Eleven-year single-center experience with the ATS Open Pivot Bileaflet heart valve.

BACKGROUND

The ATS Open Pivot Heart Valve was first introduced in 1992 and has been implanted routinely at our institution since 1993. Valve selection was based on surgeon preference. The objective of this study is to retrospectively analyze our 11-year clinical results with ATS prostheses.

METHODS

Between January 1993 and December 2003, 601 ATS valves (393 aortic valve replacement [AVR], 168 mitral valve replacement [MVR], 20 aortic plus mitral valve replacement [DVR]) were implanted in 581 patients (377 male, 204 female; mean age, 63.7 years; range 18 to 89). Preoperatively, 47 (8%) were New York Heart Association class I, 212 (36.5%) were class II, 267 (46%) were class III, and 55 (9.5%) were class IV. Preoperative comorbidities were coronary artery disease, 167 (29%); diabetes mellitus, 72 (12%); cerebrovascular disease, 2 (0.3%); endocarditis, 53 (9%); and atrial fibrillation, 115 (20%).

RESULTS

Follow-up is 99% complete. Data represent 2,500 cumulative patient-years. Mean follow-up is 4.3 +/- 2.6 years (range, 0.1 to 11.6). Overall hospital mortality is as follows: AVR, 3.8% (15 patients); MVR, 1.8% (3 patients); DVR, 10% (2 patients). Structural valve failure was not encountered. Overall survival at 10 years is AVR, 84.7% +/- 3.1%, AVR plus coronary artery bypass, 67.5% +/- 8.2%; MVR, 59.8% +/- 7.1%, MVR plus coronary artery bypass, 39% +/- 27.8%; and DVR, 74.3% +/- 10%. Freedom from valve-related death at 10 years is AVR, 99.2%; MVR, 94.6%; and DVR, 100%. Linearized rates for postoperative complications are paravalvular leak, 0.6% per patient-year; valve thrombosis, 0.04% per patient-year; thromboembolism, 1.1% per patient-year; major bleeding, 0.5% per patient-year; and de novo prosthesis endocarditis, 0.1% per patient-year. Postoperative mortality risk was significantly elevated by diabetes (p < 0.01), but not by other comorbidities.

CONCLUSIONS

Our 11-year experience demonstrates low rates of adverse events and valve-related complications with the ATS Open Pivot heart valve.