ESC Supports Renal Denervation as an Option for Treating Resistant Hypertension

April 29, 2013

SOPHIA ANTIPOLIS, FRANCE — The European Society of Cardiology (ESC) has issued a consensus statement regarding the use of catheter-based renal denervation for the treatment of high blood pressure, stating that the novel therapy can be considered a therapeutic option in patients with drug-resistant hypertension who cannot get to goal with a combination of lifestyle and pharmacologic therapy[1].

In the statement, published online April 25, 2013 in the European Heart Journal, the writing committee, led by Dr Felix Mahfoud (Saarland University, Saar, Germany), said the data support the concept that the radiofrequency ablation of the renal nerves reduces blood pressure and improves blood-pressure control in these difficult-to-treat patients. The data supporting the treatment now extend to 36 months, they write.

In the consensus statement, the ESC outlines the appropriate screening measures necessary to select the patients eligible for renal denervation and the criteria patients should comply with before renal denervation is considered. Patients are eligible for renal denervation if they meet the following criteria:

  • Office-based blood pressure >160 mm Hg (>150 mm Hg in patients with type diabetes).

  • Use of three or more antihypertensive drugs in adequate dosage and combination, including use of a diuretic.

  • Have attempted to modify blood pressure with lifestyle changes.

  • Secondary hypertension has been excluded.

  • Pseudoresistance has been excluded with the use of ambulatory blood-pressure monitoring.

  • Patients have preserved renal function (glomerular filtration rate >45 mL/min/1.732).

  • Absence of polar or accessory arteries, no renal artery stenosis, and no prior renal revascularization.

The ESC also reviews the data with renal denervation, including the proof-of-concept Symplicity HTN-1 study and the multicenter, prospective, randomized Symplicity HTN-2 study. Both of these studies were reported by heartwire . They note that one of the major challenges remains how to monitor the success of the procedure, such as tests to determine whether or not denervation has been successful.

In Europe, there are five renal denervation catheter systems that have received CE Mark approval, including the Symplicity system (Medtronic). The others include EnligHTN (St Jude Medical) used in the EnligHTN-1 study,Vessix V2 (Boston Scientific) used in REDUCE-HTN ,OneShot (Covidien) used in the Renal Hypertension Ablation System study, and Paradise (ReCor Medical) used in the REALISE study.

The ESC consensus statement acknowledges that it is not yet clear how renal denervation works, but the mechanism is likely the result of a reduction in peripheral resistance, reduced renin release, and favorable changes in water and salt handling. "The fact that renal denervation also reduces whole-body sympathetic-nerve activity suggests that this therapy may also be beneficial in other clinical states characterized by sympathetic nervous system activation--this may ultimately lead to new indications," say Mahfoud et al.

Mahfoud as well as senior author Dr Michael B öhm have received scientific support from major renal denervation system manufacturers including Medtronic, St Jude, Vessix, and ReCor, and have received speakers' honoraria from Medtronic, St Jude, and Cordis. Coauthor disclosures are listed in the paper as follows: Dr Thomas Felix Lüscher received minor fees from Medtronic; Dr Iris Baumgartner received speaker honoraria from Medtronic; Dr Horst Sievert received scientific support from Medtronic, Vessix, Maya, Covidien, and ReCor; Dr Massimo Volpe is involved in the advisory board of Medtronic's Global Symplicity Registry; Dr Bryan Williams is an National Institute for Health Research senior investigator and has consulted for Medtronic on the development of an international renal denervation registry; Dr Adam Witkowski has received speakers' honoraria from Medtronic; Dr Thomas Zeller is a member of the medical advisory boards of Medtronic-Ardian, Northwind, and St Jude Medical.

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