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A six-year experience with the omnicarbon valve in North American patients
Julie Carrier1, Javier Teijeira, David Greentree
1Division of Cardiovascular and Thoracic Surgery, Faculty of Medicine and CHUS, Sherbrooke University, Sherbrooke, Quebec, Canada.
Insights
The Omnicarbon all-carbon monoleaflet valve prosthesis shows excellent outcomes in North American patients, with low complication rates and high survival after aortic or mitral valve replacement.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Medical Device Technology
Background:
- The Omnicarbon is an all-carbon monoleaflet valve prosthesis.
- Evaluating its performance in a North American population is crucial for understanding its clinical utility.
Purpose of the Study:
- To assess the clinical outcomes of the Omnicarbon valve in patients undergoing aortic (AVR) or mitral valve replacement (MVR).
- To evaluate the safety and efficacy of this prosthesis in a real-world setting.
Main Methods:
- Prospective evaluation of 108 patients who received Omnicarbon valve implants.
- Comprehensive assessments included echocardiography, laboratory tests, and physician examinations.
- Follow-up data were collected to determine survival and complication rates.
Main Results:
- Hospital mortality was 6.1%, significantly lower than the predicted 12.1% using the Parsonnet model.
- Five-year survival was 86%, with high freedom from thromboembolic events (99%), bleeding (97%), endocarditis (99%), and structural failure.
- Patients showed improved functional status (NYHA Classes I/II) post-operatively, with favorable hematologic and hemodynamic profiles.
Conclusions:
- The Omnicarbon valve demonstrates favorable hematologic and hemodynamic characteristics.
- Low complication rates, including thromboembolism, bleeding, and endocarditis, indicate it meets contemporary performance expectations.
- This all-carbon prosthesis is a viable option for valve replacement surgery.
Aim:
We studied the results of an all-carbon monoleaflet valve prosthesis (the Omnicarbon) in a North American population.
Methods:
Patients were recalled to our valve clinic for complete evaluation, including echocardiography, laboratory tests, and physician examination. This experience includes 108 Omnicarbon valve implants. We report the results of single aortic (AVR) or mitral (MVR) valve replacement.
Results:
Patients' ages ranged from 40 to 83 (mean: 63 +/- 9 years), and most were male (60%, 59/98). Preoperatively, 71% were NYHA Classes III/IV, while most patients are now Classes I/II (86%). AVR predominated (63%, 62/98), and many patients (44%, 43/98) underwent cardiac procedures either previously or concomitant with valve replacement. Hospital mortality was 6.1% (6/98). Predicted hospital mortality using the Parsonnet additive risk model averaged 12.1%. Currently, four patients cannot be located (96% accountability). Overall, hematology indicated low hemolysis-lactate dehydrogenase: 691 +/- 184 IU/L (112%+/- 30% upper normal), reticulocytes: 1.8%+/- 0.7%, and red blood cells (10(6)/mm(3)): 4.41 +/- 0.50 (males)/4.16 +/- 0.50 (females). International normalized ratio averaged 2.67 +/- 0.72. Doppler echocardiography values were acceptable and comparable to other mechanical valves. Five-year survival (hospital death included) is 86%+/- 4%. At 5 years, freedom from any thromboembolic event is 99%+/- 1%, and freedom from bleeding is 97%+/- 2%. Endocarditis and nonstructural dysfuction also occurred at low rates (99%+/- 1% freedom at five years), and no structural failure or hemolytic anemia was observed during the 343 patient-years (mean: 3.7 +/- 1.6 years).
Conclusions:
Good hematology and hemodynamics, along with remarkably low complication rates, demonstrate that the Omnicarbon valve meets contemporary performance expectations.
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