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Eur J Cardiothorac Surg 1998;13:151-159
© 1998 Elsevier Science NL
Department of Surgery, St. Pauls Hospital-Heart Centre, Vancouver General Hospital, University of British Columbia, 3100-910 West 10th Avenue, Vancouver V5Z 4E3, Canada
Received 28 July 1997; received in revised form 8 December 1997; accepted 16 December 1997.
Corresponding author. Tel. +1 604 8754141; fax: +1 604 8754036.
Objective: The experience with the St. Jude Medical (SJM) and CarboMedics (CM) bileaflet mechanical prostheses was evaluated to determine thromboembolic and hemorrhagic complications and predictive risk factors. Methods: From 1989 to 1994, a total of 246 patients had multiple valve replacement (SJM, 140; CM, 106); concomitant procedures 20.3% (50) [coronary artery bypass 10.6% (26)] and 53.7% (132) previous cardiac surgery, primarily valve replacement procedures. The pre-operative variables [coronary artery disease, previous cardiovascular surgery, concomitant procedures, valve lesion (except mitral stenosis), status, atrial fibrillation, and NYHA III/IV] did not distinguish the prosthesis-type (pNS). Results: The prosthesis-type and the pre-operative variables, including atrial fibrillation, were not predictive of overall thromboembolism (TE). The linearized rate of total TE events for overall multiple replacements (MR) was 5.4%/patient-year (minor, 2.52; major 2.85); the total TE for CM and SJM was 5.4%/patient-year, respectively. The
30 day major TE crude rate was 0.82%, while the >30 day major event rate was 2.7%/patient-year. Of the total (major and minor) TE events 100% (3) of
30 days and 72% (29), >30 days had an INR <2.5 at or immediately prior to the event. The thrombosis rate (included in total TE events) was 0.67%/patient-year (4 events, 100% INR <2.5). Of the various TE event categories the prosthesis-types (CM and SJM) were not differentiated (pNS). The freedom, at 5 years, from major/fatal TE, thrombosis and hemorrhage from anticoagulation was 89.3±3.8% for CM and 87.9±3.7% for SJM and, 91.3±3.5% and 89.3±3.7%, respectively, (pNS) exclusive of early events. Conclusions: The performance of the CarboMedics and St. Jude Medical prostheses in multiple valve replacement surgery in this non-randomized prospective study revealed no significant differences in performance with regard to thromboembolic and hemorrhagic complications.
Key Words: Mechanical prostheses Thromboembolism Predictive factors and anticoagulation
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