Experiences with 1643 porcine prosthetic valves in 1492 patients.

Sixteen hundred and forty-three porcine prosthetic values (1102 Carpentier-Edwards, 541 Hancock) were implanted in 1492 patients at New York University Medical Center between January 1976 and June 1983. The aortic valve alone was replaced in 786 patients (53%), mitral valve alone in 556 (37%), and multiple valves in 143 patients (9.6%). Concomitant coronary artery bypass was performed in 326 patients (22%). There were 116 deaths within 30 days of operation (7.8%). Follow-up (mean: 42 months) was completed in 94% of survivors and revealed that late survival from cardiac-related death was 87% at 5 years and 81% at 7 years, with no significant difference between the Carpentier-Edwards and Hancock patients. Late thromboembolic complications, however, were significantly more frequent in Hancock patients at all intervals from 1-7 years (p less than 0.05), whether in the aortic or mitral position. Patients with coronary artery disease who had concomitant coronary bypass showed a survival from late cardiac death that did not differ significantly from that of patients undergoing valve replacement alone. Before operation, 87% of patients were in New York Heart Association Class III or IV, but after operation 80% were in Class I or II. Late anticoagulant complications, endocarditis, and valve dysfunction were relatively rare. These results from a series of such size, duration, and representative numbers of two types of porcine bioprosthesis confirm excellent results with porcine prostheses in the first 4-5 years following operation.     

Surgical treatment of the prosthetic valves in reoperation

Surgical treatment and problems in patients required reoperation for malfunctioning prosthetic valves are reviewed in our institute. The cinefluoroscopy and pulse doppler echocardiography were helpful for diagnosis of artificial valve dysfunction. In recent two decades valve replacement were performed in 382 cases and number of re-implanted valve were 469. Among them the cases of reoperation were 21 and reimplanted valves were 25 (5.6%); 4.7% in aortic, 5.0% in mitral, 6.7% in tricuspid position. Three cases of those patients had three operations. Main causes of reoperation were primary tissue failure in Carpentier-Edwards porcine xenograft (6 cases, 23%) and cloth wear in Starr-Edwards ball valve (9 cases, 38%) and thrombosis in St. Jude Medical bi-leaflet valve (3 cases, 15%). In most cases St. Jude Medical valve were chosen for the alternative prosthetic valve in reoperation. We applied IABP support to seven patients for severe low cardiac output syndrome after the operation and overall mortality was 24% in reoperation. It concluded that St. Jude Medical valve may be most reliable because of low incidence of postoperative complication in our institute.     

Long-term results of porcine bioprosthetic valves

Between November 1977 and October 1980, 54 patients underwent valve replacements with porcine bioprostheses at Hyogo Kenritsu Amagasaki Hospital. The late complications and the long term durability of 53 porcine bioprostheses were documented in 48 patients after discharge (34 mitral, 7 aortic, 2 tricuspid, and 5 multiple, consisting of 38 Hancock, 15 Carpentier-Edwards prostheses). Cumulative duration of follow-up is 420 patient-years. The valve related late mortality was 0.52%/patient-years. There were 6 thromboembolic events (1.6% patient-years), only 1 episode of endocarditis (0.26%/patient-years). Valve dysfunction is defined as stenosis or regurgitation by echocardiogram or cardiac catheterization. There were 21 instances of porcine bioprosthetic dysfunction (6.6% patient-years). Freedom from valve dysfunction at 12 years was 24.4%. There were 17 valves of mitral bioprosthetic dysfunction (6.4% patient-years). The incidences of mitral stenosis (MS), mitral regurgitation (MR), and paravalvular leakage were 4.5, 3.6, and 0.7%/patient-years respectively. Freedom from MR was higher than MS at 8 years. The 14 patients were needed reoperation due to valve dysfunction (3.6%/patient-years). We concluded that the porcine bioprostheses showed a high incidence of valve dysfunction at 7 to 8 years after operation, we presently choose mechanical valve in most cases.     

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.     

A 10-year comparison of mitral valve replacement with Carpentier-Edwards and Hancock porcine bioprostheses

Two hundred fifty-three patients who underwent isolated mitral valve replacement with a porcine bioprosthesis had long-term evaluation. One hundred forty-seven patients received a Carpentier-Edwards porcine bioprosthesis and 106, a Hancock valve. There were no significant differences in preoperative clinical characteristics between the two groups. Cumulative follow-up was 1,375 patient-years. At 10 years, 93% +/- 2.5% of the patients in the Carpentier-Edwards group and 85% +/- 7.8% of those in the Hancock group were free from valve-related death (not significant), and 95% +/- 2% and 91% +/- 3.8%, respectively, were free from thromboembolism (not significant). At 10 years, 65% +/- 7.2% of the patients in the Carpentier-Edwards group and 66% +/- 7.2% of those in the Hancock group were free from structural valve deterioration (not significant), and 64% +/- 6% and 59% +/- 7.3%, respectively, were free from reoperation (not significant). We conclude that the first generation of Carpentier-Edwards and Hancock prostheses produce comparable long-term results in the mitral position.     

Clinical and Hemodynamic Results with the Carpentier-Edwards Porcine Bioprosthesis

Carpentier-Edwards bioprostheses were implanted in 605 patients, 509 of whom had a single valve replacement, and 96 of whom had a multiple valve replacement. There were 54 early deaths (8.9%) and 26 late deaths (4.3%). The five-year actuarial survival was 87% for aortic valve replacement, 83% for mitral valve replacement, and 81% for multiple valve replacement. Of the 525 survivors, all but 3 were followed for a total of 964 patient-years; 354 patients (68%) remained asymptomatic, and 95 patients (18%) were improved. The incidences of thromboembolism, endocarditis, and reoperation due to primary tissue failure of the bioprosthesis were 2.0, 1.3, and 0.1% per patient-year, respectively. The actuarial probability of being free of all valve-related complications was 93% after five years. Satisfactory hemodynamic performance of the bioprosthesis was demonstrated by postoperative studies done in 70 patients. Thus, the Carpentier-Edwards porcine valve provides good clinical improvement, with a low incidence of valve-related complications and tissue failure at five years postoperatively.     

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.     

Eleven years' experience with Carpentier-Edwards biological valves in relation to survival and complications

The Carpentier-Edwards porcine valve bioprosthesis was implanted in 299 patients (325 prostheses) from April 1976 to April 1982. The series consisted of aortic valve replacement in 150 patients, mitral valve replacement in 120, multiple valve replacement in 26, pulmonary valve replacement in 2 and tricuspid valve replacement in 1 patient. The postoperative follow-up was 100% complete. The total accumulated follow-up was 1956 patient-years. The early mortality was 6.4% (20 patients) and the late mortality was 22% (62 patients). Valve-related mortality was seen in 8 patients (2.7%): 1 paravalvular leak during the 1st 30 postoperative days and 7 late mortalities (1 endocarditis, 2 paravalvular leaks and 4 deaths during reoperation). Three operative deaths (1.5%) occurred. The overall patient survival including operative deaths was 78.5% +/- 5% at 5 years and 66% +/- 4% at 10 years. The incidence of the different complications were: thromboembolism in 5 patients (1.7%) with a risk of 0.3%, haemorrhage in 1 (0.3%) with a risk of 0.05%, endocarditis in 2 (0.7%) with a risk of 0.1%, and paravalvular leak in 11 patients (3.7%) with a risk of 0.6%. There was a high incidence of tissue failure during the last 6 years which occurred in 54 patients (18%) with a risk of 2.7%. Sixty-seven patients (22.5%) were reoperated upon during the 11 years with an annual risk of 3.4% and the main cause of reoperation was primary tissue failure. The Carpentier-Edwards biological valve was shown to be efficient during the first 5 years of implantation after which the incidence of tissue failure increased.(ABSTRACT TRUNCATED AT 250 WORDS)     

Investigation of primary tissue failure in mitral bioprostheses

A study was conducted on 118 Hancock (HX) porcine valves, 251 Carpentier-Edwards (CE) porcine valves, and the biological valves in children used in the mitral position. Twenty-three HX valves, twenty-seven CE valves, and all valves except one operative death in children were diagnosed as primary tissue failure (PTF). Freedom from PTF for HX valves was 70.1 +/- 6.0% at ten years and for CE valves was 45.7 +/- 17.0% at ten years, although for children it was calculated 0% at eight years (significantly poor results compared with adults). No relation was found between the degree of calcified cusps and the duration of PTF valves used. The ruptures and calcifications of the cusps were most commonly observed in commissure. The peeled off commissures were characteristic in CE valves. Three adults and two children died without reoperation caused by calcified stenotic valves. Since the risk of reoperation was higher in NYHA functional class four, we recommend earlier elective reoperation.     

Results of reoperation for primary tissue failure of porcine bioprostheses

Results of reoperation for primary tissue failure of porcine bioprostheses were evaluated in 574 patients discharged from the hospital from 1970 to 1981. A total of 413 had undergone isolated mitral valve replacement and 161 isolated aortic valve replacement. Through March, 1984, 88 patients (15%) had required reoperation: 59 had undergone mitral and 29, aortic valve replacement. Primary tissue failure was the main cause of bioprosthetic dysfunction; it occurred in 64 patients (46 mitral and 18 aortic) at a mean postoperative interval of 93 +/- 4 months (range 34 to 158). During the same period, 11 patients required reoperation for bioprosthetic endocarditis, 11 for paravalvular leak, and two for thrombosis. These patients are not included in this review. Reoperation for primary tissue failure was performed after a mean interval of 72 +/- 6 months (range 38 to 158) for patients with aortic bioprostheses and after 101 +/- 5 months (range 34 to 153) for those with mitral bioprostheses (p less than 0.05). Overall mortality at reoperation was 12.5%: 11% for the mitral group and 16% for the aortic group. In 62 patients (45 mitral and 17 aortic) primary tissue failure was caused by calcification of the cusps, associated with severe fibrous tissue overgrowth in seven. Bioprosthetic failure was caused by an intracuspal hematoma in one patient with mitral valve replacement and by lipid infiltration of the cusps in one patient with aortic valve replacement. Actuarial freedom from bioprosthetic primary tissue failure at 12 years is 61% +/- 5% for the mitral group and 69% +/- 7% for the aortic group. On the basis of our long-term follow-up of patients after mitral or aortic replacement with a porcine bioprosthesis, we conclude: primary tissue failure is the most frequent indication for reoperation in patients with a porcine bioprosthesis; calcification of the cusp tissue is the leading cause of primary tissue failure; reoperation for primary tissue failure may be a major concern, although mortality for elective cases is low; and the limited durability of porcine bioprostheses suggests their use be restricted to selected patients.     

Valve replacement in the right side of the heart in children: long-term follow-up

Twenty-five patients (16 male, 9 female) underwent right-sided valve replacement (10 pulmonary valve replacement, 14 tricuspid valve replacement, 3 tricuspid plus pulmonary valve replacement, and 2 replacements of a single atrioventricular valve) at the University of Nebraska Medical Center from June 1977 to December 1986. Twenty-one patients (84%) are long-term survivors with 2,035 months follow-up (range, 41 to 143 months; mean, 96.9 months). Twenty-three Carpentier-Edwards bioprosthetic valves, one Ionescu-Shiley bioprosthetic valve, and nine St. Jude Medical valves were inserted. Follow-up of 17 patients with a Carpentier-Edwards valve ranged from 5 years 9 months to 11 years 9 months (mean, 8 years 11 months). To date there has been one reoperation after 3 years 4 months in this group. One patient who received an Ionescu-Shiley bioprosthesis required re-replacement at 20 months after operation. Three of 4 patients who received St. Jude mechanical valves and are long-term survivors have required replacement after 36 to 56 months. We conclude that the Carpentier-Edwards bioprosthetic valve is a viable option in the right side of the heart in the young age group when annular size is adequate to accommodate an appropriate bioprosthesis.     

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.     

Late results after resection of fixed subaortic stenosis

Resection of fixed subaortic stenosis was performed on 44 patients with median age 14 (range 2-61) years. Concomitant aortic valve pathology was present in 14 (32%) cases (congenital stenosis in 2, thick fibrotic cusps in 8 and incompetent cusps in 4) and other congenital cardiovascular malformations in eight (18%). There was no perioperative mortality. Of the six late deaths, three were due to non-cardiac causes. During follow-up (median 6, range 2-21 years), six reoperations were performed for residual or recurrent obstruction and/or aortic incompetence. Aortic valve replacement was required at two primary and four second operations. Actuarial 5-year and 10-year survival rates were 89% and 76%, respectively, and rates with freedom from cardiac death endocarditis and reoperation 83% and 64%. At follow-up evaluation two patients had significant aortic regurgitation and all survivors had a systolic ejection murmur. At Doppler echocardiography in 29 patients without reoperation, the median pressure difference in the left ventricular outflow tract was 10 (range 0-55) mmHg--in three cases greater than or equal to 30 mmHg. Careful follow-up is advisable after resection of fixed subaortic stenosis, because of the risk of residual or recurrent obstruction and of significant aortic valve incompetence.     

Bj?rk-Shiley and Carpentier-Edwards valves. A comparative analysis

Between January 1977 and December 1982, 986 Bj?rk-Shiley and 744 Carpentier-Edwards valves were implanted in 774 and 620 patients, respectively, at the same institution. All Bj?rk-Shiley patients and 57% of patients with a Carpentier-Edwards valve in the mitral position received long-term anticoagulation. Mean follow-up was 3.2 years (range 0 to 8.8) in the Bj?rk-Shiley patients and 3.5 years (range 0 to 8.2) in the Carpentier-Edwards group. There was no significant difference between the two groups in hospital mortality (Bj?rk-Shiley 7.6%; Carpentier-Edwards 6.0%), overall incidence of embolism (Bj?rk-Shiley 1.4 per 100 patient-years; Carpentier-Edwards 1.6% py), endocarditis (Bj?rk-Shiley 0.6% py; Carpentier-Edwards 0.8% py), periporsthetic leak (Bj?rk-Shiley 1.6% py; Carpentier-Edwards 1.4% py), anticoagulant-related complications (Bj?rk-Shiley 0.3% py; Carpentier-Edwards 0.1% py), valve failure (Bj?rk-Shiley 0.78% py; Carpentier-Edwards 0.68% py), reoperation for complication (Bj?rk-Shiley 1.68% py; Carpentier-Edwards 1.22% py), and late mortality (Bj?rk-Shiley 3.1% py; Carpentier-Edwards 3.0% py). Actuarial freedom from valve-related events was similar in the two groups. In the aortic position, freedom from embolism was significantly better in the Bj?rk-Shiley group than the Carpentier-Edwards group (Bj?rk-Shiley 99% at 3 and 5 years; Carpentier-Edwards 96% and 92% at 3 and 5 years; p = 0.023). In the mitral position, the overall incidence of reoperation was higher in the Bj?rk-Shiley group (1.78% py) than in the Carpentier-Edwards group (0.48% py) (p = 0.004). Actuarial analysis shows this difference to be confined to the first 6 years of follow-up. The commonest indication for reoperation was valve failure in both groups. However, when analysis is confined to this indication, the difference between the reoperation incidence in the mitral position becomes insignificant (Bj?rk-Shiley 0.85% py; Carpentier-Edwards 0.29% py; p = 0.085). This study confirms the satisfactory performance of both the Carpentier-Edwards and Bj?rk-Shiley valves in the short and middle term and indicates no clear-cut advantage for either prosthesis.     

Surgical strategy for severe tricuspid valve regurgitation complicated by advanced mitral valve disease: long-term outcome of tricuspid valve supra-annular implantation in eighty-eight cases

OBJECTIVE: Although annuloplasty has been the most commonly performed surgical modality for severe tricuspid regurgitation, tricuspid valve supra-annular implantation has been performed in our hospital for more than a decade. The aim of this study was to assess the long-term outcome of tricuspid valve supra-annular implantation in a subgroup of patients with severe tricuspid regurgitation, those who also had advanced mitral valve disease. METHODS: Mitral valve replacement in conjunction with tricuspid valve supra-annular implantation was performed on 88 patients at our hospital between 1984 and 1998. The patients (mean age 57 +/- 11 years) were followed up for an average of 7.2 +/- 4.5 years after the operation (range 0-14 years); total follow-up was 643.1 patient-years. All patients except 2 (97.6%) were included in the follow-up. We evaluated the mortality, the cause of death, survival, the freedom from structural valve deterioration and reoperation, postoperative complications, and long-term echocardiographic findings. RESULTS: Overall survival at 14 years was 69% +/- 7.7%. Freedom from structural valve deterioration at 14 years was 100% and from reoperation, 88% +/- 9. 4%. There were no instances of pulmonary thromboembolism or of complications associated with fatal arrhythmias. Echocardiography showed little residual tricuspid regurgitation, no atrophic and stenotic change in the native tricuspid valve, and no thrombus formation between native valve and the implanted bioprosthesis. CONCLUSIONS: The procedure's simplicity, the good long-term durability of the bioprosthesis, and the absence of fatal arrhythmias and pulmonary thromboembolism indicate that tricuspid valve supra-annular implantation is a useful procedure for patients with severe tricuspid regurgitation complicated by advanced mitral valve disease.     

The pericardial valve in the aortic position ten years later

To assess the behavior of the pericardial valve at 10 years after implantation, the cases of 240 patients who had undergone aortic valve replacement with the standard Ionescu-Shiley (Shiley, Inc., Irvine, Calif.) bovine pericardial valve between February 1977 and December 1983 were reassessed. Follow-up of the 224 hospital survivors was 99.6% complete. Fifty-seven valve-related events occurred. Fourteen were thrombotic events (1.2%/patient-year), 28 were intrinsic tissue failures (2.4%/patient-year), 13 were cases of prosthetic valve endocarditis (1.1%/patient-year), and 2 were paravalvular leaks (0.17%/patient-year). The linearized rate for death, reoperation, or both resulting from valve-related events was 3.6%/patient-year. Time-related hazard function for the instantaneous risk of death and/or reoperation resulting from valve-related events demonstrated an exponential increase after 80 months. These data, in conjunction with our previous reports on the histologic changes in pericardial collagen and the incidence of calcification (26/28), should be considered regarding new and future generations of pericardial bioprostheses. Although this device provides good hemodynamics and carries a low incidence of thromboembolism, it has a limited durability. New generations of pericardial valves may have improved structural features, but the behavior of glutaraldehyde-fixed, formaldehyde-stored bovine pericardium as currently selected and prepared is unlikely to change.     

Replacement of the ascending aorta. Early and late results

From 1978 through 1987, 225 patients underwent operations that included replacement of the ascending aorta. One hundred twenty-three patients underwent composite aortic valve and ascending aortic replacement, 30 had aortic valve replacement with separate graft replacement of the ascending aorta, and 72 underwent replacement of the ascending aorta without aortic valve replacement. Thirty-one (13.8%) in-hospital deaths occurred. Univariate testing of preoperative and operative variables followed by logistic regression analyses identified miscellaneous aortic disease, coronary artery bypass grafting, aortic arch replacement, emergency operation, surgical date (1978 to 1983), and age (all p less than 0.05) as factors having independent association with in-hospital mortality. Follow-up of in-hospital survivors (mean interval 46 months, range 8 to 123 months) documented an overall 5-year survival rate of 76%, 83% after primary operation and 37% after reoperation. Univariate analyses followed by multivariate testing indicated that previous operation (p less than 0.0001) and a history of preoperative neurologic symptoms (p = 0.021) were associated with decreased late survival. At follow-up 88% of late survivors were free of symptoms. Seven patients have undergone reoperation 1 day to 69 months postoperatively. Although the in-hospital mortality for operations that include ascending aortic replacement exceeds that for isolated aortic valve replacement, the late death rate and rate of reoperation are low.     

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.     

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.     

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.