Renal denervation in the Medicare population
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 ren...
| Main Author: | |
|---|---|
| Corporate Authors: | , , |
| Format: | eBook |
| Language: | English |
| Published: |
Rockville, MD
Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services
2016, July 2016
|
| Series: | Technology assessments
|
| Subjects: | |
| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | 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 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). |
|---|---|
| Item Description: | "Project ID: RENT1115." |
| Physical Description: | 1 PDF file (ix, 57 pages) illustrations |