Seven-year results with the St Jude Medical Silzone mechanical prosthesis.

OBJECTIVE: The Artificial Valve Endocarditis Reduction Trial was stopped on January 21, 2000, due to a higher incidence of paraprosthetic leak in the St Jude Medical Silzone prosthesis compared with the conventional prosthesis. The Artificial Valve Endocarditis Reduction Trial investigators reported the 2-year results in 2002. This retrospective study assessed the influence on thromboembolism and paraprosthetic leak to 7 years. METHODS: A total of 253 patients had 254 operations: 80 aortic valve replacements, 139 mitral valve replacements, and 35 multiple replacements with placement of Silzone prostheses. The mean age was 58.6 years (range 21-84 years, median age 59.8 years), and there were 126 women (49.8%) and 74 concomitant procedures (coronary artery bypass 28.9%). RESULTS: Major paraprosthetic leak (repair, re-replacement, or mortality) occurred in 10 of the original procedures after 30 days (3 aortic valve replacements, 3 mitral valve replacements, 4 multiple replacements). Nine occurrences in 8 patients-5 early (2 years)-were managed. Seven were managed with definitive re-replacement. One was an early nonoperative fatality. There was 1 late fatality after the second late paraprosthetic leak reoperation. One of the 10 procedures occurring after 2 years had mild to moderate aortic valve replacement paraprosthetic leak managed as an incidental re-replacement at the time of correction of supra valvular patch stenosis. One additional occurrence, in addition to the 8 patients (<30 days), was considered a technical error and not related to the Silzone prosthesis and was replaced with a Silzone prosthesis. The linearized rate of paraprosthetic leak within the first 2 years of follow-up was 1.3%/patient-year and after 2 years was 0.4%/patient-year. The linearized occurrence rate for major thromboembolism was 0.42%/patient-year for aortic valve replacement and 1.71%/patient-year for mitral valve replacement. CONCLUSIONS: Paraprosthetic leak with the St Jude Medical Silzone prosthesis was managed both during the early (2years) intervals with re-replacement. Late managed events may be manifestations of earlier occurring paraprosthetic leak. Follow-up echocardiograms should meet standards of care, 6 to 12 months after surgery and at the slightest suspicion of dysfunction. There is no advanced continuing risk of the St Jude Medical Silzone prosthesis.

Effect of prosthesis-patient mismatch on long-term survival with mitral valve replacement: assessment to 15 years.

BACKGROUND: The effect of prosthesis-patient mismatch on long-term survival after mitral valve replacement (MVR) has received limited attention. This study was performed to determine the predictors of mortality after MVR and influence of prosthesis-patient mismatch on survival. METHODS: Contemporary mechanical prostheses and bioprostheses were implanted in 2,440 patients with MVR between 1982 and 2002. The mean age was 63.9 +/- 12.1 years and the mean follow-up was 6.1 +/- 4.6 years, a total of 14,797.7 years of follow-up. Prosthesis-patient mismatch was classified by effective orifice area index categories: normal, greater than 1.2 cm(2)/m(2) (345, 14.2%); mild-to-moderate, equal to or less than 1.2 to greater than 0.9 cm(2)/m(2) (1,696, 69.5%); and severe, equal to or less than 0.9 cm(2)/m(2) (399, 16.4%). RESULTS: The predictors of overall mortality were age, age categorization, New York Heart Association III-IV, concomitant coronary artery bypass, ventricular dysfunction, prosthesis type, body mass index, and pulmonary hypertension. All categories of effective orifice area indices (EOAIs) were not predictive of overall mortality, late mortality, or early mortality. The 15-year survival was not differentiated by EOAI categories; 32.0 +/- 4.4%, 32.9 +/- 2.1%, and 36.6 +/- 6.3%, respectively, for the three categories. Pulmonary hypertension influenced mortality by EOAI categories; normal versus mild-to-moderate (p = 0.0317) and normal versus severe (p = 0.0320). The EOAI was not an independent predictor of mortality in the consideration of patients with pulmonary hypertension but there is an interaction between pulmonary hypertension and mild-to-moderate (p = 0.023) and severe (p = 0.031) EOAI. CONCLUSION: Prosthesis-patient mismatch is not a predictor of overall mortality to 15 years after MVR regardless of the category of effective orifice area index. The preoperative variable, pulmonary hypertension, influences overall mortality in the presence of mild-to-moderate and severe prosthesis-patient mismatch in the survival analysis.

Predictors of recurrence and reoperation for prosthetic valve endocarditis after valve replacement surgery for native valve endocarditis.

OBJECTIVE: Surgical treatment of native valve endocarditis remains challenging, especially in cases with paravalvular destruction. Basic principles include complete debridement and reconstruction. This study is designed to evaluate the outcomes of surgical reconstruction of complex annular endocarditis using standard techniques and materials, including autologous and bovine pericardium. METHODS: From 1975 to 2000, 358 cases (357 patients, mean age 49 +/- 16 years, range 18-88 years) of native valve endocarditis were surgically managed. Bioprosthetic valves were implanted in 189 cases, and mechanical prostheses were implanted in 169 cases. A total of 78 cases of paravalvular destruction were identified: 62 annular abscesses, 8 fistulas, and 8 combined abscesses/fistulas. These were managed with 46 pericardial patches and 32 isolated suture reconstructions after radical debridement and prosthetic valve replacement. RESULTS: The overall early mortality was 8.4% (n = 30). The mortality with paravalvular destruction was 17.9%, and the mortality with simple leaflet infection was 5.7% (P = .001). The unadjusted survival at 20 years was 26.4% +/- 4.9% for bioprosthetic valves and 56.5% +/- 8.1% for mechanical prostheses (P = .007). The freedom from recurrent prosthetic valve endocarditis was 78.9% +/- 4.4% at 15 years. The freedom from reoperation for recurrent prosthetic valve endocarditis was 85.8% +/- 4.2% at 15 years. The freedom from reoperation after reconstruction for paravalvular destruction was 88.2% +/- 6.9% at 15 years. The freedom from mortality for recurrent prosthetic valve endocarditis was 92.7% +/- 3.4% at 15 years. The independent predictors of reoperation were age (hazard ratio 0.930, P = .005) and intravenous drug use/human immunodeficiency virus plus surgical technique (hazard ratio 12.8, P = .003 for patch reconstruction plus valve and hazard ratio 3.6, P = .038 for valve replacement only). Prosthesis type was not predictive when separated from intravenous drug use/human immunodeficiency virus (hazard ratio 3.268, P = .088). CONCLUSION: Paravalvular destruction is associated with a higher operative mortality. Native valve endocarditis can be managed with reasonable long-term survival and low rates of reinfection with radical debridement and pericardial reconstruction with bioprostheses and mechanical prostheses. The type of prosthesis implanted does not influence long-term outcome. Patients with a history of intravenous drug use and human immunodeficiency virus are at increased risk for recurrent infection and reoperation.

Carpentier-Edwards supra-annular aortic porcine bioprosthesis: clinical performance over 20 years.

OBJECTIVE: Experience with the Carpentier-Edwards supra-annular porcine bioprosthesis (Edwards Lifesciences, Irvine, Calif) has been evaluated longitudinally over 20 years. Clinical performance was evaluated by actuarial and actual analysis. Hemodynamic performance was evaluated by echocardiographic/Doppler assessment. Morphology of structural failure was evaluated from pathologic examinations. METHODS: From 1981 through 1999, 1823 patients (mean age, 68.9 +/- 10.9 years; range, 19-89 years) underwent 1847 procedures. Concomitant coronary artery bypass was performed in 788 (42.7%) patients. Previous valve procedures were performed in 107 (5.8%) patients, and other cardiac procedures were performed in 87 (4.7%) patients. RESULTS: The overall valve-related complication rate was 4.36% per patient-year (630 patients), with a fatality rate of 0.96% per patient-year (139 patients). Patient survival at 18 years was 15.8% +/- 1.6%. Overall late mortality rate was 6.3% per patient-year. Overall actual cumulative freedom at 18 years from reoperation was 85.0% +/- 1.2%, valve-related mortality was 88.7% +/- 1.1%, and valve-related residual morbidity was 96.3% +/- 5.0%. Actual freedom from structural valve deterioration at 18 years was 86.4% +/- 1.2% overall, 90.5% +/- 1.8% for age 61 to 70 years, and 98.2% +/- 0.6% for age greater than 70 years. Structural valve deterioration presented with pathologic evidence consistent with stenosis in 27.6% and insufficiency in 72.4%. Hemodynamic performance at 1 year revealed normal effective orifice area indexes for sizes 23 to 27 mm and mild-to-moderate reduction for size 21 mm. CONCLUSIONS: The Carpentier-Edwards supra-annular aortic porcine bioprosthesis continues to provide excellent freedom from structural valve deterioration and overall freedom from valve-related residual morbidity, mortality, and reoperation up to 18 years. Hemodynamic performance is satisfactory. The prosthesis remains recommended for patients older than 70 years and for patients 61 to 70 years of age, especially when comorbid risk factors are not anticipated to provide extended survival.

Medtronic mosaic porcine bioprosthesis: investigational center experience to six years.

BACKGROUND AND AIM OF THE STUDY: The findings of this single-center experience with the Medtronic Mosaic porcine bioprosthesis were evaluated to determine the clinical performance of the valve. METHODS: Between 1994 and 2000, a total of 657 patients was implanted with the prosthesis. Aortic valve replacement (AVR) was performed in 415 patients (mean age 70.5+/-10.7 years; range: 26-89 years) and mitral valve replacement (MVR) in 242 patients (mean age 70.5+/-9.5 years; range: 19-86 years). Concomitant coronary artery bypass (CAB) was performed in 51.1% and 46.7% of AVR and MVR patients, respectively. The majority of patients were aged over 70 years (59.8% AVR, 58.7% MVR). RESULTS: Survival at six years was 73.0+/-2.4% after AVR, and 74.0+/-5% after MVR (p = NS). Actual freedom from valve-related mortality at six years was 98+/-1% for AVR and 96+/-1% for MVR; freedom from overall thromboembolism (TE) was 86+/-3% for AVR and 89+/-2% for MVR. After AVR, 42 thromboembolic events occurred in 39 patients (23 minor; 14 major; three reversible ischemic neurologic deficits (RIND); two thrombosis). After AVR, the late TE rate was 2.1% per pt-yr, and the major rate 0.6% per pt-yr (exclusive of thrombosis). The overall TE rate after AVR was 2.9% per pt-yr (major rate 1% per pt-yr). After MVR, 25 events occurred in 24 patients (10 minor; eight major; five RIND; two thrombosis). After MVR, the late TE rate was 2.6% per pt-yr, and the major rate 0.7% per pt-yr (exclusive of thrombosis). The overall TE rate after MVR was 3.5% per pt-yr (major rate 1.1% per pt-yr). There were four cases of structural valve deterioration (SVD) (two each after AVR and MVR). Reoperation was performed in three of four cases of thrombosis, and in two of four cases of SVD. CONCLUSION: The Medtronic Mosaic porcine bioprosthesis is safe and effective. The rate of SVD after six years was low, being zero in the aortic position of patients aged >60 years, and zero also in the mitral position of patients aged <60 years. The incidence of early and late thromboembolism was contributed to by the advanced age of the patient population.