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Ann Thorac Surg 1995;60:499-503
© 1995 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Initial Experience With the Cosgrove-Edwards Annuloplasty System

Departments of Thoracic and Cardiovascular Surgery, Cardiology, and Biomedical Engineering, The Cleveland Clinic Foundation, Cleveland, Ohio

	Abstract

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Background. The mitral valve has a nonplanar shape and a sphincter action. Pathologic dilatation occurs along the posterior annulus. To preserve the physiologic function and correct annular dilatation, we developed an annuloplasty system that is universally flexible and produces a measured plication of the posterior annulus (Cosgrove-Edwards Annuloplasty System).

Methods. The results of 150 consecutive mitral valve repairs using this system were analyzed. Mean age was 58 ± 13 years; 59% were men. The cause of the valve disease was degenerative in 75% of the patients, rheumatic in 13%, ischemic in 8%, and infectious in 4%. Associated procedures were performed in 61 patients (41%).

Results. Echocardiographic mitral regurgitation decreased from 3.7 ± 0.6 before repair to 0.2 ± 0.4 after repair (p< 0.0001). There were no hospital deaths and no cases of hemodynamically significant systolic anterior motion or other annuloplasty-related complications. Follow-up was 100% complete at a mean of 3.1 ± 3.6 months. There were three late deaths, three transient ischemic attacks, and one episode of endocarditis. Five patients (3.3%) have undergone reoperation for recurrent mitral insufficiency; no reoperations were related to the annuloplasty system. At a mean of 9 months, three-dimensional reconstruction of the mitral annulus from multiple echocardiographic images confirmed the nonplanar shape and sphincter mechanism of the annulus. Annular orifice area decreased 19% during the cardiac cycle from a mean of 10.3 cm² in diastole to 8.6 cm² in systole.

Conclusions. This annuloplasty system is effective for repair of insufficiency secondary to all causes, preserves physiologic annulus function, and is associated with a low incidence of valve-related complication.

	Introduction

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
See also page 503.

Recently, our understanding of the physiology of the mitral annulus has increased. Echocardiographic studies have demonstrated that the mitral annulus is saddle-shaped, with its highest points anteriorly and posteriorly [1]. In addition, the entire annulus flexes throughout the cardiac cycle with a sphincter mechanism, causing the annulus to be smaller in systole than in diastole [2,3]. Pathologic studies have demonstrated that when dilatation of the annulus occurs, the distance between the fibrous trigones anteriorly remains stable and dilatation occurs along the attachment of the posterior leaflet [4]. This understanding of the normal physiology and pathoanatomy of the mitral valve led us to pursue the development of an annuloplasty system that is universally flexible and produces a measured plication of the posterior annulus. The Cosgrove-Edwards Annuloplasty System (Baxter Healthcare, Irvine, CA) is the result of this effort.

This study was undertaken to evaluate the clinical results and postrepair function of the mitral annulus.

	Material and Methods

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
From February 1993 to March 1994, 150 patients underwent mitral valve reconstruction that incorporated the Cosgrove-Edwards Annuloplasty System as part of their repair. When this annuloplasty was attempted, there were no conversions to another type of annuloplasty to achieve valve competence. The mean age was 57.8 ± 12.7 years (range, 27 to 85 years). Eighty-eight patients (58.8%) were men. Fifteen patients (10%) were in New York Heart Association functional class I, 100 (66.7%) were in class II, 28 (18.7%) were in class III, and 7 (4.7%) were in class IV. The cause was degenerative disease in the majority of patients (Table 1). Mitral insufficiency was the principal pathologic anatomy present in 139 patients (93%). Mixed lesions were found in 11 patients (7%). Sixty-one patients (40%) had associated procedures: myocardial revascularization, 25; aortic valve replacement, 13; tricuspid valve repair, 14; aortic valve repair, 6; and other, 3. Appropriate repair techniques were directed to specific structures of the mitral apparatus (Table 2).

View larger version (31K): [in this window] [in a new window]   Fig 1. . The Cosgrove-Edwards Annuloplasty System consists of a handle, a rigid frame, and a polyester velour band.

View larger version (132K): [in this window] [in a new window]   Fig 2. . Sutures are placed in the posterior annulus from fibrous trigone to fibrous trigone and then passed through the annuloplasty band.

View larger version (139K): [in this window] [in a new window]   Fig 3. . The handle is removed to facilitate tying but remains attached to aid in removal of the frame.

View larger version (118K): [in this window] [in a new window]   Fig 4. . When the sutures have been tied the frame is removed.

View larger version (13K): [in this window] [in a new window]   Fig 5. . The size distribution varied from 26 mm to 38 mm, with 30 mm being the most common.

	Results

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
There were no in-hospital deaths in this series. Perioperative complications are shown in Table 3.

There were three late deaths, for an actuarial survival of 98% at 12 months. There were three thromboembolic events, for an actuarial freedom from thromboembolic events of 97% at 1 year. There was one episode of endocarditis, for an actuarial freedom from endocarditis of 98% at 1 year. Five patients required reoperation, for an actuarial freedom from reoperation of 97% at 1 year. Causes of failed repair were incomplete initial repair in 2; chordal transfer (dehiscence), 1; papillary muscle shortening, 1; and leaflet performation with a suture, 1.

It was possible to assess the size, shape, and motion of the mitral annulus using a computer-generated reconstruction from multiple echocardiographic images obtained via transesophageal echocardiograms in patients after mitral valve repair. The normal saddle shape of the mitral annulus is demonstrated in Figure 6 obtained one year postoperatively. In 5 patients it was possible to compare changes in mitral orifice area during systole and diastole. Immediately postoperatively there was a 7% increase in valve orifice area from 8.9 ± 2.6 cm² in systole to 9.6 ± 2.7 cm² in diastole. At a mean of 9 months postoperatively, this same group of patients increased the change in their mitral annulus orifice area to 19% from 8.9 ± 4.0 cm² in systole to 10.6 ± 4.9 cm² in diastole (Fig 7).

View larger version (9K): [in this window] [in a new window]   Fig 6. . Computer-generated reconstruction of the mitral annulus 1 year after repair demonstrates preservation of the saddle shape.

View larger version (21K): [in this window] [in a new window]   Fig 7. . The mitral annulus remains flexible at 1 year, being smaller in systole than in diastole.

View larger version (15K): [in this window] [in a new window]   Fig 8. . Changes in mitral valve annulus orifice area occur throughout the cardiac cycle. In the normal heart the annulus orifice area decreases in systole and increases in diastole. Almost identical changes occurred in the annulus of a valve repaired 1 year previously.

	Comment

Top Footnotes Abstract Introduction Material and Methods Results Comment References

Previous investigators have employed a device that was limited to the posterior annulus. Cooley and associates [5] described a collar that was sutured to the posterior annulus. This was flexible and did not cover the area between the two fibrous trigones anteriorly. This device was subsequently abandoned. A similar technique was described by Fundaro and colleagues [6], who used a 4-mm Gore-Tex graft through which multiple mattress sutures were placed. In the mid-1980s we experimented in a similar procedure with a strip of formaldehyde-treated bovine pericardium, doing more than 100 cases with satisfactory results using this method. These methods have the advantages of technical ease and avoidance of potential deformity of the aortic valve caused by placing sutures between the fibrous trigones. The repairs were flexible and avoided potential complications associated with the Carpentier-Edwards ring caused by malalignment of the anterior and posterior leaflets resulting in insufficiency. However, all three of these approaches failed to achieve measured plications of the posterior annulus. Each plication of the posterior annulus is dependent on the tension placed on the sutures at the time of tying. Therefore, it was possible to have too small a plication resulting in insufficiency or too large a plication resulting in obliteration of the posterior leaflet. The approach of tying down over a rigid frame eliminates the potential of plication of an inappropriate amount of the posterior annulus.

Surgeons are concerned that any nonrigid annuloplasty device can, in time, become rigid, negating the effect of placing a flexible device. When examining the three-dimensional reconstructions of the mitral annulus obtained from patients who had undergone annuloplasty with the Cosgrove-Edwards Annuloplasty System a year previously, it is apparent that the annulus maintains its saddle shape and also has a sphincter action that is close to normal throughout the cardiac cycle. Of interest is the fact that serial studies of these same patients showed that the sphincter activity of the mitral annulus increases with time. This may be the result of improving left ventricular function or other factors that are not yet evident. It clearly confirms the continuing flexibility of the annulus a significant period of time after healing.

The major perceived advantage of a rigid annuloplasty is that it ensures long-term valve stability after repair. Because recurrent mitral insufficiency is one of the main concerns of surgeons performing mitral valve reconstructions, the potential for ensured long-term competence is an attractive feature [7]. To evaluate the relative incidence of reoperation for recurrent mitral insufficiency, we compared the results of this series with those with the rigid ring. Spencer and co-workers [8] reported an early reoperation rate of 2.9% using the Carpentier-Edwards annuloplasty ring. We [9] reported a similar incidence of 3.2% early reoperation. Deloche and associates [10] reported a 4.3% incidence of reoperation in 185 patients undergoing repair with the Carpentier-Edwards annuloplasty ring. None of these rates are significantly different from the current series, which notes a 3.3% incidence of early reoperation for recurrent mitral insufficiency. It is important to note that all of the reoperations in the current series were secondary to technical problems; none were secondary to dehiscence of the annuloplasty or the presence of systolic anterior motion or other annuloplasty complications.

The final question to be answered is whether or not there is any advantage to a flexible mitral annulus. This topic has been explored extensively by two groups of laboratory investigators and one clinical study. The data on this topic are conflicting. In pig hearts, van Rijk and associates [11, 12] noted that the mitral annulus in systole was approximately 80% of its diastolic dimensions and that counter-clockwise rotation of the posterior annulus was observed. The Duran ring annuloplasty preserved normal annular motion and rotation and reduction in mitral valve area during systole. This was not observed with the Carpentier ring. Van Rijk and associates concluded that the hemodynamics were better in a flexible ring group because of less interference with diastolic filling of the left ventricle [11]. Publications by Rayhill, Castro, and their associates [13–15] failed to identify any differences in systolic function in the left ventricle whether patients had a rigid or flexible annuloplasty. The results of this carefully controlled study cast doubt as to the potential advantages of a flexible ring when measuring systolic function. The only report to clinically address this question is by David and colleagues [16]. In groups of patients with chronic regurgitation, left ventricular end-systolic volume fell significantly only in patients with Duran rings. This was thought to represent superior left ventricular pump performance. This difference in left ventricular systolic function, however, was not seen at the 1-year evaluation. The flexibility of the mitral annuloplasty device may or may not have an advantage in terms of left ventricular function, but no investigators have demonstrated any disadvantage to a flexible annuloplasty. With no proven disadvantages and with flexible annuloplasties approaching normal physiology, it seems logical to pursue an annuloplasty that results in a measured plication of the posterior annulus that is universally flexible.

	Footnotes

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 
Presented at the Thirty-first Annual Meeting of The Society of Thoracic Surgeons, Palm Springs, CA, Jan 30-Feb 1, 1995.

This product has been jointly developed by The Cleveland Clinic Foundation and Baxter Healthcare. The Cleveland Clinic Foundation has entered into a licensing agreement with Baxter Healthcare relative to this invention.

Address reprint requests to Dr Cosgrove, Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195.

	References

Top Footnotes Abstract Introduction Material and Methods Results Comment References

 

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