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Ann Thorac Surg 2005;79:784-789
© 2005 The Society of Thoracic Surgeons

Original article: Cardiovascular

A 10-Year Experience With the Carbomedics Cardiac Prosthesis

Ryuji Tominaga, MD*, Kazuhiro Kurisu, MD, Yoshie Ochiai, MD, Yukihiro Tomita, MD, Munetaka Masuda, MD, Shigeki Morita, MD, Hisataka Yasui, MD

Department of Cardiovascular Surgery, Kyushu University, Fukuoka, Japan

Accepted for publication August 30, 2004.

* Address reprint requests to Dr Tominaga, Department of Cardiovascular Surgery, National Hospital Organization, Kyushu Medical Center, 1–8–1 Jigyouhama, Chuou-ku, Fukuoka 810–8563, Japan (E-mail: tominga21{at}jcom.home.ne.jp).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 References
 
BACKGROUND: There are few reports on the long-term results of Carbomedics prosthetic heart valves.

METHODS: Five hundred five patients who underwent valve replacement with this prosthesis in the aortic or mitral position were chosen for this study. Patients' mean age was 57 years. There were 173 aortic (AVR), 253 mitral (MVR), and 79 double (DVR) valve implants. The mean follow-up was 5.1 years, and cumulative follow-up was 2,590 patient-years with an overall follow-up rate of 99.2%.

RESULTS: The early mortality rate for the total population was 2.8% (AVR 1.2%, MVR 3.6%, DVR 3.8%). Actuarial freedom from thromboembolism at 10 years was 81.8% ± 5.1%, 85.7% ± 3.2%, and 88.8% ± 6.8% for AVR, MVR, and DVR, respectively. At 10 years, 92.7% of AVR, 85.4% of MVR, and 94.7% of DVR patients were free of valve-related death. Overall survival rate at 10 years was 77.6% ± 4.6%, 71.8% ± 4.2%, and 81.3% ± 5.8% for AVR, MVR, and DVR, respectively. The linearized rate of thromboembolism was 1.45%/patient-year, 1.78%/patient-year, 0.67%/patient-year; of major bleeding events, 0.52%/patient-year, 0.85%/patient-year, 0.45%/patient-year; of valve thrombosis, 0%/patient-year, 0.25%/patient-year, 0%/patient-year; of prosthetic valve endocarditis, 0.1%/patient-year, 0.25%/patient-year, 0.22%/patient-year; and of all reoperations, 0.31%/patient-year, 0.93%/patient-year, 1.1%/patient-year for AVR, MVR, and DVR, respectively.

CONCLUSIONS: The Carbomedics prosthetic heart valves showed comparable or even better results than those of other mechanical valves with respect to morbidity and mortality. These results may justify the use of Carbomedics valves as one of the mechanical heart valves.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 References
 
The Carbomedics heart valve (Carbomedics, Inc, Austin, TX) was developed in 1986 as a second-generation bileaflet heart valve. It was intended to further improve the hemodynamic function and thromboresistance of bileaflet valves by changing the hinge mechanism. Biolite carbon was also used to cover blood-contacting surfaces on the sewing ring to reduce tissue overgrowth. These favorable characteristics have led the surgeons in our institution to select this valve for more than 10 years. The purpose of this study is to verify whether our decision-making regarding prosthetic valve selection was appropriate.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 References
 
From May 1, 1990, through August 2000, 538 patients underwent valve replacement with this prosthesis. Preoperative cardiac catheterization and coronary angiogram were performed in all cases. Thirty-five patients were diagnosed as having significant coronary artery disease. Thirteen patients who underwent tricuspid valve replacement and 20 double valve replacement (DVR) patients who underwent aortic valve replacement (AVR) with a St. Jude Medical-High Performance valve (St. Jude Medical, Inc, St. Paul, MN) were excluded from this study. Therefore, 505 patients (AVR 173, mitral valve replacement [MVR] 253, DVR 79) were included in this study. Patient age ranged from 19 to 79 years, with a mean age of 57 years. There were 268 males and 237 females. One hundred eighty-three patients (36.2%) had previous cardiac operations including 124 patients with heart valve replacement. Concomitant operations were tricuspid annuloplasty in 193 patients (by Kay's method in 90 and DeVegas's method in 103), coronary artery bypass grafting in 35 patients, aortic root replacement in 17 patients, and arch replacement in 1 patient. Two hundred fifty-two valves were implanted in the aortic position, and 332, in the mitral position. The distribution of implanted valve sizes is shown in Table 1. Preoperatively 49 patients were classified in class I, 273 in class II, 134 in class III, and 49 in class IV by New York Heart Association functional classification. Of the 173 AVR patients, aortic regurgitation (AR) was dominant in 112, aortic stenosis (AS) in 40, and both AR and AS were present in 21patients. For MVR patients, mitral regurgitation (MR) was dominant in 152, mitral stenosis (MS) in 65, and both MR and MS were present in 36 patients. For DVR, AR was the main cause of operation in 56 cases, AS in 5, AS and AR in 18, MR in 42, MS in 20, and MS and MR in 17 patients. Preoperatively, 9.8% of AVR patients, 70.8% of MVR patients, and 71.0% of DVR patients had atrial fibrillation.


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  		Table 1. Distribution of Implant Sizes by Valve Position
 
Operative techniques included a standard cardiopulmonary bypass with a membrane oxygenator and moderate hypothermia (29° to 30°C rectal temperature). Cold crystalloid cardioplegia with ice slush topical cooling was used for myocardial protection. Principally, prostheses were inserted using everting mattress sutures with 2-0 braided polyester sutures reinforced with polytetrafluoroethylene (Teflon) felt pledgets. Aortic valve replacement for patients with small aortic annulus was performed using horizontal mattress or single-suture technique. An aortic annular enlargement, if necessary, was performed with a modified Manouguian technique [1]. Prosthetic valves were placed in the antianatomic direction in the mitral position and in parallel to the sagittal plane in the aortic position. Five thousand units of heparin calcium was administered subcutaneously every 12 hours from the first postoperative day and continued until the Thrombotest reached a therapeutic range by using warfarin. Thrombotest or the prothrombin time was checked at least every 4 weeks and kept between 10% and 20% (1.8 to 2.8 international normalized ratio [INR]) in MVR patients and 15% to 25% (1.6 to 2.1 INR) in AVR patients. Antiplatelet drug (aspirin 80 mg/d or ticlopidine 100 mg/d) was used for patients who had atrial fibrillation, history of thromboembolism, or cardiomegaly with enlarged left atrium. Thus, almost all MVR patients received antiplatelet drugs. The anticoagulation regimen was not changed during the study period.

Postoperative follow-up was performed by contacting patients or their referring physicians and by written questionnaire through mailing or telephone. Four patients could not be contacted (follow-up rate, 99.2%). The mean follow-up was 5.1 ± 3.1 years, and the cumulative follow-up was 2,590 patient-years. Follow-up for AVR was 965 patient-years, MVR follow-up was 1,180 patient-years, and DVR follow-up was 446 patient-years.

Hospital and late deaths, as well as valve-related events, were strictly defined according to the published guidelines of The Society of Thoracic Surgeons [2]. All data including New York Heart Association classification were obtained between August 1, 2000, and September 30, 2000.

Actuarial estimates of survivals and event-free curves for the incidence of thromboembolic events, valve thrombosis, anticoagulant-related bleeding, and reoperation, as well as for all valve-related deaths and all valve-related morbidity and mortality, were calculated with the actuarial life table method and reported with 95% confidence limits. Late valve-related events were expressed in linearized form (percent per patient-year). Estimates were reported plus or minus the standard error of the estimates. Comparisons of these estimates were performed with the {chi}2 test or the log rank test. Values of p less than 0.05 were considered significant.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 References
 
Early Mortality
The hospital mortality rate for the total population was 2.8%. The mortality rates were 1.2% for AVR, 3.6% for MVR, and 3.8% for DVR. The main causes of hospital death were low cardiac output syndrome and multiple organ failure; these account for 86% of all early deaths. In no instances could the cause of death be related to malfunction of the valvular prosthesis.

Late Mortality
There were 66 late deaths, with a significantly (p < 0.01, {chi}2 test) higher rate of cardiac and valve-related deaths in MVR than in AVR or DVR patients (Table 2). Causes of late mortality are shown in Table 3. Sudden or unexplained deaths constituted 52% of valve-related deaths. In all of these patients, the family did not allow an autopsy. Late deaths as a result of anticoagulation-related complications including thromboembolism, thrombosed valve, and bleeding were observed mainly in MVR patients. Major causes of non–valve-related deaths were cancer and congestive heart failure. No patients died because of structural valve dysfunction. The actuarial survival rates for valve-related deaths including hospital deaths at 10 years were 92.7% ± 2.8% in AVR, 85.4% ± 2.9% in MVR, and 94.7% ± 2.6% in DVR patients. Log rank test revealed a significantly (p < 0.05) lower survival rate in the MVR group. Overall survival including hospital deaths at 10 years was 77.6% ± 4.6%, 71.8% ± 4.2%, and 81.3% ± 5.8% for AVR, MVR, and DVR, respectively (Figs 1, 2).


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  		Table 2. Early and Late Operative Results
 

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  		Table 3. Causes of Late Deaths
 


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  		Fig 1. Actuarial freedom from valve-related deaths including hospital deaths after aortic valve replacement (AVR), mitral valve replacement (MVR), and double valve replacement (DVR).

 


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  		Fig 2. Actuarial survival of all patients including hospital mortality after aortic valve replacement (AVR), mitral valve replacement (MVR), and double valve replacement (DVR).

 
Late Valve-Related Morbidity
THROMBOSIS AND THROMBOEMBOLISM
Thrombosed valves were found in 3 patients who underwent MVR. Two of 3 patients emergently underwent repeat replacement of the valve and survived. Thromboembolic complications occurred in 38 patients, of whom 4 patients died. Fourteen of those 38 patients exhibited signs of a transient ischemic attack without remaining significant neurologic defect (Table 4). The actuarial freedom from thromboembolism including thrombosed valve at 10 years was 81.8% ± 5.1%, 85.7% ± 3.2%, and 88.8% ± 6.8% for AVR, MVR, and DVR patients, respectively. During the first 5 years after the operation, a significantly higher (log rank, p < 0.05) percentage of patients were free from thromboembolism in the AVR group compared with the MVR group. However, thromboembolism in the AVR group increased in frequency after that and became similar to that in the MVR group at 10 years after the operation (Fig 3). The linearized rate of thromboembolism was 1.45%/patient-year, 1.78%/patient-year, and 0.67%/patient-year for AVR, MVR, and DVR group, respectively (Table 4).


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  		Table 4. Linearized Rates of Morbid Events
 


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  		Fig 3. Actuarial freedom from thromboembolism including transient ischemic attacks after aortic valve replacement (AVR), mitral valve replacement (MVR), and double valve replacement (DVR).

 
ANTICOAGULATION-RELATED MAJOR BLEEDING EVENTS
There were 17 (5 in AVR, 10 in MVR, and 2 in DVR group) anticoagulation-related bleeding events, yielding a linearized rate of 0.52%/patient-year, 0.85%/patient-year, and 0.45%/patient-year for AVR, MVR, and DVR, respectively (Table 4). Seven events were fatal, and 6 of them were cerebral bleeding. The others were mainly gastrointestinal tract bleeding. The percent freedom from major bleeding events at 10 years was 96.4% ± 1.6%, 94.3% ± 1.8%, and 94.8% ± 3.6% for AVR, MVR, and DVR, respectively (Fig 4).



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  		Fig 4. Actuarial freedom from anticoagulation-related hemorrhage after aortic valve replacement (AVR), mitral valve replacement (MVR), and double valve replacement (DVR).

 
PROSTHETIC VALVE ENDOCARDITIS
There were five cases of prosthetic valve endocarditis, one in the AVR group, three in the MVR group, and one in the DVR group. Repeat replacement of infected valves was undertaken successfully during the active phase in 3 patients, and medical treatment was provided to the other patients. There were no fatal events. The percent freedom from prosthetic valve endocarditis at 10 years was 99.3% ± 0.7%, 96.9% ± 1.9%, and 98.6% ± 1.4% for AVR, MVR, and DVR, respectively.

STRUCTURAL VALVE DETERIORATION
There was no incidence of mechanical failure of the leaflet or of the valve housing.

NONSTRUCTURAL VALVE DETERIORATION
There were 12 reoperations for hemolysis as a result of noninfectious perivalvular leakage: 1 for AVR, 7 for MVR, and 4 for DVR (all in the mitral position) group. One patient underwent mitral valve fixation, and the others underwent repeat replacement of the valves successfully. In 1 patient, pannus formation around the mitral prosthesis caused a cardiogenic shock, and the patient was emergently reoperated on with success. The linearized rate of nonstructural valve deterioration was 0.1%/patient-year, 0.59%/patient-year, and 0.9%/patient-year for AVR, MVR, and DVR, respectively (Table 4).

REOPERATION
Nineteen patients required reoperation. Twelve of those reoperations were owing to perivalvular leakage, 10 of which were redo mitral cases. Two were caused by thrombosed valves. Prosthetic valve endocarditis occurred in 3 patients and pannus formed in 1 patient. In a patient who developed aortic root dissection, the aortic valve was replaced again with a composite graft. All reoperations were performed successfully. The linearized rate of reoperations was 0.31%/patient-year, 0.93%/patient-year, and 1.1%/patient-year for AVR, MVR, and DVR, respectively. The percent freedom from reoperations at 10 years was 97.8% ± 1.3%, 94.4% ± 1.8%, and 92.2% ± 3.4% for AVR, MVR, and DVR, respectively (Fig 5).



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  		Fig 5. Actuarial freedom from reoperation after aortic valve replacement (AVR), mitral valve replacement (MVR), and double valve replacement (DVR).

 
ALL VALVE-RELATED COMPLICATIONS
The percent freedoms from all valve-related events were 57.9% ± 5.6%, 54.1% ± 4.4%, and 61.1% ± 7.6% at 10 years' follow-up in the AVR, MVR, and DVR groups, respectively (Fig 6). A significantly lower (log rank test, p < 0.05) percent freedom rate in the MVR group compared with that in the AVR group was observed. Postoperatively 81% of patients were classified in New York Heart Association class I or II.



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  		Fig 6. Actuarial freedom from all valve-related events after aortic valve replacement (AVR), mitral valve replacement (MVR), and double valve replacement (DVR).

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
References
 
The early mortality rate of 2.8% (1.2% for AVR, 3.6% for MVR, 3.8% for DVR) in our patient cohort is similar to or even better than the previous data on other mechanical valves: St. Jude Medical reports (3.4% to 6.8%) [3–11], Medtronic Hall valve (Medtronic, Inc, Minneapolis, MN) reports (5.0% to 7.9%) [12, 13], and Carbomedics heart valve reports (1.2% to 7.7%) [5, 14–18].

Late mortalities in terms of actuarial overall survival rates at 10 years of the current study (77.6%, 71.8%, and 81.3% in AVR, MVR, and DVR patients, respectively) are also comparable with those of St. Jude Medical valve reports (42.0% to 81.1%, 43.0% to 80.0%, and 43.0% to 89.9% in AVR, MVR, and DVR patients, respectively) [3, 6, 9–11] and Medtronic Hall reports [12, 13, 19].

The percent freedoms from valve-related death at 10 years of the current study (92.7%, 85.4%, and 94.7% in AVR, MVR, and DVR patients, respectively) also exhibit similar results: St. Jude Medical reports (66.2% to 91.0%, 84.0% to 90.5%, and 84.0% to 84.1% in AVR, MVR, and DVR patients, respectively) [6, 9–11].

Late morbidity including thromboembolism, anticoagulation-related hemorrhage, prosthetic valve endocarditis, and structural or nonstructural valve dysfunction were also comparable with those of other reports [4–18]. The linearized rate of thromboembolism of 1.45%/patient-year in AVR patients seems to be high, but it is still within the range of the previous data (0.6%/patient-year to 3.1%/patient-year) [3–18] and less than the US Food and Drug Administration objective performance criteria [20, 21]. The 0.25 linearized rate of mitral valve thrombosis of the current study is high compared with those of other mechanical valves [3, 4, 8, 10, 12, 13]. Even though the differences are small, the data of Carbomedics valves from other countries [14, 15, 22, 23] also showed high mitral valve thrombosis rates. Several factors including anticoagulation protocol, the direction of valve positioning (anatomic or antianatomic), incomplete opening or closing of the valve leaflet because of interference of remnant chordae or other tissue, pannus formation, and the prosthetic valve itself induce valve thrombosis. Inasmuch as several institutes from various countries experienced mitral valve thrombosis with similar frequency, the Carbomedics valve itself may have some problems. Further study is mandatory.

The target INR levels in this study (1.6 to 2.1 for AVR and 1.8 to 2.8 for MVR) are lower than those in reports from Europe and the United States [3, 5, 7–15, 17–19], but almost the same as those of other hospitals in Japan [4, 6, 16]. From our clinical experiences, we recognize that when the INR level increases to more than 2.8, gastrointestinal tract bleeding or bleeding from other organs frequently occurs in Japanese patients. Our target INR levels are standard in Japan.

The unexpected result of this study is that the thromboembolic complication rate in AVR patients increased gradually after 5 years postoperatively. Even though nearly one third of the events were transient ischemic attacks of the brain, this tendency may have some relevance. Thromboembolic events after prosthetic valve replacement are determined largely by conditions that promote relative stagnation in the left atrium, which is caused by atrial fibrillation, dilated left atrial size, residual mitral pressure gradient, and impaired left ventricle. As these phenomena frequently occur in MVR patients, we determined that the target INR level for MVR patients should be kept at a lower level than that for AVR patients (MVR INR, 1.8 to 2.8; AVR INR, 1.6 to 2.1), similar to previous reports [7, 10, 11, 19]. These strategies for postoperative patient care may induce a higher rate of thromboembolism in AVR patients. The target INR for AVR patients should probably be set at the same level as for MVR. Use of additional antiplatelet drugs, for which efficacy and safety results are still controversial [24–26], should be also considered to reduce thromboembolic events. Butchart and associates [27] reported that unstable INRs after valve replacement related significantly to the occurrence of thromboembolism. In an actual clinical setting, it is difficult to keep optimal anticoagulation state with only warfarin for a long time. This is probably because of the fact that the effect of warfarin can be easily affected with food, other drugs, or the general condition of the patient. Antiplatelet drugs can probably compensate for the shortage of warfarin because of their long-acting characteristics.

In this study, follow-up was not performed every year but just one time at the end of the follow-up period; therefore, the current data may underestimate the true incidence of adverse events. Furthermore, 52% of late deaths were sudden or unwitnessed, and therefore, it is unclear whether these deaths are valve-related or not. When these deaths were not related to the implanted prosthetic valve, valve-related death might be overestimated, because the sudden deaths were calculated as valve-related deaths. However, when these deaths were valve-related, complication rates of thromboembolism, thrombosis, or bleeding might be underestimated. In the current study, if all sudden deaths were related to thromboembolism, linearized rates of thromboembolism would increase from 1.45%/patient-year to 1.87%/patient-year in the AVR group and from 1.78%/patient-year to 2.46%/patient-year in the MVR group. It is important to determine the exact causes of deaths by performing an autopsy, which is, however, still difficult in Japan because of religious reasons.

In conclusion, the results of the current study may justify the use of Carbomedics valves as one of the mechanical heart valves because of its excellent early and long-term operative results.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

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Ryuji Tominaga
Yoshie Ochiai
Yukihiro Tomita
Munetaka Masuda
Shigeki Morita
Hisataka Yasui
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