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Ann Thorac Surg 2003;76:66-73
© 2003 The Society of Thoracic Surgeons

Original article: cardiovascular

A prospective controlled trial of st. jude versus starr edwards aortic and mitral valve prostheses

Andrew J. Murday, FRCSa*, Andreas Hochstitzky, MRCSa, Judith Mansfield, RSNa, Julie Miles, RSNa, Beverley Taylor, RSNa, Eileen Whitley, RSNa, Tom Treasure, FRCSa

a Department of Cardiothoracic Surgery, St. George’s Hospital, London, United Kingdom

Accepted for publication January 7, 2003.

* Address reprint requests to Dr Murday, Scottish Cardiopulmonary Transplant Unit, Glasgow Royal Infirmary, Alexandra Parade, Glasgow G31 2ER United Kingdom
e-mail: andrew.murday{at}btinternet.com


   Abstract
Top
 Abstract
Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
BACKGROUND: There is a paucity of controlled trials comparing the merits of different heart valve prostheses. In this prospective randomized trial we compared Starr Edwards and St. Jude prostheses in the aortic and mitral positions.

METHODS: Two hundred sixty-seven patients and 122 patients undergoing aortic and mitral valve replacement, respectively, were allocated by minimization to receive either St. Jude or Starr Edwards prostheses. Patients (2 patients were lost to follow-up) were followed up in a special clinic. Event definition, recording, and reporting were in accordance with published guidelines.

RESULTS: There were no demographic differences between patients receiving the two different valve models. With the exception of infective endocarditis, we found no differences in the rates of death or complication between patients receiving a Starr Edwards prosthesis or a St. Jude prosthesis in either position. Neither were there any differences between the two valve models in either position, in terms of symptomatic relief 5 years after surgery.

CONCLUSIONS: We found no differences in rates of complication or of symptomatic improvement between the Starr Edwards and St. Jude valve prostheses in either aortic or mitral position. Left ventricular function had such a marked effect on long-term survival that it overwhelmed any differences that might exist between different prosthetic designs. This confirms that historical comparisons are of limited value in deciding the respective merits of heart valve prostheses. The most reliable method of assessing surgical procedures is through prospective controlled trials.


   Introduction
Top
 Abstract
 Introduction
Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
What guides valve preference? In the late 1980s disappointment at the evident inevitability of tissue failure in frame-mounted porcine xenograft valves [1–4] and bovine pericardial valves [5, 6] caused many surgeons to advise their patients to accept life-long anticoagulation rather than face the prospect of a second valve replacement. However, when the tissue versus mechanical debate was subjected to prospective randomized trials, survival and the overall incidence of valve-related complications was largely similar at 11 [7] and 12 years [8]. Nevertheless there was a clear choice between the need for reoperation for tissue failure and an increased risk of bleeding in those who had mechanical valves [7, 8].

If a mechanical valve is preferred to a tissue valve, how do the patient and surgeon choose which type of valve to implant? In the United Kingdom in 1986, of the 2,791 mechanical valves implanted, 55.2%, 21.5%, and 23.3% were single leaflet, bileaflet, and ball and cage, respectively. By the turn of the millennium the proportions had changed dramatically, so that in 2000 of the 4,049 implants, 91.8% were bileaflet, 6.5% single leaflet, and 1.7% ball and cage [9]. On what evidence was this dramatically changed use of mechanical valves based?

The fate of the Bjork Shiley CC valve no doubt hastened a decline in the use of single-disc valves, and the bileaflet valves have taken over their market share. The low profile of the bileaflet valves is appealing to the implanting surgeon, but hemodynamic differences between well-established bileaflet valves are minimal [10]. Furthermore, there are greater similarities than differences in the behavior of St. Jude and Starr Edwards valves in terms of Doppler velocity and pressure recovery [11].

Evidence for the clinical performance of valves is based almost completely on retrospective case follow-up. For the St. Jude valve, which has been available for more than 20 years, there are large series with follow-up of 10 or more years [12–16]. However, the major determinants of survival in any series of patients with valve disease are left ventricular function and age at the time of implantation [17, 18] plus a number of other patient-related factors such as heart rhythm, pulmonary vascular resistance, and coexisting disease.

Differences in thromboembolic events are highly dependent on time frame, probably because of a change in patient-related risk factors rather than change in valve design or anticoagulant management [19]. What randomized trial evidence there is on thromboembolic rates does not favor the bileaflet valve as opposed to a single-disc valve in a comparison of Edwards-Duromedics, Medtronic Hall, and Bjork-Shiley valves [20]. It is arguable that the caged ball, with no hinge points and complete rinsing of the occluder, might be the best solution.

In the absence of trial data comparing the performance of mechanical valves we sought to compare two mechanical valves, the St. Jude and the Starr Edwards valves. The St. Jude was chosen because it was seen to be "state of the art" whereas the Starr Edwards had become the robust workhorse valve, which surgeons turned to in difficult situations for its reliability and user friendliness. Neither of these propositions seemed to us to be evidence-based.


   Patients and methods
Top
 Abstract
 Introduction
 Patients and methods
Results
 Comment
 Acknowledgments
 References
 
Patients
All patients undergoing aortic (AVR) or mitral (MVR) valve replacement between December 1991 and June 1997 were considered for entry into the trial. In general the policy in the unit is to consider patients 70 years of age or younger for prosthetic valve replacement, although there were no specific clinical features that were considered contraindicative. The trial was approved by the Local Research Ethics Committee of Wansdsworth Health Authority in October 1991. All patients for whom their surgeons was happy to randomize to either a Starr Edwards or a St. Jude valve prosthesis were put forward for consideration. There were no specific exclusion criteria for the trial. Patients with previous valve operations, endocarditis, and concomitant coronary artery disease were included. Patients were counseled about the trial and if they gave informed consent were considered for randomization. The number of patients undergoing concomitant AVR and MVR (27 in total) was insufficient to reach any worthwhile conclusions, and those patients are excluded from this report.

Randomization
Patients were randomized during the operative procedure after valve excision at the point when the operating surgeon was satisfied that he or she would be prepared to put in either of the two prostheses. Allocation of valve was by minimization using a computer program [21]. Minimization has the advantage that differences in important patient variables that might otherwise occur by chance can be avoided. Factors used for minimization were as follows: age, 65 years or less or greater than 65 years; sex; intention to perform coronary artery bypass grafts; left ventricular function, good, impaired, or poor; and valve site, mitral or aortic.

Operative technique
The operations were performed according to the individual surgeons’ usual practice. Thus there were differences in surgical technique in terms of myocardial preservation and valve suture method. In particular, two suture techniques were used: one a continuous suture using 2-0 Prolene (Ethicon, Somerville, NJ), the other an interrupted method using pledgeted 2-0 Ethibond (Ethicon) sutures.

Anticoagulation
All patients received oral anticoagulation on the first operative day, or as soon as possible thereafter. It was recommended that the international normalized ratio should be maintained at between 3 and 4 for all patients, no matter which valve model, in whichever position, was implanted. Regular control of anticoagulation was left in the care of each patient’s general practitioner or local anticoagulation clinic. However, the current international normalized ratio was documented at each follow-up clinic visit and at the time of any thromboembolic or hemorrhagic event.

Follow-up
Patients were followed up annually in a specially designated outpatient clinic. At each attendance a clinical history was taken, from which New York Heart Association class was estimated, and a physical examination was performed by a doctor not blinded to the valve type. In addition an electrocardiogram and plain chest roentgenogram were undertaken. For a few patients for whom logistical problems made clinic attendance impossible, equivalent follow-up data were obtained from their local cardiologist. Definition of complications was in accordance with the guidelines of The Society of Thoracic Surgeons [22]. In addition each patient was registered at the time of operation with the Office of Population Census and Statistics (superseded in 1998 by the National Office of Statistics). This government organization provides a death certificate whenever any registered patient dies. When appropriate, information was obtained from postmortem examination.

Two patients were lost to follow-up, of whom 1 emigrated and 1 remains unable to be contacted. Of those patients lost to follow-up, 1 underwent AVR with a St. Jude prosthesis and 1 underwent MVR with a Starr Edwards. These 2 patients have been included in the data analysis, and censored at their latest follow-up date.

Data handling and statistics
All data were handled with care to maintain patient confidentiality. Records were maintained in both computer and paper formats. The closing point for any 1 patient was the time of their last visit to the annual follow-up clinic. Statistical analysis was carried out as appropriate: Kaplan-Meier survival analysis was used to examine the incidence of death and other relevant postoperative events. Kaplan-Meier curves were compared using the log-rank test. Continuous variables were compared using Student’s t test or Mann-Whitney U test as appropriate, and categorical variables were compared using a {chi}2 test.


   Results
Top
 Abstract
 Introduction
 Patients and methods
 Results
Comment
 Acknowledgments
 References
 
Patient characteristics
The patient characteristics are given in Table 1. Left ventricular function was estimated from left ventricular angiography, wherein ejection fraction less than 30% was categorized as poor, between 30% and 50% as impaired, and more than 50% as good. There were no statistically significant differences between the patients randomized to the two valve models in either the AVR or MVR groups. During the same time frame at this institution, 179 additional patients underwent AVR and 84 patients underwent MVR who were not entered into the trial. The recruitment rates were therefore 60% and 59%, respectively. The reasons for patients not being entered into the trial were not recorded. We do know that there was a marked variation among surgeons with respect to the proportion of their patients who were entered. It is likely that those surgeons who were most cautious in this regard were most likely to exclude from the trial patients with smaller aortic root sizes.


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  		Table 1. Demographic Data of Patients

 
The distribution of prosthetic sizes is shown in Figure 1. Valve sizes are not directly comparable for any two different models of prosthetic valve. This is made particularly obvious with the Starr Edwards valve, as the size is a label rather than any particular dimension measurement.



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  		Fig 1. Aortic (A) and mitral (B) valve implant sizes. (Hatched bars = Starr Edwards; solid bars = St. Jude.)

 
Survival
Aortic valve replacement
The actuarial survival curve after AVR is shown in Figure 2A. The 30-day survival after AVR was 97% (1 standard error [SE], ±2%) for St. Jude recipients and 95% (1 SE, ±2%) for Starr Edwards recipients. The 1-year survival after AVR was 92% (1 SE, ±2%) for St. Jude recipients and 89% (1 SE, ±3%) for Starr Edwards recipients. After 8 years the respective survivals were 71% (1 SE, ±4%) and 65% (1 SE, ±5%). These differences are not statistically significant (log-rank test, p = 0.6).



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  		Fig 2. Actuarial survival after aortic (A) and mitral (B) valve replacements. (Dashed line = St. Jude; solid line = Starr Edwards.)

 
Mitral valve replacement
The actuarial survival curve after MVR is shown in Figure 2B. The respective 30-day survivals were 88% (1 SE, ±4%) for St. Jude recipients and 95% (1 SE, ±3%) for Starr Edwards recipients. The respective 1-year survivals were 85% (1 SE, ±5%) for St. Jude recipients and 84% (1 SE, ±5%) for Starr Edwards recipients. After 8 years the respective survivals were 44% (1 SE, ±8%) and 57% (1 SE, ± 7%). These differences do not reach statistical significance (p = 0.5).

Causes of death
The causes of death are shown in Table 2. Only 10% of all the deaths in the whole trial were valve-related, although 54% of all deaths were owing to non–valve-related cardiac causes. When survival after AVR is analyzed with patients stratified into three groups according to preoperative left ventricular function, it is clear that ventricular function has a profound effect on survival. Actuarial survival 1, 5, and 8 years after AVR was 95%, 80%, and 77% in patients with good left ventricular function, 87%, 76%, and 64% in patients with impaired ventricular function, and 79%, 51%, and 39% in patients with poor left ventricular function (p < 0.0002; Fig 3).


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  		Table 2. Causes of Death

 


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  		Fig 3. Actuarial survival (Kaplan-Meier) after aortic valve replacement stratified by left ventricular (LV) function. (Solid and dashed lines = poor left ventricular function; solid line = impaired ventricular function; dashed lines = good left ventricular function.)

 
Thromboembolism
The actuarial freedom from first thromboembolic event is given in Figure 4. The freedom from first embolus 1, 5, and 8 years after AVR was 95%, 89%, and 88% for St. Jude and 96%, 90%, and 86% for Starr Edwards. In the mitral position the freedoms at 1 and 5 years after surgery were 84% and 73% for St. Jude and 97% and 68% for Starr Edwards. At 8 years there were insufficient numbers of MVR patients to draw any worthwhile conclusions. Neither in the aortic (p = 0.98) nor mitral (p = 0.59) position were the differences between the two prostheses statistically significant.



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  		Fig 4. Actuarial freedom from first embolism after aortic (A) and mitral (B) valve replacements. (Dashed line = St. Jude; solid line = Starr Edwards.)

 
Postoperative endocarditis
There were 13 episodes of infective endocarditis in the follow-up period, the details of which are shown in Table 3. Excluding patients with preoperative infective endocarditis, the surprisingly large number of 8 patients who received a Starr Edwards aortic valve prosthesis developed infective endocarditis compared with only 1 patient who received a St. Jude aortic valve.


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  		Table 3. Details of Episodes of Infective Endocarditis

 
Reoperation
Table 4 shows the indication and the time since the original operation for the 14 patients who underwent reoperation after valve replacement. The single case of valve obstruction was the result of impingement of posterior leaflet tissue into the orifice of a St. Jude mitral valve.


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  		Table 4. Details of Reoperations in Patients Undergoing Aortic Valve Replacement

 
Anticoagulation
The international normalized ratio results recorded nearest to the annual follow-up appointment are represented in Figure 5. The boxes represent the 25 to 75 percentile ranges, and the whiskers represent the range excluding outliers and extremes. There were no significant differences in international normalized ratio measurements recorded at annual follow-up among any of the four groups of patients. Not surprisingly, the incidence of hemorrhage was no different between the two valve models or the two valve positions. The freedom from hemorrhage at 5 years was 85% for St. Jude AVR, 82% for Starr Edwards AVR, 79% for St. Jude MVR, and 79% for Starr Edwards MVR.



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  		Fig 5. Box and whisker plot of international normalized ratio (INR) at annual follow-up. (AVR = aortic valve replacement; MVR = mitral valve replacement.)

 
Symptomatic status
Symptomatic status was recorded at each outpatient visit. The average reduction in New York Heart Association grades from the preoperative status and to 5-year postoperative status was 1.4 for Starr Edwards AVR recipients, 1.5 for St. Jude AVR recipients, 1.8 for Starr Edwards MVR recipients, and 1.6 for St. Jude MVR recipients. The changes from preoperative New York Heart Association grade to 5-year postoperative New York Heart Association grade are shown in Figure 6.



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  		Fig 6. Change in New York Heart Association status after aortic (A) and mitral (B) valve replacements. (postop = postoperative.)

 
Event-free survival
Actuarial event-free survival curves for patients receiving AVR or MVR are shown in Figure 7, A and B, respectively. The event-free survivals at 1, 5, and 8 years after AVR were 84%, 56%, and 45% for St. Jude, and 81%, 54%, and 43% for Starr Edwards valves, respectively (p = 0.65). The event-free survivals at 1, 5, and 8 years after MVR were 64%, 37%, and 25% for St. Jude, and 79%, 35%, and 29% for Starr Edwards valves, respectively (p = 0.46).



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  		Fig 7. Event-free survival after aortic (A) and mitral (B) valve replacements. (Dashed line = St. Jude; solid line = Starr Edwards.)

 

   Comment
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
Acknowledgments
 References
 
Many widely accepted surgical interventions have not been subjected to randomized prospective trials. There are many reasons for this. Such trials can be difficult to set up, often take a long time to reach any conclusion, may be expensive, and by the time the results appear may seem to be irrelevant. Despite the fact that large amounts of money are spent each year on mechanical heart valve implants there have been very few published randomized trials to inform decisions as to which prosthesis should be used. Instead a variety of less rigorous sources inform our decisions. These include durability testing on laboratory rigs and clinical cohort studies including, at best, comparisons with matched historical controls.

It has been frequently stated that the Starr Edwards valve has a higher risk of thromboembolic complication than other more recently developed valve prostheses. Evidence for this is based on studies that compare series of patients who come from different eras. The problem with such analyses lies in the fact that so many other factors, which might well be expected to influence thromboembolic complication rates, change with time. One such factor might well be the nature of the patients themselves. During the past 30 years there has been a gradual change in the cause of valve disease, such that 20 years ago in the United Kingdom, the majority of patients undergoing heart valve replacement had rheumatic valve disease. Now the commonest surgical valve pathologic process precipitating surgical replacement in developed countries is degenerative.

Similarly, it would seem reasonable to assume that anticoagulation control has improved with the passage of time. It might be supposed that such changes could influence the incidence of thromboembolic and hemorrhagic complications irrespective of the model of valve prosthesis implanted.

One group of patients, those who underwent AVR with a Starr Edwards prosthesis, had a higher incidence of infective endocarditis than others. With the exception of this rather strange and seemingly inexplicable finding we have demonstrated that the Starr Edwards valve has an indistinguishable risk profile from the St. Jude valve in either the mitral or aortic position.

It is possible that the trial allowed a systematic exclusion of patients with very small aortic roots. The timing of randomization, after visualization of the valve and only when the surgeon was happy to insert either valve model, allowed for such systematic exclusion but ensured equipoise among the groups within the trial.

By 5 years after operation there was no difference in symptomatic status between patients with a St. Jude or a Starr Edwards valve in the aortic or mitral position. At this stage in this trial superior hemodynamics claimed for the bileaflet over the ball and cage models has made no difference in the patients’ well-being.

We believe that it is equally important that we have demonstrated that direct comparison between valve prostheses by means of randomized trials is not only possible, but that other indirect means of comparison are inadequate. Not surprisingly we have shown that factors other than the valve model itself, particularly left ventricular function, have a great effect on long-term survival after valve replacement.

With so many relatively new valve prostheses, both mechanical and biologic, currently being introduced, we believe that it is essential that whenever appropriate, the proper way to examine a new device is through controlled trials. In an age when new surgical techniques are arriving with increased frequency, it seems pertinent to remind ourselves that each new treatment should be adequately tested against the existing modalities.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
References
 
We are grateful to both St. Jude Medical UK, Ltd, and Edwards Lifesciences, Ltd, for providing financial support for this study.


   References
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Glower D.D., White W.D., Hatton A.C., et al. Determinants of reoperation after 960 valve replacements with Carpentier Edwards prostheses. J Thorac Cardiovasc Surgery 1994;107:381-393.[Abstract/Free Full Text]
  2. Jamieson W.R.E., Burr L.H., Tyers G.F.O., Munro A.I. Carpentier-Edwards standard and supra-annular porcine bioprostheses: 10 year comparison of structural valve deterioration. J Heart Valve Dis 1994;3:59-65.[Medline]
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  4. Sarris G.E., Robbins R.C., Miller C., et al. Randomized, prospective assessment of bioprosthetic valve durability: Hancock versus Carpentier-Edwards valves. Circulation 1993;88:55-64.[Abstract/Free Full Text]
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  7. Hammermeister K.E., Sethi G., Henderson W., Oprian C., Kim T., Rahimtoola S. A comparison of outcomes in men 11 years after heart-valve replacement with a mechanical valve or bioprosthesis. N Engl J Med 1993;328:1289-1296.[Abstract/Free Full Text]
  8. Bloomfield P., Wheatley D.J., Prescott R.J., Miller H.C. Twelve-year comparison of a Bjork-Shiley mechanical heart valve with porcine bioprostheses. N Engl J Med 1991;324:573-579.[Abstract]
  9. The United Kingdom Heart Valve Registry Report 2000. The Department of Cardiac Surgery, Hammersmith Hospital. UK Heart Valve Registry Copyright 2002, page 10
  10. Ruel H., Van Son J.A.M., Steinseifer U., et al. In vitro comparison of bileaflet aortic heart valve prostheses. St. Jude Medical, CarboMedics, modified Edwards-Duromedics, and Sorin-Bicarbon valves. J Thorac Cardiovasc Surg 1993;1063:412-420.
  11. Baumgartner H., Khan S., DeRobertis M., Czer L., Maurer G. Effect of prosthetic aortic valve design on the Doppler-catheter gradient correlation: an in-vitro study of normal St. Jude, Medtronic Hall, Starr-Edwards and Hancock valves. J Am Coll Cardiol 1992;19:324-332.[Abstract]
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  16. Fernandez J., Laub G.W., Adkins M.S., et al. Early and late-phase events after valve replacement with the St. Jude Medical prosthesis in 1200 patients. J Thorac Cardiovasc Surg 1994;107:394-407.[Abstract/Free Full Text]
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  20. Kuntze C.E.E., Ebels T., Eijgelaar A., Homan van der Heide J.N. Rates of thromboembolism with three different mechanical heart valve prostheses: a randomised study. Lancet 1989;1:514-517.[Medline]
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L. S. De Santo, G. Romano, A. D. Corte, F. Tizzano, A. Petraio, C. Amarelli, M. De Feo, G. Dialetto, M. Scardone, and M. Cotrufo
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The year in valvular heart disease
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R. H. Jones
The year in cardiovascular surgery
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