Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial.

Importance: Renal denervation can reduce cardiac sympathetic activity that may result in an antiarrhythmic effect on atrial fibrillation. Objective: To determine whether renal denervation when added to pulmonary vein isolation enhances long-term antiarrhythmic efficacy. Design, Setting, and Participants: The Evaluate Renal Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF) trial was an investigator-initiated, multicenter, single-blind, randomized clinical trial conducted at 5 referral centers for catheter ablation of atrial fibrillation in the Russian Federation, Poland, and Germany. A total of 302 patients with hypertension despite taking at least 1 antihypertensive medication, paroxysmal atrial fibrillation, and plans for ablation were enrolled from April 2013 to March 2018. Follow-up concluded in March 2019. Interventions: Patients were randomized to either pulmonary vein isolation alone (n = 148) or pulmonary vein isolation plus renal denervation (n = 154). Complete pulmonary vein isolation to v an end point of elimination of all pulmonary vein potentials; renal denervation using an irrigated-tip ablation catheter delivering radiofrequency energy to discrete sites in a spiral pattern from distal to proximal in both renal arteries. Main Outcomes and Measures: The primary end point was freedom from atrial fibrillation, atrial flutter, or atrial tachycardia at 12 months. Secondary end points included procedural complications within 30 days and blood pressure control at 6 and 12 months. Results: Of the 302 randomized patients (median age, 60 years [interquartile range, 55-65 years]; 182 men [60.3%]), 283 (93.7%) completed the trial. All successfully underwent their assigned procedures. Freedom from atrial fibrillation, flutter, or tachycardia at 12 months was observed in 84 of 148 (56.5%) of those undergoing pulmonary vein isolation alone and in 111 of 154 (72.1%) of those undergoing pulmonary vein isolation plus renal denervation (hazard ratio, 0.57; 95% CI, 0.38 to 0.85; P = .006). Of 5 prespecified secondary end points, 4 are reported and 3 differed between groups. Mean systolic blood pressure from baseline to 12 months decreased from 151 mm Hg to 147 mm Hg in the isolation-only group and from 150 mm Hg to 135 mm Hg in the renal denervation group (between-group difference, -13 mm Hg; 95% CI, -15 to -11 mm Hg; P < .001). Procedural complications occurred in 7 patients (4.7%) in the isolation-only group and 7 (4.5%) of the renal denervation group. Conclusions and Relevance: Among patients with paroxysmal atrial fibrillation and hypertension, renal denervation added to catheter ablation, compared with catheter ablation alone, significantly increased the likelihood of freedom from atrial fibrillation at 12 months. The lack of a formal sham-control renal denervation procedure should be considered in interpreting the results of this trial. Trial Registration: ClinicalTrials.gov Identifier: NCT01873352.

Performance of the ablation index during pulmonary vein isolation: periprocedural data from a multicenter registry.

PURPOSE: Our study aimed to assess the achievement of target ablation index (AI) values and their impact on first-pass pulmonary vein isolation (FPI) as well as to identify FPI predictors. METHODS: Atrial fibrillation (AF) ablation was performed according to the local practice, and target AIs were evaluated. The actual AI was calculated as the median value of all ablation points for the anterior and posterior left atrial (LA) walls. RESULTS: A total of 450 patients from nine centers were enrolled. Patients with first-time ablation (n = 408) were divided into the FPI and non-FPI groups. In the FPI group, a higher median target AI was reported for both the anterior and posterior LA walls than those in the non-FPI group. A higher actual AI was observed for the anterior LA wall in the FPI group. The actual AI was equal to or higher than the target AI for the posterior, anterior, and both LA walls in 54%, 47%, and 35% (n = 158) cases, respectively. Parameters such as hypertension, stroke, ablation power, actual AI value on the anterior wall, target AI values on both LA walls, AI achievement on the posterior wall, carina ablation, and operator experience were all associated with FPI in a univariate logistic regression model; only carina ablation was an independent predictor of FPI. CONCLUSIONS: According to our multicenter study, FPI and a target AI were not achieved in a significant proportion of AF ablation procedures. Higher actual and target AI values were associated with FPI, but only carina ablation can independently predict FPI.

Effect of left atrial appendage excision on procedure outcome in patients with persistent atrial fibrillation undergoing surgical ablation.

BACKGROUND: Catheter ablation is less successful for treatment of persistent atrial fibrillation (PersAF) than for paroxysmal atrial fibrillation. Some studies suggest that left atrial appendage (LAA) isolation in addition to pulmonary vein isolation (PVI) is required to maximize the benefits for PersAF after ablation. OBJECTIVE: The purpose of this study was to compare the efficacy and safety of 2 surgical ablation approaches for PersAF via video-assisted thoracoscopy: PVI + box lesion and PVI + box lesion + LAA excision. METHODS: We randomly assigned 176 patients with PersAF to video-assisted thoracoscopic surgical ablation with PVI + box lesion (88 patients) or PVI + box lesion + LAA excision (88 patients). The primary endpoint was freedom from any documented atrial arrhythmia lasting >30 seconds after a single ablation procedure without antiarrhythmic drug (AAD). RESULTS: After 18 months of follow-up, 61 of 86 patients (70.9%) assigned to PVI + box lesion were free from recurrent atrial fibrillation compared to 64 of 87 patients (73.6%) assigned to PVI + box lesion + LAA excision after a single ablation procedure without AAD (P = .73). Freedom from any atrial arrhythmia after a single procedure with or without AAD was also nonsignificant (70.9% vs 74.7%, respectively). There were no significant differences between groups with regard to adverse events, including death, transient ischemic attack, stroke, pneumothorax, and hydrothorax. CONCLUSION: Among patients with PersAF, no reduction in the rate of recurrent atrial fibrillation was found when LAA excision was performed in addition to PVI and box lesion during surgical ablation.