endograft

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  • 文章类型: Journal Article
    背景:与原发性主动脉壁血栓(PAMT)相关的多个动脉床的栓塞可能导致高发病率和死亡率。没有建议来指示最佳管理。这项研究旨在描述我们管理这种罕见疾病的经验。方法:对2015年1月至2021年12月在我院接受PAMT治疗的所有患者进行回顾性分析。记录的数据包括人口统计,血栓前危险因素,影像学发现,临床表现,和治疗。主要结果包括血栓复发,严重截肢,和死亡。结果:共纳入13例PAMT患者。中位年龄为52岁(36-68岁),男女比例为1:1.6。所有病例均通过计算机断层扫描血管造影(CTA)诊断PAMT。在92%的病例中发现了血栓形成的情况,大多数患者(92%)患有胸部PAMT。最常见的表现是血栓栓塞后的急性肢体缺血(85%),需要手术血运重建.所有患者均迅速开始抗凝治疗。两名患者出现肝素诱导的血小板减少症。在54%的患者中观察到栓塞/血栓形成复发;两名患者接受了支架移植物的血管内血栓排除。我们确定了1例与PAMT相关的死亡和1例严重截肢,中位随访时间为39个月(12-64个月)。结论:单用抗凝作为初始治疗可以完全解决PAMT,但与高栓塞复发率有关。胸主动脉腔内修复术是可行的,可以防止额外的栓塞。然而,其作为一线治疗的标准仍需要确定.我们的研究强调了密切监测这些患者的重要性。
    Background:  Embolization to multiple arterial beds associated with primary aortic mural thrombus (PAMT) could result in high morbidity and mortality. There are no recommendations to dictate the best management. This study aims to describe our experience in managing this rare disease. Methods:  A retrospective review of all patients affected by PAMT treated at our institution between January 2015 and December 2021 was performed. Recorded data included demographics, prothrombotic risk factors, imaging findings, clinical presentation, and treatment. Primary outcomes comprised thrombus recurrence, major amputation, and death. Results:  Thirteen patients with PAMT have been included. The median age was 52 years (36-68 years), and the male/female ratio was 1:1.6. The diagnosis of PAMT was made by computed tomography angiography (CTA) in all cases. Prothrombotic conditions were identified in 92% of cases, and most patients (92%) had thoracic PAMT. The most common presentation was acute limb ischemia after thrombus embolization (85%), requiring surgical revascularization. Anticoagulation was promptly started in all patients. Two patients developed heparin-induced thrombocytopenia. Recurrence of embolization/thrombosis was observed in 54% of patients; two underwent endovascular thrombus exclusion with a stent graft. We identified one PAMT-related death and one major amputation with a median follow-up time of 39 months (12-64 months). Conclusion:  Anticoagulation alone as initial therapy could completely resolve PAMT but is associated with high embolization recurrence. Thoracic endovascular aortic repair is feasible and could prevent additional embolization. However, the criteria for its use as a first-line therapy still need to be defined. Our study highlights the importance of closely monitoring these patients.
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  • 文章类型: Journal Article
    背景:采用开窗和分支装置(F/BEVAR)的复杂腹部(CAAA)和胸腹主动脉瘤(TAAA)的血管内修复术代表了老年或不适合患者的一线治疗。目前,这些技术的广泛传播导致复杂的血管内手术在年轻和更健康的患者中也逐渐增加,但相关结果报道很少,没有长期数据.我们调查了F/BEVAR在年轻和健康患者中用于CAAA和TAAA修复的长期结果。
    方法:所有连续患者,70岁或更小,在过去的13年中,在两个大专院校中接受了CAAA和TAAA的F/BEVAR。根据血管外科学会(SVS)临床合并症分级系统,所有受试者均呈现低到中等风险。主要终点是技术和临床成功,晚期总生存率和主动脉相关生存率。主要并发症和特定目标血管相关结果作为次要终点进行研究。
    结果:总共183名患者(155名男性,84.7%;平均年龄64.5+5.7岁,范围33-70)在研究期间接受F/BEVAR,共167例(91.3%)退行性动脉瘤和16例(8.7%)夹层后动脉瘤,包括44例(24%)结侧动脉瘤,33例(18%)肾旁动脉瘤和106例(58%)胸腹主动脉瘤。176例(96.2%)和171例(93.4%)患者获得技术和临床成功,分别。4名患者(2.2%)围手术期死亡,其中2人(1.1%)在紧急情况下运作。术后,5例患者(2.7%)出现永久性3级脊髓损伤,和3(1.6%)需要永久透析的肾衰竭。平均随访时间为65.739.6个月(范围1-158)。估计12、60和120个月时的总生存率和主动脉相关生存率为94.0%,85.1%,72.2%,97.8%,97.8%,96.2%,分别,而再干预和分支无不稳定生存的同时垃圾邮件为84.4%,71.8%,71.8%,和93.2%,86.3%,72.2%,分别。在6例患者(3.3%)中检测到动脉瘤生长>5mm,而在118例(64.5%)中,囊收缩>5mm。Cox回归分析表明,非计划手术是总死亡率的唯一危险因素[OR=3.331(1.397-7.940),p<0.01]。
    结论:在年轻和健康患者中,F/BEVAR导致低的围手术期死亡率和主要发病率,和良好的长期总生存率使得该技术在这样的患者亚组中特别有吸引力。从年轻患者的结果得出的长期数据的可用性,还可以提供有用的信息来重新定义治疗适应症,并允许未来的目标设备和技术改进。
    BACKGROUND: Endovascular repair of complex abdominal (CAAA) and thoracoabdominal aortic aneurysms (TAAA) with fenestrated and branched devices (F/BEVAR) represents the first-line treatment in old or unfit patients. Currently, the widespread diffusion of these techniques has led to a progressive increase of complex endovascular procedures also in younger and fitter patients, but the related results have been only minimally reported without long-term data. We investigated the long-term results of F/BEVAR for CAAA and TAAA repair in young and fit patients.
    METHODS: All consecutive patients, aged 70 or younger, undergone F/BEVAR for CAAA and TAAA over the last 13 years at two tertiary Institutions were included in the study. All subjects presented a low to intermediate risk according to the Society for Vascular Surgery (SVS) clinical comorbidity grading system. The primary endpoints were technical and clinical success, late overall and aortic-related survival. Major complications and specific target vessel-related outcomes were investigated as secondary endpoints.
    RESULTS: A total of 183 patients (155 males, 84.7%; mean age 64.5 + 5.7 years, range 33-70) underwent F/BEVAR during the study period, for a total of 167 (91.3%) degenerative and 16 (8.7%) post-dissection aneurysms including 44 (24%) juxtarenal, 33 (18%) pararenal and 106 (58%) thoraco-abdominal aortic aneurysms. Technical and clinical success were achieved in 176 (96.2%) and 171 patients (93.4%), respectively. Four patients (2.2%) died perioperatively, of which 2 (1.1%) operated in emergency. Postoperatively, 5 patients (2.7%) presented permanent grade 3 spinal cord injury, and 3 (1.6%) renal failure needing permanent dialysis. The mean follow-up was 65.7 + 39.6 months (range 1-158). Estimated overall and aortic-related survival at 12, 60, and 120 months was 94.0%, 85.1%, 72.2%, and 97.8%, 97.8%, 96.2%, respectively, while reintervention and branch instability-free survival at the same time spam was 84.4%, 71.8%, 71.8%, and 93.2%, 86.3%, 72.2%, respectively. An aneurysm growth > 5 mm was detected in 6 patients (3.3%) while a sac shrinkage > 5 mm was achieved in 118 cases (64.5%). The Cox regression analysis demonstrated the need for unplanned procedure as the only risk factor for overall mortality [OR=3.331 (1.397-7.940), p < 0.01].
    CONCLUSIONS: F/BEVAR in young and fit patients led to a low perioperative mortality and major morbidity, and favorable overall survival rate in the long-term making this technique particularly appealing in such a subgroup of patients. The availability of long-term data derived from the results of young patients, may additionally provide helpful information to re-define indication for treatment and allow future targeted device and technique improvements.
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  • 文章类型: Journal Article
    胸主动脉腔内修复术(TEVAR),最初设想部署在左锁骨下动脉(LSA)远端,最近已经扩展到更近的着陆区。在总的血管内溶液中,医师改良的胸腔血管内移植术(C-PMEGs)的“Canaud技术”已获得认可,早期效果良好。这项研究的目的是报告在理论上可以用C-PMEG治疗的0、1和2区主动脉弓病变患者的比例。
    计算机断层扫描血管造影术(CTA)所有连续的患者候选人开放,混合动力车,对我院2009年1月至2023年7月的腔内弓修复术进行了分析。根据先前广泛描述的解剖学标准进行C-PEMG的可行性评估。
    在研究期间,209名连续患者是开放的候选人,混合动力车,或腔内主动脉弓修复术。其中,164例患者的术前CTA扫描符合分析条件。一百二十六名患者为男性(76.8%),平均年龄67±10.8岁。94例(57.3%)患者受动脉粥样硬化动脉瘤影响,48个夹层后动脉瘤(29.3%)和22个穿透性主动脉溃疡(PAU)(13.4%)。20例患者(12.2%)适合双开窗C-PMEG,34例患者(20.7%)为单开窗C-PMEG,占整个队列的32.9%。在IA或左颈总动脉(LCCA)中联合使用主动脉上主干(SAT)旁路或使用覆膜支架作为辅助动作,将C-PMEGs可行性扩展到69名患者(42.1%)。在回肠股骨通路不足的3例(1.8%)患者中使用the骨移植导管将使C-PMEG的适用性增加到72例(43.9%)。排除的主要原因是78例患者(47.6%)的升主动脉直径过大。
    在32.9%至43.9%受主动脉弓动脉瘤影响的患者中,使用C-PMEG在理论上是可行的,解剖,和PAU。排除的主要原因是升主动脉的尺寸。C-PMEG技术是主动脉弓病变血管内治疗的可行选择。具有类似特性的现成设备也可以在紧急情况下使用,避免医生修改的限制(如回台手术的时间,不育,标签外使用)。
    结论:胸主动脉腔内修复术(TEVAR)已扩展到更多的近端着陆区,用于治疗主动脉弓动脉瘤,解剖,主动脉穿透性溃疡.在总的血管内溶液中,医师改良的胸腔血管内移植术(C-PMEGs)的“Canaud技术”已获得认可,早期效果良好。164例连续患者的解剖学可行性为69例(42.1%),结合主动脉上主干(SAT)旁路或在IA或左颈总动脉(LCCA)中使用覆膜支架作为辅助动作,表明C-PMEG技术是主动脉弓病变血管内治疗的可行选择。
    UNASSIGNED: Thoracic endovascular aortic repair (TEVAR), originally conceived for deployment distal to the left subclavian artery (LSA), has been recently extended to more proximal landing zones. Among total endovascular solutions, the \"Canaud technique\" for Physician-Modified Thoracic Endovascular Grafts (C-PMEGs) has gained acceptance with good early results. The aim of this study is to report the proportion of patients with zone 0, 1, and 2 aortic arch lesions that could theoretically be treated with a C-PMEG.
    UNASSIGNED: Computed tomography angiography (CTA) of all consecutive patient candidates to open, hybrid, or endovascular arch repair from January 2009 to July 2023 at our Institution were analyzed. The assessment of feasibility of C-PEMG was conducted following previously extensively described anatomical criteria.
    UNASSIGNED: During the study period, 209 consecutive patients were candidates for an open, hybrid, or endovascular aortic arch repair. Of them, 164 patients had a preoperative CTA scan eligible for analysis. One hundred twenty-six patients were male (76.8 %), with a mean age of 67 ± 10.8 years. Ninety-four patients (57.3%) were affected by atherosclerotic aneurysms, 48 post-dissecting aneurysms (29.3%) and 22 penetrating aortic ulcers (PAUs) (13.4%). Twenty patients (12.2%) were suitable for double-fenestrated C-PMEG, and 34 patients (20.7%) for single-fenestrated C-PMEG, totaling 32.9% of the entire cohort. The combination of supra-aortic trunks (SAT) bypass or the use of covered stent in IA or left common carotid artery (LCCA) as adjunctive maneuvers, would extend the C-PMEGs feasibility to 69 patients (42.1%). The use of an iliac graft conduit in 3 (1.8%) patients with inadequate ileo-femoral accesses would increase the C-PMEG suitability to 72 patients (43.9%). The main reason for exclusion was excessive ascending aortic diameter in 78 patients (47.6%).
    UNASSIGNED: The use of C-PMEG was shown to be theoretically feasible in a percentage of patients ranging from 32.9 to 43.9% affected by aortic arch aneurysms, dissections, and PAU. The main reason for exclusion was the dimension of the ascending aorta. The C-PMEG technique is a viable option in aortic arch lesions endovascular treatment. An off-the-shelf device with similar characteristics could also be used in emergency, avoiding the limitations of physician modifications (such as time for back-table procedure, sterility, off-label use).
    CONCLUSIONS: Thoracic endovascular aortic repair (TEVAR) has been extended to more proximal landing zones for the treatment of aortic arch aneurysm, dissections, penetrating aortic ulcers. Among total endovascular solutions, the \"Canaud technique\" for Physician-Modified Thoracic Endovascular Grafts (C-PMEGs) has gained acceptance with good early results. The anatomical feasibility in 164 consecutive patients was 69 patients (42.1%), with the combination of supra-aortic trunks (SAT) bypass or the use of covered stent in IA or left common carotid artery (LCCA) as adjunctive maneuvers, showing that the C-PMEG technique is a viable option in aortic arch lesions endovascular treatment.
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  • 文章类型: Journal Article
    目的:本研究的目的是描述因原发性或复发性主动脉缩窄而接受胸部支架置入治疗的成年患者的结局。
    方法:这是一项回顾性研究,对我们机构的30例因主动脉缩窄而接受胸部支架置入术的成年患者进行了回顾性研究。平均年龄为46.5岁,53.3%的患者没有接受过缩窄治疗或修复。修复的适应症包括梯度≥20mmHg,在左心室肥大的影像学上有缩窄的解剖证据,假性动脉瘤,动脉瘤,难治性高血压,或者跛行.用于修复的支架移植物包括MDT(Medtronic,圣罗莎,CA)和GORE标签(W.L.Gore&Associates,弗拉格斯塔夫,AZ).
    结果:患者的平均观察时间为979天,研究期间有一人死亡。所有患者症状完全缓解,无复发。TEVAR显著降低了跨缩窄的梯度(p<0.0001)。主动脉缩窄直径在术后30天显着增加,并在治疗后持续增加至5年。3年以上,在缩窄部位和周围区域观察到主动脉重塑。在30天,收缩压,舒张压,平均动脉压均降低。治疗后1年,收缩压和舒张压以及MAP继续显着改善。
    结论:支架移植是治疗主动脉缩窄的一种安全有效的方法。我们观察到血压的临床显着改善,缩窄段和整个主动脉的纵向主动脉重塑持续超过3年。
    BACKGROUND: This study\'s objective is to describe outcomes of adult patients who underwent thoracic stent graft placement treatment for primary or recurrent aortic coarctation.
    METHODS: This is a retrospective study of 30 adult patients who underwent thoracic stent graft placement for aortic coarctation at our institution. Average age was 46.5 years, with 53.3% of patients presented with no prior treatment or repair for coarctation. Indications for repair included gradient ≥20 mm Hg with anatomic evidence of coarctation on imaging with left ventricular hypertrophy, pseudoaneurysm, aneurysm, refractory hypertension, or claudication. Stent grafts used for repair included MDT (Medtronic, Santa Rosa, CA) and GORE TAG (W. L. Gore & Associates, Flagstaff, AZ).
    RESULTS: Patients were observed for a median of 979 days, with one death during the study. All patients had complete resolution of symptoms with no recurrences. Thoracic endovascular aortic repair significantly reduced the gradient across the coarctation (P < 0.0001). Aortic coarctation diameter significantly increased at 30 days postoperatively and continued to increase up to 5 years posttreatment. At 3+ years, aortic remodeling was observed at the coarctation site and surrounding regions. At 30 days, systolic, diastolic, and mean arterial pressure were all reduced. Systolic and diastolic blood pressure and mean arterial pressure continued to significantly improve 1-year posttreatment.
    CONCLUSIONS: Stent grafts are a safe and effective treatment for aortic coarctation. We observed a clinically significant improvement in blood pressure and longitudinal aortic remodeling of the coarctation segment and the entire aorta that persisted more than more than 3 years.
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  • 文章类型: Case Reports
    持续性坐骨动脉(PSA)是一种罕见的先天性血管异常,估计患病率为0.01%至0.05%。这种情况可能导致下肢和坐骨动脉瘤的缺血事件,但也可能无症状。由于髂外动脉和股动脉的细口径,PSA可以使其他共存血管疾病的治疗复杂化。我们报告了一例双侧PSA和肾下主动脉瘤的患者。通过血管内途径成功治疗了动脉瘤。使用与略高于通常位置的进入切口相关的超低轮廓内移植物来克服这种挑战性的进入。
    A persistent sciatic artery (PSA) is a rare congenital vascular anomaly, with an estimated prevalence ranging from 0.01% to 0.05%. This condition can cause ischemic events in the lower limbs and sciatic artery aneurysms but can also be asymptomatic. A PSA can complicate the treatment of other coexistent vascular diseases due to the thin caliber of the external iliac and femoral arteries. We report a case of a patient with bilateral PSAs and an infrarenal aortic aneurysm. The aneurysm was successfully treated by the endovascular approach. An ultra-low profile endograft associated with access incisions slightly above the usual position was used to overcome this challenging access.
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  • 文章类型: Journal Article
    胸血管内动脉瘤修复术(TEVAR)已取代开放式手术修复术,成为几种主动脉疾病的首选治疗方法。尽管发病率和死亡率较低,可能发生几种TEVAR相关并发症,其中一些可能需要手术或血管内再介入治疗.本文回顾了TEVAR手术的常见和罕见并发症,重点是横断面成像可识别的并发症和术前计划的潜在陷阱。
    Thoracic endovascular aneurysm repair (TEVAR) has replaced open surgical repair as the treatment of choice for several aortic conditions. Despite its lower morbidity and mortality, several TEVAR-related complications can occur and some of which may necessitate surgical or endovascular re-intervention. The current article reviews common and rare complications of TEVAR procedure with emphasis on complications identifiable on cross-sectional imaging and potential pitfalls of pre-procedural planning.
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  • 文章类型: Journal Article
    我们描述了使用ValiantCaptivia平台(Medtronic)治疗复杂腹主动脉瘤的四开窗医师改良内移植物(PMEG)放置的标准化方法的可行性和安全性。标准化基于解剖学可行性的特定选择标准,测量方法,和单个内移植物类型的修饰技术。六例(两例并处,两个副总统,和两个IV型胸腹动脉瘤)进行了治疗,有24个目标血管合并开窗。四例在紧急情况下接受治疗,两例是选择性治疗。所需的修改时间为121±18分钟。技术成功100%,30天没有死亡或并发症。术后3个月计算机断层扫描显示完全排除动脉瘤,没有I型或III型内漏,没有与主要移植物或开窗相关的完整性损失,没有目标血管错位或支架断裂。目前的标准化方法似乎是安全可行的,可能是与未来研究进行比较的初始基准。
    We describe the feasibility and safety of a standardized approach for four-fenestrated physician-modified endograft (PMEG) placement to treat complex abdominal aortic aneurysms using the Valiant Captivia platform (Medtronic). The standardization is based on specific selection criteria for anatomical feasibility, measurement method, and modification technique of a single endograft type. Six cases (two juxtarenal, two pararenal, and two type IV thoracoabdominal aneurysms) were treated, with 24 target vessels incorporated with fenestrations. Four cases were treated in an urgent setting and two were elective. The time modification required was 121 ± 18 minutes. Technical success was 100%, with no mortality or complications at 30 days. Postoperative computed tomography at 3 months demonstrated complete aneurysm exclusion, without a type I or III endoleak, no main graft- or fenestration-related loss of integrity, and no target vessel misalignment or stent fracture. The present standardized approach seems safe and feasible and might represent an initial benchmark for comparison with future studies.
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  • 文章类型: Journal Article
    背景:医师改良的内移植物(PMEG)已用于胸腹主动脉瘤(TAAA)的修复已有20年,效果良好,但财务数据有限。这项研究比较了PMEG与CookZenith-Fenith(ZFEN)移植物和开放式手术修复(OSR)的财务和临床结果。
    方法:对2018年1月至2022年12月在学术医学中心接受近肾侧主动脉瘤和TAAA的血管内或OSR的所有患者进行了财务和临床数据的回顾性审查。临床表现,人口统计,操作细节,并对结果进行了审查。财务数据是通过机构的财务部门获得的。主要终点是贡献幅度(CM)。
    结果:30例患者符合纳入标准,由十二个PMEG组成,七ZFEN,和11个开放式维修。PMEG维修的总CM为-110,000美元,而ZFEN为18,000美元,OSR为290,000美元。主动脉和分支动脉植入物是血管内手术的主要成本驱动因素。二级TAAA维修是最昂贵的PMEG程序,设备总费用为每箱59,000美元。PMEG修复的30天和1天死亡率为8.3%,与ZFEN没有显着差异(0.0%,P=0.46;0.0%,P=0.46)或OSR(9.1%,P=0.95;18%,P=0.51)。PMEG修复后的平均重症监护病房和住院时间与ZFEN相当,短于OSR。
    结论:我们的研究表明PMEG修复产生负CM。为了使这些案例在财务上对医院系统可行,设备成本将需要降低或报销费率增加约8800美元。
    BACKGROUND: Physician-modified endografts (PMEGs) have been used for repair of thoracoabdominal aortic aneurysms (TAAAs) for 2 decades with good outcomes but limited financial data. This study compared the financial and clinical outcomes of PMEGs to the Cook Zenith-Fenestrated (ZFEN) graft and open surgical repair (OSR).
    METHODS: A retrospective review of financial and clinical data was performed for all patients who underwent endovascular or OSR of juxtarenal aortic aneurysms and TAAAs from January 2018 to December 2022 at an academic medical center. Clinical presentation, demographics, operative details, and outcomes were reviewed. Financial data was obtained through the institution\'s finance department. The primary end point was contribution margin (CM).
    RESULTS: Thirty patients met inclusion criteria, consisting of twelve PMEG, seven ZFEN, and eleven open repairs. PMEG repairs had a total CM of -$110,000 compared to $18,000 for ZFEN and $290,000 for OSR. Aortic and branch artery implants were major cost-drivers for endovascular procedures. Extent II TAAA repairs were the costliest PMEG procedure, with a total device cost of $59,000 per case. PMEG repairs had 30-d and 1-y mortality rates of 8.3% which was not significantly different from ZFEN (0.0%, P = 0.46; 0.0%, P = 0.46) or OSR (9.1%, P = 0.95; 18%, P = 0.51). Average intensive care unit and hospital stay after PMEG repairs were comparable to ZFEN and shorter than OSR.
    CONCLUSIONS: Our study suggests that PMEG repairs yield a negative CM. To make these cases financially viable for hospital systems, device costs will need to be reduced or reimbursement rates increased by approximately $8800.
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  • 文章类型: Case Reports
    已经提出了脊柱操纵疗法(SMT)的禁忌症,在操纵上脊柱时,要求严格控制其安全实践。这里,我们报告了Eagle综合征(ES)患者颈部手法的血管并发症。
    SMT用于通过向脊柱关节施加力来治疗肌肉骨骼疾病,例如背痛和颈部疼痛。这里,我们报告了一种罕见但破坏性的SMT并发症,一个年轻的男性病人,22岁,对于ES,在无证执业医师进行SMT后,颈内动脉(ICA)出现了大的假性动脉瘤,内移植物治疗成功。使用SMT的临床医生应将细长的茎突视为该疗法的潜在禁忌症。
    UNASSIGNED: Contraindications of spinal manipulative therapy (SMT) have been proposed, which mandate rigorous control for its safe practice when manipulating the upper spine. Here, we report a vascular complication of Neck Manipulation in Eagle syndrome (ES) patient.
    UNASSIGNED: SMT is used to treat musculoskeletal conditions such as back pain and neck pain by applying force to the spinal joints. Here, we report a rare but devastating complication of SMT, where a young male patient, 22 years old, with ES, had a large pseudoaneurysm from the internal carotid artery (ICA) after SMT from an unlicensed practitioner, treated successfully with endograft. Clinicians administering SMT should consider an elongated styloid process as a potential contraindication to this therapy.
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  • 文章类型: Journal Article
    目的:为了证明在患有钝性外伤性主动脉损伤的受试者中,低剖面胸内膜移植物(19-23法语)的安全性和有效性。
    方法:前瞻性,多中心研究评估了RelayPro胸膜内移植物治疗创伤性主动脉损伤。在2017年至2021年之间,在16个美国中心招募了50名患者。主要终点是30天全因死亡率。
    结果:队列主要是男性(74%),平均年龄为42.4±17.2岁,因机动车碰撞(80%)造成的外伤(1级4%,2级8%,3级76%;4级12%)。42%的近端着陆区位于左锁骨下动脉的近端,主要通过经皮进入(80%)。大多数(71%)用非裸支架(NBS)内移植物治疗。技术成功率为98%(一个早期Ia型内漏)。全因30天死亡率为2%(预期率为8%),精确的双侧95%CI,0.1%,10.6%低于业绩目标上限25%。Kaplan-Meier分析估计,从30天到四年的全因死亡率为98%(95%CI,86.6-99.7%)。Kaplan-Meier估计无重大不良事件,全因死亡率,瘫痪和中风,30天为98.0%,6个月至4年为95.8%(95%CI,84.3-98.9%)。随访期间无中风和1例截瘫(2%)。
    结论:RelayPro是安全有效的,在治疗闭合性主动脉损伤中可能提供早期生存益处。
    OBJECTIVE: The aim of this study was to demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury.
    METHODS: A prospective, multicenter study assessed the RelayPro thoracic endograft for the treatment of traumatic aortic injury. Fifty patients were enrolled at 16 centers in the United States between 2017 and 2021. The primary endpoint was 30-day all-cause mortality.
    RESULTS: The cohort was mostly male (74%), with a mean age of 42.4 ± 17.2 years, and treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3, and 12% Grade 4) due to motor vehicle collision (80%). The proximal landing zone was proximal to the left subclavian artery in 42%, and access was primarily percutaneous (80%). Most (71%) were treated with a non-bare stent endograft. Technical success was 98% (one early type Ia endoleak). All-cause 30-day mortality was 2% (compared with an expected rate of 8%), with an exact two-sided 95% confidence interval [CI] of 0.1%, 10.6% below the performance goal upper limit of 25%. Kaplan-Meier analysis estimated freedom from all-cause mortality to be 98% at 30 days through 4 years (95% CI, 86.6%-99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, was 98.0% at 30 days and 95.8% from 6 months to 4 years (95% CI, 84.3%-98.9%). There were no strokes and one case of paraplegia (2%) during follow-up.
    CONCLUSIONS: RelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury.
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