Decision-making in the choice of heart valve for replacement in patients aged 60-70 years: twenty-year follow up of the St. Jude Medical aortic valve prosthesis.

Background And Aim Of The Study: The choice of a cardiac valve for patients with aortic valvular pathology remains controversial. Younger patients may be at risk for long-term complications from chronic anticoagulation yet require prosthesis longevity, while older patients may not outlive a bioprosthesis. To gather information to help decision-making, the 20-year experience of aortic valve replacement (AVR) with the St. Jude Medical (SJM) valve by the surgeons of Cardiac Surgical Associates, P.A., was reviewed.

Methods: Cardiac Surgical Associates Research Foundation maintains a database of all patients undergoing valve replacement with the SJM aortic prosthesis since the world's first implant in October 1977. Patient follow up is conducted by questionnaire and/or telephone interview. The 20-year follow up period ended in October 1997. Follow up is 96.3% complete, and extends to 13,208 patient-years.

Results: A total of 2,390 aortic valves (1,500 in males, 890 in females) were replaced in the period studied. Among these patients, 1,419 had isolated AVR, whilst the remainder had AVR plus coronary artery bypass (CAB) or other procedures. The mean age was 63 +/- 14 years for AVR, and 70 +/- 10 years for AVR/CAB. Over the 20-year follow up period, freedom from valve-related events for the entire group was: thromboembolism, 97%; anticoagulant-related hemorrhage, 94%; valve thrombosis, 99.7%; prosthetic valve endocarditis, 99.2%; and paravalvular leak, 99.6%. Freedom from structural failure was 100%. Mortality for these events was low (15 deaths among 250 events; 6%). Overall survival at 5, 10, 15 and 19 years was 82, 66, 51 and 45% respectively for isolated AVR, and 72, 45, 25 and 15% respectively for AVR/CAB.

Conclusion: The SJM valve has excellent hemodynamics and a low incidence of valve-related complications. Improvements in anticoagulation monitoring with the newly introduced and funded home monitoring program, as well as the introduction of newer and more effective antiplatelet drugs, will improve the safety of patients requiring chronic anticoagulation. With durability unquestioned, these long-term data show the SJM valve to be an excellent choice for AVR in patients aged 60-70 years.