Edoxaban eliminates hypercoagulability evoked by transient temperature changes in human whole blood.

Background: Thrombosis is a common critical complication relating to radiofrequency catheter ablation and cryoablation. There is a possibility that high-temperature stimulation during radiofrequency ablation or low-temperature stimulation during cryoablation may affect the coagulability of blood. In this study, we aimed to determine the impacts of transient temperature stimulations on the coagulability of whole blood and to clarify if edoxaban suppressed the hypercoagulability. Methods: Citrated blood samples were drawn from 41 healthy subjects. Some blood samples were mixed with tissue factor (TF) and several concentrations of edoxaban (50, 100, and 200 ng/mL). Blood samples were exposed to several temperature stimulations for 1 min: heat stimulation (50°C) or cryostimulation (-20°C), and compared with control (37°C). Repeated cryostimulations or sequential cryo- and heat stimulation were also applied. Coagulability of whole blood was measured using a dielectric blood coagulometry. As an index of coagulability, the end of acceleration time (EAT) was used. Results: Both heat- and cryostimulations significantly shortened the EAT compared to the control, indicating that hypercoagulability was induced by temperature stimulations. Application of TF enhanced and extended the hypercoagulability after the temperature stimulations. Sequential application of cryo- followed by heat stimulation further enhanced the hypercoagulability of blood. Application of edoxaban increased the EAT in a concentration-dependent manner in control condition. Edoxaban at 100 or 200 ng/mL completely suppressed the shortening of EAT evoked by these temperature stimulations. Conclusion: Transient temperature stimulations evoked hypercoagulability regardless of cryo- or heat stimulation. Edoxaban with 100 ng/mL or more eliminated this temperature-stimulated hypercoagulability.

Novel method to avoid serious injurious effects on the atrioventricular nodal (AVN) conduction during catheter ablation of the AVN slow pathway utilizing cryofreezing energy.

BACKGROUND: Slow pathway elimination of the atrioventricular node (AVN) is essential to treat AVN reentrant tachycardia (AVNRT). However, injury to the AVN conduction (IAVN) is one of the serious complications. Cryofreezing energy is expected to reduce the incidence of IAVN. This study aimed to investigate the usefulness of a novel method to avoid IAVN during cryoablation of AVNRT. METHODS: A total of 157 patients (average age, 65.8 years; male, 71) suffering from AVNRT were included. Once the AVNRT terminated during cryo-ablation, then rapid atrial constant pacing (RACP) was performed during freezing at a rate lower 10 bpm than that inducing Wenchebach AV block in 74 (47.1 %) patients (Group A). The RACP rate was decreasingly reduced by 10 bpm in case of the occurrence of IAVN. When the RACP reached 100 bpm, the cryoablation was prematurely terminated. Group B patients (83 = 52.9 %) underwent cryoablation during sinus rhythm. All patients were allocated in a randomized fashion. We compared the severity of the IAVN between Groups A and B. RESULTS: There were no significant differences at 12 months regarding the freedom from the AVNRT between Groups A and B. However, the duration of the IAVN was significantly longer in Group B than A (p = 0.02). There were no significant differences regarding the distance between the His recording sites and successful ablation sites between Groups A and B. No permanent IAVN requiring pacemaker implantation was provoked in either group. CONCLUSION: RACP was useful to avoid sustained and serious IAVN during cryoablation of AVNRT.

How to perform effective cryoballooon ablation of the left atrial roof: Considerations after experiencing more than 1000 cases.

INTRODUCTION: Cryoballoon ablation (CBA) of the left atrial (LA) roof in addition to a pulmonary vein isolation has been expected to improve the clinical outcomes post-atrial fibrillation (AF) ablation. We demonstrated the characteristics and efficacy of CBA of the LA roof through our experience with a large volume of procedures. METHODS: Among 1036 AF ablation procedures with CBA of the LA roof, 834 patients who underwent a de novo ablation were analyzed. RESULTS: Complete LA roof line conduction block was obtained in 767 patients (92.0%) solely by CBA (Group A). Compared with the other patients (Group B), the mean nadir balloon temperature during CBA of the LA roof (-44.5 ± 5.6°C for Group A vs. -40.5 ± 7.5°C for Group B, p < .01) and number of cryoballoon applications during the LA roof ablation with a circular mapping catheter located in the left superior pulmonary vein (1.3 ± 0.8 for Group A vs. 1.6 ± 1.0 for Group B, p = .02) were significantly lower in Group A. A multivariate analysis revealed that those were predictors of a complete LA roof conduction block after only CBA. The 1-year Kaplan-Meier atrial arrhythmia free rate estimates were 80.6% for Group A and 59.0% for Group B (p < .01). CONCLUSION: Complete LA roof line conduction block could be obtained with a cryoballoon without touch-up ablation in most cases. The LA roof CBA with a circular mapping catheter located in the right superior pulmonary vein was preferable to obtaining complete LA roof conduction block, which was important with regard to the clinical outcomes.

Paradigm Shift for Catheter Ablation of Atypical Atrioventricular Nodal Re-Entrant Tachycardia: 3-Dimensional Mapping-Based Ablation.

BACKGROUND: In current practice, the ablation target of atypical atrioventricular nodal re-entrant tachycardia (AVNRT) is the earliest atrial activation site in the coronary sinus (CS) or conventional slow pathway region. OBJECTIVES: The purposes of this study were to map the site of earliest retrograde atrial activation using electroanatomic three-dimensional mapping during atypical AVNRT and to evaluate successful ablation sites. METHODS: A total of 42 patients with a total of 49 AVNRTs (slow/fast: 30; fast/slow: 15; slow/slow: 4) underwent electrophysiological study and ablation. Among them there were 14 patients (10 women; 60 ± 19 years of age) in whom 19 atypical AVNRT (fast/slow: 15; slow/slow: 4) were induced. RESULTS: The intracardiac electrocardiograms or three-dimensional mapping of the exit site during tachycardia revealed that 7 patients had exit sites solely inside the CS (left inferior extension [LIE]), 3 solely in the right postero-septal tricuspid annulus (TA; right inferior extension [RIE]), and 4 had both LIE and RIE exits. The distance from the CS ostium to LIE exits was 14 ± 6 mm. RIE exits were located on the TA posterior to the CS ostium (between 5 and 6 o'clock in the left anterior oblique projection). Ablation targeting these exits or conventional slow pathway succeeded in long-term elimination of AVNRT in 13 of the 14 patients (93%). There were no complications. CONCLUSIONS: Catheter ablation targeting the exit sites of LIE or RIE mapped at the CS or TA holds promise as an effective and safe alternative approach to the current targets of ablation for atypical AVNRT cases.

A novel catheter ablation strategy for non-paroxysmal atrial fibrillation combining cryoballoon, radiofrequency, and Marshall-vein ethanol ablations.

BACKGROUNDS: Catheter ablation for non-paroxysmal atrial fibrillation (non-PAF) remains challenging and more effective strategy has been required to reduce postoperative arrhythmia recurrences. This study aims to investigate the efficacy and safety of a novel extensive ablation strategy for non-PAF, that is based on a combination of cryoballoon (CBA), radiofrequency (RFA), and Marshall-vein ethanol ablations (EA-VOM). METHODS: The study was a single-center, retrospective observational study. We enrolled 171 consecutive patients who underwent de-novo catheter ablation for non-PAF under conscious sedation with a novel extensive ablation strategy that included CBA for pulmonary vein isolation (PVI) and left atrial roof ablation (LARA), RFA for mitral isthmus (MI) ablation, superior vena cava isolation, and other linear ablations and EA-VOM. Recurrence of atrial arrhythmias over 1 year, procedure outcomes, and procedure-related complications were investigated. RESULTS: A total of 139 (81.3%) patients remained in sinus rhythm during 1-year follow-up. Of the 139 patients, 51 patients (29.8%) received antiarrhythmic drugs. The mean procedure time was 204 ± 45 min. PVI and LARA ablation by CBA and MI block by RFA and EA-VOM were completed in 171 (100%) and 166 (97.1%) patients, respectively. No serious procedure-related complications were observed except for one case of delayed pericardial effusion. CONCLUSION: Approximately 80% of the study patients were AF-free during 1-year follow-up period after a single procedure based on the novel extensive ablation strategy combining CBA, RFA, and EA-VOM. This strategy for non-PAF may be preferred in terms of maintenance of sinus rhythm, safety even in high-risk patients, and relatively short procedure time.

Initial multicenter clinical experience with the first-generation endoscopic guided laser balloon in Japan.

BACKGROUND: Isolation of the pulmonary veins (PVs) is the golden standard for atrial fibrillation (AF) ablation. To achieve a permanent PV isolation, the endoscopic guided HeartLight laser balloon system was invented. We analyzed the safety and efficacy of this laser balloon system. METHODS AND RESULTS: Three hundred four patients from 21 investigational sites inside Japan were enrolled in this study. One thousand sixty-two out of 1175 PVs (90.4%) were isolated using the HeartLight laser balloon. The isolation rate of the left superior, left inferior, right superior, and right inferior PVs was 87.8%, 91.3%, 91.6%, and 92.1%, respectively. The procedure time, defined as the time from the venous access to taking out the balloon, was 155 ± 39 min. The fluoroscopic time was 44 ± 25 min. The mean follow-up period was 309 ± 125 days. The freedom from AF recurrence at 3 months was 89.0% and at 12 months 82.1%. Adverse events occurred in 22 patients (7.2%) including phrenic nerve injury lasting more than 3 months in 1.6% and strokes in 1.0% of the patients. CONCLUSIONS: This initial experience demonstrated that the laser balloon ablation was feasible for PV isolation in Japanese AF patients.

Retrograde fast pathway cryoablation inside the coronary sinus for slow-fast atrioventricular nodal reentrant tachycardia in a patient with persistent left superior vena cava.

INTRODUCTION: Persistent left superior vena cava (PLSVC) is accompanied by enlarged coronary sinus (CS) and deformation of the triangle of Koch. This makes anatomical evaluation of the atrioventricular (AV) nodal pathways difficult. METHODS: We attempted cryoablation of retrograde fast pathway located in the enlarged CS roof of PLSVC for slow-fast AV nodal reentrant tachycardia (AVNRT) induced by inadvertent antegrade fast pathway elimination during ablation of left atrial tachycardia. RESULTS: Slow-fast AVNRT was successfully eliminated without AV block progression. CONCLUSIONS: This is the first case of successful retrograde fast pathway ablation of the CS ostial roof for slow-fast AVNRT with PLSVC.

Orthodromic AVRT With 2 Different Wide QRS Complexes Caused by Bilateral Bystander Nodoventricular Pathways.

We present a case of orthodromic atrioventricular re-entrant tachycardia exhibiting both right and left bundle branch block pattern wide QRS morphologies caused by bilateral bystander nodoventricular (NV) accessory pathways. These wide QRS morphologies came from pre-excitation accompanied by delta waves. In the context of NV accessory pathways, left-sided manifest NV accessory pathways are rare.

Laser Balloon Ablation in Patients with a Left Common Pulmonary Vein.

Pulmonary vein isolation (PVI) with a balloon-based visually guided laser ablation (VGLA) is regarded as a useful therapeutic tool for treating atrial fibrillation (AF). The clinical efficacy of a VGLA has never been fully investigated in patients with left common pulmonary vein (LCPV). We investigated the procedural safety as well as clinical usefulness of VGLA in patients with LCPV.This study consisted of 130 consecutive patients who underwent VGLA of de novo nonvalvular paroxysmal AF.Eleven patients (8.5%) had an LCPV (ostium maximal average diameter: 27.5 ± 4.9 mm, ostium minimal average diameter: 17.7 ± 3.5 mm). Nine out of 11 (81.8%) LCPVs were successfully occluded and isolated at the ostium with a VGLA-guided PVI. The ablation procedure time was significantly shorter in the patients with than without an LCPV (61.5 ± 15.4 versus 86.9 ± 32.9 minutes, P = 0.01). There was no difference regarding the atrial tachyarrhythmia recurrence between those with and without an LCPV (P = 0.18). A total of 15 patients underwent a redo procedure, but reconnections were not observed in any of the LCPV patients.The VGLA-guided PVI was a useful therapeutic tool even in patients with an LCPV. The presence of an LCPV might not be associated with an increased risk of any atrial tachyarrhythmia recurrence.

Pulmonary Vein Perforation and Life-Threatening Hemoptysis During Cryoballoon Ablation for Persistent Atrial Fibrillation.

Cryoballoon ablation is an effective method for pulmonary vein isolation for atrial fibrillation; however, unexpected complications may occur while performing the ablation procedure. We report an extremely rare case of pulmonary vein perforation with hemoptysis that required emergency lobectomy caused by injury from a circular mapping catheter. (Level of Difficulty: Intermediate.).

Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry.

PURPOSE: Catheter ablation is a recommended rhythm control therapy after failed or intolerant antiarrhythmic drug (AAD) treatment for patients with atrial fibrillation (AF). This study evaluates clinical performance and safety of pulmonary vein isolation (PVI) using the cryoballoon (Arctic Front Advance) in Japan. METHODS: Cryo AF Global Registry is a prospective, multi-center registry. Patients with paroxysmal AF (PAF) were treated at 10 Japanese hospitals. Efficacy was evaluated by freedom from a ≥ 30-s recurrence of AF/atrial flutter (AFL)/atrial tachycardia (AT), AF-related symptoms, and quality of life using the EQ-5D-3L questionnaire. The safety endpoint was serious device- and procedure-related adverse events. RESULTS: The study included 352 patients with PAF (65 ± 10 years of age, 36% female, 36% without prior failure of AAD). Mean duration since first diagnosis of AF was 3.0 ± 5.5 years. Serious device- and procedure-related adverse event rate was 2.6% (95% CI: 1.2-4.8%). Freedom from AF/AFL/AT was 88.5% (95% CI: 84.7-91.4%) at 12 months and 86.7% (95% CI: 81.1-90.8%) at 24 months. The number of patients with ≥ 1 AF symptom was significantly decreased from 88% at enrollment to 22% (p < 0.01) at 12-month follow-up. General quality of life using EQ-5D did not improve significantly after 12 months in the summary score. However, in the visual analog scale score, there was improvement (5.8 ± 18.4; p < 0.01). CONCLUSIONS: This study demonstrates that cryoablation used for PVI is a safe and effective treatment in real-world use for patients with PAF in Japan.

Prevalence of gastric hypomotility after additional cryoballoon ablation of the left atrial roof.

INTRODUCTION: Gastric hypomotility (GH) is a major complication of atrial fibrillation (AF) ablation. We aimed to clarify whether additional cryoballoon ablation (CBA) of the left atrial (LA) roof is associated with GH. METHODS AND RESULTS: This study included 54 patients with non-paroxysmal AF who underwent CBA for pulmonary vein isolation and of the LA roof line. GH was defined according to the results of esophagogastroscopy performed 2 days after ablation. GH was observed in 10 patients. There were significant differences in LA diameter (LAD), right inferior pulmonary vein (RIPV) diameter, and the height of the LA roof from the point where the LA posterior wall and esophagus make contact between patients with (GH+) and without GH (GH-) (LAD: 41.0 [36.3-41.8] mm vs. 46.5 [42.8-50.0] mm, p < .01; RIPV diameter: 19.7 [19.0-20.5] mm vs. 23.2 [21.2-24.9] mm, p < .01; height of LA roof: 5.7 [5.1-6.1] mm vs. 8.8 [7.1-11.2] mm for, p < .01, respectively). Multivariate analysis revealed that LA roof height was a predictor of GH. Moreover, Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) scores increased significantly 1 week after ablation (from 1.0 [0.0-2.8] to 5.0 [3.0-11.0], p = .03) in patients with GH. CONCLUSION: The height of the LA roof may be a predictor of GH after CBA of the LA roof line. Additionally, GH-related symptoms may still appear 1 week after ablation.

Cryoballoon ablation of the left atrial posterior wall reduces recurrence of persistent atrial fibrillation in patients with non-paroxysmal atrial fibrillation.

BACKGROUND: This study aimed to clarify the clinical outcomes of cryoballoon ablation of the left atrial (LA) posterior wall (LAPW), including the LA roof, in patients with non-paroxysmal atrial fibrillation (AF). METHODS: We analyzed the outcomes of 284 patients with non-paroxysmal AF, of whom 210 underwent the cryoballoon ablation of the LAPW, including the LA roof, in addition to pulmonary vein isolation with a cryoballoon. RESULTS: Complete conduction block at the LA roof was obtained in 95.7% (201/210) of patients, and LAPW was isolated in 83.3% (130/156) of patients. Over 372 (range, 208-477) days of follow-up, atrial arrhythmia recurrence was observed in 84 (29.6%) patients, and atrial tachycardia (AT) recurrence accounted for 27.4% of cases. The prevalence of LA roof cryoballoon ablation was significantly higher in patients without recurrence than in those with recurrence (78.6% vs. 63.1%, respectively; p = .01), especially those with persistent AF recurrence (77.0% vs. 55.0%, p = .01). No significant difference was found in the prevalence of AT recurrence between patients who had undergone additional LAPW ablation and those who had not. Durable LA roof lesions were confirmed in 29 (72.5%) of 40 patients who underwent redo ablation. CONCLUSIONS: Cryoballoon ablation of the LAPW leads to a sufficient acute success rate of complete conduction block and durable lesions of the LA roof without increasing AT recurrence risk. The prevalence of persistent AF recurrence decreases after additional cryoballoon ablation of the LAPW in patients with non-paroxysmal AF.

Prone-position computed tomography in the late phase for detecting intracardiac thrombi in the left atrial appendage before catheter ablation for atrial fibrillation.

BACKGROUND: Contrast computed tomography (CT) is a useful tool for the detection of intracardiac thrombi. We aimed to assess the accuracy of the late-phase prone-position contrast CT (late-pCT) for thrombus detection in patients with persistent or long-standing persistent atrial fibrillation (AF). METHODS: Early and late-phase pCT were performed in 300 patients with persistent or long-standing AF. If late-pCT did not show an intracardiac contrast defect (CD), catheter ablation (CA) was performed. Immediately before CA, intracardiac echocardiography (ICE) from the left atrium was performed to confirm thrombus absence and the estimation of the blood velocity of the left atrial appendage (LAA). For patients with CDs on late-pCT, CA performance was delayed, and late-pCT was performed again after several months following oral anticoagulant alterations or dosage increases. RESULTS: Of the 40 patients who exhibited CDs in the early phase of pCT, six showed persistent CDs on late-pCT. In the remaining 294 patients without CDs on late-pCT, the absence of a thrombus was confirmed by ICE during CA. In all six patients with CD-positivity on late-pCT, the CDs vanished under the same CT conditions after subsequent anticoagulation therapy, and CA was successfully performed. Furthermore, the presence of residual contrast medium in the LAA on late-pCT suggested a decreased blood velocity in the LAA ( ≤ 15 cm/s) (sensitivity = 0.900 and specificity = 0.621). CONCLUSIONS: Late-pCT is a valuable tool for the assessment of intracardiac thrombi and LAA dysfunction in patients with persistent or long-standing persistent AF before CA.