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Ann Thorac Surg 2000;69:1167-1172
© 2000 The Society of Thoracic Surgeons
a Department of Cardiothoracic Surgery, Christian Medical College Hospital, Vellore, India
b Department of Cardiothoracic Surgery, Manipal Heart Foundation, Bangalore, India
Address reprint requests to Dr John, Yellamma Dasappa Hospital, 25 Andree Rd, Bangalore 560 027, India
| Abstract |
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Methods. Between 1973 and 1997, 456 patients underwent combined mitral and aortic valve replacement. In light of our favorable earlier experience the Starr-Edwards ball valve prostheses were implanted in 90% and 72.8% of mitral and aortic positions, respectively. Follow-up ranged from 1 to 24 years with a median of 8.5 years.
Results. The 30-day hospital death rate was 9.2% and late death occurred in 10.1%. A low-intensity anticoagulant regimen was followed to maintain the target prothrombin time at 1.5 times the control value. The actuarial survival at 5, 10, 20, and 24 years was 90.4%, 85.6%, 84.4%, and 82.4% per year, respectively.
Conclusions. In view of the acknowledged advantage of superior durability, increased thromboresistance in our patient population, and its cost effectiveness the Starr-Edwards ball valve is the mechanical prosthesis of choice for advanced combined valvular disease. The low-intensity anticoagulant regimen has offered sufficient protection against thromboembolism as well as hemorrhage.
| Introduction |
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| Material and methods |
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Operative technique
Most patients were operated on by the same surgeon (S.J.) or his immediate associates. Cardiopulmonary bypass was accomplished utilizing a membrane oxygenator. The bubble oxygenator was utilized early in our experience. Moderate systemic hypothermia to decrease noncoronary collateral return was employed routinely. Myocardial protection was offered by instillation of cold crystalloid cardioplegia given through the coronary ostia using modified St. Thomas Hospital solution that was repeated every 20 to 25 minutes. Improved protection of the ventricles was provided by the use of topical hypothermia with saline at 4°C or ice slush. The 2M (28 mm) (model 6120) mitral SE prostheses and the 1M and 3M in decreasing frequency were implanted in 90% of patients after excision of the mitral valve. In the remaining 10% a low-profile tilting disc valve such as Björk-Shiley or Medtronic valve was utilized. The mitral valve was replaced first, nevertheless the aortic valve was excised as the first step through the aortotomy. After excision of the aortic valve a 9A (23mm), 8A, or 10A in decreasing frequency was implanted in 72.8% of patients. The remainder and those in particular with a narrow aortic root had a low-profile tilting disc valve prosthesis such as a monostrut Björk-Shiley or Medtronic-Hall valve inserted. The method invariably employed for both mitral and aortic valve implants used interrupted horizontal mattress sutures with Teflon pledgets. The SE prosthesis is the least expensive of all the valves available in our country and the one most often used in our institution for several years. In those patients with dominant tricuspid incompetence a lateral annuloplasty described by Kay and colleagues [7] and later by Boyd and colleagues [8] was utilized as the preferred technique. In this maneuver we obliterated the posterior leaflet converting the trileaflet valve to a bileaflet structure. In patients with dominant tricuspid stenosis we carried out an incisional commissurotomy with concomitant De Vegas [9] annuloplasty. In 3 patients with adverse changes that precluded a repair procedure valve replacement was accomplished.
Postoperative management
Low molecular weight dextran was used in the early postoperative period as this is known to decrease platelet adhesiveness and capillary sludging. Judicious use of inotropic agents provided further therapeutic support. Volume-controlled ventilatory assistance for 24 to 48 hours was mandatory for those patients with severe pulmonary hypertension or pronounced cardiomegaly. Anticoagulation was initiated with Coumadin (DuPont Pharmaceuticals, Wilmington, DE) or a Coumadin derivative (such as Acitrom or Sintrom) after the chest tubes were removed. A low-intensity anticoagulant regimen was followed thereafter to maintain the target prothrombin time at 1.5 times the control value.
Follow-up
In a developing country such as ours, where recognition of the need for information is a powerful asset in patient care, we spend time relating to three facets in the follow-up of patients: (1) instilling insight into the problem of chemoprophylaxis in preventing recurrent attacks of rheumatic fever (penicillin injections once every 3 weeks remain necessary until the age of 45 years); (2) advice regarding awareness about prevention of bacterial endocarditis particularly in relation to dental problems; and (3) education and counseling regarding low-intensity anticoagulation and the necessity for meticulous attention to its control. Follow-up was achieved by yearly outpatient clinic visits, mailed questionnaires, contact with the referring physicians, and use of social workers for direct patient contact. The completeness of follow-up was 85.7%; 14.3% of patients were lost to follow-up. Follow-up ranged from 1 to 24 years (median, 8.5 years). The total cumulative follow-up was 3,302.7 patient-years.
Statistical analysis
All valve-related morbidity and complication definitions follow the guidelines proposed by the ad hoc Liaison Committee for standardizing definitions of prosthetic valve morbidity [10]. All continuous variables are presented as mean ± standard deviation. Univariate analysis was performed by the
2 test. Actuarial curves were computed by the life-table method. Events were defined as death, valve-related complications. Linearized event rates were calculated from the number of events divided by the patient-years of follow-up. All statistical analyses were performed using SPSS statistical software.
| Results |
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Thromboembolism
Thromboembolism occurred in 35 patients for a linearized rate of 1.05/100 patient-years. Only 1 patient died from valvular thrombosis of an aortic SE prosthesis 5 years after surgery. An autopsy confirmed our diagnosis. Twenty-four patients had thromboembolic complications with minimal residual neurologic deficit. The other 10 patients had minor thromboembolic episodes with total recovery.
Anticoagulant-related hemorrhage
Two patients died of major bleed at varying periods of follow-up and 2 died in the postoperative period for a linearized rate of 0.12/100 patient-years. Nonfatal bleeding events occurred in 3 patients for a linearized rate of 0.09/100 patient-years. These included a gastric bleed in 1 patient and retroperitoneal hemorrhage in 2 patients.
Prosthetic valve endocarditis occurred in 10 patients for a linearized rate of 0.30/100 patient-years. Two patients died in the postoperative period and 3 patients in the late follow-up. Two of them underwent surgical procedures: 1 for re-replacement of an aortic prosthesis and 1 had a mitral prosthesis re-replaced. The latter patient remains well after operation. Four patients with gram-negative endocarditis were treated with appropriate long-term antibiotics and are in NYHA class I status at the end of our study period.
Figure 2 shows the actuarial freedom from all valve-related complications depicting an event-free survival of 88.2, 81.7, 80.0, and 78.8 per 100 patient-years at 5, 10, 20, and 24 years, respectively.
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| Comment |
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Our hospital mortality of 9.2% compares favorably with other reported series. Bernal and colleagues [16] from Spain reported a mortality of 10.7% after double valve replacement using the Carbomedics valve. Brown and coworkers [11] from the NHLBI cited an in-hospital mortality of 14%. Bortolotti and associates [17] cited hospital mortality of 19% in 221 patients having a dual mechanical prosthesis. This review identified the association of pulmonary hypertension as a strong predictor of both morbidity and mortality. The operative mortality was high (38.1%) in those patients with severe pulmonary hypertension (> 60 mm Hg). All patients in the subset with severe pulmonary hypertension and a high operative mortality belonged to NYHA class IV. Galloway and colleagues [18] in a large series of patients indicated that the operative mortality rose from 5.6% for those in whom the pulmonary artery systolic pressure was less than 60 mm Hg to a striking figure of 38.5% for those in whom the pulmonary hypertension was more than 60 mm Hg. In this review tricuspid incompetence was present in 90 patients (19.3%) and it was noteworthy that dominant tricuspid stenosis was evident in 23 patients (5%). We followed an aggressive policy on these patients with tricuspid valve disease, performing annuloplasty and commissurotomy with concomitant annuloplasty if indicated. Kays or De Vegas annuloplasty is the method of choice in our experience. Grover and associates [1] also have identified the association of tricuspid valve disease as a strong predictor of morbidity and mortality in their analysis.
In terms of certain other technical considerations, we have routinely excised the posterior mitral leaflet in addition to the anterior. However, we concur with Lillehei [19] that the preservation of this leaflet together with its chordopapillary attachment may be beneficial both early and in the long term. We have not looked into relevant echocardiographic data to indicate any detrimental changes in left ventricular function after mitral valve excision. In this series none had a bileaflet valve prosthesis implanted in either the mitral or the aortic position.
The low occurrence of thromboembolic episodes in our patient population with the use of the SE valve prosthesis is noteworthy and has been shown clearly in our earlier reports [35]. In a 20-year review [4] of valve replacement in patients less than 20 years of age, we recorded a thromboembolic event rate of 1.04/100 patient-years after MAVR. Another report from India [20] using the Björk-Shiley low-profile valve in young subjects cited a similar thromboembolic event occurrence.
In a 25-year experience with 1,129 isolated SE mitral valve replacements reported from our center in 1996 [21], the incidence of thromboembolic event and anticoagulant-related hemorrhage was 0.5 and 0.31/100 patient-years, respectively. We adhered to a low-intensity anticoagulant regimen in which the target prothrombin time is maintained at 1.5 times the control value and thus this regimen is optimized to offer sufficient protection against thromboembolism on the one hand and bleeding on the other. The concept of international normalized ratio (INR) is not implemented in all centers in our country. When and where available we opt to maintain the INR at 2.65. In our quarter-century experience with SE mitral valve replacement published in 1996 [21] we were explicit in describing the low incidence of thromboembolic events and anticoagulant-related bleeding. Earlier reviews in 1983 [3] and 1990 [4] had alluded to similar observations and conclusions. The results with aortic valve replacement reported in 1986 [5] utilizing the SE prosthesis in 76.6% of 261 subjects cited a low incidence of thromboembolism of 1.6/100 patient-years in a 12-year follow-up.
Furthermore, the low incidence of thromboembolic events is presumably related to factors such as inherent difference in coagulable states [3] and competence of the individual managing the patients anticoagulation. A modest degree of education and counseling to the patient has paid off in the follow-up. The importance of meticulous attention to anticoagulant therapy cannot be overemphasized. The linearized occurrence of thromboembolic events in this review was 1.05/100 patient-years and anticoagulant-related hemorrhage occurred at a linearized rate of 0.21/100 patient-years. Ten patients on the low-intensity anticoagulant regime carried their pregnancy to term and bore normal children. The oral anticoagulant therapy was substituted with subcutaneous heparin 5,000 units twice daily during the last trimester. Warfarin embryopathy and intracerebral hemorrhage in the newborn were not encountered in our experience. Our protocol for anticoagulation during pregnancy has been addressed in our earlier publications [3, 4]. Salazar and colleagues [22] emphasized that women with cardiac valve prostheses should be counseled against pregnancy.
In this review our data pertaining to thromboembolism and anticoagulant-related hemorrhage have emphasized and reinforced the importance of our patient population in the interpretation of the results as our series was not typical of the Western world. Thromboembolism occurred at a linearized rate of 2.3% per year as reported by Corcos and colleagues [12] with SE double valve replacement. Furthermore, it seems pertinent to mention here that the freedom from combined thromboembolism and anticoagulant-related hemorrhage at 15 years was only 40% as cited by Brown and associates [11] from the NHLBI using the SE prosthesis. The striking variability in the results using the same prosthetic devices is also known to occur from the experience of other centers. Armenti and colleagues [23] cited an actuarial survival of only 76% and 62% at 3 and 5 years, respectively, using the St. Jude Medical prostheses, and their experience was at variance from that of Brown and associates [11], whose results were most favorable with this combination.
There was no instance of paravalvar leak in the present review. We believe strongly that interrupted horizontal mattress sutures with Teflon pledgets are a sine qua non in its prevention. However, let us remind ourselves of the maxim, "It is not what you do, but how you do it." In 1986 Sethia and coworkers [24] reported on a 14-year experience with the Björk-Shiley prosthetic replacement, noting a high incidence of paravalvar leak (2% per year) and suggesting along with other experts [25] that horizontal mattress sutures provide better valve stability and may eliminate this adverse valve-related complication. In 1991 Bortolotti and colleagues [17] noted 7 patients with paravalvar leak for an incidence of 0.67% ± 0.2% among a group of 221 subjects who underwent double valve replacement with dual mechanical prostheses.
This review has clearly demonstrated excellent symptomatic improvement and late survival after simultaneous MAVR in patients with advanced rheumatic valvular disease. Furthermore, in view of the remarkable long-term durability of the SE valve, the superior thromboresistance, and its affordability in our patient population, it may be the mechanical device of choice in the rehabilitation of patients with seemingly malignant rheumatic valvulopathy.
| Acknowledgments |
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| References |
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