First-in-man safety evaluation of renal denervation for chronic systolic heart failure: Primary outcome from REACH-Pilot study

Abstract

BackgroundSympathetic overactivation, is reduced by renal denervation in drug-resistant hypertension. A similar role for renal denervation in heart failure remains unstudied, partly due to the concern about potential concomitant deleterious blood pressure reductions. This pilot study evaluated the safety of renal denervation for heart failure using an intensive follow-up protocol. Method7 patients (mean age 69years) with chronic systolic heart failure (mean BP on referral 112/65mmHg) on maximal tolerated heart failure therapy underwent bilateral renal denervation May–July 2011. Patients were admitted for pre-procedure baseline assessments and in-patient observation for 5days following denervation. Follow-up was weekly for 4weeks, and then monthly for 6months. ResultsNo significant haemodynamic disturbances were noted during the acute phase post renal denervation. Over 6months there was a non-significant trend to blood pressure reduction (Δsystolic −7.1±6.9mmHg, p=0.35; Δdiastolic −0.6±4.0mmHg, p=0.88). No hypotensive or syncopal episodes were reported. Renal function remained stable (Δcreatinine −5.7±8.4μmol/l, p=0.52 and Δurea −1.0±1.0mmol/l, p=0.33).All 7 patients described themselves as symptomatically improved. The six minute walk distance at six months was significantly increased (Δ=27.1±9.7m, p=0.03), with each patient showing an increase. ConclusionsThis study found no procedural or post procedural complications following renal denervation in patients with chronic systolic heart failure in 6months of intensive follow-up. Results suggested improvements in both symptoms and exercise capacity, but further randomised, blinded sham-controlled clinical trials are required to determine the impact of renal denervation on morbidity and mortality in systolic heart failure. These data suggest such trials will be safe.