(Circulation. 1999;99:1580-1586.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Long-Term Clinical and Echocardiographic Follow-Up After Percutaneous Mitral Valvuloplasty With the Inoue Balloon
From Unidad de Hemodinámica (R.H., C.B., F.A., J.G., A.F.-O., J.E., L.A., C.M.) and Servicio de Cardiologia (C.A.), Hospital Universitario San Carlos, Madrid, Spain.
Correspondence to Dr R. Hernandez, Unidad de Hemodinámica, Hospital Universitario San Carlos, C/Prof Martin Lagos s/n, Madrid 28040, Spain.
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Abstract |
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Background—The objective of this study was to assess the long-term clinical outcome and valvular changes (area and regurgitation) after percutaneous mitral valvuloplasty (PMV).
Methods and Results—After PMV, 561 patients were followed up for
39 (±23) months and clinical/echocardiographic data
obtained yearly. Kaplan-Meier and Cox regression analyses were
performed to estimate event-free survival, its predictors, and the
relative risks of several patient subgroups. There were several
nonexclusive events: 19 (3.3%) cardiac deaths, 55 (9.8%) mitral
replacements, 6 (1%) repeated PMVs, 56 (10%) cases of
restenosis, and 108 (19%) cases of clinical impairment.
Survival free of major events (cardiac death, mitral surgery, repeat
PMV, or functional impairment) was 69% at 7 years, ranging from 88%
to 40% in different subgroups of patients. Wilkins score was the best
preprocedural predictor of mitral opening, but the procedural result
(mitral area and regurgitation) was the only
independent predictor of major event-free survival. Mitral area loss,
though mild [0.13 (±0.21)cm2], increased with time and
was 
0.3 cm2 in 12%, 22%, and 27% of patients at 3, 5,
and 7 years, respectively. Regurgitation did not
progress in 81% of patients, and when it occurred it was usually by 1
grade.
Conclusions—Seven years after PMV, more than two thirds of patients were in good clinical condition and free of any major event. The procedural result was the main determinant of long-term outcome, although a high score had also negative implications. Mitral area decreased progressively over time, whereas regurgitation did not tend to progress.
Key Words: mitral valve • valvuloplasty • follow-up studies • restenosis • survival
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Introduction |
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Since its introduction in 1984 by Inoue,1 percutaneous mitral valvuloplasty (PMV) has emerged as a safe and effective procedure2 3 4 5 6 7 for the treatment of symptomatic mitral stenosis with immediate results that may be comparable to those of surgical commissurotomy. Although some series have provided long-term clinical data,8 9 10 11 12 13 14 15 very little information is available concerning longitudinal changes in mitral valve area (MVA) and regurgitation (MR) long after the procedure. The aim of the present study was (1) to describe and analyze long-term clinical results after PMV and (2) to provide new data on longitudinal changes in MVA and MR, not only in patients with a good procedural result but also in those with poor valvular opening or significant regurgitation.
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Methods |
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Patients
From 1989 to 1995, we performed 620 PMV procedures; in 8 (1.2%) cases no balloon inflation was performed (in 4 because of tamponade), 8 (1.2%) patients required in-hospital mitral surgery, and 3 (0.4%) died. Of the 601 patients discharged after a complete procedure, 40 were lost of follow-up. The remaining 561 (93% of eligible) were indeed followed up for 39 (±23) months (range 6 to 87) and are the subject of this report.
Procedure
PMV was performed with the Inoue balloon. Balloon size was
selected according to body surface area (26 mm if <1.5
m2, 28 mm if 1.5 to 1.7
m2, and 30 mm if >1.7
m2), modulated by anatomy (1 to 2 mm
smaller in unfavorable cases), and reached after several stepwise
inflations. Left ventriculography was performed before and after the
last balloon inflation.
Preprocedural and Postprocedural Assessments
Clinical status was determined by New York Heart Association
(NYHA) classification. All patients underwent an echo-Doppler study
before and 24 hours after PMV. Evaluation included Wilkins
scoring,16 MVA calculation (pressure half-time
method17 ), and MR estimation (graded as none, mild,
moderate, or severe by color-Doppler semiquantitative
method).18 With the purpose that MVA and MR would be
comparable over time, preprocedure, postprocedure, and follow-up data
were analyzed on the basis of echo-Doppler studies. If a
1 grade discrepancy on MR grading existed between left
ventriculography and Doppler, both studies were reviewed, the
color-Doppler study (transthoracic and
transesophageal) was repeated, and a consensus finally
was reached.
Follow-Up
Patients were scheduled for clinical and
echocardiographic follow-up in a monographic outpatient
clinic. The first visit was 6 months after PMV and yearly thereafter.
If a patient failed to keep any programmed visit, he or she or his or
her physician were encouraged to come back and/or send
clinical/Echo-Doppler reports performed elsewhere.
Definitions
Immediate results were defined as "good opening" when
post-PMV Doppler MVA was 1.5 cm2 and
regurgitation moderate or less; "insufficient
opening" when MVA <1.5 cm2 and
regurgitation moderate or less; and "severe
regurgitation" (irrespective of postprocedural area).
Clinical improvement after PMV was considered as 1 NYHA class and
class 
2. Follow-up functional impairment was considered as 1 NYHA
class and class 3. Major cardiac events were cardiac death, surgery,
repeat PMV, or functional impairment. Restenosis was defined as
loss of 50% of initial gain and MVA <1.5 cm2.
Significant area loss was defined as MVA loss 0.3
cm2.
Statistical Analysis
Data are presented as mean (±SD). A value of
P<0.05 was considered significant. Discrete data were
compared by 
2 analysis and continuous
data with the Student's 2-tailed t test. The RR for
non–time-related variables was determined by simple arithmetic
calculations, and the 95% CI was determined on the basis of the normal
distribution of the variable. A logistic regression model was
adjusted to determine independent predictors of immediate result, and a
linear regression model was used to predict MVA loss as a function of
time. Event-free survival rate for several single and composite end
points was estimated with the use of Kaplan-Meier
analysis.19 When death was noncardiac, data
on that patient were censored at the time of death. Survival curves for
different patient subgroups were compared with the use of the
Breslow exact statistic. With the assumption of proportional hazards,
the adjusted RR and CI (95%) was calculated from a Cox regression
model.20 To identify independent predictors of event-free
survival, statistically significant variables in the Cox
univariate analysis were selected and 2 models
constructed, the first based on baseline variables and the second
on preprocedural, intraprocedural, and postprocedural variables.
Several subgroups were defined according to these predictors, and
Kaplan-Meier curves were estimated in each subgroup. Adjusted RR was
calculated from the Cox regression model.
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Results |
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Baseline characteristics and initial results are displayed in Table 1
. The Inoue balloon
diameter was 28.4±2.2 mm, the effective balloon dilation
area/body surface area fraction was 3.9±0.2, and patients received a
mean of 2.2±1.1 inflations. Global result was summarized as good
results in 435 (78%), insufficient opening in 101 (18%), and severe
regurgitation in 25 (4%). Patients with good results
were younger (50 vs 55 years, P<0.05) and had a lower score
(7.3 vs 8.6, P<0.05) than those with insufficient opening.
By contrast, patients with severe
regurgitation were similar in age (49 vs 50 years, NS)
and score (7.4 vs 7.3, NS) than those with good results, but they had
an smaller pre-PMV MVA (0.84 vs 1.0 cm2,
P<0.05). RR of severe MR in subgroups of patients defined
according to baseline MVA and score is shown in Table 2.
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Follow-Up Events
Follow-up events were: (1) Death: 29 patients died, 10 (1.7%) of
noncardiac and 19 (3.3%) of cardiac causes (4 after mitral
replacement, 1 of prosthetic endocarditis, 3 of persistent
severe pulmonary hypertension after successful PMV, and 11 of
heart failure; (2)Mitral replacement: 55 (9.8%) patients underwent
surgery indicated by poor result in 13, MR in 21, a combination of both
in 14, and restenosis in 7; (3) Repeat PMV: 6 procedures in 5
patients; (4)Restenosis: 56 (10%) patients met
restenosis definition, but only 30 were in class 3; (5)
Functional impairment occurred in 108 patients; 60 underwent invasive
procedures, and 48 did not, 11 because clinical condition was thought
to be secondary to severe pulmonary hypertension and 37 because
of surgical high risk; 10 of these 48 patients died. Event-free
survival curves for several end points are presented in Figure 1.
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Echocardiographic and Clinical Data During
Follow-Up
Echocardiographic and clinical data during
follow-up are displayed in Table 1
.
MVA Loss During Follow-Up
For analysis of MVA loss, only patients with follow-up 1
year (n=480) were included. Because Doppler MVA determined early
after PMV is not accurate enough because of acute changes in left
atrial compliance, we considered the Doppler MVA determined at 6
months (when hemodynamic conditions are already stable)
as baseline. MVA loss was variable, with a mean of 0.13 (±0.21)
cm2, and was remarkably similar in all score
subgroups (Table 3). It was clearly time
related (Figure 2) and consequently, the
rate of patients with significant MVA loss (0.3
cm2) increased from 12% to 22% and 27% at 3,
5, and 7 years, respectively. None of the baseline characteristics were
able to predict area loss, being that postprocedural MVA (larger area,
larger loss, P=0.020) and follow-up duration
(P=0.001) were the only independent predictors.
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MR During Follow-Up
MR did not change significantly during follow-up for the whole
population, and if severe, it remained unchanged. When
regurgitation was not severe, it increased by 1 grade
in 114 (20%) and decreased in 77 (14%), usually from mild to moderate
and vice versa. In 14 (3%) patients there was a well-documented 2
grade increase in MR severity, usually progressive over time;
surprisingly, 8 patients had a 2-grade decrease in MR.
Predictors of Event-Free Survival
Several variables (age, sex, cardiac rhythm, previous
commissurotomy, score, balloon size, and postprocedural MVA and MR)
were tested as potential predictors of event-free survival by
continuous univariate Cox analysis, and significant
variables were categorized (Table 4).
On multivariate analysis and considering only
baseline variables, score (P=0.0021) was found to have
an independent value. When preprocedural, intraprocedural, and
postprocedural variables were included in the
multivariate analysis, only post-PMV MVA
(P=0.0000) and MR (P=0.0000) were independent
predictors. Several subgroups of patients were established according to
independent predictors (MVA and MR) and the best preprocedural
predictor (score) of event-free survival (Figure 3). A single cut-off point was
established: 1.5 cm2 for MVA and 8 for score. In
the case of MR, given that Kaplan-Meier curves for mild and moderate MR
tended to converge after 3 years (Figure 4), subgroups were none/mild/moderate and
severe MR.
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To explore the impact of score in major event-free survival, curves for
4 score ranges were constructed (Figure 5). Each score component was also
individually analyzed (1 to 2 vs 3 to 4). Kaplan-Meier curves
were not different in the case of flexibility and subvalvular
components of the score, whereas a high score for thickening (74% vs
68% at 7 years, P=0.020) and calcification (71% vs 54% at
7 years, P=0.001) had a significant impact on event-free
survival.
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Predictors of Restenosis
Because restenosis was not considered a major event, we
estimated the restenosis-free survival rate (Figure 1).
Potential predictors were tested, but only score (P=0.0002)
was found to have an independent value. Since postprocedural MVA was
not a predictor of restenosis as a continuous variable,
several cut-off points were explored, and an MVA 1.8
cm2 was found to be a negative predictor of
restenosis (P=0.0009) better than score 8
(P=0.0018).
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Discussion |
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Our report involves PMV in a population with a majority of middle-age women with pliable valves, although patients with a less favorable profile were also present. This series of Inoue balloon procedures is large and homogeneous, and follow-up was universal regardless of procedural result. The information provided on longitudinal changes in MVA and regurgitation is new and may contribute to our current understanding of post-PMV mitral disease progression.
Immediate Results
Procedural result was summarized as good in 78% of cases, 18%
had insufficient opening, and 5.7% (4.5% in these series plus 1.2%
who required in-hospital surgery), had severe MR. Clinical improvement
was the rule for patients with good results, frequent in those with
insufficient opening, and still possible in some with severe
regurgitation. As reported by
others,3 5 6 7 8 9 10 mitral anatomy was the best
predictor of mitral opening, though a good result could also be
obtained in cases with high score.
Some increase in regurgitation was frequent, but severe MR was a rather unexpected complication21 22 23 24 of PMV, although Padial et al25 have recently reported that dissimilarities in valve thickening, commissural calcification, and severe subvalvular involvement were associated with a higher risk. We found that a very tight stenosis was also a risk factor, particularly when associated with a low score. Changes in procedural indication (earlier interventions while MVA is still >1.0 cm2) and performance (smaller balloons in patients at high risk) might contribute to a rate reduction of severe MR rate.
Progression of MR
Severe MR after PMV (usually caused by a leaflet
tear23 ) persists unchanged during follow-up, and 60% of
patients required mitral replacement. When MR was mild or moderate
(originated at the split commissure26 ), it did not tend to
progress in the population as a whole, although it appeared to increase
by 1 grade in 20% and decrease in 14% of patients. We believe that
many 1-grade variations in MR severity might be caused by interobserver
variability of the method rather than in the
regurgitation in itself because 1-grade variations
either way were frequently observed. Interestingly, long-term outcome
tended to be similar to that of patients with nonsignificant MR
Clinical implications of truly stable, moderate
regurgitation requires further investigation in
long-term studies.
Longitudinal Changes in MVA
Disease progression in rheumatic mitral disease may be the result
of low-grade subclinical rheumatic process and/or abnormal turbulences
generated by the already deformed valve.27 Both mechanisms
might contribute to further commissural fusion, thickening, and
calcification of valvular and subvalvular structures
both in natural and previously commissurotomized valves. In a study of
native mitral valves, Sagie et al27 reported an MVA loss
of 0.09 cm2/y and found that patients with aortic
insufficiency experienced a more accelerated area loss probably related
to the stress caused by the aortic regurgitation jet.
In another study, Gordon et al28 reported a similar pace
of MVA loss (0.09 cm2/y) that accelerated in
valves with a high score. In a post-PMV series, Chen et
al12 reported an MVA decrease of 0.2
cm2 at 5 years and Treviño et
al10 reported 0.25 cm2 at 3 years.
In our series, although scattering was wide, MVA decreased 0.2
cm2 at 7 years (smaller than that reported in
untreated valves) and was not influenced by score; nevertheless,
because patients with a high score obtained smaller areas, they might
have been operated on before a large MVA loss had occurred.
Restenosis is an ambiguous term that includes a mixture of poor result, inaccuracies in MVA determination, very early (within days) area loss, true restenosis, and disease progression. Its definition can be made on a clinical basis or in terms of mitral area, absolute area loss, % of area loss, or loss of gain. With all these confounding factors, it is not surprising that restenosis rate after PMV has ranged from 3% to 70%9 10 at 1 to 3 years, and restenosis definition in itself may play a major role in restenosis rate. When restenosis is defined as a 50% loss of area gain, patients with a poor initial result meet restenosis criteria with only a mild area loss. This fact explains the apparent contradictory finding that patients with a high score had a smaller mitral area loss but a higher restenosis rate that those with a lower score. On the other hand, very early restenosis (within weeks), caused by a mixture of annular and/or valvular recoil and methodological aspects of MVA calculation, should be differentiate from late, true restenosis. Our data support the fact that restenosis is rare within 3 years of the procedure in patients with a good mitral opening, but it increased over time, reaching 39% at 7 years, although not always associated with clinical impairment. Whether restenosis rate at 3 to 10 years after PMV is similar to that reported after surgical commissurotomy remains unclear, but differences in baseline characteristics might justify a different pace of progression in valvular disease.
Event-Free Survival
Patients with good result have a good prognosis. An unsatisfactory
late outcome might be due to a mixture of poor result,
regurgitation, restenosis, pulmonary
hypertension, polyvalvular disease, or left
ventricular dysfunction. Cardiac death during follow-up was
due to heart failure in nonoperated patients and to postoperative death
in surgical ones. Mitral replacement was required by 15% of patients
at 7 years, and its indication was more frequently a poor result rather
than progression of mitral disease. Repeated PMV was an option in
selected patients with mitral restenosis, but otherwise mitral
replacement would be recommended. Long-term event-free survival has
been reported by others investigators. Cohen et al11 found
a 51% event-free survival at 6 years in 146 patients (mean age 59
years, score 7.7). Pavlides et al14 reported an event-free
survival rate of 85% at 3 years in 128 patients (mean age 60 years,
score 8.6). Dean et al15 from the National Heart, Lung,
and Blood Institute registry (736 patients, mean age 54 years)
described an event-free survival of 60% at 4 years, and Jung et
al13 (528 patients with successful procedures, mean age 46
years) described a rate of 76% at 5 years. In our series, the
event-free survival was 69% at 7 years and confirms the long-term
beneficial effect of PMV. It is important to emphasize that patients
with good results and low score (63% of the population undergoing PMV
in our center) had a very high probability (88%) of being event free
at 7 years. On the other hand, those with less favorable baseline
characteristics or poorer results had an event-free survival rate
between 55% and 72%, provided no severe MR had occurred. In such
cases, 60% of patients will require mitral replacement within 3 years.
That simple postprocedural assignment into 3 subgroups with good,
intermediate, or poor prognosis may be useful.
Comparison With Surgical Series
Immediate results appear to be very similar29 30 31 32 to
closed surgical commissurotomy as reported by Arora et
al29 in a prospective randomized study of very young (mean
age 19 years) patients and Raghaba et al30 in older
patients. The only long-term though relatively small (30 patients in
each group) randomized study comparing surgical closed, open, and
percutaneous commissurotomy has been recently published
by Farhat et al33 in a young population with pliable,
noncalcified valves. The 7-year results were better for open and
percutaneous procedures than for closed commissurotomy
as assessed by a higher event-free survival (93%, 90%, and 50%,
respectively), a better mitral area (1.8, 1.8, and 1.3
cm2 and a lower restenosis rate (6%,
6%, and 37%).
In long-term surgical series,34 35 36 37 38 Hickey et al34 reported on 103 patients with closed commissurotomy (mean age 38 years) a mitral replacement rate of 22% at 10 and 53% at 20 years; Rhial et al35 reported on 267 patients (mean age 43 years) a replacement rate of 43% and 76% at 10 and 20 years. In our series and others,39 even if patients have a poorer baseline clinical profile (many not even have been candidates for commissurotomy should open heart surgery be performed), mitral replacement rate was not worse than that of surgical series at least by the seventh year. Nevertheless, longer follow-up periods are needed for making such a conclusion.
Conclusions
PMV is a safe and effective procedure for patients with mitral
stenosis. Patients with a good score obtain better initial and
long-term results, but those with a less favorable profile may still
have sustained hemodynamic and symptomatic
relief. The decrease in MVA, although mild in most patients, was
progressive over time, whereas regurgitation tend to be
stable.
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Acknowledgments |
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We thank Dr Cristina Fernandez for statistical support.
Received July 30, 1998; revision received December 7, 1998; accepted December 18, 1998.
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