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Ann Thorac Surg 2009;88:76-82. doi:10.1016/j.athoracsur.2009.03.089
© 2009 The Society of Thoracic Surgeons
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Kriangkrai Tantiwongkosri
Eugene H. Blackstone
Edward R. Nowicki
Joseph F. Sabik, III
Douglas R. Johnston
Lars G. Svensson
Tomislav Mihaljevic
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Original Articles: Adult Cardiac

Is Prosthetic Anuloplasty Necessary for Durable Mitral Valve Repair?

A. Marc Gillinov, MDa,*, Kriangkrai Tantiwongkosri, MDa, Eugene H. Blackstone, MDa,b, Penny L. Houghtaling, MSb, Edward R. Nowicki, MD, MSa,b, Joseph F. Sabik, III, MDa, Douglas R. Johnston, MDa, Lars G. Svensson, MD, PhDa, Tomislav Mihaljevic, MDa

a Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
b Department of Quantitative Health Sciences, Research Institute, Cleveland Clinic, Cleveland, Ohio

Accepted for publication March 17, 2009.

* Address correspondence to Dr Gillinov, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, 9500 Euclid Ave, Desk J4-1, Cleveland, OH 44195 (Email: gillinom{at}ccf.org).

Presented at the Poster Session of the Forty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Francisco, CA, Jan 26–28, 2009.


Dr Gillinov discloses that he has a financial relationship with Edwards Lifesciences, St. Jude, and Viacor; Dr Svensson with CardioSolutions; Dr Mihaljevic with Edwards Lifesciences, Intuitive, and St. Jude.

 

   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background: Because emerging percutaneous mitral valve repair may address only leaflets and not the anulus, we compared durability of mitral valve repair with and without prosthetic anuloplasty.

Methods: From 1985 to 2007, 3,057 patients underwent primary isolated posterior leaflet repair for degenerative mitral disease either with prosthetic anuloplasty (n = 2,754, 90%) or without (n = 303, 9.9%: no anuloplasty, 68; suture anuloplasty, 7; pericardial anuloplasty, 228). Most of the latter operations occurred in the early 1990s. Differences in patient characteristics were addressed by propensity-score adjustment and matching (214 pairs). In all, 3,870 echocardiograms for 1,236 patients were available for assessing mitral regurgitation after prosthetic anuloplasty and 257 in 99 patients without one. Mean follow-up for mitral valve reoperation was 4.2 ± 4.1 years, with 13,003 patient-years of data available for analysis.

Results: Early, and to a lesser degree late, postoperative mitral regurgitation was less after prosthetic anuloplasty than repair without one, and this difference persisted after risk adjustment and in propensity-matched patients (p = 0.0002). Freedom from mitral valve reoperation was 96% and 94% at 10 years after repair with versus without prosthetic anuloplasty in unmatched groups, and 97% and 96% in matched groups (p = 0.3), respectively. Unadjusted survival was greater with than without prosthetic anuloplasty (84% versus 81% at 10 years, p = 0.009), but similar after propensity adjustment and in matched pairs.

Conclusions: Mitral valve repair without a prosthetic anuloplasty was associated with accelerated return of mitral regurgitation, although risk-adjusted survival was similar. This finding has important implications for durability of percutaneous mitral repair techniques that do not address both leaflets and anulus.

For patients with degenerative mitral valve disease, properly performed mitral repair confers excellent durability and long-term clinical outcome [1, 2]. Surgical repair of a degenerative valve normally incorporates two components: a leaflet or chordal procedure to correct prolapse, and anuloplasty to restore normal anular geometry, increase leaflet coaptation, reduce tension on suture lines, and prevent future anular dilatation [3]. Most surgeons believe these anuloplasty functions are best achieved with a prosthetic (rather than suture or pericardial) anuloplasty; however, others do not, citing studies suggesting that a prosthetic anuloplasty is unnecessary in some cases and is associated with abnormal postoperative left ventricular and mitral valve function [4, 5]. This controversy has been re-ignited by development of percutaneous leaflet repair technologies that do not include anuloplasty [6]. Although we routinely employ a prosthetic anuloplasty today, early in our experience we occasionally performed standard posterior leaflet repairs using Carpentier's resectional techniques, but without a prosthetic anuloplasty. The objective of this analysis was to determine whether the absence of a prosthetic anuloplasty jeopardized repair durability or survival.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Acknowledgments
 References
 
Study Population
From January 1985 to January 2007, 3,057 patients with isolated degenerative mitral valve disease underwent primary isolated mitral valve repair for posterior prolapse at Cleveland Clinic; 2,754 (90%) received a prosthetic anuloplasty, and 303 (10%) did not (Table 1). Most patients who did not receive a prosthetic anuloplasty had surgery between 1988 and 1994 (Fig 1). Mitral regurgitation (MR) was the primary indication for surgery in all. Preoperative MR grade was assessed semiquantitatively by echocardiography using standard techniques; all patients had moderately severe (3+, 9.4%) or severe (4+, 91%) MR. Patients having previous or concomitant operations for coronary artery disease, aortic valve disease, hypertrophic cardiomyopathy, or ascending aortic aneurysm were excluded. Results in an early subset of these patients have been reported previously [7].


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  		Table 1 Anuloplasty Techniques (n = 3,057)
 

Figure 1
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  		Fig 1. Temporal trend in anuloplasty techniques. Percent of patients who did not receive a prosthetic anuloplasty over time. Filled circles represent yearly frequency of no prosthetic anuloplasty used. Solid line is parametric trend.

 
Data were extracted from Cleveland Clinic's Cardiovascular Information Registry, a repository of clinical and surgical data manually abstracted concurrently with patient care. The echocardiographic data were extracted from Cleveland Clinic's echocardiography database. Use of these data for research was approved by the Institutional Review Board (IRB), with patient consent waived. Patient characteristics according to receipt or not of prosthetic anuloplasty are displayed in Table 2.


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  		Table 2 Patient Characteristics With and Without Prosthetic Anuloplasty
 
Surgical Techniques
Surgical approach was minimally invasive in 1,797 patients (58%) and was a full sternotomy in 1,260 (42%). Posterior leaflet repair was achieved by standard quadrangular resection in 1,660 patients (54%) and by quadrangular resection with sliding repair in 1,397 (46%).

Endpoints
Study endpoints were repair durability, assessed by mitral valve reoperation and return of MR, and all-cause mortality. Patients undergoing heart valve surgery are followed systematically at 2, 5, 10, 15, and 20 years after operation. At each follow-up, patients are mailed an IRB-approved questionnaire; nonresponders are contacted by telephone using an IRB-approved script. Patient consent is required for use of follow-up information.

Mitral valve reoperation and survival
Follow-up for mitral valve reoperation depended entirely on this active follow-up, which averaged 4.2 ± 4.1 years (median 3.3), with 5% of patients followed 12 years or more. A total of 13,003 patient-years of data was available for analyses. Information on vital status was supplemented by data from the Social Security Death Index [8, 9], yielding 19,806 patient-years of data for survival analysis, mean 6.5 ± 4.5 years (median 5.6), with 6% of patients followed 15 years or more. Graphs of reoperation were truncated at 12 years and those of survival at 15 years.

Return of mitral regurgitation
A total of 4,127 postoperative echocardiograms were available in 2,313 patients. At least one echocardiogram was performed in 99 of the 303 patients (33%) without prosthetic anuloplasty and in 2,214 of the 2,754 (80%) who received prosthetic anuloplasty. Echocardiograms obtained 1 year or more after surgery were available in 465 patients (54 without prosthetic anuloplasty and 411 receiving a prosthetic anuloplasty). Because only 8% of echocardiograms were obtained in past 10 years, depictions of their analysis are truncated then (Appendix Fig 1).


Figure 5
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  		Fig 1. Number of patients with echocardiograms (echos) available at and beyond various time points, and number of echocardiograms available for analysis. (Black bars = echocardiograms; gray bars = patients; Post-op = postoperative.)

 
Data Analysis
Propensity matching comparisons between prosthetic anuloplasty and no prosthetic anuloplasty
Multivariable logistic regression analysis was performed to identify factors associated with not receiving a prosthetic anuloplasty. Bootstrap bagging was used for variable selection with automated analysis of 500 resampled data sets, followed by tabulating the frequency of occurrence at p of 0.05 or less of both single factors and closely related clusters of factors. This parsimonious model was then augmented with additional factors to form a propensity model. Because of the large amount of information supplied by the date of operation alone, data were also analyzed without date of operation. In addition to earlier date of operation, patients without prosthetic anuloplasty had greater left ventricular end-diastolic volume and reduced left ventricular function (Appendix Table 1). A final model was constructed with a single variable encompassing date of operation so that the model could accommodate other factors for matching as well. The resulting propensity score for each patient was then forced into models of outcomes. In addition, patients were matched based on propensity score [10], yielding 214 matched pairs of 303 possible (71%).


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  		Table 1 Factors Associated With No Prosthetic Anuloplasty
 
Repair durability
Freedom from reoperation was estimated nonparametrically by the Kaplan-Meier method and parametrically by a multiphase hazard model [11] (see http://www.clevelandclinic.org/heartcenter/hazard). Risk-adjusted comparison of freedom from reoperation for prosthetic anuloplasty versus no prosthetic anuloplasty groups used 1:1 propensity matching.

Prevalence of each MR grade across follow-up time was estimated by longitudinal ordinal logistic regression for repeated measurements (PROC GENMOD; SAS Institute, Cary, NC). Because frequency of occurrence of severe (4+) and moderately severe (3+) MR was low, grades 2+, 3+, and 4+ were combined for analysis. Results are accompanied by crude independent estimates of prevalence of each grade within sequential time frames for informal comparison. Because MR returned rapidly within the first 2 weeks and far more slowly thereafter, separate analyses for risk factors were made for echocardiograms obtained within 2 weeks of operation and those obtained later. To compensate for the limited capability of PROC GENMOD to explore multivariable relations, we screened variables using ordinary ordinal logistic regression (PROC LOGISTIC; SAS Institute) with a liberal retention criterion (p < 0.1) assuming independence of observations. This analysis yielded candidates for the repeated-measurements multivariable model. These and their transformations, if any, were entered at once into the model, then eliminated individually until all variables remaining had a p value of 0.05 or less.

Survival
Nonparametric and parametric survival estimates were obtained as described for freedom from reoperation. Risk-adjusted survival was compared using the 1:1 propensity-matched groups.

Presentation
Categorical data are summarized by frequencies and percentages and continuous variables by mean and standard deviation. Uncertainty is expressed consistently as ±1 SD, ±1 SE, or equivalent 68% asymmetric confidence limits (CL). The hazard function is presented as rate per 100 patients (%/year).


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Acknowledgments
 References
 
Durability of Repair
Mitral valve reoperation
Reoperation on the mitral valve was performed in 53 patients with prosthetic anuloplasty and in 18 patients without. Progression of degenerative disease was the most common indication for reoperation in those without prosthetic anuloplasty (67%), whereas procedure-related issues (inadequate initial repair, suture dehiscence, and systolic anterior motion) were most common in patients with prosthetic anuloplasty (74%), with progression of disease accounting for only 19% of reoperations in that group (p = 0.0002).

Unadjusted freedom from reoperation at 1, 5, and 10 years was 98%, 98%, and 96%, respectively, in patients receiving prosthetic anuloplasty and 98%, 96%, and 94%, respectively, in patients who did not (p = 0.09, Fig 2A). Ten-year freedom from reoperation in propensity-matched patients was 97% for those with prosthetic anuloplasty versus 96% for those without (p = 0.3; Fig 2B). Type of prosthetic anuloplasty did not influence risk of reoperation.


Figure 2
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  		Fig 2. Freedom from mitral valve reoperation stratified by whether a prosthetic anuloplasty was used. Each symbol represents a reoperation (open circles = prosthetic anuloplasty; filled circles = no anuloplasty). Vertical bars are 68% confidence limits representing ± 1 SE, and numbers in parentheses represent patients alive and being treated. Solid lines are parametric estimates enclosed within dashed 68% confidence limits. (A) Unadjusted groups. (B) Propensity-matched groups.

 
Recurrent mitral regurgitation
All patients undergoing posterior leaflet repair left the operating room with MR grade 1+ or less. Repair without a prosthetic anuloplasty was associated with an increase of 2+/3+/4+ MR to 43% within 1 month and 30% by 5 years. In contrast, return of 2+/3+/4+ MR in the prosthetic anuloplasty group was 8.9% within 1 month and 11% by 5 years (Fig 3A). Among propensity-matched groups, return of MR was more common in those who did not receive a prosthetic anuloplasty (Fig 3B). Additional risk factors for return of MR included earlier date of operation, greater left atrial volume, and preoperative atrial fibrillation (Table 3). Type of prosthetic anuloplasty did not influence return of MR.


Figure 3
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  		Fig 3. Return of mitral regurgitation (MR) grades 2+/3+/4+ over time. Solid lines are parametric estimates enclosed within dashed 68% confidence limits. (A) Unadjusted groups. (B) Propensity-matched groups.

 

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  		Table 3 Risk Factors for Return of Mitral Regurgitation in Matched Groups
 
Survival
Overall unadjusted estimated survival at 1, 5, 10, and 15 years was 99%, 95%, 87%, and 75%, respectively. Survival in the prosthetic anuloplasty group was 99%, 95%, 88% and 74%, respectively, and without anuloplasty it was 98%, 93%, 85%, and 75%, respectively. Unadjusted survival was slightly higher in the intermediate term if a prosthetic anuloplasty was used (p = 0.009, Fig 4A). However, survival was similar among propensity-matched groups (Fig 4B). Type of prosthetic anuloplasty did not influence survival.


Figure 4
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  		Fig 4. Survival stratified by whether or not a prosthetic anuloplasty was used. Format is as in Figure 2. (A) Unadjusted groups. (B) Propensity-matched groups.

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Acknowledgments
 References
 
Key Findings
Posterior leaflet repair without prosthetic anuloplasty increases early, and to a lesser degree late, postoperative MR, but does not appear to increase risk of late reoperation or diminish survival. Apparent large differences in these outcomes before adjusting for patient characteristics were explained primarily by differences in these characteristics. Nevertheless, posterior leaflet repair without prosthetic anuloplasty does not constitute an optimal repair strategy in most cases.

Anuloplasty in Repair of Degenerative Mitral Valve Disease
With the development of the first prosthetic anuloplasty in 1969, Carpentier established a standard for repair of degenerative mitral valve disease [3]. Since then, several clinical series have demonstrated that absence of a prosthetic anuloplasty jeopardizes repair durability [7, 12, 13]. Nevertheless, some suggest that in selected patients with leaflet prolapse and minimal anular dilatation, isolated leaflet repair may be indicated [4]. Early results with percutaneous leaflet repair confirm successful repair in many patients in the absence of prosthetic anuloplasty [6]. At this time, however, there are no clinical data enabling identification of patients who might have a durable repair without a prosthetic anuloplasty. Therefore, we currently recommend use of a prosthetic anuloplasty in essentially all patients undergoing repair of degenerative mitral valve disease.

Suture and Pericardial Anuloplasty
The majority of patients in this series who did not receive a prosthetic anuloplasty were treated with a strip of bovine pericardium affixed to the posterior anulus with interrupted mattress sutures. Potential advantages of suture and pericardial anuloplasty include preserved mitral anular function, limited effect on left ventricular contraction, absence of prosthetic material, and reduced cost [5, 14, 15]. Although some investigators have achieved similar results with pericardial and prosthetic anuloplasty [14], others document reduced durability with pericardial anuloplasty [15]. In our hands, posterior pericardial anuloplasty was associated with early postoperative MR. Although it is possible that different suture or placement techniques might improve results of pericardial anuloplasty, we think that this is unlikely to be the case.

Like pericardial anuloplasty, suture anuloplasty appears to provide a good intraoperative result. However, suture anuloplasty is associated with progressive anular dilatation [16] and therefore fails to satisfy Carpentier's criterion of maintaining anular geometry over time. Although there are some data to the contrary [17], suture anuloplasty does not achieve reliable, long-term anular stabilization.

Prosthetic Anuloplasty
In our series, most patients received a flexible posterior anuloplasty band. As with suture and pericardial anuloplasty, the theoretical advantage of a flexible anuloplasty is preservation of mitral anular and left ventricular function. However, in a randomized prospective study comparing the rigid Carpentier ring to the flexible Duran ring, Chang and coworkers [18] found no statistically significant differences in postoperative left ventricular function, left ventricular dimension, or repair durability between groups. Commenting on this study, Carlos Duran [19] said, "Basically, what I think is that there is not that much difference. And there is a tendency ... of getting a new type of ring or band every few months." Examination of patients in our series who received flexible bands and rigid rings failed to reveal any difference in clinical outcome. These data, considered in the context of published data, provided the rationale for grouping together the different types of prosthetic anuloplasties for analysis.

Limitations
By design, this study focused only on patients with isolated posterior leaflet prolapse, the most common finding in patients with degenerative disease. This design provided some homogeneity, as all patients received one of two leaflet repair techniques: quadrangular resection or sliding repair. These findings may not apply to patients with anterior or bileaflet prolapse or to those with concomitant conditions, such as coronary artery disease or aortic valve disease. These findings do not apply to patients with MR of other etiologies.

Echocardiographic follow-up at Cleveland Clinic was available for 2,313 of 3,057 patients (76%), was not obtained by a fixed schedule, and was not available beyond 10 years for most patients. It is possible that patients with recurrent MR were more symptomatic, prompting them to seek medical attention and obtain echocardiograms, and thus our findings might underestimate durability. Alternatively, it is possible that patients with recurrent MR were more likely to die, eliminating the ability to obtain repeat echocardiograms. Echocardiograms obtained during this study included semiquantitative assessments of MR using established techniques that represented standard care at the time; quantitative echocardiography was not performed routinely during the time frame of this study.

Because this is a nonrandomized study that extends over 2 decades, patients treated with different anuloplasty techniques had different preoperative characteristics. We used propensity matching to attempt to account for these differences between groups.

In conclusion, repair of degenerative valves should include a prosthetic anuloplasty. Anular stabilization with prosthetic material enhances durability by increasing leaflet coaptation and preventing future anular dilatation. These findings have important implications for percutaneous techniques that address only leaflet pathology.


   Appendix
 


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
References
 
This work is supported in part by a gift from the Broyhill Family (Dr Gillinov), by the Judith Dion Pyle Chair in Heart Valve Research (Dr Gillinov), and by the Kenneth Gee and Paula Shaw, PhD, Chair in Heart Research (Dr Blackstone).


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Braunberger E, Deloche A, Berrebi A, et al. Very long-term results (more than 20 years) of valve repair with Carpentier's techniques in nonrheumatic mitral valve insufficiency Circulation 2001;104:I8-I11.[Medline]
  2. David TE, Ivanov J, Armstrong S, Christie D, Rakowski H. A comparison of outcomes of mitral valve repair for degenerative disease with posterior, anterior, and bileaflet prolapse J Thorac Cardiovasc Surg 2005;130:1242-1249.[Abstract/Free Full Text]
  3. Carpentier A. [Reconstructive valvuloplasty. A new technique of mitral valvuloplasty] Presse Med 1969;77:251-253.[Medline]
  4. Maisano F, La Canna G, Grimaldi A, et al. Annular-to-leaflet mismatch and the need for reductive annuloplasty in patients undergoing mitral repair for chronic mitral regurgitation due to mitral valve prolapse Am J Cardiol 2007;99:1434-1439.[Medline]
  5. Fundaro P, Tartara PM, Villa E, Fratto P, Campisi S, Vitali EO. Mitral valve repair: is there still a place for suture annuloplasty? Asian Cardiovasc Thorac Ann 2007;15:351-358.[Abstract/Free Full Text]
  6. Feldman T, Wasserman HS, Herrmann HC, et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST phase I clinical trial J Am Coll Cardiol 2005;46:2134-2140.[Abstract/Free Full Text]
  7. Gillinov AM, Cosgrove DM, Blackstone EH, et al. Durability of mitral valve repair for degenerative disease J Thorac Cardiovasc Surg 1998;116:734-743.[Abstract/Free Full Text]
  8. Boyle CA, Decoufle P. National sources of vital status information: extent of coverage and possible selectivity in reporting Am J Epidemiol 1990;131:160-168.[Abstract/Free Full Text]
  9. Newman TB, Brown AN. Use of commercial record linkage software and vital statistics to identify patient deaths J Am Med Inform Assoc 1997;4:233-237.[Abstract/Free Full Text]
  10. Blackstone EH. Comparing apples and oranges J Thorac Cardiovasc Surg 2002;123:8-15.[Free Full Text]
  11. Blackstone EH, Naftel DC, Turner ME. The decomposition of time-varying hazard into phases, each incorporating a separate stream of concomitant information J Am Stat Assoc 1986;81:615-624.
  12. Flameng W, Meuris B, Herijgers P, Herregods MC. Durability of mitral valve repair in Barlow disease versus fibroelastic deficiency J Thorac Cardiovasc Surg 2008;135:274-282.[Abstract/Free Full Text]
  13. Cohn LH, Couper GS, Aranki SF, Rizzo RJ, Kinchla NM, Collins JJ. Long-term results of mitral valve reconstruction for regurgitation of the myxomatous mitral valve J Thorac Cardiovasc Surg 1994;107:143-151.[Abstract/Free Full Text]
  14. Borghetti V, Campana M, Scotti C, et al. Biological versus prosthetic ring in mitral-valve repair: enhancement of mitral annulus dynamics and left-ventricular function with pericardial annuloplasty at long term Eur J Cardiothorac Surg 2000;17:431-439.[Abstract/Free Full Text]
  15. Bevilacqua S, Cerillo AG, Gianetti J, et al. Mitral valve repair for degenerative disease: is pericardial posterior annuloplasty a durable option? Eur J Cardiothorac Surg 2003;23:552-559.[Abstract/Free Full Text]
  16. Aybek T, Risteski P, Miskovic A, et al. Seven years' experience with suture annuloplasty for mitral valve repair J Thorac Cardiovasc Surg 2006;131:99-106.[Abstract/Free Full Text]
  17. Duebener LF, Wendler O, Nikoloudakis N, Georg T, Fries R, Schafers HJ. Mitral-valve repair without annuloplasty rings: results after repair of anterior leaflet versus posterior-leaflet defects using polytetrafluoroethylene sutures for chordal replacement Eur J Cardiothorac Surg 2000;17:206-212.[Abstract/Free Full Text]
  18. Chang BC, Youn YN, Ha JW, Lim SH, Hong YS, Chung N. Long-term clinical results of mitral valvuloplasty using flexible and rigid rings: a prospective and randomized study J Thorac Cardiovasc Surg 2007;133:995-1003.[Abstract/Free Full Text]
  19. Duran C. Long-term clinical results of mitral valvuloplasty using flexible and rigid rings: a prospective and randomized study [Comment] J Thorac Cardiovasc Surg 2007;133:1003.



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