(Circulation. 1995;91:671-676.)
© 1995 American Heart Association, Inc.
Articles |
Clinical Follow-up of Patients Undergoing Percutaneous Mitral Balloon Valvotomy
From the Department of Medicine (Cardiac Unit), Massachusetts General Hospital, Harvard Medical School, Boston, Mass.
Correspondence to Igor F. Palacios, MD, Director of Interventional Cardiology, Massachusetts General Hospital, Boston, MA 02114.
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Abstract |
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 Top Abstract IntroductionMethods Results Discussion References |
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Background This study is the clinical follow-up (20±12 months; range, 6 to 49 months) of 327 patients who had percutaneous mitral balloon valvotomy (PMV) at the Massachusetts General Hospital.
Methods and Results There were seven in-hospital deaths. Patients
were divided into two groups according to their echocardiographic
score; 211 patients had echocardiographic scores 
8 and 116,
echocardiographic scores >8. Patients with echocardiographic scores
>8 were older (64±11 versus 48±14 years, P<.01),
and
more had atrial fibrillation (65% versus 40%, P<.01),
calcium under fluoroscopy (81% versus 29%, P<.01), and
previous surgical commissurotomy (30% versus 16%, P<.01)
than patients with echocardiographic scores 8. With PMV, mitral valve
area increased from 1.0±0.3 to 2.2±0.8 cm2 in
patients
with echocardiographic scores 8 and from 0.8±1 to 1.7±0.7
cm2 in those with echocardiographic scores >8. Rates of
survival (98±2% versus 72±11%), survival with freedom from
mitral
valve replacement (91±4% versus 55±13%), and survival with
freedom
from combined events (79±10% versus 39±18%) at follow-up were
greater in patients with echocardiographic scores 8
(P<.00005). Cox regression analysis identified the
echocardiographic score as the most important unfavorable intermediate
long-term follow-up prediction factor after PMV.
Conclusions The excellent intermediate long-term clinical
follow-up of patients with echocardiographic score 8 and no calcified
mitral valves suggests that PMV may be the treatment of choice in this
group of patients.
Key Words: stenosis • mitral valve • follow-up studies
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Introduction |
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TopAbstractIntroductionMethods Results Discussion References |
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Percutaneous mitral balloon valvotomy (PMV) has been accepted as an alternative to surgical mitral commissurotomy in the treatment of patients with symptomatic rheumatic mitral stenosis. PMV produces good immediate hemodynamic and clinical improvement in the majority of patients with mitral stenosis.1 2 3 4 5 6 7 8 9 10 Although PMV is a relatively new technique, follow-up studies after PMV are encouraging.11 12 13 14 15 16 17 18 In the present study, we report the intermediate long-term clinical follow-up (mean 20±12 months) of 327 patients who underwent PMV at the Massachusetts General Hospital.
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Methods |
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TopAbstractIntroductionMethods Results Discussion References |
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Patient Population
Three hundred twenty-seven patients underwent PMV at the Massachusetts General Hospital between July 1986 and October 1989. Two patients died during PMV, and 5 patients died within 1 week of PMV. The remaining 320 patients were followed up for 20±12 (mean±SD; range, 6 to 49) months. There were 262 women and 58 men; mean age was 54±1 (range, 14 to 87) years.
Patients were divided into two groups by an
echocardiographic
score,19 20 which was obtained by a relatively
simple,
semiquantitative grading of leaflet thickening, mobility,
calcification, and subvalvular involvement on a scale of 0 to 4 as
described.19 20 Two hundred eleven patients had
echocardiographic scores 8, and 116 had echocardiographic scores >8.
Table 1
shows the baseline characteristics of these two
groups. Patients with echocardiographic scores >8 were older, had a
lower female/male ratio, and more frequently had atrial fibrillation,
calcified mitral valves under fluoroscopy, and previous surgical mitral
commissurotomy.
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Technique of PMV
PMV was performed in the fasting state under
local anesthesia
and mild sedation. Prophylactic antibiotics were given for 24 hours
starting 12 hours before PMV, which was performed using the transseptal
antegrade technique as described.2 3 21
The single-balloon
technique was used in 27 patients and the double-balloon technique in
300 patients. After February 1988, balloon size was chosen with respect
to body surface area.22 Left atrial pressure, left
ventricular pressure, and cardiac output were measured simultaneously
before and immediately after PMV. The corresponding pre- and post-PMV
mitral valve areas were calculated. Complete right and left heart
catheterization and oximetry studies were performed before and after
PMV to evaluate the changes in hemodynamics produced by PMV and the
presence and degree of left-to-right shunting through the created
atrial communication. Cardiac output was measured by thermodilution
technique. Blood samples were obtained from the superior vena cava,
pulmonary artery, and aorta before and after the procedure in all
patients. A diagnosis of left-to-right shunting through the created
atrial communication was made when there was a 
7% step up between
superior vena cava and pulmonary artery samples in repeated samples. In
the patients with severe tricuspid regurgitation and/or left-to-right
shunt, cardiac output was measured by using the Fick principle. Oxygen
consumption was measured using an MRM-2 oxygen consumption monitor
(Waters Instrument Inc). Significant tricuspid regurgitation was
diagnosed by clinical, Doppler echocardiographic, and hemodynamic
findings. Finally, cine left ventriculography (45° right anterior
oblique projection) was performed to assess the presence and severity
of mitral regurgitation.
Follow-up Studies
Patients were followed up for 20±12
(6 to 49) months after PMV.
End points of follow-up were death, mitral valve replacement (MVR), and
clinical evaluation according to the New York Heart Association (NYHA)
functional classification of congestive heart failure. Clinical
evaluation was performed by direct or telephone interview of the
patient. The interviewer was masked to the echocardiographic score and
immediate outcome of PMV. All patients had their status checked within
2 months of the initial submission of this article. From the total
population, 3.8% of the patients had follow-up at least up to 4 years,
11% at least up to 3 years, 33% at least up to 2 years, 68% at least
up to 1 year, and 94% at least up to 6 months.
Estimated actuarial
survivorship and rates of actuarial survival with
freedom from MVR and survival with freedom from combined events (death,
MVR, and NYHA class III or IV) were created. Curves were constructed
for the whole group and for the subgroups of patients with
echocardiographic scores 8 and >8. Predictors of each event and
combined events were determined by using Cox regression analysis.
Candidate predictor variables included in the analysis were sex,
age, pre-PMV NYHA class, presence of fluoroscopic calcium, atrial
fibrillation, history of previous surgical mitral commissurotomy,
echocardiographic score, and pre- and post-PMV mitral valve areas.
Comparison between actuarial survival rates for patients with
echocardiographic scores 8 and >8 was performed by using the
Mantel-Cox test. A similar test was conducted for rate of survival with
freedom from events.
Data on the valvotomy patients were prepared with
RS/1
data management and analysis software23 running on a
Digital Equipment Corp micro VAX 3600. Actuarial survival analysis
was performed with the BMDP survival analysis
program24 using the RS/1 interface to
BMDP provided in RS/1. Survival functions
by groups according to echocardiographic scores (8 and >8) were
compared by using the grouping feature of BMDP1L and the
Mantel-Cox statistic computed by that program. Cox proportional hazards
models of the covariates of rates of survival and survival free of
events were constructed with the BMDP2L program and were
used to identify significant predictors of survival.25
These covariates of survival were selected in a stepwise fashion, and
only significant (P[x2]<.05) covariates
were
retained in each model. It should be noted, however, that after
patients either died or were censored at the time of MVR or development
of NYHA class III or IV, only 218 patients remained after 1 year for
further observation. At the ends of 2, 3, and 4 years this number
decreased to 106, 36, and 12 patients, respectively. All candidate
independent variables were started outside the model, and only forward
stepping was used to prevent the inclusion of too many independent
variables for the limited number of events at any stage of the
modeling. Thus, although nine candidate predictors were entered, only
three were included in the final mortality model constructed from 25
deaths. This left an ample 21 df for estimation of
confidence intervals about the three parameters of the Cox model
associated with the three independent predictors. In addition, the
three most significant independent predictors of mortality were forced
into the two other models of rates of survival free of MVR and
event-free survival. This was done to render the models mutually
consistent and was justified by the fact that the three mortality
predictors were also significant univariate predictors of the other
classes of events. Estimates of errors cited in the text are mean±SD.
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Results |
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TopAbstractIntroductionMethods Results Discussion References |
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Immediate Outcome
The hemodynamic changes produced by PMV in both groups of patients (echocardiographic scores
8 and >8) are shown in Table
2. PMV resulted in a significant decrease in mitral
gradient and increases in both cardiac output and mitral valve area in
both groups of patients; the increase in mitral valve area produced by
PMV was greater in patients with echocardiographic scores 8 than in
those with echocardiographic scores >8 (2.2±0.8 versus
1.7±0.7
cm2, P<.001). The incidence of left-to-right
shunt through the atrial communication was greater in patients with
echocardiographic scores >8 (P<.05). The cohort of 116
patients with echocardiographic scores >8 was further divided into
those with echocardiographic scores >8 but <12 (n=100) and those
with
echocardiographic scores >12 (n=16). Post-PMV mitral valve areas in
these two groups were 1.7±0.7 and 1.4±0.8 cm2,
respectively. The corresponding percentages of patients having a good
outcome (defined as a post-PMV mitral valve area 1.5 cm2)
from the procedure were 57 of 100 (57%) and 5 of 16 (31%)
(P=.05), respectively.
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The 27 single-balloon PMV patients did not differ from the 300 double-balloon PMV patients with regard to sex, occurrence of atrial fibrillation, fluoroscopic calcification, or prior surgical commissurotomy. However, the single-balloon patients were older (62±15 versus 53±15 years, P=.007) and had a higher NYHA functional class (3.2±0.6 versus 2.8±0.7, P=.005), higher echocardiographic score (9.4±2.8 versus 7.6±2.1, P=.0001), smaller mitral valve area before PMV (0.74±0.25 versus 0.9±0.3 cm2, P=.008), and smaller valve area after PMV (1.4±0.5 versus 2.0±0.8 cm2, P=.0001).
Of the 25 total deaths, 7 occurred in hospital or immediately after discharge. The causes varied: electromechanical dissociation after percutaneous aortic balloon valvuloplasty, which had been undertaken 24 hours after PMV; sudden death 1 day after PMV, with the autopsy showing an acute myocardial infarction and a tear of the posterior leaflet of the mitral valve with hematoma of the annulus; massive right-to-left shunt due to pulmonary hypertension and hypoxemia leading to cardiac arrest; death in the operating room after emergency MVR (which itself was uneventful); left ventricular perforation and tamponade 12 hours after PMV; sepsis unrelated to PMV followed by renal failure and respiratory acidosis; and a death at home 3 weeks after PMV from a large pulmonary embolus. These seven patients were significantly older than the other patients in the study (76±6 versus 54±15 years, P=.0002) and had a higher NYHA class (3.7±0.5 versus 2.9±0.7, P=.001) and a higher echocardiographic score (10.8±2.5 versus 7.7±2.2, P=.0009). The individual echocardiographic scores of these seven early-death patients were 7 (one), 9 (one), 11 (three), 12 (one), and 15 (one); in all other respects they were similar to the other patients in the study.
Follow-up
The mean follow-up period was 20±12 (range,
6 to 49) months. It
should be noted, however, that after patients either died or were
censored at the time of MVR or development of NYHA class III or IV,
only 218 patients remained after 1 year for further observation. At the
ends of 2, 3, and 4 years this number decreased to 106, 36, and 12
patients, respectively. During this follow-up period there was a
significant difference in mortality and mitral valve surgery between
the subgroup of patients with echocardiographic scores 8 and those
with echocardiographic scores >8. The former group, comprising 211
patients, had 2 deaths, 13 MVRs, and 11 cases with NYHA class III or
IV. The second group, with 116 patients, had 23 deaths, 18 MVRs, and 6
cases of NYHA class III or IV. These correspond to 0.9% versus 19.8%
mortality, 6.2% versus 15.5% MVR, and an equal incidence of NYHA
class III or IV at 5.2%. Death and MVR rates differed significantly
(P<.006) and by wide margins of 19% and 9%, respectively,
all favoring the low echocardiographic score group.
Survival
The actuarial survival curve for the whole group of
patients is
shown in Fig 1A. The 1-, 2-, 3-, and 4-year estimated
actuarial survival rates were 94±2%, 91±4%, 90±4%, and
90±4%,
respectively.
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Fig 1B
shows the estimated actuarial
survival curves for patients with
echocardiographic scores 8 and >8. Actuarial survival rates
throughout the follow-up period were significantly better in patients
with echocardiographic scores 8 than in those with echocardiographic
scores >8.
Among patients with echocardiographic scores >8,
actuarial survival
rates throughout the follow-up period were significantly better in
patients with echocardiographic scores of 9 to 11 than in those with
echocardiographic scores 12. At 3 years of follow-up, actuarial
survival rates were 83±9% and 18.9±30% (P<.00005)
for
patients with echocardiographic scores 9 to 11 and 12, respectively.
Cox regression analysis demonstrated that death during follow-up was directly and independently related to echocardiographic score (P=.0004), age (P=.004), and pre-PMV NYHA class (P=.01).
Survival With Freedom From MVR
Fig 2A shows
the estimated actuarial survival with
freedom from MVR curve for the overall group.
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Fig 2B
shows the estimated actuarial survival with freedom from MVR
curves for both groups of patients (echocardiographic scores 8 and
>8). Actuarial survival with freedom from MVR rates throughout the
follow-up period were significantly better in patients with
echocardiographic scores 8 than in those with echocardiographic
scores >8.
Cox regression analysis demonstrated that the presence of MVR at follow-up was directly and independently related to echocardiographic score (P=.0008), age (P=.03), pre-PMV NYHA class (P=.026), and the presence of atrial fibrillation (P=.033) and fluoroscopic mitral valve calcification (P=.009).
Event-Free Survival
Fig 3A shows the estimated
actuarial event-free
survival curve (death, MVR, and NYHA class III or IV) for the overall
group.
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Fig 3B shows the estimated actuarial event-free
survival curves
for both groups of patients. Actuarial event-free survival rates
throughout the follow-up period were significantly greater in patients
with echocardiographic scores 8 than in those with echocardiographic
scores >8.
Among patients with echocardiographic scores >8,
actuarial survival
with freedom from combined events rates throughout the follow-up period
were significantly better in patients with echocardiographic scores of
9 to 11 than in those with echocardiographic scores 12. At 3 years of
follow-up, actuarial survival free of combined events rates were
43.9±21% and 16.2±26% (P<.005) for patients with
echocardiographic scores 9 to 11 and 12, respectively.
Cox regression analysis demonstrated that the incidence of events at follow-up (death, MVR, and NYHA class III or IV) was directly and independently related to age (P=.005), NYHA functional class before PMV (P=.03), echocardiographic score (P<.05), and history of prior surgical mitral valve commissurotomy (P=.02).
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Discussion |
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TopAbstractIntroductionMethods Results Discussion References |
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This study demonstrates that PMV results in a good immediate hemodynamic and clinical improvement in the majority of patients with mitral stenosis and produces good intermediate long-term follow-up in a selected group of patients with mitral stenosis. Throughout the follow-up period, patients with echocardiographic scores
8 had
significantly greater actuarial survival, actuarial survival with
freedom from MVR, and event-free survival rates than those patients
with echocardiographic scores >8. The patients with the lower
echocardiographic scores also experienced a significantly greater
increase in mitral valve area. The results of the present study
substantiate our previous
reports3 8 9 10 11
that the best
immediate outcome with PMV occurs in those patients with
echocardiographic scores 8. In addition to its well-known negative effect on the immediate outcome of PMV, the echocardiographic score is also the strongest independent predictor factor for intermediate long-term survival. Consequently, echocardiographic evaluation of the mitral valve is essential in both patient selection and in predicting immediate outcome and intermediate long-term follow-up of candidates for PMV.12 19 20 26
The present study also ratifies previous studies that have shown that patients with higher echocardiographic scores are more likely to be older, to have mitral valve calcification under fluoroscopy, to be on atrial fibrillation, and to have a history of previous surgical mitral commissurotomy.9 10 11 Our study shows that all these factors are significant univariate predictors of survival and event-free survival after PMV. Our findings agree with several follow-up studies27 28 of surgical commissurotomy that show that patients with advanced age, calcified mitral valves, and atrial fibrillation had a poorer rate of survival.
Although it seems reasonable to recommend PMV as the treatment of
choice in patients with an echocardiographic score <8 and no calcified
mitral valves, the question remains as to which procedure, surgical or
PMV, is more suitable for patients with echocardiographic scores >8.
Our results show that 69±9%, 58±10%, 46±15%, and
39±18% of the
patients with echocardiographic scores >8 were free of combined events
at 1, 2, 3, and 4 years of follow-up, respectively. Since a good
outcome is obtained in only 31% of patients with echocardiographic
scores 12, and only 16% of them were free of combined events at
intermediate-term follow-up, it has been our practice to recommend
surgery for these patients as a first choice and to use PMV only if
they are considered noncandidates or very-high-risk candidates for
surgery. A good immediate outcome can be achieved in 57% of patients
with echocardiographic scores between 9 and 11, with 43.9% of them
free of combined events at intermediate long-term follow-up. Therefore,
we recommend PMV as the first choice in these patients, particularly if
the contributions of mitral valve thickening and subvalvular disease to
the overall echocardiographic score are less than the other two
components.8
Although our results agree with other follow-up studies showing
a low incidence of clinical restenosis in patients with uncalcified
mitral stenosis undergoing
PMV,11 12 13 14 15 16 17 18
they appear to
disagree with those of Cohen et al,18 who report lower
(88% 2-year and 76% 5-year) survival and lower (74% 2-year and 51%
5-year) combined event-free survival rates in a group of 146 patients
undergoing PMV. Their lower combined event-free survival can be
explained by a larger number of patients with higher echocardiographic
scores and mitral valve calcification. In their study, patients were
not excluded on the basis of mitral valve calcification or
morphological features of the mitral valve. Furthermore, in that study
39% of the patients were considered to be high-risk candidates for
surgery due to the presence of important coexisting conditions or
advanced age. As we have shown, advanced age has a significant negative
effect on the immediate outcome and follow-up of patients undergoing
PMV; a successful outcome with PMV was achieved in only 46 (46%) of 99
elderly (65 years) patients.14 Event-free survival rates
at 1, 2, and 3 years of follow-up were 72±5%, 53±6%, and
46±7%,
respectively.
Other follow-up studies11 13 16 have shown that the incidence of hemodynamic and echocardiographic restenosis is low 2 years after PMV. In a prospective study13 of a group of patients undergoing simultaneous clinical evaluation, two-dimensional (2D) Doppler echocardiography, and transseptal catheterization 2 years after double-balloon PMV, we showed no significant decrease in mitral valve area. Chen et al,16 using the Inoue balloon technique, showed no significant differences in mitral valve area determined by 2D echocardiography in 71 patients at a mean follow-up of 27±11 months.
Studies show that restenosis occurs after both closed and open surgical
commissurotomy.29 30 31 32 33 34 35 36
John et al29 report a
restenosis rate of 4.2 to 11.4 per 1000 patients per year in 3724
patients who underwent surgical closed mitral commissurotomy. Although
rates of actuarial survival with freedom from MVR and actuarial
survival with freedom from combined events after PMV in the present
study are lower than reported after surgical commissurotomy, actuarial
survival rate with freedom from both MVR and combined events in the
subgroup of patients with echocardiographic scores 8 is similar to
that reported after surgical mitral
commissurotomy.29 30 31 32 33
Turi et al37 have recently reported a prospective study of 40 patients with severe mitral stenosis who were blindly randomized to either PMV or closed surgical mitral commissurotomy. They demonstrated no significant differences in immediate outcome, complications, or 3.5-year clinical follow-up between these groups of patients.
The stepwise Cox regression algorithm used in this data analysis produces a model of the hazard of a poor outcome after PMV that is composed of a small number of predictor variables that contain independent information. This does not mean that a predictive model that is not significantly worse than ours could not be constructed from other combinations of variables from our candidate set of nine variables (or, indeed, of other variables that we did not include as candidates). This is a limitation of all multiple regression analyses, but a more exhaustive comparison of alternative models is not warranted by the limited number of events (at most 72 combined, when MVR and poor NYHA class are included) in our sample of 327 patients and by the risk of spurious results due to multiple comparisons.
We conclude that PMV produces a good clinical outcome in a high
percentage of patients at intermediate-term follow-up. Patients who
have the best results are <65 years of age, have echocardiographic
scores 8, are in sinus rhythm, and have no evidence of valve
calcification under fluoroscopy. Thus, it seems reasonable to recommend
PMV for the treatment of symptomatic patients with rheumatic mitral
stenosis and suitable mitral valve anatomy (low echocardiographic
scores and absence of fluoroscopic calcium).
Received March 2, 1994; accepted July 31, 1994.
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