Endoluminal stent grafting of the thoracic aorta:
`Initial experience with the Gore Excluder
`
`Charles S. Thompson, MD, Virginia D. Gaxotte, MD, Julio A. Rodriguez, MD,
`Venkatesh G. Ramaiah, MD, Mitar Vranic, DO, Rajagopalan Ravi, MD, Leanne DiMugno, MD,
`Shoaib Shafique, MD, Dawn Olsen, PA, and Edward B. Diethrich, MD, Phoenix, Ariz
`
`Purpose: The purpose of this study was to describe our experience with endoluminal graft repair of a variety of thoracic
`aorta pathologies with a commercially developed device currently under investigation. Our patient population included
`patients eligible for open surgical repair and those with prohibitive surgical risk.
`Methods: From February 2000 to February 2001, endovascular stent-graft repair of the thoracic aorta was performed in
`46 patients (mean age, 70 years; 29 male and 17 female patients) with the Gore Excluder. Twenty-three patients (50%)
`had atherosclerotic aneurysms, 14 patients (30%) had dissections, three patients (7%) had aortobronchial fistulas, three
`patients (7%) had pseudoaneurysms, two patients (4%) had traumatic ruptures, and one patient (2%) had a ruptured aortic
`ulcer. Patient characteristics, procedural variables, outcome, and complications were recorded. All patients were followed
`with chest computed tomographic scans at 1, 3, 6, and 12 months. Follow-up period ranged from 1 month to 15 months,
`with a mean of 8.5 months.
`Results: All the procedures were technically successful. There were no conversions. Average duration of the procedure was
`120 minutes. Average length of stay was 6 days, but most patients (64%) left the hospital within 4 days after endoluminal
`grafting. The overall morbidity rate was 23%. Two patients (4%) had endoleaks that necessitated a second procedure for
`successful repair. Two patients (4%) died in the immediate postoperative period. There were no cases of paraplegia. At
`follow-up examination, one patient had an endoleak found the day after the procedure and another patient had an
`endoleak 6 months after the procedure. Both cases were treated successfully with additional stent-grafts. There were no
`cases of migration. One patient died of a myocardial infarction 6 months after graft placement. In patients treated for
`aneurysm (n ⴝ 23), the aneurysm diameter ranged from 5.0 to 9.5 cm (mean, 6.8 cm). Residual sac measurements were
`obtained at 1, 6, and 12 months, with mean sac reductions of 0.59 cm, 0.77 cm, and 0.85 cm, respectively. In three cases,
`the sac remained unchanged, without evidence of endoleak.
`Conclusion: Thoracic endoluminal grafting with the Gore Excluder is a safe and feasible alternative to open graft repair
`and can be performed successfully with good results. Early data suggest an endoluminal approach to these disease entities
`may be favorable over classical resection and graft replacement. (J Vasc Surg 2002;35:1163-70.)
`
`Thoracic aortic dissections, ruptures, fistulas, and an-
`eurysms pose a unique surgical challenge. Traditional repair
`of thoracic aortic aneurysms involves thoracotomy with
`graft interposition. Despite advances in perioperative care
`and both total and partial cardiopulmonary bypass proce-
`dures, conventional surgery still carries a significant mor-
`bidity and mortality risk. Principal complications include
`bleeding, paraplegia, stroke, cardiac events, pulmonary in-
`sufficiency, and renal failure.1-5 Recent enthusiasm for in-
`novative endovascular therapies in the treatment of aortic
`disease has spurred many centers to investigate endolumi-
`nal grafting of the thoracic aorta. Early reports on endovas-
`cular repair with custom-made “first-generation devices”
`showed the technique to be feasible with a mortality and
`morbidity rate comparable with that of open repair.6-11
`In February 2000, we initiated a single-center research
`protocol on the basis of an investigational device exception
`
`From the Department of Cardiovascular and Endovascular Surgery, Arizona
`Heart Institute and Arizona Heart Hospital.
`Competition of interest: nil.
`Reprint requests: Edward B. Diethrich, MD, Arizona Heart Institute, 2632
`N 20th St, Phoenix, AZ 85006.
`Copyright © 2002 by The Society for Vascular Surgery and The American
`Association for Vascular Surgery.
`0741-5214/2002/$35.00 ⫹ 0 24/1/122885
`doi:10.1067/mva.2002.122885
`
`with a “second-generation” device. Improvement in the
`device design reflected in the Gore Excluder thoracic stent-
`graft (WL Gore, Flagstaff, Ariz) has allowed us to pursue
`complex thoracic surgical problems with endovascular ap-
`proaches. Although previous studies of thoracic stent-grafts
`have only reported the use in patients at high risk, our
`population included those patients who would have other-
`wise been surgical candidates. We report our initial experi-
`ence with this thoracic aortic endoluminal graft in the
`treatment of a variety diseases of the thoracic aorta.
`
`METHODS
`During 2000, 46 patients were admitted to the Arizona
`Heart Hospital for thoracic endoluminal grafting to treat
`thoracic aortic aneurysms, pseudoaneurysms, dissections,
`aortobronchial fistulas, acute traumatic ruptures, and aortic
`ulcers. All prospective patients were enrolled with the pro-
`visions of a Food and Drug Administration Investigational
`Devices Exemption for the Gore Excluder without excep-
`tions during this period of time. The thoracic Gore Ex-
`cluder protocol in our institution was in compliance with
`the Institutional Review Board of the Arizona Heart Hos-
`pital.
`The Gore Excluder is a self-expandable endoprothesis
`of an expanded polytetrafluoroethylene tube and an exter-
`1163
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`1164 Thompson et al
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`June 2002
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`Fig 1. Gore Excluder, self-expandable endoprothesis for thoracic
`aorta. Device is made of expanded polytetrafluoroethylene inner
`tube and outer nitinol exoskeleton.
`
`nal nitinol wire support structure designed for the thoracic
`aorta (Fig 1). The graft is mounted on a flexible delivery
`system and surrounded by a sleeve of expanded polytetra-
`fluoroethylene (Fig 2). A pull wire releases the corset, and
`deployment occurs first in the middle of the graft and then
`rapidly proceeds to the proximal and distal ends (Fig 3). A
`unique trilobed aortic balloon expands the graft for aortic
`apposition without complete aortic occlusion (Fig 4). The
`intended size specifications, graft diameters, graft length,
`and sheath sizes are given in Table I.
`Each patient was evaluated by a staff surgeon and
`underwent chest roentgenography and contrast-enhanced
`computed tomographic (CT) scanning before the proce-
`dure. Angiography was performed with a calibrated cathe-
`ter for the thoracic aortic component with studies of the
`abdominal and iliac vessels. Patients were chosen for en-
`doluminal grafting according to presenting pathology and
`suitability of anatomy for device implantation. The aortic
`measurements were made from the preoperative studies for
`determination of device diameter and length. All stent-
`grafts were oversized 2 mm to 6 mm compared with the
`proximal neck diameter (Table I). Length of the device was
`chosen on the basis of the length of the lesion and at least 2
`cm of both proximal and distal landing zones. For graft
`pseudoaneurysms and aortobronchial fistulas caused by
`previous interposition graft material, a length was chosen to
`transverse both anastomoses to ensure no further paraanas-
`tomotic leakage.
`If the lesions were in close proximity to the subclavian
`artery with less than 2 cm of neck for the proximal landing
`zone, a standard carotid subclavian bypass procedure or
`transposition was performed before the endovascular pro-
`cedure. Distal aortic arch and proximal descending thoracic
`lesions therefore were treated in our series. These cases
`were generally staged. However, in one instance, an un-
`planned procedure was performed immediately after a de-
`vice was placed over the left subclavian artery. Concern
`existed not only for an ischemic process but for persistence
`of retrograde flow to the aneurysmal sac. The origin of the
`
`Fig 2. Device loaded on flexible over-wire delivery system with
`polytetrafluoroethylene sleeve. Wire is pulled for deployment.
`
`subclavian artery was either ligated or diverted with a
`transposition to the carotid artery.
`All procedures were performed with general anesthesia
`in endovascular suites equipped with fluoroscopic and an-
`giographic equipment. The artery for transluminal device
`placement was selected on the basis of the degree of ob-
`structing atherosclerotic plaque. One femoral arery was
`surgically exposed for device delivery. Percutaneous access
`was obtained through the contralateral common femoral
`artery. Through the left brachial artery, a 4F or 5F pigtail
`catheter was placed to assist in accurate identification of the
`left subclavian artery.
`In those patients with diseased iliac arteries, balloon
`angioplasty was performed to allow passage of the delivery
`system. If severe obstructing atherosclerotic plaque in the
`iliac vessels prohibited femoral artery delivery, an iliac artery
`delivery was performed through a retroperitoneal ap-
`proach. The iliac artery was exposed through a transverse
`lower abdominal incision and retroperitoneal dissection.
`An end-to-side anastomosis was created between the com-
`mon iliac artery and a 10-mm Hemashield graft conduit
`(Boston Scientific, Natick, Mass). The device was translu-
`minally placed into the aorta through this conduit. At the
`completion of the procedure, this conduit was attached to
`the common femoral artery, creating an iliofemoral bypass.
`Arteriography, transesophageal echocardiography (TEE),
`and intravascular ultrasound scanning (IVUS) were used to
`determine precise aortic landing zones. Aortic diameters
`also were confirmed during the procedure with IVUS. A
`shelf stock of devices allowed selection of the appropriate
`size on the basis of the preoperative CT scan measurements
`and the intraoperative measurements. TEE and IVUS pre-
`cisely located pseudoaneurysms, fistulas, entry and exit
`points of dissections, and false lumens that are not easily or
`accurately detected with aortography or CT scans. A Keller-
`Tillerman introducer sheath (Cook, Inc, Bloomington,
`Ind) was inserted through the femoral or iliac artery over a
`0.035-inch “superstiff” wire (Amplatz, Meditech, Boston
`Scientific, Boston, Mass; or Flex Finder, Microvena, White
`Bear Lake, Mich). The delivery system was loaded onto the
`wire and through the sheath to the level of the thoracic
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`JOURNAL OF VASCULAR SURGERY
`Volume 35, Number 6
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`Thompson et al 1165
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`Fig 3. Graft deploys in middle first and then proceeds toward distal ends.
`
`into place with arteriography, fluoroscopy, and TEE. Rapid
`graft deployment with a pull-wire system prevented signif-
`icant graft migration. Completion arteriography was per-
`formed to confirm adequate placement and exclusion with-
`out endoleak. TEE and IVUS confirmed elimination of
`pulsatile flow in the false lumen of dissections, exclusion of
`fistulas, and exclusion of aneurysms.
`The patients were monitored in the recovery room or
`intensive care unit overnight. A CT scan was obtained
`before discharge to confirm adequate placement and lack of
`endoleak. All postoperative care was directed by the surgi-
`cal team. Contrast CT scans were repeated at 3 months, 6
`months, and 1 year, with routine evaluation for aneurysmal
`sac measurements and presence of endoleak.
`
`RESULTS
`From February 2000 to February 2001, 46 patients at
`the Arizona Heart Hospital underwent treatment with
`thoracic stent-graft placement (Figs 5 and 6). The patients
`were operative and nonoperative candidates. All patients
`were of American Society of Anesthesiology classification
`III or IV, on the basis of their comorbid conditions (Table
`II). A total of 46 patients received 54 grafts during 48
`operations for aneurysms, dissections, pseudoaneurysms,
`aortobronchial fistulas, and an aortic ulcer (Table III).
`Three patients (6.5%) had contained ruptures. No open
`conversions were necessary (Table IV). One patient had a
`significant endoleak after the procedure, which necessitated
`a return to the operative suite 2 days after the initial
`procedure. The leak was successfully excluded with a sec-
`ond graft on the second postoperative day. A second pa-
`tient had an endoleak 5 months after the original graft
`placement. This also was successfully managed with an-
`other device placement.
`Access played an important role in facilitating the op-
`eration. Iliac arteries with extensive occlusive disease re-
`quired dilatation and balloon angioplasty to accommodate
`device placement into the aorta. However, six patients
`(13%) needed iliac access via a retroperitoneal approach
`
`Fig 4. Aortic balloon has trilobed configuration for aortic appo-
`sition without impedance of aortic blood flow.
`
`Table I. Gore Thoracic Excluder sizing guide
`
`Intended
`aortic
`diameter
`(mm)
`
`23-24
`24-26
`26-29
`29-32
`32-34
`34-37
`
`Endoprothesis
`diameter
`(mm)
`
`Overall
`endoprothesis
`lengths (cm)
`
`Recommended
`sheath size
`
`26
`28
`31
`34
`37
`40
`
`7.5, 10, 12.5
`7.5, 10, 12.5, 15
`7.5, 10, 12.5, 15
`10, 12.5, 15, 20
`10, 12.5, 15, 20
`10, 12.5, 15, 20
`
`22F
`22F
`22F
`24F
`24F
`24F
`
`aorta. If the rigid sheath could not negotiate tortuous or
`diseased iliac arteries, then the device was placed “bare-
`back” without the sheath. Arterial control then was man-
`aged with a Rummel tourniquet, and device exchange was
`more complicated. Once the delivery system was in place,
`arterial pressure was pharmacologically lowered to less than
`100 mm Hg before deployment. The device was directed
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`1166 Thompson et al
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`JOURNAL OF VASCULAR SURGERY
`June 2002
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`Fig 5. Preoperative angiogram (A) and CT scan (B) show 7-cm aneurysm in distal aortic arch and proximal
`descending thoracic aortic in 72-year-old patient.
`
`Fig 6. Postoperative angiogram (A) and CT scan (B) after deployment of Gore Excluder stent-graft show adequate
`exclusion of aneurysm described in Fig 5. Carotid subclavian bypass procedure was performed before stent placement
`to allow for adequate landing proximal landing zone.
`
`because of tortuous or diseased iliac arteries, and an iliac-
`femoral bypass procedure was performed after deployment
`through an iliac graft conduit. Mean operative time was
`120 minutes (Table IV), and the actual surgical time de-
`creased as we became familiar with the operative technique.
`Mean estimated blood loss was 300 mL. Most patients
`(64%) left the hospital within 4 days after the stent-grafting.
`The average length of stay was 5 days, and all patients who
`stayed longer had second procedures during the same
`hospitalization (Table V). Seven patients needed carotid
`
`subclavian bypass procedure or transposition before stent
`placement.
`Two patients died in the perioperative period, for an
`early mortality rate of 4% (Table VI). One patient died after
`an iliac artery rupture caused by a sheath perforation during
`device deployment. The second death occurred after the
`repair of a ruptured thoracic aortic aneurysm. An emer-
`gency repair was performed with successful device deploy-
`ment. However, the patient died 24 hours after the proce-
`dure. Autopsy results found the cause of death to be diffuse
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`JOURNAL OF VASCULAR SURGERY
`Volume 35, Number 6
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`Thompson et al 1167
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`Table II. Patient characteristics and comorbidities
`
`Table V. Procedures on same admission
`
`Patient characteristic/comorbidity
`
`No.
`
`Procedure
`
`Carotid subclavian bypass or transposition
`Abdominal aortic aneurysm repair
`Thrombectomy of iliac conduit
`Thrombectomy of lower extremity
`Reexploration of hemorrhage from conduit
`
`No.
`
`7
`3
`1
`1
`1
`
`Table VI. Morbidity and mortality
`
`Complication
`
`No. of Events
`
`Pneumonia/atelectasis/prolonged ventilation
`Renal insufficiency (not needing dialysis)
`Groin hematoma
`Iliac conduit hemorrhage
`Iliac conduit thrombosis
`Lower extremity thrombosis
`Mesenteric ischemia
`Stroke
`Early mortality
`Late morality
`
`5 (11%)
`2 (4%)
`1 (2%)
`1 (2%)
`1 (2%)
`1 (2%)
`1 (2%)
`1 (2%)
`2 (4%)
`1 (2%)
`
`Mean age (years; range)
`Male/female ratio
`Hypertension
`Coronary artery disease
`COPD
`AAA
`Previous thoracotomy
`Periphereal vascular disease
`Hyperlipidemia
`Congestive heart failure
`Renal insufficiency
`Diabetes mellitus
`Previous CVA
`Morbid obesity
`Oxygen dependence
`Steroid dependence
`Multitrauma
`
`70 (45-86)
`29/17
`34 (73%)
`23 (50%)
`20 (44%)
`14 (30%)
`13 (28%)
`11 (23%)
`9 (20%)
`6 (13%)
`6 (13%)
`6 (13%)
`4 (9%)
`3 (8%)
`2 (7%)
`2 (7%)
`2 (7%)
`
`COPD, Chronic obstructive pulmonary disease; AAA, abdominal aortic
`aneurysm; CVA, cerebrovascular accident.
`
`Table III. Anatomic characteristics
`
`Lesion
`
`Atherosclerotic aneurysm
`Dissection
`Aortobronchial fistula
`Pseudoaneurysm
`Traumatic rupture
`Aortic ulcer
`
`Table IV. Procedural characteristics
`
`Variable
`
`Operating time (minutes)
`Contrast (mL)
`Blood loss (mL)
`Femoral access/iliac access
`Endoleaks
`Conversions
`Length of stay (days)
`
`120 (60-350)
`360 (106-860)
`292 (100-1000)
`40/6
`2
`0
`5.6
`
`embolization and ischemia of the visceral organs. A third
`patient died of a myocardial infarction 6 months after the
`procedure.
`The morbidity rate was 23%, including major and mi-
`nor events (Table VI). Postoperative complications in-
`cluded pulmonary complications, such as atelectasis and
`pneumonia, renal insufficiency, mesenteric ischemia, local
`hemorrhage, iliac conduit, and lower extremity thrombo-
`sis. One patient (2%) had a left hemispheric cerebrovascular
`accident after the procedure. There were no cases of para-
`plegia. There were no cases of renal failure requiring dialy-
`sis.
`
`The follow-up period ranged from 1 to 15 months,
`with a mean of 8.5 months. During the follow-up period,
`residual sac measurements were obtained in patients who
`
`No.
`
`23 (50%)
`14 (30%)
`3 (7%)
`3 (7%)
`2 (4%)
`1 (2%)
`
`Table VII. Changes in aneurysmal sac measurements
`
`Measurements of aneurysms
`(n ⫽ 23; 50%)
`
`Follow-up interval
`(mean size/mean reduction)
`
`No.
`
`Before surgery
`(mean; cm)
`
`1 month
`
`6 months
`
`12 months
`
`16 (70%)
`10 (43.4%)
`2 (8.7%)
`
`6.86
`6.74
`6.10
`
`6.27 (0.59)
`—
`—
`
`—
`5.97 (0.77)
`—
`
`—
`—
`5.25 (0.85)
`
`underwent treatment for aneurysms or dissections with
`aneurysmal changes. Before surgery, the size of the sac
`ranged from 5.0 to 9.5 cm, with a mean of 6.8 cm. Sac
`measurements were available in 16 of the 23 patients with
`aneurysms (70%) (Table VII). At 1 month, the sac shrunk
`from a mean of 6.86 cm to 6.27 cm, for a mean reduction
`of 0.59 cm. At 6 months, 10 of 23 patients (43.4%) had sac
`measurements available. In seven of 10 patients (70%), the
`sac reduced from a preoperative mean of 6.74 cm to 5.97
`cm, for a mean reduction of 0.77 cm. In the remaining
`three cases, the sac was unchanged. No symptoms or en-
`doleaks were found in those patients.
`At 12 months, two patients had sac measurements.
`Diameter decreased from 6.1 cm to a mean of 5.25 cm, for
`a mean reduction of 0.85 cm (Table VII). All grafts re-
`mained patent and properly positioned. There were no
`ruptures.
`
`DISCUSSION
`Conventional surgical treatment of thoracic aortic an-
`eurysms, dissections, ulcers, aortobronchial fistulas, pseudo-
`aneurysms, and traumatic ruptures involves open thoracot-
`omy, aortic cross clamping, extracorporeal circulation, and
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`1168 Thompson et al
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`graft interposition. Patients are often elderly and have
`severe comorbidities, making them poor surgical candi-
`dates. However, the natural history of these conditions if
`untreated is progression of the disease, eventual rupture,
`and usually death.12,13 Given the gravity of thoracic pathol-
`ogies, repair should be undertaken in most patients. The
`decision to proceed with repair must be balanced with the
`consideration of the complexity of the procedure in an
`elderly patient at high risk. Even with elective conditions at
`specialized centers, the operative mortality rate of thoracic
`aneurysms is reported between 3% and 20%.1,3,4 Acute
`aortic dissections present an even greater challenge with
`surgical mortality rates reported as high as 50%.14,15 Com-
`plications include pulmonary insufficiency, ventilator de-
`pendency, myocardial infarction, renal failure, coagulopa-
`thy, and neurologic injury. Inadvertent compromise of the
`origin of landing zone branches (subclavian or celiac or
`both) is a potential complication. The incidence rate of
`postoperative paraplegia is 4% to 14%.1-4 Patients usually
`undergo a prolonged convalescence from an extensive op-
`eration. Strategies that incorporate less invasive techniques
`may offer a more desirable outcome and thus provide the
`impetus to seek a less physiologically demanding therapy.
`Recent advances in endovascular therapies have pro-
`vided unique solutions to complex vascular problems of the
`thoracic aorta. In 1991, Volodos et al16 reported the first
`endovascular graft placement into a thoracic aorta. In
`1991, Parodi, Palmaz, and Barone17 reported the first
`series of abdominal aortic aneurysm repair with stent-
`grafting, drawing worldwide attention to the potential of
`this technology. A Stanford group reported the first large
`clinical series of endovascular stent-grafts of the thoracic
`aorta in 1994.18 Since then, many centers have turned
`attention to the treatment of thoracic aortic diseases.6-11,19
`Endovascular stent-grafting of the descending thoracic
`aorta has been reported for a variety of aortic diseases,
`including dissection, aneurysms, aortobronchial fistulas,
`and penetrating ulcers.7,20-27 Although long-term data
`have yet to be published, the advantages of endovascular
`stent-grafting over conventional surgical treatment are a
`shorter operating time, less blood loss, and shorter hospi-
`talization. Conceptually, the strategy offers a more simpli-
`fied approach. Operative mortality rates in the largest series
`have been reported to be 8.7%.20
`Early experience with stent-grafting of the thoracic
`aorta used a variety of “first-generation” devices. These
`were primarily Gianturco (Cook) or nitinol stents covered
`with polytetrafluoroethylene graft material, deployed
`through a somewhat large and cumbersome sheath. These
`bulky handmade devices were somewhat difficult to deploy
`and had a tendency to move with the force of aortic
`pulsation. Various methods were used to reduce the force
`of systole, but the conventional methods of deployment of
`stent-grafts resulted in a “wind sock” movement and im-
`peded accurate placement.6,28,29 The result was migra-
`tions, endoleaks, and conversions. Previous reports have
`attributed a substantial portion of complications and mor-
`tality to graft problems arising from the crude constructs of
`
`the first-generation devices. Clearly, limitations in the orig-
`inal grafts tempered enthusiasm. Our experience with these
`first-generation devices mirrored those of other centers,
`and we remained skeptical about the widespread acceptance
`of these forms of stent-grafts before the availability of
`commercial devices.9,28,29
`The Gore Excluder design embodies many sought after
`improvements in stent-graft design. An innovative deploy-
`ment mechanism solves part of the problem of graft migra-
`tion during placement. By rapidly deploying the middle
`first, the graft avoids the wind-sock characteristics of the
`first-generation devices and is less prone to movement. The
`flexibility of the delivery system also allows for positioning
`along the curves of the distal aortic arch and distal descend-
`ing thoracic aorta without distortion. The device is easily
`trackable and is relatively low profile. A trifold balloon is
`also an improvement in design and allows for graft apposi-
`tion and expansion without the stent-graft migration that is
`seen with complete occlusion balloons.
`Since February of 2000, we have been using the Gore
`Excluder exclusively for thoracic stent-grafting. Our single-
`center Investigational Device Exemption differed from the
`corporate-sponsored studies by broadening the inclusion
`criteria beyond the treatment of nonsurgical patients with
`nonruptured descending thoracic aneurysms. We treated
`surgical and nonsurgical candidates with aneurysms, dissec-
`tions, fistulas, pseudoaneurysms, and traumatic ruptures.
`The patients excluded from the study had aortic morphol-
`ogy that did not allow for stent-grafting.
`We treated both acute and chronic dissections with
`endovascular techniques (Fig 7). This necessitated a high
`degree of procedural acumen to determine entry points of
`dissection and to revascularize malperfused vascular beds.
`Determination of the true and false lumens required a
`combination of arteriography, IVUS, TEE, and wire tech-
`niques. If all vital vascular branches were perfused by the
`true lumen, then the graft was placed within the true
`lumen, at the site of the intimal tear, excluding false lumen
`flow. If, however, vascular beds were perfused by the false
`lumen, then we performed a technically complex balloon or
`wire fenestration with stent-graft placement to exclude the
`false lumen and maintain visceral vessel flow. As with tho-
`racic aneurysms that involved the lower third of the tho-
`racic aorta, long thoracic dissections required careful iden-
`tification of the celiac axis, and these vessels, as opposed to
`the left subclavian, became the most important vascular
`landmark. Furthermore, in these dissections, the stent-
`grafts spanned large portions of the descending thoracic
`aorta, covering several intercostal arteries; we had no in-
`stances of paraplegia.
`Many lesions were located in serpentine areas of the
`aorta, such as distal arch lesions, large tortuous aneurysms,
`and graft pseudoaneurysms. The stent-graft readily con-
`formed to the contours of the aorta because of its flexibility,
`another characteristic not shared with the first generation
`devices. Only two patients had endoleaks, probably as the
`result of aortic curvature, and both endoleaks resolved with
`placement of an additional graft.
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`JOURNAL OF VASCULAR SURGERY
`Volume 35, Number 6
`
`Thompson et al 1169
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`Fig 7. Reconstructed preoperative angiogram (A) shows acute dissection of thoracic aorta in 77-year-old man with
`chest pain. Patient had previous thoracic aortic aneurysm and abdominal aortic aneurysm repair. Schematic overlay (B)
`of angiogram shows wire fenestration of dissection to maintain renal arterial flow. Schematic overlay (C) after
`endoluminal stent-graft placement into true lumen with exclusion of dissection at thoracic level but with allowance of
`retrograde filling to level of renal arteries after fenestration.
`
`We have treated three aortobronchial fistulas with the
`Gore Excluder with complete amelioration of hemoptysis
`in all patients. Conceptually, the placement of such a graft
`is a risk for a secondary infection from a pulmonary or a
`primary graft source. However, none of these patients had
`signs or symptoms of overwhelming infection or pneumo-
`nia, none had pathologic organisms cultured from bron-
`chial washings, and none had such symptoms develop after
`surgery. No long-term antibiotic was used in any of these
`cases. The follow-up period ranged between 6 and 12
`months, with a mean of 8 months. Of the five previously
`reported cases of aortobronchial fistula stent-grafting, one
`patient died in the postoperative period from pneumo-
`nia.22-24,27 Therefore, we would hesitate to place a stent-
`graft into a grossly infected area. However, the cause of
`aortobronchial fistulas is not always infection, and we be-
`lieve that stent-graft treatment deserves strong consider-
`ation given the reported mortality rate of 25% to 41% with
`open repair.30-33
`In instances of tortuous, diseased iliac arteries or small-
`caliber access vessels, a “bareback” introduction of the
`device was used. We theorized that this technique could
`have some potential mishaps associated with it. A bareback
`introduction of this particular device can cause the device
`tip to catch on a plaque, leading to graft damage or a
`premature deployment of the graft. Although we are not
`aware of such a complication with this device, caution
`should be exercised with bareback introduction.
`Endovascular stent-grafting for descending thoracic
`aortic diseases offers a less invasive alternative to conven-
`tional open surgical management. We began using the Gore
`Excluder after 2 years of experience with our own hand-
`
`made devices and found it superior. The first-generation
`devices exhibited inaccurate deployment and migration
`problems that have been virtually eliminated with the Gore
`device. Given the relatively low morbidity and mortality
`and excellent treatment success rates in our initial experi-
`ence, we believe that this device represents an important
`improvement in thoracic stent-graft technologies. With the
`demonstration of feasibility of thoracic stent-grafting, we
`await the long-term report of the durability of this stent-
`graft.
`
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