Original Article
Predictors of Long-Term Outcome after Percutaneous Balloon Mitral Valvuloplasty
N Engl J Med 1992; 327:1329-1335November 5, 1992
- Abstract
- Abstract
Background.
Percutaneous balloon mitral valvuloplasty is known to produce short-term hemodynamic and symptomatic improvement in many patients with mitral stenosis. Comprehensive assessment of the clinical usefulness of balloon valvuloplasty requires evaluation of patients' long-term outcomes.
Methods.
We performed balloon mitral valvuloplasty in 146 patients between October 1, 1985, and October 1, 1991. Base-line demographic, clinical, echocardiographic, and hemodynamic variables were evaluated in order to identify predictors of long-term event-free survival.
Results.
Balloon mitral valvuloplasty was completed successfully in 136 (93 percent) of the patients in whom the procedure was attempted; it resulted in an increase in the mean (±SD) mitral-valve area from 1.0±0.4 to 2.1±0.9 cm2 and a decrease in the mean transmitral pressure gradient from 14±5 to 6±3 mm Hg (P<0.001 for both comparisons). The estimated overall five-year survival rate was 76±5 percent, and the estimated five-year event-free survival rate (the percentage of patients without mitral-valve replacement, repeat valvuloplasty, or death from cardiac causes) was 51±6 percent. According to multivariate Cox proportional-hazards analysis, the independent predictors of longer event-free survival were a lower mitral-valve echocardiographic score (a measure of mitral-valve deformity; range, 0 for a normal valve to 16 for a seriously deformed valve; P<0.001), lower left ventricular end-diastolic pressure (P = 0.001), and a lower New York Heart Association (NYHA) functional class (P = 0.04). Patients with no risk factors for early re-Stenosis or only one risk factor (echocardiographic score >8, left ventricular end-diastolic pressure >10 mm Hg, or NYHA functional class IV) had a predicted five-year event-free survival rate of 60 to 84 percent, whereas patients with two or three risk factors had a predicted five-year event-free survival rate of only 13 to 41 percent.
Conclusions.
Balloon mitral valvuloplasty as a treatment for selected patients with mitral stenosis has good long-term results. The long-term outcome after this procedure can be predicted on the basis of patients' base-line characteristics. (N Engl J Med 1992;327:1329–35.)
Media in This Article
Figure 1
Kaplan–Meier Estimates of Total and Event-free Survival among 146 Patients in Whom Balloon Mitral Valvuloplasty Was Attempted.Table 1
Base-Line Characteristics of 146 Patients in Whom Balloon Mitral Valvuloplasty Was Attempted.*Article Activity
- Article
PERCUTANEOUS balloon mitral valvuloplasty was originally introduced as an alternative to surgical mitral commissurotomy or valve replacement for the treatment of mitral stenosis.1 , 2 Previous studies have demonstrated marked immediate improvement in hemodynamic measures and symptoms after balloon mitral valvuloplasty,3 4 5 6 even in patients with calcification of the mitral valve7 or severe pulmonary hypertension.8 Although comparisons of balloon mitral valvuloplasty with surgical mitral commissurotomy have shown similar immediate and short-term hemodynamic results,9 the long-term results of balloon mitral valvuloplasty have not been compared with those of the standard surgical procedures. Serial studies have demonstrated that hemodynamic evidence of valvular re-Stenosis develops in 15 to 50 percent of patients within two years after balloon mitral valvuloplasty, but most patients have continued clinical improvement well beyond two years.10 , 11 Selected subgroups of patients, however, may be at greater risk for clinical re-Stenosis, which can lead to recurrent symptoms, the need for mitral-valve replacement, or death.10 11 12 13 14 15 The purpose of this study was to identify predictors of long-term event-free survival after balloon mitral valvuloplasty and thus to define the subgroups of patients most likely to derive long-term benefit from this procedure.
Methods
Study Population
Between October 1, 1985, and October 1, 1991, we attempted percutaneous balloon mitral valvuloplasty in 146 patients with symptomatic mitral stenosis, including 18 for whom the initial results have previously been reported.3 The base-line clinical and echocardiographic characteristics of the study population are summarized in Table 1Table 1
Base-Line Characteristics of 146 Patients in Whom Balloon Mitral Valvuloplasty Was Attempted.*. All patients had symptomatic heart failure (94 percent were in New York Heart Association [NYHA] class III or IV at the time of the procedure); 39 percent were considered to be at increased risk from cardiac surgery (i.e., they were more than 70 years of age, had important coexisting conditions including cardiac disease, or had previously undergone aortic-valve replacement). Patients with more than moderate mitral regurgitation or echocardiographic evidence of left atrial thrombus were not considered to be candidates for balloon mitral valvuloplasty. No patient was excluded on the basis of valvular calcification or morphologic features.Mitral-Valvuloplasty Procedure
The technique of balloon mitral valvuloplasty has been previously described.3 Informed consent was obtained in accordance with a protocol approved by the Committee for Clinical Investigations of Beth Israel Hospital. Most patients (75 percent) were treated with warfarin sodium for six weeks before the procedure. Balloon mitral valvuloplasty was combined with balloon aortic valvuloplasty in six patients and with coronary angioplasty in one patient.
Dilation of the mitral valve was performed by the transseptal approach with a single 25-mm balloon (Mansfield Scientific, Waltham, Mass.) in 102 patients and by a double-balloon technique16 with a combination of 18-mm and 20-mm balloons in 36 patients (in 8 patients, the procedure was terminated before balloon dilation). Double-balloon dilation was performed only if single-balloon dilation failed to reduce the transmitral pressure gradient by 50 percent. Complete hemodynamic measurements of the right and left heart, including simultaneous left atrial and left ventricular pressure recordings, were made immediately before and after valvuloplasty. Cardiac output was determined by the Fick method, and oxygen consumption was measured with a metabolic-rate meter (Waters Instruments, Rochester, Minn.). After valvuloplasty, a screening right-heart oximetry series was performed to check for a residual left-to-right shunt after perforation of the interatrial septum; a full oximetry series was performed if an increase of 7 percent or more in oxygen saturation was detected between the superior vena cava and the pulmonary artery.17 A pulmonary-to-systemic flow ratio of 1.2 or higher was considered evidence of clinically important left-to-right shunting.
Echocardiographic Evaluation
Two-dimensional and Doppler echocardiography was performed 24 hours before valvuloplasty and 24 to 48 hours after the procedure in 140 patients. Beginning in November 1989, transesophageal echocardiography was also performed before valvuloplasty to exclude the presence of left atrial thrombus. The degree of mitral regurgitation (determined by pulsed Doppler echocardiography, color-flow Doppler echocardiography, or both) was graded as none, mild, moderate, or severe.18 The morphologic features of the mitral valve were categorized according to a semiquantitative echocardiographic score, as described by Wilkins et al.19 Each echocardiogram was reviewed by a blinded observer and evaluated with respect to valvular mobility, thickening, and calcification and subvalvular thickening, and a score was assigned for each feature on a scale ranging from 0 (normal) to 4 (severely deformed). The four scores for each patient were added to obtain the overall mitral-valve echocardiographic score (range, 0 to 16).
Clinical Follow-up
Clinical follow-up data were obtained 6 and 12 months after valvuloplasty and at 1-year intervals thereafter, either during patients' visits to the clinic or by telephone interviews with the patients, their referring physicians, or both. Causes of death were ascertained from patients' medical records and their attending physicians. The average length of follow-up (available for 99 percent of the patients) was 36±20 months (range, 2 to 69).
Statistical Analysis
All data are reported as means ±SD; a P value of less than 0.05 was considered to indicate statistical significance. Discrete data were compared by chi-square analysis, and continuous data were compared with use of Student's two-tailed t-test. Kaplan–Meier estimates20 were used to determine total survival and event-free survival (defined as the absence of mitral-valve replacement, repeat balloon mitral valvuloplasty, or death from cardiac causes). When the cause of death was noncardiac (five patients), data on the patient were censored from the analysis of event-free survival at the time of death. Survival analysis was based on all 146 patients in whom the procedure was attempted.
Twenty-four demographic, hemodynamic, echocardiographic, and procedural variables were evaluated by Cox proportional-hazards regression21 to identify predictors of event-free survival. Significant continuous univariate predictors of event-free survival were selected for categorical analysis, and clinically reasonable cutoff points were chosen to define subgroups for comparison with the log-rank statistic. For each categorical variable, unadjusted hazard ratios were calculated with the subgroup with the most favorable characteristic or value as the reference category, and Cox probabilities of event-free survival were estimated at one, two, three, four, and five years after balloon valvuloplasty. The hazard ratios from the Cox analysis were used as estimates of relative risk.
To identify independent predictors of event-free survival, multiple stepwise Cox regression analysis was performed with significant explanatory variables from the continuous univariate analysis. The assumption of proportional hazards for the final Cox models was confirmed graphically.22 Two models were constructed: the first based only on the independent base-line (preprocedural) variables, and the second based on expanded data including procedural and postprocedural variables. All final models were tested for two-way and three-way interactions. From these multivariate models, event-free survival one, two, three, four, and five years after balloon valvuloplasty was estimated for subgroups defined according to the independent variables.
Results
Immediate Results
Balloon mitral valvuloplasty was completed successfully in 136 (93 percent) of the 146 patients in whom it was attempted; it resulted in substantial increases in the mitral-valve area (from 1.0±0.4 to 2.1±0.9 cm2) and cardiac output (from 4.4±1.3 to 5.1±1.6 liters per minute) and decreases in the mean transmitral pressure gradient (from 14±5 to 6±3 mm Hg), the mean pulmonary-artery pressure (from 39±14 to 31±12 mm Hg), and the mean left atrial pressure (from 25±6 to 16±6 mm Hg) (P<0.001 for all comparisons). The degree of mitral regurgitation on echocardiography was unchanged in 77 (58 percent) of the 132 patients who underwent echocardiography after the procedure, increased by 1 in 37 patients (28 percent), increased by 2 in 5 patients (4 percent), and decreased in 13 patients (10 percent). One hundred twenty-four patients (91 percent of those in whom the procedure was successfully completed) had symptomatic improvement of at least one NYHA class after the procedure.
In-Hospital Course
The balloon-mitral-valvuloplasty procedure was terminated before completion in 10 patients, either because of complications (6 patients) or because it was not possible to perform transseptal catheterization (4 patients). There were major complications in 11 patients (8 percent), five of which occurred after dilation of the valve. Six patients had cardiac perforation with tamponade; two had perforation of the left ventricle by the guide wire and four had perforation of the atrium during transseptal catheterization. Of the six patients with perforation, one died and four were treated successfully by pericardiocentesis followed by operative repair of the perforation and emergency mitral-valve replacement; the sixth patient was treated with pericardiocentesis alone and underwent successful balloon mitral valvuloplasty at a later date. Cerebrovascular accidents occurred in three patients; two had transient neurologic deficits that resolved before hospital discharge, and one had a stroke with residual hemiparesis. Severe mitral regurgitation developed in two patients after valvuloplasty and required mitral-valve replacement before hospital discharge. Pretreatment with warfarin for at least six weeks in 110 patients (75 percent) did not affect the incidence of major or embolic complications.
Clinical Follow-up
Follow-up data for a period averaging 36±20 months were available for 145 of the 146 patients (99 percent) in whom balloon valvuloplasty was attempted. There were 25 deaths from cardiac causes (19±15 months after balloon valvuloplasty) and 5 deaths from other causes (3 due to severe chronic obstructive pulmonary disease, 1 due to lung cancer, and 1 due to massive pulmonary embolism). Among the patients in whom the procedure was completed, 24 (18 percent) had a recurrence of symptoms, which necessitated repeat balloon mitral valvuloplasty in 6 (30±16 months after the initial valvuloplasty) and mitral-valve replacement in 18 (18±14 months after balloon valvuloplasty). Overall, 92 patients (63 percent) were alive without further cardiac intervention 38±19 months after attempted balloon mitral valvuloplasty. At the last follow-up contact, 88 of these 92 patients (96 percent) were in NYHA class I or II. The estimated overall survival rate was 88 percent at two years (95 percent confidence interval, 82 to 94 percent) and 76 percent at five years (95 percent confidence interval, 66 to 86 percent). The probability of event-free survival at two years was 74 percent (95 percent confidence interval, 66 to 82 percent) and 51 percent at five years (95 percent confidence interval, 40 to 63 percent) (Fig. 1Figure 1
Kaplan–Meier Estimates of Total and Event-free Survival among 146 Patients in Whom Balloon Mitral Valvuloplasty Was Attempted.).Predictors of Event-free Survival
The continuous univariate Cox analysis identified numerous clinical, morphologic, hemodynamic, and procedural variables as potential predictors of long-term event-free survival after balloon mitral valvuloplasty. Direct univariate predictors of long-term event-free survival included the base-line mitral-valve area and cardiac output, the effective balloon-dilating area,23 and the mitral-valve area and the increase in the mitral-valve area after valvuloplasty. Other univariate predictors of event-free survival included age, NYHA functional class, the extent of coronary disease, the base-line left ventricular end-diastolic pressure, the mitral-valve echocardiographic score, the degree of mitral regurgitation at base line, and the transmitral pressure gradient after valvuloplasty. Sex, cardiac rhythm, previous commissurotomy, the base-line pulmonary-artery and left atrial pressures, and the mean base-line transmitral pressure gradient were not significant predictors of long-term outcome. For selected univariate predictors, clinically reasonable categories were identified, and the predicted rates of event-free survival for subgroups defined according to these variables were estimated at yearly intervals (Table 2Table 2
Categorical Predictors of Event-free Survival after Balloon Mitral Valvuloplasty, According to the Univariate Analysis.*).In the stepwise multivariate Cox analysis of baseline variables, the independent predictors of longer event-free survival were a lower mitral-valve echocardiographic score (P<0.001), lower left ventricular end-diastolic pressure (P = 0.001), and a lower NYHA functional class (P = 0.04). Estimates of event-free survival based on these variables (Table 3Table 3
Estimated Event-free Survival According to Base-Line Clinical, Morphologic, and Hemodynamic Characteristics, from the Multivariate Analysis.*) demonstrated that balloon mitral valvuloplasty provided excellent long-term freedom from clinical re-Stenosis (84 percent at five years) in patients with mitral-valve echocardiographic scores ≤8 and left ventricular end-diastolic pressures ≤10 mm Hg who were in NYHA class II or III at base line. Patients with only two of these three favorable predictive factors had a moderately high probability (60 to 72 percent) of long-term freedom from clinical re-Stenosis, whereas patients with none or one of these characteristics appeared to derive only limited long-term benefit from balloon mitral valvuloplasty (event-free survival at five years, 13 to 41 percent).When hemodynamic variables measured after the procedure were included in the multivariate analysis (Table 4Table 4
Estimated Event-free Survival According to Base-Line and Postprocedural Characteristics, from the Multivariate Analysis.*), the final mitral-valve area (P = 0.01) emerged as a strong independent predictor of long-term outcome, displacing the NYHA class (from the model including only base-line variables). According to this expanded model, patients with either a low echocardiographic score or a low left ventricular end-diastolic pressure and a final mitral-valve area ≥2.0 cm2 had a 66 to 88 percent probability of freedom from clinical re-Stenosis at five years. In contrast, among similar patients with a postprocedure mitral-valve area <2.0 cm2, the predicted five-year event-free survival was only 39 to 74 percent. Although the predictive model based only on base-line variables may be more useful in deciding whether a patient is likely to benefit from balloon mitral valvuloplasty, the model incorporating postprocedural variables provides the best indication of subsequent prognosis.Discussion
In our study, balloon mitral valvuloplasty was performed successfully in 93 percent of patients in whom it was attempted and produced immediate symptomatic improvement in 91 percent. After the procedure, the overall five-year survival rate was 76 percent, with a five-year event-free survival rate of 51 percent. Multivariate analysis of the results according to base-line variables identified three independent predictors of long-term event-free survival: the mitral-valve echocardiographic score (which reflects the morphologic features of the valve), the left ventricular end-diastolic pressure, and the base-line NYHA functional class. When the sample was stratified according to these preprocedural variables, freedom from clinical re-Stenosis at five years varied widely (from 13 to 84 percent).
The finding that the mitral-valve echocardiographic score was the strongest independent predictor of long-term benefit after balloon mitral valvuloplasty is not surprising. Many investigators have identified echocardiographic measures of mitral-valve thickening, mobility, and calcification as important predictors of the immediate results of balloon mitral valvuloplasty.5 , 24 25 26 A higher mitral-valve echocardiographic score (reflecting unfavorable structural and functional characteristics) has been associated with more rapid progression of mitral stenosis in medically treated patients27 and predicts early hemodynamic re-Stenosis and cardiac events in patients treated with balloon mitral valvuloplasty.10 11 12 13 14 Finally, mitral-valve calcification and immobility that are visible during the procedure are strongly associated with reduced event-free survival after surgical mitral commissurotomy.28 29 30 31 32 33
The independent associations of the base-line NYHA functional class and the left ventricular end-diastolic pressure with event-free survival after balloon mitral valvuloplasty have not been previously described. Many studies, however, have demonstrated a relation between the base-line NYHA functional class and both long-term functional status and survival after mitral commissurotomy,28 , 30 , 33 whereas left ventricular end-diastolic pressure has been shown to be an important predictor of survival after mitral-valve replacement.34 , 35
Our statistical model incorporating postprocedural variables identified the mitral-valve area after balloon valvuloplasty as an additional independent predictor of long-term event-free survival. Among patients with an excellent immediate result (postprocedural mitral-valve area, ≥2.0 cm2), however, stratification according to the other independent predictors of outcome yielded a wide range of expected five-year event-free survival rates (from 30 to 88 percent). These findings suggest that long-term outcome after balloon mitral valvuloplasty is not solely a function of the adequacy of the initial balloon commissurotomy but may also be influenced by other independent factors: progression of valvular fibrosis and calcification leading to progressive renarrowing (as predicted by the echocardiographic score) and progression of coexisting cardiovascular disease (as reflected by the left ventricular end-diastolic pressure and the NYHA functional class).
Recent studies of surgical commissurotomy have demonstrated overall 5-year survival rates of 90 to 96 percent and event-free survival rates of 72 to 94 percent at 5 years and 66 to 80 percent at 10 years.29 , 30 , 33 , 36 37 38 Differences in patient selection, however, make it difficult to make direct, unadjusted comparisons of the results after balloon mitral valvuloplasty and surgical commissurotomy. Most studies of either open or closed mitral commissurotomy have enrolled young patients with pliable mitral leaflets, minimal valvular calcification, little or no subvalvular disease, and little other important cardiac disease.33 , 36 , 39 Additional selection bias has been introduced by intraoperative decisions to change the surgical approach from commissurotomy to mitral-valve replacement if the morphologic features of the valve appear unfavorable.29 , 32 , 36 In contrast, in our study balloon mitral valvuloplasty was performed in a spectrum of patients, many of whom were considered to be poor candidates for surgery, with survival analysis performed on an intention-to-treat basis.
The long-term results after balloon mitral valvuloplasty are strongly influenced by base-line patient characteristics. In this study, patients with echocardiographic scores ≤8, left ventricular end-diastolic pressures ≤10 mm Hg, and symptoms placing them in NYHA class II or III had a predicted five-year event-free survival of 84 percent after balloon mitral valvuloplasty — a rate similar to that expected after surgical commissurotomy. Considering the lower cost of balloon valvuloplasty and the lower morbidity associated with it, as compared with either surgical commissurotomy or mitral-valve replacement,9 balloon mitral valvuloplasty may be a reasonable initial treatment for this subgroup of patients.
Patients in this study who had low echocardiographic scores and either elevated left ventricular end-diastolic pressure or NYHA class IV symptoms had a predicted five-year event-free survival rate of 60 to 72 percent after the procedure. Although the symptom-free period after valvuloplasty is shorter than that expected after mitral-valve replacement,34 , 35 , 40 , 41 balloon mitral valvuloplasty may have several advantages in this subgroup of patients, including its lower initial cost, lower morbidity, and lower procedure-related mortality, as well as avoidance of the risks of subsequent anticoagulation requirements, thromboembolism, infection, and reoperation.42 , 43 Thus, deferring mitral-valve replacement for at least several years by performing balloon mitral valvuloplasty may be a reasonable approach in such patients, even though only moderate long-term benefit can be expected.
Patients with multiple risk factors for early re-Stenosis, however, have a poor long-term outcome after balloon mitral valvuloplasty. Although most such patients derive substantial short-term benefit from the procedure (predicted two-year event-free survival, 41 to 79 percent), patients in this group who are reasonably good candidates for surgery are probably best treated by mitral-valve replacement. For patients for whom mitral-valve replacement is not an option, balloon mitral valvuloplasty may still offer substantial short-term palliation.
The major limitation of this study was the lack of a randomized, case-matched control group, whether defined prospectively or retrospectively, treated by surgical commissurotomy or mitral-valve replacement. Although randomized trials of this type are ongoing, the long-term results may not be available for several years. Moreover, the use of single-balloon dilation in the majority of patients may limit the applicability of our results to patients treated with the double-balloon technique. Although some studies suggest that the double-balloon technique may result in a larger mitral-valve area after the procedure,44 most evidence suggests that the immediate and middle-term results of the techniques are similar.45 46 47 48 In our study, the effective balloon-dilating area did not independently affect the long-term results. In addition, we evaluated outcomes in terms of clinical events, rather than echocardiographic or catheterization data obtained at follow-up. Although such data might have improved our understanding of hemodynamic re-Stenosis, comparison of late results after surgical commissurotomy and balloon mitral valvuloplasty requires complete ascertainment of clinical end points49; in this study, clinical follow-up was available for 99 percent of the patients. Finally, balloon mitral valvuloplasty is a technically demanding procedure. Since procedural success and complication rates have been shown to vary with the experience of the operator,50 , 51 the encouraging results reported in this study may not be directly applicable to centers where the volume is lower.
Balloon mitral valvuloplasty is effective treatment in the long term for many patients with mitral stenosis. Long-term results after this procedure depend highly on base-line patient characteristics. For patients with favorable base-line characteristics, the long-term results after this procedure are similar to those expected after surgical commissurotomy. Patients with severe mitral-valve deformity derive limited long-term benefit from balloon valvuloplasty, and other treatments should be considered for such patients.
Source Information
From the Charles A. Dana Research Institute and the Harvard—Thorndike Laboratory of the Department of Medicine, Cardiovascular Division, Harvard Medical School and Beth Israel Hospital, Boston. Address reprint requests to Dr. Diver at the Cardiovascular Division, Beth Israel Hospital, 330 Brookline Ave., Boston, MA 02215.
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- Citing Articles (50)
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Igor F. Palacios, Dabit Arzamendi. (2012) Percutaneous Mitral Balloon Valvuloplasty for Patients with Rheumatic Mitral Stenosis. Interventional Cardiology Clinics 1:1, 45-61
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OSAMA RIFAIE, MOHAMED ISMAIL, WAIL NAMMAS. (2010) Immediate and Long-Term Outcome of Redo Percutaneous Mitral Valvuloplasty: Comparison with Initial Procedure in Patients with Rheumatic Mitral Restenosis. Journal of Interventional Cardiology 23:1, 1-6
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J.-K. Song, J.-M. Song, D.-H. Kang, S.-C. Yun, D. W. Park, S. W. Lee, Y.-H. Kim, C. W. Lee, M.-K. Hong, J.-J. Kim, S.-W. Park, S.-J. Park. (2009) Restenosis and adverse clinical events after successful percutaneous mitral valvuloplasty: immediate post-procedural mitral valve area as an important prognosticator. European Heart Journal 30:10, 1254-1262
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Mohamed Eid Fawzy, Mohamed Shoukri, Walid Hassan, Vijayaraghavan Nambiar, Miltiadis Stefadouros, Charles C. Canver,. (2007) The impact of mitral valve morphology on the long-term outcome of mitral balloon valvuloplasty. Catheterization and Cardiovascular Interventions 69:1, 40-46
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