What is the clinical evidence from this study?

Study design: Cohort. Population: treatment-resistant hypertension (TRH) (n=33). Intervention: Renal denervation (RDN). Primary outcome: reduction in office systolic BP (SBP) at 6 months (13±32 mm Hg reduction, p=.03).

February 9, 2016Open Access

Controversies Surrounding Renal Denervation: Lessons Learned From Real‐World Experience in Two United Kingdom Centers

Key Result

Renal denervation in patients with treatment-resistant hypertension was associated with a 13±32 mm Hg reduction in office systolic blood pressure at 6 months (P=.03).

Study Design

Type

Cohort (n=33)

Multicenter

Yes

Structured PICO

Does renal denervation reduce office systolic blood pressure in patients with treatment-resistant hypertension?

Population

33 patients with treatment-resistant hypertension evaluated in a real-world setting, with 29 followed for 6 months after renal denervation.

Exposure

Renal denervation (RDN)

Outcome

Reduction in office systolic blood pressure (SBP) at 6 monthssurrogate

Real-world data from two UK centers demonstrates that renal denervation significantly reduces office systolic blood pressure at 6 months in selected patients with treatment-resistant hypertension, though individual responses vary widely.

Main Result

Mean Difference: 13

p-value: p=.03

Limitations

Medication alterations and nonadherence confound outcomes
Individual responses are highly variable
Selecting patients for RDN is challenging, with only 10% of screened patients eligible

Abstract

Renal denervation (RDN) is a therapy that targets treatment-resistant hypertension (TRH). The Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity) HTN-1 and Symplicity HTN-2 trials reported response rates of >80%; however, sham-controlled Symplicity HTN-3 failed to reach its primary blood pressure (BP) outcome. The authors address the current controversies surrounding RDN, illustrated with real-world data from two centers in the United Kingdom. In this cohort, 52% of patients responded to RDN, with a 13±32 mm Hg reduction in office systolic BP (SBP) at 6 months (n=29, P=.03). Baseline office SBP and number of ablations correlated with office SBP reduction (R=-0.47, P=.01; R=-0.56, P=.002). RDN appears to be an effective treatment for some patients with TRH; however, individual responses are highly variable. Selecting patients for RDN is challenging, with only 10% (33 of 321) of the screened patients eligible for the study. Medication alterations and nonadherence confound outcomes. Adequate ablation is critical and should impact future catheter design/training. Markers of procedural success and improved patient selection parameters remain key research aims.