The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) Trial: clinical rationale, study design, and implementation

Jøns, Christian; Hansen, Peter S.; Johannessen, Arne; Hindricks, Gerhard; Raatikainen, Pekka; Kongstad, Ole; Walfridsson, Håkan; Pehrson, Steen; Almroth, Henrik; Hartikainen, Juha; Petersen, Anders; Mortensen, Leif Spange; Nielsen, Jens Cosedis

doi:10.1093/europace/eup122

Cited by 36 publications

(39 citation statements)

References 9 publications

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“…2,3 Recently, catheter ablation has been proposed as first-line therapy, particularly in younger and healthier patients. 4 Ablation of AF by using strategies that eliminate AF triggers via pulmonary vein isolation produce a single-procedure success of 65% at up to 1 year. 5,6 Because of expanding training programs, the numbers of operators performing this complex procedure are increasing worldwide.…”

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confidence: 99%

In-Hospital Complications Associated With Catheter Ablation of Atrial Fibrillation in the United States Between 2000 and 2010

et al. 2013

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Background-Atrial fibrillation ablation has made tremendous progress with respect to innovation, efficacy, and safety.However, limited data exist regarding the burden and trends in adverse outcomes arising from this procedure. The aim of our study was to examine the frequency of adverse events attributable to atrial fibrillation (AF) ablation and the influence of operator and hospital volume on outcomes. Methods and Results-With the use of the Nationwide Inpatient Sample, we identified AF patients treated with catheter ablation. We investigated common complications including cardiac perforation and tamponade, pneumothorax, stroke, transient ischemic attack, vascular access complications (hemorrhage/hematoma, vascular complications requiring surgical repair, and accidental arterial puncture), and in-hospital death described with AF ablation, and we defined these complications by using validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. An estimated 93 801 AF ablations were performed from 2000 to 2010. The overall frequency of complications was 6.29% with combined cardiac complications (2.54%) being the most frequent. Cardiac complications were followed by vascular complications (1.53%), respiratory complications (1.3%), and neurological complications (1.02%). The in-hospital mortality was 0.46%. Annual operator (<25 procedures) and hospital volume (<50 procedures) were significantly associated with adverse outcomes. There was a small (nonsignificant) rise in overall complication rates. Conclusions-The overall complication rate was 6.29% in patients undergoing AF ablation. There was a significant association between operator and hospital volume and adverse outcomes. This suggests a need for future research into identifying the safety measures in AF ablations and instituting appropriate interventions to improve overall AF ablation outcomes.

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In-Hospital Complications Associated With Catheter Ablation of Atrial Fibrillation in the United States Between 2000 and 2010

et al. 2013

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“…The design of the MANTRA-PAF trial has been described in detail previously [8,9]. In brief, MANTRA-PAF was a multicentre, prospective randomized trial conducted at nine centres in Denmark, Finland, Sweden and Germany.…”

Section: Methodsmentioning

confidence: 99%

“…Recently, it has been suggested that RFA can also be used as first-line treatment in selected patients with paroxysmal AF [6,7]. The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) was the first multicentre, prospective randomized trial, which evaluated the long-term efficacy of an initial strategy of RFA versus antiarrhythmic medication (AAD) as first-line treatment for patients with paroxysmal AF [8,9]. The results of the intention-to-treat analysis of the MANTRA-PAF data showed no significant difference in the cumulative AF burden during follow-up, but at 24 months AF burden was significantly lower and more patients in the RFA than in the AAD group were free of AF [9].…”

Section: Introductionmentioning

confidence: 99%

Radiofrequency catheter ablation maintains its efficacy better than antiarrhythmic medication in patients with paroxysmal atrial fibrillation: On-treatment analysis of the randomized controlled MANTRA-PAF trial

Raatikainen

Hakalahti

Uusimaa

et al. 2015

International Journal of Cardiology

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“…2, 3 Medical therapy is of limited efficacy. 4, 5 Catheter ablation of AF is an important therapeutic modality for patients with AF.…”

Section: Patient Characteristicsmentioning

confidence: 99%

Ipsilateral Circumferential Radiofrequency Ablation of Atrial Fibrillation With Irrigated Tip Catheter

Wójcik

Erkapic

Berkowitsch

et al. 2013

Circ J

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2280WÓJCIK M et al. We present a very long-term outcome and its predictors in a cohort of patients after single ipsilateral circumferential antrum pulmonary vein isolation (PVI) with irrigated tip catheter using uniform approach without 3-D mapping system at a single center. Methods Patient CharacteristicsTo determine long-term outcome, we retrospectively followed a cohort of 356 patients who had PVI performed at Kerckhoff trial fibrillation (AF) is the most common sustained clinical arrhythmia 1 associated with significant morbidity and impaired quality of life. 2,3 Medical therapy is of limited efficacy. 4,5 Catheter ablation of AF is an important therapeutic modality for patients with AF. 4-7The aim of catheter ablation for AF is to eliminate the triggers or substrate that initiate and maintain the disorder, to maintain sinus rhythm. 8 Findings from several multicenter prospective clinical trials, 9-11 systematic reviews, and metaanalyses 4,12-15 have consistently shown that catheter ablation is more effective than anti-arrhythmic drug (AAD) therapy for maintenance of sinus rhythm. 6 Furthermore, successful catheter ablation of AF was associated with improved symptoms and quality of life. 16, 17 The published data suggest that, although sinus rhythm is better preserved after ablation procedures than with AAD, late recurrences are not uncommon. 18 Despite the fact that the re-

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The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) Trial: clinical rationale, study design, and implementation

Abstract: The MANTRA-PAF trial will determine whether catheter-based RFA is superior to optimized AAD therapy as a first-line treatment in suppressing long-term relapse of symptomatic and/or asymptomatic AF.

Cited by 36 publications

References 9 publications

In-Hospital Complications Associated With Catheter Ablation of Atrial Fibrillation in the United States Between 2000 and 2010

In-Hospital Complications Associated With Catheter Ablation of Atrial Fibrillation in the United States Between 2000 and 2010

Radiofrequency catheter ablation maintains its efficacy better than antiarrhythmic medication in patients with paroxysmal atrial fibrillation: On-treatment analysis of the randomized controlled MANTRA-PAF trial

Ipsilateral Circumferential Radiofrequency Ablation of Atrial Fibrillation With Irrigated Tip Catheter

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