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Generalizability of the CASTLE-AF trial: Catheter ablation for patients with atrial fibrillation and heart failure in routine practice.

ABSTRACT: BACKGROUND:In the Catheter Ablation for Atrial Fibrillation with Heart Failure (CASTLE-AF) trial, catheter ablation reduced the risk of death and heart failure (HF) hospitalization in patients with atrial fibrillation and HF by 40%. OBJECTIVES:The study aimed to assess the generalizability of CASTLE-AF to routine clinical practice. METHODS:Using a large US administrative database, we identified 289,831 patients with atrial fibrillation and HF treated with ablation (n = 7465) or medical therapy alone (n = 282,366) from January 1, 2008, through August 31, 2018. Patients were divided into 3 groups on the basis of trial eligibility: (1) eligible for CASTLE-AF, (2) failing to meet the inclusion criteria, and (3) meeting at least 1 of the exclusion criteria. Propensity score overlap weighting was used to balance ablated and drug-treated patients on 90 baseline characteristics. Cox proportional hazards regression was used to compare ablation with medical therapy for the primary outcome of a composite end point of all-cause mortality and HF hospitalization. RESULTS:Only 7.8% of patients would have been eligible for the trial; 91.0% failed to meet the trial inclusion criteria; and 15.5% met the exclusion criteria. Ablation was associated with a lower risk of the primary outcome in the overall cohort (hazard ratio [HR] 0.81; 95% confidence interval [CI] 0.76-0.87; P < .001), in the trial-eligible cohort (HR 0.82; 95% CI 0.70-0.96; P = .01), and in patients who failed to meet inclusion criteria (HR 0.79; 95% CI 0.73-0.86; P < .001) but not in patients who met the exclusion criteria (HR 0.97; 95% CI 0.81-1.17). The relative risk reduction was consistent regardless of whether patients had HF with reduced left ventricular ejection fraction. CONCLUSION:The benefit associated with ablation appears to be more modest in practice than that reported in the CASTLE-AF trial.

SUBMITTER: Noseworthy PA

PROVIDER: S-EPMC7648571 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Generalizability of the CASTLE-AF trial: Catheter ablation for patients with atrial fibrillation and heart failure in routine practice.

Noseworthy Peter A PA Van Houten Holly K HK Gersh Bernard J BJ Packer Douglas L DL Friedman Paul A PA Shah Nilay D ND Dunlay Shannon M SM Siontis Konstantinos C KC Piccini Jonathan P JP Yao Xiaoxi X

Heart rhythm 20200304 7

<h4>Background</h4>In the Catheter Ablation for Atrial Fibrillation with Heart Failure (CASTLE-AF) trial, catheter ablation reduced the risk of death and heart failure (HF) hospitalization in patients with atrial fibrillation and HF by 40%.<h4>Objectives</h4>The study aimed to assess the generalizability of CASTLE-AF to routine clinical practice.<h4>Methods</h4>Using a large US administrative database, we identified 289,831 patients with atrial fibrillation and HF treated with ablation (n = 7465 ...[more]

PMID: 32145348

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Project description:ImportanceRenal denervation can reduce cardiac sympathetic activity that may result in an antiarrhythmic effect on atrial fibrillation.ObjectiveTo determine whether renal denervation when added to pulmonary vein isolation enhances long-term antiarrhythmic efficacy.Design, setting, and participantsThe 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.InterventionsPatients 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 measuresThe 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.ResultsOf 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 relevanceAmong 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 registrationClinicalTrials.gov Identifier: NCT01873352.

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Generalizability of the CASTLE-AF trial: Catheter ablation for patients with atrial fibrillation and heart failure in routine practice.

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Generalizability of the CASTLE-AF trial: Catheter ablation for patients with atrial fibrillation and heart failure in routine practice.

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