Browsing by Subject "Thoracic"

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    One-Year Results with a Low-Profile Endograft in Subjects with Thoracic Aortic Aneurysm and Ulcer Pathologies
    (Elsevier, 2022-02) Szeto, Wilson Y.; Vallabhajosyula, Prashanth; Matsuda, Hitoshi; Moainie, Sina L.; Sharafuddin, Mel J.; Corvera, Joel; Smolock, Christopher J.; Miyamoto, Shinji; Naslund, Thomas; Ramaiah, Venkatesh; Medicine, School of Medicine
    Objective Evaluate safety and effectiveness of the second generation, low-profile RelayPro thoracic endograft for the treatment of descending thoracic aortic aneurysm or penetrating atherosclerotic ulcer (PAU). Method A prospective, international, non-blinded, non-randomized, pivotal trial analyzed a primary safety endpoint of major adverse events (MAE) at 30 days (death, myocardial infarction, stroke, renal/respiratory failure, paralysis, bowel ischemia, procedural blood loss), and a primary effectiveness endpoint of treatment success at one year (technical success, patency, absence of aneurysm rupture, type I/III endoleaks, stent fractures, reinterventions, aneurysm expansion, and migration) compared to performance goals from the previous generation Relay pivotal study. The study was conducted in 36 centers in the US and Japan and enrolled between 2017 and 2019. Results The study population of 110 patients had a median (IQR) age of 76 (70 – 81) years, n=69 (62.7%) were male, n=43 (39.1%) were Asian, and were treated for 76 fusiform aneurysms (69%), 24 saccular aneurysms (22%), and 10 PAUs (9%). Most patients (82.7%) were treated with a non-bare stent (NBS) configuration. Technical success was 100%: median (IQR) procedure time was 91 (64 – 131) min, deployment time was 16 (10 – 25) min; 50 patients (73.5%) of the US cohort had percutaneous access, while centers in Japan used only surgical cutdown. The 30-day composite MAE rate was 6.4% (95% upper CI 11.6%, p=.0002): 2 strokes, 2 procedural blood losses >1000 mL requiring transfusion, 2 paralysis events, and 1 renal failure. Primary effectiveness was 89.2% (lower 95% CI 81.8%, p=.0185): 9 subjects experienced 11 events (1 aneurysm expansion, 6 secondary interventions, 4 type I endoleaks). There was no loss of stent-graft patency, no rupture, no fractures, and no migration. Conclusions The low-profile RelayPro thoracic endograft met the study primary endpoints and demonstrated satisfactory 30-day safety and 1-year effectiveness for the treatment of patients with aneurysms of the descending thoracic aorta or PAUs. Follow-up is ongoing to evaluate longer term outcomes and durability.
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    Spinal Injury Associated With Firearm Use
    (Cureus, 2021-03-16) Loder, Randall T.; Mishra, Abhipri; Atoa, Bradley; Orthopaedic Surgery, School of Medicine
    Objective Injuries associated with firearms are a significant health burden. However, there is no comprehensive study of firearm spinal injuries over a large population. It was the purpose of this study to analyze the demographics of spinal firearm injuries across the entire United States for all ages using a national database. Methods A retrospective review of prospectively collected data using the Inter-University Consortium for Political and Social Research Firearm Injury Surveillance Study 1993-2015 (ICPSR 37276) was performed. The demographic variables of patients with spinal injuries due to firearms were analyzed with statistical analyses accounting for the weighted, stratified nature of the data, using SUDAAN 11.0.01™ software (RTI International, Research Triangle Park, North Carolina, 2013). A p-value of < 0.05 was considered statistically significant. Results For the years 1993 through 2015, there were an estimated 2,667,896 emergency department (ED) visits for injuries due to firearms; 10,296 of these injuries (0.4%) involved the spine. The vast majority (98.2%) were due to powder firearm gunshot wounds. Those with a spine injury were more likely to have been injured in an assault (83.7% vs. 60.2%), involved a handgun (83.5% vs. 60.2%), were male (90.8% vs. 86.4%), were admitted to the hospital (86.8% vs. 30.9%), and were seen in urban hospitals (86.7 vs. 64.6%). The average age was 28 years with very few on those < 14 years of age. Illicit drug involvement was over four times as frequent in those with a spine injury (34.7% vs. 8.0%). The cervical spine was involved in 30%, thoracic in 32%, lumbar in 32%, and sacrum in 6%. A fracture occurred in 91.8% and neurologic injury in 33%. Injuries to the thoracic spine had the highest percentage of neurologic involvement (50.4%). There was an annual percentage decrease for patients with and without spine involvement in the 1990s, followed by increases through 2015. The average percentage increase for patients with a spine injury was 10.3% per year from 1997 onwards (p < 10-6), significantly greater than the 1.5% for those without spinal involvement (p = 0.0001) from 1999 onwards. Conclusions This nation-wide study of spinal injuries associated with firearms covering all ages can be used as baseline data for future firearm studies. A reduction in the incidence of such injuries can be guided by our findings but may be difficult due to sociopolitical barriers (e.g. socioeconomic status of the injured patients, differences in political opinion regarding gun control in the US, and geospatial patterns of firearm injury).