Efficacy of LGE‐MRI‐guided fibrosis ablation versus conventional catheter ablation of atrial fibrillation: The DECAAF II trial: Study design

Abstract

Introduction Success rates of catheter ablation in persistent atrial fibrillation (AF) remain suboptimal. A better and more targeted ablation strategy is urgently needed to optimize outcomes of AF treatment. We sought to assess the safety and efficacy of targeting atrial fibrosis during ablation of persistent AF patients in improving procedural outcomes. Methods The DECAAF II trial (ClinicalTrials. gov identifier number NCT02529319) is a prospective, randomized, multicenter trial of patients with persistent AF. Patients with persistent AF undergoing a first‐time ablation procedure were randomized in a 1:1 fashion to receive conventional pulmonary vein isolation (PVI) ablation (Group 1) or PVI + fibrosis‐guided ablation (Group 2). Left atrial fibrosis and ablation induced scarring were defined by late gadolinium enhancement magnetic resonance imaging at baseline and at 3–12 months postablation, respectively. The primary endpoint is the recurrence of atrial arrhythmia postablation, including atrial fibrillation, atrial flutter, or atrial tachycardia after the 90‐day postablation blanking period. Patients were followed for a period of 12–18 months with a smartphone ECG Device (ECG Check Device, Cardiac Designs Inc.). With an anticipated enrollment of 900 patients, this study has an 80% power to detect a 26% reduction in the hazard ratio of the primary endpoint. Results and Conclusion The DECAAF II trial is the first prospective, randomized, multicenter trial of patients with persistent AF using imaging defined atrial fibrosis as a treatment target. The trial will help define an optimal approach to catheter ablation of persistent AF, further our understanding of influencers of ablation lesion formation, and refine selection criteria for ablation based on atrial myopathy burden.

LGE-MRI for diagnosis of left atrial cardiomyopathy as identified in high-definition endocardial voltage and conduction velocity mapping

“…The copyright holder for this preprint this version posted February 5, 2022. ; https://doi.org/10.1101/2022.02.02.22269817 doi: medRxiv preprint that ablation of LGE-areas in the DECAAF II study did not improve sinus rhythm maintenance rates, indicates that the detected LGE-areas (using the Utah-method) may not have a major arrhythmogenic role in human AF [19].…”

“…In this way, the most sensitive and specific LGE-extent was determined to detect significant LA-LVS. A fibrotic tissue extent ≥20% of the total LA-wall (Utah-stages III and IV) was classified as relevant LGE for the Utah method [19].…”

Identifying Atrial Fibrillation Mechanisms for Personalized Medicine

“…Fibrosis introduces heterogeneities in electrical repolarization and conduction, which can facilitate multiple wavelet re-entry or anchor driver regions in optical mapping studies of human AF [ 63 ]. It remains unclear how best to quantify fibrosis clinically, although groups have used signal intensity on gadolinium-enhanced magnetic resonance imaging [ 64 ] and low-amplitude electrograms in electrophysiology study [ 65 ].…”

Left Atrial Appendage Remodeling after Atrial Fibrillation Ablation

“…The other scan parameters for Cine of LV scan were TR = 3.48 ms, TE = 1.74 ms, FA = 90 o . Scan protocol for 3D LGE was similar to 3D LGE protocol optimized and validated in DECAAF and DECAAF II multi-center studies (18). LGE scan was initiated 20-25 minutes after contrast agent administration using a 3D inversion recovery prepared, respiration navigated, ECG-gated, spoiled gradient echo pulse sequence.…”