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JACC Vol. 27. No.

2 407
Fehnmy tW.407-14

SURGERY

Functional Results 5 Years After Successful Percutaneous Mitral


Conmissurotowy in a Series of 528 Patients sud Analysis of
Predictivb Factors
BERNARD HJNG, MD, BERTRAND CORMIER, MD, PIERRE DUCIMETIERE, PHD,*
JEAN-MARC ,pORTE, MD, OLIVIER NALLET, MD, PIERRE-LOUIS MICHEL, MD, JEAN ACAR, MD,
ALEC VAHANIAN, MD
Paris, Fmnce

O&cfirtQ. This study sought to issess late f0ilCtiuaai fesolts Associatioa hctiial class1 uTII with 110cardiac-related deaths
after snecmfd percntaneo~s mitral commissurotomy and to otwedformihal~ryorrepeatdilatios,was76=-atS
determine their predictors. years. By multivariate analysis, the ikpendent predictors of
Buckgmd. Fewstudies have reported late results of percota- gocd functional results were ecbocardiagrapldc grollp (p = @.Ol),
ueous mltd commissarotomyor have analyzed their late results fmxtiod class (p = 0.02) and cardhhra& iadex (p = 0.005)
regardless of lnnnedlate results, despite tbe fact that late deteri- beforethepro&areatbdvalveareaafterthepmcednre(p=
~tionmtry~berelatodeithertoaderreaseiova~eareaorto 0.007). Tlw prdctive model derived allowed es!imatioa of tk
poor irritial re&s. probsbility of gasd hctbaal melts according ta tbe v&e of
M&d. Detwcen 1906 and 1992, 528 patients ll&nvent tksefourpredbrsforanygiWapatieat.
soecessf~Iperent~~~eo~~mitral commissarotomy (mean [*SD] -Good-resnlts~obsmed5years
age 46 -c 18 m mean fallow-ap 32 f 18 montlts). A smxes&d aftersnccessfld persmmmmItralcommlsslwtom yiaalarge
proeedorowasdefuredbyaaritralsakrearea815aeandM, &esofvariedpatients.TEeaaalysisofprediifactm3may
regwgitation >%. Dilation was perfbrmed wing a single balloon pmvide ss&l iJiths for follow-ap rest&s in patients qader-
in W patients, a double ballt+m in 349 and the fnooc: bahoa in going this teclmiqae.
166. MuMivariate analysis was performed with a Cox made1 (I Am cdl Gzriiid 1!3%37:497-14)
Reds. The twrvld mte for patients in New York Heart

Since 1984 (1) numerous reports have demonstrated the safety Methods
of percutaneous mitral commissurotomy with regard to the Patieuts. From March 1986 to February 1992,606 consec-
improvement of mitral valve function in patients with mitral utively admitted patients residing in France undenvent percu-
stenosis (2-9). However, few series have reported late results, taneous mitral commissurotomy in our department, 528 of
and most included either a majority of old patients or essen- whom (87%) had good immediate results. which were defined
tially young patients with pliable valves (10-12). Moreover, as a final mitral valve area ~1.5 cm as assessedby echocar-
these series took into account all the procedures, whatever diography and no mitral regurgitation >S according to the
their immediate results. Poor late results may be related to Sellers classification. These 528 patients form the basis of the
different mechanisms depending on whether they are the present study, and their characteristics ?re detailed in Table 1.
consequence of restenosis or poor immediate results.
Techii. Dilation was always performed using the an-
The purpose d the present study was therefore to assess terograde transvenous approach. The mitral valve was dilated
late results after successful percutaneous mitral commissurot- with a single balloon in 13 patients (Trefoil 3 X 12 mm,
omy in a large single-center series that included a variety of Schneider Europe) and a double balloon in 349, as previously
patient subsets. This allows an accurate assessmentof late reported {Trefoil 3 X 10 mm or 3 X 12 mm plus a 15 or
results and the analysis of their predictive factors. 19-mm balloon) (3). After October 1990, the Inoue balloon
was systematically used in 166 patients, with stepwk inflation
under echocardiiphic guidance (13) (Table 2).
From the Cardii Dq&ment, Tenon Hospital and INSERM UZSS.
Measmts. The cardiothoracic index was calculated
Bmassais Hospital, Paris France. on a chest radiograph in the posteroanterior projection. After
Manuscript received January 25.1995; revised man- received June 6, echocard~ and lh~~roscopy, mitral valve anatomy was
1995, aoeeped sepremba M 19x5.
: Dr. Ilemard Iung, Cdlogie. Hepital Tenal, assess4 sod patients were classified into three groups, as
4,medehChit~,75OXlPa1&Fra11ce. prwiody ciesmhd (3,4,13,14): lkxible valves and mild sub-
408 NNG ET AL JACC Vol. 21, No. 2
MITRAL COMMISSUROTOMY FOLLOW-UP February 199h:407-14

T&te 1. Patient-Related Variables Before Percutaneous Table 2. Procedure-Related Variables


Mitral Commis5urotomy
Double balloon 349
Age@) 46.6 + 13.4 Single hallcm 13
40 326 !nc se balloon 166
50-m 176 Effectke balloon-dilating area (cm) 5.6 C 0.7
rm 26 5.5 220
Male/female 861442 >S.S 308
NYHA tilnctional clas
*Subgroup cutoff pints arc defined for univariate and multivariate analysis.
I
Data presented are mean value + SD or number of patients.
II 140
111 367
IV 19
Cardiic rhythm with extensive subvalvular disease associated with calcified
Sinus 318
valves were classified as group 3. In a subset of 40 patients in
4F 210
our series, the mean (+SD) Wilkins score was 8.0 ? 0.8 (range
previous surgical commissurotomy
YeS 86 7 to 9) for echocardiographic group 1; 9.9 2 1.3 (range 8 to 12)
No 442 for group 2; and 12.5 ? 1.3 (range 10 to 15) for group 3.
Mitral regurgitation (Sellers classification) Echpcardiographic examination was performed on the day
0 348 before and 24 to 48 h after percutaneous mitral commissurot-
1 168 omy. The reference measurement used to calculate mitral
2
valve area was planimetry by two-dimensional echocardiogra-
E!&owiiographic group
1 87
phy. In 25 patients, planimetry was not possible, and an
2 311 estimation from the transmitral pressure half-time index with
130 the Doppler technique was used for statistical analysis. In the
Cardiothoracic index 0.51 t 0.045 whole series, the correlation between the assessmentof valve
so5 307 area by planime!?j and by the pressure half-time index was r =
0.5-0.6 174 0.76 before the procedure and r = 0.81 after the procedure.
~0.6 31
Before and immediately after the procedure, right and left
Mean pulmonary artery pressure (mm Hg) 31.8 k 0.1
<30 263
heart catheterization was performed, cardiac output was de-
133 265 tennised by the thermodilution method, and degree of mitral
Mean left atria1 pressure (mm Hg)* 21.8 + 6.3 regurgitation was assessedaccording to the Sellers classifica-
Cl5 83 tion on left ventricuiograph? in a 30 right anterior oblique
15-20 128 view.
zal 317 Effective balloon-dilating area was calculated according to
Cardiac index (liters/min per m)* 2.92 4 0.65 usual geometric and trigonometric formulas (15).
C2.5 135
2.5-3 149
Echocardiographic and hemodynamic data before and after
23 244 the procedure are presented in Tabies 1 and 3. All data were
Left atrial diameter (TM echo) (mm)* 49.4 2 1.2 entered prospectively in a computerized data base beginning in
40 307 1986.
50-60 163 Folluw-up. Follow-up was performed at l-year intervals.
30 58 Data were collected either during patient visits to the depart-
Mitral valve area (plan&try) (cm2)* 1.08 2 0.22
co.75
ment or by a standardized questionnaire sent to the patients
50
0.75-l 119 cardiologist or, in case of no answer, to the patients local
l-l.25 223 physician.
ZA.25 121 Follow-up was concluded in February 1993 (the minimal
Mean trammitral gradient (Dopplerj (mm Hg) 9.9 2 4,3 duration was thrrs equal to the l-year follow-up irrterval).
Cl5 461 Follow-up was completed for 511 patients (97%), with a mean
21.5 61
follow-up period of 32 2 18 months (up to 84) in all 528.
Subgroup cotoff points are &lined for uoiwiate and multivariate analysis. Clinical vents were defined as death, mitral surgery or
Data presented are mean value + SD or number of patients. AF = atrial repeat dilation and New York Heart Association functional
fikiktiou; NYHA = New York Heart Association; TM echo = time-motion
eckardiography.
class, which were combined as the following end points:
1) global survival; 2) survival with deaths of cardiac origin only
(noncardix deaths were censored); 3) survival with no cardiac-
related death and no need for mitral surgery or repeat dilation;
valvular disease (length of chordae ~10 mm) (group I); flexible 4) survival with good functional results (functional class1 or II)
valves and extensive subvalvular disease (length of chordae and no cardiac-related death or need for mitral surgery or
<lo mm) (&oup 2); and calci&d valves (group 3). Patients repeat dilation.
JACC Vol. 27, No. 2 ICNG ET AL. 409
February tWf&7-14 MIT&t COMMISSIJROTOMY FOLLOW-UP

TabIe 3. Patrent-PeLtted Variables After Percutaneous


Mitral Comtnissurotomy
Mean pulmonary artery pressure (mm Hg) 23.2 z 8.2
620 202
>20 2&l
Mean left atrial pressure (mm Hg) 13.1 t 5.1
512 269
>I2 2.59
Cardiac index (liters/min/m) 3.1F 2 0.72
<3 211
3-3.5 Ml
23.5 157
Mitral regurgitation (Sellers classilication)
0 202 PIIre 1. Actuarial resubc after percutaneous mitral commissurot-
1 242 omy. Actuarial survival rates at. represented with 95% confidence
2 67 intervals (vertical lines). Numb7 at the bottom of the graph indicate
Mitral valve area (planimetry) (cm) 1.98 t 0.30 the ttutnher of surviving patients in functional class I or 11with no need
ct.15 119 for operation or repeat dilation at each year of follow-up (good
1.75-2 153 functional results).
22 256
Mean transmittal gradient (Doppler) (mm Hg) 4.4 2 1.8
52.5 80 Results
2.5-5 233
25 187
Global results. Five-yea: actuarial rates for global survivat;
survival with no cardiac-related death; survival with no cardiac-
*Subgroup cutog points are defined for univatiate and multivariate analysis. related death and no need for surgery or repeat dilation; and
Data presented are mean value 2 SD or number of patients.
the composite end point of good functional results were,
respectively, 93 +- 4%, 97 t 3%. 84 ? 6% and 76 t 6%
Statistical analysis. Cumulative survival curveswere deter- (Fig. 1).
mined by an actuarial method with 6-month intervals. Contin- Nineteen patients died during follow-up, 8 of cardiac-
uous variables are expressed as mean value 2 SD and were related causes (congestive heart failure in 5, postoperative
divided into subgroups with clinically reasonable cutoff points. death after mitral surgery in 2, myocardial infarction in I) and
Analysis of the predictive fs.ctors of late re~lts concerned the 11 of noncardiac-related causes (neoplasi:: in 6, respiratoT
composite end point of gc~d functional results, defined as insuthciency in 4, suicide in 1). A repeat mitral valve procedure
survival with good functiona I results (functional class I or II), was required in 40 patients: repeat dilation in 5, open heart
no cardiac-related death or reed for mitral surgery or repeat commissurotomy in 5, mitral valve replacement in 30 (the
dilation. latter was associated with aortic valve replacement in 4,
Univariate analysis was ~rformed using a log-rank test on coronary bypassgraft surgery in 1). Surgical findings during the
the 14 preprocedure-related variables in Table 1, the 2 proce- 35 operations were restenosis in 29 patients and moderate
dure-related variables in Table 2 and the 6 postprocedure- stenosis associated with mitral regurgitation in 6.
related variables listed in Table 3. Variables with p < 0.25 were At the final follow-up examination (mean 34 5 I8 months
entered in a Cox proportional hazards model with a backward after procedure), 471 patients were aliie and were free of
selection procedure using a significance level of p = 0.25. mitral surgery or repeat dilation. Twenty-two patients were in
Two-way interactions were studied between these selected functional class III or IV and did not undergo reopersuon.
variables, using a stratified log-rank test. The final Cox model Three patients experienced a transient ischemic attack without
was elaborated by a backward selection of these variables and sequelae, and one patient in functional class III had a cere-
the interaction terms, with a significance level of p = 0.05. brovascular event with moderate functional sequelae.
The assumption of proportional hazards was verified by a Predlctive factors of late huicthal malts. By univariate
graphic method. analysis, 15 variables were significant at the p = 0.25 level
A predictive model of continuing good functional results at (Table 4, Fig. 2 and 3). Neither of the two procedure-related
3 years was established using the final Cox model, in which the variables was shown to be significant by univariate analysis.
baseline survival function So(t) was bstimated from the study The first Cox proportional hazards model identified six predic-
cohort. To ensure its accuracy, the estimation of So(t) was tors: ecttocardio&aphic group, functional class and cardiitho-
limited to 3 years because 201 patients had a follow-up period racic index before the procedure and mean puhnonary artery
~3 years, although a few patients had a longer follow-up pressure, mitral valve area and mitral gradient after the
period. procedure.
Analysis was performed with SAS statistical software (MS The final Cox model included three preprocedure variables
Mitute Inc., release 6.07). Estimation of the Cox model and and one variable related to the quality of the ,result of
the sunrival fun&m was done using the PHREG procedure. percutaneous mitral corumissurotomy. Thii model did not
410 IUNGETAL JACC Vol. 27, No. 2
MITRAL COMMISSUROTOMY FOLLOW-UP February 1996~407-14

Table 4. Predictive Factors of Good Late Funci;onal Results by procedure (p = 0.007). The strength of these predictors is
Univariate Analysis indicated by the adjusted relative risks derived from the final
p Value Cox model in Table 5.
Before procedure Predictive model of late functional results. The predictive
Age 0.0001 model derived from the fmal Cox model, which included four
Gender 0.67 covariates, allowed estimation of the probability of good
Fuoetional class 0.013 functional results according to echocardiographic group, func-
Rhythm O.ooo2 tional class and cardiothoracic index before the procedure and
Previous commissurotomy 0.80 valve area after the procedure. Predicted rates of good func-
Mitral regurgitation (Sellers dassification) 0.001 tional results at 3 years are shown in Figure 4 and are as
Echocardiographic group 0.0002
Cardiothomcic index 0.001 follows: 98% for patients in echocardiographic group 1 and
wan puhnoaary army pressure 0.97 functioi.al classI or II, with a cardiothoracic index ~0.5, before
Mean left atrial prwure 0.96 dilation and a valve area ~2 cm2 after dilation; 84% for
Cardiac index 0.075 patients in echocardiographic group 2 and functional class III
Left atria! diameter !!:ne-motion or IV, with a cardiothoracic index between 0.5 and 0.6, before
echocardiography) dilation and a valve area between 1.75 and 2 cm* after dilation;
Mitral valve area (planimetly) 0.25
62% for patients in echocardiographic group 3 and functional
Mean trammitral gradient (Doppler) 0.24
Proeedore class III or IV, with a cardiothoracic index between 0.5 and 0.6,
Type of balloon 0.54 before dilation and a valve area between 1.50 and 1.75 cm*
Effective balloon dilating area 0.84 after dilation; and 44% for patients in echocardiographic
After procedure group 3 and functional class III or IV, with a cardiothoracic
Mitral regurgitation (Sellers classification) 0.001 index >0.6, before dilation and a valve area between 1.50 and
Meao pulmonary artery pressure o.OQ2
1.75 cm2 after dilation.
Mean left atrial pressure 0.009
Cardiac index 0.62
Mitral valve area (planimetry) 0.0012
&an transmittal gradient (Doppler)
Discussion
In the present study, good functional results without a need
include interaction terms. The independent predictors of for repeat dilation or mitral surgery were obtained in 76% of
continuing good functional results were lower echocardio- patients 5 years after successful percutaneous mitral commis-
graphic group (p = O.Ol), lower functional class before the surotomy. Predictive factors for continuing good functional
procedure (p = 0.02), lower cardiothoracic index before results were echocardiographic group, functional class and
the procedure (p = 0.005) and greater valve area after the cardiothoracic index before and valve area after Ihe procedure.

AOE 11 FUNCTIOWAL CLASS BEFORE Pb@---1

Figure 2. Univariate analysis. Good func-


tional results for clinically relevant predictive
factors of late functional results after percu-
taneous mitral commiscurotomy (curves were
not plotted when the number of patients was
40 for the given period). N?HA = New
York Heart Association; PMC = percutane-
ous mitral fflmmissurutomy.
JACC Vol. 2% No. 2 WNGETAL 411
Febntaty 1996~407-14 MITRAL COMMISSUROTOMY FOLLOW-UP

~VALVE mmtw ~ECHOGRA~HIC QRouP) I I wwt WuKmARY ARTERY PREsauRE I

Frgure 3. Univariate analyxis.Good fnnc-


tional resultsfor echocardioaranhicalhrand
of late functional resultsafter percutaneous
mitral commissnrotomy(carvex were not
plotted when the nnmber of patients wax
40 for the given period). PMC = percnta-
aeousmitral commixsurotomy.

De&n of the study. Late symptomatic deterioration after predictors of late results in a homogeneous cohort of patients,
percutaneous mitral commissurotomy, as after surgical com- all of whom had good immediate results from percutaneous
missurotomy, may be related to the continuation of poor mitral commksurotomy. Only one other comparable study has
immediate results or to late deterioration after a successful reported late results after successfulsurgical commimumtomy
procedure (16). Poor late results after poor immediate results (21), but it included few patients and therefore no predictor of
result from insufficient valve opening or severe mitral regurgi- late deterioration could be identified.
tation. In these cases,surgery is often required, but its timing Our definition of good immediate results associated mitral
depends on confusing factors, such as extracardiac comorbidi- valve area ~15 cm and no regurgitation >Y4. Such results
ties and the habits of the medical and surgical teams con- generally provide normal hemodynamic variables, and the
cerned. In contrast, late deterioration after a suceessfid pro- same criteria are used in most studies, alone or in combination
cedure is generally related to a progressive decrease in valve (17,22).
area (6,12,17-20). For all these reasons we chose to analyze the With regard to our end points of late results, we dii not

FiguRd~~rataofgoodfundionarresultsat3yearsasa
Table 5. RelativeRisks Derived From Cox Proportional Hazards timction of echoeardiographicgroup, fanctioaafcfasaand car&ho-
Multivariate Model rack index before aad mitral valve area after pemrtaaeoux mitral
Variable Relative Riik (95% Ci) p value commissllmt~ (1) = eehocardiographicgroup 1, hmcticrLa1clamI
or I1 and cardiomoracic index CO.5 before dilation valve area
Ecbocardiogapbic group 0.01 d.00 cm* after dilatioa; (2) = eckardi~c grwp 5 fnnctitnral
1 1 classIII or IV and cardiothoracicindex 0.5to 0.6beforedikion, valve
2 1.8(1.1-2.7) area 1.75to 2.00an* after dilation; (3) = eehocardiograpbicgroup 3,
3 3.1 (E-775) hmctional clas III or IV and card&honuic index 05 to 0.6 before
NYHA functional class 0.02 dilation, valvearea 150 to 1.75an after dilation. (4) = eebocardio-
UII 1 graphic group 3, functional daS Ill or Iv and cardiuthoracrcindex
Ill/w 3.0 (1.2-7.6) >0.6 before dilation, valve area 1.50to 1.75an* after dilation.
Cardiotitoracic index 0.005
SO.5 1
0.5-0.6 1.7 (1.2-2.5)
~0.6 2.9 (1.4-6.2)
Mitral valve area after PMC (cm*) 0.007
c-1.75 2.4(1.>4.5)
1.75-2.00 l.s(l.l-2.1)
Z?.lKl 1
Cl=amtidenceinterv&NYHA=NewYorkHeart Assodation;pMc=
peremwm mittat by.
412 IUNG ET AL. JACC Vol. 27, No. 2
MITRAL COMMISSUROTOMY FOLLOW-UP February 19%:407-14

restrict the analysis either to mortality alone, because its limited duration of follow-up and, above all, include yowg
incidence was very low, or to the need for repeat dilation or patients (mean age range 27to 31 years) with valve anitomi
mitral surgery, because some patients with late deterioration of suitable for oercutaneous mitral commissurotomv. so that their
valve function do not undergo reoperation because of refusal conclusionscannot be universally applied. *
or surgical contraindications. Our composite end point of good Predictive factors of late results of percutaneous mitral
functional results did, however, take into account all the commissurotomy. The relation between vaFe anatomy and
cIi.nicaIconsequences of deterioration of valve function. Such deterioration of late results is well established (6,7,10,11).
an end point is justified in a pragmatic approach in which the Series with repeated evaluations of valve area by echocardiog-
aim of percutaneous mitral commissurotomy is to obtain raphy or hemodynamic variables after percutaneous mitral
continuing good functional status, as attested by a cardiologist commissurotomy have included few patients (37 to 57), with a
or a physician, whereby the risk of any subjective bias is mean follow-up of 7 to 24 months (17-20,34) and may reflect
markedly reduced. a selection bias (19). All these studies reported a relation
Late results of percutaneous mitral commissurotomy. Tie between the extent of valve deformity and the occurrence of
present study showsevidence of good late results after success- restenosis. The predictive value of valve anatomy was also
ful percutaneous mitral commissurotomy, with 76% of patients demonstrated during long-term follow-up after surgical com-
having good functional results at 5 years. The analysis of these missurotomy (25,27,35).
results according to the data in the published reports must take The predictive value of functional class has been described
into account the regular inclusion of patients with poor imme- after percutaneous mitral commissurotomy (10,36) and after
diate results of percutaneous mitral commissurotoj.,! in the surgical commissurotomy (25,35,37).
other series (7,10-12,22). Moreover, late results mlrqt be Cardiothoracic index was a predictor of late results in two
analyzed according to the characteristics of the patients in- series of surgical commissurotomy (27,30). Cardiomegaly is an
volved. Late results are less satisfactory in a North American overall phenomenon that may be the consequence of several
population, where patients are older and frequently have mechanisms that have been identified aspredictors of poor late
severe valve deformities. In the series of Cohen et al. (lo), the results after surgical commissurotomy (30,35) or after percu-
mean age.of the 146 patients was 59 2 15 years, and event-free taneous mitral commissurotomy (10,ll): dilation of the left
survival was 51% at 5 years. In another North American atrium, impairment of left ventricular function and increases in
population, the early restenosisrate was 21% at 6 months (23). left ventricular end-diastolic pressure. Cardiothoracic index is
Results are naturally better when patients are younger and an easily available measure that takes into account associated
have a more suitable valjle anatomy. The European series of cardiac diseases and the consequences of mitral stenosis.
Pan et al. (11) included 350 patients with an average age of 46 Conversely, left ventricular end-diastolic pressure or ventricu-
years and reported an 85% rate of event-free survival without lar diameter is more specifically related to heart failure but is
restenosis at 5 years. In a study from lndia that included 600 generally hnked to associated diseasesmore than to the direct
patients with a mean age of 27 2 8 years, the incidence of consequences of mitraf stenosis.
restenosis was only 1.7% during a merit follow-up period of 37 The last independent predictor of late results in our study
months (12). In a series from Saudi Arabia of 41 patients was mitral valve area after the procedure. This factor was also
(mean age 26 years), no reetccosisoccurred at 1 year follow-up predictive of late results in the series of Cohen et al. (lo),
(24). which included all procedures, regardless of the immediate
Late results of suqica! coamissurotomy. These differ- results. In our study, valve area was assessedby planimetry
ences in patient charac!zii&s also limit any comparison of with two-dimensional echocardiography, which has the advan-
Iate results of percutaneous mitral commissurotomy with those tage of being a direct measurement, as valve area as assessed
of surgical commissurotomy. Most large series concerning by hemodynamic variables with the Gorlin formula may be
closed mitral commissurotomy have included young patients misleading immediately after dilation (38,39). Doppler calcu-
and reported reoperation-free survival rates of between 72% lation using the pressure half-time index may likewise lead to
and 94% at 6 years (25-27). With regard to open mitral inaccurate estimation of valve area, especially when performed
commissurotomy, reoperation-free survival ranged from 85% immediately after the procedure (40). Planimetry may be
to 95% at 5 years (28-30). In a comparative study (22), the considered as the reference measurement of mitral valve area
incidence of mitral surgery or repeat dilation was ,higher after (41). The main disadvantage of planimetry is its nonfeasibility
percutaneous mitral commissurotomy than after open mitral in patients with low echogenicity or with a very irregular mitral
commissumtomy (34% vs. 13% at 3 years), but that study was orifice (including heavily calcified valves). When vaIvc area
not randomized. It is clear that any comparison of the results could not be assessedby planimetry, we used a calculation with
of percutaneous mitral commissurotomy with those of surgical pressure half-time index performed 1 or 2 days after the
commissurotomy requires prospective randomized studies. procedure, when this measurement has recovered its validity
The few randomized studies published so far do not demon- (42). This substitution avoided a potential selection bias by
strate any superiority of closed (31,32) or of open mitral excluding patients with calcified valves from the multivariate
a3mmissurotomy (33) over percutaneous mitral commissurot- model, because such patients are more IiieIy to have poor late
omy. However, these studies involve few patients, have a results.
JACC Vol. 27. No. 2 IUNG El AL. 413
Febnmy 1996407-14 MITRAL COMMISSUROTOMY FOLLOW-UP

Several patient-related characteristics had no predictive system is widely used (10,11,17,47), but it is not possible to
value of late functional results in our multivariate analysis, in evaluate the respective values of these methods. because there
particular, mitral regurgitation, rhythm, age, previous surgical are no comparative evahiattons (2).
commissurotomy and valve area before the procedure, al- The model that we derived here may not be applied alone
though they have been identified as predictors in other studies to select patients because it does not predict immediate results
of late results after percutaneous mitral commissurotomy or and because it includes a variable linked to an immediate result
surgical commissurotomy (7,25,27,30,43). These apparent dis- of the procedure. An improvement in patient selection would
crepancies may be attributable to confounding phenomena. In require the identification of the predictive factors of immediate
our study, most of these factors were highly sign&ant predic- results from another model.
tors in univariate analysis,which did not, however, reflect their Conclusions. The good functional results observed 5 years
individual effects but their relationship with the independent after successful percutaneous mitral comrnissurotomy in a
predictors later identified in the multivariate Cox model. group of patients with varied clinical characteristics and valve
Further, age, previous surgical commissurotomy and valve area anatomy further confirm the wide applicability of this tech-
before the procedure are also independent predictors of nique. In conjunction with the analyGi of the predictors of
immediate results (2,3,7) and may influence late results after immediate results, the findings of the present study may
either percutaneous mitral commissurotomy or surgical com- contribute to better patien! selection. The predictive model
missurotomy (11,27,35) in which poor immediate results have derived should provide better guidelines for patient follow-up
been taken into account, unlike our present series. and enable a better prognosis to be made after successful
Most of the procedures were performed in our series with a percutaneous mitral commissurotomy for the individual pa-
double balloon or the Inoue balloon, which are the most tient.
commonly used techniques. There are few comparative studies
of results with the double balloon and the Inoue balloon
techniques, but immediate results do not seem to differ
(q-46). In our study, the technique used did not influence References
late results after successfulpercutaneous mitral commissurot- 1. Inoue K, Okawi T, ?kibitm T. Kitamu-a F, Mjamoto N. Clinical
omy. a;~~Gc.a cf transvenou!? mitral mmmissumtomy by a new balh7cmcathe-
Application of predIetive model. The present singlesenter :er. I Ttmmc Cardicwasc Surg 19%1;87:394-402.
series of patients with a wide range of clinical characteristics :. The NHLBI Balloon Vai~ty Re@y Pmtiits Multicenter ape
rieke with halloo mitral mmmiwmtomy. Ciiatkm 1992;85:448-61.
allowed the elaboration of a predictive model of late functional 3. Jahaniatt A, Michel PL Cornier 8, et al. Resulti of percutaneous mitral
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