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J Thorac Cardiovasc Surg 2004;127:674-685
© 2004 The American Association for Thoracic Surgery


Surgery for acquired cardiovascular disease

Tricuspid valve repair: durability and risk factors for failure

Patrick M. McCarthy, MDa,*, Sunil K. Bhudia, MDa, Jeevanantham Rajeswaran, MSca, Katherine J. Hoercher, RNa, Bruce W. Lytle, MDa, Delos M. Cosgrove, MDa, Eugene H. Blackstone, MDa

a Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio, USA

Read at the Eighty-third Annual Meeting of The American Association for Thoracic Surgery, Boston, Mass, May 4-7, 2003.

Received for publication May 5, 2003; revisions received November 3, 2003; accepted for publication November 10, 2003.

* Address for reprints: Patrick M. McCarthy, MD, Department of Thoracic and Cardiovascular Surgery, 9500 Euclid Ave, Desk F24, Cleveland, OH 44195, USA
mccartp{at}ccf.org


    Abstract
 Top
 Abstract
 Patients and methods
 Results
 Discussion
 Conclusion
 Appendix 1: Details of...
 Appendix 2: Variables used...
 References
 
OBJECTIVES: To compare durability of tricuspid valve annuloplasty techniques, identify risk factors for repair failure, and characterize survival, reoperation, and functional class of surviving patients.

METHODS: From 1990 to 1999, 790 patients (mean age 65 ± 12 years, 51% New York Heart Association functional class III or IV, and mean right ventricular systolic pressure 56 ± 18 mm Hg) underwent tricuspid valve annuloplasty for functional regurgitation using 4 techniques: Carpentier-Edwards semi-rigid ring, Cosgrove-Edwards flexible band, De Vega procedure, and customized semicircular Peri-Guard annuloplasty. Of these patients, 89% had concomitant mitral valve surgery. A total of 2245 follow-up transthoracic echocardiograms were retrieved. Tricuspid regurgitation was analyzed, and risk factors for worsening regurgitation were identified, by multivariable ordinal longitudinal methods.

RESULTS: Tricuspid regurgitation 1 week after annuloplasty was 3+ or 4+ in 14% of patients. Regurgitation severity was stable across time with the Carpentier-Edwards ring (P = .7), increased slowly with the Cosgrove-Edwards band (P = .05), and rose more rapidly with the De Vega (P = .002) and Peri-Guard (P = .0009) procedures. Risk factors for worsening regurgitation included higher preoperative regurgitation grade, poor left ventricular function, permanent pacemaker, and repair type other than ring annuloplasty. Right ventricular systolic pressure, ring size, preoperative New York Heart Association functional class, and concomitant surgery were not risk factors. Tricuspid reoperation was rare (3% at 8 years), and hospital mortality after reoperation was 37%.

CONCLUSIONS: Tricuspid valve annuloplasty did not consistently eliminate functional regurgitation, and across time regurgitation increased importantly after Peri-Guard and De Vega annuloplasties. Therefore, these repair techniques should be abandoned, and transtricuspid pacing leads should be replaced with epicardial leads.


Surgery for tricuspid valve disease has been relatively ignored. Between 1991 and 2000, 1498 papers were published in English about mitral valve surgery and 1447 about aortic valve surgery, but only 335 about tricuspid valve surgery.1 The Carpentier ring, designed specifically for tricuspid valve repair, was released over 30 years ago,2 yet most tricuspid valve repairs are still either suture-based or done with rings originally released for mitral valve repair.3-7

Most series of tricuspid valve repairs are small and focus on gross outcomes such as freedom from reoperation or survival. However, freedom from reoperation may seriously underestimate the prevalence of residual or recurrent tricuspid regurgitation because tricuspid valve reoperation is considered "high risk" and may not be offered,8 and late survival depends on many factors other than durability of tricuspid valve repair.

With increasing prevalence of heart failure and surgical intervention for severe left ventricular dysfunction, surgeons now encounter tricuspid regurgitation regularly.9,10 Therefore, we examined our experience with repair of functional tricuspid regurgitation to (1) determine durability of annuloplasty techniques, (2) identify risk factors for repair failure (including type of annuloplasty), and (3) characterize reoperation, survival, and functional class of surviving patients.


    Patients and methods
 Top
 Abstract
 Patients and methods
 Results
 Discussion
 Conclusion
 Appendix 1: Details of...
 Appendix 2: Variables used...
 References
 
Patients
From January 1990 to January 1999, 790 patients underwent annuloplasty for functional tricuspid valve regurgitation at The Cleveland Clinic Foundation. Patients with endocarditis, rheumatic valve disease, or organic disease of the tricuspid valve leaflets, including congenital anomalies, were excluded.

Patients were identified and preoperative, operative, and postoperative variables retrieved from the prospective computerized Cleveland Clinic Cardiovascular Information Registry. This database has been approved for research by the institutional review board (IRB).

Four types of annuloplasty were employed: classic Carpentier-Edwards semi-rigid ring, Cosgrove-Edwards flexible band, De Vega procedure, and a customized semicircular annuloplasty using bovine pericardium (Peri-Guard). All were used during the entire study period except for the Cosgrove-Edwards band, which became available in 1995 (Table 1). Annuloplasty type used depended on device availability and surgeon preference. Sizing of the tricuspid valve was at the discretion of the surgeon. One patient was excluded from follow-up analysis because annuloplasty type could not be determined.


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TABLE 1. Distribution of tricuspid annuloplasty techniques over the study period

 
Mean age of patients was 65 years (range 18-88), and 64% were women. Preoperative tricuspid regurgitation was 4+ in 44% of patients, 3+ in 43%, and 0 or 1+ in 2.9%. Right ventricular systolic pressure was similar at baseline in each of the 4 groups. Left ventricular ejection fraction (EF) was highest in the group undergoing Peri-Guard annuloplasty and lowest in the group undergoing the De Vega procedure. Tricuspid valve repair was the sole procedure in only 36 patients (5%). Concomitant procedures included mitral valve operation in 89% and aortic valve operation in 27% (Table 2).


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TABLE 2. Patient characteristics overall and by annuloplasty technique*

 
Follow-up
Patients were followed routinely every 2 years after operation, then cross-sectionally in 2000. Data were obtained for 725 patients (92%) by telephone interview with them, their families, or physicians using an IRB-approved questionnaire. Echocardiographic reports were solicited, as well as functional status, vital status, and occurrence of tricuspid valve reoperations. Patients untraced cross-sectionally were considered traced from operation to time of last contact for reoperations, functional status, and echocardiography; the Social Security Death Index was used to determine vital status. A total of 3302 patient-years of follow-up information was available for analysis.

Assessment of repair
Preoperative and postoperative transthoracic echocardiographic reports were utilized to assess tricuspid regurgitation grade and right ventricular systolic pressure. Echocardiograms were performed routinely before discharge and at the discretion of referring physicians during follow-up. None of the echocardiographic data in this report is based on intraoperative studies. Interpretation of follow-up echocardiograms was obtained at as many time points as available for each patient.

A total of 2245 postoperative echocardiogram reports were retrieved; 65 patients had none available for analysis. Median time of echocardiographic assessment was 6 months (25th percentile = 1 week, 75th percentile = 3 years, range 0-11.8 years). Tricuspid regurgitation was graded as 0 for no regurgitation, 1+ for mild regurgitation, 2+ for moderate regurgitation, 3+ for moderately severe regurgitation, and 4+ for severe regurgitation.

Data analysis
The following questions were addressed:

  1. What is the durability of tricuspid valve repair?
  2. Did durability differ among the 4 annuloplasty techniques?
  3. What are the risk factors for repair failure?
  4. How many patients had reoperation for tricuspid valve disease?
  5. What was the New York Heart Association (NYHA) functional class at follow-up?
  6. Did right ventricular systolic pressure change over time?
  7. What is survival following tricuspid valve repair?
  8. Do patients with high residual tricuspid regurgitation have a longer postoperative hospital stay?

To address the first 3 questions, postoperative and follow-up transthoracic echocardiograms were analyzed for change in tricuspid regurgitation across time. Temporal patterns of change among the 4 repair techniques were compared by separate analysis of each. Risk factors for time-related increase in grade of tricuspid regurgitation were identified. Freedom from tricuspid valve reoperation was assessed by time-related analyses.

NYHA class was assessed by temporal frequencies, right ventricular systolic pressure by longitudinal data analysis, survival by time-related analyses, and impact of tricuspid regurgitation on length of stay by a series of indirect analyses. Analytic methods for these data are presented in Appendix 1.

Durability
Longitudinal ordinal logistic regression for repeated measurements (SAS PROC GENMOD) was used to analyze change in postoperative regurgitation over time,11 both overall and separately for each annuloplasty technique.

Because the temporal trend of tricuspid regurgitation showed steep changes in the first 6 months following annuloplasty, risk factors for higher grades of regurgitation were sought separately for (1) the first 6 months (early) and (2) after 6 months (see Appendix 1 for details). In addition, to reduce selection bias in use of a particular annuloplasty type, a balancing score technique utilizing propensity matching was employed (described in Appendix 1).12,13

Focused studies
The influence of temporal change in tricuspid regurgitation was investigated with respect to presence of preoperative permanent pacemaker, preoperative left ventricular function, and preoperative transthoracic echocardiographic tricuspid regurgitation grade. For the latter, preoperative regurgitation grades 0, 1+, and 2+ were grouped because of their rarity.

Reoperation
Freedom from tricuspid valve reoperation was estimated both nonparametrically14 and parametrically,15 and the hazard function was estimated (see http://www.clevelandclinic.org/heartcenter/hazard).


    Results
 Top
 Abstract
 Patients and methods
 Results
 Discussion
 Conclusion
 Appendix 1: Details of...
 Appendix 2: Variables used...
 References
 
Tricuspid annuloplasty utilizing a Cosgrove-Edwards flexible band was the most frequently performed technique. The most commonly used sizes were 28 mm and 30 mm, compared with 30 mm and 32 mm for the classic Carpentier-Edwards ring (see Table 2).

Durability
Change in tricuspid regurgitation across time
Overall, the proportion of patients with regurgitation grade 0 decreased rapidly within the first 6 months, followed by a more gradual decline, and the proportion with 3+ or 4+ regurgitation rose sharply initially, then continued rising more gradually (Table 3). One month postoperatively, prevalence of 3+ or 4+ regurgitation was 15% for the Carpentier-Edwards ring, 15% for the Cosgrove-Edwards band, 14% for the De Vega procedure, and 15% for Peri-Guard annuloplasty (see Table 3).


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TABLE 3. Predicted prevalence across time of grades 3+ and 4+ tricuspid valve regurgitation for various annuloplasty techniques*

 
Regurgitation grade evolved differently among the 4 repair techniques (Figure 1). Severity of regurgitation was stable across time with the Carpentier-Edwards ring (P = .7) and increased slowly with the Cosgrove-Edwards band (P = .05); however, in comparison with one another, the temporal pattern was similar (P = .6) (Figure 2). Severity of regurgitation rose more rapidly with both the De Vega procedure (P = .002; P = .06 compared with the Carpentier-Edwards ring) and Peri-Guard annuloplasty (P = .0009; P = .002 compared with the Carpentier-Edwards ring) (see Figure 2).



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Figure 1. Tricuspid regurgitation (TR) grade change over time for each annuloplasty technique. Curves indicate predicted mean percent of patients in each regurgitation grade from longitudinal modeling. Symbols represent grouped data for TR grade. Open squares = 0; open circles = 1+; solid circles = 2+; triangles = 3+; diamonds = 4+. A, Cosgrove-Edwards flexible band. B, Peri-Guard annuloplasty. C, Carpentier-Edwards rigid ring. D, De Vega procedure.

 


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Figure 2. Tricuspid regurgitation grades 3+ and 4+ postoperatively for each annuloplasty technique. Curves indicate predicted mean percent of patients with 3+ or 4+ tricuspid regurgitation for each annuloplasty technique. Symbols represent grouped data according to percent of observations of 3+ and 4+ tricuspid regurgitation for each annuloplasty technique. Open circles = Carpentier-Edwards; squares = Cosgrove-Edwards; triangles = De Vega; solid circles = Peri-Guard. TR, Tricuspid regurgitation; RR, Carpentier-Edwards rigid ring; FB, Cosgrove-Edwards flexible band; DV, De Vega procedure; PG, Peri-Guard annuloplasty.

 
Size of the Carpentier-Edwards ring or Cosgrove-Edwards band did not influence evolution of regurgitation over time (P = .6).

Risk factors
Higher preoperative transthoracic echocardiographic tricuspid regurgitation was a risk factor for return of higher grades of tricuspid regurgitation within 6 months (Table 4). Risk factors beyond 6 months included greater left ventricular dysfunction, presence of permanent pacemaker, and Peri-Guard annuloplasty.


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TABLE 4. Risk factors for return of higher tricuspid regurgitation grade

 
Prevalence of 3+ or 4+ regurgitation among patients with a preoperative permanent pacemaker increased from 16% at 1 month postoperatively to 42% at 5 years, compared with 15% and 23%, respectively, for those without a pacemaker (Figure 3).



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Figure 3. Influence of preoperative permanent pacemaker on evolution of postoperative 3+ and 4+ tricuspid regurgitation. Format is as in Figure 2. Open circles = pacemaker; solid circles = no pacemaker. PPM, Permanent pacemaker; TR, tricuspid regurgitation.

 
Prevalence of 3+ or 4+ regurgitation among patients in preoperative left ventricular functional classes 1 (EF >= 50%), 2 (EF 36%-49%), 3 (EF 25%-35%), and 4 (EF < 25%) increased from 14%, 15%, 17%, and 20% at 1 month postoperatively to 26%, 15%, 31%, and 28% at 5 years, respectively (Figure 4).



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Figure 4. Influence of preoperative left ventricular function on evolution of postoperative 3+ and 4+ tricuspid regurgitation. Curves indicate predicted percent of patients with 3+ and 4+ regurgitation postoperatively in each of the 4 left ventricular functional groups. Solid circles = preoperative left ventricular functional grade 1; open circles = grade 2; squares = grade 3; triangles = grade 4. TR, Tricuspid regurgitation.

 
In patients with preoperative tricuspid regurgitation grades 0 versus 1+ and 2+ versus 3+ and 4+, prevalence of 3+ or 4+ tricuspid regurgitation increased from 9%, 14%, and 22% at 1 month postoperatively to 18%, 23%, and 29% at 5 years, respectively (Figure 5).



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Figure 5. Influence of preoperative tricuspid regurgitation grade on evolution of postoperative 3+ and 4+ tricuspid regurgitation. Curves indicate predicted percent of patients with 3+ and 4+ regurgitation postoperatively for patients stratified according to preoperative regurgitation grade. Grades 0, 1+, and 2+ are collapsed into 1 group. Solid circles = preoperative regurgitation grades 0, 1+, and 2+; open circles = grade 3+; squares = grade 4+. TR, Tricuspid regurgitation.

 
There was no evidence of interaction between permanent pacemaker and left ventricular dysfunction (P = .4), permanent pacemaker and preoperative tricuspid regurgitation (P = .4), or left ventricular dysfunction and preoperative tricuspid regurgitation (P = .6). Each factor had an independent effect.

Right ventricular systolic pressure, ring size, preoperative NYHA functional class, or need for concomitant surgery were not identified as risk factors.

Reoperation
Freedom from reoperation was 99% at 1 month postoperatively and 97% at 8 years. Risk of reoperation was 4.2% per year at 30 days, fell to 0.08% per year by 3 years, and increased to 2.9% per year by 10 years. Thirty-day operative mortality after reoperation (n = 6) was 32%, and 1 other patient died later in-hospital, making hospital mortality 37%. Survival at 1 year and 3 years was 31% and 19%, respectively.

Functional status
Of the patients who were 4 years or more postoperative, 24% were in NYHA functional class III or IV (Table 5).


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TABLE 5. Percent of patients in each New York Heart Association functional class at time of follow-up

 
Right ventricular systolic pressure
Postoperative mean right ventricular systolic pressure increased from 42 mm Hg at postoperative day 1 to 45 mm Hg at 8 years (P = .02) and was not influenced by annuloplasty type (P > .12).

Survival
Thirty-day operative mortality for the 790 patients was 6%, and hospital mortality was 8%. Survival was 65% at 5 years and 50% at 8 years.


    Discussion
 Top
 Abstract
 Patients and methods
 Results
 Discussion
 Conclusion
 Appendix 1: Details of...
 Appendix 2: Variables used...
 References
 
Principal findings
This study has important implications for the cardiac surgery and cardiology communities. We found that residual and recurrent regurgitation after tricuspid annuloplasty was common and some of its risk factors correctable. However, reoperation for tricuspid regurgitation was rare, despite the return of many patients to NYHA class III or IV. The low rate of reoperation may be due in part to the perception that this is a high-risk procedure, which was verified in this study.

Residual tricuspid regurgitation occurred in 14% of patients early after operation for all types of annuloplasty. This prevalence is much higher than after mitral valve repair, even for functional ischemic mitral regurgitation.16-18 By 6 months, Peri-Guard annuloplasty was already showing more recurrent regurgitation than the Carpentier-Edwards ring. The higher the grade of preoperative tricuspid regurgitation, the higher the risk of repair failure within 6 months. However, most indicators of early worsening were markers of patient disease and as such could not be altered by the surgeon.

Late worsening (beyond 6 months) of tricuspid regurgitation was associated not only with patient disease factors but also with avoidable causes such as transtricuspid pacing leads and type of annuloplasty. Results with the Carpentier-Edwards ring showed little change in tricuspid regurgitation over time, and the Cosgrove-Edwards band showed minimal increase. In contrast, the 2 nonring annuloplasties, De Vega and Peri-Guard, showed substantial worsening in late tricuspid regurgitation. Theoretically, persistent pulmonary hypertension may have affected the nonring repairs and allowed the annulus to gradually redilate because right ventricular systolic pressure did not importantly decrease during late follow-up. Other studies also have shown late recurrence of tricuspid regurgitation following De Vega repair, including a randomized trial versus the Carpentier-Edwards ring.19 Other suture-based methods of tricuspid valve repair are also inferior to the Carpentier-Edwards ring.20 Therefore, 1 risk factor for late tricuspid regurgitation could be eliminated by avoiding De Vega and Peri-Guard annuloplasties.

Second, we identified permanent pacemakers as a risk factor for late, but not early, regurgitation. Right ventricular pacing leads that traverse the tricuspid valve may cause regurgitation by several mechanisms: (1) they may be anchored in such a way that they are fixed in the right ventricle and inhibit leaflet motion, (2) they may perforate a leaflet or pin the leaflet to ventricular muscle, or (3) scar tissue or thrombus may form around them, impairing leaflet mobility.

Another important risk factor for late failure was left ventricular dysfunction. Success of biventricular synchronous pacing for patients with severe left ventricular dysfunction and left bundle branch block, along with results of the MADIT II trial, suggest that there will be many patients with the combination of severe left ventricular dysfunction and electrical leads that traverse the tricuspid valve.21,22 This will be especially important because moderate or severe tricuspid regurgitation occurs in 35% of patients with left ventricular EFs below 35%, and survival is poor.9,23 Therefore, we investigated whether these factors are multiplicative and put patients at even higher risk of tricuspid valve repair failure; this did not turn out to be the case. Five years after valve repair, 42% of patients with a permanent pacemaker had severe regurgitation, almost twice as high as those without the device. This suggests that removing the transtricuspid lead and replacing it with an epicardial lead may reduce late repair failure.

Some variables that we thought might predispose the patient to recurrent repair failure did not prove to be statistically significant after accounting for variables already in the model. Currently, it is popular to treat functional mitral regurgitation with an undersized valve ring to improve leaflet coaptation.24 We thought this might apply to functional tricuspid regurgitation as well and expected to find that patients with larger tricuspid rings would be more prone to recurrent regurgitation; this was not observed. Therefore, the strategy of undersizing the tricuspid annulus for functional tricuspid regurgitation using small rings cannot be validated as protection against late tricuspid regurgitation. We also expected that right ventricular systolic pressure might correlate with early or late tricuspid regurgitation, but it did not.

Despite frequent recurrent 3+ or 4+ tricuspid regurgitation, reoperation was rare (3% at 8 years). Some patients tolerate moderate amounts of regurgitation with minimal symptoms, and a few tolerate severe regurgitation with mild symptoms. However, this did not appear to explain the low occurrence of reoperation, because 24% of patients had returned to NYHA class III or IV in late follow-up. We cannot determine accurately whether limited functional class was related to right heart failure symptoms and recurrent tricuspid regurgitation.

Reoperation for tricuspid valve disease proved to be a high-risk procedure, as others have found8; observed in-hospital mortality of 37% makes this one of the highest-risk cardiac valve operations. This poor track record may create a self-fulfilling prophecy: patients with recurrent severe tricuspid regurgitation are managed aggressively with diuretics and medication and are referred to surgery only when they develop severe disabling symptoms including hepatic and renal dysfunction. When the patient dies or fails to thrive, this perpetuates the notion that tricuspid repair is high risk. The major discrepancy between echocardiographic findings of recurrent tricuspid regurgitation and prevalence of reoperation for tricuspid valve disease indicates an important shortcoming in any article reporting the "success" of tricuspid valve annuloplasty techniques.

Limitations
No consistent, accurate data were available regarding right ventricular function, right ventricular size and geometry, tricuspid annular size, or pulmonary artery pressure; all may be important factors influencing durability of tricuspid valve repair. Also, this study did not attempt to analyze residual mitral valve disease (either stenosis or regurgitation) and correlate it with the results of tricuspid valve repair. Furthermore, we were not able analytically to relate recurrent tricuspid regurgitation to subsequent survival or progression of NYHA class. It is unknown whether recurrent tricuspid regurgitation led to subsequent worsening of heart failure symptoms in patients in late follow-up or whether patients developed heart failure from progressive left ventricular dysfunction, with secondary pulmonary hypertension and right ventricular dysfunction that then led to tricuspid regurgitation. Finally, as with all studies of clinical experience, the data are subject to selection and ascertainment bias. For instance, symptomatic patients might have been more likely to receive follow-up echocardiography than asymptomatic ones. Additionally, in longitudinal studies the competing risk of death changes the makeup of the residual study population; to the extent that outcomes are correlated with death, temporal bias is introduced by this so-called informative censoring mechanism.


    Conclusion
 Top
 Abstract
 Patients and methods
 Results
 Discussion
 Conclusion
 Appendix 1: Details of...
 Appendix 2: Variables used...
 References
 
Recurrent or residual tricuspid regurgitation after tricuspid valve annuloplasty was common, and reports defining success as freedom from reoperation should be suspect. Peri-Guard and De Vega tricuspid valve annuloplasty techniques should be abandoned. Transtricuspid pacing leads should be removed and replaced with epicardial leads at surgery. When other risk factors related to patient disease are present, consideration of tricuspid valve replacement might be warranted.


    Appendix 1: Details of data analysis
 Top
 Abstract
 Patients and methods
 Results
 Discussion
 Conclusion
 Appendix 1: Details of...
 Appendix 2: Variables used...
 References
 
Durability
Risk factors for failure
Because of the limited ability of SAS PROC GENMOD for variable selection, we initially screened variables for multivariable analysis using ordinary multivariable logistic regression and the assumption of independence of observations with liberal entry (P = .2) and retention (P = .12) criteria to identify candidates for repeated measurements analysis. These candidates and their transformations of scale were entered simultaneously into the longitudinal model, then eliminated manually one by one until all variables remaining had a P value of .1 or less.

Construction of propensity scores
Using Carpentier-Edwards annuloplasty as the reference and PROC LOGISTIC (SAS) with a generalized logit link, 3 simultaneous multivariable logistic regression equations were solved. Using known preoperative variables (Appendix 2), factors associated with annuloplasty technique were determined. Continuous and ordinal variables were initially analyzed by decile analysis, selecting those transformations of scale that best calibrated the variable to the technique. Having established a parsimonious model, other variables were added representing groups of patient and disease factors that might be related to unrecorded selection factors (saturated model).

A propensity score for each technique was calculated for each patient by solving the 3 simultaneous multivariable logistic regression equations. To compare techniques, these 3 scores and their transformations of scale (where appropriate), repair type, and interactions with repair type were forced into the multivariable analyses.13

New York Heart Association functional class
NYHA functional status was available for 647 patients. Patients were grouped by interval from operation to follow-up and percentage in each NYHA functional class determined.

Right ventricular systolic pressure
Right ventricular systolic pressures were derived whenever possible from transthoracic echocardiograms, and temporal pattern of change was analyzed. Longitudinal linear mixed-model regression was used to analyze continuous repeated measurements of right ventricular systolic pressure change over time (PROC MIXED).11 A total of 1268 measurements were available on 556 patients. Median time of assessment was 7 months (25th percentile = 10 days, 75th percentile = 3.2 years, range 0-11.8 years). Influence of the 4 annuloplasty techniques was determined using propensity score–adjusted univariable models with a different repair technique as the reference group.

Survival
Nonparametric and parametric survival estimates and hazard function were obtained as described in the preceding text. Among survivors, median follow-up was 4.5 years, with 25% followed for 3.2 years or less and 25% followed for 6.7 to 11.8 years.

Length of hospital stay
To investigate whether postoperative length of hospital stay was affected by predischarge grade of tricuspid regurgitation, patients were stratified into those with maximum in-hospital regurgitation grade 1+ or less and those with maximum grade 2+ or more. Of 587 patients with postoperative echocardiograms prior to discharge, 369 (63%) had tricuspid regurgitation grades <=1+ and 218 (37%) had >=2+. Both groups had the maximum postoperative in-hospital regurgitation grade recorded at a similar time interval (P = .3). Multivariable hazard analysis and propensity score methods (adjusted multivariable analysis and pairwise matching) using preoperative variables alone or together with postoperative event were used to investigate the relation between hospital stay and regurgitation grade. Postoperative events used in the model were stroke, bleeding, renal failure, respiratory insufficiency, septicemia, and use of intra-aortic balloon pump.

Median length of postoperative hospital stay was 9 days (25th percentile = 7 days, 75th percentile = 14 days) for patients with maximum tricuspid regurgitation grades <=1+ and 11 days (25th percentile = 7 days, 75th percentile = 20 days) for patients with tricuspid regurgitation grades >=2+ (P = .0003). Taking into consideration preoperative variables and postoperative events, the significance of this difference was variable, ranging from .0003 to .1, depending on what other variables were included in the model and whether patients were propensity matched.


    Appendix 2: Variables used in analyses
 Top
 Abstract
 Patients and methods
 Results
 Discussion
 Conclusion
 Appendix 1: Details of...
 Appendix 2: Variables used...
 References
 
Preoperative

Demography: Gender, age, weight, height, body surface area, body mass index
Symptoms: New York Heart Association functional class, Canadian Heart Classification
Ventricular function: Ejection fraction, left and right ventricular function, right ventricular systolic pressures
Pathology: Mitral regurgitation, tricuspid regurgitation
Cardiac comorbidity: History of myocardial infarction, electrocardiographic evidence of myocardial infarction, atrial fibrillation, complete heart block, ventricular arrhythmia, history of cardiac surgery, emergency cardiac surgery, number of cardiac surgeries, coronary artery disease by coronary artery territory (left main trunk, left anterior descending artery, left circumflex artery, right coronary artery)
Noncardiac comorbidity: Insulin-dependent diabetes, non–insulin-dependent diabetes, treated diabetes, hypertension, history of peripheral vascular disease, presence of carotid disease, presence of chronic obstructive pulmonary disease, renal disease, history of smoking, creatinine, blood urea nitrogen, bilirubin, hematocrit
Experience: Date of surgery

Intraoperative

Procedure: Internal thoracic artery grafts used, concomitant procedures (mitral valve repair, mitral valve replacement, aortic valve repair, aortic valve replacement, coronary artery bypass), annuloplasty ring, annuloplasty ring size
Support: Ischemic time, perfusion time

Discussion
Dr Steven F. Bolling (Ann Arbor, Mich). I would like to thank the authors for allowing me to review this very elaborately analyzed work. The authors found that in this long-term follow-up of tricuspid repairs, a ring repair appeared to be more robust in terms of good, long-term results, whereas a stitch repair or a pericardial repair was less so.

I have a number of questions for the authors. Were they surprised by the fact that tricuspid size at the time of operation did not relate to recurrence of tricuspid regurgitation, and is there any way for the authors to tell whether their type of operation was tailored to the amount of tricuspid regurgitation seen at the operation (i.e., did those patients who had less regurgitation get a stitch repair, those patients who were felt to have higher regurgitation get a ring repair)?

Second, the authors did not correlate recurrence of tricuspid regurgitation to residual mitral regurgitation. Could it be that patients who had recurrent tricuspid regurgitation were reflective of residual or recurrent mitral regurgitation?

Third, were they surprised by the very low reoperation rate despite the very high recurrence of tricuspid regurgitation, and what do the authors now tolerate at the time of operation in terms of residual tricuspid regurgitation? In this study it appears that 14% of the patients left the hospital with significant tricuspid regurgitation.

And last, do the authors now recommend that the rings we use in the tricuspid annulus should be more rigid, as these appeared to have a longer robust outcome?

Dr McCarthy. I would like to thank Dr Bolling for his questions. First, did the size of the tricuspid valve annulus seem to have an effect on the repair durability? We did not feel that we had adequate data from our echo studies to comment specifically about the size of the tricuspid valve annulus. We were somewhat surprised to find that the smaller rings were no better than the larger ones at preventing late tricuspid regurgitation, but this may be accounted for by the effects of including Barlow's patients, who received larger rings and fared quite well. The patients with cardiomyopathy have smaller leaflets and may not do as well, although our current practice is still to undersize in that patient population.

Another question had to do with tailoring the type of tricuspid annuloplasty versus the amount of tricuspid regurgitation; for example, would we do a De Vega annuloplasty because the tricuspid regurgitation was only 2 or 3+? That did not appear to be the practice according to our analysis. Much of the choice was related to the surgeon's preference for the type of annuloplasty technique.

Also, we were unable to correlate late tricuspid regurgitation with late mitral regurgitation due to statistical techniques that Dr Blackstone tells me do not yet exist. What do we tolerate in terms of residual tricuspid regurgitation? It should be noted that the study looked at only transthoracic preoperative and then, later, postoperative studies. We are all well aware of downgrading of tricuspid regurgitation in the operating room. I expect that none of the patients would have left the operating room with anything greater than 2+ tricuspid regurgitation. Today if we saw a patient with anything over 1+ tricuspid regurgitation in the operating room, we would consider that a cause for concern. If a patient has residual 3 or 4+ tricuspid regurgitation on the predischarge echo, we would seriously consider reoperating on that patient based on the analysis of this study.

Another question had to do with the rigid ring versus the flexible band. By multivariable analysis there was no difference in the long-term outcome between the 2, although by univariable analysis the flexible band did show some decrease in effectiveness. So there was some increase in tricuspid regurgitation in that group.

Dr Alain F. Carpentier (Paris, France). I rise to congratulate this presentation, and it confirms what Dr Deloche more than 15 years ago showed when comparing remodeling annuloplasty and nonremodeling annuloplasty, that is to say, other techniques using bands or sutures. He showed a 0.6% per patient-year freedom from reoperation with remodeling versus 1.6% with the other techniques, which confirmed pretty much what Dr McCarthy and his colleagues have shown.

Now, I would like to make a kind remark, which is the use of the term of "rigid" Carpentier ring. The tricuspid ring originally has not been made rigid but semi-rigid so as to adapt to the 3-dimensional configuration of the tricuspid annulus when lowered into position. So I think it would be appropriate to use the term "semi-rigid" and to keep in mind, again, that knowing that all tricuspid orifices have a different configuration, it is better to use a semi-rigid rather than a strongly rigid structure to keep the 3-dimensional configuration.

Dr McCarthy. Thank you, Professor Carpentier. I would like to agree that it is a semi-rigid ring, which is why you can bend that ring. We referred to it as "rigid" in contrast to the other 3 types of annuloplasty techniques.

Dr Norberto G. De Vega (Malaga, Spain). Just a few comments. As I said this morning, I think that to mix rheumatic heart disease with other diseases is not right. Most of the patients need a tricuspid repair. Now there are many rheumatic patients, especially in the developing countries. I have been in India, in China, and there are thousands of patients, and they need that.

And to give the message that everybody who needs a tricuspid repair needs to have a ring implanted, to me, it is not right. Many years ago I said the same thing about mitral repair. I think that you can do mitral repair without a ring. And if you have to do mitral repair with a ring, I called that years ago "the taxed mitral repair": you have to pay a tax and put a ring in every case. I feel really that most of the patients, if they need a tricuspid repair, and this is our experience, they can have a "tax-free" tricuspid repair.

Dr McCarthy. Thank you very much. I agree that suture repair is a very inexpensive technique, and one has to take into account the cost of the rings. On the other hand, reoperations greatly underestimate the number of patients who redevelop severe tricuspid regurgitation. In the long-term one also has to take into account the cost of recurrent heart failure and the cost of rehospitalizations. Over the long term rings may be more cost-effective.

Dr Kevin D. Accola (Orlando, Fla). I enjoyed your work. Dr McCarthy, if you would elucidate a little more on what you just mentioned regarding reoperations. On one of your conclusion slides, you consider the possibility of tricuspid valve replacement. With your event-free survival results being so favorable, at which point would you put a patient through a reoperation, or even consider a tricuspid valve replacement? That seems a little extreme with such good results, and at that point, which valve would you utilize?

Dr McCarthy. First of all, I think that the reoperation rate was low for several reasons: first is that 51% of our patients were reoperations, and so now a reoperation for the tricuspid valve disease would be at least their third operation. Another issue is that we don't see these patients until many years later. The cardiologists frequently follow these patients and give diuretics. They are trying to manage them medically, and they usually only refer them to us when those patients are very advanced with hepatic dysfunction and sometimes other organ failure. That is why the risk of the reoperation was so high, at 37%, because we are seeing them so late in the natural history. For most patients we replace the valve with a tissue valve.

Dr Rainald Seitelberger (Vienna, Austria). I also congratulate you on this very nice study. I am referring to the patients with the pacemaker leads, because you reported that they have a significantly higher incidence of recurrence of insufficiency, and I would like to ask you what surgical steps you took in those patients. I just recently had 3 patients who had pacemaker leads: 2 of them actually punctured the posterior leaflet of the tricuspid valve and 1 was totally adherent to the posterior leaflet of the tricuspid valve. In all 3 cases I did a bicuspidalization of the valve together with a ring.

My question is, do you have any specific surgical techniques to avoid this problem?

Dr McCarthy. We have seen failures even in patients who had the permanent pacemaker wire free of the leaflet itself because the pacing wire may flatten the leaflet. After the analysis of this data the safest technique may be to simply remove the wire and replace it with a steroid-eluting epicardial pacing wire that maintains low thresholds for many years. If at some point the epicardial pacing wires wear out, then the patient could undergo transvenous pacing wire placement.

Dr Gilles D. Dreyfus (London, United Kingdom). First of all, I want to congratulate Patrick McCarthy and his group for this very impressive series. You had said that when you now encounter regurgitation that would be greater than 2 you would consider going back on-pump and probably doing something else, and then you even said that you would probably replace the valve in the inferences.

Would you consider doing a technique similar to what we do for mitral valve in the tricuspid valve, that is, for instance, use substitute chordal such as polytetrafluoroethylene or pericardial to extend the anterior leaflet, or even suture the posterior to the septal commissure and transform the tricuspid valve into a bicuspid valve in case you have a tethering effect? Did you analyze those 14% of cases, as you said, that were not related to the type of the technique? Therefore, you still have some cases where the tethering effect pulls down the free edge, and then whatever you do, even downsize, will leave a tricuspid regurgitation. What would you do in such an instance?

Dr McCarthy. We don't want to give the message that we have a low threshold for recommending tricuspid valve replacement. This would be in only very selected patients. For instance, in patients with Barlow's disease it is very rare that one would ever consider replacing the valve. I think that those almost uniformly could be repaired.

On the other hand, in the increasing population of patients with cardiomyopathy, in which the leaflets themselves are normal, the right ventricle is dilated, and the leaflets are tethered, it appears that not many of the repair techniques accomplish a very durable repair. Then it may be safer to replace in that group than to accept recurrent or residual tricuspid regurgitation. But, again, that would be an uncommon decision. The techniques of bicuspidization, leaflet extension with pericardium, or chorded extension in this population may be worthwhile, but we do not yet have that data.


    Footnotes
 
Supported in part by an education grant from Edwards Lifesciences. Drs McCarthy and Cosgrove have developed annuloplasty rings for tricuspid valve repair (Cosgrove-Edwards, Edwards-MC3).


    References
 Top
 Abstract
 Patients and methods
 Results
 Discussion
 Conclusion
 Appendix 1: Details of...
 Appendix 2: Variables used...
 References
 

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