THERAPY AND PREVENTION
VALVUIAR HEART DISEASE
Percutaneous transluminal balloon valvuloplasty
for pulmonary valve stenosis
JEAN S. KAN, M.D., ROBERT I. WHITE, JR., M.D., SALLY E. MITCHELL, M.D.,
JAMES H. ANDERSON, PH.D., AND TIMOTHY J. GARDNER, M.D.
ABSTRACT Transluminal balloon valvuloplasty was used to treat congenital pulmonary valve
stenosis in 20 patients. Follow-up cardiac catheterization was performed in 11 patients at intervals of
from 2 to 12 months after the procedure. Peak systolic pressure gradient across the pulmonic valve
decreased from 68 + 27 to 23 -+ 5 mm Hg (p < .001) after valvuloplasty. There were no complica-
tions. Follow-up catheterization demonstrated persistent relief of right ventricular hypertension in the
patients with typical pulmonary valve sternosis.
Circulation 69, No. 3, 554-560, 1984.
TRANSLUMINAL BALLOON ANGIOPLASTY has
been successfully used in the treatment of patients with
stenoses of the coronary and peripheral circulations
since 1976. 11 Recently transluminal angioplasty has
been applied in pediatric cardiology to treat pulmonary
valve stenosis,56 peripheral pulmonary artery steno-
sis, coarctation of the aorta,8 9 and coarctation reste-
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nosis.9, 10 Our experience with transluminal balloon an-
gioplasty in 20 patients with pulmonary stenoses and
the follow-up in 1 1 of these patients are included in this
report.
Methods
Clinical material. Twenty patients with congenital pulmo-
nary valve stenoses underwent transluminal balloon valvulo-
plasty at the Johns Hopkins Hospital between May 1981 and
September 1983. The patients ranged in age from 3 months to
56 years. All 20 patients were referred to the Cardiovascular
Diagnostic Laboratory for evaluation because of clinical evi-
dence of significant pulmonary stenosis. Eleven of the patients
underwent diagnostic cardiac catheterization at Johns Hopkins
Hospital (seven patients) or at another institution (four patients)
before being scheduled for balloon valvuloplasty. Nine patients
underwent diagnostic catheterization and balloon valvuloplasty
during the same procedure. Balloon valvuloplasty was present-
ed to the patients and their parents as an investigational proce-
dure approved by the Joint Committee for Clinical Investiga-
tion. Informed consent was obtained in writing for each patient
before the procedure.
Eighteen of the patients had typical pulmonary valve stenoses
with domed stenotic pulmonary valves that were apparent on
cineangiograms. One patient had a dysplastic pulmonary valve.
From the Departments of Pediatrics, Radiology, and Surgery of the
Johns Hopkins University School of Medicine. Baltimore.
Address for correspondence: Dr. Jean S. Kan, Department of Pediat-
rics, Johns Hopkins University School of Medicine, Baltimore, MD
21205.
Received Oct. 3. 1983; revision accepted Nov. 23, 1983.
554
One patient with pulmonary atresia and a hypoplastic right
ventricle underwent a Brock procedure during the neonatal peri-
od. At 1 year of age she had evidence of persistent right ventric-
ular outflow tract obstruction.
Technique of valvuloplasty. The method of valvuloplasty
was the same for each patient, regardless of age. Both groins
were prepared and draped. A No. 7F sheath was introduced
percutaneously into the right femoral vein. A No. 5F sheath
was introduced into the left femoral vein, and a Teflon arterial
cannula was introduced into the left femoral artery. Heparin
(100 units/kg) was administered intravenously. Cardiac output
was measured by the thermal dilution technique. Femoral arte-
rial, right ventricular, and pulmonary arterial pressures were
recorded.
A No. 7F balloon-tipped wedge pressure catheter was ad-
vanced from the right femoral vein to the left pulmonary artery.
An 0.035 inch diameter (200 cm length) angioplasty J
guidewire* was introduced through the catheter and positioned
with the J well into the left lower lobe pulmonary artery. The
No. 7F catheter and introducing sheath were removed, leaving
the guidewire in place in the left pulmonary artery. While the
catheter was being withdrawn care was taken to avoid advanc-
ing excess guidewire, so that the wire course would remain
straight and there would be no looping of the wire in the heart.
The right femoral vein was dilated with a No. 9F dilator.
Selection of the appropriate balloon size was based on mea-
surement of the dimension of the valve anulus, as determined
from the cineangiogram. The magnification factor of the cin-
eangiogram was determined by comparing the angiographically
determined diameter of the catheter to its actual diameter. The
actual dimension of the valve anulus was thus equal to:
Actual catheter diameter
Measured anulus diameter x
Measured catheter diameter
For the first six patients a balloon diameter 1 to 2 mm less
than the dimension of the pulmonary valve anulus was selected
to minimize the risk of rupture of the pulmonary artery. For the
subsequent 14 patients a balloon diameter equal to or 1 mm
*Rosen wire (Cook, Inc., Bloomington. IN).
tMedi-Tech, Watertown, MA.
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 THERAPY AND PREVENTION-VALVULAR HEART DISEASE
TABLE 1 TABLE 2
Clinical characteristics and balloon diameter Right ventricular pressure before and after valvuloplasty and at
follow-up in patients with typical pulmonary valve stenosis
Balloon
Patient diameter Right ventricular pressure
No. Age Sex (mm) (mm Hg)
Typical pulmonary valve stenosis Patient After
1 8 yr F 14 No. Initial valvuloplasty Follow-up
2 14 yr F 15
3 11/2 yr M 10 1 60 28 38
4A 3 mo M 6 2 72 44 39
6 mo M 10 3 70 45 54
5 4 yr F 15 4 132 100
6 2 yr F 12 80 50 46
7 21/2 yr M 15 5 55 40 45
8 22 yr F 20 6 72 54 56
9 3 yr M 12 7 96 36
10 l yr M 12 8 104 48 36
1-1 56 yr F 20 9 52 34 33
12 8 mo M 10 10 94 45 38
13 3 yr M 15 11 80 36
14 lOyr M 20 12 94 42
15 5 yr M 20 13 70 43
16 3 yr F 15 14 65 37 -
17 10 yr M 18 15 72 37
18 8 yr M 18 16 142 40
Dysplastic pulmonary valve 17 108 60
19B yr M 12 18 108 40
11/2 yr 15 Mean-+-SD 86+26 42+8 43+8
Pulmonary atresia (status after Brock procedure)
11 mo
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20 F 12
APatient 4 had balloon valvuloplasty twice, at 3 months and at 6
months of age.
BPatient 19 had balloon valvuloplasty twice, at 1 year and 1 1/2years.
greater than the dimension of the valve anulus was selected.
Modification of the balloons, based on the experience with the
first 10 patients, permitted rapid inflation and deflation to mini-
mize the time of occlusion of the right ventricular outflow
tract. "l Modifications included shortening balloon length from 4
to 3 cm and increasing the cross-sectional area of the balloon
inflation lumen.
The balloon used for dilation was attached through a pressure
gauge to a 20 ml syringe that was filled with diluted (30%)
contrast material. All air was evacuated from the balloon and as
a test it was filled and emptied several times. It was then
wrapped around the catheter in a clockwise direction. The bal-
loon-forming tool, which is packaged with the balloon, was
temporarily placed on the balloon to maximize wrapping around
the catheter for easier percutaneous insertion.
The catheter used for dilatation was advanced over the 0.035
inch guidewire and introduced into the right femoral vein with a
counterclockwise rotation as the balloon entered the vein. The
guidewire was held taut to avoid looping in the heart and the
catheter was advanced into the right ventricular outflow tract
with the stenotic valve at the center of the balloon. The
guidewire was left in position in the left pulmonary artery to
stabilize the tip of the stiff catheter during the balloon inflation.
This made it possible to adjust the position of the balloon rapidly
and to minimize the possibility of damage to the pulmonary
artery.
A No. SF catheter was passed into the right ventricle from the
Vol. 69, No. 3, March 1984
left femoral vein to monitor right ventricular pressure during
balloon inflation. The electrocardiogram, femoral arterial pres-
sure, and right ventricular pressure were recorded continuously
during dilatation.
The balloon was inflated by hand pressure. The "waisting"
(visible indentation of the balloon caused by the stenotic valve)
of the balloon was observed by fluoroscopy and the inflation
pressure required to eliminate the indentation of the balloon was
noted by an assistant. Disappearance of the waist occurred sud-
denly as the valve was opened. Peak inflation pressure usually
ranged from 45 to 60 psi. The balloon was rapidly deflated and
then reinflated twice subsequently to document that there was
no waisting of the balloon at the early phase of inflation. Figure
1 shows the inflated balloon during valvuloplasty in one of the
patients. Oxygen (by mask) and intravenous atropine (0.01 mg/
kg) were administered if bradycardia was observed during the
first balloon inflation (three patients).
The dilatation balloon catheter was withdrawn and removed
from the vein with a counterclockwise rotation while suction
was applied to the balloon to maximally deflate it. Hemostasis
was achieved by direct compression of the right groin. A ther-
mal dilution catheter was advanced to the pulmonary artery
from the left femoral vein and cardiac output was again mea-
sured, as were the pulmonary arterial, right ventricular, and
femoral arterial pressures. The venous catheter and arterial can-
nula were removed from the left groin and hemostasis was
achieved by direct compression. The heparinization was not
reversed at the end of the procedure and no long-term anticoagu-
lation therapy was instituted.
The ages of the patients and balloon sizes are shown in
chronologic order according to timing of the procedure in table
1. There were no complications in performing valvuloplasty in
any of these patients.
555
 KAN et al.
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FIGURE 1. Valvuloplasty balloon during inflation. A, The balloon catheter across the pulmonary valve in an early phase of
inflation. The balloon is indented by the stenotic valve. Note the guidewire placement deep in the left pulmonary artery. B, The
balloon catheter fully inflated with the waisting of the balloon, abolished.

Follow-up cardiac catheterization was performned in 1 1 of the Results

patients at intervals of 2 to 12 months after the valvuloplasty
(mean, 7 months). In each of these the follow-up catheterization
was performed percutaneously through the right femoral vein.
There was no evidence of venous occlusion from the previous
balloon valvuloplasty. At follow-up the cardiac output was
measured by the thermal dilution technique. Pulmonary arterial,
right ventricular, and femoral arterial pressures were measured.
The remaining nine patients are scheduled for follow-up cardiac
catheterization at between 6 to 12 months after their valvulo-
plasties.
556
Typical pulmonary valve stenosis. All 18 patients with
typical pulmonary valve stenoses had hemodynamic
evidence indicating relief of pulmonary stenosis after
the balloon valvuloplasty. The right ventricular pres-
sures before and after the valvuloplasty and at follow-
up are shown in table 2. Right ventricular pressure
decreased from 86 ± 26 to 42 + 8 mm Hg after the
CIRCULATION
 THERAPY AND PREVENTION-VALVULAR HEART DISEASE
TABLE 3
Right ventricular to pulmonary arterial systolic pressure gradient (SPG) and cardiac index (Cl) before and after
valvuloplasty and at follow-up in patients with typical pulmonary valve stenoses
Initial After valvuloplasty Follow-up
Patient SPG CI SPG CI SPG CI
No. (mm Hg) (1/minIm2) (mm Hg) (1/min/m2) (mm Hg) (I/min/m2)
I 45 4.2 14 2.5 20 3.7
2 60 3.7 21 3.8 11 3.0
3 48 3.9 28 3.7 31 5.0
4 120 8.7 82 8.7
58 9.6 24 7.0 22 5.4
5 37 5.0 35 6.5 23 5.4
6 43 5.3 24 4.2 26 4.4
7 76 3.4 15 3.0
8 83 2.3 30 2.5 22 3.4
9 37 3.4 15 NA 21 4.2
10 72 3.0 23 3.0 21 3.8
11 70 2.5 24 1.8
12 83 2.9 24 2.9
13 55 5.6 25 5.3
14 39 3.5 20 3.3
15 47 4.9 20 NA
16 125 4.7 13 NA
17 89 3.2 44 3.2
18 89 4.0 19 3.5
Mean+SD 68+27 4.4+ 1.9 23+8 4.1 + 1.8 22+5 4.2+0.8
NA = not available.

valvuloplasty (p < .001). The peak systolic pressure nary valves still appeared thickened, but a much
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gradients between the right ventricle and pulmonary broader front of contrast material entered their pulmo-
artery before and after valvuloplasty and at follow-up nary arteries with each systole, suggesting that the
are shown in table 3. The right ventricular to pulmo- pulmonary valves had been opened (figure 3). Follow-
nary arterial peak systolic pressure gradient decreased up catheterization in nine patients with typical pulmo-
from 68 ± 27 to 23 + 8 mm Hgt after the valvulo- nary valve stenoses demonstrated persistent relief of
plasty (p < .001).t Analysis of cardiac index along right ventricular hypertension. Peak systolic pressure
with each systolic pressure gradient suggests that the gradients, right ventricular pressures, and cardiac in-
decrease in gradient was not caused by a drop in cardi-
ac output related to the procedure. Typical Pulmonary Value Stenosis
150 r N=18
During the period of full balloon inflation peak right
ventricular pressure ranged from 88 to 238 mm Hg
(mean 141 + 49).
To compare patients of various ages and with differ-
ent systemic arterial pressures, the right ventricular 100 K
pressure was expressed as a percentage of systemic RVP (%)
pressure (right ventricular pressure/femoral arterial FAP
pressure x 100). The values for the 18 patients with
typical pulmonary valve stenoses are shown in figure 50 _
2. Mean right ventricular pressure/femoral arterial
pressure (%) decreased from 80 ± 26% to 38 ± 7%
(p < .001) after the valvuloplasty.
0
In three patients right ventriculography was per- Initial Immediately After Follow Up
Volvu loplosty n=9
formed immediately after valvuloplasty. Their pulmo-
FIGURE 2. Right ventricular pressure expressed as percentage of sys-
*Mean values -+- 1 SD are given for this and all subsequent results. temic pressure before and after valvuloplasty and at follow-up. The fall
t Significance was determined by paired t test. in right ventricular pressure after valvuloplasty persisted to follow-up.
Vol. 69, No. 3, March 1984 557
 KAN et at.

dexes were not significantly different from the results
immediately after valvuloplasty.
By clinical evaluation each of the 18 patients with
typical pulmonary valve stenosis had a decrease in the
intensity of the systolic murmur with a change in qual-
ity of the murmur to a lower frequency with early
systolic peaking. None of the patients developed an
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early diastolic murmur either immediately after valvu-
loplasty or at serial follow-up examinations. This sug-
gests that no significant pulmonary valve insufficiency
was created by the balloon valvuloplasty.
Dysplastic pulmonary valve. The one patient with a
thick nodular pulmonary valve and no poststenotic di-
latation, as demonstrated by angiography, was diag-

FIGURE 3. Right ventricular cineangiograms obtained before and after valvuloplasty. A, The lateral right ventriculogram before
the valvuloplasty shows the domed stenotic pulmonary artery. B, After the valvuloplasty the pulmonary valve is less stenotic.
Residual infundibular narrowing is still apparent.
558 CIRCULATION
 THIERAPY AND PREVENTION VALVULAR HEART DISEASE
FIGURE 4. Right ventricular cineangiogram in the patient with a dysplastic puliionary valve showing the thickened nodular
valve tissue and absence of poststenotic dilatation.
nosed to have a dysplastic pulmonary valve (figure 4).
Balloon valvuloplasty was performed and resulted in
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an initial fall in the right ventricular pressure from 78%
to 54% of systemic pressure. At follow-up catheteriza-
tion the right ventricular pressure had increased to 71 %
of systemic pressure. Balloon valvuloplasty was again
attempted and there was a fall in the right ventricular
pressure to 44% of systemic pressure. However, at
subsequent follow-up the right ventricular pressure
had again increased to 62% of systemic pressure.
Pulmonary atresia: status after Brock procedure. The
11 -month-old girl with pulmonary atresia and a hypo-
plastic right ventricle underwent a Brock procedure in
the neonatal period. Cardiac catheterization revealed a
right ventricular pressure that was 100% of systemic
pressure. She had a moderate initial response to valvu-
loplasty with a fall in right ventricular pressure to 54%
of systemic pressure. At follow-up her right ventricu-
lar pressure had increased to 71% of systemic pressure.
Her cineangiogram demonstrated redundant tissue in
the valve area with apparent subvalvular narrowing
(figure 5). She was referred for surgical reconstruction
of the right ventricular outflow tract.
Discussion
Transluminal balloon valvuloplasty appears to be an
effective method for relieving typical congenital pul-
Vol. 69, No. 3, March 1984
monary valve stenosis. Although the right ventricular
pressures remain mildly elevated, all of the nine pa-
tients who have undergone follow-up cardiac catheter-
ization have right ventricular pressures that are suffi-
ciently low so that these patients would not be
considered candidates for surgical correction of the
residual mild pulmonary stenosis.
It is not surprising that the desired result was not
obtained in the patient with a dysplastic pulmonary
valve. The stenosis caused by such a valve does not
respond to simple valvotomy, but requires valve resec-
tion to provide relief of obstruction.12
In several patients the right ventricular pressure did
not drop immediately after the valvuloplasty. After
inflation of the balloon the right ventricular pressure
remained slightly elevated and then fell slowly to its
lowest level 15 min after valvuloplasty. In these pa-
tients we speculate that the hypercontractility of the
hypertrophied right ventricle was responsible for the
delay in right ventricular pressure decrease. In patients
with severe infundibular hypertrophy we would expect
further drops in right ventricular pressure as the hyper-
trophy regresses.
Long-term results will need to be evaluated before
transluminal valvuloplasty can replace open heart sur-
gery for the management of pulmonary valvular ste-
nosis. The preliminary results suggest that balloon
559
 KAN et al.
FIGURE 5. Right ventricular cineangiogram in the patient with pulmonary atresia who had undergone Brock procedure.
valvuloplasty provides palliative if not permanent im-
provement. The early surgical experience with the
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Brock procedure1 showed that once the stenotic valve
was opened manually in an operative procedure, this
effect was lasting. If parallels can be drawn to surgical
valvuloplasty, balloon valvuloplasty should also pro-
vide a permanent effect.
We extend our gratitude and appreciation to Mrs. R. M.
Cherry for manuscript preparation.
References
1. Zeitler E, Gruntzig A, Schoop W: Percutaneous vascular recanali-
zation: technique application, clinical results. Berlin, 1978,
Springer-Verlag
2. Tegtnieyei CJ, Dyer R, Teates CD. Ayers CR. Carey RM. Wcl-
Ions HJJ Jr, Stanton LN: Percutaneous transluminal dilation of the
renal arteries: techniques and results. Radiology 135: 589, 1980
3. Gruntzig AR. Senning A, Siegonthaler WE: Noiiopcrative dilata-
tion of coronary artery stenosis: percutaneous transluininal coro-
nary angioplasty. N EngI J Med 301: 61, 1979
4. Spence RK, Freiman DB, Gatenby R, Hobbs CL, Borker CF.
560
Berkowitz HD. Roberts B, McClean G, Olega S, Ring ES: Long-
term results of transluminal angioplasty of the iliac and femoral
arteries. Arch Surg 116: 1377, 1981
5. Kan JS. White RI Jr, Mitchell SE, Gardner TJ: Percutaneous bal-
loon valvuloplasty: a new method for treating congenital pulmo-
nary valve stenosis. N Engl J Med 307: 540, 1982
6. Lababidi Z, Wu J-R: Percutaneous balloon pulmonary valvulo-
plasty. Am J Cardiol 52: 560, 1983
7. Lock JE, Castanieda-Zuniga WR, Fuhrman BP, Bass JL: Balloon
dilatation angioplasty of hypoplastic and stenotic pulmonary arter-
ies. Circulation 67: 962, 1983
8. Singer MI, Rowen M, Dorsey TJ: Transluminal aortic balloon
angioplasty for coarctation of the aorta in the newborn. Am Heart J
103: 131, 1982
9. L ock JE, Bass JL, Amplatz K, Fuhrman BP, Castaneda Zuniga W:
Balloon dilation angioplasty of aortic coaretations in infants and
children. Circulation 68: 109, 1983
10. Kan JS, White RI Jr. Mitchell SE, Farmlett EJ, Donahoo JS,
Gardner TJ: Treatment of restenosis of coarctation by percutancous
transluminal angioplasty. Circulation 68: 1087, 1983
lI. Mitchell SE, White RI, Kan J, Tolkoff J. Improved balloons for
large vessel and valvular angioplasty. Am J Roentgenol (in press)
12. Koretzky ED, Mucller JH, Korns ME, Schwartz CJ, Edwards JE:
Congenital pulmonary stenosis resulting from dysplasia of the
valve. Circulation 40: 43, 1969
13. Blalock A, Keiffer RF: Valvulotomy for the relief of congenital
valvular pulmonic stenosis with intact ventncular septunm. Ann
Surg 132: 496, 1950
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