Surgical treatment for secundum atrial septal defects in patients > 40 years old - A randomized clinical trial

OBJECTIVES We prospectively examined whether surgical treatment of secundum atrial septal defects (ASDs) in patients greater than or equal to 40 years old improves their long-term clinical outcome. BACKGROUND Surgical treatment of secundum ASDs in adults >40 years old is a subject of controversy because of the perception of good long-term clinica l outcomes in patients with unrepaired ASDs and the lack of data from rando mized trials. METHODS We recruited 521 patients >40 years old with secundum ASDs referred for treatment; 48 were excluded. Patients were randomly assigned to surgic al closure (n = 232) or medical treatment (n = 241). The primary and second ary end points were a composite of major cardiovascular events (death, pulm onary embolism, major arrhythmic event, embolic cerebrovascular event, recu rrent pulmonary infection, functional class deterioration or heart failure) and overall mortality, respectively. We assessed possible prognostic marke rs. The analysis was performed on an intention-to-treat basis. RESULTS The median follow-up period was 7.3 years (range 2 to 13). The risk of having the primary end point was significantly higher in the medical gr oup, which had a univariate hazards ratio of 1.99 (95% confidence interval [Cl] 1.23 to 3.22) and a multivariate hazards ratio of 1.85 (95% CI 1.08 to 3.17). Although the survival analysis did not reveal differences in overal l mortality between the surgical and medical treatments (hazards ratio 1.71 , 95% CI 0.76 to 3.86), the multivariate analysis, adjusted by age at entry , mean pulmonary artery pressure and cardiac index, demonstrated significan t differences between the study groups (hazards ratio 4.09, 95% CI 1.41 to 11.89). CONCLUSIONS Surgical closure was superior to medical treatment in improving both the composite of major cardiovascular events and overall mortality in patients >40 years old with secundum ASDs. This superiority was related to the mean pulmonary artery pressure, age at diagnosis and cardiac index. Be cause of the higher risk of morbidity and mortality, we believe that anatom ic closure should always be attempted as the initial treatment for ASDs in adults >40 years old with pulmonary artery systolic pressure <70 mm Hg and a pulmonary/systemic output ratio <greater than or equal to>1.7. The operat ion must be performed as soon as possible, even if the symptoms or the hemo dynamic impact seems to be minimal. (J Am Coll Cardiol 2001;38:2035-42) (C) 2001 by the American College of Cardiology.