The CryoLife-O'Brien composite stentless porcine aortic xenograft valve in 118 patients.

The CryoLife-O'Brien stentless valve is a composite trileaflet porcine aortic valve. It is assembled from 3 non-coronary leaflets and has no foreign material support. It is therefore truly stentless. From December 1992 to January 1996, 118 patients with aortic valve replacement had a CryoLife-O'Brien stentless valve inserted at the Prince Charles Hospital, Brisbane. The mean age was 73 years (range 59-89) and 54% were men. Most patients had aortic stenosis secondary to a calcific degenerative valve. Follow-up is 100% with hematological and echocardiographic studies before discharge, at 6 months, and at 12-18 months. Five deaths (2 early and 3 late) have occurred and morbidity includes 3 strokes, 1 peripheral embolism, 3 perivalvular leaks, and 1 patient with late endocarditis. Valve performance has been good, with low transvalvular gradients and only a trace or no regurgitation in over 95% of patients after 18 months. No structural deterioration or hemolysis has occurred. Echocardiographic surveillance confirms a very effective central orifice. Short-term results show that the overall performance of the CryoLife-O'Brien stentless valve has been very satisfactory, with low mortality and morbidity in this elderly group of patients. The benefits include the absence of prosthetic material, wide leaflet coaptation, and a quick and easy insertion. Long-term anticoagulation is not necessary. It is particularly suitable for elderly patients with a symmetrical aortic root.

Porcine mitral stentless valve mid-term clinical results.

OBJECTIVES: Time testing is essential with any valvular procedure, especially when a new concept is introduced such as the mitral stentless valve. Our purpose is to evaluate the results obtained over 4 years with this operation, particularly to attest the impact of preservation of annulo ventricular continuity on the long term results of these patients. METHODS: From March 1992 to August 1996, 120 patients had their mitral valves replaced with a porcine stentless mitral valve. The observation period was 54 months with total patients follow-up of 3424 months with a mean of 28.5 months. The age ranged from 11 to 72 years (mean 35.22 +/- 14.98). There were 73 females (60.8%) and 47 males (39.2%). The predominant etiology was rheumatic heart disease. Associated procedures were performed in 12 patients (10%), and the great majority of the patients were in functional class III and IV (NYHA). RESULTS: Hospital mortality occurred in seven patients (5.83%) non valve related except for one early case of endocarditis. Early reoperation related to technical failure were necessary in 4 patients without mortality. Follow-up was accomplished in 101 patients and ranged from 2 to 54 months. Late reoperations were required in 16 patients (nine due to mitral insufficiency, five because of endocarditis and two for mitral stenosis). Most reoperations were related to technical failure. Among the 82 patients presently in control, 72 showed a competent mitral stentless valve, eight with stable mild mitral regurgitation and in two a decreased mitral orifice. Hemodynamic performance of the valve has been excellent in this group, particularly in patients with left ventricular dysfunction. CONCLUSION: Although technical complexity remains the main cause of reoperations with this valve, experience has shown that it not only provides preservation of the left ventricular function but also promised significant increase of the ejection fraction in patients with poor left ventricular function.

Aortic valve replacement with patch enlargement of the aortic annulus.

BACKGROUND: Aortic annulus enlargement has long been advocated for the placement of valve prostheses larger than otherwise would have been possible. Little information exists, however, on the short- and long-term outcome of this surgical procedure. METHODS: We performed a retrospective review of 530 patients enrolled in a registry for patients who underwent aortic valve replacement using the Hancock II bioprosthesis and were followed up prospectively over the course of 11 years at a single institution. In an effort to avoid prosthetic valve-patient mismatch, the aortic annulus was enlarged in 98 patients (18%). Short- and long-term outcome was analyzed. RESULTS: Enlargement of the aortic annulus during aortic valve replacement increased the operative mortality rate from 3.5% to 7.1%, but this difference did not reach statistical significance (p = 0.10). The long-term survival of patients who had annulus enlargement was similar to that of patients who did not. Because there were differences in the clinical profile of patients who had annulus enlargement and those who did not, a case-control study was carried out. This study showed similar long-term survival, freedom from valve-related and cardiac death, and combined end points in the two groups of patients. CONCLUSION: Aortic annulus enlargement increased the operative mortality of aortic valve replacement. However, patients who underwent enlargement of a small aortic annulus had long-term survival and freedom from cardiac and valve-related death comparable to those of patients who received larger aortic prostheses.

[The Carpentier-Edwards porcine valve in the supra annular aortic position. Results after 12 years in a series of 1108 patients]. / Valve porcine de Carpentier-Edwards supra annulaire en position aortique.

In the decision concerning the choice of valvular prosthesis, certain prostheses are considered to be standards of reference: this is the case of the Carpentier-Edwards Supra Annular 2650 porcine bioprosthesis. This study reports the results in a series of patients followed up for 12 years. Between 1983 and 1995, 1108 patients were implanted with this prosthesis for isolated aortic valve replacement. The majority of patients was elderly (mean 78.3 +/- 8.3 years). The follow-up rate was 94%, representing a total of 3 925 patient-years (average 4 +/- 3 years). The survival at 5, 10 and 12 years, operative mortality included, was 70.7%, 46% and 28%. Thromboembolic events to dehiscence represented the commonest complication (0.7% per patient-year). Structural valve degeneration (21 cases) (0.5% per patient-year) was a low risk complication up to 10 years but increased suddenly at the 11th year: age and gender were risk factors for this complication. The actuarial complication-free rate was 94% at 10 years and 82% at 12 years. Other complications were much less common (infectious endocarditis, haemorrage). The Carpentier-Edwards Supra Annular porcine bioprosthesis is associated with a low risk of complications after 10 years' follow-up, especially of valve degeneration. It remains a competitive choice in the register of valve prostheses. As with the other bioprostheses, the main indications are observed in elderly patients.

[Initial results of mitral valvuloplasty using the Physio-Carpentier-Edwards ring]. / Résultats préliminaires de la plastie mitrale avec l'anneau physio-carpentier-edwards.

The Physio-Carpentier-Edwards ring is a new prosthetic ring developed to allow mitral annuloplasty associating remodelling and flexibility of the native mitral annulus. The object of this study was to assess the feasibility and reliability of mitral valvuloplasty with the Physio ring. Between December 1992 and October 1995, 100 patients with an average age of 56.8 years suffering from mitral insufficiency underwent mitral valvuloplasty with a Physio ring. The mitral insufficiency was degenerative in 94% of cases. The degree of regurgitation was scored 3+ or 4/+4/+ in 94 patients. Mitral valve prolapse was observed in 83 patients. Mitral reconstruction was undertaken using Carpentier's techniques. One patient died in the immediate postoperative period. Two patients were reoperated for valve replacement because of systolic anterior motion (SAM). One patient had SAM which regressed with medical treatment. There were no deaths after the hospital period. There were no late reoperations of thrombo-embolic complications. The average follow-up period was 19 +/- 8 months; 77 patients were followed up for over 1 year and all underwent control Doppler echocardiography. Sixty-one patients had no residual mitral insufficiency: 15 patients had grade 1/4 regurgitation and one patient had grade 2/4 regurgitation. The average mitral valve surface area was 2.8 +/- 0.3 cm2. The average left ventricular end diastolic volume decreased from 186 +/- 59 cm3 before surgery to 129 +/- 37 cm3 at the last control (p < 0.001). The authors conclude that the Physio ring enables reliable and effective mitral valvuloplasty with excellent short term results. The benefits of the flexibility of the Physio ring remain to be evaluated by a randomised trial.

Stentless porcine bioprostheses for all types of aortic root pathology.

OBJECTIVE: Conventional biological and mechanical prostheses have important limitations with regard to their results concerning thrombosis, hemorrhage and long-term durability. Aortic valve replacement with stentless devices results in superior hemodynamic function because obstructing stents and sewing rims are avoided. In addition, no anticoagulation therapy is needed. METHODS: From 1 June 1991 until 31 May 1996, 235 patients received aortic valve replacement with stentless aortic porcine bioprostheses. Patients' ages ranged from 24 to 88 years (mean 64 years). In 21.3% of all patients, concomitant procedures were performed. Coronary artery bypass graft (CABG) and mitral valve surgical therapy were the most frequent ones (31 and 12 cases, respectively). Implanted valve sizes ranged from 21 to 29 mm in diameter. RESULTS: A total of 122 patients received a subcoronary implantation with the lower row performed with interrupted stitches and the upper row with a continuous suture. In 99 cases we performed the inclusion cylinder technique, also with lower interrupted sutures and running upper sutures after adaptation of the coronary ostia into the graft. In the group with small aortic roots, the total root replacement technique (n = 14) was used. Mortality at 30 days was 4.7% (11/235). Echocardiography at discharge postoperatively revealed a mean gradient across the prosthesis of 6 mm Hg. Color Doppler suggested no or trivial regurgitation in 93% of all examined patients and mild regurgitation without clinical symptoms in 7%. Up to now, 98.2% of all discharged patients have been free of valve-related reoperation. CONCLUSIONS: With implantation of stentless bioprostheses, an improved hemodynamic function will be obtained. Almost every aortic root pathology can be safely treated with any of the techniques described. The short and intermediate results seem to be at least equal to any other prostheses or treatment methods. The long-term performance of these devices is still under investigation.

Survival and cause of death after mitral valve replacement in patients aged 80 years and over: collective results from the UK heart valve registry.

OBJECTIVE: Over the last decade there has been an increasing number of patients aged 80 years and over undergoing heart valve replacement. However, literature on the outcome of mitral valve replacement (MVR) in this age group is still limited. METHODS: We conducted the present study by analysing data extracted from the UK Heart Valve Registry. From January 1986 to December 1994, 86 patients underwent isolated MVR and 10 underwent combined MVR with aortic valve replacement (AVR) and were reported to the Registry. RESULTS: The 30 day mortality was 10.4% (9/86) in the MVR group and 10% (1/10) in the MVR and AVR group. The actuarial survival was 79.8, 64.1 and 40.7% at 1, 3 and 5 years, respectively, in the MVR group. Of the 10 early (30 day) deaths, 8 were due to cardiac reasons and 19 of the 28 late deaths were due to non-cardiac reasons. A total of 55 (57.2%) patients received a bioprosthetic valve implant and 41 (42.8%) patients received a mechanical valve implant. There was no difference in survival between the two groups. CONCLUSIONS: The above results suggest that MVR in octogenarians produces a satisfactory early postoperative outcome and moderate medium-term benefit. There is no difference in survival between patients receiving bioprosthetic and patients receiving mechanical valve implants.

Influence of age on valve related events with Carpentier-Edwards pericardial bioprosthesis.

UNLABELLED: Age is the most important factor for the durability of biological valves. With an original design the Carpentier-Edwards pericardial valve showed improved results at 10 years. The influence of age on valve related complications is studied with a 10 year follow up on 807 valvular replacements. METHODS: Between January 1984 and December 1993, 807 patients underwent valve replacements with a Carpentier-Edwards pericardial bioprosthesis. Patients, 193 were younger than 60 years, 284 between 60 and 70 years and 330 patients were older than 70 years. All patients but seven were followed up for an average of 4.18 years after their operation and total follow up was 3373 patient years. Patients were divided into three groups of age: group I, less than 60 years; group II, 60-70 years; group III, over 70 years. A retrospective comparison was made between age groups. RESULTS: At 11 years, valve related complications included 97 patients with 27 valve related deaths. Rates of valve related death increase with age linearized rate were 0.3, 0.6 and 1.2%, respectively. No difference was observed for rates of all valve related morbidity: 2.6, 2.4 and 3.5%, respectively. Risk of thromboembolism increased with age, linearized rates were: 0.3, 0.7 and 1.3%. Risk of deterioration and reoperation decreased with age, rates of deterioration were 0.8, 0.1 and 0%. Other valve related events had the same incidence in all groups. No statistical difference was observed between group II and group III for deteriorations and reoperations. CONCLUSIONS: The performance of the Carpentier-Edwards pericardial valve is the same at 10 years in group II and III. This study supports the clinical use of this tissue valve in patients over 60 years. The results in group I are satisfactory, nevertheless, a more durable biological valve is needed for young patients.

Poor clinical performance of the Wessex porcine heart valve bioprosthesis at nine years' follow up.

OBJECTIVE: To assess the long term performance of the Wessex porcine bioprostheses implanted in a consecutive series of patients. DESIGN: A retrospective case series. PATIENTS: Between January 1985 and July 1991, 184 Wessex bioprostheses (78 mitral, 102 aortic, and 4 tricuspid) were implanted in 150 patients. The patients were 55% (83/150) male and 45% (67/150) female; mean age was 60 (SD 10) years. RESULTS: Hospital mortality was 9.3% (14/150). Total follow up was 696 patient-years (mean 4.7 years per patient). Linearised rates (events per 100 patient-years (SEM) for postoperative complications for patients with isolated mitral valve replacement, isolated aortic valve replacement, and multiple valve replacement were, respectively: late mortality: 4.7 (1.6), 3.3 (0.9), and 4.9 (1.9); thromboembolism: 5.8 (1.8), 3.0 (0.9), and 2.8 (1.4); valve thrombosis: 1.0 (0.7), 0.3 (0.3), and 0.7 (0.7); structural failure: 5.8 (1.7), 1.9 (0.7), and 7.1 (2.2). Actuarial freedom from complications at nine years (70% confidence interval) was: late mortality: 61 (9)%, 57 (13)%, and 59 (12)%; thromboembolism and valve thrombosis: 71 (9)%, 79 (6)%, and 81 (8)%; structural failure: 33 (14)%, 50 (16)%, and 12 (14)%; all valve related morbidity/mortality: 31 (10)%, 21 (11)%, and 7 (9)%. Stent fractures appeared in 11 of 17 explanted prostheses; actuarial freedom from stent fracture at nine years was 66 (12)%. CONCLUSIONS: The Wessex bioprosthesis is associated with high thrombogenicity, early structural dysfunction, and a high valve related morbidity/mortality which justifies very close follow up of patients fitted with them.

Long-term relative survival after primary heart valve replacement.

OBJECTIVE: Determination of the optimal timing of primary heart valve replacement is an important issue. The present paper provides a synopsis over early and late survival after primary heart valve replacement, including an evaluation of the excess mortality among heart valve replacement patients compared with the general population. METHODS: Survival was analyzed in 2365 patients (1568 without and 797 with concomitant coronary artery bypass grafting (CABG)) who underwent their first heart valve replacement. Observed survival was related to that expected among persons from the general Swedish population stratified by age, sex, and 5-year calendar period, to calculate the relative survival and estimate the disease-specific survival. RESULTS: Early mortality (death within 30 days after surgery) was 5.9% after aortic valve replacement, 10.4% after mitral valve replacement and 10.6% after combined aortic and mitral valve replacement. Relative survival rates (excluding early deaths) were 84% 10 years after aortic, 68.5% after mitral and 80.9% after both aortic and mitral valve replacement. A multivariate model based on observed survival rates was produced for each group, using the Cox proportional hazards model. Concomitant CABG, advanced New York Heart Association (NYHA) class, preoperative atrial fibrillation, pure aortic regurgitation and higher age increased the late observed survival after aortic valve replacement. NYHA class was the only factor independently related to observed late deaths after mitral valve replacement, and mitral insufficiency the only corresponding factor after both aortic and mitral valve surgery. CONCLUSION: The use of relative survival rates tended to modify the difference between subgroups compared with observed survival rates. Relative survival rates reduced the effect of concomitant CABG on survival, but enhanced for example the effect of aortic regurgitation. In patients > or = 70 years of age and patients submitted to aortic or mitral valve replacement with mild or no symptoms, the survival rate was similar for many years to that in the Swedish population at large.

Twenty-year clinical experience with porcine bioprostheses.

BACKGROUND: For the past 25 years, porcine valves have been the most widely implanted bioprosthesis, thereby becoming the standard for comparison with newer bioprosthetic valves. METHODS: We retrospectively analyzed 2,879 patients who underwent aortic (AVR; n = 1,594) or mitral (MVR; n = 1,285) valve replacement between 1971 and 1990. Follow-up was 97% complete and extended to 20 years (total, 17,976 patient-years). Patient age ranged from 16 to 94 years; mean age in patients who underwent AVR was 60 +/- 15 (+/- standard deviation) years; that for patients who underwent MVR was 58 +/- 13 years. RESULTS: The operative mortality rates were 7% +/- 1% (70% confidence limits) for AVR and 10% +/- 1% for MVR. Actuarial estimates of freedom from structural valve deterioration at 10 and 15 years were 78% +/- 2% (SE) and 49% +/- 4%, respectively, for the AVR subgroup; and 69% +/- 2% and 32% +/- 4%, respectively, for the MVR subgroup (AVR > MVR; p < 0.05). Estimates of freedom from reoperation at 10 and 15 years were 76% +/- 2% and 53% +/- 4%, respectively, for the AVR subgroup and 70% +/- 2% and 33% +/- 4%, respectively, for the MVR subgroup (AVR > MVR; p < 0.05). Estimates of freedom from thromboembolism at 10 and 15 years were 92% +/- 1% and 87% +/- 2%, respectively, for the AVR subgroup and 86% +/- 1% and 77% +/- 3%, respectively, for the MVR subgroup (AVR > MVR; p < 0.05). Estimates of freedom from anticoagulant-related hemorrhage at 10 and 15 years were both 96% +/- 1% for the AVR subgroup and 93% +/- 1% and 90% +/- 2%, respectively, for the MVR subgroup (AVR > MVR; p < 0.05). Estimates of freedom from valve-related mortality at 10 and 15 years were 86% +/- 1% and 78% +/- 3%, respectively, for the AVR subgroup and 84% +/- 2% and 70% +/- 4%, respectively, for the MVR subgroup (p = not significant). Multivariate analysis (Cox model) showed younger age, later year of operation, and valve site (MVR > AVR) to be significant risk factors for structural valve deterioration. Younger age, later year of operation, valve site (MVR > AVR), and renal insufficiency were the significant, independent risk factors for reoperation. Multivariate analysis revealed that higher New York Heart Association functional class, longer cardiopulmonary bypass time, congestive heart failure, renal insufficiency, and longer cross-clamp time were significant risk factors for valve-related mortality. Valve manufacturer did not emerge as a factor in any analysis. CONCLUSIONS: These long-term results with porcine bioprostheses were satisfactory, particularly in older patients and those undergoing AVR. As expected, younger age was a significant risk factor for structural valve deterioration and reoperation in both groups. Surprisingly, the durability of porcine bioprosthetic valves has not improved over time, which possibly can be attributed to more enhanced postoperative surveillance and earlier reintervention. These first-generation Hancock and Carpentier-Edwards porcine bioprostheses achieved similar long-term performance.

Double valve replacement with the Carpentier-Edwards pericardial valve: 10-year results.

BACKGROUND AND AIMS OF THE STUDY: The first generation of pericardial valves was withdrawn from the market because of an excessive rate of premature failure. With an original design, the Carpentier-Edwards pericardial valve promised improved results. MATERIALS AND METHODS: From July 1984 to December 1993, 71 patients underwent double mitral and aortic valve replacement with the Carpentier-Edwards pericardial valve. Mean age was 63.4 years. 58% were male, mean clinical status was 2.9 with 71% of patients in NYHA class III or IV, 55% were in atrial fibrillation. All patients were followed for an average of 4.17 years after their operation, and total follow up was 296 patients years. RESULTS: Operative mortality was 7% (5/71). At this point of the study, 70% of patients are in clinical NYHA class I or II, 42% of patients are in atrial fibrillation and 66% receive anticoagulation treatment. We observed 19 late deaths with an actuarial survival of 58% +/- 14% at ten years. Valve-related complications include four endocarditis, four reoperations, seven anticoagulant-related hemorrhages, two structural failures, one thromboembolic episode, and one sudden death. Two patients died of valve-related causes. After 10 years, freedom from valve related death is 97% +/- 3%, from endocarditis 90% +/- 8%, from reoperation 87% +/- 10%, from thromboembolic complications 98% +/- 2%, from valve failure 93% +/- 7%, and freedom from all complications is 58% +/- 18%. No failure in patients older than 60 years was noted and no leaflet tear was observed. CONCLUSIONS: The 10-year results of this pericardial bioprosthesis make this valve an outstanding choice when a bioprosthesis is required and in patients over 60 years old.

[Surgical results of valve replacement with porcine bioprostheses].

We evaluated the 80 cases of porcine valve replacement, accomplished between April 1975 and December 1980. There were 48 males and 32 females aged between 16 and 60 years old with a mean of 37.4 +/- 11.4. Ten patients underwent aortic valve replacement (AVR), 63 mitral valve (MVR), and 7 AVR plus MVR. Twenty-seven Hancock valves (H) were implanted in aortic (3) and mitral (24) position and 61 Carpentier-Edwards valves (CE) were used in aortic (14), mitral (46), and tricuspid (1) position. The mean duration of follow-up was 9.3 years (0.2-19.2 years) and cumulative follow-up was 747.2 patient years (py). The late mortality was 3.3%/py (25 patients). Actuarial survival rates for all patients at 10 and 15 years were 67%, and 49% respectively. The linearized rates (LR) of structural valve deterioration (SVD) was 7.0%/py. The freedom from SVD for all patients at 10, and 15 years were 47.1%, and 12.4% respectively. There were no differences of free rates of SVD between H and CE. between valve sites implated, and among age at operation. The incidence of occurrence of SVD was gradually increased 6 years after operation. The LR of thromboembolism (TE), anticoagulant-related hemorrhage (ACH), prosthetic valve endocarditis (PVE), nonfunctional valve dysfunction (NVD), and reoperation (RO) were 0.7%/py, 0.1%/py, 0.3%/py, 0.1%/py and 7.4%/py, respectively. The freedom from TE, ACH, PVE, NVD, and RO for all patients at 15 years were 91.3%, 98.1%, 95.6%, 80%, and 6.5%, respectively. The surgical results of glutaraldehyde-preserved porcine bioprostheses was excellent during the first 5 years after operation. A high incidence of SVD has been occurred thereafter. According the indication for valve replacement with bioprotheses is now strictly limited for elderly, child bearing female case, contraindition for therapy of anticoagulants, and some social condition.

[Valvular surgery in the patients more than 70 years old].

One hundred twenty-eight valvular surgeries in patients over 70-year-old were reviewed (AVR:58, MVR:38, AVR and MVR: 11, mitral valvuloplasty (MVP): 11, AVR + MVP:11, mitral valvuloplasty (MVP): 11, AVR + MVP: 8, others: 2). Concomitant CABG was performed in 7, Maze in 6, TVR in 5 and Bentall in 3 cases. Early deaths occurred in 17 patients (13%). The early mortality was 5% in AVR, 21% MVR, 18% in AVR and MVR, 0% in MVP and 38% in AVR and MVP. Late death occurred in 16 patients. Forty-three percent of the late deaths were cardiac death. The actuarial survival at 10 years was around 50% in all groups. In the aortic position, a mechanical valve was implanted in 47 cases and a bioprosthetic valve was implanted in 33 cases. In the mitral position, the mechanical valve was implanted in 37 cases and the bioprosthetic valve was implanted in 12 cases. The event free rate after AVR at 10 years was 37% in patients with the mechanical valve (3 cerebral hemorrhage, 2 PVE, 1 thromboembolism and 1 sudden death) and 46% in patients with the bioprosthetic valve (2 PVE and 1 primary tissue failure). The event free rate after MVR at 10 years was 84% in patients with mechanical valves (1 perivalvular leak, 1 PVE and 1 sudden death) and 75% in patients with bioprosthetic valves (1 PVE and 1 sudden death). Between mechanical valve group and bioprosthesis group, no statistically significance was found in the event free curve after AVR nor MVR. There was no valve related event after MVP. Considering the better durability of bioprostheses in the aortic position than in the mitral position, the presence of atrial fibrillation and necessity of warfarin anticoagulation, we conclude that a choice of a bioprosthetic valve could be acceptable in the aortic position, but may not be recommended in the mitral position.

Ten-year experience with the Carpentier-Edwards pericardial xenograft in the tricuspid position.

We reviewed the cases of 66 patients who underwent 67 tricuspid valve replacements with Carpentier-Edwards pericardial xenografts between April 1985 and January 1994. Average patient age at time of operation was 52 years (range 8 to 71 years). Concomitant mitral or aortic valve replacements were performed in 46 patients. There were 10 operative deaths and 6 late deaths. Actuarial survival at 9 years was 75.4% +/- 5.7%. Prosthetic valve endocarditis occurred twice in one patient. Reoperations for tricuspid regurgitation and for concomitant procedures (maze operation and repair for leak of the mitral prosthesis) were performed in two patients. In both cases, examination of the explanted prostheses showed that the tricuspid regurgitation was the result of nonstructural dysfunction caused by fibrous pannus formation on the cusps of the ventricular side. Among the survivors, 47 patients (92%) were in functional class I or II. Prosthetic valve function was studied by color Doppler echocardiography. Among 38 patients, tricuspid regurgitation more than grade 3/4 or transprosthetic gradient more than 5 mm Hg was found in 11. One patient had right heart failure and the others had no symptoms. In 10 years of experience with the Carpentier-Edwards pericardial xenograft, mortality and morbidity after tricuspid valve replacement were satisfactory. Echocardiographic examination revealed subclinical prosthetic dysfunction in 35% of patients who were followed up for longer than 5 years, however, and we believe that these patients should receive careful follow-up.

[Tricuspid valve replacement: long-term clinical and echocardiographic follow-up]. / Le remplacement valvulaire tricuspidien: suivi clinique et échographique à long terme.

Long term results of tricuspid valve replacement, were evaluated by echocardiographic and clinical means retrospectively on 55 patients hospitalized at the Montreal Heart Institute between 1969 and 1993. Twenty seven percent were male and 73% female. Taking into account differences in means of myocardial protection the whole population was divided in 2 groups. Group 1: 19 patients from 1969 to 1980. Group 2: 36 patients - from 1981 to 1994. Forty seven patients (85%) received a bioprosthesis and 8 (15%) a mechanical valve. Forty one (74%) had another surgical procedure and 60% (33 patients) were re-operations. Mortality at 30 days is 23% (13 patients) -15% group 1 and 27% group 2. Twenty six patients (72%) of group 2 were re-operations compared with 7 (36%) for group 1 (p = 0.026). Risk factors of operative mortality were: high systolic pulmonary pressure (0.051), bypass time (0.012) and abnormal ejection fraction (0.025). Mean time of follow up is 113.8 months completed at 95%. Six patients were re-operated; 4 for failure of bioprosthesis 11.5 years (mean) after initial surgery. Forty three percent of patients presented with an amelioration of NYHA class. 26% in class I and 50% in class II. Mean gradient across the tricuspid valve was 4.1 +/- 1 mm Hg. Twenty two over 42 patients (50%) died during follow up: 75 months after surgery.

[Carpentier's supra-annular bioprosthesis in aortic position: a mid-term evaluation]. / La valve de Carpentier supra-annulaire en position aortique: évaluation à moyen terme.

The aim of this study was to assess the medium and long-term results of the Carpentier-Edwards supra-annular (CESA 2650) bioprosthesis. From the end of 1984 to January 1993, 160 patients aged 71.6 +/- 8.6 years underwent aortic valve replacement alone or associated with coronary revascularisation. The postoperative mortality was 11 patients (6.8%): follow-up included 749 patient-years with an average period of 60 +/- 29 months, which was complete in 96% of operated patients. The late mortality was 30 patients (4% patients/year): the actuarial 5 year and 10 year survival was 78.6% and 59.1% respectively (hospital mortality included). The linear complications rates were: major thromboembolism: 1.3% patients/year; structural deterioration: 1.5% patients/year; reoperation: 0.75% patients/year; total morbid/fatal complications: 5% patients/year. Despite the limited follow-up, the authors' analysis confirmed the low rate of structural deterioration requiring reoperation, especially in patients over 70 years of age in whom there were no cases of reoperation at 9 years. They conclude that the medium-term results of the CESA 2650 bioprosthesis are comparable to those of first generation porcine bioprostheses: the absence of reoperation related to valve complications in the over 70s during the study period suggests that this is the replacement of choice in this category of patients.

Evolution of the surgical approach for replacement of degenerated mitral bioprostheses.

BACKGROUND: Primary tissue failure is the most frequent indication for reoperation in patients with a mitral bioprosthetic valve (MBPV). Complete excision of the bioprosthesis is time-consuming and may be complicated by cardiac rupture at the atrioventricular junction or the posterior left ventricular wall where a strut is embedded, injury to the circumflex coronary artery, or late perivalvular leak. A new approach to avoid these complications by excision of only the bioprosthetic tissue and attachment of a St. Jude valve (SJV) to the intact stent has been developed and evaluated. METHODS: The results of replacement of failed MBPV with SJV in 71 consecutive patients between September 1992 and December 1994 were analyzed; 57 patients had the valve replaced after complete excision and 14 with stent preservation. The demographic and clinical profiles of the two groups were similar. RESULTS: Among patients undergoing complete excision of the MBPV, operative mortality was 14% (8 of 57), with 12 late deaths and a 5-year survival of 75% and three late perivalvular dehiscences requiring another operation. No operative deaths occurred in the intact stent group and one late death (cancer), and all the remaining patients are doing well without perivalvular leaks or other complications. CONCLUSIONS: Leaving the MBPV stent intact eliminates the need for extensive dissection, thus shortening and simplifying the procedure and diminishing its attendant mortality and morbidity. It offers a safe and logical approach to replacement of a degenerated MBPV with a SJV of comparable size.

Carpentier-Edwards standard porcine bioprosthesis: clinical performance to seventeen years.

BACKGROUND: The role of porcine bioprostheses in cardiac valve replacement has been under review for several years. The literature deals primarily with age as a determinant of durability, as well as the intermediate-term performance of various prostheses. The performance of the Carpentier-Edwards first-generation standard porcine bioprosthesis is presented over the long-term with further documentation on age determinants. METHODS: The "Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations" were used for definitions of valve-related complications, categorization, and statistical methods. The valve-related complications were evaluated in a time-related manner by actuarial life-table techniques. The Lee-Desu statistic test was used for comparison of performance by valve positions and age groups. Hazard function rates were demonstrated for complications and composites. RESULTS: Of the Carpentier-Edwards porcine bioprostheses implanted in 1,195 patients (1,214 operations, 1,315 valves) commencing in 1975 the early mortality was 7.6% (92). The early mortality without concomitant procedures was 6.1% and with 11.7%. The late mortality was 5.3% per patient-year; 4.6% patient-year without and 7.5% per patient-year with concomitant procedures. The valve-related causes of late mortality (131) were thromboembolism (41), antithromboembolic hemorrhage (14), prosthetic valve endocarditis (20), nonstructural dysfunction (12), and structural valve deterioration (44). The valve-related deaths (early, 7; late, 124) were 21.2% of the total 617 total deaths. Reoperation for valve-related complications was performed in 406 patients (4.1% per patient-year), of which 327 were for structural valve deterioration (3.3% per patient-year). Mortality for reoperation was 0.5% per patient-year (49 patients) or 12.1%. Of the 49 deaths, 33 were caused by structural valve deterioration. The linearized occurrence rate for thromboembolism was 1.6% per patient-year (major, 0.9% per patient-year, and minor, 0.7% per patient-year). The fatal thromboembolic rate was 0.4% per patient-year (41), undifferentiated by valve position. The freedom from thromboembolism was 76% at 17 years (p = not significant by valve position) (major, 87%; fatal, 93%). The freedom from prosthetic valve endocarditis was 92% at 17 years (p = not significant by valve position). The freedom from reoperation, at 15 years, was 38%: aortic (AVR), 55%; mitral (MVR), 20%; and multiple valve replacement (MR), 24% (p < 0.05 AVR > MVR, MR). The freedom from structural valve deterioration, at 15 years, was 41%; AVR, 58%; MVR, 21%; MR, 36% (p < 0.05 AVR > MVR, MR). The freedom from structural valve deterioration was greater for advancing age groups (p < 0.05); AVR > or = 70 years 96% at 12 years, and 65 to 69 years 94% at 12 years and 82% at 15 years; MVR > or = 70 years 85% at 12 years, and 65 to 69 years 54% at 12 years. The freedom from valve-related mortality was 73% at 17 years: AVR, 80%; ; MVR, 61%; and MR, 67% (p < 0.05 AVR > MVR, MR). The freedom valve-related residual morbidity was 94% (p = not significant by valve position). CONCLUSIONS: The Carpentier-Edwards standard porcine bioprosthesis continues to provide satisfactory clinical performance to 17 years. Thromboembolism is a more serious problem than structural failure: 92 major thromboembolic events with 41 fatalities compared with 44 fatalities of which 33 occurred with reoperation. The prosthesis is especially recommended for patients more than 65 years of age for AVR and more than 70 years of age for MVR.

Efficacy of combined coronary revascularization and valve procedures in octogenarians.

From January 1982 to October 1991, 42 consecutive patients 80 years of age and older underwent a combined cardiac procedure with coronary revascularization and valve repair or replacement. There were 20 women and 22 men. Mean age at operation was 82.8 years (range, 80 to 89.7 years). Twenty-seven patients (64%) were in New York Heart Association (NYHA) functional class III or IV preoperatively. Six patients (14.3%) had undergone previous cardiac procedures. There were six hospital deaths (14.3%). The only significant preoperative risk factor identified for the event hospital death was aortic insufficiency (p = 0.005). The 36 hospital survivors were followed up at a mean of 21.1 months after hospital discharge. There were nine (21%) late deaths occurring at a mean of 21.3 months postoperatively: two from acute myocardial infarctions and seven from chronic heart failure. Survival analysis indicated that higher preoperative NYHA class (p = 0.0003), hypertension (p = 0.015), hypercholesterolemia (p = 0.03), and elevated left atrial/left ventricular gradient (p = 0.04) were incremental risk factors for overall mortality. The actuarial survival at 40 months was 51.9%, with no significant difference as compared with an age-, sex-, and race-matched population. Of the 27 late survivors, 26 were in NYHA class I or II. We conclude that octogenarians may undergo complex cardiac surgical procedures with an expectation of an acceptable mortality rate and significant improvement in their functional status. These results must be taken into consideration in light of reported strategies to ameliorate health-care costs by limiting availability of complex medical care to the elderly.