Twenty-year experience with the St Jude Medical mechanical valve prosthesis

BACKGROUND: We have prospectively followed all adult St Jude Medical mechanical valve recipients at the Medical University of South Carolina since the initial implant in January 1979 and now present our 20-year experience. METHODS: We prospectively followed 837 valve recipients (aortic valve replacement; n = 478; mitral valve replacement; n = 359) from January 1979 to December 2000 at 12-month intervals. RESULTS: Ages ranged from 19 to 84 years. Follow-up averaged (mean +/- standard deviation) 7 +/- 5 years (98% complete). Patients were in New York Heart Association class III or IV in 77% (aortic valve replacement) and 89% (mitral valve replacement) preoperatively. A 19-mm valve was implanted in 15.5% of aortic valve replacement patients. Coronary bypass was required in 31% of aortic valve replacements and 20% of mitral valve replacements. Operative mortality was 17/478 (3.6%) in aortic valve replacement and 19/359 (5.3%) in mitral valve replacement, and multivariable predictors were 19-mm valve size, 3 or more coronary bypass grafts, and New York Heart Association class IV for aortic valve replacement and New York Heart Association class IV and age for mitral valve replacement. Actuarial survivorship at 10 and 20 years was 57% +/- 3% and 26% +/- 5% for aortic valve replacement and 61% +/- 3% and 39% +/- 4% for mitral valve replacement. Multivariable predictors of late death were African-American ethnicity, New York Heart Association class III or IV, coronary bypass, and age for aortic valve replacement and New York Heart Association class III or IV, coronary bypass, and age for mitral valve replacement. For aortic valve replacement, effective orifice area was univariately (P =.002) but not multivariately (P =.378) predictive of late death. Structural valve deterioration was not observed. For aortic valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 93% +/- 1% and 90% +/- 2%; thromboembolism, 82% +/- 3% and 68% +/- 8%; bleeding events, 77% +/- 3% and 66% +/- 6%; prosthetic valve endocarditis, 94% +/- 1% and 94% +/- 1%; valve-related mortality, 94% +/- 2% and 86% +/- 4%; and valve-related mortality or morbidity, 58% +/- 3% and 32% +/- 8%. For mitral valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 96% +/- 1% and 90% +/- 3%; thromboembolism, 77% +/- 3% and 59% +/- 7%; bleeding events, 86% +/- 2% and 65% +/- 8%; prosthetic valve endocarditis, 98% +/- 1% and 96% +/- 2%; valve-related mortality, 89% +/- 0.2% and 74% +/- 8%; and valve-related mortality or morbidity, 63% +/- 3% and 29% +/- 7%. CONCLUSIONS: After 2 decades of observation with close follow-up, the St Jude Medical mechanical valve continues to be a reliable prosthesis.     

Twelve years of experience with the ATS mechanical heart valve prostheses

Objective

The ATS Open Pivot mechanical heart valve has been implanted routinely at our institution since 1999. The objective of this study is to retrospectively analyze our 12-year clinical results with ATS prostheses.

Methods

ATS Open Pivot mechanical valves were implanted in 268 adult patients between May 1999 and August 2010. We selected 259 subjects who could be adequately followed (follow-up rate 96.6?%). Aortic valve replacement was performed in 157 patients, mitral valve replacement (MVR) in 71, and double (aortic and mitral) valve replacements (DVR) in 31. Mean age at the time of implant was 58.8?±?10.6?years. The gender ratio was 128 males/131 females. Mean follow-up was 4.4?±?7.8?years, and the cumulative follow-up was 1144 patient-years (pt-yr).

Results

Early death within 30?days after the operation occurred in 5 (2.5?%) patients. Late death occurred in 27 patients including valve-related deaths in 13. The 10-year survival rate after the operation was 82.7?±?2.9?%. The rate of freedom from valve-related death was 92.2?±?2.2?%. The incidence of valve-related complications was 2.19?%/pt-yr. Of these, the incidence of thromboembolic events and that of bleeding complications were 1.22 and that 0.87?%/pt-yr. The incidence of valve thrombosis was 0.09?%/pt-yr. No structural valve deterioration was observed in any of the three operative procedure groups.

Conclusions

Our 12-year experience with aortic and MVR using the ATS mechanical heart valve demonstrated low incidences of thromboembolic events, bleeding complications, and valve thrombosis.     

Thirty-year experience with a bileaflet mechanical valve prosthesis

Background

The objective was to evaluate the long-term outcomes of the St Jude Medical (Saint Paul, Minn) mechanical valve prosthesis implantation.

Midterm evaluation of the Sorin Bicarbon heart valve prosthesis: single-center experience

BACKGROUND: The purpose of this study was to perform midterm evaluation of the clinical performance of the Sorin Bicarbon mechanical heart valve prosthesis. METHODS: From November 1992 to December 2002, 328 patients underwent isolated aortic (AVR; 156) or mitral (MVR; 172) valve replacement with the Sorin Bicarbon mechanical valve. Concomitant surgery was performed in 83 patients (25.2%). RESULTS: Total hospital mortality was 5.2%. Survival at 7 years was 79.5% for AVR and 82.4% for MVR. Kaplan-Meier freedoms from valve-related complications were as follows: thromboembolism 92.7% (AVR 94.8%, MVR 92.1%); bleeding 93% (AVR 91.9%, MVR 94.5%); nonstructural dysfunction 96.6% (AVR 94.7%; MVR 97.9%); endocarditis 97.7% (AVR 97.4%, MVR 98.1%); and reoperation 95.7% (AVR 96.6%, MVR 93.9%). Overall freedom from valve-related death was 93.2% (AVR 99.3%, MVR 91.2%). At the end of follow-up, 88.9% of survivors were in New York Heart Association class I or II. CONCLUSIONS: The Sorin Bicarbon valve is a satisfactory mechanical valve prosthesis with low mortality and morbidity and good functional results.     

Ten years' experience with the St. Jude Medical valve prosthesis

Records of 1,298 consecutive patients who had received the St. Jude Medical prosthesis were reviewed (713 male and 585 female patients; mean age, 61.79 +/- 13.4 years). Early mortality was 5.7% (74 patients). Ninety-three percent complete follow-up was accomplished for the 1,224 patients who left the hospital (4,306.50 patient-years). One hundred ninety-two of these patients died, a late mortality of 16.9%. Sixty-four patients experienced thromboembolic episodes (17 major and 35 permanent). Twenty-four patients had anticoagulant-related bleeding, 4 had valve thrombosis, 7 had prosthetic valve endocarditis, 9 had paravalvular leak, and 10 underwent reoperation. There was no structural valve failure in this series. Twenty-two of the 118 patients who had valve-related complications died; another 15 patients died of sudden and unknown causes. Therefore, the total number of valve-related deaths was 37. Of those patients who survived, New York Heart Association functional class improved significantly (98% in classes II and III preoperatively and 96% in classes I and II postoperatively). Linearized rates for thromboembolism, valve thrombosis, and anticoagulant-related bleeding were 1.49% +/- 0.19%, 0.09% +/- 0.05%, and 0.56% +/- 0.11%/100 patient-years, respectively. The actuarial estimate of incidence free from all complications, operative death, and valve-related death was 66.9% +/- 8.2% at the end of 9 years. In spite of old age and advanced heart disease, the patients who received the St. Jude Medical prosthesis had very good results over a 10-year period.     

Long-term experience with the St. Jude Medical valve prosthesis.

BACKGROUND: All patients undergoing St. Jude Medical valve replacement at the Medical University of South Carolina since January 1979 have been followed prospectively at 12-month intervals. METHODS: This report describes long-term experience in 710 adult patients undergoing isolated aortic (AVR) (418) or mitral valve replacements (MVR) (292) with this prosthesis from January 1979 to December 1996. RESULTS: Ages ranged from 19 to 84 years (54.8 +/- 15.1 AVR, 51.8 +/- 12.9 MVR; mean +/- SD). Male gender predominated in the AVR group (70%) and female gender in the MVR group (62%). One hundred and fifty-seven patients (22%) had associated coronary artery bypass grafting (AVR 27%, MVR 15%). Thirty-day operative mortality was 5.3% (22/418) in the AVR group and 5.1% (15/292) in the MVR group. Follow-up is 96.9% complete and ranges from 1 month to 16.9 years (AVR, 2,376 patient-years, mean 5.7 +/- 4.5 years; MVR, 1,868 patient-years, mean 6.4 +/- 4.8 years). In the AVR group, 120 late deaths have occurred and actuarial survival was 78.0 +/- 2.3%, 58.0 +/- 3.2%, and 36.8 +/- 4.8%; at 5, 10, and 15 years, respectively. Forty-six patients have sustained 55 thromboembolic (TE) events (2.3%/patient-year). Fifty-one patients had anticoagulant-related bleeding complications (2.7%/patient-year). The mean improvement in New York Heart Association (NYHA) functional class from preoperative to postoperative was 3.0 +/- 0.8 to 1.7 +/- 0.1 (p < 0.05). In the MVR group, there have been 84 late deaths, and the actuarial survival was 79.3 +/- 2.5%, 60.1 +/- 3.5%, and 49.3 +/- 4.1% at 5, 10, and 15 years, respectively. Fifty-two patients have had 64 TE events (3.5%/patient-year). Twenty-three patients had anticoagulant-related bleeding complications (1.6%/patient-year). The mean improvement in NYHA functional class was from 3.3 +/- 0.6 to 1.8 +/- 0.1. There were no mechanical failures in either group. CONCLUSIONS: With a follow-up now extending to 17 years, the St. Jude Medical valve continues to be a reliable mechanical prosthesis with low and stable rates of valve-related complications.     

Late results after mitral valve replacement with bileaflet mechanical prosthesis in children: evaluation of prosthesis-patient mismatch

BACKGROUND: Mechanical prosthesis is the choice of valve at the mitral position in children, although re-replacement of prostheses because of prosthesis-patient mismatch is almost inevitable when prostheses were implanted in small children. The methods to predict prosthesis-patient mismatch as a result of patients' somatic growth or pannus formation in children by noninvasive methods have not been well established. METHODS: Thirty-two children underwent mitral valve replacement with 37 bileaflet mechanical prostheses (26 St. Jude Medical prosthetic valves, and 11 CarboMedics prosthetic valves) and were followed up a mean of 6.8 years (maximum 18.3 years) with a complete follow-up rate of 94%. RESULTS: There were no operative deaths and 5 late deaths. Re-replacement of mitral valve because of prosthesis-patient mismatch was required in 5 patients. Freedom from valve-related events and re-replacement of mitral valve at 15 years were 32% +/- 23% and 54% +/- 18%, respectively. Actuarial survival rate was 63% +/- 19% at 15 years. Prosthetic valve orifice area index (manufactured geometric prosthetic valve area divided by patient's body surface area) was well correlated with maximum transprosthesis flow velocity estimated by Doppler echocardiography during follow-up, whereas valve orifice area index had no significant correlation with pulmonary artery wedge pressure assessed by cardiac catheterization. Maximum transprosthesis flow velocity had a significant correlation with pulmonary artery wedge pressure. CONCLUSIONS: Valve orifice area index itself was not a reliable index to predict prosthesis-patient mismatch. Maximum transprosthesis flow velocity was a useful index to predict pulmonary artery wedge. Invasive cardiac catheterization to determine re-replacement of the prosthesis should be considered when maximum transprosthesis flow velocity exceeds 270 cm/s.