Comparison of High- and Low-Dose Rivaroxaban Regimens in Elderly East Asian Patients With Atrial Fibrillation.

BACKGROUND: In the Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial, rivaroxaban 20 mg was the on-label dose, and the dose-reduction criterion for rivaroxaban was a creatinine clearance of < 50 mL/min. Some Asian countries are using reduced doses label according to the J-ROCKET AF trial. The aim of this study was to assess the safety and efficacy of a high-dose rivaroxaban regimen (HDRR, 20/15 mg) and low-dose rivaroxaban regimen (LDRR, 15/10 mg) among elderly East Asian patients with atrial fibrillation (AF) in real-world practice. METHODS: This study was a multicenter, prospective, non-interventional observational study designed to evaluate the efficacy and safety of rivaroxaban in AF patients > 65 years of age with or without renal impairment. RESULTS: A total of 1,093 patients (mean age, 72.8 ± 5.8 years; 686 [62.9%] men) were included in the analysis, with 493 patients allocated to the HDRR group and 598 patients allocated to the LDRR group. A total of 765 patients received 15 mg of rivaroxaban (203 in the HDRR group and 562 in the LDRR group). There were no significant differences in the incidence rates of major bleeding (adjusted hazard ratio [HR], 0.64; 95% confidential interval [CI], 0.21-1.93), stroke (adjusted HR, 3.21; 95% CI, 0.54-19.03), and composite outcomes (adjusted HR, 1.13; 95% CI, 0.47-2.69) between the HDRR and LDRR groups. CONCLUSION: This study revealed the safety and effectiveness of either dose regimen of rivaroxaban in an Asian population for stroke prevention of AF. Considerable numbers of patients are receiving LDRR therapy in real-world practice in Asia. Both regimens were safe and effective for these patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04096547.

Long-term evaluation of sensing variability of a floating atrial dipole in a single­lead defibrillator: The mechanistic basis of long-term stability of amplified atrial electrogram.

BACKGROUND: A single­lead implantable cardioverter-defibrillator (ICD) with a floating atrial dipole has been developed to enhance the diagnostic capability of atrial arrhythmias and to facilitate adjudication of arrhythmic events without the additional effort required for atrial lead insertion. However, there have been concerns about the long-term reliability of atrial sensing. METHODS: We enrolled patients with the single-chamber ICD with atrial-sensing electrodes from 4 tertiary university hospitals in Korea. Minimal, maximal, and mean P wave amplitudes were collected at 3-6 months, 6-12 months, and 12-24 months after implantation. The difference between the minimal and maximal sensing amplitudes was calculated as an indicator of the variability of atrial sensing, while the atrial sensing stability was assessed using the mean amplitude. RESULTS: A total of 86 patients were included for analysis. The variability of atrial sensing amplitudes significantly decreased at 12-24 months compared to 3-6 months (p = 0.01), while mean atrial amplitudes were stable throughout the mean follow-up duration of 17.4 months. Nine patients (10.5%) experienced inappropriate ICD therapy mostly due to misclassification of supraventricular tachycardia. CONCLUSIONS: Under the hypothesis that sensing stability can be guaranteed as the variability decreases with time, we suggest that the concern about long-term sensing stability of a floating dipole can be abated with an ICD that has been implanted for over 2 years.

Ablation of Reentry-Vulnerable Zones Determined by Left Ventricular Activation From Multiple Directions: A Novel Approach for Ventricular Tachycardia Ablation: A Multicenter Study (PHYSIO-VT).

BACKGROUND: The optimal method to identify the arrhythmogenic substrate of scar-related ventricular tachycardia (VT) is unknown. Sites of activation slowing during sinus rhythm (SR) often colocalize with the VT circuit. However, the utility and limitations of such approach for guiding ablation are unknown. METHODS: We conducted a multicenter study in patients with infarct-related VT. The left ventricular (LV) was mapped during activation from 3 directions: SR (or atrial pacing), right ventricular, and LV pacing at 600 ms. Ablation was applied selectively to the cumulative area of slow activation, defined as the sum of all regions with activation times of ≥40 ms per 10 mm. Hemodynamically tolerated VTs were mapped with activation or entrainment. The primary outcome was a composite of appropriate implanted cardioverter-defibrillator therapies and cardiovascular death. RESULTS: In 85 patients, the LV was mapped during activation from 2.4±0.6 directions. The direction of LV activation influenced the location and magnitude of activation slowing. The spatial overlap of activation slowing between SR and right ventricular pacing was 84.2±7.1%, between SR and LV pacing was 61.4±8.8%, and between right ventricular and LV pacing was 71.3±9.6% (P<0.05 between all comparisons). Mapping during SR identified only 66.2±8.2% of the entire area of activation slowing and 58% critical isthmus sites. Activation from other directions by right ventricular and LV stimulation unmasked an additional 33% of slowly conducting zones and 25% critical isthmus sites. The area of maximal activation slowing often corresponded to the site where the wavefront first interacted with the infarct. During a follow-up period of 3.6 years, the primary end point occurred in 14 out of 85 (16.5%) patients. CONCLUSIONS: The spatial distribution of activation slowing is dependent on the direction of LV activation with the area of maximal slowing corresponding to the site where the wavefront first interacts with the infarct. This data may have implications for VT substrate mapping strategies.

Electrophysiologic Results After Thoracoscopic Ablation for Chronic Atrial Fibrillation.

BACKGROUND: Thoracoscopic ablation for lone atrial fibrillation (AF) has evolved rapidly in the past decade. We investigated the electrophysiologic results and midterm durability of totally thoracoscopic ablation in patients with lone persistent AF. METHODS: Seventy-nine consecutive patients with paroxysmal AF (8 patients, 10.1%), persistent AF (17 patients, 21.5%), and long-standing persistent AF (54 patients, 68.3%) were prospectively enrolled. Thoracoscopic ablation consisted of a bilateral closed-chest approach to performing pulmonary isolation (a box lesion), ganglionated plexus ablation, division of the Marshall ligament, and left atrial auricle resection. An electrophysiologic study was performed 5 days after the surgical procedure in 61 patients (77%). Freedom from AF was assessed with electrocardiograms or Holter monitoring every 3 months, with a mean follow-up of 12.1 (maximum, 28) months. RESULTS: No deaths or conversion to cardiopulmonary bypass occurred. During electrophysiologic study, 28 residual pulmonary vein potentials were observed in 15 patients (19%). Out of a total of 28 gaps, 20 (71%) were located in the superior and inferior ridges of pulmonary veins. Six gaps (21%) were detected in the carina of pulmonary veins. The mitral isthmus was ablated in 2 patients (7%). Freedom from AF at 2 years was 92.6 ± 3.3%. Freedom from cardiac-related events at 2 years was 74.7 ± 6.0%. Cox regression analysis demonstrated that the predictors of atrial arrhythmias were old age, hypertension, and left atrial volume index. CONCLUSIONS: Thoracoscopic ablation followed by electrophysiologic confirmation was safe and provided excellent midterm durability in patients with AF. However, the incidence of residual potentials around the pulmonary veins was not negligible.

Effect of substrate modification in catheter ablation of paroxysmal atrial fibrillation: pulmonary vein isolation alone or with complex fractionated electrogram ablation.

Catheter ablation of atrial fibrillation that targets complex fractionated electrogram sites has been widely applied in the management of persistent atrial fibrillation. The clinical outcomes of pulmonary vein isolation alone and pulmonary vein isolation plus the use of complex fractionated electrogram-guided ablation (CFEA) have not been fully compared in patients with paroxysmal atrial fibrillation.This prospective study included 70 patients with symptomatic paroxysmal atrial fibrillation that remained inducible after pulmonary vein isolation. For radio-frequency catheter ablation, patients were nonrandomly assigned to a control group (pulmonary vein isolation alone, Group 1, n=35) or a CFEA group (pulmonary vein isolation plus additional CFEA, Group 2, n=35). The times to first recurrence of atrial tachyarrhythmias were compared between the 2 groups.In Group 2, CFEA rendered atrial fibrillation noninducible in 16 patients (45.7%) and converted inducible atrial fibrillation into inducible atrial flutters in 12 patients (34.3%). Atrial fibrillation remained inducible in 7 patients (20%) after the combined ablation procedures. After a mean follow-up of 23 months, freedom from recurrence of atrial tachyarrhythmias was significantly higher in Group 2 than in Group 1 (P=0.037). In Group 1, all of the recurrent tachyarrhythmias were atrial fibrillation, whereas regular tachycardia was the major mechanism of recurrent arrhythmias in Group 2 (atrial tachycardia or atrial flutter in 5 of 6 patients and atrial fibrillation in 1 patient).We found that CFEA after pulmonary vein isolation significantly reduced recurrent atrial tachyarrhythmia and might modify the pattern of arrhythmia recurrence in patients with paroxysmal atrial fibrillation.

Recurrent polymorphic ventricular tachycardia treated by ablation of Purkinje arborization within an infarct border-zone.

A 70-year-old patient with 3-vessel coronary artery disease and a left ventricular aneurysm underwent coronary artery bypass grafting, together with a surgical anterior ventricular endocardial restoration (SAVER) procedure. Four days later, he suddenly developed recurrent sustained and nonsustained polymorphic ventricular tachycardia, preceded by monomorphic ventricular premature contractions, and did not respond to any antiarrhythmic drug, including lidocaine, esmolol, or amiodarone. Repeated electrical cardioversion procedures were performed (28 in total). Mapping was performed to target the earliest site of activation in the left ventricle during the ventricular premature contractions, a site where the premature beats were preceded by Purkinje potentials. That site was located along a scar border-zone. Ablation at that site resulted in the disappearance of the monomorphic ventricular premature contractions and in the complete suppression of the electrical storm. These findings appear to indicate that the area in which the Purkinje potentials were recorded along the scar border-zone played an important role in the mechanism of the polymorphic ventricular tachycardia after myocardial infarction.

Mechanism of regular atrial tachyarrhythmias during combined pulomonary vein isolation and complex fractionated electrogram ablation in patients with atrial fibrillation.

BACKGROUND: Atrial tachyarrhythmias (ATA) frequently develop during catheter ablation of atrial fibrillation (AF), but the mechanism of ATA during combined pulmonary vein isolation (PVI) and complex fractionated electrogram-guided ablation (CFEA) has not been reported. METHODS AND RESULTS: This study involved 105 patients with symptomatic, drug-refractory AF. After PVI, CFEA was performed in the left/right atrium if AF remained inducible in paroxysmal AF (PAF) or persisted in persistent AF (PeAF). For the 70 PAF patients, PVI alone rendered AF non-inducible in 29 patients (41.4%), and converted inducible AF into inducible atrial flutter (AFl) in 10 patients (14.3%). For the remaining 31 PAF patients, additional CFEA rendered AF non-inducible in 11 patients (15.7%), whereas only AFl was inducible in 11 patients (15.7%). For 35 PeAF patients, PVI and CFEA converted AF into sinus rhythm in 2 (5.7%) and into AFl in 21 (60.0%) patients, while AF persisted in 12 patients (34.3%). The mechanism of ATA was focal (20/114, 17.5%), roof-dependent (20/114, 17.5%), peri-mitral (33/114, 28.9%), cavotricuspid isthmus-dependent (34/114, 29.8%) AFl or unknown (7/114, 6.1%). Successful ablation was achieved in 93/114 (81.6%) tachycardias. CONCLUSIONS: The major mechanism of ATA during the combined approach of PVI and CFEA is macroreentry around large anatomic obstacles such as the pulmonary vein or the mitral or tricuspid annuli.