Matthew P Sweet1, Benjamin W Starnes2, Billi Tatum2. 1. Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, Wash. Electronic address: mpsweet@uw.edu. 2. Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, Wash.
Abstract
OBJECTIVE: To report an initial experience with physician-modified thoracic endografts for endovascular treatment of thoracoabdominal aortic aneurysm (TAAA). METHODS: Single-center cohort study of the treatment of TAAA using a physician-modified fenestrated thoracic endograft for patients deemed to be at high risk of open repair. The cohort includes 21 patients in a prospective physician-sponsored U.S. Food and Drug Administration-approved investigational device exemption study and three patients treated outside the investigational device exemption. The procedure involves physician modification of a Cook TX2 thoracic stent graft with reinforced fenestrations. Branch stents were iCast balloon expandable stents. Treatment success was defined as successful aneurysm exclusion with freedom from permanent organ system dysfunction and return to preoperative level of independent functional status. RESULTS: Twenty-four consecutive patients were treated. Twenty-one patients (88%) met the endpoint of treatment success at a mean of 11 months follow-up. One patient (4%) died within 30 days due to complications of spinal cord injury (SCI). One patient (4%) died 4 months postoperatively after a prolonged recovery from surgery. One other patient (4%) is alive 13 months after operation with permanent SCI. One renal reintervention has been required. No device failures have occurred. CONCLUSIONS: Early-term data suggest that physician-modified fenestrated thoracic endografts can be used to safely and effectively treat TAAA in patients at high risk of open repair. Physician-modified devices perform similarly to commercially manufactured grafts in terms of treatment success, SCI, perioperative death, and clinical outcome at short-term follow-up. Physician modification is immediately available and allows for a high level of customizability. Procedure success is contingent upon careful preoperative planning, patient selection, experienced providers, and a high volume center.
OBJECTIVE: To report an initial experience with physician-modified thoracic endografts for endovascular treatment of thoracoabdominal aortic aneurysm (TAAA). METHODS: Single-center cohort study of the treatment of TAAA using a physician-modified fenestrated thoracic endograft for patients deemed to be at high risk of open repair. The cohort includes 21 patients in a prospective physician-sponsored U.S. Food and Drug Administration-approved investigational device exemption study and three patients treated outside the investigational device exemption. The procedure involves physician modification of a Cook TX2 thoracic stent graft with reinforced fenestrations. Branch stents were iCast balloon expandable stents. Treatment success was defined as successful aneurysm exclusion with freedom from permanent organ system dysfunction and return to preoperative level of independent functional status. RESULTS: Twenty-four consecutive patients were treated. Twenty-one patients (88%) met the endpoint of treatment success at a mean of 11 months follow-up. One patient (4%) died within 30 days due to complications of spinal cord injury (SCI). One patient (4%) died 4 months postoperatively after a prolonged recovery from surgery. One other patient (4%) is alive 13 months after operation with permanent SCI. One renal reintervention has been required. No device failures have occurred. CONCLUSIONS: Early-term data suggest that physician-modified fenestrated thoracic endografts can be used to safely and effectively treat TAAA in patients at high risk of open repair. Physician-modified devices perform similarly to commercially manufactured grafts in terms of treatment success, SCI, perioperative death, and clinical outcome at short-term follow-up. Physician modification is immediately available and allows for a high level of customizability. Procedure success is contingent upon careful preoperative planning, patient selection, experienced providers, and a high volume center.
Authors: Carla K Scott; Anna L Driessen; Marilisa Soto Gonzalez; Fatemeh Malekpour; Gerardo G Guardiola; Mirza S Baig; Melissa L Kirkwood; Carlos H Timaran Journal: J Vasc Surg Date: 2021-09-28 Impact factor: 4.860