Catheter Ablation -> Atrial Fibrillation & Atrial Flutter: -> Clinical Trials / Outcomes D-PO03 - Poster Session III (ID 48) Poster

D-PO03-161 - Is High Frequency Stimulation Necessary To Guide Renal Denervation? Impact On Atrial Fibrillation Recurrences And Blood Pressure Control: A Substudy Of The Multicenter ERADICATE-AF Randomized Clinical Trial (ID 347)

Abstract

Background: The large randomized clinical trial ERADICATE-AF demonstrated that concomitant renal artery denervation (RDN) reduces atrial fibrillation (AF) recurrences as well as systolic blood pressure (SBP) in patients with AF and resistant arterial hypertension (HTN) undergoing pulmonary vein isolation (PVI). Prior studies have suggested that blood pressure (BP) response to high-frequency stimulation (HFS) should be the procedural endpoint for RDN.
Objective: To assess whether HFS response as an endpoint of RDN had an impact on AF recurrences and SBP control at 12-month follow-up in patients in the multicenter randomized ERADICATE-AF clinical trial (NCT 01873352).
Methods: A total of 154 patients with paroxysmal AF and HTN despite ≥1 anti-hypertensive underwent PVI + RDN in the trial. Local center procedure policy varied, and in some, HFS was performed to confirm procedural RDN effect before the initial and after each radiofrequency delivery within the renal arteries. The criterion for success was met when the sudden increase of BP ≥15 mm Hg was eliminated. If HFS was not used or did not generate a hypertensive response, the RDN was performed on an anatomic basis only. Post-hoc analyses included primary endpoint (freedom from AF recurrence at 12 months without antiarrhythmic drugs) and BP data (prespecified secondary endpoint) based on whether HFS was applied or not during RDN.
Results: In 88 (57%) of 154 patients who had HFS during the RDN, the primary end point occurred in 23 patients (14.9%) versus 19 patients (12.3%) in those without HFS, HR 0.85 (95% CI, 0.46 to 1.57). Among those who did and did not undergo HFS, the SBP was not significantly different at 12 months (median [IQR], 120 [120, 130] mm Hg vs 125 [125, 135] mm Hg; P=0.16).
Conclusion: In this large randomized trial testing the value of adjunctive RDN with PVI, freedom from AF recurrences and BP control were similar whether HFS was applied or not as procedural endpoint for RDN. Future studies, or clinical application, of RDN does not require the routine use of HFS.
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