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2018 AF Symposium: REAFFIRM Trial—Kiss of Death for FIRM Mapping?

by Steve S. Ryan, PhD

John Hummel MD

In a late-breaking presentation, the interim results of REAFFIRM were presented by Dr. John Hummel from the Ohio State University Wexner Medical Center.

Focal impulse and rotor modulation (FIRM)

Note: REAFFIRM stands for “Randomized Evaluation of Atrial Fibrillation Treatment with Focal Impulse and Rotor Modulation Guided Procedures” (REAFFIRM).
FIRM stands for Focal impulse and rotor modulation (FIRM) and is used for mapping electrical signals of the heart.

The trial was intended to assess the safety and effectiveness of FIRM mapping used with conventional ablation (including PVI) versus a standard PVI procedure for the treatment of persistent atrial fibrillation.

REAFFIRM Trial Design

In a prospective multi-center trial, 350 patients with persistent or long-standing persistent A-Fib who had not had a previous ablation were randomized in a 1:1 fashion. The trial was designed to compare FIRM mapping used with standard catheter ablation (including PVI) versus PVI without use of FIRM mapping.

The non-FIRM ablation control group included CTI (Cavo Tricuspid Isthmus Ablation for atrial flutter) and extra non-PV trigger ablations. Irrigated catheters were used in all cases, but not all used contact force sensing catheters.

Patients were monitored for 12 months with Holter and implantable monitors. The patients were primarily white males 65+ years old. There were no significant differences in the two groups of patients.

Trial Results: No Significant Difference in FIRM+PVI vs. PVI Alone

Prediction: It was anticipated that the control arm (PVI alone) would have a freedom from A-Fib success rate of 40% versus the treatment arm (FIRM+ PVI) would have a success rate of 75%.

Actual: At 12 months the success rate of the treatment (FIRM+ PVI) was 78%, while the control group with PVI alone had a success rate of 70%. This was a non-significant difference (not what the researchers had expected).

Translation: The control arm of the trial (PVI alone) did much better than anticipated. The researchers are trying now to look more closely at the details of the non-FIRM trial to identify why it did so well.

What this Trial Means for Patients

The REAFFIRM trial was a well designed study which showed that FIRM is not significantly better that a standard well-performed PVI ablation.
This is not the first study to call into question the effectiveness of the FIRM system. Critical Analysis of the FIRM Mapping System (2015) and More FIRM Research: Mapping System Falls Short (Again) (2016).
Unless and until the smoke clears and we have further research, the FIRM system probably won’t be an effective player long-term in the world of A-Fib ablation.
Bottom line: Don’t go out of your way to find a center or EP using the FIRM mapping system.

If you find any errors on this page, email us. Y Last updated: Wednesday, February 28, 2018

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