Ten-year echocardiographic and clinical follow-up of aortic Carpentier-Edwards pericardial and supraannular prosthesis: a case-match study

BACKGROUND: There are little comparative data on Carpentier-Edwards supraannular and pericardial second-generation bioprostheses. The aim of this work was to compare their hemodynamic and clinical outcomes in patients with aortic stenosis. METHODS: We conducted a retrospective study including 150 patients operated on for aortic stenosis between 1989 and 1993. Patients undergoing aortic valve replacement with either a Carpentier-Edwards supraannular or pericardial prosthesis were matched for sex (49% male), age (72 +/- 8 years), body surface area, valve size, associated procedures, and left ventricular ejection fraction. RESULTS: Mean follow-up was 6.5 +/- 3.3 years, giving a total follow-up of 983 patient-years. Thirty-day mortality and 10-year actuarial survival were, respectively, 8% and 51% in the supraannular group and 6.7% and 43.4% in the pericardial group. At 10 years, freedom from thromboembolism, structural failure, and all valve-related events were, respectively, 88.7%, 88.9%, and 68.7% in the supraannular group and 85%, 100%, and 82.2% in the pericardial group. There were four (5.3%) structural failures, and four (5.3%) reoperations for degeneration (n = 3) and endocarditis (n = 1) in the supraannular group. Freedom from structural dysfunction or reoperation was 87.3% in the supraannular group and 100% (p < 0.05) in the pericardial group. Echocardiographic review of 62 of 76 survivors (81.5%) demonstrated a trend toward a better hemodynamic profile of pericardial valves at the end of follow-up. CONCLUSIONS: Ten years after aortic valve replacement for aortic stenosis, Carpentier-Edwards pericardial prostheses give comparable and probably better results than Carpentier-Edwards supraannular prostheses.     

Does the type of biological valve affect patient outcome?

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.     

Aortic Carpentier-Edwards supraannular porcine bioprosthesis: a 12-year experience.

BACKGROUND: After 35 years of cardiac valve replacement, the ideal substitute remains to be found. Homografts are considered best but, due to their scarcity, cannot meet the need of valve replacement. Artificial valves (mechanical or biological) remain the most commonly used but controversy is still present as to the better choice. We tested the Carpentier-Edwards bioprosthesis for its efficacy in valve replacement operations. METHODS: From 1983 to 1995, 1,108 consecutive patients had an isolated aortic valve replacement with a porcine Carpentier-Edwards bioprosthesis, model 2650 supraannular valve. Mean age was 73.8+/-8.3 years. Aortic stenosis was the most common lesion (1,049 patients, 94.7%). The follow-up of 980 operative survivors was 96% complete and represented a total of 4,735 patient-years (maximum, 13.8 years; mean, 4 years and 10 months). RESULTS: Actuarial survival including operative mortality (128 patients, 11.6%) was 43.6%+/-2.3% at 10 years and 27.3%+/-3.3% at 12 years and, at that time, was not statistically different from those of the normal French population matched for age and sex. Structural deterioration of the valve was observed in 27 patients, an actuarial freedom of 94.2%+/-1.5% at 10 years and 83.8%+/-4.5% at 12 years. Hazard function revealed a stable and low risk of structural deterioration until 10 years and significantly increased risk after that. Young age was found to be an increasing risk factor of deterioration. Reoperation for valve-related complications was necessary in 30 patients, an actuarial freedom of 94.5%+/-1.4% at 10 years. CONCLUSIONS: The Carpentier-Edwards porcine supraannular valve affords a good durability up to 10 years, with a low rate of reoperation. The risk of structural deterioration decreases with older age. It is our valve of choice in elderly patients.     

Choice of a mechanical valve or a bioprosthesis for AVR: does CABG matter?

OBJECTIVE: Mechanical valves and bioprostheses are the commonly used devices in aortic valve replacement (AVR). Many patients with valvular disease also require concomitant coronary artery bypass grafting (CABG). We used a microsimulation model to provide insight into the outcomes of patients after AVR with mechanical valves and stented bioprostheses, with and without CABG, and to determine the age-thresholds or age crossover points in outcomes between the two valve types. METHODS: We conducted a meta-analysis of published results after primary AVR with mechanical prostheses (nine reports, 4274 patients, 25,726 patient-years) and stented porcine bioprostheses (13 reports, 9007 patients, 54,151 patient-years) to estimate risks of valve-related events. A hazard ratio of 1.3 was used to incorporate the effect of CABG on long-term survival. Estimates were entered into a microsimulation model, which was then used to predict the outcomes of patients after AVR, with and without CABG. The model calculations were validated using a large data set from Portland, USA. RESULTS: For a 65-year-old male without CABG, the life expectancy (LE) was 11.2 and 11.6 years and the event-free life expectancy (EFLE) was 8.2 and 8.9 years, respectively, after implantation with mechanical valves and bioprostheses. The lifetime risk of at least one valve-related event was 51 and 47%, respectively. The age crossover point between the two valve types, considering the above outcome parameters, was 59, 60 and 63 years, respectively. CABG reduced LE and consequently EFLE and lifetime risk of an event, but only minimally influenced the patient age crossover points. The model calculations showed good agreement with the Portland data. CONCLUSIONS: The currently recommended patient age for using a bioprosthesis (65 years) could be lowered further, irrespective of concomitant CABG. The trade-off between the reduced risks of bioprosthetic failure and of hemorrhage in mechanical valves, resulting from a lower LE, minimized the effect of CABG on the age crossover points between the two valve types.     

A morphologic study of Carpentier-Edwards pericardial xenografts in the mitral position exhibiting primary tissue failure in adults in comparison with Ionescu-Shiley pericardial xenografts

OBJECTIVE: We sought to investigate the durability and mechanism of the Carpentier-Edwards pericardial xenograft in the mitral position in comparison with that of the Ionescu-Shiley pericardial xenograft. METHODS: A total of 284 patients who received the Ionescu-Shiley pericardial xenograft in the mitral position between 1980 and 1984 and 84 patients who received the Carpentier-Edwards pericardial xenograft in the mitral position between 1984 and 1999 were included in the study. The freedom from reoperation rates for both graft types were determined. For morphologic study, the pathologic findings of 23 valves of 123 explanted Ionescu-Shiley pericardial xenografts with structural valve deterioration, nonstructural valve deterioration, or both were determined and compared with those of 20 explanted Carpentier-Edwards pericardial xenografts with structural valve deterioration, nonstructural valve deterioration, or both. Each pathologic finding was graded and assigned a score. Both types were matched for age at reoperation (50-75 years) and duration of valve function (8-11 years). RESULTS: Freedom from reoperation caused by structural valve deterioration, nonstructural valve deterioration, or both was significantly better for Carpentier-Edwards pericardial xenografts than for Ionescu-Shiley pericardial xenografts at 8 years after the operation (Carpentier-Edwards pericardial xenografts: 91.3% vs Ionescu-Shiley pericardial xenografts: 71.9%, P =.0061), but it was similar for both types at 12 years (Carpentier-Edwards pericardial xenografts: 43.6% vs Ionescu-Shiley pericardial xenografts: 43.6%, P =.2865). No severe leaflet tears were seen among Carpentier-Edwards pericardial xenografts. The mean area percentage of tissue overgrowth was 15.3% in Carpentier-Edwards pericardial xenografts and 3.4% in Ionescu-Shiley pericardial xenografts (P =.0001). The mean calcification area percentage was 13.6% in Carpentier-Edwards pericardial xenografts and 31.5% in Ionescu-Shiley pericardial xenografts (P =.0001). CONCLUSIONS: Tissue overgrowth on the atrial surface, ventricular surface, or both was the cause of structural valve deterioration, nonstructural valve deterioration, or both of Carpentier-Edwards pericardial xenografts in adults. This was different from Ionescu-Shiley pericardial xenograft failure, which resulted from severe calcification and leaflet tears. Organized thrombi on cusps, in addition to valve design, may have contributed to such tissue overgrowth on Carpentier-Edwards pericardial xenografts.     

Twenty-year comparison of tissue and mechanical valve replacement

OBJECTIVE: We sought to compare outcomes with tissue and St Jude Medical mechanical valves over a 20-year period. METHODS: Valve-related events and overall survival were analyzed in 2533 patients 18 years of age or older undergoing initial aortic, mitral, or combined aortic and mitral (double) valve replacement with a tissue valve (Hancock, Carpentier-Edwards porcine, or Carpentier-Edwards pericardial) or a St Jude Medical mechanical valve. Total follow-up was 13,390 patient-years. There were 666 St Jude Medical aortic valve replacements, 723 tissue aortic valve replacements, 513 St Jude Medical mitral valve replacements, 402 tissue mitral valve replacements, 161 St Jude Medical double valve replacements, and 68 tissue double valve replacements. The mean age was 68 +/- 13.3 years (St Jude Medical valve, 64.5 +/- 12.9; tissue valve, 72.0 +/- 12.6). RESULTS: There were no overall differences in survival between tissue and mechanical valves. Multivariable analysis indicated that the type of valve did not affect survival. Analysis by age less than 65 years or 65 years or older and presence or absence of coronary disease revealed similar long-term survival in all subgroups. The risk of hemorrhage was lower in patients receiving tissue aortic valve replacements but was not significantly different in patients receiving mitral valve or double valve replacements. Thromboembolism rates were similar for tissue and mechanical valve recipients. However, reoperation rates were significantly higher in patients receiving both aortic and mitral tissue valves. The reoperation hazard increased progressively with time both in patients receiving aortic and in those receiving mitral tissue valves. Overall valve complications were initially higher with mechanical aortic valves but not with mechanical mitral valves. However, valve complication rates later crossed over, with higher rates in tissue valve recipients after 7 years in patients undergoing mitral valve replacement and 10 years in those undergoing aortic valve replacement. CONCLUSIONS: Tissue and mechanical valve recipients have similar survival over 20 years of follow-up. The primary tradeoff is an increased risk of hemorrhage in patients receiving mechanical aortic valve replacements and an increased risk of late reoperation in all patients receiving tissue valve replacements. The risk of tissue valve reoperation increases progressively with time.     

The Carpentier-Edwards supraannular porcine bioprosthesis. A new generation tissue valve with excellent intermediate clinical performance

The Carpentier-Edwards supraannular porcine bioprosthesis, an investigational valve, was implanted in 1167 patients (1174 operations, 1274 valves) between November 1981 and December 1985 (age range 13 to 85 years, mean 61 years). The early mortality rate was 7.2% (with concomitant procedures 10.9%, without 4.8%; with previous operation 10.5%, without 6.6%). The late mortality rate was 4.5% per patient-year (aortic valve replacement, 4.0%; mitral valve replacement, 4.8%; multiple valve replacement, 5.6%). Total cumulative follow-up was 2272.3 years. The prevalence of thromboembolism was 2.6% per patient-year (fatal 0.4% per patient-year, major 1.4%, minor 1.2%); hemorrhage related to antithromboembolic therapy, 0.7% (fatal 0.1%); prosthetic valve endocarditis, 0.4% (fatal 0.2%); periprosthetic leak, 0.4% (fatal 0%); structural valve deterioration (primary tissue failure/structural failure), 0.1% per patient-year; and clinical valve dysfunction, 0.4%. The reoperation rate was 0.8% per patient-year (thromboembolism, 0.1%; clinical valve dysfunction, 0.1%; prosthetic valve endocarditis, 0.1%; periprosthetic leak, 0.4%; structural valve deterioration, 0.1%). Thromboembolism occurred throughout the observation period but with decreasing frequency, hemorrhage throughout the period in no predictable fashion, prosthetic valve endocarditis within 2 years, periprosthetic leak within 2 years, and structural valve deterioration occurred during the fourth year of assessment. The overall survival rate was 79.8% +/- 1.7% (4 years). Freedom (at 4 years) from thromboembolism was 92.2% +/- 1.2%; from structural valve deterioration, 98.8% +/- 0.8%; and from reoperation, 95.8% +/- 1.3%. Freedom from all complications (4 years) was 85.9% +/- 1.7%; from complication mortality, 98.4% +/- 0.4%; and from valve failure (mortality and reoperation), 94.3% +/- 1.3%. This investigational Carpentier-Edwards supraannular porcine bioprosthetic valve has provided excellent clinical performance and remains our overall prosthesis of choice.     

Comparison of porcine valve xenografts with mechanical prostheses. A 7 1/2 year experience

A total of 479 valve replacements were performed in 469 patients for aortic, mitral, and tricuspid disease. A total of 529 valves were implanted (311 Carpentier-Edwards, 118 Hancock, 94 Bj?rk-Shiley, and six other mechanical valves). Of the 479 operations, 51.1% (245) were carried out in male patients and 48.9% (234) were carried out in female patients. The mean age was 57.6 years; however, 28.6% (137) of the operations were performed in patients over 65 years of age. One hundred five patients (21.9%) had had previous cardiac operations of one type or another. Follow-up was 99.6% and the average length of follow-up was 36.2 months. The overall operative mortality was 5.6%. The operative mortality in the isolated aortic valve replacement group was 2.0% and that in the mitral valve replacement group, 4.4%. There was a 5.9% valve explant rate in the Hancock series; however, no valve explants were required because of valve dysfunction in either the Carpentier-Edwards or the Bj?rk-Shiley groups. The thromboembolic rate in the aortic valve position was 2.4, 1.1, and 2.1 emboli per 100 patient-years in the Hancock, Carpentier-Edwards, and Bj?rk-Shiley groups, respectively. The thromboembolic rate in the mitral valve position was 2.8, 2.2, and 1.0 emboli per 100 patient-years in the Hancock, Carpentier-Edwards, and Bj?rk-Shiley groups, respectively.     

In vivo hemodynamic comparison of porcine and pericardial valves

The bovine pericardial valve and the SupraAnnular valve have been developed to improve the hemodynamic function of tissue valves. Hemodynamic performances of the standard Carpentier-Edwards porcine valve, the Carpentier-Edwards SupraAnnular valve, and the Carpentier-Edwards bovine pericardial valve were compared in the aortic position. One hundred patients undergoing aortic valve replacement were studied intraoperatively. Mean gradient across the valve decreased for standard and pericardial valves as valve size increased. At the same flow rate, the 23 mm pericardial valve had larger valve orifice areas, higher performance indices, and lower gradients than the 23 mm SupraAnnular valve. The SupraAnnular valve is hemodynamically superior to the standard Carpentier-Edwards porcine bioprosthesis. The Carpentier-Edwards pericardial valve, however, is less obstructive in the aortic position than either of the porcine valves.     

Aortic valve replacement with pericardial valves in patients with small aortic roots. Clinical results in a consecutive series of patients receiving 19 and 21 mm prostheses

OBJECTIVE: To determine how second generation pericardial valves perform in patients with small aortic roots. DESIGN: Ninety patients who underwent isolated aortic valve replacement (AVR) with 19 or 21 mm Mitroflow or Carpentier-Edwards (Perimount) valves between 1989 and 1996 were studied. Mean age was 78 years. Concomitant coronary bypass surgery was performed in 41%. RESULTS: Thirty-day mortality was 5.6%. Ninety-seven percent had acceptable transprosthetic mean pressure gradients (25 mmHg or less) 1 week after surgery. Follow-up was 100% complete and 76% of the patients were alive after a mean of 5 years. There was no structural valve failure or valve thrombosis. One patient required reoperation for perivalvular leak. Four patients had transient ischemic attacks and seven had strokes. These figures are, however, within the expected range for the age. CONCLUSION: Second generation pericardial valves perform well in elderly patients with small aortic roots. Postoperative hemodynamics are acceptable, valve durability of up to 8 years adequate, and the clinical results good, considering the age of the patients.     

Long-term evaluation of Carpentier-Edwards porcine bioprosthesis for rheumatic heart disease

OBJECTIVES: The clinical results of Carpentier-Edwards standard bioprosthesis have been extensively studied for valvular heart surgery in America and Europe. However, the data of long-term performance of Carpentier-Edwards standard porcine valve in areas with a high prevalence of rheumatic heart disease are still lacking. In this study, we assessed the clinical performance of Carpentier-Edwards standard porcine bioprostheses in a patient group with high prevalence of rheumatic heart disease. METHODS: A total of 872 patients underwent valvular heart surgery with Carpentier-Edwards standard porcine bioprostheses replacement between 1975 and 1999 and the results were analyzed. Rheumatic etiology counts for 95% of the patients. Mean age of operation was 40 +/- 14 years (mitral valve), 43 +/- 19 years (aortic valve), and 45 +/- 13 years (double valve). Follow-up was 95.6% complete and continued up to 24 years (total 7017 patient-years) with mean of 8.9 +/- 5.1 years. RESULTS: The operative mortality rate was 5.85%. Actuarial patient survival rates after discharge at 5, 10, 15, and 20 years were 92.5%, 83.8%, 72.3%, and 35.8%, respectively. A total of 442 cases received reoperation due to failure of bioprostheses. The mean duration to valve failure is 12.2 +/- 0.4 years. Actuarial estimate of freedom from structural valvular failure at 5, 10, 15, and 20 years were 96.3%, 63.7%, 24.4%, and 7.7%, respectively. CONCLUSION: The long-term result of Carpentier-Edwards standard bioprostheses in the present patient group is satisfactory. However, freedom from valve failure is lower than that of Western series. Younger age at operation and higher prevalence of rheumatic etiology in this area are possible causes.     

Use of the Carpentier-Edwards porcine bioprosthesis: assessment of a patient selection policy.

The Carpentier-Edwards bioprosthesis was implanted in 369 patients (414 valves) between May 1977 and December 1987 (age 67.2 +/- 0.5 years); 242 had aortic valve replacement, 80 had mitral valve replacement, 44 had multiple valve replacement, of which 41 were aortic and mitral valve replacement, 2 had isolated tricuspid valve replacement, and 1 had a pulmonary valve replacement. The selection criteria were the following: shorter life expectancy (253 patients) or contraindications to anticoagulants for organic (113 patients) or psychologic (38 patients) reasons, or both. The early mortality rate was 11.1% (aortic valve replacement, 9.1%; mitral valve replacement, 12.4%; aortic and mitral valve replacement, 23.1%). Total cumulative follow-up was 1456 pt-yr (mean 4.4 years, range 1 to 148 months), and the patient evaluation was 99.5% complete. Late mortality was 4.9%/pt-yr. Five-year survival was 70.4% +/- 2.7% overall, 74.3% +/- 3.2% after aortic valve replacement, 60.9% +/- 6.2% after mitral valve replacement (p < 0.03), and 60.7% +/- 8.1% after aortic and mitral valve replacement. Eight patients were reoperated on for primary tissue failure, and freedom from reoperation for structural valve deterioration was 97.5% +/- 1.2% at 5 years and 95.6% +/- 1.8% at 8 years. Failing aortic bioprostheses were explanted in four patients (0.4%/pt-yr) and mitral bioprostheses in seven (1.6%/pt-yr). No patient whose valve was inserted after the age of 70 had to be reoperated on for structural valve dysfunction. The probability of freedom from thromboembolism after 5 and 8 years of follow-up was 93.1% +/- 1.6% and 92.2% +/- 1.8%, respectively. The prevalence of anticoagulant-related hemorrhage was 0.8%/pt-yr (major 0.6%, minor 0.2%). Anticoagulants had to be maintained in 16.3% of the patients: 5.9% after aortic valve replacement, 35.7% after mitral valve replacement, and 45.8% after aortic and mitral valve replacement, while 80.0% were on a regimen of antiplatelet drug therapy. Prosthetic valve endocarditis happened in five patients (0.3%/pt-yr). Freedom from all valve-related morbidity and mortality, including hospital deaths, was 71.0% +/- 2.7% at 5 years and 58.6% +/- 4.6% at 8 years and was significantly better in the aortic valve replacement group (61.3% +/- 6.6% at 8 years) compared with the mitral valve replacement group (54.4% +/- 7.7% at 8 years; p = 0.04). This study confirms the satisfactory performance of the Carpentier-Edwards valve after aortic valve replacement in elderly patients.(ABSTRACT TRUNCATED AT 400 WORDS)     

Influence of Pulmonic Position on Durability of Bioprosthetic Heart Valves

Background. The insertion of bioprosthetic valves into the pulmonic position is not performed commonly because of uncertainty concerning the necessity and durability of such valves.

Methods. We reviewed the long-term outcome of 10 patients who underwent pulmonary valve replacement with bioprostheses between March 1985 and March 1997. A Carpentier-Edwards supraannular bioprosthesis was used in 7 patients, a Hancock II bioprosthesis was used in 2 patients, and a Carpentier-Edwards pericardial bioprosthesis was used in 1 patient. The mean patient age at the time of pulmonary valve replacement was 38.9 ± 16.3 years (range, 15 to 63 years). The diagnoses were pulmonary valvular regurgitation after corrective surgery for tetralogy of Fallot in 7 patients, right ventricular outflow tract stenosis and absent right pulmonary artery combined with a double-outlet right ventricle in 1 patient, pulmonary valvular regurgitation with pulmonary artery dilatation in 1 patient, and aortic valve stenosis treated with our modification of the Ross procedure using a pulmonary bioprosthesis in 1 patient. Survivors were followed up for a mean of 5 years and 5 months.

Results. One patient underwent reoperation because of infective endocarditis of the bioprosthesis. No bioprosthetic valve dysfunction has been observed on Doppler echocardiography during a maximum follow-up period of 12.2 years, except in the patient who underwent replacement at 15 years of age.

Conclusions. Bioprostheses in the pulmonic position are durable in adult patients because they face a minimal hemodynamic load, but they may undergo early leaflet degeneration in younger patients.     

Prognosis after aortic root replacement with cryopreserved allografts in adults

BACKGROUND: Aortic root replacement with cryopreserved allografts is associated with excellent hemodynamics, little endocarditis, low thromboembolic event rates, and no need for anticoagulation. There is, however, concern regarding the long-term durability of this valve substitute, especially in younger patients. Meta-analysis and microsimulation were used to calculate age-specific long-term prognosis after allograft aortic root replacement based on current evidence. METHODS: Our center's experience with cryopreserved allograft aortic root replacement in 165 adult patients was combined in a meta-analysis with reported and individual results from four other hospitals. Using this information, the microsimulation model predicted age- and gender-specific total and reoperation-free and event-free life expectancy. RESULTS: The pooled results comprised 629 patients with a total follow-up of 1860 patient-years (range 0 to 12.8 years). Annual risks were 0.6% for thromboembolism, 0.05% for bleeding, 0.5% for endocarditis, and 0.5% for nonstructural valve failure. Structural allograft failure requiring reoperation occurred in 15 patients, and a patient age-specific Weibull function was constructed accordingly. Calculated total life expectancy varied from 27 years in a 25-year-old to 12 years in a 65-year-old male; corresponding actual lifetime risk of reoperation was 89% and 35%, respectively. CONCLUSIONS: Cryopreserved aortic allografts have an age-related limited durability. This results in a considerable lifetime risk of reoperation, especially in young patients. The combination of meta-analysis and microsimulation provides an appropriate tool for estimating individualized long-term outcome after aortic valve replacement and can be useful both for patient counseling and prognostic research purposes.     

Rest and exercise hemodynamics following aortic valve replacement. A comparison between 19 and 21 mm Ionescu-Shiley pericardial and Carpentier-Edwards porcine valves

When aortic valve replacement is performed in a patient with a small anulus, significant obstruction of the left ventricular outflow tract may remain. Most prostheses are obstructive in the smaller sizes, and enlargement of the aortic anulus may be required to allow placement of a larger valve. To evaluate the hemodynamic performance of two commonly used tissue prostheses, the Ionescu-Shiley pericardial and Carpentier-Edwards porcine valves, 22 patients with either the 19 or 21 mm size were electively studied at rest and after exercise at a mean of 15 months after operation. The resting mean transvalvular gradient for 19 mm Ionescu-Shiley pericardial valves (n = 7), 10.6 +/- 9.2 mm Hg, was significantly lower than that for 19 mm Carpentier-Edwards valves (n = 3), 33.3 +/- 2.1 mm Hg, p less than 0.01. Following exercise, the mean gradient for 19 mm Ionescu-Shiley pericardial valves rose only to 13.8 +/- 8.5 mm Hg. No exercise data were available for the 19 mm Carpentier-Edwards valve. Among patients with 21 mm Ionescu-Shiley pericardial valves (n = 7), the mean transvalvular gradient at rest was 5.6 +/- 9.5 mm Hg, not significantly different from that of patients with 21 mm Carpentier-Edwards valves (n = 5), 9.8 +/- 18.3 mm Hg. After exercise, the gradients rose to 16.0 +/- 10.0 mm Hg and 25.5 +/- 23.8 mm Hg for the Ionescu-Shiley pericardial and Carpentier-Edwards valves, respectively (no statistical significance). Cardiac index was not different between groups. Gradients were not significantly higher in patients with body surface areas greater than 1.5 m2. It is concluded that the 19 and 21 mm Ionescu-Shiley pericardial valves possess excellent hemodynamics, even after exercise. This valve appears hemodynamically superior to the Carpentier-Edwards valve, particularly in the 19 mm size. Procedures to enlarge the aortic anulus are usually unnecessary when small Ionescu-Shiley pericardial valves are used, even in patients who have large body surface areas.     

Long-term outcome after biologic versus mechanical aortic valve replacement in 841 patients

OBJECTIVE: The purpose of this study was to optimize selection criteria of biologic versus mechanical valve prostheses for aortic valve replacement. METHODS: Retrospective analysis was performed for 841 patients undergoing isolated, first-time aortic valve replacement with Carpentier-Edwards (n = 429) or St Jude Medical (n = 412) prostheses. RESULTS: Patients with Carpentier-Edwards and St Jude Medical valves had similar characteristics. Ten-year survival was similar in each group (Carpentier-Edwards 54% 3% versus St Jude Medical 50% 6%; P =.4). Independent predictors of worse survival were older age, renal or lung disease, ejection fraction less than 40%, diabetes, and coronary disease. Carpentier-Edwards versus St Jude Medical prostheses did not affect survival (P =.4). Independent predictors of aortic valve reoperation were younger age and Carpentier-Edwards prosthesis. The linearized rates of thromboembolism were similar, but the linearized rate of hemorrhage was lower with Carpentier-Edwards prostheses (P <.01). Perivalvular leak within 6 months of operation was more likely with St Jude Medical than with Carpentier-Edwards prostheses (P =.02). Estimated 10-year survival free from valve-related morbidity was better for the St Jude Medical valve in patients aged less than 65 years and was better for the Carpentier-Edwards valve in patients aged more than 65 years. Patients with renal disease, lung disease (in patients more than age 60 years), ejection fraction less than 40%, or coronary disease had a life expectancy of less than 10 years. CONCLUSIONS: For first-time, isolated aortic valve replacement, mechanical prostheses should be considered in patients under age 65 years with a life expectancy of at least 10 years. Bioprostheses should be considered in patients over age 65 years or with lung disease (in patients over age 60 years), renal disease, coronary disease, ejection fraction less than 40%, or a life expectancy less than 10 years.     

Long-term results of bioprosthetic mitral valve replacement: the pericardial perspective

Pericardial valve bioprostheses were introduced in early 1970s and were widely used in the 1980s. The longterm results with the Ionescu-Shiley valve, the first commercially available pericardial valve, were disappointing because of high rate cusp tears during the first decade after implantation. The enthusiasm for this type of bioprosthetic valve was further hampered by the premature failure of the Hancock pericardial valve. The long-term results of aortic valve replacement with the Carpentier-Edwards pericardial valve, which was introduced in 1981, indicated that that valve was durable and the issue of cusp tears had been resolved by an appropriate design. This knowledge prompted surgeons to revisit the merits of pericardial valves for mitral valve replacement and several other pericardial valves are now commercially available. The largest data on long-term results are with the Carpentier-Edwards pericardial mitral valve. The reported freedom from structure valve failure ranged from 69% to 85% at 10 years in patient population with mean age of 60 to 70 years. Young age is a major determinant of valve failure, which is largely due to calcification. There are also long-term data, albeit more limited on the Sorin Pericarbon and Mitroflow valves used for mitral valve replacement. This paper review the published experience with various pericardial bioprosthetic valves used for mitral valve replacement during the past 3 decades.     

Twenty-year follow-up of the Carpentier-Edwards standard porcine bioprosthesis in the Oriental population

AIM: The 20-year period long-term results of porcine bioprosthetic valve use are limited. In addition, the majority of these reports come from Western countries. Given the scanty information reported in Oriental countries, this study was therefore designed to examine 20-year long-term results in patients who received a Carpentier-Edwards porcine bioprosthetic valve in an effort to contribute further information on the long-term clinical performance of porcine prosthetic valves from a viewpoint of results in the Oriental population. METHODS: From July 1979 to April 2001, 82 patients received valve replacement with a standard Carpentier-Edwards porcine valve. There were 40 men and 42 women with a mean age of 42.3+/-15.1 years (range 16 to 73 years). Follow-up time extended more than 20 years (mean 10.9+/-3.2 years, range 0.5 to 21.5 years ) for a total of 719.5 patient-years. RESULTS: The overall operative mortality was 16.9% (14 of 83 procedures). At 5, 10, 15, and 20 years, the actuarial survival rate of patients was 71.7%, 66.9%, 55.5%, and 44.4%, respectively. Actuarial estimates of freedom from structural valvular deterioration (SVD) at 5, 10, 15, and 17 years were 96.3%, 64.0%, 24.3%, and 24.3%, respectively; from reoperation 96.3%, 64.5%, 24.5%, and 24.5%; from operated valvular endocarditis 96.8%, 92.6%, 92.6%, and 92.6%; and from overall thromboembolism 96.3%, 88.5%, 67.2%, and 52.2%. In normal sinus rhythm, actuarial estimates of freedom from thromboembolism at 5, 10, 15, and 17 years were 100.0%, 100.0%, 81.8%, and 81.8%, respectively. Whereas for those in patients with atrial fibrillation, the estimates of freedom from thromboembolism were 94.5%, 82.4%, 57.7%, and 38.5%. CONCLUSION: This study demonstrates the very satisfactory 20-year period long-term performance of freedom from bleeding events, thromboembolism (except in patients with atrial fibrillation), and valvular endocarditis in Oriental patients undergoing replacement with a porcine valve. However, the remarkable rate of SVD and reoperation ensued at 6 years after bioprosthesis implanted which does not differ from the series reported from Western countries.     

Clinical and hemodynamic evaluation of the 19-mm Carpentier-Edwards supraannular aortic valve.

The clinical and hemodynamic performance of the 19-mm Carpentier-Edwards supraannular aortic valve is largely unknown compared with that of the larger valves. Over 4 years we implanted the 19-mm Carpentier-Edwards supraannular aortic valve into 21 patients (20 female) with a mean age of 75 +/- 1.2 years (range, 59 to 86 years) and a mean body surface area of 1.6 +/- 0.03 m2 (range, 1.3 to 1.7 m2). There were four deaths, one operative and three late noncardiac deaths. Follow-up of the 17 survivors for a mean of 20 +/- 3.1 months (range, 2 to 42 months) demonstrated symptomatic improvement in all 17 (all are now in New York Heart Association functional class I or II). There were no valve-related complications and no patient required long-term anticoagulation. Doppler echocardiographic studies were used to assess the in vivo hemodynamic profile of the valve. Mean postoperative aortic valve gradient was 34.1 +/- 2.7 mm Hg (range, 19 to 52 mm Hg). Functional valve orifice area was 1.1 +/- 0.09 cm2 (range, 0.6 to 1.8 cm2). Mean cardiac output was 3.92 +/- 0.17 L/min (range, 3.2 to 5.1 L/min) with a mean cardiac index of 2.5 +/- 0.11 L.min-1 x m-2 (range, 2.1 to 3.2 L.min-1 x m-2). In conclusion, we have demonstrated that aortic valve replacement with the 19-mm Carpentier-Edwards supraannular aortic valve has a low operative mortality and offers major clinical benefits despite moderate transprosthetic gradients. This approach provides an alternative management strategy in elderly patients who would otherwise require low-profile mechanical valves or aortic root enlargement.     

Bioprosthetic aortic valve replacement in elderly patients: Meta-analysis and microsimulation

ObjectiveTo support decision-making in aortic valve replacement (AVR) in elderly patients, we provide a comprehensive overview of outcome after AVR with bioprostheses.MethodsA systematic review was conducted of studies reporting clinical outcome after AVR with bioprostheses in elderly patients (mean age ≥70 years; minimum age ≥65 years) published between January 1, 2000, to September 1, 2016. Reported event rates and time-to-event data were pooled and entered into a microsimulation model to calculate life expectancy and lifetime event risks.ResultsForty-two studies reporting on 34 patient cohorts were included, encompassing a total of 12,842 patients with 55,437 patient-years of follow-up (pooled mean follow-up 5.0 ± 3.3 years). Pooled mean age was 76.5 ± 5.5 years. Pooled early mortality risk was 5.42% (95% confidence interval [CI], 4.49-6.55), thromboembolism rate was 1.83%/year (95% CI, 1.28-3.61), and bleeding rate was 0.75%/year (95% CI, 0.50-1.11). Structural valve deterioration (SVD) was based on pooled time to SVD data (Gompertz; shape: 0.124, rate: 0.003). For a 75-year-old patient, this translated to an estimated life expectancy of 9.8 years (general population: 10.2 years) and lifetime risks of bleeding of 7%, thromboembolism of 17%, and reintervention of 9%.ConclusionsThe low risks of SVD and reintervention support the use of bioprostheses in elderly patients in need of AVR. The estimated life expectancy after AVR was comparable with the general population. The results of this study inform patients and clinicians about the expected outcomes after bioprosthetic AVR and thereby support treatment decision-making. Furthermore, our results can be used as a benchmark for long-term outcomes after transcatheter aortic valve implantation in patients who were eligible for surgery and other (future) alternative treatments (eg, tissue-engineered heart valves).