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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., (© 2017 American Heart Association, Inc.)

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., (© 2016 American Heart Association, Inc.)

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., (© 2016 American Heart Association, Inc.)

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., (© 2016 American Heart Association, Inc.)

Background: In the meantime, catheter ablation is widely used for the treatment of persistent atrial fibrillation (AF). There is a paucity of data about long-term outcomes. This study evaluates (1) 5-year single and multiple procedure success and (2) prognostic factors for arrhythmia recurrences after catheter ablation of persistent AF using the stepwise approach aiming at AF termination., Methods and Results: A total of 549 patients with persistent AF underwent de novo catheter ablation using the stepwise approach (2007-2009). A total of 493 patients were included (Holter ECGs ≥ every 6 months). Mean follow-up was 59 ± 16 months with 2.1 ± 1.1 procedures per patient. Single and multiple procedure success rates were 20.1% and 55.9%, respectively (80% off antiarrhythmic drug). Antiarrhythmic drug-free multiple procedure success was 46%. Long-term recurrences (n=171) were paroxysmal AF in 48 patients (28%) and persistent AF/atrial tachycardia in 123 patients (72%). Multivariable recurrent event analysis revealed the following factors favoring arrhythmia recurrence: failure to terminate AF during index procedure (hazard ratio [HR], 1.279; 95% confidence interval [CI], 1.093-1.497; P = 0.002), number of procedures (HR, 1.154; 95% CI, 1.051-1.267; P = 0.003), female sex (HR, 1.263; 95% CI, 1.027-1.553; P = 0.027), and the presence of structural heart disease (HR, 1.236; 95% CI, 1.003-1.524; P = 0.047). AF termination was correlated with a higher rate of consecutive procedures because of atrial tachycardia recurrences (P = 0.003; HR, 1.71; 95% CI, 1.20-2.43)., Conclusions: Catheter ablation of persistent AF using the stepwise approach provides limited long-term freedom of arrhythmias often requiring multiple procedures. AF termination, the number of procedures, sex, and the presence of structural heart disease correlate with outcome success. AF termination is associated with consecutive atrial tachycardia procedures., (© 2015 American Heart Association, Inc.)

Background: The role of subsequent atrial tachycardias (AT) in the context of persistent atrial fibrillation (AF) remains undetermined. This study evaluated the prognostic role of subsequent ATs for arrhythmia recurrences after catheter ablation of persistent AF., Methods and Results: A total of 110 patients with persistent AF (63±9 years; 22 women; 61 long-lasting persistent AF) underwent pulmonary vein isolation followed by electrogram-guided ablation. After AF terminated to AT, patients were separated by the randomization protocol to receive either direct cardioversion (group A) or further ablation of subsequent ATs to sinus rhythm (group B). After a mean follow-up of 20.1±13.3 months after the first procedure, significantly more group B patients were in sinus rhythm as compared with patients in group A (30 [57%] versus 18 [34%]; P=0.02). Moreover, recurrences of AF were significantly less frequent of group B than in group A patients (10 [19%] versus 26 [49%]; P=0.001). After the last procedure (follow-up, 34.0±6.4 months), significantly more group B patients were free of AF as compared with patients of group A (49 [92%] versus 39 [74%]; P=0.01). The proportion of AT recurrences did not differ between the 2 groups after the first and final procedures. The strongest predictor for an arrhythmia-free survival after a single procedure was randomization to the procedural end point of termination to sinus rhythm by elimination of subsequent ATs (P=0.004)., Conclusions: Catheter ablation of subsequent ATs increases freedom from AF but not AT, suggesting a contributing role of subsequent ATs in the mechanisms of persistent AF., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01896570.

Background: Recently, subcutaneous implantable cardioverter-defibrillator (S-ICD) has become available. The aim of our study was to assess the efficacy of S-ICD in a clinical setting., Methods and Results: Between June 2010 and July 2011, 40 consecutive patients (42 ± 15 years; body mass index, 27 ± 6 kg/m(2); left ventricular ejection fraction, 47 ± 15%; 28 men) received an S-ICD for primary (n=17) or secondary prevention (n=23 [58%]) at 3 institutions in Germany. Intraoperative defibrillation efficacy testing failed in 1 patient with severely reduced left ventricular ejection fraction; testing was effective in all other patients. All episodes stored in the S-ICD were analyzed for appropriate and inappropriate detection, as well as effective shock delivery to convert ventricular tachyarrhythmia into sinus rhythm. During a median follow-up of 229 (interquartile range, 116-305) days, 4 patients experienced 21 episodes, with correct detection of ventricular tachyarrhythmia and subsequent shock therapy. A total of 28 shocks were delivered in these 4 patients. Mixed logistic regression modeling revealed a shock efficacy of 96.4% (95% CI, 12.8%-100%). The efficacy of first shocks, however, was only 57.9% (95% CI, 35.6%-77.4%). Four episodes were incorrectly classified as ventricular tachyarrhythmia, which led to inappropriate shock delivery in 2 patients., Conclusions: Ineffective shock delivery may occur in patients with S-ICD, even after successful intraoperative testing. Multicenter trials are required with close monitoring of safety and efficacy end points to identify patients who may be at risk for shock failure.

Background: Termination of persistent atrial fibrillation (AF) can be achieved through ablation, with the majority of patients terminating to an atrial tachycardia (AT) and fewer directly to sinus rhythm (SR). We aimed to identify potential predictors for the existence of a substrate for AT on termination to SR., Methods and Results: We assessed 95 persistent AF patients (age, 60+/-10 years) who underwent catheter ablation to the end point of AF termination. Forty patients terminated directly to SR (SRterm) and 55 to ATs (ATterm). Compared with the ATterm group, the SRterm group were younger (56+/-10 versus 63+/-9 years, P=0.001), had shorter durations of AF before ablation (9+/-26 versus 14+/-20 months, P<0.001), smaller left atrial diameters (41+/-5 versus 45+/-5 mm, P=0.015), and longer baseline AF cycle lengths (178+/-23 versus 159+/-31 ms, P=0.005). However, AF cycle length was the sole independent predictor of direct termination to SR. The most frequent AF termination site in SRterm patients was the pulmonary veins (53%), whereas in ATterm patients this was within the left atrium (58%). After follow-up of 12+/-6 months, there was a trend toward a greater proportion of patients in SR among those who terminated directly to SR after a single procedure. The most frequent type of recurrence was paroxysmal AF in SRterm patients and AT in ATterm patients., Conclusions: Patients who terminate to SR through ablation without an intermediate AT are characterized by a less altered arrhythmogenic substrate. Baseline AF cycle lengths emerged as a sole independent predictor of a substrate for consecutive arrhythmias.

Background: Atrial tachycardias (AT) often occur after ablation of long-lasting persistent AF (CAF) and are difficult to treat conservatively. This study evaluated mechanisms and success rates of conventional mapping and catheter ablation of recurrent ATs occurring late after stepwise ablation of CAF., Methods and Results: A total of 320 patients underwent de novo ablation of CAF using a stepwise ablation approach in 2006 to 2007 at our institution. This study comprised patients who presented with recurrent ATs at their first redo procedure after initial de novo CAF ablation. All procedures were guided by conventional mapping techniques exclusively. Sixty-one patients (63+/-10 years, 14 women) presented with their clinical AT at their redo procedure 7.7+/-4.4 months after initial de novo CAF ablation. A total of 133 ATs (2.2+/-0.9 per patient) were mapped. Forty-four (72%) were due to reentry; 17 (28%) were focal ATs. Reentry ATs were mainly characterized as roof and perimitral flutter (43% and 34%, respectively). Focal ATs mainly originated from the great thoracic veins (pulmonary veins: 41%, coronary sinus: 23%). Forty-five (74%) patients had conduction recovery of at least 1 pulmonary vein (mean, 1.2+/-0.8). Overall, 124 (93%) ATs could be ablated successfully. The mean procedure duration was 181+/-59 minutes, with a mean fluoroscopy time of 45+/-21 minutes. After a mean follow-up of 21+/-4 months, 50 (82%) patients were free of any arrhythmia recurrences after a single redo procedure., Conclusions: Although late recurrent ATs may have complex mechanisms, catheter ablation guided exclusively by conventional techniques is highly effective with excellent acute and long-term success rates.

Background: Termination of chronic atrial fibrillation (CAF) can be achieved by catheter ablation using a stepwise approach. However, there are limited data on the contribution of the right atrium to the CAF process. Furthermore, the prognostic value of CAF termination remains unclear., Methods and Results: Eighty-eight patients (61+/-10 years of age) underwent de novo ablation of CAF in 2006 at our institution. The ablation procedure was performed sequentially in the following order: pulmonary vein isolation, defragmentation of the left atrium, coronary sinus, and right atrium. Attempted procedural end point was termination of CAF. Consecutive arrhythmias occurring after AF termination were mapped, and ablation was attempted. AF termination was achieved in 68 (77%) patients: in 37 (55%) patients it occurred in the left atrium, in 18 (26%) patients in the right atrium, and in 13 (19%) patients in the coronary sinus. In 54 patients, at least one redo was performed (total number of procedures: 154). After the first redo, another 30 patients were in sinus rhythm (total 63), 8 patients were in atrial tachycardia (AT), and 17 patients were in AF. Another 11 patients underwent a second redo. After a mean follow-up of 20+/-4 months, 71 (81%) patients were in sinus rhythm, 1 (1%) patient was in AT, and 16 (18%) patients were in AF. Patients with CAF termination had predominantly ATs as recurrent arrhythmias (83%), whereas those without mainly presented with recurrent CAF (85%). The overall success rate in patients with CAF termination was 95% compared with 5% of patients without CAF termination in 2 procedures (n=12). In almost all redo procedures attributable to AT, at least 1 AT during redo was documented previously., Conclusions: AF termination is a prognostic important end point of catheter ablation for CAF. Termination of AF was achieved in both atria and the coronary sinus, suggesting a biatrial substrate of CAF. Subsequent arrhythmias often recur during follow-up and, therefore, should be targeted for ablation.