Atrial fibrillation: paroxysmal: ablation and a pacemaker controlled symptoms better than drugs in antiarrhythmic-resistant cases.

Clinical bottom line (level 1b)

  1. Patients with recurrent paroxysmal atrial fibrillation and intolerable symptoms who had ablation and pacemaker insertion compared with drug therapy had fewer symptoms (NNT = 1 at 6 months) .
  2. Fewer required hospitalisation or DC cardioversion (NNT = 4 at 6 months) .
  3. However more were in permanent atrial fibrillation (NNH = 4 at 6 months) .
Brignole et al: Circulation 1997; 96 (8): 2617-2624
Expires November 2003

The study

Unblinded ?concealed randomised trial without intention-to-treat
Setting: seven acute hospitals, Italy

43 patients (aged ?, 53% female) recurrent paroxysmal atrial fibrillation (at least three episodes in the last 6 months) and:
  • intolerable severe symptoms including palpitations, dyspnoea, easy fatigue and chest discomfort
  • failure of at least three antiarrhythmics to control symptoms or maintain sinus rhythm


Excluded if
  • aged < 50
  • symptomatic bradycardia in bradycardia-tachycardia form in sick sinus syndrome
  • need for pacemaker other than to control tachyarrhythmia
  • acute clinical disease within previous 6 months
  • associated severe general medical illness


    • Control Group: (n = 21, 18 analysed): treated with antiarrhythmic drug regimen that best controlled symptoms
    Experimental Group: (n = 22, 21 analysed): ablation of AV node and insertion of DDDR permanent pacemaker. Patients discontinued all antiarrhythmics, except digoxin

    93% followed for 6 months
    Outcome notes:
    • permanent AF : present last two months of visit

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    permanent AF 6 months 0
    (0.00%)    		 5
    (23.8%)    		 %
    (% to %)    		 -23.8%
    (-42.0% to -5.59%)    		 -4
    (-18 to -2)
    subjective perception of AF tachyarrhythmia 6 months 16
    (88.9%)    		 4
    (19.1%)    		 79%
    (47% to 91%)    		 69.8%
    (47.6% to 92.0%)    		 1
    (1 to 2)
    hospitalisation or DC cardioversion 6 months 6
    (33.3%)    		 1
    (4.76%)    		 86%
    (-8% to 98%)    		 28.6%
    (4.97% to 52.2%)    		 4
    (2 to 20)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    quality of life score at 6 months (using Minnesota Living with Heart Failure Questionnaire) 43.0
    (22.0)     		20.0
    (16.0)     		23
    (11 to 35)

    Citation

    1. Brignole M, Gianfranchi L, Menozzi C, et al: Assessment of atrioventricular junction ablation and DDDR mode-switching pacemaker versus pharmacological treatment in patients with severely symptomatic paroxysmal atrial fibrillation: a randomized controlled study. Circulation 1997; 96 (8): 2617-2624
    Contributor: Nick Shenker and Chris Ball, November 2000
    Reviewer:

    Clinical Question.
    Patient paroxysmal atrial fibrillation
    Intervention or Exposure ablation and pacemaker insertion
    Comparison drug therapy
    Outcome symptoms, hospitalisation, permanent AF