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Ann Thorac Surg 1998;65:137-143
© 1998 The Society of Thoracic Surgeons
Department of Cardiovascular Surgery, Hospital Universitario Valdecilla, Universidad de Cantabria, Santander, Spain
Accepted for publication August 25, 1997.
Dr Bernal, Cirugía Cardiovascular, Hospital Universitario Valdecilla, 39008-Santander, Spain.
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Abstract |
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Methods. Between January 1989 and March 1994, 1,049 CarboMedics valves were implanted in 859 patients. The rotatability was used in 109 mitral prostheses (21.5%) and in 61 aortic prostheses (11.6%). Follow-up was 97.1% complete, with 3,049 patient-years.
Results. The hospital mortality was 6.9% for the mitral group, 3.4% for the aortic group, and 10.7% for the double-valve group (p < 0.005). The actuarial survival curve at 5 years was 77.3% ± 3.6%, 90.1% ± 2.5%, and 79.2% ± 3.7% (p = 0.0003), freedom from thromboembolism was 89.1% ± 3.6%, 87.1% ± 3.8%, and 68.8% ± 8.2%, freedom from reoperation was 95.9% ± 1.4%, 98.9% ± 0.6%, and 94.9% ± 2.4%, and freedom from valve-related complications was 68.8% ± 4.1%, 79.5% ± 3.5%, and 55.3% ± 5.9% after mitral, aortic, and mitral and aortic valve replacement, respectively. There were five episodes of valve thrombosis, but no structural deterioration occurred.
Conclusions. The clinical performance of the CarboMedics valve is quite satisfactory, with a low incidence of valve-related mortality and morbidity. The rotatability feature was useful when the native valve was preserved or for repeat valve replacement.
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Introduction |
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TopAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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The CarboMedics valve has been our mechanical prosthesis of choice since 1989, when the first valve was implanted in our institution. We were encouraged by the mentioned characteristics, particularly its rotatability in our patient population with a high rate of valve reoperations. Since then, 1,049 prostheses have been implanted in 859 patients with a total follow-up of 3,049 patient-years. The object of the present study is to analyze the clinical experience with this second-generation bileaflet valve.
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Material and Methods |
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TopAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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The cause of valve disease in the primary valve replacement group was predominantly rheumatic heart valve disease. Those 3 patients who had isolated tricuspid, pulmonary, or tricuspid and pulmonary valve replacement were excluded from this study.
From the repeat valve replacement group, 43 patients had a previous open valve repair (14.8%) and 247 a previous valve replacement (85.2%). The causes of valve disease in the AVR, MVR, and DVR groups are shown in Table 1. Preoperative clinical data are summarized in Table 2.
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For mitral valves, sizes 27 and 29 were most common, and for aortic valves, sizes 21 and 23 were most common. The rotation feature of the CarboMedics valve was used in 109 mitral prostheses (21.5%) and in 61 aortic prostheses (11.6%). Orientation of the mitral valve was most commonly in the anatomic position, whereas the orientation of the aortic prosthesis was most commonly transverse with pivots at the midpoint of the noncoronary cusp and in the commissure between the right and left cusps.
In the MVR group, the posterior mitral leaflet was preserved in 84 patients (25.5%), the anterior in 4 (1.2%), and both (transvalvular implantation) in 19 (5.8%). Both leaflets were resected in 172 patients (52.1%), and this information was not reported in 51 instances (15.5%). In the DVR group, the posterior mitral leaflet was preserved in 38 patients (21.5%) and both leaflets were preserved in 3 (1.7%). Nonleaflet preservation or previous valve replacement occurred in 102 patients (57.6%), and leaflet preservation was not reported in 34 patients (19.2%).
Associated cardiac procedures are summarized in Table 3. One hundred twenty-nine patients from the MVR group required an associated cardiac procedure (39.1%).
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Follow-up
The follow-up data were procured over a 6-month period between October 1994 and April 1995. From 802 patients discharged, follow-up was obtained in 779 patients. Those patients were followed up directly in our outpatient clinic, mailed questionnaires, or contacted directly by telephone. The completeness of follow-up during the closing interval was 97.1%. The mean follow-up was 46.2 months, ranging from 12 to 76 months. Cumulative follow-up was 3,049 patient-years.
Statistical Analysis
All valve-related mortality and complication definitions follow the guidelines approved by the Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity [8]. All continuous variables are presented as mean ± standard deviation. Basic methods of univariate analysis included the 
2 and Student’s t test. Actuarial curves were obtained by the life-table method. The Patient Analysis and Tracking System database, version 06.02.03 (Dendrite Clinical Systems, Inc, Portland, OR), was used for collection and analysis of data.
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Results |
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TopAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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Thromboembolism
Thromboembolism occurred in a total of 47 patients. There were 10 peripheral episodes and 37 central nervous system occurrences (21 patients with permanent neurologic impairment and 16 with total recovery). Three patients died due to direct thromboembolic occurrences. The actuarial freedom from thromboembolism at 5 years was 89.1% ± 3.6% for the MVR group, 87.1% ± 3.8% for the AVR group, and 68.8% ± 8.2% for the DVR group, none of which displayed statistical significance. Fig 4 displays the actuarial freedom from thromboembolism and Fig 5
the respective hazard function.
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Reoperation
Twenty-one patients required a valve reoperation. Reoperation was needed in 9 patients from the MVR group, in 4 patients from the AVR group, and in 8 patients from the DVR group. Nonstructural deterioration (paravalvular leak) was the most common cause of reoperation and was found in 10 patients (3 MVR, 2 AVR, and 5 DVR). Reoperation due to valve thrombosis occurred in 5 patients (2 MVR with one death, 1 AVR, and 2 DVR). Three patients with reoperation suffered from early prosthetic valve endocarditis, with one death. Another patient died of prosthetic endocarditis before reoperation. No late prosthetic endocarditis requiring reoperation was observed. In three instances in the MVR group of patients, reoperation was required due to progression of aortic (n = 1) or tricuspid (n = 1) valve disease between 10 and 36 months after the initial procedure. The third patient underwent cardiac transplantation. Of the 21 patients requiring a reoperation, two late deaths occurred, one in the MVR group and one in the DVR group.
Freedom from valve reoperation was 97.1% ± 0.8% at 5 years for the whole series (95.9% ± 1.4% for the MVR group, 98.9% ± 0.6% for the AVR group, and 94.9% ± 2.4% for the DVR group) (Fig 6). The hazard function for reoperation is shown in Fig 7.
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Comment |
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TopAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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In our experience, hospital mortality was 6.3% and was significantly higher in the DVR group (10.7%) as compared with the MVR group (6.96%) and the AVR group (3.4%). This ratio is similar to that reported by Nitter-Hauge and Abdelnoor [13] for the Medtronic-Hall prosthesis. Consequently, the actuarial survival at 5 years is also significantly better for isolated AVR, compared with isolated MVR and DVR. In our study, primary valve replacement produced better results than repeat valve replacement, in terms of mortality and long-term survival. The proportion of repeat valve replacements in the series analyzed, together with other preoperative risk factors, may justify the different results in terms of hospital and late mortality and actuarial survival among patients receiving different types of prostheses. Although no statistically significant differences were found when the mitral valve was totally or partially preserved or completely resected, lower hospital mortality were observed in the group of patients who had mitral valve preservation. Linearized rates are frequently used to describe the occurrence of valve-related complications. According to the "Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations" [8], in those events that do not occur on a constant basis in time, the complications must be analyzed as linearized rates for each study period (the hazard function). The results of the largest published series of patients implanted with the CarboMedics valve were presented in 1994 and 1995 [5][12]. These groups differ in their mean follow-up (16.1 versus 30.2 months). A significant decrease of the linearized rates is observable between them, even with the small difference in follow-up time. The incidence of anticoagulant-related hemorrhage decreased from 2.36%/patient-year in 1994 to 1.51%/patient-year in 1995, for example. The same is true for other incidence rates, that is, valve thrombosis, hemolysis, and reoperation. In our initial experience with the CarboMedics prosthesis [14], we found that valve-related complications were more frequent during the first years of follow-up. Furthermore, as observed in the different hazard functions for thromboembolism, reoperation, and all valve-related complications, the linearized rates for each year of follow-up do not remain constant.
Thromboembolism has been the most frequent valve-related complication in our series, especially in the DVR group. These data contrast significantly with those reported by Smith and associates [15] with the St. Jude prosthesis in a group of 1,184 patients averaging 59 years of age. This group presented actuarial freedom-from-thromboembolism curves at 10 years with values greater than 96% for the three patient groups. The curves reported by Smith and associates are probably similar to those of the human population without prosthetic heart valves. The results of other authors are more logical. Ibrahim and colleagues [16], in a study of 1,184 patients implanted with a St. Jude prosthesis, show actuarial freedom-from-thromboembolism rates of 76% at 13 years for the MVR and DVR groups. These data also correspond to those published by Fernandez and co-workers [17] in a study of 1,200 patients with a St. Jude prosthesis, who had an actuarial freedom-from-thromboembolism curve of 81% at 9 years. Furthermore, the linearized rate of thromboembolism with the St. Jude prosthesis ranges from 0.5%/patient-year, as reported by Smith and co-workers [15], to 6.62%/patient-year, published by Horstkotte and associates [18]. The disparity of the results for the same prosthesis, for example, Smith and associates [15] versus Horstkotte and associates [18], indicates that the specific characteristics of each patient and the method of anticoagulation may play a greater role in thromboembolism than the type of mechanical prosthesis. Anticoagulation-related hemorrhage is closely linked to thromboembolism. As mentioned before [18], those patients maintained at a higher international normalized ratio (3.0 to 4.5) have a greater incidence of anticoagulant-related hemorrhage, whereas the thromboembolism rate is not significantly higher in groups of patients maintained with an international normalized ratio less than 3.0.
In accordance with results reported by Copeland and associates [12], the risks of endocarditis and nonstructural deterioration, such as paravalvular leak, encountered in our series do not appear to be different from those mentioned for other types of prostheses, whether mechanical or biological. Conversely, valve thrombosis requiring emergency reoperation or fibrinolytic treatment is considered to be one of the most serious complications of mechanical prostheses. Although the role of well-managed anticoagulation seems to be essential, some models of mechanical prostheses may be more thrombotic than others. The North American experience with the CarboMedics valve reported 10 cases of thrombosis in 1,228 patients, with a cumulative follow-up of 3,082 patient-years. In all such cases, a level of anticoagulation lower than that recommended was documented. In our experience, only 5 cases of thrombosis were diagnosed in 859 patients with a cumulative follow-up of 3,049 patient-years, also in the presence of lowered levels of anticoagulation. Although Smith and colleagues [15] reported just a single case of thrombosis with a St. Jude prosthesis in 3,075 patient-years, 4 cases of thrombosis with a St. Jude prosthesis were reported by Horstkotte and associates [18] in 4,080 patient-years. Thirty events of thrombosis are discussed in an article by Baudet and colleagues [19] in a series of 1,112 patients. Except for the most optimistic data [15], most of the series of mechanical bileaflet valves present similar results. The study reported by Baudet and colleagues [19] mentioned above is one of the largest series of patients implanted with a St. Jude bileaflet prosthetic valve. With a follow-up of 8,988 patient-years, it showed actuarial curves of freedom from each of the valve-related complications similar to those of our study. Based on published results of mortality, endocarditis, thromboembolism, anticoagulant-related hemorrhage, nonstructural deterioration, and prosthetic thrombosis, we conclude that our outcomes were generally comparable with those reported by other authors for the St. Jude prosthesis.
There are two main differences between the two types of mechanical bileaflet prosthetic valves. Although cases of structural deterioration have been described for the St. Jude prosthesis [20][21][22][23], none have been reported for the CarboMedics prosthesis. However, the worldwide experience with the St. Jude Medical valve is significantly higher and has longer follow-up than with the CarboMedics valve, so a longer experience and follow-up is mandatory to find any significant differences in the behavior of the two bileaflet prosthesis. The largest CarboMedics valve series [5][12], plus ours, have shown a total absence of structural deterioration. In the St. Jude prosthesis, two types of structural deterioration were reported. Leaflet fracture was reported by Orsinelli and colleagues [20], and leaflet dislocation causing leaflet embolization was described on several occasions [21][22][23], both for aortic and mitral prostheses. In contrast to the St. Jude prosthesis, the use of a titanium stiffening ring in the valve housing minimizes the chance for orifice distortion and likely explains the absence of structural deterioration in the CarboMedics prosthesis. Another remarkable difference is valve rotatability, which is absent in the St. Jude prosthesis. In our experiment, the rotatability feature of the CarboMedics valve was used in at least 21.5% of the mitral prostheses and in 11.6% of the aortic prostheses. These data correspond to those reported in the CarboMedics North American experience [12]. The rotation was used in many cases out of the need to improve leaflet mobility or to properly orient them, which was particularly useful when the subvalvular apparatus was totally or partially preserved. This also applied to situations where the valve was used in patients with prior valve replacements. Not everyone agrees on the need for mechanical prostheses to have the rotation feature, but the recent introduction for clinical use of a new prosthesis marketed by St. Jude Medical, Inc (St. Paul, MN), which has a rotation feature, appears to give significant importance to this feature.
The midterm results with the CarboMedics mechanical valve prostheses are similar to those reported by most authors for other bileaflet prostheses, in terms of hospital and late mortality and other valve-related complications, which are frequently due more to the patient than the prosthesis itself. The rate of valve thrombosis is low and always related to inadequate anticoagulation. The great advantages of this second-generation, bileaflet, mechanical valve over its predecessor are the total absence of structural deterioration and, in our opinion, the rotation feature, which is very useful when a decision is made to preserve the mitral leaflets or when a previous prosthesis is explanted.
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References |
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TopAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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