Original ArticlesAortic root replacement with the freestyle stentless porcine aortic root bioprosthesis
Section snippets
Patients and methods
Wake Forest University Baptist Medical Center was selected in 1992 to serve as one of the United States study centers to begin implanting the Freestyle investigational valve. Before initiation of the study at our hospital, the institution’s investigational review board approved the study design. Written informed consent was obtained for each patient before operation prior to November 1997 FDA approval.
From September 17, 1992 to April 13, 1998, 112 patients received the Freestyle aortic root
Results
Patient improvement from preoperative to 1 year postoperative in NYHA class for congestive heart failure is depicted in Table 7. On clinical examination at the 1–year postoperative interval, 92.8% of patients were in class 1 and 4.8% were in class 2. No patients reaching 1 year were in class 3 or 4.
The mean cross–clamp time was 109.6 ± 13.1 minutes in patients who had isolated aortic root replacement and 128.6 ± 23.6 minutes in patients who had a concomitant procedure in addition to aortic
Comment
The non–physiologic flow through a stented bioprosthesis produces obstructive hemodynamics with resultant increased pressure gradients. Turbulent flow promotes micro–abrasions, platelet deposition, calcific degeneration, and may promote the development of prosthetic valve endocarditis.
The superior hemodynamics and improved late clinical outcomes for stentless porcine bioprostheses have been demonstrated 4, 11, 12, 13, 14, 15. The disadvantages of a stent include an increase in stress forces
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