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(Circulation. 1995;92:893-897.)
© 1995 American Heart Association, Inc.
Articles |
Repeat Dilation of Intravascular Stents in Congenital Heart Defects
From Schneider Children's Hospital, Department of Pediatric Cardiology, New Hyde Park, NY (F.F.I.), and Texas Children's Hospital, Department of Pediatric Cardiology, Houston, Tex (R.G.G., M.R.N., C.E.M.).
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Abstract |
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 Top Abstract IntroductionMethods Results Discussion References |
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Background Intravascular (Palmaz) stents have been successfully implanted in patients with congenital and acquired branch pulmonary stenosis. Early results are excellent; however, there is no information on restenosis and repeat dilation in patients with congenital heart disease. The purpose of this study is to review the incidence of restenosis and demonstrate the safety and efficacy of repeat dilation of stents in this group of patients.
Methods and Results Of 94 patients with 163 implanted stents in this single-center study, 43 patients with 73 implanted stents underwent recatheterization. Only 2 of 73 restudied stents (3%) developed significant restenosis. In 20 patients, 30 stents were redilated. At stent implantation, the mean age of this subgroup was 14.2 years, the mean intraluminal diameter increased from 4.9 to 10.7 mm (P=.0001), and the systolic gradient (mean) across the stent decreased from 52 to 11 mm Hg (P=.0001). At recatheterization (mean, 13 months), all stents were patent. The mean diameter decreased by 1.2 mm (P=.0001), but the increase in the gradient (mean, 3 mm Hg) was not significant (P=.11). After repeat dilation, the diameter increased from 9.5 to 12.2 mm (P=.0001), and the gradient decreased from 14 to 8 mm Hg (P=.0003). The 2 stents with restenosis were redilated successfully. Two patients underwent a successful second redilation of 3 stents at 18 and 26 months. There were no complications.
Conclusions All stents remained patent. The occurrence of significant restenosis is low (3%), and these restenoses can be redilated and/or restented. Repeat dilation of the Palmaz stent implanted in branch pulmonary artery stenosis can be performed with safety and efficacy (94% success rate) up to 3 years after stent implantation.
Key Words: stents • restenosis • heart defects • congenital
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Introduction |
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TopAbstractIntroductionMethods Results Discussion References |
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The concept of intravascular stent implantation to maintain vessel patency was first introduced by Dotter1 in 1969. However, extensive clinical trials were not carried out until the late 1980s, after improvements in stent technology and design were made. The Palmaz stent (Johnson and Johnson Interventional Systems) has been undergoing clinical evaluation in adults since 1987, and its results have been reported widely.2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Various animal experiments have been carried out to demonstrate successful implantation of the Palmaz stent in pulmonary arteries, systemic veins, and the ductus arteriosus.17 18 More recently, this stent has been used to treat stenotic or hypoplastic vessels in children with congenital heart disease,19 20 21 22 and early results are excellent. However, there is no information on long-term patency of stents, restenosis, or the ability to further dilate stents to accommodate growth in the child with branch pulmonary artery stenoses.
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Methods |
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TopAbstractIntroductionMethods Results Discussion References |
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Patient Profile
The study was performed under a Food and Drug Administration protocol after Institutional Review Board approvals and parental/patient consent had been obtained. Between October 1989 and July 1993, 94 patients with congenital heart disease underwent cardiac catheterization and implantation of 163 stents. Forty-three of these patients, with 73 stents, were recatheterized as part of the investigational protocol. Thirty of 31 stents in 20 patients underwent repeat dilation. Two patients with 3 stents underwent a second repeat dilation, for a total of 33 repeat dilation procedures. Seven of the 20 patients had 1 additional stent implanted at the time of the repeat dilation, for a total of 38 stents.
There were 12 male and 8 female patients. Diagnoses included branch pulmonary artery stenoses after repair of tetralogy of Fallot (10), pulmonary atresia (5), truncus arteriosus (2), transposition of the great arteries (1), and congenital bilateral branch pulmonary artery hypoplasia (2). Patient age at stent placement was 3.8 to 30.2 years (mean, 14.2 years), and weight was 13.7 to 76 kg (mean, 40.4 kg). The time interval between initial stent implant and repeat dilation was 0.25 to 31.2 months (mean, 13.2 months).
Indications for repeat dilation included (1) initial limited dilation in 18 stents, (2) a residual waist in 10 stents, and (3) severe restenosis due to intimal proliferation in 2 stents. At implantation, limited dilation was carried out in those patients who were very small and/or whose pulmonary arteries had very severe stenoses. It was anticipated that these stents could be further dilated at follow-up catheterization. By the technique of serial dilations, these vessels could be expanded to approach normal caliber for the patient size, thereby decreasing the need for initial overdilation and the risk of vessel rupture.
Cardiac Catheterization
Techniques of stent placement and
stent specifications have been
reported previously19 and will not be reviewed here.
Repeat dilation was performed with the balloon catheter passed directly
over the guide wire through the previously placed stent without the
need for a long sheath. Right heart catheterization was performed via a
femoral vein. After pressure data across the stent were obtained, an
angiogram of the pertinent vessel and stent was taken with a calibrated
Cardiomarker catheter (USCI) as a measurement reference. The
minimal diameter of the contrast column within the stent was used as
the minimal vessel diameter. Care was taken so that the calibration
marks on the catheter were aligned exactly as thin straight bands on
edge on the angiocardiograms. An end-hole catheter was advanced across
the stent, and a 0.038-in short-tip SuperStiff exchange wire (MediTech)
was inserted into a distal pulmonary artery beyond the stent. A balloon
catheter with a diameter approximating that of the adjacent normal
pulmonary artery segment (usually 12, 15, or 18 mm) was advanced over
the wire until it was positioned in the middle of the stent. The
balloon was inflated to the recommended atmospheric pressure for 8 to
12 seconds. Inflations were often repeated to further increase the
stent diameter (mean, three inflations). If a stenosis persisted,
another dilation was performed with either a larger balloon or a
high-pressure BlueMax balloon (Medi-Tech). When stents were placed
bilaterally in very proximal branch pulmonary arteries, repeat dilation
required simultaneous bilateral balloon inflations to avoid puncture of
the balloon by the adjacent stent or proximal distortion of either
stent (Fig 1
). After redilation, pressure measurements
and angiography were repeated. Although heparin (3 U/mL) is added
to the flush solution, the patients were not anticoagulated routinely
with heparin as they were during stent implantation unless an
additional stent was to be deployed. Antibiotic prophylaxis was not
given for routine redilation. The patients were restarted on aspirin
and dipyridamole for 6 months (Fig 2).
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Statistical Analysis
All data were expressed as the group
mean±SD. A Student's
paired t test was used to compare the minimal vessel
diameters and the systolic pressure gradients before and after stent
placement and repeat dilation. A value of P
.05 was
considered statistically significant.
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Results |
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TopAbstractIntroductionMethods Results Discussion References |
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Stents
Twenty patients underwent initial placement of 31 stents. At follow-up catheterization, 30 of 31 stents underwent repeat dilation. Seven patients received 1 additional stent. Five of these were for additional areas of stenoses found at follow-up catheterization. One patient required a stent to be placed inside an initial stent to treat a restenosis due to an intimal waist. In the seventh patient, a stent had become distorted as a result of extrinsic compression by the adjacent enlarged aorta. A second stent was implanted overlapping the proximal half of the first stent. This effectively "rounded out" the disfigured oval shape of the first stent, added structural support against the pulsations of the aorta, and relieved a more proximal stenosis. Two patients underwent a second repeat dilation of 3 stents, for a total of 33 redilation procedures.
Stent Patency/Restenosis
After initial stent placement, the
group mean systolic
gradient across the stent decreased from 52 to 11 mm Hg
(P=.0001), and the mean minimal intraluminal diameter
increased 118%, from 4.9 to 10.7 mm (P=.0001). The ratio of
right ventricular systolic pressure to femoral artery pressure (RV/FA)
decreased from 0.71 to 0.47 (P=.0001) (see the
Table).
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At follow-up catheterizations, all stents
remained patent. The mean
diameter of the stents decreased by 1.2 mm (P=.0001), and
the mean systolic gradient increased by 3 mm Hg (P=.11). In
most cases, a thin intimal lining, usually a few tenths of a
millimeter, can be seen covering the stent, as evidenced by
radiolucency between the metallic stent struts and the contrast in the
lumen. Occasionally, an intimal mound 1 to 2 mm thick is seen at the
proximal or distal segment of the stent or in the area of any residual
waist. This type of intimal proliferation decreased the diameter of the
stent but generally did not create significant gradients. However, a
large discrete intimal waist was seen in 2 stents, which resulted in
large pressure gradients. One was located in the distal end of a stent,
and the second was at the region of minimal overlap between two stents
placed in series in a patient with congenital hypoplasia of the
pulmonary arteries. Both were redilated successfully (Fig 3).
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Repeat Dilation
After repeat dilation, the group mean
diameter increased
28%, from 9.5 to 12.2 mm (P=.0001), and the mean gradient
decreased from 14 to 8 mm Hg (P=.0003) (Figs 4
and 5). The mean RV/FA ratio decreased
from 0.53 to 0.46 (P=.002). Including the three stents that
underwent a second repeat dilation, the diameters increased by an
average of 30% (see Table
).
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Standard-pressure balloons
were successful in further dilating 14
stents, but 19 stents required high-pressure balloons. Serial dilations
with increasingly larger-diameter balloons were performed in 13 stents.
The high-pressure balloons were more effective in relieving residual
waists and increasing the overall stent size. Since high-pressure
balloons were not available in sizes larger than 12 mm in diameter, two
side-by-side simultaneously inflated high-pressure balloons were
required in three cases of the repeat dilations and one of the second
repeat dilations (Fig 6). Because the double-balloon
inflation technique resulted in an oval stent as seen in cross section,
a larger-diameter standard-pressure balloon was used to "round
out" the stent after a double-balloon inflation.
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Repeat dilation
was not successful in 2 stents. In 1 previously
described patient who developed an intimal waist inside her stent,
redilation with standard-pressure balloons did not relieve the severe
restenosis. This same patient underwent a repeat catheterization 26
months later, and a second stent was placed within the first stent.
With two high-pressure balloons, the intimal waist was
successfully eliminated. In the second patient with congenital
hypoplastic pulmonary arteries, although the stent was further dilated
from 4.4 to 6.6 mm, the gradient remained significant because of distal
diffuse hypoplasia. With the exception of these two cases, all
gradients after repeat dilation were 15 mm Hg (see Fig 3).
Complications
There were no complications during the repeat
dilation procedures.
No deaths, emergent surgery, or blood transfusions were related to the
interventions. All patients were discharged within 24 hours after
catheterization. Three adverse events occurred. Balloon rupture
occurred in 2 patients. In 1 of these patients, the balloon had entered
through the side of a previously placed left pulmonary artery (LPA)
stent whose proximal end was protruding into the main pulmonary artery.
Despite this position, the stent did not impede blood flow.
Furthermore, balloon rupture did not result in any stent fractures,
distortion, or dislodgment. The patient eventually underwent surgery
for a conduit revision, tricuspid annuloplasty, and placement of a St
Jude valve. The proximal end of the LPA stent was noted to be free of
thrombus and was resected uneventfully. In 1 patient with bilateral
proximal branch pulmonary artery stents, the proximal end of the right
pulmonary artery stent was disfigured while the LPA stent was
redilated, and this was "pruned" at the time of his full repair
(pulmonary atresia/ventricular septal defect).
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Discussion |
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TopAbstractIntroductionMethods Results Discussion References |
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The results of Palmaz stent implantation for stenotic arteries in adults have been encouraging. This treatment modality has been applied recently to the pediatric population with congenital heart disease, and early results have been excellent.19 20 This is extremely important since surgical options for some of these stenotic lesions are limited. This is particularly true for congenital and postsurgical (shunts, anastomoses) branch pulmonary stenosis and postsurgical systemic vein stenosis, for which the results of operative repair are dismal.23 24 25 26 27 28 29 Balloon dilation of branch pulmonary stenosis has had mixed results, with initial success of <60% for achieving a normal vessel size for the patient's size and restenosis rates of 16% to 40%.30 31 32 The lack of success with balloon dilation alone is thought to be due to elastic recoil of the pulmonary arteries. Although the early success of stenting stenotic branch pulmonary arteries in children is encouraging, there is little information on long-term stent patency and vessel restenosis in pediatric cases.
In our group of patients with a mean follow-up of 13.2 months, all of the stents were patent. Most developed a thin intimal lining within the stent that decreased the lumen diameter by 1.5 mm (mean). This is similar to reports in the adult literature.3 7 27 In the restudied stents, we found only a 3% (2/73) rate of significant restenosis, which is similar to those found for the iliac stents in adults.9 33 If a residual waist was present from the initial stent placement, often there was intimal hyperplasia on both sides of the waist, resulting in a constant vessel diameter within the stent. Animal studies indicate that neointima remodels the lumen by filling in the depressions produced by the waist and struts.34 Some have suggested that local eddy currents and turbulence created by the waist may cause microscopic vessel wall injury and result in more severe intimal hyperplasia.15
In an animal model, Tominaga et al35 studied the effects of gaps in stents on intimal proliferation within stents and found greater intimal hyperplasia in those stents without gaps. They theorized that gaps between the wires allow more rapid endothelialization of the stent and potentially reduce subacute thrombus deposition and prevent neointimal reaction and hyperplasia. Furthermore, stents with gaps have less metallic surface area for neointimal growth. It is of interest that in our series, 1 of 2 patients with restenosis had a severe intimal waist that developed in the region of minimal overlap (2.5 mm) of two stents in the right pulmonary artery. However, greater overlapping of stents placed in the same patient's LPA (7 mm) did not develop stenosis. This patient was 1 of 2 patients who had congenital hypoplastic pulmonary arteries and never had surgery. Whether the occurrence of restenosis in this particular patient was due to minimal overlapping stents and hence, a variable gap or was part of his overall congenital disease or some other mechanism is unclear. Longer-term evaluation of all our patients will be necessary to determine the mechanism and rate of restenosis.
A second concern is the ability of a stent to be further dilated to accommodate a child's growth. Repeat dilations of stents in animal studies have been carried out with success.36 37 Grifka et al36 reported success in further dilation of stents in the aorta of growing minipigs, with weights increasing by 200%. Morrow et al,37 in a recent article, reported up to 21% increase in stent diameter after repeat dilation 11 weeks after stent implant. The goal of repeat dilation is to expand the stent to equal the size of the adjacent normal pulmonary artery. In our series, actual stent expansion was the major contributor to the larger vessel size and lumen diameter after redilation. The balloon size ranged from 10 to 20 mm in diameter, with the majority 15 or 18 mm in diameter. Nineteen of 33 repeat dilations required high-pressure balloons. The lack of high-pressure balloons larger than 12 mm posed obvious limitations. In four cases, we circumvented the problem by inflating two high-pressure balloons simultaneously to further expand a stent. Since this created an oval stent as seen in cross section, a larger standard-pressure balloon was used to reshape the stent after the initial reexpansion with the two balloons. The double-balloon technique was effective for stents that failed dilations with the larger-diameter, standard-pressure balloons. Interestingly, in four cases, repeat dilation was performed using balloons of the same size and pressure as during initial stent implantation but still resulted in a further increase in minimal internal stent diameter that was larger by an average of 2 mm. A possible explanation is that the stent itself, over time, exerts a compression and a "thinning or softening" effect on the surrounding vessel architecture.
In our series, the redilation success rate was 94% (31/33), with no major complications. The limitations remaining are more distal and diffuse stenoses and the lack of larger higher-pressure balloons. Continuing improvements in stent and balloon technology should challenge those limits. Although the number of patients in our series is relatively small and follow-up is short, the low rate of restenosis and our initial success at redilation are encouraging. Obviously, long-term follow-up and ongoing evaluation of these patients are necessary. If these excellent intermediate results of stent implantation continue to hold up, intravascular pulmonary artery stents may become the treatment of choice for branch pulmonary stenosis. O'Laughlin et al38 recently summarized intermediate-term results of 121 stents in 85 patients in a combined Boston Children's and Texas Children's Hospital study and concluded that there was a continuing efficacy of this treatment modality.
Conclusions
In conclusion, we have demonstrated that (1) all
stents restudied
remained patent, with a low incidence of significant restenosis (2 of
73, or 3%) in intermediate restudy of a small nonselected sample of
vessels with stents previously implanted and (2) the Palmaz stent can
be redilated safely and effectively in patients with congenital heart
defects with an overall success rate of 94% (31 of 33).
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Acknowledgments |
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We express our appreciation to Dr Wesley Vick III for his computer expertise in the preparation of our graphs and angiograms and to the catheterization laboratory staff at Texas Children's Hospital.
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Footnotes |
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Reprint requests to Charles Mullins, MD, FACC, Texas Children's Hospital, Department of Pediatric Cardiology, 6621 Fannin St, Houston, TX 77030.
Guest editor for this article was James E. Lock, MD, Department of Cardiology, Children's Hospital, Boston, Mass.
Received October 17, 1994; revision received December 29, 1994; accepted February 8, 1995.
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