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BACKGROUND: Acute renal failure (ARF) is a serious complication of valve replacement surgery. The aim of this study was to determine the predictors of early mortality and if causative factors are preventable. METHODS: In the 25-year period between 1977 and 2002, 255 (2.6%) of 9721 patients (11,007 operations), who had valve replacement surgery, were managed for ARF with dialysis. The mean age of the patient population was 67.1 +/- 11.6 years (range 24 to 87 years, median 70.3 years). Fifty preoperative, operative, and postoperative risk factors were assessed as predictors of early mortality by univariate and multivariate modeling. RESULTS: The early mortality was 25.1% (64 patients). The predictors by univariate analysis were: New York Heart Association class (p = 0.001); ASA within 5 days (p = 0.030); cardiogenic shock (p = 0.010); infection--perioperative sepsis and preoperative endocarditis (p = 0.000); intraoperative stroke (p = 0.003); status--emergent (p = 0.000); mitral valve replacement (p = 0.040); ischemic (X-clamp) time >120 minutes (p = 0.020); cardiopulmonary bypass time >180 minutes (p = 0.000); surgical time >360 minutes (p = 0.000); surgical hemorrhage (p = 0.020); acute respiratory distress syndrome (ARDS) (p = 0.040). Multivariate predictors were urgent status of operation, odds ratio (OR) 0.3 (p = 0.029); emergent status of operation, OR 5.8 (p = 0.034); ischemic (X-clamp) time >120 minutes, OR 4.4 (p = 0.030); surgical time >360 minutes, OR 6.3 (p = 0.019); surgical hemorrhage, OR 5.1 (p = 0.003); perioperative nosocomial sepsis, OR 3.8 (p = 0.006); and preoperative endocarditis, OR 4.4 (p = 0.004). CONCLUSIONS: Early mortality from ARF in valve replacement surgery is related to emergent status, ischemic and surgical times, surgical hemorrhage, and nosocomial infection/preoperative endocarditis. Among the variables assessed, preoperative renal insufficiency, unstable angina/recent myocardial infarction <6 weeks, and concomitant coronary artery bypass were not predictive. The evaluation of predictors of ARF requires further extensive assessment. [ABSTRACT FROM AUTHOR]

Background and Aim of the Study: Increased life expectancy has resulted in the elderly frequently presenting with severe aortic stenosis. It has therefore become important to define indications for conventional aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) in this patient population. Thus, patients aged > or = 70 years undergoing conventional isolated AVR were evaluated for predictors of early and late mortality., Methods: A retrospective analysis was conducted of prospectively collected data available from 1,061 consecutive patients (age range: 70-94 years) who underwent isolated AVR between 1982 and 2002. The patient age groups were 70-74 years (n = 466), 75-79 years (n = 367), and > or = 80 years (n = 228). The mean follow up was 6.0 +/- 4.4 years, and the total follow up 6,390 patient-years. Twenty-two variables were considered as potential risk factors for early and late mortality., Results: Early mortality was higher in patients aged > or = 80 years than in those aged 70-79 years. Early mortality in patients aged > or = 80 years was lower between 1998 and 2002 than between 1982 and 1997. Multivariate predictors of early mortality were age > or = 80 years, operative status, previous intervention, renal failure, and mitral regurgitation. The early nonfatal complication rate was similar for patients aged 70-79 years and > or = 80 years, but late mortality was lower between 1998 and 2002 than between 1982 and 1997 in patients aged 70-79 years, and in those aged > or = 80 years. The 10-year actuarial survivals after AVR in patients aged 70-74, 75-79, and > or = 80 years were 54 +/- 3.0%, 43 +/- 3.8% and 17 +/- 3.9%, respectively. Multivariate predictors of late mortality were age 75-79 years, age > or = 80 years, peripheral vascular disease (PVD) and chronic obstructive pulmonary disease (COPD). Female gender was shown to be protective., Conclusion: Early mortality was higher in patients aged > or = 80 years undergoing AVR, though this has declined recently and is currently at an acceptable level. Other important predictors of mortality in elderly patients undergoing AVR are operative status, previous interventions, renal failure, mitral regurgitation, male gender, PVD, and COPD. Thus, conventional AVR remains a safe treatment option for the elderly patient.

Objective: To assess the influence of gender on mortality after aortic valve replacement for aortic stenosis., Methods: A retrospective analysis was performed on data prospectively collected from all patients undergoing aortic valve replacement for aortic stenosis. Multivariate regression analysis was performed to evaluate the effect of 22 preoperative and operative variables on early, late, and overall mortality., Results: Aortic valve replacement was performed in 3343 patients with aortic stenosis between 1982 and 2003. The female patients were older, with a smaller body mass index. The women were less likely to have diabetes, chronic obstructive pulmonary disease, previous myocardial infarction, or left ventricular ejection fraction <35% but were more likely to have hypertension or a New York Heart Association III-IV classification. The female patients received a smaller prosthetic valve, with a smaller effective orifice area index (EOAI). The mean follow-up period was 6.18 ± 4.96 years, with a total of 2066.142 years of follow-up. The independent predictors of early mortality for the male patients included age, concomitant surgical revascularization, congestive heart failure, and valve size of ≤21 mm. The independent predictors of late mortality for the male patients included age, concomitant surgical revascularization, diabetes, renal failure, chronic obstructive pulmonary disease, congestive heart failure, and a bioprosthetic valve. The independent predictors of overall mortality for the male patients included age, concomitant surgical revascularization, diabetes, renal failure, heart failure, and valve size of ≤21 mm. For the female patients, the risk factors for early mortality included body mass index <25 kg/m(2); for late mortality included age, concomitant surgical revascularization, New York Heart Association class III-IV, and diabetes; and for overall mortality included age, concomitant surgical revascularization, New York Heart Association class III-IV, and renal failure. Furthermore, male gender was an independent predictor of late (but not early or overall) mortality., Conclusions: The independent predictors of mortality after aortic valve replacement for aortic stenosis differed between the male and female patients. Male gender increased the risk of late mortality, and a valve size of ≤21 mm increased the risk of early and overall mortality among the male patients only. These differences need to be taken into consideration preoperatively and require consideration during operative management., (Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: The Mosaic porcine bioprosthesis (Medtronic, Inc, Minneapolis, Minn) was approved in 2000 by the US Food and Drug Administration. Clinical performance was evaluated in 6 centers., Methods: From 1994 to 2000, 797 patients (mean age 69 years) had aortic valve replacement (AVR) and 232 (mean 67 years) had mitral valve replacement (MVR). Concomitant coronary artery bypass grafting was performed with aortic valve replacement (45.4%) and mitral valve replacement (43.5%). Mean follow-ups were 7.5 years for aortic position and 7.3 years for mitral position., Results: Early mortalities were 2.8% for AVR and 3.0% for MVR. Late mortalities were 4.2%/patient-year for AVR and 5.1%/patient-year for MVR. Overall 12-year survivals were 55.8% ± 3.7% for AVR and 43.9% ± 7.4% for MVR. Twelve-year freedoms from valve-related mortality were 87.1% ± 3.1% for AVR and 82.5% ± 7.7% for MVR. Twelve-year freedoms from reoperation were 84.0% ± 3.3% for AVR and 82.5% ± 7.5% for MVR. Freedoms from structural valve deterioration (SVD) by explant reoperation at 12 years for AVR were 93.3% ± 2.6% for patients at least 60 years old and 75.9% ± 9.3% for patients younger than 60 years. Freedoms from SVD by explant reoperation at 10 years for MVR were 95.3% ± 7.8% for patients at least 70 years old and 84.0% ± 9.3% for patients younger than 70 years. Hemodynamic performance data at 1 year for AVR (sizes 21-27 mm) were mean systolic gradient range 13.7 ± 4.8 to 10.3 ± 3.2 mm Hg and effective orifice area range 1.5 ± 0.3 to 2.5 ± 0.4 cm(2). For MVR (sizes 25-31 mm), data were mean diastolic gradient range 6.7 ± 1.7 to 3.7 ± 0.9 mm Hg and effective orifice area range 1.9 ± 0.3 to 2.4 ± 0.6 cm(2)., Conclusions: Overall performance of Mosaic porcine bioprosthesis to 12 years is satisfactory. Freedoms from SVD by explant reoperation were most satisfactory for aortic position in patients at least 60 years old and mitral position in patients at least 70 years old. Overall actuarial freedom from SVD by explant reoperation is encouraging for patients with MVR., (Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: The St Jude Medical Epic heart valve (St Jude Medical, Inc, St Paul, Minn) is a tricomposite glutaraldehyde-preserved porcine bioprosthesis. The St Jude Medical Biocor porcine bioprosthesis is the precursor valve to the St Jude Medical Epic valve. The Epic valve is identical to the Biocor valve except that it is treated with Linx AC ethanol-based calcium mitigation therapy., Methods: The St Jude Medical Epic valve was implanted in 761 patients (mean age 73.9 ± 9.2 years) between 2003 and 2006 in the US Food and Drug Administration regulatory study in 22 investigational centers. The position distribution was 557 aortic valve replacements, 175 mitral valve replacements, and 29 double valve replacements. Concomitant coronary artery bypass grafting was performed in 50.8% of patients undergoing aortic valve replacement and 36.6% of those undergoing mitral valve replacement., Results: The early mortality was 3.6% in aortic and 2.3% in mitral valve replacement. The follow-up was 1675.5 patient-years with a mean of 2.2 ± 1.2 years/patient. Late mortality was 5.2%/patient-year in aortic and 6.6%/patient-year in mitral valve replacement. The late major thromboembolism rate was 0.98%/patient-year for aortic and 2.6%/patient-year for mitral valve replacement. There were 19 reoperations, including 2 for structural valve deterioration, 1 for thrombosis, 9 for nonstructural dysfunction, and 7 for prosthetic valve endocarditis. The actuarial freedom from reoperation owing to structural valve deterioration for aortic valve replacement at 4 years for age 60 years or less was 93.3% ± 6.4%; for ages 61 to 70 years, 98.1% ± 1.9%; and for older than 70 years, 100% (P = .0006 > 70 vs ≤ 60 years). There were no events of structural deterioration with mitral valve replacement. The actuarial freedom from major thromboembolism for all patients at 4 years was 93.6% ± 1.0%. The 2 cases of structural valve deterioration occurred in aortic valves that became perforated without calcification causing aortic regurgitation., Conclusions: The performance of the St Jude Medical Epic porcine bioprosthesis is satisfactory at 4 years for both aortic and mitral valve replacement. This study establishes the early clinical performance including durability of this porcine bioprosthesis., (Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: Long-term thromboembolic and hemorrhagic outcomes after mechanical valve replacement have been well described; however, few studies have described these outcomes after valve replacement with the On-X mechanical prosthesis (On-X Life Technologies, Inc, Austin, Tex)., Methods: Between 2003 and 2008, 737 patients underwent either aortic valve replacement (n = 400), mitral valve replacement (n = 282), or double-valve replacement (n = 55). Longitudinal performance, freedom evaluation, and risk analysis were assessed with regard to major thromboembolism and hemorrhage. Risk modeling was performed with 16 variables inclusive of age, atrial fibrillation, concomitant coronary artery bypass grafting, New York Heart Association class, and ventricular dysfunction., Results: Early mortality was 2.5% (n = 10) for aortic valve replacement and 3.2% (n = 9) for mitral valve replacement. Late mortality for aortic valve replacement was 4.8% per patient-year and 6.0% per patient-year for mitral valve replacement. Five-year freedom from major thromboembolism was 96.5% ± 1.2% for aortic valve replacement and 97.7% ± 0.9% for mitral valve replacement. Five-year freedom from hemorrhage was 93.6% ± 1.8% for aortic valve replacement and 95.7% ± 1.5% for mitral valve replacement. Concomitant coronary artery bypass grafting was predictive of major thromboembolism after aortic valve replacement (hazard ratio, 5.3; P = .02) and antithrombotic hemorrhage after mitral valve replacement (hazard ratio, 4.7; P = .03). No other independent predictors of major thromboembolism or hemorrhage were identified. One thrombosed mitral prosthesis was observed after deliberate discontinuation of anticoagulation. The major thromboembolic events occurred with variation of international normalized ratio levels inclusive of subtherapeutic levels. The majority of hemorrhagic events occurred with high international normalized ratio levels., Conclusions: The On-X mechanical prosthesis provides favorable intermediate-term results with regard to major thromboembolism and hemorrhage., (Copyright © 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Since the 2006 Surgical Technology International monograph on valvular prostheses, there have been significant developmental and investigative advances, particularly for transcatheter implantation. Aortic bioprostheses and mechanical prostheses continue to incorporate design changes to optimize hemodynamics and prevent prosthesis-patient mismatch and to have a potential satisfactory influence on survival. There have been continual technological improvements striving to bring forward advances that improve the durability of bioprostheses and reduce the thrombogenicity of mechanical prostheses. There also has been a continuance to preserve biological tissue with glutaraldehyde, rather than clinically evaluate other cross-linking technologies, by controlling or retarding calcification with therapies to control phospholipids and residual aldehydes. The techniques of mitral valve reconstruction have now been well established, and annuloplasty rings have been designed for the potential of maintaining the anatomical and physiological characteristics of the mitral annulus. There has been limited advancement in the past four years for interventional annuloplasty, for remodeling of the length and shape of the dilated annulus, prevention of dilatation of the annulus, and support for the potentially fragile area after partial-leaflet resection. Currently, there continues to be emergence of catheter-based therapies, particularly for management of aortic stenosis but not mitral regurgitation. For management of selected populations with critical aortic stenosis, the techniques for aortic valve substitution have had further advancement for retrograde catheter techniques, as well as apical transventricular implantation. There has not been significant advancement during the past four years to address mitral regurgitation by experimental transcoronary sinus, stent-like devices and transventricular, edge-to-edge leaflet devices. The devices, descriptions, and pictorial images comprising this monograph have been limited to technologies that are considered to be predominant, at least for the immediate duration. The general purpose of the monograph is to serve as an educational document.

Background: We performed the first human case of successful transapical transcatheter aortic valve implantation on a beating heart in October 2005, and therefore we have the longest follow-up on transapical aortic valve implantation in humans. We now report clinical and echocardiographic outcomes of transapical aortic valve implantation in 71 patients., Methods: Between October 2005 and February 2009, 71 patients (44 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement owing to unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-ups were performed before discharge, at 1 and 6 months, and then yearly. The mean follow-up was 12.9 +/- 11.5 months with a total of 917.3 months of follow-up., Results: Mean age was 80.0 +/- 8.1 years and predicted operative mortality was 34.5% +/- 20.4% by logistic EuroSCORE and 12.1% +/- 7.7% by The Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Twelve patients died within 30 days (30-day mortality: 16.9% in all patients, 33% in the first 15 patients, and 12.5% in the remainder), and 10 patients died subsequently. Overall survival at 24 and 36 months was 66.3% +/- 6.4% and 58.0% +/- 9.5%, respectively. Among 59 patients who survived at least 30 days, 24- and 36-month survivals were 79.8% +/- 6.4% and 69.8% +/- 10.9%, respectively. Late valve-related complications were rare. New York Heart Association functional class improved significantly from preoperative 3.3 +/- 0.8 to 1.8 +/- 0.8 at 24 months. The aortic valve area and mean gradient remained stable at 24 months (1.6 +/- 0.3 cm(2) and 10.3 +/- 5.9 mm Hg, respectively)., Conclusion: Our outcome suggests that transapical transcatheter aortic valve implantation provides sustained clinical and hemodynamic benefits for up to 36 months in selected high-risk patients with symptomatic severe aortic stenosis., (2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Documentation of the hemodynamics of the Mitroflow aortic pericardial bioprosthesis has been incomplete. The aim of the study was to provide reference effective orifice areas for the implant calculation of effective orifice area indexes to avoid prosthesis-patient mismatch., Methods: Echocardiograms were evaluated in 55 patients (39 females, 16 males), mean age 77.0 +/- 6.9 years (range 51-90 years). The mean time of the studies was 11.0 months. The prosthesis sizes and numbers evaluated were 19 mm (n = 13), 21 mm (n = 19), 23 mm (n = 13) and 25 mm (n = 10)., Results: Peak aortic velocities averaged from 2.2 to 2.7 m/sec, mean gradients from 10.6 to 15.1 mmHg, peak gradients from 20.7 to 29.7 mmHg, and effective orifice area (EOA) from 1.4 to 1.8 cm (2). When accounting for the subaortic velocity, mean gradients averaged from 7.5 to 10.0 mmHg, and peak gradients averaged 15.1 to 23.5 mmHg. The effective orifice area indexes ranged from 0.8 to 1.0 cm (2)/m (2). The mean postoperative left ventricular mass index was 101.6 gm/m (2)., Conclusions: The IN VIVO effective orifice areas by valve size of the Mitroflow aortic pericardial bioprosthesis provide the opportunity of avoiding obstructive characteristics for all valve sizes, including optimizing the management of the small aortic annulus.

Background: The effect of prosthesis-patient mismatch on long-term survival after aortic valve replacement has received considerable attention but there remains controversy. This study was performed to determine the predictors of mortality after aortic valve replacement and influence of prosthesis-patient mismatch on survival., Methods: Contemporary mechanical prostheses and bioprostheses were implanted in 3,343 patients with aortic valve replacement between 1982 and 2003. The mean age was 68.06 +/- 11.20 years (median 70.06; range, 19 to 94), and the mean follow-up was 6.18 +/- 4.96 years, for a total of 20,666 years of follow-up. Prosthesis-patient mismatch was classified by effective orifice area index categories: normal (> 0.85 cm(2)/m(2)), 1,547 (46.3%); mild-to-moderate (> 0.65 cm(2)/m(2) to < or = 0.85 cm(2)/m(2)), 1,584 (47.4%); and severe (< 0.65 cm(2)/m(2)), 212 (6.3%)., Results: The predictors of overall mortality were age, age categorization, New York Heart Association functional class III/IV, concomitant coronary artery bypass graft surgery, prosthesis type, preoperative congestive heart failure, diabetes mellitus, renal failure, and chronic obstructive pulmonary disease. All categories of effective orifice area indexes were not predictive of overall mortality, late mortality, or early mortality. The 15-year overall survival was differentiated by effective orifice area index categories: 38.1% +/- 2.1%, 37.0% +/- 2.2%, and 22.1% +/- 6.5%, respectively, for the three categories. Survival adjusted for the covariates (effective orifice area index, age, basal mass index, and ejection fraction) determined no effect except severe effective orifice area index when adjusted for ejection fraction more than 50% (p = 0.049)., Conclusions: Prosthesis-patient mismatch is not a predictor of overall standard unadjusted mortality to 15 years after aortic valve replacement, regardless of the category of effective orifice area index., (2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Advancing life expectancy with the increased prevalence of aortic valve degenerative disease brings the need for an aortic bioprosthesis with excellent haemodynamic performance and comparable durability. The Mitroflow bioprosthesis has been on the worldwide market, except in the United States, since 1982, while the current model (1991) has only recently gained regulatory approval in the latter country. This study was primarily performed to determine the durability of the current Mitroflow bioprosthesis., Methods: The contemporary Mitroflow bioprosthesis was implanted in 381 patients in three centres. The mean age was 76.4 years (range 53-91 years) and the mean follow-up period was 5.4+/-3.4 years, a total of 2048.7 years of evaluation. Prosthesis-patient mismatch (PPM) was classified by reference effective orifice area index categories: normal > or = 0.85 cm(2) m(-2) (53.9%), mild 0.84-0.76 cm(2) m(-2) (33.9%), moderate < or = 0.75-0.66 cm(2) m(-2) (11.7%) and severe < or = 0.65 cm(2) m(-2) (0.5%)., Results: The survival, at 10 years, was 39.9+/-7.9% for 50-69 years, 27.0+/-3.7% for 70-79 years and 16.6+/-4.4% for > or = 80 years (p=0.011). There was a trend (p=0.063) influencing survival for moderate-to-severe PPM. Of the independent predictors influencing survival--moderate-to-severe projected effective orifice area index (pEOAI) (Hazard Ratio (HR) 1.6, p=0.0142) and left ventricular dysfunction (ejection fraction < 35%) (HR 1.9, p=0.0193) were included. The 10-year freedom from structural valve deterioration (SVD) at explant assessing the same age groups as survival was not different (p=0.081). The 10-year actual/actuarial freedom from SVD, at explant was for > or = 60 years--94.4+/-1.4% (85.2+/-3.9%), for > or = 65 years--94.2+/-1.4% (85.0+/-4.0%), for 61-70 years--97.4+/-2.6% (95.7+/-4.3%) and for > 70 years--94.0+/-1.5% (83.2+/-4.6%)., Conclusions: The Mitroflow external mounted, pericardial aortic bioprosthesis with documented excellent haemodynamics (especially for the small aortic root), demonstrates that prosthesis-patient mismatch in moderate and severe categories can essentially be eliminated, with durability performance comparable to other heterograft (porcine and pericardial) bioprostheses.

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.

Objective: Although the results of aortic valve replacement with different valve prostheses are well documented in terms of survival, the risks of (valve-related) events are less well explored., Methods: We used a dataset of 3934 patients who underwent aortic valve replacement with either a bioprosthesis (73%) or a mechanical prosthesis (27%) between 1982 and 2003 to simulate the outcome of patients after aortic valve replacement with either valve type. With the use of microsimulation, we compared total age and gender-specific life expectancy, event-free life expectancy, reoperation-free life expectancy, lifetime risks of reoperation, and valve-related events for both valve types., Results: The total follow-up was 26,467 patient-years. The mean follow-up was 6.1 years in the biological arm and 8.5 years in the mechanical arm. The mean age at implantation was 70 and 58 years for biological and mechanical prostheses, respectively, and the percentage of concomitant coronary artery bypass grafting was 47% and 28%, respectively. For a 60-year-old man, simulated life expectancy in years for biological versus mechanical prostheses was 11.9 versus 12.2, event-free life expectancy was 9.8 versus 9.3, and reoperation-free life expectancy was 10.5 versus 11.9. Lifetime risk of reoperation was 25% versus 3%. Lifetime risk of bleeding was 12% versus 41%., Conclusion: Even for patients aged 60 years, event-free life expectancy is better with a bioprosthesis. Although the chance of reoperation is higher, the lifetime risk of bleeding is lower compared with a mechanical prosthesis. Comparing lifetime event risks between different types of valve prostheses provides more insight into patient outcome after aortic valve replacement and aids patient selection and counseling.

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.

Objective: : This meta-analysis sought to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement., Methods: : A comprehensive search was undertaken to identify all randomized and nonrandomized controlled trials comparing stentless to stented bioprosthetic valves in patients undergoing aortic valve replacement available up to March 2008. The primary outcomes were clinical and resource outcomes in randomized controlled trial (RCT). Secondary outcomes clinical and resource outcomes in nonrandomized controlled trial (non-RCT). Odds ratios (OR), weighted mean differences (WMD), or standardized mean differences and their 95% confidence intervals (CI) were analyzed as appropriate., Results: : Seventeen RCTs published in 23 articles involving 1317 patients, and 14 non-RCTs published in 18 articles involving 2485 patients were included in the meta-analysis. For the primary analysis of randomized trials, mortality for stentless versus stented valve groups did not differ at 30 days (OR 1.36, 95% CI 0.68-2.72), 1 year (OR 1.01, 95% CI 0.55-1.85), or 2 to 10 years follow-up (OR 0.82, 95% CI 0.50-1.33). Aggregate event rates for all-cause mortality at 30 days were 3.7% versus 2.9%, at 1 year were 5.5% versus 5.9% and at 2 to 10 years were 17% versus 19% for stentless versus stented valve groups, respectively. Stroke or neurologic complications did not differ between stentless (3.6%) and stented (4.0%) valve groups. Risk of prosthesis-patient mismatch was numerically lower in the stentless group (11.0% vs. 31.3%, OR 0.30, 95% CI 0.05-1.66), but this parameter was reported in few trials and did not reach statistical significance. Effective orifice area index was significantly greater for stentless aortic valve compared with stented valves at 30 days (WMD 0.12 cm/m), at 2 to 6 months (WMD 0.15 cm/m), and at 1 year (WMD 0.26 cm/m). Mean gradient at 1 month was significantly lower in the stentless valve group (WMD -6 mm Hg), at 2 to 6 month follow-up (WMD -4 mm Hg,), at 1 year follow-up (WMD -3 mm Hg) and up to 3 year follow-up (WMD -3 mm Hg) compared with the stented valve group. Although the left ventricular mass index was generally lower in the stentless group versus the stented valve group, the aggregate estimates of mean difference did not reach significance during any time period of follow-up (1 month, 2-6 months, 1 year, and 8 years)., Conclusions: : Evidence from randomized trials shows that subcoronary stentless aortic valves improve hemodynamic parameters of effective orifice area index, mean gradient, and peak gradient over the short and long term. These improvements have not led to proven impact on patient morbidity, mortality, and resource-related outcomes; however, few trials reported on clinical outcomes beyond 1 year and definitive conclusions are not possible until sufficient evidence addresses longer-term effects.

Objective: : The purpose of this consensus conference was to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement, and to outline evidence-based recommendations for the use of stentless and stented bioprosthetic valves in adult aortic valve replacement., Methods: : Before the consensus conference, the best available evidence was reviewed in that systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance. At the consensus conference, evidence-based statements were created, and consensus processes were used to determine the ensuing recommendations. The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of recommendation., Results and Recommendations: : Seventeen randomized studies published in 23 articles involving 1317 patients, and 14 nonrandomized trial published in 18 articles involving 2485 patients were included in the meta-analysis and consensus conference. All randomized trials inserted the stentless bioprosthetic valves in the subcoronary configuration. The consensus panel agreed upon the following statements and recommendations in patients undergoing aortic valve replacement:Because there were no randomized control trial comparing subcoronary stentless prosthetic valve and root replacement, the following recommendations are derived from expert opinion:

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.

Objective: The durability of mitral bioprostheses has long been known to be inferior to aortic bioprostheses. Mitral valve reconstruction/repair is currently recommended for most mitral valve procedures. The choice of prostheses for non-reparable or failed mitral valve repairs has not been specified or given appropriate attention within the literature. The objective of this study is to address the role of bioprostheses in the specific subset of non-reparable or failed repair patients by using the knowledge of the general durability of mitral porcine bioprostheses, inclusive of the Carpentier-Edwards mitral porcine bioprosthesis., Methods: The CE-SAV was implanted in 1135 patients (1175 operations) for mitral valve replacement (MVR) from 1982 to 2000. The mean age was 65.0+/-12.1 years (range 13-86 years). The mean follow-up was 6.4+/-4.5 years, 7555.9 patient-years and 98.3% complete. The evaluation considered freedom from structural valve deterioration (SVD) and freedom from composites of complications, as well as risk assessment., Results: For the 51-60 year age group, the actual and actuarial freedom from SVD was, at 18 years, 56.0+/-4.1% and 14.7+/-5.8%; for the 61-70 year age group was, at 18 years, 69.6+/-2.6% and 26.5+/-5.9%, respectively. For the >70 group, at 15 years was 92.2+/-2.0% and 69.0+/-9.7%, respectively. There were a total of 256 SVD events with 31 fatalities and 226 reoperations with 10 fatalities (4.42%). The predictors of SVD were age (hazard ratio [HR] 0.98, p=0.0002), concomitant CAB (HR 0.66, p=0.020) and valve size (HR 1.08, p=0.034). The overall actual freedom, at 15-18 years, for >70 age group was, for valve-related reoperation, 94.3+/-1.5%; and for valve-related mortality was 87.8+/-2.3%., Conclusions: The CE-SAV mitral porcine bioprosthesis cannot be recommended as representative of prosthesis-type of choice for non-reparable or failed repair of native mitral valves for ages 70 years of age. The clinical performance of the CE-SAV is similar to other mitral bioprostheses.

Background: The purpose of this study was to carry out a current assessment of the Mitroflow pericardial bioprosthesis (model 11) according to the durability of the prosthesis after 15 years in patients aged 60 years or older., Methods: This bioprosthesis was implanted in 161 patients (mean age 69.5 +/- 6.3 years; range 60 - 94 years) undergoing aortic valve replacement (AVR) between 1982 and 1992. There were 84 patients aged 60 - 69 years (mean 64.5 +/- 3.1years) and 77 patients aged 70 years or older (mean 74.8 +/- 4.3 years). Of the total population, concomitant procedures were performed in 63 patients (39.1 %); of these, coronary artery bypass grafting was performed in 39 (24.2 %)., Results: Early mortality was 4.8 % (4 patients) in the 60 - 69 year age group and 10.4 % (8) in patients aged 70 years or older ( P = 0.290). Late mortality was 4.5 %/patient-year (35) for those aged 60 - 69 years and 8.1 %/patient-year (49) for those aged 70 years or older ( P = 0.007). Patient survival at 15 years of patients aged 60 - 69 years was 47.6 +/- 6.3 % and of patients aged 70 years or older was 20.9 +/- 5.4 % ( P = 0.003) ( ). Freedom from valve-related mortality for patients in the 60 - 69 year age group was 92.1 +/- 3.5 % at 15 years (0.6 %/patient-year [5]), and in the patient group aged 70 years or older it was 84.4 +/- 5.3 % (1.3 %/patient-year [8]; P = 0.194). Freedom from reoperation for patients in the 60 - 69 year age group was 73.9 +/- 5.0 % (2.6 %/patient-year [20]), and for patients aged 70 years or older it was 91.4 +/- 3.4 % (1.0 %/patient-year [6]; P = 0.029). The structural valve deterioration (SVD) rate for patients in the 60 - 69 year age group was 2.4 %/patient-year (19), and for patients aged 70 years or older it was 1.0 %/patient-year (6) ( P = 0.041). Actuarial freedom from structural valve deterioration at 15 years for patients aged 60 - 69 years was 62.0 +/- 7.3 %, and 80.8 +/- 7.9 % for patients aged 70 years and older ( P = 0.049) (actual freedom 73.9 +/- 5.2 % and 91.4 +/- 3.4 %, respectively)., Conclusions: The Mitroflow pericardial bioprosthesis can still be recommended for aortic valve replacement in patients 70 years and older.

Objective: Numerous reports have been published documenting the results of aortic valve replacement. It is often not easy to translate these outcomes involving the condition of the valve into the actual consequences for the patient. We previously developed an alternative method to study outcome after aortic valve replacement that allows direct estimation of patient outcome after aortic valve replacement: microsimulation modeling. The goal of this article is to provide insight into microsimulation methodology and to give an overview of the advantages and disadvantages of simulation methods (in particular microsimulation) in comparison with standard methods of outcome analysis., Methods: By using a primary dataset containing 1847 patients and 14,429 patient-years, advantages and disadvantages of standard methods of outcome analysis are discussed, and the potential role of microsimulation is illustrated by means of a step-by-step explanation of building, testing, and using such a model., Results: Total life expectancy, event-free life expectancy, and reoperation-free life expectancy for a 65-year-old male patient were 10.6 years, 9.2 years, and 9.8 years, respectively. Lifetime risk of reoperation due to structural valve deterioration was 13.3%., Conclusions: Microsimulation is capable of providing accurate estimates of age-related life expectancy and lifetime risk of reoperation for patients who underwent aortic valve replacement with the Carpentier-Edwards supra-annular valve. It provides a useful tool to facilitate and optimize the choice for a specific heart valve prosthesis in a particular patient.

Background: Consensus reports over the past 10 years from the United States, Europe, United Kingdom, and Canada have not provided consistent guidelines for antithrombotic therapy of aortic valve bioprostheses for the three-month period after surgery. This study was conducted to determine if antithrombotic therapy was protective against TE with aortic bioprostheses 30 days or less after aortic valve replacement (AVR)., Methods: From 1994 to 2000, 1,372 patients implanted with three currently marketed aortic bioprostheses, Medtronic Mosaic (Medtronic, Inc, Minneapolis, MN) (415 patients), Carpentier-Edwards SAV (462), and Carpentier-Edwards PERIMOUNT (495) (Edwards Lifesciences, Irvine, CA), with a mean age of greater than 70 years were evaluated. Patient populations were comparable, inclusive of concomitant coronary artery bypass grafting (CABG) for the overall populations and for patients greater than 70 years., Results: There were 37 thromboembolic (TE) events: major TE, 14; reversible ischemic neurologic deficit (RIND), 12; and minor TE, 11. There were 4 TE deaths. Multivariate (stepwise logistic regression) analysis revealed no predictive risk factors for overall TE. For the combination of major TE plus RIND there were two predictive risk factors with analysis of 12 risk variables: preoperative cerebrovascular accident (odds ratio [OR] 4.45, 95% confidence interval [CI] 1.17 to 16.87, p = 0.028); and concomitant CABG (OR 3.19, 95% CI 1.16 to 8.76, p = 0.025). Neither anticoagulant nor antiplatelet therapies gave significant protection., Conclusions: There does not appear to be an indication for routine antithrombotic management. The study supports the potential use of antithrombotic therapy for comorbidities of preoperative cerebrovascular accident and concomitant CABG but not atrial fibrillation, left ventricular dysfunction, or elderly age greater than 70 years. Vascular burden and advanced age are likely contributing factors to these independent predictors. There may still be a need for, or at least consideration of, a randomized trial for AVR with bioprostheses.

Background: The fate of bioprostheses (BP) and mechanical prostheses (MP) after valve re-replacement for bioprostheses is not well-documented. This research compares the late fate of these two valve types after valve re-replacement for structural valve deterioration (SVD) of a bioprosthesis., Methods: Between 1975 and 2000, 298 patients had successful aortic valve re-replacements (AVRR) (BP n = 149, average age = 67.1 +/- 12.3 years; MP 149, 58.9 +/- 10.9) and 442 patients had successful mitral valve re-replacements (MVRR) (BP 155, 65.8 +/- 14.1; MP 287, 60.8 +/- 11.7) after SVD of a previous BP. Follow-up was five years in all groups., Results: (1) Aortic position (AVRR): Survival favored MP over BP overall, at 10 years (70.3 +/- 5.4% vs 56.7 +/- 5.7%, p = 0.0220). This survival advantage was seen to be significant only in patients less than 60 years of age (at 10 years, 85.3 +/- 4.9% vs 59.2 +/- 9.8%, p = 0.038). No significant difference in survival between the two valve types was observed in patient age groups greater than 60 years of age. Freedoms from valve-specific complications, including reoperation for SVD-thrombosis, major thromboembolism and hemorrhage, and valve-related mortality were not significantly different between the two groups overall. (2) Mitral position (MVRR): Survival favored MP over BP overall (58.6 +/- 4.2% vs 42.1 +/- 5.2%, p = 0.0011), and in patients greater than 70 years of age (32.8 +/- 8.9% vs 16.7 +/- 7.1%, p = 0.008). Freedoms from valve-specific complications and valve-related mortality favored MP over BP., Conclusions: There was no clinical performance difference between mechanical and bioprosthetic valves in patients greater than 60 years of age upon AVRR. Mechanical valves generally outperformed bioprosthetic valves in all age groups in MVRR.

Patient background mortality and excess mortality related to aortic valve disease may play a greater role than implanted valve type in explaining the observed survival differences after aortic valve replacement. This study attempts to identify the differences between the performance of selected biological valves, given similar patient characteristics and excess mortality. Four biological valve types, the Carpentier-Edwards pericardial and supra-annular valve, Medtronic Freestyle valve and allografts were used for this analysis. Primary data calculated observed patient-survival and median time to structural valvular deterioration. We then used a microsimulation model to calculate age-specific patient survival and reoperation- and event-free life expectancies. The model incorporated the US population mortality and a uniform excess mortality, while the hazards of valve-related events after implantation of the four valve types were estimated from corresponding meta-analysis and primary data. Observed 10-year survival (60-69)-year age group survival and median time to SVD for the different valve types did not differ. Microsimulation calculated, for a 65-year-old male for example, a 10-year survival of 51%, 51%, 53% and 56% for Carpentier-Edwards pericardial and Supra-annular valve, Freestyle and allografts, respectively. Patient life expectancy was 10.8, 10.8, 11.0 and 11.4 years, respectively. Assuming uniform patient characteristics and excess mortality, the observed difference in performance between the four biological valve types is less marked. Patient selection and the timing of operation may explain most of the observed differences in prognosis after aortic valve replacement with biological prostheses.

Objective: This study was conducted to compare the composites of valve-related complications, namely reoperation, morbidity (defined as permanent neurologic or other functional impairment), and mortality, between bioprostheses and mechanical prostheses for aortic valve replacement., Methods: Between 1982 and 1998, 2195 bioprostheses were implanted in 2179 patients and 980 mechanical prostheses were implanted in 883 patients. Total follow-up was 16,442 years and 5740 years for bioprostheses and mechanical prostheses, respectively. Eight variables were considered as predictors of risk for the composites of valve-related complications., Results: Linearized rates for valve-related reoperation were 1.3%/patient-year and 0.3%/patient-year for bioprostheses and mechanical prostheses (P < .001), respectively. All age groups were differentiated, except >70 years. Valve-related morbidity was differentiated for all age groups and overall, for bioprostheses and mechanical protheses, was 0.4 %/patient-year and 2.1%/patient-year, respectively (P < .001). Overall valve-related mortality was 1.0%/patient-year for bioprostheses and 0.7%/patient-year for mechanical prostheses (P = .018). Age and valve-type were predictive risk factors for reoperation and morbidity, whereas age alone was predictive of mortality. Actual freedom from valve-related reoperation favored mechanical prostheses for all age groups, except 61-70 years and >70 years. Actual freedom from valve-related morbidity favored bioprostheses in all age groups, except < or =40 years. Actual freedom from valve-related mortality was undifferentiated in patients 51-60, 61-70, and >70 years., Conclusion: No differences were observed in valve-related reoperation and mortality in patients >60 years. Comparative evaluation gives high priority for bioprostheses in patients >60 years based on improved morbidity profile. This evaluation extends this center's recommendation for bioprostheses in aortic valve replacement to include patients >60 years.

Aim: The goal of aortic valve replacement (AVR) surgery in the elderly (= or >75 years) is to extend survival and minimize valve-related morbidity, mortality and reoperation. As the elderly population lives longer, those with implanted valves are at risk of suffering valve related complications. We hypothesize that bioprostheses are appropriate for the elderly., Methods: The follow-up evaluation of 966 patients with valves (AVR, 666; mitral valve replacements [MVR], 226; multiple valve replacements [MR], 74) implanted between 1975 and 1999 was examined. There were 879 bioprotheses (BP) and 87 mechanical prostheses (MP). The mean age was 78.9+/-3.3 years (range 75-94.6 years). Concomitant coronary artery bypass was performed in AVR in 51.7%, MVR in 50.4% and MR in 28.4%. Valve type, valve lesion, coronary artery bypass (previous/concomitant), age and gender were considered as independent predictors of composites and survival. The total follow-up was 3905 patient-years., Results: Early mortality was for AVR 9.6% (64), MVR 15.0% (34) and MR 25.7% (19). The late mortality was for AVR 8.8%, MVR 10.4% and MR 8.8%/patient-year. The only independent predictor of survival and valve-related mortality, morbidity and reoperation was age for survival in those with AVR, hazard ratio 1.15 [CL 1.03-1.27] p=0.0094). The BP reoperative rate was 0.5%/patient-year (reoperation was fatal in 6/15) of total, MP reoperative rate was 0% [reasons for reoperation structural valve deterioration (4), non-structural dysfunction (6), prosthetic valve endocarditis (5), reoperation fatality due to non-structural dysfunction (2), prosthetic valve endocarditis (4)]. Overall patient survival at 10 and 15 years, respectively, was 30.5+/-2.4% and 3.6+/-2.2% irrespective of valve position and type. Overall actual and actuarial freedom from valve-related morbidity at 15 years was 96.8+/-0.9% and 93.7+/-2.3%, respectively. Actual and actuarial overall freedom from valve-related mortality at 15 years was 84.3+/-2.4% and 58.4+/-0.9%, respectively. Overall actual and actuarial freedom from valve related reoperation at 15 years was 95.8+/-1.6% and 74.8+/-16.9%, respectively., Conclusions: BP valves are further confirmed to be a good option for AVR in patients = or >75 years of age.

Background: The 1998 American College of Cardiology/American Heart Association Guidelines recommend mechanical prostheses for valve replacement in patients with end-stage renal disease requiring dialysis. The aim of the study is to evaluate the combined experience at two academic centers., Methods: Sixty-nine valve replacements (aortic 40; mitral 22; multiple 7; 47 bioprostheses, 22 mechanical prostheses) were performed. Total follow-up was 128.7 patient-years (bioprostheses, 68.4; mechanical prostheses, 60.4)., Results: Patient populations were homogeneous, except for age (bioprostheses greater than mechanical prostheses, p = 0.012), previous myocardial infarction (bioprostheses greater than mechanical prostheses, p = 0.040), and concomitant CABG (bioprostheses greater than mechanical prostheses, p = 0.019). A survival advantage was observed in favor of mechanical prostheses (p = 0.0299) at 5 years. Freedom from valve-related complications at 5 years was calculated for thromboembolism plus thrombosis plus hemorrhage (bioprostheses, 93.0% +/- 3.9%; mechanical prostheses, 76.4% +/- 12.7%), thromboembolism excluding thrombosis (bioprostheses, 93.0% +/- 3.9%; mechanical prostheses, 88.9% +/- 10.5%), and hemorrhage (bioprostheses, 100%; mechanical prostheses, 95.2% +/- 4.7%). One case of structural valve deterioration occurred in the bioprostheses group at 95 months after surgery. Five-year freedom from all valve-related complications was 82.8% +/- 8.1% for bioprostheses and 76.4% +/- 12.7% for mechanical prostheses., Conclusions: Overall survival was poor. Differences between populations were related to age at operation and coronary artery disease. Structural valve deterioration was not accentuated with bioprostheses. Considering lack of homogeneity between prostheses groups there was no superiority of mechanical prostheses over bioprostheses in terms of freedom from composites of complications. Bioprostheses should be considered in the management of valvular disease in end-state renal disease patients.

Objective: This study aimed at calculating and comparing the long-term outcomes of patients after aortic valve replacement with the Carpentier-Edwards bovine pericardial and porcine supraannular bioprostheses using microsimulation., Methods: We conducted a meta-analysis of eight studies on the Carpentier-Edwards pericardial valves (2,685 patients, 12,250 patient-years) and five studies on the supraannular valves (3,796 patients, 20,127 patient-years) to estimate the occurrence rates of valve-related events. Eighteen-year follow-up data sets were used to construct age-dependent Weibull curves that described their structural valvular deterioration. The estimates were entered into a microsimulation model, which was used to calculate the outcomes of patients after aortic valve replacement., Results: The annual hazard rates for thrombo-embolism after aortic valve replacement were 1.35% and 1.76% for the pericardial and supraannular valves, respectively. For a 65-year-old male, median time to structural valvular deterioration was 20.1 and 22.2 years while the lifetime risk of reoperation due to structural valvular deterioration was 18.3% and 14.0%, respectively. The life expectancy of the patient was 10.8 and 10.9 years and event-free life expectancy 9.0 and 8.8 years, respectively., Conclusions: The microsimulation methodology provides insight into the prognosis of a patient after aortic valve replacement with any given valve type. Both the Carpentier-Edwards pericardial and supraannular valve types perform satisfactorily, especially in elderly patients, and show no appreciable difference in long-term outcomes when implanted in the aortic position.

Since the 2002 Surgical Technology International monograph on valvular prostheses, there have been significant developmental and investigative advances. Aortic bioprostheses and mechanical prostheses have undergone design changes to optimize hemodynamics and prevent patient-prosthesis mismatch to have a potential satisfactory influence on survival. There has been continual technological improvements striving to bring forward advances that improve the durability of bioprostheses and reduce the thrombogenicity of mechanical prostheses. There also has been a continuance to preserve biological tissue with glutaraldehyde, rather than clinically evaluate other cross-linking technologies, by controlling or retarding calcification with therapies to control phospholipids and residual aldehydes. The techniques of mitral valve reconstruction have now been well established and new annuloplasty rings have been designed for the potential of maintaining the anatomical and physiological characteristics of the mitral annulus. Several objectives exist for annuloplasty, namely remodeling of the length and shape of the dilated annulus, prevention of dilatation of the annulus, and support for the potentially fragile area after partial-leaflet resection. Currently, there exists an emergence of catheter-based therapies for management of aortic stenosis and mitral regurgitation. For management of selected populations with critical aortic stenosis, techniques for aortic valve substitution have been developed for both antegrade and retrograde catheter techniques, as well as apical transventricular implantation. Mitral regurgitation has been addressed by experimental transcoronary sinus, stent-like devices and transventricular, edge-to-edge leaflet devices. The devices, descriptions and pictorial images comprise this monograph.

Objective: To examine risk factors for major paravalvular leak (PVL) events after mechanical heart valve replacement., Methods: We analyzed outcome of 807 patients randomized into the Artificial Valve Endocarditis Reduction Trial (AVERT). The mean follow-up time was 30.6 months and 21 major PVL events were reported. Three additional major PVL events associated with endocarditis were excluded from analysis. All baseline medical history variables, as well as operative parameters (including use of pledgets and suture technique) were examined using Cox regression., Results: Major PVL was reported after 11 aortic, 9 mitral, and 1 double valve replacement. 6/404 (1.5%) patients with conventional valves experienced a major PVL event versus 15/403 (3.7%) in the Silzone group. 10/172 (5.8%) patients with valve suture technique without pledgets experienced a major PVL event versus 11/635 (1.7%) patients with pledgets. Final multivariable model showed that only suture technique without pledgets (p=0.005) was an independent significant risk factor for major PVL events. Silzone cuff showed a strong trend (p=0.055)., Conclusions: Suture technique without pledgets is an independent significant risk factor for major PVL events. In this study, use of pledgets during valve replacement had a protective effect against subsequent paravalvular leak, supporting the use of buttress reinforcement for valve suture. The use of Silzone cuff, although not statistically significant, showed a strong trend as a risk factor.

Background and Aim of the Study: The present authors' experience with mitral valve reconstruction was reviewed to determine the influence of anatomical and functional abnormalities on mortality and reoperation., Methods: Between 1991 and 2001, a total of 397 patients (mean age 59.0 +/- 13.4 years) underwent mitral valve reconstruction at the authors' institution. Patients were grouped according to the Carpentier functional classification as follows: type I, n = 88 (mean age 57.4 years; range: 24-81 years); type II, n = 169 (mean age 59.8 years; range: 16-81 years); type IIIa, n = 44 (mean age 52.8 years; range: 22-78 years); type IIIb, n = 85 (mean age 65.1 years; range: 33-82 years); and congenital (C), n = 11 (mean age 36.2 years; range: 18-65 years)., Results: The total follow up was 1,485.8 patient-years (pt-yr). Early mortality was: type I, 3.4% (n = 3); type II, 0; type IIIa; 2.3% (n = 1); type IIIb, 9.4% (n = 8); and C, 0 (p = 0.0028, IIIb > II and C). The late mortality was: type I, 2.1%/pt-yr (n = 6); type II, 1.1%/pt-yr (n = 7); type IIIa, 1.8%/pt-yr (n = 4); type IIIb, 4.3%/pt-yr (n = 12); and C, 1.7%/pt-yr (n = 1) (p = 0.0035 IIIb > II). The overall survival at 10 years was 79.6 +/- 4.2% (p <0.001, II > IIIb; p = 0.029, I > IIIb; p = 0.046, II > I). The reoperations were: type I, 1.4%/pt-yr (n = 4); type II, 1.9%/pt-yr (n = 12); type IIIa, 0.9%/pt-yr (n = 2); type IIIb, 0.4%/pt-yr (n = 1); and C, 0 (p = 0.0435 II > IIIb). Among the 19 reoperations there were 17 replacements, one re-repair, and one annuloplasty. The failures were predominantly type II, posterior (n = 5) and anterior (n = 5), or a combination (n = 2). The overall freedom from reoperation was 92.0 +/- 2.2% (p = NS between groups)., Conclusion: Mitral valve reconstruction can be performed in all four functional categories with generally satisfactory results, except possibly for functional ischemic disease. The results of surgery for degenerative disease afford the opportunity for early surgical management, if proven techniques are adhered to in order to minimize the risk of reoperation. The repair of ischemic disease due primarily to ventricular dysfunction is in a state of evolution.

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.

Background and Aim of the Study: The performance of bioprostheses (BP) and mechanical prostheses (MP) from valve-related composites of complications and combined major thromboembolism and hemorrhage were considered in order to facilitate decision-making for the patient age group of 61-70 years., Methods: The aortic valve replacement (AVR) population (BP, n = 619; MP, n = 303) was differentiated by age, concomitant coronary artery bypass, diabetes mellitus, chronic obstructive pulmonary disease (COPD) and preoperative renal failure. The mitral valve replacement (MVR) population (BP, n = 353; MP, n = 312) was differentiated by valve type, age, concomitant coronary artery bypass, ejection fraction, NYHA and preoperative renal failure., Results: Actual freedom from reoperation for AVR was 92.1 +/- 1.5% for BP and 98.7 +/- 6.6% for MP, and for MVR was 74.5 +/- 2.6% for BP and 93.8 +/- 2.2% (12 years) for MP. Actual freedom from major thromboembolism and hemorrhage for AVR was 85.1 +/- 1.7% for BP and 76.9 +/- 3.6% for MP, and for MVR was 82.7 +/- 2.4% for BP and 76.7 +/- 3.8% (12 years) for MP. Linearized rates were undifferentiated for major thromboembolism. The hemorrhage rate for AVR-BP was 0.55%/pt-yr and for AVR-MP was 2.3%/pt-yr (p < 0.0001); for MVR-BP, the rate was 0.69%/pt-yr and for MVR-MP was 1.85%/pt-yr (p = 0.0011). The only predictor of AVR reoperation was age, and predictors for MVR reoperation were prosthesis type and follow up NYHA class. Predictors of AVR major thromboembolism and hemorrhage were prosthesis type, age, diabetes mellitus and COPD. There were no predictors of MVR major thromboembolism and hemorrhage., Conclusion: For the age group of 61-70 years, MP are recommended for MVR to protect from BP reoperation, whilst for AVR BP are recommended to protect from anticoagulant hemorrhage. Freedom from reoperation for AVR was undifferentiated for BP and MP at 12-15 years.

Objective: Atrial fibrillation remains one of the most common postoperative complications of coronary artery bypass grafting. Despite many clinical studies, there is still no consensus regarding the best prevention strategy for atrial arrhythmia. A randomized, double-blind, placebo-controlled trial was conducted to determine the effect of steroids on the occurrence of atrial fibrillation after elective coronary artery bypass grafting., Methods: Eighty-eight consecutive patients were prospectively entered in this study. No patient had documented or suspected arrhythmias before surgery. Forty-three patients received 1 g of methylprednisolone before surgery and 4 mg of dexamethasone every 6 hours for 1 day after surgery, and 43 patients received only placebo. The primary end point was the overall occurrence of postoperative atrial fibrillation., Results: Postoperative atrial fibrillation occurred in 9 (21%) of the 43 patients in the steroid group, as compared with 22 (51%) of the 43 patients in the placebo group ( P = .003). Minor postoperative complications occurred in 15 steroid patients (35%) and in 6 patients (14%) receiving placebo ( P = .01). Major complications occurred in 4 patients who received steroids (9%) and in 2 patients (5%) who received placebo ( P = .68; for all complications, P = .05)., Conclusions: Prophylactic short-term steroid administration in patients undergoing coronary artery bypass grafting significantly reduced postoperative atrial fibrillation. In this study, there was no significant difference between the steroid group and the placebo group with regard to the length of hospital stay; however, the steroid group had more complications, which may contribute to prolonged hospitalization.

Objective: Predominant concerns of patients undergoing valve replacement surgery are risks of death, stroke, antithrombotic bleeding, and reoperation related to the replacement prosthesis. The purpose of this study was to compare valve-related reoperation, morbidity (permanent impairment), and mortality between bioprostheses and mechanical prostheses for mitral valve replacement., Methods: Between 1982 and 1998, a total of 959 bioprostheses were implanted in 943 patients, and a total of 961 mechanical prostheses were implanted in 839 patients. Total follow-ups were 5730 years for bioprostheses and 5271 years for mechanical prostheses. Eight variables were considered as predictors of risk for the composites of valve-related complications., Results: The linearized occurrence rates for valve-related reoperation were 3.7 events/100 patient-years for bioprostheses and 0.5 events/100 patient-years for mechanical prostheses ( P < .001), with all age groups differentiated except older than 70 years. Valve-related morbidity was undifferentiated for bioprostheses and mechanical prostheses. Valve-related mortalities were 1.7 events/100 patient-years for bioprostheses and 0.7 events/100 patient-years for mechanical prostheses ( P < .001). Predictors of valve-related reoperation were age and valve type. The only predictor of valve-related morbidity was age, whereas age and valve type were predictors for valve-related mortality. Actual freedom from valve-related reoperation favored mechanical prostheses in all age groups except older than 70 years (91.7% +/- 2.0% for bioprostheses at 15 years and 96.7% +/- 1.5% at 12 years for mechanical prostheses). Actual freedom from valve-related morbidity was not different between bioprostheses and mechanical prostheses. Actual freedom from valve-related mortality favored mechanical prostheses in all groups except older than 70 years., Conclusion: Comparative evaluation gives high priority in mitral valve replacement for mechanical prostheses relative to bioprostheses for freedom from valve-related reoperation and valve-related mortality but not valve-related morbidity. Freedom from valve-related reoperation and valve-related mortality favors mechanical prostheses for all age groups except older than 70 years. Valve-related morbidity, due to neurologic or functional impairments, does not differentiate between bioprostheses and mechanical prostheses.