Mark A Farber1, Raghuveer Vallabhaneni2, William A Marston2. 1. Division of Vascular Surgery, University of North Carolina, Chapel Hill, NC. Electronic address: mark_farber@med.unc.edu. 2. Division of Vascular Surgery, University of North Carolina, Chapel Hill, NC.
Abstract
BACKGROUND: Fenestrated devices currently require a 3- to 4-week manufacturing period before implantation; as such, there have been efforts to develop "off-the-shelf" (OTS) devices to reduce the time before definitive treatment can be accomplished. We examined all patients treated for complex aortic problems at our institution during the past 12 months to evaluate the suitability and early outcomes of the OTS devices vs commercially available endovascular options. METHODS: Between July 2012 and September 2013, patients undergoing aortic aneurysm repair were extracted from a prospectively managed aortic database. Two OTS devices, the Cook (Bloomington, Ind) p-Branch and the Endologix (Irvine, Calif) Ventana device, were being evaluated through clinical trials during this time frame. The custom Cook Zenith fenestrated endovascular (ZFEN) device was also available and approved by the U.S. Food and Drug Administration (FDA) during the study period. RESULTS: Of 224 aortic aneurysms treated at our institution during this period, there were a total of 85 patients with type IV thoracoabdominal aneurysms including juxtarenal aneurysms. Only 23 patients (27%) met anatomic criteria for OTS devices, with 16 patients having these investigational devices implanted. The major exclusion criterion for the p-Branch device was renal axial or circumferential position; the limiting factor for Ventana was infrasuperior mesenteric artery neck length restriction. Five of the patients who would have fit criteria for an OTS device had an FDA-approved (ZFEN) device implanted instead, and two patients opted for open repair as a result of follow-up requirements. An additional 25 patients received custom-designed (ZFEN) devices (n = 30; 35%), whereas 37 (44%) others did not meet criteria for any available endovascular device and were repaired with alternative management strategies. The mean age and maximal aortic diameter of the two cohorts (OTS and ZFEN) were 71.8 years and 72.7 years (P = NS) and 61.3 mm and 58.5 mm (P = NS), respectively. Technical success was 100%, with an overall 30-day mortality of 2.1% (n = 1, ZFEN). Major complications occurred in eight patients (17%; two OTS, six ZFEN). CONCLUSIONS: Whereas OTS device strategies will reduce the waiting times for patients with complex aortic aneurysmal disease, a significant number will still require custom-made device repair until additional device designs become available. Early experience with OTS devices does not demonstrate any significant renal risks; however, the treatment numbers are low and should be interpreted with caution until larger confirmatory studies are published. Further studies comparing the outcomes of these techniques are required to establish the best approach to handle endovascular repair of complex aortic aneurysm.
BACKGROUND: Fenestrated devices currently require a 3- to 4-week manufacturing period before implantation; as such, there have been efforts to develop "off-the-shelf" (OTS) devices to reduce the time before definitive treatment can be accomplished. We examined all patients treated for complex aortic problems at our institution during the past 12 months to evaluate the suitability and early outcomes of the OTS devices vs commercially available endovascular options. METHODS: Between July 2012 and September 2013, patients undergoing aortic aneurysm repair were extracted from a prospectively managed aortic database. Two OTS devices, the Cook (Bloomington, Ind) p-Branch and the Endologix (Irvine, Calif) Ventana device, were being evaluated through clinical trials during this time frame. The custom Cook Zenith fenestrated endovascular (ZFEN) device was also available and approved by the U.S. Food and Drug Administration (FDA) during the study period. RESULTS: Of 224 aortic aneurysms treated at our institution during this period, there were a total of 85 patients with type IV thoracoabdominal aneurysms including juxtarenal aneurysms. Only 23 patients (27%) met anatomic criteria for OTS devices, with 16 patients having these investigational devices implanted. The major exclusion criterion for the p-Branch device was renal axial or circumferential position; the limiting factor for Ventana was infrasuperior mesenteric artery neck length restriction. Five of the patients who would have fit criteria for an OTS device had an FDA-approved (ZFEN) device implanted instead, and two patients opted for open repair as a result of follow-up requirements. An additional 25 patients received custom-designed (ZFEN) devices (n = 30; 35%), whereas 37 (44%) others did not meet criteria for any available endovascular device and were repaired with alternative management strategies. The mean age and maximal aortic diameter of the two cohorts (OTS and ZFEN) were 71.8 years and 72.7 years (P = NS) and 61.3 mm and 58.5 mm (P = NS), respectively. Technical success was 100%, with an overall 30-day mortality of 2.1% (n = 1, ZFEN). Major complications occurred in eight patients (17%; two OTS, six ZFEN). CONCLUSIONS: Whereas OTS device strategies will reduce the waiting times for patients with complex aortic aneurysmal disease, a significant number will still require custom-made device repair until additional device designs become available. Early experience with OTS devices does not demonstrate any significant renal risks; however, the treatment numbers are low and should be interpreted with caution until larger confirmatory studies are published. Further studies comparing the outcomes of these techniques are required to establish the best approach to handle endovascular repair of complex aortic aneurysm.
Authors: Salvatore T Scali; Dan Neal; Vida Sollanek; Tomas Martin; Julie Sablik; Thomas S Huber; Adam W Beck Journal: J Vasc Surg Date: 2015-08-05 Impact factor: 4.268