Renal Denervation System Potentially Cost-Effective

Medtronic Symplicity Renal Denervation System Potentially Cost-Effective and May Reduce Clinical Events in Treatment-Resistant Hypertension

Does this sound like you?

Have you been diagnosed with hypertension (high blood pressure)?

Have you been unable to control your hypertension even when taking 3 or more blood pressure medications?

If you answered “yes” to these questions, you may be eligible to take part in a Medtronic-sponsored clinical trial for the treatment of certain patients with resistant hypertension.

The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in patients whose blood pressure is not controlled despite treatment with multiple blood pressure medications. This website provides general information about our clinical trial for people interested in participating.

Learn more about this investigational therapy and our clinical trial. To see if you may qualify for this clinical trial, please take this short survey or connect with a participating doctor.

Medtronic has announced that it will start a trial with its Symplicity renal denervation system in patients with chronic heart failure. The Symplicity system, one of the most innovative approaches to treating hypertension in recent years, consists of a flexible catheter and proprietary generator, which are used during an endovascular procedure to denervate the renal arteries using low-power radio-frequency energy. This results in a reduction of hyper-activation of the sympathetic nervous system.

Medtronic Symplicity device Medtronic Starts Trial with Symplicity Renal Denervation System for Chronic Heart Failure and Renal ImpairmentThe main indication for the Symplicity is therapy-resistant hypertension, however Medtronic is looking into expanding indications for the device and the new trial (SYMPLICITY-HF) is designed to evaluate the safety and physiologic response to renal denervation in patients with chronic heart failure and renal impairment. It will include 40 adult subjects with chronic heart failure and renal impairment in Europe and Australia.

Increased sympathetic activity is thought to play an important role in these conditions, and current pharmaceutical management already includes blocking the renin-angiotensin-aldosterone system with ACE inhibitors and addressing the sympathetic nervous system with beta-blockers. Renal denervation allows the selective reduction of the kidney’s contribution to central sympathetic drive.

In addition to this trial, Medtronic also announced the launch of a global patient registry for the Symplicity, with the goal of evaluating real-world, long-term results of renal denervation in over 5,000 patients with a number of conditions associated with hyperactive sympathetic nervous system drive, including treatment-resistant hypertension, heart failure, insulin resistance, chronic kidney disease and sleep apnea.

The Symplicity catheter system has received CE Mark approval in Europe in early 2010 but remains investigational in the United States. A large U.S. clinical trial in patients with treatment-resistant hypertension is currently underway (SYMPLICITY HTN-3).

Objectives

The purpose of this study was to assess cost-effectiveness and long-term clinical benefits of renal denervation in resistant hypertensive patients.

Background

Resistant hypertension affects 12% of hypertensive persons. In the Symplicity HTN-2 randomized controlled trial, catheter-based renal denervation (RDN) lowered systolic blood pressure by 32 ± 23 mm Hg from 178 ± 18 mm Hg at baseline.

Methods

A state-transition model was used to predict the effect of RDN and standard of care on 10-year and lifetime probabilities of stroke, myocardial infarction, all coronary heart disease, heart failure, end-stage renal disease, and median survival. We adopted a societal perspective and estimated an incremental cost-effectiveness ratio in U.S. dollars per quality-adjusted life-year, both discounted at 3% per year. Robustness and uncertainty were evaluated using deterministic and probabilistic sensitivity analyses.

Results

Renal denervation substantially reduced event probabilities (10-year/lifetime relative risks: stroke 0.70/0.83; myocardial infarction 0.68/0.85; all coronary heart disease 0.78/0.90; heart failure 0.79/0.92; end-stage renal disease 0.72/0.81). Median survival was 18.4 years for RDN versus 17.1 years for standard of care. The discounted lifetime incremental cost-effectiveness ratio was $3,071 per quality-adjusted life-year. Findings were relatively insensitive to variations in input parameters except for systolic blood pressure reduction, baseline systolic blood pressure, and effect duration. The 95% credible interval for incremental cost-effectiveness ratio was cost-saving to $31,460 per quality-adjusted life-year.

Conclusions

The model suggests that catheter-based renal denervation, over a wide range of assumptions, is a cost-effective strategy for resistant hypertension that might result in lower cardiovascular morbidity and mortality.

Source : http://www.sciencedirect.com/science/article/pii/S0735109712030240

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