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REAFFIRM: Rotor ablation similar to conventional ablation in persistent AF
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SAN FRANCISCO — Focal impulse rotor modulation-guided rotor ablation was not superior to conventional ablation for treatment of persistent atrial fibrillation, researchers reported at the Heart Rhythm Society Annual Scientific Sessions.
The researchers conducted the REAFFIRM study of 375 patients who were assigned focal impulse rotor modulation (FIRM)-guided (RhythmView, Abbott) rotor ablation procedures followed by pulmonary vein isolation with or without additional ablation (mean age, 64 years; 74% men) or pulmonary vein isolation with or without additional ablation (mean age, 63 years; 71% men).
“Additional ablation beyond PVI was at the operator’s discretion and represented nearly half of patients in both arms of the study,” Johannes Brachmann, MD, FACC, FHRS, professor and chief of cardiology at Coburg Clinic, Coburg, Germany, said during a presentation.
The primary effectiveness endpoints were freedom from AF/atrial tachycardia and reintervention at 3 months and at 3 to 12 months. The primary safety endpoints were freedom from procedure-related serious adverse events at 7 days and 12 months after the procedure.
The primary effectiveness endpoint at 3 months occurred in 71.8% of the rotor ablation group and 76.9% of the control group (P = .2401), and at 3 to 12 months, occurred in 69.3% of the rotor ablation group and 67.5% of the control group (P = .9618), Brachmann said.
The primary safety endpoint at 7 days occurred in 88.9% of the rotor ablation group and 92.7% of the control group (P = .2179), and at 12 months, occurred in 86.2% of the rotor ablation group and 89.6% of the control group (P = .2423), he said.
Procedure-related serious adverse events occurred in 13.5% of the rotor ablation group and 10.6% of the control group, according to the researchers. There were three deaths, none of which were related to the procedure, and no strokes.
In a four way analysis comparing FIRM plus pulmonary vein isolation with additional ablation, FIRM plus pulmonary vein isolation without additional ablation, pulmonary vein isolation alone with additional ablation and pulmonary vein isolation alone without additional ablation, none were significantly more effective than the others (log-rank P = .0949), Brachmann said.
“While this study failed to provide evidence for superiority in the FIRM arm, effectiveness in both arms was higher than historically reported success rates,” he said. “This improvement may be related to other factors such as operator experience, new technologies, and different patient populations. FIRM-guided ablation procedures continue to be safe and effective.” – by Erik Swain
Reference:
Brachmann J, et al. LBCT01-02. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 8-11, 2019; San Francisco.
Disclosure: The study was sponsored by Abbott. Brachmann reports no relevant financial disclosures.
Perspective
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Wilber Su, MD
Our institution has used the FIRM technology. There were cases where we thought there may be something there, and there were cases where we thought it would not help. AF is a complex spectrum of disease pathology. While the technology does its best to tackle the whole spectrum, it is difficult for a trial like this to show enough difference to make a positive impact. So, for the persistent AF population, applying this method has been proven to be somewhat of a negative in terms of added benefit.
The trial is interesting in terms of both arms getting additional lesions ablated if the operator chose. It may be a case of the technology just not being all that additive on top of that strategy. When our FIRM maps have identified rotors, they are at typical locations. We often ablate those sites anyway.
I don’t think rotor ablation is dead. I think the expectation needs to be that this approach tackles a problem that is only a part of the complexity of AF. It is not the case that it will tackle everything involved with persistent AF. Mapping systems are being developed that are trying to characterize all the different pathologies for AF to eradicate the triggers and perpetuators of AF. Clearly, the rotor strategy alone does not tell the whole story.
This was the largest rotor ablation trial to date. For a rotor believer, it may be a little disappointing, but there have been cases where the technology has guided us to success. We just have to decipher where that utility should be.
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