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Clinical Study of a Physician Modified Y-Type Iliac Branch Device (PMYIBD) in the Endovascular Repair of Abdominal Aortic Aneurysms to Preserve the Internal Iliac Artery. 保留髂内动脉的腹主动脉瘤血管内修复术中医生改良 Y 型髂支装置 (PMYIBD) 的临床研究。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-04-17 DOI: 10.1177/15266028231165185
Zihe Zhao, Yi Jin, Dongsheng Fu, Chen Liu, Tong Qiao, Xiaoqiang Li, Xia Gao, Zhao Liu

Objectives: To report the method and curative effect of using a physician modified Y-type iliac branch device (PMYIBD) to preserve the internal iliac artery during the endovascular repair of abdominal aortic aneurysms.

Methods: From September 2018 to April 2022, 24 patients with abdominal aortic aneurysms or dissecting aneurysms, including 19 true aneurysms and 5 dissecting aneurysms involving the common iliac artery were treated in our department. The average age was (65.3 ± 7.6) years. All patients underwent preoperative evaluation by enhanced computed tomography. Combined with intraoperative angiography, a Y-type stent graft was prepared during surgery to perform endovascular repair of abdominal aortic aneurysms.

Results: All operations were successfully completed. The average operative duration was (224.8 ± 44.1) minutes. A total of 24 internal iliac arteries were reconstructed. The average follow-up time was (27.1 ± 13.5) months. During the follow-up, there was no expansion of aneurysm cavity, no endoleak or stent displacement, and no death occurred in all patients.

Discussion: The physician-modified Y-type iliac branched device (PMYIBD) provides an effective method for full-cavity repair. It has a wide range of indications and convenience. According to follow-up results, the early and mid-term had good curative effects; however, the long-term effects require further follow-up.

Conclusion: The modified Y-type IBD technique is safe and effective for aortic diseases involving internal iliac artery especially with complex anatomy.

Clinical impact: It is meaningful to preserve the IIA during EVAR. The use of PMYIBD provides a simple and effective method for the total endovascular repair of aortic diseases involving the IIA. Several advantages such as minimal trauma, low mortality, low complication rates and perfect short- and medium-term effects emerge in clinical practice. PMYIBDs are good choices for clinicians before suitable commercial stents are available in markets.

目的报告在腹主动脉瘤血管内修复过程中使用医生改良Y型髂支装置(PMYIBD)保留髂内动脉的方法及疗效:2018年9月至2022年4月,我科收治了24例腹主动脉瘤或夹层动脉瘤患者,其中19例为真性动脉瘤,5例为涉及髂总动脉的夹层动脉瘤。平均年龄为(65.3 ± 7.6)岁。所有患者术前都接受了增强型计算机断层扫描评估。结合术中血管造影,手术中准备了Y型支架移植物,对腹主动脉瘤进行血管内修复:所有手术均顺利完成。平均手术时间为(224.8±44.1)分钟。共重建了 24 条髂内动脉。平均随访时间为(27.1 ± 13.5)个月。随访期间,所有患者均未出现动脉瘤腔扩大、内漏或支架移位,也未出现死亡:讨论:医生改良 Y 型髂支装置(PMYIBD)是一种有效的全腔修补方法。它适应症广泛,使用方便。根据随访结果,早期和中期疗效良好,但长期疗效还需进一步随访:结论:改良 Y 型 IBD 技术对于涉及髂内动脉的主动脉疾病,尤其是解剖结构复杂的主动脉疾病,安全有效:临床影响:在EVAR期间保留IIA是有意义的。使用 PMYIBD 为涉及 IIA 的主动脉疾病的全血管内修复提供了一种简单有效的方法。在临床实践中,它具有创伤小、死亡率低、并发症发生率低、中短期效果完美等优点。在合适的商业支架上市之前,PMYIBD 是临床医生的良好选择。
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引用次数: 0
Systematic Review on Abdominal Penetrating Atherosclerotic Aortic Ulcers: Outcomes of Endovascular Repair. 关于腹部穿透性动脉粥样硬化性主动脉溃疡的系统性综述:血管内修复的结果。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-03-04 DOI: 10.1177/15266028231157636
Johannes Hatzl, Dittmar Böckler, Jonathan Fiering, Samuel Zimmermann, Moritz Sebastian Biscshoff, Eva Kalkum, Rosa Klotz, Christian Uhl

Purpose: To systematically review existing evidence on outcomes of endovascular repair of abdominal atherosclerotic penetrating aortic ulcers (PAUs).

Material and methods: Cochrane Central Registry of Registered Trials (CENTRAL), MEDLINE (via PubMed), and Web of Science databases were systematically searched. The systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocol (PRISMA-P 2020). The protocol was registered in the international registry of systematic reviews (PROSPERO CRD42022313404). Studies reporting on technical and clinical outcomes of endovascular PAU repair in 3 or more patients were included. Random effects modeling was used to estimate pooled technical success, survival, reinterventions, and type 1 and type 3 endoleaks. Statistical heterogeneity was assessed using the I2 statistic. Pooled results are reported with 95% confidence intervals (CIs). Study quality was assessed using an adapted version of the Modified Coleman Methodology Score.

Results: Sixteen studies including 165 patients with a mean/median age ranging from 64 to 78 years receiving endovascular therapy for PAU between 1997 and 2020 were identified. Pooled technical success was 99.0% (CI: 96.0%-100%). In all, 30-day mortality was 1.0% (CI: 0%-6.0%) with an in-hospital mortality of 1.0% (CI: 0.0%-13.0%). There were no reinterventions, type 1, or type 3 endoleaks at 30 days. Median/mean follow-up ranged from 1 to 33 months. Overall, there were 16 deaths (9.7%), 5 reinterventions (3.3%), 3 type 1 (1.8%), and 1 type 3 endoleak (0.6%) during follow-up. The quality of studies was rated low according to the Modified Coleman score at 43.4 (+/- 8.5) of 85 points.

Conclusion: There is low-level evidence on outcomes of endovascular PAU repair. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. Recommendations with regard to treatment indications and techniques in asymptomatic PAU should be made cautiously.

Clinical impact: This systematic review demonstrated that evidence on outcomes of endovascular abdominal PAU repair is limited. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. In the context of a benign prognosis of asymptomatic PAU and lacking standardization in current reporting, recommendations with regard to treatment indications and techniques in asymptomatic PAUs should be made cautiously.

目的:系统回顾腹部动脉粥样硬化性穿透性主动脉溃疡(PAU)血管内修复术疗效的现有证据:系统检索了Cochrane中央注册试验登记中心(CENTRAL)、MEDLINE(通过PubMed)和Web of Science数据库。系统综述按照《系统综述和元分析首选报告项目》(PRISMA-P 2020)进行。该方案已在国际系统性综述注册中心(PROSPERO CRD42022313404)注册。纳入了对 3 例或 3 例以上患者进行血管内 PAU 修复的技术和临床结果进行报告的研究。采用随机效应模型估算汇总的技术成功率、存活率、再干预率以及 1 型和 3 型内漏。统计异质性采用 I2 统计量进行评估。汇总结果与 95% 置信区间 (CI) 一并报告。研究质量采用改良版科尔曼方法评分法进行评估:1997年至2020年间,165名平均/中位年龄在64岁至78岁之间的PAU患者接受了血管内治疗。汇总的技术成功率为99.0%(CI:96.0%-100%)。30天死亡率为1.0%(CI:0%-6.0%),院内死亡率为1.0%(CI:0.0%-13.0%)。30天内无再次介入、1型或3型内漏。中位/平均随访时间为 1 至 33 个月。总体而言,随访期间有16例死亡(9.7%)、5例再次介入(3.3%)、3例1型内漏(1.8%)和1例3型内漏(0.6%)。根据改良科尔曼评分法,研究质量较低,在85分中占43.4(+/- 8.5)分:结论:有关血管内PAU修复术结果的证据水平较低。结论:有关腹腔PAU血管内修复术疗效的证据较少,虽然短期内腹腔PAU血管内修复术似乎安全有效,但缺乏中期和长期数据。对于无症状PAU的治疗指征和技术,应谨慎提出建议:本系统综述表明,有关腹腔PAU血管内修复术疗效的证据有限。虽然腹腔PAU的血管内修复术在短期内似乎安全有效,但缺乏中期和长期数据。鉴于无症状PAU的良性预后以及目前的报告缺乏标准化,应谨慎推荐无症状PAU的治疗指征和技术。
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引用次数: 0
Intravascular Ultrasound Versus Computed Tomography Angiography in Sizing and Operative Management of Endovascular Aortic Aneurysm Repair. 血管内超声与计算机断层扫描血管造影在血管内主动脉瘤修补术的选型和手术管理中的对比。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-03-16 DOI: 10.1177/15266028231158964
Mohammad A Taalab, Ahmed M Kamal, Ahmed F Mohammad, Mohamed M Zaki
<p><strong>Objectives: </strong>An abdominal aortic aneurysm (AAA) is a potentially life-threatening condition, the management of which has dramatically evolved over the past 2 decades with an increasing tendency toward endovascular repair (EVAR) rather than open surgical repair. Classically, contrast-enhanced multislice computed tomography (CT) angiography (CTA) is performed preoperatively for procedure sizing and EVAR planning. This entails voluminous contrast injection with risk of allergic reaction, nephropathy, and radiation exposure. Intra-vascular ultrasound (IVUS) has been increasingly used to guide EVAR procedures intraoperatively. The aim of this study is to investigate the accuracy of IVUS in sizing AAAs, device selection, and EVAR planning compared to the gold standard CTA.</p><p><strong>Design: </strong>This is a prospective observational study enrolling 10 patients who underwent standard infrarenal EVAR procedures performed for unruptured infrarenal AAAs over the course of 1 year. All patients had a preoperative CTA done upon which aneurysm sizing and device planning were performed, and the measurements obtained were compared to those obtained from intraoperative IVUS.</p><p><strong>Methods: </strong>All participating patients had unruptured infrarenal AAA, had no renal impairment, and had anatomical suitability for EVAR according to the instructions for use (IFU) of the device manufacturer. Primary endpoint was comparing anatomical measurements recorded by IVUS with those obtained from the preoperative CTA.</p><p><strong>Results: </strong>Mean age was 65.6 (±6.19), all patients were males and hypertensives and 4 (40%) had a positive family history for AAA. On comparing mean measurements taken by CTA and IVUS, there was no statistically significant differences with exception of maximal aortic diameter and aortic diameter at site of bifurcation (both p-values <.001). There were no statistically significant differences in length measurements between the 2 imaging modalities. Computed tomography angiography was more associated with neck thrombus detection, and IVUS was more associated with calcification detection.</p><p><strong>Conclusion: </strong>Although CT angiography is still the gold standard imaging modality for AAA, IVUS use is very beneficial in EVAR sizing and planning, in addition to intra-operative guidance of the procedure, saving the patient significant time, contrast administration, and radiation exposure, especially in patients with renal impairment and contrast allergy.</p><p><strong>Clinical impact: </strong>A preoperative CT angiogram is the gold standard required investigation for planning and sizing EVARs, with subsequent contrast injection entailing a risk of contrast induced nephropathy and allergic reactions. IVUS has been used as an adjuvant technique to guide EVAR stent graft deployment. However, our study concluded that it can also be reliably used in sizing and planning of the EVAR stent graft along with com
目的:腹主动脉瘤(AAA)是一种可能危及生命的疾病,其治疗方法在过去 20 年中发生了巨大变化,越来越倾向于血管内修复(EVAR)而非开放手术修复。通常,术前要进行造影剂增强多层计算机断层扫描(CT)血管造影术(CTA),以确定手术大小和 EVAR 计划。这需要注射大量造影剂,存在过敏反应、肾病和辐射风险。血管内超声(IVUS)越来越多地被用于术中指导EVAR手术。本研究旨在探讨与金标准 CTA 相比,IVUS 在确定 AAA 大小、设备选择和 EVAR 计划方面的准确性:这是一项前瞻性观察研究,10 名患者在一年内接受了标准的肾下腔动脉 AAA EVAR 手术。所有患者术前都做了 CTA,并在此基础上进行了动脉瘤大小和设备规划,并将获得的测量结果与术中 IVUS 获得的测量结果进行了比较:所有参与研究的患者均为未破裂的肾下AAA,无肾功能损害,根据设备制造商的使用说明(IFU),在解剖学上适合进行EVAR。主要终点是比较 IVUS 与术前 CTA 所记录的解剖测量结果:平均年龄为 65.6 (±6.19)岁,所有患者均为男性和高血压患者,其中 4 人(40%)有阳性 AAA 家族史。比较 CTA 和 IVUS 的平均测量值,除主动脉最大直径和分叉处的主动脉直径外,两者无统计学差异(均为 p 值):尽管CT血管造影仍是AAA的金标准成像方式,但IVUS的使用对EVAR的大小和规划非常有益,此外还能在术中指导手术,为患者节省大量时间、造影剂用量和辐射暴露,尤其是对肾功能受损和造影剂过敏的患者:临床影响:术前 CT 血管造影是规划和确定 EVAR 大小所需的金标准检查,而随后的造影剂注射会带来造影剂诱发肾病和过敏反应的风险。IVUS 已被用作指导 EVAR 支架移植物部署的辅助技术。然而,我们的研究得出结论,IVUS 也可以可靠地用于确定 EVAR 支架移植物的大小和规划,同时辅以非造影剂成像,尤其适用于造影剂诱发肾病和造影剂过敏的高危患者。
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引用次数: 0
Technical Feasibility and Safety of a Snare-Less, EVAR-First Technique for Iliac Branch Endoprosthesis. 髂支内膜置换术的无卡环、EVAR-First 技术的可行性和安全性。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-07-14 DOI: 10.1177/15266028231187200
Julia Fayanne Chen, Sarah Ann Loh, Uwe Fischer, Naiem Nassiri

Objective: The purpose of this study was to evaluate the technical feasibility, safety, and early outcomes of a snare-less, endovascular abdominal aortic aneurysm repair (EVAR)-first technique (SET) for iliac branch endoprosthesis (IBE) placement.

Methods: We retrospectively reviewed all patients who received IBEs between July 2018 and March 2022. Patients were divided into 2 categories based on method of IBE deployment: SET or Standard. Primary endpoints were technical success, major adverse events, mortality, reintervention, internal iliac artery (IIA) patency, and freedom from IIA branch instability. Technical success was defined by successful deployment of both the EVAR and the IBE with maintained patency of the IIA and no stent graft migration.

Results: There were 20 patients (90% male, median age 72 [65.4-74.5] years) who underwent IBE placement. Among these, 5 (33.3%) underwent SET to treat 5 common iliac artery (CIA)/IIA aneurysms, while the remaining 15 (66.7%) underwent standard IBE deployment with through-and-through femoral access (n=13) or trans-brachial access (n=2) to treat 19 CIA/IIA aneurysms. Overall median renal to iliac bifurcation length was 169 (152-177) mm, with 9 patients falling short of the minimum of 165 mm for on-label IBE placement. Median contrast used was 148 (120-201) mL, fluoroscopy time 42.8 (35.0-49.8) minutes, estimated blood loss 200 (100-275) mL, and procedure time 192 (167-246) minutes, with no significant differences between the 2 groups. Technical success was achieved in 100% of cases. At 30 days, there were no mortalities or major adverse events in either group; there were 100% IIA patency, no IIA instability, and no reinterventions in both groups. Median follow-up in the SET group was 5.7 (5.5-6.2) months, with 1 death at 6 months and 1 type 1B endoleak at 6 months requiring reintervention. Median follow-up for the Standard group was 1.6 (0.8-2.1) years with 2 non-aneurysm-related deaths and no reinterventions at 1 year.

Conclusions: SET for IBE is a safe and effective approach that decreases technical complexity and mitigates anatomic barriers to IBE placement.

Clinical impact: SET for IBE is a safe and effective approach to IBE placement that decreases technical complexity. A critical component to this technique is a large bore sheath with a stiff steerable tip. Importantly, this approach also mitigates anatomic barriers to IBE placement, expanding applicability of IBE technology to patients who may be otherwise ineligible.

研究目的本研究旨在评估无卡环、血管内腹主动脉瘤修补术(EVAR)--髂支内膜假体(IBE)置入先行技术(SET)的技术可行性、安全性和早期疗效:我们回顾性审查了2018年7月至2022年3月期间接受IBE的所有患者。根据 IBE 置入方法将患者分为两类:SET或标准。主要终点是技术成功率、主要不良事件、死亡率、再介入、髂内动脉(IIA)通畅率和 IIA 支不稳的自由度。技术成功的定义是:EVAR和IBE均成功部署,IIA保持通畅,支架移植物无移位:共有 20 名患者(90% 为男性,中位年龄 72 [65.4-74.5] 岁)接受了 IBE 置入术。其中,5 名患者(33.3%)接受了 SET,治疗 5 个髂总动脉 (CIA)/IIA 动脉瘤,其余 15 名患者(66.7%)接受了标准的 IBE 置入术,通过股动脉通路(13 人)或经肱动脉通路(2 人)治疗 19 个 CIA/IIA 动脉瘤。肾脏到髂骨分叉的总长度中位数为 169(152-177)毫米,其中 9 名患者未达到标签上 IBE 置入的最小值 165 毫米。造影剂用量中位数为 148(120-201)毫升,透视时间为 42.8(35.0-49.8)分钟,估计失血量为 200(100-275)毫升,手术时间为 192(167-246)分钟,两组之间无明显差异。100%的病例都取得了技术成功。30 天后,两组患者均无死亡或重大不良事件发生;两组患者的 IIA 通畅率均为 100%,无 IIA 不稳定现象,也无再次介入治疗。SET 组的中位随访时间为 5.7(5.5-6.2)个月,其中 1 例在 6 个月时死亡,1 例在 6 个月时发生 1B 型内漏,需要再次介入治疗。标准组的中位随访时间为1.6(0.8-2.1)年,1年中有2例非动脉瘤相关死亡,无再次介入:IBE的SET是一种安全有效的方法,可降低技术复杂性并减轻IBE置入的解剖障碍:IBE SET 是一种安全有效的 IBE 置入方法,可降低技术复杂性。这种技术的关键部件是带有坚硬可转向尖端的大口径鞘。重要的是,这种方法还能减少放置 IBE 的解剖障碍,从而将 IBE 技术的适用范围扩大到那些原本不符合条件的患者。
{"title":"Technical Feasibility and Safety of a Snare-Less, EVAR-First Technique for Iliac Branch Endoprosthesis.","authors":"Julia Fayanne Chen, Sarah Ann Loh, Uwe Fischer, Naiem Nassiri","doi":"10.1177/15266028231187200","DOIUrl":"10.1177/15266028231187200","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this study was to evaluate the technical feasibility, safety, and early outcomes of a snare-less, endovascular abdominal aortic aneurysm repair (EVAR)-first technique (SET) for iliac branch endoprosthesis (IBE) placement.</p><p><strong>Methods: </strong>We retrospectively reviewed all patients who received IBEs between July 2018 and March 2022. Patients were divided into 2 categories based on method of IBE deployment: SET or Standard. Primary endpoints were technical success, major adverse events, mortality, reintervention, internal iliac artery (IIA) patency, and freedom from IIA branch instability. Technical success was defined by successful deployment of both the EVAR and the IBE with maintained patency of the IIA and no stent graft migration.</p><p><strong>Results: </strong>There were 20 patients (90% male, median age 72 [65.4-74.5] years) who underwent IBE placement. Among these, 5 (33.3%) underwent SET to treat 5 common iliac artery (CIA)/IIA aneurysms, while the remaining 15 (66.7%) underwent standard IBE deployment with through-and-through femoral access (n=13) or trans-brachial access (n=2) to treat 19 CIA/IIA aneurysms. Overall median renal to iliac bifurcation length was 169 (152-177) mm, with 9 patients falling short of the minimum of 165 mm for on-label IBE placement. Median contrast used was 148 (120-201) mL, fluoroscopy time 42.8 (35.0-49.8) minutes, estimated blood loss 200 (100-275) mL, and procedure time 192 (167-246) minutes, with no significant differences between the 2 groups. Technical success was achieved in 100% of cases. At 30 days, there were no mortalities or major adverse events in either group; there were 100% IIA patency, no IIA instability, and no reinterventions in both groups. Median follow-up in the SET group was 5.7 (5.5-6.2) months, with 1 death at 6 months and 1 type 1B endoleak at 6 months requiring reintervention. Median follow-up for the Standard group was 1.6 (0.8-2.1) years with 2 non-aneurysm-related deaths and no reinterventions at 1 year.</p><p><strong>Conclusions: </strong>SET for IBE is a safe and effective approach that decreases technical complexity and mitigates anatomic barriers to IBE placement.</p><p><strong>Clinical impact: </strong>SET for IBE is a safe and effective approach to IBE placement that decreases technical complexity. A critical component to this technique is a large bore sheath with a stiff steerable tip. Importantly, this approach also mitigates anatomic barriers to IBE placement, expanding applicability of IBE technology to patients who may be otherwise ineligible.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1190-1196"},"PeriodicalIF":1.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9775049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Fractured Sealing Rings in a Fenestrated Anaconda Stent-Graft. Anaconda 支架移植瘘管中的密封环断裂。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-03-03 DOI: 10.1177/15266028231158955
Shaneel Patel, George Ninkovic-Hall, Richard McWilliams, Simon Neequaye

An 81 year-old man presented with an asymptomatic juxtrarenal abdominal aortic aneurysm and was subsequently treated with a fenestrated endovascular Anaconda stent-graft. Surveillance imaging within the first postoperative year demonstrated a lower proximal sealing ring fracture. In the second postoperative surveillance year, the upper proximal sealing ring was also fractured with extension of the wire into the right paravertebral space. Despite these sealing ring fractures, there were no endoleak nor visceral stent complications and the patient continued on standard surveillance protocols. There are an increasing number of reports of fractured proximal sealing rings with the fenestrated Anaconda platform. Those analysing the surveillance scans of patients treated with this device should stay vigilant for the development of this complication.

一名 81 岁的男性患有无症状的并肾上腹部主动脉瘤,随后接受了栅栏式血管内 Anaconda 支架移植治疗。术后第一年的监测成像显示,下部近端密封环断裂。在术后第二年的监测中,上部近端密封环也发生骨折,导线延伸至右侧椎旁间隙。尽管出现了这些密封环骨折,但没有出现内漏或内脏支架并发症,患者继续接受标准监测方案。有越来越多的报告称,Anaconda 平台栅栏式近端密封环发生断裂。对使用该装置治疗的患者的监控扫描进行分析的人员应该对这种并发症的发生保持警惕。
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引用次数: 0
Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Common Femoral Artery Atherosclerotic Disease. 血管内碎石术和药物涂层球囊血管成形术治疗严重钙化的股总动脉粥样硬化疾病。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-03-10 DOI: 10.1177/15266028231158313
Konstantinos Stavroulakis, Giovanni Torsello, Gregory Chlouverakis, Theodosios Bisdas, Sarah Damerau, Nikolaos Tsilimparis, Angeliki Argyriou

Objectives: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions.

Methods: This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (<30% stenosis), freedom from target lesion revascularization (TLR), secondary patency, and overall mortality were additionally analyzed.

Results: Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2-3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18-4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29-5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13-2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13-3.53; p=0.65) did not influence the primary patency.

Conclusions: In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions.

Clinical impact: Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months.

目的:血管内碎石术(IVL)后进行药物涂层球囊(DCB)血管成形术,可能是治疗股总动脉(CFA)动脉粥样硬化钙化性疾病手术的重要替代方案。然而,这种治疗策略在12个月内的疗效仍不得而知。本研究报告了IVL辅助DCB血管成形术治疗股总动脉钙化病变的12个月疗效:这是一项回顾性单中心、单臂研究。对 2017 年 2 月至 2020 年 9 月间接受 IVL 和 DCB 治疗的钙化 CFA 病变的连续患者进行了评估。本分析的主要衡量结果是主要通畅率。手术技术成功率(结果:本研究共纳入 33 名(n=33)患者。大多数患者有生活方式限制性跛行(20 人,61%),52%(17 人)的患者患有慢性肾病(CKD),33%(11 人)的患者患有糖尿病。手术技术成功率为 97%(32 人)。2名患者(6%)在IVL术后出现血流限制性夹层,1名患者(3%)出现外周栓塞,而支架保送率为12%(n=4)。未观察到穿孔。住院时间中位数为2天(四分位数间距为2-3)。12个月时,主要通畅率为72%。无 TLR 和二次通畅率分别为 94% 和 88%。12个月的存活率为100%,75%的患者(25人)无症状或有轻度跛行。慢性肢体缺血(CLTI)(危险比[HR],0.92;置信区间(CI);0.18-4.8,P=0.7)或慢性肾脏病(CKD)(HR,1.30;95% CI,0.29-5.8;P=0.72)的存在,以及是否使用血管造影术(CKD),都会影响患者的生存率。72),以及使用7毫米IVL导管(HR,0.59;95% CI,0.13-2.63;P=0.49)或高剂量DCB(HR,0.68;95% CI,0.13-3.53;P=0.65)均不影响一次通畅率:在这项研究中,IVL和DCB血管成形术联合治疗钙化CFA疾病的围手术期并发症风险低,12个月的临床结果可接受,再干预率低:临床影响:血管内碎石术联合DCB血管成形术可替代手术治疗经过严格筛选的CFA动脉粥样硬化患者。在该队列中,联合疗法可获得可接受的临床效果,12 个月后的再干预率较低。
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引用次数: 0
Differences in Biologic Drug Effects and Distal Particulate Embolization in Three Paclitaxel-Coated Balloons for Femoropopliteal Lesions in a Rabbit Model. 三种紫杉醇涂层球囊治疗兔股骨腘动脉病变的生物药物效应和远端微粒栓塞的差异。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-03-23 DOI: 10.1177/15266028231161215
Marie Yoshikawa, Sho Torii, Kazuki Aihara, Masatoshi Ito, Norihito Nakamura, Satoshi Noda, Ayako Yoshikawa, Sayo Utsunomiya, Gaku Nakazawa Md, Yuji Ikari

Background: A recent meta-analysis of randomized control trials demonstrated a significantly higher risk of major amputation in patients treated with drug-coated balloons (DCBs) compared with standard treatment, especially in high-dose paclitaxel-coated DCBs. Distal particulate embolization after DCB use was considered a potential cause of the higher incidence of major amputation. The current study aimed to histologically and biologically compare biologic drug effect and distal particulate embolization in 3 DCBs (a high-dose paclitaxel-coated DCB [IN.PACT Admiral] and 2 low-dose paclitaxel-coated DCBs [Ranger and Lutonix]).

Methods and results: The DCBs were inflated in the healthy descending aortas of 18 rabbits, followed by euthanasia 28 days after the procedure. The treated descending aorta and distal skeletal muscles were histopathologically evaluated, and paclitaxel concentrations were measured. The paclitaxel concentration of the treated lesion was highest for Ranger, followed by IN.PACT and Lutonix (Ranger vs IN.PACT vs Lutonix: 1089 [745-2170] pmol/mg vs 638 [160-2075] pmol/mg vs 25 [10-304] pmol/mg, respectively; p<0.0001). In the histopathological evaluation, the angle of severe medial smooth muscle cell loss was largest for Ranger followed by IN.PACT and Lutonix (12.8 [8.0-20.4] degree vs 1.4 [1.2-5.2] degree vs 0.8 [0.5-2.5] degree, respectively), with significant differences for Ranger vs IN.PACT (p=0.007) and Ranger vs Lutonix (p=0.002). However, paclitaxel concentrations of distal skeletal muscles were lowest for Lutonix, followed by Ranger and IN.PACT (12 [1-58] pmol/mg vs 15 [13-21] pmol/mg vs 42 [19-108] pmol/mg, respectively, p<0.0001). The numbers of arteries with downstream DCB effects were highest for IN.PACT, followed by Ranger and Lutonix (Ranger vs IN.PACT vs Lutonix, 3 [3-4] vs 4 [3-7] vs 2 [1-2], respectively), which was consistent with the measured tissue paclitaxel concentrations.

Conclusion: These findings suggest that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization, making it a good treatment option for patients with peripheral artery disease among the 3 DCBs evaluated in the current study. Further clinical head-to-head comparisons with larger numbers of patients are needed to explore which DCB is the most effective and safe treatment option.Clinical Impact:The findings of the current preclinical study suggests that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization making it a good treatment for patients with intermittent claudication and chronic limb-threatening ischemia.

背景:最近一项随机对照试验的荟萃分析表明,与标准治疗相比,使用药物涂层球囊(DCB)治疗的患者发生大截肢的风险明显更高,尤其是使用高剂量紫杉醇涂层DCB的患者。使用DCB后出现的远端微粒栓塞被认为是导致大截肢发生率较高的潜在原因。本研究旨在从组织学和生物学角度比较 3 种 DCB(一种高剂量紫杉醇涂层 DCB [IN.PACT Admiral] 和两种低剂量紫杉醇涂层 DCB [Ranger 和 Lutonix])的生物药物效应和远端微粒栓塞情况:在 18 只兔子的健康降主动脉中充气 DCB,然后在手术 28 天后安乐死。对处理过的降主动脉和远端骨骼肌进行组织病理学评估,并测量紫杉醇浓度。Ranger治疗病变部位的紫杉醇浓度最高,其次是IN.PACT和Lutonix(Ranger vs IN.PACT vs Lutonix: 分别为1089 [745-2170] pmol/mg vs 638 [160-2075] pmol/mg vs 25 [10-304] pmol/mg;p结论:这些研究结果表明,Ranger 的紫杉醇效果最强,远端微粒栓塞效果次之,是目前研究中评估的 3 种 DCB 中治疗外周动脉疾病患者的最佳选择。临床影响:目前的临床前研究结果表明,Ranger的紫杉醇效果最强,远端微粒栓塞效果次之,是间歇性跛行和慢性肢体缺血患者的理想治疗方法。
{"title":"Differences in Biologic Drug Effects and Distal Particulate Embolization in Three Paclitaxel-Coated Balloons for Femoropopliteal Lesions in a Rabbit Model.","authors":"Marie Yoshikawa, Sho Torii, Kazuki Aihara, Masatoshi Ito, Norihito Nakamura, Satoshi Noda, Ayako Yoshikawa, Sayo Utsunomiya, Gaku Nakazawa Md, Yuji Ikari","doi":"10.1177/15266028231161215","DOIUrl":"10.1177/15266028231161215","url":null,"abstract":"<p><strong>Background: </strong>A recent meta-analysis of randomized control trials demonstrated a significantly higher risk of major amputation in patients treated with drug-coated balloons (DCBs) compared with standard treatment, especially in high-dose paclitaxel-coated DCBs. Distal particulate embolization after DCB use was considered a potential cause of the higher incidence of major amputation. The current study aimed to histologically and biologically compare biologic drug effect and distal particulate embolization in 3 DCBs (a high-dose paclitaxel-coated DCB [IN.PACT Admiral] and 2 low-dose paclitaxel-coated DCBs [Ranger and Lutonix]).</p><p><strong>Methods and results: </strong>The DCBs were inflated in the healthy descending aortas of 18 rabbits, followed by euthanasia 28 days after the procedure. The treated descending aorta and distal skeletal muscles were histopathologically evaluated, and paclitaxel concentrations were measured. The paclitaxel concentration of the treated lesion was highest for Ranger, followed by IN.PACT and Lutonix (Ranger vs IN.PACT vs Lutonix: 1089 [745-2170] pmol/mg vs 638 [160-2075] pmol/mg vs 25 [10-304] pmol/mg, respectively; p<0.0001). In the histopathological evaluation, the angle of severe medial smooth muscle cell loss was largest for Ranger followed by IN.PACT and Lutonix (12.8 [8.0-20.4] degree vs 1.4 [1.2-5.2] degree vs 0.8 [0.5-2.5] degree, respectively), with significant differences for Ranger vs IN.PACT (p=0.007) and Ranger vs Lutonix (p=0.002). However, paclitaxel concentrations of distal skeletal muscles were lowest for Lutonix, followed by Ranger and IN.PACT (12 [1-58] pmol/mg vs 15 [13-21] pmol/mg vs 42 [19-108] pmol/mg, respectively, p<0.0001). The numbers of arteries with downstream DCB effects were highest for IN.PACT, followed by Ranger and Lutonix (Ranger vs IN.PACT vs Lutonix, 3 [3-4] vs 4 [3-7] vs 2 [1-2], respectively), which was consistent with the measured tissue paclitaxel concentrations.</p><p><strong>Conclusion: </strong>These findings suggest that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization, making it a good treatment option for patients with peripheral artery disease among the 3 DCBs evaluated in the current study. Further clinical head-to-head comparisons with larger numbers of patients are needed to explore which DCB is the most effective and safe treatment option.Clinical Impact:The findings of the current preclinical study suggests that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization making it a good treatment for patients with intermittent claudication and chronic limb-threatening ischemia.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1234-1243"},"PeriodicalIF":1.7,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9169831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Outcomes of the Gore® Excluder® Iliac Branch Endoprosthesis Using Self Expanding or Balloon-Expandable Stent Grafts for the Internal Iliac Artery Component. Gore® Excluder® Iliac 支内膜假体髂内动脉部分使用自膨胀或球囊扩张支架移植物的疗效。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-05-06 DOI: 10.1177/15266028231169177
Nicholas S Cortolillo, Andres Guerra, Eric Murphy, Andrew W Hoel, Mark K Eskandari, Tadaki M Tomita

Objective: The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Arizona) was developed to be used in combination with a self-expanding stent graft (SESG) for the internal iliac artery (IIA) bridging stent. Balloon-expandable stent grafts (BESGs) are an alternative for the IIA, offering advantages in sizing, device tracking, precision, and lower profile delivery. We compared the performance of SESG and BESG when used as the IIA bridging stent in patients undergoing EVAR with IBE.

Methods: This is a retrospective review of consecutive patients who underwent EVAR with IBE implantation at a single center from October 2016 to May 2021. Anatomic and procedural characteristics were recorded via chart review and computed tomography (CT) postprocessing software (Vitrea® v7.14). Devices were assigned to SESG vs. BESG groups based on the type of device landing into the most distal IIA segment. Analysis was performed per device to account for patients undergoing bilateral IBE. The primary endpoint was IIA patency, and secondary endpoint was IBE-related endoleak.

Results: During the study period, 48 IBE devices were implanted in 41 patients (mean age 71.1 years). All IBE devices were implanted in conjunction with an infrarenal endograft. There were 24 devices in each of the self-expanding internal iliac component (SE-IIC) and balloon-expandable internal iliac component (BE-IIC) groups. The BE-IIC group had smaller diameter IIA target vessels (11.6±2.0 mm vs. 8.4±1.7 mm, p<0.001). Mean follow-up was 525 days. Loss of IIA patency occurred in 2 SESG devices (8.33%) at 73 and 180 days postprocedure, and in zero BESG devices, however, this difference was not statistically significant (p=0.16). There was 1 IBE-related endoleak requiring reintervention during the study period. A BESG device required reintervention due to Type 3 endoleak at 284 days.

Conclusions: There were no significant differences in outcomes between SESG and BESG when used for the IIA bridging stent in EVAR with IBE. The BESGs were associated with using 2 IIA bridging stents and were more often deployed in smaller IIA target arteries. Retrospective study design and small sample size may limit the generalizability of our findings.

Clinical impact: This series compares postoperative and midterm outcomes of self expanding stent grafts and balloon expandable stent grafts (BESG) when used as the internal iliac stent graft as part of a Gore® Excluder® Iliac Branch Endoprosthesis (IBE). With similar outcomes between the two stent-grafts, our series suggests that some of the advantages of BESG, device sizing, tracking, deployment, and profile, may be able to be leveraged without impacting the mid-term performance of the IBE.

目的:GORE® EXCLUDER® Iliac Branch Endoprosthesis(IBE;W.L. Gore & Associates,亚利桑那州弗拉格斯塔夫)的开发目的是与自膨胀支架移植物(SESG)结合使用,用于髂内动脉(IIA)桥接支架。球囊扩张支架移植物(BESG)是髂内动脉桥接支架的替代品,在尺寸、设备跟踪、精确性和低剖面输送方面具有优势。我们比较了 SESG 和 BESG 作为 IIA 桥接支架在接受 IBE EVAR 患者中的表现:这是一项回顾性研究,研究对象是 2016 年 10 月至 2021 年 5 月期间在一个中心接受 EVAR 并植入 IBE 的连续患者。通过病历审查和计算机断层扫描(CT)后处理软件(Vitrea® v7.14)记录了解剖和手术特征。根据植入最远 IIA 节段的器械类型,将器械分配到 SESG 组和 BESG 组。为了考虑接受双侧 IBE 的患者,分析是按器械进行的。主要终点是IIA通畅率,次要终点是IBE相关内漏:研究期间,共为 41 名患者(平均年龄 71.1 岁)植入了 48 个 IBE 装置。所有 IBE 装置均与肾下腔内移植物一起植入。自膨胀髂内组件(SE-IIC)组和球囊膨胀髂内组件(BE-IIC)组各有 24 个装置。BE-IIC组的IIA靶血管直径较小(11.6±2.0 mm vs. 8.4±1.7 mm,P结论):在使用IBE的EVAR中,SESG和BESG用于IIA桥接支架的结果没有明显差异。BESG 与使用 2 个 IIA 桥接支架有关,并且更多用于较小的 IIA 靶动脉。回顾性研究设计和样本量较小可能会限制我们研究结果的推广性:该系列研究比较了作为 Gore® Excluder® Iliac Branch Endoprosthesis(IBE)一部分的髂内支架移植物时,自膨胀支架移植物和球囊可膨胀支架移植物(BESG)的术后和中期疗效。两种支架移植物的疗效相似,我们的系列研究表明,BESG 在设备尺寸、跟踪、部署和外形等方面的一些优势或许可以加以利用,而不会影响 IBE 的中期性能。
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引用次数: 0
Re: In Situ Fenestrated Thoracic Endovascular Repair Using the Upstream Peripheral Go Back™ Re-Entry Catheter From Antegrade Approach. 关于使用上游外周 Go Back™ 再进入导管从逆行入路进行原位胸腔内血管瘘修复术。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-04-20 DOI: 10.1177/15266028231167991
Konstantinos Spanos, Miltiadis Matsagkas
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引用次数: 0
Geniculate Artery Endovascular Embolization Post-Total Knee Arthroplasty for Hemarthrosis Treatment: A Systematic Review of the Literature. 膝关节全关节置换术后根状动脉血管内栓塞治疗关节半脱位:系统性文献综述。
IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-12-01 Epub Date: 2023-03-04 DOI: 10.1177/15266028231157642
Christina M Melian, Stefanos Giannopoulos, Ioannis Tsouknidas, Panagiotis Volteas, Dimitrios Virvilis, George J Koullias

Purpose: To provide an updated systematic review on the use of geniculate artery embolization (GAE) in the management of recurrent hemarthrosis post-total knee arthroplasty (TKA).

Materials and methods: A systematic literature review was conducted, and all clinical reports in the English language from inception to July 2022 were identified. References were manually reviewed to identify additional studies. Demographics, procedural techniques, post-procedural complications, and follow-up data were extracted and analyzed using STATA 14.1.

Results: A total of 20 studies (9 case reports, 11 case series; n= 214) were included for review. In all cases, patients underwent coil embolization of one or more geniculate arteries. Procedure success was reported in 94.8% (n=203/214) of cases without perioperative adverse events. Improvement of symptoms was seen in 72.6% (n=119/164) of cases, with 30.7% (n=58/189) of cases requiring repeat embolization. Recurrent hemarthrosis occurred in 22.2% (n=22/99) of cases over a mean follow-up of 48 months.

Conclusion: GAE appears to be a safe and effective treatment for recurrent hemarthrosis following TKA. Future studies in the form of randomized controlled trials should be conducted to further evaluate such embolization techniques and compare outcomes between GAE and standard techniques.

Clinical impact: Conservative management of post total knee arthroplasty (TKA) hemarthrosis is successful in only one third of cases. Geniculate artery embolization (GAE) has recently gained attention due to its minimally invasive nature compared to open or arthroscopic synovectomy promising faster rehabilitation, decreased infection rates and less additional surgeries. The purpose of this article was to summarize current literature, provide an updated review on the use of GAE in the management of recurrent hemarthrosis post-TKA and describe immediate and long-term outcomes in an effort to help optimize current treatment algorithms.

目的:就膝关节全关节置换术(TKA)后复发性血肿的治疗中使用膝曲动脉栓塞术(GAE)进行最新的系统性综述:进行了系统性文献综述,确定了从开始到 2022 年 7 月的所有英文临床报告。人工查阅参考文献以确定其他研究。使用 STATA 14.1 对人口统计学、手术技术、术后并发症和随访数据进行提取和分析:共纳入 20 项研究(9 项病例报告,11 项系列病例;n= 214)进行审查。在所有病例中,患者均接受了一条或多条膝状动脉的线圈栓塞术。据报道,94.8%(n=203/214)的病例手术成功,且无围手术期不良事件。72.6%的病例(n=119/164)症状得到改善,30.7%的病例(n=58/189)需要重复栓塞。在平均48个月的随访中,22.2%的病例(n=22/99)出现了复发性血肿:结论:GAE似乎是治疗TKA术后复发性血运重建的一种安全有效的方法。今后应开展随机对照试验形式的研究,进一步评估此类栓塞技术,并比较 GAE 和标准技术的疗效:临床影响:对全膝关节置换术(TKA)后血肿的保守治疗仅在三分之一的病例中取得成功。膝关节小动脉栓塞术(GAE)因其微创性优于开刀或关节镜滑膜切除术,有望加快康复速度、降低感染率和减少额外手术,近来备受关注。本文旨在总结目前的文献,提供关于使用 GAE 治疗 TKA 术后复发性血运重建的最新综述,并描述近期和远期疗效,以帮助优化目前的治疗算法。
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引用次数: 0
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Journal of Endovascular Therapy
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