PV isolation and lesion completeness were improved with Arctic Front Advance, while no unexpected findings were found related to safety.

A single application with the second-generation cryoballoon catheter results in a high rate of PV isolation. The degree of vascular injury was not increased by active balloon deflation and no differences in acute efficacy or mature transmural circumferential lesions were observed with 2- versus 4-minute applications.

Anthropometric variability and body position do not adversely influence the EIT estimation of changes in lung volume. These data suggest EIT could be used to monitor critically ill mechanically ventilated adults with variable body habitus regardless of position.

Phrenic nerve injury induced by cryoballoon ablation is axonal in nature and characterized by Wallerian degeneration, with potential for recovery. An EMG-guided approach is superior to standard monitoring in limiting phrenic nerve damage.

Spirometry and electrical impedance tomography (EIT) data from 26 healthy subjects (14 males, 12 females) were used to develop a model linking contrast variations in EIT difference images to lung volume changes. Eight recordings, each 64 s long, were made for each subject in four postures (standing, sitting, reclining at 45 degrees, supine) and two breathing modes (quiet tidal and deep breathing). Age, gender and five anthropometric variables were recorded. The database was divided into four subsets. The first subset, data from 22 subjects (12 males, 10 females) recorded in deep breathing mode, was used to create the model. Validation was done with the other subsets: data recorded during quiet tidal breathing in the same 22 subjects, and data recorded in both breathing modes for the other four subjects. A quadratic equation in DeltaV(P) (lung volume changes recorded by the spirometer) provided a very good fit to total contrast changes in the EIT images. The model coefficients were found to depend on posture, gender, thoracic circumference and scapular skin fold. To validate the model, the quadratic equation was inverted to estimate lung volume changes from the EIT images. The estimated changes were then compared to the measured volume changes. Validations with each data subset yielded mean standard errors ranging from 9.3% to 12.4%. The proposed model is a first step in enabling inter individual comparisons of EIT images since: (1) it provides a framework for incorporating the effects of anthropometric variables, gender and posture, and (2) it references the images to a physical quantity (volume) verifiable by spirometry.

Introduction MRI based ablation provides an attractive capability of seeing ablation related tissue changes in real-time. Here we describe a real time MRI based cardiac cryo-ablation system. Methods Studies were performed in canine model (n=4) using MR-compatible cryo-ablation devices built for animal use: focal cryo-catheter with 8 mm tip and 28 mm diameter cryo-balloon. The main steps of MRI guided cardiac cryo-ablation procedure (real-time navigation, confirmation of tip–tissue contact, confirmation of vessel occlusion, real-time monitoring of a freeze zone formation, and intra-procedural assessment of lesions) were validated in a 3 Tesla clinical MRI scanner. Results The MRI compatible cryo devices were advanced to the right atrium (RA) and right ventricle (RV) and their position was confirmed by real-time MRI. Specifically, contact between catheter tip and myocardium and occlusion of superior vena cava (SVC) by the balloon was visually validated. Focal cryo lesions were created in the RV septum. Circumferential ablation of SVC-RA junction with no gaps was achieved using the cryo-balloon. Real-time visualization of freeze zone formation was achieved in all studies when lesions were successfully created. The ablations and presence of collateral damage were confirmed by T1-weighted and late gadolinium enhancement MRI and gross pathological examination. Conclusion This study confirms the feasibility of a MRI based cryo-ablation system in performing cardiac ablation procedures. The system allows real-time catheter navigation, confirmation of catheter tip–tissue contact, validation of vessel occlusion by cryo-balloon, real-time monitoring of a freeze zone formation, and intra-procedural assessment of ablations including collateral damage.

In a canine model, effective PV isolation could be found even in the shortest duration dosing cohort (TTE + 60 s). One complication (phrenic nerve injury) was observed in the longest duration dosing group (2 × 180 s). Further studies will be required to correlate these results to a 28-mm cryoballoon (more commonly used in the cryoablation of a human LA); however, to date, this is the first reporting of a successful cryoablation using TTE + 60 s dosing (approximately 90 s total duration of freezing).

This study reports on the development of an MRI-based cryoablation system and shows that with acute cryolesions there is a large area of reversible injury. Real-time MRI provides the ability to visualize the freeze-zone formation during the freeze cycle and for focal lesions reaches a maximum after 120 s suggesting that for maximizing lesion size 120 s might be the lower limit for dosing duration.