Long-term follow up of patients undergoing reoperative surgery with aortic or mitral valve replacement using a St. Jude Medical prosthesis.

BACKGROUND AND AIM OF THE STUDY: Between June 1978 and September 2002, a total of 440 reoperative open-heart patients (mean age 62 +/- 14 years; range: 18-91 years), following various primary cardiac operations, underwent single-valve replacement with the St. Jude Medical (SJM) heart valve. Of 241 patients having aortic replacement (AVR) and 199 mitral valve replacement (MVR), 86 (35%) and 42 (21%), respectively, underwent concomitant coronary artery bypass grafting. The study aim was to document patient survival and valve-related events in an experience extending up to 24 years after reoperative open-heart surgery with a single model cardiac valve prosthesis. METHODS: The Cardiac Surgical Associates Research Foundation (CSARF) has maintained an independent database of those patients with the SJM prosthesis since the world's first implant in October 1977. Patients were contacted by questionnaire and/or telephone between November 2002 and June 2003. The hospital course and valve-related events were verified by patient chart review and/or physician contact. RESULTS: Follow up was 94% complete, for a total of 3,114 patient-years (1,671 pt-yr after AVR; 1,443 pt-yr after MVR). The average follow up was 7 +/- 6 years (range: 0.1-24.3 years). The operative mortality was 9% (10% AVR, 8% MVR). Five deaths (13%) were valve-related. Freedom from all late mortality at 10 and 20 years, respectively, was 57% and 35% for AVR and 52% and 22% for MVR, and for valve-related mortality was 89% and 77% for AVR and 84% and 22% for MVR. Freedom from thromboembolic events at 10 and 20 years, respectively, was 93% and 93% after AVR and 92% and 81% after MVR; from anticoagulant-related hemorrhage it was 78% and 76% after AVR and 81% and 67% after MVR; and from reoperation it was 94% and 94% after AVR and 95% and 89% after MVR. CONCLUSION: Reoperative valve replacement carries a significant operative morbidity and mortality. Long-term results with the SJM valve demonstrated a durable prosthetic valve, excellent long-term patient survival, and freedom from valve-related events followed reoperative open-heart valve replacement surgery. However, the early postoperative period carried an increased risk for valve-related events.

The St. Jude Medical cardiac valve prosthesis: long-term follow up of patients having double valve replacement.

BACKGROUND AND AIM OF THE STUDY: Between October 1977 and February 2002, a total of 343 patients (mean age 62 +/- 13 years; range: 19-91 years) underwent double valve replacement (DVR) with the St. Jude Medical (SJM) heart valve. Among the replacements, 337 (98%) were aortic and mitral in nature. Concomitant coronary artery bypass was performed in 73 patients (21%). METHODS: Cardiac Surgical Associates has maintained an independent database of patients undergoing valve replacement with the SJM prosthesis since the valve's first implantation in October 1977. Patients were contacted by questionnaire and/or telephone (94% complete) between November 2002 and June 2003. The patients' hospital course and valve-related events were verified by patient chart review and/or physician contact. RESULTS: Operative mortality was 8% (n = 29); mortality was valve-related in two cases. The mean follow up was 6.5 +/- 6.0 years (range: 1 month to 24 years); total follow up was 2,226 patient-years. Over 25 years, patient freedom from late mortality was 62%, and from valve-related mortality 78%. Freedom from thromboembolic events was 82% (93% from permanent defect), from bleeding events 76%, from endocarditis 98%, from valve thrombosis 99.9%, and from reoperation 98%. Six reoperations were carried out in five patients (2%), valve repair or replacement in five (2%), and suture closure of paravalvular leak in one patient (0.3%). There were no valve structural failures reported. CONCLUSION: The SJM valve has proven to be an effective and durable heart valve prosthesis. Over the long-term, the event rate is low and there is excellent freedom from reoperation in the double valve configuration.

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.