Darren B Schneider1, Ross Milner2, Jan M M Heyligers3, Nabil Chakfé4, Jon Matsumura5. 1. Division of Vascular and Endovascular Surgery, Weill Cornell Medicine, NewYork-Presbyterian Hospital, New York, NY. Electronic address: dbs9003@med.cornell.edu. 2. Division of Vascular Surgery and Endovascular Therapy, University of Chicago Medicine, Chicago, Ill. 3. Department of Vascular Surgery, Elisabeth TweeSteden Hospital, Tilburg, The Netherlands. 4. Department of Vascular Surgery and Kidney Transplantation, University Hospital of Strasbourg, Strasbourg, France. 5. Division of Vascular Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisc.
Abstract
BACKGROUND: We report midterm outcomes with the GORE Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) in the U.S. investigational device exemption (IDE) trial and comparatively assess outcomes in the IDE trial with outcomes in a real-world population of patients treated in the Gore Global Registry for Endovascular Aortic Treatment (GREAT). METHODS: From 2013 to 2016, the IDE trial enrolled 99 patients treated with the IBE for common iliac artery (CIA) aneurysms or aortoiliac aneurysms. Bilateral IBE treatment was allowed only in the continued access phase. From 2013 to 2016, there were 92 patients treated with the IBE in the GREAT registry. Baseline characteristics, procedural variables, and reinterventions through 6 months were compared in the IDE trial and GREAT registry. Clinical and core laboratory-assessed imaging outcomes were assessed in the IDE trial through 2 years. RESULTS: GREAT patients were significantly older (P = .01) and of shorter height (P < .001) and lower weight (P < .001). There were also significantly more women treated in GREAT vs the IDE trial (8% vs 1%; P = .02). Thirteen GREAT patients (14%) and 4 of 35 continued access IDE patients (11%) had bilateral IBE placement (P = .70). IDE patients were more likely to be treated with percutaneous access methods (55% vs 40%; P = .04). Three IDE patients and three GREAT patients underwent 1-month reintervention, with two IDE reinterventions (2.1%) and one GREAT reintervention (1.6%) for thrombotic events. Five additional patients in each study underwent reintervention through 6 months (5% vs 5%; P = .92), all for nonthrombotic events. Internal iliac limb patency was 93.6% (95% confidence interval, 86.4%-97.1%) at 12 and 24 months in the IDE study. Subset analyses of the 10 IDE and GREAT patients with ≤6-month reintervention vs 181 intervention-free patients found that acute myocardial infarction (P = .01), nonpercutaneous access (P = .01), and surgical conduit use (P < .001) were associated with reintervention through 6 months. In the IDE trial, 3.4% and 4.1% of patients underwent reintervention at 12 months and 24 months, respectively, all for treatment of type II endoleaks. At 24 months, 8.7% of IDE patients exhibited abdominal aortic aneurysm sac expansion; 21.7% exhibited abdominal aortic aneurysm sac regression. No patients exhibited CIA aneurysm sac expansion; 45% exhibited CIA aneurysm sac regression. CONCLUSIONS: Midterm IDE outcomes and 6-month outcomes in the worldwide GREAT registry suggest that endovascular aortic aneurysm repair with concomitant CIA aneurysm repair with the IBE device is safe and effective. Thrombotic events are uncommon and are concentrated in the first month after the index procedure, and they typically can be resolved with endovascular reintervention.
BACKGROUND: We report midterm outcomes with the GORE Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) in the U.S. investigational device exemption (IDE) trial and comparatively assess outcomes in the IDE trial with outcomes in a real-world population of patients treated in the Gore Global Registry for Endovascular Aortic Treatment (GREAT). METHODS: From 2013 to 2016, the IDE trial enrolled 99 patients treated with the IBE for common iliac artery (CIA) aneurysms or aortoiliac aneurysms. Bilateral IBE treatment was allowed only in the continued access phase. From 2013 to 2016, there were 92 patients treated with the IBE in the GREAT registry. Baseline characteristics, procedural variables, and reinterventions through 6 months were compared in the IDE trial and GREAT registry. Clinical and core laboratory-assessed imaging outcomes were assessed in the IDE trial through 2 years. RESULTS:GREATpatients were significantly older (P = .01) and of shorter height (P < .001) and lower weight (P < .001). There were also significantly more women treated in GREAT vs the IDE trial (8% vs 1%; P = .02). Thirteen GREATpatients (14%) and 4 of 35 continued access IDE patients (11%) had bilateral IBE placement (P = .70). IDE patients were more likely to be treated with percutaneous access methods (55% vs 40%; P = .04). Three IDE patients and three GREATpatients underwent 1-month reintervention, with two IDE reinterventions (2.1%) and one GREAT reintervention (1.6%) for thrombotic events. Five additional patients in each study underwent reintervention through 6 months (5% vs 5%; P = .92), all for nonthrombotic events. Internal iliac limb patency was 93.6% (95% confidence interval, 86.4%-97.1%) at 12 and 24 months in the IDE study. Subset analyses of the 10 IDE and GREATpatients with ≤6-month reintervention vs 181 intervention-free patients found that acute myocardial infarction (P = .01), nonpercutaneous access (P = .01), and surgical conduit use (P < .001) were associated with reintervention through 6 months. In the IDE trial, 3.4% and 4.1% of patients underwent reintervention at 12 months and 24 months, respectively, all for treatment of type II endoleaks. At 24 months, 8.7% of IDE patients exhibited abdominal aortic aneurysm sac expansion; 21.7% exhibited abdominal aortic aneurysm sac regression. No patients exhibited CIA aneurysm sac expansion; 45% exhibited CIA aneurysm sac regression. CONCLUSIONS: Midterm IDE outcomes and 6-month outcomes in the worldwide GREAT registry suggest that endovascular aortic aneurysm repair with concomitant CIA aneurysm repair with the IBE device is safe and effective. Thrombotic events are uncommon and are concentrated in the first month after the index procedure, and they typically can be resolved with endovascular reintervention.
Authors: Jonathan Aaron Barnes; Mark A Eid; Kayla Moore; Suvekshya Aryal; Eden Gebre; Jennifer Nicole Woodard; Napong Kitpanit; Jialin Mao; David P Kuwayama; Bjoern D Suckow; Darren Schneider; Tiffany Abushaikha; Robbert Zusterzeel; Sreekanth Vemulapalli; Elizabeth A Shenkman; James Williams; Art Sedrakyan; Philip Goodney Journal: BMJ Surg Interv Health Technol Date: 2022-07-29