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OBJECTIVE: Ischemic complications account for significant patient morbidity following aneurysmal subarachnoid hemorrhage (aSAH). The Prevention and Treatment of Vasospasm with Clazosentan (REACT) study was designed to assess the safety and efficacy of clazosentan, an endothelin receptor antagonist, in preventing clinical deterioration due to delayed cerebral ischemia (DCI) in patients with aSAH. METHODS: REACT was a prospective, multicenter, randomized, double-blind, phase 3 study. Eligible patients had aSAH secured by surgical clipping or endovascular coiling, and had presented with thick and diffuse clot on admission CT scan. Patients were randomized (1:1 ratio) to 15 mg/hour intravenous clazosentan or placebo within 96 hours of the aSAH for up to 14 days, in addition to standard of care treatment including oral or intravenous nimodipine. The primary efficacy endpoint was the occurrence of clinical deterioration due to DCI up to 14 days after initiation of the study drug. The main secondary endpoint was the occurrence of clinically relevant cerebral infarction at day 16 after study drug initiation. Other secondary endpoints included clinical outcome assessed on the modified Rankin Scale (mRS) and the Glasgow Outcome Scale-Extended (GOSE) at week 12 post-aSAH. Imaging and clinical endpoints were centrally adjudicated. RESULTS: A total of 409 patients were randomized between February 2019 and May 2022 across 74 international sites. Three patients did not start study treatment and were not included in the analysis set. The occurrence of clinical deterioration due to DCI was 15.8% (32/202 patients) in the clazosentan group and 17.2% (35/204 patients) in the placebo group, and the difference was not statistically significant (relative risk reduction [RRR] 7.2%, 95% CI -42.6% to 39.6%, p = 0.734). A nonsignificant RRR of 34.1% (95% CI -21.3% to 64.2%, p = 0.177) was observed in clinically relevant cerebral infarcts treated with clazosentan (7.4%, 15/202) versus placebo (11.3%, 23/204). Rescue therapy was less frequently needed for patients treated with clazosentan compared to placebo (10.4%, 21/202 vs 18.1%, 37/204; RRR 42.6%, 95% CI 5.4%-65.2%). A nonsignificant relative risk increase of 25.4% (95% CI -10.7% to 76.0%, p = 0.198) was reported in the risk of poor GOSE and mRS scores with clazosentan (24.8%, 50/202) versus placebo (20.1%, 41/204) at week 12 post-aSAH. Treatment-emergent adverse events were similar to those reported previously. CONCLUSIONS: Clazosentan administered for up to 14 days at 15 mg/hour had no significant effect on the occurrence of clinical deterioration due to DCI. Clinical trial registration no.: NCT03585270 (ClinicalTrials.gov) EU clinical trial registration no.: 2018-000241-39 (clinicaltrialsregister.eu).
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BACKGROUND: The effect of endovascular therapy (EVT) on the outcome of stroke patients with a medium distal vessel occlusion (MDVO) is unclear. We report the results of MDVO patients treated with the 3â¯mm Trevo stent retriever (SR) and/or the AXS Catalyst 5 distal access catheter. METHODS: Data was derived from a prospective, multicenter global registry (ASSIST registry) which enrolled patients treated with operator preferred EVT technique at 71 sites from January 2019 to January 2022. Three techniques were assessed: SR classic, direct aspiration, and a combined approach. Additional inclusion criteria were (a) EVT performed with the 3â¯mm Trevo SR and/or AXS Catalyst 5 distal access catheter on the first pass and (b) an occlusion of the M2 segment or M3 segment of the middle cerebral artery or the A1, A2 or A3 segment of the anterior cerebral artery. The primary outcome was achieving an expanded Thrombolysis in Cerebral Infarction (eTICI) score of 2c or 3 on the first pass, with the primary technique as adjudicated by core lab. The primary clinical outcome measure was a 90-day modified Rankin Scale (mRS) score of 0-2. RESULTS: A total of 155 patients (10.4% of the ASSIST population) were included. Most patients had an M2 occlusion (93.5%). First pass eTICI reperfusion was achieved in 43.1% of the patients. No modifying effect of the frontline technique was found. The rate of mRS 0-2 (overall 65.0%) did not significantly differ between groups. CONCLUSION: The data suggests that the Trevo 3â¯mm SR and/or the AXS Catalyst 5 may be an option to treat medium distal vessel occlusion, but more data is needed to demonstrate safety and efficacy in this patient cohort. Further improvements are needed regarding materials and techniques to improve reperfusion results in this patient cohort in the future.
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BACKGROUND: Few clinical studies perform detailed analyses of subtypes of intracranial hemorrhage (ICH) after mechanical thrombectomy (MT) used to treat acute ischemic stroke. Symptomatic intracranial hemorrhage (sICH) is a formidable complication of MT and is widely used in clinical trials as a safety outcome. However, variable definitions of sICH are used across clinical studies. OBJECTIVE: To radiographically subcategorize post-MT ICH development within this large cohort and examine overlap with sICH. Second, to examine the agreement of this definition of sICH with local site-reported occurrences of sICH to see how sICH rates change with modifications of the definitions used. METHODS: A large cohort of patients treated with MT for acute ischemic stroke (n=1395) was analyzed to (1) radiographically characterize hemorrhagic subtypes of intracranial hemorrhage (ICH) occurring after MT; (2) examine associations of hemorrhagic subtypes with sICH; and (3) compare core laboratory-adjudicated occurrences of sICH with site-reported sICH. RESULTS: The overall rate of ICH was 552/1395 patients (39.6%), and the overall rate of sICH was 47/1395 (3.4%). The most common type of ICH was hemorrhagic infarction type 1 (HI1), which represented 45.3% of all ICH cases- followed by HI2 (31.5%) and subarachnoid hemorrhage (SAH, 29.2%). Parenchymal hematoma 2 (PH2) represented only 3.3% of all ICH cases. Of the PH2 hemorrhages, only 33.3% were determined to be symptomatic. Of sICH cases, the most common ICH subtypes were HI2 (48.9%) and SAH (38.3%). Comparison of sICH rates as determined by core laboratory adjudication versus local site-reported results showed that only 14 patients were identified as having sICH with both definitions, with 47 patients total with sICH according to one definition, but not the other. CONCLUSIONS: Results of this analysis demonstrate the radiographic subtypes of ICH and also highlight the limitations of variable criteria used to define sICH, suggesting that it might be appropriate to revisit how sICH is defined post-MT. TRIAL REGISTRATION NUMBER: Clinical trial NCT03845491.
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BACKGROUND: Mechanical thrombectomy (MT) is part of the standard of care for stroke treatment, and improving its efficacy is one of the main objectives of clinical investigation. Of importance is placement of the distal end of balloon-guided catheters (BGC). We aim to determine if this influences outcomes. METHODS: We analyzed data from the ASSIST Registry, an international, multicenter prospective study of 1492 patients. We divided patients treated with BGC according to the placement of the BGC: low cervical (LCG (the lower 2/3 of cervical internal carotid artery (ICA)) or high cervical (HCG (upper 1/3 of cervical ICA, petro-lacerum or higher)). We analyzed characteristics and outcomes overall and stratified on the primary MT technique: Stent-Retriever only (SR Classic), Combined use of aspiration catheter and SR (Combined), and Direct Aspiration (ADAPT). RESULTS: Our study included 704 subjects -323 in the low cervical and 381 in the high cervical groups. Statistical differences were seen in the proportion of females and tandem lesions (both higher for LCG). Placing the BGC in the high cervical segment is associated with better recanalization rates (expanded treatment in cerebral infarction (eTICI) score of 2c-3) at the end of the procedure (P<0.0001) and shorter procedures (P=0.0005). After stratifying on the three primary techniques (SR Classic, Combined, and ADAPT), placing the BGC in the high segment is associated with a better first-pass effect (FPE), less distal emboli, and better clinical outcomes in the SR Classic technique. CONCLUSIONS: Placing the distal end of the BGC at the high cervical segment or higher is associated with better recanalization.
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BACKGROUND: Patients treated with mechanical thrombectomy (MT) for acute ischemic strokes from large vessel occlusion (LVO) have better outcomes with effective reperfusion. However, it is unknown which technique leads to better technical and clinical success. We aimed to determine which technique yields the most effective first pass reperfusion during MT. METHODS: In a prospective, multicenter global registry we enrolled patients treated with operator preferred MT technique at 71 hospitals from January 2019 to January 2022. Three techniques were assessed: SR Classic with stent retriever (SR) and balloon guide catheter (BGC); SR Combination which employed SR with contact aspiration with or without BGC; and direct aspiration (DA) with or without BGC. The primary outcome was achieving an expanded Thrombolysis In Cerebral Infarction (eTICI) score of 2c or 3 on the first pass, with the primary technique as adjudicated by core lab. The primary clinical outcome measure was a 90-day modified Rankin Scale (mRS) score of 0-2. RESULTS: A total of 1492 patients were enrolled. Patients treated with SR Classic or SR Combination were more likely to achieve first pass eTICI 2c or 3 reperfusion (P=0.01). There was no significant difference in mRS 0-2 (P=0.46) or safety endpoints. CONCLUSIONS: The use of SR Classic or SR Combination was more likely to achieve first pass eTICI 2c or 3 reperfusion. There were no significant differences in clinical outcomes and safety endpoints.
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RATIONALE: Oxygen is essential for cellular energy metabolism. Neurons are particularly vulnerable to hypoxia. Increasing oxygen supply shortly after stroke onset could preserve the ischemic penumbra until revascularization occurs. AIMS: PROOF investigates the use of normobaric oxygen (NBO) therapy within 6 h of symptom onset/notice for brain-protective bridging until endovascular revascularization of acute intracranial anterior-circulation occlusion. METHODS AND DESIGN: Randomized (1:1), standard treatment-controlled, open-label, blinded endpoint, multicenter adaptive phase IIb trial. STUDY OUTCOMES: Primary outcome is ischemic core growth (mL) from baseline to 24 h (intention-to-treat analysis). Secondary efficacy outcomes include change in NIHSS from baseline to 24 h, mRS at 90 days, cognitive and emotional function, and quality of life. Safety outcomes include mortality, intracranial hemorrhage, and respiratory failure. Exploratory analyses of imaging and blood biomarkers will be conducted. SAMPLE SIZE: Using an adaptive design with interim analysis at 80 patients per arm, up to 456 participants (228 per arm) would be needed for 80% power (one-sided alpha 0.05) to detect a mean reduction of ischemic core growth by 6.68 mL, assuming 21.4 mL standard deviation. DISCUSSION: By enrolling endovascular thrombectomy candidates in an early time window, the trial replicates insights from preclinical studies in which NBO showed beneficial effects, namely early initiation of near 100% inspired oxygen during short temporary ischemia. Primary outcome assessment at 24 h on follow-up imaging reduces variability due to withdrawal of care and early clinical confounders such as delayed extubation and aspiration pneumonia. TRIAL REGISTRATIONS: ClinicalTrials.gov: NCT03500939; EudraCT: 2017-001355-31.
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Isquemia Encefálica , Procedimentos Endovasculares , AVC Isquêmico , Humanos , Isquemia Encefálica/complicações , Procedimentos Endovasculares/métodos , AVC Isquêmico/complicações , AVC Isquêmico/diagnóstico , Estudos Multicêntricos como Assunto , Oxigênio/uso terapêutico , Qualidade de Vida , Trombectomia/métodos , Resultado do Tratamento , Ensaios Clínicos Fase II como AssuntoRESUMO
PURPOSE: Portal hypertension (PHT) and its sequelae are the most clinically important manifestations in cystic fibrosis-related liver disease (CFLD). This paper aimed to evaluate the safety and efficacy of a pre-emptive transjugular intrahepatic portosystemic shunt (TIPS) to prevent PHT-related complications in pediatric patients with CFLD. METHODS: This was a prospective single-arm study on pediatric patients with CFLD, signs of PHT, and preserved liver function who underwent a pre-emptive TIPS in a single tertiary CF center between 2007 and 2012. The long-term safety and clinical efficacy were assessed. RESULTS: A pre-emptive TIPS was performed on seven patients with a mean age of 9.2 years (± standard deviation: 2.2). The procedure was technically successful in all patients, with an estimated median primary patency of 10.7 years [interquartile range (IQR) 0.5-10.7)]. No variceal bleeding was observed during the median follow-up of 9 years (IQR 8.1-12.9). In two patients with advanced PHT and rapidly progressive liver disease, severe thrombocytopenia could not be stopped. Subsequent liver transplantation revealed biliary cirrhosis in both patients. In the remaining patients with early PHT and milder porto-sinusoidal vascular disease, symptomatic hypersplenism did not occur, and liver function remained stable until the end of the follow-up. Inclusion for pre-emptive TIPS was discontinued in 2013 following an episode of severe hepatic encephalopathy. CONCLUSION: TIPS is a feasible treatment with encouraging long-term primary patency to avoid variceal bleeding in selected patients with CF and PHT. However, as the progression of liver fibrosis, thrombocytopenia, and splenomegaly is inevitable, the clinical benefits due to pre-emptive placement appear to be minor.
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Fibrose Cística , Varizes Esofágicas e Gástricas , Hipertensão Portal , Derivação Portossistêmica Transjugular Intra-Hepática , Humanos , Criança , Varizes Esofágicas e Gástricas/complicações , Derivação Portossistêmica Transjugular Intra-Hepática/efeitos adversos , Derivação Portossistêmica Transjugular Intra-Hepática/métodos , Fibrose Cística/complicações , Fibrose Cística/cirurgia , Estudos Prospectivos , Hemorragia Gastrointestinal/etiologia , Hipertensão Portal/complicações , Hipertensão Portal/cirurgia , Cirrose Hepática/complicações , Cirrose Hepática/cirurgia , Resultado do TratamentoRESUMO
Cerebral proliferative angiopathy (CPA) is a rare cerebrovascular disease comprised of a diffuse network of blood vessels, often spread over several lobes. Due to the presence of normal brain tissue within the malformation, complete resection is not desirable. Several imaging characteristics help to distinguish CPA from brain arteriovenous malformations. We report the case of a patient diagnosed with CPA five years after a spontaneous intraventricular hemorrhage and an initial negative angiogram. Teaching Point: The radiologist should be able to differentiate CPA from brain AVM to prevent potentially harmful treatment.
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PURPOSE: To investigate the technical outcome, clinical outcome, and patency of transjugular intrahepatic portosystemic shunt (TIPS) in pediatric portal hypertension (PHT). METHODS: A systematic search of MEDLINE/PubMed, EMBASE, Cochrane databases, ClinicalTrials.gov, and WHO ICTRP registries was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. An a priori protocol was registered at the PROSPERO database. Original full-text articles on pediatric patients (sample size of ≥5 patients with upper age limit of 21 years) with PHT who underwent TIPS creation for any indication were included. RESULTS: Seventeen studies with 284 patients (average-weighted age of 10.1 years) were included, with an average-weighted follow-up of 3.6 years. TIPS was technically successful in 93.3% (95% confidence interval [CI], 88.5%-97.1%) of patients, with a major adverse event rate of 3.2% (95% CI, 0.7-6.9) and adjusted hepatic encephalopathy rate of 2.9% (95% CI, 0.6-6.3). The pooled 2-year primary and secondary patency rates were 61.8% (95% CI, 50.0-72.4) and 99.8% (95% CI, 96.2%-100.0%), respectively. Stent type (P = .002) and age (P = .04) were identified as a significant source of heterogeneity for clinical success. In subgroup analysis, the clinical success rate was 85.9% (95% CI, 77.8-91.4) in studies with a majority of covered stents, and 87.6% (95% CI, 74.1-94.6) in studies with a median age of 12 years or older. CONCLUSIONS: This systematic review and meta-analysis demonstrates that a TIPS is a feasible and safe treatment for pediatric PHT. To improve clinical outcome and patency on the long term, the use of covered stents should be encouraged.
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Varizes Esofágicas e Gástricas , Encefalopatia Hepática , Hipertensão Portal , Derivação Portossistêmica Transjugular Intra-Hepática , Humanos , Criança , Adulto Jovem , Adulto , Derivação Portossistêmica Transjugular Intra-Hepática/efeitos adversos , Derivação Portossistêmica Transjugular Intra-Hepática/métodos , Resultado do Tratamento , Hipertensão Portal/cirurgia , Hipertensão Portal/etiologia , Stents , Encefalopatia Hepática/etiologia , Hemorragia Gastrointestinal/etiologia , Estudos Retrospectivos , Varizes Esofágicas e Gástricas/etiologiaRESUMO
BACKGROUND: Recently, an empiric Cone-beam Computed Tomography (CBCT)-guided transarterial embolization (TAE) technique has been investigated for lower gastrointestinal bleeding (LGIB). Although this empirical strategy reduced the rate of rebleeding in hemodynamically unstable patients compared to a 'wait and see' strategy, the specified technique is challenging and time-consuming. CASE PRESENTATION: We present two methods to perform a prompt empiric TAE in LGIB when catheter angiography is negative. Based on the pre-procedural Computed Tomography Angiography bleeding site and using vessel detection and navigation software tools that are integrated in contemporary angiosuites, the culprit bleeding artery could be targeted with only one selective intraprocedural CBCT acquisition. CONCLUSION: The proposed techniques are promising to reduce procedure time and facilitate the implementation of empiric CBCT-guided TAE in clinical practice when angiography is negative.
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INTRODUCTION: Coronavirus disease 2019 (COVID-19) leads to thoracic complications requiring surgery. This is challenging, particularly in patients supported with venovenous extracorporeal membrane oxygenation (VV-ECMO) due to the need for continuous therapeutic anticoagulation. We aim to share our experience regarding the safety and perioperative management of video-assisted thoracic surgery for this specific population. METHODS: Retrospective, single-center study between November 2020 and January 2022 at the ICU department of a 1.061-bed tertiary care and VV-ECMO referral center during the COVID-19 pandemic. RESULTS: 48 COVID-19 patients were supported with VV-ECMO. A total of 14 video-assisted thoracic surgery (VATS) procedures were performed in seven patients. Indications were mostly hemothorax (85.7%). In eight procedures heparin was stopped at least 1 h before incision. A total of 10 circuit changes due to clot formation or oxygen transfer failure were required in six patients (85.7%). One circuit replacement seemed related to the preceding VATS procedure, although polytransfusion might be a contributing factor. None of the mechanical complications was fatal. Four VATS-patients (57.1%) died, of which two (50%) immediately perioperatively due to uncontrollable bleeding. All three survivors were treated with additional transarterial embolization. CONCLUSION: (1) Thoracic complications in COVID-19 patients on VV-ECMO are common. (2) Indication for VATS is mostly hemothorax (3) Perioperative mortality is high, mostly due to uncontrollable bleeding. (4) Preoperative withdrawal of anticoagulation is not directly related to a higher rate of ECMO circuit-related complications, but a prolonged duration of VV-ECMO support and polytransfusion might be. (5) Additional transarterial embolization to control postoperative bleeding may further improve outcomes.
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COVID-19 , Oxigenação por Membrana Extracorpórea , Humanos , Hemotórax/complicações , Hemotórax/epidemiologia , Oxigenação por Membrana Extracorpórea/métodos , Cirurgia Torácica Vídeoassistida/efeitos adversos , Estudos Retrospectivos , COVID-19/complicações , Pandemias , Estado Terminal/epidemiologia , Hemorragia/etiologia , Anticoagulantes/uso terapêuticoRESUMO
Background Transarterial chemoembolization (TACE) is the recommended treatment for intermediate hepatocellular carcinoma (HCC) according to the Barcelona Clinic Liver Cancer guidelines. Prospective uncontrolled studies suggest that yttrium 90 (90Y) transarterial radioembolization (TARE) is a safe and effective alternative. Purpose To compare the efficacy and safety of TARE with TACE for unresectable HCC. Materials and Methods In this single-center prospective randomized controlled trial (TRACE), 90Y glass TARE was compared with doxorubicin drug-eluting bead (DEB) TACE in participants with intermediate-stage HCC, extended to Eastern Cooperative Oncology Group performance status 1 and those with early-stage HCC not eligible for surgery or thermoablation. Participants were recruited between September 2011 and March 2018. The primary end point was time to overall tumor progression (TTP) (Kaplan-Meier analysis) in the intention-to-treat (ITT) and per-protocol (PP) groups. Results At interim analysis, 38 participants (median age, 67 years; IQR, 63-72 years; 33 men) were randomized to the TARE arm and 34 (median age, 68 years; IQR, 61-71 years; 30 men) to the DEB-TACE arm (ITT group). Median TTP was 17.1 months in the TARE arm versus 9.5 months in the DEB-TACE arm (ITT group hazard ratio [HR], 0.36; 95% CI: 0.18, 0.70; P = .002) (PP group, 32 and 34 participants, respectively, in each arm; HR, 0.29; 95% CI: 0.14, 0.60; P < .001). Median overall survival was 30.2 months after TARE and 15.6 months after DEB-TACE (ITT group HR, 0.48; 95% CI: 0.28, 0.82; P = .006). Serious adverse events grade 3 or higher (13 of 33 participants [39%] vs 19 of 36 [53%] after TARE and DEB-TACE, respectively; P = .47) and 30-day mortality (0 of 33 participants [0%] vs three of 36 [8.3%]; P = .24) were similar in the safety groups. At the interim, the HR for the primary end point, TTP, was less than 0.39, meeting the criteria to halt the study. Conclusion With similar safety profile, yttrium 90 radioembolization conferred superior tumor control and survival compared with chemoembolization using drug-eluting beads in selected participants with early or intermediate hepatocellular carcinoma. Clinical trial registration no. NCT01381211 © RSNA, 2022 Online supplemental material is available for this article.
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Braquiterapia , Carcinoma Hepatocelular , Quimioembolização Terapêutica , Neoplasias Hepáticas , Idoso , Carcinoma Hepatocelular/patologia , Quimioembolização Terapêutica/métodos , Feminino , Humanos , Neoplasias Hepáticas/patologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoRESUMO
Teaching point: We report magnetic resonance imaging characteristics of a dural arteriovenous fistula (dAVF), a possible cause of pulsatile tinnitus.
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OBJECTIVES: To evaluate the clinical effect and safety of cone-beam CT (CBCT)-guided empirical embolization for acute lower gastrointestinal bleeding (LGIB) in patients with a positive CT angiography (CTA) but subsequent negative digital subtraction angiography (DSA). METHODS: A retrospective study of consecutive LGIB patients with a positive CTA who received a DSA within 24 h from January 2008 to July 2019. Patients with a positive DSA were treated with targeted embolization (TE group). Patients with a negative DSA underwent an empiric CBCT-guided embolization of the assumed ruptured vas rectum (EE group) or no embolization (NE group). Recurrent bleeding, major ischemic complications, and in-hospital mortality were compared by means of Fisher's exact test. Further subgroup analysis was performed on hemodynamic instability. RESULTS: Eighty-five patients (67.6 years ± 15.7, 52 men) were included (TE group, n = 47; EE group, n = 19; NE group, n = 19). If DSA was positive, technical success of targeted embolization was 100% (47/47). If DSA was negative and the intention to treat by empiric CBCT-guided embolization, technical success was 100% (19/19). Recurrent bleeding rates in the TE group, EE group, and NE group were 17.0% (8/47), 21.1% (4/19), and 52.6% (10/19) respectively. Empiric CBCT-guided embolization reduced rebleeding significantly in patients with a negative DSA and hemodynamic instability (EE group, 3/10 vs NE group, 10/12, p = .027). Major ischemic complications occurred in one patient (TE group). Overall, the in-hospital mortality rate was 7.1% (6/85). CONCLUSION: Empiric cone-beam CT-guided embolization proved to be a feasible, effective, and safe treatment strategy to reduce rebleeding and improve clinical success in hemodynamically unstable patients with acute LGIB, positive CTA but negative DSA. KEY POINTS: ⢠A novel transarterial embolization technique guided by cone-beam CT could be developed extending the "empiric" embolization strategy to lower gastrointestinal bleeding. ⢠By implementing the empiric treatment strategy, nearly all patients with an active lower gastrointestinal bleeding on CTA will be eligible for a superselective empiric embolization, even if subsequent catheter angiography is negative. ⢠In patients with a negative catheter angiography, empiric embolization reduces the rebleeding rate and, particularly in hemodynamically unstable patients, improves clinical success compared with a conservative "wait-and-see" management.
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Embolização Terapêutica , Hemorragia Gastrointestinal , Angiografia Digital , Tomografia Computadorizada de Feixe Cônico , Hemorragia Gastrointestinal/diagnóstico por imagem , Hemorragia Gastrointestinal/terapia , Humanos , Masculino , Estudos Retrospectivos , Resultado do TratamentoAssuntos
Tomografia Computadorizada de Feixe Cônico , Embolização Terapêutica , Etanol/administração & dosagem , Hemangioma/terapia , Radiografia Intervencionista , Compressão da Medula Espinal/terapia , Neoplasias da Coluna Vertebral/terapia , Adulto , Feminino , Hemangioma/complicações , Hemangioma/diagnóstico por imagem , Humanos , Injeções Intralesionais , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Compressão da Medula Espinal/diagnóstico por imagem , Compressão da Medula Espinal/etiologia , Neoplasias da Coluna Vertebral/complicações , Neoplasias da Coluna Vertebral/diagnóstico por imagem , Resultado do TratamentoRESUMO
On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications "No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial".
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BACKGROUND: Recently, CT perfusion (CTP) has been proposed as a selection tool for stroke patients to be treated with endovascular thrombectomy. We investigated whether functional outcome following endovascular treatment was improved after the introduction of CTP. METHODS: This retrospective single-centre study includes all patients with a major vessel occlusion in the anterior circulation that received a CTP and underwent a mechanical thrombectomy from 2014 up to 2015. CTP were visually evaluated. Demographics, stroke and time data, procedural data, functional outcomes as measured by the modified Rankin Scale (mRS) and the association between these variables were studied. A comparison was made with the results of a similar local retrospective study from before the CTP "era". RESULTS: Eighty-nine patients were included in this study. Median National Institutes of Health Stroke Scale (NIHSS) was 16 (Interquartile range 6). At three months, good functional outcome (GFO; mRS 0-2) was achieved in 48.4% and excellent functional outcome (EFO; mRS 0-1) in 34.4% of patients. The mortality rate at three months was 14.5%. GFO at one year was 44.8%, EFO was 31.3% and mortality 21.1%. The duration of the thrombectomy procedure and the EFO were associated (p = 0.032). The outcome improvement achieved with CTP was higher compared to the reference study (GFO 48.4% versus 44%; EFO 34.4% versus 29%) but remained below the statistical significance. CONCLUSIONS: Mechanical thrombectomy for anterior circulation strokes based on CTP did not result in a significant functional outcome improvement. The duration of the thrombectomy procedure was the sole time-interval related to improved functional outcome.
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PURPOSE: To prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction. MATERIALS AND METHODS: After failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene-covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared. RESULTS: Three patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178-438 d) for covered and 442 d (95% CI, 172-712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68-124 d) with covered stents and 75 days (95% CI, 42-108 d) with uncovered stents (P = .6). CONCLUSIONS: In malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.
Assuntos
Ligas , Colestase/terapia , Materiais Revestidos Biocompatíveis , Neoplasias do Sistema Digestório/tratamento farmacológico , Drenagem/instrumentação , Cuidados Paliativos , Politetrafluoretileno/análogos & derivados , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Bélgica , Colestase/diagnóstico por imagem , Colestase/etiologia , Colestase/mortalidade , Neoplasias do Sistema Digestório/complicações , Neoplasias do Sistema Digestório/diagnóstico por imagem , Neoplasias do Sistema Digestório/mortalidade , Drenagem/efeitos adversos , Drenagem/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: To investigate whether covered stents show a higher efficacy than uncovered stents in percutaneous treatment of malignant hilar biliary obstruction. METHODS: Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed endoscopic intervention in a prospective randomized trial comparing expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents. Exclusion criteria were as follows: primary tumors existing more than 3 months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50. Safety, clinical success, and adjuvant chemotherapy were compared as well as occlusion rate, patency, and survival. RESULTS: A total of 120 patients were included. One patient was post hoc excluded. Fourteen patients who died within 7 days and one patient without patency data were excluded from patency analysis. Serious adverse events (p = 0.4), 30-day mortality (p = 0.5), and clinical success (p = 0.8) were equivalent for both stent groups. Twenty-one out of 61 (34%) patients in the covered and 24/58 (41%) in the uncovered stent groups received adjuvant chemotherapy (p = 0.5). Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8). Median patency was 229 days (95% CI 113-345) for covered stents and 130 days (95% CI 75-185) for uncovered stents (p = 0.1). Median survival in patients with covered stents was 79 days (95% CI 52-106) and with uncovered stents 92 days (95% CI 60-124) (p = 0.3). CONCLUSION: In malignant hilar biliary obstruction, there is no evidence that ePTFE-FEP-covered stents are superior to uncovered stents in terms of safety, clinical success, adjuvant chemotherapy, patency, or survival. KEY POINTS: ⢠Percutaneous palliation of hilar biliary obstruction is feasible with both uncovered and covered stents. ⢠Clinical success in terms of bilirubin decrease and adjuvant chemotherapy is achievable with both stents. ⢠Thirty-day mortality is considerable when stenting is also offered to patients with a low performance status.