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[Remote results of aortic valve replacement with the St. Jude medical prosthesis]
G Montalescot1, D Thomas, G Chatellier
1Service de cardiologie, Hôpital Pitié-Salpêtrière, Paris.
Insights
This study evaluated the St. Jude Medical aortic valve prosthesis in 49 patients over 7 years. While survival was 79.6% at 6 years, complications included anticoagulant issues and reduced quality of life.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Outcomes Research
Context:
- The St. Jude Medical prosthesis is an artificial heart valve used in aortic valve replacement surgery.
- Aortic valve disease affects a significant patient population, necessitating reliable prosthetic solutions.
- Long-term outcomes and complication rates are crucial for evaluating prosthetic device efficacy.
Purpose:
- To prospectively evaluate the long-term safety and efficacy of the St. Jude Medical aortic valve prosthesis.
- To assess survival rates, complication incidence, and quality of life in patients receiving this prosthesis.
- To identify patient factors associated with adverse outcomes.
Summary:
- A 7-year prospective study of 49 patients demonstrated an overall survival rate of 79.6% at 6 years.
- No deaths were attributed to the prosthesis itself; however, deaths occurred early, particularly in patients with left ventricular enlargement.
- Complications included a thromboembolic accident rate of 0.93% per patient-year and anticoagulant-related accidents at 3.26% per patient-year.
- Pacemaker implantation was required in 10.2% of patients, exclusively those with aortic stenosis.
- Quality of life was compromised in approximately half of the survivors.
Impact:
- The St. Jude Medical prosthesis shows promise but is associated with significant initial mortality, especially in patients with pre-existing left ventricular enlargement.
- High rates of anticoagulant-related complications and a mediocre quality of life in survivors warrant further investigation and potential improvements in patient management.
- Findings highlight the need for careful patient selection and monitoring to mitigate risks associated with this aortic valve prosthesis.
Abstract:
The St Jude Medical prosthesis on the aortic valve was evaluated in a 7-year prospective study which involved 49 patients. Survivors were followed up for 2,577 patient-months, meaning a mean follow-up of 5 years per patient and a minimum follow-up of 4 years per patient. The overall survival rate at 6 years was 79.6 +/- 5.7 p. 100. All deaths occurred during the first two years, and none of them was ascribable to the prosthesis. The left ventricular systolic and diastolic echocardiographic diameters were significantly greater in the patients who died. The linear rate of thromboembolic accidents was 0.93 p. 100 per patient-year, and that of accidents due to anticoagulants was 3.26 p. 100 per patient-year. The probability of freedom from all complication at 6 years was 71 +/- 9 p. 100. In the totality of patients, 10.2 p. 100 required pacemaker implantation; these patients had aortic stenosis exclusively, and all were alive at 7 years. The quality of live, assessed during consultations, was altered in one-half of the survivors. The good results obtained with the St Jude Medical prosthesis are marred by a high initial mortality rate, notably in patients with left ventricular enlargement, by the frequency of accidents due to anticoagulants and by the mediocre quality of life of survivors.