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Experienced hypertension centers should be ‘gatekeepers’ of renal denervation
Study results published in the journal Hypertension have found that only about 40% of patients referred for renal denervation were eligible after careful screening, suggesting to researchers that experienced hypertension centers should remain the “gatekeepers” before the procedure is considered.
The study was conducted by investigators at 11 expert centers participating in the European Network Coordinating Research on Renal Denervation Consortium (ENCOReD). The analysis included 731 patients (mean age, 61.6 years) who had an office BP at screening of 177 mm Hg/96 mm Hg and were taking an average of 4.1 BP-lowering drugs. Three-quarters (75.6%) of patients were referred by specialists.
According to data, 42.5% (95% CI, 38-47) of patients were eligible for renal denervation according to the SYMPLICITY HTN-2 criteria, and 39.7% (36.2%-43.2%) were eligible based on each center’s criteria, with substantial variability reported between centers.
Researchers observed the following main reasons for patient ineligibility: normalization of BP after treatment adjustment (46.9%); unsuitable renal arterial anatomy (17%); and previously undetected secondary causes of hypertension (11.1%).
“Our findings highlight that hypertension centers with a record in clinical experience and research should remain the gatekeepers before renal denervation is considered,” the researchers wrote. “Renal denervation remains a last-resort approach that should only be applied at expert hypertension centers in a context of clinical research. The failure of SYMPLICITY HTN-3 to reach its primary endpoint of efficacy supports this contention.”
In a supplement accompanying the study, the researchers added that assuming renal denervation would be efficacious in a large number of patients with a variety of conditions may be overly optimistic. “This groundless belief might well explain why SYMPLICITY HTN-3 failed to reach its primary endpoint for efficacy,” they wrote.
Disclosure: One researcher reports receiving speaker and consultancy fees from Medtronic and St. Jude Medical, and unrestricted research grants from Medtronic. The other researchers report no relevant financial disclosures.