title: First-in-man safety evaluation of renal denervation for chronic systolic heart failure: primary outcome from REACH-Pilot study.
abstract: BACKGROUND
  Sympathetic 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.
  
  
  METHODS
  7 patients (mean age 69 years) with chronic systolic heart failure (mean BP on referral 112/65 mmHg) 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 5 days following denervation. Follow-up was weekly for 4 weeks, and then monthly for 6 months.
  
  
  RESULTS
  No significant haemodynamic disturbances were noted during the acute phase post renal denervation. Over 6 months there was a non-significant trend to blood pressure reduction (Δsystolic -7.1 ± 6.9 mmHg, p=0.35; Δdiastolic -0.6 ± 4.0 mmHg, p=0.88). No hypotensive or syncopal episodes were reported. Renal function remained stable (Δcreatinine -5.7 ± 8.4 μmol/l, p=0.52 and Δurea -1.0 ± 1.0 mmol/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 ± 9.7 m, p=0.03), with each patient showing an increase.
  
  
  CONCLUSIONS
  This study found no procedural or post procedural complications following renal denervation in patients with chronic systolic heart failure in 6 months 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. ClinicalTrial.gov NCT01584700
authors.affiliation: National Heart and Lung Institute, International Centre for Circulatory Health, Imperial College London & Imperial College Healthcare NHS Trust, London, UK. justin.davies@imperial.ac.uk
authors.forename: Justin E
authors.initials: JE
authors.lastname: Davies
authors.forename: Charlotte H
authors.initials: CH
authors.lastname: Manisty
authors.forename: Ricardo
authors.initials: R
authors.lastname: Petraco
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Barron
authors.forename: Beth
authors.initials: B
authors.lastname: Unsworth
authors.forename: Jamil
authors.initials: J
authors.lastname: Mayet
authors.forename: Mohamad
authors.initials: M
authors.lastname: Hamady
authors.forename: Alun D
authors.initials: AD
authors.lastname: Hughes
authors.forename: Peter S
authors.initials: PS
authors.lastname: Sever
authors.forename: Paul A
authors.initials: PA
authors.lastname: Sobotka
authors.forename: Darrel P
authors.initials: DP
authors.lastname: Francis
mesh_terms: D000368:Aged; D002908:Chronic Disease; D003714:Denervation / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D054143:Heart Failure, Systolic / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007668:Kidney / Q000294:innervation* / Q000502:physiology; D008297:Male; D008875:Middle Aged; D061214:Patient Safety / Q000592:standards*; D010865:Pilot Projects; D016896:Treatment Outcome