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Questionable levels of evidence in new atrial fibrillation guidelines?

Hans Van Brabandt, Mattias Neyt, Carl Devos
DOI: http://dx.doi.org/10.1093/europace/eus393 461 First published online: 29 November 2012

We read with interest the 2012 focused update of the ESC Guidelines for the management of atrial fibrillation (AF), and more specifically the recommendations formulated for catheter ablation (CA).1

A class I-level of evidence (LoE) A recommendation is attributed to CA for paroxysmal AF in symptomatic drug-refractory patients. In randomized controlled trials (RCTs), AF recurs off-antiarrhythmic drug (AAD) in one-third of patients, 1 year after a single CA.2,3 We have documented that AF recurs in up to 50% after 2 years, which is in line with other observational studies.4,5 The procedure has a mortality risk of up to 1.5 per thousand,6 and life-threatening complications such as cardiac tamponade or stroke occur in 1–3% of cases.7 Long-term effects beyond 5 years remain unknown. Based on real-world Belgian data, we calculated that one CA–AF on average costs €9600.5 The overall effect of CA–AF is disappointing considering the fact that the primary aim of CA ideally should be to cure AF.8,9

The 2012 guideline upgrades the abovementioned recommendation from class IIa-LoE A to class I-LoE A in patients who prefer rhythm control. This is not supported by new RCT evidence. Moreover, how might patients be able to express such preference? Rhythm control with AADs has not been documented to be superior over rate control.10,11 Furthermore, no single trial has compared CA with rate control in paroxysmal AF.

A class IIA-LoE B recommendation is given to CA as a first-line therapy in selected patients. Two recent RCTs have tested this strategy in paroxysmal AF. In the MANTRA-PAF trial, the cumulative AF burden over 2 years was not significantly different among patients treated with drugs vs. those treated with CA. There was no difference in AF burden between the two study groups at 3, 6, 12, and 18 months. At 2 years, the difference was significant in favour of CA. Symptomatic AF occurred in 6.8% of CA patients vs. in 16.2% in drug-treated patients. In this healthy population, there were three deaths in the ablation group and four deaths in the drug group.12

In the RAAFT-2 trial, patients who underwent CA had a significantly lower risk of a first recurrence of atrial tachyarrhythmia over 21 months (55 vs. 72%). However, there was no significant difference in symptomatic events between the two groups (24% with CA vs. 31% with AADs).13

For CA as first-line treatment, the new guideline upgrades its recommendation from class IIb-LoE B to class IIa-LoE B. In contrast, RCTs indicate that the symptomatic benefit of CA as a first-line treatment is hardly better than an initial treatment with an AAD.

Labelling the abovementioned recommendations with an LoE A/B is misleading since they are not supported by solid evidence. CA–AF is an invasive procedure that is expensive and performs relatively poorly with an unknown long-term effect. Its use should be strictly limited to well-informed and highly symptomatic drug-refractory patients.

Conflict of interest: none declared.


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