Journal of Endovascular Therapy最新文献

{"title":"Review of Systemic Mock Circulation Loops for Evaluation of Implantable Cardiovascular Devices and Biological Tissues.","authors":"Emmanouil Agrafiotis, Daniel Zimpfer, Heinrich Mächler, Gerhard A Holzapfel","doi":"10.1177/15266028241235876","DOIUrl":"10.1177/15266028241235876","url":null,"abstract":"<p><p>Implantable cardiovascular devices must undergo evaluation prior to animal testing and clinical trials to ensure their performance and efficiency. Mock circulation loops (MCLs) are on-demand tools capable of reproducing physiological conditions in vivo and are also devices for preventative testing. Recognition of their success as useful tools comes from the fact that over 100 MCLs have been submitted for device assessment in recent years. Mock circulation loops could detect malfunctions that patients might otherwise experience. Thus, MCLs can complement preclinical and prototype evaluation rather than being mutually exclusive. In this review, we emphasize the experimental value of MCLs while providing a brief overview of the history of the field. In addition, the necessary hemodynamic parameters are analyzed to reproduce physiological scenarios in vitro. We also discuss the relevant setups when evaluating devices to assist heart failure and aortic pathologies, namely artificial hearts, left ventricular assist devices, stent-grafts, and artificial heart valves. Finally, we report novel setups developed to evaluate soft biological tissues for translational research.Clinical ImpactOn needs-based ex vivo monitoring of implantable devices or tissues/organs in cardiovascular simulators provides new insights and paves new paths for device prototypes. The insights gained could not only support the needs of patients, but also inform engineers, scientists and clinicians about undiscovered aspects of diseases (during routine monitoring). We analyze seminal and current work and highlight a variety of opportunities for developing preclinical tools that would improve strategies for future implantable devices. Holistically, mock circulation loop studies can bridge the gap between in vivo and in vitro approaches, as well as clinical and laboratory settings, in a mutually beneficial manner.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1278-1300"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140289451","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}

{"title":"Serration Angioplasty Is Associated With Less Recoil in Infrapopliteal Arteries Compared With Plain Balloon Angioplasty.","authors":"Arash Fereydooni, Venita Chandra, Peter A Schneider, Robert Giasolli, Michael Lichtenberg, Stefan Stahlhoff","doi":"10.1177/15266028231215284","DOIUrl":"10.1177/15266028231215284","url":null,"abstract":"<p><strong>Purpose: </strong>Recoil following balloon angioplasty of tibial arteries is a known mechanism of lumen loss and widely considered to be a contributing factor in early failure or later restenosis. The Serranator balloon has been designed to provide a controlled lumen gain while minimizing vessel injury. The objective of this study was to assess the ability to define and measure postangioplasty recoil in infrapopliteal arteries and to compare recoil after serration angioplasty and plain balloon angioplasty (POBA).</p><p><strong>Methods: </strong>This multi-center, sequential comparative study included patients with de novo or restenotic lesions of infrapopliteal arteries up to 22 cm in length. Patients were enrolled sequentially and underwent alternating POBA or serration angioplasty with Serranator. The study captured angiographic imaging at pre, immediately post, and 15-minute after angioplasty. Vessel recoil, final diameter stenosis, and dissection were compared using core laboratory analysis.</p><p><strong>Results: </strong>This study enrolled 36 patients who underwent treatment of 39 infrapopliteal lesions. There was no significant difference between Serranator (n=20) and POBA (n=19) with respect to baseline demographics and lesion characteristics. Arterial recoil (>10%) occurred in 25% of Serranator-treated lesions versus 64% in POBA-treated lesions (p=0.02. Clinically relevant recoil (>30%) was present after serration angioplasty in 10% of patients and after POBA in 53% (p=0.01). There was no significant difference in technical success (100% for both), dissection rate between Serranator (5%) and POBA (5.2%).</p><p><strong>Conclusions: </strong>Arterial recoil occurs after infrapopliteal angioplasty. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes.Clinical ImpactPrior studies have demonstrated over 90% recoil in patients after balloon angioplasty (POBA) of the infrapopliteal vessels, which significantly impacts the durability and impact of endovascular interventions in this clinical space. This study compared recoil after infrapopliteal angioplasty with serration angioplasty and POBA. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1600-1606"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138500045","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}

{"title":"Spinal Cord Protection During Thoracic and Thoracoabdominal Endovascular Aortic Repair: 5-Year Results of a Preventive Protocol Including Prophylactic Cerebrospinal Fluid Drainage in High-Risk Patients.","authors":"Ottavia Borghese, Laurent Brisard, Tom Le Corvec, Alexandra Hauguel, Guillaume Guimbretière, Blandine Maurel","doi":"10.1177/15266028231215972","DOIUrl":"10.1177/15266028231215972","url":null,"abstract":"<p><strong>Purpose: </strong>Spinal cord injury (SCI) is a devastating complication of thoracoabdominal aortic (TAA) repair. The use of prophylactic cerebrospinal fluid drainage (CSFD) as part of a protective protocol during endovascular repair is controversial. This article reports the results of the prophylactic use of CSFD as part of the of a prevention protocol implemented in 2016.</p><p><strong>Methods: </strong>Retrospective review of spinal cord outcomes (SCI rate and CSFD-related complications) in patients treated endovascularly for TAA disease at a single institution from 2016 (implementation of an institutional SCI risk reduction protocol) to 2021. Patients were classified as high risk (≥2 factors), intermediate risk (1 factor), or low risk (0 factor). Only high-risk patients without contraindications underwent a prophylactic CSFD placement.</p><p><strong>Results: </strong>One hundred eighty-one patients were analyzed (124 males; 69.6 years): 130 (69%) aneurysms (n=24 thoracic, n=28 Crawford 1-2-3, and n=78 Crawford 4/pararenal), 35 (19.9%) chronic aneurysmal dissections, and 16 (8.8%) acute complicated type B dissections. Interventions were staged in 31 (17.2%) cases, and consisted of 74 (41%) Thoracic EndoVascular Aneurysm Repair (TEVAR) and 107 (59%) Fenestrated Branched EndoVascular Aneurysm Repair (F-BEVAR). Sixty-nine (38.1%) patients were identified as being at high risk of SCI and CSFD was used prophylactically in 64 of them (4 failures and 1 contraindication). Spinal cord injury occurred in 8 cases (4 paraparesis, 4 paraplegias including 2 permanent), of which 3 had a prophylactic CSFD and 5 underwent rescue drainage. In addition, 4 patients developed SCI related to prophylactic CSFD (intradural hematoma), resulting in 1 paraparesis and 3 paraplegias. Other CSFD-related complications were mild (6) or moderate (2), for a total of 12 complications (17%). Factors associated with major drain complications were: curative anticoagulation 36 hours after drain removal (n=1), multiple punctures (n=1), platelet count <100 000 at drain removal (n=1), and bipolar disorder (n=2). Overall, 4 patients had permanent paraplegia and 1 had sphincter dysfunction at the last follow-up. Mean follow-up was 17 months. Mortality was 4.4% at 30 days and 13.3% at 18 months, including 3 (1.6%) aortic-related deaths.</p><p><strong>Conclusions: </strong>With the protocol we used to protect the spinal cord, we report results comparable with the SCI literature and highlight the risks associated with prophylactic CSFD use, which requires a better understanding of contraindications.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1654-1665"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138812530","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}

{"title":"Outcomes of Clampless Real Chimney Technique with Dacron Graft and Sleeve Banding of the Ascending Aorta for Total Debranching Endovascular Arch Repair.","authors":"Sohei Matsuura, Manabu Motoki, Atsushi Akai, Masaaki Kato","doi":"10.1177/15266028231219214","DOIUrl":"10.1177/15266028231219214","url":null,"abstract":"<p><strong>Background: </strong>Hybrid aortic arch repair with debranching of the supra-aortic vessels carries a high risk of cerebral infarction and fatal complications associated with side clamping of the ascending aorta. A previous study had reported the \"real chimney\" technique, a novel method for clamp-free total debranching thoracic endovascular aortic repair with the ascending aortic sleeve banding with dacron. In this study, we aim to build upon this foundation by presenting our experience with the early and midterm outcomes of this technique.</p><p><strong>Methods: </strong>We retrospectively reviewed the medical records of 61 consecutive older adult patients with aortic arch pathologies and a high risk of open repair who underwent total debranching thoracic endovascular aortic repair using the real chimney technique at our institution between January 2014 and June 2022. This technique was used to anastomose the ascending aorta with the main trunk of the triple-branched prosthetic graft.</p><p><strong>Results: </strong>The mean patient age was 75.1 years, and 54% of patients were transferred from medical facilities with cardiothoracic surgery departments. The comorbidities included chronic obstructive pulmonary disease (49.2%), chronic kidney disease (63.9%), coronary artery disease (27.9%), and history of stroke (31.1%). No 30-day mortality was observed. Complications included postoperative renal failure requiring permanent hemodialysis (4; 6.6%), stroke (modified Rankin scale score: ≥2 in 5; 8.2%), permanent paraplegia (1; 1.6%), and permanent paraparesis (4; 6.6%). The median follow-up period was 40.5±28.5 months. The postoperative survival rates at 5 years were 66.8%. No patients experienced complications associated with the aorta or anastomosis site; only 1 patient required an additional procedure for stenosis of the anastomosis site (midterm). An aneurysmal diameter reduction of ≥3 mm was observed in 37 cases (60.7%), and the mean aneurysmal diameter reduction was 5.3 mm.</p><p><strong>Conclusions: </strong>The postoperative outcome of total debranching thoracic endovascular aortic arch repair is not only acceptable but also promising, particularly in patients at high risk of open repair.Clinical ImpactOur novel real chimney technique for total debranching thoracic endovascular aortic repair of aortic arch pathologies in patients who were at a high-risk for open repair resulted in no 30-day mortality and no complications related to the aorta or the real chimney anastomosis site.The real chimney technique is effective for managing aortic arch pathologies and enables less invasive total debranching thoracic endovascular aortic arch repair without the need for extracorporeal circulation and clamping of the ascending aorta.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1690-1698"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12433521/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138812516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pelvic AVM Embolization: A Tricky Affair-Multicenter Retrospective Experience.","authors":"Maciej Szmygin, Francesco Giurazza, Pierre De Marini, Tomasz Jargiełło, Krzysztof Pyra","doi":"10.1177/15266028231221977","DOIUrl":"10.1177/15266028231221977","url":null,"abstract":"<p><strong>Purpose: </strong>Pelvic arteriovenous malformations (pAVMs) are congenital or acquired vascular anomalies, presenting with hematuria, menometrorrhagia, pelvic pain, and varices; they can be life-threatening in case of rupture. Surgical therapies have been proposed but endovascular embolization has been recognized as the primary modality. The aim of this article was to report a retrospective multicenter experience concerning embolization of pelvic AVMs and provide literature overview.</p><p><strong>Materials and methods: </strong>We describe 18 patients (14 female and 4 male) diagnosed with pAVM and treated with minimally invasive methods. The pre-procedural imaging evaluation was based on transpelvic and/or transvaginal color Doppler ultrasound, contrast-enhanced computed tomography, and/or magnetic resonance. In 3 cases, the malformation was congenital and in other 15, acquired. Most common symptoms were menometrorrhagia, hematuria, pelvic pain and pressure, and heaviness in the lower abdominal region. In 10 cases (56%), only 1 procedure was required. Eight patients underwent multistage treatment.</p><p><strong>Results: </strong>Complete occlusion of the lesion in post-procedural angiography was observed in 12 patients (67%). No major periprocedural complications were observed. In 14 cases (78%), both satisfactory embolization and significant clinical improvement was achieved in long-term follow-up. Sixteen patients (88%) were at least satisfied with the clinical outcome. One patient reported subsequent successful pregnancy 5 years after the treatment.</p><p><strong>Conclusion: </strong>Hemodynamics of pAVM are variable and thorough understanding of the vessel anatomy is crucial in planning and choosing proper treatment. Both transarterial and percutaneous direct puncture embolization strategies appear safe, technically feasible, and clinically effective.Clinical ImpactIn this manuscript, we discuss the role of interventional radiology methods in the treatment of pelvic arteriovenous malformations along with its advantages, limitations and possible complications. In addition to this, we review the current literature and confront our findings with those made by other authors. We believe that modern endovascular methods offer safe and reliable alternative for traditional surgical therapy and should be therefore considered during multidisciplinary treatment of these patients.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1717-1723"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139099113","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}

{"title":"Systematic Review and Meta-analysis of Short-term and Mid-term Outcomes After Use of t-Branch Off-the-shelf Multibranched Endograft for Elective and Urgent Treatment of Thoracoabdominal Aortic Aneurysms.","authors":"Yonghui Chen, Zongwei Liu, Shuaishuai Wang, Mario D'Oria, Xiaoxing Zhang, Jiaxue Bi, Dongsheng Cui, Xiangchen Dai","doi":"10.1177/15266028231220322","DOIUrl":"10.1177/15266028231220322","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To conduct a meta-analysis to assess the safety and efficacy of t-Branch off-the-shelf multibranched endograft for the treatment of thoracoabdominal aortic aneurysm (TAAA).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data sources: &lt;/strong&gt;PubMed, Embase, and Web of Science.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Review methods: &lt;/strong&gt;Online databases were searched from June 2012 to March 2023. The data were pooled together using a random-effects model of proportions. The outcomes overall included technical success, spinal cord ischemia, target vessel occlusion, type I or III endoleak, reintervention, early mortality (30-day), and mid-term outcomes. Subgroup meta-analyses and meta-regression were performed to explore variation among studies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 15 studies containing 1238 patients were included in the meta-analysis. The overall study quality assessment was found to be moderate to good. The pooled technical success was 97.0% (95% confidence interval [CI]=95.5-98.6, &lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt;=53.01%, 1185/1238 cases, 15 studies). Overall, early mortality was 7.3% (95% CI=4.4-10.1, &lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt;=74.48%, 124/1238 cases, 15 studies). Early spinal cord ischemia was 13.4% (95% CI=9.6-17.2, &lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt;&lt;i&gt;=&lt;/i&gt;67.24%, 160/1238 cases, 15 studies), and early type I or III endoleak was 6.0% (95% CI=3.4-8.5, &lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt;=53.71%, 68/1032 cases, 9 studies). Mid-term outcomes showed target vessel occlusion was 4% (95% CI=1.4-6.5, &lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt;=65.18%, 28/528 cases, 10 studies, 5-21.2 months), type I or III endoleak was 4.7% (95% CI=2-7.5, &lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt;=49.74%, 38/512 cases, 10 studies, 5-21.2 months), reintervention was 11.2% (95% CI=8.1-14.3, &lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt;=31.06%, 85/650 cases, 10 studies, 5-21.2 months), and pooled mortality was 13.9% (95% CI=7.2-20.7, &lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt;&lt;i&gt;=&lt;/i&gt;76.32%, 84/550 cases, 11 studies, 5-21.2 months). Meta-regression found a significant linear association between higher technical success and earlier publication year (p=0.014) and studies with anatomic inclusion criteria (p=0.037). Urgent patients (p=0.021) and later publication year (p=0.048) were significantly associated with higher early mortality.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The use of the off-the-shelf t-Branch multibranched endograft for elective or urgent endovascular TAAA repair is associated with high technical success rates and proved to be safe and effective at early and mid-term follow-up. However, the heterogeneity between the included studies is high, and prospective, randomized studies along with future larger studies with long-term follow-up are needed.Clinical ImpactThe Zenith t-Branch (Cook Medical, Bloomington, Ind) was approved as a commercially available device in Europe in June 2012. Although a decade has past, the outcomes of t-Branch have rarely been synthesized at the global level. This meta-analysis included 15 studies containing 1238 patients. The meta-analyses included technical success, major","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1360-1373"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139075718","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}

{"title":"The Effect of Smoking on the Activated Clotting Time and the Incidence of Complications in Noncardiac Arterial Procedures.","authors":"Liliane C Roosendaal, Tristan E K van Os, N van Es, M Hoebink, Arno M Wiersema, Jan D Blankensteijn, Vincent Jongkind","doi":"10.1177/15266028231207027","DOIUrl":"10.1177/15266028231207027","url":null,"abstract":"<p><strong>Purpose: </strong>Smoking is a well-known risk factor for developing arterial diseases and for an increase of complications during and after vascular procedures. Although smoking has a proven effect on hemostasis, no literature is available on the effect of smoking on the activated clotting time (ACT), which is used to monitor the effect of heparin during noncardiac arterial procedures (NCAP). The aim of this study was to examine the effect of smoking on ACT values and the incidence of complications during the same admission or 30 day follow-up of NCAP.</p><p><strong>Materials and methods: </strong>A post hoc analysis of a prospective multicenter cohort study was performed. Patients older than 18 years, who underwent NCAP between December 2016 and April 2021, were enrolled. Patients were divided into 2 groups based on smoking status: never/former smokers and current smokers. Two heparin dosing protocols were used: an initial bolus of 5000 IU or 100 IU/kg bodyweight.</p><p><strong>Results: </strong>In total, 773 patients met the inclusion criteria. Five minutes after administration of 5000 IU of heparin, mean ACT values were 190 and 196 seconds for nonsmokers and smokers, respectively (p=0.078). After 100 IU/kg of heparin, mean ACT values were 229 and 226 seconds for nonsmokers and smokers, respectively (p=0.37). Incidence of complications in the whole study cohort was not significantly different for nonsmokers compared with smokers (arterial thrombo-embolic complication [ATEC] 4.7% vs 5.7% p=0.55; hemorrhagic complications 15% vs 18% p=0.29). In subgroup-analysis, a significant difference between smoking groups was found for hemorrhagic complications after open aneurysm repair (p=0.024). However, after adjusting for confounders, the difference between the smoking groups annulled.</p><p><strong>Conclusion: </strong>The results of this study suggest that smoking does not have a significant effect on ACT values or on the incidence of complications in NCAP. Large-scale studies are required to further analyze potential factors having an effect on the ACT and perioperative and postoperative complications, which could help individualize heparinization strategy.Clinical impactThere is high variance between patients in their response on administration of heparin, this is not yet fully understood. This study investigated the effect of smoking in a large prospective multicentre cohort. The results suggests that active smoking does not have an effect on the activated clotting time after administration of heparin. Also no significant effect of smoking could be found on the incidence of all registered complications. Monitoring of the effect of heparin remains important to provide patients with safe anticoagulation during vascular procedures.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1440-1447"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12433525/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54231981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database.","authors":"Aida Ahrari, Gerard M Healy, Adam Min, Fahd Alkhalifah, George Oreopoulos, Kong Teng Tan, Arash Jaberi, Dheeraj K Rajan, Sebastian Mafeld","doi":"10.1177/15266028231219226","DOIUrl":"10.1177/15266028231219226","url":null,"abstract":"<p><strong>Purpose: </strong>Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed.</p><p><strong>Materials and methods: </strong>Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system.</p><p><strong>Results: </strong>There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%).</p><p><strong>Conclusions: </strong>The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered.Clinical ImpactOur study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1508-1516"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12433524/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138812526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multimodal Prehabilitation for Patients Undergoing Endovascular Aortic Aneurysm Repair Surgery: A Feasibility Study.","authors":"Miquel Coca-Martinez, Jade St-Pierre, Elie Girsowicz, Robert J Doonan, Daniel I Obrand, Jason P Bayne, Oren K Steinmetz, Kent S Mackenzie, Francesco Carli, Graciela Martinez-Palli, Heather L Gill","doi":"10.1177/15266028231219674","DOIUrl":"10.1177/15266028231219674","url":null,"abstract":"<p><strong>Background: </strong>Elective treatment options for aortic abdominal aneurysms include open repair or the less-invasive endovascular aortic aneurysm repair (EVAR). Recovery from EVAR is generally considered easier and faster than open repair. Despite this, EVAR remains a major procedure, and average return to preoperative quality of life is at least 3 months. The purpose of this study is to determine the safety and feasibility of multimodal prehabilitation, a multidisciplinary preoperative optimization intervention, in patients undergoing EVAR and its impact on perioperative functional capacity and quality of life.</p><p><strong>Methods: </strong>Candidates for EVAR with an infra-renal abdominal aortic aneurysm <7.5cm were invited to participate in a 6-week multimodal prehabilitation program that included (1) supervised and home-based exercise, (2) nutritional support, (3) psychosocial support, and (4) smoking cessation. Functional capacity and quality of life were assessed at baseline, before surgery and 6 weeks postoperatively. Recruitment rate, safety, and compliance were also assessed.</p><p><strong>Results: </strong>A total of 24 patients were included, 17 males (70%) and 7 females (30%). No adverse events occurred during the program. Compliance to each component of the program (median [Q1-Q3]) was 66% [67] for supervised training, 100% [67] for home-based training, and 100% [100] for nutrition. The multimodal prehabilitation program elicited a significant increase in functional capacity and quality of life preoperatively.</p><p><strong>Conclusion: </strong>Multimodal prehabilitation for patients awaiting EVAR is feasible and safe. Multimodal prehabilitation improves both functional capacity and quality of life preoperatively. Further research is needed to assess the impact of multimodal prehabilitation on postoperative quality of life and functional capacity.Clinical ImpactMultimodal prehabilitation is safe and feasible in patients awaiting endovascular aneurysm repair. The importance of this finding is that multimodal prehabilitation can be safely delivered preoperatively in patients awaiting EVAR. Although further research is needed, multimodal prehabilitation seems to improve preoperative functional capacity and quality of life. This could have an impact for the future implementation of prehabilitation interventions in order to increase functional reserve and quality of life preoperatively so that this high-risk population can cope better with the surgical stress and return to their normal life faster postoperatively.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1681-1689"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139075717","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}

{"title":"A New Method for Common Femoral Arterial Access Using a Mixed Reality-Assisted Technique on a Phantom Model.","authors":"Johannes Hatzl, Daniel Henning, Niklas Hartmann, Dittmar Böckler, Christian Uhl","doi":"10.1177/15266028231208640","DOIUrl":"10.1177/15266028231208640","url":null,"abstract":"<p><strong>Purpose: </strong>The purpose of this study was to investigate the technical feasibility and usability of a mixed reality (MiR)-assisted common femoral arterial (CFA) access technique using a sonography-assisted registration method.</p><p><strong>Materials and methods: </strong>A total of 60 CFA punctures were performed on a phantom model by 2 observers. Thirty punctures were performed using MiR (MiR group) and 30 punctures were performed using a conventional sonography-guided access procedure (control group). In the MiR group, a virtual object was created based on a computed tomography (CT) angiography scan of the model and registered to the physical patient in an MiR environment utilizing a software prototype that allowed registration based on a sonography scan. Positional error assessment encompassed 4 measurements using cone beam CT scans: (1) distance of the needle tip to the centerline, (2) distance of the needle entry site from the mid-level of the ostium of the profound femoral artery, (3) angle of entry of the needle in coronal, and (4) sagittal planes. Technical success rates as well as positional errors were compared between both groups. In addition, the usability of the system was assessed according to the system usability scale (SUS).</p><p><strong>Results: </strong>Technical success was 96.7% and 100% in the MiR and control groups, respectively. The median distance between the needle tip and the centerline was 3.0 (interquartile range [IQR]: 2.0-4.6) in the MiR group and 3.2 mm (IQR: 2.3-3.9) (p=0.63) in the control group. Similarly, the median distance from the needle entry site to the mid-level of the ostium of the profound femoral artery was 3.0 mm (IQR: 2.0-5.0) in the MiR group and 4.5 mm (IQR: 2.0-7.8) (p=0.18) in the control group. The median coronal angles of needle entry were 7.5° (IQR: 6-11) and 6° (IQR: 2-12) (p=0.13), and the median sagittal angles were 50° (IQR: 47-51) and 51° (IQR: 50-55) (p<0.01) in the MiR and control groups, respectively. The mean SUS score provided by both observers was 51.3.</p><p><strong>Conclusion: </strong>The feasibility of an MiR-assisted CFA access technique could be demonstrated on a phantom model. Further studies are needed to investigate the technique beyond phantom model experiments and in different anatomical settings.Clinical ImpactThis study demonstrates the technical feasibility of a Mixed-Reality-assisted common femoral arterial access procedure on a phantom model. The positional accuracy was comparable to a conventional sonography-guided technique. However, there are several limitations that need to be resolved prior to potential implementation into clinical practice. Further studies are needed to investigate its performance beyond phantom model experiments and the prototypical application requires further technical refinement to increase its usability.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"1259-1266"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12433519/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71428612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}