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J Thorac Cardiovasc Surg 2007;133:117-126
© 2007 The American Association for Thoracic Surgery
Surgery for Acquired Cardiovascular Disease |
a Division of Cardiac Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, Mass
b Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, Mass.
Read at the Eight-sixth Annual Meeting of The American Association for Thoracic Surgery, Philadelphia, Pa, April 29-May 3, 2006.
Received for publication May 5, 2006; revisions received August 10, 2006; accepted for publication August 25, 2006. * Address for reprints: Lawrence H. Cohn, MD, Division of Cardiac Surgery, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115. (Email: lcohn{at}partners.org).
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Abstract |
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 Top Abstract IntroductionPatients and MethodsResultsDiscussionLimitationsConclusionsReferences |
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METHODS: From 1999 to 2003, 237 patients underwent tricuspid annuloplasty for functional tricuspid regurgitation as part of their cardiac surgical procedure. Bicuspidization was performed in 157 patients and ring annuloplasty in 80 patients. Preoperatively, 227 (96%) patients had moderate or greater tricuspid regurgitation with a median regurgitation of 3+. Follow-up information was obtained for 234 (99%) patients with a mean follow-up time of 3 years. Postoperative transthoracic echocardiograms were assessed for severity of tricuspid regurgitation. Moderate or greater tricuspid regurgitation was considered significant. Survival and development of recurrent tricuspid regurgitation were evaluated by Kaplan–Meier analysis. Tricuspid regurgitation and risk factors for recurrent regurgitation were identified and analyzed by multivariable ordinal longitudinal methods.
RESULTS: At 3 years postoperatively, tricuspid regurgitation in patients treated by bicuspidization annuloplasty was zero to mild in 75%, moderate in 11%, moderate to severe in 6%, and severe in 8% of patients. In those undergoing ring annuloplasty, tricuspid regurgitation was zero to mild in 69%, moderate in 14%, moderate to severe in 7%, and severe in 10%. There was no significant difference between the two groups (P = .18). Risk factors for recurrent tricuspid regurgitation included higher preoperative regurgitation grade, preoperative tricuspid regurgitation without concomitant mitral regurgitation, and higher pulmonary artery systolic pressure.
CONCLUSIONS: Bicuspidization annuloplasty and ring annuloplasty were effective at eliminating tricuspid regurgitation at 3 years postoperatively. Bicuspidization annuloplasty is a simple, inexpensive option for addressing functional tricuspid regurgitation. All patients with moderate-to-severe functional tricuspid regurgitation should undergo tricuspid annuloplasty regardless of the technique used.
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Introduction |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionLimitationsConclusionsReferences |
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Subsequent studies, however, have demonstrated that TR does not necessarily regress after repair of left-sided valve lesions.2-7 Uncorrected TR increases both postoperative morbidity and mortality and is associated with poor long-term results with medical management alone.8,9 Thus, many cardiac surgeons advocate tricuspid annuloplasty at the time of aortic or mitral valve surgery in patients with moderate or severe TR.10,11 Several annuloplasty methods have been described; however, few studies have evaluated and compared the efficacy and durability of these techniques.12
Suture bicuspidization was originally described by Kay, Maselli-Campagna, and Tsuji13 in 1965 as a technique to correct TR. This relatively simple technique involved figure-of-eight suture plication of the posterior leaflet to reduce annulus size. Bicuspidization, however, has since been superseded by other techniques seeking to remodel the annulus by maintaining a trileaflet valve with a more physiologic, stabilized annulus. These techniques include De Vega’s semicircular annuloplasty14 and the use of prosthetic annuloplasty rings, such as the Carpentier-Edwards semirigid ring (Edwards LifeSciences, Irvine, Calif),10 the Cosgrove-Edwards flexible band (Edwards LifeSciences),15 and the Duran flexible ring.16 A small number of studies comparing ring annuloplasty with suture annuloplasties (primarily the De Vega) have concluded that ring annuloplasty offers a more durable repair and that ring annuloplasty should supplant suture annuloplasty for repair of functional TR.12,17-19 Other investigators have reported good experience with the De Vega annuloplasty and continue to advocate its use.20,21 In North America, most surgeons currently favor ring annuloplasty.
At our institution, we routinely perform a modified suture bicuspidization of the tricuspid valve or a ring annuloplasty in all patients with moderate-to-severe functional TR who present for cardiac surgery. Since the dilation of the tricuspid valve primarily occurs at the posterior leaflet, posterior suture bicuspidization offers an inexpensive, simple, and rapid repair. Bicuspidization may have a role, particularly in cases of moderate TR, where a simple repair may be all that is required. The option to perform a simple repair without significantly prolonging operative time or requiring a prosthetic ring is appealing. In this study, we review and compare our experience with bicuspidization and ring annuloplasty for repair of functional TR to determine the efficacy and durability of tricuspid annuloplasty.
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Patients and Methods |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionLimitationsConclusionsReferences |
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Suture bicuspidization was performed in 157 (66%) patients. Ring annuloplasty was performed in 80 (34%) patients. Of those undergoing ring annuloplasty, 60 (75%) patients received a Cosgrove-Edwards flexible band (Edwards LifeSciences), 13 (16%) a Carpentier-Edwards semirigid ring (Edwards LifeSciences), and 7 (9%) a Carbomedics Annuloflex ring (Sulzer Carbomedics, Inc, Austin, Tex). Annuloplasty type depended on surgeon preference. Seven surgeons contributed patients to this study.
Patient preoperative and surgical characteristics are given in Table 1. The mean age of the patients was 67 years (range 20-90 years) and 53% were women. Fifty-three percent of patients were in New York Heart Association (NYHA) functional class III or IV. Concomitant mitral valve surgery was performed in 82% of patients, coronary artery bypass grafting in 32%, and aortic valve surgery in 29%. Triple valve surgery was performed in 53 (22%) patients. Only 23 (9.7%) patients had tricuspid valve repair as the sole valve procedure. There was no significant difference between the bicuspidization and ring annuloplasty patients in age, gender, NYHA class, preoperative pulmonary artery systolic pressure (PASP), preoperative right ventricular (RV) dysfunction, and concomitant surgical procedures. RV dysfunction was defined as any impairment in RV contraction noted on echocardiography. Left ventricular ejection fraction (EF) was higher in patients undergoing bicuspidization annuloplasty than in those undergoing ring annuloplasty (49% vs 43%, P = .004). The bicuspidization annuloplasty patients also had a higher prevalence of aortic insufficiency (AI) than the ring annuloplasty patients (P = .01).
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Operative Techniques
All annuloplasties were performed during concomitant aortic and/or mitral valve surgery with cardioplegic arrest. Ring annuloplasty was performed by standard operative techniques.10,15 The suture bicuspidization technique was performed by placing a double pledget-supported mattress suture of 2-0 Ethibond (Ethicon, Inc, Somerville, NJ) on a large MH needle from the anteroposterior commissure to the posteroseptal commissure along the posterior annulus (Figure 1). This double multifilament suture is then tied down over an obturator, such as the barrel of a 20-mL syringe or 29-mm valve sizer, which satisfactorily reduces the orifice size without placing undue strain on the annuloplasty repair and obliterates the posterior leaflet. Studies by Deloche and associates22 have shown that the primary anatomic problem in functional TR is anatomic dilation of the posterior tricuspid annulus, because this is the only unsupported area of the tricuspid valve ring, as opposed to the anterior and septal positions. Thus, a posterior annuloplasty should be effective for most cases of functional TR. The entire procedure may be accomplished in less than 8 minutes and does not produce tricuspid stenosis. In all patients, intraoperative transesophogeal echocardiography was performed to confirm elimination of TR.
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Assessment of Repair
Preoperative and postoperative transesophageal echocardiographic reports were used to assess TR grade. Interpretation of follow-up echocardiograms was obtained at as many time points as available for each patient. Transesophageal echocardiographic data were excluded so that TR grade determination would be consistent between patients and time points. A total of 519 postoperative echocardiographic reports were obtained. Twenty-seven patients had no postoperative echocardiograms available for analysis and were excluded. Median time of echocardiographic assessment was 1 year (25th percentile = 1 week, 75th percentile = 1.5 years, range = 0-4.7 years). TR was graded as 0 for no regurgitation, 1+ for mild, 2+ for moderate, 3+ for moderate to severe, and 4+ for severe, as defined by the American Society of Echocardiography.
End Points
We sought to address the following questions:
Data Analysis
Preoperative variables were compared between groups by the Fisher exact test (categorical variables) and the Student t test (continuous variables). Kaplan–Meier analysis was used to evaluate mortality and development of 2+ (moderate) recurrent TR.23 In the Kaplan–Meier analysis, development of 2+ TR was defined as the presence of sustained 2+ TR on serial echocardiograms. Patients were censored at time of mortality or last follow-up. To evaluate TR (mean TR and TR grade) over time, we performed repeated-measures mixed models (using SAS Proc Mixed; SAS Institute, Inc, Cary, NC) and longitudinal ordinal logistic regression (using SAS Proc Glimmix) for each annuloplasty technique.24,25 These longitudinal methods ensure that patients with more repeat echocardiograms and/or more follow-up are not given excessive weight and do not have a disproportionate influence on estimated means and proportions over time. We performed a similar longitudinal regression on postoperative recurrent mitral regurgitation (MR) to evaluate the effect of MR on TR. To evaluate the risk factors for development of higher recurrent postoperative TR, we performed univariate followed by multivariate Cox regression. Because there were preoperative differences in TR, EF, and AI between the bicuspidization and ring annuloplasty groups, weighted propensity score adjustment was performed to better compare the two groups when performing the longitudinal and survival analyses for recurrent TR.26 In this propensity score approach, the data for each patient are weighted by the inverse of the probability of receiving his or her treatment given the preoperative TR, EF, and AI. This propensity score analysis ensures that the effect of treatment is not confounded by the fact that bicuspidization patients tended to have better lower preoperative TR, better EF, and higher prevalence of AI. In all analyses, both weighted and unweighted comparisons were performed.
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Results |
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Mortality, Reoperations, and Functional Improvement
There were 10 (6.4%) early deaths (within 30 days or during the same hospitalization after the operation) in the bicuspidization annuloplasty group and 9 (11.3%) early deaths in the ring annuloplasty group. The Kaplan–Meier survival curve is shown in Figure 2. There was no statistically significant difference in mortality between the two groups; however, the ring annuloplasty patients demonstrated a trend to poorer survival (P = .07). Interestingly, the ring group had a lower preoperative EF and higher preoperative TR than the bicuspidization group. This may account for the trend to poorer survival. There was no statistically significant difference (P = .37) in mortality in patients who had significant recurrent TR. The actuarial survival at 3 years postoperatively was 75.3% in the bicuspidization group and 61.2% in the ring annuloplasty group.
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Efficacy and Durability of Tricuspid Annuloplasty
To evaluate overall efficacy and durability of annuloplasty, we evaluated TR grades by 3 different methods. We determined TR grade at last follow-up, assessed freedom from development of 2+ TR over time using Kaplan–Meier analysis (Figure 3), and used the serial echocardiographic data to predict mean TR and TR prevalence over time using longitudinal regression analyses (Figure 4). All annuloplasty types proved efficacious at reducing TR. Mean TR grade decreased by approximately 40% in both groups from before the operation to the last follow-up. The mean TR grade for each group was 3+ preoperatively and improved to 2+ TR at last follow-up. TR, however, was not significantly reduced in all patients. At last echocardiographic follow-up, TR in bicuspidization annuloplasty patients was zero to mild in 75%, moderate in 11%, moderate to severe in 6%, and severe in 8%. In ring annuloplasty patients, TR was zero to mild in 69%, moderate in 14%, moderate to severe in 7%, and severe in 10%. There was no statistically significant difference in mean TR grade or prevalence of TR at last follow-up between the two groups (P = .18). Between the different ring annuloplasty techniques, there was no statistically significant difference in mean TR grades at last follow-up (P =. 21). In the Cosgrove-Edwards band group, 7 (12%) patients had 3+ or 4+ recurrent TR at last follow-up, compared with 1 (8%) patient in the Carpentier-Edwards ring group.
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Figure 4 demonstrates the predicted TR prevalence over time for both groups. The evolution of TR is similar between both groups. Mean TR drops significantly postoperatively, increases in the next 6 months, continues to gradually increase up to 2 years postoperatively, and then remains relatively unchanged up to 3 years postoperatively (Figure 4, A). The percentage of patients with 3+ and 4+ TR is the same between the two groups (Figure 4, B). The distribution of TR grades is also similar between the two groups (Figure 4, C and D).
Risk Factors for Repair Failure
According to the Cox proportional hazards model, higher preoperative TR and the presence of preoperative TR with lower concomitant preoperative MR were found to be risk factors for development of recurrent TR (Table 2). Higher left ventricular EF demonstrated a trend to being a risk factor for significant recurrent TR. In patients with better left heart function (ie, better left ventricular EF and lower MR), preoperative TR may indicate a greater degree of valve dysfunction, such as annular dilation or valve tethering, which may be less amenable to repair.27 Significantly, tricuspid annuloplasty type was not found to be a risk factor for recurrent TR. Preoperative and follow-up NYHA class were also not found to be significant factors. Of the 19 patients in NYHA class III or IV, only 4 (17%) had 2+ or greater TR at last follow-up. There was no statistically significant difference (P = .32) in prevalence of TR between patients in NYHA class I/II and those in NYHA class III/IV. Similarly, preoperative PASP and RV dysfunction were not found to be risk factors for recurrent TR. To evaluate whether there was a correlation between postoperative PASP and tricuspid repair failure, we determined the PASP at the time of failure (from the echocardiographic data) and, using a time-varying covariate Cox model, compared it with patients whose repair did not fail. Higher postoperative PASP was a significant risk factor for repair failure, regardless of annuloplasty type. PASP was higher in patients who had unsuccessful annuloplasty than in patients who did not (Table 3).
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Dreyfus,29 and their associates, have also demonstrated a lack of correlation between recurrent MR and recurrent TR after mitral valve surgery. |
Discussion |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionLimitationsConclusionsReferences |
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Despite logistical and statistical challenges, a better outcome to evaluate is the degree of TR, as this is typically the indication for operation.30
In this study, we have evaluated TR over time after bicuspidization and ring tricuspid annuloplasty. In our experience, both bicuspidization and ring annuloplasty produce an effective, durable repair at 3 years postoperatively. Significant 3+ or 4+ residual TR occurred in 8% of patients early after operation for all types of annuloplasty. These results are similar to a previous study performed by McCarthy and colleagues.12 Their detailed study of 790 patients found that 14% of patients had 3+ or 4+ residual TR early after operation for all annuloplasty types, but ring repairs (Carpentier semirigid ring and Cosgrove–Edwards flexible band) provided a more durable repair than suture annuloplasty over an 8-year period. In McCarthy’s study,12 at 3 years postoperatively, 3+ or 4+ TR occurred in approximately 25% of De Vega patients, 27% of Peri-Guard (Bio-Vascular, Inc, St Paul, Minn) patients, 15% of Carpentier–Edwards ring patients, and 18% of Cosgrove-Edwards band patients. In this study, 16% of bicuspidization and 18% of ring annuloplasty patients had 3+ or 4+ TR at 3 years postoperatively. Thus, at 3 years, our outcomes with suture bicuspidization were superior to the De Vega and Peri-Guard annuloplasties and equivalent to ring annuloplasty outcomes presented in the McCarthy study.
Suture annuloplasties, particularly the continuous running type, like the De Vega,14 have been criticized for being unpredictable and unreliable, perhaps owing to the long suture line or the use of polypropylene suture material, which may break and slide through the tissue as the annulus dilates.31 Bernal and colleagues,20 however, have reported excellent results in 232 patients with the De Vega annuloplasty at 6.8 years postoperatively, with 86% of patients having zero to mild TR. Similar to the Revuelta segmental annuloplasty, the posterior suture bicuspidization technique described in this article is performed with a braided, multifilament suture (2-0 Ethibond).32 This suture is less likely to break and thus provides a more durable repair to the area that primarily dilates to produce functional TR. This repair may be performed in less than 8 minutes. In this study, we found that cardiopulmonary bypass and aortic crossclamp times were 27 minutes and 17 minutes shorter in the bicuspidization group. Since there were no differences in the number and distribution of concomitant procedures between the two groups, the reduced cardiopulmonary bypass and aortic crossclamp times were primarily because of the faster tricuspid annuloplasty performed.
Despite 40 years of evolving annuloplasty techniques, there has been no consensus on the management of functional TR. Recent guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) recommend tricuspid annuloplasty during mitral or aortic valve surgery in patients with severe TR.33 Although most surgeons agree that a patient with severe, symptomatic TR requires repair, many surgeons favor a conservative approach in patients with only moderate TR. The ACC/AHA guidelines suggest that functional TR without annular dilation or significant pulmonary hypertension does not require repair.33 There is a growing body of information, however, that the conservative approach is ineffective and that a substantial number of patients will be left with residual TR, which is associated with increased perioperative and late postoperative morbidity and mortality.6,8,9,28 In this study, significant 3+ or 4+ early residual TR developed in 8% of patients and 2+ or greater TR developed within 3 years in 27% of patients. Although these results are inferior to outcomes of mitral valve repair, tricuspid annuloplasty was effective in the majority of patients and may be significantly better than the alternative—no repair. Matsunaga and Duran28 have recently reported that 53% (10/19) of patients have 2+ or greater TR at 3 years after mitral valve repair alone. Matsuyama and colleagues7 recently reported that 37% (17/46) of patients with 2+ preoperative TR have 3+ or 4+ TR at 8 years after mitral valve repair alone. It should be noted that, in the Matsunaga study, only 30% of patients had 2+ or greater preoperative TR. In this study, 96% of patients had 2+ or greater TR preoperatively. Thus, the difference between conservative management and tricuspid annuloplasty may be even more pronounced in patients with 3+ or 4+ TR. A prospective study may be indicated to definitively compare conservative management versus tricuspid annuloplasty.
Previously, patients with zero to mild TR have demonstrated a significantly lower mortality than patients with moderate-to-severe TR.9 At 3 years, 73% of patients in this study had zero to mild TR. Thus, we believe that tricuspid annuloplasty should be performed not only in patients with severe TR, but in all patients with even moderate TR, especially when an effective annuloplasty technique can be performed rapidly and reproducibly. Dreyfus and colleagues29 even advocate that any patient with substantial annular dilation should undergo repair regardless of TR grade or even no TR. We believe that our suture bicuspidization is a relatively simple, inexpensive technique that can be performed rapidly and should be used in all patients with at least moderate TR who present for left-sided valve surgery. In our experience, this technique has been as effective as ring annuloplasty in the midterm postoperative period.
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Limitations |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionLimitationsConclusionsReferences |
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adjust for such follow-up data, the true TR prevalence may in fact have been lower if all patients were routinely screened with echocardiography. Second, this is a retrospective review and, as such, patients were not randomized, creating an inherent selection bias with regard to the annuloplasty performed. Although the two groups were very similar, the ring annuloplasty group had slightly worse preoperative TR and left ventricular EF. We adjusted for this difference using propensity scores, and there was no difference in the findings with and without adjustment. Third, the ring annuloplasty group was a composite of three different prosthetic annuloplasty techniques. The Cosgrove–Edwards band, the Carpentier–Edwards ring, and the Carbomedics Annuloflex ring are different prosthetic annuloplasty systems, each with different sizes, shapes, and rigidities. We did find a lower percentage of patients with recurrent 3+ or 4+ TR who received the Carpentier–Edwards semirigid ring compared with the Cosgrove–Edwards flexible band. However, we did not have a sufficient number of patients to compare each subgroup. No study, however, has demonstrated that any one of these prosthetic annuloplasties is superior to the others. Therefore, we believe it is appropriate to combine these annuloplasties into a single group to simplify the comparison of prosthetic annuloplasty with suture bicuspidization. |
Conclusions |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionLimitationsConclusionsReferences |
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Bicuspidization annuloplasty is inexpensive, simple to perform, and reduces operative time. Our experience suggests that bicuspidization annuloplasty is a reliable method for tricuspid annuloplasty and should be given consideration when approaching every patient with functional TR undergoing aortic or mitral valve surgery.
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Footnotes |
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References |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionLimitationsConclusionsReferences |
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