Performance of the Smeloff aortic valve beyond ten years

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Performance

Background:

• The Smeloff aortic valve prosthesis has utilized a consistent design and material composition since 1966.
• Long-term clinical data on the performance and durability of this specific aortic valve prosthesis are essential for clinical decision-making.

Purpose of the Study:

• To evaluate the long-term efficacy and safety of the Smeloff aortic valve replacement.
• To assess the rates of survival, thromboembolism, and mechanical complications associated with the Smeloff aortic valve.

Main Methods:

• A retrospective review of 394 patients who underwent elective aortic valve replacement with the Smeloff prosthesis.
• Analysis of actuarial survival rates, thromboembolic events, and prosthetic complications over a maximum follow-up of 13.1 years.
• Comparison of outcomes between patients on continuous anticoagulation and the general patient group.

Main Results:

• Operative mortality was 7.4%.
• Actuarial survival rates were 66.3% at 5 years and 48.7% at 10 years.
• Thromboembolism occurred at 3.8% per patient-year overall, reduced to 1.8% per patient-year with continuous anticoagulation.
• No mechanical failures or prosthetic thrombosis were observed over 1,690 patient-years.
• 5-year embolus-free rates were 91% overall and 92% with anticoagulation; 10-year rates were 85% overall and 89% with anticoagulation.

Conclusions:

• The Smeloff aortic valve demonstrates excellent long-term durability.
• Thromboembolism rates are significantly reduced in patients managed with continuous anticoagulation.
• The prosthesis exhibits a favorable safety profile with low complication rates over extended follow-up periods.