Management of arch aneurysms with a single-branch thoracic endograft in zone 0Central MessagePerspective
Background: We present preliminary data from a patient cohort undergoing thoracic endovascular aortic repair for Ishimaru zone 0 and 1 using a novel branched arch endograft. Methods: This US multicenter early feasibility investigational device exemption clinical trial treated 9 patients with a mean...
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| Format: | Article |
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Elsevier
2021-06-01
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| Series: | JTCVS Techniques |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666250721000651 |
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| author | Michael D. Dake, MD Joseph E. Bavaria, MD Michael J. Singh, MD Gustavo Oderich, MD Mark Filinger, MD Michael P. Fischbein, MD, PhD Jon S. Matsumura, MD Himanshu J. Patel, MD |
| author_facet | Michael D. Dake, MD Joseph E. Bavaria, MD Michael J. Singh, MD Gustavo Oderich, MD Mark Filinger, MD Michael P. Fischbein, MD, PhD Jon S. Matsumura, MD Himanshu J. Patel, MD |
| author_sort | Michael D. Dake, MD |
| collection | DOAJ |
| description | Background: We present preliminary data from a patient cohort undergoing thoracic endovascular aortic repair for Ishimaru zone 0 and 1 using a novel branched arch endograft. Methods: This US multicenter early feasibility investigational device exemption clinical trial treated 9 patients with a mean age 72.8 ± 8.0 years (77.8% male). The endograft was designed with a single side branch designed to facilitate aortic coverage proximal to the innominate or left carotid artery while maintaining branch vessel patency. Pathology treated included fusiform (n = 2) or saccular (n = 7) aneurysm, with a maximum aortic diameter of 6.3 ± 0.7 cm. Treatment was into zone 0 in 8 patients, and zone 1 in 1 patient. Results: All patients underwent initial successful first-stage supra-aortic trunk revascularization using a variety of techniques, without the occurrence of stroke. For the second thoracic endovascular aortic repair stage, median total treatment length was 20 cm. The primary end point of device delivery and branch vessel patency was achieved in 100% of patients, without 30-day mortality or spinal cord ischemia. Cerebrovascular events were observed in 2 patients through 30 days. No type I or III endoleaks were reported and all side branches were patent at 12-month imaging follow-up. Conclusions: Endovascular repair of Ishimaru zone 0 or 1 arch aortic aneurysms can be achieved with a novel branched arch endograft. Future studies will evaluate the mid-term outcomes with this device in other pathologies and further define the occurrence of postoperative neurologic events. |
| format | Article |
| id | doaj-art-91f8732ab0f548ef9d1a49b02344e5d4 |
| institution | Kabale University |
| issn | 2666-2507 |
| language | English |
| publishDate | 2021-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JTCVS Techniques |
| spelling | doaj-art-91f8732ab0f548ef9d1a49b02344e5d42025-08-20T03:36:37ZengElsevierJTCVS Techniques2666-25072021-06-0171610.1016/j.xjtc.2021.01.011Management of arch aneurysms with a single-branch thoracic endograft in zone 0Central MessagePerspectiveMichael D. Dake, MD0Joseph E. Bavaria, MD1Michael J. Singh, MD2Gustavo Oderich, MD3Mark Filinger, MD4Michael P. Fischbein, MD, PhD5Jon S. Matsumura, MD6Himanshu J. Patel, MD7Department of Medical Imaging, University of Arizona Health System, Tucson, ArizDepartment of Surgery, Hospital of the University of Pennsylvania, Philadelphia, PaDepartment of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PaDepartment of Surgery, Mayo Clinic, Rochester, MinnDepartment of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NHDepartment of Cardiothoracic Surgery, Stanford University Hospitals, Palo Alto, CalifUniversity of Wisconsin School of Medicine and Public Health, Madison, WisDepartment of Cardiac Surgery, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Mich; Address for reprints: Himanshu J. Patel, MD, Department of Cardiac Surgery, CVC Room 5144, 1500 E Medical Center Dr, SPC 5864, Ann Arbor, MI 48109-5864.Background: We present preliminary data from a patient cohort undergoing thoracic endovascular aortic repair for Ishimaru zone 0 and 1 using a novel branched arch endograft. Methods: This US multicenter early feasibility investigational device exemption clinical trial treated 9 patients with a mean age 72.8 ± 8.0 years (77.8% male). The endograft was designed with a single side branch designed to facilitate aortic coverage proximal to the innominate or left carotid artery while maintaining branch vessel patency. Pathology treated included fusiform (n = 2) or saccular (n = 7) aneurysm, with a maximum aortic diameter of 6.3 ± 0.7 cm. Treatment was into zone 0 in 8 patients, and zone 1 in 1 patient. Results: All patients underwent initial successful first-stage supra-aortic trunk revascularization using a variety of techniques, without the occurrence of stroke. For the second thoracic endovascular aortic repair stage, median total treatment length was 20 cm. The primary end point of device delivery and branch vessel patency was achieved in 100% of patients, without 30-day mortality or spinal cord ischemia. Cerebrovascular events were observed in 2 patients through 30 days. No type I or III endoleaks were reported and all side branches were patent at 12-month imaging follow-up. Conclusions: Endovascular repair of Ishimaru zone 0 or 1 arch aortic aneurysms can be achieved with a novel branched arch endograft. Future studies will evaluate the mid-term outcomes with this device in other pathologies and further define the occurrence of postoperative neurologic events.http://www.sciencedirect.com/science/article/pii/S2666250721000651aortic archoutcomesendovascular |
| spellingShingle | Michael D. Dake, MD Joseph E. Bavaria, MD Michael J. Singh, MD Gustavo Oderich, MD Mark Filinger, MD Michael P. Fischbein, MD, PhD Jon S. Matsumura, MD Himanshu J. Patel, MD Management of arch aneurysms with a single-branch thoracic endograft in zone 0Central MessagePerspective JTCVS Techniques aortic arch outcomes endovascular |
| title | Management of arch aneurysms with a single-branch thoracic endograft in zone 0Central MessagePerspective |
| title_full | Management of arch aneurysms with a single-branch thoracic endograft in zone 0Central MessagePerspective |
| title_fullStr | Management of arch aneurysms with a single-branch thoracic endograft in zone 0Central MessagePerspective |
| title_full_unstemmed | Management of arch aneurysms with a single-branch thoracic endograft in zone 0Central MessagePerspective |
| title_short | Management of arch aneurysms with a single-branch thoracic endograft in zone 0Central MessagePerspective |
| title_sort | management of arch aneurysms with a single branch thoracic endograft in zone 0central messageperspective |
| topic | aortic arch outcomes endovascular |
| url | http://www.sciencedirect.com/science/article/pii/S2666250721000651 |
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