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Ann Thorac Surg 2004;77:1598-1606
© 2004 The Society of Thoracic Surgeons
a Department of Thoracic and Cardiovascular Surgery, Cleveland, Ohio, USA
b Department of Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
Accepted for publication September 22, 2003.
* Address reprint requests to Dr McCarthy, The Cleveland Clinic Foundation, Department of Thoracic and Cardiovascular Surgery, 9500 Euclid Ave, Desk F25, Cleveland, OH 44195, USA
e-mail: mccartp{at}ccf.org
Presented at the Thirty-ninth Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 31–Feb 2, 2003.
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Abstract |
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 Top Abstract IntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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METHODS: From January 1997 to October 2001, 224 patients underwent Alfieri repair. Indications included ischemic cardiomyopathy (n = 143, 64%), myxomatous disease (n = 31, 14%), dilated cardiomyopathy (n = 27, 12%), and hypertrophic obstructive cardiomyopathy (n = 14, 6%). Concomitant ring annuloplasty was performed in 188 patients (84%). Two additional patients had takedown of an Alfieri repair in the operating room for obstruction. Preoperative MR was 4+ in 109 patients (50%) and 3+ in 65 (30%). Postoperative and follow-up mitral gradient and return of MR were assessed using 396 transthoracic echocardiograms and longitudinal analyses.
RESULTS: Hospital mortality was 2% (5 of 224). Mitral valve mean gradient was low (3.7 mm Hg) and nonprogressive (p = 0.7), although peak gradient rose slightly, from mean 8.4 to 10.0 mm Hg (p = 0.01). During the first 3 postoperative months, absence of MR declined to 40%, and prevalence of 3+ MR increased to 14%, then rose slowly thereafter. Fourteen patients—12 within 2 years—underwent mitral valve reoperation, none for stenosis; 7 patients—6 within 2 years—underwent heart transplantation.
CONCLUSIONS: Alfieri mitral repair can be used in a variety of settings with a low risk of creating mitral stenosis. However, in ischemic MR, steadily increasing prevalence of moderately severe and severe regurgitation after edge-to-edge repair suggests other techniques are needed.
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Introduction |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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| This article has been selected for the open discussion forum on the CTSNet Web site: http://www.ctsnet.org/discuss
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For most patients with mitral regurgitation (MR), valve repair is desirable [1], but may be technically challenging, particularly when complex jets accompany ischemic MR. Alfieri and colleagues [2, 3] introduced a simple edge-to-edge suture approximation of anterior and posterior mitral leaflets as a reproducible and effective technique for restoring valve competence. However, most of their patients had degenerative (myxomatous) disease [2–4]. In 1996, we began applying the edge-to-edge technique in patients with end-stage heart failure who were undergoing partial left ventriculectomy [5]. We then expanded its use to a wider variety of causes of MR, particularly ischemic cardiomyopathy with complex MR. Objectives of this study were to demonstrate causes of MR amenable to edge-to-edge repair, particularly ischemic cardiomyopathy, and to determine safety, potential for mitral valve obstruction, and durability of edge-to-edge repair.
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Patients and methods |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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Operative technique
Exposure of the mitral valve was generally through the left atrium (76%; Table 2).
Approach was through the aorta (15%) in patients undergoing myectomy for hypertrophic obstructive cardiomyopathy (HOCM) and in those undergoing aortic valve replacement who had less than 4+ MR and underwent mitral valve repair without annuloplasty. Twenty patients (9%) undergoing left ventricular reconstruction for ischemic cardiomyopathy had stitches placed through the ventriculotomy.
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Edge-to-edge approximation was accomplished using a figure-of-eight 4-0 polyester suture for most repairs, with the suture placed in the center (89%) of the anterior and posterior leaflets. However, after further experience in ischemic cardiomyopathy patients with complex jets arising near the posteromedial commissure, a more extensive repair using four figure-of-eight sutures was used to close the posteromedial commissure (10%). In 1 patient the anterolateral commissure was closed.
Annuloplasty was performed in the majority of patients (84%), almost exclusively using a flexible partial band that extended from trigone to trigone. Size of annuloplasty ring varied according to disease cause (Table 3). In ischemic or functional MR, small annuloplasty rings were used, the most common size being 26 mm (70%). Larger rings were used in patients with degenerative disease, the most common size being 32 mm. Frequency distribution for ring size was highly biased toward small rings for ischemic cardiomyopathy, but was not biased in patients with degenerative mitral valve disease. No annuloplasty was performed in patients with HOCM.
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Assessment of repair
The repair was assessed with intraoperative transesophageal echocardiography. Preoperative and postoperative transthoracic echocardiographic reports were used to assess MR, mitral valve orifice area, transmitral pressure gradients, and left ventricular function. Mitral regurgitation was graded as 0 for no regurgitation, 1+ for mild, 2+ for moderate, 3+ for moderately severe, and 4+ for severe.
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Data analysis |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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To address the first question, postoperative transthoracic echocardiograms were analyzed for mean and peak transmitral gradients and mitral orifice area. Durability of edge-to-edge repair was assessed by evolution of MR postoperatively. Preoperative and intraoperative risk factors for return of higher grade MR were sought in general, but in particular, durability was compared (1) between patients with and without ischemic MR, and (2) between patients with and without left ventricular reconstruction or ischemic MR. Survival was assessed by time-related analysis.
Data
Values for preoperative, operative, and postoperative variables were retrieved from the prospective computerized Cardiovascular Information Registry. Values for preoperative, operative, and postoperative echocardiogram assessments were retrieved from the echocardiography database. Both databases have been approved for research by the institutional review board. Postoperative and follow-up transthoracic echocardiograms were available in 214 patients with a total of 396 assessments made between 1 day and 4.8 years after repair (median, 3 weeks; quartiles, 6 days and 8 months; Appendix Table 1).
Safety (hospital outcomes)
Hospital morbidity, recorded in the Cardiovascular Information Registry database, included in-hospital death, cerebral vascular accident, perioperative myocardial infarction based on routine creatine kinase MB and electrocardiographic criteria, renal failure (dialysis or creatinine > 2.5 mg/dL), respiratory insufficiency (reintubation or ventilatory support > 48 hours), septicemia or sepsis (by blood cultures), and postoperative bleeding or tamponade requiring reoperation.
Orifice obstruction
Temporal trends of mean transmitral gradient, peak transmitral gradient, mitral valve orifice area, and indexed orifice area (square centimeter per square meter body surface area) after repair were analyzed using longitudinal mixed-model regression for repeated measurements (SAS PROC MIXED) [7]. Mitral valve orifice area measurements were available on only 40 patients, with a total of 49 assessments.
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Durability |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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Because of the limited capability of PROC GENMOD to explore multivariable relationships, we initially screened variables using ordinary multivariable logistic regression and the assumption of independence of observations with liberal entry (p = 0.2) and retention (p = 0.12) criteria. This analysis identified possible candidates for repeated-measurement analysis. These candidates and their transformations of scale were entered simultaneously into the longitudinal model, then eliminated one by one until all variables remaining had a p value of 0.1 or less. Variables analyzed are shown in the Appendix.
Because frequency of occurrence of severe MR (4+) was rare, moderately severe (3+) and severe (4+) MR were combined for the risk factor analysis.
Strategy of analysis was to first identify preoperative risk factors, then to add to these intraoperative factors.
Influence of ischemic cause on durability
As a focused study, patients were stratified into ischemic and nonischemic cardiomyopathy groups, and influence of cause on repair durability was analyzed. Nonischemic group was further stratified into dilated cardiomyopathy and degenerative mitral disease, and durability of repair was compared with the ischemic group. In the later analysis, patients with HOCM and other causes of MR were excluded.
Influence of left ventricular reconstruction procedure in ischemic cause on durability
As another focused study, patients with ischemic cardiomyopathy were stratified by whether or not they had left ventricular reconstruction. For this analysis, 254 assessments of MR were available on 134 patients.
Influence of position of edge-to-edge repair on durability
Patients were stratified by the position of edge-to-edge repair, either central or commissural. For this analysis, 353 assessments for MR were available on 200 patients with central edge-to-edge repair and 43 assessments were available on 24 patients with commissural repair.
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Survival |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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Results |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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Obstruction
On postoperative day 1, mean transmitral pressure gradient was 3.7 mm Hg (Table 5).
As a function of time, no demonstrable increase occurred (p = 0.7). Similarly, peak transmitral pressure gradient was 8.4 mm Hg (Table 5) immediately after operation, and with time it rose only slightly, although statistically significantly (p = 0.01). Mean mitral valve orifice area on postoperative day 1 was 2.1 cm2; indexed area was 1.16 cm2/m2 and was stable with time (p = 0.4; Table 5).
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Two sequential models (preoperative variables only and preoperative plus intraoperative factors) for return of higher grades of MR within the first month after operation identified history of previous cardiac operation and earlier date of operation as risk factors (Table 6). Two sequential models of late (after 1 month) return of higher grades of MR identified ischemic cardiomyopathy, higher preoperative MR, history of myocardial infarction, and nonuse of an annuloplasty ring as risk factors (Table 6).
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Survival
Survival was 65% at 5 years (Fig 4).
Thirty-day operative mortality for the 224 patients was 1%, and hospital mortality was 2% (5 patients). Hospital mortality for ischemic cardiomyopathy patients was 2% (3 patients).
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Comment |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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Although our initial results using edge-to-edge approximation in addition to a small flexible band were satisfactory, 24% of patients had recurrence of 3+ MR within 2 years. This leaves them at risk for further volume overload with an impaired left ventricle and return of heart failure symptoms.
There are several reasons why repair may have failed. First, at reoperation the most common finding was progressive annular dilatation with a well-seated ring and intact edge-to-edge repair. A recent report indicates that the trigone to trigone area is not a rigid fixed structure, as was previously thought, and dilatation occurs in this area [13, 14]. Second, left ventricular remodeling in a failing heart can be progressive. However, we do not have three-dimensional studies to determine whether the ventricles were in fact increasing in size and volume, leading to further displacement of the papillary muscles with increased tethering and subsequent reduction in the zone of coaptation. Third, Calafiore and coworkers [15] have reported that some patients have such extensive tethering, as determined by displacement of the leaflets into the ventricle, that this cannot be overcome with annuloplasty. Instead, they suggest chord-sparing mitral valve replacement. We did not determine from echocardiography whether our patients who developed recurrent MR had this degree of tethering preoperatively. Fourth, some authors claim that patients with ischemic MR treated with a flexible band have a more-rapid return of regurgitation than those treated with a complete remodeling ring [16]. Others suggest not only that a remodeling ring is necessary, but that a rigid one that fixes the annulus more effectively in place closes the septal lateral dimension and does not allow late dilatation [17]. Although our results with a flexible band have been excellent for patients with myxomatous disease [18], this may not be the best choice for those with ischemic or idiopathic cardiomyopathy.
The type of annuloplasty ring and the underlying pathologic process, not disruption of the edge-to-edge approximation, most likely led to recurrence of MR. Disruption was identified in only 1 patient, in whom the stitch had pulled through the leaflet tissue. It is possible that disruption had occurred in others, but it was difficult to appreciate by transthoracic echocardiography.
As our clinical experience with patients with ischemic cardiomyopathy and ventricular reconstructive surgery for ischemic cardiomyopathy increased, we evolved our technique so that Alfieri repair is less frequently used. Currently, we use a 24-mm Physio annuloplasty ring (the smallest available) or a 26-mm classic Carpentier ring (which is more rigid). We do not add an edge-to-edge approximation with these small remodeling rings because of anecdotal reports that such a combination may create mitral stenosis. Although our results have not been analyzed with this strategy, our impression is that residual MR is less than with the flexible band and Alfieri repair, but it is not eliminated. This strategy will be studied in a later report. Also, occasionally we use chord-sparing mitral valve replacement for patients with severely enlarged ventricles and extensive tethering of valve leaflets, as described by Calafiore and associates [15].
Interestingly, patients with ischemic MR were far more likely to redevelop 3+ or 4+ MR than those with dilated cardiomyopathy or, as in the series of Alfieri and colleagues [2], patients with myxomatous disease. Ischemic cardiomyopathy typically is accompanied by complex MR with eccentric jets and tethering or restriction at the medial commissure with annular dilatation. Some patients also have a second jet originating at the lateral commissure [19]. On the other hand, dilated cardiomyopathy has a more symmetric tethering and annular dilatation that may respond more favorably to central edge-to-edge placement. We were not able to determine an advantage to closure of the medial commissure over central edge-to-edge approximation in ischemic cardiomyopathy, but this may be in part related to the small number of patients and the four other possible causes of recurrence previously noted in this paper.
We also report on the use of the edge-to-edge technique for patients with HOCM. The Alfieri repair should lessen the likelihood of systolic anterior motion occasionally seen in HOCM patients after myectomy. However, elimination of systolic anterior motion does not always occur. The stitch is placed centrally, so the lateral portion of the anterior leaflet still can be displaced. Two patients with HOCM who required reoperation had residual gradients associated with myectomy, not failure of edge-to-edge approximation per se.
Apart from the 2 patients who had edge-to-edge approximation taken down because of intraoperative mitral stenosis, we found that once patients left the operating room, there was no evidence of mitral stenosis in the early term or midterm.
In conclusion, like Alfieri and colleagues [2] and Maisano and associates [3], we found good early term and midterm results of edge-to-edge approximation in selected patients with myxomatous mitral valve disease. Creation of mitral stenosis was rare and did not appear to increase with time. Use of a small flexible band with Alfieri repair for patients with ischemic or idiopathic dilated cardiomyopathy had good short-term results but unacceptable late recurrence of 3+ MR. Other techniques and prostheses to treat this complex form of regurgitation are needed.
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Discussion |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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DR SARA J. SHUMWAY (Minneapolis, MN): If you cannot answer that question for political reasons, we would understand.
DR BHUDIA: Not all of The Cleveland Clinic Foundation surgeons have used the edge-to-edge repair.
DR SHUMWAY: Were the 16% of patients who did not get a ring annuloplasty more prone to developing late mitral regurgitation, and what was the time interval?
DR BHUDIA: Of the 16 patients who did not have the annuloplasty ring—usually ischemic mitral regurgitation (MR) patients who had left ventricular reconstruction surgery—the time range of increasing MR was anywhere from 1 month to 2 years.
DR STEVEN F. BOLLING (Ann Arbor, MI): You state now that your policy for these patients with ischemic or myopathic MR is to put a very small ring in. Was that your policy in this series?
Was there a difference in ring size between the patients who had recurrent MR and nonrecurrent MR? One can imagine a scenario of a small ring in place, and the Alfieri stitch continues to do its good work in a small ring, whereas in a large ring it is allowed to pull apart and deformation occurs. So could you tell us the difference between ring size in the patients who had MR and did not have MR?
DR BHUDIA: The majority of the patients with ischemic MR had 24 or 26 ring size; in fact, that was about 80% of the patients. Despite that, we saw a high number of patients who experienced return of high-grade MR with time.
DR CRAIG R. SMITH (New York, NY): It would help me to understand exactly when you choose edge-to-edge repair. Was it usually applied when you put in a ring and it was not perfect, so you added an edge-to-edge stitch? Or did you put in an edge-to-edge stitch and reinforce it with a ring, or a little bit of both? I imagine the first scenario is the most common, and it would support your hypothesis.
DR BHUDIA: It is the first scenario. We put the ring in first, and then if there was residual regurgitation, we used the Alfieri stitch.
DR HUMBERTO R. RAVELO (Long Beach, CA): During the earlier Tech Conference portion of the STS meeting, a question was posed to Dr Alfieri regarding the potential hemodynamic consequences of his "edge-to-edge" mitral valve repair. I am not certain this question was clearly answered, and I would like to bring this issue up again.
It was mentioned that, according to fluid hemodynamic principles, [Poiseuille's Law: F = (difference in Pressure)(
)(the fourth power of the Radius) / (8)(Viscosity)(Length)], the dependence of flow through an orifice on the fourth power of its radius leads to a major change in flow when that radius is altered. Accordingly, if all other variables remain equal, a decrease in the radius of the mitral annulus by 1/2 after an "edge-to-edge" repair should decrease the additive flow through the two newly created smaller orifices to 1/8 of the original flow. Based on this reasoning, could the "edge-to-edge" repair clinically induce some degree of hemodynamic mitral stenosis?
DR BHUDIA: We looked at that with the mean pressure gradient and the peak transmitral pressure gradient. With the mean pressure gradient, we saw that with time it did not change. Although the peak pressure gradient was statistically significantly higher during 2 years, we did not find that it was clinically important. Also, looking at the orifice area, it was greater than 2 cm2 in most patients for whom we had a measurement, and with time it did not change. With all these echocardiographic variables, we did not find any clinically important mitral stenosis.
DR ALVAN W. ATKINSON (Raleigh, NC): One thought is that probably your studies of mitral valve gradients were done at rest. And that is one of our saving graces, I think, in doing some of these repairs, whether we narrow the annulus with a small ring, that we have elderly patients with limited cardiac clinical ability anyway. But did you do any functional studies at high rates of cardiac output?
DR BHUDIA: No, we did not do any stress echocardiographic studies on these patients.
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Appendix. Variables Used in the Analysis |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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Symptoms
New York Heart Association functional class
Ventricular function
Ejection fraction, left and right ventricular function, left ventricular internal diameter in systole and diastole
Pathology
Mitral regurgitation, aortic regurgitation, aortic valve stenosis, tricuspid regurgitation, pulmonary regurgitation
Cause
Ischemic cardiomyopathy, dilated cardiomyopathy, degenerative valvar disease, hypertrophic obstructive cardiomyopathy, endocarditis, functional mitral 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
Experience
Date of surgery
Intraoperative
Procedure
Internal thoracic artery grafts used, concomitant procedures (coronary artery bypass grafting, left ventricular reconstruction, aortic valve replacement), approach to mitral valve (left atrium, left ventricle, or aorta), annuloplasty ring, annuloplasty ring size.
Support
Ischemic time, perfusion time
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Appendix Table 1 |
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TopAbstractIntroductionPatients and methodsData analysisDurabilitySurvivalResultsCommentDiscussionAppendix. Variables Used in...Appendix Table 1References |
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K. J. Grande-Allen, J. E. Barber, K. M. Klatka, P. L. Houghtaling, I. Vesely, C. S. Moravec, and P. M. McCarthy Mitral valve stiffening in end-stage heart failure: Evidence of an organic contribution to functional mitral regurgitation J. Thorac. Cardiovasc. Surg., September 1, 2005; 130(3): 783 - 790. [Abstract] [Full Text] [PDF]
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F. Langer, F. Rodriguez, S. Ortiz, A. Cheng, T. C. Nguyen, M. K. Zasio, D. Liang, G. T. Daughters, N. B. Ingels, and D. C. Miller Subvalvular Repair: The Key to Repairing Ischemic Mitral Regurgitation? Circulation, August 30, 2005; 112(9_suppl): I-383 - I-389. [Abstract] [Full Text] [PDF]
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M. De Bonis, E. Lapenna, G. La Canna, E. Ficarra, M. Pagliaro, L. Torracca, F. Maisano, and O. Alfieri Mitral Valve Repair for Functional Mitral Regurgitation in End-Stage Dilated Cardiomyopathy: Role of the "Edge-to-Edge" Technique Circulation, August 30, 2005; 112(9_suppl): I-402 - I-408. [Abstract] [Full Text] [PDF]
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R. A. Levine and E. Schwammenthal Ischemic Mitral Regurgitation on the Threshold of a Solution: From Paradoxes to Unifying Concepts Circulation, August 2, 2005; 112(5): 745 - 758. [Full Text] [PDF]
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R. H. Jones The Year in Cardiovascular Surgery J. Am. Coll. Cardiol., May 3, 2005; 45(9): 1517 - 1528. [Full Text] [PDF]
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T. A. Vassiliades Jr, P. C. Block, L. H. Cohn, D. H. Adams, J. S. Borer, T. Feldman, D. R. Holmes, W. K. Laskey, B. W. Lytle, M. J. Mack, et al. The Clinical Development of Percutaneous Heart Valve Technology: A Position Statement of the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI) Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) J. Am. Coll. Cardiol., May 3, 2005; 45(9): 1554 - 1560. [Full Text] [PDF]
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P. C. Block Percutaneous Mitral Valve Repair: Are They Changing the Guard? Circulation, May 3, 2005; 111(17): 2154 - 2156. [Full Text] [PDF]
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American College of Cardiology Foundation (ACCF) a, T. A. Vassiliades Jr, P. C. Block, L. H. Cohn, D. H. Adams, J. S. Borer, T. Feldman, D. R. Holmes, W. K. Laskey, B. W. Lytle, et al. The clinical development of percutaneous heart valve technology: A position statement of the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI) J. Thorac. Cardiovasc. Surg., May 1, 2005; 129(5): 970 - 976. [Full Text] [PDF]
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T. A. Vassiliades Jr, P. C. Block, L. H. Cohn, D. H. Adams, J. S. Borer, T. Feldman, D. R. Holmes, W. K. Laskey, B. W. Lytle, M. J. Mack, et al. The Clinical Development of Percutaneous Heart Valve Technology: A Position Statement of The Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI) Ann. Thorac. Surg., May 1, 2005; 79(5): 1812 - 1818. [Full Text] [PDF]
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O. Alfieri and F. Maisano INVITED COMMENTARY Ann. Thorac. Surg., February 1, 2005; 79(2): 474 - 474. [Full Text] [PDF]
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S. H. Rahimtoola The year in valvular heart disease J. Am. Coll. Cardiol., January 4, 2005; 45(1): 111 - 122. [Full Text] [PDF]
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= 1+; 
= 2+; 
= 3+; 
= 4+. Solid lines indicate predicted mean percentage of patients in each MR grade with time from longitudinal modeling.
