Intra-procedural three-dimensional rotational angiography in cryoballoon ablation of atrial fibrillation - a randomised clinical trial. (19th May 2022) - Prepolec, I
Abstract: Funding Acknowledgements: Type of funding sources: None. Introduction: To facilitate atrial fibrillation (AF) ablation procedures there is a variety of approaches for pre-procedural imaging of pulmonary veins (PV) and left atrium (LA), including CT angiography and cardiac MRI. Intra-procedural three-dimensional rotational angiography (3DRA) is the least employed method and it can be advantageous regarding efficiency and procedural logistics. Data supporting different practices is still evolving and there is an open question whether LA imaging could improve safety and outcomes of CB ablation. Purpose: The aim of this study is to evaluate possible benefits of 3DRA for procedural success, safety and long-term outcomes of CB ablation. Methods: We designed a single-centre unblinded randomised clinical trial and recruited 101 patients (65.3% male, 59.3±11.5 years) with paroxysmal (92%) 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 all the patients recruited, 48 (47%) underwent 3DRA. In patients who received no imaging (non-3DRA group) one PV couldn't be isolated while in 3DRA group isolation of one PV could not be achieved in 3 patients (OR 3.47, 95% CI 0.35-34.51). The occurrence of left common PV, an anatomical variation that could have potential to influence results, was similar in both groups (25, 4% in non-3DRA and 25.0% in 3DRA group). Procedure time was significantly longer when 3DRA was performed (87.4±27.7 min compared to 69.9±23.0 in non-3DRA group, p<0.001). Total radiation dose (148.2±177.7 vs 387.7±203.8 mGy, p<0.001) and contrast administration (42.5±27.1 vs 133.8±26.8 ml, p<0.001) were significantly lower in the control group. Only minor complications were reported in both groups. Three patients developed large haematoma (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.