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Ann Thorac Surg 2008;85:1303-1308. doi:10.1016/j.athoracsur.2007.12.031
© 2008 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Long-Term Results of Aortic Valve Replacement With a Small St. Jude Medical Valve in Japanese Patients

Kazuhiro Yoshikawa, MD*, Shuji Fukunaga, MD, Koichi Arinaga, MD, Hidetsugu Hori, MD, Eiji Nakamura, MD, Tomohiro Ueda, MD, Eiki Tayama, MD, Shigeaki Aoyagi, MD

Department of Surgery, Kurume University School of Medicine, Kurume, Japan

Accepted for publication December 10, 2007.

* Address correspondence to Dr Yoshikawa, Department of Surgery, Kurume University School of Medicine, 67 Asahi-machi, Kurume, 830-0011, Japan (Email: yosshi{at}med.kurume-u.ac.jp).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 References
 
Background: The use of small aortic valve prostheses is still controversial because of negative effects caused by residual obstruction of the left ventricular outflow tract. This study evaluated the long-term results after aortic valve replacement with a small valve from St. Jude Medical (St. Paul, MN).

Methods: Between 1980 and 1999, 221 patients underwent isolated aortic valve replacement with a 23-mm or smaller St. Jude Medical valve. The mortality rate and complications were analyzed, echocardiography was performed, and peak pressure gradient, mean pressure gradient, indexed effective orifice area, and left ventricular mass index were measured.

Results: The follow-up rate in the 221 patients was 99.5% (maximum length, 24.1 years; mean, 10.3 years). Patients with a 19-mm valve were mainly women, older, and had smaller body surface areas. Freedom from valve-related death at 20 years was 100%, 86.0%, and 90.2% in patients with 19-, 21-, and 23-mm valves, respectively. There were no significant differences in the actuarial freedom from valve-related deaths. Echocardiography showed significantly higher peak (32.3 mm Hg) and mean pressure gradients (17.6 mm Hg) and a smaller indexed effective orifice area (0.70 ± 0.15 cm2/m2) in patients with a 19-mm valve than in those with a 21- or 23-mm valve. Moderate prosthesis–patient mismatch was present in most patients with a 19-mm valve according to one definition; however, the improvements in ejection fraction and left ventricular mass index were significant, and functional recovery (mean New York Heart Association class, 1.3 ± 0.5; mean specific activity scale, 5.1 ± 0.8 metabolic equivalents) was satisfactory.

Conclusions: The present long-term results demonstrate that a small St. Jude Medical valve can be advantageously used in most Japanese patients because their body size is generally smaller than that of Western patients. These findings also emphasize that it is not prosthesis size per se that matters but rather the relation between body size and prosthesis size.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 References
 
Aortic valve replacement (AVR) is an established treatment for diseases of the aortic valve. Advancements in valve design, surgical techniques, cardioplegia, and perioperative care have resulted in decreases in operative mortality and morbidity. However, the relationship between the size of a valve prosthesis and body surface area of the patient has been reported as being important for late results. A small-sized valve prosthesis may cause residual obstruction of the left ventricular (LV) outflow tract and may interfere with regression of LV hypertrophy and clinical improvement and affect long-term survival [1, 2]. This concept has been termed patient–prosthesis mismatch (PPM), and it has been reported that PPM has an effect on the clinical results. This study was undertaken to evaluate the long-term results and postoperative hemodynamic changes after AVR with a small valve prosthesis in Japanese patients.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 References
 
Patients
This study was approved by the Ethics Committee of Kurume University School of Medicine. Informed written consent was obtained from all patients. The current study was approved by the Institutional Research Ethics Board, and individual patient consent was waived.

Between 1980 and 1999, 334 patients underwent isolated AVR with a St. Jude Medical (SJM) valve (St. Jude Medical Inc, St. Paul, MN) at our hospital. The study enrolled 221 patients who underwent AVR with a standard SJM protheses sized 19 mm in 11 patients, 21 mm in 71, or 23 mm in 139 (Table 1). All patients gave their informed consent to the examinations and surgical procedures.


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  		Table 1 Patient Characteristics by Valve Size at Implant
 
Data Collection and Follow-Up
Preoperative and perioperative data were obtained by retrospective review of clinical and surgical records. Hospital survivors were followed up annually or biannually at our outpatient clinic. At that time, an echocardiographic evaluation, including Doppler study, was routinely conducted for all patients. Patients were contacted directly by questionnaire or telephone or through the referring physician, and additional data were collected from clinical records. To determine the degree of cardiovascular disability, the New York Heart Association (NYHA) functional class was assessed and a modified specific activity scale (SAS) system [3, 4] was used to obtain maximum metabolic equivalents (METS) of activity (Table 2). Deaths and complications were stringently defined according to published guidelines of The Society of Thoracic Surgeons [5].


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  		Table 2 Specific Activity Scale
 
Echocardiography
An echocardiographic study was performed in 177 of 221 late survivors. The variables measured were ejection fraction, LV mass index (LVMI), peak pressure gradient (PPG), mean pressure gradient (MPG), and the in vivo effective orifice area (EOA). The ejection fraction and LVMI were calculated using previously reported formulas [6]. The PPG and MPG were calculated using the modified Bernoulli equation. The in vivo EOA was calculated using the continuity equation method [7]: EOA = (LV outflow cross-sectional area) x (subvalvular flow/supravalvular flow). The EOA index (EOAI) was calculated by dividing EOA by body surface area (BSA). The criteria are an EOAI of less than 0.85 cm2/m2 for moderate PPM and less than 0.65 cm2/m2 for severe PPM [2].

Statistical Methods
Values are expressed as the mean ± standard deviation (SD). Simple comparisons were performed using a standard {chi}2 test or a nonpaired t test. The paired t test or repeated-measures analysis of variance was used for continuous variable comparisons. A value of p < 0.05 was considered significant. Actuarial curves were constructed to describe mortality and the incidence of value-related complications. Event-free curves were calculated for valve-related mortality and overall mortality. Actuarial estimates were calculated using the Kaplan-Meier method and are reported with the standard error of the estimate.


   Results
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 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 References
 
Clinical Outcome
Most of the patients who received a 19- or 21-mm valve were women, and most of those who received a 23-mm valve were men. The BSA of the patients with a small valve was significantly smaller than that of the patients with a 23-mm valve (Table 1).

Two hospital deaths (operative mortality, 0.09%) occurred. Both patients had received a 23-mm valve and died of low cardiac output syndrome. Among the 219 operative survivors, 218 (99.5%) were followed up. The mean follow-up period was 10.3 ± 5.0 years (range, 1 month to 24.1 years) for a total of 2270.4 patient-years.

During follow-up, 37 (18%) patients died of a variety of reasons, including 17 valve-related deaths. Eight died of thromboembolism or anticoagulant-related bleeding, and another patient who required reoperation for paravalvular leakage died after reoperation. The remaining 8 patients died of sudden, unexplained, and unexpected causes.

The actuarial freedom from valve-related death at 10 and 20 years was 100% and 100% in patients with a 19-mm valve, 91.9% ± 3.4% and 86.5% ± 5.2% with a 21-mm valve, and 97.6% ± 1.3% and 90.2% ± 3.9% with a 23-mm valve (19 mm vs 21 mm, p = 0.24; 19 mm vs 23 mm, p = 0.44; 21 mm vs 23 mm, p = 0.11). The differences in the actuarial freedom of valve-related deaths were not significant (Fig 1). The linearized incidence of valve-related mortality per patient-year was 1.1% and 0.6% in patients with 21- and 23-mm valves, respectively. Cardiac death occurred in 6 patients, consisting of progressive congestive heart failure in 4 and acute myocardial infarction in 2, and 14 patients died of noncardiac causes.


Figure 1
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  		Fig 1. Freedom from valve-related deaths according to valve size of 19 mm (dotted line), 21 mm (thin line), and 23 mm (thick line).

 
Actuarial survival, including early death, at 10 and 20 years was 90.9% ± 8.7% and 25.2% ± 21.0% in patients with 19-mm valves, 85.3% ± 4.6% and 72.2% ± 9.1% with 21-mm valves, and 86.8% ± 3.1% and 74.4% ± 5.2% with 23-mm valves (19 mm vs 21 mm, p = 0.44; 19 mm vs 23 mm, p = 0.36; 21 mm vs 23 mm, p = 0.99). Differences in the actuarial survival were not significant (Fig 2).


Figure 2
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  		Fig 2. Actuarial survival rate according to valve size of 19 mm (dotted line), 21 mm (thin line), and 23 mm (thick line).

 
A thromboembolic event was observed in 18 patients. The linearized incidence of a thromboembolic event per patient-year was 0.7%, 1.1%, and 0.6% in patients with 19-, 21-, and 23-mm valves, respectively. Cerebral embolism was observed in 17 patients, and peripheral embolism was observed in 1 patient. The percentage freedom from thromboembolism at 10 and 20 years was 88.9% ± 10.4% and 88.9% ± 10.4% in patients with a 19-mm valve, 90.4% ± 3.7% and 87.4% ± 4.7% with the 21-mm valve, and 97.6% ± 1.4% and 64.0% ± 19.2% with the 23-mm valve (19 mm vs 21 mm, p = 0.56; 19 mm vs 23 mm, p = 0.77; 21 mm vs 23 mm, p = 0.08. The differences in the freedom from thromboembolism were not significant.

Bleeding complications related to anticoagulant therapy occurred in 8 patients. The linearized incidence of an anticoagulant-related event per patient-year was 0.7% in patients with 21-mm valves and 0.2% with 23-mm valves. Cerebral bleeding occurred in 5 patients, and 3 others had lung, gastrointestinal, or ovarian bleeding. A fatal bleeding complication occurred in 6 patients. Actuarial freedom from anticoagulant-related hemorrhage at 10 and 20 years was 100% and 100% in patients with a 19-mm valve, 90.5% ± 4.1% and 90.5% ± 4.1% with the 21-mm valve, and 98.4% ± 1.1% and 96.8% ± 1.9% with the 23-mm valve (19 mm vs 21 mm, p = 0.48; 19 mm vs 23 mm, p = 0.61; 21 mm vs 23 mm, p = 0.33). The differences in the freedom from anticoagulant-related hemorrhage were not significant.

Fourteen patients (6.0%) had nonstructural valve dysfunction for an incidence of 0.6% per patient-year. Paravalvular leakage occurred in 2 patients with 23-mm valves. Entrapment of the leaflet by pannus formation was observed in 11 patients, 6 with a 21-mm valve and 5 with a 23-mm valve.

No intrinsic abnormalities or structural failures were observed in this series.

Reoperation was required in 14 patients, and the linearized incidence of reoperation was 0.6% per patient-year. The reasons for the reoperations were paravalvular leakage in 2 patients (23-mm), prosthetic valve endocarditis in 1 patient (23-mm), and entrapment of the leaflet by pannus in 11 patients (21-mm in 6 patients, 23-mm in 5 patients). Actuarial freedom from reoperation at 10 and 20 years was 100% and 100% in patients with a 19-mm valve, 96.6% ± 2.4% and 84.2% ± 9.0% with the 21-mm valve, and 96.2% ± 1.9% and 85.0% ± 6.9% with the 23-mm valve.

The actuarial freedom from valve-related complications at 10 and 20 years was 88.9% ± 10.4% and 88.9% ± 10.4% in patients with a 19-mm valve, 80.8% ± 4.7% and 75.6% ± 5.7% with a 21-mm valve, and 95.3% ± 1.8% and 79.8% ± 7.0 % with a 23-mm valve (19 mm vs 21 mm, p = 0.30; 19 mm vs 23 mm, p = 0.95; 21 mm vs 23 mm, p = 0.005). The differences between patients with 21- and 23-mm valves were significant (p < 0.01).

The actuarial freedom from all complications, including all deaths at 10 and 20 years, was 90.9% ± 8.6% and 25.9% ± 20.6% with the 19-mm valve, 75.6% ± 5.4% and 62.8% ± 9.2% with the 21-mm valve, and 85.9% ± 3.2% and 48.4% ± 14.9% with the 23-mm valve (19 mm vs 21 mm, p = 0.60; 19 mm vs 23 mm, p = 0.16; 21 mm vs 23 mm, p = 0.19). The differences in the freedom from all complications were not significant. The linearized incidence of all complications per patient-year was 4.9%, 4.7%, and 3.5% in patients with 19-, 21-, and 23-mm valves, respectively (Fig 3).


Figure 3
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  		Fig 3. Freedom from all complications, including all death, according to valve size of 19 mm (dotted line), 21 mm (thin line), and 23 mm (thick line).

 
The NYHA functional class was assessed during follow-up (Fig 4). For the 19-mm valve, the NYHA functional class was improved: most patients were in NYHA class I, and 1 patient was in class II. For the 21-mm valve, 49 of 60 patients (81.7%) improved to NYHA class I or II, and 3 patients were in class III. For the 23-mm valve, 98 of 115 patients (85.2%) improved to NYHA class I or II, and 11 were at III or IV. The difference between the preoperative and postoperative NYHA functional classes in all groups was statistically significant; however, the difference in the postoperative NYHA functional class among the three groups was not significant.


Figure 4
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  		Fig 4. Postoperative and follow-up by New York Heart Association (NYHA) functional class, excluding operative death and late death.

 
The mean SAS score at last follow-up was 5.1 ± 0.8 METS in patients with the 19-mm valve, 5.8 ± 1.1 METS with the 21-mm valve, and 5.7 ± 1.3 METS with the 23-mm valve. The difference in the SAS score among the three groups was not statistically significant.

Echocardiographic Data at Follow-Up
Two-dimensional transthoracic echocardiography was performed in 9 patients with a 19-mm valve (81% of current survivors), 55 with 21-mm valve (77% of current survivors), and 113 with a 23-mm valve (81% of current survivors; Table 3). The transprosthetic PPGs and MPGs were 32.3 ± 7.7 and 17.6 ± 3.5 mm Hg in the 19-mm valve patients, 27.0 ± 10.5 and 15.1 ± 6.1 mm Hg in the 21-mm valve patients, and 23.2 ± 11.8 and 11.3 ± 5.3 mm Hg in the 23-mm valve patients. The transprosthetic PPGs and MPGs were significantly higher in patients with a 19-mm valve (p < 0.05) than in those with a 23-mm valve.


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  		Table 3 Postoperative Echocardiography Data by Valve Size
 
The EOAI was 0.70 ± 0.15 cm2/m2 (< 0.65, 11%; 0.65 to 0.85, 78%; < 0.85, 11%) in the 19-mm valve patients, 0.88 ± 0.16 cm2/m2 (< 0.65, 5%; 0.65 to 0.85, 20%; < 0.85, 75%) in the 21-mm valve patients, and 0.98 ± 0.22 cm2/m2 (< 0.65, 2%; 0.65 to 0.85, 12%; < 0.85, 86%) in the 23-mm valve patients. The EOAI was significantly lower in patients with a 19-mm valve (p < 0.05) than in those with a 21- or 23-mm valve. These results suggest that most 19-mm valve patients could be considered to have mild PPM.

The differences in the preoperative and postoperative ejection fractions in any group were not significant.

The LVMI was improved from 234.4 ± 90.8 g/m2 to 127.4 ± 54.7 g/m2 in 19-mm valve patients, from 225.6 ± 120.6 g/m2 to 130.0 ± 28.7 g/m2 in 21-mm valve patients, and from 238.6 ± 81.1 g/m2 to 130.6 ± 34.9 g/m2 in 23-mm valve patients. Although the changes in preoperative and postoperative LVMI in each group were significant (p < 0.01), no significant differences were found in the preoperative and postoperative values of LVMI among the three groups.


   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
References
 
The concept of PPM has been defined as existing "when the effective prosthetic valve area, after insertion into the patient, is less than that of a normal valve [1]." Patient–prosthesis mismatch occurs when the EOA of an artificial valve is inadequate for the recipient. Patient–prosthesis mismatch can result in persistent LV out flow obstruction, which increases LV work and reduces LV mass regression, with a presumed shortening of lifespan. Pibarot and colleagues [2] defined PPM as being present if the EOAI was less than 0.85 cm2/m2. Furthermore, PPM was considered as moderate if the EOAI was between 0.65 and 0.85 cm2/m2 and severe if it was less than 0.65 cm2/m2. This is currently the most common definition of PPM.

Patient–prothesis mismatch has been reported to be a strong predictor of short-term mortality. Rao and colleagues [8] reported the results of 2981 AVR patients and concluded that PPM significantly increased early and late valve-related deaths. They recommended that PPM should be avoided by using a prospective strategy at the time of operation.

Some reports, however, have indicated that the PPM does not influence the outcome. Hanayama and colleagues [9] examined the effect of PPM in 1129 AVR patients, with their definition of PPM being an EOAI of less than 0.6 cm2/m2. Their results indicated there was no significant difference between the PPM group and non-PPM group in regression of the LVMI, 7-year survival rate, or improvement in NYHA functional class. They concluded that PPM did not influence LVMI regression or intermediate-term survival. Blackstone and colleagues [10] examined the results of AVR done at 9 facilities on 13,258 patients, using the indexed internal prosthesis orifice area as an indicator, and concluded that PPM affected neither intermediate- nor long-term survival. From these results, it is unclear whether or not PPM is related to clinical outcome because of the marked differences between the various reports.

Patient–prosthesis mismatch has been defined using EOA and BSA. Normally, this EOA was obtained from the manufacturer, and matching or mismatching of a prosthesis was defined at implantation. In this study, the mean BSA was 1.44 ± 0.12 m2 with 19-mm valves and 1.47 ± 0.14 m2with 21-mm valves. The EOAI values calculated according to the manufacturer’s data in our patients were not included in the PPM category, which demonstrates that our patients were smaller than those in other reports [2, 8–14], especially those from Western countries. This difference in physique between Japanese and Western populations will have an effect on whether PPM influences the results of AVR. We therefore used EOAI measured directly from echocardiography as in vivo data.

The results of our study showed there was no difference among the three valve sizes in terms of valve-related deaths even after more than 20 years of follow-up. We previously reported [15] that the 19- and 21-mm valves were reliable options for elderly Japanese patients on the basis of the good mid-term results we obtained. Furthermore, the results of dobutamine stress testing showed that a 19-mm valve could be safely used in patients with a BSA of less than 1.31 m2 [16].

Although the 19-mm valve revealed high peak and mean transprosthetic pressure gradients and low EOAI, the LVMI and ejection fraction were improved to normal values. The main explanation for this improvement observed in our study is that most of the smaller prosthetic valves were used in elderly and small female patients with aortic stenosis and that the EOAI calculated using the manufacturer’s data was sufficiently large. Although these patients with 19-mm valves exhibited moderate PPM by in vivo EOAI obtained from echocardiography, we believed that moderate PPM would not have an influence on LV recovery after AVR.

This study assessed postoperative symptomatic recovery by using the NYHA functional class and SAS score. The NYHA classification system has been used widely to categorize the functional status of patients. This system classifies patients according to the degree of symptoms resulting from ordinary or less-than-ordinary activity. The precise details of the definition of the activity are obscure, however, and it has been pointed out that functional class is not assessed accurately by this classification. Although using the exercise treadmill test to estimate oxygen consumption appears to be reasonable for assessing functional capacity, several factors such as concern about symptoms, habits, or leg weakness influence the results of exercise.

As an alternative, Goldman and colleagues [3] proposed the usefulness of the SAS score, which is derived from the metabolic requirements of specific activities. The reproducibility and validity of the SAS score make it more useful than the NYHA functional class; thus, we used the SAS score modified for Japanese patients in this study. The mean value of the SAS score was not different among the three groups. In the patients with small prosthetic valves, the SAS score exceeded 5 METS. This value means that the patients can weed the garden, take a bath by themselves, or walk up and down stairs. Almost all of our patients were aged older than 70 years at follow-up, and this level of activity is sufficient for their daily activities. This may partly explain the excellent long-term clinical outcome and the significant improvement in LV function after AVR in our patients.

This study has some limitations. First, the total number of patients was too small to allow us come to any definite conclusions. However, the follow-up periods were more than 20 years, which was adequate for examining the effect of PPM. Second, we calculated EOAI from echocardiographic data. As is well known, there are technical errors with respect to obtaining echocardiographic data among operating physicians. To minimize the possibility of this type of error, only one physician (K.Y.) reviewed all of the echocardiographic data.

The present findings, however, should not be used as justification to avoid calculating projected indexed EOA of the prosthesis to be implanted and to decide if this is adequate given the overall clinical context of the patient.

In conclusion, the present long-term results demonstrate that a small SJM valve can be advantageously used in most Japanese patients because their body size is generally smaller than that of Western patients. These findings also emphasize that it is not prosthesis size per se that matters but rather the relation between body size and prosthesis size.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

  1. Rahimtoola SH. The problem of valve prosthesis-patient mismatch Circulation 1978;58:20-24.[Abstract/Free Full Text]
  2. Pibarot P, Dumesnil J. Patient-prosthesis mismatch and the predictive use of indexed effective orifice area: is it relevant? Cardiac Surg Today 2003;1:143-151.
  3. Goldman L, Hashimoto B, Cook EF, Loscalzo A. Comparative reproducibility and validity of systems for assessing cardiovascular functional class: advantage of a new specific-activity scale Circulation 1981;64:1227-1234.[Abstract/Free Full Text]
  4. Asanoi H. Treatment and management of congestive heart failure[in Japanese] Curr Ther 1991;9:1742-1745.
  5. Edmunds Jr LH, Clark RE, Cohn LH, Grunkemeiser GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations Ann Thorac Surg 1996;62:932-935.[Abstract/Free Full Text]
  6. Christakis GT, Joyner CD, Morgan CD, et al. Left ventricular mass regression early after aortic valve replacement Ann Thorac Surg 1996;62:1084-1089.[Abstract/Free Full Text]
  7. Chafizadeh ER, Zoghbi WA. Doppler echocardiographic assessment of the St. Jude Medical prosthetic valve in aortic position using the continuity equation Circulation 1991;83:213-223.[Abstract/Free Full Text]
  8. Rao V, Jamieson WR, Ivanov J, et al. Prosthesis-patient mismatch affects survival after aortic valve replacement Circulation 2000;102(19 suppl 3):115-119.
  9. Hanayama N, Christakis GT, Mallidi HR, et al. Patient prosthesis mismatch is rare after aortic valve replacement: valve size may be irrelevant Ann Thorac Surg 2002;73:1822-1829.[Abstract/Free Full Text]
  10. Blackstone EH, Cosgrove DM, Jamieson WR, et al. Prosthesis size and long-term survival after aortic valve replacement J Thorac Cardiovasc Surg 2003;126:783-796.[Abstract/Free Full Text]
  11. Del Rizzo DF, Abdoh A, Cartier P, Doty D, Westaby S. Factors affecting left ventricular mass regression after aortic valve replacement with stentless valves Semin Thorac Cardiovasc Surg 1999;11(4 suppl 1):114-120.[Medline]
  12. Blais C, Dumesnil JG, Baillot R, et al. Impact of valve prosthesis-patient mismatch on short-term mortality after aortic valve replacement Circulation 2003;108:983-988.[Abstract/Free Full Text]
  13. Medalion B, Blackstone EH, Lytle BW, et al. Aortic valve size replacement: is valve size important? J Thorac Cardiovasc Surg 2000;119:963-974.[Abstract/Free Full Text]
  14. Ruel M, Rubens FD, Masters RG, et al. Late incidence and predictors of persistent or recurrent heart failure in patients with aortic prosthetic valves J Thorac Cardiovasc Surg 2004;127:149-159.[Abstract/Free Full Text]
  15. Aoyagi S, Arinaga K, Fukunaga S. Aortic valve replacement with a small mechanical valve prosthesis--a clinical and echocardiographic study of a St Jude Medical valve prosthesis Jpn Circ J 1998;62:244-248.[Medline]
  16. Arinaga K. Dobutamine-stress Doppler echocardiographic evaluation for the optimal size of a valve prosthesis in aortic valve replacement[in Japanese] Jpn J Kurume Med Assoc 1996;59:344-360.

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