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Interact CardioVasc Thorac Surg 2007;6:731-735. doi:10.1510/icvts.2007.156786
© 2007 European Association of Cardio-Thoracic Surgery

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Institutional report - Valves

Tricuspid valve annuloplasty with a flexible prosthetic band

Giuseppe Gattia,*, Fortunato Marcianòa, Francesco Antonini-Canterinb, Bruno Pinamontia, Bernardo Benussia, Aniello Pappalardoa and Bartolo Zingonea

a Department of Cardiovascular Medicine, Divisions of Cardiac Surgery and Cardiology, Ospedali Riuniti di Trieste, Strada di Fiume 447, 34100 Trieste, Italy
b Division of Cardiology, Ospedale Santa Maria degli Angeli, Pordenone, Italy

Received 26 March 2007; received in revised form 29 July 2007; accepted 1 August 2007

*Corresponding author. Tel.: +39 040 3994856; fax: +39 040 3994995.

E-mail address: giusep.gatti{at}tiscali.it (G. Gatti).


    Abstract
 Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 
This study evaluates the application to the tricuspid valve of a flexible prosthetic band originally devised for mitral repair. Between March 2001 and May 2005, 53 consecutive patients (age 66.2±8.5 years) with significant tricuspid regurgitation and dilatation of the right-sided cardiac chambers underwent tricuspid valve annuloplasty with the band and concomitant mitral repair or replacement. Thirty-one patients (58.5%) were in NYHA class III or IV, and 33 (62.3%) had a history of right heart failure. Follow-up was 19.2±14.0 months. Three patients (5.7%) died before discharge, and one during follow-up. One late reoperation was required for mitral endocarditis. NYHA class decreased in survivors from 2.7±0.8 to 1.4±0.6 (P<0.0001), and the symptoms of right heart failure improved significantly after surgery. Tricuspid regurgitation was mild or absent in 44 survivors (89.8%) and moderate in 5 (10.2%). Regurgitation significantly decreased even in patients with risk factors for tricuspid repair failure or with persistent left ventricular dysfunction. The 4-year actuarial freedom from tricuspid regurgitation grade >1 was 88.7%. By univariable analysis, preoperative tricuspid regurgitation grade >2, right ventricular shortening fraction <35%, and permanent pacemaker were associated with the risk of recurrent moderate regurgitation, though only probably so (P=0.077, 0.061, and 0.097, respectively).

Key Words: Echocardiography; Heart valves; Mitral valve; Tricuspid valve


    1. Introduction
 Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 
The treatment of significant tricuspid regurgitation (TR) concurrently to mitral valve surgery is a well-established practice, and the role of annuloplasty rings or bands for the most severe degrees of TR is no longer disputed [1]. At variance with the wide number of devices reported for mitral valve repair, however, the choice of annuloplasty rings and bands used to repair regurgitant tricuspid valves is quite limited [2–5].

In this study we shall describe the early clinical and echocardiographic results in a series of patients with tricuspid incompetence secondary to mitral disease who underwent tricuspid valve annuloplasty with the Koehler band (Koehler Medical Ltd, Swillington, Leeds, UK) at our surgical unit.


    2. Materials and methods
 Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 
This flexible band is made of knitted polytetrafluoroethylene containing a radiopaque barium-impregnated silicon marker mounted on a buttress holder. It was originally designed for the repair of regurgitant mitral valves, and reported as such in several clinical series [6, 7]. To the best of our knowledge its use for tricuspid repair has not been reported before.

In the period March 2001 through May 2005 we have used the band to perform tricuspid valve annuloplasty in 53 consecutive patients (on maximum diuretic therapy) with significant TR and dilatation of the right-sided cardiac chambers due to mitral valve disease. Right heart dilatation and tricuspid disease were assessed preoperatively by means of two-dimensional transthoracic echocardiography and confirmed at surgery by inspection of the heart and visual exploration of the tricuspid valve following right atriotomy. Preoperative right atrial maximum end-systolic area index (right atrial maximum end-systolic area indexed by body surface area), retrospectively measured by reviewing recorded echocardiographic examinations, was >10 cm2·m–2 in all patients (range of normal values 4.5–10.5), with no correlation with the degree of TR. Fifteen additional patients with tricuspid incompetence treated in the same period were excluded from the study. Of these, 13 patients without significant right heart dilatation were managed by a DeVega suture annuloplasty [8], and two more had a Koehler band implanted for TR in the absence of mitral valve disease or combined with tricuspid reconstruction for organic disease.

Mitral valve disease consisted in stenosis in four (7.5%), incompetence in 34 (64.2%), and mixed lesions in the 15 remaining patients (28.3%). The etiology was degenerative in 22 patients (41.5%), rheumatic in 21 (39.6%), ischemic in five (9.4%), bacterial endocarditis in two (3.8%), failure of previous repair in two (3.8%), and periprosthetic leak in one patient (1.9%). Significant aortic valve disease coexisted in 13 cases (24.5%), and coronary artery disease in 11 (20.8%). Seven patients (13.2%) had undergone mitral valve operation from 4.4 to 30.2 years previously (mean 16.6±11.2). Thirty-one patients (58.5%) were in New York Heart Association (NYHA) functional class III or IV, and 33 (62.3%) had a history of right heart failure. Permanent or paroxysmal atrial fibrillation was recorded in 66.0% of cases. Additional demographic and clinical descriptors are shown in Table 1. Surgical priority was graded according to The Society of Thoracic Surgeons classification. Operative risk was estimated by the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) model.


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Table 1 Preoperative descriptors in the 53 study patients

 
Preoperatively, right and left heart catheterization and color-Doppler echocardiography were performed in all patients. Tricuspid regurgitation was ultrasonographically assessed using Doppler color-flow imaging and graded as follows: grade 0=absent (no tricuspid regurgitant jet); grade 1=mild (regurgitant jet area <4 cm2); grade 2=moderate (regurgitant jet area ≥4 cm2 but <8 cm2); grade 3=moderately severe (regurgitant jet area ≥8 cm2); grade 4=severe (regurgitant jet area ≥8 cm2 and reverse systolic blood flow into the hepatic veins). Using a clinical estimate of the right atrial pressure, the systolic pulmonary artery pressure was calculated summing up the right ventricle-to-right atrium systolic gradient (obtained from the simplified Bernoulli equation applied to the regurgitant jet). Echocardiographic left ventricular volumes and ejection fraction were calculated according to the modified Simpson method. The right ventricular shortening fraction was retrospectively measured by reviewing recorded echocardiographic examinations, and adopted for right ventricular systolic functional assessment (Table 1).

At operation, both tricuspid sizing and band implantation were performed with Koehler obturators and bands applied upside-down relative to the recommended mitral valve procedure. The tricuspid valve was sized using the straight margin of the obturators to measure the base of the septal leaflet. The selected annuloplasty band was then implanted onto the tricuspid annulus by 2-0 braided sutures placed circumferentially along the hinge of the anterior and posterior leaflets. Annular plication was obtained by passing the suture ends closer to each other onto the band compared to the corresponding bites in the annulus, with most of the plication made along the posterior leaflet [4]. Bands were labeled 28 in one patient (1.9%), 30 in 7 (13.2%), 32 in 20 (37.7%), 34 in 16 (30.2%), and 36 in the remaining 9 (17.0%).

Eighty-two concomitant surgical procedures were performed, for a procedure/patient ratio of 2.5. By definition, all patients had a mitral procedure consisting in valve repair (=29), valve replacement (=23), or suturing of periprosthetic leak (=1). In addition, aortic valve replacement was performed in 13 patients, coronary artery bypass grafting in 11, Cox-maze procedure in two, left ventricular aneurysmectomy in one, replacement of the ascending aorta in one, and implantation of epicardial catheters for biventricular stimulation in one patient. Mean cardiopulmonary bypass and aortic cross-clamp times were 136.5±34.4 and 113.0±28.7 min, respectively.

Echocardiographic evaluations of the tricuspid repairs were carried out intraoperatively by the transesophageal approach, and by the transthoracic approach before hospital discharge, at two months from operation, and yearly thereafter. Clinical follow-up was completed for all patients from 6.6 to 61.4 months, and averaged 19.2±14.0 months (133.2 cumulative patient-years).

Deaths and complications were defined according to guidelines of The Society of Thoracic Surgeons and The American Association for Thoracic Surgery. Data were recorded in a prospective manner. Our Institutional Ethical Committee approved this research. Each patient entering the study gave informed consent specific to the type of surgery.

This study was funded completely through the division of cardiac surgery, and there were no commercial sponsors.

2.1. Statistical analysis

Values are expressed as absolute number of cases with percentage, or mean±S.D. Continuous variables were compared by the Student t or Mann–Whitney U-test, and categorical variables by using the Pearson {chi}2 or Fisher exact test where appropriate. Statistical significance was graded according to Blackstone [9]. Survival and freedom from TR grade >1 were estimated with the Kaplan–Meier method.

Statistical analysis was performed using MINITAB statistical software (MINITAB Inc., State College, PA).


    3. Results
 Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 
Three patients (5.7%) died within 30 days from operation, the cause being low cardiac output in two and multiple organ failure in one. Their logistic EuroSCORE was 64.2%, 33.8%, and 4.3%, respectively. Length of stay in the intensive care unit and total postoperative hospital stay for survivors averaged 2.9±3.0 days (range 1–16, median 2) and 10.2±9.8 days, respectively. One patient died of myocardial infarction two years after the operation, with no TR at the 1-year postoperative echocardiographic assessment. The 4-year actuarial survival (including in-hospital deaths) was 91.7% (95% confidence interval 83.7%–99.6%) (Fig. 1). One additional patient successfully underwent mitral valve replacement for bacterial endocarditis one year after valve repair, and mild recurrent TR disappeared after redo surgery. No other complications were recorded during follow-up, and atrioventricular conduction defects were notably absent.


Figure 1
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Fig. 1. Survival, with in-hospital deaths included. The solid diamond shapes are the nonparametric estimates of rates. The 95% confidence interval (CI) is also shown. The number of patients remaining at risk at various intervals is in square brackets.

 
In survivors, NYHA class decreased from 2.7±0.8 to 1.4±0.6 (P<0.0001). The symptoms of right heart failure improved significantly after surgery and cleared up in 24 patients. Palpable hepatomegaly was still present in five patients (10.2% vs. 49.1% preoperative, P=0.037), jugular venous distension in two (4.1% vs. 45.3% preoperative, P=0.0055), hepatojugular reflux in one (2.0% vs. 37.7% preoperative, P=0.0082), and important peripheral edema in four patients (8.2% vs. 35.8% preoperative, P=0.0021). Pulsatile liver and ascites were no longer seen after surgery (P=0.022 and P=0.5, respectively). Three patients changed their sinus rhythm into atrial fibrillation, and two were cardioverted into stable sinus rhythm. Two more patients with atrial fibrillation and drug-induced low ventricular response had a permanent pacemaker.

During follow-up, the left ventricular ejection fraction decreased from 56.1%±7.9% to 54.0%±7.6% (P=0.069) and the estimated right atrial pressure from 8.4±2.5 mmHg to 6.8±1.1 mmHg (P<0.001). The right atrial maximum end-systolic area index decreased from 17.2±3.5 cm2·m–2 to 15.3±3.2 cm2·m–2 (P=0.097). The systolic pulmonary artery pressure decreased from 55.0±18.1 mmHg to 33.5±10.5 mmHg (P=0.0063) in the 33 survivors with postoperative TR (67.3%). The mean grade of TR decreased from 2.2±0.6 preoperatively to 0.8±0.6 at follow-up (P<0.0001). No change in the grade of regurgitation was observed in four patients (8.2%). Regurgitation was mild or absent in 44 survivors (89.8%) and moderate in 5 (10.2%) (Fig. 2). By univariable analysis, preoperative TR grade >2, right ventricular shortening fraction <35%, and permanent pacemaker were associated with the risk of recurrent moderate regurgitation, though only probably so (P=0.077, 0.061, and 0.097, respectively). The 4-year actuarial freedom from TR grade >1 was 88.7% (95% confidence interval 74.7%–100%) (Fig. 3). The improvement of TR was not adversely affected by commonly recognized risk factors for tricuspid repair failure (Table 2) [10–12]. Regurgitation significantly decreased even in patients with persistent left ventricular dysfunction after surgery (Table 3). There were no significant correlations between postoperative TR grade and persisting of symptoms of right heart failure.


Figure 2
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Fig. 2. Changes in the degree of tricuspid regurgitation (TR) before (left column) and after tricuspid valve annuloplasty with the Koehler band (right column). Three patients (two with TR grade 2, and one with TR grade 4) died within 30 days from operation (their postoperative TR was trivial). Right column: one patient with preoperative TR grade 3 died two years after the operation, with no TR at the 1-year postoperative echocardiographic assessment (TR grade 0); one additional patient successfully underwent mitral valve replacement for bacterial endocarditis one year after valve repair, and recurrent TR grade 1 disappeared after redo surgery (TR grade 0).

 

Figure 3
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Fig. 3. Freedom from tricuspid regurgitation (TR) grade >1. The solid diamond shapes are the nonparametric estimates of rates. The 95% confidence interval (CI) is also shown. The number of patients remaining at risk at various intervals is in square brackets.

 

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Table 2 Changes in the degree of TR after annuloplasty in the presence of commonly recognized risk factors for tricuspid repair failure

 

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Table 3 Changes in the degree of TR after annuloplasty in the patients with persistent left ventricular dysfunction after surgery

 

    4. Discussion
 Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 
Significant TR secondary to right ventricular dilatation and dysfunction associated with mitral valve disease is a risk factor for poor functional outcome and mortality after mitral surgery [1]. Satisfactory correction of left-sided valve disease does not assure, by itself, against the persistence or even worsening of TR, while predicting the fate of unrepaired TR remains a moot question [1, 10–12]. On the other hand, reoperations to correct residual or recurrent TR have been associated with high operative mortality and disappointing long-term results [1, 13]. This all would make highly desirable that sensitive detection and liberal correction of TR be accomplished at the time of initial mitral valve surgery [1, 10–15]. Though fairly well agreed in principle, such an attitude hardly takes any uniform conversion into practice, probably due to the uncertainty as to the degree of TR that is significant enough to warrant correction. In addition, the potential for persisting TR is easily underestimated once medical therapy is upgraded following a clinical episode of failure. A single, semiquantitative ultrasonographic assessment of regurgitation severity, when the extremes of severity are excluded, remains a basic but probably insufficient information to this end, as it is seriously affected by a number of clinical and hemodynamic variables such as the circulating blood volume, pulmonary vascular resistances, right ventricular volume and contractility, and venous tone. Perhaps, more weight should be given to historical clinical and echocardiographic assessment of tricuspid incompetence, to the history and the severity of symptoms of right heart failure, to the drugs and dosages necessary for their control, and to objective, direct [14] or ultrasonographic [15] measurements such as the dimensions of the right-sided cardiac chambers and tricuspid annulus, and to descriptors of right ventricular function. Still, tricuspid annular dimension, tricuspid valve tethering area, and right ventricular eccentricity index are generally considered good ultrasonographic parameters to grade the severity of functional tricuspid incompetence [10–12, 14, 15].

From the surgical point of view, several techniques are available to correct TR. The simple suture annuloplasty approach is easy and effective in the immediate, but recurrent TR and reoperation have been reported in 34% and 10% of the survivors, respectively, at midterm follow-up [8]. Several studies have indeed found the simple suture annuloplasty to be a risk factor for tricuspid repair failure [10, 11]. Perhaps, suture annuloplasty is reliable when used for minor degrees of TR in the absence of right heart dilatation. On the other hand, prosthetic annuloplasty remodels the annulus, decreases tension on suture lines, increases leaflet coaptation, and prevents recurrent annular dilatation [1–5, 10–15], all reasons to prefer prosthetic over simple suture annuloplasty in the presence of risk factors for tricuspid repair failure, such as significant right heart dilatation and dysfunction [10, 11]. There are no reports in the literature, however, to demonstrate any differential effect of variable ring/band designs and their mechanical properties on both the right ventricular function and the tricuspid valve efficiency. By its very design a flexible band corrects the excess lengthening of the tricuspid annulus corresponding to the right ventricular free wall, i.e. along the anterior and posterior leaflets hinge, and theoretically allows annular and ventricular shape changes throughout the cardiac cycle. The septal annulus is ignored as it is not expected to lengthen significantly, which simplifies the procedures and prevents inadvertent injury to the conduction system [4]. Spherical remodeling of the overloaded right ventricle may cause the septum-parietal dimension to preferentially increase, similar to what happens to the left ventricle with cardiomyopathy. The very reasons why many surgeons do prefer rigid mitral rings in that setting could therefore apply to tricuspid valve pathology as well.

Our study aimed to evaluate the application to the tricuspid valve of a flexible prosthetic band originally devised for mitral valve repair [6, 7]. Patients studied had moderate or severe TR associated with mitral valve disease, though cases with mild TR were similarly treated in the presence of significant dilatation of right heart chambers. The severity of this dilatation was confirmed at surgery by inspection of the heart and visual exploration of the tricuspid valve following right atriotomy. We are well aware this subjective evaluation is the main drawback of the study. However, subjective as it may be, assessment of right atrial and ventricular volumes, right atrial free wall thickness, caval size and tricuspid ostium may indirectly indicate a significant degree of volume overload no less reliably than a single episodic measurement of the regurgitant jet flow. Also, the preoperative right atrial maximum end-systolic area index >10 cm2·m–2 retrospectively confirmed the severe degree of right atrial dilatation, supporting the surgeon's visual inspection and evaluation.

Our results support an aggressive surgical approach to significant tricuspid regurgitation as defined above. In-hospital mortality compared favorably with predicted estimates. Only one patient died during follow-up. No deaths could be imputed to the tricuspid annuloplasty band. Significant decrease of NYHA class and systolic pulmonary artery pressure confirmed good surgical treatment of the left-sided cardiac valves pathology. Correction of mitral regurgitation accounted for mild and non-significant decrease in left ventricular ejection fraction after surgery. Significant postoperative improvement of symptoms of right heart failure and decrease of right atrial pressure confirmed better right ventricular performance and good tricuspid competence. Regurgitation was well controlled within grade 1 in nearly 90% of survivors. Tricuspid regurgitation significantly improved even in patients at higher risk for tricuspid repair failure or with persisting left ventricular dysfunction. Preoperative TR grade >2, right ventricular shortening fraction <35%, and permanent pacemaker turned out to be probably associated to recurrent moderate regurgitation from univariable statistical analysis. Multivariable analysis was not performed due to the limited number of tricuspid repair failures (=5).

In conclusion, the Koehler band proved easy to implant, effectively corrected TR secondary to mitral valve disease, and provided satisfactory short-term clinical and echocardiographic results in our series. Longer term evaluations are required to determine the stability of tricuspid valve repair using this device.


    References
 Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 

  1. Tang GH, David TE, Singh SK, Maganti MD, Armstrong S, Borger MA. Tricuspid valve repair with an annuloplasty ring results in improved long-term outcomes. Circulation 2006; 114:I577–581.[CrossRef][Medline]
  2. Onoda K, Yasuda F, Takao M, Shimono T, Tanaka K, Shimpo H, Yada I. Long-term follow-up after Carpentier-Edwards ring annuloplasty for tricuspid regurgitation. Ann Thorac Surg 2000; 70:796–799.[Abstract/Free Full Text]
  3. Duran CG, Ubago JL. Clinical and hemodynamic performance of a totally flexible prosthetic ring for atrioventricular valve reconstruction. Ann Thorac Surg 1976; 22:458–463.[Abstract]
  4. Gatti G, Maffei G, Lusa AM, Pugliese P. Tricuspid valve repair with the Cosgrove-Edwards annuloplasty system: early clinical and echocardiographic results. Ann Thorac Surg 2001; 72:764–767.[Abstract/Free Full Text]
  5. Filsoufi F, Salzberg SP, Coutu M, Adams DH. A three-dimensional ring annuloplasty for the treatment of tricuspid regurgitation. Ann Thorac Surg 2006; 81:2273–2277.[Abstract/Free Full Text]
  6. Enriquez-Sarano M, Schaff HV, Orszulak TA, Tajik AJ, Bailey KR, Frye RL. Valve repair improves the outcome of surgery for mitral regurgitation. A multivariate analysis. Circulation 1995; 91:1022–1028.[Abstract/Free Full Text]
  7. Lee EM, Shapiro LM, Wells FC. Superiority of mitral repair in surgery for degenerative mitral regurgitation. Eur Heart J 1997; 18:655–663.[Abstract/Free Full Text]
  8. De Paulis R, Bobbio M, Ottino G, Donegani E, Di Rosa E, Casabona R, Girotto M, Morea M. The De Vega tricuspid annuloplasty. Perioperative mortality and long-term follow-up. J Cardiovasc Surg (Torino) 1990; 31:512–517.[Medline]
  9. Blackstone EH. Generating knowledge from information, data, and analyses. In: Kouchoukos NT, Blackstone EH, Doty DB, Hanley FL, Karp RB. eds Kirklin/Barratt-Boyes cardiac surgery 3rd edition 2003;New York, NY: Churchill Livingstone 254–350. In:.
  10. McCarthy PM, Bhudia SK, Rajeswaran J, Hoercher KJ, Lytle BW, Cosgrove DM, Blackstone EH. Tricuspid valve repair: durability and risk factors for failure. J Thorac Cardiovasc Surg 2004; 127:674–685.[Abstract/Free Full Text]
  11. Fukuda S, Gillinov AM, McCarthy PM, Stewart WJ, Song JM, Kihara T, Daimon M, Shin MS, Thomas JD, Shiota T. Determinants of recurrent or residual functional tricuspid regurgitation after tricuspid annuloplasty. Circulation 2006; 114:I582–587.[Medline]
  12. Matsunaga A, Duran CMG. Progression of tricuspid regurgitation after repaired functional ischemic mitral regurgitation. Circulation 2005; 112:I453–457.[CrossRef][Medline]
  13. Staab ME, Nishimura RA, Dearani JA. Isolated tricuspid valve surgery for severe tricuspid regurgitation following prior left heart valve surgery: analysis of outcome in 34 patients. J Heart Valve Dis 1999; 8:567–574.[Medline]
  14. Dreyfus GD, Corbi PJ, Chan KM, Bahrami T. Secondary tricuspid regurgitation or dilatation: which should be the criteria for surgical repair. Ann Thorac Surg 2005; 79:127–132.[Abstract/Free Full Text]
  15. Cohn LH. Tricuspid regurgitation secondary to mitral valve disease: when and how to repair. J Card Surg 1994; 9:237–241.[Medline]

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