The epidemiology, evaluation, and management of severe and resistant
hypertension in the United States (US) are evolving. The American Society of
Hypertension held a multi-disciplinary forum in October 2013 to review the available evidence related to the management of resistant
hypertension with both
drug and device
therapies. There is strong evidence that resistant
hypertension is an important clinical problem in the US and many other regions of the world. Complex
drug therapy is effective in most of the patients with severe and resistant
hypertension, but there are certain individuals who may be refractory to multiple-
drug regimens or have adverse effects that make adherence to the regimen difficult. When secondary forms of
hypertension and pseudo-resistance, such as medication nonadherence, or
white-coat hypertension based on marked differences between clinic and 24-hour ambulatory blood pressure monitoring, have been excluded, the impact of device
therapy is under evaluation through clinical trials in the US and from clinical practice registries in Europe and Australia. Clinical trial data have been obtained primarily in patients whose resistant
hypertension is defined as systolic clinic blood pressures of ≥160 mm Hg (or ≥ 150 mm Hg in
type 2 diabetes) despite pharmacologic treatment with at least three
antihypertensive drugs (one of which is a
thiazide or
loop diuretic). Baroreceptor stimulation
therapy has shown modest benefit in a moderately sized
sham-controlled study in
drug-resistant
hypertension. Patients selected for renal
denervation have typically been restricted to those with preserved kidney function (estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2). The first
sham-controlled safety and efficacy trial for renal
denervation (SYMPLICITY HTN-3) did not show benefit in this population when used in addition to an average of five
antihypertensive medications. Analyses of controlled clinical trial data from future trials with novel designs will be of critical importance to determine the effectiveness of device
therapy for patients with severe and resistant
hypertension and will allow for proper determination of patient selection and whether it will be acceptable for clinical practice. At present, the focus on the management of severe and resistant
hypertension will be through careful evaluation for pseudo-resistance and secondary forms of
hypertension, appropriate use of combination pharmacologic
therapy, and greater utility of specialists in
hypertension.