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Ann Thorac Surg 2000;69:717-721
© 2000 The Society of Thoracic Surgeons

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Original Articles

Cosgrove-Edwards Annuloplasty System: midterm results

^a Departments of Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
^b Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
^c Department of Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA

Address reprint requests to Dr Gillinov, Department of Thoracic and Cardiovascular Surgery/F25, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195
e-mail: gillinom{at}ccf.org

Presented at the Forty-sixth Annual Meeting of the Southern Thoracic Surgical Association, San Juan, Puerto Rico, Nov 4–6, 1999.

	Abstract

Top Abstract Introduction Patients and methods Results Comment References

 
Background. The Cosgrove-Edwards Annuloplasty System includes a universally flexible band that corrects mitral annular dilatation via measured plication of the posterior annulus. The purpose of this study was to evaluate midterm clinical and functional results in the first 197 patients receiving this flexible annuloplasty band at mitral valve repair.

Methods. From February 1993 to July 1994, 197 consecutive patients with mitral regurgitation had mitral valve repair using this system. Valve disease was degenerative in 73%, rheumatic in 15%, ischemic in 5%, infectious in 2.5%, and other in 4%.

Results. Immediately after repair, echocardiographic mitral regurgitation was none or trivial in 92%, 1+ in 5%, and 2+ in 3%. There were no hospital deaths. Late follow-up was available in 195 patients (99%), with 661 patient-years of follow-up available for analysis. Four-year actuarial survival was 93%, freedom from thromboembolism 94%, from endocarditis 98%, and from reoperation 95%. At a mean interval of 18 months, echocardiography in 157 patients demonstrated no or trace mitral regurgitation in 56%, 1+ in 24%, 2+ in 9%, 3+ in 6%, and 4+ in 3%. At a mean of 61 ± 5 months, reconstruction of the mitral annulus from real-time three-dimensional echocardiographic images in 10 patients confirmed preserved nonplanar shape and sphincter mechanism of the mitral annulus. Annular orifice area decreased 28% ± 11% during the cardiac cycle from a mean of 10.1 ± 3.9 cm² in diastole to 7.2 ± 2.8 cm² in systole.

Conclusions. This annuloplasty system is effective for repair of mitral regurgitation secondary to all causes and preserves mitral annular flexibility and function at 5-year follow-up.

	Introduction

Top Abstract Introduction Patients and methods Results Comment References

 
Durability of mitral valve repair is enhanced by use of an annuloplasty [1, 2]. However, there is considerable controversy concerning choice of annuloplasty technique. Excellent results have been reported using a variety of annuloplasty techniques [3–6]. In addition to providing a durable repair, the ideal annuloplasty should also preserve physiologic annulus function [3, 7]. Five years ago we introduced an annuloplasty system that is universally flexible and produces a measured plication of the posterior annulus [3]. The purpose of this study was to evaluate midterm clinical and functional results in the first 197 patients receiving the Cosgrove-Edwards Annuloplasty System at mitral valve repair.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment References

 
Patients
From February 1993 to July 1994, 197 consecutive patients with mitral regurgitation (MR) underwent mitral valve reconstruction that incorporated the Cosgrove-Edwards Annuloplasty System as part of the repair. The mean age was 58 ± 13 years; 61% were men. The cause of mitral regurgitation was degenerative disease in 73%, rheumatic in 15%, ischemic in 5%, endocarditis in 3%, and other in 4%. Mitral regurgitation was the principal pathologic anatomy in 177 patients (90%). Mixed lesions were present in 20 patients (10%). Eighty-three patients (42%) had associated procedures, including coronary artery bypass grafting in 41.

Appropriate repair techniques were directed to specific structures of the mitral valve. The most common repair technique was posterior leaflet quadrangular resection and annuloplasty, used in 83 patients (42%). Sliding leaflet repair was used in 24%, chordal transfer in 20%, commissurotomy in 10%, and chordal shortening in 2%. Intraoperative echocardiography was used to monitor the results of repair in all patients.

Follow-up
Patients were contacted by telephone annually and a systematic questionnaire was completed. Follow-up was closed in June 1999. Echocardiograms performed at The Cleveland Clinic Foundation were reviewed, and reports of echocardiograms performed at outside institutions were obtained. Complete follow-up information was available in 195 patients (99%). Two patients could not be traced beyond hospital discharge. Mean length of follow-up among survivors was 3.4 ± 1.0 years (range, 2 months to 5 years). Six hundred sixty-one patient-years of follow-up were available for analysis.

Clinical outcomes
Durability of mitral valve repair was assessed primarily by the event reoperation after valve repair. When available, echocardiograms also were used to assess repair durability. Other events briefly investigated included all-cause death, thromboembolism, bleeding, and endocarditis.

Three-dimensional echocardiography and annulus function
Ten patients were chosen to undergo late three-dimensional echocardiography to assess annular geometry and function. All 10 patients had degenerative mitral valve disease and less than 1+ mitral regurgitation by two-dimensional color Doppler echocardiography. These results were compared with three-dimensional echocardiograms performed in 8 healthy volunteers. A newly developed, phased-array, real-time volumetric three-dimensional imaging system was used in this study. The system was developed in the Duke University Center for Emerging Cardiovascular Technology and is described in detail in a previous publication [8]. Three-dimensional echocardiographic images were acquired form apical views using the recently developed three-dimensional ultrasound system (Volumetrics Medical Imaging, Inc, Durham, NC) and stored on optical disks for later reconstruction. After the three-dimensional data sets were transferred to a computer system, each three-dimensional volume data was segmented in nine consecutive apical rotational planes (20 degrees between each plane) with a custom digital program. Subsequently, the coordinates of the two mitral leaflet insertion points were identified in each plane. The geometry of the mitral valve annulus was reconstructed from these coordinates (x, y, z) in three-dimensional space. Then the circumference and area of the mitral valve annulus at end-diastolic and end-systolic frames were calculated using the custom computer software.

Data analysis
Nonparametric, non–risk-adjusted estimates of freedom from events were obtained by the method of Kaplan and Meier [9]. A paired t test was used to compare the degree of MR before and after repair. Unless otherwise specified, all values are expressed as mean ± standard deviation.

	Results

Top Abstract Introduction Patients and methods Results Comment References

 
Before repair, mean degree of MR was 3.6 ± 0.7. Immediately after repair, mean degree of MR was 0.1 ± 0.4 (p < 0.0001). There were no instances of left ventricular outflow tract obstruction caused by systolic anterior motion of the mitral valve documented by intraoperative transesophageal echocardiography. There were no hospital deaths. Operative morbidity included reexploration for bleeding (5%), stroke (1.5%), respiratory insufficiency (1%), renal failure (1%), and myocardial infarction (0.5%).

There were 13 late deaths, and 4-year actuarial survival was 93% (confidence limits [CL], 91% and 95%) (Fig 1). Late deaths were of cardiac origin in 9 patients. Ten patients required reoperation for recurrent mitral valve dysfunction, and 4-year freedom from reoperation was 95% (CL, 93% and 96%) (Fig 2). Causes of failed mitral valve repair were progression of native valve disease (4 patients), endocarditis (2 patients), incomplete initial repair (2 patients), suture dehiscence (1 patient), and unknown (1 patient). Four-year freedom from endocarditis was 98% (CL, 96% and 99%) and 4-year freedom from thromboembolism was 94% (CL, 92% and 96%). At a mean interval of 18 months, echocardiograms in 157 patients demonstrated no or trace MR in 56%, 1+ in 24%, 2+ in 9%, 3+ in 6%, and 4+ in 3%.

View larger version (11K): [in this window] [in a new window]   Fig 1. Survival. Each circle is positioned at the time of a death according to the Kaplan-Meier estimation. Vertical bars represent asymmetric confidence limits equivalent to one standard error. The solid line is a parametric estimate and its confidence limits. The number of patients still traced at 1, 2, and 3 years is shown in parentheses. Note the expanded vertical axis.

View larger version (11K): [in this window] [in a new window]   Fig 2. Freedom from reoperation. The depiction is formatted as in Figure 1.

View larger version (61K): [in this window] [in a new window]   Fig 3. Computer-generated reconstruction of the mitral annulus from three-dimensional echocardiographic images 5 years after mitral valve repair demonstrates annular flexibility (A) and preservation of the saddle shape (B).

View larger version (12K): [in this window] [in a new window]   Fig 4. Changes in mitral annular orifice area occur throughout the cardiac cycle. In the normal heart, the annulus orifice area decreases in systole and increases in diastole. Similar changes are demonstrated in the annulus of a patient who had mitral valve repair 5 years previously.

	Comment

Top Abstract Introduction Patients and methods Results Comment References

The addition of an annuloplasty enhances the durability of mitral valve repair [1, 2]. The ring annuloplasty concept was introduced by Carpentier [14] in 1969. The purposes of the annuloplasty ring were to remodel the annulus, decrease tension on suture lines, increase leaflet coaptation, and prevent recurrent annular dilatation. Carpentier clearly demonstrated superior predictability and long-term stability with a rigid ring annuloplasty [15]. Shortly thereafter, Duran developed a flexible annuloplasty ring that offered the theoretical advantage of maintaining physiologic function of the mitral annulus; results with this prosthesis were also excellent [6]. There is a wide range of annuloplasty devices and techniques available now, and it is clear that, when properly employed, all produce good clinical results [1–6].

Several studies have examined the impact of annuloplasty type on left ventricular function, with particular reference to comparison of rigid and flexible annuloplasty rings. In a small clinical series, David and associates [16] demonstrated that a flexible annuloplasty ring resulted in superior left ventricular function in the early months after surgery. However, these differences between flexible and rigid rings had no clinical impact, and measurable differences in left ventricular function disappeared by the end of the first postoperative year [16]. Okada and colleagues [17] found similar advantages in left ventricular function early after mitral valve reconstruction with a flexible ring. In addition, that group showed that diastolic blood flow across the mitral valve during exercise was better in patients with a flexible ring than in those who received a rigid ring. Although these two clinical studies seem to suggest a potential advantage to a flexible annuloplasty in terms of left ventricular function, laboratory data have not consistently supported this assertion. Van Rijk-Zwikker and colleagues [18] found that a rigid ring restricted motion of the basal left ventricular wall. However, an elegant series of laboratory studies at Stanford demonstrated no difference between rigid and flexible rings with respect to effect on left ventricular performance [19].

Although available evidence suggests little impact of annuloplasty type on left ventricular function, there are data to suggest that a flexible annuloplasty results in better preservation of mitral annular function. We [3] and others [20] have demonstrated that the flexible Cosgrove-Edwards annuloplasty band maintains its flexibility early after implantation, allowing normal annular motion and changes in annular orifice area during the cardiac cycle. Similarly, the mitral annulus remains nonplanar with preserved sphincter function after placement of a Duran ring [7, 21]. Although a recent laboratory study from Stanford suggests that mitral annular area and shape do not change during the cardiac cycle after flexible or rigid ring annuloplasty, results from this sheep model contradict observations in humans [22].

Although the preponderance of data supports the notion that a flexible annuloplasty preserves mitral annular function, the clinical importance of this observation is unclear. Recent data suggest that a rigid ring may cause perturbations in annular dynamics and papillary muscle geometry that favor left ventricular outflow tract obstruction after mitral ring annuloplasty [23]. However, systolic anterior motion of the mitral valve and left ventricular outflow tract obstruction have been reported after mitral valve repair with a rigid ring [24] and a flexible ring [25]. Furthermore, Carpentier’s elucidation of the mechanism of left ventricular outflow tract obstruction and development of the sliding leaflet repair have virtually eliminated this complication of mitral valve repair [24].

Although the potential advantages of a flexible annuloplasty system and preserved annular motion remain largely speculative, the notion of preserving mitral annular function is attractive. The Cosgrove-Edwards Annuloplasty System incorporates a universally flexible annuloplasty band that provides a measured plication of the posterior annulus [3]. No sutures are placed along the anterior mitral annulus, simplifying the procedure and eliminating the risk of injury to the aortic valve. The template prevents purse-stringing of the suture line, ensuring a measured plication of the posterior annulus. Early results with this system demonstrated excellent clinical results and preserved mitral annular flexibility [3, 20].

In this study, we report midterm results with the Cosgrove-Edwards Annuloplasty System. Clinical results are excellent and are similar to those reported using other annuloplasty devices [1–6]. In the first 197 patients, there were no instances of left ventricular outflow tract obstruction due to systolic anterior motion. Four-year freedom from reoperation for recurrent mitral valve dysfunction is 95%. Thus, the absence of an annuloplasty along the anterior mitral annulus does not influence midterm repair durability.

There have been no clinical studies examining late mitral annular function and flexibility after prosthetic ring annuloplasty. In fact, there has been concern that fibrous ingrowth would render a flexible annuloplasty inflexible with time. The results reported herein demonstrate that mitral annular flexibility and function are maintained for at least 5 years after implantation of a flexible posterior annuloplasty band. After mitral valve repair using the Cosgrove-Edwards Annuloplasty System, the mitral annulus remains universally flexible, and changes in mitral annular area and circumference during the cardiac cycle are similar to those observed in normal volunteers. Although the clinical importance of preserved annular function remains speculative, it seems logical to employ a universally flexible annuloplasty technique that results in measured plication of the posterior mitral annulus.

This study provides intermediate follow-up of patients having mitral valve repair using the Cosgrove-Edwards Annuloplasty System; long-term follow-up is not yet available. Late echocardiograms were available in only 157 of 197 patients (80%). Therefore, the incidence of recurrent MR may be underestimated. The patients chosen for late three-dimensional echocardiograms all had degenerative mitral valve disease and successful repair. No inferences can be drawn concerning late annular flexibility or function in patients with MR of other etiologic processes or in patients with unsuccessful mitral valve repair. Finally, the 10 patients having late three-dimensional echocardiograms did not have preoperative three-dimensional echocardiograms; therefore, we cannot assess the precise impact of annuloplasty on annular area or flexibility in individual patients.

	Acknowledgments

 
The authors thank Judy Borsh, RN, Karen Mrazeck, and the other members of the Thoracic and Cardiovascular Research team for their efforts in assembling and verifying the clinical data and follow-up.

	References

Top Abstract Introduction Patients and methods Results Comment References

 

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