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Ann Thorac Surg 2004;77:913-917
© 2004 The Society of Thoracic Surgeons

Original article: cardiovascular

Late results after mitral valve replacement with bileaflet mechanical prosthesis in children: evaluation of prosthesis-patient mismatch

Munetaka Masuda, MDa*, Hideaki Kado, MDb, Hideki Tatewaki, MDa, Yuichiro Shiokawa, MDb, Hisataka Yasui, MDa

a Department of Cardiovascular Surgery, Kyushu University Hospital, Fukuoka, Japan
b Department of Cardiovascular Surgery, Fukuoka Children's Hospital, Fukuoka, Japan

Accepted for publication September 8, 2003.

* Address reprint requests to Dr Masuda, Department of Cardiovascular Surgery, Kyushu University Hospital, Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
e-mail: masudam{at}heart.med.kyushu-u.ac.jp


   Abstract
Top
 Abstract
Introduction
 Patients and methods
 Results
 Comment
 References
 
BACKGROUND: Mechanical prosthesis is the choice of valve at the mitral position in children, although re-replacement of prostheses because of prosthesis-patient mismatch is almost inevitable when prostheses were implanted in small children. The methods to predict prosthesis-patient mismatch as a result of patients' somatic growth or pannus formation in children by noninvasive methods have not been well established.

METHODS: Thirty-two children underwent mitral valve replacement with 37 bileaflet mechanical prostheses (26 St. Jude Medical prosthetic valves, and 11 CarboMedics prosthetic valves) and were followed up a mean of 6.8 years (maximum 18.3 years) with a complete follow-up rate of 94%.

RESULTS: There were no operative deaths and 5 late deaths. Re-replacement of mitral valve because of prosthesis-patient mismatch was required in 5 patients. Freedom from valve-related events and re-replacement of mitral valve at 15 years were 32% ± 23% and 54% ± 18%, respectively. Actuarial survival rate was 63% ± 19% at 15 years. Prosthetic valve orifice area index (manufactured geometric prosthetic valve area divided by patient's body surface area) was well correlated with maximum transprosthesis flow velocity estimated by Doppler echocardiography during follow-up, whereas valve orifice area index had no significant correlation with pulmonary artery wedge pressure assessed by cardiac catheterization. Maximum transprosthesis flow velocity had a significant correlation with pulmonary artery wedge pressure.

CONCLUSIONS: Valve orifice area index itself was not a reliable index to predict prosthesis-patient mismatch. Maximum transprosthesis flow velocity was a useful index to predict pulmonary artery wedge. Invasive cardiac catheterization to determine re-replacement of the prosthesis should be considered when maximum transprosthesis flow velocity exceeds 270 cm/s.


   Introduction
Top
 Abstract
 Introduction
Patients and methods
 Results
 Comment
 References
 
Although numerous reconstructive measures of mitral valve have been reported to avoid valve replacement in young children [1–6], reparative procedure is not always feasible in congenitally malformed mitral valve. Mechanical prosthesis is the choice of valve replacement at the mitral position in children because durability of biologic prostheses in children is known to be worse when compared with that in adults [7]. Mitral valve replacement in small children has more difficulties when compared with that in adults, not only at the time of implantation but also throughout follow-up management. Anticoagulation regimen in small children is considered cumbersome and troublesome [8–11]. Re-replacement of prostheses because of somatic growth of the patients is almost inevitable when prostheses were implanted in small children.

Precise predictive method of prosthesis-patient mismatch along with somatic growth of the patient with or without pannus formation of the prosthesis has not been well established. Indication of re-replacement of prosthesis is usually determined by cardiac catheterization data combined with signs of heart failure. However, frequent application of invasive cardiac catheterization is unfavorable to children. Signs of heart failure are not always correlated with prosthetic valve dysfunction. Doppler echocardiography is noninvasive and a useful tool to assess transvalvular pressure gradient, not only in native valve but also in prosthetic valve. In this study, we evaluated our clinical experience of mitral valve replacement with bileaflet mechanical prosthesis in children to establish an indication of invasive cardiac catheterization to decide re-replacement of the prosthetic valve during follow-up period of these children.


   Patients and methods
Top
 Abstract
 Introduction
 Patients and methods
Results
 Comment
 References
 
Since 1982, 37 mitral valve replacements using a bileaflet mechanical prosthetic valve were performed in 32 children at Fukuoka Children's Hospital or Kyushu University Hospital. The age at implantation of the prosthesis ranged from 2 months to 16 years (mean, 5.6 years of age), and body weight ranged from 3 kg to 37.3 kg (mean, 15.9 kg). As a previous procedure, correction of atrioventricular septal defect was performed in 12 patients (partial type in 9 and complete type in 3), correction of double-outlet right ventricle combined with atrioventricular septal defect in 1, subclavian flap aortoplasty for coarctation of the aorta in 2, aortic valvuloplasty in 3 (balloon valve plasty in 2 and surgical valve plasty in 1), mitral valve replacement with bioprosthesis followed by replacement with tilting disc mechanical prosthesis in 1, mitral valve plasty in 7, closure of ventricular septal defect in 3, closure of patent ductus arteriosus in 1, and arterial switch operation for transposition of the great arteries in 1.

The indications for mitral valve replacement were uncorrectable congenital malformation of the mitral valve in 16 patients (including 1 patient with previous mitral valve replacement), postoperative mitral regurgitation after total repair of atrioventricular septal defect in 13, hypertrophic obstructive cardiomyopathy in 2, and infective endocarditis in 1. As a concomitant procedure, tricuspid annuloplasty was performed in 4 patients, relief of left ventricular outflow tract obstruction in 3, aortic valve replacement in 1, aortic valve plasty in 1, enlargement of the ascending aorta in 1, relief of right ventricular outflow tract obstruction in 1, closure of ventricular septal defect in 1, and closure of patent ductus arteriosus in 1.

The types of implanted prosthetic valve were St. Jude Medical standard valve in 20 (19 mm in 4, 23 mm in 4, 25 mm in 2, 27 mm in 4, 29 mm in 4, and 31 mm in 2), St. Jude Medical valve hemodynamic plus series in 6 (17 mm in 2, 19 mm in 3, and 21 mm in 1), and CarboMedics standard valve in 11 (16 mm in 9, 23 mm in 1, and 25 mm in 1). Selection of prostheses was dependent on patient's mitral annular size and situation of Japanese market. Because of its rotatability, CarboMedic standards valve is now our choice of prosthesis when mitral valve replacement is required in infants [12]. The prostheses were fixed at the supraannular position in 7 patients and at the annulus in the remaining patients.

Postoperative anticoagulation was achieved by intravenous administration of heparin sodium (400 U/kg per day), with subsequent oral intake of warfarin potassium in a dosage to maintain the value of the Thrombotest within the range from 10% to 20% (a prothrombin time–international normalized ratio level between 2.8 and 1.8).

Patients' follow-up was done either by referencing patients' hospital records or through direct telephone call. Follow-up period ranged from 1 month to 18.4 years (mean, 6.8 ± 4.8 years) with complete follow-up rate of 94%. Seventy-eight echocardiography images and 15 cardiac catheterization results were obtained during the follow-up period of our 32 patients.

All data in text are expressed as the mean ± standard deviation. Time-related changes in survival and freedom from re-replacement of mitral valve and valve-related events were analyzed with the Kaplan-Meier method. Statistical analysis was made using StatView software (Abacus Concept, Inc, Berkeley, CA) on an Apple/Macintosh-based computer program. A p value equal or less than 0.05 was considered statistically significant.


   Results
Top
 Abstract
 Introduction
 Patients and methods
 Results
Comment
 References
 
Figure 1 shows the size of the prosthesis and body weight of the patients at the time of implantation. The sizes of St. Jude Medical valve hemodynamic plus series is considered to be 2 mm bigger than its original size, because the manufactured valve orifice area of the St. Jude Medical valve hemodynamic plus series is 2 mm bigger than the manufactured valve orifice area of the St. Jude Medical standard valve with the same valve diameter.



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  		Fig 1. Scatterplot of prosthetic valve size versus body weight. Open circles represent St. Jude Medical prosthetic valve, and open triangles represent CarboMedics prosthetic valve.

 
There was no operative death. There were 5 late deaths, one as a result of thrombosed valve and 4 as a result of heart failure. Three patients had a thrombosed valve, and thrombolytic therapy was effective in 2 patients. One patient underwent aortic valve replacement 1.7 years after mitral valve replacement. Five patients required replacement of mitral valve prosthesis because of prosthesis-patient mismatch with an interval between 4.9 and 11.5 years (mean, 6.9 years) after mitral valve replacement with bileaflet mechanical prosthesis.

Actuarial survival rate was 63% ± 19% at 15 years after initial mitral valve replacement. Freedom from re-replacement of mitral valve and valve-related events was 54% ± 18% and 32% ± 23% at 15 years, respectively (Fig 2).



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  		Fig 2. Actuarial survival curve (filled circle), valve-related event-free curve (open triangle), and freedom from re-replacement of the mitral valve (open circle) during 15 years of follow-up. (MVR = mitral valve replacement.)

 
Maximum transprosthesis flow velocity (Vmax) estimated by follow-up Doppler echocardiography was well correlated with prosthetic valve orifice area index (manufactured geometric prosthetic valve area divided by patient's body surface area) at the time of examination (Vmax = valve orifice area index x 292.2 - 30.6; r2 = 0.35; p < 0.0001; Fig 3).



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  		Fig 3. Scatterplot of prosthetic valve orifice area index versus maximum transprosthetic flow velocity assessed by Doppler echocardiography (Vmax). There is a good correlation between these two indices.

 
Valve orifice area index, however, had no significant correlation with pulmonary artery wedge pressure assessed by cardiac catheterization (p = 0.17, r2 = 0.142; Fig 4).



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  		Fig 4. Scatterplot of prosthetic valve orifice area index versus pulmonary artery wedge pressure assessed by simultaneous cardiac catheterization. There is no significant correlation.

 
Pulmonary artery wedge pressure, however, had a good correlation with Vmax assessed by simultaneous echocardiography (pulmonary artery wedge pressure = Vmax x 0.058 + 0.361; r2 = 0.428; p = 0.0082; Fig 5).



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  		Fig 5. Scatterplot of maximum transprosthetic flow velocity assessed by Doppler echocardiography (Vmax) and pulmonary artery wedge pressure. There is a significant correlation between these two indices.

 
At the time of replacement of mitral valve prosthesis, Vmax exceeded 270 cm/s in all patients. Prosthetic valve orifice area index in patients requiring re-replacement ranged between 1.6 and 2.4 cm2/m2. At the time of re-replacement, all redo patients had received prostheses of one or two sizes bigger than the initial prosthesis (Table 1).


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  		Table 1. Patients With Re-Replacement of Mitral Valve Prosthesis

 

   Comment
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
References
 
Although reparative techniques of the mitral valve abnormalities in children have made remarkable progress with acceptable midterm and long-term results [1–6], a reparative procedure is not always feasible. Uva and colleagues [2] reported that one fourth of their patients who had undergone repair of congenitally malformed mitral valve needed subsequent replacement of the valve. Their result was comparable with the data of our previous report [5] of 20% incident rate of mitral valve replacement in these children. Development of uncorrectable mitral regurgitation after correction of atrioventricular septal defect is also a major cause of mitral valve replacement in children [13–15].

The recent trend of selection of prosthesis at the mitral position in children is a bileaflet mechanical prosthesis because it has a low profile, excellent hemodynamic properties, and good durability when compared with biologic prosthetic valve [7]. Although troublesome and cumbersome anticoagulation therapy is mandatory, long-term results of mitral valve replacement with mechanical prosthesis in children are acceptable [16–21]. Prosthesis-patient mismatch as a result of somatic growth of the patients, however, is an unavoidable problem, especially when the prosthesis is implanted in small children.

The reported incident rates of re-replacement of mitral valve prosthesis in children varied from 0% to 63%, and the time interval between the initial and the second valve replacements also varied widely [16–20, 22, 23]. This is because there were big differences in the age at the initial mitral valve replacement, the type and the size of prosthesis, and the duration of follow-up among the previous studies. Friedman and associates [24] concluded that the increase of body weight nearly 2.5 times that at the initial implantation is a good predictor for re-replacement of mitral valve prosthesis in Starr-Edwards valve. Yoshimura and coworkers [23] recommended evaluation of prosthetic valve function and hemodynamic variables when the body surface area of the patient achieves twice that at the time of the initial replacement, especially in patients who underwent mitral valve replacement in infancy. However, their conclusions cannot be applied generally to all pediatric cases.

Recently, there have been increasing interests in prosthesis-patient mismatch in adults. Dumesnil and Yoganathan [25] reported that the effective valve orifice area of biologic prosthesis at the mitral position should not be less than 1.3 to 1.5 cm2/m2 body surface area to prevent postoperative transprosthetic pressure gradient. Yazdanbakhsh and colleagues [26] reported that small geometric valve area of less than 1.9 cm2/m2 body surface area affects early mortality of mitral valve replacement with a St. Jude Medical or a Medtronic Hall prosthetic valve, whereas Fernandez and coworkers [27] reported that geometric valve area of 1.3 cm2/m2 body surface area of the mitral St. Jude Medical prosthetic valve did not influence early and late morbidity or mortality. In growing children, however, the level of valve orifice area index at which signs of heart failure develop has not been well documented except for a report of old-type prosthesis, the Starr-Edwards valve [28].

In our study, prosthetic valve orifice area index was not a good predictor for pulmonary artery wedge pressure. In addition to patient's somatic growth, pannus formation of the prosthesis might contribute to prosthetic dysfunction and might affect the size of the prosthetic valve orifice area. Then, manufactured geometric prosthetic valve orifice area is no longer a reliable index to predict prosthesis-patient mismatch.

It is an established method to evaluate valve orifice area by Doppler echocardiography in native valves and prosthetic valves [22, 29]. We have decided to choose the Vmax assessed by Doppler echocardiography as an index for indication of invasive cardiac catheterization to decide re-replacement of prosthetic valve of our patients, because Doppler echocardiography is noninvasive and is easy to apply to children. In our patients' population, Vmax was well correlated with pulmonary artery wedge pressure. For example, when measured Vmax is 270 mm Hg, pulmonary artery wedge pressure is predicted as 16 mm Hg.

This study is retrospective, and the number of patients is relatively small and the follow-up period is not sufficiently long to be conclusive. Our indication for re-replacement of mitral valve prosthesis has not been well established, although elevated pulmonary artery wedge pressure evaluated by cardiac catheterization with or without signs of heart failure is our indication for re-replacement of the prosthetic valve at this moment. Regardless of these limitations, we believe that our study gives useful information to the physicians who follow children with a bileaflet mechanical prosthetic valve at the mitral position.

In conclusion, Vmax is a useful index to predict pulmonary artery wedge pressure of children with a bileaflet mechanical valve prosthesis at the mitral position. Invasive cardiac catheterization to determine re-replacement of the prosthesis should be considered when Vmax exceeds 270 cm/s.


   References
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 

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