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• W203060076 abstract "Since August 1993 we have been studying the new ATS Medical Open Pivot Bileaflet Valve; up to the end of September 1996, 890 ATS valves have been implanted into 810 patients. Methods. To evaluate the performance and reliability of this new valve, we started after a successful pilot study a prospective, randomized study in April 1994, comparing the ATS valve with the SJM mechanical bileaflet prothesis. Up to April 1996 this study included 293 patients (141 females, 152 males). In 146 patients 152 ATS and in 147 patients SJM valves were implanted. The mean age was 62.2 years (range 23–78) in the ATS and 64.1 years (range 30–78) in the SJM group. There were 103 aortic, 37 mitral, 5 aortic plus mitral, 1 mitral plus tricuspid valve replacements with the ATS prothesis and 91 aortic, 46 mitral, 9 aortic plus mitral and 1 mitral plus tricuspid valve replacement in the SJM group, respectively. The target INR was 2.0–2.5 in the aortic and 3.0–4.5 in the mitral group. Postoperative controls are performed at discharge, 3 months, 12 months, and annually up 5 years postoperatively. At the moment, the follow up rate is 100% after 3 months, 81% after one year and 44% after two years. Results. The early mortality rate was 5.26% (8/153) for the ATS and 4.45% (7/157) for the SJM group. There have been 9 late deaths in the SJM and 2 in the ATS group.The hemodynamics as measured by gradients directly (intraoperative) or echocardiography (postoperative) are similar in both groups.Up to 24 months there occurred 5 thromboembolic and 7 hemorrhage complications: 2 thromboembolic in the ATS group (1.29 per 100 patient-years) and 3 in the SJM group (1.89 per 100 patient-years). Four bleeding complications in the ATS (2.58 per 100 patient-years) and 3 in the SJM group (1.89 per 100 patient-years) occurred. In all bleedings the INR was greater than 5.25, whereas the INR values in the thromboembolic events were borderline (1.6–2.12).The LDH levels were significantly (p < 0.001) lower in the ATS group at all controls. Additionally, we found that the sound level of the ATS valve was significantly lower compared to the SJM; nearly all of the patients are not disturbed by the noise.There were no other valve related complications or problems found in the study. The clinical status of all patients is good. Conclusions. In summary, our overall experience with 890 ATS mechanical bileaflet valves demonstrates excellent clinical results as well in the whole group as it does in the prospective, randomized study comparing the ATS with the SJM valve. We had no intraoperative technical problems, superior hemodynamic results, and very low hemolysis rates. Since all major thromboembolic and bleeding complications occured in situations out of the limits of the protocol, the postoperative anticoagulant therapy has to be controlled closer and stronger. Intraoperatively, the ATS valve is much more comfortable and easier to handle. Due to our experience the ATS medical open pivot bileaflet valve is the standard mechanical valve at our institution." @default.
• W203060076 created "2016-06-24" @default.
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• W203060076 date "1998-01-01" @default.
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• W203060076 title "Clinical results of a large series of ATS valve implants" @default.
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• W203060076 doi "https://doi.org/10.1007/978-3-642-93691-3_6" @default.
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