RESUMO
BACKGROUND: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. METHODS: Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689. FINDINGS: Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7-79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02-1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00-1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive). INTERPRETATION: In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy. FUNDING: UK National Institute of Health Research Health Technology Programme.
Assuntos
Angioplastia Coronária com Balão , Ocimum basilicum , Doença Arterial Periférica , Masculino , Humanos , Feminino , Idoso , Isquemia Crônica Crítica de Membro , Isquemia/cirurgia , Doença Arterial Periférica/complicações , Doença Arterial Periférica/cirurgia , Fatores de Risco , Perfusão , Dor , Resultado do TratamentoRESUMO
OBJECTIVE: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial enrolled participants with chronic limb threatening ischaemia who required an infrapopliteal, with or without a femoropopliteal, revascularisation procedure to restore limb perfusion. Participants randomised to a vein bypass (VB) first revascularisation strategy were over one third more likely than those randomised to a best endovascular treatment (BET) first revascularisation strategy to die from any cause during a median follow up of 40.0 (interquartile range 20.9, 60.6) months. The aim was to describe the timing and causes of death in BASIL-2 as a first step towards trying to better understand why randomisation to a VB first revascularisation strategy was associated with this excess mortality. METHODS: A 10 person international panel comprising vascular and endovascular surgeons as well as vascular interventional radiologists, who had all been principal investigators in BASIL-2, took part in a modified Delphi consensus exercise to adjudicate the primary cause of death and, in particular, whether the cause was primarily cardiac or non-cardiac. RESULTS: In 151/168 deaths (89.9%) the Delphi panel achieved a consensus regarding the cause of death being probably cardiac or non-cardiac. In the BET group, 16/77 deaths (21%) were classified as probably cardiac compared with 32/91 (35%) in the VB group (unadjusted subdistribution hazard ratio 2.16, 95% confidence interval [CI] 1.20 - 3.87; unadjusted cause specific hazard ratio 2.15, 95% CI 1.19 - 3.90). At the point of randomisation, 64/344 (18.6%), 37/344 (10.8%), and 40/342 (9%) participants had a previous myocardial infarction (MI), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG), respectively. There was no evidence of varying treatment effects for cause of death in subgroup analyses of previous PCI, CABG, or MI. CONCLUSION: The excess mortality observed in the VB first revascularisation strategy group in BASIL-2 was largely due to deaths that were adjudicated by the Delphi panel as probably primarily cardiac. These excess cardiac deaths were observed throughout follow up and there was no evidence of non-proportional hazards. Further work is ongoing to try to better understand the reasons for these findings.
RESUMO
The discovery of increasing numbers of actionable molecular and gene targets for cancer treatment has driven the demand for tissue sampling for next-generation sequencing (NGS). Requirements for sequencing can be very specific, and inadequate sampling leads to delays in management and decision making. It is important that interventional radiologists are aware of NGS technologies and their common applications and be cognizant of the factors that contribute to successful sample sequencing. This review summarizes the fundamentals of cancer tissue collection and processing for NGS. It elaborates on sequencing technologies and their applications with the aim of providing readers with a working understanding that can enhance their clinical practice. It then describes imaging, tumor, biopsy, and sample collection factors that improve the chances of NGS success. Finally, it discusses future practice, highlighting the problem of undersampling in both clinical and research settings and the opportunities within interventional radiology to address this.
Assuntos
Neoplasias , Humanos , Neoplasias/genética , Biópsia , Sequenciamento de Nucleotídeos em Larga Escala/métodosRESUMO
OBJECTIVES: This article aims to present a prospective study investigating the safety and efficacy of the Mynx Control extravascular closure device (Cordis Corporation, FL, USA), for femoral arterial closure in patients undergoing peripheral arterial procedures. METHODS: Between January 2020 and February 2021, 100 Mynx Control devices were deployed in 91 consecutive patients (mean age: 67.5 ± 16.9 years) who underwent peripheral arterial procedures. We used ultrasound and/or fluoroscopy during Mynx Control deployment and ultrasound post-procedure to detect complications. Femoral artery punctures included 62 (62%) antegrade and 38 (38%) retrograde punctures. The mean activated clotting time at time of device deployment was 221s. The primary endpoints were technical success, device failure, and complication rates up to 30 days. RESULTS: A 5F vascular sheath was used in 43 cases (43%) (36 (36%) 6F and 21 (21%) 7F). The majority of our cases had antegrade access (62%). Overall technical success rate was 97% in both antegrade and retrograde cases. In total, there were 4 minor complications: 3 (3%) cases of pseudoaneurysm and 1 (1%) case of haematoma. No major complications were recorded post-procedure or 30 days post index procedure. CONCLUSION: The Mynx Control vascular closure device is safe and effective in achieving haemostasis in patients undergoing antegrade and retrograde peripheral angioplasty procedures.
Assuntos
Dispositivos de Oclusão Vascular , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Estudos Prospectivos , Técnicas Hemostáticas/efeitos adversos , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Resultado do Tratamento , Desenho de Equipamento , Estudos RetrospectivosRESUMO
Background: Haemodialysis access thrombosis is associated with significant morbidity and access abandonment rates, for which endovascular salvage is a well described treatment option. This study aimed to evaluate the outcomes of endovascular salvage procedures of thrombosed vascular access circuits and identify factors influencing outcomes. Patients and methods: Retrospective review of 328 consecutive procedures performed over 10 years at our institution between January 2010 and December 2019. Patient demographics, access circuit characteristics, procedure details and outcome data were collected. Kaplan-Meier survival curves were used to estimate patency rates and Cox multivariate regression analysis to identify factors affecting outcomes. Results: Technical and clinical success rates were 87.8% and 75.9% respectively. The primary, primary assisted and secondary patency rates at 6 months were 42.2%, 46.7% and 59.1%; and at 12 months were 23.4%, 28.3% and 41.8% respectively. Median access circuit survival was 9.2 months. Major complication rate was 5.2% including 3 procedure-related deaths. Native AVF, lower time from thrombosis to intervention and pharmacomechanical thrombectomy using AngioJetTM predicted positive outcomes. Previous thrombectomy within 3 months and residual thrombus at completion were associated with poorer outcomes. Age and hypertension predicted higher complication rates. Conclusions: This is one of the largest single center series of endovascular salvage of thrombosed haemodialysis access and demonstrates that endovascular treatment is effective and provides durable access circuit survival. Careful patient screening is essential to optimize outcomes.
Assuntos
Derivação Arteriovenosa Cirúrgica , Trombose , Humanos , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/cirurgia , Grau de Desobstrução Vascular , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Resultado do Tratamento , Trombose/diagnóstico por imagem , Trombose/etiologia , Trombose/cirurgia , Trombectomia/efeitos adversos , Trombectomia/métodos , Diálise Renal/efeitos adversos , Estudos RetrospectivosRESUMO
OBJECTIVE: The incidence of chronic limb-threatening ischemia in diabetic patients is increasing. The factors influencing outcome after infrapopliteal revascularization in these patients are largely unknown. Therefore, this study aims to identify the impact of perioperative glucose control on the long-term outcomes in this patient cohort, and furthermore to identify other factors independently associated with outcome. METHODS: Consecutive diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia were identified. Patients' demographics, procedural details, daily capillary blood glucose, and hemoglobin A1C levels were collected and analyzed against the study end points using Kaplan-Meier and Cox regression analysis. RESULTS: A total of 437 infrapopliteal target vessels were successfully crossed in 203 patients. Amputation-free survival by Kaplan-Meier (estimate (standard error)%) was 74 (3.3)% and 63 (3.7)%, primary patency was 61 (4.2)% and 50 (4.9)%, assisted primary patency was 69 (5.2)% and 55 (6.1)%, and secondary patency was 71 (3.8)% and 59 (4.1)% at 1 year and 2 years, respectively. Cox regression analysis showed high perioperative capillary blood glucose levels to be an independent predictor of binary restenosis (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.31-1.1.78; P = .015). Postprocedural dual-antiplatelet therapy was found to be an independent predictor of amputation-free survival (HR, 1.69; 95% CI, 1.04-2.75; P = .033), and freedom from major adverse limb events (HR: 1.96; 95% CI, 1.16-3.27; P = .023) and baseline estimated glomerular filtration rate was significantly associated with better amputation-free survival (HR, 0.52; 95% CI, 0.31-0.87; P = .014). CONCLUSIONS: Poor perioperative glycemic control is associated with a higher incidence of restenosis after infrapopliteal revascularization in diabetic patients. Dual antiplatelet therapy is associated with better outcomes in this group.
Assuntos
Isquemia Crônica Crítica de Membro/cirurgia , Angiopatias Diabéticas/complicações , Procedimentos Endovasculares/métodos , Extremidade Inferior/irrigação sanguínea , Artéria Poplítea , Idoso , Isquemia Crônica Crítica de Membro/epidemiologia , Isquemia Crônica Crítica de Membro/etiologia , Angiopatias Diabéticas/epidemiologia , Angiopatias Diabéticas/cirurgia , Feminino , Humanos , Incidência , Masculino , Prognóstico , Taxa de Sobrevida/tendências , Reino Unido/epidemiologiaRESUMO
PURPOSE: To examine the association between acute kidney injury (AKI) severity and duration with cardiovascular mortality, following endovascular treatment of femoropopliteal disease, and whether it is AKI in itself that confers an increased risk of cardiovascular mortality. METHODS: A retrospective analysis of prospectively collected data obtained between 2014 and 2019 from 3 vascular centers. Renal function was followed up for a minimum of 90 days. Electronic records were queried to establish a cause of death, where applicable. Patients were excluded if unable to provide written informed consent or if presenting with acute limb ischemia. Primary outcomes were the hazard ratios for cardiovascular death (AKI patients vs no AKI; no AKI vs stage 1 AKI vs stage 3 AKI; and no AKI vs transient AKI vs established AKI). Propensity score-matched analysis was used to establish whether developing AKI, in patients with similar demographics and procedural characteristics, is associated with a higher risk of cardiovascular death. RESULTS: Overall 239 patients developed AKI, and this was associated with an increased risk of cardiovascular mortality (hazard risk [HR]: 4.3, 95% confidence intervals [CIs]: 2.1-6.8, pairwise comparison p value=0.006]. This was dependent on the severity of the AKI stage (HR 5.4, 95% CI: 2.4-7.3, pairwise comparison p value=0.01) and duration (HR 4.2, 95% CI: 2.3-6.2, pairwise comparison p value=0.04). The propensity score-matched analysis showed that even when patients are matched for comorbidity and procedural characteristics, AKI confers an increased risk of mortality (p=0.04). CONCLUSIONS: Acute kidney injury is common after femoropopliteal endovascular therapy. It confers an increased risk of long-term cardiovascular mortality, which is still present when renal decline is transient, and highest for patients with established decline in renal function. CLINICAL IMPACT: This is the first study in the setting of peripheral arterial disease to show that acute kidney injury has an adverse effect on cardiovascular mortality, in the long-term, that is dependent on its severity, and present even when the AKI is transient. We have also shown that this difference in cardiovascular mortality becomes more pronounced from the medium-term, and thus closer follow-up of these patients is required.
RESUMO
PURPOSE: To assess the efficacy and safety of a catheter-directed hemorrhoidal dearterialization technique for the management of hemorrhoidal bleeding. MATERIALS AND METHODS: A systematic review and meta-analysis of pubmed, cochrane, and scopus databases was conducted according to the preferred reporting items for systematic reviews and meta-Analysis (PRISMA) guidelines. Clinical studies reporting on catheter-directed hemorrhoidal dearterialization for rectal bleeding were analyzed. RESULTS: Fourteen studies (n = 362) were identified. The mean maximum follow-up duration was 12.1 months (SD, 7.31; range, 1-28; median, 12), and the mean length of hospital stay was 1.5 days (SD, 1.1; range, 0-2.5). The mean technical success was 97.8% (SD, 3.5), and the mean clinical success was 78.9% (SD, 10.5). A statistically significant reduction in the french bleeding score before and after embolization was noted (P = .004). In subgroup analysis, when the coils-only group was compared with the coils and particles group, the average rebleeding rate was 21.5% (n = 111; SD, 18.2; range, 0%-44%) versus 10.05% (N = 108; SD, 4.8; range, 5%-15.7%), respectively (P < .0001). No bowel ischemia/necrosis or anorectal complications were reported. CONCLUSIONS: The current preliminary clinical evidence suggests that catheter-directed hemorrhoidal dearterialization is an effective and safe procedure for the treatment of hemorrhoidal bleeding. The standardization of the technique and the generation of higher level evidence will be required to compare this minimally invasive procedure with more invasive surgical options for patients with grades I-III hemorrhoids and chronic bleeding.
Assuntos
Hemorroidectomia , Hemorroidas , Catéteres , Hemorroidas/diagnóstico por imagem , Hemorroidas/cirurgia , Humanos , Ligadura , Reto , Resultado do TratamentoRESUMO
OBJECTIVE: Paclitaxel based drug coated balloons (DCBs) and drug eluting stents (DESs) may be associated with increased mortality in patients with peripheral arterial occlusive disease (PAOD), based on a recent meta-analysis. This study, however, had a number of limitations, which have been discussed at great length among the vascular community. The aim of this research was to assess the association between paclitaxel based endovascular treatment (PTX) in the femoropopliteal (F-P) segment and mortality, adjusting for relevant risk factors and including patients with chronic limb threatening ischaemia (CLTI). METHODS: This was a retrospective cohort study of a prospectively maintained multicentre (three sites) database of patients with claudication or CLTI. Patients having F-P angioplasty between 1 January 2014 and 30 May 2019 with or without PTX were included. Survival was compared in Cox regression analyses adjusted for parameters of the Charlson comorbidity index. A separate nested case matched (based on each individual's Charlson index) analysis was performed to compare mortality rates between those who received PTX and those who did not. RESULTS: A total of 2 071 patients were analysed: 966 patients (46.6%) were treated with PTX (952 [46%] had CLTI and 1 119 [54%] severe claudication [Rutherford stage 3]). Over a 24 month median follow up, 456 (22.1%) patients died. Using multivariable Cox regression, PTX was not associated with mortality (HR 0.94, p = .46), even when assessed separately for those with intermittent claudication (HR 1.30, p = .15) or CLTI (HR 0.81, p = .060). In the case matched analysis (885 matched pairs of patients), PTX was not associated with mortality (HR 0.89, p = .17). Paclitaxel dose and use of a DCB or DES were not associated with mortality in any subanalysis. CONCLUSION: When relevant risk factors were taken into account, there were no associations between PTX and mid term mortality in patients with PAOD.
Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Artéria Femoral , Claudicação Intermitente/terapia , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Fármacos Cardiovasculares/efeitos adversos , Bases de Dados Factuais , Inglaterra , Feminino , Artéria Femoral/diagnóstico por imagem , Grécia , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/mortalidade , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Artéria Poplítea/diagnóstico por imagem , Desenho de Prótese , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoAssuntos
Varizes , Humanos , Resultado do Tratamento , Feminino , Masculino , Varizes/cirurgia , Varizes/terapia , Reino Unido/epidemiologia , Pessoa de Meia-Idade , IdosoRESUMO
BACKGROUND: Percutaneous transluminal angioplasty (PTA) is a common procedure in patients with peripheral arterial disease (PAD) affecting the femoropopliteal segment (F-P). Biomimetic nitinol stents (Supera peripheral stent, SPS) and drug eluting stents (DES) were designed to improve the longevity of F-P PTA; however, their performance has not been compared in a pragmatic setting, taking atherosclerotic plaque characteristics into account. METHODS: Overall, 296 consecutive patients (mean age: 73 y, SD: 11 y, 65% male, 68% with chronic limb threatening ischaemia) who underwent F-P PTA using SPS or DES between 2013 and 2018 were identified from a prospectively maintained institutional database. Patient and plaque characteristics, including F-P plaque characterisation based on computed tomography, were collected; 121 case matched pairs were created using a propensity score based on patient and plaque data. RESULTS: During the median two year follow up, 28% of the cohort (32% SPS vs. 24% DES, p = .07) developed target lesion restenosis (TLR) > 50%. Among the 121 case matched pairs of patients, those with SPS vs. DES were not significantly more likely to develop TLR >50% (31% vs. 27%, p = .34), or stent occlusion (13% vs. 12%, p = .85 - secondary patency rate 87% vs. 88%), have a major amputation (10% vs. 6%, p = .16), require re-intervention (14% vs. 9%, p = .12), or die (7% vs.4%, p = .31). Plaque calcification did not predict restenosis or occlusion in either stent group, both in the matched and non matched populations. Multivariable analysis adjusted for patient and plaque characteristics revealed that the main predictors of restenosis >50% at two years were female sex [odds ratio (OR): 2.05, p = .01], hypertension (OR: 2.10, p = .04) and previous F-P occlusion (OR: 1.35, p = .04). CONCLUSION: Medium term results following F-P PTA with either SPS or DES are comparable, regardless of plaque calcification and patient characteristics.
Assuntos
Ligas/uso terapêutico , Angioplastia/instrumentação , Artéria Femoral , Oclusão de Enxerto Vascular , Doença Arterial Periférica , Artéria Poplítea , Stents , Idoso , Angioplastia/efeitos adversos , Angioplastia/métodos , Angiografia por Tomografia Computadorizada/métodos , Angiografia por Tomografia Computadorizada/estatística & dados numéricos , Extremidades/irrigação sanguínea , Feminino , Artéria Femoral/patologia , Artéria Femoral/cirurgia , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/epidemiologia , Oclusão de Enxerto Vascular/etiologia , Humanos , Salvamento de Membro/métodos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Doença Arterial Periférica/patologia , Doença Arterial Periférica/fisiopatologia , Doença Arterial Periférica/cirurgia , Placa Aterosclerótica/diagnóstico por imagem , Artéria Poplítea/patologia , Artéria Poplítea/cirurgia , Prognóstico , Stents/efeitos adversos , Stents/classificação , Calcificação Vascular/diagnóstico por imagem , Grau de Desobstrução VascularRESUMO
PURPOSE: To report use of the Outback reentry device for targeted distal reentry during subintimal recanalization of chronic total occlusions (CTOs) in the infragenicular arteries. METHODS: During an 18-month period, the Outback device was applied in 10 patients (mean age 71.8±18.8 years; 8 men) to achieve reentry at the infragenicular segment following either unsuccessful spontaneous reentry after subintimal crossing of a CTO or when a targeted reentry was desired. The mean occlusion length was 117.5±101.0 mm. Technical (device) success, overall procedure success, and reentry accuracy are reported, along with any major or minor complications. RESULTS: The device was technically successful in achieving reentry in 9 of 10 cases; overall procedure success was achieved in 8 owing to heavy calcifications in a distal posterior tibial artery and a distal popliteal artery. The reentry accuracy was 10.8±14.6 mm. There were no major complications and only 3 minor sequelae, including 2 dissections and 1 small perforation; all were treated successfully with stenting. CONCLUSION: The Outback device has a high technical success rate in achieving targeted true lumen reentry in infragenicular subintimal angioplasty when spontaneous reentry is not possible or a targeted reentry is desirable.
Assuntos
Angioplastia com Balão/instrumentação , Doença Arterial Periférica/terapia , Dispositivos de Acesso Vascular , Calcificação Vascular/terapia , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Doença Crônica , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Estudos Retrospectivos , Stents , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/fisiopatologiaRESUMO
BACKGROUND: Endovascular treatment of infrapopliteal peripheral arterial disease (PAD) is an established and effective treatment strategy for patients with symptomatic PAD. Increasingly, complex infrapopliteal lesions are treated with an endovascular first approach, especially in the setting of critical limb ischemia (CLI) for limb salvage, avoiding major amputations which impact on mobility and quality of life. However, many complex infrapopliteal lesions involving the bifurcation of the tibial arteries remain challenging to treat because of recoil or acute dissection after angioplasty and may require stenting using specialized techniques. METHODS AND RESULTS: We illustrated techniques for infrapopliteal arterial bifurcation stenting using case-based examples. The techniques covered include the single-stent, culottes, kissing, crush, and T-stenting techniques, and each is considered based on individual strengths and limitations. CONCLUSIONS: Infrapopliteal bifurcation stenting allows complex bifurcation lesions to be treated effectively when flow-limiting complications are encountered after angioplasty.
Assuntos
Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/métodos , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Angiografia , Angioplastia com Balão/instrumentação , Estado Terminal , Procedimentos Endovasculares/efeitos adversos , Humanos , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Radiografia Intervencionista , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
PURPOSE: To provide a qualitative analysis and quantitative synthesis of randomized controlled trials (RCTs) investigating paclitaxel-coated balloons (PCBs) in the femoropopliteal artery. METHODS: PubMed, EMBASE, AMED, Scopus, CENTRAL, online content, and abstracts from international meetings were last screened in April 2015 for eligible RCTs using the PRISMA selection process. Risk of bias was assessed using the Cochrane Collaboration's tool, and quality of evidence was evaluated with the GRADE system. Outcome measures included late lumen loss (LLL) at 6 months and event rates of major limb amputations, binary lesion restenosis, and target lesion revascularization (TLR). Pooled treatment effects were analyzed in a random effects model to account for clinical heterogeneity; the outcomes are presented as the rate ratios (RRs) and their 95% confidence intervals (CIs). Extensive meta-regression was performed to analyze potential confounders. The review was registered in the PROSPERO database (CRD42015023938; www.crd.york.ac.uk/PROSPERO). RESULTS: Eleven RCTs with 1609 subjects (1403 claudicants and 206 patients with critical limb ischemia) with medium-length femoropopliteal lesions (mean range 5.1-11.9 cm) were included. There was consistently high-quality evidence supporting the clear superiority of PCBs in terms of reduced LLL (mean difference -0.89 mm, 95% CI -1.14 to -0.64, p<0.001), less binary restenosis (RR 0.47, 95% CI 0.37 to 0.61, p<0.001), and fewer TLR events (RR 0.33, 95% CI 0.22 to 0.49, p<0.001). Major amputations were rare in both active and control arms (pooled event rate: 0.7%, 95% CI 0.3% to 1.2%). Results were stable across all potential risk modifiers and in the presence of stents as well. There was high-quality evidence that the dose of paclitaxel was related to the magnitude of the treatment effect; standard dose (3.0-µg and 3.5-µg) PCBs were significantly more effective compared with low-dose 2-µg PCB in reducing both restenosis (RR 2.1, 95% CI 1.2 to 3.4, p<0.001) and TLR (RR 2.5, 95% CI 1.9 to 3.8, p<0.001). CONCLUSION: PCBs reduce by more than half the rates of restenosis and TLR in the femoropopliteal artery regardless of stent placement. Biologic effect size may vary according to paclitaxel bioavailability.
Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral/efeitos dos fármacos , Paclitaxel/análogos & derivados , Doença Arterial Periférica/terapia , Artéria Poplítea/fisiopatologia , Dispositivos de Acesso Vascular , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Disponibilidade Biológica , Fármacos Cardiovasculares/efeitos adversos , Fármacos Cardiovasculares/farmacocinética , Distribuição de Qui-Quadrado , Constrição Patológica , Desenho de Equipamento , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Salvamento de Membro , Razão de Chances , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Paclitaxel/farmacocinética , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
PURPOSE: To report a Bayesian network meta-analysis of randomized controlled trials (RCTs) comparing bare metal stents (BMS), paclitaxel-coated balloons (PCBs), and drug-eluting stents (DES) with balloon angioplasty (BA) or with each other in the infrapopliteal arteries. METHODS: Sixteen RCTs comprising 1805 patients with 1-year median follow-up were analyzed. Bayesian random effects binomial models were employed (WinBUGS). Relative treatment effects were expressed as odds ratios (ORs) with 95% credible intervals (CrI), and the cumulative rank probabilities were calculated to provide hierarchies of competing treatments. Quality of evidence (QoE) was assessed with the GRADE (grading of recommendations assessment, development, and evaluation) system. Sensitivity, heterogeneity, and consistency analyses were performed. RESULTS: There was high QoE that infrapopliteal DES significantly reduced restenosis compared with BMS (OR 0.26, 95% CrI 0.12 to 0.51) and BA (OR 0.22, 95% CrI 0.11 to 0.45). Likewise, DES significantly reduced target lesion revascularization (TLR) compared with BA (OR 0.41, 95% CrI 0.22 to 0.75) and BMS (OR 0.26, 95% CrI 0.15 to 0.45). Paclitaxel-coated balloons also reduced TLR compared with BA (OR 0.55, 95% CrI 0.34 to 0.90) and BMS (OR 0.35, 95% CrI 0.18 to 0.67), but QoE was low to moderate. BA had lower TLR than BMS (OR 0.63, 95% CrI 0.40 to 0.99) with high QoE. DES was the only treatment that significantly reduced limb amputations compared with BA (OR 0.58, 95% CrI 0.35 to 0.96), PCB (OR 0.51, 95% CrI 0.26 to 0.98), or BMS (OR 0.38, 95% CrI 0.19 to 0.72) with moderate to high QoE. DES also significantly improved wound healing compared with BA (OR 2.02, 95% CrI 1.01 to 4.07) or BMS (OR 3.45, 95% CrI 1.41 to 8.73) with high QoE. Results were stable on sensitivity and meta-regression analyses without any significant publication bias or inconsistency. CONCLUSION: Infrapopliteal DES were associated with significantly lower rates of restenosis, TLR, and amputations and improved wound healing compared to BA and BMS. DES also significantly reduced amputations compared with PCB.
Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Metais , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Dispositivos de Acesso Vascular , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Teorema de Bayes , Fármacos Cardiovasculares/efeitos adversos , Pesquisa Comparativa da Efetividade , Constrição Patológica , Humanos , Salvamento de Membro , Cadeias de Markov , Metanálise em Rede , Razão de Chances , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/fisiopatologia , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular , CicatrizaçãoRESUMO
We report two cases of early aneurysmal vessel dilatation after a paclitaxel-coated balloon (PCB) was used for angioplasty of the peripheral vessels. The first case refers to a failing vein bypass with a tight proximal anastomotic stenosis, whereas the second refers to a distal tibial artery occlusion. A PCB was used to treat both patients. Aneurysmal dilatation of the previously treated segment was noted in both patients during subsequent follow-up imaging. In the absence of other causal factors, we attribute both cases to PCB application. The aneurysms that formed had no detrimental effect on the patients' health and required no further treatment; however, it is important to bear in mind this potential risk of presumed paclitaxel toxicity.
Assuntos
Aneurisma/induzido quimicamente , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/efeitos adversos , Materiais Revestidos Biocompatíveis , Paclitaxel/efeitos adversos , Veia Safena/efeitos dos fármacos , Veia Safena/transplante , Artérias da Tíbia/efeitos dos fármacos , Dispositivos de Acesso Vascular , Idoso de 80 Anos ou mais , Aneurisma/diagnóstico , Fármacos Cardiovasculares/administração & dosagem , Dilatação Patológica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Radiografia , Veia Safena/diagnóstico por imagem , Veia Safena/patologia , Artérias da Tíbia/diagnóstico por imagemRESUMO
PURPOSE: To report a single-center experience with the Outback re-entry device for targeted distal true lumen re-entry during subintimal recanalization of chronic total occlusions (CTOs) and compare the results with a systematic review of the literature. METHODS: Between February 2011 and July 2013, 104 Outback devices were employed in 91 patients (mean age 64±9 years; 57 men) for subintimal recanalization of 100 vessels with CTOs after initial failure of spontaneous reentry. Fifty-two cases involved a retrograde approach to aortoiliac occlusions and 48 were re-entry attempts in infrainguinal CTOs. Outcome measures included complications and technical success, defined as successful targeted re-entry at the preplanned site of the distal true lumen. To evaluate device accuracy, the re-entry distance (between the point of true vessel reconstitution and the eventual re-entry point) was measured. RESULTS: Outback success was 93% (93/100); only 7 cases failed owing to heavy calcification (5/52 aortoiliac vs 2/48 infrainguinal, p=0.44). Re-entry was highly accurate, with a re-entry distance of ~1 cm in both subgroups (1.2±0.1 cm in aortoiliac vs 1.3±0.1 cm in infrainguinal, p=0.40). There were no major and 17 minor complications (9/52 aortoiliac vs 8/48 infrainguinal, p=0.93). Results are in line with the systematic review that identified 11 studies (only 1 randomized trial) involving mostly the femoropopliteal segment (119 aortoiliac and 464 infrainguinal segments). The pooled Outback success rate was 90% (95% confidence interval 85% to 94%) and the pooled complication rate was 4.3% (95% confidence interval 1.6% to 8.3%). CONCLUSION: The Outback device is safe and has a very high rate of achieving targeted true lumen re-entry, which minimizes the sacrifice of healthy vessel in the aortoiliac and infrainguinal arteries.