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Ann Thorac Surg 2001;72:764-767
© 2001 The Society of Thoracic Surgeons


Original article: cardiovascular

Tricuspid valve repair with the Cosgrove-Edwards annuloplasty system: early clinical and echocardiographic results

Giuseppe Gatti, MDa, Giuseppe Maffei, MDa, Anna M. Lusa, MDa, Peppino Pugliese, MDa

a Division of Cardiac Surgery, Nursing Home "Villa Torri," Bologna, Italy

Accepted for publication May 9, 2001.

Address reprint requests to Dr Gatti, via Pignolini 5, Peschiera d/G, 37019 Verona, Italy
e-mail: cardiochirurgia{at}villatorri.it


    Abstract
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Background. The use of flexible rings for tricuspid valve repair is becoming popular. The purpose of this study was to evaluate the Cosgrove-Edwards annuloplasty system for tricuspid regurgitation.

Methods. From June 1998 to December 2000, 22 patients with significant secondary tricuspid regurgitation underwent tricuspid valve repair with the Cosgrove-Edwards annuloplasty system. All patients had disease of left-sided heart valves in addition to tricuspid disease; 34 concomitant procedures were performed. Twenty-one patients (95.5%) were in preoperative New York Heart Association functional class 3 or 4. The mean follow-up was 19.9 ± 9.7 months.

Results. There were two in-hospital nonvalve-related cardiac deaths (9.1%) and one noncardiac death after discharge (4.5%). All survivors were in New York Heart Association functional class 1 or 2; their tricuspid regurgitation was well controlled within grade 1+ and there was a significant reduction of systolic pulmonary artery pressure. Five (83.3%) of the 6 survivors with preoperative pulmonary hypertension had no or trivial residual tricuspid regurgitation.

Conclusions. The Cosgrove-Edwards annuloplasty system is very effective in the treatment of secondary tricuspid regurgitation, also in the presence of pulmonary hypertension.


    Introduction
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
The surgical treatment of significant secondary tricuspid regurgitation (TR) associated with disease of the left-sided heart valves is now widely accepted [1, 2].

Suture annuloplasty, such as the Kay method [3] or the De Vega method [4], and rigid ring annuloplasty, such as that with the Carpentier-Edwards ring [5], are routinely used for tricuspid valve repair. However, the flexible ring, such as the Duran ring [6] and the Cosgrove-Edwards ring [7], has been developed to permit physiologic motion of the tricuspid annulus. The use of flexible rings is becoming popular, although there are no reports demonstrating which type of ring (rigid versus flexible) is better for right ventricular function and regulation of TR.

In the present study, we evaluated the early clinical and echocardiographic results in patients with significant secondary TR who underwent tricuspid valve repair with the Cosgrove-Edwards annuloplasty system (Baxter Healthcare Corporation, Irvine, CA) [8].


    Material and methods
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
From June 1998 to December 2000, at our Division, 22 consecutive adult patients with significant secondary TR underwent tricuspid valve repair with the Cosgrove-Edwards annuloplasty system.

Therewere 17 women (77.3%) and five men (22.7%) aged from 32 to 82 years (mean, 66.5 ± 10.9 years).

All patients had disease of the left-sided heart valves in addition to tricuspid disease. The TR was always secondary to right ventricular dilatation or dysfunction caused by mitral valve rheumatic disease in 7 patients (31.8%), mitral and aortic valves rheumatic disease in 3 (13.6%), mitral prosthesis dysfunction and aortic valve rheumatic disease in 1 (4.5%), mitral and aortic prosthesis dysfunction in 1 (4.5%), mitral valve degenerative disease in 4 (18.2%), mitral valve ischemic disease in 2 (9.1%), idiopathic dilated cardiomyopathy in 1 (4.5%), and chronic constrictive pericarditis in 1 patient (4.5%).

Eight patients (36.4%) had had previous valve operations: one prior operation in 5 patients (22.7%) and two prior operations in 3 patients (13.6%) (Table 1). The mean interval between the first operation and the current procedure was 22.7 ± 8.3 years, with a range of 14.3 to 37.5 years; the mean interval from the second previous operation to the current one was 11.8 ± 5.5 years, with a range of 5.5 to 15.3 years.


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Table 1. Previous Cardiac Operations (11) in Eight Patients (36.4%)

 
Sixteen patients (72.7%) were in preoperative New York Heart Association (NYHA) functional class 4, 5 (22.7%) in NYHA functional class 3, and 1 (4.5%) in NYHA functional class 2. Eighteen patients (81.8%) had palpable hepatomegaly, 12 (54.5%) pulsatile liver, 3 (13.6%) ascites, 14 (63.6%) jugular venous distension, and 4 (18.2%) had important peripheral edema. Seventeen patients (77.3%) had atrial fibrillation, 3 (13.6%) were in sinus rhythm, and 2 patients (9.1%) paced.

All patients were investigated preoperatively by means of right- and left-side heart catheterization and Doppler echocardiography. The severity of TR was assessed echocardiographically in four grades using color-Doppler flow images and flow direction in the inferior vena cava or hepatic veins: 1+ = mild; 2+ = middle; 3+ = moderate; 4+ = severe [2]. Pulmonary hypertension (PH) was defined as systolic pulmonary artery pressure more than 59 mm Hg and diagnosis was made by right-side heart catheterization and Doppler echocardiography [9].

Tricuspid valve repair was performed for TR graded 3+ (10 patients, 45.5%) or 4+ (12 patients, 54.5%), with regurgitation in single or multiple directions. The mean systolic pulmonary artery pressure was 49.9 ± 14.6 mm Hg, with a range of 30 to 86 mm Hg. Seven patients (31.8%) presented with PH. The mean left ventricular ejection fraction was 48.5% ± 11.6% with a range of 30% to 79%.

The priority of each operation, graded according to The Society of Thoracic Surgeons classification, was elective in 14 patients (63.6%), urgent in 6 (27.3%), and emergent in 2 patients (9.1%).

The mean Ontario Province Risk SCORE [10] was 7.2 ± 2.7 (predicted mortality, 11.4% ± 6.9%) and the mean European SCORE [9] was 8.0 ± 4.4 (predicted mortality, 9.2% ± 3.7%).

The surgical technique of Cosgrove-Edwards annuloplasty system was performed by the same experienced surgeon (PP) as described by McCarthy and Cosgrove [7]. Using the tricuspid sizing obturator, the appropriate size was selected based on the length of the septal annulus: 18 32 mm-flexible annuloplasty bands (81.8%) and four 34 mm-flexible annuloplasty bands (18.2%) were implanted. Transesophageal echocardiography was used to confirm the competence of the tricuspid valve repair. Thirty-four concomitant procedures were performed in the 22 patients, with a procedures/patients ratio of 2.5 (56 of 22) (Table 2).


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Table 2. Concomitant Cardiac Operations (34) in the 22 Patients

 
The mean hospital stay was 10.1 ± 4.1 days, with a range of 6 to 24 days.

Echocardiographic evaluation was done at hospital discharge and at 2 months, 1 year, and 2 years from operation.

The mean follow-up was 19.9 ± 9.7 months, with a range of 4.9 to 34.5 months.

Deaths and complications were defined according to published guidelines of The Society of Thoracic Surgeons and The American Association for Thoracic Surgery [11].

Statistical analysis
Values are expressed as the mean ± standard deviation, or as percentage. Continuous variables were compared by Student’s t test, and categorical variables were compared using {chi}2 or Fisher’s test. Statistical significance was considered present with a p value less than 0.05.


    Results
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Mortality and causes of death
Two patients (9.1%) died within 30 days from operation, and the cause of death in both patients was low cardiac output syndrome not related to the tricuspid valve repair.

The first patient was a 64-year-old woman, in NYHA functional class 4, with mitral valve rheumatic disease (and severe secondary TR) causing left ventricular failure (left ventricular ejection fraction, 37%) and systolic pulmonary artery pressure augmentation (48 mm Hg), undergoing urgent mitral valve replacement and tricuspid valve repair. Her Ontario Province Risk SCORE was six (predicted mortality, 5.76%) and her European SCORE was five (predicted mortality, 3.0%).

The second patient was a 77-year-old woman, in NYHA functional class 4 and cardiac cachexia, with mitral prosthesis dysfunction and aortic valve rheumatic disease (and severe secondary TR) causing left ventricular failure (left ventricular ejection fraction, 30%) and PH (systolic pulmonary artery pressure, 65 mm Hg), undergoing emergent mitral prosthesis replacement, aortic valve replacement and tricuspid valve repair (third cardiac operation). Her Ontario Province Risk SCORE was 15 (predicted mortality, 20.62%) and her European SCORE was 22 (predicted mortality, 11.2%).

One patient (4.5%) died at 10.4 months from cardiac operation owing to a major internal bleeding after extensive colon resection for diverticulitis.

In all survivors, other irreversible complications were not recorded.

Clinical results
An improvement of NYHA functional class was recognized at discharge (mean NYHA functional class, 1.6 ± 0.6; p = 0.003) and at the most recent evaluation (mean NYHA functional class, 1.3 ± 0.5; p = 0.002) (Fig 1).



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Fig 1. New York Heart Association functional class before and after tricuspid valve repair with the Cosgrove-Edwards annuloplasty system: preoperative (left column), at discharge (middle column), and at the latest clinical evaluation (right column). *One patient died at 10.4 months after operation.

 
There was also an improvement of the preoperative symptoms of right heart failure; palpable hepatomegaly was present in 4 patients (20.0%; p = 0.0002), pulsatile liver in 2 (10.0%; p = 0.0001), ascites in 1 (5.0%; p = not significant), jugular venous distension in 1 (5.0%; p = 0.01), and important peripheral edema was present in 1 patient (5.0%; p = not significant). Ascites and important peripheral edema persisted in 1 patient with hepatitis C virus-positive cirrhosis.

Postoperatively, there was no variation of the preoperative heart rhythm.

Echocardiographic results
Tricuspid regurgitation was significantly reduced at discharge (mean, 0.5 ± 0.5; p = 0.0001) and at the most recent echocardiographic evaluation (mean, 0.3 ± 0.5; p = 0.0006), and it was well controlled within grade 1+ in all survivors (Fig 2).



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Fig 2. Grades of tricuspid regurgitation before and after tricuspid valve repair with the Cosgrove-Edwards annuloplasty system: preoperative (left column), at discharge (middle column), and at the latest echocardiographic evaluation (right column). *One patient died at 10.4 months after operation.

 
Postoperatively, the mean systolic pulmonary artery pressure in the patients with trivial or mild residual TR decreased to 32.2 ± 4.8 mm Hg (p = 0.006). Five (83.3%) of the 6 survivors with preoperative PH had no or trivial residual TR.

The mean left ventricular ejection fraction increased to 53.3% ± 8.6%, but the variation was not statistically significant.


    Comment
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Like the mitral annulus, the tricuspid annulus is a complex dynamic structure undergoing periodic and constant changes in size and shape during the cardiac cycle. Furthermore, these changes involve both the anterior and posterior annulus rather than the septum [12].

The disease of the left-sided heart valves cause pulmonary artery pressure augmentation and, consequently, right ventricular and tricuspid annulus dilatation or dysfunction; secondary TR can appear [1, 2]. Anatomic studies demonstrated that five-sixths of this annular dilatation takes place at the anterior and posterior annulus [13].

Although Kay’s and De Vega’s methods [3, 4] are reproducible and have been widely used for suture annuloplasty, the residual or recurrent TR among hospital survivors was rated as moderate or severe in 16.2% [14] or also in 33.8% [15]. Usually, postoperative TR is more frequent in patients with deterioration of the residual disease of left-sided heart valves or persisting high pulmonary artery pressure [1416].

The ring annuloplasty concept was introduced for the mitral regurgitation by Carpentier [17]; the ring annuloplasty remodels the annulus, decreases tension on suture lines, increases leaflet coaptation, and prevents recurrent annular dilatation.

The tricuspid valve repair with rigid ring annuloplasty is effective for regulation of secondary TR even in patients with PH [18].

A limit of rigid ring annuloplasty is the loss of tricuspid annular contraction, which is involved in right ventricular function. To preserve physiologic annulus function, a flexible ring was developed. However, there have been no reports indicating a relationship between right ventricular function and rigid or flexible rings in the tricuspid position. The effect of prosthetic rings even in the mitral position on left ventricular function is still controversial [19]. It is more difficult to evaluate the effect of prosthetic rings in the tricuspid position on right ventricular function because left-side heart procedures and left heart conditions have a significant effect on right ventricular function.

At present, there is a wide range of ring annuloplasty devices and techniques available, and it is clear that, when properly used, all produce acceptable clinical results. Although the potential advantages of a flexible ring annuloplasty system remain largely speculative, the notion of preserving right ventricular function and tricuspid annular contraction is attractive.

The Cosgrove-Edwards annuloplasty system incorporates a universally flexible annuloplasty band that provides, in the tricuspid valve position, a measured plication of the anterior and posterior annulus. No sutures are placed along the septal annulus, simplifying the procedure and eliminating the risk of injury to the conduction system [7]. Short-term and midterm results with this system in the mitral valve position have been good [8, 20].

In this study, we report immediate results and short-term follow-up of tricuspid valve repair with the Cosgrove-Edwards annuloplasty system. Clinical and echocardiographic results were very good. Hospital mortality was acceptable and according to predicted mortality by both the Ontario Province Risk SCORE and European SCORE; the cause of death was not related to the tricuspid valve repair. All survivors were in NYHA functional class 1 or 2, and there was a significant reduction of the preoperative symptoms of right heart failure. New arrhythmias were not recorded. The TR was always well controlled within grade 1+, even in patients with PH. There was one noncardiac death at 10.4 months after operation. Midterm and long-term follow-up are not yet available.

Although these preliminary results must be verified in a more numerous population of patients, and on a long-term basis, the Cosgrove-Edwards annuloplasty system appears to be a simple, easily reproducible, safe, and valid option for surgical treatment of secondary TR.


    References
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

  1. Von Segesser L.K., Stauffer J.C., Delabays A., Chassot P.G. Tricuspid valve insufficiency: what should be done?. Ther Umsch 1998;55:767-772.[Medline]
  2. Porter A., Shapira Y., Wurzel M., et al. Tricuspid regurgitation late after mitral valve replacement: clinical and echocardiographic evaluation. J Heart Valve Dis 1999;8:57-62.[Medline]
  3. Kay J.H., Maselli-Campagna G., Tsuji H.K. Surgical treatment of tricuspid insufficiency. Ann Surg 1965;162:53-58.[Medline]
  4. De Vega N.G. La anuloplastia selectiva, regulable y permanente. Una technica original para el tratamiento de la insufficiencia tricuspide. Rev Esp Cardiol 1972;25:555-556.[Medline]
  5. Carpentier A., Deloche A., Dauptain J., et al. A new reconstructive operation for correction of mitral and tricuspid insufficiency. J Thorac Cardiovasc Surg 1971;61:1-13.[Medline]
  6. Duran C.G., Ubago J.L. Clinical and hemodynamic performance of a totally flexible prosthetic ring for atrioventricular valve reconstruction. Ann Thorac Surg 1976;22:458-463.[Abstract/Free Full Text]
  7. McCarthy J.F., Cosgrove D.M., III Tricuspid valve repair with the Cosgrove-Edwards annuloplasty system. Ann Thorac Surg 1997;64:267-268.[Abstract/Free Full Text]
  8. Cosgrove D.M., III, Arcidi J.M., Rodriguez L., Stewart W.J., Powell K., Thomas J.D. Initial experience with the Cosgrove-Edwards annuloplasty system. Ann Thorac Surg 1995;60:499-503.[Abstract/Free Full Text]
  9. Nashef S.A.M., Roques F., Michel P., Gauducheau E., Lemeshow S., Salamon R., EuroSCORE study group. European System for Cardiac Operative Risk Evaluation (EuroSCORE). Eur J Cardiothorac Surg 1999;16:9-13.[Abstract/Free Full Text]
  10. Tu J.V., Jaglal S.B., Naylor C.D. Multicenter validation of a risk index for mortality, intensive care unit stay, and overall hospital length of stay after cardiac surgery. Circulation 1995;91:677-684.[Abstract/Free Full Text]
  11. Edmunds L.H., Jr, Clark R.E., Cohn L.H., Grunkemeier G.L., Miller D.C., Weisel R.D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg 1996;62:932-935.[Abstract/Free Full Text]
  12. Chandra S, Powell K, Breburda CS, et al. Three-dimensional reconstructive (shape, and motion) of tricuspid annulus in normals, and in patients after tricuspid annuloplasty with a flexible ring. In: IEE Computers Society Press, ed. Computers in cardiology. Los Alamedos, CA: IEEE Computers Society Press, 1996:693–6.
  13. Deloche A., Guéinon J., Fariani J.M., et al. Etude anatomique des valvuloplasties rhumatismales tricuspidiennes. Application à l’étude critique des différentes méthodes d’annuloplastie. Arch Mal Coeur 1974;67:497-505.
  14. Holper K., Haehnel J.C., Augustin N., Schening F. Surgical for tricuspid insufficiency: long term follow-up after De Vega annuloplasty. Thorac Cardiovasc Surgeon 1993;41:1-8.[Medline]
  15. De Paulis R., Bobbio M., Ottino G., et al. The De Vega tricuspid annuloplasty. Perioperative mortality and long term follow-up. J Cardiovasc Surg 1990;31:512-517.[Medline]
  16. Kratz J.M., Crawford F.A., Stroud M.R., Appleby D.C., Hauger K.H. Trends and results in tricuspid valve surgery. Chest 1985;88:837-840.[Medline]
  17. Carpentier A. La valvuloplastie reconstitutive: une nouvelle technique de valvuloplastie mitral. Presse Med 1969;77:251-253.
  18. Onoda K., Yasuda F., Takao M., et al. Long-term follow-up after Carpentier-Edwards ring annuloplasty for tricuspid regurgitation. Ann Thorac Surg 2000;70:796-799.[Abstract/Free Full Text]
  19. Okada Y., Shomura T., Yamaura Y., Yashikawa J. Comparison of the Carpentier and Duran prosthetic rings used in mitral reconstruction. Ann Thorac Surg 1995;59:658-663.[Abstract/Free Full Text]
  20. Gillinov A.M., Cosgrove D.M., III, Shiota T., et al. Cosgrove-Edwards annuloplasty system: midterm results. Ann Thorac Surg 2000;69:717-721.[Abstract/Free Full Text]



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