Original articleCardiovascularMulticentered European Study on Safety and Effectiveness of the On-X Prosthetic Heart Valve: Intermediate Follow-Up
Section snippets
Patients and Methods
A prospective, nonrandomized, multicentered clinical trial was conducted at 11 centers in Europe to determine the safety and effectiveness of the On-X valve (Medical Carbon Research Institute, Austin, TX; Table 1). The study was approved by the ethics committee of each participating center. All patients included in the study had severe aortic or mitral valve disease requiring valve replacement on the basis of clinical, echocardiographic, and cardiac catheterization data. All patients signed an
Results
Early (30-day) and late postoperative events are presented in Table 3, Table 4, respectively.
Comment
The major concern for mechanical valves is the long-term need for warfarin-based anticoagulation as it relates to the thrombogenic potential of these valves and to bleeding from erroneously high anticoagulant dosage. In this study, the patients were maintained on permanent anticoagulation with warfarin at a slightly higher level than now recommended owing to the change of anticoagulation recommendations for bileaflet valves in 1998, while this study was ongoing [7]. We did not lower
References (22)
- et al.
Guidelines for reporting morbidity and mortality after cardiac valvular operations
Ann Thorac Surg
(1996) Results with mechanical cardiac valvular prostheses
Ann Thorac Surg
(1995)- et al.
Risk stratification for cardiac valve replacementNational Cardiac Surgery Database
Ann Thorac Surg
(1999) - et al.
Midterm evaluation of the Sorin Bicarbon heart valve prosthesis: single-center experience
Ann Thorac Surg
(2004) - et al.
Prospective randomized comparison of CarboMedics and St. Jude Medical bileaflet mechanical heart valve prostheses: an interim report
J Thorac Cardiovasc Surg
(2002) - et al.
Predictors of mortality for patients undergoing cardiac valve replacements in New York State
Ann Thorac Surg
(2000) - et al.
The initial experience with the ATS Medical mechanical cardiac valve prosthesis
Ann Thorac Surg
(2003) - et al.
Frequency and severity of intravascular hemolysis after left-sided cardiac valve replacement with Medtronic Hall and St. Jude Medical prostheses, and influence of prosthetic type, position, size and number
Am J Cardiol
(1993) - et al.
Intravascular hemolysis in patients with new-generation prosthetic heart valves: a prospective study
J Thorac Cardiovasc Surg
(2002) - et al.
Five-year follow-up after heart valve replacement with the CarboMedics bileaflet prosthesis
Ann Thorac Surg
(1997)