Results of a multicenter, prospective trial of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial)
Ali Khoynezhad, Ali Azizzadeh, Carlos E Donayre, Alan Matsumoto, Omaida Velazquez, Rodney White, RESCUE investigators, Rodney A White, Ali Azizzadeh, Alan H Matsumoto, Omaida C Velazquez, Joshua Rovin, Joseph V Lombardi, Ernest Moore, Robert Allen, Robert Hieb, Bart E Muhs, G Chad Hughes, Francios Dagenais, Himanshu J Patel, Clifford J Buckley, Robert J Feezor, Marc L Schermerhorn, Ali Khoynezhad, Jean M Panneton, John P Pigott, William D Jordan, Nirman Tulsyan, Ali Khoynezhad, Ali Azizzadeh, Carlos E Donayre, Alan Matsumoto, Omaida Velazquez, Rodney White, RESCUE investigators, Rodney A White, Ali Azizzadeh, Alan H Matsumoto, Omaida C Velazquez, Joshua Rovin, Joseph V Lombardi, Ernest Moore, Robert Allen, Robert Hieb, Bart E Muhs, G Chad Hughes, Francios Dagenais, Himanshu J Patel, Clifford J Buckley, Robert J Feezor, Marc L Schermerhorn, Ali Khoynezhad, Jean M Panneton, John P Pigott, William D Jordan, Nirman Tulsyan
Abstract
Objective: To evaluate the early outcomes of patients undergoing thoracic endovascular aortic repair for blunt thoracic aortic injuries.
Methods: A prospective, nonrandomized, multicenter trial using the Medtronic Valiant Captivia stent graft was conducted at 20 sites in North America. Fifty patients with blunt thoracic aortic injuries were enrolled between April 2010 and January 2012 and will be followed for 5 years. The injuries were classified into categories (grades I-IV) based on severity: intimal tear, intramural hematoma, pseudoaneurysm, or rupture. The primary end point was 30-day all-cause mortality. Secondary end points were adverse events occurring within 30 days that were related to the procedure, device or aorta, and aortic-related mortality. Technical success was measured as successful device delivery and deployment.
Results: Seventy-six percent (38/50) of patients were male with mean age of 41 ± 17 years. Fifty-one Medtronic Valiant Captivia thoracic stent grafts and a single Talent thoracic stent graft were implanted within a median of 1.0 days following injury (mean, 1.8 ± 4.0 days). Seventy percent (35/50) of aortic injuries were grade III or higher, including one patient with free rupture. Mean injury severity score was 38 ± 14. Fifty-four percent of stent grafts were ≤26 mm (28/52). The left subclavian artery was completely covered in 40% of patients (20/50) and partially covered in 18% of patients (9/50). Four patients underwent subclavian artery revascularization: one at the time of the endograft procedure and three others after developing arm ischemia after the initial endograft procedure. Cerebral spinal fluid was drained in two patients. The median procedure time was 91 minutes, and median hospital stay was 12 days. There was 100% successful device delivery and deployment. Four (8%) patients died within 30 days. Nonfatal adverse events within 30 days that were related to the procedure, device, or aorta were experienced by 12% (6/50) of patients. No nonfatal adverse events related to the device were reported; a single death was conservatively adjudicated as device-, procedure-, and aorta-related because of insufficient information. No patient developed spinal cord injury, and there were no cerebrovascular accidents. However, one patient had an anoxic brain injury following aortic rupture. No patient underwent conversion to open repair or required an endovascular reintervention.
Conclusions: Based on the early outcomes, the Medtronic Valiant Captivia stent graft appears to be a promising treatment modality for blunt thoracic aortic injuries. Long-term follow-up is necessary to substantiate the effectiveness of thoracic endovascular aortic repair in treatment of blunt thoracic aortic injuries.
Trial registration: ClinicalTrials.gov NCT01092767.
Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
Source: PubMed