(Circulation. 1995;91:1506-1511.)
© 1995 American Heart Association, Inc.
Articles |
Early Balloon Dilatation of the Pulmonary Valve in Infants With Tetralogy of Fallot
Risks and Benefits
From the Departments of Pediatric Cardiology and Cardiac Surgery (J.R.), Cliniques Universitaires St-Luc, Université Catholique de Louvain, Brussels, Belgium.
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Abstract |
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Background Balloon dilatation, an established treatment for pulmonary valve stenosis, remains a controversial procedure in tetralogy of Fallot.
Methods and Results Balloon dilatation of the pulmonary valve was performed in 19 infants with tetralogy of Fallot. Its effects on the severity of cyanosis, the growth of the pulmonary valve and pulmonary arteries, and the need for transannular patching were evaluated. Clinical, echographic, angiographic, hemodynamic, and operative data were analyzed. The procedure was safe in all, without significant complications. After balloon dilatation, systemic oxygen saturation increased from a mean value of 79% to 90%. This increase proved to be short-lasting in 4 patients, who required surgery before the age of 6 months. Balloon dilatation increased pulmonary annulus size in each case, from a mean value of 4.9 to 6.9 mm (P<.001). This gain in size remained stable over time, with a mean Z score of -4.8 SD before dilatation, -3.1 SD immediately after the procedure, and -2.7 SD at preoperative catheterization (P<.001). Pulmonary artery dimensions remained unchanged immediately after balloon dilatation but increased at follow-up from a Z score mean value of -2.5 to -0.06 SD and from -2.2 to 0.04 SD for right and left pulmonary arteries, respectively (P<.001). At the time of corrective surgery, the pulmonary annulus was considered large enough to avoid a transannular patch in 69% of the infants. This represented a 30% to 40% reduction in the need for a transannular patch compared with the incidence of transannular patch expected before balloon dilatation.
Conclusions Pulmonary valve dilatation in infants with tetralogy of Fallot is a relatively safe procedure and appears to produce adequate palliation in most patients. It allowed the growth of the pulmonary annulus and of the pulmonary arteries, resulting in a mean gain of 2 SD for those structures.
Key Words: catheterization • tetralogy of Fallot • pulmonary heart disease • balloon
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Introduction |
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Since the first repair of a tetralogy of Fallot in 1955 by Lillehei and associates,1 there has been continuous progress in the management of this complex congenital malformation. Information regarding the advantages of primary correction of tetralogy of Fallot in infancy is emerging,2 3 4 and symptomatic infants now benefit from corrective surgery with low operative mortality rate, thanks to improved surgical management and enhanced myocardial protection.5 6 7 8 Even with optimal conditions, however, young age at repair remains a risk factor for early postoperative death.9 10 In addition, early surgical correction more frequently requires a transannular patch,7 9 predisposing to pulmonary regurgitation and reoperation.9 11
Balloon dilatation, an established treatment for pulmonary valve stenosis, remains a controversial procedure in tetralogy of Fallot.12 13 14 15 16 17 The purpose of this study was to assess prospectively the risks and benefits of balloon dilatation of the pulmonary valve in young infants with tetralogy of Fallot. The effects on the severity of cyanosis, on the growth of the pulmonary valve and arteries, and on the need for transannular patching were evaluated.
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Methods |
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Study Population
After a multidisciplinary review of the protocol and general agreement concerning the ethical and technical issues involved, 19 infants (8 girls, 11 boys) with tetralogy of Fallot, for whom an informed consent was obtained, were enrolled in the study from January 1991 through July 1993. They had a balloon dilatation of the pulmonary valve soon after the first visit, regardless of the cyanotic level and of the size of the pulmonary valve and arteries. Age and weight at the time of balloon dilatation ranged from 1 to 20 weeks (median, 9.5 weeks) and from 2.3 to 7 kg (median, 4.2 kg), respectively. Except for a secundum atrial septal defect in 4 cases and an anterior descending coronary artery originating from the right coronary artery in 1 case, no additional cardiac lesions were observed. Primary corrective surgery was planned between ages 6 and 12 months or earlier if required by the clinical conditions.
Data Collection
Catheterization was performed under general
anesthesia. A
biplane orthogonal right ventricular (RV) cineangiogram was obtained
with the patient sitting up at 30° before and after balloon
angioplasty. The end-systolic size of the pulmonary annulus was
measured in the lateral view at the level of the valve
commissures.18 19 The origins of the pulmonary
arteries
were measured at end systole on the anterioposterior
view.18 19 Systemic arterial saturation was measured
before and after balloon valvuloplasty. An exchange guide wire was
passed through a 5F multipurpose or right coronary artery catheter, and
the tip was positioned in the distal right pulmonary artery. The
balloon used had an external diameter of 4 to 14 mm (ratio of mean
balloon to pulmonary annulus diameter, 1.5±0.26). The balloon catheter
was advanced over the guide wire and positioned across the pulmonary
valve. The balloon was hand inflated with diluted contrast and deflated
immediately. Two children required two and three dilatations,
respectively. A control RV angiogram was obtained in 10 infants at
least 2 months after balloon dilatation and before any surgery. The
same measurements were repeated. The pulmonary valve and artery were
inspected at the time of surgical correction, and the postoperative
RV–to–pulmonary artery pressure gradient was recorded by the
surgeon
after correction. Doppler echographic evaluation was performed before
and a median of 2.6 months (range, 1.5 to 4 months) after balloon
dilatation, and the diameters of the pulmonary annulus and of the
pulmonary arteries were measured. One to 2 months after surgery, the
degree of pulmonary regurgitation was evaluated by color Doppler
echocardiography and graded subjectively on a scale of 1 to 4. The
degree of residual pulmonary stenosis was studied by Doppler, and the
systolic RV pressure was derived from the velocity of a
Doppler-detected tricuspid regurgitation.
Statistical Analysis
To allow comparisons at different stages
of body growth, the
diameters of the pulmonary valve and the pulmonary arteries were
transformed in Z score or number of SDs from the mean normal
for body size: (measurement minus mean normal measurement)/SD.
Sievers' analysis and regression equations were used to express the relation between body surface area and the mean normal values and SDs,18 his observations in normal subjects being similar to the observations of Bini et al.20 The evolution after balloon dilatation was tested with a paired t test. Differences between groups were assessed by univariate ANOVA. Linear regression was used to study the relation between the ratio of balloon to pulmonary annulus dimensions and the percentage of pulmonary annulus size increase after dilatation and to examine the relation between pulmonary annulus size and postoperative RV-to-pulmonary artery pressure gradient. A value of P<.05 was considered significant. The results are presented as mean±SD with 95% CI for difference of means when required.
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Results |
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Oxygenation
After balloon dilatation, the systemic oxygen saturation increased by a mean of 11.2% (95% CI, 9% to 13.5%; range, 0% to 37%; P<.001) from a mean value of 78.9±8% to 90.1±4.5% (Fig 1
). Oral propanolol (2 to 7
mg · kg-1 · d-1) was started
in 8
infants in whom a significant infundibular stenosis was observed at the
time of balloon dilatation or at follow-up echocardiogram. Despite
propanolol therapy, adequate palliation did not last in 4 patients who
had surgery before the age of 6 months because of increasing cyanosis:
2 infants had a Blalock-Taussig shunt, whereas 2 infants with adequate
anatomy were corrected (Table 1). The oxygen saturation
remained stable, with a mean value of 85±8% (range, 75% to 87%) in
the 10 patients in whom a second catheterization was performed before
surgery.
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Complications
Four children experienced cyanotic spells, with
transient
increasing cyanosis and agitation 1 to 2 hours after the procedure,
controlled in each case with sedation (midazolam 0.1 to 0.2 mg/kg) and
propanolol (0.1 mg/kg IV). One patient had a venous thrombosis of the
right femoral vein, treated successfully by intravenous thrombolysis
with streptokinase.
Outcome
In total, 3 infants had a Blalock-Taussig shunt
before surgical
correction because of increasing cyanosis and underwent surgical
correction later. The other 13 had primary correction a mean of 6
months after balloon dilatation (range, 1 to 11 months). Three children
are still awaiting corrective surgery (Table 1
).
Growth of the Pulmonary Valve Annulus
The infants in this
study exhibited pulmonary valve dimensions
before pulmonary valvuloplasty similar to the dimensions reported by
Shimazaki et al19 in a previous large series of infants
with tetralogy of Fallot (our values versus Shimazaki's: median,
-4.8
versus -4.7 SD; minimum, -8.1 SD versus percentile 5%, -7.8
SD;
maximum, -2 SD versus percentile 95%, -0.8 SD).
Balloon
dilatation increased pulmonary annulus size from a mean value
of 4.9±1.4 to 6.9±1.5 mm (95% CI, 1.2 to 2.6 mm,
P<.001). The increase was a function of the size of the
balloon used for the dilatation (r=.93, P<.001).
This gain in size remained stable over time with a mean Z
score for the pulmonary annulus of -4.83±1.15 SD before
dilatation,
-3.09 SD immediately after the procedure (95% CI, 1 to 2.3 SD), and
-2.67±1.39 SD at preoperative catheterization (95% CI, 1.3 to
3.2,
P<.001) (Figs 2 and 3).
Echographic measurements showed a similar increase from a Z
score mean value of -4.4±1 SD at initial evaluation to a mean
value
of -2.7±0.7 SD after balloon dilatation (P<.001).
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Growth of the Pulmonary Arteries
Dimensions of the pulmonary
arteries before valvuloplasty were in
the same range as the dimensions observed by Shimazaki et
al19 (values for the right pulmonary artery [RPA] in
our
study versus Shimazaki's series: median, -2.5 versus -2.4
SD;
minimum, -5.7 SD versus percentile 5%, -5.5 SD; maximum, 1.2 SD
versus percentile 95%, 0.8 SD).
The size of the pulmonary arteries at
angiography remained almost
unchanged immediately after valvuloplasty (mean value for the RPA,
4.9±1.7 to 5.3±1.7 mm; for the left pulmonary artery
[LPA],
5.1±1.9 to 5.5±1.9 mm; P=NS). However, the size
of
abnormally small pulmonary arteries (<-2 SD) increased dramatically
at follow-up. The size of the RPA and LPA increased from a Z
score mean value of -2.5±1.7 to -0.06±1.16 SD (95%
CI, 1.9 to 3.5
SD) and from -2.18±1.9 to 0.04±1.52 SD (95% CI, 1.5 to 3.9
SD),
respectively (P<.001) (Fig 4). A comparable
change was measured by echocardiography from a mean Z score
of -3.38±0.86 to -1.6±1.8 SD (95% CI, 0.44 to 3 SD)
and from
-3.36±0.88 to -1.64±1.8 SD (95% CI, 0.76 to 3.6 SD)
for RPA and
LPA, respectively (P<.05).
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Operative Findings, Procedures, and Outcomes
Thirteen infants
benefited from a primary correction between 2.5
and 13 months of age (median, 8 months), with weight ranging from 5 to
10 kg (median, 6.9 kg), a mean of 4.7 months after balloon dilatation
(range, 1 to 11 months). Three infants had corrective surgery 7 to 10
months after a Blalock-Taussig shunt (Table 1). One of them
experienced
a severe form of choreoathetosis. There were no deaths. Two infants
required reoperation for residual shunt.
In 8 of 16 children (50%), the surgeon noticed anatomic alterations in relation to the balloon dilatation. In 3 patients, one or two cusps were detached (the leaflet was separated from its hinge point for a variable length, starting from one of the commissures), and in the other 5, a leaflet was either split by a vertical tear or perforated. There was no relation between the ratio of balloon size to pulmonary annulus diameter and the presence of morphological findings. In 11 of 16 infants (69%; 95% confidence limits, 46% and 92%), the pulmonary annulus was considered large enough, whereas in 5 infants (31%; 95% confidence limits, 8% and 54%), transannular patching (n=2) or a homograft (n=3) was required. Patients not requiring reconstruction of the RV outflow tract had a larger annulus measured on angiography after pulmonary valve dilatation (Z score mean value, -2.2±0.96 SD; range, -2.9 to -0.17 SD) compared with those with transannular patching (Z score mean value, -3.9±0.8 SD; range, -4.96 to -3 SD) (95% CI, 0.5 to 2.9; P<.05). Mean postoperative RV pressure measured in the operating room was 49±12 mm Hg (range, 25 to 70 mm Hg), and the mean RV–to–pulmonary artery pressure gradient was 20±10 mm Hg (range, 0 to 35 mm Hg). In infants who benefited from a repair without transannular patching (n=11), there was no significant relation between the immediate operative RV–to–pulmonary artery pressure gradient and the size of the pulmonary annulus at angiography (r=.3).
Follow-up Doppler Echocardiography
Follow-up Doppler
echocardiograms 2 to 18 months after
corrective surgery without transannular patching revealed a mean
RV–to–pulmonary artery peak pressure gradient of 19±21
mm Hg
(median, 20 mm Hg; range, 0 to 55 mm Hg). RV systolic pressure
determined by Doppler evaluation of tricuspid regurgitation velocity
ranged from 25 to 65 mm Hg (mean, 39±15 mm Hg; median, 35 mm Hg).
The RV–to–pulmonary artery pressure gradients in the operating
room
and at follow-up Doppler echocardiogram were similar to previously
reported gradients after similar
surgery.6 8 10 The
relation between the residual pressure gradient and the pulmonary
annulus diameter before surgery was not significant
(r=-.1,
P=NS). Trivial to mild pulmonary regurgitation was
present in 9 of the 11 infants in whom the pulmonary annulus was
not patched (grade 1/4, n=8; grade 2/4, n=1). No significant
relation
was observed between pulmonary valve incompetence and ratio of balloon
to pulmonary annulus diameter. The presence of postdilatation anatomic
lesions observed during surgery was associated with a 100% occurrence
of trivial to mild (grade 1/4) pulmonary valve regurgitation (7 of 7)
at color Doppler contrasting with a 50% incidence of pulmonary valve
regurgitation (2/4) in patients without anatomic lesions (grade 1/4,
n=1; grade 2/4, n=1).
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Discussion |
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Optimal surgical repair in tetralogy of Fallot should tend toward zero mortality and the absence of residual lesions. Young age at repair remains a risk factor for early postoperative death, especially if severe hypoplasia of the RV–pulmonary trunk junction is present.9 10 Balloon dilatation of the pulmonary valve was performed in 19 infants younger than 5 months of age in the hope of improving the growth of the pulmonary arterial tree and RV–pulmonary trunk junction and with the aim of different surgical correction after 6 months of age.
As previously reported,13 21 22 the
procedure proved to be
safe, without significant complications. Since it clearly reduced the
intensity of cyanosis (Fig 1), balloon dilatation should be
regarded as
an alternative form of palliation in tetralogy of
Fallot,13 17 21 22 even if in
4 of the 19 infants (21%),
surgery had to be resorted to before the age of 6 months. This relative
failure rate should be compared with a reported 7% of early (<30
days) occlusion of Blalock-Taussig shunt10 and an
intermediate 3% to 20% shunt closure rate occurring in heterogeneous
groups of infants and
children.23 24 25 26 27
The concern of cyanotic "spells" has been raised16 and questioned.17 Balloon valvuloplasty does not prevent cyanotic spells and could even induce their occurrence. The relief of an obstruction distal to the infundibulum would decrease the systolic pressure and consequently the systolic wall stress opposing ventricular contraction into the RV outflow tract, with the possibility of reaching closure and of causing a so-called "infundibular spasm" such as observed after valvuloplasty for isolated pulmonary stenosis.28 This probably accounts for the transient increase in cyanosis observed in 4 infants 1 to 2 hours after the procedure and for the failure of the palliation in 2 of these infants and in 2 others who required early surgery. Before balloon dilatation, those infants did not have a more severe infundibular stenosis than the other infants, and they could not be identified in retrospect. This potentially very dangerous complication should limit the procedure to cardiologists who are skilled in interventional catheterization, and surgery is recommended in the case of increasing cyanosis or cyanotic spells that are not controlled by propanolol therapy.
Strict comparisons between series of infants with tetralogy of Fallot
is difficult because of the peculiar features of cardiac malformations
in each infant, a fact that prevented the realization of an appropriate
control study. Our population appeared to be a good sample of a
population with tetralogy of Fallot; as mentioned, pulmonary valve and
artery dimensions were similar to the dimensions reported in previous
large series.19 Balloon dilatation clearly resulted in a
rise of pulmonary valve dimension (Fig 3), with a mean gain of
1.74 SD
immediately after dilatation and 2.17 SD before surgical correction
(Fig 2). This represents a real benefit, since surgical
correction without transannular patching does not affect the size of
the RV–pulmonary trunk junction.10 29 The
balloon-to-annulus ratio correlated significantly with the change in
pulmonary annulus diameter, and the biggest increases were observed
with a balloon-to-annulus ratio 
1.5. However, balloons >50% larger
than the pulmonary valve annulus produced extensive hematoma in the
anterior RV outflow tract in normal lambs.30 To allow a
benefit of the dilatation in tetralogy of Fallot with abnormal RV
outflow tract and to avoid the possible damaging effect of large
balloons, the balloon-to-annulus ratio should probably be close to 1.5
and not larger than 2.21
As a result of the growth of the pulmonary annulus after dilatation,
according to Kirklin's study on morphological and surgical
determinants of outcome events after repair of tetralogy of
Fallot,9 the predicted probability of transannular patch
insertion during repair would have fallen from an expected 77%
(probability corresponding to a mean Z score for pulmonary
annulus of -4.83 SD before dilatation) to an expected probability of
30% (probability corresponding to a mean Z score for
pulmonary annulus of -2.67 SD at preoperative
catheterization).10 In our study group, the observed 31%
necessity for either transannular patch or RV–to–pulmonary artery
homograft is in accordance with this prediction and is significantly
lower than in most reports of primary repair in
infancy6 7
(Table 2). In one series, a similar low incidence of
transannular patch (36%) was required but probably resulted from
surgical preference, in the opinion of those authors.8
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Transannular patching does not reduce survival time,4 and good long-term results have been achieved in most infants.6 However, pulmonary valve regurgitation is more severe after transannular patching10 and, if associated with high pulmonary pressure, may have significant long-term deleterious effects on RV performance. Strong correlations exist between valve incompetence and decreased exercise performance,31 increased end-diastolic RV volume,32 and elevated diastolic RV pressure, with an increased incidence of late sudden death3 and important ventricular arrhythmias.33 In addition, a transannular patch clearly represents a risk factor for reoperation for pulmonary regurgitation.9 11
Pulmonary artery size remained unchanged immediately after balloon valvuloplasty, but a dramatic increase was documented at follow-up for abnormally small pulmonary arteries. The expression of pulmonary artery dimensions in Z score allowed study of the evolution of the pulmonary artery size independently of body growth. The increase of small pulmonary artery dimensions was greater than expected solely from the normal growth, and the observed catch-up resulted from increased pulmonary blood flow, as observed after a Blalock-Taussig shunt,34 35 but without the risks of iatrogenic pulmonary artery problems related to the shunt.23
Balloon dilatation of the pulmonary valve in infants with tetralogy of Fallot is a useful palliative procedure17 and has potential benefits by allowing the growth of the pulmonary annulus and arteries. It does not prevent cyanotic spells, and surgery remains recommended if increasing cyanosis is not responding to propanolol therapy. In our study, the procedure was associated with a 30% to 40% decrease in the need for transannular patching. Its use should be considered for cyanotic infants with pulmonary annulus smaller than -3 SD below normal, because young age at repair remains a lethal risk factor in such patients and because their pulmonary valve is at risk of being sacrificed at the time of surgical correction.9 10
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Footnotes |
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Reprint requests to Thierry Sluysmans, Cardiologie Pédiatrique, Cliniques Universitaires St-Luc, UCL, 10 Ave Hippocrate, B1200 Bruxelles, Belgium.
Received August 12, 1994; accepted September 28, 1994.
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