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Ann Thorac Surg 1997;63:1018-1025
© 1997 The Society of Thoracic Surgeons
Departments of Cardiology and Cardio-Thoracic Surgery, University of Vienna, Vienna, Austria
Accepted for publication October 25, 1996.
| Abstract |
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Methods. We implanted 640 CarboMedics prostheses in 583 patients in the aortic (n = 359), mitral (n = 167), or aortic and mitral positions (double valve replacement; n = 57). Patient ages ranged from 11 to 81 years (mean age, 58 ± 12.3 years).
Results. Overall hospital mortality was 9.0%; however, when high-risk urgent cases were removed from the calculation, the operative mortality fell to 4.5%. Follow-up was 98% complete, comprising 2,027 patient-years for a mean follow-up of 44 months (range, 6 to 72 months). Actuarial freedom from complications (linearized rates in parentheses) was as follows: late mortality, 85% ± 2.0% (2.3%/patient-year); thromboembolism, 92% ± 1.1% (1.6%/patient-year); anticoagulation-related hemorrhage, 87% ± 1.2% (2.8%/patient-year); prosthetic valve endocarditis, 98% ± 0.5% (0.1%/patient-year); and overall valve-related morbidity and mortality, 76% ± 2.1% (4.3%/patient-year).
Conclusions. The CarboMedics valve shows a low rate of valve-related complications comparable with other new mechanical heart valve prostheses.
| Introduction |
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Clinical implantation of the CarboMedics prosthesis was started in 1986 on the European continent. This report details our experience with this valve from 1988 to 1994.
| Patients and Methods |
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In this study 160 patients (27.4.%) had a previous cardiac operation; 176 patients (30%) had additional, associated procedures, including coronary artery bypass grafting (n = 122), de Vega tricuspid annuloplasty (n = 11), mitral reconstruction (n = 9), thrombectomy (n = 6), aortic annulus enlargement (n = 4), ventricular aneurysmectomy (n = 2), and other procedures (n = 22). Patient data are shown in Table 1
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Follow-up
All patients undergoing valve operations were contacted 6 months postoperatively and every year thereafter with a detailed written questionnaire, which was signed by the patient's primary physician. After the first year, they were invited to our outpatient department, where physical examination, laboratory tests, electrocardiography, and echocardiography were done. Patients with complications were examined in our outpatient department. Information was available for 572 of the 583 patients, a 98% complete follow-up. The cumulative patient follow-up was 2,027 patient-years, with a mean observation time of 44 months and a range of 6 to 72 months.
Statistical Analysis
Actuarial estimates of morbid events were calculated by the Kaplan-Meier survival analysis method (product limit). Confidence limits of 95% for the survival function were calculated according to the Greenwood formula [7], that is, the incidence of complications for 12 months was determined as the conditional probability of an event. The survival rates of an age- and sex-matched normal population were calculated from Austrian life tables (Österreichisches Statistisches Zentralamt 1989). The Wilcoxon log rank test for equality of survival curves was used to compare the groups.
| Results |
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Sixteen patients died of low cardiac output syndrome, 13 sustained lethal myocardial infarctions, 11 died of sepsis, and in 9 bleeding (including three ventricular ruptures) was the major cause of death. Four patients died of uncontrollable arrhythmias.
Late Deaths
Sixty-four (10.9%) patients died during the follow-up period, most of progressive heart failure, suddenly of unknown causes, or of noncardiac causes (Table 3
). Five years after operation, survival was 85% ± 2% excluding operative mortality and 81% ± 2.2% including operative mortality (Fig 3
). The survival rate of an age- and sex-matched population according to Austrian life-tables was estimated to be 96% after 60 months (Fig 4
). The linearized rate of late deaths after operation was 2.3%/patient-year: 2.3% for aortic valve replacement, 1.4% for mitral valve replacement, and 2.6% for double-valve replacement (Table 4
; Fig 5
). Survival according to valve site, excluding operative mortality, was 87% ± 1.2% for aortic valve replacement, 89% ± 1.2% for mitral valve replacement, and 82% ± 2.7% for double-valve replacement. Thirty-four late deaths were valve-related (1.7%/patient-year.)
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Nonstructural Valve Dysfunction
Twelve patients exhibited evidence of nonstructural valve dysfunction (0.7%/patient-year), leaving 98% ± 0.1% event-free. Among these, 2 patients sustained obstruction of the valve, 1 due to massive tissue overgrowth and 1 due to pannus formation.
Thromboembolism
Thromboembolic events were observed in 32 patients, leaving 92% ± 1.1% event-free (Fig 6
). (The linearized rate is 1.6%/patient year; see Table 4
.) Event-free rates were 94% ± 1.4% (1.4%/patient-year) for aortic valve replacement, 89% ± 2.3% (2.1%/patient-year) for mitral valve replacement, and 95% ± 2.0% (1.1%/patient-year) for double-valve replacement. Four embolic episodes were lethal (two myocardial infarctions and two cerebral infarctions, one of the latter in relation to prosthetic valve endocarditis). Seven embolic episodes resulted in permanent neurologic deficits.
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Anticoagulant-Related Hemorrhage
Sixty-two events of anticoagulation-related hemorrhage were observed in 56 patients with a linearized incidence of 2.8%/patient-year (see Table 4
). Of these, 87% ± 1.2% were event-free after 60 months (see Fig 6
). Nine events were lethal.
Paravalvular Leak
A hemodynamically significant paravalvular leak developed in 7 patients (0.34%/patient-year), leaving 97% ± 0.7% event-free. Five patients underwent reoperation, without operative mortality.
Endocarditis
Prosthetic valve endocarditis developed in 7 patients, leaving 98% ± 0.5% free from this event after 60 months. One patient died of this complication, and 3 underwent reoperation.
Hemolysis
Hemolysis that did not produce clinically significant anemia was found in all patients (Table 5
).
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| Comment |
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The CarboMedics cardiac prosthesis was introduced into clinical use in 1986. Preliminary results were reported by de Luca and associates [10] and Subotic and colleagues [11] in 1990. This report details our experience from 1988 to 1994. The relatively high perioperative mortality (9%) and low 5-year survival rates in our study reflect the inclusion of the previously described high-risk patients, in addition to those in the older age groups and those with severe ischemic heart disease, advanced left ventricular dysfunction, serious preoperative ventricular arrhythmias, and previous cardiac operation.
In a similar, high-risk group of patients, Czer and associates [8] reported an operative mortality of 8.3%, and Hammermeister and colleagues [12] reported an operative mortality of 11%. The leading cause of hospital mortality in our study, as in other series, was perioperative low output syndrome and myocardial infarction [8, 12, 13]. Patients with previous cardiac operations constitute an increasing percentage of all valve operations performed at this institution. In an earlier report describing our experience with the Edwards-Duromedics prosthesis, most reoperations were performed for prosthetic dysfunction. In that report, we reported a reoperation rate of 15% [14]. The incidence of cardiac reoperations in the present series was 27% (see Table 1
).
The most frequent valve-related complication was hemorrhage, which occurred at a rate of 2.8%/patient-year. Nine events (15%) were fatal, and these deaths accounted for 26% of all valve-related deaths (see Table 3
). Thus, warfarin-related hemorrhage has been the major contributor to valve-related morbidity and mortality in our series. Recognizing that anticoagulation regimens based on current available prothrombin assays may lead to excessive anticoagulation, we are considering lowering the upper limit of our target prothrombin time ratio.
Spontaneous fluctuations in the prothrombin time are a well-described occurrence in patients maintained on stable dosages of warfarin [2, 15]. Unfortunately, these fluctuations may cause significant shortfalls or excesses in anticoagulation that, in turn, increase the risk of adverse clinical events such as thrombosis, embolism, or hemorrhage. Butchart and associates [15] have shown the safety of decreasing the warfarin intensity with resultant significantly lower bleeding complications, and minimal, if any, increase in thrombotic problems. They reported 5-year embolism-free rates of 92%, 84%, and 83% for aortic, mitral, and double valves. Although warfarin is considered to be the most effective drug for reducing intravascular thrombogenesis, the primary thrombogenic mechanism starts from the adhesion and aggregation of platelets with endothelium mediated by the von Willebrand factor and fibrinogen [16]. Hayashi and colleagues [17], reporting on their experience with the St. Jude prosthesis, noted an increased survival, lower incidence of cerebrovascular stroke, and better quality of life using a combined warfarin plus antiplatelet therapy. The lower incidence of hemorrhage in this series was probably due to a less intensive warfarin treatment regimen (a Thrombotest level of 10% to 20%, which is equivalent to a prothrombin time international normalized ratio of 1.8 to 2.8) and the use of an antiplatelet agent.
Thromboembolism is one of the major risk factors for patients with prosthetic heart valves, and therefore, it is one of the most specific measures of valve performance. The linearized rate of thromboembolic complications in our series was 1.6%/patient-year or 92% ± 1.1% event-free. This incidence can be favorably compared with 2.0%/patient-year reported by Czer and colleagues for the St. Jude valve [8] and 2.3% ± 0.3%/patient-year by Keenan and associates for the Medtronic Hall valve [18]. Our more successful experience was probably due to the improved hemodynamic design that resulted in a better flow-velocity profile, less turbulence, and a reduction of stagnant areas, all of which are known to affect the thrombogenicity of the prosthesis.
In our study, the 2 patients with valve thromboses had atrial fibrillation, left atrial enlargement, and poor anticoagulant compliance. Both patients were reoperated on successfully.
The fact that the orifice (with the valve leaflets) can be rotated in situ was found to be a distinct advantage; potential interference between the valve leaflets and surrounding tissue could thus be avoided in a technically simple manner. Data published in the available literature [4] have now shown that there are no secondary axial changes and that there will be no secondary interference with the surrounding tissue. Endocarditis, although a significant determinant of fatal valve failure and reoperation, did not significantly influence the likelihood of thromboembolism, valve failure, or late survival.
As for durability, no structural deterioration such as stress fracture or leaflet escape or binding occurred.
As we previously reported [19], echocardiographic examinations of the aortic valves showed mean peak velocity of 2.6 ± 0.4 m/s, and calculated instantaneous peak pressure gradient ranged from 11 to 58 mm Hg (mean, 28.1 ± 10.3 mm Hg). These results presented earlier compare favorably with those of other mechanical valves of similar design [20, 21]. When comparing patients with different valve sizes, peak velocity and pressure gradients are inversely related to annulus diameter. As in all small aortic roots, the pressure gradient increased with diminishing root size. In patients with these small aortic roots, consideration should be given to the use of the supraannular valve to obtain the greatest flow area for the smallest outside diameter. We have previously reported on our favorable experience using the CarboMedics Top Hat valve in these cases [22].
In conclusion, at 5 years of careful follow-up, the CarboMedics bileaflet prosthesis demonstrates no structural deterioration, a low incidence of complications, and good hemodynamic performance. Additionally, it has the features of rotatability and protection against deformity of the valve housing, thus avoiding leaflet escape and binding of the leaflets. The continued use of this valve is recommended.
| Footnotes |
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| References |
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