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Ann Thorac Surg 2003;75:444-452
© 2003 The Society of Thoracic Surgeons

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Original article: cardiovascular

The initial experience with the ATS Medical mechanical cardiac valve prosthesis

^a Cardiac Surgical Associates, Minneapolis, Minnesota, USA
^b University Hospital, Gent, Belgium
^c The Prince Charles Hospital, Brisbane, Queensland, Australia

Accepted for publication July 26, 2002.

* Address reprint requests to Dr Emery, 920 East 28th St, Suite 420, Minneapolis, MN 55407, USA
e-mail: remery{at}csa-heart.com

BACKGROUND: From May 1994 through October 2000, a total of 1,146 patients underwent valve replacement with the ATS Medical mechanical cardiac valve prosthesis under a study protocol approved by international ethics committees (non–United States participants) or under a United States Food and Drug Administration–approved Investigational Device Exemption study. The study took place at 19 domestic and three international centers.

RESULTS: Aortic valve replacement (AVR) was conducted in 801 patients (309 with coronary bypass) and mitral valve replacement (MVR) in 345 patients (78 with coronary bypass). Overall operative ( 30 days post implant) mortality was 2.1% (17 AVR = 2.1%, 7 MVR = 2.0%), 7 of which (AVR = 4, MVR = 3) were valve related. In 2,086 patient-years (1,459 AVR patient-years, 627 MVR patient-years) of follow-up, there were an additional 50 patient deaths of these, 18 were valve related, 9 due to anticoagulant related bleeding, 5 sudden/unexplained, and 1 each after stroke, thrombosis, prosthetic valve endocarditis, and thromboembolism. Late (>30 days post implant) valve-related complications included: transient and chronic thromboembolism (27 AVR (linearized rate 1.85%/patient-year) and 20 MVR (3.19%/patient-year), of which 11/47 (0.53%/patient-year) had chronic deficits, thrombosis (1 AVR = 0.07%/patient-year and 4 MVR = 0.64%/patient-year), paravalvular leak (10 AVR = 0.69%/patient-year and 8 MVR = 1.28%/patient-year), anticoagulant related hemorrhage (34 AVR = 2.33%/patient-year and 8 MVR = 1.28%/patient-year), prosthetic valve endocarditis (3 AVR = 0.21%/patient-year and 2 MVR = 0.32%/patient-year), and structural valve failure or dysfunction (0%). Echocardiographic gradients were proportional to valve size and did not significantly change over the follow-up period.

CONCLUSIONS: This study documented the ATS Medical mechanical cardiac valve prosthesis to be a valuable addition to the surgeon’s armamentarium in the treatment of cardiac valvular disease.

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