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Arteriovenous fistula (AVF) is the optimal form of vascular access for most haemodialysis dependant patients; however, it is prone to the formation of stenoses that compromise utility and longevity. Whilst there are many factors influencing the development of these stenoses, pathological flow-related phenomena may also incite the formation of intimal hyperplasia, and hence a stenosis. Repeated CFD-derived resistance was calculated for six patient who had a radiocephalic AVF, treated with an interwoven nitinol stent around the juxta-anastomotic region to address access dysfunction. A three-dimensional freehand ultrasound system was used to obtain patient-specific flow profiles and geometries, before performing CFD simulations to replicate the flow phenomena in the AVF, which enabled the calculation of CFD-derived resistance. We presented six patient cases who were examined before and after treatment and our results showed a 77% decrease in resistance, recorded after a surgical intervention to address access dysfunction. Problematic AVFs were found to have high resistance, particularly in the venous segment. AVFs with no reported clinical problems, and clinical patency, had low resistance in the venous segment. There did not appear to be any relationship with clinical problems/patency and resistance values in the arterial segment. Identifying changes in resistance along the circuit allowed stenoses to be identified, independent to that determined using standard sonographic criteria. Our exploratory study reveals thatCFD-derived resistance is a promising metric that allows for non-invasive identification of diseased AVFs. The pipeline analysis enabled regular surveillance of AVF to be studied to aid with surgical planning and outcome, further exhibiting its clinical utility.
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Diálise Renal , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Derivação Arteriovenosa Cirúrgica , Modelos Cardiovasculares , Resistência Vascular/fisiologia , Stents , Fístula Arteriovenosa/fisiopatologiaRESUMO
BACKGROUND: During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an 'anastomosis', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients. OBJECTIVES: To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023. SELECTION CRITERIA: We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients. DATA COLLECTION AND ANALYSIS: We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes. AUTHORS' CONCLUSIONS: Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.
Assuntos
Anastomose Cirúrgica , Hemostasia Cirúrgica , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Vasculares , Humanos , Hemostasia Cirúrgica/métodos , Hemostáticos/uso terapêutico , Adesivo Tecidual de Fibrina/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Adesivos Teciduais/uso terapêuticoRESUMO
Background: Chronic limb-threatening ischaemia can be a debilitating disease and may result in limb amputation if untreated. Atherosclerotic disease of the infra-popliteal arteries is particularly challenging to treat due to the small caliber of the vessels and the heavy burden of atherosclerotic plaque. Percutaneous transluminal angioplasty is the conventional first-line approach and is advantageous due to its minimal invasiveness, repeatability, and cost-effectiveness but is limited by high rates of elastic recoil, dissection, and short- to mid-term re-stenosis. Methods: This review analyses the growing body of published and presented clinical data from multiple randomised controlled trials that have investigated the role of coronary drug-eluting stents in the treatment of infrapopliteal disease. Results: Coronary drug-eluting stents demonstrate superior primary patency compared with angioplasty and/or bare metal stenting alone but are limited to application in short-segment disease and have not been widely adopted due to the nature of the permanent implant. Conclusions: Newer devices like drug-eluting resorbable scaffolds are promising as they allow the restoration of vessel wall vasomotion without a residual foreign body and can be used to treat longer, complex lesions.
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BACKGROUND: The overall goal of this report is to provide a high-level, practical approach to managing venous outflow obstruction (VOO). METHODS: A group of vascular surgeons from Australia and New Zealand with specific interest, training, and experience in the management of VOO were surveyed to assess current local practices. The results were analyzed and areas of disagreement identified. After this, the group performed a literature review of consensus guidelines published by leading international organizations focused on the management of chronic venous disease, namely, the Society for Vascular Surgery, American Venous Forum, European Society for Vascular Surgery, American Vein and Lymphatic Society, Cardiovascular and Interventional Radiology Society of Europe, and American Heart Association. These guidelines were compared against the consensus statements obtained through the surveys to determine how they relate to Australian and New Zealand practice. In addition, selected key studies, reviews, and meta-analyses on venous stenting were discussed and added to the document. A selection of statements with >75% agreement was voted on, and barriers to the guideline's applicability were identified. The final recommendations were further reviewed and endorsed by another group of venous experts. RESULTS: The document addresses two key areas: patient selection and technical aspects of venous stenting. Regarding patient selection, patients with clinically relevant VOO, a Clinical-Etiologic-Anatomic-Physiologic score of ≥3 or a Venous Clinical Severity Score for pain of ≥2, or both, including venous claudication, with evidence of >50% stenosis should be considered for venous stenting (Level of Recommendation Ib). Patients with chronic pelvic pain, deep dyspareunia, postcoital pain affecting their quality of life, when other causes have been ruled out, should also be considered for venous stenting (Level of Recommendation Ic). Asymptomatic patients should not be offered venous stenting (Level of Recommendation IIIc). Patients undergoing thrombus removal for acute iliofemoral deep vein thrombosis, in whom a culprit stenotic lesion of >50% has been uncovered, should be considered for venous stenting (Level of Recommendation Ib). CONCLUSIONS: Patients with VOO have been underdiagnosed and undertreated for decades; however, in recent years, interest from physicians and industry has grown substantially. International guidelines aimed at developing standards of care to avoid undertreating and overtreating patients are applicable to Australia and New Zealand practice and will serve as an educational platform for future developments.
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Procedimentos Endovasculares , Veia Ilíaca , Stents , Humanos , Nova Zelândia , Austrália , Procedimentos Endovasculares/normas , Guias de Prática Clínica como Assunto/normas , Insuficiência Venosa/terapia , Insuficiência Venosa/diagnóstico por imagem , Consenso , Seleção de Pacientes , Resultado do TratamentoRESUMO
PURPOSE: To compare procedural and long-term costs associated with the use of Balloon-Expandable Covered Stents (BECS) in the management of Aortoiliac Occlusive Disease (AIOD). MATERIALS AND METHODS: A cost-consequence model was developed to simulate the intra- and post-operative management of patients with AIOD from the perspective of private health-payers. The study assessed the costs of the LifeStream (BD, Franklin Lakes, New Jersey), iCAST/Advanta V12 (Getinge, Goteborg, Sweden), BeGraft Peripheral (Bentley, Hechingen, Germany), and Viabahn Balloon Expandable (VBX) (W.L. Gore, Flagstaff, Arizona) BECS devices. Device costs were identified from the Australian Prosthesis List, whereas clinical outcomes of BECS were estimated from a systematic review of the literature. Costs were calculated over 24 and 36 month time horizons and reported in US dollars. RESULTS: Long-term, per-patient cost of each device at 24 and 36 months was $6253/$6634 for the LifeStream; $6359/$6869 for the iCAST/Advanta V12; $4806 (data available to 24 months) for the BeGraft Peripheral; and $4839/$5046 for the Viabahn VBX, respectively. Most of the cost difference was attributed to the number of stents required per treated limb and frequency of clinically-driven target lesion revascularization events. CONCLUSIONS: Best-available clinical evidence and economic modeling demonstrates that the BeGraft Peripheral and Viabahn VBX were of similar cost and the least costly options at 24 months, whereas at 36 months, the lowest cost BECS option for the treatment of AIOD was the Viabahn VBX. CLINICAL IMPACT: This analysis supports economically informed decision-making for health-payers managing systems that care for patients with AIOD. Stent length and avoiding reintervention were identified as key areas of cost-saving for future BECS development.
RESUMO
Patients with chronic limb-threatening ischemia, the terminal stage of peripheral artery disease, are frequently afflicted by below-the-knee disease. Although all patients should receive guideline-directed medical therapy, restoration of inline flow is oftentimes necessary to avoid limb loss. Proper patient selection and proficiency in endovascular techniques for below-the-knee revascularization are intended to prevent major amputation and promote wound healing. This review, a consensus among an international panel of experienced operators, provides guidance on these challenges from an endovascular perspective and offers techniques to navigate this complex disease process.
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Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Resultado do Tratamento , Fatores de Risco , Salvamento de Membro , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/métodos , Isquemia/diagnóstico por imagem , Isquemia/terapia , Estudos Retrospectivos , Doença CrônicaRESUMO
BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).
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Angioplastia , Implante de Prótese Vascular , Isquemia Crônica Crítica de Membro , Stents Farmacológicos , Doença Arterial Periférica , Artéria Poplítea , Humanos , Implantes Absorvíveis , Angioplastia/efeitos adversos , Angioplastia/métodos , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/métodos , Implante de Prótese Vascular/métodos , Doença Crônica , Isquemia Crônica Crítica de Membro/etiologia , Isquemia Crônica Crítica de Membro/cirurgia , Everolimo/administração & dosagem , Everolimo/efeitos adversos , Everolimo/uso terapêutico , Imunossupressores/administração & dosagem , Imunossupressores/efeitos adversos , Imunossupressores/uso terapêutico , Isquemia/tratamento farmacológico , Isquemia/etiologia , Isquemia/cirurgia , Doença Arterial Periférica/complicações , Doença Arterial Periférica/tratamento farmacológico , Doença Arterial Periférica/cirurgia , Artéria Poplítea/cirurgia , Alicerces Teciduais , Resultado do TratamentoRESUMO
The arteriovenous fistula (AVF) is commonly faced with stenosis at the juxta-anastomotic (JXA) region of the vein. Implantation of a flexible nitinol stent across the stenosed JXA has led to the retention of functioning AVFs leading to the resulting AVF geometry being distinctly altered, thereby affecting the haemodynamic environment within it. In this study, large eddy simulations of the flow field within a patient-specific AVF geometry before and after stent implantation were conducted to detail the change in flow features. Although the diseased AVF had much lower flow rates, adverse flow features, such as recirculation zones and swirling flow at the anastomosis, and jet flow at the stenosis site were present. Larger velocity fluctuations (leading to higher turbulent kinetic energy) stemming from these flow features were apparent in the diseased AVF compared to the stented AVF. The unsteadiness at the stenosis created large regions of wall shear stress (WSS) fluctuations downstream of the stenosis site that were not as apparent in the stented AVF geometry. The larger pressure drop across the diseased vein, compared to the stented vein, was primarily caused by the constriction at the stenosis, potentially causing the lower flow rate. Furthermore, the WSS fluctuations in the diseased AVF could lead to further disease progression downstream of the stenosis. The change in bulk flow unsteadiness, pressure drop, and WSS behaviour confirms that the haemodynamic environment of the diseased AVF has substantially improved following the flexible stent implantation.
Assuntos
Fístula Arteriovenosa , Hemodinâmica , Humanos , Velocidade do Fluxo Sanguíneo , Constrição Patológica , Stents , Fístula Arteriovenosa/cirurgiaRESUMO
Peripheral artery disease (PAD) is a vascular disorder caused by occlusive atherosclerosis, which commonly impairs blood flow to the lower extremities. The prevalence of PAD is increasing globally with >200 million people affected. PAD remains a growing global health problem as the population continues to age and diabetes incidence grows. Many patients with PAD, most notably those with critical limb ischemia, fail attempts at surgical and percutaneous intervention to improve blood flow and are at risk of amputation. Gene therapy provides an opportunity to change the clinical course of PAD in these patients via strategies that increase vascular supply through angiogenesis and arteriogenesis improving muscle perfusion and function in ischemic legs. This article discusses gene therapy approaches in the context of PAD, both intermittent claudication and critical limb ischemia, and the promise of adeno-associated virus-based strategies delivering not just VEGFs (vascular endothelial growth factors) but a range of other mediators as potential new therapeutics. We also highlight challenges and failures in the clinical translation of gene therapy for PAD and how at least some of these obstacles may be overcome using adeno-associated virus.
Assuntos
Dependovirus , Doença Arterial Periférica , Humanos , Dependovirus/genética , Isquemia Crônica Crítica de Membro , Doença Arterial Periférica/genética , Doença Arterial Periférica/terapia , Doença Arterial Periférica/metabolismo , Claudicação Intermitente/terapia , Extremidade Inferior , Isquemia/genética , Isquemia/terapia , Isquemia/metabolismoRESUMO
BACKGROUND: The overall goal of this report is to provide a high-level, practical approach to managing venous outflow obstruction (VOO) in Australia and New Zealand. METHODS: A group of vascular surgeons from the Australian and New Zealand Society for Vascular Surgery with specific interest, training, and experience in the management of VOO were surveyed to assess current local practice. The results were analyzed and areas of disagreement identified. Following this, the group performed a literature review of consensus guidelines published by leading international organizations focused on the management of chronic venous disease, namely the Society for Vascular Surgery, American Venous Forum, European Society for Vascular Surgery, American Vein and Lymphatic Society, Cardiovascular and Interventional Radiology Society of Europe, and American Heart Association. These guidelines were compared against the consensus statements obtained through the surveys to determine how they relate to Australian and New Zealand practice. In addition, selected key studies, reviews, and meta-analyses on venous stenting were discussed and added to the document. Finally, a selection of statements with >75% agreement was voted on, and barriers to the guideline's applicability were identified. RESULTS: The document addresses two key areas: patient selection and technical aspects of venous stenting. Regarding patient selection, patients with a CEAP (Clinical-Etiologic-Anatomic-Physiologic) score of ≥3 or a venous clinical severity score for pain of ≥2, or both, and evidence of >50% stenosis on venography, computed tomography venography, magnetic resonance venography, and/or intravascular ultrasound should be considered for venous stenting (level of recommendation Ib) Patients undergoing thrombus removal for acute iliofemoral deep vein thrombosis, in whom a culprit stenotic lesion has been uncovered, should be considered for venous stenting (level of recommendation Ib). Patients with chronic pelvic pain, deep dyspareunia, postcoital pain affecting their quality of life, when other causes have been ruled out, should be considered for venous stenting (level of recommendation Ic). Asymptomatic patients should not be offered venous stenting (level of recommendation IIIc). CONCLUSIONS: Patients with deep VOO have been underdiagnosed and undertreated for decades; however, in recent years, interest from physicians and industry has grown substantially. The advent of simpler and safer treatment options has revolutionized its management, but, unfortunately, formal training for venous disease has not grown at the same rate. Simplifying the technology and training required can result in inconsistent outcomes. These guidelines are aimed at developing standards of care and will serve as an educational platform for future developments.
Assuntos
Dor Crônica , Doenças Vasculares , Humanos , Austrália , Doença Crônica , Constrição Patológica , Veia Ilíaca/cirurgia , Nova Zelândia , Qualidade de Vida , Estudos Retrospectivos , Stents , Resultado do Tratamento , Doenças Vasculares/patologia , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Guias de Prática Clínica como AssuntoRESUMO
Together with colleagues from different disciplines, including cardiologists, interventional radiologists and vascular surgeons, committee members of the of the German Society of Angiology (Deutsche Gesellschaft für Angiologie [DGA]), developed a novel algorithm for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs). Our aim is to improve patient and limb related outcomes, by increasing the success rate of endovascular procedures. This can be achieved by adherence to the proposed crossing algorithm, aiding the standardization of endovascular procedures. The following steps are proposed: (i) APPLY Duplex sonography and if required 3D techniques such as computed tomography or magnetic resonance angiography. This will help you to select the optimal access site. (ii) EVALUATE the CTO cap morphology and distal vessel refilling sites during diagnostic angiography, which are potential targets for a retrograde access. (iii) START with antegrade wiring strategies including guidewire (GW) and support catheter technology. Use GW escalation strategies to penetrate the proximal cap of the CTO, which may usually be fibrotic and calcified. (iv) STOP the antegrade attempt depending on patient specific parameters and the presence of retrograde options, as evaluated by pre-procedural imaging and during angiography. (v) In case of FAILURE, consider advanced bidirectional techniques and reentry devices. (vi) In case of SUCCESS, externalize the GW and treat the CTO. Manage the retrograde access at the end of the endovascular procedure. (vii) STOP the procedure if no progress can be obtained within 3 hours, in case of specific complications or when reaching maximum contrast administration based on individual patient's renal function. Consider radiation exposure both for patients and operators. In this manuscript we systematically follow and explain each of the steps (i)-(vi) based on practical examples from our daily routine. We strongly believe that the integration of this algorithm in the daily practice of endovascular specialists, can improve vessel and patient specific outcomes.
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Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Procedimentos Endovasculares/efeitos adversos , Angiografia , Cateterismo , Resultado do Tratamento , Doença CrônicaRESUMO
A crossing algorithm was developed for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs) to educate, guide, and appropriately influence clinical practice aiming at harmonization and standardization of endovascular procedures. The following steps are proposed: One, duplex sonography and if required computed tomography or magnetic resonance angiography for the selection of the optimal access site. Two, angiographic evaluation of the proximal/distal cap morphology, presence of collaterals at the origin of the proximal cap and at the distal vessel refilling site. In addition, evaluation of distal vessels, including their diameters and quality, and the presence of calcification or stents within the occlusion zone. Three, antegrade wiring strategies, guidewire (GW) and support catheter technology, as well as GW escalation strategies. Stop the antegrade attempt depending on clinical indication for peripheral artery disease treatment and the presence of retrograde options. Four, retrograde access site, support catheter, or sheath insertion and wiring technology from distally. Five, considering strategy change when progress cannot by achieved, using advanced bidirectional techniques and re-entry devices. Six, in case of successful GW passage from retrograde, GW externalization and treatment from antegrade. Management of the retrograde access by internal or external hemostasis at the end of the procedure. Alternatively, stop the procedure if no progress can be obtained within 3 hours or in case of specific complications. By establishing the algorithm in the daily routine of endovascular specialists, improvements in vessel- and patient-specific outcomes are anticipated. In addition, future research, and continuous collaboration between experts is warranted.
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Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Prova Pericial , Resultado do Tratamento , Procedimentos Endovasculares/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Algoritmos , Doença CrônicaRESUMO
OBJECTIVE: Compare long-term mortality, secondary intervention and secondary rupture following elective endovascular aneurysm repair (EVAR) and open surgical repair (OSR). BACKGROUND: EVAR has surpassed OSR as the most common procedure used to repair abdominal aortic aneurysm (AAA), but evidence regarding long-term outcomes is inconclusive. METHODS: We included patients in linked clinical registry and administrative data undergoing EVAR or OSR for intact AAA between January 2010 and June 2019. We used an inverse probability of treatment-weighted survival analysis to compare all-cause mortality, cause-specific mortality, secondary interventions and secondary rupture, and evaluate the impact of secondary interventions and secondary rupture on all-cause mortality. RESULTS: The study included 3460 EVAR and 427 OSR patients. Compared to OSR, the EVAR all-cause mortality rate was lower in the first 30 days [adjusted hazard ratio (HR) = 0.22, 95% confidence interval (CI) 0.140.33], but higher between 1 and 4 years (HR = 1.29, 95% CI 1.12-1.48) and after 4years (HR = 1.41, 95% CI 1.23-1.63). Secondary intervention rates were higher over the first 30 days (HR = 2.26, 95% CI 1.11-4.59), but lower between 1 and 4years (HR = 0.59, 95% CI 0.48-0.74). Secondary aortic intervention rates were higher across the entire follow-up period (HR = 2.52, 95% CI 2.06-3.07). Secondary rupture rates did not differ significantly (HR = 1.06, 95% CI 0.73-1.55). All-cause mortality beyond 1 year remained significantly higher for EVAR after adjusting for any secondary interventions, or secendary rupture. CONCLUSIONS: EVAR has an early survival benefit compared to OSR. However, elevated long-term mortality and higher rates of secondary aortic interventions and subsequent aneurysm repair suggest that EVAR may be a less durable method of aortic aneurysm exclusion.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Aneurisma da Aorta Abdominal/cirurgia , Dados de Saúde Coletados Rotineiramente , Procedimentos Endovasculares/métodos , Sistema de Registros , Resultado do Tratamento , Fatores de Risco , Estudos Retrospectivos , Complicações Pós-OperatóriasRESUMO
INTRODUCTION: Juxta-anastomotic stenosis (JXAS) is a common problem afflicting the arteriovenous fistula (AVF). This study aimed to evaluate the safety and long-term efficacy of an interwoven nitinol stent (Supera, Abbott Vascular, Santa Clara, CA, USA) in the treatment of radiocephalic AVF JXAS. METHODS: A single-center, retrospective, observational study was conducted of patients with failing AVF due to JXAS treated with an interwoven nitinol stent. End points included JXAS target lesion primary patency, access circuit primary patency, assisted access circuit primary patency, and endovascular intervention rate (EIR). RESULTS: Sixty patients were treated with a Supera stent in the JXAS between February 2014 and March 2020. One patient was excluded (AVF used for illicit drug use), leaving 59 patients (67.8% male, mean age 66.9 ± 11.4 years [range: 40-84]) with typical medical comorbidities. Overall, 45.8% of patients had previous AVF intervention. The stent was inserted with a 100% technical success rate with a mean follow-up of 729.6 ± 456.0 days (range: 5-2182 days). Juxta-anastomotic stenosis target lesion primary patency was 68.2 ± 6.6%, 53.3 ± 7.5%, and 46.2 ± 8.1% at 12, 24, and 36 months, respectively. The EIR was .64 (0-3.29) procedures/patient/year, after which the assisted access circuit primary patency rate was 94.3 ± 3.2% at 12, 24, and 36 month time points. Three thrombosed circuits occurred which were all successfully salvaged with no difference in patency by indication for procedure and no AVFs lost/abandoned out to 3 years. Avoidance of stent post-dilatation and the presence of stent mal-apposition were associated with improved primary patency, and reduced EIR, which may suggest an importance in vessel preparation prior to stent implantation. CONCLUSION: Interwoven nitinol stent treatment of the failing AVF with JXAS results in promising 3 year JXAS patency, with a low rate of endovascular re-intervention for those circuits developing restenosis. All AVFs were maintained over 3 years, demonstrating this treatment allows for long-term radiocephalic AVF vascular access.
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Angioplastia com Balão , Fístula Arteriovenosa , Derivação Arteriovenosa Cirúrgica , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/terapia , Grau de Desobstrução Vascular , Estudos Retrospectivos , Constrição Patológica , Diálise Renal , Angioplastia com Balão/efeitos adversos , Resultado do Tratamento , Stents , Fístula Arteriovenosa/etiologiaRESUMO
OBJECTIVE: To compare rates of mortality, rupture, and secondary intervention following endovascular repair (EVAR) of intact abdominal aortic aneurysms (AAA) using contemporary endograft devices from three major manufacturers. METHODS: This was a retrospective cohort study using linked clinical registry (Australasian Vascular Audit) and all payer administrative data. Patients undergoing EVAR for intact AAA between 2010 and 2019 in New South Wales, Australia were identified. Rates of all cause death, secondary rupture, and secondary intervention (subsequent aneurysm repair; other secondary aortic intervention) were compared for patients treated with Cook, Medtronic, and Gore standard devices. Inverse probability of treatment weighted proportional hazards and competing risk regression were used to adjust for patient, clinical, and aneurysm characteristics, using Cook as the referent device. RESULTS: This study identified 2 874 eligible EVAR patients, with a median follow up of 4.1 (maximum 9.5) years. Mortality rates were similar for patients receiving different devices (ranging between 7.0 and 7.3 per 100 person years). There was no statistically significant difference between devices in secondary rupture rates, which ranged between 0.4 and 0.5 per 100 person years. Patients receiving Medtronic and Gore devices tended to have higher crude rates of subsequent aneurysm repair (1.5 per 100 person years) than patients receiving Cook devices (0.8 per 100 person years). This finding remained in the adjusted analysis, but was only statistically significant for Medtronic devices (HR 1.57, 95% CI 1.02 - 2.47; HR 1.73, 95% CI 0.94 - 3.18, respectively). CONCLUSION: Major endograft devices have similar overall long term safety profiles. However, there may be differences in rates of secondary intervention for some devices. This may reflect endograft durability, or patient selection for different devices based on aneurysm anatomy. Continuous comparative assessments are needed to guide evidence for treatment decisions across the range of available devices.
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OBJECTIVE: To examine long-term outcomes after endovascular (EVAR) and open repairs (OAR) for intact abdominal aortic aneurysms in Australia, Germany, and the United States, using a unified study design. BACKGROUND: Similarities and differences in long-term outcomes after EVAR versus OAR across countries remained unclear, given differences in designs across existing studies. METHODS: We identified patients aged >65 years undergoing intact abdominal aortic aneurysm repairs during 2010-2017/2018. We compared long-term patient mortality and reintervention after EVAR and OAR using Kaplan-Meier analyses and Cox regressions. Propensity score matching was performed within each country to adjust for differences in baseline patient characteristics between procedure groups. RESULTS: We included 3311, 4909, and 145363 patients from Australia, Germany, and the United States, respectively. The median patient age was 76 to 77 years, and most patients were males (77%-84%). Patient mortality was lower after EVAR than OAR within the first 60 days and became similar at 3-year follow-up (Australia 14.7% vs 16.5%, Germany 18.2% vs 19.7%, United States: 24.4% vs 24.4%). At the end of follow-up, patient mortality after EVAR was higher than OAR in Australia [ hazard ratio (HR) 95% CI: 1.21 (0.96-1.54)] but similar to OAR in Germany [HR 95% CI: 0.92 (0.80-1.07)] and the United States [HR 95% CI: 1.02 (0.99-1.05)]. The risk of reintervention after EVAR was more than twice that after OAR in Australia [HR 95% CI: 2.60 (1.09-6.15)], Germany [HR 95% CI: 4.79 (2.56-8.98)], and the United States [HR 95% CI: 2.67 (2.38-3.00)]. The difference in reintervention risk appeared early in German and United States patients. CONCLUSIONS: This multinational study demonstrated important similarities in long-term outcomes after EVAR versus OAR across 3 countries. Variation in long-term mortality and reintervention comparisons indicates possible differences in patient profiles, surveillance, and best medical therapy across countries.
Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Humanos , Estados Unidos/epidemiologia , Feminino , Fatores de Risco , Procedimentos Endovasculares/métodos , Resultado do Tratamento , Fatores de Tempo , Estudos Retrospectivos , Aneurisma da Aorta Abdominal/cirurgia , Alemanha/epidemiologia , Implante de Prótese Vascular/efeitos adversosRESUMO
Background: Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients. Methods: The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years. Conclusions: Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.
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BACKGROUND: There has been growing use of intravascular ultrasound (IVUS) during lower extremity arterial and venous revascularization. Observational data suggest that the use of IVUS can improve periprocedural and long-term outcomes, but largescale prospective data remain limited. Consensus opinion regarding the appropriate use of IVUS during peripheral intervention is needed. OBJECTIVES: The purpose of this consensus document is to provide guidance on the appropriate use of IVUS in various phases of peripheral arterial and venous interventions. METHODS: A 12-member writing committee was convened to derive consensus regarding the appropriate clinical scenarios for use of peripheral IVUS. The group iteratively created a 72-question survey representing 12 lower extremity arterial interventional scenarios. Separately, a 40-question survey representing 8 iliofemoral venous interventional scenarios was constructed. Clinical scenarios were categorized by interventional phases: preintervention, intraprocedure, and postintervention optimization. Thirty international vascular experts (15 for each survey) anonymously completed the survey instrument. Results were categorized by appropriateness using the median value and disseminated to the voting panel to reevaluate for any disagreement. RESULTS: Consensus opinion concluded that IVUS use may be appropriate during the preintervention phase for evaluating the etiology of vessel occlusion and plaque morphology in the iliac and femoropopliteal arteries. IVUS was otherwise rated as appropriate during iliac and femoropopliteal revascularization in most other preintervention scenarios, as well as intraprocedural and postprocedural optimization phases. IVUS was rated appropriate in all interventional phases for the tibial arteries. For iliofemoral venous interventions, IVUS was rated as appropriate in all interventional phases. CONCLUSIONS: Expert consensus can help define clinical procedural scenarios in which peripheral IVUS may have value during lower extremity arterial and venous intervention while additional prospective data are collected.