NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
This publication is provided for historical reference only and the information may be out of date.
Renal Denervation in the Medicare Population
Technology Assessments
Investigators: Tariq Shafi, MBBS, MHS, Matthews Chacko, MD, Zackary Berger, MD, PhD, Lisa M Wilson, ScM, Jessica Gayleard, BS, Eric B Bass, MD, MPH, and Stephen M Sozio, MD, MHS.
Author Information and AffiliationsStructured Abstract
Background:
Renal denervation refers to catheter-based radiofrequency ablation of renal sympathetic nerves, which may reduce blood pressure in patients with resistant hypertension, but data on its effectiveness are conflicting.
Purpose:
The purpose of this technical brief is to evaluate the effectiveness of renal denervation for resistant hypertension, and determine its applicability to the Medicare population.
Methods:
We searched for relevant studies using PubMed and input from Key Informants and the experts on our team. Study eligibility criteria were defined in terms of population, intervention, comparison, outcomes, timing, and study design. Two reviewers independently reviewed each article. We reviewed articles if they reported a randomized controlled trial (RCT), a comparative cohort with at least 10 patients in each arm, or a non-comparative cohort with at least 25 patients. We defined between-group differences in 24-hour ambulatory systolic blood pressure as the primary metric for effectiveness of renal denervation.
Findings:
We retrieved 1,233 unique citations from our literature search. We selected 83 studies (published in 98 articles) for abstraction; 9 were RCTs, 8 were comparative cohorts, and 66 were non-comparative cohorts. The study populations were only partially comparable to the Medicare-eligible population. In patients with resistant hypertension who continue to receive antihypertensive medications, renal denervation reduced 24-hour ambulatory systolic blood pressure, but the mean absolute change (between-group difference) was small in RCTs (range: -8.0 mm Hg to +2.1 mm Hg). The within-group differences in office systolic blood pressure were higher than the between-group differences for renal denervation in RCTs and comparative cohorts (-42.0 mm Hg to -8 mm Hg) as well as in non-comparative cohorts (range -58.2 mm Hg to 12 mm Hg), likely overestimating the effect of renal denervation due to white coat effect, observation bias, and placebo effect. Data were scant on clinical endpoints, such as stroke, myocardial infarction, kidney events, hospitalization, or death. Adverse effects were uncommon but potentially serious, and included hematomas, pseudoaneurysms, and renal artery interventions.
Contents
- Preface
- Acknowledgments
- Key Informants
- Peer Reviewers
- Background
- Methods
- Results
- Discussion
- References
- Appendix A. Detailed Electronic Database Search Strategies
- Appendix B. Forms
- Appendix C. List of Excluded Studies
- Appendix D. Studies Excluded for Overlapping Populations
- Appendix E. Evidence Tables
- Appendix F. References
Suggested citation:
Shafi T, Chacko M, Berger Z, Wilson LM, Gayleard J, Bass EB, Sozio SM. Renal Denervation in the Medicare Population. Technology Assessment Program Project ID: RENT1115.(Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-2015-00006-I) Rockville, MD: Agency for Healthcare Research and Quality; July 2016. http://www.ahrq.gov/research/findings/ta/index.html.
This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-00006-I). The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies may not be stated or implied.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
- Catheter-based renal denervation for resistant hypertension: 12-month results of the EnligHTN I first-in-human study using a multielectrode ablation system.[Hypertension. 2014]Catheter-based renal denervation for resistant hypertension: 12-month results of the EnligHTN I first-in-human study using a multielectrode ablation system.Papademetriou V, Tsioufis CP, Sinhal A, Chew DP, Meredith IT, Malaiapan Y, Worthley MI, Worthley SG. Hypertension. 2014 Sep; 64(3):565-72. Epub 2014 Jun 16.
- Randomized sham-controlled trial of renal sympathetic denervation in mild resistant hypertension.[Hypertension. 2015]Randomized sham-controlled trial of renal sympathetic denervation in mild resistant hypertension.Desch S, Okon T, Heinemann D, Kulle K, Röhnert K, Sonnabend M, Petzold M, Müller U, Schuler G, Eitel I, et al. Hypertension. 2015 Jun; 65(6):1202-8. Epub 2015 Mar 30.
- Renal denervation in moderate treatment-resistant hypertension.[J Am Coll Cardiol. 2013]Renal denervation in moderate treatment-resistant hypertension.Ott C, Mahfoud F, Schmid A, Ditting T, Sobotka PA, Veelken R, Spies A, Ukena C, Laufs U, Uder M, et al. J Am Coll Cardiol. 2013 Nov 12; 62(20):1880-6. Epub 2013 Jul 10.
- Review Lipid Screening in Childhood for Detection of Multifactorial Dyslipidemia: A Systematic Evidence Review for the U.S. Preventive Services Task Force[ 2016]Review Lipid Screening in Childhood for Detection of Multifactorial Dyslipidemia: A Systematic Evidence Review for the U.S. Preventive Services Task ForceLozano P, Henrikson NB, Morrison CC, Dunn J, Nguyen M, Blasi P, Whitlock EP. 2016 Aug
- Review Renal denervation: unde venis et quo vadis?[Rofo. 2015]Review Renal denervation: unde venis et quo vadis?Nähle CP, Düsing R, Schild H. Rofo. 2015 Apr; 187(4):237-47. Epub 2015 Jan 28.
- Renal Denervation in the Medicare PopulationRenal Denervation in the Medicare Population
Your browsing activity is empty.
Activity recording is turned off.
See more...