Key result
On-X mitral valve replacement associated with ~71% ten-year survival and high freedom from reoperation.
Why the study?
Mitral valve replacement remains the only option when mitral valve repair is not feasible, and outcomes with the latest generation On-X prosthesis need investigation.
Observational (n=318)
No
The On-X mitral valve prosthesis demonstrates safe long-term durability and a low incidence of thromboembolism up to 10 years post-replacement.
Supports On-X mitral replacement in selected patients; leaves open randomized comparisons with contemporary prostheses.
OBJECTIVES: If mitral valve repair is not feasible, mitral valve replacement remains the only option. Based on our overall experience with the On-X mitral valve, the aim of this study was to investigate early and late outcomes after mitral valve replacement using this latest generation prosthesis. METHODS: From 1998 to 2016, 600 patients received an On-X prosthesis in the mitral position. Of them, we excluded all patients who had combined aortic procedures and retrospectively analysed 318 consecutive patients who had a mitral valve replacement. Associated procedures (53.5%) were tricuspid valve repair, coronary artery bypass graft and the maze procedure. The mean follow-up time was 5.6 ± 4.0 years. RESULTS: The overall hospital mortality rate was 4.4%, including acute cases of ischaemic mitral regurgitation (9.4%) and infective endocarditis (9.4%). Survival rates at 1, 3, 5 and 10 years were 97.8 ± 1.0%, 92.4 ± 1.7%, 88.4 ± 2.2% and 70.9 ± 4.0%, respectively. Independent predictors of late mortality were hypertension [hazard ratio (HR) 1.91; P = 0.027], chronic obstructive pulmonary disease (HR 2.91; P = 0.003) and chronic renal failure (HR 5.27; P < 0.001). Freedom from reoperation was 99.3 ± 0.5%, 98.4 ± 0.8%, 97.2 ± 1.2% and 92.5 ± 2.4% at 1, 3, 5 and 10 years, respectively. At follow-up, 8.5% events were recognized as thromboembolic or haemorrhagic events; freedom from events related to anticoagulation therapy at 1, 3, 5 and 10 years was 99.0 ± 0.6%, 96.8 ± 1.1%, 93.7 ± 1.8% and 89.0 ± 2.7%, respectively. CONCLUSIONS: According to the results of this observational study, the unique design of the On-X valve works well with mitral valve diseases of various aetiologies, especially in cases with an unfavourable anatomy. This prosthesis also guarantees safe long-term durability associated with a low incidence of thromboembolism.
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Murana et al. (2018) conducted an observational in Mitral valve disease (n=318). On-X mitral valve replacement was evaluated on overall hospital mortality. On-X mitral valve replacement was associated with an overall hospital mortality rate of 4.4%, a 10-year survival rate of 70.9%, and 92.5% freedom from reoperation at 10 years.
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