The initial United States experience with the ATS mechanical cardiac valve prosthesis

From January 1, 1997 through June 30, 2000, 224 patients underwent valve replacement with the ATS Medical cardiac valve prosthesis under a USFDA-approved investigational device exemption study. Aortic valve replacement (AVR) was conducted in 152 patients (39 with coronary bypass) and mitral replacement (MVR) in 72 patients (18 with coronary bypass). Overall operative mortality was 1.8% (AVR = 2.8%, MVR = 0%), with only one valve-related death. In 372 patient-years of follow-up, there were an additional four patient deaths, two of which were valve related following a stroke. Valve-related complications included: thromboembolism (linearized rate = 3.8% per patient year), of which 3/11 had chronic deficits (0.8% per patient year); thrombosis (1 MVR = 0.8% per patient year); paravalvular leak (1 AVR = 0.4% per patient year); anticoagulant-related hemorrhage (1 AVR and 5 MVR = 1.6% per patient year) with no patient mortality; prosthetic valve endocarditis (1 MVR = 0.8% per patient year); and valve dysfunction (0%). Echocardiographic gradients were proportional to valve size and did not significantly change over the follow-up period. This study documented the ATS Medical prosthesis to be a valuable addition to the surgeon's armamentarium in the treatment of cardiac valvular disease.