Late outcome of patients with Braunwald-Cutter mitral valve replacement

Eighty patients who underwent mitral valve replacement (MVR) with Braunwald-Cutter prostheses (54, single valve replacement; 26, multiple valve replacement) between December, 1972, and September, 1975, are discussed. The period of follow-up ranged from 72 to 120 months with a mean of 84.6 months. For the hospital survivors, actuarial survival at ten years was 73 +/- 6.7% for patients with MVR alone and 30 +/- 17.5% for those with multiple valve replacement. The linearized rate of embolic complications in patients with MVR was 3.2% per year and in patients with multiple valve replacement, 1.5% per year. These low rates of embolism allow a favorable comparison of the Braunwald-Cutter valve with other mechanical prostheses. There was no evidence of serious poppet wear or poppet escape after ten years of the valve in the mitral and tricuspid positions. Thus, elective replacement of the Braunwald-Cutter valve from the atrioventricular position because of this potential problem is not considered necessary. In the aortic position, escape of the poppet from the valve has occurred as late as 101 months. The overall morbidity for the group was high. Only 34% of the patients having MVR and 12% of those with multiple valve replacement are expected to be alive and to remain free from any major complication ten years after operation.     

Experience with the Carpentier-Edwards Porcine Valve Prosthesis in 700 Patients

The Carpentier-Edwards porcine valve prosthesis has afforded our patients a satisfactory quality of life and a low incidence of valve-related complications at follow-up periods of up to five years. From December, 1975 to March, 1980, 768 prostheses were implanted in 700 patients (aortic valve replacement [AVR], 334; mitral valve replacement [MVR], 292; tricuspid valve replacement [TVR], 6; and multiple valve replacement, 68). One hundred and thirty-seven patients (19.6%) had had previous cardiac operations. Concomitant aortocoronary bypass was performed in 127 patients (18.1%). There were 52 hospital deaths, for a mortality of 7.4% (AVR, 4.8%; MVR, 9.2%; multiple valve replacement, 11.8%). Total follow-up was 1,047 patient-years (range, 6 to 60 months, mean, 19.4 months). There were 33 late deaths (AVR, 1.7% per patient-year; MVR, 4.0% per patient-year; multiple valve replacement, 8.1% per patient-year). Eight percent of AVR patients and 47% of MVR and multiple valve replacement patients were taking anticoagulants. The valve-related complications (expressed as events per 100 patient-years) were as follows: (1) thromboembolism (AVR, 0.94; MVR, 1.42; multiple valve replacement, 4.62); (2) infective endocarditis (AVR, 0.94; MVR, 0.24; multiple valve replacement, 2.31); (3) periprosthetic leak (AVR, 0.94; MVR, 0.71; multiple valve replacement, 3.46); and (4) valve dysfunction (MVR, 0.24). The only case of valve dysfunction was a calcified mitral prosthesis in a 13-year-old girl. Actuarial survival, including operative deaths, was as follows: AVR, 90.5% at 36 months; MVR, 84% at 36 months; and multiple valve replacement, 74% at 24 months. Of surviving patients, 93.6% were in New York Heart Association Class I or II at follow-up evaluation.     

Long-term experience with porcine aortic valve xenografts

Between 1971 and 1975, glutaraldehyde-preserved porcine aortic valve xenografts were employed for isolated replacement of the mitral valve (MVR) in 243 patients, replacement of the aortic valve (AVR) in 167 patients, and double valve replacement (AVR and MVR) in 51 patients. Postoperatively, long-term anticoagulation was not routinely given. Operative mortality rates for AVR, MVR, and double valve groups were 7.8, 6.0, and 11.8 per cent, respectively; the majority of early postoperative deaths were associated with concomitant coronary artery disease. No death was attributable to xenograft dysfunction. Follow-up of all patients was obtained. The total duration of follow-up for the MVR group was 347 patient-years, for the AVR GROUP 148 148 patient-years, and for double valve replacement 37 patient-years; maximum follow-up for these three groups was 4.4, 4.0, and 2.4 years, respectively. Actuarial analysis of postoperative survival rates at a common interval of 3 years showed 78 per cent for MVR patients, 91 per cent for AVR patients, and 80 per cent (projected) for patients with double valve replacement (85, 96, and 91 per cent for operative survivors, respectively. At this same interval 92 per cent of MVR patients, 99 per cent of AVR patients, and 93 per cent (projected) of patients with double valve replacement were free of thromboembolic episodes. Altogether, 12 of the total 512 valves implanted exhibited some evidence of dysfunction during the entire period of follow-up evaluation, but in only 2 instances (both mitral) was intrinsic pathological involvement of the xenograft tissue documented. Actuarial analysis of xenograft dysfunction at a common interval of 3 years after operation showed 95 per cent of MVR patients, 98 per cent of AVR patients, and 97 per cent (projected) of patients with double valve replacement to be free of this complication. These data support the use of glutaraldehyde-preserved porcine xenografts as superior bioprostheses that pose a low risk of thromboembolism without anticoagulation. The over-all durability of such valves, within the restriction of a maximum current follow-up interval of 4.4 years, appears comparable to that of currently available mechanical prostheses and justifies continued clinical use.     

A comparison of mitral valve reconstruction with mitral valve replacement: intermediate-term results

The continued good results after mitral valve reconstruction prompted this retrospective study to compare operative and late results from our institutional experience since 1976 with 975 porcine mitral valve replacements (MVRs) (1976 to December 1987), 169 mechanical MVRs (1976 to December 1987), and 280 Carpentier-type mitral valve reconstructions (CVRs) (1980 to mid-1988). The operative mortality was 2.0% for isolated CVR, 6.6% for isolated mechanical MVR, and 8.5% for isolated porcine MVR. The overall operative mortality was 5.0% for CVR, 16.6% for mechanical MVR, and 10.6% for porcine MVR. The overall 5-year survival including hospital deaths was 76% for CVR, 72% for mechanical MVR, and 69% for porcine MVR. By multivariate analysis, the predictors of increased operative risk and of decreased survival were age, New York Heart Association functional class IV status, previous cardiac operation, and performance of concomitant cardiac surgical procedures. The type of valvular procedure was not predictive of operative risk or overall survival. The 5-year freedom from reoperation was 94.4% for nonrheumatic patients having CVR, 77.4% for rheumatic patients having CVR, 96.4% for mechanical MVR, and 96.6% for porcine MVR (p less than 0.05, rheumatic patients with CVR versus both MVR groups). The 5-year freedom from all valve-related morbidity and mortality was significantly better for valve reconstruction compared with both types of valve replacement. Thus, the operative risk and late survival obtained after mitral valve reconstruction were at least equivalent to those obtained after MVR. In addition, patients receiving mitral valve reconstruction had less valve-related combined morbidity than patients receiving valve replacement, thus making mitral valve reconstruction preferable in some patients with mitral insufficiency.     

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.     

Porcine Cardiac Xenograft Valves: Analysis of Survival,Valve Failure,and Explantation

Porcine cardiac xenografts were used for cardiac valve replacement in 1,093 patients. Hospital mortality for aortic valve replacement (AVR) was 3.7%; for mitral valve replacement (MVR), 7.8%; and for AVR + MVR, 4.7%. Total follow-up was 2,036 patient-years; maximum, 7.3 years; and mean, 1.89 years. Actuarial survival (± standard error of the mean) for AVR was 84% ± 2% at 56 months; for MVR, 84% ± 3% at 56 months; and for AVR + MVR, 86% ± 4% at 30 months. Nonfatal thromboembolism occurred in 8 of 1,030 patients (0.78%). Anticoagulation was not routinely employed.Fifty hospital survivors (4.8%) experienced valve dysfunction; 18 of the survivors (1.7%) died; and 32 of the survivors (3.1%) underwent reoperation. The rate of dysfunction increased slowly until the sixth year when an increased rate was observed (p < 0.0001). Patients less than 34 years old had a higher incidence of dysfunction (p < 0.01). Thirty-two hospital survivors (3.1%) underwent explanation of the porcine valve for late dysfunction. Valve dysfunction secondary to endocarditis and paravalvular leak occurred early, while leaflet deterioration or thrombosis was more gradual in onset and was noted later.The porcine valve has functioned well for 1 to 7 years with a low incidence of valve related morbidity and mortality without routine anticoagulation in patients older than 34 years of age.     

Carpentier-Edwards standard porcine bioprosthesis: primary tissue failure (structural valve deterioration) by age groups

Primary tissue failure (structural valve deterioration) has been documented as the most prominent complication of porcine bioprostheses. The influence of age on primary tissue failure has received limited consideration. From 1975 to 1986, 1,301 Carpentier-Edwards standard porcine bioprostheses were implanted in 1,183 patients in 1,201 operations. Of the total number of prostheses, 97.7% were implanted prior to 1983. The mean follow-up was 5.6 years and was 97.5% complete. Primary tissue failure was identified in 96 patients (98 operations) at reoperation (95) or autopsy (3). One hundred four (104) prostheses were involved. Thirty-one failed after aortic valve replacement (AVR), 49 after mitral valve replacement (MVR), and 24 after multiple-valve replacement (18 patients). There were 47 male and 49 female patients. The mean age at implantation was 47 years (range, 8 to 72 years). The mean implantation time was 74.0 months. The freedom from primary tissue failure at 10 years is 77.0 +/- 2.9% overall; for AVR, 83.1 +/- 3.7%; for MVR, 72.1 +/- 4.9%; and for multiple-valve replacement, 65.5 +/- 7.8%. The freedom from deterioration for patients less than 20 years of age is significantly less than that for other age groups. The freedom from deterioration increased by decades; the greatest freedom was noted in patients 70 to 80 years old and 80 years old or older. The freedom from deterioration at 10 years for patients less than 30 years of age is 26.8 +/- 17.2%; 30 to 59 years, 77.4 +/- 3.0%; and 60 years and older, 83.1 +/- 4.2%.(ABSTRACT TRUNCATED AT 250 WORDS)     

Open heart surgery in the elderly

Of 3254 open heart surgical cases performed since 1972, 126 patients (3.9%) were 70 years of age or older. The mean age was 72 years, the oldest being 82. Sixty-seven per cent were male. The following procedures were performed: coronary artery bypass grafting (CABG) 51, aortic valve replacement (AVR) 44, AVR + CABG 16, mitral valve replacement (MVR) 3, MVR + CABG 6, MVR + AVR 4, and other, 2. Of those undergoing CABG, 33% came from the Coronary Care Unit and 24% had left main coronary artery stenosis. There was one peri-operative death (2.0%). Of those undergoing AVR, 43% had coronary artery disease and 13% triple vessel disease. Operative mortality for AVR, and AVR + CABG was 11.4% (5/44) and 18.8% (3/16), respectively. Twenty-six per cent of operative survivors had significant postoperative complications (excluding atrial arrhythmias). The postoperative hospital stay for CABG, AVR and other cases was 11, 13 and 16 days, respectively. Seven year survival of all patients was 61.2 +/- 6.5% (+/- 1 SE) and for AVR +/- CABG was 51.5 +/- 8.6%. Five year survival for CABG was 83.9 +/- 6.3%. We conclude that, in selected cases, CABG can be performed safely in the elderly. Although valvular and combined surgery may result in significant morbidity and mortality, the satisfactory long term results in survivors justifies surgery in this group of patients.     

Clinical and hemodynamic assessment of the Hancock II bioprosthesis.

The Hancock II bioprosthesis was used for heart valve replacement in 614 patients from 1982 to 1990. Aortic valve replacement (AVR) was performed in 376 patients, mitral valve replacement (MVR) in 195, and aortic and mitral valve replacement (DVR) in 43. The mean age was 62.7 years, and 78% of all patients were in New York Heart Association functional class III or IV before operation. Coronary artery bypass graft was necessary in 232 patients and replacement of ascending aorta in 55. There were 31 operative deaths (AVR, 4%; MVR, 6%; DVR, 9%). Follow-up was complete in 98.5% of the patients and extended from 12 to 103 months, with a mean of 49 months. At the last follow-up, 85% of the patients were in New York Heart Association class I or II. The actuarial survival at 8 years was 79% +/- 3% for AVR, 68% +/- 4% for MVR, and 65% +/- 10% for DVR. The freedom from stroke at 8 years was 93% +/- 2% for AVR, 83% +/- 5% for MVR, and 90% +/- 5% for DVR. At the end of 8 years 96% +/- 1% of all patients were free from endocarditis, 92% +/- 1% were free from primary tissue failure, and 89% +/- 3% were free from reoperation. The actuarial freedom from valve-related death at 8 years was 98% +/- 1% for AVR, 86% +/- 5% for MVR, and 91% +/- 6% for DVR. Hemodynamic assessment was obtained by Doppler echocardiography in all operative survivors and demonstrated satisfactorily effective valve orifices and transvalvular gradients. The clinical results obtained with the Hancock II bioprosthesis have been gratifying, particularly in the aortic position. This bioprosthesis is our biological valve of choice.     

Long-term clinical experience with the Omnicarbon prosthetic valve.

BACKGROUND: From February 1985 to December 1994, 781 Omnicarbon valve prostheses were implanted in 647 patients. These were 357 male and 290 female patients with a mean age of 53.5+/-10.5 years (range, 4 to 78 years). Before operation, 81% of the patients were in New York Heart Association class III or IV, 16% were in class II, and only 3% were in class I. METHODS: There were 227 aortic valve replacements (AVR) (35%), 286 mitral valve replacements (MVR) (44%), and 134 double-valve replacements (DVR) (21%) (AVR + MVR). Follow-up was 96.3% complete and consisted of 2,746 patient-years (mean follow-up, 4.6 years, and maximum follow-up, 10.7 years). RESULTS: Hospital mortality rates were 7.0% for AVR, 8.0% for MVR, and 8.2% for DVR. The annualized rate of anticoagulant-related hemorrhage was 0.8% per patient-year, and thromboembolism occurred at a rate of 0.7% per patient-year. No structural failure was observed during 10-year follow-up. Twenty-one instances of nonstructural dysfunction (two, pannus growth, and 19, dehiscence) of the Omnicarbon valve occurred in 20 patients, an incidence of 0.8% per patient-year. Hemolytic anemia was observed only in the presence of valvular dehiscence (6 of 19). Eight patients (0.3% per patient-year) had development of prosthetic valve endocarditis (4, AVR; 2, MVR; and 2 DVR). At the end of 10 years of follow-up, 91% of the survivors were in New York Heart Association class I or II. The overall survival rate at 10 years was 82.5%+/-2.6% (85.0%+/-3.9%, AVR; 81.0%+/-4.1%, MVR; and 82.5%+/-2.6%, DVR). Considering only valve-related deaths, the survival rate at 10 years was 91.9%+/-2.4% (90.0%+/-2.7%, AVR; 93.1%+/-3.8%, MVR; and 90.0%+/-1.8%, DVR). CONCLUSIONS: Clinical results over a 10-year follow-up are excellent with the Omnicarbon prosthesis.     

Hematological complications with the St. Jude valve and reduced-dose Coumadin

We examined hematological complications in 415 patients having valve replacement with the St. Jude mechanical prosthesis (212, aortic valve replacement [AVR]; 159, mitral valve replacement [MVR]; and 44, AVR + MVR). There were 164 men and 251 women with a mean age of 59 years (range, 20 to 88 years). Preoperatively 386 patients were in New York Heart Association functional classes III and IV. There were 154 associated procedures (37%), the most common being myocardial revascularization. Overall hospital mortality was 7.5% (31/415), 7% after AVR, 8% after MVR, and 7% after AVR + MVR. All operative survivors were anticoagulated with Coumadin (crystalline warfarin sodium) to maintain the prothrombin time at 1.5 times control. During a mean follow-up of 21 months (range, 6 to 60 months), there were 29 late deaths (7.6%) and 5 patients (1.3%) lost to follow-up. No patient experienced structural valve degeneration. At 48 months, actuarial freedom from thromboembolism was 87% +/- 3% after AVR and 91% +/- 9% after MVR; from anticoagulation-related hemorrhage, 97% +/- 3% after AVR and 91% +/- 3% after MVR; and from hemolysis, 100% after AVR and 98% +/- 2% after MVR. Freedom from all valve-related morbidity at 4 years was 82% +/- 5% after AVR and 75% +/- 10% after MVR. Actuarial survival at 48 months was 80% +/- 4% after AVR and 65% +/- 7% after MVR.     

Pulmonary valve replacement with a mechanical prosthesis. Promising results of 28 procedures in patients with congenital heart disease.

OBJECTIVE: Pulmonary valve replacement is performed increasingly late after correction of Tetralogy of Fallot. Most reports deal with pulmonary allografts as the valvar substitute of choice, although late deterioration and reoperation(s) are the rule. Mechanical valves are scarcely reported and if so only because of complications. Although life-long anticoagulation therapy is indicated for mechanical prostheses, the chance of subsequent re-operations can be expected to be low. We report the results of 28 mechanical valve replacements in the pulmonary position. METHODS: A mechanical valve was implanted in 27 of 79 patients indicated for pulmonary valve replacement. Tetralogy of Fallot was the most common basic lesion. The results and follow-up were reviewed retrospectively, where death and re-operation were primary end points. Routine outpatient follow-up, including trans-thoracic echocardiography, was performed. RESULTS: Twenty-eight pulmonary valve implantations were done in 27 patients. Thirty-day hospital mortality was 1/28 (3.6%), because of a cerebro-vascular accident. One patient died late (2.8 years postoperatively). Median age was 33 years and the median interval between primary repair and insertion of the prosthesis was 26 years. Freedom from re-operation at 1 year was 100%. One valve had to be replaced 14 years after implantation because of malfunction due to ingrowth of endomyocardial fibrosis. No thrombo-embolic events were observed. CONCLUSIONS: Our series do not confirm the bad reputation of mechanical valvar prostheses in the pulmonary position. On the contrary they perform well and result in a much lower re-operation rate than can be expected and in fact is reported after allograft usage. No thrombo-embolic complications were noted. In our experience pulmonary mechanical valve prostheses do well.     

Does Metabolic Syndrome Influence Bioprosthetic Mitral Valve Degeneration and Reoperation Rate?

Abstract Background: Evidence suggests that metabolic syndrome (MbS) is associated with early senescence of bioprosthetic aortic valve prostheses. The purpose of this study was to determine whether MbS is also associated with accelerated failure of bioprosthetic valves prostheses in the mitral position. Methods: Records of all patients undergoing bioprosthetic mitral valve replacement (MVR) from 1993 to 2000 were reviewed. Results: Of 114 patients undergoing bioprosthetic MVR, 48 (42%) had MbS. Mean age was 73 years (vs. 74 years for no MbS). Patients underwent MVR for regurgitation (n = 97; 85%), stenosis (n = 12; 11%), or mixed lesions (n = 4; 4%). Etiology was degenerative (n = 35; 32%), rheumatic (n = 26; 24%), ischemic (n = 30; 28%), calcific (n = 9; 8%), and endocarditis (n = 8; 8%). Mean follow‐up was 4.5 years. Overall survival at 5 and 10 years was 56% and 26%, respectively. Survival was similar between groups (p = 0.15). Five patients (2 MbS; 4% vs. 3 no MbS; 5%) required mitral reoperation at a mean of 3.8 years after initial MVR. The risk of prosthetic valve failure was not different between groups (p = 0.66). Despite no initial difference in transmitral gradients, gradients beyond five‐year follow‐up were greater for those with MbS (6.8 mmHg MbS vs. 4.7 mmHg no MbS, p = 0.007). Independent predictors of gradient progression beyond two years were MbS (p = 0.027) and female gender (p = 0.012). There were no significant differences in valve area, regurgitation, or ejection fraction. Conclusions: Although overall survival following bioprosthetic MVR is challenging, MbS did not predict diminished survival or excess reoperative risk compared to non‐MbS patients. The trend toward more rapid progression of transprosthetic gradients in MbS patients warrants further investigation.     

Fifteen-year experience with 1678 Hancock porcine bioprosthetic heart valve replacements

The Hancock porcine valve was the first commercially available biologic heart valve and has been in continuous use at the Brigham and Women's Hospital since January 1972. Through December 1987 we implanted 1678 valves in 1533 patients (885 male; 648 female; 17 to 95 years of age, with a mean of 60 years). There were 825 aortic valve replacements (AVR), 562 isolated mitral valve replacements (MVR), and 146 aortic mitral replacements (DVR). Ninety-four per cent of the patients were functional class III or IV. Associated coronary bypass was done in 25% of patients. Four per cent of patients were lost to follow up during a 1- to 16-year period with a mean of 6 years. Morbidity and mortality rates on a actuarial basis were calculated 10 and 15 years after operation for AVR, MVR, and DVR. The data indicates that the probability of reoperation for structural valve failure is quite reasonable as of 10 years, but from 10 to 15 years the numbers sharply fall off so that the probable effective life of the valve is 10 years. However in the elderly age group (equal to or greater than 70 years of age) the incidence of structural valve degeneration is markedly diminished, making this an ideal valve substitute for the elderly. It is also an ideal valve substitute in any patient who has a contraindication to long-term anticoagulation because of current medical or surgical problems.     

Clinical experience with omniscience and omnicarbon prosthetic heart valves

Omniscience valves were implanted in sixty-two patients. Twenty-eight of these patients underwent aortic valve replacement (AVR), 15 had mitral valve replacement (MVR) and 8 had aortic and mitral valve replacement (DVR). Post-operative events occurred in nine (5.9%/patient year) of the AVR group, in three (1.7%/patient year) of the MVR group and in three (5.4%/patient year) of the DVR group. The actuarial freedom from all events at five years in the AVR, MVR and DVR was 74 +/- 8%, 88 +/- 6%, 67 +/- 16%, respectively. Cardiac death occurred in four (2.5%/patient year) of the AVR, one (0.6%/patient year) of the MVR and two (3.6%/patient year) of the DVR. The freedom at five years in the AVR, MVR and DVR was 88 +/- 6%, 96 +/- 4%, and 77 +/- 14%, respectively. Valve-related complications were noted in four patients. Post-operative cerebral hemorrhage was seen in three of the AVR. Maximum opening angle of the Omniscience valve was 39.1 +/- 4.5 degrees at the aortic position and 44.6 +/- 9.7 degrees at the mitral position. Omnicarbon valves implanted in ninety-five patients, fifty-eight of these patients underwent AVR, 24 had MVR and 13 had DVR. Events occurred post-operatively in four (2.6%/patient year) of the AVR group, in three (12.2%/patient year) of the MVR group, but in none of the DVR group. The freedom at five years was 89 +/- 6% in the AVR and 84 +/- 8% at three years in the MVR. Post-operative cardiac death occurred in one (0.7%/patient year) of the AVR and in two (8.1%/patient year) of the MVR.(ABSTRACT TRUNCATED AT 250 WORDS)     

Mechanical versus biological heart valves: a ten-year comparison in a single centre

Between January 1977 and December 1986, 1606 Bj?rk-Shiley tilting disc prostheses (BS) and 1346 Carpentier Edwards porcine prostheses (CE) were implanted in 1300 and 1156 patients, respectively, at the same institution. During the time of implantation, both valves have developed: the BS through standard disc and convexo-concave to monostrut, and the CE valves from standard to supra-annular. Newer valve types were used where applicable as they became available. Preoperative status in respect of age and cardiac rhythm were similar. There were significantly more females (64% BS: 54% CE, P less than 0.001); worse NYHA grade (74% Grade 111 and IV-BS: 56% 111 and IV-CE, P less than 0.001) more closed heart surgery (26% BS: 18% CE, P less than 0.001) and more previous open heart surgery (11.6% BS: 8.9% CE, P less than 0.001) in the BS group. All BS patients were anticoagulated and 49% of mitral CE patients and 7% of aortic CE patients were anticoagulated. There was no significant difference between the two groups in hospital mortality (BS 7.2%: CE 6.3%), late mortality (BS 2.5%/patient year: CE 3.2%/patient year) overall incidence of systemic embolism (BS 1.3%/patient year: CE 1.4/patient year), prosthetic valve endocarditis (BS 0.7%/patient year: CE 0.9%/patient year), valve failure (BS 0.5%/patient year: CE 0.9%/patient year) or peri-prosthetic leak (BS 1.2%/patient year: CE 1.3%/patient year). The incidence of systemic embolism in the aortic position was lower with the BS prosthesis (BS 0.2%/patient year: CE 1.2%/patient year, P less than 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)     

Primary failure of pericardial valvular heterografts

From July 1981 to October 1984, 79 Hancock pericardial valves were implanted in 74 patients surviving the hospital period and with a mean age of 64.2 years. Fifty-two patients underwent aortic valve replacement, 16 had mitral valve replacement, 5 bad a double replacement and 19 associated procedures were performed. The mean survival is 48 months. Until 1st June 1987, 11 primary failures have required reoperation (14.9%), 4 in the mitral position (4.6% patient-years), 7 in the aortic position (3.01% patient-years). The time to reoperation was 48.4 months for the aortic orifice and 36.5 months for the mitral orifice. The lesions most frequently encountered were tears (7 cases), calcifications (5 cases) and stretching of valvular tissue (2 cases); two patients died during the postoperative phase of this operation. Despite the small number of patients followed, this series demonstrates of high incidence of dysfunction due to primary tissue degeneration as, after the 5th year, the actuarial rate of absence of primary lesion is 85.3 +/- 8% with no significant difference between the aortic and the mitral orifices, although dysfunction appears to occur more rapidly in mitral prostheses. These results are much less favourable than those obtained with Ionescu bioprostheses in the aortic position of those obtained with porcine bioprostheses in either position. This justifies very regular clinical and echocardiographic follow-up of patients with Hancock pericardial valvular heterografts.     

Predicting the performance of mitral prostheses implanted in children under 5 years of age.

BACKGROUND: Mitral valve replacement (MVR) is occasionally indicated in infants and young children, necessitating the use of small prostheses. The performance of these small valves during somatic growth of the patient can lead to patient-prosthesis mismatch. This study examines performance of these valves over time to establish predicted performance and timing of replacement. METHODS: Records were reviewed of all patients under 5 years of who underwent small mechanical MVR between 1988 and 2004 (n=24). Valve sizes were between 17 and 23 mm (Bileaflet 91.6%, Tilting Disc 8.3%) with a median size of 19 mm. Mean age of patients was 1.4+/-1.3 years with a mean weight of 7.8+/-3.4 kg. RESULTS: Early deaths (n=5, 20.8%) were excluded. There were two late deaths and five patients required redo-MVR: four for outgrowth and one for acute thrombosis at 3 months. Age at redo for outgrowth was 8.6+/-6.6 years with mean body weight of 22.5+/-17.5 kg. Mean time between original operation and redo was 8.6+/-6.1 years in these four patients. Follow-up was a median of 7.5 years (range 0.1-15.7 years). Overall freedom from death or valve replacement was 82.6+/-9.1% at 5 years and 75.7+/-10.6% at 10 years. The performance of the original prostheses showed a peak blood flow velocity across the valves of 1.5+/-0.6 m/s at 5 years and 2.2+/-0.5 m/s at 10 years. Seventy-five percent of the survivors still have their original valve at a mean of 8.1+/-4.4 years postoperative with New York Heart Association status of I or II. Actuarial curves suggest that gradients across the valves reach a peak of >10 mmHg at a mean between 6.5 and 7 years postoperative. CONCLUSION: MVR in children under 5 years carries a high mortality. Nevertheless, small mechanical MVR perform remarkably well in young children with durable haemodynamics despite growth of the patients well beyond more than double the initial bodyweight. Valves can be expected to last over 8 years before requiring re-replacement.     

Mitral-valve replacement in children under 6 years of age.

OBJECTIVE: In patients with congenital mitral-valve disease, reconstructive surgery is the primary goal. However, in cases with severely dysplastic valves or failed repair, mitral-valve replacement (MVR) is the only option. We analyzed, retrospectively, data of 35 patients younger than 6 years of age, who underwent MVR at our institution. METHODS: Between 1974 and 1997, 35 children underwent MVR. The ages ranged from 2.7 months to 5.5 years (mean=1. 9+/-1.7 years) and body weight varied between 3.2 and 16.7 kg (mean=8.2+/-4 kg). The main indication (57%) for valve replacement was severe mitral-valve insufficiency. Eighteen patients (51%) had undergone at least one previous reconstructive operation (mean=1. 46+/-1.86 years) before the MVR. In 29 cases (83%), mechanical prostheses were implanted. Six patients received a bioprosthesis. The size of the prostheses ranged between 14 and 27 mm. RESULTS: The overall hospital mortality was 17.1% (6/35), and decreased from 33 (1974-1985) to 11.5% (1986-1997). Seven children died late. The actuarial survival after 20 years was 51.2+/-13.3%. Eight patients (23%) required 10 reoperations (8.2%/100 patient-years). Freedom from reoperation at 10 years was 50+/-22%. Valve-related complications were thrombo-embolism (n=2; 1.6%/100 patient-years), hemorrhage (n=1; 0.8%/100 patient-years), structural deterioration (n=3; 2.5%/100 patient-years) and non-structural dysfunction (n=3; 2. 5%/100 patient-years). Follow-up is 96% complete, with a total of 122 patient-years (mean=4.2+/-4.7 years). Eighty six percent of the patients are in New York Heart Association (NYHA) class I, 95% have sinus rhythm and 59% do not need medication. All survivors, except for those who received a bioprosthesis, were placed on a regimen of Phenprocoumon (Marcumar((R))), aiming to maintain the International Normalized Ratio (INR) between 2.5 and 3.5. In one third of these children, self-management of oral anticoagulation was performed either by the patients or their parents. CONCLUSIONS: MVR in small children still carries a high risk. In our experience, the long-term results are satisfying. After failed reconstructive surgery, or as a primary procedure, we prefer mechanical prostheses. They are well tolerated and the incidence of anticoagulation-related complications is low.     

Long-term clinical results after aortic valve replacement with mechanical heart valves and mitral valve replacement with porcine valves]

Long-term clinical results of aortic valve replacement (AVR) with mechanical heart valves and mitral valve replacement (MVR) with porcine valves were analysed. Sixty-three patients received isolated AVR and 48 received isolated MVR. Sixty-eight patients with MVR including double or triple valve replacement were also added in order to evaluate the primary tissue failure (PTF). The patients with operative deaths were excluded. Survival rate at 11 years in AVR was 68 +/- 10% and 67 +/- 15% in MVR without statistical difference. At 11 years, 76 +/- 8% of the patients in AVR were free from valve-related complications in contrast with the poor result of 34 +/- 31% in MVR (p less than 0.01). Main cause of this poor result in MVR was PTF as indicated in following event free rates; 83 +/- 9% at 7 years, 61 +/- 25% at 10 years and 49 +/- 31% at 13 years. There was no statistical difference between patients of above 50 years and below 49 years in PTF. Valve-related death event free was 93 +/- 5% in AVR and 86 +/- 11% in MVR at 11 years (not significant), however, there was statistical difference in re-operation event free rate as 94 +/- 5% in AVR and 76 +/- 11% in MVR at 11 years (p less than 0.001). These results suggest that the use of porcine valves in mitral position is confined to the selected patients.