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3.
JAMA ; 328(6): 534-542, 2022 08 09.
Artículo en Inglés | MEDLINE | ID: mdl-35943472

RESUMEN

Importance: Prior randomized trials have generally shown harm or no benefit of stenting added to medical therapy for patients with symptomatic severe intracranial atherosclerotic stenosis, but it remains uncertain as to whether refined patient selection and more experienced surgeons might result in improved outcomes. Objective: To compare stenting plus medical therapy vs medical therapy alone in patients with symptomatic severe intracranial atherosclerotic stenosis. Design, Setting, and Participants: Multicenter, open-label, randomized, outcome assessor-blinded trial conducted at 8 centers in China. A total of 380 patients with transient ischemic attack or nondisabling, nonperforator (defined as nonbrainstem or non-basal ganglia end artery) territory ischemic stroke attributed to severe intracranial stenosis (70%-99%) and beyond a duration of 3 weeks from the latest ischemic symptom onset were recruited between March 5, 2014, and November 10, 2016, and followed up for 3 years (final follow-up: November 10, 2019). Interventions: Medical therapy plus stenting (n = 176) or medical therapy alone (n = 182). Medical therapy included dual-antiplatelet therapy for 90 days (single antiplatelet therapy thereafter) and stroke risk factor control. Main Outcomes and Measures: The primary outcome was a composite of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. There were 5 secondary outcomes, including stroke in the qualifying artery territory at 2 years and 3 years as well as mortality at 3 years. Results: Among 380 patients who were randomized, 358 were confirmed eligible (mean age, 56.3 years; 263 male [73.5%]) and 343 (95.8%) completed the trial. For the stenting plus medical therapy group vs medical therapy alone, no significant difference was found for the primary outcome of risk of stroke or death (8.0% [14/176] vs 7.2% [13/181]; difference, 0.4% [95% CI, -5.0% to 5.9%]; hazard ratio, 1.10 [95% CI, 0.52-2.35]; P = .82). Of the 5 prespecified secondary end points, none showed a significant difference including stroke in the qualifying artery territory at 2 years (9.9% [17/171] vs 9.0% [16/178]; difference, 0.7% [95% CI, -5.4% to 6.7%]; hazard ratio, 1.10 [95% CI, 0.56-2.16]; P = .80) and 3 years (11.3% [19/168] vs 11.2% [19/170]; difference, -0.2% [95% CI, -7.0% to 6.5%]; hazard ratio, 1.00 [95% CI, 0.53-1.90]; P > .99). Mortality at 3 years was 4.4% (7/160) in the stenting plus medical therapy group vs 1.3% (2/159) in the medical therapy alone group (difference, 3.2% [95% CI, -0.5% to 6.9%]; hazard ratio, 3.75 [95% CI, 0.77-18.13]; P = .08). Conclusions and Relevance: Among patients with transient ischemic attack or ischemic stroke due to symptomatic severe intracranial atherosclerotic stenosis, the addition of percutaneous transluminal angioplasty and stenting to medical therapy, compared with medical therapy alone, resulted in no significant difference in the risk of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. The findings do not support the addition of percutaneous transluminal angioplasty and stenting to medical therapy for the treatment of patients with symptomatic severe intracranial atherosclerotic stenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT01763320.


Asunto(s)
Implantación de Prótesis Vascular , Arteriosclerosis Intracraneal , Ataque Isquémico Transitorio , Accidente Cerebrovascular Isquémico , Inhibidores de Agregación Plaquetaria , Stents , Angioplastia/efectos adversos , Angioplastia/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Constricción Patológica/complicaciones , Constricción Patológica/tratamiento farmacológico , Constricción Patológica/mortalidad , Constricción Patológica/terapia , Humanos , Arteriosclerosis Intracraneal/complicaciones , Arteriosclerosis Intracraneal/tratamiento farmacológico , Arteriosclerosis Intracraneal/mortalidad , Arteriosclerosis Intracraneal/terapia , Ataque Isquémico Transitorio/tratamiento farmacológico , Ataque Isquémico Transitorio/etiología , Ataque Isquémico Transitorio/mortalidad , Ataque Isquémico Transitorio/terapia , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Accidente Cerebrovascular Isquémico/etiología , Accidente Cerebrovascular Isquémico/mortalidad , Accidente Cerebrovascular Isquémico/terapia , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Riesgo , Stents/efectos adversos , Resultado del Tratamiento
4.
Eur J Vasc Endovasc Surg ; 61(5): 810-818, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33810975

RESUMEN

OBJECTIVE: The benefit of preventive treatment for superior mesenteric artery (SMA) stenosis remains uncertain. The latest European Society for Vascular Surgery (ESVS) guidelines remain unclear given the lack of data in the literature. The aim of this study was to evaluate asymptomatic SMA stenosis prognosis according to the presence of associated coeliac artery (CA) and/or inferior mesenteric artery (IMA) stenosis. METHODS: This was a single academic centre retrospective study. The entire computed tomography (CT) database of a single tertiary hospital was reviewed from 2009 to 2016. Two groups were defined: patients with isolated > 70% SMA stenosis (group A) and patients with both SMA and CA and/or IMA > 70% stenosis (group B). Patient medical histories were reviewed to determine the occurrence of mesenteric disease (MD) defined as development of acute mesenteric ischaemia (AMI) or chronic mesenteric ischaemia (CMI). RESULTS: Seventy-seven patients were included. Median follow up was 39 months. There were 24 patients in group A and 53 patients in group B. In group B, eight (10.4%) patients developed MD with a median onset of 50 months. AMI occurred in five patients with a median of 33 months and CMI in three patients with a median of 88 months. Patients of group B developed more MD (0% vs. 15.1%; p = .052). The five year survival rate was 45% without significant difference between groups. CONCLUSION: Patients with SMA stenosis associated with CA and/or IMA seem to have a higher risk of developing mesenteric ischaemia than patients with isolated SMA stenosis. Considering the low life expectancy of these patients, cardiovascular risk factor assessment and optimisation of medical treatment is essential. Preventive endovascular revascularisation could be discussed for patients with non-isolated > 70% SMA stenosis, taking into account life expectancy.


Asunto(s)
Procedimientos Endovasculares/efectos adversos , Isquemia Mesentérica/epidemiología , Oclusión Vascular Mesentérica/complicaciones , Adulto , Anciano , Enfermedades Asintomáticas/mortalidad , Enfermedades Asintomáticas/terapia , Arteria Celíaca/diagnóstico por imagen , Arteria Celíaca/patología , Angiografía por Tomografía Computarizada , Constricción Patológica/complicaciones , Constricción Patológica/diagnóstico , Constricción Patológica/mortalidad , Constricción Patológica/patología , Procedimientos Endovasculares/normas , Estudios de Seguimiento , Factores de Riesgo de Enfermedad Cardiaca , Humanos , Masculino , Arteria Mesentérica Inferior/diagnóstico por imagen , Arteria Mesentérica Inferior/patología , Arteria Mesentérica Superior/diagnóstico por imagen , Arteria Mesentérica Superior/patología , Isquemia Mesentérica/etiología , Isquemia Mesentérica/prevención & control , Oclusión Vascular Mesentérica/diagnóstico , Oclusión Vascular Mesentérica/mortalidad , Oclusión Vascular Mesentérica/patología , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Pronóstico , Estudios Retrospectivos , Medición de Riesgo/estadística & datos numéricos , Tasa de Supervivencia
5.
Am Heart J ; 233: 59-67, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33321119

RESUMEN

BACKGROUND: The connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries. METHODS: Patients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved. RESULTS: In the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844). CONCLUSION: There were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use.


Asunto(s)
Antineoplásicos Fitogénicos/uso terapéutico , Stents Liberadores de Fármacos , Arteria Femoral/patología , Paclitaxel/uso terapéutico , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/patología , Sistema de Registros/estadística & datos numéricos , Anciano , Centers for Medicare and Medicaid Services, U.S./estadística & datos numéricos , Constricción Patológica/mortalidad , Constricción Patológica/terapia , Femenino , Humanos , Masculino , Enfermedad Arterial Periférica/mortalidad , Factores de Tiempo , Estados Unidos
6.
J Neurointerv Surg ; 13(4): 307-310, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32561658

RESUMEN

BACKGROUND: Prior studies evaluating the Wingspan stent for treatment of symptomatic intracranial atherosclerotic disease have included patients with a spectrum of both on-label and off-label indications for the stent. The WEAVE trial assessed 152 patients stented with the Wingspan stent strictly by its current on-label indication and found a 2.6% periprocedural stroke and death rate. OBJECTIVE: This WOVEN study assesses the 1-year follow-up from this cohort. METHODS: Twelve of the original 24 sites enrolling patients in the WEAVE trial performed follow-up chart review and imaging analysis up to 1 year after stenting. Assessment of delayed stroke and death was made in 129 patients, as well as vascular imaging follow-up to assess for in-stent re-stenosis. RESULTS: In the 1-year follow-up period, seven patients had a stroke (six minor, one major). Subsequent to the periprocedural period, no deaths were recorded in the cohort. Including the four patients who had periprocedural events in the WEAVE study, there were 11 strokes or deaths of the 129 patients (8.5%) at the 1-year follow-up. CONCLUSIONS: The WOVEN study provides the 1-year follow-up on a cohort of 129 patients who were stented according to the current on-label use. It provides a more homogeneous patient group for analysis than prior studies, and demonstrates a relatively low 8.5% 1-year stroke and death rate in stented patients.


Asunto(s)
Arteriosclerosis Intracraneal/terapia , Enfermedades del Sistema Nervioso/etiología , Stents/tendencias , Accidente Cerebrovascular/terapia , Anciano , Estudios de Cohortes , Constricción Patológica/diagnóstico por imagen , Constricción Patológica/etiología , Constricción Patológica/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Arteriosclerosis Intracraneal/diagnóstico por imagen , Arteriosclerosis Intracraneal/mortalidad , Masculino , Persona de Mediana Edad , Mortalidad/tendencias , Enfermedades del Sistema Nervioso/diagnóstico por imagen , Enfermedades del Sistema Nervioso/mortalidad , Stents/efectos adversos , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/mortalidad , Resultado del Tratamiento
7.
Thorac Cardiovasc Surg ; 68(1): 51-58, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-30743276

RESUMEN

BACKGROUND: Left pulmonary artery (LPA) sling (PAS) is a vascular ring, which is frequently associated with long-segment tracheal stenosis (TS). Mortality rate in operated children is still high, especially in cases of severe tracheal hypoplasia and/or associated congenital heart defects (CHDs). We report our experience of treatment and follow-up in a pediatric cohort of patients affected by PAS with severe tracheobronchial involvement. METHODS: From 2005 to 2017, we enrolled 11 children diagnosed with PAS and congenital TS requiring surgical intervention. Echocardiography, computed tomography, and bronchoscopy were performed in all patients. Associated CHD were present in 5 (45%) patients. Tracheal reconstruction techniques included slide tracheoplasty (7/11; 63%), slide tracheoplasty and costal cartilage graft (2/11; 18%), and Hazekamp technique (2/11; 18%).Nine patients underwent LPA direct reimplantation and concomitant tracheoplasty; concomitant surgical repair for CHD was performed in three children. RESULTS: Over a mean follow-up of 30 months (range: 3-75 months), a late mortality of 18% was registered; no early death occurred. Good flow through LPA could be documented in all patients. Ten children required operative bronchoscopies (mean: 16/patients) aimed at stent positioning/removal, treatment of granulomas, and tracheobronchial dilatation. CONCLUSIONS: Severe tracheobronchial stenosis and associated CHD were the main determinants for hospitalization time, intensive assistance, and repeated endoscopic procedures.Patients affected by PAS/TS complex require a careful management at high-specialized centers providing multidisciplinary team.Respiratory endoscopy may play a central role both in preoperatory assessment and in postoperative management of patients showing severe tracheobronchial involvement.


Asunto(s)
Bronquios/anomalías , Enfermedades Bronquiales/cirugía , Procedimientos Quirúrgicos Cardíacos , Constricción Patológica/cirugía , Cartílago Costal/trasplante , Cardiopatías Congénitas/cirugía , Procedimientos de Cirugía Plástica , Arteria Pulmonar/cirugía , Reimplantación , Estenosis Traqueal/cirugía , Bronquios/diagnóstico por imagen , Bronquios/cirugía , Enfermedades Bronquiales/diagnóstico por imagen , Enfermedades Bronquiales/mortalidad , Broncoscopía/efectos adversos , Broncoscopía/instrumentación , Broncoscopía/mortalidad , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/mortalidad , Niño , Preescolar , Constricción Patológica/diagnóstico por imagen , Constricción Patológica/mortalidad , Femenino , Cardiopatías Congénitas/diagnóstico por imagen , Cardiopatías Congénitas/mortalidad , Humanos , Lactante , Masculino , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Arteria Pulmonar/anomalías , Arteria Pulmonar/diagnóstico por imagen , Procedimientos de Cirugía Plástica/efectos adversos , Procedimientos de Cirugía Plástica/mortalidad , Reimplantación/efectos adversos , Reimplantación/mortalidad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Stents , Factores de Tiempo , Estenosis Traqueal/diagnóstico por imagen , Estenosis Traqueal/mortalidad , Resultado del Tratamiento
8.
Heart Fail Rev ; 25(6): 985-992, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-31820204

RESUMEN

Stenosis in the continuous-flow left ventricular assist device (CF-LVAD) outflow graft is caused by various factors. We discuss indications for percutaneous intervention of outflow graft complications and evaluate the use of this treatment in re-establishing adequate CF-LVAD flow. An electronic search was performed to identify all studies in the English literature reporting CF-LVAD outflow graft stenting. Twenty-one studies consisting of 26 patients were included. Patient-level data were extracted for statistical analysis. Median patient age was 59 years [45.8-67.0] and 65.4% (17/26) were male. 58.3% (14/24) of patients had HeartWare HVAD, 37.5% (9/24) had HeartMate II LVAD, and 4.2% (1/24) had HeartMate III LVAS. Median time from device placement to outflow graft stenting was 24.0 months [7.8-30.4]. 76.9% of patients (20/26) presented with heart failure. Complications of the CF-LVAD outflow graft included thrombosis in nine patients (34.6%), stenosis in nine patients (34.6%), kinking in three patients (11.5%), pseudoaneurysm in one patient (3.8%), external graft compression in one patient (3.8%), and bronchial-arterial fistula in one patient (3.6%). Immediate flow improvement occurred in 23/26 patients (88.5%), with the remaining 11.5% (3/26) requiring additional procedures. Pre- and post-intervention flows were 2.9 L/min [2.0-3.5] and 4.7 L/min [4.1-4.8] respectively (p = 0.01). Of patients, 96.2% (25/26) were discharged with a median time to discharge of 4 days [3.0-5.0]. The 30-day mortality was 6.7% (1/15). Overall mortality during the median follow-up of 90 days was 9.5% (2/21). Outflow graft stenting appears to effectively alleviate CF-LVAD outflow graft obstruction and is associated with low overall mortality.


Asunto(s)
Insuficiencia Cardíaca/cirugía , Ventrículos Cardíacos/fisiopatología , Corazón Auxiliar/efectos adversos , Complicaciones Posoperatorias/mortalidad , Stents/efectos adversos , Constricción Patológica/mortalidad , Salud Global , Insuficiencia Cardíaca/fisiopatología , Humanos , Falla de Prótesis , Tasa de Supervivencia/tendencias
9.
Dig Liver Dis ; 51(9): 1287-1293, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31036471

RESUMEN

BACKGROUND: Endoscopic placement of SEMSs for malignant hilar biliary strictures (MHBS) is well-established palliative treatment for inoperable patients. Objectives of this study were evaluation of survival and stents patency after placement of multiple SEMS for palliation of complex MHBS. METHODS: Retrospective review of patients with MHBS that underwent ERCP with insertion of multiple SEMSs for palliation. Survival-associated factors and stents patency were analyzed by Cox multivariate analysis. RESULTS: Between January 1998 and January 2015, 740 patients with nonoperable MHBS that underwent ERCP were identified and only 18.2% of these received multiple SEMSs. Complications were observed in 7.5% of the patients with no procedure-related mortality. Palliative therapies (chemotherapy, external beam radiotherapy and high dose rate brachytherapy) were done in some patients, and outcomes were evaluated. Overall mean survival of the 134 patients was 323 days. Of these, 59% did not had stents malfunction while 41% patients had episodes of SEMSs malfunction and mean survival after re-interventions was 502.9 days. Survival was not influenced by type of tumor, sex or age. CONCLUSIONS: Endoscopic multiple SEMSs placement is safe and effective in patients with complex MHBS. Survival is independent from the type and complexity of MHBS while is prolonged in patients undergoing HDR brachytherapy. Prompt recognition of SEMSs malfunction is fundamental for survival.


Asunto(s)
Colangiopancreatografia Retrógrada Endoscópica/métodos , Constricción Patológica/mortalidad , Constricción Patológica/cirugía , Stents , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de los Conductos Biliares/complicaciones , Neoplasias de los Conductos Biliares/mortalidad , Colangiocarcinoma/complicaciones , Colangiocarcinoma/mortalidad , Constricción Patológica/etiología , Femenino , Neoplasias de la Vesícula Biliar/complicaciones , Neoplasias de la Vesícula Biliar/mortalidad , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Cuidados Paliativos/métodos , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Stents/efectos adversos
10.
Liver Transpl ; 25(8): 1209-1219, 2019 08.
Artículo en Inglés | MEDLINE | ID: mdl-30980451

RESUMEN

Right lobe (RL) living donor liver transplantation (LDLT) usually includes 2 bile duct anastomosis sites, namely, the right anterior and the right posterior segmental ducts. This study aimed to evaluate the optimal treatment for biliary strictures following RL LDLT with respect to unilateral or bilateral drainage techniques. From January 2005 to December 2017, 883 patients at Seoul National University Hospital underwent RL LDLT. Of these, 110 patients were enrolled who had 2 duct-to-duct anastomosis sites and who were considered at risk of developing biliary anastomotic strictures. Unilateral or bilateral biliary drainage during the follow-up period was identified by endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous transhepatic biliary drainage (PTBD). The clinical success, complication, and 180-day mortality rates were compared between the unilateral and bilateral biliary drainage groups according to the initial ERCP findings. The mean age at the time of LDLT was 54.2 ± 8.2 years. The median time from LDLT to initial biliary anastomotic strictures was 177 (interquartile range, 18-1085) days. At the initial ERCP, unilateral drainage was performed in 55 (50.0%) patients, and bilateral drainage was performed in 11 (10.0%) patients. Of the patients who underwent unilateral drainage, 35 (63.6%) patients required conversion to bilateral drainage during follow-up. Overall, 71 (64.5%) patients required bilateral drainage more than once, whereas only 27 (24.5%) patients reached a resolution with unilateral biliary drainage. In this study, most patients required bilateral biliary drainage more than once during follow-up. An active attempt should be made to drain bilaterally in patients with biliary anastomotic strictures following RL LDLT.


Asunto(s)
Conductos Biliares/cirugía , Colangiopancreatografia Retrógrada Endoscópica/métodos , Drenaje/métodos , Trasplante de Hígado/efectos adversos , Complicaciones Posoperatorias/cirugía , Aloinjertos/cirugía , Anastomosis Quirúrgica/efectos adversos , Conductos Biliares/diagnóstico por imagen , Colangiopancreatografia Retrógrada Endoscópica/instrumentación , Constricción Patológica/diagnóstico , Constricción Patológica/etiología , Constricción Patológica/mortalidad , Constricción Patológica/cirugía , Drenaje/instrumentación , Duodenoscopios , Femenino , Estudios de Seguimiento , Humanos , Hígado/cirugía , Trasplante de Hígado/métodos , Donadores Vivos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Estudios Retrospectivos , Stents , Resultado del Tratamiento
11.
Cochrane Database Syst Rev ; 1: CD012510, 2019 01 26.
Artículo en Inglés | MEDLINE | ID: mdl-30684445

RESUMEN

BACKGROUND: Stents are placed in the femoropopliteal arteries for numerous reasons, such as atherosclerotic disease, the need for dissection, and perforation of the arteries, and can become stenosed with the passage of time. When a stent develops a flow-limiting stenosis, this process is known as "in-stent stenosis." It is thought that in-stent restenosis is caused by a process known as "intimal hyperplasia" rather than by the progression of atherosclerotic disease. Management of in-stent restenosis may include performing balloon angioplasty, deploying another stent within the stenosed stent to force it open, and creating a bypass to deliver blood around the stent. The role of drug-eluting technologies, such as drug-eluting balloons (DEBs), in the management of in-stent restenosis is unclear. Drug-eluting balloons might function by coating the inside of stenosed stents with cytotoxic chemicals such as paclitaxel and by inhibiting the hyperplastic processes responsible for in-stent restenosis. It is important to perform this systematic review to evaluate the efficacy of DEB because of the potential for increased expenses associated with DEBs over uncoated balloon angioplasty, also known as plain old balloon angioplasty (POBA). OBJECTIVES: To assess the safety and efficacy of DEBs compared with uncoated balloon angioplasty in people with in-stent restenosis of the femoropopliteal arteries as assessed by criteria such as amputation-free survival, vessel patency, target lesion revascularization, binary restenosis rate, and death. We define "in-stent restenosis" as 50% or greater narrowing of a previously stented vessel by duplex ultrasound or angiography. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to November 28, 2017. Review authors also undertook reference checking to identify additional studies. SELECTION CRITERIA: We included all randomized controlled trials that compared DEBs versus uncoated balloon angioplasty for treatment of in-stent restenosis in the femoropopliteal arteries. DATA COLLECTION AND ANALYSIS: Two review authors (AK, WA) independently selected appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (AD) adjudicated any disagreements. MAIN RESULTS: Three trials that randomized a combined total of 263 participants met the review inclusion criteria. All three trials examined the treatment of symptomatic in-stent restenosis within the femoropopliteal arteries. These trials were carried out in Germany and Austria and used paclitaxel as the agent in the drug-eluting balloons. Two of the three trials were industry sponsored. Two companies manufactured the drug-eluting balloons (Eurocor, Bonn, Germany; Medtronic, Fridley, Minnesota, USA). The trials examined both anatomical and clinical endpoints. We noted heterogeneity in the frequency of bailout stenting deployment between studies as well as in the dosage of paclitaxel applied by the DEBs. Using GRADE assessment criteria, we determined that the certainty of evidence presented was very low for the outcomes of amputation, target lesion revascularization, binary restenosis, death, and improvement of one or more Rutherford categories. Most participants were followed up to 12 months, but one trial followed participants for up to 24 months.Trial results show no difference in the incidence of amputation between DEBs and uncoated balloon angioplasty. DEBs showed better outcomes for up to 24 months for target lesion revascularization (odds ratio (OR) 0.05, 95% confidence Interval (CI) 0.00 to 0.92 at six months; OR 0.24, 95% CI 0.08 to 0.70 at 24 months) and at six and 12 months for binary restenosis (OR 0.28, 95% CI 0.14 to 0.56 at six months; OR 0.34, 95% CI 0.15 to 0.76 at 12 months). Participants treated with DEBs also showed improvement of one or more Rutherford categories at six and 12 months (OR 1.81, 95% CI 1.02 to 3.21 at six months; OR 2.08, 95% CI 1.13 to 3.83 at 12 months). Data show no clear differences in death between DEBs and uncoated balloon angioplasty. Data were insufficient for subgroup or sensitivity analyses to be conducted. AUTHORS' CONCLUSIONS: Based on a meta-analysis of three trials with 263 participants, evidence suggests an advantage for DEBs compared with uncoated balloon angioplasty for anatomical endpoints such as target lesion revascularization (TLR) and binary restenosis, and for one clinical endpoint - improvement in Rutherford category post intervention for up to 24 months. However, the certainty of evidence for all these outcomes is very low due to the small number of included studies and participants and the high risk of bias in study design. Adequately powered and carefully constructed randomized controlled trials are needed to adequately investigate the role of drug-eluting technologies in the management of in-stent restenosis.


Asunto(s)
Angioplastia de Balón/métodos , Arteria Femoral , Arteria Poplítea , Stents , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Índice Tobillo Braquial , Constricción Patológica/etiología , Constricción Patológica/mortalidad , Constricción Patológica/terapia , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Grado de Desobstrucción Vascular
12.
Br J Surg ; 105(12): 1591-1597, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-30019751

RESUMEN

BACKGROUND: In the POISE-2 (PeriOperative ISchemic Evaluation 2) trial, perioperative aspirin did not reduce cardiovascular events, but increased major bleeding. There remains uncertainty regarding the effect of perioperative aspirin in patients undergoing vascular surgery. The aim of this substudy was to determine whether there is a subgroup effect of initiating or continuing aspirin in patients undergoing vascular surgery. METHODS: POISE-2 was a blinded, randomized trial of patients having non-cardiac surgery. Patients were assigned to perioperative aspirin or placebo. The primary outcome was a composite of death or myocardial infarction at 30 days. Secondary outcomes included: vascular occlusive complications (a composite of amputation and peripheral arterial thrombosis) and major or life-threatening bleeding. RESULTS: Of 10 010 patients in POISE-2, 603 underwent vascular surgery, 319 in the continuation and 284 in the initiation stratum. Some 272 patients had vascular surgery for occlusive disease and 265 had aneurysm surgery. The primary outcome occurred in 13·7 per cent of patients having aneurysm repair allocated to aspirin and 9·0 per cent who had placebo (hazard ratio (HR) 1·48, 95 per cent c.i. 0·71 to 3·09). Among patients who had surgery for occlusive vascular disease, 15·8 per cent allocated to aspirin and 13·6 per cent on placebo had the primary outcome (HR 1·16, 0·62 to 2·17). There was no interaction with the primary outcome for type of surgery (P = 0·294) or aspirin stratum (P = 0·623). There was no interaction for vascular occlusive complications (P = 0·413) or bleeding (P = 0·900) for vascular compared with non-vascular surgery. CONCLUSION: This study suggests that the overall POISE-2 results apply to vascular surgery. Perioperative withdrawal of chronic aspirin therapy did not increase cardiovascular or vascular occlusive complications. Registration number: NCT01082874 ( http://www.clinicaltrials.gov).


Asunto(s)
Aspirina/administración & dosificación , Inhibidores de Agregación Plaquetaria/administración & dosificación , Procedimientos Quirúrgicos Vasculares/efectos adversos , Anciano , Constricción Patológica/etiología , Constricción Patológica/mortalidad , Femenino , Humanos , Masculino , Infarto del Miocardio/etiología , Infarto del Miocardio/mortalidad , Atención Perioperativa/métodos , Atención Perioperativa/mortalidad , Inhibidores de Agregación Plaquetaria/efectos adversos , Complicaciones Posoperatorias/inducido químicamente , Complicaciones Posoperatorias/prevención & control , Hemorragia Posoperatoria/inducido químicamente , Resultado del Tratamiento , Enfermedades Vasculares/etiología , Enfermedades Vasculares/mortalidad , Procedimientos Quirúrgicos Vasculares/mortalidad
13.
Neurol Sci ; 39(11): 1955-1959, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-29987436

RESUMEN

INTRODUCTION: The objective of this single-center pilot study was to assess if symptomatic intracranial atherosclerotic disease (ICAD) ultrasound features change through the 2 years after acute ischemic stroke or TIA, being ICAD a relevant cause of acute ischemic stroke or TIA, linked to high rates of recurrent stroke. METHODS: We consecutively enrolled 48 patients with acute ischemic stroke or TIA with symptomatic ICAD detected by transcranial color-coded duplex sonography (TCCS) and confirmed by MR-angiography and/or CT-angiography. We set a neurosonological and clinical follow-up at 3, 6, 12, and 24 months (T0, T1, T2, T3, and T4). RESULTS: We observed that the hemodynamic effect of the stenosis changed during the 2-year follow-up, as revealed by the modifications of Peak Systolic Velocity (PSV) (Friedman-ANOVA test, p < 0.001). The pairwise post-hoc analysis showed a statistically significant difference between PSV at T0 and PSV at T3 (p = 0.005) and between PSV at T0 and PSV at T4 (p < 0.001) being PSV at T3 and T4 lower than PSV at T0. Seven patients had a new event in the first 12 months. CONCLUSIONS: The high rate of recurrent stroke or death among ICAD patients seems to be independent of progressive arterial narrowing. A wide multicenter follow-up study is needed in order to identify the factors that, alongside the hemodynamic features, contribute to the high risk of recurrent stroke among patient with symptomatic ICAD.


Asunto(s)
Arteriosclerosis Intracraneal/diagnóstico por imagen , Ultrasonografía Doppler Transcraneal , Adulto , Anciano , Anciano de 80 o más Años , Isquemia Encefálica/diagnóstico por imagen , Isquemia Encefálica/mortalidad , Isquemia Encefálica/fisiopatología , Angiografía Cerebral , Constricción Patológica/diagnóstico por imagen , Constricción Patológica/mortalidad , Constricción Patológica/fisiopatología , Femenino , Estudios de Seguimiento , Hemodinámica , Humanos , Arteriosclerosis Intracraneal/mortalidad , Arteriosclerosis Intracraneal/fisiopatología , Angiografía por Resonancia Magnética , Masculino , Persona de Mediana Edad , Proyectos Piloto , Estudios Prospectivos , Recurrencia , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/fisiopatología , Tomografía Computarizada por Rayos X
14.
World J Gastroenterol ; 24(10): 1134-1143, 2018 Mar 14.
Artículo en Inglés | MEDLINE | ID: mdl-29563757

RESUMEN

AIM: To investigate 30-year treatment outcomes associated with Budd-Chiari syndrome (BCS) at a tertiary hospital in China. METHODS: A total of 256 patients diagnosed with primary BCS at our tertiary hospital between November 1983 and September 2013 were followed and retrospectively studied. Cumulative survival rates and cumulative mortality rates of major causes were calculated by Kaplan-Meier analysis, and the independent predictors of survival were identified using a Cox regression model. RESULTS: Thirty-four patients were untreated; however, 222 patients were treated by medicine, surgery, or interventional radiology. Forty-four patients were lost to follow-up; however, 212 patients were followed, 67 of whom died. The symptom remission rates of treated and untreated patients were 81.1% (107/132) and 46.2% (6/13), respectively (P = 0.009). The cumulative 1-, 5-, 10-, 20-, and 30-year survival rates of the treated patients were 93.5%, 81.6%, 75.2%, 64.7%, and 58.2%, respectively; however, the 1-, 5-, 10-, 20-, and 30-year survival rates of the untreated patients were 70.8%, 70.8%, 53.1%, 0%, and unavailable, respectively (P = 0.007). Independent predictors of survival for treated patients were gastroesophageal variceal bleeding (HR = 3.043, 95%CI: 1.363-6.791, P = 0.007) and restenosis (HR = 4.610, 95%CI: 1.916-11.091, P = 0.001). The cumulative 1-, 5-, 10-, 20-, and 30-year mortality rates for hepatocellular carcinoma were 0%, 2.6%, 3.5%, 8%, and 17.4%, respectively. CONCLUSION: Long-term survival is satisfactory for treated Chinese patients with BCS. Hepatocellular carcinoma is a chronic complication and should be monitored with long-term follow-up.


Asunto(s)
Síndrome de Budd-Chiari/mortalidad , Carcinoma Hepatocelular/mortalidad , Várices Esofágicas y Gástricas/mortalidad , Hemorragia Gastrointestinal/mortalidad , Neoplasias Hepáticas/mortalidad , Adolescente , Adulto , Anciano , Síndrome de Budd-Chiari/complicaciones , Síndrome de Budd-Chiari/terapia , Carcinoma Hepatocelular/etiología , Niño , China/epidemiología , Constricción Patológica/etiología , Constricción Patológica/mortalidad , Várices Esofágicas y Gástricas/etiología , Femenino , Estudios de Seguimiento , Hemorragia Gastrointestinal/etiología , Venas Hepáticas/patología , Humanos , Estimación de Kaplan-Meier , Neoplasias Hepáticas/etiología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tasa de Supervivencia , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
15.
J Pediatr Surg ; 53(11): 2140-2144, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-29370890

RESUMEN

BACKGROUND: Mortality and morbidity of congenital tracheal stenosis (CTS) remain high. The aim of this study was to determine the factors predicting 12-month survival and 2-month successful extubation after tracheoplasty in patients with CTS. METHODS: Retrospective chart reviews were conducted in patients with CTS undergoing tracheoplasty at a single institution between 1997 and 2014. Patients' characteristics at disease onset and tracheoplasty were summarized. Twelve-month survival rate and 2-month extubation rate without tracheotomy after tracheoplasty were analyzed. RESULTS: We reviewed 81 patients' records. Multivariate analysis for 12-month survival revealed that older age (>2 months, hazard ratio [HR]: 0.08, 95% confidence interval [CI]: 0.02-0.36) or heavier body weight (>4.4 kg, HR: 0.13, 95% CI: 0.02-0.73) at tracheoplasty was a predictive factor for survival. Body weight at tracheoplasty (>8.2 kg, HR: 3.83, 95% CI: 1.88-7.79), preoperative balloon dilatation (HR: 0.30, 95% CI: 0.12-0.78), and carina involvement (HR: 0.36, 95% CI: 0.19-0.69) were predictive factors for successful extubation. CONCLUSIONS: Although CTS management is individualized, age or body weight at tracheoplasty needs to be considered and assessed for survival, as well as preoperative balloon dilatation, and carina involvement for successful extubation. LEVELS OF EVIDENCE: Level III.


Asunto(s)
Constricción Patológica/mortalidad , Constricción Patológica/cirugía , Procedimientos de Cirugía Plástica/mortalidad , Tráquea/anomalías , Humanos , Lactante , Recién Nacido , Estudios Retrospectivos , Tráquea/cirugía , Resultado del Tratamiento
16.
Int J Pediatr Otorhinolaryngol ; 101: 57-64, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28964311

RESUMEN

OBJECTIVES: Tracheal atresia (TA) is a rare congenital condition that typically requires an unexpected and emergent resuscitation in the delivery room. The mortality rate associated is very high, with only a few long-term survival cases reported. We describe the findings of a systematic review on the clinical presentation and airway management of TA. METHODS: Using the keywords "tracheal atresia", "tracheal agenesis" and "tracheal hypoplasia" a search through Embase and Pubmed databases was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol. Articles published from 1950 to 2015 in English, French, Italian, Portuguese and Spanish were included. Exclusion criteria were cases of stillborn, and unclear diagnosis or outcome. RESULTS: 149 cases of TA were identified after reviewing 1125 initial references. There was a male preponderance (65%), and associated malformations were described in 94.2% of patients. Prenatal ultrasound was abnormal in 56.3% of cases, with polyhydramnios being the most common finding. The most frequent type of TA was Faro Type C. 94 (41.3%) patients did not survive beyond the first 24 h of life. Only 13 (8.4%) patients survived more than three months of life, after undergoing a variety of surgical approaches. CONCLUSION: This review, which to our knowledge is the largest one to date, confirms that TA is a rare malformation, occurs more frequently in males, and has a very high mortality rate. Depending on the presence and type of concomitant malformation, as well of the length of the remaining trachea, different surgical management options are described.


Asunto(s)
Manejo de la Vía Aérea/métodos , Constricción Patológica/diagnóstico , Tráquea/anomalías , Constricción Patológica/mortalidad , Constricción Patológica/cirugía , Femenino , Humanos , Recién Nacido , Masculino , Embarazo , Tasa de Supervivencia , Tráquea/cirugía
17.
Clin Transplant ; 31(7)2017 07.
Artículo en Inglés | MEDLINE | ID: mdl-28489291

RESUMEN

BACKGROUND: Endoscopic treatment of anastomotic biliary stricture (ABS) after liver transplantation (LT) has been proven to be effective and safe, but long-term outcomes of early compared to late onset ABS have not been studied. The aim of this study is to compare the long-term outcome of early ABS to late ABS. METHODS: Of the 806 adult LT recipients (04/2006-12/2012), 93 patients met the criteria for inclusion, and were grouped into non-ABS (no stenosis on ERCP, n=41), early ABS (stenosis <90 days after LT, 18 [19.3%]), and late ABS (stenosis ≥90 days after LT, 34 [36.5%]). A propensity matched control group for the ABS group (n=42) was obtained matched for outcome variables for age, gender, and calculated MELD score at listing. RESULTS: Mean number of ERCPs (2.33±1.3 vs 2.56±1.5, P=.69) were comparable between the groups; however, significantly better long-term resolution of the stricture was noted in the early ABS group (94.44% vs 67.65%, P=.04). Kaplan-Meier analysis revealed worst survival in the early ABS group compared to the non-ABS, late ABS, and control groups (P=.0001). CONCLUSION: LT recipients with early ABS have inferior graft survival despite better response to endoscopic intervention.


Asunto(s)
Anastomosis Quirúrgica/mortalidad , Sistema Biliar/patología , Colestasis Extrahepática/mortalidad , Constricción Patológica/mortalidad , Rechazo de Injerto/mortalidad , Trasplante de Hígado/efectos adversos , Complicaciones Posoperatorias/mortalidad , Adulto , Estudios de Casos y Controles , Colestasis Extrahepática/etiología , Colestasis Extrahepática/terapia , Constricción Patológica/etiología , Constricción Patológica/terapia , Femenino , Estudios de Seguimiento , Rechazo de Injerto/etiología , Rechazo de Injerto/terapia , Supervivencia de Injerto , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia , Factores de Tiempo
19.
Semin Thorac Cardiovasc Surg ; 28(1): 62-8, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-27568138

RESUMEN

Tracheobronchomalacia (TBM) is frequently present in infants and children with congenital heart disease (CHD). Infants with CHD and TBM appear to do worse than those without TBM. The principle of operative intervention for TBM is to improve function of the airway and clinical status. When indicated, conventional surgical options include tracheostomy, aortopexy, tracheoplasty, and anterior tracheal suspension. There is no consensus on the optimal treatment of severe tracheobonchomalacia, which can be associated with a mortality rate as high as 80%. Congenital tracheal stenosis is also frequently associated with CHD (vascular rings, atrioventricular canal defects, and septal defects) and may require concomitant repair. Repair of tracheal stenosis is often associated with distal TBM. This article addresses new techniques that can be performed in corrective surgery for both TBM and congenital tracheal stenosis.


Asunto(s)
Bronquios/cirugía , Constricción Patológica/cirugía , Procedimientos Quirúrgicos Torácicos , Tráquea/anomalías , Tráquea/cirugía , Traqueobroncomalacia/cirugía , Bronquios/anomalías , Bronquios/fisiopatología , Constricción Patológica/diagnóstico , Constricción Patológica/mortalidad , Constricción Patológica/fisiopatología , Difusión de Innovaciones , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Recuperación de la Función , Índice de Severidad de la Enfermedad , Procedimientos Quirúrgicos Torácicos/historia , Procedimientos Quirúrgicos Torácicos/tendencias , Tráquea/fisiopatología , Traqueobroncomalacia/diagnóstico , Traqueobroncomalacia/mortalidad , Traqueobroncomalacia/fisiopatología , Resultado del Tratamiento
20.
Liver Transpl ; 22(7): 923-33, 2016 07.
Artículo en Inglés | MEDLINE | ID: mdl-27097277

RESUMEN

Hepatic artery stenosis (HAS) is a rare complication of orthotopic liver transplantation (LT). HAS could evolve into complete thrombosis and lead to graft loss, incurring significant morbidity and mortality. Even though endovascular management by percutaneous transluminal angioplasty ± stenting (PTA) is the primary treatment of HAS, its longterm impact on hepatic artery (HA) patency and graft survival remains unclear. This study aimed to evaluate longterm outcomes of PTA and to define the risk factors of treatment failure. From 2006 to 2012, 30 patients with critical HAS (>50% stenosis of HA) and treated by PTA were identified from 870 adult patients undergoing LT. Seventeen patients were diagnosed by post-LT screening, and 13 patients were symptomatic due to HAS. PTA was completed successfully in 27 (90%) patients with angioplasty plus stenting in 23 and angioplasty alone in 4. The immediate technical success rate was 90%. A major complication that was observed was arterial dissection (1 patient) which eventually necessitated retransplantation. Restenosis was observed in 10 (33%) patients. One-year, 3-year, and 5-year HA patency rates were 68%, 62.8%, and 62.8%, respectively. Overall patient survival was 93.3% at 3 years and 85.3% at 5 years. The 3-year and 5-year liver graft survival rates were 84.7% and 64.5%, respectively. No significant difference was observed in patient and graft survivals between asymptomatic and symptomatic patients after PTA. Similarly, no difference was observed between angioplasty alone and angioplasty plus stenting. In conclusion, endovascular therapy ensures a good 5-year graft survival (64.5%) and patient survival (85.3%) in patients with critical HAS by maintaining HA patency with a low risk of serious morbidity (3.3%). Liver Transplantation 22 923-933 2016 AASLD.


Asunto(s)
Angioplastia/estadística & datos numéricos , Arteria Hepática/cirugía , Análisis de Intención de Tratar , Hepatopatías/cirugía , Trasplante de Hígado/efectos adversos , Adolescente , Adulto , Anciano , Angioplastia/efectos adversos , Angioplastia/métodos , Angiografía por Tomografía Computarizada , Constricción Patológica/diagnóstico por imagen , Constricción Patológica/etiología , Constricción Patológica/mortalidad , Constricción Patológica/cirugía , Femenino , Oclusión de Injerto Vascular/diagnóstico por imagen , Oclusión de Injerto Vascular/epidemiología , Supervivencia de Injerto , Arteria Hepática/patología , Humanos , Trasplante de Hígado/métodos , Masculino , Persona de Mediana Edad , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Stents , Insuficiencia del Tratamiento , Resultado del Tratamiento , Ultrasonografía Doppler , Grado de Desobstrucción Vascular , Adulto Joven
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