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Gordon K. Danielson
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Ann Thorac Surg 1997;63:620-626
© 1997 The Society of Thoracic Surgeons

Original Article: Cardiovascular

Event Status of the Starr-Edwards Aortic Valve to 20 Years: A Benchmark for Comparison

Thomas A. Orszulak, MD, Hartzell V. Schaff, MD, Francisco J. Puga, MD, Gordon K. Danielson, MD, Charles J. Mullany, MB, MS, Betty J. Anderson, RN, Duane M. Ilstrup, MS

Division of Thoracic and Cardiovascular Surgery and Section of Biostatistics, Mayo Clinic, Mayo Foundation, Rochester, Minnesota

Accepted for publication December 27, 1996.


   Abstract
Top
 Footnotes
 Abstract
Introduction
 Materials and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background. Considerable effort and expense has been invested in the evolutionary development of cardiac valvular prostheses with the goal of reducing or minimizing specific events related to these prostheses. It is important to measure any improvement achieved with such development by comparison against a historic standard. The Starr-Edwards caged-ball prosthesis model 1260 has been used for 30 years as the predominant or sole model of its kind for aortic valve replacement. This historic opportunity provides a benchmark for subsequent improvement and comparison of current prostheses.

Methods. Between 1969 and 1991, 1,100 patients (median age, 57 years; 838 men and 194 women) underwent aortic valve replacement with or without coronary artery bypass grafting (aortic valve replacement, 964; aortic valve replacement plus coronary artery bypass grafting, 136) with the 1260 Starr-Edwards caged-ball prosthesis.

Results. Operative mortality was 6.2% (68 patients). Univariate patient characteristics predictive of early mortality were female sex (p = 0.003), age (>56 years; p = 0.002), recent operative interval (1985 to 1991 versus 1969 to 1976 or 1977 to 1984;p = 0.002), presence of atrial fibrillation (p = 0.001), and small valve size (7A to 8A = 19 to 21 mm; p < 0.001). Follow-up extended to 11,293 patient-years (mean, 24.8 years) and was 96.9% complete. Survival at 5, 10, 15, and 20 years for all patients including operative mortality was 76.6%, 59.6%, 44.9%, and 31.2%, respectively. Operative variables predictive of poor late survival were advanced New York Heart Association class (III or IV); (p = 0.0001), older age (>56 years; p = 0.0001), and lower (<0.56) ejection fraction (p = 0.0001). Freedom from thromboemboli and anticoagulant-related bleeding at 5 years was 90.8% and 98.7%, respectively. Univariate model for greater risk of late thromboemboli identified female sex (p = 0.04), older age (>56 years; p = 0.0002), and New York Heart Association class III or IV (p = 0.0058), as risk factors. Multivariate analysis for thromboemboli demonstrated older age (p = 0.0007) and New York Heart Association class III or IV (p = 0.0041) as significant. Alternatively, univariate analysis for late bleeding found only the most recent operative interval (p = 0.009) as significant, and the rarity of events prevented a multivariate query. There were no valve failures.

Conclusions. The late results of survival and freedom from late anticoagulant-related bleeding or thromboemboli are excellent, especially in larger (9A and above) sizes, and with the long implant record comparable with more recent prostheses, the Starr-Edwards valve provides an excellent, safe, and durable alternative in the aortic position and provides a benchmark against which to compare other prostheses.


   Introduction
Top
 Footnotes
 Abstract
 Introduction
Materials and Methods
 Results
 Comment
 Acknowledgments
 References
 
The benefits and liabilities of all cardiac valve prostheses are common knowledge to physicians caring for patients with valvular heart disease, and considerable literature and financial investment has attested to the advantages and disadvantages of the past and present valve models [1–11]. Several facts have become general knowledge. Survival alone provides little insight into the optimum prosthesis. Individual patient-related variables are the strongest determinants of early and late results [12, 13]. With the investment of time and money devoted toward the development of "newer and better" devices, there has been improvement compared with the earliest of the mechanical prostheses implanted. Starr's pioneering insertion of the caged-ball valve revolutionized the treatment of valvular heart disease [14]. It prompted an industry of many models and advances in valvular devices, which have helped treat many patients otherwise destined for heart failure and death. However, has the 30 years since that groundbreaking endeavor demonstrated significant improvements in design that are interpreted as better patient event-free survival? To answer that question requires a standard of achievement for comparison. The Starr-Edwards (S-E) aortic model 1260 has been implanted unchanged since 1965, providing a potential of 30 years of follow-up as a benchmark for any and all devices to compare. The S-E 1260 prosthesis has been implanted since 1969 at our institution as a continuum, not as the sole or necessarily the preferred choice, but in sufficient numbers to provide an excellent data base to review and chart the early and late results for this aortic prosthesis in a large population from a single institution.


   Materials and Methods
Top
 Footnotes
 Abstract
 Introduction
 Materials and Methods
Results
 Comment
 Acknowledgments
 References
 
Patients
Between January 1, 1969, and December 31, 1991, all 1,100 patients undergoing aortic valve replacement (AVR) with the S-E aortic ball-valve prosthesis (model 1260) were reviewed. The earliest AVR with an S-E valve (models 1000, 1200) was in 1961 at our institution; however, those models were replaced by the 1260, and this was the sole S-E prosthesis implanted from 1969. Ages of the 838 men and 194 women ranged from 18 to 86 years (median, 57 years), and the overall 30-day or hospital mortality was 6.2%. Nine hundred sixty-four patients had AVR (30-day mortality, 5.8%; median age, 56 years) and 136 patients had AVR + coronary artery bypass grafting (CABG) (30-day mortality, 8.8%; median age, 62 years). Associated procedures other than CABG (1.68 grafts/patient) were mitral valve repair in 47 and tricuspid valve repair in 10 patients. Fifteen percent of patients had a previous cardiac operation before the implantation of the S-E valve: 142 patients had prior AVR, 18 had prior aortic commissurotomy, and 10 patients had previous CABG. Any patient receiving any other valve prosthesis or a prosthesis in another location was excluded from the review. Follow-up data required at least a recent (preceding 12 month) clinic visit, correspondence, or phone contact and ranged from 1 to 24.9 years, with a median of 10 years, for a total of 11,293 patient-years. Follow-up was 96.9% complete with 34 patients lost from contact. The series was interrogated for operative and late survival and events and variables influencing these results. The late survivals were determined both with and without operative mortality and are presented with the operative mortality included, although there was no significant difference in late event calculation whether early mortality was included or excluded. When death occurred, the rate of postmortem examination was 27.4%. The review also detailed the valve-related events according to the criteria established by the Guidelines Committee for Reporting Morbidity and Mortality after Cardiac Valvular Operations [15].

The operative techniques included cardiopulmonary bypass and hypothermic perfusion. The method of myocardial preservation evolved during the period of the review. Thirty patients had ischemic arrest, 722 underwent continuous perfusion, and 366 had cold cardioplegia.

The patient population was equally distributed across pathologic causes, with 338 patients having aortic stenosis, 335 patients having aortic regurgitation, and 409 patients having mixed aortic stenosis and regurgitation. Two hundred forty-two patients had unknown or class I New York Heart Association symptoms, 254 class II, 550 class III, and 14 class IV. Seventy-one percent demonstrated cardiomegaly on chest roentgenograms, 63.5% of patients had left ventricular hypertrophy, and 81.1% had strain on electrocardiograms. Thirty-seven percent had some evidence of preoperative conduction disturbance. Half of the patients (536) had bicuspid valve disease and 299 had degenerative aortic stenosis. Postoperatively, all but 1 patient received warfarin chronically for anticoagulation, although intermittent interruptions could not be denied nor verified, and most recently patients were also receiving antiplatelet therapy (136 patients). Also in the most recent era, 285 patients received intravenous heparin therapy until their prothrombin times were therapeutic. Valve size distribution can be seen in Table 1Go.


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  		Table 1. . Patient: Valve Distribution by Size
 
Statistical Methods
Survival and survivorship free of late events were calculated using the Kaplan-Meier method [16]. Survivor and survivorship free of late events were originally calculated both including and excluding 30-day mortalities, but because the relationships of survival to risk factors were similar, all survivals presented in this article include patients who died in the hospital or within 30 postoperative days. For survivorship free of late events, patients without a late event at the time of reoperation unrelated to their aortic valve were censored at the time of reoperation. Univariate analysis of risk factors were tested for significance using log-rank tests [17]. The Cox proportional hazards model [18] was used to evaluate whether continuous variables such as age or ejection fraction were significantly related to survival or survivorship free of late events. Continuous distributions were divided at their median to graphically demonstrate the effect of continuous variables on survival. Expected survival was estimated using age- and sex-specific death rates from life tables of the West North Central Region of the United States [19]. The relationships of risk factors to perioperative mortality were investigated univariately with {chi}2 tests and Wilcoxon rank-sum tests and multivariately with logistic regression [20]. Values of p less than 0.05 were considered to be statistically significant.


   Results
Top
 Footnotes
 Abstract
 Introduction
 Materials and Methods
 Results
Comment
 Acknowledgments
 References
 
Hospital and 30-day mortality overall was 6.2%. The operative variables did not differ substantially between the cohorts of patients with and without CABG; however, the 5-year survival was lower (p = 0.0008) in women having AVR + CABG than men, 47.1% versus 77.9%, respectively. The cohort with CABG was a smaller but older (62 years versus 56 years) group (136 patients, 17 women), and this may mask other significant differences. The percentage of patients having associated CABG in the three successive eras (1969 to 1976, 1977 to 1984, and 1985 to 1991) was 7.1%, 17.8%, and 27.1%, respectively.

Univariate and multivariate analyses were performed for early or operative mortality, and with the univariate model, female sex (p < 0.003), older age (>56 years; p < 0.002), presence of atrial fibrillation (p < 0.0001), recent operative interval (1985 to 1991 versus 1969 to 1976 or 1977 to 1984; p < 0.0002), and small valve size (7A to 8A = 19 to 21 mm; p < 0.001) (Fig 1Go) were found to increase the risk of operative mortality. With multivariate analysis, older age (p < 0.0484), recent era (p < 0.0045), preoperative atrial fibrillation (p < 0.0001), and small valve size (p < 0.0002) were significant for operative mortality (Table 2Go).



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  		Fig 1. . Comparative survival, including hospital and 30-day mortality, demonstrating negative influence of small valve size.

 

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  		Table 2. . Significant Operative Variables From Multivariate Analysis
 
The 5-, 10-, 15-, and 20-year survival for the 1,100 patients was 76.9%, 59.8%, 44.8%, 31.2%, respectively. Comparison with an aged-matched population is demonstrated in Figure 2Go. Factors negatively influencing late survival were advanced New York Heart Association class (III or IV; p < 0.0001), older age at operation (>56 years; p < 0.0001), and lower ejection fraction (<0.56; p < 0.001). We did not identify era of implantation as a variable affecting late survival.



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  		Fig 2. . Actuarial survival of all patients ( PTS), including hospital and 30-day mortality, compared with an age- and sex-matched population.

 
The freedom from reoperation for any or all causes (coronary artery disease, other valve disease) at 10 and 20 years was 85.5% and 64.6%, respectively. The freedom from reoperation on the S-E valve specifically (eg, paravalvular leak) at 10 and 20 years was 91.5% and 80.4%, respectively. The freedom from reoperation that required S-E valve replacement at 10 and 20 years was 93.7% and 86.1%, respectively.

Three patients' follow-up correspondence reported needing reoperation for "valve failure." All of these valves were traced to the hospital or physician in charge of the removal, and on final analysis, the valves were removed for failure due to thrombosis not valve component malfunction. Thus no intrinsic valve failure was found, and the freedom from thrombosis at 10 and 20 years was 99.9% and 99.1%, respectively. This is an optimistic rate with our postmortem examination rate of 27.4%, but this parallels other series' rate of postmortem examinations.

The freedom from endocarditis at 10 and 20 years was 94.8% and 92.8%, respectively.

Due to the concern about the long-term events in all mechanical prostheses and the skepticism about the S-E prosthesis, we diligently examined the incidence of major neurologic complications cumulatively (stroke) and individually (thromboemboli and hemorrhage) and the variables that may affect their incidence. The freedom from thromboemboli (TE) and hemorrhage at 10 and 20 years was 84.3% and 74.5%, respectively. Individually, freedom from TE at 10 years was 86.7% (Fig 3Go), and freedom from bleeding at 10 years was 97.8% (Fig 4Go). Due to the potential effect of different implantation times, the entire cohort was divided into three time periods to compare the reality of events. This limits the duration of time the most recent cohort could be followed up, and the results are thus expressed as freedom from events at 5 years. Within the three cohorts, the freedom from thromboemboli at 5 years was 91.2% (Fig 5Go) and freedom from hemorrhage at 5 years was 98.7% (Fig 6Go). The inclusion or exclusion of perioperative deaths did not statistically alter the results, which are presented with early deaths included. Both events were scrutinized under the same variables applied to early and late mortality, and older age (>=56 years) and New York Heart Association class III and IV were significantly associated with an increased incidence of thromboemboli with both univariate and multivariate models. The univariate model identified a recent decade of implantation as an increased risk of hemorrhage (see Fig 6Go); however, due to a low number of events (21), no multivariate analysis was possible. Late survival was not significantly different between eras of implantation (Fig 7Go).



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  		Fig 3. . Freedom from thromboemboli to 20 years postoperatively (excludes hospital and 30-day mortality).

 


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  		Fig 4. . Freedom from anticoagulant-related bleed to 20 years postoperatively (excludes hospital and 30-day mortality).

 


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  		Fig 5. . Comparative freedom from thromboemboli by cohorts determined by era of operation. ( NS = not significant.)

 


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  		Fig 6. . Comparative freedom from anticoagulant-related bleed by cohorts determined by era of operation.

 


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  		Fig 7. . Actuarial survival by era of implantation. ( NS = not significant.)

 
The final consideration is the freedom from any major event, and the 10- and 20-year freedom was 47.2% and 19.5%, respectively. The linearized rate of the events is tabulated in Table 3Go.


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  		Table 3. . Linearized Rates of Events
 
The anticoagulation status was evaluated, and it was impossible to establish adequacy of therapy over the 24.9 years of follow-up. There was only 1 patient who had not been on any anticoagulation and had no major events at 23 years postoperatively. There was not a standard in-hospital protocol for heparin administration early in our experience; however, the most recent time period did include patients who received intravenous heparin until the warfarin levels became therapeutic. We did determine that the patients were receiving warfarin at the time of follow-up, but we could not ascertain the adequacy of the anticoagulant therapy.


   Comment
Top
 Footnotes
 Abstract
 Introduction
 Materials and Methods
 Results
 Comment
Acknowledgments
 References
 
It has become common knowledge that survival statistics provide a less than satisfactory standard with which to compare prostheses. There is substantial literature complimenting or condemning the broad choice of prostheses, and on close scrutiny, the late results of survival are striking in their similarity. We have reviewed the S-E prosthesis, which has been a stalwart valve of implantation at our institution since 1969. Volumes of literature have been written and millions of dollars have been spent to develop better devices to overcome the "limitations" of this pioneering prosthesis. On close observation, there have been little improvements in events despite recent advances in prosthetic design. Why did we write another article on a prosthetic dinosaur that few surgeons use and consider obstructive and obsolete? We thought that the volume of data, albeit retrospective, with these 1,100 patients using a single model (1260) or prosthesis from a single institution would provide an excellent basis for comparison for other current prostheses and demonstrate that this prosthesis performs well and compares excellently with any other mechanical valve. It is more common to find reports of several different prostheses used in one valve location rather than a single type of device. All aspects of this review stand up to the scrutiny of other series in relation to operative mortality, survival, and all the event-free periods to and beyond 20 years. This prosthesis provides a benchmark of a currently used prosthesis against which to compare all of the past and current valve prostheses.

The mortality rate of 6.2% compares favorably with those in the literature ranging from 3% [21] to 15% [6]. The higher mortality of 8.8% with associated CABG was similarly described by Lytle and colleagues [22] and Magovern and associates [13] in their descriptions of combined AVR and CABG. This difference did not reach statistical significance as a determinant variable for early or late mortality in our study, and this is likely due to the relatively small numbers of patients with CABG (136) compared with those without (964) and the older age of the CABG patients (62 years versus 56 years). These variables may also explain the lower survival seen in women having AVR plus CABG in our review. This is in contrast to the study by Magovern and associates [13], where male sex was associated with a higher rate of late death in patients having AVR plus CABG. Male patients also fared worse in Gehlot and associates' [23] report of AVR in patients older than 80 years, especially with the addition of CABG.

Another variable that increased the operative mortality was older age, which has also been described by others with similar patient cohorts [10, 13, 21, 24] undergoing AVR with or without CABG. The inference is obvious and supports patient selection as a facet of risk modification. It is also important to state that older age alone is not a sufficient reason to avoid or refuse operation, but as defined by Gehlot and associates [23], proceeding before decompensation will minimize the adverse effect of age.

The presence of atrial fibrillation as an associated operative risk for death has also been described by Lytle and colleagues [10]; also in their report, atrial fibrillation did not adversely influence late survival. A speculative explanation for this is that patients with atrial fibrillation secondary to end-stage aortic stenosis provide a marker for ventricular decompensation, which is unusual but significant. This was not correlated with operative mortality in Lytle and colleagues' study, and we were similarly unable to correlate this finding with operative mortality. There is also speculation that possible emboli from left atrial or ventricular thrombus would adversely affect operative mortality manifesting as myocardial infarction or stroke. In fact, the variable of atrial fibrillation is more notable as a marker for early or perioperative neurologic events [24].

Survival in the recent operative era was comparitively lower than in the preceding eras. This would seem contrary to recent developments in technique and myocardial preservation. No patient-related variable or explanation could be identified that would withstand statistical scrutiny. It was noted that the latest era had the least number of patients (125), but these patients had the highest percentage of coronary disease and CABG, 27.1% versus 17.8% versus 7.1%. This would imply that the operative approach might be more complex and the myocardium at greater risk for ischemia and injury. This increase in operative mortality with the addition of CABG was identified by other groups including those of Magovern [13], Lytle [21], and Gehlot [23], who described the increase in risk over isolated AVR from 3.5% to 13.5%. The lack of statistical significance with the entire cohort may be due to the small numbers of patients with CABG in the overall group.

The notable variable of small S-E valve size (7A and 8A, 19 to 21 mm) as adversely influencing operative mortality is not specific to this prosthesis. Kratz and colleagues [25] demonstrated an increased death rate with the small (19 to 21 mm) St. Jude valve. They were able to relate this to the placement of the small prosthesis in patients with a body surface area greater than 1.9 m2. Valve size as a determinant for mortality was also described by Gehlot and associates [23] in patients older than 80 years, and by Morris and colleagues [21]. Morris and colleagues' report, however, did not find this variable to be dependent on sex or body surface area. The explanation was speculative and included undetected or unqueried interactive variables or possibly the patient–prosthesis mismatch originally described by Rahimtoola [26] in 1978. Sim and associates [27] demonstrated better left ventricular mass index reduction with aortic root enlargement for patients with a small aortic root as compared with patients having a small prosthesis implanted without root enlargement. A goal of prosthetic design is to reduce obstruction and turbulence, although it would appear that valve model or design may not be as important as implanting a valve large enough to minimize or eliminate the outflow tract obstruction inherent in small prostheses. An interesting study by Chandran and coworkers [28] with laser anemometry described a higher degree of turbulent stress distally with a tilting-disc prosthesis over the caged ball by a factor of 2:1. It must be remembered that during the early years of this experience, the S-E valve was the only prosthesis available for AVR before the development of other prostheses.

Freedom from reoperation with the S-E prosthesis is similar to that of other mechanical prostheses when comparing their inherent risks for paravalvular leak, infection, or subsequent development of other cardiac disease (ie, coronary artery disease). The relation of event-free period comparing reoperative causes can be seen in Table 3Go.

The two major limitations of any mechanical prosthesis requiring discussion are the thrombotic and hemorrhagic complications. The overall freedom (1,100 patients) from TE at 10 years is 86.7%. This compares very favorably with the reports by several authors. In an earlier series by Miller and associates [8], the 10-year freedom from TE was 74%, excluding operative deaths, in patients having AVR with the S-E valve. Lund and colleagues [7] compared the S-E and the St. Jude valve in the aortic position, and no difference in survival or events (freedom from TE at 5 years: S-E 95% versus St. Jude 97%) was detected, although the series was not randomized. Patients and their physicians are unlikely to omit a major embolic or hemorrhagic event even at a later date; however, transient ischemic events may go unreported or unrecognized if orthostatism or medication is blamed, and reports of such events are thus unreliable. A consistent approach and categorization of events was undertaken with each visit or contact information with patients, and the reports are as reliable as those of any retrospective study. From the aspect of our study, the S-E valve performed at least as well as other current mechanical prostheses, and in some situations, better.

Due to reports [29–31] that time of implantation may affect the rate of TE or survival, we also focused on different years of implantation. The entire group was divided into 7-year periods (1969 to 1976, 1977 to 1984, and 1985 to 1991) to assess any change or affect of change of practice on results. We found no difference in rate of TE or survival (see Fig 7Go) between the three timed cohorts. This is in contrast to Cobanoglu and associates' [31] report, in which the rates of freedom of almost all events including TE were improved in the second decade of follow-up. In that study, the second decade "time clock" was returned to zero for the calculation of events, which may have influenced the results. An earlier review by Fuster and coworkers [32] from our institution described a higher rate of TE with the S-E valve, although this review included patients from 1962 to 1971 and included three S-E models (1000, 1200, and 1260). These series overlap minimally in the early stages due to the concentration of use of the 1260 model solely since 1969.

A similar comparison was performed with anticoagulant-related bleeding. The freedom from bleeding at 10 years was 97.8% for all patients. The results are considerably better than those of other series of S-E valves and St. Jude valves. A somewhat unexpected finding in the timed subsets of patients was that the most recent time interval had a statistically greater degree of bleeding. This was in contrast to reports by Cobanoglu and associates [30] and Wein and colleagues [31], that showed a decrease in bleeding rate in the later time period. The explanation is based on the influence of Fuster and coworkers' [32] study in which, in an effort to decrease the TE rate, antiplatelet therapy (aspirin, dipyridamole, or both) was universally used in addition to warfarin, which was used at our institution. A potential added explanation was the application, near the end of the study period, of the international normalized ratio as a more controlled method of monitoring levels of anticoagulation. In the formative times of this change, the reagents were not standardized and the anticoagulant levels varied widely. Due to geographic distance and the retrospective nature of the follow-up, we were unable to confirm adequate or excess levels of anticoagulation in this study.

It would appear that many prostheses in their smaller sizes may be obstructive despite the most advanced hemodynamic designs, and serious consideration should be given to an annulus-enlarging procedure in any or all patients who have an aortic root diameter of 21 mm or less, especially if their body surface area is greater than 1.8 or 1.9 m2. There has been considerable reluctance, explained by added time and technical difficulty, to enlarge the aortic annulus and root; however, Sim and associates [27] compared the cross-clamp times of those patients with and without pericardial patch enlargement of the aortic root and demonstrated that there was no difference in aortic cross-clamp time or bypass time between the two groups. This aspect of the small root, especially in those patients having the 7A and 8A S-E valves implanted, may correlate with and help explain the variable of female sex (smaller body surface area) being a negative influence on operative mortality. Due to the early time periods of use of the 7A and 8A S-E valves and its fairly early discontinuation, accurate correlation of body surface area could not be performed in our patient cohort; however, it would appear to be a safe speculation that the variables of small valve size and female sex are closely associated. If we examine the data at hand, the S-E valve compares favorably with current-generation prostheses. It has, however, withstood the test of time and is the aortic mechanical prosthesis longest in use, verifying its durability. This durability is embellished by the absence of intrinsic or premature mechanical or component failure. Other event rates for the S-E valve are comparable with those of other prostheses, and although the S-E valve is not immune to thrombosis, there may be a noncatastrophic occurrence of thrombosis in that ball motion may be restricted, causing progressive stenosis or insufficiency, but it is unlikely to stick open or closed suddenly. It has the added advantage of being easy to insert, with a robust sewing ring. The silicone poppet is quiet in its seating in the struts and the housing ring and thereby minimizes noise. The disadvantages of the caged-ball valve have been verified, with its higher operative risk and obstruction in the smaller sizes, and thus it should not be used in the small aortic root. Although elaborate procedures can be performed to insert an S-E valve in the small aortic root, and because its event statistics are quite comparable with those of other prostheses, a low-profile valve may be a better option, although it is necessary to factor in the body surface area such that a root enlargement may be required even with a low-profile, tilting-disc, or bileaflet valve [25].

In conclusion, there is no ideal valve that meets the characteristics so well proposed early in prosthetic valve history and reiterated by Roberts [33] in 1976. With limitations of the healthcare dollar, it is prudent to closely examine these statistics and recognize the similarity or equality of mechanical prostheses given the boundaries outlined above. We may be at the limits of valve design as we know it in relation to the most efficient flow with the least obstruction to cardiac output. Given an appropriately sized valve for an individual, the most discouraging and most catastrophic events are related to thromboemboli and bleeding, which balance the sword of Damocles over the patient's future. Perhaps advances will be made in the components of prostheses such that they are less thrombogenic or different anticoagulants will be developed to decrease or eliminate the current problems with thromboemboli and bleeding.

We believe that the S-E (1260) aortic valve, especially in sizes 9A/23 mm and larger, is an excellent prosthesis, and due to its excellent durability, no intrinsic failures, and low thrombosis rate, should be given serious consideration for patients requiring mechanical aortic valve replacement.


   Acknowledgments
Top
 Footnotes
 Abstract
 Introduction
 Materials and Methods
 Results
 Comment
 Acknowledgments
References
 
We thank Betty Anderson for her involvement with data acquisition and statistical help. We also are indebted to Darcey Reinartz and Terrie Bohlsen for the secretarial help without which this article could not have been printed.


   Footnotes
Top
 Footnotes
Abstract
 Introduction
 Materials and Methods
 Results
 Comment
 Acknowledgments
 References
 
Address reprint requests to Dr Orszulak, Mayo Clinic, 200 First St, SW, Rochester, MN 55905 (e-mail: orszulak.thomas{at}mayo.edu).


   References
Top
 Footnotes
 Abstract
 Introduction
 Materials and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Starr A, Grunkemeier GL, Lambert LE, Thomas DR, Sugimura S, Lefrak EA. Aortic valve replacement: a ten-year follow-up of non–cloth-covered vs cloth-covered caged-ball prostheses. Circulation 1977;56(Suppl 2):133–9.[Free Full Text]
  2. Pyle RB, Mayer JE Jr, Lindsay WG, Jorgensen CR, Wang Y, Nicoloff DM. Hemodynamic evaluation of Lillehei-Kaster and Starr-Edwards prostheses. Ann Thorac Surg 1978;26:336–43.
  3. Macmanus Q, Grunkemeier GL, Lambert LE, Starr A. Non–cloth-covered caged-ball prostheses. The second decade. J Thorac Cardiovasc Surg 1978;76:788–94.[Abstract]
  4. Macmanus Q, Grunkemeier G, Housman L, et al. Early results with composite strut caged-ball prostheses. Am J Cardiol 1980;46:566–9.[Medline]
  5. Teply JF, Grunkemeier GL, Sutherland HD, Lambert LE, Johnson VA, Starr A. The ultimate prognosis after valve replacement: an assessment at twenty years. Ann Thorac Surg 1981;32:111–9.[Abstract]
  6. Meurs AAH, Grundemann AM, Bezemer PD, et al. Early and 8-year results of aortic valve replacement: a clinical study of 232 patients. Eur Heart J 1985;6:870–81.[Abstract/Free Full Text]
  7. Lund O, Knudsen MA, Pilegaard HK, Magnussen K, Nielsen TT. Long-term performance of Starr-Edwards Silastic ball valves and St. Jude Medical bi-leaflet valves: a comparative analysis of implantations during 1980–86 for aortic stenosis. Eur Heart J 1990;11:108–19.[Abstract/Free Full Text]
  8. Miller DC, Oyer PE, Mitchell RS, et al. Performance characteristics of the Starr-Edwards model 1260 aortic valve prosthesis beyond ten years. J Thorac Cardiovasc Surg 1984;88:193–207.[Abstract]
  9. Fernandez J, Laub GW, Adkins MS, 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]
  10. Lytle BW, Cosgrove DM, Taylor PC, et al. Primary isolated aortic valve replacement: early and late results. J Thorac Cardiovasc Surg 1989;97:675–94.[Abstract]
  11. Aoyagi S, Oryoji A, Nishi Y, Tanaka K, Kosuga K, Oishi K. Long-term results of valve replacement with the St. Jude Medical valve. J Thorac Cardiovasc Surg 1994;108:1021–9.[Abstract/Free Full Text]
  12. Craver JM, Weintraub WS, Jones EL, Guyton RA, Hatcher CR Jr. Predictors of mortality, complications, and length of stay in aortic valve replacement for aortic stenosis. Circulation 1988;78(Suppl 1):I85–90.
  13. Magovern JA, Pennock JL, Campbell DB, et al. Aortic valve replacement and combined aortic valve replacement and coronary artery bypass grafting: predicting high risk groups. J Am Coll Cardiol 1987;9:38–43.[Abstract]
  14. Starr A, Edward ML. Mitral replacement: clinical experience with a ball valve prosthesis. Ann Surg 1961;154:726–40.[Medline]
  15. Edmonds LH, Clark RE, Cohn LH, Miller C, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg 1988;46:257–9.[Medline]
  16. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457–81.
  17. Peto R, Peto J. Asymptotically efficient rank invariant procedures. J R Statist Soc Series A 1972;135:185–207.
  18. Cox DR. Regression models and life-tables. J R Statist Soc Series B 1972;34:187–220.
  19. Therneau T, Sicks J, Bergstralh E, Offord J. Expected survival based on hazard rates. Technical Report Series, No. 52. Rochester, MN: Section of Biostatistics, Mayo Clinic, 1994.
  20. Walker SH, Duncan DB. Estimation of the probability of an event as a function of several independent variables. Biometrika 1967;54:167–79.[Abstract/Free Full Text]
  21. Morris JJ, Schaff HV, Mullany CJ, et al. Determinants of survival and recovery of left ventricular function after aortic valve replacement. Ann Thorac Surg 1993;56:22–30.[Abstract]
  22. Lytle BW. Impact of coronary artery disease on valvular heart surgery. Cardiol Clin 1991;9:301–14.[Medline]
  23. Gehlot A, Mullany CJ, Ilstrup D, et al. Aortic valve replacement in patients aged eighty years and older: early and long-term results. J Thorac Cardiovasc Surg 1996;111:1026–36.[Abstract/Free Full Text]
  24. Orszulak TA, Schaff HV, Mullany CJ, et al. Risk of thromboembolism with the aortic Carpentier-Edwards bioprosthesis. Ann Thorac Surg 1995;59:462–8.[Abstract/Free Full Text]
  25. Kratz JM, Sade RM, Crawford FA Jr, Crumbley AJ III, Stroud MR. The risk of small St. Jude aortic valve prostheses. Ann Thorac Surg 1994;57:1114–9.[Abstract]
  26. Rahimtoola SH. The problem of valve prosthesis–patient mismatch. Circulation 1978;58:20–4.[Abstract/Free Full Text]
  27. Sim EKW, Orszulak TA, Schaff HV, Shub C. Influence of prosthesis size on change in left ventricular mass following aortic valve replacement. Eur J Cardiothorac Surg 1994;8:293–7.[Abstract]
  28. Chandran KB, Cabell GN, Khalighi B, Chen CJ. Laser anemometry measurements of pulsatile flow past aortic valve prostheses. J Biomech 1983;16:865–73.[Medline]
  29. Macmanus Q, Grunkemeier GL, Lambert LE, Teply JF, Harlan BJ, Starr A. Year of operation as a risk factor in the late results of valve replacement. J Thorac Cardiovasc Surg 1980;80:834–41.[Abstract]
  30. Wain WH, Drury PJ, Ross DN. Aortic valve replacement with Starr-Edwards valves over 14 years. Ann Thorac Surg 1982;33:562–9.[Abstract]
  31. Cobanoglu A, Fessler CL, Guvendik L, Grunkemeier G, Starr A. Aortic valve replacement with the Starr-Edwards prosthesis: a comparison of the first and second decades of follow-up. Ann Thorac Surg 1988;45:248–52.[Abstract]
  32. Fuster V, Pumphrey CW, McGoon MD, Chesebro JH, Pluth JR, McGoon DC. Systemic thromboembolism in mitral and aortic Starr-Edwards prostheses: a 10–19 year follow-up. Circulation 1982;66(Suppl 1):I157–61.
  33. Roberts WC. Choosing a substitute cardiac valve: type, size, surgeon. Am J Cardiol 1976;38:633–44.[Medline]



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