Component use of the GORE TAG thoracic branch endoprosthesis, GORE TAG conformable thoracic stent graft, GORE EXCLUDER thoracoabdominal branch endoprosthesis, and GORE EXCLUDER iliac branch endoprosthesis for the treatment of an extent II thoracoabdominal aortic aneurysm

Abstract

We report the first published component use of the GORE TAG thoracic branch endoprosthesis, GORE TAG conformable thoracic stent graft, GORE EXCLUDER thoracoabdominal branch endoprosthesis (TAMBE), and GORE EXCLUDER iliac branch endoprosthesis together in a 77-year-old woman who underwent repair of an extent II thoracoabdominal aortic aneurysm. The retrograde left subclavian artery branch portal of the GORE TAG thoracic branch endoprosthesis was used to facilitate fenestrated-branched endovascular repair in this case.

Treatment for extended thoracoabdominal aortic pathology has seen an emergence of technology in the last two years with the introduction of the GORE TAG thoracic branch endoprosthesis (TBE; W. L. Gore & Associates, Flagstaff, AZ) and the GORE EXCLUDER thoracoabdominal branch endoprosthesis (TAMBE). Initial experience demonstrates technical feasibility and favorable outcomes with both devices for a variety of clinical presentations.1, 2, 3, 4, 5, 6, 7, 8

The primary study arm of the GORE EXCLUDER TAMBE system was limited to thoracoabdominal aortic aneurysms requiring only the TAMBE system. The secondary study arm's results, including treatment with the TAMBE system and the GORE TAG conformable thoracic stent graft (CTAG), have not yet been presented. Furthermore, their use together as a component system with the TBE device has not been published. We present the case of a patient with an extent II thoracoabdominal aortic aneurysm who underwent total endovascular repair with the GORE component system. The patient provided written informed consent for the report of their case details and imaging studies.

Case report

A 77-year-old woman was referred from an outside hospital for elective repair of a 70-mm extent II thoracoabdominal aortic aneurysm. Medical history included hypertension and hyperlipidemia. Past surgical history included infrarenal endovascular aneurysm repair (EVAR) with a 36 mm GORE EXCLUDER Conformable abdominal aortic aneurysm (AAA) Endoprosthesis, thoracic endovascular aneurysm repair (TEVAR) with two 40-mm GORE CTAG devices, and superior mesenteric artery stenting for chronic mesenteric ischemia. She was referred to our institution for progressive degeneration of the supraceliac and paravisceral aorta with a maximum diameter of 70 mm, a type Ia endoleak of the EVAR component, and a 28-mm proximal left subclavian artery aneurysm involving the origin (Fig 1, A-C). At the time of consultation, the TAMBE system had recently been approved by the US Food and Drug Administration and the patient met all aortic, branch vessel, and vascular access requirements for surgical repair. A staged approach was considered for repair of the patient's left subclavian artery aneurysm with a GORE TBE, followed by repair of the thoracoabdominal aortic aneurysm with the TAMBE system. The distance from the distal edge of the left common carotid artery ostium to the distal edge of the left subclavian artery ostium was 30 mm and the maximum inner aortic diameter in zone 2 was 30 mm.

Fig 1.

Three-dimensional reconstruction of the thoracoabdominal aorta at index presentation (A) with demonstration of a 28-mm left subclavian artery aneurysm (B) and a type Ia endoleak of the endovascular aneurysm repair (EVAR) component (C).

The patient underwent stage I repair of the left subclavian artery aneurysm with a GORE TBE. Percutaneous left common femoral and radial artery access were obtained with 22F GORE DRYSEAL Flex Introducer and 5 French Terumo Glidesheath Slender sheaths (Terumo Medical, Somerset, NJ). The procedure was performed per the manufacturer's suggested guidelines, placing a 34 mm × 150 mm GORE TBE device with an 8-mm portal and a 12 mm × 6 cm side branch component for the left subclavian artery with a seal just proximal to the left vertebral artery. Completion imaging demonstrated no endoleak of the left subclavian artery aneurysm. The GORE TBE was extended distally with a GORE CTAG 34 mm × 200 mm TEVAR to the supraceliac aorta in preparation for the TAMBE system. The patient's perioperative course was uncomplicated, and she was discharged on postoperative day 1.

The patient underwent thoracoabdominal aortic aneurysm repair with the GORE TAMBE system 8 weeks after their index procedure without prophylactic cerebrospinal fluid drainage. The procedure was performed per the manufacturer's suggested guidelines with percutaneous bilateral common femoral artery access and open cutdown of the distal left axillary artery. Four preloaded guidewires were established for the celiac, superior mesenteric, and bilateral renal artery portals and a 37-mm GORE TAMBE device was deployed into the previously placed TEVAR from stage 1. The retrograde left subclavian artery branch portal of the GORE TAG TBE was used to facilitate fenestrated-branched endovascular repair with a 14F × 33 cm GORE DRYSEAL FLEX introducer sheath. A coaxial CATAPULT 7F × 90 cm straight guide sheath (Boston Scientific, Marlborough, MA) was used to perform sequential cannulation and bridge stenting of the visceral vessels.

The patient underwent relining of their infrarenal abdominal aorta with a distal bifurcated GORE EXCLUDER iliac branch endoprosthesis (IBE) with extended iliac limbs to the bifurcations of the bilateral common iliac arteries. Relining was preferred because of the significant size mismatch of the distal aspect of the GORE TAMBE device and the previously placed 36-mm GORE EXCLUDER conformable AAA endoprosthesis in addition to intramural thrombus within the AAA endoprosthesis. The patient's perioperative course was uncomplicated, and she was discharged on postoperative day 1. After 9 months of follow-up, all junctional components remain intact with widely patent left subclavian and visceral artery bridge stents and no endoleak (Fig 2).

Fig 2.

Three-dimensional reconstruction of an extent II thoracoabdominal aortic aneurysm with total GORE component system including the GORE thoracic branch endoprosthesis (TBE), GORE TAG conformable thoracic stent graft (CTAG), GORE EXCLUDER thoracoabdominal branch endoprosthesis (TAMBE), and GORE EXCLUDER iliac branch endoprosthesis (IBE).

Discussion

The GORE TAMBE system represents a significant advancement for patients with thoracoabdominal aortic aneurysms and this case report demonstrates the feasibility of its use with other component systems from W. L. Gore & Associates. Previous research has also demonstrated the feasibility and safety of manufactured off-the-shelf or patient-specific fenestrated and branched stent grafts from Cook Medical, Inc., for thoracoabdominal aortic aneurysms.8, 9, 10, 11, 12 A total transfemoral approach with a physician-modified endograft was considered and would have been an appropriate alternative for this patient. Although the authors have a robust experience with physician-modified endografts, we do not have a physician-sponsored investigational device exemption for custom-manufactured devices, and when appropriate our algorithm favors using Food and Drug Administration-approved devices if patient anatomy meets the inclusion criteria. A second consideration in this case was the ability to seal device components with the same biomechanical properties using the conformable expanded polytetrafluorethylene.¹³

The GORE TAMBE system is the only off-the-shelf endovascular solution for treatment of complex aneurysmal disease involving the visceral aorta in the United States. Farber et al⁵ recently presented the results of the primary arm of the GORE TAMBE system, which demonstrate a high technical success rate and low rate of safety events. The secondary arm includes treatment with the TAMBE system and the GORE TAG CTAG. Although the results of the secondary arm are expected in the future, we anticipate that component use of the GORE device system will become prevalent with the off-the-shelf approval for the GORE TAMBE system. Two important end points to be considered will be the rate of spinal cord ischemia with extended aortic coverage of multiple aortic devices, and the long-term rate of target artery instability, type III endoleak, and secondary interventions with the component of use of multiple devices. The authors do not routinely perform prophylactic cerebrospinal fluid drainage in staged thoracoabdominal aortic aneurysm repair. The authors use somatosensory evoked potentials and motor-evoked potentials for extent I to III thoracoabdominal aortic aneurysm repair.

Another consideration with the use of the GORE TBE and GORE TAMBE system is the use of the retrograde left subclavian artery branch portal for thoracoabdominal aortic aneurysm repair. DiBartolomeo et al¹⁴ previously demonstrated the feasibility of the GORE TBE left subclavian artery portal for target artery catheterization of a fenestrated-branched physician-modified endograft. The TBE portal is particularly advantageous for access secondary to the retrograde internal portal facing toward the descending thoracic aorta, eliminating the need for arch manipulation, while the branch component supported by the portal provides additional stability of the left arm sheath.¹⁴ However, even with the added stability, we have found the large left upper extremity sheath can still prolapse during its use for fenestrated-branched repair, and it is important to meticulously monitor the position of the large sheath with sheath, catheter, and wire exchanges. We prefer to use a 14F GORE DRYSEAL flex introducer sheath, which provides additional stability within the GORE TBE portal. The larger sheath size provides additional room if it is necessary to leave wires target vessels after bridge stenting. Consideration can also be given to using a GORE TBE with the larger 12-mm internal portal instead of the 8-mm internal portal. However, the 12-mm internal portals have longer proximal covered lengths and require longer minimum lengths along the outer curvature of the aorta from the distal edge of the left subclavian artery to the distal edge of the left common carotid artery. We have also found that the smaller 8-mm internal portal provides more coaxial support for the GORE DRYSEAL Flex introducer sheath, helping to cinch it down and stabilize its position. Finally, right upper extremity access can also be used for fenestrated-branched endovascular aortic aneurysm repair with low morbidity and minimal risk of perioperative ischemic stroke or transient ischemic attacks.¹⁵ Right upper extremity access would also avoid the risk of dislodging the left subclavian artery bridging limb in patients with a prior GORE TBE.

Conclusions

This case report highlights the recent significant advancements for repair of thoracoabdominal aortic aneurysms in the United States with the commercially available off-the-shelf GORE TBE and TAMBE devices. The GORE TBE, CTAG, TAMBE, and IBE together offer a feasible solution for off-the-shelf repair of thoracoabdominal aortic aneurysms for patients who meet the instructions for use of these component devices.

Funding

None.

Disclosures

None.