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  • 1
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    Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort
    SAGE Publications ; 2020
    In:  Journal of Endovascular Therapy Vol. 27, No. 5 ( 2020-10), p. 693-705
    Details
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 27, No. 5 ( 2020-10), p. 693-705
    Abstract: Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p 〈 0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    URL: Article
    DOI: 10.1177/1526602820931477
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 2
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    Safety and Efficacy of Periprocedural Anticoagulation With Enoxaparin in Patients Undergoing Peripheral Endovascular Revascularization
    SAGE Publications ; 2014
    In:  Clinical and Applied Thrombosis/Hemostasis Vol. 20, No. 5 ( 2014-07), p. 530-535
    Details
    In: Clinical and Applied Thrombosis/Hemostasis, SAGE Publications, Vol. 20, No. 5 ( 2014-07), p. 530-535
    Abstract: Periprocedural anticoagulation is primarily used in endovascular procedures to prevent acute reocclusion of the target vessel, but periprocedural anticoagulation might also have an impact on long-term outcome. Consecutive bleeding events are feared complications. Despite changes in peripheral endovascular revascularizations (EVRs), the periprocedural management has remained unchanged for years. Unfractionated heparin is still the treatment of choice during and immediately after EVR. Materials and Methods: We performed a prospective, single-center, open-label phase III study comparing 2 different regimes of enoxaparin peri-interventional to peripheral EVR stratified into low- and high-risk groups according to the acute and long-term reocclusion risk due to their vessel morphology. In both groups, 0.5 mg/kg of enoxaparin as a bolus was administered intravenously 10 to 15 minutes before the start of the procedure. In the low-risk group, 40 mg of enoxaparin were administered once daily for 7 days; whereas in the high-risk group, 1 mg/kg of enoxaparin was administered subcutaneously (sc) 2 times a day for 48 hours after the procedure and afterward 40 mg of enoxaparin was administered sc once daily for 5 days. Results: For the analysis of the per protocol population, 44 patients remained in the low-risk group and 140 in the high-risk group. Concerning the primary safety end point, a total of 25 (13.59%) bleeding events occurred until day 30; 5 (11.36%) of them in the low-risk group and 20 (14.29%) in the high-risk group ( P = .809 for low vs high risk). None of the bleeding events observed were major according to Thrombolysis In Myocardial Infarction criteria. Concerning our primary efficacy end point, none of the patients showed an acute reocclusion classified as a significant decrease in ankle–brachial index (ABI) or elevated peak systolic velocity ratio confirmed by duplex sonography until day 30. Concerning the second end point of prevention of chronic reobstruction, at day 180 ABI has decreased in the low-risk group from mean 0.94 at day 30 to mean 0.89 and from 1.28 at day 30 to 0.85 after 6 months in the high-risk group. No significant reobstruction was found in the low-risk group, whereas 5 significant reobstruction events were objectified in the high-risk group, all of them in the femoropopliteal arterial segment at day 180. Conclusion: We conclude that low-molecular-weight heparin either in a low-dose or high-dose regime during a peripheral EVR is safe concerning bleeding complications and acute reobstructions. The long-term follow-up showed no significant difference between our high- and low-risk groups concerning reobstruction. The periprocedural anticoagulation seems to have no influence on the long-term patency rate after peripheral EVR.
    Type of Medium: Online Resource
    ISSN: 1076-0296 , 1938-2723
    URL: Article
    DOI: 10.1177/1076029613492877
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
    detail.hit.zdb_id: 2230591-9
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  • 3
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    Balloon Angioplasty of Infrapopliteal Arteries: A Systematic Review and Proposed Algorithm for Optimal Endovascular Therapy
    SAGE Publications ; 2020
    In:  Journal of Endovascular Therapy Vol. 27, No. 4 ( 2020-08), p. 547-564
    Details
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 27, No. 4 ( 2020-08), p. 547-564
    Abstract: Endovascular revascularization has been increasingly utilized to treat patients with chronic limb-threatening ischemia (CLTI), particularly atherosclerotic disease in the infrapopliteal arteries. Lesions of the infrapopliteal arteries are the result of 2 different etiologies: medial calcification and intimal atheromatous plaque. Although several devices are available for endovascular treatment of infrapopliteal lesions, balloon angioplasty still comprises the mainstay of therapy due to a lack of purpose-built devices. The mechanism of balloon angioplasty consists of adventitial stretching, medial necrosis, and dissection or plaque fracture. In many cases, the diffuse nature of infrapopliteal disease and plaque complexity may lead to dissection, recoil, and early restenosis. Optimal balloon angioplasty requires careful attention to assessment of vessel calcification, appropriate vessel sizing, and the use of long balloons with prolonged inflation times, as outlined in a treatment algorithm based on this systematic review. Further development of specific devices for this arterial segment are warranted, including devices for preventing recoil (eg, dedicated atherectomy devices), treating dissections (eg, tacks, stents), and preventing neointimal hyperplasia (eg, novel drug delivery techniques and drug-eluting stents). Further understanding of infrapopliteal disease, along with the development of new technologies, will help optimize the durability of endovascular interventions and ultimately improve the limb-related outcomes of patients with CLTI.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    URL: Article
    DOI: 10.1177/1526602820931488
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 4
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    Standard Balloon Angioplasty Versus Serranator Serration Balloon Angioplasty for the Treatment of Below-the-Knee Artery Occlusive Disease: A Single-Center Subanalysis From the PRELUDE-BTK Prospective Study
    SAGE Publications ; 2022
    In:  Journal of Endovascular Therapy
    Details
    In: Journal of Endovascular Therapy, SAGE Publications
    Abstract: Endovascular interventions in infrapopliteal occlusive artery disease are becoming more complex, and this frequently tests the standard method of treatment, plain old balloon angioplasty (POBA). The potential that serration angioplasty could produce a more acceptable tibial artery lumen was assessed in this study. Aim: The aim of this single-center subgroup analysis was to compare acute angiographic results after endovascular treatment using the Serranator serration balloon catheter in patients participating in the PRELUDE-BTK trial with POBA of the infrapopliteal arteries. A secondary objective was to assess post-treatment hemodynamic improvements. Methods: Our center enrolled 15 subjects and treated 17 lesions within the multicenter prospective core laboratory–adjudicated PRELUDE-BTK study. A 25 lesions analyzed separately were treated with POBA and then compared with the Serranator subset. In both cohorts, lesions were treated with either plain angioplasty or Serranator as a stand-alone therapy; subsequent methods, such as drug elution technologies, were not used. Acute angiographic results were analyzed by the SynvaCor angiographic core laboratory. To assess volumetric flow rates, data were analyzed with a fluid flow simulation software and compared against Poiseuille’s Law. Results: Final residual stenosis was 17.2%±8.2% in the Serranator group versus 33.7%±15.7% in the POBA group. The mean lumen diameter (MLD) gain for the Serranator group and the POBA group was 1.64±0.41 mm and 1.33±0.63 mm, respectively. The average atmospheric balloon inflation pressure was 5 ATM in the Serranator group versus 9 ATM in the POBA group. Neither group required a bailout stent; however, it was notable that there were significantly more chronic total occlusions (CTOs) treated in the Serranator group at 41.2% versus 12% in the POBA group. Regarding the effectiveness in improving hemodynamic blood flow for non-CTO lesions, the calculated average ratio of post-treatment to pre-treatment flow rates in the Serranator group was 238% than that for the POBA group. For CTO cases where pre-treatment flow rate was zero, final residual stenosis was used as the parameter for comparison. The Serranator group showed a 62% improvement in final residual stenosis over POBA. Conclusion: Endovascular treatment of the infrapopliteal arteries by use of the Serranator serration balloon provides a novel and promising method of action compared with standard balloon angioplasty and, thus, may have a leading role in complex below-the-knee arterial lesions. Clinical Impact The Serranator device might help to adequately address issues with conventional routine techniques for the treatment of complex lesions in infrapopliteal arteries in patients with advanced stages of PAD and critical limb ischemia. Integrating modern technologies such as the Serranator balloon catheter into clinical routine is mandatory in order to gain a more favorable outcome in these severely diseased patients and, particularly, to reduce mortality and morbidity.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    URL: Article
    DOI: 10.1177/15266028221134891
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
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  • 5
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    Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry
    SAGE Publications ; 2020
    In:  Journal of Endovascular Therapy Vol. 27, No. 2 ( 2020-04), p. 304-315
    Details
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 27, No. 2 ( 2020-04), p. 304-315
    Abstract: Purpose: To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. Materials and Methods: BIOLUX P-III is an international, prospective, observational registry ( ClinicalTrials.gov identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0±10.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7±73.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. Results: At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in 〉 80% of all subgroups at 12 months. Conclusion: In a real-world patient population, the safety and performance of the Passeo-18 Lux DCB for the treatment of atherosclerotic infrainguinal lesions are maintained, with good performance outcomes and low complication rates at 12 months.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    URL: Article
    DOI: 10.1177/1526602819898804
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 6
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    Pulmonary embolism and intracardiac thrombi - individual therapeutic procedures
    SAGE Publications ; 2000
    In:  Vascular Medicine Vol. 5, No. 1 ( 2000-02), p. 27-31
    Details
    In: Vascular Medicine, SAGE Publications, Vol. 5, No. 1 ( 2000-02), p. 27-31
    Abstract: Mobile right heart thrombus is a severe but rare presentation of thromboembolic disease and usually coexists with an already massive pulmonary embolism (PE). But looking at the literature there is no clear consensus on therapeutic management. We therefore tried to find possible therapeutic guidelines and to evalute an optimal diagnostic procedure looking at three patients who presented at our department with mobile right heart thrombbus in the last year. The first patient with a small (diameter = 1 cm) thrombus in the right ventricle and peripheral pulmonary embolism underwent successful thrombolytic therapy without any complications. Patients II and III showed large intracardiac masses, in patient III extending into the superior vena cava, with central PE. These two patients underwent pulmonary arteriotomy. The diagnostic line in each case was transthoracal echocardiography followed by a helix lung CT scan. Only patients with small intracardiac thrombi and thrombotic masses in the peripheral pulmonary arteries but with hemodynamically significant PE should be treated with thrombolytic agents.
    Type of Medium: Online Resource
    ISSN: 1358-863X , 1477-0377
    URL: Article
    DOI: 10.1177/1358836X0000500105
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2000
    detail.hit.zdb_id: 2027562-6
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  • 7
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    Coumarin skin necrosis: a severe complication of oral anticoagulation
    SAGE Publications ; 2006
    In:  Vascular Medicine Vol. 11, No. 4 ( 2006-11), p. 273-273
    Details
    In: Vascular Medicine, SAGE Publications, Vol. 11, No. 4 ( 2006-11), p. 273-273
    Type of Medium: Online Resource
    ISSN: 1358-863X , 1477-0377
    URL: Article
    DOI: 10.1177/1358863x06072229
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2006
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  • 8
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    Utility of paclitaxel-coated balloons for the treatment of infrainguinal disease in the Asian population – 24-month outcome data from the BIOLUX P-III Global Registry 24-month Asian outcomes of BIOLUX P-III
    SAGE Publications ; 2023
    In:  Vascular Vol. 31, No. 4 ( 2023-08), p. 767-776
    Details
    In: Vascular, SAGE Publications, Vol. 31, No. 4 ( 2023-08), p. 767-776
    Abstract: Results from the BIOLUX P-III registry have demonstrated favourable outcomes of Passeo-18 Lux™ (Biotronik®, Buelach, Switzerland) drug-coated balloon in treating obstructive infrainguinal peripheral artery disease, but it has not been established if Asians would benefit to the same extent as non-Asians. Methods A subgroup analysis was performed on the 24-month data comparing the Asian cohort (AC) to non-Asian cohort (NAC). Results AC included 49 patients with 77 lesions. AC was significantly younger (65.6 vs 70.3 years, p 〈 0.05), had more diabetes (87.8% vs 45.3%, p 〈 0.05), and was more likely to present with CLTI (73.5% vs 35.3%, p 〈 0.001) compared to NAC. They had significantly longer mean target lesions (115 vs 86.9 mm, p = 0.006), and received significantly higher paclitaxel doses (10.7 vs 7.2 mg, p = 0.0005). Device, technical and procedural successes were 125/125(100%), 95/97(97.5%) and 45/49(91.8%), respectively. There was no significant difference in target lesion revascularization rates between groups (10.5% vs 12%, p = 0.91). However, the AC had more major adverse events (30.2% vs 16.1%, p = 0.001), amputations (26.3% vs 6.2%, p 〈 0.05) and mortality (37.9% vs 10.6%, p 〈 0.05) at 24 months. Conclusion Passeo-18 Lux™ use was efficacious in Asians, but was associated with higher adverse events, amputations and mortality rates, likely attributable to poorer patient comorbidities and more extensive PAD.
    Type of Medium: Online Resource
    ISSN: 1708-5381 , 1708-539X
    URL: Article
    DOI: 10.1177/17085381221081969
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2143006-8
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  • 9
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    Osteomyelitis of the Spine and Abscess Formation in the Left Thigh after Stent-Graft Implantation in the Superficial Femoral Artery
    SAGE Publications ; 2000
    In:  Journal of Endovascular Therapy Vol. 7, No. 2 ( 2000-04), p. 150-154
    Details
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 7, No. 2 ( 2000-04), p. 150-154
    Abstract: To present a rare case of abscess formation around a covered stent in the superficial femoral artery. Methods and Results: Two weeks after balloon dilation of a left superficial femoral artery (SFA) occlusion, during which a Hemobahn covered stent had been placed to treat dissection, a 77-year-old nondiabetic male developed intolerable pain and swelling of his left thigh. An abscess had formed around the stent, which was patent; intravenous antibiotic therapy quelled the symptoms, and the patient discontinued his oral antibiotic regimen weeks after discharge. General septicemia ensued. Acute lower limb ischemia and excruciating back pain prompted readmission. The SFA stent-graft occlusion required femoropopliteal bypass; the abscess and spondylodiskitis that had developed in the T12 and L1 vertebrae responded to intravenous antibiotics. The patient is without signs of infection at 6 months. Conclusions: Local and systemic infections associated with intraluminal prostheses are rare, and prophylactic antibiotic therapy is not commonly employed. Balloon- or device-induced arterial injury may expose the arterial wall to bacterial colonization, suggesting that patients receiving lengthy stents or experiencing arterial injury during angioplasty should receive antibiotics as a precautionary measure.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    URL: Article
    DOI: 10.1177/152660280000700211
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2000
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  • 10
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    Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study)
    SAGE Publications ; 2015
    In:  Journal of Endovascular Therapy Vol. 22, No. 5 ( 2015-10), p. 690-697
    Details
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 22, No. 5 ( 2015-10), p. 690-697
    Abstract: Purpose: To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). Methods: In the EXPAND trial ( ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. Results: Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p 〉 0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. Conclusion: Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    URL: Article
    DOI: 10.1177/1526602815598955
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
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