Correspondence Article Type Response to Letter Regarding Article, “Ambulatory Blood Pressure Changes After Renal Sympathetic Denervation in Patients With Resistant Hypertension”
Bodo Cremers, MD Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin Homburg/Saar, Germany
We received a letter by Jin et al on our article published recently in Circulation.1 The following points should be clarified: It was argued that we did not measure, but extrapolated, cardiovascular risk. We neither extrapolated nor measured risk in the article. We only reported blood pressure data. Jin et al argue that the proportions of patients at 3, 6 and 12 months are different. This is due to different follow-up periods, as stated in the article as a potential limitation.1 We reported that no major differences existed in medications before and after renal denervation but did not provide doses and drug classes. The study was not aimed to provide an in-depth analysis of drug classes or doses. Jin et al claim that we provided different classifications in the abstract and Methods section. Classification of patients was done in classic way.1 Jin et al also claim that there are contradictions in the summary statistics. They mention that Table 3 provides only the odds that office blood pressure declined by >10 mm Hg. This was a defined criterion of response and was evaluated as described in the article. They argue that there is a disproportion between the responses in office and ambulatory blood pressures. These were the data, which correspond to most of the drug trials in hypertension. The assertion that our center would have performed >600 renal denervations is incorrect; it was ≈200 at that time of Der Spiegel publication.2 Health insurances would cover renal denervation in some countries. Most of the procedures were not reimbursed because patients were treated in trials or investigative protocols. Today, there is indeed a reimbursement, which does not cover the costs of the procedure and the materials. Many centers, at least in Germany, pay the cost of this procedure from their own scientific budgets. In conclusion, our study aimed to investigate the effects of renal denervation on 24-hour blood pressure. Therefore, the involved centers pooled their data and shared their experiences.1,3 The goal is to facilitate and improve the design of randomized and controlled trials, being well aware that these investigations cannot substitute them. The authors of the letter acknowledge concerns already raised by the authors themselves.4,5
Lars C. Rump, MD Oliver Vonend, MD Universitätsklinikum Klinik für Nephrologie Düsseldorf, Germany Joachim Weil, MD Medizinische Klinik II Universität Schleswig-Holstein Campus Lübeck Lübeck, Germany Martin Schmidt, MD Städtisches Klinikum München GmbH München, Germany Uta C. Hoppe, MD Klinik III für Innere Medizin Universität zu Köln Köln, Germany Thomas Zeller, MD Herz-Zentrum Bad Krotzingen Bad Krotzingen, Germany Axel Bauer, MD Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin III Tübingen, Germany Christian Ott, MD Medizinische Klinik 4 Nephrologie und Hypertensiologie Universitätsklinikum Erlangen Erlangen, Germany Erwin Blessing, MD Uni-Klinikum Heidelberg Medizinische Klinik Innere Medizin III Kardiologie, Angiologie und Pneumologie Heidelberg, Germany
Disclosures Drs Mahfoud, Ukena, and Böhm are supported by the Ministry of Science and Economy of the Saarland and Deutsche Forschungsgemeinschaft (KFO 196). Dr Mahfoud is supported by the Deutsche Hochdruckliga and Deutsche Gesellschaft für Kardiologie. Dr Schlaich is supported by a National Health and Medical Research Council Senior Research Fellowship. Dr Sobotka was an employee of Medtronic Ardian Inc. All authors received scientific support and speaker honorarium from Medtronic Ardian Inc.
Paul A. Sobotka, MD Ohio State University Columbus, OH Henry Krum, MBBS, PhD Monash University/Alfred Hospital Melbourne, Victoria, Australia
Felix Mahfoud, MD Christian Ukena, MD Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin Homburg/Saar, Germany
Markus Schlaich, MD Murray Esler, MBBS, PhD, FRACP Baker IDI Heart and Diabetes Institute Victoria, Australia Michael Böhm, MD Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin Homburg/Saar, Germany
Roland E. Schmieder, MD Universität Erlangen-Nürnberg Medizinische Klinik 4 Nürnberg, Germany
(Circulation. 2014;129:e500-e501.) © 2014 American Heart Association, Inc. Circulation is available at http://circ.ahajournals.org
DOI: 10.1161/CIRCULATIONAHA.114.008029
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Correspondence e501
References 1. Mahfoud F, Ukena C, Schmieder RE, Cremers B, Rump LC, Vonend O, Weil J, Schmidt M, Hoppe UC, Zeller T, Bauer A, Ott C, Blessing E, Sobotka PA, Krum H, Schlaich M, Esler M, Böhm M. Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension. Circulation. 2013;128:132–140. 2. Blech J. Vergebens verbrutzelt. Der Spiegel. 2013;28:102–103. 3. Mahfoud F, Cremers B, Janker J, Link B, Vonend O, Ukena C, Linz D, Schmieder R, Rump LC, Kindermann I, Sobotka PA, Krum H, Scheller B, Schlaich M, Laufs U, Böhm M. Renal hemodynamics and renal
function after catheter-based renal sympathetic denervation in patients with resistant hypertension. Hypertension. 2012;60:419–424. 4. Mahfoud F, Lüscher TF, Andersson B, Baumgartner I, Cifkova R, Dimario C, Doevendans P, Fagard R, Fajadet J, Komajda M, Lefèvre T, Lotan C, Sievert H, Volpe M, Widimsky P, Wijns W, Williams B, Windecker S, Witkowski A, Zeller T, Böhm M; European Society of Cardiology. Expert consensus document from the European Society of Cardiology on catheter-based renal denervation. Eur Heart J. 2013;34:2149–2157. 5. Mahfoud F, Kjeldsen S. Catheter-based renal denervation: a word of caution. EuroIntervention. 2013;8:997–998.
Copyright of Circulation is the property of Lippincott Williams & Wilkins and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Bodo Cremers, MD Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin Homburg/Saar, Germany
We received a letter by Jin et al on our article published recently in Circulation.1 The following points should be clarified: It was argued that we did not measure, but extrapolated, cardiovascular risk. We neither extrapolated nor measured risk in the article. We only reported blood pressure data. Jin et al argue that the proportions of patients at 3, 6 and 12 months are different. This is due to different follow-up periods, as stated in the article as a potential limitation.1 We reported that no major differences existed in medications before and after renal denervation but did not provide doses and drug classes. The study was not aimed to provide an in-depth analysis of drug classes or doses. Jin et al claim that we provided different classifications in the abstract and Methods section. Classification of patients was done in classic way.1 Jin et al also claim that there are contradictions in the summary statistics. They mention that Table 3 provides only the odds that office blood pressure declined by >10 mm Hg. This was a defined criterion of response and was evaluated as described in the article. They argue that there is a disproportion between the responses in office and ambulatory blood pressures. These were the data, which correspond to most of the drug trials in hypertension. The assertion that our center would have performed >600 renal denervations is incorrect; it was ≈200 at that time of Der Spiegel publication.2 Health insurances would cover renal denervation in some countries. Most of the procedures were not reimbursed because patients were treated in trials or investigative protocols. Today, there is indeed a reimbursement, which does not cover the costs of the procedure and the materials. Many centers, at least in Germany, pay the cost of this procedure from their own scientific budgets. In conclusion, our study aimed to investigate the effects of renal denervation on 24-hour blood pressure. Therefore, the involved centers pooled their data and shared their experiences.1,3 The goal is to facilitate and improve the design of randomized and controlled trials, being well aware that these investigations cannot substitute them. The authors of the letter acknowledge concerns already raised by the authors themselves.4,5
Lars C. Rump, MD Oliver Vonend, MD Universitätsklinikum Klinik für Nephrologie Düsseldorf, Germany Joachim Weil, MD Medizinische Klinik II Universität Schleswig-Holstein Campus Lübeck Lübeck, Germany Martin Schmidt, MD Städtisches Klinikum München GmbH München, Germany Uta C. Hoppe, MD Klinik III für Innere Medizin Universität zu Köln Köln, Germany Thomas Zeller, MD Herz-Zentrum Bad Krotzingen Bad Krotzingen, Germany Axel Bauer, MD Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin III Tübingen, Germany Christian Ott, MD Medizinische Klinik 4 Nephrologie und Hypertensiologie Universitätsklinikum Erlangen Erlangen, Germany Erwin Blessing, MD Uni-Klinikum Heidelberg Medizinische Klinik Innere Medizin III Kardiologie, Angiologie und Pneumologie Heidelberg, Germany
Disclosures Drs Mahfoud, Ukena, and Böhm are supported by the Ministry of Science and Economy of the Saarland and Deutsche Forschungsgemeinschaft (KFO 196). Dr Mahfoud is supported by the Deutsche Hochdruckliga and Deutsche Gesellschaft für Kardiologie. Dr Schlaich is supported by a National Health and Medical Research Council Senior Research Fellowship. Dr Sobotka was an employee of Medtronic Ardian Inc. All authors received scientific support and speaker honorarium from Medtronic Ardian Inc.
Paul A. Sobotka, MD Ohio State University Columbus, OH Henry Krum, MBBS, PhD Monash University/Alfred Hospital Melbourne, Victoria, Australia
Felix Mahfoud, MD Christian Ukena, MD Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin Homburg/Saar, Germany
Markus Schlaich, MD Murray Esler, MBBS, PhD, FRACP Baker IDI Heart and Diabetes Institute Victoria, Australia Michael Böhm, MD Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin Homburg/Saar, Germany
Roland E. Schmieder, MD Universität Erlangen-Nürnberg Medizinische Klinik 4 Nürnberg, Germany
(Circulation. 2014;129:e500-e501.) © 2014 American Heart Association, Inc. Circulation is available at http://circ.ahajournals.org
DOI: 10.1161/CIRCULATIONAHA.114.008029
e500
Correspondence e501
References 1. Mahfoud F, Ukena C, Schmieder RE, Cremers B, Rump LC, Vonend O, Weil J, Schmidt M, Hoppe UC, Zeller T, Bauer A, Ott C, Blessing E, Sobotka PA, Krum H, Schlaich M, Esler M, Böhm M. Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension. Circulation. 2013;128:132–140. 2. Blech J. Vergebens verbrutzelt. Der Spiegel. 2013;28:102–103. 3. Mahfoud F, Cremers B, Janker J, Link B, Vonend O, Ukena C, Linz D, Schmieder R, Rump LC, Kindermann I, Sobotka PA, Krum H, Scheller B, Schlaich M, Laufs U, Böhm M. Renal hemodynamics and renal
function after catheter-based renal sympathetic denervation in patients with resistant hypertension. Hypertension. 2012;60:419–424. 4. Mahfoud F, Lüscher TF, Andersson B, Baumgartner I, Cifkova R, Dimario C, Doevendans P, Fagard R, Fajadet J, Komajda M, Lefèvre T, Lotan C, Sievert H, Volpe M, Widimsky P, Wijns W, Williams B, Windecker S, Witkowski A, Zeller T, Böhm M; European Society of Cardiology. Expert consensus document from the European Society of Cardiology on catheter-based renal denervation. Eur Heart J. 2013;34:2149–2157. 5. Mahfoud F, Kjeldsen S. Catheter-based renal denervation: a word of caution. EuroIntervention. 2013;8:997–998.
Copyright of Circulation is the property of Lippincott Williams & Wilkins and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
