Results of a multicenter, prospective trial of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial)

ObjectiveTo evaluate the early outcomes of patients undergoing thoracic endovascular aortic repair for blunt thoracic aortic injuries.MethodsA 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.ResultsSeventy-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.ConclusionsBased 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

Computed tomography assessment of abdominal aortic aneurysm morphology after endograft exclusion

AbstractObjectives: Assessment of the long-term function of endografts to exclude abdominal aortic aneurysm (AAA) includes determination of aneurysm dimensions and morphologic changes that occur after implantation. This study reports the dimensional analysis of patients treated with AneuRx bifurcated endoprostheses with postintervention, 1-year (n = 51), 2-year (n = 28), and 3-year (n = 10) postimplantation contrast computed tomography data. Methods: Maximal diameter (D) and cross-sectional area (CSA) of the AAA were measured from axial computed tomography images. Total volume, AAA thrombus volume (AAA volume minus the volume of the device and luminal blood flow), diameter of the aorta at the level of the renal arteries and within the device, distance from the renal arteries to the device, length of the device limbs, and the angle of the proximal neck were also determined at the same follow-up intervals after deployment with computed tomography angiograms reconstructed in an interactive environment. Results: Fifty-one of 98 consecutively treated patients with the AneuRx bifurcated prosthesis (29 “stiff” and 22 “flexible” body devices) had complete data from the postprocedure and follow-up computed tomography studies available for analysis. Max D, CSA, total volume of the AAA, and AAA thrombus volume decreased sequentially from year to year compared with the postimplantation values. D and CSA decreased or were unchanged in all except four patients, two who had unrestricted enlargement of the aneurysm with eventual rupture and one who had surgical conversion for continued expansion despite four diagnostic angiograms and attempted embolizations. Total volume of the AAA increased in 11 of 51 patients at 1 year, eight of whom had endoleaks at some interval during the follow-up. Thrombus volume increased more than 5% in four of these patients, including the two with eventual rupture and the one conversion. Patients with endoleaks who had spontaneous thrombosis or were successfully treated either remained at the same volume or had decreased volume on subsequent examinations. D at the renal arteries increased an average of 0.9 mm during the first year, with a concomitant increase of 2.8 mm within the proximal end of the device related to the self-expanding nature of the Nitinol suprastructure. Subsequent enlargement of the proximal neck continued at a slow rate in some cases but never exceeded the diameter of the endoluminal device. The distance from the renal arteries to the device increased by an average of 3 mm over the first year, with the greatest increases occurring in patients with a “stiff” body device and those with rapid regression (>10% total volume) in 1 year. As regression of the AAA occurred, the angle of the proximal neck varied from -5° to +25° from the original alignment. Limb length varied from -8 mm to +10 mm, with no consistent pattern for the change, that is, ipsilateral or contralateral limb. Conclusion: Significant variation in the quantitation of aneurysm size occurs depending on the technique of computed tomography assessment used. In most patients diameter assessment is adequate, although volumetric analysis appears to be very helpful in certain patients who do not show aneurysm regression, or in whom the diameter increases or where endoleaks persist. Three-dimensional reconstruction and volumetric analysis are also useful to assess the mechanism by which the endovascular device accommodates to morphology changes and to determine criteria for reintervention. (J Vasc Surg 2001;33:S1-10.

Midterm results of endovascular treatment of complicated acute type B aortic dissection

ObjectivesThe operative mortality and morbidity of patients with complicated acute type B aortic dissection remain high. The endovascular approach has been proposed as a potential alternative. The purpose of this study is to review the contemporary outcome of patients undergoing endovascular treatment for complicated acute type B aortic dissection.MethodsA retrospective analysis of 28 patients undergoing endovascular interventions for acute type B aortic dissection was performed. Kaplan–Meier survival analysis was used for statistical computation.ResultsIndications for emergency endografting were rupture in 4 (14%) patients, severe lower body malperfusion in 8 (29%) patients, visceral/renal malperfusion in 7 (25%) patients, persistent chest pain despite proper anti-impulsive therapy in 5 (18%) patients, uncontrollable hypertension in 1 (4%) patient, and acute dilatation of false lumen with impending rupture in 3 (11%) patients. Three (11%) patients died early. Three patients died during follow-up of non–aorta-related causes. Overall survival was 82% and 78% at 1 and 5 years' follow-up, respectively. The aorta-related mortality was 10% for the entire follow-up period. Complete thrombosis of the false lumen in the thoracic aorta was achieved in 22 (85%) members of the surviving cohort, and partial thrombosis was achieved in the remainder. The rate of treatment failure according to Stanford criteria was 18% at 5 years. Mean follow-up was 36 months, and follow-up was complete in 28 (100%) patients.ConclusionsThoracic aortic endografting for complicated acute type B aortic dissection can be performed with a relatively low postoperative morbidity and mortality in experienced hands. The endovascular approach to life-threatening complications of acute type B aortic dissection appears to have a favorable outcome in midterm follow-up