Introduction: This is a multicenter, prospective, randomized controlled trial to determine the effect of add-on arrhythmia surgery on health-related quality of life during 1-year follow-up of cardiac surgery patients with atrial fibrillation.
Methods: 150 patients with documented atrial fibrillation were randomly assigned to undergo cardiac surgery with or without add-on surgery. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6, and 12 months following operation.
Results: 132 patients completed the questionnaires at a minimum of one time-point during follow-up. At baseline patient characteristics, operative data and health-related quality of life were comparable. At 12-month follow-up 62 patients were free of atrial fibrillation without significant differences between groups (P = 0.28). Conversion to SR occurred in 69.8% (37/53) of patients with paroxysmal AF, in 28.2% (11/39) of patients with permanent AF and in 44.4% (12/27) of patients in persistent AF. Cardiac surgery in general resulted in an overall improvement of the RAND SF-36 and the MFI-20. However, the EQ-5D showed a significant deterioration in the subscale Pain/Discomfort for both groups (P < 0.001), with a significant worse outcome for the control group (P = 0.006).
Conclusions: Health-related quality of life in patients with paroxysmal, permanent and persistent atrial fibrillation improves after cardiac surgery regardless of giving add-on surgery or not, but this improvement is presumably more affected by treating the underlying heart disease than by restoring sinus rhythm.
Trial registration: ClinicalTrials.gov NCT00886080.