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The CarboMedics valve: midterm follow-up with analysis of risk factors
A E Fiane1, K Saatvedt, J L Svennevig
1Department of Cardiothoracic Surgery, Rikshospitalet, University of Oslo, Norway.
Insights
The CarboMedics mechanical prosthesis shows reliable midterm results with acceptable rates of valve complications. This study followed 569 patients, demonstrating good survival and low rates of thrombosis, thromboembolism, and bleeding.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
Background:
- The CarboMedics prosthetic valve is a mechanical device used in cardiac surgery.
- Assessing the long-term performance and safety of prosthetic valves is crucial for patient outcomes.
Purpose of the Study:
- To evaluate the midterm clinical outcomes of the CarboMedics mechanical prosthesis.
- To determine the incidence of valve-related complications and survival rates.
Main Methods:
- A cohort of 569 patients received the CarboMedics prosthesis between 1987 and 1991.
- Midterm follow-up was 100% complete for mortality, with a mean follow-up of 3 years.
- Patient outcomes were assessed through hospital follow-ups and questionnaires.
Main Results:
- Early mortality was 4.9%, associated with several preoperative and intraoperative factors.
- Cumulative survival at 1 and 4 years was 91.2% and 83.7%, respectively.
- Valve-related complications included thrombosis (0.3%/patient-year), thromboembolism (0.9%/patient-year), bleeding (0.6%/patient-year), and paraprosthetic leak (0.4%/patient-year). No structural valve failure occurred.
Conclusions:
- The CarboMedics mechanical prosthesis demonstrates reliable midterm performance.
- The rate of valve-related complications is acceptable in this patient cohort.
Background:
This study examined the midterm results with the CarboMedics prosthetic valve.
Methods:
From 1987 through 1991 a total of 569 patients received the CarboMedics prosthesis.
Results:
Early mortality was 4.9% and related to emergency operation, presence of diabetes mellitus, coronary artery disease, preoperative New York Heart Association class, duration of cardiopulmonary bypass, and aortic cross-clamp time. Midterm follow-up with respect to mortality was 100% complete. All patients were followed up in the hospital after 1 year. In addition 86% of the patients responded to a questionnaire. Mean follow-up was 3 years (range, 0 to 5.6 years). Cumulative survival at 1 and 4 years was 91.2% +/- 1.2% and 83.7% +/- 1.8%, respectively. Five patients experienced obstructive valve thrombosis (0.3%/patient-year), 16 patients had major thromboembolic events (0.9%/patient-year), and 10 patients had major warfarin-related bleeding (0.6%/patient-year) requiring hospitalization or blood transfusions. Eight patients were reoperated on for paraprosthetic leak (0.4%/patient-year). Prosthetic valve endocarditis developed in 4 patients (0.2%/patient-year). No structural valve failure was observed.
Conclusions:
Midterm follow-up demonstrates that the CarboMedics mechanical prosthesis is reliable and has an acceptable rate of valve-related complications.