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External validation of the OAC3-PAD risk score after endovascular revascularisation. 血管内再通术后 OAC3-PAD 风险评分的外部验证。
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2025-01-01 Epub Date: 2024-11-20 DOI: 10.1024/0301-1526/a001159
Kevin Pelicon, Klemen Petek, Anja Boc, Nataša Kejžar, Aleš Blinc, Vinko Boc

Background: The OAC3-PAD bleeding risk score was developed to assess the bleeding risk in patients with peripheral arterial disease (PAD), however its performance in patients treated exclusively with endovascular revascularisation has not yet been tested. We aimed to externally validate the bleeding risk score for this patient cohort. Patients and methods: A retrospective observational study, analysing the data of all PAD patients successfully treated with endovascular revascularisation in a single centre within a five-year period. The performance of the Cox proportional hazards (CPH) model, upon which the OAC3-PAD bleeding risk score is based, was tested using calibration methods, discrimination, and a scaled Brier score for overall performance. The OAC3-PAD bleeding risk score was calculated for all patients, classifying them into the four respective risk groups. Kaplan-Meier curves were plotted for all risk groups and discrimination was tested using log-rank tests. Results: While discrimination of the CPH model was adequate, calibration of the model was poor and the scaled Brier score was 3.27% (95% CI 0.65%-4.40%). Of the 1,434 patients, 33 (2.3%) experienced a major bleeding event. The frequency of bleeding was 0.4% in the low risk group (3/736 patients), 0.8% in the low-to-moderate risk group (2/243 patients), 5.8% in the moderate-to-high risk group (15/258 patients), and 6.6% in the high risk group (13/197 patients). The OAC3-PAD score successfully discriminated each of the two lower bleeding risk groups from one of the two higher risk groups, but failed to discriminate among the two lower risk groups and the two higher risk groups, respectively. Conclusions: Although the OAC3-PAD score did not stratify patients into the four respective risk groups, it allowed discrimination between the low risk patients and the high risk patients. It could therefore become a useful tool for predicting major bleeding events in patients with PAD after endovascular revascularisation.

背景:OAC3-PAD出血风险评分是为评估外周动脉疾病(PAD)患者的出血风险而开发的,但其在完全接受血管内再通治疗的患者中的表现尚未经过测试。我们的目的是对这一患者群体的出血风险评分进行外部验证。患者和方法:一项回顾性观察研究,分析了一个中心五年内所有成功接受血管内再通术治疗的 PAD 患者的数据。使用校准方法、区分度和整体性能的标度 Brier 评分测试了作为 OAC3-PAD 出血风险评分基础的 Cox 比例危险(CPH)模型的性能。计算了所有患者的 OAC3-PAD 出血风险评分,并将其分为四个相应的风险组。绘制了所有风险组的 Kaplan-Meier 曲线,并使用对数秩检验测试了区分度。结果显示虽然 CPH 模型的辨别能力较强,但模型的校准能力较差,标度 Brier 评分为 3.27%(95% CI 0.65%-4.40%)。在 1434 名患者中,33 人(2.3%)发生了大出血。出血频率在低风险组为 0.4%(3/736 名患者),在中低风险组为 0.8%(2/243 名患者),在中高风险组为 5.8%(15/258 名患者),在高风险组为 6.6%(13/197 名患者)。OAC3-PAD 评分成功区分了两个较低出血风险组和两个较高风险组中的一个,但未能分别区分两个较低风险组和两个较高风险组。结论:虽然 OAC3-PAD 评分没有将患者分为四个相应的风险组,但它可以区分低风险患者和高风险患者。因此,它可以成为预测血管内血运重建术后 PAD 患者大出血事件的有用工具。
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引用次数: 0
Importance of pseudoaneurysms after TAVI - a retrospective analysis of 2063 patients. TAVI 术后假性动脉瘤的重要性--对 2063 例患者的回顾性分析。
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2025-01-01 Epub Date: 2024-07-17 DOI: 10.1024/0301-1526/a001135
Patricia Wischmann, Manuel Stern, Sven Baasen, Miriam Schillings, Johanna Schremmer, Marc Oliver Stern, Kathrin Klein, Christian Jung, Tobias Zeus, Christian Heiss, Malte Kelm, Lucas Busch

Background: Bifemoral arterial access is common in patients undergoing transcatheter aortic valve implantation (TAVI), with a primary treatment access (TAVI access) and a secondary non-TAVI access. Pseudoaneurysm (PSA) is an important complication of femoral arterial puncture. Major vascular complications after TAVI are well described, but little is known about PSA. Patients and methods: A total of 2063 patients underwent transfemoral TAVI between January 2014 and January 2020. Vascular ultrasound of the common femoral artery was assessed before and after TAVI. We compared patient characteristics, periprocedural risk scores, procedural characteristics, and access site bleeding events according to Valve Academic Research Consortium 3 (VARC-3) criteria, length of stay (LOS), and all-cause mortality at one year between patients with (46) and without (2017) PSA. Results: The incidence of PSA after TAVI was 2.2% (46/2063). All PSA were successfully treated with ultrasound-guided manual compression (UGMC) or thrombin injection (UGTI) without complications. Patients with PSA had lower platelet counts (210×1000/μl vs. 234×1000/μl; p<0.05), more heart failure symptoms on admission (91% vs. 25%; p<0.05), were more often treated with (N)OACs for atrial fibrillation (AF; 54% vs. 38%; p <0.05), and were less often treated with aspirin (35% vs. 51%; p<0.03). Multivariate analysis identified secondary access site (odds ratio [OR] 8.11; p<0.001) and (N)OAC therapy (OR 1.31; p = 0.037) as risk factors for PSA development. PSA is associated with VARC-3 type 1-3 access site bleeding and longer LOS (15.2 ± 11.3 d vs. 11.6 ± 8.9 d; p<0.01), but this did not affect one year mortality (17% vs. 14%; p = 0.53). Conclusions: Pseudoaneurysms are an important complication after TAVI and are associated with access site bleeding and prolonged hospital stay. (N)OAC therapy and secondary access are important risk factors. Pseudoaneurysms can be safely and effectively treated with thrombin injection and do not affect one-year mortality.

背景:在接受经导管主动脉瓣植入术(TAVI)的患者中,双股动脉通路很常见,其中有一条主要治疗通路(TAVI 通路)和一条次要非 TAVI 通路。假性动脉瘤(PSA)是股动脉穿刺的一个重要并发症。TAVI 术后的主要血管并发症已被充分描述,但对假性动脉瘤却知之甚少。患者和方法:2014年1月至2020年1月期间,共有2063名患者接受了经股动脉TAVI手术。在 TAVI 前后对股总动脉的血管超声进行了评估。我们比较了有 PSA 患者(46 例)和无 PSA 患者(2017 例)的患者特征、围手术期风险评分、手术特征、根据瓣膜学术研究联盟 3 (VARC-3) 标准的入路部位出血事件、住院时间(LOS)和一年后的全因死亡率。结果:TAVI术后PSA发生率为2.2%(46/2063)。所有PSA患者均在超声引导下成功接受了人工压迫(UGMC)或凝血酶注射(UTI)治疗,未出现并发症。PSA患者的血小板计数较低(210×1000/μl vs. 234×1000/μl;p结论:假性动脉瘤是 TAVI 术后的一个重要并发症,与入路部位出血和住院时间延长有关。(非)OAC 治疗和二次入路是重要的风险因素。假性动脉瘤可以通过注射凝血酶得到安全有效的治疗,并且不会影响一年的死亡率。
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引用次数: 0
Spontaneous walking characteristics of patients with peripheral arterial disease. 外周动脉疾病患者的自主行走特征。
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2025-01-01 Epub Date: 2024-12-05 DOI: 10.1024/0301-1526/a001149
Anne-Noëlle Heizmann, Antoine Morel, Christian Boissier, Claire Le Hello

Background: Walking rehabilitation is the cornerstone of patients with peripheral arterial disease (PAD) treatment. In order to propose a personalised walking rehabilitation program to each patient, it is important to know the PAD-patients walking characteristics. Such data are lacking in the literature. The aim of this study was to analyse the spontaneous walking characteristics of PAD patients. Patients and methods: This study was conducted between May 2016 and March 2018. Walking characteristics (cadence, stride, number of daily walking episodes, duration of an episode, distance covered during an episode, daily total walking duration and distance, walking speed) were recorded by Withings Pulse O2® activity trackers for one week in patients with asymptomatic or symptomatic PAD. Walking intensity was classified as ambling pace (<2 METs), slow walking (2-3 METs) and active walking (>3 METs). Study protocol has been approved by an independent ethics committee. Results: Eighty-seven patients were included (males 87%, mean age 66 ± 9 years, intermittent claudication 86%, right ankle brachial index (ABI) = 0.80 ± 0.19 and left ABI = 0.79 ± 0.15). The mean recording duration was 8 ± 1.2 days. Most of the steps were shuffling pace (shuffling pace 55.7%, active walking 32.8%, slow walking 11.5%). There was no significant difference between weekdays and weekend days nor for cadence, stride, episode duration, distance covered during an episode, number of daily walking episodes, daily total walking duration and distance. The average duration of active walking episodes was 3 minutes. Duration of active walking was less than 3 minutes in 66% of patients with a mean duration of 1 minute and 55 seconds. Conclusion: Analysis of PAD patients spontaneous walking characteristics with an activity tracker can get the maximum active walking duration achieved by each patient and be useful to offer a personalised walking rehabilitation program.

背景:行走康复是外周动脉疾病(PAD)患者治疗的基石。为了给每个患者提供个性化的行走康复方案,了解pad患者的行走特征是很重要的。文献中缺乏这样的数据。本研究的目的是分析PAD患者的自发行走特征。患者和方法:本研究于2016年5月至2018年3月进行。通过Withings Pulse O2®活动追踪器记录无症状或有症状PAD患者一周的行走特征(节奏、步幅、每日行走次数、每次行走持续时间、每次行走所覆盖的距离、每日总行走持续时间和距离、行走速度)。步行强度分为步行步速(3 METs)。研究方案已获得独立伦理委员会的批准。结果:纳入87例患者(男性87%,平均66±9岁,间歇性跛行86%,右踝肱指数(ABI) = 0.80±0.19,左踝肱指数= 0.79±0.15)。平均记录时间为8±1.2 d。以慢走为主,慢走占55.7%,慢走占32.8%,慢走占11.5%。工作日和周末之间没有显著差异,节奏、步幅、发作持续时间、发作期间行走距离、每日行走次数、每日总行走时间和距离也没有显著差异。活跃行走的平均持续时间为3分钟。66%的患者活动步行时间少于3分钟,平均持续时间为1分55秒。结论:利用活动追踪器分析PAD患者的自发行走特征,可以得到每个患者的最大活动行走时间,有助于提供个性化的行走康复方案。
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引用次数: 0
The Postthrombotic syndrome, where are we now? 血栓后综合征,我们现在在哪里?
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2025-01-01 Epub Date: 2024-11-20 DOI: 10.1024/0301-1526/a001156
Ruben Hupperetz, Arina Ten Cate-Hoek

Post thrombotic syndrome (PTS) is a frequent complication occurring in patients with deep venous thrombosis (DVT). This chronic condition is associated with a negative impact on quality of life and substantial economic costs. Despite current treatment with anticoagulants and compression therapy, a significant proportion of DVT patients develop PTS. Optimising the diagnosis and identification of high-risk patients is important to provide more appropriate individualised treatment. In addition, a better understanding of the pathogenesis is leading to the necessary improvement of both current treatment strategies and the development of new treatment modalities. Treatments aimed at prevention as well as those aimed at reducing the symptoms of already manifested PTS should be further investigated. Research is currently taking place on promising therapeutical targets including pharmacological (anti-inflammatory and venoactive drugs), and interventional approaches (e.g. mechanical thrombectomy) in patients at different stages of PTS. Progress in all these areas is needed to solve the complex problem of PTS.

血栓后综合征(PTS)是深静脉血栓(DVT)患者经常出现的一种并发症。这种慢性疾病会对患者的生活质量造成负面影响,并带来巨大的经济损失。尽管目前使用抗凝剂和加压疗法进行治疗,但仍有相当一部分深静脉血栓患者会出现 PTS。优化诊断和识别高危患者对于提供更适当的个体化治疗非常重要。此外,对发病机理的深入了解也有助于改进当前的治疗策略和开发新的治疗方法。应进一步研究旨在预防和减轻已出现的创伤后应激障碍症状的治疗方法。目前正在对有前景的治疗目标进行研究,包括针对处于 PTS 不同阶段的患者的药物治疗(抗炎和静脉活性药物)和介入治疗(如机械性血栓切除术)。要解决复杂的 PTS 问题,就必须在所有这些领域取得进展。
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引用次数: 0
Efficacy of medical compression stockings class I on the reduction of symptoms in patients with uncomplicated varicose veins. I 级医用弹力袜对减轻无并发症静脉曲张患者症状的疗效。
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2025-01-01 Epub Date: 2024-11-25 DOI: 10.1024/0301-1526/a001163
Markus Stücker, Dennis Braß, Luis Möckel, Karsten Hartmann, Eberhard Rabe

Background: Aim of this study was to analyze the effect of medical compression stockings (MCS) class I (according to the German classification "RAL-GZ 387"; 18-21 mmHg) on symptoms in patients with uncomplicated varicose veins (C2s-C4a). Patients and methods: We conducted a randomized (1:1), controlled, clinical trial enrolling patients with uncomplicated varicose veins (CEAP: C2s-C4a). The study consisted of a one-week baseline period and a four-week follow-up period with MCS treatment (compression class I, 18-21 mmHg) in the intervention group and non-treatment in the control group. The frequency and severity of symptoms on the leg including heaviness, pain, swelling, throbbing and itching were measured every evening using an app-based measuring tool. The primary endpoint was the reduction of symptoms during compression therapy, measured by a symptom sum score over a period of 5 weeks ranging from 0 (no symptoms during the day) to 25 (symptoms all day). Results: Patients treated with MCS (n = 25) showed a significant improvement in the overall symptom sum score from 8.90 ± 4.26 at baseline to 6.37 ± 3.55 at follow-up (p = 0.004) whereas for patients in the control group without MCS (n = 25) the overall score remained unchanged (baseline: 7.46 ± 3.71; follow-up: 7.67 ± 4.74; p = 0.293). The intervention group reported significant improvements in symptom frequency scores for pain, leg swelling and feeling of leg heaviness (p ≤ 0.002). In the control group the score for pain significantly increased during the follow-up period. Leg itching was numerically more frequent in patients with MCS. Conclusion: This study indicates that medical compression stockings class I (according to the German classification "RAL-GZ 387"; 18-21 mmHg) significantly improve the frequency and severity of symptoms in patients with uncomplicated varicose veins (CEAP: C2s-C4a).

研究背景本研究旨在分析 I 级医疗压力袜(根据德国分类 "RAL-GZ 387";18-21 mmHg)对无并发症静脉曲张(C2s-C4a)患者症状的影响。患者和方法我们对无并发症静脉曲张(CEAP:C2s-C4a)患者进行了随机(1:1)对照临床试验。研究包括一周的基线期和四周的随访期,干预组接受 MCS 治疗(压力等级 I,18-21 mmHg),对照组不接受治疗。每天晚上使用基于应用程序的测量工具测量腿部症状的频率和严重程度,包括沉重感、疼痛、肿胀、刺痛和瘙痒。主要终点是在压力治疗期间症状的减轻情况,以5周内的症状总分来衡量,从0分(白天无症状)到25分(全天有症状)不等。研究结果接受 MCS 治疗的患者(25 人)的症状总分从基线时的 8.90 ± 4.26 显著改善到随访时的 6.37 ± 3.55(P = 0.004),而未接受 MCS 治疗的对照组患者(25 人)的症状总分保持不变(基线:7.46 ± 3.71;随访:7.67 ± 4.74;P = 0.293)。干预组在疼痛、腿部肿胀和腿部沉重感方面的症状频率评分有了明显改善(p ≤ 0.002)。对照组的疼痛评分在随访期间明显上升。多发性硬化症患者腿部瘙痒的频率更高。结论这项研究表明,I级医疗弹力袜(根据德国分类 "RAL-GZ 387";18-21 mmHg)可明显改善无并发症静脉曲张患者(CEAP:C2s-C4a)的症状频率和严重程度。
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引用次数: 0
The year in vascular medicine: Highlights in Vasa - European Journal of Vascular Medicine 2024. 血管医学的一年:Vasa的亮点-欧洲血管医学杂志2024。
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2025-01-01 DOI: 10.1024/0301-1526/a001166
Christos Rammos, Stefano Barco, Christian-Alexander Behrendt, Jill Belch, Erwin Blessing, Marianne Brodmann, Christine Espinola-Klein, Christian Heiss, Grigorios Korosoglou, Oliver Schlager, Oliver J Müller
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引用次数: 0
Advances in the management of venous thromboembolism. 静脉血栓栓塞治疗的进展。
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2025-01-01 Epub Date: 2024-11-25 DOI: 10.1024/0301-1526/a001162
Gabor Forgo, Stefano Barco
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引用次数: 0
Association between atherogenic index of plasma and peripheral arterial disease. 血浆致动脉粥样硬化指数与外周动脉疾病之间的关系
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-11-26 DOI: 10.1024/0301-1526/a001160
Huiqi Hong, Lei Wu, Shaofang Chen

Background: Growing body of evidence suggests that the atherogenic dyslipidemia phenotype is a precursor to Peripheral Arterial Disease (PAD). Nonetheless, there is limited research regarding the association between Atherogenic Index of Plasma (AIP) and PAD which utilized a community population-based database in the United States. We sought to fill this knowledge gap. Methods: A total of 3,517 participants from the National Health and Nutrition Examination Survey 1999-2004 cycles were enrolled in our study. AIP was calculated as log10 (triglycerides/high-density lipoprotein cholesterol). Logistic regression models were adopted to reveal the relationship of AIP and PAD. Additionally, stratified and interaction analyses were also undertaken to see if the relationship was stable in different subgroups. Results: Participants in the higher tertile of AIP tended to have higher prevalence of PAD. A positive correlation was identified between AIP increase and PAD after fully multivariate adjustment (OR=1.30, 95% CI: 1.06-1.59). The multivariable-adjusted OR and 95% CI of the highest AIP tertile compared with the lowest tertile was 1.50 (1.07-2.1). Subgroup analysis demonstrated that the positive association between AIP and PAD was persistent across population subgroups. Conclusions: Our findings demonstrate a positive association between AIP and the incidence of PAD among adults in American adults. Specifically, 1 unit increase in AIP led to a 30% greater risk of PAD.

背景:越来越多的证据表明,致动脉粥样硬化性血脂异常表型是外周动脉疾病(PAD)的前兆。然而,关于血浆致动脉粥样硬化指数(AIP)与 PAD 之间的关系,利用美国社区人口数据库进行的研究十分有限。我们试图填补这一知识空白。研究方法共有 3,517 名来自 1999-2004 年全国健康与营养调查周期的参与者参与了我们的研究。AIP 以 log10(甘油三酯/高密度脂蛋白胆固醇)计算。采用逻辑回归模型来揭示 AIP 与 PAD 的关系。此外,还进行了分层分析和交互分析,以了解不同亚组的关系是否稳定。研究结果AIP分层越高,PAD患病率越高。经完全多变量调整后发现,AIP增加与PAD之间存在正相关(OR=1.30,95% CI:1.06-1.59)。最高 AIP 三分层与最低三分层相比,经多变量调整后的 OR 和 95% CI 为 1.50(1.07-2.1)。亚组分析表明,AIP与PAD之间的正相关在不同人群亚组中持续存在。结论:我们的研究结果表明,在美国成年人中,AIP 与 PAD 的发病率呈正相关。具体来说,AIP 每增加一个单位,PAD 的发病风险就会增加 30%。
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引用次数: 0
Real world experience with the TREO device in standard EVAR: Mid-term results of 150 cases from a German Multicenter study. 在标准 EVAR 中使用 TREO 设备的实际经验:德国多中心研究 150 例病例的中期结果。
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-11-01 Epub Date: 2024-09-09 DOI: 10.1024/0301-1526/a001148
Sebastian Zerwes, Ana-Maria Ciura, Hans-Henning Eckstein, Oksana Heiser, Johannes Kalder, Paula Keschenau, Mario Lescan, Bartosz Rylski, Stoyan Kondov, Jörg Teßarek, Hans-Kees Bruijnen, Alexander Hyhlik-Dürr

Background: The objective of the study was to analyze mid-term results of unselected patients treated with the TREO (Terumo Aortic, Florida, USA) device at six German hospital sites. Methods: A multicenter, retrospective analysis of patients treated within and outside instructions for use (IFU) from January 2017 to November 2020 was performed. Primary outcomes were technical success, mortality and endograft related complications according to IFU status. Secondary outcomes were aneurysm/procedure related re-interventions. Results: 150 patients (92% male, mean age 73 ±8 years) were treated (within IFU 84% vs. outside IFU 16%) with the TREO device for abdominal aortic aneurysms (n=127 intact, n=17 symptomatic and n=6 ruptured; p=0.30). Technical success was achieved in 147/150 (within IFU 99% vs. outside IFU 92%, p=0.08). 30-day mortality was 2%, one year and overall mortality was 3% and 5%. During a mean follow-up of 28.4 months (range: 1-67.4 months), 35 (25%; within IFU 23% vs. outside IFU 35%, p=0.23) patients suffered from endoleaks. The majority were endoleaks type II (n=33), the remaining type Ia (n=5) and type Ib (n=3). No endoleaks type III-V, migrations or aneurysm ruptures occurred. Overall, 19 patients (13%; within IFU 13% vs. 15% outside IFU, p=0.70) received a secondary intervention: nine endoleak related endovascular procedures, three open conversions, two endograft limb related interventions, four surgical revisions of the femoral access sites and two bowl ischemia related procedures, respectively. Conclusions: This non industry-sponsored, multicenter trial indicates that using the TREO device in a real-world setting (both within and outside IFU) seems feasible in the treatment of patients suffering from AAA. While the rate of complications and secondary interventions is in line with previously published data, the findings highlight the fact that standard EVAR is associated with serious adverse events.

研究背景该研究的目的是分析德国六家医院使用 TREO(美国佛罗里达州泰尔茂主动脉)装置治疗的未入选患者的中期结果。研究方法对2017年1月至2020年11月期间在使用说明(IFU)内和使用说明(IFU)外接受治疗的患者进行了多中心回顾性分析。根据 IFU 状态,主要结果是技术成功率、死亡率和内移植物相关并发症。次要结果是动脉瘤/手术相关的再干预。结果150名患者(92%为男性,平均年龄为73±8岁)接受了TREO装置治疗腹主动脉瘤(IFU内84%,IFU外16%)(127例为完整动脉瘤,17例为无症状动脉瘤,6例为破裂动脉瘤;P=0.30)。147/150获得了技术成功(IFU内99%对IFU外92%,P=0.08)。30天死亡率为2%,一年死亡率为3%,总死亡率为5%。在平均 28.4 个月的随访期间(范围:1-67.4 个月),35 名患者(25%;IFU 内 23% 对 IFU 外 35%,P=0.23)出现内漏。大多数为 II 型内膜渗漏(33 人),其余为 Ia 型(5 人)和 Ib 型(3 人)。没有发生 III-V 型内漏、移位或动脉瘤破裂。总体而言,有19名患者(13%;IFU内13%,IFU外15%,P=0.70)接受了二次干预:分别是9例与内漏相关的血管内手术、3例开放式转换手术、2例与内移植肢体相关的干预、4例股动脉通路部位的手术翻修和2例与碗状缺血相关的手术。结论这项非行业赞助的多中心试验表明,在实际环境中(包括在 IFU 内部和外部)使用 TREO 设备治疗 AAA 患者似乎是可行的。虽然并发症和二次干预的发生率与之前公布的数据一致,但研究结果强调了标准 EVAR 与严重不良事件相关这一事实。
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引用次数: 0
Technical aspects of the new BYCROSSTM atherectomy device - preliminary results after 28 patients. 新型 BYCROSSTM 动脉粥样硬化切除术设备的技术方面--28 例患者的初步治疗结果。
IF 2.1 4区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-11-01 Epub Date: 2024-10-18 DOI: 10.1024/0301-1526/a001151
Dominik Liebetrau, Jörg Teßarek, Florian Elger, Viktoria Peters, Christian Scheurig-Münkler, Alexander Hyhlik-Dürr

Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients.

Materials and methods: We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSSTM Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention.

Results: Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m2. Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions.

Conclusion: The BYCROSSTM atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSSTM Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.

目的:技术方面对于计划和实施治疗外周动脉疾病的动脉粥样硬化切除术至关重要。本报告说明了新型粥样斑块切除术设备的使用情况,并调查了对 28 名患者实施粥样斑块切除术的可行性、有效性和安全性:我们对 2022 年 8 月至 2023 年 9 月期间在一家三级转诊中心接受 BYCROSSTM 动脉粥样硬化切除术的患者进行了前瞻性分析。招募对象为主动脉分叉以下病变(血管直径≥ 3 毫米)且存在新发或再狭窄(包括支架)的患者。主要不良事件(MAE)的定义为截肢、死亡、心肌梗死或需要单独干预的血管造影远端栓塞:在接受 BYCROSS 装置治疗的 28 位患者中,23 位为男性,平均年龄为 65.6 ± 9.6 岁,平均体重指数为 24.6 ± 3.9 kg/m2。大多数患者都有典型的动脉粥样硬化风险以及多种原有合并症。在所有患者中,有症状的外周动脉疾病(PAD)是进行干预的主要原因。最常见的卢瑟福分类为 5(12/28)。最常见的病变区域是股骨干段(25/28),其中23处为新发狭窄。平均病变长度为 218.0 ± 93.7 毫米。平均 PACCS 评分为 3.0 ± 1.0。狭窄等级平均为 99.3 ± 3.7%。BYCROSS 动脉粥样硬化切除术后,踝肱指数(ABI)明显增加(术前 0.44 ± 0.43,术后 0.84 ± 0.30):BYCROSSTM 动脉瘤切除术系统是一种新型设备,在治疗 PAD 的高级别钙化狭窄和闭塞过程中具有诸多优势。基于上述研究结果,BYCROSSTM 动脉瘤切除术是一种可行、安全且有效的外周动脉疾病血管内治疗方法。
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Vasa-european Journal of Vascular Medicine
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