Incidence of renal artery damage following percutaneous renal denervation with radio frequency renal artery ablation systems: Review and Meta-Analysis of published reports
Raymond R. Townsend1, ; Antony Walton2; Douglas A Hettrick3, PhD; Graeme L. Hickey4; Joachim Weil5; Andrew S.P. Sharp6; Peter J. Blankestijn7; Michael Böhm8; Giuseppe Mancia9;
1. Perlman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA, United States 2. The Alfred Hospital, Melbourne, Australia 3. Medtronic, Coronary Medical Afairs, Andover, MN, United States 4. Medtronic PLC, Santa Rosa, CA, USA 5. Medizinische Klinik II, Sana Kliniken Lübeck, Lübeck, Germany 6. University Hospital of Wales, Cardiff, UK 7. Department of Nephrology and Hypertension, University Medical Center Utrecht, Netherlands 8. University Hospital of Saarland, Homburg/Saar, Germany 9. Clinica Medica, Milan, Italy
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Aims: We estimated the rate of renal artery adverse events following renal denervation with the most commonly applied radiofrequency catheter system based on a comprehensive review of published reports.
Methods and results: We reviewed 50 published renal denervation (RDN) trials reporting on procedural safety including 5,769 subjects with 10,249 patient-years of follow up. Twenty-six patients with renal artery stenosis or dissection (0.45%) were identified of which 24 patients (0.41%) required renal artery stenting. The primary meta-analysis of all reports indicated an 0.20% pooled annual incidence rate of stent implantation (95% CI: 0.12 to 0.29% per year). Additional sensitivity analyses yielded consistent pooled estimates (range: 0.17% to 0.42% per year). Median time from RDN procedure to all renal intervention was 5.5 months (range: 0 to 33 months) and 79% of all events occurred within 1 year of the procedure. A separate review of 14 clinical trials reporting on prospective follow up imaging using either magnetic resonance imaging, computed tomography or angiography following RDN in 511 total subjects identified just one new significant stenosis (0.20%) after a median of 11 months post procedure (1 to 36 months).
Conclusion: Renal artery re-intervention following renal denervation with the most commonly applied RF renal denervation system (Symplicity™) is rare. Most events were identified within 1 year.