Global SYMPLICITY Registry: Renal Artery Denervation in Uncontrolled HTN

Since it began enrollment in February 2012, the Global SYMPLICITY Registry has become the largest dataset for patients with uncontrolled hypertension treated with renal denervation. Established to examine the safety and effectiveness of the procedure, new findings of an open-label, multicenter study have revealed that patients with uncontrolled high blood pressure treated with renal denervation exhibit low rates of adverse events and significant lowering of blood pressure at six months. The results were announced March 30 as part of ACC.14 in Washington, DC.

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Gathering data from the first 1,000 consecutively enrolled patients, outcomes showed that five adverse events were attributed to the procedure, including four vascular access site complications (0.34 percent) and one renal artery dissection that was treated. In addition there were nine hospitalizations for hypertensive emergency (1.0 percent), eight for atrial fibrillation (0.9 percent), eight strokes (0.9 percent), six for new onset heart failure (0.7 percent), five heart attacks (0.6 percent), four deaths (0.4 percent) and two cases of new onset end stage kidney disease (0.2 percent) that were considered unrelated to the procedure.

Despite these rare adverse occurrences the results of the study revealed that a significant drop in blood pressure took place at six months: 11.9 mmHg for all patients and 19.8 mmHg for patients with baseline office pressures greater than or equal to 160. Ambulatory systolic blood pressure also dropped dramatically for all patients at six months, decreasing 7.9 mmHg for all patients with blood pressure readings of 140 or higher, and 9.2 mmHg for a subset of patients with ambulatory systolic blood pressure of 160 or higher.

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"This study shows that renal denervation may be an alternative treatment for uncontrolled hypertension," says Michael Böhm, MD, PhD, University of Saarland in Homburg, Germany, and lead investigator of the study. "Our study provides a significant contribution to the discussion about renal denervation when considering the procedure for high risk patients who are suffering from uncontrolled hypertension and have exhausted all other options."

Yesterday it was revealed that SYMPLICITY HTN-3, a pivotal trial examining renal denervation treatment in patients with severe resistant hypertension – high blood pressure not controlled with three classes of medication – failed to reach its secondary efficacy goals. Moving forward, Böhm recommends that further research is needed to demonstrate the full efficacy of renal denervation and to identify the patient populations who might best benefit from the procedure.

Keywords: Registries, Stroke, Renal Artery, Denervation, Kidney Failure, Chronic, Heart Failure, Blood Pressure, Hospitalization, Hypertension

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