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J Thorac Cardiovasc Surg 1998;115:389-396
© 1998 Mosby, Inc.

SURGERY FOR ACQUIRED HEART DISEASE

Valve Repair Versus Replacement For Mitral Insufficiency: When Is A Mechanical Valve Still Indicated?

Supported in part by the Foundation for Research in Cardiac Surgery and Cardiovascular Biology.

Read at the Seventy-seventh Annual Meeting of The American Association for Thoracic Surgery, Washington, D.C., May 4-7, 1997.

Received for publication May 5, 1997; revisions requested June 19, 1997; revisions received August 6, 1997; accepted for publication Oct. 8, 1997. Address for reprints: Eugene A. Grossi, MD, Suite 9V, Skirball Building, New York University Medical Center, 530 First Ave., New York, NY 10016.

Abstract

Objectives: Although many advantages of mitral valve reconstruction have been demonstrated, whether specific subgroups of patients exist in whom mechanical valve replacement offers advantages over mitral reconstruction remains undetermined.

Methods: This study examined the late results of mitral valve surgery in patients with mitral insufficiency who received either a St. Jude Medical valve (n = 514) or a mitral valve reconstruction with ring annuloplasty (n = 725) between 1980 and 1996.

Results: Overall operative mortality was 7.2% in the patients receiving a St. Jude Medical mitral valve and 5.4% in those undergoing mitral valve reconstruction (no significant difference); isolated mortality was 2.5% in the St. Jude Medical group and 2.2% in the valve reconstruction group (no significant difference). The follow-up interval was more than 5 years for 340 patients with a mean of 39.8 months (98.5% complete). Overall 8-year freedom from late cardiac death, reoperation, and all valve-related complications was 72.8% for the St. Jude Medical group and 64.8% for valve reconstruction group (no significant difference). For patients with isolated, nonrheumatic mitral valve disease, 8-year freedom from late cardiac death and reoperation was better in the mitral valve reconstruction group (88.3%) than in the St. Jude Medical valve group (86.0%; p = 0.05). Furthermore, Cox proportional hazards regression revealed that mitral valve reconstruction was independently associated with a lesser incidence of late cardiac death (p = 0.04), irrespective of preoperative New York Heart Association class. However, the St. Jude Medical valve offered better 8-year freedom from late cardiac death, reoperation, and all valve-related complications than did mitral valve reconstruction in patients with multiple valve disease (77.0% vs 45.3%; p < 0.01).

Conclusions: Therefore, mitral valve reconstruction appears to be the procedure of choice for isolated, nonrheumatic disease, whereas insertion of a St. Jude Medical valve should be preferred for patients with multiple valve disease.

Numerous long-term studies have substantiated the excellent durability and freedom from structural degeneration and valve-related complications provided by mitral valve reconstruction. ^1-4 Likewise, the St. Jude Medical valve (St. Jude Medical, Inc., St. Paul, Minn.) in the mitral position has repeatedly been shown to provide excellent durability and hemodynamic function. ^5-7 The St. Jude Medical valve in the mitral position also has been reported to perform well compared with tissue prostheses ⁸ and has demonstrated superior freedom from valve-related complications compared with earlier mechanical valves. ⁵ Use of any mechanical valve, however, exposes the patient to an incremental risk of thromboembolism and anticoagulant-related complications.

Unfortunately, few direct comparisons have been made between the performance of the St. Jude Medical valve in the mitral position and mitral valve reconstruction among various patient groups. ⁴ Such studies might prove particularly informative in view of the demonstrated inferior durability of mitral reconstruction in rheumatic patients. We attempted to address this issue by retrospectively comparing our institution's experience with St. Jude Medical mitral valve replacement and mitral valve reconstruction with regard to both patient survival and valve-related complications.

Patients and methods

From January 1976 through July 1996, 2631 patients underwent mitral valve surgery at New York University Medical Center. Of the 677 patients who underwent mechanical valve replacement, 514 (75.9%) received St. Jude Medical valves (SJMV). Of the 1049 patients who underwent mitral valve reconstruction, "ringed" mitral reconstructions (MVP) (Carpentier mitral annuloplasty rings; Baxter Healthcare, Edwards CVS Division, Irvine, Calif.) were performed in 725 (69.1%). Replacements with other mechanical or tissue valves were excluded from the analysis of mitral replacements; Kay or Reed annuloplasties, pure mitral commisurotomies, and mitral annuloplasties without ring placement were excluded from the analysis of mitral reconstructions.

The mean patient age was 60.9 years (range 1 to 83 years) for the SJMV patients and 59.4 years (range 3 to 87 years) for the MVP patients. Concomitant bypass surgery was performed in 86 (16.7%) of the SJMV patients and 219 (30.2%) of the MVP patients (p < 0.001). Concomitant valvular heart surgery was performed in 243 (47.3%) of the SJMV patients and 94 (13.0%) of the MVP patients (p < 0.001). The distribution of the causes of the valvular disease in the SJMV and MVP patients is listed in Table I. Fifty-two percent (267/514) of the SJMV mitral replacements were in patients with rheumatic disease, whereas the preponderance (66.1%, 479/725) of valves treated with MVP were in patients with degenerative or ischemic mitral disease. To attempt to identify any relative advantages of use of the SJMV or MVP approaches for specific types of patients, this study was further restricted to the following subgroups: patients without rheumatic valve disease undergoing isolated mitral procedures; patients with rheumatic disease undergoing isolated mitral procedures; and patients with multiple valve disease undergoing mitral procedures plus one or more other valve procedures irrespective of the cause of their mitral disease. Table II gives the basic characteristics of the overall patient group and these subgroups.

Although this was a nonrandomized study, most of data for this study were collected prospectively. Patient follow-up was performed at 6-month intervals with a nurse specialist interviewing the patient. Three hundred forty patients had a follow-up interval longer than 5 years; 51 patients had a follow-up interval longer than 10 years (mean follow-up 39.8 months; 98.5% complete; total follow-up 4045 patient-years). The recommended guidelines for nomenclature and reporting morbidity and mortality after cardiac valvular operations were observed. ¹⁰ Data were analyzed using SPSS statistical software (SPSS, Inc., Chicago, Ill.). Comparisons of categoric variables were performed with the ² test; continuous variables were compared by the nonpaired Student's t test. Survival and freedom from late complications were determined by life table methods and the Wilcoxon (Gehan) statistic was used for intergroup comparisons. The Cox proportional hazards regression model was used to examine multiple predictors of time-related events.

Results

Table II lists the basic clinical characteristics of all the patients who received either MVP or mitral valve replacement with a SJMV and the isolated nonrheumatic, isolated rheumatic, and multivalve subgroups. Table III compares the basic clinical characteristics of MVP and mitral valve replacement with a SJMV in the isolated, nonrheumatic and the isolated, rheumatic subgroups. In the isolated, nonrheumatic subgroup, MVP patients had a greater incidence of degenerative disease (75% vs 58%; p < 0.01), a higher proportion of men (60% vs 42%; p < 0.01), and a better mean preoperative New York Heart Association classification (2.8 vs 3.3; p < 0.001). In addition, preoperatively 46.2%, of the SJMV patients had atrial fibrillation/flutter compared with 35.1% of the MVP (p = 0.06). Postoperatively, 99% of the SJMV patients were on a warfarin sodium (Coumadin) regimen compared with only 33% of the MVP patients (p < 0.001).

A comparison of preoperative risk factors for patients with multivalve procedures is shown in Table IV. It is important to note that 50% of these MVP patients had a rheumatic cause for their valvular heart disease. In 72% of the patients with multivalve replacements, the second valve operation was aortic valve replacement. Among the SJMV patients 100% had a second St. Jude Medical valve placed, whereas 54% of the MVP had a second valve placed.

A comparison of the patients with isolated rheumatic disease in both groups failed to reveal any significant differences in freedom from late cardiac death, reoperation, or all valve-related complications (Table V). The relatively small number of patients in each group, however, should be noted.

In the multivalve subgroup the SJMV patients fared better than MVP patients in freedom from late cardiac death and reoperation (89.4% vs 50.0% at 8 years; p < 0.001) (Table V). This difference was also noted in freedom from late cardiac death, reoperation, and all valve-related complications (SJMV 77.0% vs MVP 45.3% at 8 years; p < 0.001). The SJMV patients in this subgroup also had better freedom from reoperation (SJMV 99.0% vs MVP 76.1% at 8 years; p < 0.01), endocarditis (SJMV 99.5% vs MVP 91.3% at 8 years; p = 0.03), and thromboembolic complications (SJMV 91.7% vs MVP 84.7% at 8 years; p = 0.02) (Table VI).

Discussion

The results presented here show that both St. Jude Medical mitral valve replacement and mitral valve reconstruction provided good results in the overall patient group with freedom from late cardiac death, reoperation, and all valve-related complications at 8 years of 72.8% for SJMV replacement and 64.8% for MVP (p > 0.13) (Table V). As noted previously, however, concomitant coronary artery bypass grafting profoundly diminished survival from late cardiac death in all patients. When various other subgroups are compared, additional important distinctions emerge.

Isolated, nonrheumatic mitral insufficiency.
For isolated mitral insufficiency in patients with nonrheumatic disease, mitral reconstruction appears to provide some advantages, with an 8-year survival from late cardiac death of 95.4% compared with 91.6% for the SJMV group (p = 0.03). Likewise in this subgroup, 8-year freedom from late cardiac death and reoperation was marginally significantly better in the MVP group (88.3%) compared with the SJMV group (86.0%; p = 0.05). It might be suggested that this difference in survival from late cardiac death was due to significant differences in the incidence and severity of preoperative risk factors between the SJMV and MVP groups, as shown in Table III. However, multivariable analysis showed that only the use of MVP was a significant predictor of survival from late cardiac death. This may be related to the fact that although both groups had comparable freedom from major late valve-related complications (Table VI), the complications in the SJMV group were more likely to be fatal, resulting in this group's lower survival from late cardiac death (Table V).

Isolated rheumatic mitral insufficiency.
Prior reports have documented that patients with isolated rheumatic mitral disease do not obtain as much long-term benefit from mitral repair as do patients with nonrheumatic disease. ^1,2 We have previously reported freedom from reoperation at 5 years for a group of all patients with rheumatic disease undergoing mitral reconstruction to be only 77.4%. ² In recent years refinements in our selection criteria for patients undergoing mitral reconstruction, as well as improvements and innovations in mitral reconstruction, have improved freedom from reoperation for isolated mitral reconstruction with a ring in patients with rheumatic disease to 85.6% at 8 years. Nevertheless, the fact that the SJMV-isolated rheumatic replacement group does not show a significantly better freedom from reoperation compared with a similar group of MVP patients may be because so few patients were in the follow-up at 8 years. In the future, a longer follow-up period with a greater number of patients should reveal a difference in freedom from reoperation between SJMV and MVP patients because of the known progression of the rheumatic valvular disease.

Nevertheless, the possibility of using mitral valve reconstruction in patients with isolated rheumatic mitral valve disease should not be summarily excluded. Under certain circumstances, such as in a woman of child-bearing age and intention, the advantages of mitral reconstruction with the reduced need for an anticoagulant regimen could well outweigh considerations based on the inferior durability of mitral reconstruction in patients with rheumatic mitral valve disease.

Patients with multivalve disease.
All the SJMV patients who underwent concomitant aortic valve replacement had another St. Jude Medical valve placed in the aortic position, whereas among the MVP patients only half the concomitant aortic valve replacements were done with a St. Jude Medical valve. In patients with multivalve disease the differences between the SJMV and MVP groups for late cardiac death or valve-related mortality were not statistically significant (Table V). However, the results for the SJMV group were significantly better for freedom from late cardiac death and reoperation and for freedom from late cardiac death, reoperation, and all valve-related complications. As might be anticipated in patients with double valve disease, 50% of the MVP patients and 55% of the SJMV patients had rheumatic mitral disease. The high number of reoperations and valve-related complications in the MVP group may be attributable to the known inferior durability of MVP in patients with rheumatic disease.

The major weakness of this study is that the patients were not randomized into the MVP and SJMV study groups. However, we have attempted to describe any factors that may have affected treatment selection and results.

In conclusion, the present results suggest that in patients with isolated nonrheumatic mitral valve disease, repair offers better freedom from late cardiac death and reoperation. In patients with isolated rheumatic mitral valve disease, mitral valve reconstruction, although its durability is not as good as in patients without rheumatic disease, offers a great advantage in certain subgroups of patients in whom the need to avoid anticoagulation exists. In patients with multiple valve disease, St. Jude Medical valve replacement offered better freedom from combined late cardiac death, reoperation, and all valve-related complications. Therefore mitral valve repair appears to be the procedure of choice for patients with isolated, nonrheumatic valve disease, whereas St. Jude Medical mitral valve replacement seems to provide improved late results in patients with multiple valve disease.

Appendix: Discussion

Dr. Cary W. Akins (Boston, Mass.). Previous comparisons of mitral valve replacement and mitral valve reconstruction, including our own, have almost invariably demonstrated an advantage in event-free survival for mitral valve reconstruction versus mitral valve replacement, especially when the operations are done for degenerative or ischemic mitral regurgitation. Today in a large, long-term study comparing mitral valve reconstruction and mitral valve replacement with a St. Jude Medical mechanical prosthesis, Grossi and colleagues have examined the freedom from late cardiac death and valve-related complications after the two operations in all patients.

As expected, mitral valve reconstruction patients in the nonrheumatic subgroup had significantly better freedom from late cardiac death and late cardiac death or reoperation than the St. Jude Medical mitral valve replacement patients. In addition, by multivariate analysis, only mitral valve reconstruction predicted improved freedom from late cardiac death.

The study then compares patients with rheumatic mitral valve disease and patients having multivalve operations. In the abstract for the rheumatic subgroup, patients with the St. Jude Medical mitral valve replacement had better freedom from late cardiac death and reoperation, but in the manuscript no significant difference was observed. In the multivalve subgroup, both in the abstract and the manuscript, St. Jude Medical mitral valve replacement was associated with better freedom from late cardiac death, reoperation, and valve-related complications. The authors suggest that some of this can be explained by the well-known higher reoperation rate after mitral valve reconstruction in patients with rheumatic mitral valve disease. Are there other possible explanations?

Concomitant coronary artery bypass grafting was performed twice as often in the mitral valve reconstruction patients as in the St. Jude Medical valve replacement patients, and the authors statistically document the important negative influence of coronary artery disease on late survival.

My first question to the authors is, did you assess the impact of concomitant coronary disease on survival for the two operations in the patients with rheumatic and multivalve disease? Indeed, while you performed a multivariate analysis of the risk factors for patients with nonrheumatic disease, you did not for those with rheumatic and multivalve disease. In a comparison of two disparate and nonrandomized patient populations, isn't multivariate analysis into which procedure performed is inserted as a variable the best way to assess a multivariate situation?

Secondly, all mitral valve reconstructions were presumably done for isolated mitral regurgitation. My second question to the authors is whether the St. Jude Medical valve replacement patients had isolated mitral regurgitation. Is it possible that the inclusion of patients with other valve diseases in the St. Jude Medical operative group of rheumatic and multivalve patients influenced the late results (another question that can be addressed by multivariate analysis)?

Finally, in the manuscript the authors list very low linearized rates for thromboembolism and anticoagulant-related bleeding for the St. Jude Medical valve replacement patients. In fact, the linearized rates for anticoagulant-related bleeding were all less than 1% per patient-year. Yet we know from the placebo arms of the various randomized trials of anticoagulants that the background rate of bleeding in the normal population varies from 1% and 1.5% per patient-year. How did the authors define anticoagulant-related bleeding, and how do they account for bleeding rates in an anticoagulated population that are lower than the background rate of bleeding in the unanticoagulated population?

Dr. Jacques R. Seguin (Creteil-Paris, France). I would like to congratulate the authors on this excellent presentation and to thank the New York University team for promoting valve repair with such wonderful results.

I think, like your team, in nonrheumatic disease, mitral regurgitation can be repaired in a very large group of patients, probably more than 90% of the patients, whereas I do not share totally your conclusions concerning patients with rheumatic disease. We have the impression there is not one type of rheumatic disease but multiple types of thoracic lesions, and to make things simple, probably two groups of patients: one with severely calcified anterior leaflet where repair might not be advisable, whereas in patients with calcified posterior leaflets, repair is possible with excellent long-term results. Don't you think there are different types of patients with rheumatic lesions and they should be differentiated in your presentation and thus possibly modify your conclusions?

Dr. Manuel J. Antunes (Coimbra, Portugal). I concur with your conclusions inasmuch as the results for repair for rheumatic mitral valve disease are usually worse than those for nonrheumatic valves, although in your conclusions it appears that the difference was only for patients with multivalve disease. However, your rheumatic population is a selected one; I am quite sure about that. Hence, in my view, you could be sending out the wrong message.

Most of the patients with rheumatic valve disease operated on now are from a Third World population. I continue to operate on many patients coming from Africa, and the last one that I operated on, only about a couple of weeks ago, was 4 years old. In this patient, replacing a valve with a mechanical or with a tissue valve would be short of a crime, I think. And our results have shown that in that particular population, the results of mitral valve repair are still better than those of mitral valve replacement. Hence, I urge surgeons treating these types of patients to continue concentrating their efforts in repairing valves.

Currently in Portugal, where two thirds of our patients still have rheumatic disease, we repair approximately 85% of all mitral valves coming to operation and continue to be pleased with the results. New techniques have been added to surgeons' armamentarium since 1980 when you started your series, and today your story may be a little bit different from that which you depicted. Do you have any information about these questions? Are your results today better than they were in 1980 in respect to rheumatic valves?

Dr. Alain F. Carpentier (Paris, France). Any conclusion coming from this group is very important to take into consideration, particularly when we do not think exactly the same way.

I do have two questions. Number one, you mentioned that you had 51 patients over 10 years, 51 patients overall, and based on your presentation, apparently you have about one fourth of your total cohort being rheumatic and three fourths being degenerative.

Now, going back to the 8-year prediction or your 8-year conclusion, if you have only 51 patients beyond 10 years, one fourth means only, let's say, 15% of rheumatic valve disease. How can you derive such a conclusion from 15 patients over 10 years? This is my first question.

Now number two, as far as multiple valve disease is concerned, when you are comparing multiple-valve replacement with multiple-valve repair, does this imply that these patients had aortic valve repair because we all know that aortic valve repair does not work and should not be used. So if you compare a technique that works in the mitral position with a technique that does not work in the aortic position, probably your conclusion is not valid.

Dr. Grossi. Dealing with the questions, first to clarify, in the isolated rheumatic group that we presented, there was no concomitant bypass surgery. The isolated rheumatic patients were those patients with rheumatic etiology undergoing isolated mitral valve replacement or repair without concomitant bypass surgery. So we do not think that was a problem. It was impossible to add that as an additional risk factor.

We demonstrated in the manuscript that overall, looking at all the patients, multivariate analysis showed that the effect of concomitant bypass grafting has the greatest single effect on long-term freedom from late cardiac death.

With regard to the cause of the valve diseases, all these patients had mitral insufficiency. Of those patients who had rheumatic causes, approximately 15% of them had some element of mitral stenosis in addition to that, and that was equal across both the replacements and the reconstructions.

With regard to the linearized rates of anticoagulated bleeding, I do not think in terms of linearized rates. I was quite happy when our rates were calculated. We looked at them, and we thought they were within the table of the review article Dr. Akins had published; they were well within the standard errors of those. The complications that we count as anticoagulants causing bleeding are defined according to the guidelines published in The Journal of Thoracic and Cardiovascular Surgery.

With regard to the different types of rheumatic disease in terms of anterior calcification versus posterior calcification, we did not quantify that or put a label on that type of rheumatic disease and break down our patients into those groups. These are patients with rheumatic disease who we see in North America, and we do have a large percentage of them.

With regard to Professor Carpentier's questions, we do have patients out 15 years after reconstruction, and our reconstruction data goes out that far. We could not present that here because it would be meaningless; we do not have enough data for a uniform mechanical group.

With regard to the patients with multiple valve disease, it is sort of an interesting group. Of those, most of them were aortic valve replacements and either mitral valve replacements or reconstructions. Of those, 50% had either a mechanical valve placed in their aortic valve or a tissue valve placed in their aortic valve. So these are not aortic valve reconstructions.

Specifically when we are talking about the freedom from reoperation, this is with regard to dysfunction of the mitral valve.

Footnotes

12/6/86882

References

1. Galloway AC, Colvin SB, Baumann FG, Esposito R, Vohra R, Harty S, et al. Long-term results of mitral valve reconstruction with Carpentier techniques in 148 patients with mitral insufficiency. Circulation 1988;78(Suppl):I-97-105.
   
2. Galloway AC, Colvin SB, Baumann FG, Grossi EA, Ribakove GH, Harty S, et al. A comparison of mitral valve reconstruction with mitral valve replacement: intermediate term results. Ann Thorac Surg 1989;47:655-62.[Abstract]
   
3. Deloche A, Jebara VA, Relland JY, Chauvaud S, Fabiani JN, Perier P, et al. Valve repair with Carpentier techniques: the second decade. J Thorac Cardiovasc Surg 1990:99:990-1002.
   
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6. Jegaden O, Eker A, Delahaye F, Montagna P, Ossette J, de Gevigney GD, et al. Thromboembolic risk and late survival after mitral valve replacement with the St. Jude Medical valve. Ann Thorac Surg 1994;58:1721-8.[Abstract]
   
7. Fire AC, Naunheim KS, D'Orazio S, Kaiser GC, McBride LR, Pennington G, et al. Mitral valve replacement: randomized trial of St. Jude and Medtronic-Hall prostheses. Ann Thorac Surg 1992;54:68-73.[Abstract]
   
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