Journal of Endovascular Therapy最新文献

{"title":"The Fate of False Lumen in Type B and Residual Type A Aortic Dissection Using the Candy-Plug Technique: A Systematic Review and Meta-Analysis.","authors":"Georgios I Karaolanis, Konstantinos Kotopoulos, Rosalinda D'Amico, Drosos Kotelis, Edin Mujagic, Vladimir Makaloski","doi":"10.1177/15266028251344808","DOIUrl":"https://doi.org/10.1177/15266028251344808","url":null,"abstract":"<p><strong>Objective: </strong>We performed a systematic review and meta-analysis to evaluate the technical and clinical success of false lumen occlusion with the Candy-plug (CP) technique in patients with type B and residual type A aortic dissection.</p><p><strong>Materials and methods: </strong>A systematic search of all the literature reported until November 2024 was performed according to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. The pooled technical and clinical success and corresponding 95% confidence intervals (CIs) were estimated using fixed or random effect methods.</p><p><strong>Results: </strong>A total of 106 study titles were identified by the initial search strategy, of which 6 were considered eligible for inclusion in the meta-analysis. A total of 128 patients (83% male) were identified among the eligible studies. The pooled technical and clinical success rate among the studies were 96% (95% CI, 88-98) and 76% (95% CI, 58-88) respectively. The technical success for custom-made manufacturing device (CMD) was 98.5% (95% CI, 92-99; <i>I</i><sup>2</sup>=0%; p=0.78, 2 studies) while for the physician modified CP technique (pmCP) technique was 92.7% (95% CI, 77-98; <i>I</i><sup>2</sup>=0%; p=0.79, 4 studies). Overall, false lumen thrombosis rate was 71% (95% CI, 55-83): 80% (95% CI, 57-92; <i>I</i><sup>2</sup>=0%; p=0.90, 2 studies) for CMD while for the pmCP technique was 63% (95% CI, 27-88; <i>I</i><sup>2</sup>=0%; p=0.99, 4 studies). The pooled aortic remodeling rate was 50% (95% CI, 33-66): 63.2% (95% CI, 52.7-72.5; <i>I</i><sup>2</sup>=69%; p=0.68, 2 studies) for CMD, while for the pmCP technique was 35.9% (95% CI, 17-54%; <i>I</i><sup>2</sup>=39%; p=0.17, 4 studies). The incidence of CP related reinterventions were 7.1% [11.5% for CMD (95% CI, 0.3-8.4; <i>I</i><sup>2</sup>=0%; p=0.09, 2 studies) and 5.1% for pmCP (95% CI, 1.3-18; <i>I</i><sup>2</sup>=0%; p=0.96, 4 studies)] and 12.8% [4.5% for CMD (95% CI, 0.3-39; <i>I</i><sup>2</sup>=69%; p=0.68, 2 studies), while for the pmCP technique was 4.6% (95% CI, 0.9-19; <i>I</i><sup>2</sup>=0%; p=0.90, 4 studies)] in the early and late period.</p><p><strong>Conclusion: </strong>CP technique appears to be a promising solution demonstrating high technical success, false lumen thrombosis, and aortic remodeling rate. However, the clinical success rate tends to be lower. Life-long and strict follow-up of these patients may be necessary to monitor CP-related complications, given the limited data on the long-term durability of these devices.Clinical ImpactThis study provides detailed information on a physician-modified candy plug technique in patients with patent False lumen in Type B or residual Type A aortic dissection. As the custom-made candy plug devices have been developed, the delivery time for them varies between countries and vascular surgery services, making the planning of the procedure difficult, especially in symptomatic patients or ","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251344808"},"PeriodicalIF":1.7,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144303468","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 Terumo Aortic Global Endovascular Registry: A Multiarm, Multicenter, Open Label, Prospective Observational Registry to Obtain Safety and Performance Data on off-the-Shelf and Custom-Made Stent-Grafts.","authors":"Michel M P J Reijnen, Bartosz Rylski, Antoine Millon, Robert H Geelkerken, Alexander Hyhlik-Dürr, Arjan W J Hoksbergen, Pierfrancesco Veroux, Ernst Weigang, Jörg Tessarek, Vincent Riambau","doi":"10.1177/15266028251344790","DOIUrl":"https://doi.org/10.1177/15266028251344790","url":null,"abstract":"<p><strong>Background: </strong>Approval of medical devices is typically based on data from relatively small clinical studies with a highly selected patient population. Postmarket surveillance is required by regulatory bodies after approval to collect and evaluate experience gained from real world use in larger and unselected populations. Terumo Aortic is a manufacturer of off-the-shelf and custom-made stent-grafts for endovascular repair of thoracic and abdominal aortic pathologies and is assessing device performance in a large registry.</p><p><strong>Methods: </strong>A multiarm, multicenter, open label, prospective observational registry designed to obtain both short- and long-term safety and performance data on the use of standard and custom-made Terumo Aortic endovascular devices in patients with thoracic and abdominal aortic pathologies. Eligibility requirements are minimal, and a standard-of-care protocol will ensure real-world evidence is collected as far as 10 years.</p><p><strong>Discussion: </strong>Challenges to this research reflect its real-world nature such as differences in standard of care between centers and geographies, varying levels of experience and expertise with the devices or techniques, all-comer populations that may not always be comparable, and a design specifically limited to a single manufacturer. Advantages of this registry design include long-term follow-up, different modules to collect standardized outcomes across pathologies and global reach to reflect practice in many different geographies with a wide range of latest-generation endovascular devices.</p><p><strong>Conclusion: </strong>This protocol is a large endovascular registry of all aortic pathologies that are treated by both off-the-shelf and custom-made Terumo Aortic products. It is ambitious in scope and projection and will be part of an overall response involving patients, physicians, and manufacturers to answer the remaining questions of endovascular aortic repair, contribute to continuing improvement of the techniques and technologies, and present an accurate picture of outcomes with latest generation stent-graft devices.Clinical ImpactThis large, long-term registry will generate robust real-world evidence on the safety and performance of both standard and custom-made Terumo Aortic endovascular devices in treating thoracic and abdominal aortic pathologies. By including a broad, minimally selected patient population across diverse global centers, the study mirrors everyday clinical practice and helps bridge the gap between clinical trials and real-world outcomes. Its findings will inform clinical decision-making, support regulatory compliance, and guide ongoing device development. Ultimately, the registry aims to enhance patient care by improving the understanding of endovascular treatment effectiveness and long-term durability in heterogeneous populations.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251344790"},"PeriodicalIF":1.7,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144303469","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":"Primary Drug-Coated Balloon Versus Drug-Eluting Stent for Native Atherosclerotic Femoropopliteal Lesions: An Updated Systematic Review and Meta-Analysis.","authors":"Alessio Mario Cosacco, Gladiol Zenunaj, Pierfilippo Acciarri, Aaron Thomas Fargion","doi":"10.1177/15266028251344877","DOIUrl":"https://doi.org/10.1177/15266028251344877","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the clinical outcomes after endovascular treatment of native femoropopliteal lesions with a drug-coated balloon (DCB) and drug-eluting stent (DES) as a primary option in patients with symptomatic peripheral artery disease.</p><p><strong>Materials and methods: </strong>A comprehensive literature search was performed through PubMed and Embase databases. Studies written in the English language and reporting a direct comparison of the outcomes between primary angioplasty with DCB and primary stenting with DES were included. The endpoints were considered the primary patency (PP), clinical-driven target lesion revascularization (cdTLR), major adverse limb events (free-MALE), and freedom from all-cause mortality.</p><p><strong>Results: </strong>Eleven studies were considered eligible for the metanalysis (3 randomized clinical trials and 8 cohort studies). Overall, 3231 femoropopliteal lesions in 3137 patients were included, with DCB and DES performed in 1951 and 1280 lesions, respectively. No differences were found in demographics, clinical limb presentation, lesions length [173.9±80.2 mm DES vs 195.1±103.3 mm DCB; odds ratio (OR) -2.44; 95% confidence interval (CI) -11.26 to 6.38; p=0.59] and total occlusions (OR 1.41; 95% CI 0.87-2.27; p=0.16). In the DCB group, there was a significant rate of adjunctive procedures such as atherectomy and bailout stenting OR 0.13 (95% CI 0.09-0.18; p<0.001). No differences among PP, cdTLR, free-MALE and freedom from all-cause mortality at 1 year for DCB and DES: OR 1.11 (95% CI 0.74-1.66, p=0.61); OR 1.01 (95% CI 0.72-1.41, p=0.97); OR 1.08 (95% CI 0.69-1.69, p=0.74) and OR 1.85 (95% CI 0.82-4.17, p=0.14) respectively. No differences were found at 2 years: OR 0.89 (95% CI 0.64-1.23, p=0.47); OR 0.79 (95% CI 0.49-1.27, p=0.32); OR 0.74 (95% CI 0.49-1.10, p=0.14); OR 1.21 (95% CI 0.75-1.96, p=0.44) respectively.</p><p><strong>Conclusions: </strong>Both approaches proved to be effective and safe for treating complex femoropopliteal lesions, with comparable clinical outcomes between the 2 groups. In the DCB arm, adjunctive procedures such as atherectomy and bailout stenting were required to optimize the results.Clinical ImpactThe introduction of drug-coated technologies, such as drug-coated balloons (DCBs) and drug-eluting stents (DESs), has significantly improved clinical outcomes for native femoropopliteal lesions. However, despite ongoing advancements in drug-coated device technology, the optimal treatment approach remains unclear due to limited comparative data in the literature. This meta-analysis aims to bridge this gap by reviewing current evidence, highlighting the latest developments, and providing valuable insights that may aid clinical decision-making in the management of native femoropopliteal lesions.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251344877"},"PeriodicalIF":1.7,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144286993","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":"Corrigendum to \"A cost-consequence analysis comparing balloon-expandable covered stents for the management of aortoiliac occlusive disease\".","authors":"","doi":"10.1177/15266028251348788","DOIUrl":"https://doi.org/10.1177/15266028251348788","url":null,"abstract":"","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251348788"},"PeriodicalIF":1.7,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144250618","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":"Endovascular Treatment of Abdominal Aortic Aneurysm Using a Branched Stent-Graft With Perfusion of the Adamkiewicz Artery.","authors":"Antoni Wołoszyn, Piotr Kasprzak, Małgorzata Toroń, Wacław Kuczmik","doi":"10.1177/15266028251344785","DOIUrl":"https://doi.org/10.1177/15266028251344785","url":null,"abstract":"<p><strong>Introduction: </strong>Exclusion of long aortic segments in the treatment of endovascular thoracoabdominal aortic aneurysms is associated with a higher risk of spinal cord ischemia. We present the successful implantation of a branch stent graft with perfusion of the great Adamkiewicz artery to diminish risk of paraplegia.</p><p><strong>Case description: </strong>An 81-year-old man was diagnosed with a perirenal aneurysm of the abdominal aorta (64 mm). Imaging examination revealed an Adamkiewicz artery with a diameter of 4.5 mm. Endovascular treatment was conducted using a customized branched stent graft with an additional branch to the Adamkiewicz artery, with access via the right femoral artery and the left axillary artery. After embolization of the inferior mesenteric artery, a stent graft was implanted, maintaining patency of the renal arteries, Adamkiewicz artery and visceral vessels.</p><p><strong>Discussion: </strong>This case demonstrates the effectiveness of personalized stent grafts adapted to the patient's anatomy. The stent graft used, with a branch to the Adamkiewicz artery, allowed the aneurysm to be excluded from the circulation while maintaining spinal cord perfusion.</p><p><strong>Conclusion: </strong>In our opinion, such a solution should be considered in cases of extensive aortic aneurysms involving the large Adamkiewicz artery treated with branched endovascular aneurysm repair.Clinical ImpactPresented case illustrates the potential of customized stent-grafts, which can be adapted to the patient's anatomy. Spinal cord ischemia remains a significant complication of endovascular repair of aortic aneurysms. A prosthesis providing adequate perfusion of the Adamkiewicz artery may prove an additional method of preventing paraplegia. There is a paucity of literature on the repair of aortic aneurysms with the implantation of branched stent grafts with a branch into the Adamkiewicz artery, which serves to highlight the innovation of our treatment. The presented case offers new insights into the prevention of paraplegia with branched endovascular aneurysm repair procedures.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251344785"},"PeriodicalIF":1.7,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144217428","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":"Comparing the Safety and Feasibility of Endovascular Therapy via Transradial and Transfemoral Approaches in Patients with Aortoiliac Occlusive Disease: A Propensity Score-Matched Analysis of the Nationwide Registry.","authors":"Kazunori Horie, Mitsuyoshi Takahara, Osamu Iida, Shun Kohsaka, Tatsuya Nakama, Toshiro Shinke, Norio Tada, Tetsuya Amano, Ken Kozuma","doi":"10.1177/15266028231187625","DOIUrl":"10.1177/15266028231187625","url":null,"abstract":"<p><strong>Purpose: </strong>Our objective was to evaluate the feasibility of performing endovascular therapy (EVT) for aortoiliac artery disease using transradial approach (TRA) as compared to transfemoral approach (TFA).</p><p><strong>Methods: </strong>We analyzed 9671 cases with symptomatic lower extremity artery disease due to aortoiliac occlusive disease (AIOD) treated using EVT from a Japanese Nationwide EVT Registry between January and December 2021. We compared the baseline characteristics, procedural information, and 30-day outcomes of patients who received EVT only via TRA (n=863 [16.9%]) and those only via TFA (n=4255 [83.1%]) by using propensity score (PS) matching, after excluding those who required regular dialysis, those who underwent hybrid surgeries, and those who received EVT through 2 or more approach sites.</p><p><strong>Results: </strong>After matching, the final study population consisted of 862 matched patients with similar baseline characteristics in each group. Technical success rate was comparable between the 2 groups (99.3% vs. 99.3%, p>0.99). No significant differences were observed with respect to the composite of all-cause death within 48 hours after EVT and post-procedural complications within 30 days, including severe bleeding that required transfusion, revascularization procedures, urgent surgeries, cerebral infarction, and major limb amputation (0.2% vs. 0.7%, p=0.29). Transradial approach was associated with shorter operation time (85 vs. 90 minutes, p=0.016), but longer fluoroscopy time (26 vs. 20 minutes, p<0.001) and higher contrast agent volume (80 vs. 75 mL, p<0.001).</p><p><strong>Conclusion: </strong>After PS matching, TRA showed the comparable rates of successful EVT and 30-day complications in patients with AIOD compared to TFA. Transradial approach was found to be safe and be a viable alternative of TFA for the treatment of AIOD.Clinical ImpactThe efficacy of transradial approach (TRA) is established in percutaneous coronary intervention; however, its safety and feasibility are unclear in endovascular therapy (EVT). We analyzed 9,671 cases with symptomatic aortoiliac occlusive disease treated using EVT from a Nationwide Registry to compare the 30-day outcomes of those who received EVT only via TRA (n = 863 [16.9%]and those only via TFA (n=4,255 [83.1%]) by using propensity score matching. Technical success rate (99.3% vs. 99.3%, p > 0.99) and 30-day complications (0.2% vs. 0.7%, p = 0.29) were comparable between the two groups. EVT via TRA could be performed safely.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"756-765"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9846322","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":"Physician Modification of a Custom-Made Fenestrated Endograft By Closure of a Fenestration With Bovine Patch.","authors":"D Becker, A Ali, C Prendes, K Stavroulakis, J Stana, N Tsilimparis","doi":"10.1177/15266028231187749","DOIUrl":"10.1177/15266028231187749","url":null,"abstract":"<p><strong>Purpose: </strong>Ruptured mycotic pararenal aortic aneurysms are rare and serious condition that requires prompt treatment. Open surgery with aortic resection and in-situ or extra-anatomic reconstruction is the standard treatment. The aim of this technical note is to report urgent endovascular treatment using a readily available custom-made device (created for another patient), with a back-table modification using pericardium patch and a new fenestration.</p><p><strong>Technique: </strong>In preoperative measurements on centerline-based workstation, aortic diameter in proximal and distal landing zone and target vessel position matched the measurements of graft plan of custom-made device (CMD) besides left renal artery. To address current patient`s anatomy, closure of the nonsuitable fenestration with pericardial patch and creation of new fenestration (1 cm above and 1:15 hours posterior to original fenestration) for the respective target vessel have been performed. Postoperative computed tomography angiography (CTA) scan showed complete exclusion of aneurysm, perfused target vessels, and no endoleak. Under resistance-based antibiotic therapy, the patient was asymptomatic and showed normal infection parameters in blood samples postoperatively.</p><p><strong>Conclusion: </strong>In the hands of an experienced endovascular aortic surgeon modification of a custom-made device is a quick and feasible technique in this emergency situation. Long-term follow-up must confirm the durability and reliability of this new technique.</p><p><strong>Clinical impact: </strong>The described technique of modification of a custom-made endograft can provide an alternative endovascular treatment option for urgent complex abdominal aortic pathologies. Compared to the current available treatment modalities, like physician modified endografts, off-the-shelf branched devices, parallel grafts and in-situ fenestration, it can save considerable time and provides reasonable sealing in ruptured cases. The technique offers a valuable add-on to the armamentarium of experienced endovascular physicians.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"645-652"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089663/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9831443","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":"Pulsatile Deformations of a Conformable Descending Thoracic Aortic Endograft in Aneurysm, Dissection, and Blunt Traumatic Aortic Injury Patients.","authors":"Christopher P Cheng, Ga-Young Suh, Sina L Moainie, Jordan R Stern, Wilson Y Szeto","doi":"10.1177/15266028231187741","DOIUrl":"10.1177/15266028231187741","url":null,"abstract":"<p><strong>Purpose: </strong>This study presents analytic techniques to quantify cardiac pulsatility-induced deformations of thoracic aortic endografts in patients with thoracic aortic aneurysm (TAA), dissection (TAD), and blunt thoracic aortic injury (BTAI) after thoracic endovascular aortic repair (TEVAR).</p><p><strong>Technique: </strong>We analyzed 19 image data sets from 14 patients treated for TAA, TAD, and BTAI with cardiac-gated post-TEVAR CTs. Systolic and diastolic geometric models were constructed and diametric, axial, and bending deformations were quantified. For patients with cardiac-gated pre-op scans, the damping of pulsatile diametric distension was computed. Maximum localized diametric distension was 2.4±1.0%, 4.2±1.7%, and 5.5±1.6%, and axial deformation was 0.0±0.1%, -0.1±0.3%, and 1.1±0.6% in the endografts of TAA, TAD, and BTAI cohorts, respectively. Diametric distension damping from pre- to post-TEVAR was ~50%. Diametric and bending deformations were localized at certain axial positions on the endograft, and the inner curve bends more than the centerline, especially adjacent to overlapping regions.</p><p><strong>Conclusion: </strong>The presented techniques support investigation of multi-axial endograft deformations between disease causes and geometric locations on the device. Discretized quantification of deformation is needed to define device fatigue testing conditions and predict device durability in patients.Clinical ImpactThis study demonstrates analytic techniques to quantify discretized deformation of thoracic endografts. Cardiac-resolved computed tomography is sometimes acquired for surgical planning and follow-up, however, the dynamic data are not typically used to quantify pulsatile deformations. Our analytic techniques extract the centerline and surface geometry of the stented thoracic aorta during the cardiac cycle, which are used to quantify diametric, axial, and bending deformations to provide better understanding of device durability and impact on the native anatomy.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"653-659"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9858022","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":"Impact of Hospital Volume on Long-Term Outcomes After Endovascular Therapy for Peripheral Artery Disease.","authors":"Nao Setogawa, Hiroyuki Ohbe, Hiroki Matsui, Hideo Yasunaga","doi":"10.1177/15266028231198206","DOIUrl":"10.1177/15266028231198206","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the association between annual hospital volume of endovascular therapy (EVT) and long-term outcomes in patients with lower-extremity peripheral artery disease (PAD).</p><p><strong>Materials and methods: </strong>We identified patients who underwent percutaneous endovascular transluminal angioplasty and thrombectomy of the extremities or percutaneous endovascular removal in the Japanese Diagnosis Procedure Combination inpatient database from April 2014 to March 2020 linked to the Survey of Medical Institutions data. A generalized linear model analysis was performed to assess 12-month amputation, all-cause death, composite outcome (amputation and death), and readmission. We also analyzed length of hospital stay and total health care costs during the first hospitalization.</p><p><strong>Results: </strong>Among 127 486 eligible patients, 31 579, 31 913, 31 999, and 31 995 were in the first (1-27 cases/year), second (28-44 cases), third (45-67 cases), and fourth (68-289 cases) quartiles, respectively. There were no significant differences in 12-month amputation among the second (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.90-1.04), third (OR, 1.00; 95% CI, 0.93-1.07), and fourth (OR, 1.00; 95% CI, 0.93-1.07) quartile volumes compared with the first quartile. Significant differences were observed in 12-month death (OR for fourth quartile with reference to the first quartile, 0.71; 95% CI, 0.65-0.76), composite outcome (OR, 0.84; 95% CI, 0.80-0.89), and readmission (OR, 1.05; 95% CI, 1.02-1.09).</p><p><strong>Conclusions: </strong>We found that the annual hospital volume of EVT was not associated with decreased 12-month amputation in patients with lower-extremity PAD. In contrast, all-cause death and composite outcome were significantly decreased in hospitals with the highest volume.Clinical ImpactThe association between hospital volume of endovascular therapy and long-term adverse clinical outcomes remains unclear. The present analyses showed no significant differences in 12-month amputation rates among the hospital volumes, whereas higher-volume quartiles were significantly associated with decreased 12-month all-cause death rates and composite outcome. There was also a positive association in the length of stay between the first quartile volume and the others, while no significant difference in total health care costs among the quartiles was observed. Further investigations are needed, including insights into operator volume and procedural characteristics, to clarify the relationship between hospital volume and long-term adverse outcomes.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"841-850"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10542325","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":"Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study.","authors":"Giovanni Torsello, Luca Bertoglio, Richard Kellersmann, Jan J Wever, Hans van Overhagen, Konstantinos Stavroulakis","doi":"10.1177/15266028231214162","DOIUrl":"10.1177/15266028231214162","url":null,"abstract":"<p><strong>Purpose: </strong>Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study.</p><p><strong>Materials and methods: </strong>Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory.</p><p><strong>Results: </strong>The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively.</p><p><strong>Conclusions: </strong>In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years.Clinical ImpactLow-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.</p><p><strong>Clinicaltrials: </strong>gov Identifier: NCT02477111.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"766-773"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138464066","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}