Giovanni Pratesi1, Carlo Pratesi2, Roberto Chiesa3, Gioacchino Coppi4, Dierk Scheinert5, Jan S Brunkwall6, Stefaan van der Meulen7, Giovanni Torsello8,9. 1. Vascular Surgery Unit, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy - giovanni.pratesi@uniroma2.it. 2. Vascular Surgery Unit, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. 3. Department of Vascular Surgery, Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy. 4. Department of Vascular Surgery, S. Agostino-Estense Hospital, University of Modena and Reggio Emilia, Baggiovara, Modena, Italy. 5. Department of Interventional Angiology, Faculty of Medicine, University of Leipzig, Leipzig, Germany. 6. Department of Vascular Surgery, Faculty of Medicine, University Clinic of Cologne, Cologne, Germany. 7. Syntactx Clinical Research Organization, New York, NY, USA. 8. St. Franziskus Hospital, Münster, Germany. 9. University Clinic of Münster, Münster, Germany.
Abstract
BACKGROUND: This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. METHODS: The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow-up. RESULTS: A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4-years of follow-up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow-up. At 4 years, 38 out of 39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4-year follow-up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae. CONCLUSIONS: The INCRAFT® AAA Stent-Graft System provides a minimally invasive and durable solution for patients undergoing EVAR that has been associated with a low frequency of device-related events through 4 years of follow-up.
BACKGROUND: This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. METHODS: The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow-up. RESULTS: A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4-years of follow-up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow-up. At 4 years, 38 out of 39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4-year follow-up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae. CONCLUSIONS: The INCRAFT® AAA Stent-Graft System provides a minimally invasive and durable solution for patients undergoing EVAR that has been associated with a low frequency of device-related events through 4 years of follow-up.