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a Department of Cardiothoracic Surgery, Shaare Zedek Medical Center, Jerusalem, Israel
b Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel
c Center for Clinical Quality and Safety, Hadassah Medical Center, Jerusalem, Israel
Accepted for publication March 25, 2009.
* Address correspondence to Dr Silberman, Department of Cardiothoracic Surgery, Shaare Zedek Medical Center, PO Box 3235, Jerusalem, 91031, Israel (Email: ssilberman{at}szmc.org.il).
Presented at the Forty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Francisco, CA, Jan 26–28, 2009.
| Abstract |
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Methods: There were 169 patients. A flexible ring was implanted in 117 and a rigid ring in 52. Age and clinical profile, degree of left ventricular dysfunction, and degree of MR (mean 3.2) were similar between groups.
Results: Operative mortality was 9% in each group. Follow-up (58 ± 30 months for flexible group and 14 ± 7 months for rigid group) was available for 91%. For the flexible and rigid ring groups, respectively, mean New York Heart Association functional class was 1.9 and 1.6, with 33% and 14% in classes III to IV (p = 0.03); mean MR grade was 1.25 and 0.7 (p = 0.006). There was no difference in left ventricle function or dimensions. At follow-up, 29 patients (34%) in the flexible group had residual MR of moderate degree or greater compared with 6 (15%) in the rigid group (p = 0.03). Mean tricuspid incompetence gradient was 39 and 34 mm Hg (p = nonsignificant); however, the degree of reduction was greater in the rigid group (p = 0.001). Late mortality was observed in 32 patients, all in the flexible group.
Conclusions: Clinical and hemodynamic results are better with rigid mitral annuloplasty rings compared with flexible rings. That result may be due to ring design, which dictates not only the annular diameter but also annular configuration. Longer follow-up is needed to determine differences in survival.
| Introduction |
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| Patients and Methods |
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Echocardiography
Echocardiography data presented are from transthoracic examinations. Transesophageal echocardiograms were performed routinely during surgery, but the data were not used in our analysis. Echocardiograms were analyzed by certified experienced cardiologists. The following measurements were prospectively collected: left atrial size, left ventricular end-systolic diameter (LVESD) and end-diastolic diameter (LVEDD) in parasternal long axis, global LV function, and regional wall motion. The method of grading of MR included regurgitant jet area by color Doppler, diameter of the vena contracta, quantitative assessment by the proximal isovelocity surface area method, and the presence of reverse flow in the pulmonic veins [8]. The severity of tricuspid regurgitation was assessed by visual estimation of the jet area. The TI gradient was measured to evaluate the pulmonary arterial pressure.
Data and Follow-Up
Patient data were collected on the standard computerized Society of Thoracic Surgeons database (Summit Vista for Windows, Version 1.97, Summit Medical Systems, Europe). Collected data included demographic, preoperative, operative, and early postoperative data. This information was collected during hospitalization. Follow-up data were obtained from outpatient clinic, echocardiography laboratory, contact with family physician, and telephone interviews. For patients for whom follow-up was unavailable, the ministry of interior was contacted to establish whether the patient was alive, so that follow-up for survival was 100% complete. Echocardiograms used for comparison between the two groups were those performed early (discharge to 1 month) and at 6 to 12 months after surgery.
Statistical Analysis
Data were imported and analyzed using JMP software (SAS Institute, Cary, NC). Continuous variables were compared using the nonparametric Wilcoxon test and are presented as mean ± SD. Nominal and categorical values were compared using the
2 likelihood ratio or Fisher's exact tests. Univariate and multivariate Cox proportional hazard functions were used to determine predictors for late mortality. Linear regression was used to compare the degree of MR as a function of postoperative interval. This was graphically presented using a smoothing spline with lambda = 5.443. Predictors for outcomes found to be of statistical significance by univariate analysis were subject to stepwise multivariate logistic regression to determine predictors for operative mortality and postoperative MR.
| Results |
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Follow-up was available in 140 patients (91% of operative survivors). For the flexible and rigid groups, respectively, follow-up was available in 100 (93%) and 40 (85%; p = nonsignificant), and late echocardiogram in 86 (80%) and 39 (83%). Mean follow-up was 58 ± 30 months (median, 60; range, 8 to 110) in the flexible group and 14 ± 7 months (median, 15; range, 3 to 26) in the rigid group. Thirty-two patients (30%) in the flexible group died during follow-up at 36 ± 30 months after surgery. Of these, 9 (28%) were within the first year, and 14 (44%) were within the first 2 years. By Kaplan-Meier estimates 1-, 3-, and 5-year survival was 84%, 79%, and 75%, respectively, for the flexible group. At time of follow-up, there were no deaths in the rigid group (p = 0.03; Fig 1). By multivariate Cox proportional hazard, age (p = 0.002) and ring type (p = 0.008) were found to be predictors for late mortality (Table 3).
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Timing of Surgery
Eighteen patients were operated on within 1 week of admission for MI. No cases were due to papillary muscle rupture. One patient died of stroke. Early surgery was not associated with operative mortality, nor was it associated with late MR.
Effect of Atrial Fibrillation
Chronic atrial fibrillation was present in 28 patients. We found no correlation between the presence of atrial fibrillation and postsurgical MR or TI gradient.
| Comment |
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While there is active debate in the literature whether mitral valve repair will affect survival, there are few data regarding the importance of residual or recurrent ischemic MR after surgical correction. Hausmann and colleagues [20] found reduced survival among patients undergoing CABG with concomitant mitral repair who remained with MR grade greater than 1. However, they did not implant annuloplasty rings; therefore, it is difficult to project their results to current methods. Failure of a good initial result could be attributed to ongoing remodeling of the left ventricle [21]. In this case, the type of ring may have an impact on the results. McGee and coworkers [22] found that recurrent MR is usually evident by 6 months after surgery, after which the MR stabilizes. We too found that almost all failures are apparent by 6 months. In the McGee study [22], the researchers did not see any effect of annuloplasty type on survival, although they could not preclude any survival effect of other annuloplasty techniques. Since MR is a predictor for reduced survival [1–3, 13, 14], we might assume that improving surgical technique and achieving a better repair should have a positive impact on survival.
Braun and associates [23] found that preoperative LVEDD of 65 mm or less or LVESD of 51 mm or less were predictive for reverse LV remodeling, and this conferred a survival advantage [24]. We could not demonstrate any direct influence of ring type on reverse remodeling nor could we correlate between reverse remodeling and survival.
In our study, we have shown a hemodynamic advantage to performing mitral annuloplasty with rigid rings as opposed to flexible rings. Overall, reduction in the degree of MR was observed with both ring types, but there was a more pronounced reduction with the rigid rings. There was also a decreased incidence of recurrent MR in the rigid group. In addition, the reduction of TI gradient was apparent in the rigid group and almost absent in the flexible group. We believe these results to be due to ring design. Although both rings determine annular size, the rigid ring also dictates annular shape, with emphasis on anteroposterior to lateral diameter ratio. Moreover, the rigid rings implanted in our series were slightly larger than the flexible rings, lending further support to the advantage of ring design. In the long run, these differences may translate to better survival.
The best way to resolve the issue of whether to repair the valve, and by which method to perform the repair, is by conducting a prospective randomized study, with lengthy follow-up enabling detection of survival differences. This study may be difficult to conduct as ring designs continue to evolve, so that by the time any significant results are available, they may be irrelevant. Disappointment with nonrepair coupled with increased comfort in performing annuloplasty in patients with ischemic MR has led us to repair ischemic MR of moderate or greater degree at the time of CABG. Exceptions are patients with friable tissue, in whom difficult exposure of the valve may lead to excessive tissue trauma. In our minds, it is not any more a question of whether or not to repair the valve. Rather, it is how to improve the quality of the repair.
The main limitations of this study include its retrospective nature, as well as the temporal difference in usage of the two ring types. Surgical technique, however, did not vary, so that we do not believe these had any effect on results. Another limitation is the recording of echocardiography data. More detailed information, such as coaptation height, tenting area, tethering height, sphericity index, and so forth, may shed better insight. Because these data were not routinely recorded in the past, and digital data storage was available only recently, retrieval of this information was difficult. Finally, the follow-up period may be too short to detect true survival differences.
In conclusion, both flexible and rigid annuloplasty rings enable good results for repair of ischemic MR. However, there are some differences in favor of using rigid rings, the most prominent being a more stable repair with less late failure.
| Discussion |
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DR ROBERT A. DION (Genk, Belgium): As you may know, we have published our series of ischemic mitral regurgitation in a few journals, and one of the endpoints after surgery was the length of coaptation. For us, a length of coaptation of 8 mm was absolutely mandatory to avoid the recurrence of mitral regurgitation. Did you measure the length of coaptation after surgery? After surgery, we measure not only the absence of mitral regurgitation but we measure also the gradient and the length of coaptation. Did you measure the length of coaptation, did you compare it between flexible and rigid rings, and do you have a clue, a technical reason, for the difference in results?
DR SILBERMAN: I was actually expecting this question from someone. We did look at our echoes to try to look at the coaptation distance, tethering height and so on. Unfortunately, in the early experience, all the echoes were recorded on tape and only recently do we have digital recordings that could be brought up again and looked at. We did not have full information on this, so I don't have an answer to that question. I am sorry.
DR DION: Thank you. What you will find has been described in the results of Steve Bolling's series, and he has abandoned using a flexible ring and he went back to a rigid ring. So I think your study is certainly very well done. Thank you.
DR EDWARD B. SAVAGE (St. Louis, MO): First, a quick comment. I like the term ischemia-induced mitral regurgitation, because the mitral valve degenerates, it has changes due to rheumatic disease, but it doesn't become ischemic.
I have a few brief questions for you. First of all, related to Dr Verrier's comment, do you have the ring sizes? I know each of these was measured for a certain size ring, and do you have the sizes for comparison? In other words, did you use a smaller ring size as time went on, because I didn't see ring size in your data. The second is, what type of rigid ring are you using? Are you using the special "ischemic" ring or are you using a symmetrical ring? And the third question is, what implication do you think your results have relative to the paper that was published by the Cleveland Clinic a couple of years ago with a 20% or 30% failure rate after repair of ischemia-induced mitral regurgitation?
DR SILBERMAN: I did show a slide with the ring sizes. They were quite similar. We were undersizing from the beginning. I could not get any statistical comparison between the sizes. I am not sure if it is because of the labeling of the rings, even numbers versus odd numbers, but the mean sizes were 25.7 and 26.1—I don't remember the exact number.
DR SAVAGE: But very close?
DR SILBERMAN: They were very close. Anyway, we did look at it and we got some funny statistical evaluation of it. We were using complete flexible rings, not bands, and just a regular rigid ring, not any special dedicated ring for ischemia-induced MR. And, sorry, the last question?
DR SAVAGE: Have you looked back at that series from the Cleveland Clinic a couple of years ago where they had such a high failure rate of 20% to 30%?
DR SILBERMAN: Are you talking about Dr McGee's paper using, I think, pericardial strips, posterior bands?
DR SAVAGE: No. They looked at all their repair experience for ischemia-induced mitral regurgitation. I am sorry if you are not familiar with it. But in that paper, I don't remember if they used rigid rings or flexible rings and what the breakdown was, and I would be curious to know, because if they used a lot of flexible rings as opposed to rigid, you may have basically told us why their failure rate was so high and that we can continue to go on and do simple annuloplasty in many of these cases.
DR SILBERMAN: Sorry, I don't think I can compare.
DR SAVAGE: Thank you.
DR HAROLD G. ROBERTS (Plantation, FL): I gathered from your talk that you only did pure annuloplasty, no other adjunctive maneuvers. I also noticed that both the flexible and the rigid series often had trace or mild residual MR, although much less so in the rigid. My question to you is, do you now use any additional maneuvers such as closing the indentation between P2 and P3 and a posteromedial commissuroplasty? These kind of things can give you absolutely zero MR when you come out of the operating room. I believe that is really imperative, since these types of repairs, MR secondary to annular dilatation, have a tendency to degrade with time.
DR SILBERMAN: Well, actually we were happy with our results in the operating room, and we were happy with our results within the first month after surgery. What I presented was the later follow-up data, in other words, around 6 months, where we found the failure rate. Patients did not leave the operating room with moderate MR or greater. If it failed, we would do something about it.
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