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Catheter ablation with renal denervation may eliminate AF at 12 months
Renal denervation with catheter ablation in patients with paroxysmal atrial fibrillation and hypertension significantly increased the likelihood of freedom from AF at 12 months compared with catheter ablation alone, according to results of the ERADICATE-AF trial published in JAMA.
The publication confirms findings previously presented at the Heart Rhythm Society Annual Scientific Sessions in 2019.
“The results of this study provide strong proof that renal denervation can augment the results of standard catheter ablation for AF and suggest that a strategy of incorporating autonomic modulation is a useful approach to arrhythmia control independent of direct targeting of cardiac tissue,” Jonathan S. Steinberg, MD, FHRS, adjunct professor of medicine at the University of Rochester School of Medicine and Dentistry and director of SMG Arrhythmia Services at Summit Medical Group of New Jersey, told Healio.
AF and hypertension
Researchers analyzed data from 302 patients (median age, 60 years; 60% men) with a history of symptomatic paroxysmal AF, a history of clinically significant hypertension and plans to undergo ablation. Patients were assigned catheter ablation using pulmonary vein isolation alone (n = 148) or with renal denervation (n = 154).
The primary endpoint was freedom from AF recurrence at 12 months without taking antiarrhythmic drugs. Several secondary endpoints were assessed including mean systolic BP and procedural complications.
Patients attended follow-up visits at 1 month, 3 months, 6 months, 9 months and 12 months. Treatment failure was defined as the initiation of antiarrhythmic drugs or repeat ablation procedures.
The majority of patients (93.7%) completed the trial, and all patients successfully underwent assigned procedures.
At 12 months, freedom from AF, atrial flutter or atrial tachycardia occurred in 56.5% of patients assigned pulmonary vein isolation alone vs. 72.1% of those assigned pulmonary vein isolation with renal denervation (HR = 0.57; 95% CI, 0.38-0.85).
From baseline to 12 months, mean systolic BP decreased from 151 mm Hg to 147 mm Hg in patients assigned pulmonary vein isolation only. By contrast, patients assigned pulmonary vein isolation plus renal denervation had a decline in systolic BP from 150 mm Hg to 135 mm Hg (between-group difference = 13 mm Hg, 95% CI, 15 to 11; P < .001).
Procedural complications occurred in 4.7% of patients in the isolation-only group vs. 4.5% of those in the renal denervation group (absolute risk difference = 0.1%; 95% CI, 4 to 4.4; P > .99).
“We have designed additional trials to expand the potential universe of patients who may be eligible to the approach used in this trial,” Steinberg said in an interview. “Our highest priority are patients with persistent AF as well as controlled hypertension or absence of hypertension.”
Steinberg added that the absence of a sham-controlled group in this trial does not detract from the findings “because patients were fully sedated and completely unaware of which procedure was being performed (or whether an arterial puncture or renal angiogram was done.”
‘Important incremental step’
N.A. Mark Estes III, MD, cardiologist at the UPMC Heart and Vascular Institute at the University of Pittsburgh School of Medicine, wrote a related editorial that the study “represents an important incremental step in emerging treatment for reducing the burden of atrial fibrillation and improving outcomes in hypertensive patients with symptomatic atrial fibrillation. Further evidence is needed from ongoing trials before renal artery denervation becomes a standard clinical approach.” – by Darlene Dobkowski
For more information:
Jonathan S. Steinberg, MD, FHRS, can be reached at University of Rochester School of Medicine and Dentistry, 85 Woodland Road, Short Hills, NJ 07079; email: jsteinberg@smgnj.com.
Disclosures: Steinberg reports he consults for Allergan, Atricure, Biosense Webster, Corfigo, Medtronic, National Cardiac and Omron; has equity in AliveCor and National Cardiac; and receives research support from Medtronic and the NIH. Estes reports he receives personal fees from Abbott-St. Jude Medical, Boston Scientific and Medtronic. Please see the study for all other authors’ relevant financial disclosures.