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Background Fingolimod can lead to increased risk of cardiac events such as bradycardia or atrioventricular (AV) block. Objective Evaluate acute and long-term effects of fingolimod on heart rhythm (HR), heart rate variability (HRV) and development of AV-blocks. Methods In 64 patients with relapsing–remitting multiple sclerosis Holter ECG monitoring (HEM) and HRV analysis were performed 24 h before, six h during and 72 h after initiation of fingolimod. We additionally analyzed a 24 h HEM after a follow up of ≥ three months. Results Heart rate (HR) decreased significantly (p < 0.001) under fingolimod treatment with nadir at five hours after starting and maintained decreased for 72 h. Five (7.8%) patients suffered from new-onset AV-block requiring cessation of treatment. In four of five patients (80%), the AV-block could only be documented in the 72 h-HEM with a median time of occurrence at 14 h. The mean heart rate was still significant lower after a mean follow up time of 14.1 ± 9.6 months (85.0 ± 9.8 vs. 75.3 ± 16.2 bpm; p = 0.002) in comparison to baseline. Conclusion The treatment with fingolimod leads to an increase of vagal activation which persists even after 14 months of treatment. These changes did not return to baseline levels on treatment with fingolimod. Based on our data an additional at least 24 h hour-HEM after the initiation of fingolimod therapy should be considered. [ABSTRACT FROM AUTHOR]

Background: The implantable cardioverter-defibrillator (ICD) is the standard therapy to prevent sudden cardiac death in patients with coronary artery disease and unstable ventricular tachyarrhythmias. The prospective multinational SMS (Substrate Modification Study) was designed to assess whether prophylactic ablation of the arrhythmogenic substrate reduces or prevents the recurrence of ventricular tachycardia/ventricular fibrillation in such patients.Methods and Results: Of 111 patients included in an intention-to-treat analysis, 54 were randomly assigned catheter ablation plus ICD implantation (ablation group: 68±8 years; 47 men), whereas 57 were assigned ICD implantation without catheter ablation (ICD-only group: 66±8 years; 46 men). Primary study end point was the time to first recurrence of ventricular tachycardia/ventricular fibrillation. ICD episodes were assessed and verified by an independent board. Patients were followed up for 2.3±1.1 years. The primary end point was reached by 25 ablation patients and 26 ICD-only patients. Two-year event-free survival was estimated at 49.0% (95% confidence interval, 33.3%-62.9%) in the former and 52.4% (36.7%-65.9%) in the latter groups. Comparison of episode incidence revealed no significant difference in the primary end point (P=0.84). In an Andersen-Gill regression model with multiple end point recurrences, the difference between the study arms significantly favored catheter ablation for both the primary end point and all but one of the predefined subgroups of detected arrhythmia events.Conclusions: SMS failed to meet the primary end point of time to first ventricular tachycardia/ventricular fibrillation recurrence. However, catheter ablation did reduce the total number of ICD interventions during the duration of follow-up.Clinical Trial Registration: https://clinicaltrials.gov. Unique identifier: NCT00170287. [ABSTRACT FROM AUTHOR]

Background: Early recurrences (ERs) of atrial tachyarrhythmia are common after catheter ablation of atrial fibrillation. A 3-month blanking period is recommended by current guidelines. This study sought to investigate the significance of ER during the first 3 months post ablation in predicting late recurrences and determine whether it varies according to timing.Methods and Results: A total of 401 patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation were followed for 12 months with transtelephonic monitoring in the ADVICE (Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination) trial. Patients with atrial tachyarrhythmia ≥30 s within the 3-month blanking period were stratified according to the timing of ER. A total of 179 patients (44.6%) experienced their last episode of ER during the first (n=53), second (n=44), or third (n=82) month of the 3-month blanking period. One-year freedom from symptomatic atrial tachyarrhythmia was 77.2% in patients without ER compared with 62.6%, 36.4%, and 7.8% in patients with ER 1, 2, and 3 months post ablation, respectively (P<0.0001). Receiver operating curve analyses revealed a strong correlation between the timing of ER and late recurrence (area under the curve 0.82, P<0.0001). Corresponding hazard ratios for ER during the first, second, and third months were 1.84, 4.45, and 9.64, respectively.Conclusions: This study validates the use of a blanking period after catheter ablation for paroxysmal atrial fibrillation but calls into question the 90-day cut-off value. In particular, >90% of patients with ER during the third month post ablation experience late recurrence by 1 year. However, pending further study, repeat ablation before 90 days cannot be routinely advocated.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01058980. [ABSTRACT FROM AUTHOR]

Background: The success rate of catheter ablation for persistent atrial fibrillation (AF) is still far from satisfactory. Identification of patients who will benefit from ablation is highly desirable. We investigated the predictive value of noninvasive AF complexity parameters derived from standard 12-lead ECGs for AF termination and long-term success of catheter ablation and compared them with clinical predictors.Methods and Results: The study included a training (93 patients) and a validation set (81 patients) of patients with persistent AF undergoing stepwise radiofrequency ablation. In the training set AF terminated in 81% during catheter ablation, 77% were in sinus rhythm after 6 years and multiple ablations. ECG-derived complexity parameters were determined from a baseline 10-s 12-lead ECG. Prediction of AF termination was similar using only ECG (cross-validated mean area under the curve [AUC], 0.76±0.15) or only clinical parameters (mean AUC, 0.75±0.16). The combination improved prediction to a mean AUC of 0.79±0.13. Using a combined model of ECG and clinical parameters, sinus rhythm at long-term follow-up could be predicted with a mean AUC of 0.71±0.12. In the validation set AF terminated in 57%, 61% were in sinus rhythm after 4.6 years. The combined models predicted termination with an AUC of 0.70 and sinus rhythm at long-term follow-up with an AUC of 0.61. Overall, fibrillation-wave amplitude provided the best rhythm prediction.Conclusions: The predictive performance of ECG-derived AF complexity parameters for AF termination and long-term success of catheter ablation in patients with persistent AF is at least as good as known clinical predictive parameters, with fibrillation-wave amplitude as the best predictor. [ABSTRACT FROM AUTHOR]

Background: Ablation of atrial fibrillation (AF) is an established treatment option for symptomatic patients. It is not known whether complete pulmonary vein isolation (PVI) is superior to incomplete PVI with regard to the patients' clinical outcome.Methods and Results: Patients with drug-refractory, symptomatic paroxysmal AF were randomly assigned to either incomplete (group A) or complete PVI (group B). In group A, a persistent gap was intentionally left within the circumferential ablation line, whereas in group B, complete PVI without any gaps was intended. At 3 months, all patients underwent invasive reevaluation to assess the rate of persistent PVI. Clinical follow-up was based on daily 30-s transtelephonic ECG transmissions. Primary study end point was the time to first recurrence of (symptomatic or asymptomatic) AF. A total of 233 patients were enrolled (116 in group A and 117 in group B). AF recurrence within 3 months was observed in a total of 161 patients (136 [84.5%] with symptomatic and 25 [15.5%] with asymptomatic AF); AF recurred in 62.2% of group B patients and 79.2% of group A patients (P<0.001), for a difference in favor of complete PVI of 17.1% (95% confidence interval, 5.3%-28.9%). Invasive restudy in 103 group A patients and 93 group B patients revealed conduction gaps in 92 (89.3%) and 65 (69.9%) patients, respectively.Conclusions: This study proves the superiority of complete PVI over incomplete PVI with respect to AF recurrence within 3 months. However, the rate of electric reconduction 3 months after PVI is high in patients with initially isolated PVs.Clinical Trial Registration: URL: http://clinicaltrials.gov; Unique identifier: NCT00293943. [ABSTRACT FROM AUTHOR]

Background: Single procedure success rates of pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF) are still unsatisfactory. In patients with persistent atrial fibrillation (AF), ablation of complex fractionated atrial electrograms (CFAEs) after PVI results in improved outcomes.Objective: We aimed to investigate if PAF-patients with intraprocedurally sustained AF after PVI might benefit from additional CFAE ablation.Methods: A total of 1134 consecutive patients underwent a first catheter ablation procedure of PAF between June 2008 and December 2012. In most patients, AF was either not inducible or terminated during PVI. In 68 patients (6%), AF sustained after successful PVI. These patients were randomized to either cardioversion (PVI-alone group; n = 33) or additional CFAE ablation (PVI+CFAE group; n = 35) and followed up every 1-3 months and serial Holter recordings were also obtained. The primary end point was the recurrence of AF/atrial tachycardia (AT) after a blanking period of 3 months.Results: Procedure duration (127 ± 6 minutes vs 174 ± 10 minutes), radiofrequency application time (44 ± 3 minutes vs 74 ± 5 minutes), and fluoroscopy time (26 ± 2 minutes vs 41 ± 3 minutes) were longer in the PVI+CFAE group (all P < .001). In 30 of 35 patients (86%) in the PVI+CFAE group, ablation terminated AF. There was no significant group difference with respect to freedom from AF/AT (22 of 33 [67%] vs 22 of 35 [63%]; P = .66). Subsequently, 10 of 11 patients in the PVI-alone group (91%) and 11 of 13 patients in PVI+CFAE group (85%) underwent repeat ablation (P = 1.00). Overall, 29 of 33 [88%] vs 30 of 35 [86%] patients (P = 1.00) were free from AF/AT after 1.4 ± 0.1 vs 1.4 ± 0.2 (P = .87) procedures.Conclusion: Patients with sustained AF after PVI in a PAF cohort are rare. Regarding AF/AT recurrence, these patients did not benefit from further CFAE ablation compared to PVI alone, but are exposed to longer procedure duration, fluoroscopy time, and radiofrequency application time. [ABSTRACT FROM AUTHOR]

The article assesses the efficacy of subcutaneous implantable cardioverter-defibrillator (S-ICD) in a clinical setting. It informs that ICD therapy is established as the best option to prevent sudden cardiac death due to ventricular tachyarrythmia. It concludes that ineffective shock delivery may occur in patients with S-ICD even after successful intraoperative testing. The article also suggests that multicenter trials are required with close monitoring of safety and efficacy end points.

Background: Stepwise ablation is an effective treatment for persistent atrial fibrillation (AF), although it often requires multiple procedures to eliminate recurrent arrhythmias. Objective: This study evaluated single- and multiple-procedure long-term success rates and potential predictors of a favorable single-procedure outcome of stepwise ablation for persistent AF. Methods: This study comprised 395 patients with persistent AF (duration 16 months) undergoing de novo catheter ablation using the stepwise approach. Procedural success was defined as the absence of any arrhythmia recurrence. Patient characteristics and electrophysiological parameters were analyzed with respect to single- and multiple-procedure outcomes. Results: After a follow-up of 27 ± 7 months, 108 (27%) patients were free of arrhythmia recurrences with a single procedure. After 2.3 ± 0.6 procedures, 312 (79%) patients were free of arrhythmia with concomitant antiarrhythmic treatment in 38% (23% on β-blocker). Female gender, duration of persistent AF, and congestive heart failure were predictive for the outcome after first ablation. However, the strongest predictors for single-procedure success were longer baseline AF cycle length (CL) and procedural AF termination. Moreover, procedural AF termination during the index procedure also predicted a favorable outcome after the last procedure, while the existence of congestive heart failure was associated with an increased risk for eventual arrhythmia recurrences. Conclusions: Single-procedure long-term success is anticipated in approximately a quarter of patients undergoing de novo ablation of persistent AF. Baseline AFCL emerged as the strongest predictor of single-procedure success, while AF termination during index ablation predicts the overall outcome. However, an overall success rate of 79% is achievable with multiple procedures. [ABSTRACT FROM AUTHOR]

Background: Catheter ablation (CA) is considered the treatment of choice for patients with atrioventricular nodal reentrant tachycardia (AVNRT). However, there is a tendency to avoid CA in the elderly because of a presumed increased risk of periprocedural atrioventricular (AV) nodal block. Objective: The purpose of this prospective registry was to assess age-related differences in the efficacy and safety of CA within a large population with AVNRT. Methods: A total of 3,234 consecutive patients from 48 German trial centers who underwent CA of AVNRT between March 2007 and May 2010 were enrolled in this study. The cohort was divided into three age groups: <50 years (group 1, n = 1,268 [39.2%]; median age = 40 [30.0–45.0] years, 74.1% women), 50–75 years old (group 2, n = 1,707 [52.8%]; 63.0 [58.0–69.0] years, 63.0% women), and > 75 years old (group 3, n = 259 [8.0%]; 79.0 [77.0–82.0] years, 50.6% women). Results: CA was performed with radiofrequency current (RFC) in 97.7% and cryoablation technology in 2.3% of all cases. No differences were observed among the three groups with regard to primary CA success rate (98.7% vs. 98.8 % vs. 98.5%; P = .92) and overall procedure duration (75.0 minutes [50.0–105.0]; P = .93). Hemodynamically stable pericardial effusion occurred in five group 2 (0.3%) and two group 3 (0.8%) patients but in none of the group 1 (P <.05) patients. Complete AV block requiring permanent pacemaker implantation occurred in two patients in group 1 (0.2%) and six patients in group 2 (0.4%) but none in group 3 (P = 0.41). During a median follow-up period of 511.5 days (396.0–771.0), AVNRT recurrence occurred in 5.7% of all patients. Patients >75 years (group 3) had a significantly longer hospital stay (3.0 days [2.0–5.0]) compared with group 1 (2.0 days [1.0–2.0]) or group 2 (2.0 days [1.0–3.0]) patients (P <.0001). Conclusion: CA of AVNRT is highly effective and safe and does not pose an increased risk for complete AV block in patients over 75 years of age, despite a higher prevalence of structural heart disease. Antiarrhythmic drug therapy is often ineffective in this age group; thus, CA for AVNRT should be considered the preferred treatment even in elderly patients. [Copyright &y& Elsevier]

The article discusses a study which examined the mechanisms and success rates of conventional mapping and catheter ablation of recurrent atrial tachycardias (AT) after stepwise ablation of long-lasting persistent atrial fibrillation (CAF). The study included 320 patients who underwent de novo ablation of CAF using a stepwise ablation in 2006 and 2007. Study authors concluded that catheter ablation guided by conventional techniques is an effective treatment approach to late recurrent AT.

The article presents a study on the acute success rates of termination of chronic atrial fibrillation (CAF) using a sequential ablation approach and on the contribution of the right atrium to the CAF process. The results of the study showed that atrial fibrillation termination is a prognostic crucial end point of catheter ablation for CAF. It also mentions that subsequent arrythmias requently recur during follow-up, thus, should be targeted for ablation.

Background: Conventional catheter ablation for common-type atrial flutter (AFL) is a widely established therapy but has not been compared with the use of a robotic navigation system (RNS) thus far. Objectives: The purpose of this study was to investigate the feasibility of a new, nonmagnetic RNS with regard to safety, efficacy, and X-ray exposure to investigator and patient compared with the conventional ablation approach in patients with AFL. Methods: Fifty patients (65.7 ± 9.3 years, 40 male) undergoing de novo catheter ablation for AFL were randomly assigned to conventional or RNS-guided cavotricuspid isthmus (CTI) ablation. Results: Complete bidirectional isthmus block was achieved for all patients without occurrence of procedure-related complications. The fluoroscopy time and the investigator X-ray exposure (8.2 ± 4.6 vs. 5.8 ± 3.6, P = .038; and 8.2 ± 4.6 vs. 1.9 ± 1.1 minutes, P<.001) as well as the mean radiofrequency (RF) duration and the energy delivered were significantly higher in the conventional than in the RNS group (321.7 ± 214.6 vs. 496.4 ± 213.9 seconds, P = .006; 8279 ± 5767 vs. 16,308 ± 6870 J, P<.001, respectively). The overall procedure time in the RNS group was significantly longer than in the conventional group (79.2 ± 30.6 vs. 58.4 ± 17.7 minutes; P = .04) but significantly decreased comparing the first 10 with the last 10 patients in the RNS group (105.3 ± 34.8 vs. 60.6 ± 6.3 minutes; P = .003). Starting ablation during AFL, bidirectional block instantly after termination was observed in 90% of the RNS and 50% of the conventionally treated patients (P = .03). Conclusion: The present study demonstrates the safety and feasibility of RNS for performing CTI ablation in patients with common-type AFL for use in the clinical routine. As a result of the remote navigation, X-ray exposure and RF duration to achieve bidirectional block were significantly decreased and occurred more often immediately after AFL termination. These findings are consistent with increased catheter stability and RF application efficacy using RNS compared with conventional catheter manipulation. [Copyright &y& Elsevier]