The St. Jude Medical cardiac valve prosthesis: a 25-year experience with single valve replacement.

BACKGROUND: From October 1977 to October 2002, 4,480 patients (age range, 17 to 94 years; average, 64 +/- 13 years) underwent single valve replacement with the St. Jude Medical heart valve. Of 2,982 aortic (AVR) and 1,498 mitral valve replacements (MVR), concomitant coronary artery bypass grafting was performed on 42% and 33%, respectively. METHODS: Cardiac Surgical Associates has maintained an independent database of patients having valve replacement with the St. Jude Medical prosthesis since the world's first implant. Patients were contacted by questionnaire or phone from November 2002 through June 2003. Hospital course and valve-related events were verified by patient chart review or physician contact. RESULTS: Follow-up was 95% complete. Operative mortality was 4% with AVR and 9% with MVR. Total follow-up was 32,190 patient-years (range, 1 month to 24.8 years; average, 7 +/- 5 years). During the study period, patient freedom from late mortality was 61% (AVR, 61%; MVR, 63%), and from valve-related mortality 92% (AVR, 93%; MVR, 91%). Freedom from thromboembolic events was 85% (86% AVR, 81% MVR), from bleeding events, 81% (81% AVR, 81% MVR), from reoperation, 98% (99% AVR, 97% MVR), from endocarditis, 98% (99% AVR, 98% MVR), and from valve thrombosis, 99% (99% AVR, 98% MVR). There was one MVR structural failure (0.06%). CONCLUSIONS: The St. Jude Medical valve has proven to be an effective and durable valve prosthesis with a low event rate during the long term.

Five-year follow up of the ATS mechanical heart valve.

BACKGROUND AND AIM OF THE STUDY: Between January 1, 1997 and December 31, 2001, a total of 342 patients underwent aortic valve replacement (AVR) or mitral valve replacement (MVR) with the ATS Medical prosthesis. The initial three-year phase of this study took place under a United States Food and Drug Administration-approved investigational device exemption study. The study aim was to determine the incidence of valve-related events in up to five years of follow up after valve implantation, and to assess patient disturbance from valve noise. METHODS: Patients were consecutively enrolled to undergo AVR or MVR with the ATS prosthesis. Follow up studies were conducted by patient questionnaire and/or telephone call. Follow up was 96% complete. AVR was conducted in 246 patients (80 with coronary bypass), and MVR in 96 patients (29 with coronary bypass). RESULTS: The overall operative mortality was 2.6% (n = 9; AVR 3.2%, n = 8; MVR 1.0%, n = 1), with two deaths being valve-related (0.6%). In 878 patient-years (pt-yr) of follow up (613 pt-yr for AVR; 265 pt-yr for MVR) there were an additional 22 deaths. Five deaths (0.6%/pt-yr) were valve-related: two were neuroembolic (both MVR), one from endocarditis (AVR), and two from bleeding events (both AVR). Late valve-related complications (>30 days) included 17 episodes of major bleeding (11 AVR, 1.8%/pt-yr; six MVR, 2.3%/pt-yr), five permanent neuroembolic events (four AVR, 0.7%/pt-yr; one MVR, 0.4%/pt-yr); 16 transient neuroembolic events (10 AVR, 1.6%/pt-yr; six MVR, 2.3%/pt-yr); three transient peripheral emboli (two AVR, 0.3%/pt-yr; one MVR, 0.4%/pt-yr); four paravalvular leaks (two AVR, 0.3%/pt-yr; two MVR, 0.8%/pt-yr); and one episode of valve thrombosis (MVR, 0.4%/pt-yr; AVR, 0%/pt-yr). Reoperation was required in two patients: one AVR (paravalvular leak, 0.2%/pt-yr) and one MVR (replacement due to thrombosis, 0.4%/pt-yr). CONCLUSION: These results indicate that intermediate-term results with the ATS mechanical prosthesis continue to be excellent, though further long-term follow up is warranted.

Opposite trends in coronary artery and valve surgery in a large multisurgeon practice, 1979-1999.

BACKGROUND: Trends in coronary artery bypass (CAB) and valve operations (VO) may help predict the future of cardiac surgery in the context of changing case mix, shifting paradigms, emerging technology, and population demographics. METHODS: We retrospectively reviewed all 30,319 adult CAB and VO in our group from 1979 to 1999 according to specific procedures. RESULTS: Coronary artery bypass volumes peaked in 1996 at 1,895 cases, declining 15.3% to 1,605 cases in 1999 with a decrease in risk profile and percent reoperations and an increase in mean age and percent octogenarians, prior percutaneous coronary interventions (PCI), left internal mammary artery (LIMA) graft usage, off-pump technology usage, and hospital mortality of reoperations. Right internal mammary grafts were employed infrequently and radial artery grafts transiently. Overall VO volumes continued to increase 24.0% since 1996, from 470 to 583 cases with a decreased risk profile, increased mean age, and percent octogenarians and prior PCI. The percentage of mechanical valve implants decreased, while the percentage of various tissue solutions for valve disease increased. Limited access incisions and port-access were employed transiently with CAB and VO. CONCLUSIONS: Coronary artery bypass volumes are decreasing, with an increasing percentage of LIMA grafts and off-pump cases. Valve operation volumes are steadily increasing, with a decreasing percentage of mechanical valve implants, in favor of various tissue solutions.

Replacement of the aortic valve in patients under 50 years of age: long-term follow-up of the St. Jude Medical prosthesis.

BACKGROUND: Aortic valve replacement in the young adult (aged 18 to 50 years) is a choice between a mechanical prosthesis with attendant lifelong anticoagulation or biological prostheses of varying types that may have limited life expectancy in this age group. METHODS: The Cardiac Surgical Research Foundation database was accessed to determine long-term outcomes in patients having aortic valve replacement with the St. Jude Medical Valve. This database has been privately maintained since the world's first St. Jude Medical (SJM) valve implant in 1977. Patients were contacted by questionnaire or by telephone if the survey was not returned. Follow-up was 93% complete. RESULTS: From October 1977 through October 1997, 271 patients less than 50 years of age had isolated aortic valve replacement. Follow-up was 1957 patient years. Thirty-day operative mortality was 1.1% with 18 late deaths, 4 of which were valve related. Ninety percent of survivor INR responses indicated a frequency of monthly INR checks or less. Valve-related events including percent per patient year and mortality related to these events included thromboembolism, 6 episodes (0.3% per patient year, no deaths); anticoagulant-related bleeding, 6 events (0.3% per patient year, 2 deaths); paravalvular leak, 6 events (0.3% per patient year, 2 deaths); valve thrombosis, 2 events (0.1% per patient year, no deaths); and endocarditis, 3 events (0.15% per patient year, no deaths). There was no incidence of structural valve failure. CONCLUSIONS: The SJM valve has a long record of excellent performance with durability lasting more than 20 years. The incidence of untoward events is low and death over time due to valve-related complications is low (4 of 271). The SJM valve has become our valve of choice for younger patients.

Trends in aortic valve surgery in a large multi-surgeon, multi-hospital practice, 1979-1999.

BACKGROUND AND AIM OF THE STUDY: Trends in aortic valve operations (AVO) may help to predict the future of aortic valve surgery in the context of changing case mix, population demographics, emerging technology and shifting paradigms. METHODS: All adults undergoing single AVO between 1979 and 1999 were reviewed retrospectively according to age, gender and other typical clinical variables, surgical complexity, specific operation and immediate outcome. RESULTS: There were 3,917 single AVO. Although coronary artery bypass (CAB) volumes declined by 15.3% between 1996 and 1999, AVO volumes have continued to increase by 11.7% since 1996. Over the entire period, there was no significant change in mean age or percent female gender, but increases in the prevalence of octogenarians and aortic stenosis were noted. During the 1990s, degenerative valve disease predominated and the prevalence of sicker patients according to heart failure class and surgical priority decreased. Trends in surgical complexity included an increase in AVO combined with CAB, but a stable 9:1 distribution of first operations to reoperations. Technology adoption included a decreased prevalence of mechanical valve use at the expense of increased use of tissue valves, especially stented xenografts and homografts. Transient technology adoption included stentless xenografts. Small numbers of pulmonary autografts, aortic valve repairs and valve-sparing aortic replacements were carried out. Predictors of hospital mortality rates for AVO included age 65 years, reoperation and combined AVO. Hospital mortality rates for AVO decreased for most age groups between the 1980s and 1990s, but not during the 1990s. CONCLUSION: AVO volumes are steadily increasing, apparently as a result of the increase in octogenarians and the start of the 'baby boom' wave. Hospital mortality risk is related to age and surgical complexity, but is modest and has stabilized during the past decade. The prevalence of mechanical valve implants has decreased in favor of tissue valve replacement categories. The fastest growth rates have been with stented xenografts, and especially homografts. This may represent a paradigm shift away from mechanical solutions in favor of tissue solutions for aortic valve disease.

Is low-intensity anticoagulant therapy possible with an open pivot valve?: analysis of its development.

In 1976, the authors became the codevelopers of the first successful bileaflet heart valve which has become the standard in valvular surgery. However, there still remains a significant rate of thromboembolism and thrombosis which can be attributed to the inherent design of cavities in the pivot area. These cavities contribute to stagnant areas that lead to thrombus formation. The literature indicates that this rate is approximately 2% to 2.5% per patient year. To maintain these thromboembolism rates, certain levels of warfarin have had to be used leading to a significant rate of bleeding complications. We present the theory and development of the new generation of heart valves without cavities and with an open semisphere pivot area. Results of 912 years of clinical studies of almost 50,000 valves, as well as additional features that have been incorporated to improve hemodynamics and quality of life for the patient, are discussed. The clinical results of the European Community Certification and U.S. Food and Drug Administration premarket application (PMA) studies also are given. The differences in the pivot area suggest that a reduction in thromboembolism is possible at anticoagulant levels as low as 1.5 international normalization ratio (INR) resulting in virtually no bleeding complications. Midterm clinical results are encouraging, and studies are being conducted presently to eliminate totally anticoagulants in certain patients.

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.