Results of valve replacement surgery with mechanical prostheses

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Engineering

Background:

• Heart valve replacement surgery is crucial for patients with valvular heart disease.
• Existing prostheses have limitations, necessitating the development of improved devices.
• Pyrolytic carbon tilting disc prostheses offer potential advantages in durability and biocompatibility.

Purpose of the Study:

• To report the clinical outcomes of a new Italian-manufactured pyrolytic carbon tilting disc prosthesis.
• To evaluate the safety and efficacy of this prosthesis in mitral and aortic valve replacement.
• To compare the performance of the new prosthesis against established models like Starr-Edwards and Björk-Shiley.

Main Methods:

• A clinical study involving 644 patients undergoing heart valve replacement with the new prosthesis.
• Analysis of a subset of 207 patients with a minimum follow-up period for survival and complication rates.
• Utilized clinical evaluation, electrocardiography, phonocardiography, echocardiography, and radiological assessments.

Main Results:

• Hospital mortality rates were 10.5% for mitral and 4.8% for aortic valve replacement.
• Three-year survival probabilities were 94% for mitral and 97.5% for aortic valve replacement.
• Three-year embolism probabilities were 8.5% for mitral and 5% for aortic valve replacement, appearing lower than historical controls.

Conclusions:

• The new pyrolytic carbon tilting disc prosthesis demonstrates satisfactory clinical results and survival rates.
• The prosthesis shows a potentially lower rate of mortality and embolism compared to older valve prostheses.
• Further studies are warranted to confirm the long-term performance and benefits of this new device.