When is catheter-based renal sympathetic denervation indicated in the treatment of hypertension (high blood pressure)?

Updated: Feb 22, 2019
  • Author: Matthew R Alexander, MD, PhD; Chief Editor: Eric H Yang, MD  more...
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Answer

There was initial enthusiasm for catheter-based renal sympathetic denervation in the treatment of resistant hypertension based on several early studies that compared renal denervation to standard medical treatment. Originally published as a small, 45-patient proof-of-principle and safety study in 2009, [111]  a follow-up nonrandomized study with 153 patients (Symplicity HTN-1) conducted in Australia, Europe, and the United States showed that this technique lowered BP for an extended period of up to 2 years in patients with resistant hypertension (defined here as a SBP >160 mm Hg and taking more than three antihypertensive drugs, including a diuretic). [112]  Postprocedure office BPs were reduced by 20/10 mm Hg, 24/11 mm Hg, 25/11 mm Hg, 23/11 mm Hg, 26/14 mm Hg, and 32/14 mmHg at 1, 3, 6, 12, 18, and 24 months, respectively. The complication rate was 3% and consisted of three groin pseudoaneurysms and one renal artery dissection, all managed without further sequelae.

Subsequently, an open-label prospective, randomized study conducted in 24 centers in Europe, Australia, and New Zealand (Symplicity HTN-2) confirmed the safety and efficacy of this treatment in 106 patients randomized to renal denervation with previous treatment (n = 52) or to previous treatment alone (n = 54). [113]  At 6 months, renal denervation resulted in a reduction in SBP of 10 mm Hg or more in 84% of patients, compared to 35% of controls. No serious procedure-related or device-related complications occurred.

Of note, these earlier studies were unblinded and did not include a sham procedure as a control. The first single-blind, randomized, sham-controlled trial of renal denervation therapy, SYMPLICITY HTN-3, failed to demonstrate a significant difference in office-based BP measurements after 6 months. [114]  Although recruitment for ongoing studies of renal denervation in the United States were halted based on these results, a number of new studies that attempt to address shortcomings in SYMPLICITY HTN-3 by utilizing modifications such as bipolar electrode catheters and denervation of the main renal arteries along with distal branches and accessory arteries are recruiting patients. [76]

 


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