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Ann Thorac Surg 1995;59:908-914
© 1995 The Society of Thoracic Surgeons

Experimental Assessment of Newly Devised Transcatheter Stent-Graft for Aortic Dissection

Division of Cardiovascular Surgery, Osaka Prefectural Hospital, and Department of Bioengineering, National Cardiovascular Center Research Institute, Osaka, Japan

Accepted for publication November 7, 1994.

	Abstract

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Despite recent advances, surgical results for Stanford type B dissection are not yet satisfactory because the procedure is so highly invasive. The aim of this study was to devise a new intraaortic (IA) graft that would offer less invasive treatment for type B dissection. To close the entry of type B dissections using transcatheter placement, we devised an IA graft (inner diameter, 15--20 mm; length, 40 to 60 mm) in which a self-expandable stent was covered with a thin, open-cell--structured polyurethane jacket. In acute animal experiments in which type B aortic dissections were prepared in 4 mongrel dogs, IA grafts were implanted to close the entry using a transfemoral catheter sheath, and closure of all the entries was confirmed by aortography. In chronic experiments, five IA grafts for normal descending aortas and one IA graft for an experimentally dissected aorta were implanted to observe histologic biocompatibility for up to 8 months. Histopathologic examination conducted at the projected sacrifice periods revealed that endothelialization of the luminal surface of the IA graft had begun as early as 1 month after implantation and was completed within 4 months. The prototype device that we developed may be promising as an effective, minimally invasive therapeutic intervention for closure of the entry site of type B dissection.

	Introduction

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
See also page 914.

Acute aortic dissection is a life-threatening condition [1, 2]. Surgical intervention for type B dissection has not provided satisfactory results [3–7] because of the advanced age of patients at onset [8, 9] and the high incidence of postoperative pulmonary complications accompanying lateral thoracotomy [3, 5, 6, 8, 9]. It has been argued that medical treatment is superior to surgical treatment in acute type B dissection [2–4, 7, 10, 11]. However, in 20% to 50% of patients who have survived the acute stage with medical treatment, enlarged aneurysms develop within 1 to 5 years of onset [2, 3, 11]. In addition, in chronic type B dissection, distinct enlargement of the false lumen and narrowing of the true lumen occur in most cases, making surgical treatment at a later stage more difficult [12].

Thus, it is necessary to develop a less invasive therapeutic procedure to treat the type B dissection at an acute or subacute stage. Recently, intraluminal devices have been developed that may conceivably cure aortic dissection [13, 14]. These devices are designed to pressure the inner dissected wall from the aortic true lumen, and subsequently to cure the diseased vessel. These are metallic intravascular stents that are expanded by balloon or self-expand by their own elasticity.

In this article, we report on a transcatheter-placed, self-expandable intraaortic (IA) graft that we developed to accomplish less invasive obliteration of aortic dissection. Our IA graft consists of a tandem-type Gianturco stent with an outer jacket of thin, microporous polyurethane. The effectiveness and safety of this new graft and the vascular tissue regeneration process associated with the implanted graft were examined in acute and chronic phases.

	Material and Methods

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Concept of Transcatheter Closure of Entry Site
Figure 1 shows our concept of transcatheter treatment for type B dissection. The dissection into a true and a false lumen is shown in Figure 1A. A catheter sheath, inserted through the femoral artery, is positioned slightly proximal to the entry site of the dissection (Fig 1B). A compressed IA graft is inserted into the catheter sheath and pushed out at the entry site. The graft expands in the vascular lumen as a result of the decompression of the stent and concomitantly attaches to the aortic intima, resulting in the closure of the entry site (Fig 1C). The true lumen thrusts aside the false lumen, where sooner or later a thrombus is formed.

View larger version (34K): [in this window] [in a new window]   Fig 1. . Catheter-aided treatment of type B dissection. (A) Type B dissection. (B) A catheter sheath bearing the compressed graft is inserted from the femoral artery into the true lumen. (C) The intraaortic (IA) graft expands in the vascular lumen, resulting in closure of the entry site.

To meet the first requirement, we used a self-expandable stent as the structural support of the graft. To meet the second and third requirements, we selected segmented polyurethane, the most durable and elastic material among the existing synthetic elastomers, as a material for a thin-wall graft which outer-jackets the stent. To promote tissue regeneration and ensure a nonthrombogenic potential similar to the native artery in the chronic phase, microporous structure was impregnated into a graft.

Preparation of IA Graft
A self-expandable stent (a Gianturco-type stent known as the Z-stent; William Cook Europe A/S, Bjaeverskov, Denmark) and a porous polyurethane jacket were prepared separately and these were then assembled into a one-piece graft.

POROUS POLYURETHANE JACKET.
A segmented polyurethane, Cardiomat 610 (Kontron Inc, Everett, MA), was used for fabrication of the graft. Crystals of sodium chloride (mean granular size, 0.1 mm) were mixed with 5% tetrahydrofuran solution of polyurethane. After the crystal-impregnated solution was cast in a cylindrical vessel by a rotation method at room temperature, impregnated crystals were eluted by washing with warm water to form an open-cell-structured, microporous polyurethane jacket (wall thickness, 0.2 mm; average pore size, 0.1 mm). Jackets with diameters of 12, 15, and 19 mm were prepared and their lengths were adjusted to the stent lengths. The luminal and external surfaces and the cross-section of porous polyurethane jacket were examined by a scanning electron microscope (Hitachi S-400; Hitachi Co Ltd, Tokyo, Japan).

STENT.
The device consisted of two or three self-expandable Gianturco stents connected in tandem with two stainless steel struts. Each stent was constructed of 0.35 mm stainless steel wire (Nippon Seisen Co Ltd, Osaka, Japan) bent into a nine-tip zigzag configuration that was 2 cm long and had an internal diameter of 15 or 20 mm (full length, 40 mm or 60 mm).

FABRICATION OF ONE-PIECE GRAFT.
The tetrahydrofuran solution of polyurethane was used as a glue to attach the stent to the porous polyurethane jacket as follows. The expanded form of the stent was inserted into the porous polyurethane jacket, and drops of solution were applied to the respective bending points of the stent and then air-dried. A structural support with two stents was covered with polyurethane jackets in full length (40 mm), and a support with three stents was covered only in proximal two stents (covered length, 40 mm; uncovered length, 20 mm). A 15-mm--diameter stent was used for a 12-mm--diameter graft, and a 20-mm--diameter stent was used for a 15-mm or 19-mm--diameter graft. The fabricated grafts were compressed by hand and inserted into a 12F catheter sheath.

In Vivo Performance
Ten adult mongrel dogs (body weight, 14 to 18 kg) were anesthetized and maintained under anesthesia with Nembutal (Abbott, Abbott Park, IL; pentobarbital sodium, 4 mg/kg). Mechanical ventilation was performed for dogs subjected to the experimental type B dissection. All animals were handled in compliance with the Principles of Laboratory Animal Care formulated by the National Society for Medical Research (USA) and the Guide for the Care and Use of Laboratory Animals published by the National Institutes of Health (NIH publication 85-23, revised 1985).

PREPARATION OF EXPERIMENTAL DISSECTION.
After systemic heparinization the descending aorta exposed by left lateral thoracotomy was simply clamped and a transverse incision was made in the adventitia. The aorta then was dissected semicircularly between the intima and adventitia and the resultant flap was separated toward the distal side using a special spatula. A reentry site was made at about 10 to 15 cm distal to the incision (the intima was punctured by a probe). Next, an entry site was made at the intima of the incision site using a 6-mm punch. After the dissected adventitia was sutured, the aorta was unclamped to complete the experimental dissection.

IA GRAFT IMPLANTATION.
After the entry site and false lumen were confirmed by aortography, the position of the entry site was marked on the body surface. A 12F catheter sheath (William Cook Europe A/S, Bjaeverskov, Denmark) inserted through the femoral artery was positioned at the entry site of the true lumen. After an IA graft was delivered up to the site of the entry through the catheter sheath using a pushing rod (William Cook Europe A/S), the graft was expanded from the sheath into the aorta by pulling the sheath without moving the push rod. On the basis of the preliminary aortogram study, the size of IA graft was selected to be 20% to 30% larger than the aortic diameter at the proximal side of the dissection. For acute experiment, 4 animals were sacrificed 2 hours after implantation. For chronic experiment, implantation was performed on 5 adult mongrel dogs that had normal descending aortas and 1 dog that had been subjected to experimental type B dissection prepared 3 weeks before implantation.

HISTOLOGIC EXAMINATION.
At the projected sacrifice periods, the entire graft complex and adjacent segments of aorta were excised. Each specimen was divided into three parts: proximal junction, middle portion, and distal junction. Each of the three parts was further divided into two parts, one for light microscopic examination, the other for electron microscopic examination. Specimens for light microscopic examination were immersed in 10% neutral buffered Formalin, and stained by hematoxylin and eosin, azan Mallory, elastica van Gieson, and peroxidase-antiperoxidase methods. The specimens for electron microscopic examination were fixed in a 3% solution of glutaraldehyde (0.1 mol/L cacodylic acid buffer solution, pH 7.2) for 2 hours at room temperature, after which the specimens were dehydrated using 1% tannic acid and an alcohol series method. After critical-point drying, the specimens were subjected to vapor deposition of platinum palladium (Polaron, scanning electron microscopy coating system) and then examined with scanning electron microscopy.

	Results

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Intraluminal Aortic Graft
The finished form of the IA graft with two self-expandable metallic stents is shown in the right side of Figure 2. A tandem-type Gianturco stent (shown in the left side of Figure 2) had an outer jacket composed of the microporous polyurethane film. Both the stent and the porous polyurethane film, which were securely glued to each other, were elastic enough to be compressed into the form of a bar. The compressed graft, easily insertable into a 12F catheter sheath (inner diameter, 4 mm) was expanded to 15 to 20 mm upon decompression, depending on the size of the Gianturco stent used. Scanning electron microscopic examination of the porous polyurethane jacket showed that the luminal surface possessed numerous micropores that were approximately 100 to 150 µm in diameter (Fig 3). In the IA graft with three stents, only proximal two stents were layered with polyurethane microporous membrane.

View larger version (147K): [in this window] [in a new window]   Fig 2. . (Left) Gianturco stent (double-tandem type), which can be inserted into the 8F catheter sheath. (Right) Finished form of the intraaortic graft, which can be inserted into the 12F catheter sheath.

View larger version (135K): [in this window] [in a new window]   Fig 3. . Cross-section of the porous polyurethane film that covered the stent. Open-cell--structured graft wall approximately 150 to 200 µm in thickness and micropores approximately 100 to 150 µm in diameter were observed (original magnification x100).

Aortography clearly revealed that entry sites and false lumens were created in the descending aorta of all the experimentally dissected animals (Fig 4A). Grafting at entry sites was attained in all cases (Figs 4B, 4C); neither jumping at the time of grafting nor migration after grafting was observed. Aortograms at 30 minutes after the implantation revealed that the entry site was fully closed in all cases, whereas the false lumen was partly visualized retrogradely from the reentry (see Fig 4C). Cineangiography displayed elastic motion of the graft in synchrony with aortic pulsation.

View larger version (115K): [in this window] [in a new window]   Fig 4. . Aortograms of intraaortic (IA) graft in acute phase. (A) Experimentally created double-barrel-type dissection was clearly observed in the descending aorta (F = false lumen; T = true lumen.) (B) The intraaortic graft (IA graft) was compressed into the 12F catheter sheath and then transported intraluminally to the aneurysmal entry site (E) of the descending aorta by a push rod. (C) The entry site was completely closed by the IA graft 30 minutes after implantation. False lumen was partly visualized retrogradely as a result of blood flow from the reentry.

Aortography showed that no migration took place in any of the animals in chronic phase. In animals with experimentally created dissection, the false lumen was completely obliterated 8 months after implantation.

Tissue Regeneration
Six IA grafts, five of which were implanted in normal descending aortas and the remaining one that was in an experimentally dissected aorta, were histologically examined as to how tissue regeneration proceeded after graft implantation. The vessel segments were removed at 1, 4, 6, and 8 months. Little complication (such as necrosis) was observed in any of explanted samples.

On gross examination at 1 month after implantation, minimal gross thrombus formation was observed on the luminal surface, most of which was covered with a thin, yellowish-white membrane. A small number of tiny thrombi were present on the distal portion of the graft. At 6 months (Fig 5A), there was no thrombus on the IA graft, which was totally covered with a yellowish-white uniform tissue that resembled vascular endothelium. In the luminal surface of the dissected aorta removed at 8 months, the entry site was closed and the false lumen was completely filled with clot (Fig 5B). A thrombotic layer was observed between the intima and the adventitia of experimentally created vessel wall.

View larger version (180K): [in this window] [in a new window]   Fig 5. . Gross luminal appearances. (A) Six months after implantation, the luminal surface was covered with yellowish-white membrane. (B) Eight months after implantation, the false lumen was completely clotted by the intraaortic graft, and a thrombotic layer was observed between the intima and the adventitia.

View larger version (120K): [in this window] [in a new window]   Fig 6. . (A) Light micrograph stained by peroxidase-antiperoxidase method (original magnification, x400) from middle portion of the intraaortic graft at 4 months. Black-stained cells that cover the graft were identified as endothelial cells. (B) Light micrograph stained with elastica van Gieson (original magnification, x400) from proximal portion of the intraaortic graft of the same sample. (PU = polyurethane.)

View larger version (242K): [in this window] [in a new window]   Fig 7. . (A) Scanning electron micrograph of the luminal surface of an intraaortic graft removed 1 month after implantation (original magnification, x2,000). The graft is extensively covered by adherent, proliferating endothelial cells (EC) and some blood components (neutrophils, platelets, and fibrin) attached to portions of the surface (upper left). (B) A cross-sectional scanning electron micrograph of the graft and descending aorta removed 4 months after implantation (original magnification, x40) showing that a newly formed intima (NI) was composed of a uniform layer 0.15 mm in thickness. There is no evidence of thinning of the aortic wall due to pressure. (PU = polyurethane.) (C) Scanning electron micrograph of the surface of a graft removed 6 months after implantation (original magnification, x500) showing the smooth luminal surface covered with EC and newly formed capillaries (NC) that had grown in through micropores.

	Comment

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

Percutaneous transluminal angioplasty for atherosclerotic vascular disease has led to percutaneously implantable intraluminal devices which are either self-expandable or balloon-expandable [16–19]. Catheter-aided methods based on these devices have been studied in recent years to develop new, minimally invasive techniques for treatment of type B dissection [13, 14, 20]. In 1986, Akaba and associates [20] devised a cylinder-type balloon catheter that was used for intraluminal compression of a dissection that had been induced by an inflated balloon. A metallic stent was later developed and introduced to prevent re-narrowing of the peripheral artery and the biliary tract after procedures were performed to dilate their lumens [16–19]. These metallic stents were used not only for preventing stenosis of peripheral blood vessels and coronary arteries, but also for maintaining the true lumen and the closure of the false lumen in aortic dissection [13, 14]. Recently developed balloon-expandable stents for curing aortic dissection include the Trent stent [13], Palmaz stent [14], and Fontaine stent [14]. These intraluminal devices successfully induce clot formation as a result of compression at the false lumen of experimentally created aortic dissection. Due to the very nature of their design, however, rapid obliteration at entry site would not be expected and furthermore incomplete obliteration may occur.

We developed a new graft especially for treatment of acute type B dissection by covering a Gianturco stent, a typical self-expandable stent, with an elastomeric polyurethane jacket. We expect that its elasticity should make it function well not only at the time of insertion into the sheath and expansion in the lumen, but also during the chronic phase, so that it provides a constant pressure against the false lumen. We fabricated three different sizes of IA grafts with microporous segmented polyurethane. This material, extensively used for blood pumps such as intraaortic balloon pumps, assist devices, and artificial hearts, is elastic and durable. This microporous film is much more flexible than a nonporous film; it is so compressible that an IA graft can be inserted easily into a catheter sheath. In addition, the open-cell structure was designed to enhance tissue regeneration on and through the porous jacket.

We consider the diameter of the IA graft relative to that of the dissected aorta to be very critical. An oversized graft may result in pressure necrosis of the aortic wall, whereas an undersized graft may lead to graft migration. In this study, the diameter of the implanted IA graft was set at 120% to 130% of the diameter of the normal segment of the aorta proximal to the dissection. In all animal subjects, the IA graft was placed successfully in the predesignated part of the aorta, and closed the entry site of the dissection. Autopsy at 2 hours after implantation showed that the IA graft stretched tightly against the intima of the aortic wall and that blood was already coagulated in the false lumen, which was under stent pressure. Observations for up to 8 months revealed no thinning or pressure necrosis of the aortic wall, and no migration of the graft. Our selected proportions, therefore, seem to be appropriate for application in clinical cases. Although our IA grafts did not have any hooks to prevent migration, structural modification of stents to include hooks could greatly guarantee the stabilization of implanted grafts.

The tissue regeneration process on the IA graft, assessed by light and electron microscopic evaluation, was extremely encouraging. Endothelialization, probably initiated by ingrowth through micropores, began within several weeks. At 4 months, the entire surface of the IA graft was endothelialized, and micropores were filled with regenerated collagen fibers. In addition, the elastic fiber was regenerated. Fewer foreign-body giant cells were observed 6 months after implantation, indicating that tissue regeneration was completed within this period. Neovascularization also occurred beneath the endothelial layer through transinterstitial micropores. Thus, the microporous structure of segmented polyurethane film seems to enhance the tissue regeneration potential with minimal foreign-body reaction.

The essential requirement of this IA graft therapy is to close the entry point, which requires precise diagnosis of the entry site. In addition to aortograms used in this study, intravascular echography, magnetic resonance imaging spectroscopy, and other diagnostic techniques may help to precisely position IA grafts. Our current device uses a self-expandable Z-stent, which cannot adapt itself to a curved part of the aorta. This hampers application of the IA graft to the segment of the aorta immediately distal to the left subclavian artery, which is the most common site of the entry of type B dissection. Extended application to these dissections will require further modification of the IA graft. And as for the application of our IA graft to aneurysmal diseases, we think it is necessary to modify the covering material because our extremely elastic covering jacket may be the cause of graft aneurysm formation after implantation.

In summary, we developed a novel intraaortic prosthesis composed of a Gianturco stent and a microporous segmented polyurethane jacket, and successfully closed off the entry site of experimentally prepared type B dissection using the transcatheter technique. These results in dogs, together with satisfactory histologic biocompatibility in chronic experiments, suggest that our IA graft may be effective in treating the acute stage of type B dissection with minimal invasion.

	Acknowledgments

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
We are grateful to Dr Shigeko Takaichi and Dr Kiyoshi Kotoh for their excellent assistance in scanning electron and light microscopic examinations. Doctor Masaaki Kato highly appreciates the continuous advice and encouragement of Professor Hikaru Matsuda, First Department of Surgery, Osaka University Medical School.

	Footnotes

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Address reprint requests to Dr Kato, Division of Cardiovascular Surgery, Osaka Prefectural Hospital, 3-1-56 Mandai-higashi, Sumiyoshiku, Osaka 558, Japan.

	References

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 

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This Article Abstract Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Masaaki Kato Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Kato, M. Articles by Ohnishi, K. Search for Related Content PubMed PubMed Citation Articles by Kato, M. Articles by Ohnishi, K.