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[St. Jude Medical valve replacement: clinical experience with 1,039 patients]
S Watanabe1, K Nakano, H Misumi
1Department of Cardiovascular Surgery, Heart Institute of Japan, Tokyo Women's Medical College, Japan.
Insights
St. Jude Medical valve replacements demonstrated excellent long-term outcomes. Survival rates at 10 years were high, with low incidences of complications for aortic, mitral, and double valve replacements.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
Context:
- Valvular heart disease necessitates surgical intervention.
- Prosthetic heart valves are crucial for restoring cardiac function.
- Long-term durability and safety of prosthetic valves are paramount.
Purpose:
- To evaluate the long-term safety and efficacy of St. Jude Medical valves.
- To assess survival rates and complication incidences after valve replacement surgery.
Summary:
- A study of 1,039 patients undergoing St. Jude Medical valve replacement (320 AVR, 543 MVR, 176 DVR) showed low early mortality (4.2%).
- Ten-year survival rates were 60.5% (AVR), 89.6% (MVR), and 90.3% (DVR).
- Incidences of valve thrombosis, thromboembolism, hemorrhage, endocarditis, and hemolysis were low (e.g., 0.11%/pt-yr for thrombosis). No structural failures occurred within 10 years. Reoperation was needed in 10 patients for leakage, thrombosis, or technical error.
Impact:
- St. Jude Medical valves offer a durable and safe option for surgical treatment of valvular heart disease.
- The findings support the use of these valves, with over 98% of patients free from valve-related mortality at 10 years.
- Demonstrates excellent long-term performance and patient outcomes in prosthetic valve surgery.
Abstract:
St. Jude Medical valve replacement was performed in 1,039 patients; 320 had aortic (AVR), 543 mitral (MVR), and 176 had double valve replacement (DVR). There were 44(4.2%) early deaths. Follow-up extended in 995 patients from 10 to 130 months, with a cumulative period of 2,730 patients-years. The overall survival rates of AVR, MVR, and DVR patients at 10 years were 60.5%, 89.6%, 90.3% respectively. The linearized incidences of valve thrombosis, thromboembolism, anticoagulation-related hemorrhage, prosthetic valve endocarditis, and significant hemolysis were as follows: 0.11%/pt-yr, 1.33%/pt-yr, 0.04%/pt-yr, 0.18%/pt-yr, and 0.11%/pt-yr, respectively. There were no structural failure after 10 years follow-up. Reoperation (explant and re-replacement or suture repair) was required in 10 patients. Seven of them had periprosthetic leakage, 2 had valve thrombosis, and one underwent reoperation because of a technical error. Actuarially over 98% of patients were free of valve-related mortality at 10 years. St. Jude Medical valve is an excellent alternative for use in the surgical treatment of valvular heart disease.