VP101 Medical Devices For Treatment-resistant Hypertension: Health Technology Assessment Report

Abstract

INTRODUCTION:

While optimal medical therapy (OMT) represents the current standard of care for treatment-resistant hypertension, non-pharmaceutical therapeutic approaches, such as renal denervation and carotid baroreceptor stimulation therapy, have been proposed. The present Health Technology Assessment (HTA) project was aimed at assessing benefits and risk of those approaches versus OMT.

METHODS:

A systematic review of evidence on effectiveness and safety was performed together with a review of economic studies. A contextual analysis of market availability and use of the technology in Italy was also performed.

RESULTS:

In Italy, ninety-nine renal denervation procedures were performed in 2014. Ten studies from six trials were included in the review and meta-analysis. No evidence of dominance or increased harms of renal denervation compared to OMT were found. Four economic evaluations were included and reported dominance of renal denervation. These were based on short-term clinical data and three evaluations used the same Markov model assuming dominance of renal denervation. Estimated average prospective cost of the procedure was EUR6,129.90 (range EUR3,821.15 – EUR9,714.23). We updated the results of an earlier assessment published by an Italian Regional agency on carotid baroreceptor stimulation therapy (1). None of the three studies identified as ongoing in 2015 were completed or had published preliminary results and the technology was not assessed further within the present HTA project.

CONCLUSIONS:

Even if follow-up was limited to 6 months, randomised evidence showed no benefits of the procedure. Economic evaluations were unreliable, based on unrealistic assumptions of effectiveness and contrived therapy regimes. Further investment in renal denervation should await the results of well-designed and adequately followed-up trials assessing the impact of renal denervation on major cardiovascular events compared to OMT. Future economic evaluations should be based on realistic assumptions of cost and effectiveness.