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OBJECTIVE: To present a single-center prospective study of 126 consecutively treated patients who underwent endovascular repair of a thoracoabdominal aortic aneurysm with the physician-modified, nonanatomic-based Unitary Manifold (UM) device. METHODS: Data were collected from 126 consecutive all-comer patients treated with the physician-modified, nonanatomic-based UM from 2015 to 2023. Treatment was performed at a single center by a single physician under a Physician Sponsored Investigation Exemption G140207. RESULTS: The UM was indicated for repair of all Crawford extents including juxtarenal, pararenal, and short-neck infrarenal aneurysms (<10 mm) in 126 consecutive patients. Patients were not excluded from the study based on presentation, extent of aneurysm or dissection, or history of a spinal cord event. Patients with a thoracoabdominal aortic aneurysm were categorized by Crawford classification: types I and V (3.3%, n = 4), type II (3.3%, n = 4), type III (1%, n = 1), and type IV (93.3%, n = 117). The type IV classification patients were further categorized with 33 (28.2%) true type IV, 68 (58.1%) pararenal or infrarenal, and 16 (13.7%) with dissection. Technical success was 99.2% (n = 125). The most common major adverse event within both 30 days and 365 days of all patients was respiratory failure (11.9%, n = 15, and 13.5%, n = 17, respectively). One patient (0.8%) experienced persistent paraplegia at 365 days. Reintervention for patients at 365 days was 5.6% (n = 7). Of the 444 branches stented, the primary patency rate was remarkably high as only three patients (2.4%) required reintervention due to loss of limb patency within 365 days. Aneurysm enlargement (≥5 mm) occurred in 1.6% (n = 2) patients, and no patients experienced aneurysm rupture. No patients underwent conversion to open repair. The aneurysm-related mortality at 365 days for all patients was 4.0% (n = 5), whereas all-cause mortality was 16.7% (n = 21). Physician-modified endograft device integrity failure was not observed in any patient. CONCLUSIONS: The UM device demonstrated remarkable technical surgical success, treatment success, and device patency rates with very reasonable major adverse events and reintervention rates. This study is the most representative example of the general population in comparison with other studies of off-the-shelf devices, with 126 consecutive all-comer patients with diverse pathologies.
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INTRODUCTION: Many orthopedic providers currently treat chronic spondylolysis as self-limited fractures. While the condition has previously been associated with back pain in pediatrics, there has been little attention on the risk of neurologic harm. Electromyography (EMG) is a common study used to evaluate nerve injury, but it has not been previously reported for testing pediatric patients with stress fractures. In this study, pediatric patients with chronic pars fractures and muscle extremity weakness who underwent EMG testing were reviewed to analyze their risk of chronic nerve injury. METHODS: 120 pediatric patients who underwent EMG testing between 2015 and 2021 were analyzed, and 41(21F,20M) patients with a mean age of 16(13-20) met criteria of chronic lumbar pediatric spondylolysis with weakness on ankle dorsiflexion or plantarflexion. No exclusions were made. Initial EMG testing was indicated for the extremity weakness; pain was not the major concern. All exams were completed by JWM. Thin-cut lumbar CT studies were done at the same institution, and EMGs were completed by one of three physiatrists. EMGs were determined as normal, abnormal but not meeting chronic nerve injury threshold, or abnormal and meeting threshold for chronic nerve injury. RESULTS: Of the 41 patients, 33 had bilateral and 8 had unilateral fractures with 95% (39/41) of them located at L4 or L5. 55% (18/33) of the bilateral fractures had abnormal EMGs and demonstrated chronic nerve injury; 1 had an abnormal EMG but did meet chronic injury threshold. 75% (6/8) of the unilateral fractures had abnormal EMGs and demonstrated chronic nerve injury; 1 had an abnormal EMG but did meet chronic injury threshold. Overall, 36% (15/41) had normal EMGs, 5% (2/41) had abnormal results but did not reach chronic injury threshold, and 59% (24/41) met threshold for chronic nerve injury. CONCLUSION: Chronic pars fractures have historically been treated as a benign and self-limited sports injury. However, our analysis showed that 59% of adolescent patients presenting with chronic pars fractures and dorsiflexion or plantarflexion weakness have developed a chronic nerve injury. This study is the first to demonstrate the risk of neurologic harm in unhealed pediatric lumbar stress fractures, and it indicates the importance of EMG testing in young patients presenting with chronic spondylolysis and extremity weakness.
