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1.
N Engl J Med ; 383(8): 733-742, 2020 08 20.
Artículo en Inglés | MEDLINE | ID: mdl-32813949

RESUMEN

BACKGROUND: Standard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes. METHODS: In this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or access-circuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data. RESULTS: A total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, target-lesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P<0.001). Drug-coated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, -0.2 percentage points; 95% CI, -5.5 to 5.0; P = 0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses. CONCLUSIONS: Drug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit-related serious adverse events within 30 days. (Funded by Medtronic; IN.PACT AV Access Study ClinicalTrials.gov number, NCT03041467.).


Asunto(s)
Angioplastia de Balón/métodos , Derivación Arteriovenosa Quirúrgica , Fármacos Cardiovasculares/administración & dosificación , Paclitaxel/administración & dosificación , Dispositivos de Acceso Vascular/efectos adversos , Grado de Desobstrucción Vascular , Anciano , Angioplastia de Balón/instrumentación , Derivación Arteriovenosa Quirúrgica/instrumentación , Fármacos Cardiovasculares/efectos adversos , Materiales Biocompatibles Revestidos , Constricción Patológica/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Paclitaxel/efectos adversos , Estudios Prospectivos , Diálisis Renal/efectos adversos , Método Simple Ciego , Extremidad Superior/irrigación sanguínea
2.
J Vasc Interv Radiol ; 33(8): 895-902.e4, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-35472578

RESUMEN

PURPOSE: To study, from a U.S. payer's perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae. MATERIALS AND METHODS: Cost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated. RESULTS: Using the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48. CONCLUSIONS: Endovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.


Asunto(s)
Angioplastia de Balón , Fístula Arteriovenosa , Enfermedad Arterial Periférica , Anciano , Angioplastia de Balón/economía , Fístula Arteriovenosa/diagnóstico por imagen , Fístula Arteriovenosa/patología , Fístula Arteriovenosa/terapia , Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Constricción Patológica/patología , Análisis Costo-Beneficio , Arteria Femoral , Humanos , Medicare , Paclitaxel , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Grado de Desobstrucción Vascular
3.
J Vasc Interv Radiol ; 33(5): 510-517.e1, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35150838

RESUMEN

PURPOSE: The albumin-bilirubin (ALBI) grade has been established as an improved predictor of survival in patients with hepatocellular carcinoma (HCC) treated with conventional transarterial chemoembolization and yttrium-90 radioembolization. The purpose of the study was to investigate the utility of ALBI grade in prognosticating outcomes in patients with HCC treated with drug-eluting embolic (DEE) transarterial chemoembolization (TACE). MATERIALS AND METHODS: A single-center retrospective review was performed to compare the efficacy of ALBI grade and Child-Pugh (CP) classification in predicting the survival of patients with HCC receiving DEE-TACE. A total of 303 patients with HCC were identified who had received DEE-TACE without concomitant locoregional therapy within 30 days. Survival analysis was performed using Kaplan-Meier methods and censored for curative therapy. Survival curves were stratified based on the ALBI grade, CP class, Barcelona Clinic Liver Cancer (BCLC) stage, Eastern Cooperative Oncology Group performance status, and presence of ascites. The discriminatory ability of survival curves was calculated by C-Index. RESULTS: Kaplan-Meier survival curves stratified by the ALBI grade produced distinct, nonoverlapping curves (P < .001), showing greater discriminatory ability than the CP classification (C-index = 0.568 and 0.545, respectively). The substratification of the BCLC stage by the ALBI grade yielded greater discriminatory ability than the substratification by the CP classification (C-index = 0.573 and 0.565, respectively). For patients with BCLC stage B, the substratification by the ALBI grade yielded distinct curves, whereas the substratification by the CP classification did not (P = .011 and P = .379, respectively). CONCLUSIONS: ALBI grade showed improved discriminatory ability compared with CP classification in differentiating overall survival among patients with HCC receiving DEE-TACE. Furthermore, ALBI grade was effective in substratifying survival among patients categorized as CP class A and patients with BCLC stage B, whereas CP classification was not effective.


Asunto(s)
Carcinoma Hepatocelular , Quimioembolización Terapéutica , Neoplasias Hepáticas , Bilirrubina , Carcinoma Hepatocelular/diagnóstico por imagen , Carcinoma Hepatocelular/terapia , Quimioembolización Terapéutica/métodos , Humanos , Estimación de Kaplan-Meier , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/terapia , Pronóstico , Estudios Retrospectivos , Albúmina Sérica
4.
Radiographics ; 42(6): 1861-1880, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-36190861

RESUMEN

Acute pulmonary embolism (PE) affects more than 100 000 people in the United States annually and is the third leading cardiovascular cause of death. The standard management for PE is systemic anticoagulation therapy. However, a subset of patients experience hemodynamic decompensation, despite conservative measures. Traditionally, these patients have been treated with systemic administration of thrombolytic agents or open cardiac surgery, although attempts at endovascular treatment have a long history that dates back to the 1960s. The technology for catheter-based therapy for acute PE is rapidly evolving, with multiple devices approved over the past decade. Currently available devices fall into two broad categories of treatment methods: catheter-directed thrombolysis and percutaneous suction thrombectomy. Catheter-directed thrombolysis is the infusion of thrombolytic agents directly into the occluded pulmonary arteries to increase local delivery and decrease the total dose. Suction thrombectomy involves the use of small- or large-bore catheters to mechanically aspirate a clot from the pulmonary arteries without the need for a thrombolytic agent. A thorough understanding of the various risk stratification schemes and the available evidence for each device is critical for optimal treatment of this complex entity. Multiple ongoing studies will improve our understanding of the role of catheter-based therapy for acute PE in the next 5-10 years. A multidisciplinary approach through PE response teams has become the management standard at most institutions. An invited commentary by Bulman and Weinstein is available online. Online supplemental material is available for this article. ©RSNA, 2022.


Asunto(s)
Fibrinolíticos , Embolia Pulmonar , Enfermedad Aguda , Anticoagulantes , Catéteres , Humanos , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/terapia , Terapia Trombolítica , Resultado del Tratamiento , Estados Unidos
5.
Vasc Med ; 26(1): 38-46, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33332237

RESUMEN

Positive relationships between volume and outcome have been seen in several surgical and medical conditions, resulting in more centralized and specialized care structures. Currently, there is a scarcity of literature involving the volume-outcome relationship in pulmonary embolism (PE). Using a state-wide dataset that encapsulates all non-federal admissions in New York State, we performed a retrospective cohort study on admitted patients with a diagnosis of PE. A total of 70,443 cases were separated into volume groups stratified by hospital quartile. Continuous and categorical variables were compared between cohorts. Multivariable regression analysis was conducted to assess predictors of 1-year mortality, 30-day all-cause readmission, 30-day PE-related readmission, length of stay, and total charges. Of the 205 facilities that were included, 128 (62%) were labeled low volume, 39 (19%) medium volume, 23 (11%) high volume, and 15 (7%) very high volume. Multivariable analysis showed that very high volume was associated with decreased 30-day PE-related readmission (OR 0.64; 95% CI, 0.55 to 0.73), decreased 30-day all-cause readmission (OR 0.84; 95% CI, 0.79 to 0.89), decreased 1-year mortality (OR 0.85; 95% CI, 0.80 to 0.91), decreased total charges (OR 0.96; 95% CI, 0.94 to 0.98), and decreased length of stay (OR 0.94; 95% CI, 0.92 to 0.96). In summary, facilities with higher volumes of acute PE were found to have less 30-day PE-related readmissions, less all-cause readmissions, shorter length of stay, decreased 1-year mortality, and decreased total charges.


Asunto(s)
Embolia Pulmonar , Enfermedad Aguda , Hospitalización , Hospitales , Humanos , Tiempo de Internación , Readmisión del Paciente , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/terapia , Estudios Retrospectivos
6.
J Vasc Interv Radiol ; 31(3): 370-377, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31956004

RESUMEN

PURPOSE: To evaluate outcomes after prostatic artery embolization (PAE) in patients with severe intravesical prostatic protrusion (IPP). MATERIALS AND METHODS: This was a retrospective, single health system, 2-hospital study from April 2015 to December 2018 of 54 patients who underwent elective PAE procedures (age mean 67.5 years; standard deviation [SD] 8.5). The cohort had a mean ellipsoid prostate volume of 100.1 cm3 (SD 56.7), a mean baseline International Prostate Symptom Score (IPSS) of 18.7 (SD 8.2), a mean baseline quality of life (QOL) score of 4.1 (SD 1.4), and a median follow-up of 38 days (range 10-656 days). Outcomes including IPSS and QOL score reduction (where a lower QOL score indicates an improvement in QOL), and clinical success were compared between severe (≥10 mm) and nonsevere (<10 mm) IPP patients. A linear regression model was used to examine the impact of IPP on these outcomes. RESULTS: No significant differences in patient characteristics were found between nonsevere (n = 17) and severe (n = 37) IPP patients. Both cohorts showed IPSS reduction (nonsevere 6.0, P = .0397; severe 8.2, P < .0001) and QOL score reduction (nonsevere 1.0, P = .102; severe 2.0, P < .0001). No significant differences in IPSS or QOL score reduction were found between the cohorts (P = .431 and P = .127). Linear regression found that baseline IPP was not a significant contributor to the outcomes (IPSS: R2 = .5, P < .0001; IPP: P = .702; QOL: R2 = .5, P = .0003; IPP: P = .108). CONCLUSIONS: There were no significant differences in early outcomes in PAE between patients with severe and nonsevere IPP.


Asunto(s)
Embolización Terapéutica , Síntomas del Sistema Urinario Inferior/terapia , Próstata/irrigación sanguínea , Hiperplasia Prostática/terapia , Anciano , Embolización Terapéutica/efectos adversos , Humanos , Síntomas del Sistema Urinario Inferior/diagnóstico por imagen , Síntomas del Sistema Urinario Inferior/fisiopatología , Masculino , Persona de Mediana Edad , Tamaño de los Órganos , Próstata/diagnóstico por imagen , Hiperplasia Prostática/diagnóstico por imagen , Hiperplasia Prostática/fisiopatología , Calidad de Vida , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento
8.
J Vasc Interv Radiol ; 30(3): 342-346, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30819475

RESUMEN

This report describes a single-center experience with balloon-occluded transarterial chemoembolization for liver-directed therapy. A total of 26 patients (11 male, 4 female; mean age, 65 y ± 7) with 28 tumors (mean diameter, 2.7 cm; range, 1.1-5.9 cm) were treated. Technical success rate was 100% (28 of 28 cases), with 1 minor complication of left portal vein thrombosis and small liver infarct. Of the 15 tumors analyzed for response, 60% (9 of 15) exhibited complete response, 33.3% (5 of 15) exhibited partial response, and 6.6% (1 of 15) had stable disease on follow-up. Eight patients exhibited overall progression with a new hepatic lesion and a median time to progression of 7.9 months (range, 5-11 mo).


Asunto(s)
Oclusión con Balón , Carcinoma Hepatocelular/terapia , Quimioembolización Terapéutica/métodos , Neoplasias Hepáticas/terapia , Anciano , Angiografía de Substracción Digital , Oclusión con Balón/efectos adversos , Carcinoma Hepatocelular/diagnóstico por imagen , Carcinoma Hepatocelular/patología , Quimioembolización Terapéutica/efectos adversos , Progresión de la Enfermedad , Estudios de Factibilidad , Femenino , Humanos , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/patología , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Ciudad de Nueva York , Datos Preliminares , Estudios Retrospectivos , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
9.
J Vasc Interv Radiol ; 30(3): 414-420, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30819485

RESUMEN

PURPOSE: To determine patient preference for transradial access (TRA) or transfemoral access (TFA) after experiencing both. MATERIALS AND METHODS: A randomized controlled crossover trial was conducted at a single institution. Thirty patients with hepatocellular carcinoma undergoing mapping and transarterial radioembolization (TARE) were enrolled to experience 1 TRA and 1 TFA procedure each, with randomization of which access approach was experienced first. Surveys assessing pain and quality of life (QOL) were administered after each procedure. Access site preference was collected after completion of both procedures. RESULTS: Twenty-two subjects (73.3%) preferred TRA, 4 (13.3%) preferred TFA, and 4 (13.3%) had no preference; 14 (46.7%) reported bruising after TRA, and 17 (53.3%) reported bruising after TFA. TRA was associated with significantly lower pain scores overall during the procedure, at the access site during the procedure, and in the recovery room compared with TFA (2.0 vs 2.9, P = .0046; 2.0 vs 3.0, P = .0004; 2.1 vs 2.9, P = .0357). Pain score after discharge was not significantly different (1.4 vs 1.5, P = .4235). QOL scores were not significantly different between TRA and TFA. No significant differences were found for fluoroscopy time, air kerma, dose-area product, or procedure time between TRA and TFA for either mapping (P = .1442, P = .5871, P = .6667, P = .6131) or radioembolization (P = .8574, P = .2344, P = .1119, P =.8474). For radioembolizations, TRA had significantly shorter recovery times compared with TFA (108 min vs 153 min, P = .0193). CONCLUSIONS: Patients exhibited a strong preference for TRA. With TRA, patients experienced less periprocedural pain and shorter recovery times without significant differences in radiation exposure or procedure length.


Asunto(s)
Carcinoma Hepatocelular/radioterapia , Cateterismo Periférico/métodos , Embolización Terapéutica/métodos , Arteria Femoral , Neoplasias Hepáticas/radioterapia , Prioridad del Paciente , Arteria Radial , Radiofármacos/administración & dosificación , Anciano , Cateterismo Periférico/efectos adversos , Estudios Cruzados , Embolización Terapéutica/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor/etiología , Estudios Prospectivos , Calidad de Vida , Radiofármacos/efectos adversos , Factores de Tiempo , Resultado del Tratamiento
10.
J Vasc Surg ; 67(2): 637-644.e30, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-29389426

RESUMEN

OBJECTIVE: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. METHODS: Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. RESULTS: The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. CONCLUSIONS: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.


Asunto(s)
Prótesis Vascular , Aprobación de Recursos/normas , Procedimientos Endovasculares/instrumentación , Enfermedad Arterial Periférica/terapia , Sistema de Registros/normas , Stents , United States Food and Drug Administration/normas , Procedimientos Quirúrgicos Vasculares/instrumentación , Minería de Datos/normas , Registros Electrónicos de Salud/normas , Procedimientos Endovasculares/efectos adversos , Humanos , Cooperación Internacional , Informática Médica/normas , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/fisiopatología , Vigilancia de Productos Comercializados/normas , Diseño de Prótesis , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiología , Procedimientos Quirúrgicos Vasculares/efectos adversos , Flujo de Trabajo
12.
J Vasc Interv Radiol ; 29(1): 30-37.e2, 2018 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-29169782

RESUMEN

PURPOSE: To compare outcomes of radiation segmentectomy (RS) and segmental transarterial chemoembolization in treatment of unresectable, solitary hepatocellular carcinoma (HCC) ≤ 3 cm. MATERIALS AND METHODS: From January 2012 to January 2016, 534 and 877 patients were treated with radioembolization and transarterial chemoembolization, respectively. A cohort of 112 (radiation segmentectomy [RS], 55; chemoembolization, 57) locoregional therapy-naïve patients with solitary HCC ≤ 3 cm without vascular invasion or metastasis was retrospectively identified and stratified according to baseline patient demographics, tumor characteristics, and laboratory values. Propensity score matching (PSM) was conducted using a nearest neighbor algorithm (1:1). Outcomes analyzed included laboratory toxicities, imaging response, time to secondary therapy (TTST), and overall survival. RESULTS: Before PSM, complete response (CR) rate was 81.2% for RS and 49.1% for chemoembolization (odds ratio 2.2; 95% confidence interval [CI], 1.4-3.3; P < .001). Median (95% CI) TTST after initial therapy was 246 days (135-250 d) in chemoembolization group and 700 days (308-812 d) in RS group (hazard ratio 0.71; 95% CI, 0.55-0.92; P = .009). Overall survival before PSM was not significantly different between the 2 groups (P = .29). Overall CR rate after PSM was 92.1% in RS group and 52.6% in chemoembolization group (P = .005). Median (95% CI) TTST after matching was 161 days (76-350 d) in chemoembolization group and 812 days (363-812 d) in RS group (P = .001). Overall survival after matching was not significantly different between the 2 groups (P = .71). CONCLUSIONS: RS results in improved imaging response and longer TTST compared with transarterial chemoembolization in treatment of early-stage HCC.


Asunto(s)
Carcinoma Hepatocelular/terapia , Quimioembolización Terapéutica , Neoplasias Hepáticas/terapia , Adulto , Anciano , Carcinoma Hepatocelular/patología , Carcinoma Hepatocelular/radioterapia , Femenino , Humanos , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/radioterapia , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Puntaje de Propensión , Estudios Retrospectivos , Tasa de Supervivencia , Resultado del Tratamiento
13.
J Vasc Interv Radiol ; 29(7): 936-942, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29753675

RESUMEN

PURPOSE: To compare differences in patient radiation exposure (PRE) during transarterial yttrium-90 (90Y) radioembolization (TARE) between transradial access (TRA) and transfemoral access (TFA). MATERIALS AND METHODS: A total of 810 consecutive first-time TARE procedures in patients from 2013 to 2017 were retrospectively reviewed. A propensity score-matching (PSM) analysis matched TRA and TFA groups on the basis of patient age, sex, weight, height, cancer type, 90Y microsphere type, and number of previous procedures from the same and opposite approaches. Matched groups were then compared by PRE measures fluoroscopy time (FT), dose-area product (DAP), and cumulative air kerma (AK). Effect size for each PRE measure was calculated. RESULTS: Before PSM, TRA and TFA groups differed significantly in mean age, weight, and number of previous procedures from the same and opposite approach (all P < .05). After PSM, each group consisted of 302 procedures (overall, n = 604) and no longer differed in any procedure performed before surgery measure. TRA did not differ from the matched TFA group regarding median FT (9.50 vs 9.40 minutes, P = .095), median DAP (67,066 vs 67,219 mGy·cm2; P = .19), or median AK (323.63 vs 248.46 mGy; P = .16). Effect sizes were 0.068, 0.054, and 0.110 for FT, DAP, and AK, respectively. CONCLUSIONS: No statistical differences were found for PRE measures between the matched TRA and TFA approach groups. Furthermore, practical effect sizes were considered to be small for AK and less than small for FT and DAP, and therefore, any differences in PRE between the radial and femoral approaches for TARE are minor and unlikely to be noticeable in everyday clinical practice.


Asunto(s)
Cateterismo Periférico/métodos , Embolización Terapéutica/métodos , Arteria Femoral , Neoplasias/radioterapia , Arteria Radial , Dosis de Radiación , Exposición a la Radiación , Radioisótopos de Itrio/administración & dosificación , Anciano , Cateterismo Periférico/efectos adversos , Embolización Terapéutica/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/patología , Seguridad del Paciente , Puntaje de Propensión , Exposición a la Radiación/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Radioisótopos de Itrio/efectos adversos
14.
J Vasc Surg ; 66(1): 151-159, 2017 07.
Artículo en Inglés | MEDLINE | ID: mdl-28259571

RESUMEN

OBJECTIVE: The purpose of this study was to evaluate the impact of preoperative inflammatory status, as determined by complete blood count test parameters, on 12- and 24-month patency of femoropopliteal stenting for peripheral arterial disease. METHODS: We retrospectively analyzed baseline clinical and angiographic data among 138 patients (median age, 73 years; 46% female) from 2005 to 2014 at our institution with preoperative complete blood count test values and information of patency for at least 12 months after first-time femoropopliteal stenting. Patients were stratified into tertiles on the basis of preoperative blood counts to evaluate associations with in-stent restenosis (ISR) leading to loss of primary patency, defined by a Doppler velocity ratio ≥2.5:1, computed tomography angiography demonstrating ≥50% luminal narrowing within the stent, or reintervention. RESULTS: Univariate analysis determined that the 81 patients (59%) who experienced ISR within 12 months had significantly higher preoperative white blood cell (WBC), platelet, neutrophil, and lymphocyte counts than the 57 patients (41%) whose stents remained patent for longer than 12 months (8.7 vs 6.7 [P < .001], 246 vs 184 [P < .001], 5.7 vs 4.7 [P = .001], and 1.8 vs 1.2 [P = .004], respectively). Compared with patients in the lower WBC tertile (n = 45) who had a median patency of 19.4 months, those in the upper WBC tertile (n = 44) had a median patency of only 7.0 months and a 3.3-fold increased risk for ISR after adjusting for age, sex, lesion type, TransAtlantic Inter-Society Consensus II score, tibial vessel runoff, antiplatelet therapy, presence of diabetes, critical limb ischemia, adjunct procedures, hyperlipidemia, and end-stage renal disease in multivariate analysis (P < .001). Compared with patients in the lower platelet tertile (n = 45) who had a median patency of 16.9 months, those in the upper platelet tertile (n = 47) had a median patency of 7.1 months and a 2.7-fold increased adjusted risk (P = .001). Compared with patients in the lower neutrophil tertile (n = 33) who had a median patency of 14.3 months, those in the upper neutrophil tertile (n = 33) had a median patency of 6.2 months and a 3.2-fold increased adjusted risk (P = .001). After adjusting for covariates, patients divided into tertiles by lymphocyte counts exhibited no significant differences for ISR. CONCLUSIONS: Routine preoperative tests that determine baseline inflammatory status may provide strong clinical utility in assessing potential risk stratification of patients for ISR after femoropopliteal stenting. Circulating WBCs, platelets, and neutrophils may be important inflammatory mediators of ISR.


Asunto(s)
Angioplastia de Balón/instrumentación , Arteria Femoral/fisiopatología , Inflamación/complicaciones , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/fisiopatología , Stents , Grado de Desobstrucción Vascular , Anciano , Anciano de 80 o más Años , Angioplastia de Balón/efectos adversos , Plaquetas/inmunología , Distribución de Chi-Cuadrado , Angiografía por Tomografía Computarizada , Femenino , Arteria Femoral/diagnóstico por imagen , Humanos , Inflamación/sangre , Inflamación/diagnóstico , Inflamación/inmunología , Estimación de Kaplan-Meier , Recuento de Linfocitos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Neutrófilos/inmunología , Ciudad de Nueva York , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Recuento de Plaquetas , Arteria Poplítea/diagnóstico por imagen , Modelos de Riesgos Proporcionales , Recurrencia , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Doppler en Color
15.
J Vasc Interv Radiol ; 28(6): 889-894, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28532748

RESUMEN

This report describes the technical feasibility of using the filter eversion technique after unsuccessful retrieval attempts of Option and Option ELITE (Argon Medical Devices, Inc, Athens, Texas) inferior vena cava (IVC) filters. This technique entails the use of endoscopic forceps to evert this specific brand of IVC filter into a sheath inserted into the common femoral vein, in the opposite direction in which the filter is designed to be removed. Filter eversion was attempted in 25 cases with a median dwell time of 134 days (range, 44-2,124 d). Retrieval success was 100% (25/25 cases), with an overall complication rate of 8%. This technique warrants further study.


Asunto(s)
Remoción de Dispositivos/métodos , Endoscopios , Vena Femoral , Filtros de Vena Cava , Remoción de Dispositivos/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento
16.
J Vasc Surg ; 64(1): 63-74.e2, 2016 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-27017100

RESUMEN

OBJECTIVE: Studies have shown that a sizable percentage of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) is performed outside the instructions for use (IFU). We report our long-term outcomes after EVAR with respect to device-specific IFU. METHODS: Computed tomography angiography data from a cohort of 566 patients meeting inclusion criteria who underwent elective EVAR between 2003 and 2014 were examined. Preoperative anatomic measurements for each patient were taken and compared with device-specific IFU. Primary outcomes included all-cause mortality and AAA-related mortality. Secondary outcomes were late-onset rupture, need for reintervention, endoleaks, aneurysm sac enlargement, and intraoperative and perioperative complications. RESULTS: Nine different stent grafts were placed in this set of patients with a mean follow-up of 3.54 ± 2.65 years. Most patients (465; 82.2%) were male, and the mean age was 74.8 ± 8.70 years. Overall, 176 patients (31.1%) fit all IFU anatomic criteria, and 535 patients (94.5%) fit at least half of IFU criteria. In patients, iliac artery diameter was most commonly outside of IFU (253; 44.7%). A total of 1114 iliac arteries were treated, with 463 (41.6%) treated outside of iliac artery diameter IFU; the majority of these (374; 80.7%) were larger than IFU. Demographics and comorbidities were comparable between the groups within and outside of IFU. AAA-related mortality and all-cause mortality were similar between these two groups, as was late-onset rupture, need for reintervention, rates of endoleak, aneurysm sac enlargement, and major intraoperative and perioperative complications. The sole statistically significant difference in secondary outcomes was increased perioperative blood transfusion needed in those treated outside the IFU, 13.2% vs 6.2% in those treated within IFU (P = .02); however, this was not associated with decreased access vessel diameter or iliac artery rupture. CONCLUSIONS: Despite most EVAR patients being treated outside of IFU, there was no difference in outcomes with respect to all-cause mortality or aneurysm-related mortality. In addition, with the exception of perioperative blood transfusions, there was no association between IFU adherence and late-onset rupture, need for reintervention, rates of endoleak, aneurysm sac enlargement, or most other major complications.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Selección de Paciente , Stents , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Angiografía por Tomografía Computarizada , Bases de Datos Factuales , Supervivencia sin Enfermedad , Procedimientos Quirúrgicos Electivos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Adhesión a Directriz , Humanos , Estimación de Kaplan-Meier , Masculino , Ciudad de Nueva York , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/cirugía , Guías de Práctica Clínica como Asunto , Etiquetado de Productos , Diseño de Prótesis , Reoperación , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
17.
J Vasc Interv Radiol ; 27(2): 159-66, 2016 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-26706186

RESUMEN

PURPOSE: To review safety and feasibility in a single center using transradial access (TRA) for noncoronary interventions. MATERIALS AND METHODS: Retrospective analysis was performed of 946 patients evaluated for 1,531 consecutive TRA procedures from April 2012 to July 2015. Exclusion criteria included sheath > 6 F, Barbeau D waveform, radial artery (RA) diameter < 2 mm on ultrasound, history of severe aortic tortuosity or RA occlusion, and dialysis. TRA was attempted in 936 patients (62% men; median age, 62.4 y) who underwent 1,512 consecutive procedures (chemoembolization [n = 485], yttrium-90 mapping [n = 391] and infusion [n = 293], renal/visceral intervention [n = 172], uterine artery embolization [n = 116], peripheral intervention [n = 43], endoleak repair [n = 10], and other [n = 2]). Patients were evaluated for complications during follow-up at ~30 days. RESULTS: Technical success was 98.2% (1,485/1,512). Major complications (0.13%) included pseudoaneurysm (n = 1) and seizure (n = 1). Minor complications (2.38%) included hematoma/bleeding (n = 13), RA occlusion (n = 11), arm pain (n = 6), and RA spasm (n = 6). Univariate analysis demonstrated a lower rate of adverse events in African American patients (hazard ratio [HR], 0.25; 95% confidence interval [CI], 0.07-0.86; P = .027). Twenty-seven cases (1.8%) required crossover to transfemoral access (TFA). Crossover rates were higher in female patients (P = .0055), height < 1.7 m (P = .024), renal/visceral interventions (P = .0003), and endoleak interventions (P = .0357). Multivariate analysis demonstrated intervention type to be the only significant predictor of TFA crossover (renal/visceral [HR, 4.48; 95% CI, 1.84-10.9; P = .001]; endoleak repair [HR, 9.54; 95% CI, 1.09-83.8; P = .042]). CONCLUSIONS: TRA was safe and well tolerated in a heterogeneous patient population across a range of peripheral vascular interventions.


Asunto(s)
Cateterismo/métodos , Arteria Radial , Anciano , Quimioembolización Terapéutica , Endofuga/cirugía , Estudios de Factibilidad , Femenino , Humanos , Infusiones Intraarteriales , Masculino , Persona de Mediana Edad , Seguridad del Paciente , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Embolización de la Arteria Uterina
19.
AJR Am J Roentgenol ; 207(5): 1112-1121, 2016 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-27767350

RESUMEN

OBJECTIVE: The transradial approach (TRA) has been shown to reduce the morbidity and mortality associated with arterial coronary interventions. Selective internal radiation therapy (SIRT) performed via the TRA can enhance patient comfort, compared with the traditional transfemoral approach (TFA), by allowing immediate ambulation and precluding potential complications associated with the TFA, such as closure device injury or retroperitoneal hematoma. We report our initial experience with and technique for using the TRA for SIRT. MATERIALS AND METHODS: Between May 1, 2012, and April 30, 2015, a total of 574 procedures, including planning angiograms (n = 329) and infusions of 90Y (n = 245), were performed for 318 patients (mean age, 64.5 years). Of the 245 patients who received 90Y infusions, 52 had SIRT performed with the use of a permanent single-use implant of 90Y resin microspheres and 193 had SIRT performed with the use of millions of small glass microspheres containing radioactive 90Y. Procedural details, technical success, the radial artery (RA) occlusion rate noted at 30 days (as assessed via pulse examination), and the major and minor adverse events noted at 30 days were evaluated. RESULTS: Technical success was achieved in 561 of 574 cases (97.7%). The reasons for crossover to use of the TFA included an RA loop (n = 2), RA occlusion (n = 9), and type D response as determined by use of a Barbeau test (n = 2). Patients had undergone between zero and six previous TRA procedures. The mortality rate at 30 days was 0%. Superficial bruising occurred in 13 of 574 cases (2.3%). A grade 2 hematoma that required a second nonocclusive hemostasis cuff occurred in one case. Transient forearm numbness or pain occurred in two of 574 cases. One patient had a transient convulsive event occur after receiving intraarterial infusion of verapamil. RA occlusion occurred in nine of 574 cases (1.6%). CONCLUSION: Use of the TRA for SIRT is safe, feasible, and well tolerated and is associated with high rates of technical success and rare complications.


Asunto(s)
Carcinoma Hepatocelular/radioterapia , Embolización Terapéutica/métodos , Neoplasias Hepáticas/radioterapia , Arteria Radial , Radioisótopos de Itrio/uso terapéutico , Anciano , Angiografía , Embolización Terapéutica/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
20.
J Vasc Surg ; 62(6): 1636-9, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24840744

RESUMEN

Arterioportal fistulas (APFs) are rare vascular communications between the mesenteric arterial tree and the portal vein. The causes and presentations of this entity are varied. APFs related to tumor, infection, and trauma have been described. Patients may be asymptomatic or present with hemobilia, portal hypertension, or mesenteric steal syndrome. Small APFs require no intervention, with treatment indicated for large or symptomatic APFs. The treatment has shifted from surgical ligation or hepatic resection to an endovascular-first approach. We describe an endovascular treatment option for the management of an acquired extrahepatic (type 2) APF and present a review of the literature.


Asunto(s)
Embolización Terapéutica/métodos , Arteria Hepática , Vena Porta , Dispositivo Oclusor Septal , Adulto , Aneurisma/etiología , Fístula Arteriovenosa/complicaciones , Fístula Arteriovenosa/diagnóstico por imagen , Fístula Arteriovenosa/patología , Fístula Arteriovenosa/terapia , Dilatación Patológica , Embolización Terapéutica/instrumentación , Femenino , Arteria Hepática/diagnóstico por imagen , Humanos , Hígado/irrigación sanguínea , Vena Porta/diagnóstico por imagen , Tomografía Computarizada por Rayos X
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