Repair of thoracoabdominal aortic aneurysms with fenestrated and branched endovascular stent grafts
Article Outline
Objective
To report the repair of thoracoabdominal aortic aneurysms (TAAAs) with fenestrated and branched endovascular stent grafts (EVSGs).
Methods
Four patients with asymptomatic TAAAs were treated with custom-designed Zenith fenestrated and branched EVSGs. Three patients had undergone previous open aortic aneurysm repair. Thirteen visceral vessels in four patients were targeted for incorporation by graft fenestrations and branches.
Results
The fenestration/orifice interface was secured with balloon-expandable Genesis stents or Jostent stent grafts in 9 of 13 target vessels. Completion angiography demonstrated antegrade perfusion in 12 of 13 target vessels. One renal artery occluded because of graft rotation during deployment. There were no endoleaks. Three patients required additional surgical procedures related to access vessels. One patient required reoperation for bleeding from an extra-anatomic bypass graft and subsequently died from multisystem organ failure. Three patients made an uncomplicated recovery. No patient developed spinal cord ischemia. Computed tomography at 12 months in the 3 survivors demonstrated complete aneurysm exclusion with antegrade perfusion in all 10 target vessels.
Conclusions
TAAA repair with fenestrated and branched EVSGs is feasible and provides an acceptable and promising alternative to conventional surgical repair in selected patients.
Open surgical repair of nonruptured thoracoabdominal aortic aneurysms (TAAA) is associated with an operative mortality rate of 4% to 16% in specialist centers and has an average mortality rate of 22% in the United States. Significant morbidity occurs in more than 50% of patients: cardiac complications, acute renal failure, hemorrhage, and spinal cord ischemia (SCI) each affect 10% to 15% of patients, and 20% to 30% develop pulmonary complications.1, 2 Two endovascular techniques have been proposed as alternatives to open surgical repair of TAAA. Hybrid open/endovascular repair has been described3, 4, 5, 6, 7, 8, 9, 10 whereby laparotomy and extra-anatomic surgical revascularization of the visceral vessels precedes endoluminal repair of the entire thoracoabdominal aorta. Endovascular repair of juxtarenal and suprarenal abdominal aortic aneurysms (AAAs) with preservation of visceral perfusion by fenestrated11, 12, 13, 14, 15, 16, 17, 18 or branched19 endovascular stent grafts (EVSG) has been shown to be feasible, and, using similar technology, several authors have described total endovascular repair of complex thoracic aortic disease. Inoue et al20 used a branched EVSG to maintain perfusion of the celiac axis in a patient with a distal type I endoleak after previous endoluminal repair of a descending thoracic aortic pseudoaneurysm, and Bleyn et al21 used a similar technique to preserve perfusion of the celiac axis in a patient with a Crawford extent I TAAA. In contrast, Stanley et al15 reported endovascular repair of a descending thoracic aortic aneurysm with graft fenestration for the celiac axis to increase the distal attachment zone. Until now, Chuter et al22, 23 had reported the only patient to have undergone total endovascular repair of TAAA with preservation of all four visceral vessels by using a multibranched EVSG. Using endovascular techniques similar to those previously described in patients with juxtarenal AAA,14 together with advances in graft design, we have extended our indications for endovascular repair to patients with TAAA.
Methods
Patients
Between April and October 2003, four patients underwent endovascular repair of asymptomatic nonruptured TAAAs under the care of the principal author (J.L.A.). Informed consent was obtained from all patients.
Aneurysm assessment and graft design
High-resolution spiral computed tomographic angiography (CTA) was performed from the aortic arch to the common femoral arteries (CFAs). Axial images were reconstructed at 1-mm intervals throughout the visceral segment of the aorta. Transfemoral digital subtraction angiography (DSA) with a calibrated catheter was performed in all patients. Custom-designed Zenith endoluminal prostheses were used in all patients (William A. Cook Australia Pty Ltd, Brisbane, Australia).14 Graft design and manufacturing techniques were based on the standard fenestrated EVSG technology that is now well established and has been used in more than 800 cases of AAA with short infrarenal necks. Each device was custom-designed to match the anatomy of the specific patient. Measurement of the aortic diameter and angulation, the ostial diameter of each visceral vessel, the relative distance of the visceral vessels from a fixed landmark, and the orientation of each visceral vessel from an aortic cross section were essential for accurate graft planning and design. Because more fenestrations were often required than with a standard fenestrated EVSG for AAA, design assistance was given by the Cook (Australia) Zenith Endovascular Graft Planning Service, which has personnel with the knowledge and experience of how the fenestrations can be placed to fit within the confines of the self-expanding stents used in the manufacture of these devices.
A tubular module with graft fenestrations for the target vessels was designed for deployment within the visceral segment of the aorta. Diameter-reducing restraining ties were placed along the posterior aspect of this module to limit the initial expansion of the graft after sheath withdrawal, thereby reducing the device profile and increasing longitudinal and axial maneuverability. Graft fenestrations and branches were placed to match the target vessel ostia that would be crossed by the graft. Side branches were designed only if there was significant space within the aortic lumen to allow deployment. Radiopaque markers were incorporated at quarter-hour positions around the fenestration or branch to facilitate accurate alignment with the vessel ostia. The most important modification from the standard fenestrated EVSG was the addition of a nitinol reinforcing ring to the fenestrations to aid in seal and security when a stent graft was introduced to form a side branch. Anterior and posterior markers were placed on the body of the graft to facilitate correct axial alignment. Other customized modular components were designed as required.
Normal construction, packing, and sterilization times are approximately 3 to 5 weeks from the signing-off on an agreed design. The devices for this application are not registered for general sale and are supplied in Australia under the provisions allowable by the regulatory body as a “Custom Made Device.” In Australia to date, the pricing has been based on the standard registered fenestrated AAA graft, but this may be adjusted depending on the complexity of the device.
Implantation technique
All procedures were performed with patients under general anesthesia in a dedicated angiography suite by using high-resolution imaging (Advantx; GE Medical Systems, Milwaukee, Wis). Preoperative and postoperative N-acetyl cysteine and perioperative aminophylline infusion were used for renal protection. Cerebrospinal fluid drainage was not used.
After systemic heparinization, the fenestrated module of the EVSG was oriented extracorporeally and then inserted through the access vessel over a superstiff 0.035-inch Lunderquist wire and positioned in relation to the visceral vessels. Axial orientation was obtained by aligning the anteroposterior markers on the body of the graft. Alignment of multiple markers at the joints of the Z stents ensured that the EVSG was not twisted. With the image intensifier positioned craniocaudally perpendicular to the visceral aorta, the delivery sheath was withdrawn, and the upper graft stents were released, with the anchoring stent remaining capped. Alignment of the radiopaque graft markers, reference to the digital graft image and graft plan, and intraprocedural DSA ensured that the fenestrations or branches were aligned axially and longitudinally with the target vessels. The delivery sheath was then withdrawn to deploy the device completely. At this stage, the device remained attached to the delivery sheath by the diameter-reducing restraining ties, the top cap restraining the proximal anchoring stents, and the distal anchoring wire. No further graft rotation was possible.
The visceral vessels were next cannulated from the contralateral CFA by using steerable catheter-guidewire systems from within the endograft lumen. Glyceryl trinitrate was injected into each visceral artery after catheterization to prevent spasm during manipulations. A 4-cm-long Opta angioplasty balloon (Cordis Corporation, Miami Lakes, Florida) with a diameter matched to the visceral vessel diameter was tracked over a wire into each target vessel and inflated to 2 to 4 atm to ensure accurate alignment of the graft fenestrations and vessel ostia. With the balloons inflated to guide the graft fenestrations or branches to the vessel ostia, the wire tethering the diameter-reducing restraining ties was removed to fully expand the EVSG. The top cap was then deployed, followed by release of the distal anchoring wire (Fig 1). The delivery system was then retrieved. The image intensifier was angled appropriately to ensure accurate alignment of the fenestration markers and visceral artery origins for stent deployment within the target vessels. If there was contact between the graft material and the wall of the aorta, then the interface between the graft fenestration and the target vessel was secured with a balloon-expandable Genesis stent (Cordis) sized to match the diameter of the target vessel. If there was no contact between graft and aorta or if significant intraluminal thrombus was present, then a balloon-expandable Jostent stent graft (Abbott Laboratories, Abbott Park, Illinois) was used to bridge the gap and secure the graft fenestration/target vessel interface. During deployment of the Jostent stent graft, there is a relative shortening of the middle layer of polytetrafluoroethylene compared with the inner and outer uncovered stents. Two thirds of the stent was deployed within the target vessel, with one third in the endograft lumen, and the luminal segment of the stent was flared by using larger angioplasty balloons. The body of the EVSG was then dilated; inflation of the balloon over the visceral stents was avoided. Further nonfenestrated modular components were deployed as required.
Fig 1.
Optimal alignment of the graft fenestrations and branch vessels is achieved by inflating angioplasty balloons in the celiac axis, superior mesenteric artery, and both renal arteries from within the endograft lumen.
Results
Case 1
An 82-year-old man presented with a 60-mm-diameter asymptomatic TAAA. Comorbidity consisted of hypertension (HT), ischemic heart disease, and stenting of a left renal artery stenosis. Previous surgery included coronary artery bypass grafting and open repair of a ruptured infrarenal AAA with an aortoaortic graft 19 years previously. The patient was assessed as American Society of Anesthesiologists (ASA) grade III. Preoperative CTA and DSA demonstrated occlusion of the celiac axis at its origin with antegrade flow in the superior mesenteric artery (SMA) and good back-filling of the branches of the celiac axis. The SMA and both renal arteries originated from the aneurysmal aorta (Fig 2). The aortic diameter at the proximal and distal implantation sites was 34 and 20 mm, respectively. A one-piece EVSG with three fenestrations to accommodate the SMA (8 mm diameter) and both renal arteries (6 mm diameter) was constructed (Fig 3). The EVSG had a proximal and distal diameter of 40 and 28 mm, respectively, and the diameter at the level of the visceral vessels was 36 mm.
Fig 2.
Diagramatic representation of aneurysm morphology in patients 1 to 4.
Fig 3.
Custom-designed Zenith fenestrated and branched stent grafts inserted in patients 1 to 4.
Both CFAs were exposed surgically, and the EVSG was delivered through a 20F sheath in the right CFA. Graft maneuverability was significantly limited by the fact that one third of the previously inserted left renal artery stent protruded into the aortic lumen. The SMA and right renal artery were successfully cannulated, but apposition of the left renal artery graft fenestration and the left renal artery stent proved impossible. Graft rotation occurred during deployment and resulted in occlusion of the left renal artery and dissection and occlusion of the right common iliac artery. The interface between the graft fenestrations and the SMA and the right renal artery orifices were secured with 8-mm-diameter Jostent stent grafts. A 28-mm-diameter Zenith aortouni-iliac EVSG was deployed within the customized EVSG via the left CFA, and an 8-mm polytetrafluoroethylene left to right femorofemoral crossover graft was inserted. Completion angiography demonstrated no endoleak and antegrade perfusion of the SMA and right renal artery. The total procedural time was 10 hours. The patient received a total of 9000 IU of intravenous heparin and 300 mL of contrast medium, and five units of packed red cells were transfused. Within 24 hours of the procedure, the patient had a major hemorrhage from the left groin anastomosis of the crossover graft and returned to the operating room for control of bleeding. The patient died on the second postoperative day from multisystem organ failure.
Case 2
A 76-year-old man presented with a 60-mm-diameter asymptomatic TAAA. Comorbidity consisted of mild renal impairment with a serum creatinine of 150 μmol/L. The patient was assessed as ASA grade II. CTA and DSA demonstrated a patent celiac axis, SMA, and both renal arteries originating from the aneurysmal aorta (Fig 2). A three-piece EVSG was constructed. The aortic diameter at the proximal and distal implantation sites was 34 and 26 mm, respectively. The fenestrated component included three fenestrations to accommodate the SMA (8 mm diameter) and both renal arteries (6 mm diameter) and an 8-mm-diameter, 4-mm-long branch for the celiac axis (Fig 3). The fenestrated component had a proximal and distal diameter of 36 and 28 mm, respectively, and the diameter at the level of the visceral vessels was 36 mm. Both CFAs were exposed surgically, and the EVSG was delivered through a 22F sheath in the right CFA. The fenestrated component was deployed first in a satisfactory position. Minimal aortic thrombus was present at the level of the SMA and renal arteries, and the graft diameter was sufficient (36 mm) to ensure good apposition with the aortic wall. The interface between the graft fenestrations and the SMA and both renal artery orifices were, therefore, secured with 8- and 6-mm-diameter Genesis stents, respectively. Perfusion of the celiac axis was maintained by the graft side branch and an 8-mm-diameter Jostent stent graft. A second nonfenestrated thoracic EVSG (40 mm proximal diameter and 36 mm distal diameter) was deployed distal to the left subclavian artery, and a third EVSG (36 mm proximal and distal diameters) was deployed to bridge the gap between the first two stent grafts. Completion angiography demonstrated no endoleak and antegrade perfusion in all four branch vessels. Four sheaths had been inserted in the left CFA, which occluded at the end of the procedure, and surgical thrombectomy was required. The total procedural time was 6 hours. The patient received a total of 7000 IU of intravenous heparin and 385 mL of contrast medium. No blood transfusion was required. The patient made an uncomplicated recovery and was discharged home on the fifth postoperative day. Postoperative creatinine improved to 130 μmol/L. CTA at 1 and 12 months demonstrated complete aneurysm exclusion with antegrade perfusion in all four branch vessels (Fig 4, Fig 5).
Fig 4.
Follow-up computed tomographic angiography in patient 2 demonstrating aneurysm exclusion and patent celiac axis, superior mesenteric artery, and both renal arteries.
Fig 5.
Follow-up computed tomographic angiography in patient 2 demonstrating patent celiac axis, superior mesenteric artery, and both renal arteries.
Case 3
A 62-year-old woman presented with a 55-mm-diameter asymptomatic TAAA. Comorbidity included HT, warfarin therapy, chronic obstructive pulmonary disease, and renal impairment (serum creatinine, 230 μmol/L). Previous surgery included aortic valve replacement, replacement of the ascending aorta and aortic arch, left subclavian to carotid artery transposition, and repair of the proximal descending thoracic aorta for thoracic aortic dissection. The patient had also required hysterectomy and right ureteric diversion with radical pelvic radiotherapy for gynecologic malignancy. The patient was assessed as ASA grade III. CTA and DSA demonstrated a patent celiac axis originating 5 mm below the aneurysm, with the SMA and both renal arteries arising from nonaneurysmal aorta (Fig 2). The aortic diameter at the proximal and distal implantation sites was 25 and 19 mm, respectively. A three-piece EVSG was constructed. The fenestrated component of the EVSG included a single 20-mm-wide, 18-mm-high scallop to accommodate the celiac axis (Fig 3). The fenestrated component had a proximal and distal diameter of 42 and 26 mm, respectively, and the diameter at the level of the scallop was 26 mm.
Small-caliber external iliac arteries and dense scarring in the left groin from multiple previous cannulations for cardiopulmonary bypass precluded the insertion of the delivery sheath. The left common iliac artery was therefore exposed by an extraperitoneal approach, and a 10-mm Dacron graft (DuPont, Wilmington, Del) was sutured end to side to the artery. The EVSG was delivered through a 22F sheath via the Dacron graft. A percutaneous approach was used to the right CFA. The first nonfenestrated thoracic EVSG (30-mm proximal diameter and 42-mm distal diameter) was deployed distal to the left subclavian artery, followed by a second EVSG (42-mm proximal and distal diameters) and, finally, the fenestrated component. The graft was deployed in a satisfactory position, and the celiac axis was not stented. Completion angiography demonstrated no endoleak with antegrade perfusion of the celiac axis and SMA. The total procedure time was 6.5 hours. The patient received a total of 5000 IU of intravenous heparin and 345 mL of contrast medium, and four units of packed red cells were transfused. The patient made an uncomplicated recovery and was discharged home on the sixth postoperative day. CTA at 1 and 12 months demonstrated complete aneurysm exclusion with antegrade perfusion in the celiac axis and SMA.
Case 4
A 75-year-old man presented with an 85-mm-diameter asymptomatic TAAA. Comorbidity consisted of HT and chronic obstructive pulmonary disease. Previous surgery included open repair of nonruptured infrarenal AAA with an aortoaortic graft 14 years previously and left hemicolectomy for colonic carcinoma 11 years previously. The patient was assessed as ASA grade III. CTA and DSA demonstrated that the celiac axis, SMA, and both renal arteries originated from the aneurysmal aorta (Fig 2). The aortic diameter at the proximal and distal implantation sites was 40 and 22 mm, respectively. A one-piece EVSG with four fenestrations to accommodate the celiac axis (12-mm diameter), SMA (10-mm diameter), and both renal arteries (6 mm wide and 8 mm high) was constructed (Fig 3). The EVSG had a proximal and distal diameter of 46 and 26 mm, respectively, and the diameter at the level of the celiac axis and SMA was 46 mm.
A percutaneous approach to both CFAs was used. A “preclose” technique was used for the right CFA that used a suture-mediated arterial closure device (Perclose; Abbott Laboratory, Redwood City, Calif). The EVSG was delivered through a 24F sheath in the right CFA (Fig 6). The graft was deployed in a satisfactory position. Three sheaths were inserted into the left CFA for cannulation of the SMA and both renal arteries. The interface between the graft fenestrations and the SMA and the right renal artery orifices were secured with 10- and 8-mm-diameter Jostent stent grafts, respectively. Three 28 × 8-mm Jostent stent grafts were deployed within a track through the laminated thrombus between the graft fenestration and the left renal artery. Because there was minimal thrombus and good apposition between the EVSG and the aorta at the level of the celiac axis, it was not considered necessary to stent the celiac axis once the graft fenestration/SMA interface had been secured. Completion angiography demonstrated no endoleak with antegrade perfusion of all four branch vessels. The total procedural time was 9 hours. The patient received a total of 10,000 IU of intravenous heparin and 500 mL of contrast medium. No blood transfusion was required. The patient made an uncomplicated recovery and was discharged home on the third postoperative day. CTA at 1 and 12 months demonstrated complete aneurysm exclusion with antegrade perfusion in all four target vessels (Fig 7).
Fig 6.
Percutaneous approach to endovascular thoracoabdominal aortic aneurysm repair in patient 4.
Fig 7.
Follow-up computed tomographic angiography in patient 4 demonstrating aneurysm exclusion and patent celiac axis, superior mesenteric artery, and both renal arteries.
Discussion
Considerable experience with the use of graft fenestration techniques for the treatment of juxtarenal AAA14 has allowed the authors to expand their clinical indications for endovascular repair to include patients with TAAA. This article describes four consecutive patients who underwent endovascular repair of TAAA with fenestrated and branched EVSGs. Three of the patients (cases 1, 3, and 4) were ASA grade III and were considered at high risk for conventional surgical repair. Previous open aortic reconstruction and extensive aneurysmal disease would have added to the complexity of open repair and increased the risk of SCI in these patients. The approach described in this article has obvious advantages over conventional open repair and hybrid open/endovascular techniques in that laparotomy or thoracotomy and aortic cross-clamping are avoided and cardiovascular instability, operative blood loss, and visceral ischemic times are minimized. One potential disadvantage, however, is that this technique does not facilitate preservation of flow to the intercostal arteries, and this may be associated with an increased risk of SCI. In contrast, other factors that contribute to SCI are avoided, such as prolonged lower torso and visceral ischemia and reperfusion and cardiovascular instability. Despite these considerations, the first reported case of total endovascular repair of TAAA, by Chuter et al,22, 23 was complicated by SCI. Adjuvant techniques for spinal cord protection were not used in the present series because of a lack of clinical experience. None of the patients in this series had evidence of postoperative SCI.
Minor refinements in endovascular technique were required in this series. In patients with juxtarenal AAA, transgraft catheterization and balloon inflation within the renal arteries alone is sufficient to ensure accurate alignment of the graft fenestrations and vessel ostia before full graft deployment. Two patients in this series had grafts with four fenestrations, and catheterization of all four visceral vessels was considered necessary to ensure accurate graft alignment and prevent branch vessel occlusion. To prevent proximal type I endoleak, Jostent stent grafts were used to seal the fenestration/vessel orifice interface if there was no contact between the graft and the vessel or if significant laminated intraluminal thrombus was present. In the fourth patient in the series, three overlapping 28 × 8-mm Jostent stent grafts were required to bridge the gap through the thrombus from the graft fenestration to the left renal artery. These stent grafts have excellent early patency rates in the treatment of renal artery lesions,24 but their long-term patency in visceral arteries is unknown. Stent graft migration and subsequent branch vessel occlusion during sac remodeling has been shown to be a potential problem with thoracic aortic EVSGs.15 In patients with extensive thoracic aneurysmal disease, considerable overlapping of the thoracic EVSGs is recommended to minimize stent graft migration. The technique of flaring of the luminal segment of the branch vessel stents is intended to add increased security to the fixation at the fenestration/orifice interface and also improves ease of access to the vessel for further endovascular intervention should this be required. The presence of a renal artery stent protruding into the aortic lumen caused considerable technical difficulties in our first patient and resulted in occlusion of the renal artery, conversion to an aortouni-iliac EVSG and femorofemoral crossover graft, and, ultimately, death as a consequence of graft hemorrhage.
To our knowledge, this study includes the first uncomplicated cases of TAAA repair with preservation of all four visceral vessels by fenestrated and branched EVSGs, as well as the first case of endovascular TAAA repair by an entirely percutaneous approach. CTA at 12 months’ follow-up in the 3 survivors has demonstrated complete aneurysm exclusion, with reductions in aneurysm diameter and antegrade perfusion in all 10 target vessels. The efficacy and durability of the technique will require corroboration in larger clinical series. High-quality preoperative imaging for graft customization, advanced graft design, high-resolution intraoperative imaging, excellent catheter skills, and careful clinical and radiologic follow-up are essential for the successful treatment of these complex aneurysms. This study has demonstrated that endovascular repair of TAAA is feasible and that it provides an acceptable and promising alternative to conventional surgical repair in selected patients. With advances in graft technology and increasing experience, endovascular repair may become the optimal treatment for patients with these challenging lesions.
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Competition of interest: Dr Anderson has received financial assistance from Cook Inc for travel and accommodation to attend meetings. Mr Hartley has registered patents assigned to Cook Inc and is a paid consultant to Cook Inc.
PII: S0741-5214(05)01080-3
doi:10.1016/j.jvs.2005.05.063
© 2005 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
