The clinical impact of the left atrial posterior wall lesion formation by the cryoballoon application for persistent atrial fibrillation: Feasibility and clinical implications.

INTRODUCTION: The left atrial (LA) posterior wall (LAPW) has been targeted to improve the clinical outcomes in patients with persistent atrial fibrillation (PersAF). This study aimed to investigate the feasibility, safety, and clinical implications of cryoballoon (CB) applications on the LAPW to accomplish electrical isolation (EI) of the LAPW with CB. METHODS: A total of 100 patients (males, 84; mean age, 64 ± 10 years) with PersAF were enrolled. The first 50 patients underwent only pulmonary vein isolation (PVI) (PVI-only group) and the remaining 50 patients underwent PVI and EI of the LAPW with CB (EI-LAPW group). RESULTS: One-year sinus rhythm maintenance probability was significantly higher in the EI-LAPW group than in PVI-only group (80.0% vs 55.1%, P = 0.01). The success rate of constructing an LA roof block line (LA-RB), bottom block line, and EI of the LAPW was 92%, 60%, and 58%, respectively. The nadir CB temperature (-45°C ± 4°C vs -39°C ± 5°C, P = 0.005) and anatomical angle of the left atrial roof (106°C ± 30°C vs 144°C ± 17°C, P < 0.001) significantly predicted the successful LA-RB construction. The left ventricular ejection fraction was significantly higher in unsuccessful cases than in successful cases of an EI of the LAPW (64% ± 8% vs 58% ± 11%, P = 0.041). Even though the EI of the LAPW was unsuccessful, CB freezing in LAPW significantly debulked the nonscar area (≥0.1 mV) in LAPW (18.1 ± 5.6 vs 2.2 ± 3.1 cm 2 , P < 0.001) and provided the equivalent 1-year outcome of successful cases (79.3% vs 81.0%, P = 0.90). CONCLUSION: The combination of PVI and EI of the LAPW with CB provided better clinical outcomes than conventional PVI procedure for patients with PersAF.

"Clinical Impact of the Cryoballoon Temperature and Occlusion Status on the Success of Pulmonary Vein Isolation".

BACKGROUND: Complete occlusion of the pulmonary veins (PVs) with the cryoballoon (CB) is considered to be the crucial factor for a successful PV isolation (PVI). We investigated whether a complete occlusion was indispensable for a successful CB based PVI of every PV. METHODS AND RESULTS: Atrial fibrillation patients (n=123, 97; paroxysmal) undergoing a de novo PVI were enrolled. A total of 477 PVs were analyzed. The occlusion grade (OG) was scored as follows: OG3 (complete occlusion), OG2 (incomplete occlusion with slight leakage), OG1 (poor occlusion with massive leakage). There was no significant difference in the CB temperature (CBT) at all measured time points (from 30 to 120sec after freezing) and nadir CBT between OG2 and OG3 in all PVs except for the right inferior PV (RIPV). The RIPV isolation success rate was significantly lower for the OG2 status than OG3 (97.5 vs. 57.6%; p<0.0001). In contrast, there was not significant difference in the isolation success rate of the other three PVs between OG2 and OG3. In particular, the success rate of the right superior PV (RSPV) isolation was >95% for both OG2 and OG3. Phrenic nerve paralysis (PNP) was provoked during the RSPV isolation in two patients in whom the RSPVs were frozen during OG3. CONCLUSION: An OG3 may not always be required for a successful PVI of all PVs except the RIPV. OG2 could have comparable effects as OG3 in terms of a successful RSPV isolation. Not aiming for OG3 for the RSPV may reduce the risk of PNP.

Clinical assessment of cryoballoon ablation in cases with atrial fibrillation and a left common pulmonary vein.

INTRODUCTION: Pulmonary vein isolation (PVI) using a cryoballoon (CB) is a useful tool for treating atrial fibrillation (AF); however, the clinical efficacy of the CB has never been fully investigated in patients with a left common pulmonary vein (LCPV). METHODS AND RESULTS: Three hundred twenty-four consecutive paroxysmal AF patients underwent PVI with a CB. Three-dimensional computed tomography was performed in all patients before the ablation. The clinical outcomes of the AF ablation between patients with (Group A) and without an LCPV (Group B) were compared. An LCPV was observed in 27 (8%) patients. There were no significant differences in the procedure time (149 ± 45 min vs. 143 ± 40 min, respectively; P = 0.42) and percentage needing touch up ablation between the 2 groups (26% vs. 20%, respectively; P = 0.45). At a mean follow-up of 454 ± 195 days, 282 of 324 (87%) patients were free from any atrial tachyarrhythmias (ATs) after a single procedure. Twenty out of 27 (74%) Group A patients and 262 of 297 (88%) Group B patients were free from ATs (15-month Kaplan-Meier event free rate estimates, 77% and 89%, respectively; P = 0.02). A multivariate analysis identified the presence of an LCPV and the left atrial diameter as reliable predictors of recurrent ATs. CONCLUSIONS: The long-term clinical outcomes of ablation of AF with the CB was worse in patients with an LCPV than in those without. The presence of an LCPV and the LA size seemed to be reliable predictors of a worse outcome.

Incidence of silent cerebral infarctions after catheter ablation of atrial fibrillation utilizing the second-generation cryoballoon.

AIMS: Pulmonary vein (PV) isolation (PVI) utilizing a cryoballoon (CB) has become one of the standard therapeutic options for atrial fibrillation (AF). However, it connotes a potential risk of cerebral ischaemic events (CIEs). This study aimed to clarify the prevalence of CIEs after PVI using second-generation CBs assessed by magnetic resonance imaging (MRI) of the brain. METHODS AND RESULTS: This prospective observational study consisted of 160 patients that underwent PVI with second-generation CBs for drug-refractory AF. Irrigated radiofrequency (RF) ablation for 'touch-up' procedures was utilized when conduction gaps between the left atrium (LA) and PVs were found after the CB application. Radiofrequency linear ablation was added in select patients. Cerebral MRI and neurological examinations were performed on the day following the ablation procedure. The MRI depicted micro-cerebral infarctions in 43 patients (26.9%, 1.49 lesions per case). All patients were free from symptomatic focal neurological deficits. Touch up ablation was required for the PVI establishment in 35 patients (21.9%). Linear ablation was performed in 59 patients (36.9%). Additional RF ablation within the LA was an independent risk of CIEs in the uni- and multivariate analyses. When the analyses were limited to patients who had undergone only CB ablation, CIEs were found in 12 of 66 patients (18.2%). CONCLUSION: Pulmonary vein isolation utilizing second-generation CBs carries a negligible risk of symptomatic CIEs; however, it includes a comparable risk of asymptomatic CIEs as in the previous similar reports using the first-generation CB. Radiofrequency applications in addition to the CB within the LA were the only predictor of this adverse effect.

Comparative study of hemorrhagic and ischemic complications among anticoagulants in patients undergoing cryoballoon ablation for atrial fibrillation.

OBJECTIVE: Few data exist to evaluate the safety and efficacy of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) undergoing cryoballoon ablation (CB-A). This study is aimed to clarify the usefulness of DOACs in patients undergoing CB-A. METHODS: The patients (average age; 65.8±11.9 years old, male 69%) were stratified into one of five subsets based on the type of anticoagulation (warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban), and underwent CB-A. A brain MRI was performed in all patients the day after the CB-A for AF. A total of 257 (19 on warfarin, 30 on apixaban, 66 on dabigatran, 81 on rivaroxaban, and 61 on edoxaban) patients met the inclusion criteria. RESULTS: The incidence of silent cerebral ischemic lesion was 1 (11.1%) patients on warfarin, 5 (33.3%) on apixaban, 8 (27.6%) on dabigatran, 10 (21.3%) on rivaroxaban, and 10 (29.4%) on edoxaban (p=0.17). Major ischemic events occurred in one patient (1.6%) on edoxaban and one (5.3%) on warfarin. Minor bleeding complications occurred in 1 patient (5.3%) on warfarin, 2 (6.7%) on apixaban, 1 (1.2%) on rivaroxaban, 5 (7.6%) on dabigatran, and 2 (3.3%) on edoxaban (p=0.24). Of note, major bleeding complications occurred in 2 patients (3.3%) on apixaban, 1 (1.2%) on rivaroxaban, 1 (1.5%) on dabigatran, 1 (1.6%) on edoxaban, and 2 (10.5%) on warfarin (p<0.05). CONCLUSIONS: Warfarin use significantly increased the risk of serious bleeding, in contrast, CB-A did not place the patients at an increased risk of complications under a DOAC treatment. There were no significant differences regarding preventing embolic events among the DOAC drugs.

Novel method for earlier detection of phrenic nerve injury during cryoballoon applications for electrical isolation of pulmonary veins in patients with atrial fibrillation.

BACKGROUND: Diaphragmatic electrogram recording during cryoballoon ablation (CB-A) of atrial fibrillation is commonly used to predict phrenic nerve palsy (PNP). OBJECTIVE: The purpose of this study was to investigate a novel method for predicting PNP at an earlier stage to prevent sustained PNP. METHODS: A total of 197 patients undergoing CB-A were enrolled. We attempted to detect PNP using fluoroscopic images of diaphragmatic contractions and by monitoring diaphragmatic compound motor action potentials (CMAPs) provoked by superior vena cava (SVC) and left subclavian vein (LCV) pacing during CB-A for bilateral pulmonary veins (PVs). Pacing of the SVC and LCV was performed at 2 outputs, 1 exceeding the pacing threshold by 10% (MIN) and the other at maximum output (MAX). The time from freezing to the initiation of PNP, values of the CMAP amplitude, and severity of PNP were compared for the 2 outputs. RESULTS: There was a significant difference in the time from freezing to initiation of PNP between MIN and MAX pacing (25.7 ± 5.7 vs 81.3 ± 7.4 seconds, P<.01). CMAP amplitudes also differed significantly (0.71 ± 0.39 vs 1.13 ± 0.42, P<.0001). SVC/LCV pacing with MIN output was able to detect PNP significantly earlier than MAX (27 ± 8 vs 91 ± 12 seconds, P<.01), and the time to PNP recovery was significantly shorter for the MIN output (20.2 ± 8.88 hours vs 4.8 ± 1.6 months, P<.001). CONCLUSION: Pacing the SVC and LCV with lower output detect PNP significantly earlier than maximal output pacing and leads to recovery from PNP on the order of hours postprocedure rather than months.

Reappraisal of the clinical implications of adenosine triphosphate in terms of the prediction of reconnection sites in cases with electrical isolation of the pulmonary veins.

PURPOSE: Dormant conduction (DC) induced by intravenous adenosine triphosphate (ATP) after pulmonary vein (PV) isolation (PVI) could predict subsequent PV reconnection (RC) sites. This study aimed to investigate the relationship between the DC and RC sites during the long-term follow-up. METHODS: Ninety-one consecutive patients (62 males; mean age, 62 ± 11 years) with symptomatic persistent (n = 18) or paroxysmal (n = 73) atrial fibrillation (AF) who underwent PVI were included in this study. After a successful PVI, we administered ATP to reveal the DC sites. In total, DC sites were observed in 46 (51%) patients, and all were left un-ablated after marking or tagging all of them using fluoroscopic images and a three-dimensional (3D) mapping system. After the follow-up period (14.8 ± 3.6 months), AF recurred in 29 (32%) patients, all of whom had a DC in the initial ablation session, and underwent redo sessions. We divided the DC sites into three groups; in group A, the RC sites differed from the DC sites, in group B, the RC sites were identical to the DC sites, and in group C, the RC sites involved both DC and other sites. RESULTS: As a result, 20 (69%), 3 (11.5%), and 6 (19.5%) patients belonged to groups A, B, and C, respectively. Statistical analyses comparing the agreement between DC and the RC sites yielded a weak relationship. CONCLUSIONS: DC sites implying RC sites had a weak agreement, and other options to predict RC sites will be required to improve the clinical benefit of CA of AF.