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June 16, 2013

European Societies Issue 2013 Guidelines for the Management of Arterial Hypertension

June 14, 2013—The European Society of Hypertension (ESH) and European Society of Cardiology (ESC) issued the 2013 ESH/ESC Guidelines for the management of arterial hypertension, including renal denervation to treat uncontrolled hypertension. The guidelines were introduced at the ESH scientific meeting in Milan, Italy, and simultaneously published online in ESH's Journal of Hypertension, ESC's European Heart Journal, and in Blood Pressure.

Prof. Giuseppe Mancia, MD, served as ESH Co-Chairperson of the Guidelines Task Force. Prof. Robert Fagard, MD, was ESC Co-Chairperson. The 2013 task force reviewed all relevant data since the 2007 revision, with 18 specific diagnostic and therapeutic areas identified as containing significant change.

Resistant hypertension is addressed in section 6.14 of the guidelines, and section 6.14.2 reviews the use of renal denervation to treat resistant hypertension.

The guidelines state, “At present, the renal denervation method is promising, but in need of additional data from properly designed long-term comparison trials to conclusively establish its safety and persistent efficacy versus the best possible drug treatments. Understanding what makes renal denervation effective or ineffective (patient characteristics or failure to achieve renal sympathectomy) will also be important to avoid the procedure in individuals unlikely to respond.”

The guidelines advise that until more evidence is available on the long-term efficacy and safety of renal denervation, implementation of the procedure should be restricted to experienced operators, and diagnosis and follow-up restricted to hypertension centers.

Additionally, the guidelines note that the ESH position paper on renal denervation should be consulted for more details. The position paper was published in May 2012 by Roland E. Schmeider, MD, et al in the Journal of Hypertension (2012;30:837–841).

In section 6.14.3, the guidelines briefly review other invasive approaches that are being studied: “Examples are creation of a venous-arterial fistula and neurovascular decompression by surgical interventions, which has been found to lower blood pressure in a few cases of severe resistant hypertension (presumably by reducing central sympathetic overactivity) with, however, an attenuation of the effect after 2 years. New catheters are also available to shorten the renal ablation procedure and to achieve renal denervation by means other than radiofrequency, eg by ultrasounds.”

Renal denervation, the guidelines conclude, “should be restricted to resistant hypertensive patients at particularly high risk, after fully documenting the inefficacy of additional antihypertensive drugs to achieve blood pressure control.” The guidelines further note that “it will be of fundamental importance to determine whether the blood pressure reductions are accompanied by a reduced incidence of cardiovascular morbid and fatal events, given the recent evidence from the FEVER study and the VALUE study that, in patients under multidrug treatment, cardiovascular risk (i) was greater than in patients on initial randomized monotherapy and (ii) did not decrease as a result of a fall in blood pressure. This raises the possibility of risk irreversibility, which should be properly studied.”

The societies stated that a major development in the guidelines is the decision to recommend a single systolic blood pressure target of 140 mm Hg for almost all patients. This contrasts with the 2007 version, which recommended a 140/90 mm Hg target for moderate- to low-risk patients, and a 130/80 mm Hg target for high-risk patients. There was insufficient evidence for supporting the recommendation of two targets.

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