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First-in-Man Data Confirm Safety of Renal Denervation for HF
A small, first-in-man study has shown renal denervation to be safe in patients with chronic systolic HF during 6 months of intensive follow-up.
In the REACH-Pilot study, seven patients (mean age, 69 years) with chronic systolic HF (mean BP on referral, 112 mm Hg/65 mm Hg) on maximal tolerated HF therapy underwent bilateral renal denervation with a denervation catheter (Ardian Symplicity, Medtronic) from May to July 2011. A minimum of four denervation therapies were delivered to each artery. Researchers followed an intensive protocol of observation and assessment, which was composed of a 5-day hospital stay post-procedure and 6 months of regular outpatient follow-up.
During the acute phase after renal denervation, researchers reported no significant hemodynamic disturbances. At 6 months, nonsignificant improvements were observed in BP (systolic BP, −7.1 ± 6.9 mm Hg; P=.35; diastolic BP, −0.6 ± 4 mm Hg; P=.88); however, a significant improvement was reported in 6-minute walking distance (+27.1 ± 9.7 m; P=.03). There were no reports of hypotensive or syncopal episodes, and renal function remained stable. All patients described themselves as symptomatically improved.
Although there may be a theoretical concern that patients with HF may be relying upon contributions from their renal nerves to sustain BP and organ perfusion, researchers said these data suggest symptoms are not made worse by denervation.
“This may parallel the observations with ACE inhibitors, which greatly reduce BP in hypertensive patients but have a much smaller effect on BP in HF despite yielding substantial survival benefits,” they wrote.
Justin E. Davies
To Cardiology Today’s Intervention, Justin E. Davies, BSc, MBBS, MRCP, PhD, trial investigator with Imperial College London, said randomized, sham-controlled blinded clinical trials are required to determine the impact of renal denervation on morbidity and mortality in systolic HF. “Such a study, REACH, is now actively recruiting at Imperial College London,” he said.