(Circulation. 1999;99:3272-3278.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Late Results of Percutaneous Mitral Commissurotomy in a Series of 1024 Patients
Analysis of Late Clinical Deterioration: Frequency, Anatomic Findings, and Predictive Factors
From the Cardiology Department, Tenon Hospital, Paris, France.
Correspondence to Dr Bernard Iung, Cardiologie, Hopital Tenon, 4, rue de la Chine, 75020 Paris, France. E-mail vahan001{at}wanadoo.fr
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Abstract |
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Background—The optimal use of percutaneous mitral commissurotomy (PMC) in a wide range of patients requires accurate evaluation of late results and identification of their predictors.
Methods and Results—Late results of PMC were assessed in 1024
patients whose mean age was 49±14 years.
Echocardiography showed that 141 patients (14%)
had pliable valves and mild subvalvular disease, 569 (55%) had
extensive subvalvular disease, and 314 (31%) had
calcified valves. A single balloon was used in 26 patients, a double
balloon in 390, and the Inoue Balloon in 608. Good immediate results
were defined as valve area 
1.5 cm2 without
regurgitation >2/4 (Sellers' grade) and were
obtained in 912 patients. Median duration of follow-up was 49 months.
The 10-year actuarial rate of good functional results (survival with no
cardiovascular death and no need for surgery or repeat
dilatation and in New York Heart Association [NYHA] class I or II)
was 56±4% in the entire population. Follow-up
echocardiography was available in 90% of the
patients who experienced poor functional results after good immediate
results and showed restenosis in 97% of these. In
multivariate analysis, the predictors of poor
functional results were old age (P=0.0008), unfavorable
valve anatomy (P=0.003), high NYHA class
(P<0.0001), atrial fibrillation
(P<0.0001), low valve area after PMC
(P=0.001), high gradient after PMC
(P<0.0001), and grade 2 mitral
regurgitation after PMC (P=0.04).
Conclusions—PMC can be performed with good late results in a variety of patient subsets. Prediction of late events is multifactorial. Knowledge of these predictors can improve patient selection and follow-up.
Key Words: mitral valve • balloon • valvuloplasty • follow-up studies
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Introduction |
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The safety and immediate efficacy of percutaneous mitral commissurotomy (PMC) have been widely demonstrated for >10 years.1 2 3 However, the consequences of its widespread use are less well known, because large published series report mainly midterm follow-up, do not always include a great diversity of patient subsets, and do not report anatomic findings associated with late deterioration.4 5 6 7 8 9
We report herein on the longest follow-up after PMC in a large single-center series, in which clinical events are detailed according to the quality of the immediate results. In the patients who had good immediate results from PMC, we analyzed the frequency of late clinical deterioration, associated anatomic findings, and predictive factors.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Study Population
From March 1986 to March 1995, 1024 consecutively admitted patients residing in France underwent PMC in our department. Their characteristics are described in Table 1
; 5.6% had left
ventricular ejection fraction <0.45. The usual
contraindications to the procedure were previously
detailed.3
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Technique
All procedures were performed via the antegrade transvenous
approach. We used a single balloon in 26 cases and a double balloon in
the 390 subsequent cases.10 After October 1990, the Inoue
balloon was systematically used in 608 patients, according to the
stepwise technique, under echocardiographic
guidance.11
Measurements
Echocardiography was performed in the same
laboratory on the day preceding PMC and 24 to 48 hours
afterward.
Mitral valve anatomy based on transthoracic
echocardiography and fluoroscopy has been
classified in 3 groups, as previously detailed3 10 12 :
flexible valves and mild subvalvular disease (chordae 10
mm long) (group 1), flexible valves and extensive subvalvular
disease (chordae <10 mm long) (group 2), and calcified valves
confirmed by fluoroscopy (group 3). In a subset of 40 patients, the
mean±SD (range) Wilkins score was 8.0±0.8 (7 to 9) for
echocardiographic group 1, 9.9±1.3 (8 to 12) for group
2, and 12.5±1.3 (10 to 15) for group 3.
The reference measurement for valve area was planimetry by 2-dimensional echocardiography.13 Mean mitral gradient was assessed by Doppler.14 The degree of mitral regurgitation was assessed according to Sellers' classification on left ventriculography in a 30° right anterior oblique view. In cases of missing data, substitution measurements were used as previously described3 : Doppler half-time pressure for valve area and color Doppler for mitral regurgitation.15
Follow-Up
Clinical follow-up was performed at 1-year intervals since 1986.
It was based on visits to the department or on a standardized
questionnaire sent to the patient's cardiologist. Any unexplained
death was considered cardiovascular related.
Follow-up was concluded in June 1997, and patients were considered lost to follow-up if their last contact was before June 1996. Follow-up was completed for 994 patients (97%), and the median duration was 49 months (range, 1 to 132 months).
End Points
Good immediate results were defined by a composite end point
that associated a mitral valve area 1.5 cm2
with no regurgitation >2/4.
Clinical events occurring during follow-up were combined in the following end points: (1) global survival; (2) survival considering only cardiovascular-related death, noncardiovascular death being censored at the time of death; (3) survival considering no cardiovascular-related death or need for mitral surgery or repeat dilatation; and (4) "good functional results," ie, survival considering no cardiovascular-related death or need for mitral surgery or repeat dilatation and patient in New York Heart Association (NYHA) functional class I or II. Survival status was censored at the time of surgery or repeat dilatation.
Statistical Analysis
Cumulative survival curves were determined for these 4 end
points of late results according to the Kaplan-Meier method. Continuous
variables and actuarial survival rates were expressed as mean±SD,
except for follow-up duration, which was expressed as a median. In the
predictive analysis, continuous variables were divided into
subgroups with clinically chosen cutoff points. Comparisons before and
after PMC were made by use of paired Student's t test.
The aim of the predictive analysis was to identify the
predictors of late clinical deterioration after good immediate results
from PMC (valve area 1.5 cm2 with no
regurgitation >2/4). Predictive analysis
concerned the predefined end point of "good functional results."
Univariate analysis was performed with a Cox model
that included 1 covariate and concerned the 12 preprocedure
variables, the 2 procedure-related variables, and the 3
postprocedure variables listed in Table 2. Variables with P<0.25
were entered in a Cox multivariate model with a
backward selection procedure and a significance level of
P=0.25. Two-way interactions were studied between these
selected variables with a stratified log-rank test. The final Cox
multivariate model was established by a backward
selection of these variables with a significance level of
P=0.05.
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A predictive model of continuing good functional results was
established with the final Cox model, in which the baseline survival
function So(t) was estimated from the study population. We validated
this model by comparing the predicted and observed numbers of good and
poor functional results at 7 years in the study population, according
to the method described by Lemeshow and Hosmer.16 The
quality of the discrimination achieved with the final Cox model was
measured by the area under the receiver-operating characteristic (ROC)
curve.17 Validation and testing of the model were
performed at 7 years to ensure that late functional results were
accurately estimated, because 211 patients had 7-year follow-up, 58
of whom experienced 1 cardiovascular event.
All data were entered prospectively in a computerized database beginning in 1986. Analysis was performed with SAS statistical software (SAS Institute Inc, release 6.11).
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Results |
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Immediate Results
Severe adverse events were in-hospital death in 4 patients (0.4%), embolism with sequelae in 3 (0.3%), severe mitral regurgitation with Sellers' grade
3 in 35 (3.4%),
and vascular complications requiring surgery in 11 (1.1%). No
tamponade occurred in this series. After PMC, mean valve area increased from 1.1±0.2 to 1.9±0.3 cm2 (P<0.0001), and mean gradient decreased from 10±4 to 5±2 mm Hg (P<0.0001). Mitral regurgitation was absent after the procedure in 318 patients and was recorded as grade 1 in 441 patients, grade 2 in 222, grade 3 in 32, and grade 4 in 3.
Good immediate results as defined by the composite end point were
obtained in 912 patients (89%). The 112 poor immediate results were
related to valve area <1.5 cm2 in 77 cases and
Sellers' grade mitral regurgitation 3 in 35. All
cases of death or embolism occurred in patients with poor immediate
results.
Late Results
The cumulative curves of late events are represented
in Figures 1, 2, 3, and 4.
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In the entire population of 1024 patients, 10-year actuarial rates were 85±4% for global survival, 92±2% for survival considering only cardiovascular-related deaths, 61±4% for survival with no need for surgery or repeat dilatation, and 56±4% for good functional results.
The events that occurred during follow-up are detailed in Table 3. Thirty-seven deaths were
cardiovascular in origin (heart failure in 24, sudden
death in 6, stroke in 4, and myocardial infarction in 3). The other 25
deaths were caused by neoplasia in 13 patients, respiratory
insufficiency in 6, suicide in 2, cirrhosis in 1, AIDS in 1, accident
in 1, and Alzheimer disease in 1. A subsequent procedure was
performed on the mitral valve in 183 patients, including 135 who had
valve replacement. The procedures combined with mitral surgery were,
singly or in combination, aortic valve replacement in 14, tricuspid
annuloplasty in 5, and coronary bypass grafting in 3. The 46
patients who were in NYHA functional class III or IV were awaiting
operation or were being medically treated because of refusal to undergo
surgery or contraindications to surgery.
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Of the 112 patients who had poor immediate results, only 19±4% were
free from surgery, and 14±3% had good functional results at 5 years
(Figures 1 through 4
). Surgery was performed in 74 patients.
Median duration between unsuccessful balloon commissurotomy and surgery
was 1 month (range, 1 to 54 months). Surgery was conservative in
9 patients with severe mitral regurgitation and 5 with
insufficient valve opening.
For the 912 patients who had good immediate results, 10-year actuarial
rates were 87±4% for global survival, 93±2% for survival
considering only cardiovascular-related deaths, 67±4%
for survival with no need for surgery or repeat dilatation, and 61±5%
for good functional results (Figures 1 through 4). After good
immediate results, a new procedure on the mitral valve was performed in
109 patients, the median duration being 48 months (range, 1 to 115
months). Valve replacement was the most frequent treatment. Open-heart
commissurotomy was performed in 13 patients and repeat dilatation in 21
with favorable anatomy. Follow-up
echocardiography was available in 154 (90%) of the
172 patients who experienced poor functional results
(cardiovascular death, surgery, repeat PMC, or symptoms
in NYHA class III or IV). It showed a mean valve area of 1.2±0.2
cm2 and mitral restenosis, as defined by
a valve area <1.5 cm2 and a loss >50% of the
initial gain, in 150 patients (97%). Mitral restenosis was
pure in 125 cases and combined with a regurgitation
2/4 in the remaining 25. In the patients who underwent surgery,
surgical findings confirmed mitral restenosis as assessed by
echocardiography. Of the 15 patients who had
combined surgery, progression of aortic valve disease was the major
reason for surgery in 5 cases.
Predictive Factors of Late Results
Univariate predictors of late results after a
successful PMC are detailed in Table 2; neither of the
procedure-related variables was predictive (type of balloon,
P=0.72; effective balloon dilating area,
P=0.92).
Multivariate analysis identified 7 predictors
of late functional results after good immediate results from PMC (Table 4). Four predictors were preprocedural
characteristics, and the other 3 were related to the immediate
results.
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The good fit of the model was shown by the absence of significant
difference between predicted and observed results at 7 years
(
2=5.3, df=5, P=0.38). The area
under the ROC curve was 0.71 (Figure 5).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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In this single-center series that reports clinical follow-up after PMC in 1024 patients, 10-year actuarial rates of survival with no cardiovascular-related death, no subsequent procedure on the mitral valve, and good functional results were 56±4% in the entire population and 61±5% after good immediate results. Mitral restenosis, pure or associated with regurgitation, was documented in most of the patients who had poor functional results after good immediate results from PMC. The occurrence of poor functional results was related to the baseline characteristics of the patients and to the quality of the immediate results.
Late Clinical Deterioration After PMC
As has been shown with surgical commissurotomy, late outcome
differs according to the quality of the immediate results. Inadequate
correction of valve impairment leads to only transient or no functional
improvement.18 19 On the other hand, good immediate
results generally provide sustained improvement, and when functional
deterioration occurs, it is late and mainly related to mitral
restenosis.20 The present study clearly shows
the same findings with regard to PMC.
Of our 112 patients who had poor immediate results, 94 (84%)
experienced 1 cardiovascular event, and the majority
underwent early mitral valve replacement. In such patients, the
indication and timing of surgery depended on confounding factors such
as comorbidities and the prevailing views of the medical and surgical
teams. Our policy is to recommend early surgery after poor immediate
results from PMC, without waiting for secondary deterioration. Patients
who did not undergo surgery generally had contraindications to surgery,
and most of them died of cardiovascular causes or
became rapidly symptomatic.
Conversely, only 172 (19%) of the 912 patients with good immediate results experienced cardiovascular events. In the patients who experienced poor functional results, follow-up echocardiography showed mitral restenosis in 97% of cases. Valve replacement was frequently required because of unfavorable anatomy or mitral regurgitation greater than or equal to grade 2. Those who had isolated mitral restenosis with favorable anatomy underwent open-heart commissurotomy or a second dilatation.
Predictive Factors of Late Clinical Deterioration
The predictive analysis of late functional results was
based only on patients who had good immediate results to eliminate the
consequences of poor immediate results. The high number of events
reported in the present series and the diversity of the population
enabled predictive factors to be analyzed accurately.
The values of the relative risks indicate that patients cannot be classified as at high risk for poor late results on the basis of a single predictor and that prediction of late results is multifactorial.
Age has been identified as a predictor of late results in series of surgical21 22 or balloon commissurotomy.6 As was the case after surgical commissurotomy,21 mitral valve anatomy was a predictor of midterm results in most series of balloon commissurotomy, whatever the scoring system used.23 24 25 The few studies including echocardiographic follow-up have shown that impaired valve anatomy increases the risk of restenosis.26 27 Two other predictors are related to the evolutive stage of the cardiopathy, ie, functional class and atrial fibrillation, which have been identified as predictors of late outcome in series of balloon4 6 7 and surgical commissurotomy procedures.21
The prognostic value of these 4 patient-related characteristics provides useful data to improve selection of candidates for PMC. Because late outcome depends strongly on the presence of good immediate results, patient selection must also take into account factors that are only predictors of immediate results, such as initial valve area or previous commissurotomy.1 2 3
In the present series, 3 predictors of late results were related to
the quality of the immediate results. The prognostic value of final
mitral valve area is well known,4 7 8 and it remained a
strong predictor in patients who had a valve area 1.5
cm2 after PMC. Mean mitral gradient was the other
strong predictor related to immediate results. It provided information
that was additional to mitral valve area, which suggests the potential
interest of an end point of good immediate results that combines valve
area and gradient. The third predictor of late results in our series,
although of less prognostic value, was the presence of moderate mitral
regurgitation after PMC (Sellers' grade 2).
These predictors are of particular relevance for follow-up. Patients who have good immediate results but who are at high risk for further events must be carefully followed up to allow for timely intervention.
The 2 procedure-related variables did not modify late outcome in the present study, which is the only series comprising a high number of patients who have undergone PMC with both of the most widely used techniques, ie, the double balloon and the Inoue balloon.
The test of the model shows that it is not possible to achieve perfect discrimination in the prediction of late outcome. This is not related to insufficient modeling, because the model fits to observed data, but to intrinsic limitations in the prediction of late outcome, as was also shown for immediate results.3
Late Results of PMC and Mitral Surgery
Late results of series of PMC and mitral surgery must be
analyzed with reference to patient characteristics. Randomized
studies have shown that the results of closed- or open-heart
commissurotomy were not better than those of PMC, but these studies
were performed only in populations comprising a limited number of
patients, all of whom were young.28 29
No randomized study is available for older patients who have a less-favorable outcome,4 6 7 and a comparison with surgical series is difficult because of the differences in the patients involved and the fact that the surgical alternative can be not only commissurotomy but also valve replacement.
Limitations of the Study
The present study does not enable the rate of
restenosis after PMC to be established accurately. This could
be achieved only with repeat echocardiographic
examinations, standardized in their technique and frequency regardless
of patient symptoms. Echocardiographic follow-up was
not prospectively planned in the present study because it would
have been difficult to perform owing to the number and geographic
diversity of the patients involved. Nevertheless,
echocardiographic data were obtained in 90% of
patients who had poor functional results after an initially successful
PMC.
In our previous experience of follow-up after successful PMC, we found that hemodynamic variables did not provide any additional information to clinical and echocardiographic variables in a multivariate model.30 For this reason and to simplify the procedure, we have not performed systematic hemodynamic measurements before and after PMC since 1994. In the present series, we did not study the predictive value of hemodynamic variables to avoid a bias related to a high number of patients with missing data in our multivariate analysis. For the same reason, we did not mention atrial shunts after PMC. Generally, they are small and decrease or disappear on follow-up.31
Clinical Implications
This single-center series confirms the late efficacy of PMC in a
large population comprising a variety of patient subsets. The
identification of the predictors of late outcome provides useful
information in improving patient selection and follow-up.
Good continuing results can be expected in patients with favorable characteristics. When late clinical deterioration occurs, the high frequency of restenosis suggests the potential interest of repeating PMC.
Patients with nonideal anatomy are more frequently encountered in western countries and form a particularly heterogeneous group with regard to their other characteristics. Because prediction of late clinical deterioration is multifactorial, selection of these patients must not rely exclusively on valve anatomy but should take into account all other predictors. Furthermore, the strong predictive value of the quality of the immediate results stresses the importance of evaluating them carefully on the basis of valve area and gradient.
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Received December 8, 1998; revision received April 1, 1999; accepted April 9, 1999.
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R. O. Bonow, B. A. Carabello, K. Chatterjee, A. C. de Leon Jr, D. P. Faxon, M. D. Freed, W. H. Gaasch, B. W. Lytle, R. A. Nishimura, P. T. O'Gara, et al. ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease) Developed in Collaboration With the Society of Cardiovascular Anesthesiologists Endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons J. Am. Coll. Cardiol., August 1, 2006; 48(3): e1 - e148. [Full Text] [PDF]
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M. E. Fawzy, H. Hegazy, M. Shoukri, F. El Shaer, A. ElDali, and M. Al-Amri Long-term clinical and echocardiographic results after successful mitral balloon valvotomy and predictors of long-term outcome Eur. Heart J., August 2, 2005; 26(16): 1647 - 1652. [Abstract] [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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H. Nakajima, J. Kobayashi, K. Bando, Y. Yasumura, S. Nakatani, K. Kimura, K. Niwaya, O. Tagusari, and S. Kitamura Consequence of atrial fibrillation and the risk of embolism after percutaneous mitral commissurotomy: The necessity of the maze procedure Ann. Thorac. Surg., September 1, 2004; 78(3): 800 - 805. [Abstract] [Full Text] [PDF]
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A. Vahanian and I. F. Palacios Percutaneous Approaches to Valvular Disease Circulation, April 6, 2004; 109(13): 1572 - 1579. [Full Text] [PDF]
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B. Iung, A. Nicoud-Houel, O. Fondard, H. Akoudad, T. Haghighat, E. Brochet, E. Garbarz, B. Cormier, G. Baron, P. Luxereau, et al. Temporal trends in percutaneous mitral commissurotomy over a 15-year period Eur. Heart J., April 2, 2004; 25(8): 701 - 707. [Abstract] [Full Text] [PDF]
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H Gamra, F Betbout, K Ben Hamda, F Addad, F Maatouk, Z Dridi, S Hammami, M Abdellaoui, H Boughanmi, T Hendiri, et al. Balloon mitral commissurotomy in juvenile rheumatic mitral stenosis: a ten-year clinical and echocardiographic actuarial results Eur. Heart J., July 2, 2003; 24(14): 1349 - 1356. [Abstract] [Full Text] [PDF]
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S. H. Rahimtoola, A. Durairaj, A. Mehra, and I. Nuno Current Evaluation and Management of Patients With Mitral Stenosis Circulation, September 3, 2002; 106(10): 1183 - 1188. [Full Text] [PDF]
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B. Iung, C. Gohlke-Barwolf, P. Tornos, C. Tribouilloy, R. Hall, E. Butchart, and A. Vahanian Recommendations on the management of the asymptomatic patient with valvular heart disease Eur. Heart J., August 2, 2002; 23(16): 1253 - 1266. [PDF]
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B D Prendergast, T R D Shaw, B Iung, A Vahanian, and D B Northridge Contemporary criteria for the selection of patients for percutaneous balloon mitral valvuloplasty Heart, May 1, 2002; 87(5): 401 - 404. [Full Text] [PDF]
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Y. Boudjemline and P. Bonhoeffer Steps Toward Percutaneous Aortic Valve Replacement Circulation, February 12, 2002; 105(6): 775 - 778. [Abstract] [Full Text] [PDF]
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A. Vahanian and B. Iung Percutaneous mitral balloon commissurotomy: a useful and necessary treatment for the western population Eur. Heart J., October 2, 2000; 21(20): 1651 - 1652. [PDF]
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T. O. Cheng, C. R. Chen, B. Iung, E. Garbarz, P. Michaud, S. Helou, B. Farah, P. Berdah, P.-L. Michel, B. Cormier, et al. Late Results of Percutaneous Balloon Mitral Valvuloplasty: The Chinese Experience Response Circulation, July 11, 2000; 102 (2): e18 - e18. [Full Text] [PDF]
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I. F. Palacios, P. L. Sanchez, L. C. Harrell, A. E. Weyman, and P. C. Block Which Patients Benefit From Percutaneous Mitral Balloon Valvuloplasty?: Prevalvuloplasty and Postvalvuloplasty Variables That Predict Long-Term Outcome Circulation, March 26, 2002; 105(12): 1465 - 1471. [Abstract] [Full Text] [PDF]
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