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.     

Long-term clinical results after combined aortic and mitral valve replacement

The results after 282 consecutive double (aortic & mitral) valve replacements (DVR) are compared with our previously reported experience after mitral (MVR, n = 810) and aortic valve replacement (AVR, n = 1753). All but one patient received Bj?rk-Shiley valves. The follow-up which closed on August 1, 1985 was 99.3% and covered 16,869 patient-years (mean 6.3 years/patient). Autopsies were performed in 74% of all fatalities. Early mortality rates were identical in the three patient groups, and late mortality did not differ between MVR and DVR patients. The fraction of valve-related mortality was similar in all groups. Anticoagulant-related bleeding was equally common in all patient groups. The incidences of thromboembolism, reoperation and valve failure did not differ between MVR and DVR patients, but were significantly higher than among AVR patients. With the exception of a slightly increased incidence of prosthetic valve endocarditis, the results after DVR equal those after MVR. In cases with severe mitral valve disease but borderline aortic valve disease, primary DVR is clearly justified and eliminates the need for, and risks of, a secondary AVR.     

Medium-term results of aortic valve replacement with cryopreserved homograft valves: importance of a domestic homograft valve bank

There are advantages to using aortic homografts as aortic valve replacements (AVR), particularly in patients with complex infective endocarditis. To determine the importance of a domestic homograft valve bank, our 23 surgical cases of homograft-AVR were reviewed. Since 2000, the Tissue Bank of the National Cardiovascular Center has supplied 23 aortic homograft valves for the treatment of complex aortic valve endocarditis. Fourteen of 23 patients had prosthetic valve endocarditis and 20 patients had an aortic annular abscess. The early mortality rate was 17% (4 patients), in all of whom prosthetic valve replacement had been performed previously. No recurrent endocarditis and no recurrent aortic regurgitation were noted at medium-term follow-up. An aortic homograft valve is the conduit of choice in cases of infective endocarditis and the importance of a domestic homograft valve bank should be recognized.     

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.     

Comparison of the aortic homograft and the pulmonary autograft for aortic valve or root replacement in children

To assess late results of aortic homograft and pulmonary autograft valves implanted into the left ventricular outflow tract of children, we reviewed the case histories of 146 patients 18 years of age or younger who underwent aortic valve or root replacement between November 1964 and April 1990. One hundred three patients (mean, 12 +/- 3.9 years) received an aortic homograft and 43 (mean, 14 +/- 4.1 years) had their own pulmonary valve transferred to the aortic position. There were 54 valve and 49 root replacements with homografts and 36 valve and seven root replacements with autografts. Hospital mortality rate was 15.5% (16 patients) in the homograft group and 11.6% (five patients) in the autograft group. Survivors were followed up for a total of 867 (homograft) and 297 (autograft) patient-years. The late mortality rate was 16.7% (1.9% per patient-year) for patients with homografts and 13.2% (4.4% per patient-year) for patients with autografts, whereas the incidence for reoperation per patient-year was 2.9% and 2.0%, respectively. At 15 years actuarial rates for homografts and autografts for freedom from reoperation were 54% +/- 8.1% and 68% +/- 11.1%; freedom from endocarditis, 97% +/- 2.4% and 75% +/- 10.2%; and freedom from any complication, 41% +/- 6.5% and 50% +/- 10.3%. Valve degeneration occurred in 19 homografts (2.2% per patient-year), whereas there was no definite instance of primary tissue failure among the pulmonary autografts. This experience would indicate that either the homograft or the autograft valve can be used with acceptable results in children. However, the pulmonary autograft gives better long-term performance and, if growth potential is realized, may be the ideal valve substitute in children.     

Intermediate-term results after the aortic valve replacement using bileaflet mechanical prosthetic valve in children.

OBJECTIVE: Intermediate/long-term results after aortic valve replacement using bileaflet mechanical valve in children should be clarified as a standard of treatment of aortic valve disease in children. METHODS: Forty-five patients aged under 15 years underwent 46 aortic valve replacements using bileaflet mechanical prosthetic valve. Patients' ages ranged from 1 to 15 years (9 years as a median value), and follow-up period was 9.2 years as a median value (maximum 19 years). RESULTS: In situ valve replacement was performed in 21 procedures, while annular enlargement was required in 25 procedures (Nicks 10, Yamaguchi 3, Manouguian 2, Konno 10). All patients except two received prosthesis 19mm or larger in size. There was one operative death and two late deaths. Two episodes of cerebral infarction, two valve thrombosis, two re-operations, one infective endocarditis, and one sudden death were recognized as valve-related complications in five patients. The reasons for re-operation were prosthesis-patient mismatch in one (Ross procedure) and valve thrombosis in one (re-replacement). At 15 years after the operation, re-replacement free rate, valve-related event free rate and actuarial survival rate were 94+/-4%, 86+/-6% and 92+/-4%, respectively. The transprosthetic flow velocity estimated by Doppler echocardiography at the final follow-up was well correlated with manufactured valve area index (cm(2)/body surface area). CONCLUSIONS: Although aortic annular enlargement was required in more than half of the cases, intermediate-term results after aortic valve replacement using bileaflet mechanical prosthetic valve in children was satisfactory. Indications for alternative treatment such as Ross procedure might be considered in limited cases.     

Midterm evaluation of the Sorin Bicarbon heart valve prosthesis: single-center experience

BACKGROUND: The purpose of this study was to perform midterm evaluation of the clinical performance of the Sorin Bicarbon mechanical heart valve prosthesis. METHODS: From November 1992 to December 2002, 328 patients underwent isolated aortic (AVR; 156) or mitral (MVR; 172) valve replacement with the Sorin Bicarbon mechanical valve. Concomitant surgery was performed in 83 patients (25.2%). RESULTS: Total hospital mortality was 5.2%. Survival at 7 years was 79.5% for AVR and 82.4% for MVR. Kaplan-Meier freedoms from valve-related complications were as follows: thromboembolism 92.7% (AVR 94.8%, MVR 92.1%); bleeding 93% (AVR 91.9%, MVR 94.5%); nonstructural dysfunction 96.6% (AVR 94.7%; MVR 97.9%); endocarditis 97.7% (AVR 97.4%, MVR 98.1%); and reoperation 95.7% (AVR 96.6%, MVR 93.9%). Overall freedom from valve-related death was 93.2% (AVR 99.3%, MVR 91.2%). At the end of follow-up, 88.9% of survivors were in New York Heart Association class I or II. CONCLUSIONS: The Sorin Bicarbon valve is a satisfactory mechanical valve prosthesis with low mortality and morbidity and good functional results.     

Twenty-year experience with the St Jude Medical mechanical valve prosthesis

BACKGROUND: We have prospectively followed all adult St Jude Medical mechanical valve recipients at the Medical University of South Carolina since the initial implant in January 1979 and now present our 20-year experience. METHODS: We prospectively followed 837 valve recipients (aortic valve replacement; n = 478; mitral valve replacement; n = 359) from January 1979 to December 2000 at 12-month intervals. RESULTS: Ages ranged from 19 to 84 years. Follow-up averaged (mean +/- standard deviation) 7 +/- 5 years (98% complete). Patients were in New York Heart Association class III or IV in 77% (aortic valve replacement) and 89% (mitral valve replacement) preoperatively. A 19-mm valve was implanted in 15.5% of aortic valve replacement patients. Coronary bypass was required in 31% of aortic valve replacements and 20% of mitral valve replacements. Operative mortality was 17/478 (3.6%) in aortic valve replacement and 19/359 (5.3%) in mitral valve replacement, and multivariable predictors were 19-mm valve size, 3 or more coronary bypass grafts, and New York Heart Association class IV for aortic valve replacement and New York Heart Association class IV and age for mitral valve replacement. Actuarial survivorship at 10 and 20 years was 57% +/- 3% and 26% +/- 5% for aortic valve replacement and 61% +/- 3% and 39% +/- 4% for mitral valve replacement. Multivariable predictors of late death were African-American ethnicity, New York Heart Association class III or IV, coronary bypass, and age for aortic valve replacement and New York Heart Association class III or IV, coronary bypass, and age for mitral valve replacement. For aortic valve replacement, effective orifice area was univariately (P =.002) but not multivariately (P =.378) predictive of late death. Structural valve deterioration was not observed. For aortic valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 93% +/- 1% and 90% +/- 2%; thromboembolism, 82% +/- 3% and 68% +/- 8%; bleeding events, 77% +/- 3% and 66% +/- 6%; prosthetic valve endocarditis, 94% +/- 1% and 94% +/- 1%; valve-related mortality, 94% +/- 2% and 86% +/- 4%; and valve-related mortality or morbidity, 58% +/- 3% and 32% +/- 8%. For mitral valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 96% +/- 1% and 90% +/- 3%; thromboembolism, 77% +/- 3% and 59% +/- 7%; bleeding events, 86% +/- 2% and 65% +/- 8%; prosthetic valve endocarditis, 98% +/- 1% and 96% +/- 2%; valve-related mortality, 89% +/- 0.2% and 74% +/- 8%; and valve-related mortality or morbidity, 63% +/- 3% and 29% +/- 7%. CONCLUSIONS: After 2 decades of observation with close follow-up, the St Jude Medical mechanical valve continues to be a reliable prosthesis.     

Reoperation after fresh homograft replacement: 23 years’ experience with 655 patients

Objective: Through a retrospective study on the use of fresh homografts in 655 aortic valve replacement patients over a period of 23 years, we aimed to assess the reasons for eventual reoperation and causes of valve dysfunction. Methods: Between January 1980 and December 2002, 655 patients received fresh homografts. All homografts were antibiotic sterilized and stored at 4 °C. During this time, 139 patients (116 male and 23 female) with a mean age of 46.7 years (range 18–72) required reoperation. Results: The 30-day hospital overall mortality was 2.87%. The mean durability for all homografts was 12.4±4.54 years (1 month to 23 years). The cumulative rates for freedom from reoperation for any cause were 94.09±2% at 5 years and 87.9%±4% at 10 years, 76.6 at 15 years, 49.55 at 20 years. The major cause of valve dysfunction and indication for reoperation was degeneration in 111 patients (79.8%). Predominant aortic valve insufficiency in 87 patients (62.5%) and predominant stenosis in 24 patients (17.26%). Endocarditis occurred in 21 patients (15.1%). Early endocarditis was diagnosed in five patients (3.59%), late endocarditis in 16 patients (11.5%). Additional causes for reoperation included ascending aortic aneurysm, mitral valve insufficiency and congestive cardiomyopathy. Seventeen patients (12.2%) required concomitant procedures. Coronary artery bypass grafting was performed in six cases (4.3%), mitral valve replacement in five cases (3.59%), mitral valve annuloplasty in six (4.3%). The primary reoperative procedure was artificial/mechanical aortic valve implantation. In five cases, St. Jude Medical conduit grafts were implanted due to ascending aortic aneurysms. Homograft reimplantation was performed in four cases. One patient underwent mitral valve replacement and one patient received a heart transplant. Conclusion: The results of the study suggest that reoperation in patients with aortic homografts is a low-risk procedure as compared to alternative therapies. Primary allograft aortic valve replacement can give acceptable results for up to 23 years. The major cause of valve dysfunction and indication for reoperation was degeneration. Cumulative rates for freedom from reoperation for any cause in age groups suggest careful selection and indications in homograft implantation in the younger patients. Young age is a risk factor for an early homograft structural deterioration (degeneration).     

St. Jude Medical valve replacement: clinical experience with 1,039 patients

St. Jude Medical valve replacement was performed in 1,039 patients; 320 had aortic (AVR), 543 mitral (MVR), and 176 had double valve replacement (DVR). There were 44(4.2%) early deaths. Follow-up extended in 995 patients from 10 to 130 months, with a cumulative period of 2,730 patients-years. The overall survival rates of AVR, MVR, and DVR patients at 10 years were 60.5%, 89.6%, 90.3% respectively. The linearized incidences of valve thrombosis, thromboembolism, anticoagulation-related hemorrhage, prosthetic valve endocarditis, and significant hemolysis were as follows: 0.11%/pt-yr, 1.33%/pt-yr, 0.04%/pt-yr, 0.18%/pt-yr, and 0.11%/pt-yr, respectively. There were no structural failure after 10 years follow-up. Reoperation (explant and re-replacement or suture repair) was required in 10 patients. Seven of them had periprosthetic leakage, 2 had valve thrombosis, and one underwent reoperation because of a technical error. Actuarially over 98% of patients were free of valve-related mortality at 10 years. St. Jude Medical valve is an excellent alternative for use in the surgical treatment of valvular heart disease.     

Prosthetic valve type for patients undergoing aortic valve replacement: a decision analysis

Background. In two large, randomized, clinical trials long-term survival after aortic valve replacement (AVR) was similar for patients receiving tissue and mechanical aortic heart valve prostheses. Higher bleeding rates among patients with mechanical valves, who must receive permanent oral anticoagulation to prevent thromboembolism, were offset by higher reoperation rates for valve degeneration among patients with tissue valves. Because the average age of patients undergoing AVR and clinical practices have changed considerably since the randomized clinical trials were conducted, we performed a decision analysis to reassess the optimal valve type for patients undergoing AVR.

Methods. We used a Markov state-transition model to simulate the occurrence of valve-related events and life expectancy for patients undergoing AVR. Probabilities of clinical events and mortality were derived from the randomized clinical trials and large follow-up studies.

Results. Although the two valve types were associated with similar life expectancy in 60-year-old patients (mean age of patients in the randomized clinical trials), tissue valves were associated with greater life expectancy than mechanical valves (10.7 versus 11.1 years) in 70-year-old patients (currently mean age of AVR patients). For 70-year-old patients, the effects of major bleeding complications (24%) with mechanical valves substantially outweighed those of reoperation for valve failure (12%) with tissue valves at 12 years. Of the clinical practice changes assessed, the recommended valve type was most sensitive to changes in bleeding rates with anticoagulation. However, bleeding rates would have to be 68% lower than those reported in the European randomized clinical trial to affect the recommended valve type for 70-year-old patients. Reoperation rates would have to be five times higher, and mortality rates at reoperation would have to be four times higher to affect the recommended valve type for 70-year-old patients.

Conclusions. Although mechanical valves are preferred for AVR patients less than 60 years old, most patients currently undergoing AVR are elderly and would benefit more from tissue valves.     

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.     

More than ten years' follow-up of the Hancock porcine bioprosthesis in Japan.

From February 1975 through October 1981, 256 Hancock porcine bioprostheses (Johnson & Johnson Cardiovascular, King of Prussia, Pa.) (60 aortic, 169 mitral, and 27 pulmonary/tricuspid position) were implanted in 220 patients (104 male and 116 female, aged 9 to 67 years; mean 43.3) at Kyushu University Hospital in Japan. The procedures include 41 aortic valve replacements, 121 mitral valve replacements, 4 pulmonary valve replacements, 6 tricuspid valve replacements, and 48 combined valve replacements (31 aortic plus mitral, 13 mitral plus tricuspid, and 4 aortic plus mitral plus tricuspid). Hospital mortality was 6.4%. Follow-up was 98% during 8 to 14 (mean 10.5) years. Cumulative follow-up was 1836 patient-years and 2078 valve-years. At 10 years the overall actuarial survival rate, including hospital morality, was 70% +/- 3%, and freedom from valve-related mortality with sudden death was 87% +/- 3%. More than half of the current survivors required no anticoagulant therapy. Freedom from thromboembolism or anticoagulant-related hemorrhage (or both) and prosthetic valve endocarditis was common. Freedom from structural valve failure and reoperation declined more than 9 years after replacement of left-sided heart valves but not after replacement of right-sided heart valves. Sixty-seven patients underwent 68 repeat operations, and there were four deaths (5.9%). The rate of freedom from overall valve-related complications at 10 years was 62% +/- 8% for aortic valve replacement, 53% +/- 5% for mitral valve replacement, 80% +/- 13% for pulmonary/tricuspid valve replacement, and 42% +/- 9% for combined valve replacement. There was a significant difference between pulmonary/tricuspid valve replacement and combined valve replacement (p less than 0.05). The Hancock bioprosthesis is suitable for the replacement of valves in the right side of the heart but not for combined valve replacement.     

Long-Term Performance of Homograft and Autograft Valves

Five hundred and eighty homograft valves have been inserted into the aortic position as isolated valve replacements, and followed up for 7–14 years. After ten years 90% of frozen homografts, 80% of autografts and 70% of freeze-dried homografts were free of valve-related death. There was only one embolism reported giving an incidence of one embolism per 143,928 patient months. Degeneration occurred in 14% of the autografts, in 30% of the freeze dried and in 60% of the frozen homografts after ten years. Eighty per cent of the fresh homografts have been free of degeneration after seven years, and 54% of freeze-dried valves have been free of degeneration after 14 years. Long-term performance of homograft and autograft valves in the aortic positon is comparable to that of any prosthetic or bioprosthetic valve. In addition, they are non-thrombogenic and excellent in terms of patient survival.     

Operative risk of reoperative aortic valve replacement

OBJECTIVE: The contemporary risk of reoperative aortic valve replacement is ill-defined. We therefore compared the recent early results of reoperative and primary aortic valve replacement in our institution. METHODS: Between January 1993 and January 2001, a total of 162 patients underwent reoperative aortic valve replacement with or without coronary artery bypass grafting, and 2290 underwent primary aortic valve replacement with or without coronary artery bypass grafting. The reoperative and primary groups were similar with regard to gender (37% female in both), preoperative New York Heart Association functional class (2.8 +/- 1 vs 2.8 +/- 1), and ejection fraction (58% +/- 15% vs 57% +/- 15%). Patients undergoing reoperative aortic valve replacement were younger than those undergoing primary aortic valve replacement (64 +/- 15 years vs 70 +/- 13 years, P < .001). Previous prostheses were xenografts in 77 patients (48%), homografts and autografts in 25 (15%), and mechanical prostheses in 60 (37%). Mean time to reoperation was 9.7 +/- 6.8 years. RESULTS: Early mortality for reoperative aortic valve replacement (8/162, 5%) was not statistically different from that for primary aortic valve replacement (71/2290, 3%, P = .20). Endocarditis was more common in the reoperative group (22% vs 3%, P < .001); when endocarditis was excluded from the analysis, early mortality was 3% in both groups. Multivariate predictors for early mortality were prosthetic valve endocarditis ( P < .001, odds ratio 9.8), advanced preoperative functional class ( P < .001, odds ratio 2.0), peripheral vascular disease ( P = .008, odds ratio 2.0), preserved left ventricular ejection fraction ( P = .004, odds ratio 0.98), and male gender ( P = .009, odds ratio 0.49). After adjustment for these factors, there was no difference in early mortality between the groups ( P = .095). CONCLUSION: The risk of reoperative aortic valve replacement is similar to that for primary aortic valve replacement. These data support the expanded use of bioprosthetic valves in younger patients.     

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.     

Clinical performance of the Duromedics bileaflet pyrolite mechanical prosthesis.

The Duromedics (Baxter Healthcare Corp., Edwards CVS Div., Irvine, Calif.) mechanical cardiac valvular prosthesis was implanted in 480 patients between 1984 and 1987 at the Montreal Heart Institute, the Hospital Clinic of Barcelona and the teaching hospitals of the University of British Columbia. The mean age of the patients was 52 years. The early mortality was 7.9% and the late mortality was 4.1% per patient-year. The overall survival at 4 years for aortic valve replacement (AVR) was 87.0% +/- 3.7% and for mitral valve replacement (MVR) was 81.9% +/- 2.9%. There were 16 valve-related reoperations in 14 patients--for prosthetic valve endocarditis in 9 patients, for thromboembolism in 1 patient and for nonstructural dysfunction in 4 patients. The freedom from thromboembolism at 3 and 4 years was 94.3% +/- 3.1% for AVR and 95.1% +/- 1.8% for MVR. The freedom from prosthetic valve endocarditis at 3 and 4 years was 95.3% +/- 2.2% for AVR and 96.2% +/- 1.6% for MVR. The freedom from structural valve deterioration for all positions was 100%. The freedom from reoperation at 4 years was 95.3% +/- 2.1% for AVR and 92.3% +/- 4.3% for MVR and from valve-related death was 98.7% +/- 1.3% for AVR and 96.2% +/- 1.6% for MVR. The freedom from all valve-related complications at 4 years was 87.7% +/- 3.8% for AVR and 85.7% +/- 2.9% for MVR. Long-term evaluation of the Duromedics prosthesis is required to determine the influence of documented structural valve deterioration.     

Ten-year experience with the porcine bioprosthetic valve: interrelationship of valve survival and patient survival in 1,050 valve replacements

The porcine bioprosthetic valve was used in 440 patients having isolated mitral valve replacement (MVR), 522 patients having isolated aortic valve replacement (AVR), and 88 patients having MVR + AVR between 1974 and 1981. Patients with associated surgical procedures were excluded. Mean follow-up was 8.3 years. At 10 years, there was no difference in patient survival between those having AVR and those having MVR. Reoperations were performed on 192 patients. Endocarditis was the reason for reoperation in 3.7% of patients who had MVR and 10.6% of those who had AVR. Structural valve degeneration was the reason for reoperation in 89.7% of MVR patients and 78.8% of AVR patients (p = 0.04). Hospital mortality among patients having valve reoperations was 4.7%. At 10 years, the freedom from valve reoperation for all causes and from structural valve degeneration was significantly better for the AVR group than the MVR group (74% +/- 3% versus 61% +/- 4%, p = 0.004; and 79% +/- 3% versus 63% +/- 4%, p = 0.0006, respectively). For patients in their 60s, the 10-year freedom from reoperation was 92% +/- 2% for AVR and 80% +/- 6% for MVR (p = not significant). At 10 years, freedom from cardiac-related death and valve reoperation was best for both MVR and AVR patients in their 60s. Patients 70 years old or older rarely had reoperation but died before valve failure occurred. The 10-year freedom from all major valve-related events (cardiac-related death, reoperation, thromboembolism, endocarditis, and anticoagulant-related bleeding) was practically the same for both MVR and AVR patients (48% +/- 3% versus 49% +/- 3%, respectively). The porcine bioprosthetic valve is the valve of choice only for patients 60 years old or older. Patients in their 70s have an extremely low rate of reoperation but a high rate of cardiac-related death and do not outlive the prostheses.     

Seven-year performance of the Edwards Prima Plus stentless valve with the intact non-coronary sinus technique

OBJECTIVES: Late results after stentless aortic valve replacement (AVR) may be jeopardized by progressive aortic dilatation. To define functional outcome using the intact non-coronary sinus technique, all patients operated using the stentless Edwards Prima Plus xenograft were assessed. METHODS: Between January 2000 and August 2007, 154 patients, aged 71 +/- 9 years, underwent stentless AVR using a technique, which replaces the non-coronary sinus and stabilizes two of three commissures. Indication was aortic valve stenosis (AS) in 103 (67%) patients: 33 (21%) had bicuspid valve and four endocarditis. Ninety-six (62%) patients were in NYHA III-IV, and 13 (8%) had LVEF <30%. Associated procedures were required in 59 (38%) patients (CABG, 34; ascending aorta, 22; others 3). Study endpoints were survival, freedom from valve-related events, clinical status, and graft function. RESULTS: There were two hospital and two late deaths during a 48 +/- 19 months (1-92) follow-up (97 +/- 3% survival at seven years). Seven-year freedom from structural failure, nonstructural failure, and endocarditis was 99 +/- 1%, 97 +/- 3%, and 98 +/- 2%. Follow-up NYHA (96 vs ten patients in class III-IV, p = 0.001), and cardiac function (13 vs one patient with LVEF <30%, p = 0.02) were improved. Xenograft performance was satisfactory: 0-2 + aortic insufficiency (AI) in 147 (98%) patients, mean trans-prosthetic pressure gradient 8 +/- 4 (0-25 mmHg). Aortic root diameters were comparable to postoperative values (sinus of Valsalva, 36 +/- 8 vs 35 +/- 9 mm, p = ns; sinotubular junction, 32 +/- 7 vs 34 +/- 8 mm, p = ns). CONCLUSIONS: Stentless AVR with non-coronary sinus replacement affords excellent late outcome and low rate of valve-related events, even in complex patients (bicuspid valve, LV failure, and endocarditis). Aortic root dimensions remain stable over time allowing rewarding xenograft function.     

Durability and low thrombogenicity of the St. Jude Medical valve at 5-year follow-up

Between November, 1978, and December, 1983, 736 patients had valve replacement with the St. Jude Medical valve prosthesis. There were 478 patients with aortic valve replacement (AVR), 188 with mitral valve replacement (MVR), 63 with double valve replacement, and 7 with tricuspid valve replacement (they were not included in this study). The mean age at the time of operation was 46.7 years for patients having AVR and 48.6 years for those having MVR and AVR + MVR. Follow-up totaled 1,116 patient-years (range, 4 to 82 months). Early (30-day) mortality was lowest for isolated MVR (2.3%) and AVR (3.7%), and increased with reoperation or when associated procedures were combined with valve replacement. Patients undergoing reoperation or having associated procedures made up 49% of the AVR and 54% of the MVR groups. All patients were advised of the need for long-term anticoagulation with warfarin sodium. Nine patients (7 with AVR, 1 with MVR, 1 with AVR + MVR) had suspected or confirmed episodes of systemic thromboembolism, a linearized incidence of 0.99% per patient-year for AVR, 0.36% per patient-year for MVR, and 0.98% per patient-year for AVR + MVR. Eight patients with AVR underwent reoperation for prosthetic valve endocarditis (5 of the 8 patients had endocarditis prior to initial valve replacement). There were no instances of structural valve failure. There were 37 late deaths. Actuarial survival at 5 years (excluding early mortality, 95% confidence limits) was 89.8% for AVR, 84.8% for MVR, and 95.2% for AVR + MVR.(ABSTRACT TRUNCATED AT 250 WORDS)