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OBJECTIVES To assess the feasibility and results of trans-axillary approach for balloon aortic valvoplasty (BAV) in early infancy. BACKGROUND Severe aortic valve stenosis (SAVS) is rare but serious condition in infancy, which may be promptly treated either by surgical aortic valvotomy or BAV. BAV is usually performed via the femoral artery route, which is associated with significant vascular complications and long procedure times. METHODS BAV via the trans-axillary approach was performed on twenty-seven sequential infants with SAVS presenting to a single tertiary referral center over an 11-year period. Maximum inflated balloon size was less than or equal to the aortic valve diameter. RESULTS Twenty-seven infants aged 1-77 days underwent BAV. Weight at time of procedure was 2.0-4.42 kgs. The median procedure and screening times were 82 and 7.9 minutes, respectively. Mean instantaneous Doppler gradient across the aortic valve reduced from 68 +/- 33 to 37 +/- 14 mmHg ( p < 0.0001). Three infants developed at least moderate aortic regurgitation. Right arm pulse volume was decreased in 12 infants; 5 received an intravenous heparin infusion. Longer-term follow-up demonstrated reduced or absent peripheral pulse in 5 infants. Transection of the axillary artery occurred in one infant requiring emergency microvascular repair. There was one post-procedural and one late death due to non-cardiac causes. CONCLUSIONS In early infancy balloon aortic valvoplasty via the axillary artery approach for severe aortic stenosis is an acceptable and safe alternative to the femoral arterial approach and results in short procedure and screening times. Longer-term vascular follow-up is required. (c) 2006 Wiley-Liss, Inc.