Aortic valve replacement with medtronic freestyle bioprosthesis: operative technique and results

OBJECTIVE: This study evaluates the initial results for safety and efficacy of aortic valve replacement (AVR) using the Medtronic Freestyle Bioprosthesis. METHODS: One hundred three patients underwent AVR with the Medtronic Freestyle Bioprosthesis over a 40-month period. There were 59 male and 44 female patients with a mean age of 74 years (range 36 to 88 years). Valve size ranged from 19 to 27 mm, and all valves were implanted using a freehand subcoronary technique. Anticoagulation with coumadin was only used for atrial fibrillation. Aspirin was given to patients with associated coronary artery disease. Echocardiography to assess transvalvular pressure gradient and effective valve orifice area was performed at discharge, 3 to 6 months, 1 year, and then annually. RESULTS: There were 4 (3.9%) deaths within 30 days of operation and 5 (4.9%) late deaths. Two (1.9%) deaths were valve-related, one from commissural dehiscence and one from bacterial endocarditis. Three (2.9%) deaths, two early and one late, were from other cardiac causes. The remaining deaths were from noncardiac causes. Five (4.9%) patients suffered a thromboembolic event, two had permanent neurological deficits, two had transient neurological events, and one had coronary artery occlusion. Mean transvalvular gradient assessed by echocardiography was low at all time intervals: discharge (12.8 mmHg), 3 to 6 months (11.3 mmHg), 1 year (12.0 mmHg), and 2 years (11.6 mmHg). Mean effective valve orifice area was good at all time intervals: discharge (1.4 cm2), 3 to 6 months (1.5 cm2), 1 year (1.6 cm2), and 2 years (1.6 cm2). Of the 38 patients assessed by echocardiography at 1 year, 33 (87%) had no or trivial valve incompetence and the remainder had mild valve incompetence. CONCLUSIONS: Aortic valve replacement with the Medtronic Freestyle Bioprosthesis has a low incidence of early valve-related mortality and thromboembolism. The bioprosthesis demonstrates good hemodynamic performance even in small diameters and is particularly well suited for older patients and the small aortic root.