The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Interventions for hypertension and stroke

Review and meta-analysis of renal artery damage following percutaneous renal denervation with radiofrequency renal artery ablation

EuroIntervention 2020;16:89-96. DOI: 10.4244/EIJ-D-19-00902

1. Perlman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 2. The Alfred Hospital, Melbourne, Australia; 3. Medtronic PLC, Santa Rosa, CA, USA; 4. Medizinische Klinik II, Sana Kliniken Lübeck, Lübeck, Germany; 5. University Hospital of Wales, Cardiff, United Kingdom; 6. Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, the Netherlands; 7. University Hospital of Saarland, Homburg/Saar, Germany; 8. Clinica Medica, Milan, Italy

Aims: We aimed to estimate 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 whom 24 (0.41%) required renal artery stenting. The primary meta-analysis of all reports indicated a 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); 79% of all events occurred within one 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 1 new significant stenosis (0.20%) after a median of 11 months post procedure (one to 36 months).

Conclusions: Renal artery reintervention following renal denervation with the most commonly applied RF renal denervation system (Symplicity) is rare. Most events were identified within one year.

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