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.

Adult cardiac surgery during the first 50 years of the Southern Thoracic Surgical Association.

This is a review of some of the outstanding adult cardiac surgical papers presented during the first 50 years of the Southern Thoracic Surgical Association to commemorate the 50th Anniversary meeting. Since the founding of the Southern Thoracic Surgical Association in 1954 there have been a total 512 adult cardiac surgery and great vessels papers presented, 138 from 1954 to 1970, 157 from 1971 to 1986, and 217 from 1987 to 2002. Since 1964 most of these papers have been published in The Annals of Thoracic Surgery. Forty-three papers were reviewed, the first having been presented in 1956 and the last in 2002. Not all of the papers could be located but the vast majority were retrievable and reviewed. This paper presents a broad spectrum of adult cardiac surgery beginning with early pump technology, early myocardial revascularization including the Vineberg procedure followed by coronary bypass as we know it today, valvular surgery, including several papers on aortic valve homograft and autograft procedures, ventricular aneurysms, aortic aneurysms and aortic dissections. Evaluations of various valve prostheses, cardiac transplantation, mitral valve reconstruction, quality assurance in cardiac surgery, neurobehavioral outcome after cardiac surgery, endocarditis and off-pump coronary bypass surgery were reviewed. We hope that this article is representative of the broad spectrum of issues that have characterized the specialty of cardiothoracic surgery over the second half of the 20th century and the beginning of the 21st century.

Technique of using the St. Jude aortic connector with the radial artery.

We present a technique for the use of St. Jude Aortic Connector System with the radial artery. This technique will allow surgeons, who prefer the radial artery to the vein, to use this approach whenever feasible.

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.

Surgical steps toward complete revascularization in off-pump coronary bypass.

Surgical techniques aimed at complete myocardial revascularization without the use of cardiopulmonary bypass are described. Between January 1998 and June 2000, coronary artery bypass was performed in 3,003 patients; an off-pump technique was used in 676 and cardiopulmonary bypass was employed in 2,327. Patient characteristics, demography, and preoperative risk factors of the two groups were compared retrospectively, and differences in operative variables and postoperative outcomes were analyzed. Using a commercially available suction stabilization device and the surgical and anesthetic techniques described herein, off-pump coronary revascularization was accomplished with results comparable to the on-pump approach.

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.