Renal Denervation for Uncontrolled Hypertension: A Health Technology Assessment.

Background: When blood pressure remains elevated despite treatment, a person is considered to have uncontrolled hypertension, which increases the risk of serious health outcomes (e.g., cardiovascular disease, stroke, kidney failure, and death) over time. Renal denervation, a minimally invasive procedure targeting sympathetic nerves in the wall of renal arteries, has emerged as a promising adjunctive treatment to standard care (e.g., health behaviour modifications and antihypertensive medications). We conducted a health technology assessment of renal denervation for adults with uncontrolled hypertension, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding renal denervation, and patient and provider preferences and values. Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included systematic review using the Risk of Bias in Systematic Reviews (ROBIS) tool. We performed a systematic economic literature search and conducted a cost-utility analysis with a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding renal denervation in adults with uncontrolled hypertension in Ontario. To contextualize the potential value of renal denervation, we conducted a review of the quantitative evidence of patient and provider preferences and values, and we spoke with people with hypertension. Results: We included 10 systematic reviews of randomized controlled trials in our clinical evidence review, all of which showed that renal denervation statistically significantly lowered systolic blood pressure more than standard care (by a mean of 2.1-6.3 mmHg), regardless of the type of renal denervation system used, the blood pressure end points assessed, and whether people were taking antihypertensive medications at the time of the procedure. Renal denervation in addition to standard care is more effective and more expensive than standard care alone. The incremental cost-effectiveness ratio of renal denervation in addition to standard care compared with standard care alone is $121,237 per quality-adjusted life-year (QALY) gained over a lifetime horizon. The probability of renal denervation in addition to standard care being cost-effective versus standard care alone is 0% at a willingness-to-pay (WTP) of $50,000 per QALY gained, 18.02% at a WTP of $100,000 per QALY gained, and 80.50% at a WTP of $150,000 per QALY gained. The cost-effectiveness results were sensitive to changes in time horizon, assumptions about the duration of treatment effect, and the cost of the renal denervation procedure (including the cost of the renal denervation system). The annual budget impact of publicly funding renal denervation for adults with uncontrolled hypertension in Ontario over the next 5 years ranges from an additional $0.42 million in year 1 to an additional $3.78 million in year 5. Our review of the quantitative evidence of patient and provider preferences and values found that about 30% of patients preferred renal denervation over drug therapy, with younger individuals and those with poor medication adherence more likely to favour it. All interview participants expressed a positive view of renal denervation. Those we spoke with who had undergone the procedure reported lower blood pressure, fewer doctor's visits, and greater peace of mind compared with those who had not, and some reported a reduction in medication. Others reported being open to renal denervation if it were recommended by their physician after other treatments had failed. Barriers to accessing renal denervation included limited awareness of the procedure and limited geographic access. Conclusions: In our overview of reviews, we found that renal denervation consistently lowers blood pressure more than standard care in adults with uncontrolled hypertension, including treatment-resistant hypertension. No statistically significant differences in safety outcomes or adverse events between groups were reported in the included reviews. Renal denervation in addition to standard care is more effective and more expensive than standard care alone. We estimate that publicly funding renal denervation for adults with uncontrolled hypertension in Ontario would result in additional annual costs of between $0.42 million and $3.78 million over the next 5 years. Our review of the quantitative evidence of patient and provider preferences and values and our direct patient engagement findings highlight renal denervation as a potential treatment option for adults with uncontrolled hypertension. Renal denervation was viewed favourably by all those we interviewed, particularly when other treatments have failed.