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Ann Thorac Surg 1997;63:613-619
© 1997 The Society of Thoracic Surgeons

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Original Article: Cardiovascular

Thirty-Year Results of Starr-Edwards Prostheses in the Aortic and Mitral Position

Department of Cardiac Surgery and Institute for Medical Statistics, Biometry, and Epidemiology, University Hospital Großhadern, Ludwig-Maximilians-University, Munich, Germany

Accepted for publication July 12, 1996.

	Abstract

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Background. Between 1963 and 1977 a total of 415 patients admitted to the University Hospital Munich underwent an isolated valve replacement with a Starr-Edwards prosthesis in the aortic or mitral position.

Methods. A retrospective follow-up of 87.1% of the patients representing 4,254 patient-years was completed. Surviving patients were examined by means of echocardiography.

Results. Survival rates after 10, 20, and 30 years were 62.3%, 39.4%, and 19.9% after aortic valve replacement and 75%, 36.5%, and 22.6% after mitral valve replacement (operative mortality excluded). Freedom from all valve-related complications, reoperations, and valve-related death was 66.4%, 43.3%, and 23.8% after aortic valve replacement and 73.4%, 35.4%, and 14.3% after mitral valve replacement. Of the surviving patients, 82% and 76% who received aortic or mitral valves, respectively, are in New York Heart Association class I or II. The pressure gradients of the aortic valves were between 20 and 73 mm Hg; those of the mitral valves were between 9 and 30 mm Hg. Fifty-two percent of aortic and 68% of mitral valves show no echocardiographic peculiarities. The left ventricular function in both groups is normal in 64%.

Conclusions. The long-term results together with the echocardiographic results show that after 30 years the Starr-Edwards valve represents a standard that still needs to be achieved by newer prostheses.

	Introduction

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
The first successful prosthetic replacement of irreversibly damaged aortic and mitral valves was reported by Harken and associates [1] and Starr and associates [2, 3] 36 years ago. These historic surgical procedures mark the beginning of the modern era of heart valve replacement. The ball valve that carries the names of Albert Starr and engineer Lowell Edwards was the first of many to be commercially manufactured in large numbers. Implantations of the Starr-Edwards valve, which experienced several modifications, exceed 200,000, and the valve continues to be implanted today [4–6]. Long-term results with this uniquely designed valve [5, 7–10] have established a standard that prostheses with newer designs and improved hemodynamics still need to achieve.

Between April 1963 and May 1977, we used the Starr-Edwards prosthesis in our clinic for aortic and mitral valve replacements on a routine basis. This study reports 30 years of long-term results in these patients.

	Material and Methods

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Patient Population
Operations were performed on a total of 416 patients (295 male and 121 female patients) with a mean age of 40.1 ± 10.1 years (range, 14 to 62 years). Aortic valves were replaced 286 times (group A), the mitral valve 130 times (group M). The majority of patients were in NYHA class III (Fig 1). Preoperatively, right and left heart catheterization with pulmonary artery pressure and transvalvular gradient measurements were performed on each patient. Based on heart catheterization findings, the indication for valve replacement in group A was insufficiency in 44.1% (126 patients), combined failure in 33.2% (95 patients) and stenosis in 22.7% (65 patients) of cases. In group M, combined valvular defects were diagnosed in 69.2% (90 patients), insufficiency in 23.1% (30 patients), and stenosis in 7.7% (10 patients). Only patients who required isolated aortic or mitral valve replacement were included in the study; those with concomitant coronary artery operation were excluded.

View larger version (11K): [in this window] [in a new window]   Fig 1. . Preoperative New York Heart Association ( NYHA) classification of patients before aortic and mitral valve replacement.

Within the implantation time frame at our clinic, the design of the valve was changed several times by the manufacturer. The most noteworthy modifications were the covering of the cage with Dacron or Teflon cloth and the variation of the ball material. Table 1 describes the various models, manufacturing dates, the most important manufacturing changes, and the number of each model implanted at our clinic. In Figure 2 the most frequently used cloth-covered and non–cloth-covered models in this study are shown.

View larger version (118K): [in this window] [in a new window]   Fig 2. . Frequently used Starr-Edwards valves: aortic models 1000 (A) and 2320 (with cloth-covered cage) (B), mitral models 6000 (C) and 6320 (with cloth-covered cage) (D).

Follow-up
All patients whose patient record did not note a date of death were sent a questionnaire to their last known address to be completed by the patients and their physician. A resting echocardiographic examination was performed on these identified survivors. Prosthetic function, peak transvalvular gradients, contractility, myocardial thickness, and the diameter of the atria and ventricles were determined.

Attempts were made to find patients who did not return a questionnaire by contacting central telephone information, resident registration offices, medical insurance companies, and finally known treating physicians. In patients who had already died, our patient records, the records of other treating physicians, and the records of hospitals and insurance companies were examined for the causes of death and nonfatal complications.

Those patients who could not be located are reported as being lost to follow-up. Retrospective postoperative follow-up for up to 30 years was possible for 241 patients (84.2%) in group A and 117 patients in group M (90.0%). Fifty-eight patients were lost to follow-up, mainly through relocation to foreign countries (Fig 3). Overall follow-up was completed on 358 of 416 patients (86.1%), representing 4,254 patient years (pt-y) (group A, 2,649 pt-y; group M, 1,605 pt-y).

View larger version (35K): [in this window] [in a new window]   Fig 3. . Fate and causes of death (excluding early mortality) in patients after Starr-Edwards aortic and mitral valve replacement. ( Pts = patients.)

Definitions
All valve-related data have been collected and are reported according to the guidelines for reporting morbidity and mortality after cardiac valvular operations as published by Edmunds and associates [12].

	Results

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Operative Mortality
Forty-nine aortic valve patients and 13 mitral valve patients died within the first 30 days after the implantation of a prosthesis, for a total early mortality of 17.1% and 10.0%, respectively. The perioperative mortality rate decreased from 22.1% (A) and 14.3% (M) during the early years of the implantation period of the prosthesis to a rate of 5.4% (A) to 3.9% (M) during the last 5 years. All causes of perioperative death were not valve-related. The causes and number of deaths are listed in Table 2.

View larger version (18K): [in this window] [in a new window]   Fig 4. . Long-term survival (excluding 30-day mortality) after Starr-Edwards aortic and mitral valve implantation. (Numbers in the lower part indicate the number of surviving patients at the time, expected curve shows the long-term survival of a corresponding control population according to the mortality table of the German Federal Department of Statistics.)

Complications
Thromboembolic events after the implantation of a Starr-Edwards aortic valve were observed 36 times, corresponding to a linearized rate of 1.36% per pt-y. Patients receiving a Starr-Edwards mitral valve suffered a thromboembolic complication in 20 cases, with a linearized rate of 1.25% per pt-y. Anticoagulant-related hemorrhage was recorded in 28 cases in group A (1.06% per pt-y) and in 9 cases in group M (0.56% per pt-y). According to the definition [12], structural valve deterioration has been found only once in the aortic group. In this prosthesis (model 1000) we found evidence of "ball variance" [13]. Nonstructural dysfunctions in aortic and mitral valves were seen 11 and 5 times, respectively. Endocarditis was diagnosed in 7 group A patients and 3 group M patients.

Reoperations were performed in a total of 33 patients (1.25% per pt-y or 13.7% of the patient population) with aortic prostheses and in 8 mitral valve patients (6.8% of the patient population). In 1 group A patient and 2 group M patients paravalvular leaks were closed. A new Starr-Edwards valve was implanted in 4 aortic patients and 1 mitral valve patient. Nine aortic valve patients and 1 mitral valve patient had a Starr-Edwards valve replaced with a bioprosthesis. Another type of mechanical valve was implanted in 17 group A and 4 group M patients. All patients whose original valve has been replaced have been censored from follow-up at the time of reoperation. The average length of time to reoperation was 8.2 years in group A and 9.7 years in group M. The reasons and number of reoperations are summarized in Table 3. In four explanted group A valves and two group M valves, damage to the cloth covering of the cage was found. Only 2 of these patients, however, were reoperated on due to recurring emboli. A significant difference in the rates of reoperation between the various valve types was not found in either the aortic or mitral valve group.

View larger version (15K): [in this window] [in a new window]   Fig 5. . Freedom from reoperation after Starr-Edwards aortic and mitral valve replacement. (Numbers in the lower part indicate the number of patients at the time.)

View larger version (17K): [in this window] [in a new window]   Fig 6. . Freedom from all valve-related complications including valve-related causes of death after aortic and mitral valve replacement. (Numbers in the lower part indicate the number of patients at the time.)

Complications in Surviving Patients
Twenty surviving patients in group A and 4 surviving patients in group M required reoperation. The average time to reoperation in group A was 10.3 years. A new Starr-Edwards valve was implanted in 3 patients, and 17 patients received another type of artificial valve. For the mitral valve group, time to reoperation averaged 13.1 years. One patient again had a Starr-Edwards prosthesis implanted and 3 patients had other prostheses. Linearized complication rates based on pt-y in surviving patients (A, 1,192 pt-y; M, 749 pt-y) were calculated to provide a comparison with the entire patient population. Complication rates in all surviving patients are presented together with the total complications in Table 4.

Surviving Patients With Starr-Edwards Prostheses
Follow-up examinations found 39 (16.4%) and 25 patients (21.4%) with their respective originally implanted Starr-Edwards aortic and mitral valves alive. Mean survival of these patients was 21.1 years in the aortic and 24.1 years in the mitral valve group. Six patients out of both groups have survived for 30 years. All patients are now anticoagulated, maintained with a prothrombin time between 20% and 30% (international normalized ratio, 4.5 to 3.0).

Thirty-two of the 39 patients (82%) in group A are currently in New York Heart Association class I or II, 7 patients are in class III, and no patients are in class IV. In group M, 19 of 25 patients (76%) are in class I or II, 6 patients (24%) in class III, and no patients are in class IV (Fig 7). At the time of examination, all patients in class III were under close medical supervision. Twenty-four patients with aortic prostheses (61.5%) and 16 patients (64%) with mitral prostheses are retired; 15 and 9, respectively, are working.

View larger version (10K): [in this window] [in a new window]   Fig 7. . Current New York Heart Association ( NYHA) classification of surviving patients with Starr-Edwards aortic and mitral valve. (Numbers on top of each block indicate the number of patients.)

Echocardiographic Results
The peak pressure gradients ranged between 20 and 73 mm Hg (mean, 36.2 mm Hg) in aortic prostheses and between 9 and 30 mm Hg (mean, 16.6 mm Hg) in the mitral prostheses. Grade 1 insufficiency was identified in 33% of aortic and 20% of mitral valves. A stenotic condition with high gradients was seen in 15% of group A and 12% of group M patients.

Left ventricular myocardial function was measured as a function of fractional shortening and was normal in 64% of both groups. Significant left ventricular hypertrophy was seen in 64% of group A patients (wall thickness > 12 mm). In group M, left ventricular configuration was normal in 52% of the patients. The left atrium was normal in 62% of patients with an aortic prosthesis; however, left atrial dilatation was found in all patients with mitral prostheses (left atrial diameter > 40 mm). All echocardiographic results are summarized in Table 5.

	Comment

Top Footnotes Abstract Introduction Material and Methods Results Comment References

The survival rates of our patients are higher than those of other authors [4, 6, 9, 10, 14, 15] within the reported time periods after Starr-Edwards valve replacement. In these studies the 10-year survival rates after aortic valve replacement range between 54% [10] and 56% [9] and between 54% [10] and 70% [6] after mitral valve replacement. After 15 years, the survival of patients who received an aortic valve was between 40% [6] and 42% [10]; that of mitral valve recipients was between 35% [10] and 48% [14]. The higher survival rates in our patient groups are caused by excluding early mortality. The high 30-day mortality that we observed early on is probably related to the limited possibilities of myocardial protection and the still-developing possibilities of postoperative intensive care medicine and not to the prosthesis itself. Therefore it is justifiable not to include early mortality in the evaluation of the 30-year long-term qualities of this device. When operative mortality is still included, the survival in our patient group is 49.2% (A) and 70.0% (M) after 10 years, 46.6% (A) and 39.2% after 20 years, and 16.6 (A) and 18.4% (M) at 30 years. Now survival in our aortic group up to 15 years is slightly less than in the compared studies; survival in the mitral group does not differ from the other authors' reports.

Considering that this is a retrospective study, there may have been incomplete data collection, particularly for complications. This is especially true because we did this review only once at the end of 30 years and not on an annual or semiannual basis. To rule out this possible data loss as much as possible, we additionally evaluated the complications of surviving patients, where we were certain to obtain all information relevant to specific questions. If one places these data next to the complication rates of the total patient population (see Table 4), there only is a clear difference in the rates of thromboembolism in the aortic group and in the incidence of reoperations in both groups. As is expected, among the survivors there are more patients who have undergone reoperation and who have probably survived as a result of the reoperation. The lower incidence of thromboembolism implies that this could be the most frequent cause of valve-related death in our patients, and therefore the rate of thromboembolism in surviving patients will be less than in the total group. One major reason for this low complication rate may be the mean patient age of 40.1 years, which is much younger than in most series. Because patient characteristics are known to have a profound influence on valve performance, this additionally must be considered in comparing our data with other studies with an older patient population.

The better long-term survival rate of mitral valve patients when compared with aortic valve patients partially contradicts other experiences, but is in our opinion related to operative techniques. In our patients the myocardium was not perfused during aortic valve replacement, whereas in mitral valve procedures continual myocardial perfusion with blood was maintained. This should result in a reduction of intraoperative myocardial injury, which is positively revealed in the long-term results.

The fact that the majority of the surviving patients are in New York Heart Association class II and that more than one-third of these patients are still working demonstrates a good quality of life in patients who have had a Starr-Edwards valve for more than 20 years. No patient complained about the noise of the prosthesis; most of them state that they do not even hear it.

Echocardiographic results show that over time the heart does adapt in specific conditions to the prosthesis. Fifty-four percent of hypertrophied left ventricles with only 15% stenotic valves in the surviving aortic patient group prove that sufficient cardiac function could only be maintained by significant ventricular hypertrophy. Therefore, not every hypertrophy is necessarily be related to a nonstructural valvular dysfunction like entrapment by pannus or suture [10]; hypertrophy may be caused by the high transvalvular gradient of this particular type of prosthesis itself. Dilatation of the left atrium in the same way is the response to the additional burden of a mitral Starr-Edwards prosthesis. Because in patients with mitral valve replacement, the aortic valves are not affected, the left ventricles are not hypertrophied or dilated and demonstrate normal function. Overall, the echocardiographic results are satisfactory, and we believe that earlier implanted Starr-Edwards valves should not be prophylatically removed, eg, after 20 years. The removal of the prosthesis should be evaluated on an individual basis in patients who require an additional cardiac operation for other indications.

In conclusion, in view of the ultra-long-term course, echocardiographic findings, and the quality of life of the surviving patients, we conclude that the results with Starr-Edwards prostheses are satisfactory. Because only two of the valve models used in this study are still available today, these results do not demonstrate a final standard for succeeding devices; nevertheless, until the modern prostheses can show a significant improvement in long-term results, the Starr-Edwards valve will represent the gold standard in mechanical valve replacement.

	Footnotes

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Address reprint requests to Dr Gödje, Department of Cardiac Surgery, Ludwig-Maximilians-University, University Hospital Großhadern, 81366 Munich, Germany.

	References

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 

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This Article Abstract Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Teddy Fischlein Georg Nollert Werner Klinner Bruno Reichart Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Gödje, O. L. Articles by Reichart, B. Search for Related Content PubMed PubMed Citation Articles by Gödje, O. L. Articles by Reichart, B.