Global LEADR pivotal trial results.

BACKGROUND: Implantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure™ defibrillation lead is a novel small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform. OBJECTIVE: This trial assessed safety and efficacy of the OmniaSecure defibrillation lead. METHODS: The worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator, all of whom received the study lead. The primary efficacy end point was successful defibrillation at implantation per protocol. The primary safety end point was freedom from study lead-related major complications at 6 months. The primary efficacy and safety objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively. RESULTS: In total, 643 patients successfully received the study lead, and 505 patients have completed 12-month follow-up. The lead was placed in the desired right ventricular location in 99.5% of patients. Defibrillation testing at implantation was completed in 119 patients, with success in 97.5%. The Kaplan-Meier estimated freedom from study lead-related major complications was 97.1% at 6 and 12 months. The trial exceeded the primary efficacy and safety objective thresholds. There were zero study lead fractures and electrical performance was stable throughout the mean follow-up of 12.7 ± 4.8 months (mean ± SD). CONCLUSION: The OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.

Outcomes following persistent atrial fibrillation ablation using localized sources identified with Ripple map.

BACKGROUND: Ablation of persistent atrial fibrillation (AF) remains challenging. Identification and ablation of localized AF drivers may offer the possibility for improved outcomes. Ripple map is a novel software algorithm that may allow improved localization of possible AF drivers through the whole chamber graphical display of continuously recorded bipolar electrograms. The objective of this study was to determine whether regions of high-frequency Ripple activation (HFRA) observed on Ripple map provide useful ablation targets in patients with persistent AF. METHODS AND RESULTS: Consecutive patients underwent the first-time ablation of persistent AF (n = 162) using a standard stepwise (n = 105) or a Ripple map guided approach (n = 57). Ripple map guided patients underwent pulmonary vein antral isolation followed by ablation of HFRA sites. Acute termination of AF was observed in 91.2% of the Ripple-guided patients vs 52.4% in the stepwise approach, P < .0001. Following a single ablation procedure, after 18 months 98.2% of Ripple map guided patients were free of AF, compared with 81.4% of standard stepwise ablation (P = .005). Freedom from atrial tachycardia (54.4% Ripple map vs 52.4% standard, P = .9) or any atrial arrhythmia (52.6% Ripple map vs 39.0% standard, P = .10) did not differ between the two strategies. In a subset analysis (n = 30 of 56), Ripple map regions corresponded to sites with spatiotemporal dispersion in all atrial locations. No differences were observed in the rate of procedural complications. CONCLUSIONS: Ablation of HFRA sites identified with Ripple map resulted in a higher rate of acute termination and improved freedom from AF compared to a standard stepwise approach.

Long-term outcome of patients after successful radiofrequency ablation for typical atrial flutter.

The aim of the study was to determine the long-term freedom from atrial arrhythmias after radiofrequency ablation of atrial flutter and to determine the factors associated with recurrent arrhythmias. Radiofrequency ablation has emerged as the preferred treatment for recurrent, typical atrial flutter. Although the short-term results after radiofrequency ablation of atrial flutter have been widely reported, there is insufficient data on long-term outcome with respect to the occurrence of atrial arrhythmias in patients after successful ablation. The first 108 patients to undergo successful ablation for typical atrial flutter at the authors' institutions were followed prospectively until the occurrence of typical atrial flutter, atrial fibrillation, atypical atrial flutter, or death. Several prespecified clinical and procedural factors were tested using univariate and multivariate analysis as predictors of arrhythmia recurrence. Patients were followed for a minimum of 3 years and a maximum of 8 years, or until the first arrhythmia recurrence (average duration 17 +/- 17 months). Recurrences of typical atrial flutter were usually observed within the first 6 months (73%, n = 16), with the remainder (27%, n = 6) occurring between 6 months and 2 years, and none were observed later. Freedom from recurrence of typical atrial flutter was 80% at 1 year (95% CIs 72-89%), 73% at 2 years (CIs 63-83%), and 73% at 5 years (CIs 63-83%). By contrast, freedom from occurrence of atrial fibrillation or atypical atrial flutter progressively declined over time; 80% at 1 year (CIs 71-88%), 59% at 2 years (CIs 48-70%), and 33% at 5 years (CIs 19-48%). A history of atrial fibrillation or atypical atrial flutter prior to ablation was associated with an increased risk of occurrence during follow-up (relative risk 3.4, CIs 1.5-8.1, P < 0.05). Freedom from occurrence of any atrial arrhythmia was only 27% at 5 years (CIs 15-40%). After successful ablation of typical atrial flutter, recurrence of typical flutter is relatively uncommon and usually occurs early. However, there is a progressive occurrence of atrial fibrillation and/or atypical flutter during follow-up so that many patients require further antiarrhythmic or additional ablative therapy. Radiofrequency ablation of typical atrial flutter should be considered a palliative procedure for most patients and only one component of the long-term care of the patient with atrial tachyarrhythmias.