Aortic root replacement with the freestyle stentless porcine aortic root bioprosthesis

Background. Stentless porcine prosthetic valves offer several advantages ov er traditional valves. Among these are superior hemodynamics, laminar flow patterns, lack of need for anticoagulation and perhaps improved durability. Methods. One hundred and twelve patients were operated on from September 17 , 1992 to April 13, 1998 as part of a multi-center worldwide investigation. All patients received a total aortic root replacement. Patients were evalu ated postoperatively at discharge, 3 to 6 months, and yearly by clinical ex am and color flow Doppler echocardiography. Results. There were 4 deaths either in the hospital or within 30 days after surgery for an operative mortality of 3.6%. No patients experienced struct ural valve deterioration, non-structural valve deterioration, paravalvular leak, unacceptable hemodynamic performance, or postoperative endocarditis. The linearized rates for survival and thromboembolic complications at 5 yea rs were 82.8% and 90.5% respectively. Excellent hemodynamic function is dem onstrated by very low gradients, large EGA, and an exceedingly low incidenc e of any aortic regurgitation. Conclusions. The Medtronic Freestyle aortic root bioprosthesis can be used safely to replace the aortic root for aortic valve and aortic root patholog y. Root replacement allows optimal hemodynamic performance with no signific ant aortic regurgitation. Early and intermediate results are encouraging, b ut further follow-up is needed to determine valve durability. (C) 1999 by T he Society of Thoracic Surgeons.