Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry.
Felix Mahfoud,Michael Böhm,Roland E. Schmieder,Krzysztof Narkiewicz,Sebastian Ewen,Luis M. Ruilope,Markus P. Schlaich,Bryan Williams,Martin Fahy,Giuseppe Mancia +9 more
TLDR
Long-term data from the Global SYMPLICITY Registry representing the largest available cohort of hypertensive patients receiving RDN in a real-world clinical setting demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years.Abstract:
AIMS Several studies and registries have demonstrated sustained reductions in blood pressure (BP) after renal denervation (RDN). The long-term safety and efficacy after RDN in real-world patients with uncontrolled hypertension, however, remains unknown. The objective of this study was to assess the long-term safety and efficacy of RDN, including its effects on renal function. METHODS AND RESULTS The Global SYMPLICITY Registry is a prospective, open-label registry conducted at 196 active sites worldwide in hypertensive patients receiving RDN treatment. Among 2237 patients enrolled and treated with the SYMPLICITY Flex catheter, 1742 were eligible for follow-up at 3 years. Baseline office and 24-h ambulatory systolic BP (SBP) were 166 ± 25 and 154 ± 18 mmHg, respectively. SBP reduction after RDN was sustained over 3 years, including decreases in both office (-16.5 ± 28.6 mmHg, P < 0.001) and 24-h ambulatory SBP (-8.0 ± 20.0 mmHg; P < 0.001). Twenty-one percent of patients had a baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Between baseline and 3 years, renal function declined by 7.1 mL/min/1.73 m2 in patients without chronic kidney disease (CKD; eGFR ≥60 mL/min/1.73 m2; baseline eGFR 87 ± 17 mL/min/1.73 m2) and by 3.7 mL/min/1.73 m2 in patients with CKD (eGFR <60 mL/min/1.73 m2; baseline eGFR 47 ± 11 mL/min/1.73 m2). No long-term safety concerns were observed following the RDN procedure. CONCLUSION Long-term data from the Global SYMPLICITY Registry representing the largest available cohort of hypertensive patients receiving RDN in a real-world clinical setting demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years.read more
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Journal ArticleDOI
Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial
Michael Böhm,Kazuomi Kario,David E. Kandzari,Felix Mahfoud,Felix Mahfoud,Michael A. Weber,Roland E. Schmieder,Konstantinos Tsioufis,Stuart J. Pocock,Dimitris Konstantinidis,James W. Choi,Cara East,David P. Lee,Adrian Ma,Sebastian Ewen,Debbie L. Cohen,Robert L. Wilensky,Chandan Devireddy,Janice P. Lea,Axel Schmid,Joachim Weil,Tolga Agdirlioglu,Denise Reedus,Brian K. Jefferson,David Reyes,Richard D'Souza,Andrew S.P. Sharp,Andrew S.P. Sharp,Faisal Sharif,Martin Fahy,Vanessa DeBruin,Sidney Cohen,Sandeep Brar,Raymond R. Townsend,Ertan Akarca,Suhail Allaqaband,Eirini Andrikou,Jiro Aoki,Ahran D. Arnold,Herbert D. Aronow,Masahiko Asami,William Bachinsky,John H. Barton,Kyle Bass,Bryan Batson,Christopher Bell,Barry Bertolet,Yvonne Bewarder,Karl Bihlmaier,Christian Binner,Jason Bloom,Benjamin Blossom,Somjot S Brar,Angela L. Brown,Robert E. Burke,Martin N. Burke,Michael Butler,William J. Calhoun,James Campbell,Steve Carroll,Neil Chapman,Craig Chasen,Shi Chi Cheng,Beth Chia,Nishit Choksi,Jordana B. Cohen,Niall Connolly,Johanna Contreras,Ronan Cusack,George Dangas,Shukri David,Justin E. Davies,Juliane Dederer,Matthew G. Denker,Udo Desch,Matthaios Didangelos,Thomas Dienemann,Kyriakos Dimitriadis,Jean François Dorval,John Estess,Sarah Fan,Karl Fengler,Lee Ferguson,Marat Fudim,Valentin Fuster,Fidel Garcia,Santiago Garcia,Alex Garton,Carl Gessler,Magdi Ghali,Bharat Gummadi,Amit Gupta,A.M. Gutiérrez,Peggy Hardesty,Phillip Hartung,Walter H. Haught,Yonghong Haun,Sara Hays,Wolfgang Helmreich,Douglas Hill,Ingrid Hopper,Yu Horiuchi,Satoshi Hoshide,James P. Howard,Wanda Ikeda,Fued Jan,Rajiv Jauhar,Desmond Jay,James R. Johnson,Thomas Johnston,Schuyler Jones,Susanne Jung,Theodoros Kalos,Mihar Kanitkar,Dennis Kannenkeril,Alexandros Kasiakogias,Samer Kazziha,Daniel Keene,Jayant Khitha,Hosei Kikushima,Taisei Kobayashi,Kota Komiyama,Takahiro Komori,John Kotter,Antonios Kouparanis,Joshua Krasnow,Saarraangan Kulenthiran,Sarwan Kumar,Philippe L. L’Allier,Phillip Laney,Lucas Lauder,Marc A. Lavoie,Matthias Lerche,Elena Linesky,Nelson Little,Carl Lomboy,Jelena Lucic,Philipp Lurz,Shannon Lynch,Prakash Mansukhani,Katie McDuffie,Brian McGrath,Brent T. McLaurin,Ashley Meade,Perwaiz Meraj,Dominic Millenaar,Naing Moore,Fumiko Mori,Phillip Munch,James R. Murphy,Jennifer M. Murray,Aravinda Nanjundappa,Kai Ninomiya,Yusuke Oba,Tim O'Connor,Yukiyo Ogata,Yukako Ogoyama,Rachel Onsrud,Christian Ott,Bimal Padaliya,Neha J. Pagidipati,Manesh R. Patel,Kiritkumar Patel,Emanouela Petteinidou,Wendy Porr,Anjani Rao,Rabia Razi,Christopher Regan,Michael Remetz,David Rizik,Monique Robison,Karl Philipp Rommel,Liesbeth Rosseel,Marcos Rothstein,Randolph Rough,Jose M. Saavedra,Souhell Saba,Robert S. Schwartz,Shaun Selcer,Sayan Sen,Jacqueline Sennott,Ramin Shadman,Samit Shah,Douglas Shemin,Hayato Shimizu,Masahisa Shimpo,Mehdi H. Shishehbor,Matthew J. Shun-Shin,Francisco Sierra,Jasvindar Singh,Avneet Singh,Yassir Sirajeldin,Nedaa Skeik,George Soliman,Sarah Statton,Julia Stehli,Susan Steigerwalt,Kristina Striepe,Jason Stuck,Markus Suppan,Laura P. Svetkey,Ganpat Takker,Kengo Tanabe,Tetsu Tanaka,Daijiro Tomii,Sabino Torre,Jay H. Traverse,Crystal C. Tyson,Alejandro Arias Vasquez,Enrique Velasquez,Sreekanth Vemulapalli,Hirotaka Waki,Tony Walton,Yale Wang,Thomas Weber,Bryan Wells,Robert Wilkins,Thomas C. Wright,Kazuyuki Yahagi,Alan C. Yeung,Ray Zadegan,Thomas Zeller,Khaled M. Ziada,Antonios Ziakas,David A. Zidar +224 more
TL;DR: The SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications.
Journal ArticleDOI
Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial.
Michel Azizi,Michel Azizi,Kintur Sanghvi,Manish Saxena,Philippe Gosse,John P. Reilly,Terry Levy,Lars C Rump,Alexandre Persu,Alexandre Persu,Jan Basile,Michael J. Bloch,Joost Daemen,Melvin D. Lobo,Felix Mahfoud,Felix Mahfoud,Roland E. Schmieder,Andrew S.P. Sharp,Andrew S.P. Sharp,Michael A. Weber,Marc Sapoval,Pete Fong,Atul Pathak,Pierre Lantelme,David H. 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 J. Reilly,Stephen J. Jenkins,Michael Cash,Shannon Williams,Maria Jarvis,Cheryl L. Laffer,James V. 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 M. Todoran,Eric R. Powers,Emily Hodskins,Vijay Paladugu,Anna Tecklenburg,Chandan Devireddy,Janice P. 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 A. Calhoun,Thomas McElderry,William Maddox,Suzanne Oparil,Sheila Kinder,Jai Radhakrishnan,Candido Batres,Suzanne Edwards,Joseph M. 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 S. Schwartz,Rose Peterson,Jo Anne Goldman,Jessie Goldman,Gary Ledley,Nancy Katof,Srinivasa Potluri,Scott Biedermann,Jacquelyn Ward,Megan White,Naomi D.L. Fisher,Laura Mauri,Piotr Sobieszczky,Alexander McCall Smith,Laura Aseltine,Rick Stouffer,Alan L. Hinderliter,Eric Pauley,Tyrone Wade,David A. Zidar,Mehdi H. Shishehbor,Barry Effron,Marco A. Costa,Terence Semenec,Chanwit Roongsritong,Priscilla Nelson,Bridget Neumann,Deborah A. Cohen,Jay Giri,Robin Neubauer,Thu Vo,Atul R. Chugh,Pei-Hsiu Huang,Powell Jose,John Flack,Robert Fishman,Michael P. Jones,Todd Adams,Christopher Bajzer,Anthony Mathur,Ajay Jain,Armida Balawon,Olivier Zongo,Clare Bent,David Beckett,Nicki Lakeman,Sarah Kennard,Andrew S P Sharp,Richard D'Souza,Sarah Statton,Lindsay Wilkes,Christine Anning,Jeremy Sayer,Sudha Ganesh Iyer,Nicholas M Robinson,Annaliza Sevillano,Madelaine Ocampo,Robert Gerber,Mohamad Faris,Andrew John Marshall,Janet Sinclair,Hayley Pepper,Justin E. 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 J. 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 +245 more
TL;DR: In this article, the authors evaluated the efficacy and safety of endovascular renal denervation in patients with hypertension resistant to three or more antihypertensive medications including a diuretic.
Journal ArticleDOI
Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial
TL;DR: The SPYRAL HTN-ON MED trial as discussed by the authors compared changes in blood pressure, antihypertensive drug use, and safety up to 36 months in renal denervation versus a sham control group.
Journal ArticleDOI
Renal Denervation in High-Risk Patients With Hypertension.
Felix Mahfoud,Giuseppe Mancia,Roland E. Schmieder,Krzysztof Narkiewicz,Luis M. Ruilope,Markus P. Schlaich,Robert Whitbourn,Andreas Zirlik,Thomas Zeller,Philipp Stawowy,Sidney Cohen,Martin Fahy,Michael Böhm +12 more
TL;DR: BP reduction after RDN was similar for patients with varying high-risk comorbidities and across the range of ASCVD risk scores, which was sustained to 3 years.
Journal ArticleDOI
Proceedings from the 3rd European Clinical Consensus Conference for clinical trials in device-based hypertension therapies.
Felix Mahfoud,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 J. Kirtane,Sverre E. Kjeldsen,Melvin D. Lobo,Thomas F. Lüscher,John W. McEvoy,Gianfranco Parati,Patrick Rossignol,L. M. Ruilope,Markus P. Schlaich,Markus P. Schlaich,Atif Shahzad,Atif Shahzad,Faisal Sharif,Faisal Sharif,Andrew S.P. Sharp,Andrew S.P. Sharp,Horst Sievert,Massimo Volpe,Michael A. Weber,Roland E. Schmieder,Costas Tsioufis,William Wijns +35 more
TL;DR: In this paper, the authors proposed a method to solve the problem of the problem: this paper ] of "uniformity" of the distribution of data points in the data set.
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