Long-term follow-up of small (size 20 and 21) Medtronic-Hall aortic valve prostheses.

BACKGROUND: Our goal was to study the long-term follow-up of patients having aortic valve replacement and to focus particularly on the patients receiving small prostheses. METHODS: Four hundred twenty-eight Medtronic-Hall valves were implanted (156 size 20 or 21 mm, 149 size 22 or 23 mm, and 123 size 25 or 27 mm). Group 20-21 had a higher number of female patients, more associated coronary lesions, and more patients with aortic stenosis. RESULTS: The actuarial survival rate at 8 years was 80% for group 20-21, 80% for group 22-23, and 76% for group 25-27 (p = not significant). In group 20-21, the actuarial event-free rates at 8 years were as follows: thromboembolic complications, 94%; prosthetic valve endocarditis, 99%; reoperation, 98%; and hemorrhagic complications, 78%. The only factors of prognostic value in this group were age and associated coronary lesions. CONCLUSIONS: The durable nature of the results obtained with the Medtronic-Hall 20- and 21-mm prostheses compared with large-diameter prostheses allows the use of a simple and reliable surgical technique and should mean that indications for ring enlargement become rare.

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.

Single-institution effectiveness assessment of open-heart surgery in octogenarians.

OBJECTIVE: To determine short- and long-term outcome of open-heart surgery in octogenarians. METHODS: We reviewed the medical charts of 130 consecutive octogenarians undergoing open-heart surgery. Patients with significant comorbidity were excluded from the study. The effect of cardiac and operative risk factors on mortality and morbidity was evaluated. General practitioners and cardiologists were contacted in order to obtain information on the patients' current medical and functional status. RESULTS: Operative mortality for valve replacement (VR) and coronary artery bypass grafting (CABG) was 11.5%. Four-year survival was 73.5% with 75.9% still living independently. The relative risk for operative mortality was 4.3 in case of extracorporeal bypass time exceeding 95 min and 3.6 in case of significant left main stem disease. The risk of late death increased 2.5 times at a left ventricular ejection fraction lower than 50%. CONCLUSIONS: Our data match the results of similar studies involving large numbers of patients. When a multicenter data bank is missing, the evaluation of a relatively small patient group can yield information that may be as useful to patient and physician as information obtained by large studies. Open-heart surgery in octogenarians carries an acceptable mortality risk and its effectiveness in terms of improved quality of life is good.

Incidence and risk of developing fungal prosthetic valve endocarditis after nosocomial candidemia.

PURPOSE: To determine the incidence of prosthetic valve endocarditis (PVE) in fungemic patients with prosthetic heart valves (PHV), estimate risk of subsequent PVE, and describe risk factors and diagnostic and therapeutic management issues in such patients. PATIENTS AND METHODS: This is a retrospective chart review in a 1,100-bed tertiary referral center with an active cardiothoracic surgical service. Forty-four patients with PHVs developed nosocomial fungemia between January 1985 and April 1995. RESULTS: Of 44 patients, 33 never developed evidence of PVE (group 1), 7 (16%) had evidence of PVE at the time of candidemia (group 2), and 4 (9%) developed PVE a mean of 232 days after candidemia (group 3). Predisposing factors including intravascular lines, prior antibiotic therapy, and an identifiable portal of entry for fungemia were common in group 1 but not group 2. Candidemia occurred significantly later after PHV surgery in group 2 (mean 270 days) as compared to groups 1 and 3 (means 48 and 15.5 days, respectively; P = 0.02). Ten of 11 patients with Candida PVE (group 2 and 3) were treated with amphotericin B and valve replacement. Three relapses after combined therapy were documented in two patients. Mortality was significantly higher for patients without Candida PVE (group 1) as compared to patients with Candida PVE (groups 2 and 3) at 1 month (53% vs 9%), 2 months (69% vs 20%) and 1 year (83% vs 25%) after candidemia. CONCLUSIONS: Patients with prosthetic heart valves who develop nosocomial candidemia are at notable risk of either having or developing Candida PVE months or years later. Late onset candidemia and lack of an identifiable portal of entry should heighten concern about Candida PVE in such patients.

[Mitral surgery: prognostic and survival factors. Value of the French score]. / Chirurgie mitrale: facteurs de pronostic et de survie. Intérêt du score "français".

OBJECTIVES: Conservative mitral surgery is the preferred treatment for mitral regurgitation whatever the etiology. Morbidity and mortality figures, both during hospitalization and after long-term follow-up, are better than for mitral valve replacement. This difference could result from a selection bias or express a specific effect of conservative mitral surgery on survival. In addition, concerns about cost-containment justify rigorous analysis of treatment quality. The "French" score can be used for preoperative assessment of individual and population operative risk and for inter-institution comparisons. Its value for assessing overall survival is unknown. METHODS: Using the French score, we compared the clinical features and laboratory data in 100 patients who underwent conservative mitral valve surgery and in 35 patients who had valve replacement. We looked for independent factors predicting overall survival. RESULTS: Overall survival tended to be better after conservative mitral surgery, reaching 86% at 4 years versus 72% after replacement (p = 0.08). The populations were different as the valve replacement group included more women, was more symptomatic (p = 0.022), had heart failure more often (p = 0.003) and tended to have a higher French score (p = 0.06). Inversely, the hemodynamic and echocardiographic parameters were not different between the two groups. DISCUSSION: Independent factors predicting late mortality were preoperative heart failure and the French score. The type of mitral surgery did not have any predictive value. CONCLUSION: In addition to its value for assessing operative risk, the French score appears to be useful for predicting overall survival after mitral surgery.

[Heart valvular disease in patients 70 years old and older].

From June 1986 to December 1996, 69 patients older than 70 years old underwent AVR (29 cases), MVR (21 cases), MVP (5 cases), DVR (10 cases), aortic root replacement (3 cases), repair of PVL (1 case) in our hospital. There are five (7.2%) operative and hospital deaths. The survival rate was 88.4% at 10 year after surgery and three (4.7%) late deaths. The factors associated with early deaths were renal dysfunction and DVR. Our surgical results suggest that open heart surgery can be performed safely even elderly patients, in spite of their precarious physiologic homeostasis. Not the chronological age but the physiological age is important determinant for surgical indication. If quality of life (QOL) can be expected to be enhanced, we recommend an aggressive surgical approach.

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.

Long-term results of heart valve replacement with bileaflet prostheses.

Bileaflet cardiac prostheses (St. Jude, CarboMedics, Duromedics, Bicarbon, Jyros) have shown a low incidence of complications and good haemodynamic performance. In the last twelve years, 783 bileaflet prostheses were implanted in 690 patients at our Institution. The population of our study comprises 591 bileaflet prostheses (418 CarboMedics, 124 St. Jude, 49 Bicarbon) implanted in the mitral (MVR) (n = 305) or aortic (AVR), (n = 286) position. The follow-up study evaluated 292 male and 295 female patients with age ranging from 13 and 79 years (mean 50.4 +/- 14.7 years). Hospital mortality was 6.6%. Follow-up was 97% complete, with 1822 +/- 33 patient/years and a mean follow-up of 37 months (range 1 to 144 months). Twelve years actuarial freedom from complication according to prosthetic site were calculated as follows (linearized rates in parentheses): late mortality AVR 97.6% +/- 0.6% (2.3%), MVR 96% +/- 0.5% (2.1%); thrombosis AVR 100%, MVR 96% +/- 0.9% (0.8%); embolism AVR 97% +/- 0.5% (1.5%), MVR 96.6% +/- 0.7% (1.8%). Global freedom from anticoagulant-related haemorrhage was 95% +/- 1.2% (2.3%) and 94.5% +/- 0.7% (2.2%) following AVR, 94 +/- 0.6% (2.1%) following MVR. The difference of the haemorrhagic risk for prosthetic site was not significant (p > 0.05). Functional improvement was confirmed by the low postoperative NYHA functional class. According to our results, cumulative experience with bileaflet valves has shown very good long-term results in term of low rate of complication, long-term survival and quality of life.

Sternal wound complications--incidence, microbiology and risk factors.

OBJECTIVE: Sternal wound complications, i.e. instability and/or infection (mediastinitis), are important causes of morbidity in patients undergoing cardiac surgery via median sternotomy. Coagulase negative staphylococci, a normal inhabitant of the skin, have evolved as a cause of sternal wound infections. Since these opportunistic pathogens often are multiresistant, they can cause therapeutic problems. METHODS: From 1980 through 1995 open heart surgery, was performed on 13,285 adult patients. Reoperation necessitated by sternal wound complications occurerd in 203 patients (1.5%). The incidence was 1.7% (168/9987) after coronary artery bypass grafting (CABG group) and 0.7% (35/3413) after heart valve surgery with or without concomitant CABG (HVR group). RESULTS: Factors independently related to sternal complications in the CABG group (variable odds ratio [95% C.I.]): year of surgery, 1.9 [1.3-2.8] in 1990-1992, 2.0 [1.4-2.9] in 1993-1995; female sex, 0.4 [0.2-0.6]; diabetic disease, 1.8 [1.2-2.5]; bilateral ITA procedure, 3.3 [1.1-7.7]; and postoperative dialysis, 3.1 [1.4-6.9]. In the HVR group they were: use of ITA graft, 3.7 [1.7-7.7]; early re-exploration because of bleeding 3.0 [1.1-8.2]; and postoperative dialysis 3.1, [1.4-9.3]. Multivariate models were used to compute the risk for sternal complications in each patient. However, the prognostic models based on these risk scores provided low sensitivity and low predictive value. Patients with sternal wound complications showed no increased early mortality but worse long-term survival even after adjustment for other factors (relative hazard in CABG group 1.9 [1.2-2.8]; in HVR group 2.1 [1.1-4.3]. CONCLUSIONS: The use of ITA grafts seems to be one of the most important factors related to sternal wound complications. However, patients at truly increased risk for this complication could not be identified on the basis of the risk factors considered in this study.

Aortic valve replacement in the elderly. Risk factors and long-term results.

OBJECTIVE: The current study was undertaken to determine long-term results of aortic valve replacement (AVR) in the elderly, to ascertain predictors of poor outcome, and to assess quality of life. SUMMARY BACKGROUND DATA: Aortic valve replacement is the procedure of choice for elderly patients with aortic valve disease. The number of patients aged 70 and older requiring AVR continues to increase. However, controversy exists as to whether surgery devoted to this subset reflect a cost-effective approach to attaining a meaningful quality of life. METHODS: This study reviews data on 247 patients aged 70 to 89 years who underwent isolated AVR between 1980 and 1995; there were 126 men (51%) and 121 women (49%). Follow-up was 97% complete (239/247 patients) for a total of 974.9 patient-years. Mean age was 76.2 +/- 4.8 years. Operative mortality and actuarial survival were determined. Patient age, gender, symptoms, associated diseases, prior conditions, New York Health Association class congestive heart failure, native valve disease, prosthetic valve type, preoperative catheterization data, and early postoperative conditions were analyzed as possible predictors of outcome. Functional recovery was evaluated using the SF-36 quality assessment tool. RESULTS: Operative mortality was 6.1% (15/247). Multivariate logistic regression showed that poor left ventricular function and preoperative pacemaker insertion were independent predictors of early mortality. After surgery, infection was predictive of early mortality. Overall actuarial survival at 1, 5, and 10 years was 89.5 +/- 2% (198 patients at risk), 69.3 +/- 3.4% (89 patients at risk), and 41.2 +/- 6% (13 patients at risk), respectively. Cox proportional hazards model showed that chronic obstructive pulmonary disease and urgency of operation were independent predictors of poor long-term survival. Postoperative renal failure also was predictive of poor outcome. Using the SF-36 quality assessment tool, elderly patients who underwent AVR scored comparably to their age-matched population norms in seven of eight dimensions of overall health. The exception is mental health. CONCLUSIONS: Aortic valve replacement in the elderly can be performed with acceptable mortality. Significant preoperative risk factors for early mortality include poor left ventricular function and preoperative pacemaker insertion. Predictors of late mortality include chronic obstructive pulmonary disease and urgency of operation. These results stress the importance of operating on the elderly with aortic valve disease; both long-term survival and functional recovery are excellent.

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.

[Simultaneous tricuspid valve operation in patients undergoing aortic and mitral double valve replacement].

In triple valvular surgery, AVR+MVR+TVR or TVP, there are some problems around operation, because patients impaired cardiac function after a long history of the disease and some of them are reoperation cases. The sixty-five patients operated from May in 1980 to June in 1993 were examined. They were divided into two groups, group P and group R, depending upon procedure of tricuspid position. Group P consisted of 51 patients and group R of 14 patients. There were 22 (34%) reoperations. In group P, organic changes in tricuspid valve were mild, however in group R, there were commissural fusion in 8 patients, destruction of leaflet due to infectious endocarditis in one patient, and marked tricuspid annular dilatation in five patients. There was one early death in group R, no early death in group P. Actuarial survival rate at the 10th postoperative year was good as 81.6% in group P and 85.7% in group R. There were no significant differences in operative mortality and actuarial survival between group P and R.

A comparison of a moderate with moderate-high intensity oral anticoagulant treatment in patients with mechanical heart valve prostheses.

BACKGROUND: The long-term administration of oral anticoagulants to patients with mechanical heart valve prostheses is generally accepted. However, the appropriate intensity of oral anticoagulant treatment in these patients is still controversial. METHODS AND RESULTS: From March 1991 to March 1994, patients referred to the Padova Thrombosis Center who had undergone mechanical heart valve substitution at least 6 months earlier were randomly assigned to receive oral anticoagulants at moderate intensity (target INR = 3) or moderate-high intensity (target INR = 4). Principal end points were major bleeding, thromboembolism and vascular death. Minor bleeding was a secondary end-point. A total of 104 patients were assigned to the target 3 group and 101 to the target 4 group; they were followed for from 1.5 years to up 4.5 years (mean, 3 years). Principal end-points occurred in 13 patients in the target 3 group (4 per 100 patient-years) and in 20 patients in the target 4 group (6.9 per 100 patient-years). Major hemorrhagic events occurred in 15 patients, 4 in the target 3 group (1.2 per 100 patient-years) and 11 in the target 4 group (3.8 per 100 patient-years) (p = 0.019). The 12 recorded episodes of thromboembolism, 4 of which consisted of a visual deficit, were all transient ischemic attacks, 6 in the target 3 group (1.8 per 100 patient-years) and 6 in the target 4 group (2.1 per 100 patient-years). There were 3 vascular deaths in each group (0.9 and 1 per 100 patient-years for target 3 and target 4 groups, respectively). Minor bleeding episodes occurred 85 times (26 per 100 patient-years) in the target 3 group and 123 times (43 per 100 patient-years) in the target 4 group (p = 0.001). CONCLUSIONS: Mechanical heart valve patients on anticoagulant treatment who had been operated on at least 6 months earlier experienced fewer bleeding complications when maintained on a moderate intensity regimen (target INR = 3) than those on a moderate-high intensity regimen (target INR = 4). The number of thromboembolic events and vascular deaths did not differ between the two groups.

[Intermediary results with the CarboMedics bileaflet valvular prosthesis]. / Résultats intermédiares avec la prothèse valvulaire à ailettes CarboMedics.

From December 1988 to December 1995, 212 patients underwent valve replacement with a CarboMedics bileaflet valve in our institution (103 aortic valve replacements, 72 mitral valve replacements, and 37 double valve replacements). Fifty-five percent were male patients. Mean age was 53.8 +/- 12.7 years. Forty seven percent of patients were in NYHA clinical status III or IV. Operative mortality was 3.7% (8/212). All patients but eight were followed-up for an average of 2.9 years after their operation and total follow-up was 617 patient-years. At the time of the study, more than 90% of patients were in NYHA class I or II, 26% were in atrial fibrillation and 100% of patients received anticoagulation treatment. There were 15 late deaths. After 7 years, the actuarial survival rate was 84 +/- 7%. Three patients died of valve-related causes. Valve-related complications included 5 thromboembolic episodes (0.8% patient-year), 18 anticoagulant-related complications (2.9% patient-years), 3 endocarditis (0.5% patient-year), and 4 reoperations (0.6% patient-year). After 7 years, freedom from thrombo-embolic complication was 97 +/- 2%, from anticoagulant-related complications was 88 +/- 6%, from endocarditis was 96 +/- 4%, and from reoperation was 95 +/- 5%. We conclude that the 7-year results compare with other bileaflet valves. More follow-up and larger studies are mandated to give definite conclusions.