Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms.

OBJECTIVE: The objective of this study was to report midterm results of an ongoing physician-sponsored investigational device exemption pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for treatment of patients with juxtarenal aortic aneurysms who are deemed unfit for open repair. METHODS: Data from a nonrandomized, prospective, consecutively enrolling investigational device exemption clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on May 31, 2015, with outcomes analysis through December 31, 2015. Primary safety and efficacy end points were used to measure treatment success. The primary safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The primary efficacy end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of those branch vessels intended to be preserved; and freedom from type I and III endoleak, stent graft migration >10 mm, aortic aneurysm sack enlargement >5 mm, and aortic aneurysm rupture or open conversion. RESULTS: During the 50-month study period, 64 patients were enrolled; 60 began the implant procedure and 59 received the PMEG implant. Aneurysm anatomy, operative details, and lengths of stay were recorded and included aneurysm diameter (mean, 65.9 mm; range, 49-104 mm), proximal seal zone length (mean, 40.8 mm; range, 18.9-72.2 mm), graft manufacture time (mean, 55.1 minutes), procedure time (mean, 156.8 minutes), fluoroscopy time (mean, 39.6 minutes), contrast material use (mean, 75.3 mL), estimated blood loss (mean, 213 mL), and length of hospital stay (mean, 4.1 days) with intensive care unit length of stay (mean, 2.2 days). There were 145 fenestrations made for 110 renal arteries and 38 superior mesenteric arteries (SMAs). One patient had an SMA stent placed before the procedure for severe stenosis, and one subject had the SMA stented during the procedure. Renal arteries were stented whenever possible (93%). There were 102 stented renal arteries in 58 patients. There were no open conversions or explantations. Thirty-day mortality was 5.1% (3/59). There were zero type Ia, one type Ib, and two type III endoleaks during follow-up treated with successful reintervention. The overall rate of major adverse events at 30 days was 11.9%. The primary efficacy end points were achieved in 94.1% of patients. CONCLUSIONS: These midterm results are favorable and verify our early report that endovascular repair with PMEG is safe and effective for managing patients with juxtarenal aortic aneurysms. PMEG has exceptional midterm rates of morbidity, mortality, and endoleak and may outperform standard endovascular aneurysm repair with favorable anatomy. In patients who are poor open surgical candidates who present with symptomatic or ruptured juxtarenal aortic aneurysms, PMEG continues to be an extremely appealing option as reliable off-the-shelf solutions are not widely available. Preoperative planning remains the key ingredient for success with use of these techniques.

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

OBJECTIVE: The 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. METHODS: Patients 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. RESULTS: We 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. CONCLUSIONS: Our 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.

Renal duplex ultrasound findings in fenestrated endovascular aortic repair for juxtarenal aortic aneurysms.

OBJECTIVE: This study characterized duplex ultrasound (DUS) findings and clinical outcomes associated with covered stent placement in renal arteries during fenestrated endovascular aortic repair (FEVAR) to determine if velocity criteria for native renal artery stenosis can be applied. METHODS: Data from a prospectively maintained database of patients who underwent FEVAR between January 2010 and August 2014 were obtained before FEVAR (preoperative or baseline) and at follow-up assessments at 30 days, 6 months, and 1, 2, and 3 years. The established DUS threshold criteria for ≥60% stenosis in native renal arteries were applied at baseline and all follow-up intervals: renal artery peak systolic velocity (PSV) ≥200 cm/s or renal-aortic velocity ratio (RAR) ≥3.5. RESULTS: Forty-nine patients underwent placement of 88 covered renal artery stents during FEVAR. At least 30-day follow-up was available for 43 patients with 80 stents. A ≥60% stenosis was identified in seven renal arteries of six patients on baseline DUS, and these patients were analyzed separately. The remaining 73 renal arteries were classified as normal or <60% stenosis at baseline, with a median PSV of 121 cm/s (interquartile range, 96-143) and median RAR of 1.4 (interquartile range, 1.1-1.7). No significant differences were found between the baseline and follow-up PSV measurements at any time point. The RAR differed significantly at some time points, although median values remained below the ≥60% stenosis threshold. Some increased RAR values were attributed to low aortic velocities after repair. In the 13 patients with 17 covered renal artery stents found to have PSV or RAR exceeding a DUS threshold for ≥60% native renal artery stenosis, there was no evidence of stenosis by computed tomography angiography, of renal dysfunction by estimated glomerular filtration rate, or of renal volume decrease by three-dimensional analysis. None of the seven renal arteries with ≥60% stenosis at baseline showed evidence of restenosis at 1, 2, or 3 years. CONCLUSIONS: Covered stent placement in nonstenotic renal arteries during FEVAR is safe and durable, with PSV and RAR remaining in the normal or <60% stenosis range in most patients. Increases in PSV or RAR that occur are not associated with clinically significant sequelae or in-stent stenosis on computed tomography angiography. DUS velocity criteria for stenosis in native renal arteries appear to overestimate the severity of stenosis in covered stents after FEVAR.

Successful emergent endovascular repair of a ruptured mycotic thoracic aortic aneurysm.

BACKGROUND: Mycotic thoracic aortic aneurysms are a life-threatening diagnosis and carry a high risk of morbidity and mortality in the perioperative setting. Traditional open repair consists of debridement, drainage, and either in situ or extra-anatomic bypass. Acute rupture portends a dismal prognosis; however, emergent endovascular repair of ruptured mycotic aneurysms has been described in the literature and we present a case of successful endovascular treatment of a ruptured mycotic descending thoracic aortic aneurysm. CASE REPORT: We report the case of a 42-year-old male with hypertension and active intravenous drug use who presented with 3 weeks of chest pain, dyspnea, and hemoptysis, and on computed tomography scan was found to have a contained 4.1-cm ruptured mycotic thoracic aortic aneurysm. Blood cultures were positive for methicillin-resistant Staphylococcus aureus. Emergent repair was recommended because of likelihood of further rupture and death. Thoracic endovascular aortic repair (TEVAR) was performed using a rifampin-soaked stent graft without complication. At 2-year follow-up, the patient was asymptomatic and imaging demonstrated the stent graft in excellent position, without endoleak, and complete resolution of the aneurysm sac. CONCLUSIONS: TEVAR can be safely employed to treat a ruptured mycotic thoracic aneurysm when open repair is not possible because of patient's comorbidity or complex rupture, as these patients face imminent death. Long-term follow-up is necessary for detection of endoleak, recurrence, or propagation of the aneurysm, and persistent bacterial infections.

Abdominal aortic aneurysm in a patient with occipital horn syndrome.

Occipital horn syndrome is a rare X-linked recessive connective tissue disorder caused by deficient copper transport. Our patient presented with abdominal pain, and a computed tomography scan demonstrated a 15-cm infrarenal abdominal aortic aneurysm and bilateral common iliac artery aneurysms. After discussion of surgical management, he wished to proceed with comfort measures only. We report the first known case of an abdominal aortic aneurysm in a patient with occipital horn syndrome.

A multi-institutional international study of risk factors for hematoma after thyroidectomy.

BACKGROUND: Cervical hematoma can be a potentially fatal complication after thyroidectomy, but its risk factors and timing remain poorly understood. METHODS: We conducted a retrospective, case-control study identifying 207 patients from 15 institutions in 3 countries who developed a hematoma requiring return to the operating room (OR) after thyroidectomy. RESULTS: Forty-seven percent of hematoma patients returned to the OR within 6 hours and 79% within 24 hours of their thyroidectomy. On univariate analysis, hematoma patients were older, more likely to be male, smokers, on active antiplatelet/anticoagulation medications, have Graves' disease, a bilateral thyroidectomy, a drain placed, a concurrent parathyroidectomy, and benign pathology. Hematoma patients also had more blood loss, larger thyroids, lower temperatures, and higher blood pressures postoperatively. On multivariate analysis, independent associations with hematoma were use of a drain (odds ratio, 2.79), Graves' disease (odds ratio, 2.43), benign pathology (odds ratio, 2.22), antiplatelet/anticoagulation medications (odds ratio, 2.12), use of a hemostatic agent (odds ratio, 1.97), and increased thyroid mass (odds ratio, 1.01). CONCLUSION: A significant number of patients with a postoperative hematoma present >6 hours after thyroidectomy. Hematoma is associated with patients who have a drain or hemostatic agent, have Graves' disease, are actively using antiplatelet/anticoagulation medications or have large thyroids. Surgeons should consider these factors when individualizing patient disposition after thyroidectomy.