Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts

ObjectiveTo determine whether a physician-modified endovascular graft (PMEG) is a safe and effective method for treating patients with juxtarenal aortic aneurysms who are deemed unsuitable for open repair.MethodsA nonrandomized, prospective, consecutively enrolling investigational device exemption clinical trial was used. Data collected on patients treated with PMEG between April 2011 and August 2012 were analyzed. Subjects were followed with computed tomography, visceral duplex, and four-view X-ray at 30 days, 6 months, and 1 year. The protocol was designed to include follow-up to 5 years. The primary safety end point was the proportion of subjects who experienced a major adverse event (MAE) within 30 days of the procedure. The primary efficacy end point was the proportion of subjects experiencing treatment success.ResultsDuring the 16-month study period, 28 patients were consented and 26 underwent endovascular repair using PMEGs. Anatomic, operative details, and length of stay were recorded and included aneurysm diameter (mean, 62.5 mm), proximal neck length (mean, 4.4 mm), graft manufacture time (mean, 59.7 minutes), procedure time (mean, 169 minutes), fluoroscopy time (mean, 42.8 minutes), total contrast usage (mean, 63 mL), estimated blood loss (mean, 221 mL), and length of hospital stay (mean, 4.9 days). There were 63 fenestrations created for 48 renal arteries and 15 superior mesenteric arteries. Renal artery fenestrations were stented whenever possible (96%) and superior mesenteric artery fenestrations were all left unstented. There were no unanticipated adverse device events, no MAEs, and only a single minor adverse device event treated with a successful reintervention. At 30 days, there were no type I or III endoleaks and only four type II endoleaks (15.4%). Two patients died during the study period, one at day 23 from respiratory failure (in-hospital and 30-day mortality = 3.8%) and one at day 210 from urosepsis and congestive heart failure. MAEs occurred in 11.5% of patients at 30 days. The primary efficacy end point was achieved in 87.5% of patients (technical success 100%, freedom from migration, rupture or conversion, type I or III endoleaks, or sac enlargement = 100%, 100%, 87.5%, and 87.5%, respectively).ConclusionsThese preliminary data suggest that endovascular repair with PMEG is safe and effective for managing patients with juxtarenal aortic aneurysms. Endovascular repair with PMEG has acceptable early rates of morbidity, mortality, and endoleak. This endovascular aortic strategy is particularly appealing for those patients presenting with symptomatic or ruptured aortic aneurysms until reliable off-the-shelf solutions become widely available

Aberrant right subclavian artery syndrome: A case of chronic cough1 1Competition of interest: none.

AbstractA young, otherwise healthy man had chronic cough of 16 months’ duration. Evaluation revealed an aberrant right subclavian artery. Kommerell’s diverticulum without aneurysmal degeneration was present. Imaging studies showed compression of the esophagus but not the trachea. Results of methacholine challenge test were negative for evidence of reactive airway disease, but suggested mild variable intrathoracic obstruction. While aberrant right subclavian artery syndrome most commonly involves dysphagia, our patient’s only symptom was cough. Right subclavian artery to right common carotid artery transposition was performed, with oversewing of the subclavian artery stump to the left of the esophagus through a right supraclavicular incision. This treatment was curative, with complete resolution of symptoms

Safety of transfer, type of procedure, and factors predictive of limb salvage in a modern series of acute limb ischemia

ObjectiveThe primary objective was to evaluate the safety of transfer, type of procedure, and factors associated with limb salvage in patients with acute limb ischemia (ALI) treated at a quaternary referral center.MethodsA retrospective review of all patients with ALI secondary to thrombotic or embolic occlusion at a quaternary referral hospital from 2013 to 2016 was conducted. Patients were transferred from throughout Washington and Alaska by ambulance, helicopter, or fixed-wing modes of transportation. Demographics, transport and operative timing, Rutherford classification, level of occlusion, procedural information, and fasciotomy characteristics were reviewed. Outcomes measured included limb salvage rates, discharge disposition, and mortality.ResultsOne hundred twelve patients with ALI were identified, with 82% due to thrombosis and 18% due to arterial embolization. Fifty-seven percent of patients were transferred from a referring hospital with low mean transfer times (1.9 hours for embolic, 2.7 hours for thrombotic). Although the initial operative strategy varied according to the etiology, with 50% of thrombotic occlusions treated with endovascular therapies and 80% of embolic occlusions treated with open thrombectomy, the rates of limb salvage did not vary based on operative approach (92% endovascular first, 90% open first). Further, limb salvage rates were identical between transferred and nontransferred patients (77%). Limb salvage was successful in 91% of patients with Rutherford class 1 and 2 disease, but only 8% in patients with Rutherford class 3 disease. In-hospital and 30-day mortality rates were not different based on ischemic etiology (5%), although patients with Rutherford class 3 disease had significantly higher mortality rates (15%) compared with patients with class 1 (6%), class 2a (6%), and class 2b (2%) disease. Fasciotomy was performed in 29% of patients, with 59% of fasciotomy wounds closed primarily. Predictors of amputation include multiple attempts at limb salvage, higher Rutherford class, multilevel occlusion, more proximal levels of occlusion, and nonviable muscle seen after fasciotomy, with ischemic times trending toward higher amputation rates without statistical significance. There was no difference in discharge disposition based on ischemic etiology.ConclusionsThe modern treatment of patients with ALI is effective, with high rates of limb salvage and low mortality regardless of transfer status, etiology, or initial operation performed. In situations where compartment syndrome is unclear, fasciotomy should not be withheld because it provides valuable predictive information regarding limb salvage

Call for a new classification system and treatment strategy in blunt aortic injury

ObjectiveThe current Society for Vascular Surgery (SVS) classification scheme for blunt aortic injury (BAI) is descriptive but does not guide therapy. We propose a simplified classification scheme based on our robust experience with BAI that is descriptive and guides therapy.MethodsPatients presenting with BAI between January 1999 and September 2014 were identified from our institution's trauma registry. We divided patients into eras by time. Era 1: before the first United States Food and Drug Administration (FDA)-approved thoracic endovascular aortic repair (TEVAR) device (1999-2005); era 2: FDA-approved TEVAR devices (2005-2010); and era 3: FDA-approved BAI-specific devices (2010-present). Baseline demographic information, Injury Severity Score, hospital details, and survival were collected and compared. Our classification scheme was minimal aortic injury, SVS grade 1 and 2; moderate aortic injury, SVS grade 3; and severe aortic injury, SVS grade 4.ResultsWe identified 226 patients with a diagnosis of BAI: 75 patients in era 1, 84 in era 2, and 67 in era 3. Mean Injury Severity Score was 39.5 (range, 16-75). The BAI-related in-hospital mortality was significantly higher before endovascular introduction in era 1 (14.6% vs 4.8%; P = .03), but was not significantly different between eras 2 and 3 or before and after BAI-specific devices were introduced (P = .43). Of 146 patients (64.6%) who underwent aortic intervention, 91 underwent endovascular repair, and 55 underwent open repair. All but nine patients (94%) had a moderate or severe injury. Survival across all three eras of patients undergoing operative intervention was 80.2%. Survival in eras 2 and 3 was higher than in era 1 (86.4% vs 73.8%) but was not significant (P = .38). Of 47 patients in eras 2 and 3 with minimal aortic injury, 45 (96%) were managed nonoperatively, with no BAI-related deaths. After 2007, follow-up imaging was obtained in 38 patients (80%) with minimal aortic injury, and progression was not observed. Computed tomography scans showed the injury in 13 patients appeared stable, 19 had complete resolution (50%), and 6 had a decreasing size of injury.ConclusionsOur experience confirms that BAI-related mortality for patients who survive to presentation is now 5%. From our findings during the past 15 years, we propose simplification of the SVS grading criteria of BAI into minimal, moderate, and severe based on treatment differences among the three groups. Minimal aortic injury can be successfully managed nonoperatively without mandatory follow-up imaging. Moderate aortic injury can be managed semielectively with TEVAR, and severe aortic injury, requires emergency TEVAR

Limb Salvage Does Not Predict Functional Limb Outcome after Revascularization for Traumatic Acute Limb Ischemia

BackgroundTraumatic vascular injury leading to acute limb ischemia (ALI) is an uncommon problem with a potential for high morbidity. We describe a contemporary series of patients with traumatic ALI managed primarily by vascular surgeons at a tertiary referral center and review factors associated with limb salvage and functional limb outcomes.MethodsWe conducted a single institution, retrospective review of all patients requiring revascularization for upper extremity (UE) and lower extremity (LE) ALI secondary to trauma from 2013 to 2016. Demographic data, transfer timing, injury severity score (ISS), Rutherford classification (RC), preoperative imaging, level of occlusion, procedural information, fasciotomy characteristics, and discharge disposition were reviewed. Outcome measures included limb salvage and functional limb outcomes.ResultsWe identified 68 patients with traumatic ALI requiring revascularization. The majority of patients had moderate ISS scores, were RC 2a or 2b on presentation (65%), were transferred from another institution (53%), and underwent preoperative imaging (62%) with expeditious time to operation (median 4.5 hr). The most common location of vascular injury for UE was axillary-brachial (88%) and for LE was femoral-popliteal (69%). Open vascular procedures dominated the treatment strategy, and the median number of operations was 3. Fasciotomy was performed in 25% of UE and 58% of LE injuries. Shunts were utilized in only 2 patients. Overall LS was 94% for UE and 78% for LE. The median length of stay (LOS) was 11 days, with 25% of patients discharged to a skilled nursing facility. Follow-up was obtained for 59% of patients. For UE injuries, 57% of patients had no or minimal functional deficits, while 33% had major functional deficits and 10% underwent amputation. For LE injuries, 68% of patients had no or minimal functional deficits, while 6% had major functional deficits, and 26% had undergone amputation. Rutherford class and the number of operations performed were independent predictors of amputation and functional limb at follow-up in our logistic regression model (P < 0.05).ConclusionsRevascularization for traumatic ALI yields high limb salvage rates in patients with RC 1 and 2 ischemia and patients with UE injuries. However, limb salvage does not necessarily equate to good functional outcomes. This signifies the complex nature of injuries in this patient population, especially when multiple operations are required

Evaluation of the redesigned conformable GORE TAG thoracic endoprosthesis for traumatic aortic transection

Objective: To evaluate the safety and effectiveness of the conformable GORE TAG thoracic endoprosthesis (CTAG) device (W. L. Gore and Associates, Flagstaff, Ariz) for the endovascular repair of traumatic aortic transections. Methods: A prospective, nonrandomized, multicenter trial was conducted at 21 sites. Primary safety end points included 30-day all-cause mortality. The effectiveness end point was freedom from a major device event requiring reintervention through 1-month follow-up. Results: Fifty-one subjects were enrolled between December 2009 and January 2011 with polytraumatic injuries and a mean Injury Severity Score of 32 6 14. The proximal mean intimal aortic diameter measured 24 mm, while the mean distal intimal diameter was 22 mm. A total of 57 CTAG devices were implanted (mean, 1.1/subject; range, 1-2) with a mean patient age of 44 years (range, 21-87) and a male-to-female ratio of 2:1. Technical success was 100% with an operative mortality of 0%. Femoral access was utilized in 96% of patients. The mean procedure time and blood loss was 105 minutes and 148 mL, respectively. All subjects required admission to an intensive care unit with a mean hospital stay of 14.6 days. Adjuvant techniques (ie, lumbar drains and induced hypertension) to prevent paraplegia were used in only 7.8% of patients. No patient developed paraplegia despite 63% having complete or partial left subclavian artery coverage and only 9% of those receiving left subclavian artery revascularization. In addition, there were no device compressions or major device events reported. Overall mortality at 30 days was 7.8%, and all were adjudicated by the clinical events committee as not being device or procedure related. Serious adverse events occurred in 39.2% of patients through 30 days. To date, there have been no conversions to open repair. Two site-reported endoleaks were detected during the mean follow-up of 4.2 months, which did not require reintervention. Conclusions: The CTAG device was demonstrated to be a safe and effective treatment for traumatic aortic transection based on 30-day outcomes. There were no device-related serious adverse events. (J Vasc Surg 2013;58:651-8.

Evaluation of the redesigned conformable GORE TAG thoracic endoprosthesis for traumatic aortic transection

Objective: To evaluate the safety and effectiveness of the conformable GORE TAG thoracic endoprosthesis (CTAG) device (W. L. Gore and Associates, Flagstaff, Ariz) for the endovascular repair of traumatic aortic transections. Methods: A prospective, nonrandomized, multicenter trial was conducted at 21 sites. Primary safety end points included 30-day all-cause mortality. The effectiveness end point was freedom from a major device event requiring reintervention through 1-month follow-up. Results: Fifty-one subjects were enrolled between December 2009 and January 2011 with polytraumatic injuries and a mean Injury Severity Score of 32 6 14. The proximal mean intimal aortic diameter measured 24 mm, while the mean distal intimal diameter was 22 mm. A total of 57 CTAG devices were implanted (mean, 1.1/subject; range, 1-2) with a mean patient age of 44 years (range, 21-87) and a male-to-female ratio of 2:1. Technical success was 100% with an operative mortality of 0%. Femoral access was utilized in 96% of patients. The mean procedure time and blood loss was 105 minutes and 148 mL, respectively. All subjects required admission to an intensive care unit with a mean hospital stay of 14.6 days. Adjuvant techniques (ie, lumbar drains and induced hypertension) to prevent paraplegia were used in only 7.8% of patients. No patient developed paraplegia despite 63% having complete or partial left subclavian artery coverage and only 9% of those receiving left subclavian artery revascularization. In addition, there were no device compressions or major device events reported. Overall mortality at 30 days was 7.8%, and all were adjudicated by the clinical events committee as not being device or procedure related. Serious adverse events occurred in 39.2% of patients through 30 days. To date, there have been no conversions to open repair. Two site-reported endoleaks were detected during the mean follow-up of 4.2 months, which did not require reintervention. Conclusions: The CTAG device was demonstrated to be a safe and effective treatment for traumatic aortic transection based on 30-day outcomes. There were no device-related serious adverse events. (J Vasc Surg 2013;58:651-8.

Framing the neoliberal canon: resisting the market myth via literary enquiry

here is widespread recognition that neoliberal rhetoric about ‘free markets’ stands in considerable tension with ‘really existing’ neoliberalizing processes. However, the oft-utilized analytical distinction between ‘pure’ economic and political theory and ‘messy’ empirical developments takes for granted that neoliberalism, at its core, valorizes free markets. In contrast, the paper explores whether neoliberal intellectuals ever made such an argument. Using Friedrich Hayek and Milton Friedman as exemplars, our reading of canonical neoliberal texts focuses on author framing gestures, particular understandings of the term ‘science’, techniques of characterization, and constructions of epistemological legitimacy. This enables us to avoid the trap of assuming that these texts are about free markets and instead enquires into their constitution as literary artefacts. As such, we argue that the remaking of states and households rather than the promotion of free markets is at the core of neoliberalism. Our analysis has significant implications. For example, it means that authoritarian neoliberalism is not a departure from but actually more in line with the ‘pure’ neoliberal canon than in the past. Therefore, neoliberalism ought to be critiqued not for its rhetorical promotion of free markets but instead for seeking to reorganize societies in coercive, non-democratic and unequal ways. This also enables us to acknowledge that households are central to resistance to neoliberalism as well as to the neoliberal worldview itself