kerstin Fröhlich-Endres, Sabine Genth-Zotz, Denise Kämpfner, Armin Grawe, Johannes Höhne, Bärbel Kaesberger, Constantin von zur Mühlen, Dennis Wolf, Markus Welzel, Gudrun Heinrichs, Barbara Trabitzsch, Antoine Cremer, Hervé Trillaud, Panteleimon Papadopoulos, Florent Maire, Julie Gaudissard, Erika Cornu, David Fouassier, Marine Livrozet, Aurélien Lorthioir, Valérie Paquet, Benjamin Honton, Marianne Cottin, Frédéric Petit, Constance Berge, Pierre-Yves Courand, Fatou Langevin, Pascal Delsart, Benjamin Longere, Guillaume Ledieu, François Pontana, Coralie Sommeville, Fabien Bertrand, Lida Feyz, Victor Zeijen, Arno Ruiter, Elisabeth Huysken, Peter Blankestijn, Michiel Voskuil, Zwaantina Rittersma, Helma Dolmans, A A Kroon, W H van Zwam, Jeannique Vranken, Claudia de Haan, Jean Renkin, Frédéric Maes, Christophe Beauloye, Jean-Philippe Lengelé, Dominique Huyberechts, Anne Bouvie, Andrzej Januszewicz, Jacek Kdziela, Aleksander Prejbisj, Dagmara Hering, Dariusz Ciecwierz, Milosz J Jaguszewski, Radoslaw Owczuk, RS: Carim - V02 Hypertension and target organ damage, MUMC+: MA Alg Interne Geneeskunde (9), Interne Geneeskunde, RS: Carim - B06 Imaging, RS: Carim - B05 Cerebral small vessel disease, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: CARIM School for Cardiovascular Diseases, and Cardiology

Subjects
Male, Ambulatory blood pressure, medicine.drug_class, medicine.medical_treatment, Sodium Chloride Symporter Inhibitors, Population, Drug Resistance, Calcium channel blocker, 030204 cardiovascular system & hematology, Kidney, law.invention, 03 medical and health sciences, Angiotensin Receptor Antagonists, 0302 clinical medicine, Renal Artery, ADHERENCE, Randomized controlled trial, law, Ultrasonic Surgical Procedures, medicine, Humans, Single-Blind Method, 030212 general & internal medicine, education, Denervation, education.field_of_study, PLACEBO, business.industry, Endovascular Procedures, General Medicine, Blood Pressure Monitoring, Ambulatory, Middle Aged, Calcium Channel Blockers, Blood pressure, Anesthesia, Ambulatory, Hypertension, Female, Diuretic, business
Abstract

Summary Background Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications. Methods In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18–75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov , NCT02649426 . Findings Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (−8·0 mm Hg [IQR –16·4 to 0·0] vs –3·0 mm Hg [–10·3 to 1·8]; median between-group difference –4·5 mm Hg [95% CI –8·5 to –0·3]; adjusted p=0·022); the median between-group difference was –5·8 mm Hg (95% CI –9·7 to –1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups. Interpretation Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension. Funding ReCor Medical.

Published
2021

5. Evaluation of a new beads reflux control microcatheter in drug-eluting bead transarterial chemoembolization

Author

Youssef Zaarour, Haytham Derbel, Charles Tran, Laetitia Saccentia, Benjamin Longère, Maxime Blain, Giuliana Amaddeo, Alain Luciani, Hicham Kobeiter, and Vania Tacher

Subjects
Reflux control, Microcatheter, DEB-TACE, Hepatocellular carcinoma, Beads, Medicine (General), R5-920
Abstract

Rationale and objectives: A new microcatheter was recently developed claiming to reduce beads reflux in drug-eluting bead transarterial chemoembolization (DEB-TACE). The aim of this study was to compare the reflux control microcatheter ability versus a standard microcatheter for TACE treatment in patients with hepatocellular carcinoma. Material and methods: Patients were prospectively included between November 2017 and February 2022. They received a DEB-TACE treatment with charged radiopaque beads using standard microcatheters or the SeQure reflux control microcatheter (Guerbet, France) and were assigned respectively to a control and a test group. Beads distribution mismatch was evaluated between the targeted territory on treatment planning CBCT and beads’ spontaneous opacities on the post-intervention CBCT and the 1-month CT scanner. Results: Twenty-three patients (21 men, median age 64 years [12.5 years]) with 37 hepatocellular carcinoma nodules were treated. The control group consisted of 13 patients – 19 nodules, while the test group included ten patients - 18 nodules. Non target embolization (NTE) was found in 20 % (2/10) of patients in the test group and 85 % (11/13) in the control group. NTE involved only an adjacent segment in the test group while it affected the adjacent biliary sector or even the contralateral liver lobe in the control group. No complication linked to NTE was found in the test group, while it led to one case of ischemic cholangitis and another case of biloma in the control group. Conclusion: The reflux control microcatheter may be efficient in reducing NTE and thus eventual adverse events in comparison to standard of care end-hole microcatheters.

Published
2024
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7. Fatal Enterovirus-related Myocarditis in a Patient with Devic’s Syndrome Treated with Rituximab

Author

Ava Diarra, Guillaume Gantois, Mouna Lazrek, Basile Verdier, Vincent Elsermans, Hélène Zephir, Benjamin Longère, Xristos Gkizas, Céline Goeminne, Gilles Lemesle, Francis Juthier, Johana Bene, David Launay, Romain Dubois, Sandrine Morell-Dubois, Fanny Vuotto, and Anne-Laure Piton

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Enteroviruses are a frequent source of infection and among the most common central nervous system viral pathogens. Enteroviruses – in particular, the Coxsackie B viruses – are a known cause of myocarditis. Rituximab is a genetically engineered chimeric anti-CD20 monoclonal antibody. Many reports in the literature suggest a higher risk of infection following repeated rituximab therapy, including viral infection. However, observations of enterovirus-related myocarditis in the context of rituximab treatment are scarce. The authors describe the case of a patient with neuromyelitis optica spectrum disorder who developed severe and fatal enterovirus-related myocarditis after rituximab therapy with a difficult differential diagnosis of autoimmune or giant-cell myocarditis. This case highlights the importance of complete diagnostic workup in difficult cases of myocarditis, including endomyocardial biopsies.

Published
2021
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