Failure of Hancock pericardial xenografts: is prophylactic bioprosthetic replacement justified?

The incidence of major valve-related complications was evaluated in a series of patients in whom the Hancock pericardial xenograft was used for aortic (AVR; n = 84), mitral (MVR; n = 17) and mitral-aortic (MAVR; n = 13) valve replacement. At 7 years actuarial survival is 66% +/- 8% after AVR, 64% +/- 13% after MVR, and 41% +/- 15% after MAVR, whereas actuarial freedom from valve-related death is 79% +/- 7% after AVR, 78% +/- 13% after MVR, and 81% +/- 12% after MAVR. Actuarial freedom from thromboemboli and anticoagulant-related hemorrhage at 7 years is 93% +/- 4% and 98% +/- 2% after AVR and 83% +/- 10% and 88% +/- 11% after MVR; no such complications occurred after MAVR. Structural valve deterioration determined at reoperation, at autopsy, or by clinical investigation was observed in 34 patients with AVR (10.0 +/- 0.2%/patient-year), in 10 with MVR (10.6 +/- 3.3%/patient-year), and in 9 with MAVR (16.6 +/- 5.5%/patient-year). After AVR, 19 patients underwent reoperation and 2 died before reoperation; 4 patients with MVR underwent reoperation, and 7 patients with MAVR underwent reoperation and 1 died before reoperation. Seventy-eight percent of the current survivors (13 patients with AVR, 7 with MVR, and 1 with MAVR) have clinical evidence of valve failure. At 7 years actuarial freedom from structural deterioration of the Hancock pericardial xenograft is 25% +/- 7% after AVR, 29% +/- 14% after MVR, and 0% after MAVR.(ABSTRACT TRUNCATED AT 250 WORDS)     

Carpentier-Edwards supra-annular porcine bioprosthesis. Clinical experience and implantation characteristics

The investigational Carpentier-Edwards supra-annular valve was implanted in 592 patients from November, 1981, to February, 1984 (aortic valve replacement in 286, mitral valve replacement in 259, and multiple valve replacement in 47, for a total of 638 prostheses). A previous cardiac operation had been performed in 77 patients (13%). Concomitant procedures were performed in 202 patients (34.1%), including coronary artery bypass in 163 patients. The patient evaluation was 98.6% complete. The early mortality was 7.4% (44 patients) and the late mortality was 6.2% per patient-year (41 patients). The valve-related causes of late mortality were thromboembolism (five), anticoagulant-related hemorrhage (one), and prosthetic valve endocarditis (one). The overall patient survival, including operative death, was 85% at 2 years. The linearized occurrence rate for valve-related complications was 5.6% per patient-year (37 events)--thromboembolism 2.7% per patient-year (18) anticoagulant-related hemorrhage 1.2% (eight), prosthetic valve endocarditis 0.8% (five), and periprosthetic leak 0.9% per patient-year (six). There were no cases of primary tissue failure or structural failure. At 2 years, the freedom from valve-related complications was 86.9%, from valve-related mortality, 98.7%, and from valve-related mortality and reoperation, 97.7%. This valve is fixed in glutaraldehyde at low pressure and is designed to improve durability. It has provided a low incidence of valve-related complications without structural failure. The structural design of the prosthesis does not always conform to the anatomy of bicuspid aortic valves.     

Aortic valve selection in the elderly patient

To determine the influence of valve selection on valve-related morbidity and mortality and patient survival, comparative long-term performance characteristics of mechanical (N = 68) and bioprosthetic (N = 73) heart valves were analyzed for 141 patients more than 70 years old who underwent isolated aortic valve replacement between 1970 and 1985. Cumulative patient follow-up was 491 patient-years (average, 4.3 years per patient). Hospital mortality was 18% and 19% for patients with mechanical valves and bioprosthetic valves, respectively. Survival at 5 years was 61 +/- 7% (+/- the standard error) and 67 +/- 10% for recipients of mechanical valves and bioprosthetic valves, respectively. Male sex (p = 0.014) and urgency of operation (p = 0.006) were independent risk factors for hospital mortality. Atrial fibrillation increased valve-related mortality (p = 0.01). No patient required reoperation or experienced structural valve failure. While anticoagulant-related hemorrhage was increased in recipients of mechanical valves (9.2 +/- 2.1%/patient-year) compared with recipients of bioprosthetic valves (2.3 +/- 1.1%/patient-year), it did not result in a death or lead to permanent disability. There was no difference in freedom from any valve-related complication at 5 years. However, when all morbid events are considered, recipients of bioprosthetic valves experienced fewer valve-related complications than patients receiving mechanical valves (10.7 +/- 2.3%/patient-year versus 17.6 +/- 2.5%/patient-year, respectively; p less than 0.05). The reduced incidence of anticoagulant-related hemorrhage and the infrequent need for warfarin sodium anticoagulation favor selection of a bioprosthetic heart valve in patients older than 70 years.     

Durability of combined aortic and mitral valve repair

BACKGROUND: This study was undertaken to determine the durability of combined aortic and mitral valve repair. METHODS: From 1979 through 1999, 158 patients underwent simultaneous aortic and mitral valve repair. Multivariable, multi-phase hazard function analysis was used to determine risk factors for the outcomes of death and reoperation. RESULTS: Hospital mortality was 3%. Survival after operation was 97%, 93%, 82%, and 62% after 30 days and 1, 5, and 10 years, respectively. Risk factors for late death included aortic stenosis (p = 0.0001), older age (p = 0.002), and abnormal left ventricular function (p = 0.007). Thirty-six patients required reoperation for valvular dysfunction, and freedom from reoperation was 94%, 82%, and 65% after 1, 5, and 10 years, respectively. Risk factors for reoperation included severe aortic regurgitation (p = 0.004), aortic cusp shaving (p = 0.05), mitral valve chordal transfer (p = 0.004), and bovine pericardial annuloplasty (p = 0.002). Five-year freedoms from endocarditis, thromboembolism, and hemorrhage were 97%, 98%, and 99%, respectively, with freedom from any of these valve-related morbidities of 99%, 95%, and 94% after 1, 5, and 10 years, respectively. CONCLUSIONS: Double valve repair is associated with acceptable late survival and excellent freedom from valve-related morbidity, but limited durability. Therefore, double valve repair should be reserved for patients who cannot be anticoagulated, and should be used with caution in patients with aortic stenosis, rheumatic valve disease, or anterior mitral leaflet pathology.     

Eight years' experience with the Medtronic-Hall valve prosthesis

During the period January 1981 to September 1986, 444 Medtronic-Hall heart valve prostheses were implanted in 351 patients (mean age, 45 +/- 10 years) mainly for rheumatic valve disease (63.2%). Most of the patients were in New York Heart Association functional class III. Concomitant surgical procedures, mainly conservative tricuspid or mitral procedures or coronary artery bypass grafting, were performed in 101 patients (28.7%). Single-valve replacement was performed in 262 patients (74.6%) (aortic in 117 patients, mitral in 143, and tricuspid in 2), double-valve replacement in 85 (24.2%) (mitral and aortic in 83 and mitral and tricuspid in 2), and triple-valve replacement in 4 (1.1%). Hospital mortality was 6.2%. Follow-up was 97.7% complete. The overall actuarial 8-year survival rate was 77.2%. The linearized incidence of valve-related complications was as follows: thromboembolism, 1.5%/patient-year; reoperation, 1.5%/patient-year; endocarditis, 1.25%/patient-year; hemolysis, 0.52%/patient-year; anticoagulant-related hemorrhage, 0.39%/patient-year; and noninfection-related paraprosthetic leak, 0.33%/patient-year. There were no instances of structural failure. We conclude that after 8 years of follow-up, the Medtronic-Hall valve prosthesis has an excellent clinical performance and a low range of valve-related complications.     

Ionescu-Shiley pericardial xenografts: follow-up of up to 6 years

The results of valve replacement with the Ionescu-Shiley pericardial xenograft compare favorably with results obtained with other bioprostheses. From March, 1977, to July, 1983, 497 Ionescu-Shiley pericardial valves were implanted in 463 patients at the University of Ottawa Heart Institute. There were 292 patients who had aortic valve replacement (AVR), 140 with mitral valve replacement (MVR), 28 with double valve replacement, and 3 with triple valve replacement. The survivors were followed regularly. Actuarial analysis of late results indicates an expected survival of 71% at 6 years for patients who underwent AVR and 72% at 3 years for patients who had MVR. The only valve-related deaths were due to endocarditis, which occurred at a rate of 3.9% per patient-year for aortic valves and 0.6% per patient-year for mitral valves. Despite a low usage of formal anticoagulation, embolic complications occurred at a rate of 1.4% per patient-year for aortic valves and 4.0% per patient-year for mitral valves. Five valves were removed for intrinsic failure after 36 to 72 months of follow-up. New York Heart Association Functional Class improved an average of 1.28 classes per patient.     

Performance of bioprostheses and mechanical prostheses assessed by composites of valve-related complications to 15 years after mitral valve replacement

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

Late results with bioprosthetic valves in the elderly

AIM: We report the long-term outcome of aortic and mitral bioprostheses in patients over 65 years of age at the time of implantation. The aim was to determine actuarial patient survival, causes of death, and the rate of documented primary structural deterioration. METHODS: One hundred ten patients > or = 65 years of age (mean, 73.4; range, 65-82) underwent successful bioprosthetic valve replacement (aortic, n = 71; mitral, n = 32; both, n = 7) from 1979 to 1985. The valve was pericardial in 39 cases and porcine in 78. The mean follow-up was 8.5 years (101.9 months-total; 934 patient-years; range, 2 months to 15 years). RESULTS: Actuarial patient survival was 79.6% (71-86) at 5 years and 62.4% (52-71) at 10 years. Forty-four patients died, 21 from valve-related causes and 23 from other causes. Thirteen patients (11.8%) had reoperation for valve-related complications: 10 structural deteriorations, 2 paravalvular leaks, and 1 case of endocarditis. One surgical death occurred (7.7%). Twenty-six percent of the patients were receiving anticoagulants because of atrial fibrillation, and 6.4% developed severe bleeding (2.9% patient-years). CONCLUSIONS: Long-term follow-up of these patients > 65 years of age, undergoing bioprosthetic value replacement surgery revealed a low rate of documented primary structural deterioration (0.95% per patient-year), a low mortality rate on reoperation (7.7%), and a high mortality rate due to non-value-related causes (52.3%).     

Elderly valve replacement with bioprostheses and mechanical prostheses. Comparison by composites of complications

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

Twenty years' experience with the Model 6120 Starr-Edwards valve in the mitral position

A total of 549 nonconsecutive patients underwent isolated mitral valve replacement with a Starr-Edwards valve prosthesis (Model 6120) at the University of Louvain (Belgium) from 1965 to 1985. Ninety-seven percent of the patients could be traced and only 17 patients were lost to follow-up. Cumulative follow-up totalled 3,130 patient-years. Actuarial and linearized statistical techniques were used to describe the survival and the incidence of valve-related complications (according to stringent criteria). Long-term overall survival rate including early deaths was 79% +/- 0.02% at 5 years, 65% +/- 0.03% at 10 years, and 54% +/- 0.04% at 19 years, with a linearized incidence of late deaths of 3.9% +/- 0.5% per patient-year. The incidence of late valve-related deaths was 1.25% per patient-year. Valve-related complications occurred at the following rates: thromboembolism 3.1% per patient-year, anticoagulant-related hemorrhage 1.08% per patient-year, endocarditis 0.26% per patient-year, reoperation and periprosthetic leak 0.45% per patient-year, and structural failure 0% per patient-year. All valve-related mortality and morbidity were calculated at 4.9% per patient-year and the rate of valve failure (deaths and reoperations) at 1.4% per patient-year. Among 376 survivors, 352 clinical functions could be obtained: 95% of patients belong to Class I or II of the New York Heart Association after operation versus 24% before operation. The study shows the structural durability of the Starr-Edwards mitral valve with a follow-up over 20 years. The Model 6120 valve may be considered a faithful standard.     

A single-center experience with 1,378 CarboMedics mechanical valve implants

BACKGROUND: The CarboMedics bileaflet prosthetic heart valve was introduced in 1986. We first implanted it in March 1991. The purpose of this study was to analyze our clinical experience with this valve. METHODS: Between March 1991 and December 1997, 1,378 valves were implanted in 1,247 patients, 705 men (56.5%) and 542 (43.5%) women with a mean age of 62 +/- 11.9 years (+/- the standard deviation). Follow-up is 99% complete and totals 3,978 patient-years. RESULTS: The early mortality rate was 4.4% (55/1,247). The survival rates at 1 year and 5 years were 91.8% +/- 0.8% (+/- the standard error of mean) (n = 1,062) and 79.2% +/- 1.4% (n = 281), respectively. Freedom from valve-related complications (linearized rate, 4.9% per patient-year) at 1 year and 5 years was 90.6% +/- 0.8% (+/- the standard error of the mean) (n = 996) and 80.6% +/- 1.4% (n = 243), respectively. Linearized rates for various complications were as follows: bleeding events, 1.73% per patient-year; embolic events, 1.76% per patient-year; operated valvular endocarditis, 0.18% per patient-year; valve thrombosis, 0.10% per patient year; and nonstructural dysfunction, 1.21% per patient-year. Freedom from reoperation at 1 year and 5 years was 98.6% +/- 0.3% (+/- the standard error of the mean) (n = 1,070) and 97.7% +/- 0.5% (n = 285), respectively. CONCLUSIONS: Midterm results demonstrate that the CarboMedics prosthetic heart valve exhibits a low incidence of valve-related complications.     

Allografts for aortic valve or root replacement: insights from an 18-year single-center prospective follow-up study.

OBJECTIVE: Whether allografts are the biological valve of choice for AVR in non-elderly patients remains a topic of debate. In this light we analyzed our ongoing prospective allograft AVR cohort and compared allograft durability with other biological aortic valve substitutes. METHODS: Between April 1987 and October 2005, 336 patients underwent 346 allograft AVRs (95 subcoronary, 251 root replacement). Patient and perioperative characteristics, cumulative survival, freedom from reoperation, and valve-related events were analyzed. Using microsimulation, for adult patients, age-matched actual freedom from allograft reoperation was compared to porcine and pericardial bioprostheses. RESULTS: Mean age was 45 years (range 1 month to 83 years); 72% were males. Etiology was mainly endocarditis 32% (active 22%), congenital 31%, degenerative 9%, and aneurysm/dissection 12%. Twenty-seven percent underwent prior cardiac surgery. Hospital mortality was 5.5% (N=19). During follow-up (mean 7.4 years, maximum 18.5 years, 98% complete), 54 patients died; there were 57 valve-related reoperations (3 early technical, 11 non-structural, 39 structural valve deterioration (SVD), 4 endocarditis), 5 cerebrovascular accidents, 1 fatal bleeding, 8 endocarditis. Twelve-year cumulative survival was 71% (SE 3), freedom from reoperation for SVD 77% (SE 4); younger patient age was associated with increased SVD rates. Actual risk of allograft reoperation was comparable to porcine and pericardial bioprostheses in a simulated age-matched population. CONCLUSIONS: The use of allografts for AVR is associated with low occurrence rates of most valve-related events, but over time the risk of SVD increases, comparable to stented xenografts. It remains in our institute the preferred valve substitute only for patients with active aortic root endocarditis and for patients in whom anticoagulation should be avoided.     

Cardiac valve replacement in the elderly: clinical performance of biological prostheses

From 1975 to 1987, 1,127 elderly patients underwent 1,223 valve replacements with the Carpentier-Edwards standard or supraannular porcine bioprostheses in 1,147 operations. Of the total patient population seen during these years, 33.5% receiving a standard porcine bioprosthesis and 48.6% receiving a supraannular bioprosthesis were 65 years of age or older. Of this elderly patient population, 465 patients were between 65 and 69 years old; 618 patients, 70 and 79 years old; and 52 patients, 80 years old and older. Aortic valve replacement was performed in 635 patients, mitral valve replacement in 417 patients, tricuspid valve replacement in 2 patients, and multiple-valve replacement in 80 patients. The cumulative follow-up was 3,957 patient-years. Early mortality was 9.5%: 7.3% for the 65- to 69-year-old group, 10.7% for the 70- to 79-year-old group, and 15.4% for the group 80 years old and older. Late mortality was 5.5% per patient-year: 4.2% per patient-year for the 65- to 69-year-old group, 6.3% per patient-year for the 70- to 79-year-old group, and 14.1% per patient-year for the group 80 years old and older. Valve-related causes contributed to 7 early deaths and 33 late deaths. The overall patient survival, including operative deaths, was 70.7% +/- 1.6% at 5 years and 47.8% +/- 3.7% at 10 and 12 years. The freedom from all valve-related complications was 52.1% +/- 6.1% at 10 and 12 years. The overall rate of valve-related complications was 5.0% per patient-year (fatal complications, 1.13% per patient-year). The overall rate of thromboembolism was 2.3% per patient-year and the freedom from thromboembolism, 69.6% +/- 5.2% at 10 and 12 years. The freedom from structural valve deterioration was 80.8% +/- 8.1% at 10 and 12 years: 71.7% +/- 11.0% at 10 and 12 years for the 65- to 69-year-old group, 97.9% +/- 1.2% at 10 years for the 70- to 79-year-old group, and 100% at 12 years for the group 80 years old and older. At 10 and 12 years, the freedom from valve-related death was 83.7% +/- 4.3% and the freedom from reoperation, 73.3% +/- 8.6%. The freedom from valve-related death, residual morbidity from thromboembolism and anticoagulant-related hemorrhage, and reoperation was 61.7% +/- 7.0% at 10 and 12 years. The clinical performance of porcine bioprostheses in the elderly patient population has been excellent. The early mortality increases in patients 70 years old or older.(ABSTRACT TRUNCATED AT 400 WORDS)     

Valvuloplasty for rheumatic mitral valve disease. A surgical challenge

From January 1981 through February 1985, 241 patients with rheumatic mitral valve disease (mean age 21.5 +/- 11.8 years) were subjected to comprehensive mitral valvuloplasty. One hundred seven patients (44.4%) were 15 years or younger and 63 (26.1%) were 12 years or younger. One hundred seventy five patients had pure or predominant regurgitation (mean age 19.3 +/- 10.7 years) and 40 (16.6%) had active rheumatic carditis at the time of the operation. Almost all patients (229) were in New York Heart Association Functional Class III or IV. The techniques used included shortening of anterior leaflet chordae tendineae (136 patients), resection of secondary, tertiary, and basal posterior leaflet chordae (156 patients), commissurotomy (113 patients), and implantation of a Carpentier ring (164 patients). Current operative mortality is 1.9%. The survivors were followed up for 576 patient-years (mean 2.64 +/- 1.32 years). Late mortality was 2.60% per patient-year and was valve related in 1.04% per patient-year. Reoperation was required in 25 patients (4.34% per patient-year), mostly (72%) in the first year. There were only two cases (0.35% per patient-year) of thromboembolism and three cases (0.52% per patient-year) of infective endocarditis. Hence valve failure occurred at a linearized rate of 6.08% per patient-year but was fatal in only 22% of the patients. There was no relationship between valve failure and the type of lesion or procedure performed, but reoperation was required more frequently in patients aged 12 years or less (7.33% per patient-year) than in those older than 12 years (3.29% per patient-year) (p less than 0.05). Actuarial survival rate at 41/2 years was 90%, and 82% of the patients were free from valve-related complications. Valve function after valvuloplasty was assessed clinically. Eighty-four percent of the patients had a good immediate result, but this figure dropped to 69% at the end of the follow-up period (p less than 0.05). The remainder had moderate valve dysfunction. However, 85% of the patients remain in New York Heart Association Functional Class I. Mitral valvuloplasty is an excellent alternative to valve replacement in young patients with rheumatic mitral valve disease. Persistent or reactivated rheumatic carditis may be a significant factor of valve failure, and penicillin prophylaxis is mandatory after operation.     

The Carpentier-Edwards Supra-Annular Porcine Bioprosthesis: New Generation Low Pressure Glutaraldehyde Fixed Prosthesis

The Carpentier-Edwards supra-annular porcine bioprosthesis was implanted in 1,576 operations (1,536 patients with 1,704 valves) between 1981 and 1987. The mean age of the patients was 61.9 years (range 13 to 87 years). During the years 1981 and 1987, approximately 90% of the total valvular surgery population received the prosthesis. The early mortality was 7.0% (included patients with concomitant procedures including coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 4.0% per patient-year. The total cumulative follow-up was 4,237 years. Thromboembolism (TE) was 2.4% per patient-year (fatal 0.4% per patient-year) (minor 1.2%; major 1.3%); antithromboembolic therapy-related hemorrhage (ATH) 0.5% (fatal 0.07%); prosthetic valve endocarditis (PVE) 0.5% (fatal 0.2%); periprosthetic leak (PPL) 0.3% (fatal 0%); clinical valve dysfunction (CVD) 0.3% (fatal 0.02%); and structural valve deterioration/primary tissue failure (SVD) 0.2%/patient-year (fatal 0%). Thromboembolism and structural valve deterioration were the significant complications, SVD occurring primarily between the fourth and fifth year of evaluation. The overall patient survival was 77.1% +/- 1.4% at five years. The patients were classified as 89.6% NYHA functional Class III and IV preoperatively and 96.1% Class I and II postoperatively. The freedom at five years from TE was 90.6% +/- 1.0%; SVD 98.9% +/- 0.5%; and reoperation 95.9% +/- 0.9%. Freedom from all valve-related complications at five years was 84.1% +/- 1.3%; valve-related mortality 96.8% +/- 0.7%; mortality and reoperation (valve failure) 92.9% +/- 1.1%; mortality and residual morbidity (treatment failure) 93.7% +/- 0.9%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 90.0% +/- 1.2%. There were 28 valve-related deaths of a total 280 deaths (early 4, late 24) (TE 17; ATH 3; CVD 1; PVE 7; PPL 0; and SVD 0). Valve-related reoperations were performed in 32 patients (TE 2; CVD 4; PVE 7; PPL 11; and SVD 8). The supra-annular Carpentier-Edwards porcine bioprosthesis has provided very satisfactory clinical performance and afforded patients an excellent quality of life. The long-term durability of this low pressure glutaraldehyde fixed prosthesis will be determined by observation over the next five to seven years.     

Long-term performance of 555 aortic homografts in the aortic position

Long-term results with 555 aortic homografts used for isolated aortic valve replacement (AVR) between 1964 and 1986 were analyzed to assess valve performance and the time-related onset of valve-related events. The total follow-up was 2,931 patient-years. Twenty years after operation, overall survival was 51.6 +/- 8.1%, freedom from valve-related death was 67.1 +/- 8.9%, freedom from primary tissue failure was 12.4 +/- 4.8%, freedom from infective endocarditis was 82.7 +/- 4.3%, freedom from surgical technical failure was 88.1 +/- 2.3%, and freedom from all complications including valve-related death was 9.0 +/- 3.5%. The incidence of thromboembolism was 0.034% per patient-year (one potential event). Long-term results after homograft insertion for aortic stenosis were significantly better than those after insertion for aortic incompetence. It is concluded that the good quality of life and the median life expectancy, which extends more than 20 years after operation, make the homograft an excellent choice for AVR.     

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.     

Valve failure with the Ionescu-Shiley bovine pericardial bioprosthesis: analysis of 2680 patients

Early reports on the excellent hemodynamic function and low thromboembolic rates of the Ionescu-Shiley bovine pericardial bioprosthetic valve (BPV) encouraged us to use it as our choice for valve replacement in 2680 patients from 1978 through 1983. Analysis of these patients at 5-year follow-up (mean 21.6 months) demonstrated the following important trends. Despite anticoagulation therapy in 48%, thromboembolism occurred in 88 patients for a linearized rate of 1.87% emboli per patient-year and was not time-related. The highest incidence of thromboembolism was in mitral valve replacement (MVR) (2.76% per patient-year). The actuarial freedom from reoperation resulting from valve failure at 5 years was 82% in aortic valve replacement (AVR), 87.1% in MVR, and 92.6% in AVR/MVR. The most distressing causes for reoperation were valve calcification (33 patients, 0.68% per patient-year) and leaflet disruption (11 patients, 0.23% per patient-year). Valve calcification was related to age, small valve size, and AVR position and increased with time, especially at the 4- to 5-year intervals. In patients under 30 years of age, calcification occurred in 18.7% at a mean time of 40.8 months in AVR and in 8.2% at 44 months in MVR, for an overall rate of 11.6%. Over the age of 30 years, it occurred in 14 patients (0.6%) at a mean time of 44 months. Leaflet disruption was not related to age and occurred later in AVR (50 to 58 months) than MVR (1.5 to 61 months). Events increased with time (mean range 37 to 58 months). Because of calcification and leaflet disruption, valve failure causing reoperation has increased significantly at the 4- to 5-year intervals even when valve replacement in patients under 30 years of age is excluded. If this trend continues, the valve failure rate will be exceedingly high on further follow-up. Thus we have limited the use of the BPV to a selected group of patients in whom valve longevity is less important than effective orifice size, thromboembolic rate, and freedom from anticoagulation.     

Clinical experience with the omnicarbon valve prosthesis]

Between January 1985 and March 1990, isolated valve replacements with the Omnicarbon valve were performed in 90 patients aged 34-72 years. There were 53 aortic valve replacements (AVR) and 37 mitral valve replacements (MVR). The cumulative follow-up was 320 patient-year (py) with a mean follow-up of 3.7 +/- 1.4 years. There were 3 operative and hospital mortalities (3.3%), resulting from retrograde aortic dissection during cardiopulmonary bypass, postoperative renal failure, and rupture of infective pseudoaneurysm in ascending aorta. Seven patients died during the late postoperative period, 4 due to valve-related causes. Two of these patients died of prosthetic valve endocarditis (PVE), while the others died of thromboembolism (including valve thrombosis). The overall actuarial survival rate at 6 years was 86.3% (98.8% for AVR, and 82.1% for MVR). There were 2 thromboembolic events (one mesenteric artery thrombosis, and the other valve thrombosis). The linearized incidence of thromboembolism was 0.63%/py. PVE occurred in 3 patients (0.94%/py). One patient (0.31%/py) was found to have a valve dehiscence due to aortitis syndrome. There were no instances of anticoagulant-related hemorrhage, or valve-related hemolysis. The actuarial rate of freedom from valve-related mortality at 6 years was 93.5% (100% for AVR, and 88.1% for MVR). On the basis of a follow-up period of 6 years, good clinical results and a low incidence of valve-related complications can be demonstrated with Omnicarbon valve.     

The Carpentier-Edwards standard porcine bioprosthesis. A first-generation tissue valve with excellent long-term clinical performance

The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1190 patients (1201 operations, 1303 valves) between January 1975 and June 1986; most implants were before 1982. The mean age of the patients was 57.2 years (range 8 to 85 years). The early mortality was 7.6% (aortic valve replacement 5.1%, mitral valve replacement 8.8%, and multiple valve replacement 15.3%). Late mortality was 3.9% per patient-year (aortic valve replacement 3.6%, mitral valve replacement 4.2%, and multiple valve replacement 3.8%). The total cumulative follow-up period was 6737 years. Thromboembolism was 1.5% per patient-year (fatal 0.4% per patient-year) (minor 0.6%, major 0.9%); antithromboembolic therapy-related hemorrhage was 0.5% (fatal 0.1%); prosthetic valve endocarditis was 0.6% (fatal 0.2%); nonstructural dysfunction was 0.5% (fatal 0.2%); and structural valve deterioration and/or primary tissue failure was 1.5% per patient-year (fatal, 0.2% per patient-year). Thromboembolism and structural valve deterioration were the significant complications, structural valve deterioration occurring primarily between the sixth and 10th year of evaluation. The overall patient survival was 65.0% for aortic valve replacement and 54.8% for mitral valve replacement (p less than 0.05) at 10 years. The patients were classified as 92.9% New York Heart Association functional classes III and IV preoperatively and 92.3% classes I and II postoperatively. Freedom at 10 years from thromboembolism was 84.3% for aortic valve replacement and 76.5% for mitral valve replacement (p = 0.05); structural valve deterioration was 78.6% for aortic valve replacement and 71.6% for mitral valve replacement (p less than 0.05); reoperation was 74.4% for aortic valve replacement and 67.1% for mitral valve replacement (p less than 0.05). Freedom from all valve-related complications at 10 years was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); valve-related mortality was 89.5% for aortic valve replacement and 82.6% for mitral valve replacement (p = not significant); mortality and reoperation was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); mortality and residual morbidity (treatment failure) was 87.2% for aortic valve replacement and 75.1% for mitral valve replacement (p = not significant); mortality, residual morbidity, and reoperation were 66.3% for aortic valve replacement and 54.9% for mitral valve replacement (p less than 0.05). The standard Carpentier-Edwards porcine bioprosthesis has provided satisfactory clinical performance and has afforded patients excellent quality of life.