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INTRODUCTION: We aimed to investigate the performance of several neuroimaging markers provided by perfusion imaging of Acute Ischemic Stroke (AIS) patients with large vessel occlusion (LVO) in order to predict clinical outcomes following reperfusion treatments. METHODS: We prospectively evaluated consecutive AIS patients with LVO who were treated with reperfusion therapies, during a six-year period. In order to compare patients with good (mRS scores 0-2) and poor (mRS scores 3-6) functional outcomes, data regarding clinical characteristics, the Alberta Stroke Programme Early Computed Tomography Score (ASPECTS) based on unenhanced computed tomography (CT), CT angiography collateral status and perfusion parameters including ischemic core, hypoperfusion volume, mismatch volume between core and penumbra, Tmax > 10 s volume, CBV index and the Hypoperfusion Index Ratio (HIR) were assessed. RESULTS: A total of 84 acute stroke patients with LVO who met all the inclusion criteria were enrolled. In multivariable logistic regression models increasing age (odds ratio [OR]: 0.93; 95%CI: 0.88-0.96, p = 0.001), lower admission National Institute of Health Stroke Scale (NIHSS)-score (OR: 0.88; 95%CI: 0.80-0.95, p = 0.004), pretreatment with intravenous thrombolysis (OR: 3.83; 95%CI: 1.29-12.49, p = 0.019) and HIR (OR:0.36; 95%CI: 0.10-0.95, p = 0.042) were independent predictors of good functional outcome at 3 months. The initial univariable associations between HIR and higher likelihood for symptomatic intracranial hemorrhage (sICH) and parenchymal hematoma type 2 (PH2) were attenuated in multivariable analyses failing to reach statistical significance. DISCUSSION: Our pilot observational study of unselected AIS patients with LVO treated with reperfusion therapies demonstrated that pre-treatment low HIR in perfusion imaging and IVT were associated with better functional outcomes.
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BACKGROUND: Compression ultrasonography of the leg is established for triaging proximal lower extremity deep vein thrombosis (DVT). AutoDVT, a machine-learning software, provides a tool for nonspecialists in acquiring compression sequences to be reviewed by an expert for patient triage. The purpose of this study was to test image acquisition and remote triaging in a clinical setting. METHODS: Patients with a suspected DVT were recruited at 2 centers in Germany and Greece. Enrolled patients underwent an artificial intelligence-guided two-point compression examination by a nonspecialist using a handheld ultrasound device prior to a standard scan. Images collected by the software were uploaded for blind review by 5 qualified physicians. All reviewers rated the quality of all sequences on the American College of Emergency Physicians (ACEP) image quality scale (score 1-5, ≥ 3 defined as adequate imaging quality) and for an ACEP score ≥3, chose "Compressible", "Incompressible", or "Other". Sensitivity and specificity were calculated for adequate quality scans with an assessment as "Compressible" or "Incompressible". We define this group as diagnostic quality. To simulate a triaging clinical algorithm, a post hoc analysis was performed merging the "incomplete", the "low quality", and the "Incompressible" into a high-risk group for proximal DVT. RESULTS: Seventy-three patients (average age 64.2 years, 44% females) were eligible for inclusion and scanned by 3 nonultrasound-qualified healthcare professionals. Three patients were excluded from further analysis due to incomplete scans. Sixty two of 70 (88.57%) of the completed scans were judged to be of adequate image quality with an average ACEP score of 3.35. Forty seven of 62 adequate AutoDVT scans were assessed as diagnostic quality, of which 8 were interpreted as positive for proximal DVT by the reviewers resulting in a sensitivity of 100% and specificity of 95.12%. When simulating a triaging algorithm, 34/73 (46.58%) of patients would be triaged as high risk and 8 would be confirmed as positive for proximal DVT (6 in the diagnostic and 2 in the low-quality cohort). Of 39/73 patients triaged as low risk, all were negative for proximal DVT in standard duplex; thus, this triaging algorithm could potentially save 53.42% of standard duplex scans. CONCLUSIONS: Machine learning software was able to aid nonexperts in acquiring valid ultrasound images of venous compressions and allowed remote triaging. This strategy allows faster diagnosis and treatment of high-risk patients and can spare the need for multiple unnecessary duplex scans, the vast majority being negative.
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Inteligencia Artificial , Trombosis de la Vena , Femenino , Humanos , Persona de Mediana Edad , Masculino , Triaje , Resultado del Tratamiento , Trombosis de la Vena/diagnóstico por imagen , Ultrasonografía/métodosRESUMEN
OBJECTIVES: Cerebral venous thrombosis is an uncommon, yet life-threatening condition, affecting mainly young and middle-aged individuals. Moreover, it represents an underrecognised etiology of lobar intracerebral hemorrhage (ICH). The clinical course of CVT is variable in the first days after diagnosis and medical complications including pulmonary embolism (PE) may result in early neurological deterioration and death if left untreated. MATERIALS AND METHODS: Case report. RESULTS: We describe a 46-year-old man with acute left hemiparesis and dysarthria in the context of lobar ICH due to underlying CVT of Trolard vein. Diagnosis was delayed because of misinterpretation of the initial neuroimaging study. Subsequently, the patient rapidly deteriorated and developed submassive PE and left iliofemoral venous thrombosis in the setting of previously undiagnosed hereditary thrombophilia (heterozygous prothrombin gene mutation G2021A). Emergent aspiration thrombectomy was performed resulting in the successful management of PE. A follow-up MRI study confirmed the thrombosed Trolard vein, thus establishing the CVT diagnosis. Anticoagulation treatment was immediately escalated to enoxaparine therapeutic dose resulting in clinical improvement of neurological deficits. CONCLUSIONS: Delayed diagnosis of cerebral venous thrombosis with underlying causes of lobar ICH may result in dire complications. Swift initiation of anticoagulants is paramount even in patients with lobar intracerebral hemorrhage as the initial manifestation of cerebral venous thrombosis.
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Anticoagulantes , Hemorragia Cerebral , Trombosis Intracraneal , Trombosis de la Vena , Humanos , Masculino , Persona de Mediana Edad , Hemorragia Cerebral/etiología , Hemorragia Cerebral/diagnóstico por imagen , Hemorragia Cerebral/terapia , Hemorragia Cerebral/diagnóstico , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/etiología , Trombosis de la Vena/terapia , Trombosis de la Vena/diagnóstico , Trombosis de la Vena/complicaciones , Trombosis Intracraneal/diagnóstico por imagen , Trombosis Intracraneal/terapia , Trombosis Intracraneal/etiología , Trombosis Intracraneal/diagnóstico , Trombosis Intracraneal/complicaciones , Anticoagulantes/uso terapéutico , Resultado del Tratamiento , Trombectomía , Diagnóstico Tardío , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/terapia , Embolia Pulmonar/etiología , Embolia Pulmonar/diagnóstico por imagen , Valor Predictivo de las PruebasRESUMEN
OBJECTIVE: Carotid cavernous fistulas (CCFs) represent uncommon and anomalous communications between the carotid artery and the cavernous sinus. MATERIALS AND METHODS: Case report RESULTS: We present the clinical details and successful management of a previously healthy 44-year-old patient who presented with one-month worsening headache, bilateral abducens palsy and conjunctival injection. Imaging modalities including magnetic resonance imaging (MRI) with contrast and digital subtraction angiography (DSA) facilitated the diagnosis of CCF. The patient underwent endovascular coiling of the CCF, leading to neurological recovery and symptom remission. CONCLUSION: This case highlights the importance of promptly CCF diagnosis in patients with multiple cranial nerve palsies and conjunctival hyperemia. Moreover, it emphasizes the efficacy of endovascular coiling in achieving symptom remission.
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Enfermedades del Nervio Abducens , Fístula del Seno Cavernoso de la Carótida , Seno Cavernoso , Embolización Terapéutica , Hiperemia , Humanos , Adulto , Fístula del Seno Cavernoso de la Carótida/complicaciones , Fístula del Seno Cavernoso de la Carótida/diagnóstico por imagen , Hiperemia/diagnóstico por imagen , Hiperemia/complicaciones , Seno Cavernoso/diagnóstico por imagen , Enfermedades del Nervio Abducens/diagnóstico por imagen , Enfermedades del Nervio Abducens/etiología , Enfermedades del Nervio Abducens/terapia , Arterias Carótidas , Embolización Terapéutica/efectos adversosRESUMEN
Transarterial chemoembolization (TACE) has revolutionized the treatment landscape for malignant liver disease, offering localized therapy with reduced systemic toxicity. This manuscript delves into the use of degradable microspheres (DMS) in TACE, exploring its potential advantages and clinical applications. DMS-TACE emerges as a promising strategy, offering temporary vessel occlusion and optimized drug delivery. The manuscript reviews the existing literature on DMS-TACE, emphasizing its tolerability, toxicity, and efficacy. Notably, DMS-TACE demonstrates versatility in patient selection, being suitable for both intermediate and advanced stages. The unique properties of DMS provide advantages over traditional embolic agents. The manuscript discusses the DMS-TACE procedure, adverse events, and tumor response rates in HCC, ICC, and metastases.
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Quimioembolización Terapéutica , Neoplasias Hepáticas , Microesferas , Humanos , Quimioembolización Terapéutica/métodos , Neoplasias Hepáticas/terapia , Carcinoma Hepatocelular/terapiaRESUMEN
BACKGROUND: Endovascular treatment (EVT) for acute ischemic stroke (AIS) patients presenting with National Institutes of Health Stroke Scale score of 0 to 5 is common in clinical practice but has not yet been proven safe and effective. Our objective is to assess whether EVT on top of best medical treatment (BMT) in AIS patients with large-vessel occlusion of the anterior circulation presenting with mild symptoms is beneficial compared with BMT. METHODS: We searched MEDLINE, SCOPUS, and reference lists of retrieved articles published until December 28, 2022. A systematic literature search was conducted to identify clinical trials or observational cohort studies evaluating patients with AIS due to anterior circulation large-vessel occlusion and admission National Institutes of Health Stroke Scale score ≤5 treated with EVT versus BMT alone. The primary outcome was excellent functional outcome (modified Rankin Scale score 0-1) at 3 months. The protocol had been registered before data collection (PROSPERO). RESULTS: Eleven observational eligible studies were included in the meta-analysis, comprising a total of 2019 AIS patients with National Institutes of Health Stroke Scale score ≤5 treated with EVT versus 3171 patients treated with BMT. EVT was not associated with excellent functional outcome (risk ratio, 1.10 [95% CI, 0.93-1.31]). When stratified for different study design (per-protocol versus intention-to-treat), there were no significant subgroup differences. EVT was not associated with good functional outcome (modified Rankin Scale score 0-2; risk ratio, 1.01 [95% CI, 0.89-1.16]) or reduced disability at 3 months (common odds ratio, 0.92 [95% CI, 0.60-1.41]). Symptomatic intracranial hemorrhage was more common in the patients receiving EVT (risk ratio, 3.53 [95% CI, 2.35-5.31]). No correlation was found between EVT and mortality at 3 months (risk ratio, 1.34 [95% CI, 0.83-2.18]). The same overall associations were confirmed in the sensitivity analysis of studies that performed propensity score matching. CONCLUSIONS: EVT appears equivalent to BMT for patients with anterior circulation large-vessel occlusion AIS with low baseline National Institutes of Health Stroke Scale, despite the increased risk for symptomatic intracranial hemorrhage. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42022334417.
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Isquemia Encefálica , Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Lesiones del Sistema Vascular , Humanos , Accidente Cerebrovascular/cirugía , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular Isquémico/complicaciones , Isquemia Encefálica/cirugía , Isquemia Encefálica/tratamiento farmacológico , Resultado del Tratamiento , Procedimientos Endovasculares/métodos , Hemorragias Intracraneales/etiología , Trombectomía/métodos , Lesiones del Sistema Vascular/etiologíaRESUMEN
PURPOSE: To investigate whether Doppler ultrasound (DUS) blood flow parameters could serve as quantifiable functional endpoints of peripheral endovascular arterial procedures for chronic limb-threatening ischemia (CLTI), influencing wound healing. METHODS: This is a prospective single-center study investigating intraprocedural DUS parameters (pulsatility index [PI] and pedal acceleration time [PAT]) in quantifying immediate hemodynamic alterations in consecutive CLTI patients with wound, ischemia, and foot infection wound class ≥1 undergoing endovascular interventions. Primary endpoints were feasibility of preendovascular and postendovascular treatment measurements of PI/PAT, quantification of immediate PI/PAT modifications of the posterior and anterior foot circulation following revascularization, the correlation between PI and PAT, and 6-month complete wound healing. Secondary endpoints included the 6-month limb salvage (no major amputation) and complete and partial wound healing rates. RESULTS: A total of 28 patients (75.0% male) were enrolled, and 68 vessels were treated. The overall mean PAT values significantly decreased from 154.15±70.35 ms preprocedural to 107.21±49.6 ms postprocedural (p<0.01), and the mean PI values significantly increased from 0.93±0.99 to 1.92±1.96 (p<0.01). Postprocedural PAT at the anterior tibial (r2=0.804; p=0.346) and the posterior tibial arteries (r2=0.784; p=0.322) had a strong correlation and postprocedural PI at the anterior tibial (r2=0.704; p=0.301) and the posterior tibial arteries (r2=0.707; p=0.369) had a good correlation with 6-month complete wound healing. The 6-month complete and partial wound healing rates were 38.1% and 47.6%, respectively. Limb salvage was 96.4% and 92.4% at 6 and 12 months of follow-up, respectively. CONCLUSIONS: Pedal acceleration time and PI accurately detected immediate hemodynamic changes of foot perfusion following revascularization and could serve as prognostic factors of wound healing in patients with CLTI. CLINICAL IMPACT: Intraprocedural measurement of simple Doppler ultrasound blood flow parameters, Pulsatility Index (PI) and Pedal Acceleration Time (PAT), accurately detected immediate hemodynamic changes of foot perfusion following endovascular revascularization and could therefore serve as intraprocedural prognostic factors of wound healing in patients with chronic limb-threatening ischemia. This is the first time that PI has been proposed as a hemodynamic index of successful angioplasty outcome. The optimization of intraprocedural PAT and PI could be used to guide angioplasty and predict clinical success.
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PURPOSE: This study aims to investigate the safety and efficacy of a new device using microwave technology for the endovenous ablation of the great saphenous vein (GSV) causing symptomatic lower limb varicose veins (LLVV). MATERIALS AND METHODS: This prospective, single-arm, single-center, cohort study investigated the safety and effectiveness of endovenous microwave ablation for the treatment of symptomatic LLVV. Enrollment period was set between January and December 2020. Primary safety endpoint was the occurrence of procedure-related complications and primary efficacy endpoint was anatomical success defined as the duplex ultrasound (DUS)-proven GSV occlusion at 1 year follow-up. Secondary endpoints included 1-year clinical success (CEAP classification improvement), repeat procedures rate due to GSV recanalization, and pain assessment at 24 h post treatment. RESULTS: In total, 50 patients (42 female; mean age: 62 ± 12 years) with 64 limbs were treated. No procedure-related complications were noted. Technical success was 95.3% (61/64 GSVs), as three cases of GSV recanalization were detected. Clinical success was 100%, as in all cases symptoms improvement by at least one grade according to CEAP classification, was achieved. Mean CEAP grade significantly improved from 3.3 ± 0.72 (median: 3) at baseline to 1.8 ± 0.85 (median: 2) at 1-year (p < 0.0001). There were no repeat procedures due to GSC recanalization. The median 24-h VAS value was 2 (mean: 1.9 ± 1.4). CONCLUSIONS: Endovenous microwave ablation was safe and effective for the treatment of varicose veins, achieving high 1-year GSV occlusion rates.
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Terapia por Láser , Várices , Insuficiencia Venosa , Humanos , Femenino , Persona de Mediana Edad , Anciano , Estudios de Cohortes , Estudios Prospectivos , Microondas/efectos adversos , Resultado del Tratamiento , Várices/diagnóstico por imagen , Várices/cirugía , Extremidad Inferior , Vena Safena/diagnóstico por imagen , Vena Safena/cirugía , Terapia por Láser/efectos adversos , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/etiologíaRESUMEN
PURPOSE: To evaluate the clinical efficacy and safety of drug-coated balloon (DCB) ureteroplasty for the management of non-malignant ureteral strictures. MATERIAL AND METHODS: A prospective "off-label" monocentric single-arm pilot study investigating the safety and efficacy of drug-coated balloon (DCB) (Lutonix®; BD, USA) was performed. Twenty-five patients with benign ureteral strictures related to uretero-enteric anastomosis (n = 13); lithiasis (n = 5), post-surgical complications (iatrogenic n = 5), transplanted kidney (n = 1) and post-radiotherapy (n = 1) were included. Following lesion crossing, predilatation was performed using 4-7 mm high-pressure balloon catheter (5-6Fr) with a balloon pressure of 6-7 atm based on the manufacturer's recommendation. In the absence of rupture of the ureteral wall, the DCB was dilated for 4 min. across the lesion. The process was repeated if deemed necessary to a maximum of three stricture dilatations. We analysed both clinical and radiological primary patency (no signs of ipsilateral hydronephrosis or improvement of the existing residual dilatation at the follow-up examinations) and secondarily safety endpoints. RESULTS: Mean lesion length was 40 ± 28.5 mm. Mean time follow up was 36 months ± 10.46 months. Strictures were located at upper ureteric (12%), lower ureteric (32%), ureterovesical anastomosis (4%) and uretero-enteric anastomosis (52%) levels. The overall radiological success at 1-year follow-up was 88% (22/25 patients). In 56% patients (14/25 patients with primary patency) the nephrostomy catheter was removed 21 days following a single DCB procedure. In 32% (8/25 patients) an additional dilatation sessions were required for maintaining the ureteral patency. The overall failure rate at 1-year follow-up was 12% (3/25 patients). Only one case of febrile urinary tract infection in a female patient (acute pyelonephritis) was encountered after the first dilatation. CONCLUSIONS: Paclitaxel-coated balloon ureteroplasty proved to be safe and effective for the treatment of non-malignant ureteral strictures. Larger studies are warranted to validate these promising initial results.
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Paclitaxel , Obstrucción Ureteral , Constricción Patológica/etiología , Femenino , Humanos , Masculino , Proyectos Piloto , Estudios Prospectivos , Resultado del Tratamiento , Obstrucción Ureteral/etiología , Obstrucción Ureteral/cirugíaRESUMEN
OBJECTIVES: To investigate the feasibility of VF-assisted angioplasty (VFA) in dysfunctional AVF using sequential intraprocedural duplex ultrasound (DUS), to utilize intraprocedural VF as a quantifiable, functional endpoint in endovascular treatment. METHODS: This prospective study included 20 consecutive patients (23 lesions; 16 men; mean age 67 ± 16 years) with dysfunctional AVF undergoing fluoroscopically guided balloon angioplasty between June 2019 and May 2020. Primary endpoints were quantification of outcome using sequential DUS VF analysis following each dilation, 6-month target lesion re-intervention (TLR)-free rate, standard technical success, procedural success (achievement of a postprocedural VF value equal (or 10% less) or superior to the baseline steady-state access), and correlation between procedural success and TLR-free rate. Secondary endpoints included 6-month lesion late lumen loss (LLL), correlation between balloon diameter used and intraprocedural VF values, and correlation between VF and LLL at 6 months follow-up. RESULTS: Mean VF increase was 168.5% ± 102.5% (range: 24.24-493.33%). Procedural success was 80% (16/20 cases). VFA improved procedural success by 20% (4/20 cases) compared to standard assessment (< 30% residual stenosis and palpable thrill). TLR-free rate was 78.3% and 67.3% at 6 and 12 months. Significantly less TLR was noted in cases of procedural success (82.4% vs. 66.7% 6 months; p = 0.041). Unweighted linear regression showed a significant positive relationship between diameter of balloon and VF (146.9 ± 42.3 mL/min VF gain per mm of balloon diameter; p = 0.001, R2 = 0.23) and a significant negative relationship between LLL and VF decline at follow-up (102.0 ± 34.6 mL/min loss per mm of LLL; p = 0.01, R2 = 0.35). Optimal VF cutoff value and percentile increase to predict access failure were 720 mL/min (sensitivity 58.3%, specificity 71.4%) and 153% (sensitivity 66.7%, specificity 85.7%), respectively. CONCLUSION: Intraprocedural VF assessment could be used to optimize AVF angioplasty. KEY POINTS: ⢠A newly proposed functional endpoint of angioplasty in dysfunctional dialysis fistula was evaluated and angioplasty outcome was quantified using volume flow (VF) assessment with sequential intraprocedural DUS. ⢠Intraprocedural VF assessment improved immediate procedural success; increased balloon diameter was correlated with VF gain and late lumen loss with VF decline. ⢠Intraprocedural VF values ≥ to baseline steady-state values were correlated with less re-interventions.
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Fístula Arteriovenosa , Derivación Arteriovenosa Quirúrgica , Anciano , Anciano de 80 o más Años , Angioplastia , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Estudios ProspectivosRESUMEN
PURPOSE: Thoracic endovascular aortic aneurysm repair (TEVAR) has emerged as an attractive alternative option in the treatment of thoracoabdominal aortic aneurysm (TAAA) diseases, reporting lower morbidity and mortality rates compared with open or hybrid repair. A challenging situation arises when the aneurysm involves the celiac artery (CA), precluding a safe distal landing zone. We investigated the safety and efficacy of CA coverage in the treatment of complex TAAA diseases during endovascular management. MATERIALS AND METHODS: A review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. The electronic bibliographic sources searched were MEDLINE and SCOPUS databases. Primary outcomes of interest were perioperative and 30-day mortality. Any type of endoleak, mesenteric ischemia, perioperative spinal cord ischemia, and reintervention rates were secondary end points. A random-effects meta-analysis was performed. Summary statistics of event risks were expressed as proportions and 95% confidence interval (CI). RESULTS: Ten observational cohort studies published between 2009 and 2020, reporting a total of 175 patients, were eligible for quantitative synthesis. Indications for TEVAR were primary TAAAs in 82% of patients, aortic dissection in 14% of patients, type Ib endoleak after previous endograft deployment in 3% of patients, and penetrating aortic ulcer in 1 patient. Reintervention rate was 9% (95% CI, 4%-20%) and spinal cord ischemia was 7% (95% CI, 4%--12%). Type II endoleak was the predominant type of endoleak in 10% of patients (95% CI, 4%-22%), followed by type I endoleak in 5% of patients (95% CI, 2%-12%) and type III endoleak in 1% (95% CI, 0%-16%) of patients. Mesenteric ischemia occurred in 6% of patients (95% CI, 3%-10%). Thirty-day mortality was 5% (95% CI, 2%-13%) and the pooled estimate for overall mortality was 21% (95% CI, 14%-31%). CONCLUSIONS: Celiac artery coverage during TEVAR is a challenging but feasible option for the treatment of TAAA diseases, providing acceptable morbidity and mortality rates. Demonstration of adequate visceral collateral pathways before definitive CA coverage is the sine quo non for the success of the technique.
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Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Isquemia Mesentérica , Isquemia de la Médula Espinal , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Arteria Celíaca/diagnóstico por imagen , Arteria Celíaca/cirugía , Endofuga/diagnóstico por imagen , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Humanos , Isquemia Mesentérica/cirugía , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: There have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD). METHOD: This systematic review was registered with PROSPERO (ID 227761). A broad bibliographic search was performed for RCTs investigating paclitaxel coated balloons in the peripheral arteries (femoropopliteal and infrapopliteal) for treatment of intermittent claudication or critical limb ischaemia (CLI). The literature search was last updated on 20 February 2021 without any restrictions on publication language, date, or status. Major amputations were analysed with time to event methods employing one and two stage models. Sensitivity and subgroup analyses, combinatorial meta-analysis, and a multivariable dose response meta-analysis to examine presence of a biological gradient were also performed. RESULTS: In all, 21 RCTs with 3 760 lower limbs were analysed (52% intermittent claudication and 48% CLI; median follow up two years). There were 87 major amputations of 2 216 limbs in the paclitaxel arms (4.0% crude risk) compared with 41 major amputations in 1 544 limbs in the control arms (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel coated balloons with a hazard ratio (HR) of 1.66 (95% CI 1.14 - 2.42; p = .008, one stage stratified Cox model). The prediction interval was 95% CI 1.10 - 2.46 (two stage model). The observed amputation risk was consistent for both femoropopliteal (p = .055) and infrapopliteal (p = .055) vessels. Number needed to harm was 35 for CLI. There was good evidence of a significant non-linear dose response relationship with accelerated risk per cumulative paclitaxel dose (chi square model p = .007). There was no evidence of publication bias (p = .80) and no significant statistical heterogeneity between studies (I2 = 0%, p = .77). Results were stable across sensitivity analyses (different models and subgroups based on anatomy and clinical indication and excluding unpublished trials). There were no influential single trials. Level of certainty in evidence was downrated from high to moderate because of sparse events in some studies. CONCLUSION: There appears to be heightened risk of major amputation after use of paclitaxel coated balloons in the peripheral arteries. Further investigations are warranted urgently.
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Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Extremidad Inferior/cirugía , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/cirugía , Angioplastia de Balón/métodos , Arteria Femoral/cirugía , Humanos , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/complicaciones , Arteria Poplítea/cirugía , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de RiesgoRESUMEN
Renal artery aneurysm (RAA) concomitant with a renal arteriovenous fistula (RAVF) has been infrequently reported in the literature. We report a case of a 42-year-old man suffering from a giant RAA combined with a congenital high-flow RAVF. The contrast-enhanced CTA showed a 12.7-cm RAA synchronous with an RAVF between the right renal artery and a draining vein. After a comprehensive preoperative assessment, an endovascular approach was decided. Successful embolization was performed using an Amplatzer vascular Plug, and multiple coils. Completion angiogram demonstrated no flow into the RAA. The results of longterm follow-up demonstrate that endovascular techniques are safe and effective for the management of RAAs combined with high-flow RAVF.
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Aneurisma , Fístula Arteriovenosa , Embolización Terapéutica , Procedimientos Endovasculares , Masculino , Humanos , Adulto , Arteria Renal/diagnóstico por imagen , Arteria Renal/cirugía , Fístula Arteriovenosa/complicaciones , Fístula Arteriovenosa/diagnóstico por imagen , Aneurisma/complicaciones , Aneurisma/diagnóstico por imagen , Embolización Terapéutica/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Admission chest CT is often included in COVID-19 patient management. PURPOSE: To evaluate the inter- and intraobserver variability of the Covid Visual Assessment Scale ("Co.V.A.Sc.") used for stratifying chest CT disease extent and to estimate its prospect to predict clinical outcomes. MATERIALS AND METHODS: This single-center, retrospective observational cohort study included all RT-PCR-confirmed COVID-19 adult patients undergoing admission chest CT, between 01/03/2021 and 17/03/2021. CTs were independently evaluated by two radiologists according to the "Co.V.A.Sc." (0: 0%, 1: 1-10%, 2: 11-25%, 3: 26-50%, 4: 51-75%, 5: > 75%). Patient demographics, laboratory, clinical, and hospitalization data were retrieved and analyzed in relation to the "Co.V.A.Sc." RESULTS: Overall, 273 patients (mean age 60.7 ± 14.8 years; 50.9% male) were evaluated. Excellent inter- and intraobserver variability was noted between the two independent radiologists' "Co.V.A.Sc." EVALUATIONS: "Co.V.A.Sc." classification (Exp(B) 0.391, 95%CI 0.212-0.719; p = 0.025) and patient age (Exp(B) 0.947, 95%CI 0.902-0.993; p = 0.25) were the only variables correlated with ICU admission, while age (Exp(B) 1.111, p = 0.0001), "Co.V.A.Sc." (Exp(B) 2.408; p = 0.002), and male gender (Exp(B) 3.213; p = 0.028) were correlated with in-hospital mortality. Specifically, for each "Co.V.A.Sc." unit increase, the probability of ICU admission increased by 1.47 times, and the probability of death increased by 11.1 times. According to ROC analysis, "Co.V.A.Sc." could predict ICU admission and in-hospital death with an optimal cutoff value of unit 3 (sensitivity 56.0%, specificity 84.3%) and unit 4 (sensitivity 41.9%, specificity 93.6%), respectively. CONCLUSION: "Co.V.A.Sc." upon hospital admittance seems to predict ICU admission and in-hospital death and could aid in optimizing risk-stratification and patient management.
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COVID-19 , Adulto , Anciano , Femenino , Mortalidad Hospitalaria , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , SARS-CoV-2 , Tomografía Computarizada por Rayos X/métodosRESUMEN
INTRODUCTION: This was a European, multicenter, investigator-initiated and run, single-arm retrospective analysis to assess the safety and the clinical benefit of the use of paclitaxel-coated balloon (PCB) for the treatment of symptomatic central venous stenosis (CVS). MATERIALS AND METHODS: Eleven centers from 7 countries across Europe, submitted 86 cases performed during the period between October 2015 and June 2018. Minimum follow-up was 6 months. Patient baseline demographics and procedural details were collected. Mean age was 62.6 years (SD 15.2 years). Median vascular access age was 3.0 years (IQR 1.2-4.8 years). A total of 55 were arteriovenous fistulas (64%) the rest arteriovenous grafts (31/86, 36%). Vessels treated were 43 subclavian veins, 42 brachiocephalic veins and 1 superior vena cava. Median drug-coated balloon diameter was 10 mm (IQR 8-12 mm). Primary outcome measures were clinically assessed intervention-free period (IFP) of the treated segment at 6 months and procedure-related minor and major complications. Secondary outcome measures included access circuit survival, patient survival, and the investigation of independent factors that influence the IFP. RESULTS: IFP was 62.7% at 6 months. Median patient follow-up time was 1.0 year (IQR 0.5-2.2 years). There was 1 minor complication (1/86; 1.2%) and no major complications. Access circuit survival was 87.7% at 6 months. Patient survival was 79.7% at 2 years according to Kaplan-Meier survival analysis. Higher balloon diameters significantly favored IFP [HR 0.71 (0.55-0.92), p=0.006; 5-7 mm group vs 8-12 mm group, p=0.025]. CONCLUSION: In this analysis, use of PCBs for the treatment of symptomatic CVS was safe. Efficacy was comparable to previous trials. Increased balloon size had a significant effect on patency rates.
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Angioplastia de Balón , Derivación Arteriovenosa Quirúrgica , Angioplastia de Balón/efectos adversos , Derivación Arteriovenosa Quirúrgica/efectos adversos , Preescolar , Constricción Patológica , Europa (Continente) , Humanos , Lactante , Persona de Mediana Edad , Paclitaxel/efectos adversos , Diálisis Renal , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular , Vena Cava SuperiorRESUMEN
There have been concerns about the long-term risk of all-cause death with the use of paclitaxel-coated devices in the lower limbs. Results from a 2018 meta-analysis were corroborated by the US Food and Drug Administration and later confirmed by an individual patient data meta-analysis. However, population-based observational studies have produced contradictory results and often claimed a survival benefit with the use of paclitaxel. The recently published Swedish drug-elution trial in peripheral arterial disease did not confirm a significant mortality risk. In this review, the authors discuss the key elements of the identified mortality signal and stress important facts and figures that remain underrecognized and elusive. They also highlight the important types of epidemiological bias that pertain to the ongoing debate on paclitaxel.
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Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Extremidad Inferior/irrigación sanguínea , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Dispositivos de Acceso Vascular , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Fármacos Cardiovasculares/efectos adversos , Medicina Basada en la Evidencia , Humanos , Paclitaxel/efectos adversos , Seguridad del Paciente , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Diseño de Prótesis , Medición de Riesgo , Factores de Riesgo , Resultado del TratamientoRESUMEN
PURPOSE: To assess the safety and efficacy of computed tomography-guided radiofrequency (RF) ablation and magnetic resonance-guided focused ultrasound (MRgFUS) in the treatment of osteoid osteoma with a long-term follow-up study. MATERIALS AND METHODS: Database research was performed at 2 different centers with experience in musculoskeletal interventions. Both centers, one performing RF ablation and the other MRgFUS, identified 116 patients who underwent either RF ablation or MRgFUS procedures for the treatment of symptomatic osteoid osteoma and retrospectively evaluated data regarding pain scores using a visual analog scale (VAS). Complications were recorded according to the Cardiovascular and Interventional Radiological Society of Europe classification system. Propensity score matching for multiple variables was performed. Pain scores before and after therapy were compared. RESULTS: Of 116 patients treated, 61 and 55 underwent RF ablation and MRgFUS, respectively. Before treatment, the mean reported pain in the 2 groups were 9.1 ± 0.88 (RF ablation) and 8.7 ± 0.73 (MRgFUS) VAS units. After treatment, a statistically significant (P < .00001) overall reduction in pain symptomatology was recorded. No statistically significant difference was observed between the mean values of pain after treatment in both groups (P = .256). Over a mean of >2 years of follow-up, 4 cases of relapse (RF ablation, 1; MRgFUS, 3) and 1 complication (RF ablation) were observed. The analysis from propensity score matching that identified a matched cohort of 48 patients showed similar results. CONCLUSIONS: The 2 techniques for the treatment of osteoid osteoma resulted in profound and similar pain relief. The presence of thick cortical bone over the nidus can reduce the effectiveness of MRgFUS.
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Neoplasias Óseas , Ablación por Catéter , Osteoma Osteoide , Ablación por Radiofrecuencia , Neoplasias Óseas/diagnóstico por imagen , Neoplasias Óseas/cirugía , Ablación por Catéter/efectos adversos , Estudios de Seguimiento , Humanos , Espectroscopía de Resonancia Magnética , Recurrencia Local de Neoplasia , Osteoma Osteoide/diagnóstico por imagen , Osteoma Osteoide/cirugía , Puntaje de Propensión , Ablación por Radiofrecuencia/efectos adversos , Estudios Retrospectivos , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
PURPOSE: To assess the feasibility of multi-detector computed tomography angiography (MDCTA) volumetry for the quantification and grading of acute non-cerebral, non-gastrointestinal bleeding. METHODS: This retrospective, single-center study investigated consecutive patients with MDCTA positive for active non-cerebral, non-gastrointestinal bleeding, between January 2020 and June 2020. Outcome measures were the quantification of active extravasation at the arterial and parenchymal phase using volumetry measurements, the calculation of active bleeding rate and bleeding grading, 30-day mortality rate, identification of independent predictors of mortality and correlation between volumetric analysis, various clinical features, and the decision to proceed with an intervention. RESULTS: In total 30 patients (17 females; 56.6%; mean age 70.0 ± 16.0 years) were analyzed. Volumetric analysis was feasible in all cases resulting in excellent inter-observer variability (interclass correlation coefficient 0.999 for arterial and 0.919 for venous volume measurements). Mean volume of contrast extravasation was 1.06 ± 1.09 ml and 3.07 ± 2.48 ml at the arterial and parenchymal phases, respectively. Mean bleeding rate was 6.95 ± 7.82 ml/min. High bleeding volume at arterial phase (grade 4 bleeding) was the only independent predictor of 30-day mortality (HR 1383.58; p = 0.042). There was a positive correlation between bleeding volume at arterial phase (rs = 0.340; p = 0.033) and arterial bleeding rate (rs = 0.381; p = 0.019) with the decision to proceed with an intervention. Bleeding volume of 0.6 ml was the cutoff value for the prediction of intervention (sensitivity 96.3%; specificity 66.7%). CONCLUSIONS: MDCTA volumetric analysis for the quantification and grading of acute hemorrhage was feasible with excellent inter-observer agreement. The proposed bleeding grading system could optimize decision making and predict clinical outcomes.
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Angiografía , Hemorragia Gastrointestinal , Anciano , Anciano de 80 o más Años , Estudios de Factibilidad , Femenino , Hemorragia Gastrointestinal/diagnóstico por imagen , Humanos , Persona de Mediana Edad , Tomografía Computarizada Multidetector , Estudios RetrospectivosRESUMEN
BACKGROUND: True giant splenic artery aneurysms (GSAAs) >5 cm are rare and present unique therapeutic challenges. The aim of this study was to evaluate the anatomic and clinical characteristics of these lesions and the current surgical and endovascular techniques available for their treatment. METHODS: A systematic review of the literature from 2004 to 2018 and the personal experience of the authors with management of GSAAs are presented. A total of 92 GSAA cases were reviewed. Analyses were performed on anatomic and clinical features and management modalities and outcomes of GSAA, including reintervention, morbidity, and mortality. RESULTS: GSAA presented at a mean age of 56.1 ± 17.3 years, with no sex predilection; 73% were symptomatic at presentation. Abdominal pain was the presenting symptom in >50% of cases; 34% percent were ruptured, with an overall mortality rate of 12.5%. This group often presented with gastrointestinal bleeding or hemodynamic collapse. The aneurysms were almost evenly distributed across the splenic artery and were not uncommonly associated with arteriovenous fistula formation (8.7%). There were 88 patients who had surgical (53.4%), endovascular (44.3%), or combination (2.3%) therapy. The most commonly performed procedure was aneurysmectomy and splenectomy with or without additional resection. Overall, surgical treatment had a lower morbidity (P = .041) than endovascular therapy and comparable reintervention and mortality rates. CONCLUSIONS: GSAAs are uncommon vascular lesions, with distinct clinical features and aneurysm characteristics. Considering their high risk of rupture, timely diagnosis and management are essential to attain a satisfactory outcome. Surgery remains the standard treatment of these lesions. Endovascular intervention is a viable alternative in high-risk patients, particularly those with lesions <10 cm or with anomalous origin.
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Aneurisma/cirugía , Arteria Esplénica , Enfermedades del Bazo/cirugía , Procedimientos Endovasculares , Humanos , Esplenectomía , Procedimientos Quirúrgicos VascularesRESUMEN
A formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infrapopliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was conducted. Medical databases and online content were last screened in September 2019. The primary safety and efficacy endpoint was amputation-free survival defined as freedom from all-cause death and major amputation. Target lesion revascularization (TLR) constituted a secondary efficacy endpoint. Summary effects were synthesized with a random-effects model. Some 8 randomized controlled trials with 1,420 patients (97% CLI) were analyzed up to 1 year follow-up. Amputation-free survival was significantly worse in case of paclitaxel (13.7% crude risk of death or limb loss compared to 9.4% in case of uncoated balloon angioplasty; hazard ratio 1.52; 95% confidence interval: 1.12-2.07, p = .008). TLR was significantly reduced in case of paclitaxel (11.8% crude risk of TLR versus 25.6% in control; risk ratio 0.53; 95% confidence interval: 0.35-0.81, p = .004). The harm signal was evident when examining the high-dose (3.0-3.5 µg/mm2) devices, but attenuated below significance in case of a low-dose (2.0 µg/mm2) device. Actual causes remain largely unknown, but non-target paclitaxel embolization is a plausible mechanism.