Sutureless stented aortic valve implantation under direct vision: lessons from a negative experience in sheep.

ABSTRACT

BACKGROUND AND AIM OF THE STUDY Percutaneous aortic valve replacement has been proposed as a valid alternative to surgery in selected cases; however, it still has many problems. As a less radical preliminary step, we implanted a balloon-expandable stented aortic valve under direct vision in sheep. METHODS: Under cardiopulmonary bypass (CPB) and through a transverse aortotomy, an aortic valve mounted in a long tubular balloon-expandable stent was implanted in six acute sheep. The leaflets were not excised and no anchoring sutures were used between stent and native annulus. Epicardial, two-dimensional color Doppler echocardiography was used to assess the function of the stented valve followed by macroscopic inspection at necropsy. RESULTS: Direct visualization of the entire annulus when the collapsed, valved stent was placed within the aortic root was difficult in all animals. Valve deployment took less than 1 minute. The surgical procedure resulted in major complications in all cases. Migration (3/6), paravalvular leak (2/6), mitral conflicts resulting in mitral regurgitation (1/6), and coronary ostia obstruction (2/6) were the major events at the origin of the failure. Only three animals could be weaned from CPB but did not recover enough to survive the procedure. CONCLUSIONS: Sutureless implantation of a stented aortic valve through standard CPB and aortotomy is far more complex than expected. Changes in stent design and surgical approach are indicated.