Preliminary report from an randomized clinical trial on
intra-procedural three-dimensional rotational angiography in cryoballoon ablation for atrial fibrillation

    Authors

    Keywords

    atrial fibrillation, cryoballoon ablation, three-dimensional rotational angiography

    DOI

    https://doi.org/10.15836/ccar2021.14

    Full Text

    Introduction : There is a variety of approaches to pre-procedural imaging of pulmonary veins (PV) and left atrium (LA) in order to facilitate atrial fibrillation (AF) ablation, including CT angiography, cardiac MRI and intra-procedural three-dimensional rotational angiography (3DRA). Data supporting different practices is still evolving and there is an open question whether LA imaging could improve safety and outcomes of cryoballoon ablation (CB) ablation. ( 1 , 2 ) Here we present the preliminary data from a single-centre unblinded randomized clinical trial. Patients and Methods : So far, we recruited 82 patients (68.3% male, 59.0±11.6 years) with paroxysmal (92.8%) and early-persistent AF. Patients were randomized to no imaging or 3DRA which was performed intra-procedurally after trans-septal puncture. Angiographic images were segmented and overlaid to the fluoroscopy screen to guide the ablation procedure. All patients are followed for 1 year and data concerning procedural characteristics, safety outcomes and AF recurrence are being collected. Results : Of 82 patients recruited so far, 40 (48%) underwent 3DRA. In patients who received no imaging (non-3DRA group) all PVs were successfully isolated while in 3DRA group isolation of one PV could not be achieved in 1 patient. Procedure time was significantly longer when 3DRA was performed (89.4±29.7 min compared to 69.4±21.4 in non-3DRA group, p<0.001). Total radiation dose (146.9±186.1 vs 399.8±216.5 mGy, p<0.001) and contrast administration (44.2±27.6 vs 136.8±28.4 ml) were significantly lower in the control group. Only minor complications were reported in both groups. Three patients developed large hematoma (2 in 3DRA group vs 1 in control group). In each group there was one incident of transient phrenic nerve palsy. Conclusion : 3DRA is a safe and efficient intra-procedural imaging method to guide CB ablation for AF. However, it significantly increases procedure duration, total radiation dose and contrast expenditure. In our trial it did not have any impact on the acute success rate of PV isolation. One-year follow up data is still being collected and will subsequently be presented.

    Cardiologia Croatica
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    Preliminary report from an randomized clinical trial on
intra-procedural three-dimensional rotational angiography in cryoballoon ablation for atrial fibrillation

    Extended Abstract
    Issue1-2
    Published
    Pages14
    PDF via DOIhttps://doi.org/10.15836/ccar2021.14
    atrial fibrillation
    cryoballoon ablation
    three-dimensional rotational angiography

    Authors

    Ivan Prepolec*ORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Vedran PašaraORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Borka Pezo-NikolićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Mislav PuljevićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Davor PuljevićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Davor MiličićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia
    Vedran VelagićORCIDUniversity of Zagreb School of Medicine, Zagreb, Croatia

    Full Text

    Introduction : There is a variety of approaches to pre-procedural imaging of pulmonary veins (PV) and left atrium (LA) in order to facilitate atrial fibrillation (AF) ablation, including CT angiography, cardiac MRI and intra-procedural three-dimensional rotational angiography (3DRA). Data supporting different practices is still evolving and there is an open question whether LA imaging could improve safety and outcomes of cryoballoon ablation (CB) ablation. ( 1 , 2 ) Here we present the preliminary data from a single-centre unblinded randomized clinical trial. Patients and Methods : So far, we recruited 82 patients (68.3% male, 59.0±11.6 years) with paroxysmal (92.8%) and early-persistent AF. Patients were randomized to no imaging or 3DRA which was performed intra-procedurally after trans-septal puncture. Angiographic images were segmented and overlaid to the fluoroscopy screen to guide the ablation procedure. All patients are followed for 1 year and data concerning procedural characteristics, safety outcomes and AF recurrence are being collected. Results : Of 82 patients recruited so far, 40 (48%) underwent 3DRA. In patients who received no imaging (non-3DRA group) all PVs were successfully isolated while in 3DRA group isolation of one PV could not be achieved in 1 patient. Procedure time was significantly longer when 3DRA was performed (89.4±29.7 min compared to 69.4±21.4 in non-3DRA group, p<0.001). Total radiation dose (146.9±186.1 vs 399.8±216.5 mGy, p<0.001) and contrast administration (44.2±27.6 vs 136.8±28.4 ml) were significantly lower in the control group. Only minor complications were reported in both groups. Three patients developed large hematoma (2 in 3DRA group vs 1 in control group). In each group there was one incident of transient phrenic nerve palsy. Conclusion : 3DRA is a safe and efficient intra-procedural imaging method to guide CB ablation for AF. However, it significantly increases procedure duration, total radiation dose and contrast expenditure. In our trial it did not have any impact on the acute success rate of PV isolation. One-year follow up data is still being collected and will subsequently be presented.