(Circulation. 1995;91:1840-1846.)
© 1995 American Heart Association, Inc.
Articles |
From the Lillie Frank Abercrombie Section of Pediatric Cardiology, Texas Children's Hospital, Baylor College of Medicine, and Texas Heart Institute, Houston.
Correspondence to Ronald G. Grifka, MD, Texas Children's Hospital, Pediatric Cardiology, 6621 Fannin St, Houston, TX 77030.
| Abstract |
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Methods and Results A total of 26 GGVODs were implanted as part of short- and long-term studies. In the short-term study, 1 GGVOD was implanted in each of 11 systemic arteries from 3.2 to 9.0 mm in diameter. All 11 arteries were occluded immediately. In the long-term study, an aortopulmonary shunt was placed in 10 dogs (9, Gore-tex graft; 1, subclavian artery) followed by GGVOD implantation; additionally, a GGVOD was implanted in 5 subclavian arteries. The dogs were boarded for 3 to 6 months, then recatheterized and euthanatized. Immediately after implantation, the 5 subclavian arteries and 9 Gore-tex shunts were occluded completely; the 1 subclavian artery shunt had a small residual leak. At recatheterization, all 10 shunts and 5 subclavian arteries were occluded completely. Necropsy revealed all shunts to be occluded, with the aortic and pulmonic orifices covered with a neointimal layer. The mean fluoroscopic time needed for GGVOD implantation was 9 minutes (range, 3 to 22 minutes).
Conclusions (1) In a canine model, the GGVOD is effective for transcatheter occlusion of arteries and aortopulmonary shunts from 3 to 9 mm in diameter. Possible indications in children include aortopulmonary collateral vessels, long patent ductus arteriosus, systemic-pulmonary shunts, AV malformations, and arteries supplying tumors. (2) GGVOD implantation requires a short fluoroscopic time.
Key Words: heart defects, congenital catheterization occlusion ductus arteriosus, patent
| Introduction |
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| Methods |
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The sack is constructed from two pieces of tightly woven
nylon. The
edges of the nylon pieces are thermally sealed, affording a circular
sack enclosure. The sack is attached to the sack catheter, which is a
4.5F end-hole catheter with an everted flare on the distal tip (Fig
1
). The sack fits tightly over the flared catheter tip
and is secured by a radiopaque metal tie string. A 5.5F release
catheter is used to push the sack off the sack catheter. The sack is
delivered to the vessel through a modified 8F 70-cm-long delivery
sheath.
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Two separate wires are used in the device, a floppy filler wire
and a
stiff pusher wire (Fig 2
). The filler wire is a standard
0.025-in spring guide wire with three modifications: the stiff inner
core removed, internal threads on the proximal end, and a
J-curve on the distal tip. The filler wire
internal threads screw onto the external threads of the pusher wire.
The pusher wire forces the filler wire through the sack catheter into
the sack. Once inside the sack, the filler wire coils, which serves two
functions: (1) filling the sack, thus occluding the vessel lumen, and
(2) providing transmural pressure to maintain the sack position in the
vessel. To remove the pusher wire, its crank handle is rotated
counterclockwise, which unscrews and separates it from the filler
wire.
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At this point, the sack is filled with the filler wire, but the
sack
remains attached to the sack catheter. To release the sack, the release
catheter is advanced up against the sack and held firmly in position
(Fig 3
). The sack catheter is withdrawn firmly (into the
fixed release catheter), which inverts the flared tip, allowing the
catheter to pull out of the sack.
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The GGVOD design allows for repositioning of the device before release. After the filler wire is inserted and before the pusher wire is unscrewed, an angiogram can be performed to assess device position and vessel occlusion. If needed, the filler wire can be pulled out of the sack, the device repositioned, and the filler wire reinserted into the sack. The filler wire can be removed and reinserted numerous times until the appropriate device position is obtained. If the GGVOD does not occlude the vessel, the wire can be pulled out of the sack and the sack pulled carefully back into the sheath and replaced with a different GGVOD (the same size, larger, or smaller) inserted through the same sheath.
To have devices that will allow a wide range of blood vessel diameters to be occluded, we evaluated sacks varying in diameter from 3 to 9 mm. Initially, the sack was manufactured in three sizes: 3-, 6-, and 9-mm diameter. However, this resulted in a range of vessel diameters too large for each size GGVOD. Currently, the GGVOD sack is manufactured in four sizes: 3-, 5-, 7-, and 9-mm diameter; all four GGVOD sizes are delivered through the same 8F sheath. Sacks of each size have filler wires of appropriate lengths to completely fill the sack. To provide sufficient transmural pressure, the sack diameter should be 1.0 to 1.5 mm larger than the diameter of the blood vessel to be occluded.
Short-term Model
A short-term study was performed in a canine
model using mongrel
dogs weighing from 22 to 32 kg. All studies were performed according to
institutional guidelines and the principles of the American
Physiological Society. In 6 dogs, GGVODs were implanted in various
subclavian, carotid, and renal arteries ranging from 3 to 9 mm in
diameter. Thirty minutes before surgery, each dog received an
intramuscular injection (acepromazine 0.5 mg/kg and atropine 0.05
mg/kg), had a peripheral intravenous line placed, then received general
anesthesia (isoflurane 0.5% to 4%, nitrous oxide 5% to 50%, oxygen
25% to 50%) and was intubated. The femoral areas were shaved,
prepared, and draped. By percutaneous technique, a 7F introducer sheath
with hemostasis valve (Argon Inc) was inserted into the femoral artery.
A 7F NIH Cardiomarker catheter (USCI Inc) was advanced through the
sheath into the aorta. In the lateral projection, angiograms were
obtained in the subclavian, carotid, and renal arteries. The artery
diameter was calculated from the 1-cm calibration marks on the
Cardiomarker catheter. The NIH catheter was removed and replaced with
an end-hole catheter (Cook Inc), which was advanced into the
corresponding subclavian, carotid, or renal artery. A 0.038-in stiff
exchange wire (Cook Inc) was inserted through the end-hole catheter
into the artery distal to the measured area. The catheter and sheath
were removed, with wire position maintained. The modified 8F long
sheath and dilator (Cook Inc) were inserted over the exchange wire into
the artery and advanced to the measured area. The dilator and wire were
removed. Contrast medium was injected through the sheath to confirm
position. The GGVOD sack (Cook Inc) was inserted into the long sheath
and advanced out the distal end. The (empty) sack was positioned in the
artery at the desired point of occlusion. The pusher wire was advanced
into the sack catheter, filling the sack with the filler wire. After
the pusher wire was inserted completely, the crank handle was rotated
counterclockwise, and the pusher wire was removed. The release catheter
was advanced up to the sack, then the sack catheter was pulled firmly,
which released the sack. To confirm vessel occlusion, the sheath was
withdrawn 20 mm and used to perform an angiogram. If a residual leak
occurred, a repeat angiogram was performed 5 minutes later. In 5 dogs,
a second GGVOD was placed in a separate artery supplying a different
vascular location. After device implantation, the dogs received
intravenous euthanasia solution (Beuthanasia D solution, 10 to 20 mL),
and the arteries containing the devices were removed at necropsy.
Long-term Model
With the experience and results obtained from
the short-term
study, a long-term animal model was created to evaluate the GGVOD. Ten
dogs (weight, 23 to 32 kg) underwent placement of an aortopulmonary
shunt; nine Gore-tex shunts were placed from the descending aorta to
the main pulmonary artery, and one shunt was a classic Blalock-Taussig
shunt. These aortopulmonary shunts facilitated GGVOD implantation by
providing a rather straight catheter course from the femoral vessels to
the shunt, possibly an easier catheter course than some aortopulmonary
shunts in children.
Under general anesthesia and by a standard left thoracotomy approach, the left lung was retracted. The anterior aspect of the descending aorta was dissected cleanly, as was the superior aspect of the main pulmonary artery. Heparin (100 U/kg) was administered. An aortopulmonary shunt was created by use of nonringed Gore-tex tubing (W.L. Gore & Assoc Inc) 5 or 6 mm in diameter and 5 cm long. The thoracotomy incision was closed in layers. The dogs remained intubated; catheterization and GGVOD implantation were performed. In each shunt, a GGVOD equal to or 1 mm larger than the shunt diameter was implanted. In 5 of the 10 dogs, a second GGVOD was implanted in a subclavian artery.
A 7F sheath was placed in both the femoral artery and vein. A 7F pigtail catheter (Cook Inc) was advanced into the arterial sheath to the level of the shunt. Angiography was performed to evaluate shunt patency and location; the best angiographic projection was either straight posteroanterior or shallow (20°) left anterior oblique angulation. A 7F end-hole catheter was advanced into the femoral venous sheath prograde through the right heart and into the main pulmonary artery. A 0.035-in angled Terumo Glidewire (Medi-Tech Inc) was advanced through the end-hole catheter, into the shunt, and down the descending aorta; this wire did not damage the recent surgical shunt anastomoses. The end-hole catheter was advanced over the wire. The wire was removed and replaced with a 0.038-in stiff exchange wire, then the catheter and sheath were removed. The 8F long sheath and dilator were advanced over the wire into the middle of the shunt. The GGVOD was advanced through the sheath into the shunt. As described previously, the filler wire was inserted into the sack, and the GGVOD was implanted. After device implantation, three angiograms were performed: one using the sheath in the main pulmonary artery to ensure that there was no obstruction to pulmonary blood flow and two in the aorta to assess the effectiveness of the GGVOD occlusion. In several dogs, the pigtail catheter was exchanged for a Judkins right coronary artery catheter (Cook Inc), which was positioned in the aortic end of the shunt for an additional angiogram.
The catheters and sheaths were removed, and hemostasis was obtained. The dogs awoke from anesthesia, were observed closely for several days, then were boarded for 3 to 6 months. Repeat catheterization was performed, with angiograms done in both the aorta and main pulmonary artery. If a second GGVOD was placed in a subclavian artery, an angiogram was performed proximal to this device. The animals received intravenous euthanasia solution, then the GGVODs were harvested. The shunts and arteries were evaluated macroscopically, followed by thin sectioning of the GGVOD. The sections were stained (hematoxylin and eosin, Masson's trichrome, and toluidine blue), then examined microscopically.
| Results |
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Long-term Model
Ten dogs had aortopulmonary shunts created: 9
Gore-tex
shunts (three 5 mm, six 6 mm) and 1 Blalock-Taussig shunt. A GGVOD was
implanted successfully in each shunt. The GGVODs remained in position
and resulted in immediate, complete occlusion of all 9 Gore-tex shunts
(Figs 5
, 6
, and 7
). The
Blalock-Taussig shunt had a small residual leak immediately after GGVOD
implantation. However, postcatheterization review of the cineangiograms
revealed that the subclavian artery diameter was 0.2 mm larger than the
occlusion device. Three to 6 months after device implantation, all 10
dogs underwent a follow-up catheterization. At recatheterization, all
GGVODs remained well positioned, and every aortopulmonary shunt was
occluded completely, including the Blalock-Taussig shunt.
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The 5 additional GGVODs, which were implanted in subclavian arteries, resulted in immediate complete subclavian artery occlusion. At recatheterization, each subclavian artery remained occluded completely, the GGVOD position was unchanged, and the vessels were intact.
Necropsy
evaluation revealed that both ostia of the shunt were
occluded, covered by a layer of uninterrupted endothelium (Figs
8
and 9
). Beneath the endothelial layer was a
neointima composed of dense fibrous connective tissue; this
showed a transition to thrombus undergoing organization in the region
of the GGVOD. There was a minimal inflammatory response to the nylon
sack (Fig 10
).
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Fluoroscopic time was recorded during GGVOD implantation. For device implantation in a subclavian artery, 2 to 6 minutes (mean, 4 minutes) of fluoroscopy was needed. For device implantation in an aortopulmonary shunt, 3 to 22 minutes (mean, 9 minutes) of fluoroscopy was needed. A majority of this time was used manipulating the wires and catheters carefully across the recent shunt anastomoses.
Complications
One complication occurred during this
investigation. During device
implantation in a Gore-tex shunt, a sack dislodged from the delivery
catheter and embolized to the distal left pulmonary artery. A second
device was implanted successfully in the shunt. The embolization was
caused by two factors: a kinked sheath and an insufficient flare on the
delivery catheter. The sheath material has been improved, and the
flaring mechanism has been corrected. Subsequently, eight devices were
implanted without an embolization.
Although there are several components to the complete GGVOD system (sheaths, catheters, wires), no other technical malfunctions occurred. Also, when the long sheath was allowed to fill with blood (from the high-pressure aorta) before the sack was inserted, air could not enter the sheath, eliminating the possibility of an air embolism.
| Discussion |
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Each occlusion device is effective for a specific defect. Problems arise when patients have other cardiovascular defects that require occlusion, and the present devices are technically suboptimal for treatment of these defects. When an occlusion device is used for such a defect, the procedure is more complicated and the results are often less successful than desired. Improved occlusion devices, including both improved old devices and totally new devices, will broaden the spectrum of cardiovascular defects that can be treated without surgery. With this as our goal, we have been developing and evaluating the GGVOD.18 19
Animal Studies Using the GGVOD
In the short-term study, the
GGVOD was implanted in various
systemic arteries. Each GGVOD remained in position, all vessels were
occluded completely, and there were no device embolizations. However,
since each artery had a gradually tapering diameter, if the GGVOD were
to embolize, it could only migrate distally several millimeters.
Nonetheless, this model demonstrated the feasibility of GGVOD
implantation. Also, it confirmed the hypothesis that if the sack was
not in the desired position (due to catheter manipulation, wire
insertion, patient movement, etc) before release, the wire could be
withdrawn and the sack repositioned. None of the occlusion devices
currently available afford this margin of safety.
The long-term study addressed several additional questions. Over a 3- to 6-month period, the nylon sack retained its integrity, and the device did not migrate from the implantation site. This is encouraging information, since in the aortopulmonary shunts, there was a persistent high pressure gradient against the GGVOD. Thrombus formed on both sides of the GGVOD, ensuring vessel occlusion and device position. As anticipated, a smooth neointimal layer covered the thrombus. The one shunt with the small residual leak closed spontaneously and also developed thrombus formation and neointimal covering. Since GGVOD implantation in Gore-tex grafts did not provide information about "native" vessel reaction to the device, a GGVOD was implanted in subclavian arteries; each GGVOD remained well positioned in the subclavian artery, the arterial walls were intact, and the vessel remained occluded.
Comparison of GGVOD With Other Occlusion Devices
Advantages
(1) The GGVOD is inserted through an 8F
sheath, which is smaller
than the sheath size required for many other occlusion devices. (2) The
nylon sack is flexible and will conform readily to the intravascular
contour of any vessel. (3) If the wire-filled sack is not in the
appropriate position, the wire can be withdrawn from the sack and the
sack repositioned. This repositioning can be repeated multiple times
until the desired device position is obtained. (4) Once it is inserted
into the vessel, if the GGVOD is too small, the wire and sack may be
pulled out of the long sheath and replaced with a larger device.
Conversely, if the GGVOD is too large, it can be removed and replaced
with a smaller sack. (5) Since the GGVOD position and degree of
occlusion can be evaluated before device release, this should result in
a decreased incidence of residual leaks and device embolizations. (6)
Short fluoroscopic times are needed to implant the GGVOD. For GGVOD
implantation in children and adults, fluoroscopic times will be reduced
further, since device implantation will be performed with a
high-resolution cineangiographic unit and will not be implanted
immediately after surgery, as was performed in this study.
Technical Limitations
(1) Although the GGVOD is
inserted through an 8F sheath (see
"Advantages"), if an arterial approach is required, this sheath
size may limit GGVOD use in small infants. (2) As with all occlusion
devices, to implant the GGVOD, a long delivery sheath must be
positioned in the desired vessel. Sheath placement may be difficult if
the vessel has a tortuous course or has an acute-angle bend (which
occurs in some modified Blalock-Taussig shunts). To minimize this
problem, an improved sheath is used. This sheath is made of a
high-quality blue Teflon (Cook Inc) that is very resistant to kinking
and can be curved manually in a hot water bath. (3) For the sack to
maintain sufficient transmural pressure on the vessel, we recommend a
sack diameter 1.0 to 1.5 mm larger than the vessel diameter. Although
during several successful implantations, the sack and vessel diameters
were equal, theoretically this could result in incomplete vessel
occlusion or device embolization. Since veins are more compliant than
arteries, a larger sack diameter may be needed for venous structures.
Also, large vessels (7 to 9 mm) may require a sack more than 1.0 to 1.5
mm larger to provide sufficient transmural pressure. Studies are
continuing to determine the optimal diameter for the sack relative to
the vessel diameter. (4) To safely implant the GGVOD, a minimal length
of vessel is required. In this study, a vessel length of at least twice
the sack diameter was used (eg, a 5-mm-diameter sack implanted in a
10-mm-long vessel). As more experience is gained with the GGVOD, the
minimal vessel length may be reduced to 1.0 to 1.5 times the vessel
diameter.
Summary
We conclude that the GGVOD was effective in
completely occluding
peripheral vessels and surgically created aortopulmonary shunts in a
canine model. We speculate that the GGVOD may prove useful in humans
for the occlusion of both tapered and nontapered tubular vessels,
including long PDA, aortopulmonary collateral vessels,
systemictopulmonary artery shunts, AV malformations, and
arteries
supplying tumors.
| Acknowledgments |
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| Footnotes |
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Received July 19, 1994; revision received October 5, 1994; accepted October 30, 1994.
| References |
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