Clinical data with Symplicity renal denervation system shows efficacy in uncontrolled hypertension
Investigators reported new, three-year data from the Global SYMPLICITY Registry (GSR) with the Medtronic Symplicity renal denervation system in a real-world setting in patients with uncontrolled hypertension. The data showed renal denervation led to significant and clinically meaningful reductions in both office and ambulatory blood pressure that were sustained out to three years post-procedure (16.5 mm Hg office blood pressure (OSBP) and 8.9 mm Hg 24H systolic ambulatory blood pressure (ABPM)). The Registry findings showed blood pressure reductions were consistent and sustained across various high-risk patient subgroups, including those with diabetes, isolated systolic hypertension (ISH), chronic kidney disease (CKD), resistant hypertension and those aged 65 years and older. Results from the single-center, randomized, sham-controlled study were presented at the 2019 EuroPCR Annual Meeting.
In addition, new clinical data indicates that renal denervation with the Medtronic Symplicity renal denervation system was associated with reduced occurrence of subclinical atrial fibrillation (AF) in a small subset of high-risk patients with hypertensive heart disease over a median follow-up period of more than two years. The results from the study demonstrate subclinical AF developed at a lower rate in the group of patients who received RDN than those receiving the sham procedure (19 percent versus 47 percent).
Comment: Hypertension is the single largest contributor to cardiovascular death; it dramatically increases risk of heart attack, stroke, heart failure, and kidney failure. The annual direct costs of hypertension are estimated at $500 billion worldwide. It is estimated that almost 20 percent of patients are completely non-adherent to oral medications while nearly half are partially non-adherent, highlighting the need for alternative treatment options.
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