Comparison of Carpentier-Edwards pericardial and supraannular bioprostheses in aortic valve replacement.

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.     

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.     

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.     

Clinical and hemodynamic evaluation of small Perimount aortic valves in patients aged 75 years or older

BACKGROUND: There is the potential for iatrogenic aortic stenosis and poor quality of life when small aortic valve bioprostheses are used in elderly patients. The alternative is enlarging the aortic annulus to accommodate larger size prostheses, increasing operative mortality. It was hoped that bovine pericardial valves would improve hemodynamic performance in the smaller valve sizes. METHODS: To determine long-term results and in vivo hemodynamic performance of small-size aortic Carpentier-Edwards bovine pericardial valves (Perimount) in elderly patients, we analyzed our follow-up and echocardiographic data from patients 75 years of age or older receiving isolated 19-mm and 21-mm Perimount valves. Ninety-four patients with a mean age of 77 +/- 2.2 years were followed for 12 years. Seventeen patients with 19-mm and 25 patients with 21-mm Perimount valves underwent transthoracic echocardiograms. RESULTS: Operative mortality was 6.3% (6 of 94). Twelve-year survival was 82.7%. Freedom from thromboembolism was 86.9% at 12 years. Two patients had anticoagulation-related bleeding. Overall New York Heart Association class decreased from 3 +/- 1 to 1.6 +/- 0.7 at the end of follow-up. Hemodynamic performances were satisfactory in both 19-mm and 21-mm Perimount valves, with low peak and mean transvalvular gradients and good effective orifice areas, orifice area indices, and performance indices. CONCLUSIONS: Perimount aortic valve in the small aortic annulus has yielded excellent long-term results and hemodynamic performances. Perimount is a very satisfactory option in elderly patients. Implantation of a Perimount bioprosthesis avoids enlargement of the small aortic annulus, reducing mortality and morbidity associated with this procedure.     

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.     

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.     

Aortic valve replacement in adult patients with small aortic annuli

Fifty-five patients with small aortic annuli underwent valve replacement either isolated or combined with other procedures. Patch enlargement of the aortic annulus in the area of the noncoronary sinus was used in 32 patients. The width of the patch was calculated by multiplying the desired increase in diameter by pi and adding 8 mm for suturing. The remaining 23 patients had aortic valve replacement with a prosthesis larger than the aortic annulus. The prosthesis was sutured in a supraannular position in the area corresponding to the noncoronary sinus. This slightly tilted position does not compromise function of Carpentier-Edwards or Bj?rk-Shiley prostheses. Prosthetic gradients ranged from 0 to 18 mm Hg (9.2 +/- 3.9 mm Hg) in patients with patch enlargement of the aortic annulus and from 0 to 22 mm Hg (7.2 +/- 5.8 mm Hg) in patients with supraannular aortic prostheses. Although these techniques allow for insertion of prosthetic valves only one and two sizes larger than the aortic annulus, they appear to be satisfactory in most adult patients with a small aortic annulus.     

The Carbomedics Top Hat supraannular aortic valve: a multicenter study

BACKGROUND: Introduced in 1993, the Carbomedics Top Hat (Sulzer, Carbomedics, Austin, TX) valve is a bileaflet mechanical aortic prosthesis designed to be placed in a supraannular position. Five institutions pooled their clinical experiences to evaluate early outcome in patients with this prosthesis. METHODS: From 1994 to 2000, 639 patients underwent aortic valve replacement with Top Hat (Sulzer Carbomedics) valves at 5 institutions. Mean age was 60 +/- 13 years. In this heterogeneous population, 28% of patients had previous cardiac operations and 64% had concomitant procedures, including procedures involving more than 1 heart valve in 32%. Implanted prostheses sizes included the 19 mm (15%), 21 mm (37%), 23 mm (33%), 25 mm (13%), and 27 mm (2%). Mean follow-up was 2.0 +/- 1.5 years, and there were 1,206 patient-years of follow-up available for analysis. RESULTS: Thirty-day mortality was 5.3%. Five-year survival was 74%. Risk factors for death included older age (p = 0.01), decreased ejection fraction (p = 0.007), and increased New York Heart Association functional class (p = 0.003). Five-year freedoms from thromboembolism and hemorrhage were 90% and 85%, respectively. Five-year freedoms from explant and endocarditis were both 99%. There were no structural valve failures. CONCLUSIONS: The Top Hat valve outcomes have been similar to those of the standard Carbomedics intraannular prostheses. The unique design of the Top Hat valve, with all its components in the aortic sinuses, has particular advantages in the small aortic root, in settings where leaflet entrapment may occur, and in multiple valve replacement.     

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.     

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)     

Late hemodynamic and clinical outcomes of aortic valve replacement with the Carpentier-Edwards Perimount pericardial bioprosthesis

OBJECTIVES: The aim of this study was to investigate the long-term clinical and hemodynamic outcomes after aortic valve replacement with the Carpentier-Edwards Perimount bioprosthesis (Edwards Lifesciences, Irvine, Calif), which has been used in our institution since 1984. METHODS: From January 1984 to December 1995, the Carpentier-Edwards pericardial bioprosthesis was used for aortic valve replacement in 254 patients (male/female ratio 117:137) with a mean age of 71 years (range 25-87 years). Before the operation, 216 patients (85%) were in New York Heart Association functional class III or IV. The predominant diagnosis was aortic stenosis (n = 219, 86%). Associated surgical procedures included coronary artery bypass grafting in 130 cases (51%), mitral valve replacement in 11 cases (4%), and tricuspid or mitral valve repair in 12 cases (5%). Previous cardiac operations had been performed in 36 cases (14%). Follow-up was 100% complete at a mean of 60 +/- 31 months. Univariate estimates of time-related cumulative probabilities were calculated by the Kaplan-Meier method. Multivariable adjustment was performed by Cox proportional hazards regression. Echocardiography was performed in 61% of long-term survivors. RESULTS: There were 11 early deaths (4%) and 58 late deaths. Actuarial survivals at 5, 10, and 12 years were 80% +/- 3%, 50% +/- 8%, and 36% +/- 9%, respectively. At 12 years the freedom from cardiac death was 73% +/- 7%, the freedom from valve-related death was 84% +/- 11%, the freedom from valve reoperation was 83% +/- 9%, the freedom from primary tissue failure was 86% +/- 9%, the freedom from thromboembolism was 67% +/- 13%, and the freedom from endocarditis was 98% +/- 1%. Echocardiography was performed on long-term survivors (mean follow-up 67 +/- 25 months) and showed that transvalvular peak and mean pressure differences measured with Doppler echocardiography were 23.2 +/- 9.6 and 12.3 +/- 4.8 mm Hg, respectively. Aortic regurgitation was found by Doppler echocardiography to be none or trivial, mild, moderate, and severe in 64%, 30%, 3%, and 1% of patients, respectively. Mean left ventricular mass index was 107.2 +/- 35.3 g/m(2) (118.9 +/- 40.2 g/m(2) in men and 98.8 +/- 28.8 g/m(2) in women) at late follow-up. One third of all patients, regardless of sex (n = 26/64 women and n = 14/45 men), had evidence of left ventricular hypertrophy. However, our analyses indicate that the residual left ventricular hypertrophy was not caused by valve mismatch but was probably multifactorial. CONCLUSION: The Carpentier-Edwards Perimount bioprosthesis has provided satisfactory clinical and hemodynamic outcome. However, at long-term follow-up about one third of the patients being investigated still had left ventricular hypertrophy examined by echocardiography.     

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.     

Hemodynamic evaluation of 19-mm Carpentier-Edwards pericardial bioprosthesis in aortic position

BACKGROUND: The aortic Carpentier-Edwards pericardial bioprosthesis offers good long-term clinical outcomes with a low rate of structural deterioration. However, little in vivo hemodynamic data is available for this bioprosthesis. METHODS: To determine the hemodynamic performance of the 19-mm Carpentier-Edwards pericardial valve, both cardiac catheterization and dobutamine stress echocardiography were electively performed in 10 patients. The mean age at the study was 71.6 +/- 4.4 years and the mean body surface area was 1.39 +/- 0.11 m2. The peak-to-peak gradient, instantaneous peak gradient, mean gradient, and valve orifice area were measured by standard cardiac catheterization. The Doppler-derived gradients and valve orifice area were also measured both at rest and during dobutamine infusion. RESULTS: The average peak-to-peak gradient, instantaneous peak gradient, mean gradient, and valve orifice area measured by catheterization were 13.0 +/- 5.4 mmHg, 28.5 +/- 7.7 mmHg, 12.0 +/- 4.9 mmHg, and 1.55 +/- 0.45 cm2, respectively. The peak and mean Doppler gradients, and valve orifice area by resting echocardiography were 27.7 +/- 9.5 mmHg, 12.3 +/- 4.8 mmHg, and 1.39 +/- 0.26 cm2, respectively. At a dosage of 10 microg/kg/min of dobutamine, the mean Doppler gradient rose mildly to 22.2 +/- 4.8 mmHg, while the cardiac output increased from 4.49 +/- 0.44 to 6.64 +/- 0.87 L/min. The valve orifice area during the 10 microg/kg/min dobutamine infusion (1.55 +/- 0.25 cm2) was significantly larger than its value at rest (p < 0.05). CONCLUSIONS: With acceptable hemodynamic performance, use of the aortic 19-mm Carpentier-Edwards pericardial valve is a reliable option for elderly patients with a small annulus.     

Structural valve deterioration in mitral replacement surgery: comparison of Carpentier-Edwards supra-annular porcine and perimount pericardial bioprostheses.

BACKGROUND: Bioprostheses preserved with glutaraldehyde, both porcine and pericardial, have been available as second-generation prostheses for valve replacement surgery. The performance with regard to structural valve deterioration with the Carpentier-Edwards supra-annular (CE-SAV) porcine bioprosthesis and the Carpentier-Edwards Perimount (CE-P) pericardial bioprosthesis (Baxter Healthcare Corp, Edwards Division, Santa Ana, Calif) was evaluated to determine whether there was a difference in mitral valve replacement. METHODS: The CE-SAV bioprosthesis was implanted in 1266 overall mitral valve replacements (isolated mitral, 1066; mitral in multiple, 200) and the CE-P bioprosthesis in 429 overall mitral valve replacements (isolated mitral, 328; mitral in multiple, 101). The mean age of the CE-SAV population was 64.2 +/- 12.2 years and that of the CE-P population, 60.7 +/- 11.7 years (P =.0001). For the study, structural valve deterioration was diagnosed at reoperation for explantation. RESULTS: The freedom from structural valve deterioration was evaluated to 10 years, and the freedom rates reported are at 10 years. For the overall mitral valve replacement groups, the actuarial freedom from deterioration was significant (P =.0001): CE-P > CE-SAV for 40 years or younger, 80% versus 60%; 41 to 50 years, 91% versus 61%; 51 to 60 years, 84% versus 69%; 61 to 70 years, 95% versus 75%. The older than 70-year group was 100% versus 92% (no significant difference). The actual freedom from structural valve deterioration also demonstrated the same pattern at 10 years: 40 years or younger, CE-P 82% versus CE-SAV 68%; 41 to 50 years, 92% versus 70%; 51 to 60 years, 90% versus 80%; 61 to 70 years, 97% versus 88%; and older than 70 years, 100% versus 97%. The independent risk factors of structural valve deterioration for the overall mitral valve replacement group were age and age groups and prosthesis type (CE-SAV > CE-P). The prosthesis type either in isolated replacement or in multiple replacement was not predictive of structural valve deterioration. The pathology of structural valve deterioration was different: 70% of CE-P failures were due to calcification and 57% of CE-SAV failures were due to combined calcification and leaflet tear. CONCLUSION: The actuarial and actual freedom from structural valve deterioration, diagnosed at reoperation, is greater at 10 years for CE-P than for CE-SAV bioprostheses. The mode of failure is different, and the cause remains obscure. Long-term evaluation is recommended, because the different modes of failure may alter the clinical performance by 15 and 20 years.     

Surgical technique of aortic valve replacement for small aortic annulus in elderly patients

Recent reports have shown that aortic valve replacement in elderly patients over 65 years with atherosclerotic aortic stenosis and a small aortic annulus is possible by using a small sized bioprosthesis (Carpentier-Edwards pericardial valve). Here we present out surgical technique. Firstly, the native calcified aortic valve was removed completely to gain total exposure of the surrounding aortic root and sinus of Valsalva like Bentall procedure. Secondly, a small sized bioprosthesis was implanted with intermittent noneverting mattress 2-0 sutures with spaghetti and small polytetrafluoroethylene (PTFE) felt. Aortic annulus is the dilated by inserting Hegar dilator sizing from 25 to 27 mm. Therefore, aortic valve replacement for small aortic annulus in intra- or supra-annular position should be easily accomplished. Good surgical results and hemodynamic state were achieved in 25 consecutive cases using this technique.     

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.     

Performance of 21-mm size perimount aortic bioprosthesis in the elderly

BACKGROUND: Aortic valve replacement in elderly patients with a small aortic annulus may pose difficult problems in terms of prosthesis selection. We have evaluated the hemodynamic performance of the 21-mm Carpentier-Edwards Perimount bioprosthesis implanted in elderly patients. METHODS: From July 1996 to June 1998, 19 patients (17 women and 2 men, mean age 76+/-4 years and mean body surface area 1.73+/-0.13 m2), had aortic valve replacement with a 21-mm Carpentier-Edwards Perimount bioprosthesis. The hemodynamic performance of the valve was evaluated in 16 patients, who completed at least a 6-month follow-up interval, with transthoracic color-Doppler echocardiography with particular reference to peak and mean transprosthetic gradients, effective orifice area index, and regression of left ventricular mass index. RESULTS: There were no late deaths and no major postoperative complications. At a mean follow-up of 12+/-7 months, compared to discharge, all patients showed clinical improvement with a significant reduction of peak gradient (from 23+/-4 to 21+/-6 mm Hg, p = 0.04) and left ventricular mass index (from 181+/-23 to 153+/-20 g/m2; p<0.001), whereas mean gradient (from 13+/-3 to 13+/-4 mm Hg, p = not significant) and effective orifice area index (from 1.12+/-0.34 to 1.13+/-0.28 cm2/m2, p = not significant) remained substantially unchanged. CONCLUSIONS: The use of a 21-mm Carpentier-Edwards Perimount bioprosthesis is associated with low transprosthetic gradients and significant reduction in left ventricular hypertrophy after aortic valve replacement. The results of our study suggest that a 21-m Carpentier-Edwards Perimount bioprosthesis should be considered a valid option in elderly patients with aortic valve disease and a small aortic annulus.     

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.     

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.     

Intermediate results of aortic valve replacement using 19 mm bioprosthetic valve

Pre- and postoperative hemodynamic parameters and activity of daily life were reviewed to estimate the effectiveness of the valve in 12 cases of single aortic valve replacement (AVR) using 19 mm bioprosthesis. All implanted prostheses were stented-valves. Carpentier-Edwards pericardial valve was used in 7 cases and Mosaic valve in 5. Left ventricular mass index (LVMI) significantly decreased from 167 +/- 36 to 133 +/- 27 g/m2 in the early postoperative period, and to 115 +/- 24 g/m2 in the intermediate phase. However, postoperative LVMI remained higher in patients with body surface area (BSA) over 1.5 m2 than in those under 1.5 m2. Postoperative activity indicated by New York Heart Association (NYHA) grade significantly improved from 2.3 +/- 1.1 to 1.4 +/- 0.5. These results indicates usefulness of 19 mm bioprosthetic valve for reducing left ventricular hypertrophy and improving activity, especially in patients with BSA smaller than 1.5 m2.