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1.
Cardiovasc Intervent Radiol ; 42(10): 1405-1412, 2019 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-31062066

RESUMEN

INTRODUCTION: Prostate artery embolization (PAE) is recognized as a treatment for lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia. LUTS and urinary retention are common in men with prostate cancer (PCa). The purpose of this study was to estimate the efficacy and safety of palliative PAE on LUTS or urinary retention in men with advanced PCa. MATERIALS AND METHODS: This prospective, single-center trial was conducted from March 2017 to November 2018. The trial protocol was registered online (ClinicalTrials.gov Identifier: NCT03104907). Only men with advanced PCa suffering from LUTS or urinary retention were included. The primary outcome was the ability to void without a catheter and International Prostate Symptom Score (IPSS) in non-catheter-dependent patients. The paired t test was used to analyze changes from baseline with 95% confidence intervals (CI). A p value < 0.05 was considered statistically significant. RESULTS: Seventeen patients were assessed for eligibility, and 15 patients with a mean age of 73.8 years were enrolled. Four men did not complete follow-up: cancer-related death (n = 2), lost to follow-up (n = 1), and unsuccessful embolization due to severe atherosclerosis (n = 1). Bilateral embolization was achieved in ten cases, and urinary retention resolved in one of six patients. LUTS improved in the remaining (n = 5) patients by a mean 12.2-point reduction in IPSS (95% CI - 23.53; - 0.87). According to the CIRSE classification, two grade 1 and two grade 3 complications occurred. CONCLUSION: In this study, palliative PAE was safe and efficient for treatment for LUTS associated with PCa. LEVEL OF EVIDENCE: Level 4, Case Series. Trial registration ClinicalTrials.gov Identifier: NCT03104907.


Asunto(s)
Embolización Terapéutica/métodos , Síntomas del Sistema Urinario Inferior/complicaciones , Síntomas del Sistema Urinario Inferior/terapia , Cuidados Paliativos/métodos , Neoplasias de la Próstata/complicaciones , Retención Urinaria/terapia , Anciano , Anciano de 80 o más Años , Estudios de Factibilidad , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Retención Urinaria/complicaciones
2.
Eur Radiol ; 29(1): 287-298, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-29948079

RESUMEN

OBJECTIVES: Prostate artery embolisation (PAE) is a new minimally invasive treatment for lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). The purpose of this study was to review the efficacy and safety of PAE in the treatment of BPH with LUTS. METHODS: A systematic review performed according to the PRISMA guidelines with a pre-specified search strategy for PubMed, Web of Science, Cochrane Library and Embase databases protocol (PROSPERO ID: CRD42017059196). Trials studying the efficacy of prostate artery embolisation to treat LUTS with more than ten participants and follow-up longer than 6 months were included by two independent authors. Outcomes investigated were International Prostate Symptom Score (IPSS), quality of life (QoL), International Index of Erectile Function (IIEF-5), prostate volume (PV), prostate-specific antigen (PSA), peak void flow (Qmax), post-void residual (PVR) and complications. To summarise mean change from baseline, a meta-analysis was done using the random-effects model. RESULTS: The search returned 210 references, of which 13 studies met the inclusion criteria, representing 1,254 patients. Patients in the included studies with data available for meta-analysis had moderate to severe LUTS and a mean IPSS of 23.5. Statistically significant (p value < 0.05) improvements of all investigated outcomes were seen at 12-month follow-up. Major complications were reported in 0.3% of the cases. CONCLUSIONS: Our findings suggest that PAE can reduce moderate to severe LUTS in men with BPH with a low risk of complications. KEY POINTS: • Prostate artery embolisation (PAE) improved International Prostate Symptom Score (IPSS) by 67%. • Major complications after PAE are very rare. • Use of cone-beam CT may reduce risk of non-target embolisation.


Asunto(s)
Embolización Terapéutica/métodos , Próstata/irrigación sanguínea , Hiperplasia Prostática/terapia , Arterias , Tomografía Computarizada de Haz Cónico , Humanos , Masculino , Próstata/diagnóstico por imagen , Hiperplasia Prostática/diagnóstico , Resultado del Tratamiento
3.
Transfus Med ; 28(5): 386-391, 2018 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-29781549

RESUMEN

BACKGROUND: In patients undergoing open surgery for a ruptured abdominal aortic aneurysm (rAAA), survivors demonstrate a high platelet count, and proactive administration of platelets (and fresh frozen plasma) appears to influence mortality. OBJECTIVES: This trial investigated the effect of platelets administered before transport to surgery. METHODS: In a prospective study design, patients were randomised to receive platelets (intervention; n = 61) or no platelets (control; n = 61) before transport to vascular surgery from 11 local hospitals. The study was terminated when one of the vascular surgical centres implemented endovascular repair for rAAA patients. RESULTS: Thirty days after surgery, mortality was 36% for patients with intervention vs 31% for controls (P = 0·32). Post-operative thrombotic events (14 vs 15; P = 0·69), renal failure (11 vs 10; P = 0·15) and pulmonary insufficiency (34 vs 39; P = 0·15) were similar in the two groups of patients. No adverse reactions to platelet administration were observed. In addition, length of stay in the intensive care unit was unaffected by intervention. CONCLUSIONS: For patients planned for open repair of a rAAA, we observed no significant effect of early administration of platelets with regard to post-operative complications and stay in the ICU or in hospital and also no significant effect on mortality.


Asunto(s)
Aneurisma de la Aorta Abdominal , Rotura de la Aorta , Transfusión de Plaquetas , Procedimientos Quirúrgicos Vasculares , Anciano , Aneurisma de la Aorta Abdominal/mortalidad , Aneurisma de la Aorta Abdominal/terapia , Rotura de la Aorta/mortalidad , Rotura de la Aorta/terapia , Femenino , Estudios de Seguimiento , Humanos , Masculino , Complicaciones Posoperatorias , Estudios Prospectivos , Procedimientos Quirúrgicos Vasculares/mortalidad
4.
Eur J Vasc Endovasc Surg ; 54(4): 439-445, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28765014

RESUMEN

OBJECTIVES: Rupture risk in abdominal aortic aneurysms (AAAs) is assessed using AAA diameter; yet 10% of ruptures occur in a small aneurysm. This underlines the inadequacy of diameter as a standalone parameter. In this prospective follow-up study, ultrasound determined aneurysm diameter was compared with aneurysm volume determined by three dimensional ultrasound (3D-US) in a group of 179 AAAs. DESIGN: This was a prospective cohort study with repeated diameter and volume measurements by 3D-US. MATERIAL AND METHODS: In total, 179 patients with small infrarenal AAAs (diameter 30-55 mm) were enrolled consecutively. At enrolment and at 12 month follow-up, maximum diameter, using dual plane technique, and three dimensional volume were measured. Based on a previous accuracy study, significant change in diameter and volume were defined as an increase exceeding the known range of variability (ROV) of each US technique; ±3.7 mm and ±8.8 mL, respectively. Post-hoc Kaplan-Meier analysis was performed to estimate time to conversion to treatment after the conclusion of the follow-up period between two groups. RESULTS: In total, 125 patients (70%) had an unchanged diameter during follow-up. In this group, 50 patients (40%) had an increasing aortic volume. Forty-five (83%) of the 54 patients with an increasing aortic diameter showed a corresponding volume increase. During a median follow-up of 367 days (364-380 days), a mean increase in diameter of 2.7 mm (±2.6 mm) and a mean increase in volume of 11.6 mL (±9.9 mL) were recorded. In post-hoc analysis, it was found that more AAAs with a stable diameter and a growing volume than AAAs with a stable diameter and volume were undergoing aortic repair during follow-up, based on the maximum diameter. CONCLUSION: In this cohort of small AAAs, 40% of patients with a stable diameter had an increasing volume at 12 month follow-up. From this perspective, 3D-US could have a future supplemental role in AAA surveillance programmes.


Asunto(s)
Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Imagenología Tridimensional , Ultrasonografía , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/cirugía , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Selección de Paciente , Estudios Prospectivos , Espera Vigilante
5.
Transfus Med ; 27(4): 268-274, 2017 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-28661030

RESUMEN

OBJECTIVES: To study the effect of red blood cell (RBC) storage duration on long-term mortality in patients undergoing cardiac intervention. BACKGROUND: RBCs undergo numerous structural and functional changes during storage. Observational studies have assessed the association between RBC storage duration and patient outcomes with conflicting results. METHODS: Between January 2006 and December 2014, 82 408 patients underwent coronary angiography. Of these, 1856 patients received one to four RBC units within 30 days after this procedure. Patients were allocated according to length of RBC storage duration: short-term (≤11 days), intermediate (IM)-term (12-23 days) and long-term (≥24 days). The study endpoints were 30-day and long-term all-cause mortality. RESULTS: A total of 4168 RBC units were given to 1856 patients. The mean RBC storage duration was 8.5 ± 2.1, 17.7 ± 3.4 and 29.9 ± 3.4 days in the short-term, IM-term and long-term storage groups, respectively. There was no difference in baseline characteristics between the groups. The long-term storage group received significantly more units (2.4 ± 1.0 units) as compared to the short-term (2.0 ± 1.0 units; P < 0.001) and IM-term storage group (2.2 ± 1.0 units; P < 0.01). In the survival analysis, there was no significant difference in all-cause mortality between the groups (log-rank: 0.509 for 30-days mortality; 0.493 for 5-year mortality). Additional stratified analysis demonstrated no association between RBC storage duration and long-term mortality. CONCLUSION: This study did not find an association between RBC storage duration and 30-days or long-term mortality in patients undergoing cardiac intervention.


Asunto(s)
Conservación de la Sangre/efectos adversos , Angiografía Coronaria/mortalidad , Transfusión de Eritrocitos/mortalidad , Eritrocitos , Anciano , Anciano de 80 o más Años , Dinamarca , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Estudios Retrospectivos , Factores de Tiempo
6.
Eur J Vasc Endovasc Surg ; 54(1): 34-41, 2017 07.
Artículo en Inglés | MEDLINE | ID: mdl-28549712

RESUMEN

OBJECTIVE/BACKGROUND: To develop a procedure specific global rating scale for assessment of operator competence in endovascular aortic repair (EVAR). METHODS: A Delphi approach was used to achieve expert consensus. A panel of 32 international experts (median 300 EVAR procedures, range 200-3000) from vascular surgery (n = 21) and radiology (n = 11) was established. The first Delphi round was based on a review of endovascular skills assessment papers, stent graft instructions for use, and structured interviews. It led to a primary pool of 83 items that were formulated as global rating scale items with tentative anchors. Iterative Delphi rounds were executed. The panellists rated the importance of each item on a 5 point Likert scale. Consensus was defined as 80% of the panel rating an item 4 or 5 in the primary round and 90% in subsequent rounds. Consensus on the final assessment tool was defined as Cronbach's alpha > .8 after a minimum of three rounds. RESULTS: Thirty-two of 35 invited experts participated. Three rounds of surveys were completed with a completion rate of 100% in the first two rounds and 91% in round three. The 83 primary assessment items were supplemented with five items suggested by the panel and reduced to seven pivotal assessment items that reached consensus, Cronbach's alpha = 0.82. The seven item rating scale covers key elements of competence in EVAR stent placement and deployment. Each item has well defined grades with explicit anchors at unacceptable, acceptable, and superior performance on a 5 point Likert scale. CONCLUSION: The Delphi methodology allowed for international consensus on a new procedure specific global rating scale for assessment of competence in EVAR. The resulting scale, EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE), represents key elements in the procedure. EVARATE constitutes an assessment tool for providing structured feedback to endovascular operators in training.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/normas , Competencia Clínica/normas , Técnica Delphi , Procedimientos Endovasculares/normas , Evaluación de Procesos, Atención de Salud/normas , Indicadores de Calidad de la Atención de Salud/normas , Adulto , Anciano , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Consenso , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Stents , Análisis y Desempeño de Tareas , Resultado del Tratamiento
7.
Eur J Vasc Endovasc Surg ; 53(6): 844-852, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28442183

RESUMEN

OBJECTIVES AND BACKGROUND: The aims of this study were to develop a test of competence in endovascular aortic repair (EVAR) stent graft sizing and selection; to examine the test for evidence of validity; and to explore the experience required for the task. METHODS: The test was developed based on a literature review resulting in 22 anatomical assessment points and a graft selection. Validity evidence was explored in an international cross sectional study. Twenty-two consultants with varying levels of experience in the field (novices, intermediates, and experts) were presented with computed tomography angiography of the aortic vessels from three patients. Test scores were based on summed z-scores using the anatomical measurements and graft choices of the experts as a reference. A proficiency score was established using the contrasting groups standard setting method. RESULTS: The assessment was shown to be reliable with an intraclass correlation coefficient of 0.83 (p<.001) and high internal consistency with a Cronbach's α of .91 (p<.001). Mann-Whitney U test showed that experts performed significantly better than novices and intermediates (p<.002 and p<.005, respectively). Regarding anatomical measurements, Mann-Whitney U test could discriminate between experts and novices (p=.002), between experts and intermediates (p=.010), and between novices and intermediates (p=.036). In stent selection the experts performed significantly better than both the novices and the intermediates (p=.002 and p=.007, respectively), while there was no significant difference between the two non-expert groups (p=1). A credible passing standard with appropriate consequences was established using the contrasting groups methods. CONCLUSION: This study presents a standardised and objective assessment tool of competence in vessel analysis and stent graft selection for endovascular aortic repair. This was supported by strong validity evidence with good internal consistency and discriminatory ability. The tool may be used to facilitate training and certification of future endovascular specialists.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Competencia Clínica , Toma de Decisiones Clínicas , Técnicas de Apoyo para la Decisión , Procedimientos Endovasculares/instrumentación , Diseño de Prótesis , Stents , Adulto , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía/métodos , Angiografía por Tomografía Computarizada , Humanos , Persona de Mediana Edad , Selección de Paciente , Valor Predictivo de las Pruebas , Interpretación de Imagen Radiográfica Asistida por Computador , Reproducibilidad de los Resultados
8.
Acta Neurol Scand ; 135(1): 17-24, 2017 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-27558404

RESUMEN

Multiple sclerosis (MS) is associated with inflammatory lesions in the brain and spinal cord. The detection of such inflammatory lesions using magnetic resonance imaging (MRI) is important in the consideration of the diagnosis and differential diagnoses of MS, as well as in the monitoring of disease activity and predicting treatment efficacy. Although there is strong evidence supporting the use of MRI for both the diagnosis and monitoring of disease activity, there is a lack of evidence regarding which MRI protocols to use, the frequency of examinations, and in what clinical situations to consider MRI examination. A national workshop to discuss these issues was held in Stockholm, Sweden, in August 2015, which resulted in a Swedish consensus statement regarding the use of MRI in the care of individuals with MS. The aim of this consensus statement is to provide practical advice for the use of MRI in this setting. The recommendations are based on a review of relevant literature and the clinical experience of workshop attendees. It is our hope that these recommendations will benefit individuals with MS and guide healthcare professionals responsible for their care.


Asunto(s)
Imagen por Resonancia Magnética/métodos , Esclerosis Múltiple/diagnóstico por imagen , Guías de Práctica Clínica como Asunto , Humanos , Imagen por Resonancia Magnética/normas , Neurología/organización & administración , Sociedades Médicas , Suecia
9.
Eur J Vasc Endovasc Surg ; 52(6): 729-734, 2016 12.
Artículo en Inglés | MEDLINE | ID: mdl-27760698

RESUMEN

OBJECTIVE/BACKGROUND: Surveillance after endovascular aortic aneurysm repair (EVAR) is mandatory and computed tomography angiography (CTA) is considered the standard imaging modality, although patients are exposed to ionizing radiation and nephrotoxic contrast medium. The primary aim of this study was to determine the diagnostic efficacy of duplex ultrasound (DUS) and contrast enhanced ultrasound (CEUS) using CTA as the gold standard. The secondary aim was to determine the clinical consequences of endoleaks missed by DUS and CEUS, or CTA. METHODS: All patients with EVAR for an aorto-iliac aneurysm between 1 August 2011 and 31 October 2014 were prospectively and consecutively enrolled. CEUS was added to the existing surveillance protocol, which included DUS, plain abdominal X-ray, and CTA at 3 and 12 months after stent implantation. RESULTS: In 278 patients, endoleaks were detected in 68, 69, and 46 cases by CTA, CEUS, and DUS, respectively. The sensitivity and specificity of DUS and CEUS were 46% and 93%, and 85% and 95%, respectively. CEUS and CTA were diagnostically equivalent, as opposed to DUS and CTA (p = .002). Endoleaks detected by CTA led to re-intervention in 11 (4%) patients. These endoleaks were also detected by CEUS; however, three out of 11 patients were missed by DUS and underwent re-intervention: limb extension, re-cuff, and attempt to coil lumbar leaks. Endoleaks missed by CEUS or CTA were type II endoleaks without sac expansion. CONCLUSION: In surveillance programs after EVAR a diagnostic CEUS examination may replace CTA.


Asunto(s)
Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aortografía/métodos , Implantación de Prótesis Vascular , Angiografía por Tomografía Computarizada , Medios de Contraste/administración & dosificación , Endofuga/diagnóstico por imagen , Procedimientos Endovasculares , Fosfolípidos/administración & dosificación , Hexafluoruro de Azufre/administración & dosificación , Ultrasonografía Doppler Dúplex/métodos , Anciano , Anciano de 80 o más Años , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Estudios Transversales , Errores Diagnósticos , Endofuga/etiología , Endofuga/terapia , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Masculino , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Estudios Retrospectivos , Stents , Factores de Tiempo , Resultado del Tratamiento
10.
Perspect Med Educ ; 5(1): 3-4, 2016 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-26797929
11.
Scand J Surg ; 105(1): 42-8, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25663149

RESUMEN

BACKGROUND AND AIM: To evaluate the amputation-free survival after below the knee percutaneous transluminal angioplasty in a consecutive group of patients with critical ischemia of the lower extremity. MATERIALS AND METHODS: A total of 70 consecutive patients with critical ischemia were treated with below the knee percutaneous transluminal angioplasty at the vascular center at Rigshospitalet with the purpose of limb salvage. All patients were deemed unfit for major surgery due to anatomical limitations or severe co-morbidity, and no prior attempts of revascularization were performed. Follow-up clinical examinations were performed within 6 weeks and after 1 year. All medical records were crosschecked with the national vascular registry ensuring a valid 1-year status in 97% of the patients. RESULTS: A total of 15 major amputations were performed during follow-up, with 11 amputations performed within the first year. Complications after percutaneous transluminal angioplasty were rare. Cumulative mortality after 1 and 2 years was 22% and 34%, respectively. Amputation-free survival at 1 and 2 years of follow-up was 68% and 58%, respectively. There were no association between known risk factors such as diabetes, ischemic ulcers, cardiac disease, history of smoking, major amputation, or overall amputation. CONCLUSION: Below the knee percutaneous transluminal angioplasty in patients with end-stage peripheral arterial disease and critical limb ischemia is a safe procedure in relieving critical ischemia, reducing the short-term rate of a major amputation as opposed to best medical treatment alone.


Asunto(s)
Amputación Quirúrgica/estadística & datos numéricos , Angioplastia/métodos , Isquemia/cirugía , Pierna/irrigación sanguínea , Recuperación del Miembro/métodos , Enfermedad Arterial Periférica/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Isquemia/etiología , Estimación de Kaplan-Meier , Pierna/cirugía , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/complicaciones , Estudios Retrospectivos , Resultado del Tratamiento
12.
Eur J Vasc Endovasc Surg ; 49(3): 289-96, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25662155

RESUMEN

OBJECTIVE: Non-invasive and reproducible size measurements that correlate well with computed tomography (CT) are desirable in the management of small abdominal aortic aneurysms (AAA). Three dimensional ultrasound (3D-US) technology may reduce inaccuracy because of variations in orientation of the image planes and axis. This study aimed to determine any differences in paired size estimation associated with three 3D-US derived methods using 3D-CT as the gold standard. When CTA was not available, the patients were enrolled anyway to assess 3D-US reproducibility in terms of agreement between two physicians. METHODS: In the period from 1 March 2013 to 27 February 2014, consecutive patients with a small AAA, <5.5 cm for men and <5.2 cm for women, underwent 3D-US examination and three AAA size measures were obtained: dual plane diameter, diameter perpendicular to the residual sac's centreline and a partial volume. RESULT: In all, 122 consecutive US examinations were performed. Patients were excluded because of inadequate AAA size (n = 11) and for technical reasons (n = 11). Thus, 100 patients (F/M; 20/80) with a median maximum AAA diameter of 46 (range 31-55) mm were analysed. The mean US dual plane diameter and the 3D-US centreline diameter were 2.6 mm and 1.8 mm smaller than the mean 3D-CT centreline diameter, respectively (p = .003). The inter-observer reproducibility coefficient was 3.7 mm for the US dual plane diameter and 3.2 mm for the 3D-US centreline diameter (p = 0.222). For the partial volume, the reproducibility was 8-12%, corresponding to a diameter variability of ±3 mm. The median time used for post-processing of the 3D-US acquisition was 72 (range 46-108) seconds per examination. CONCLUSION: 3D-US demonstrated an acceptable reproducibility and a good agreement with 3D-CT, and has the potential to improve future AAA management through more reliable ultrasound guided size estimates.


Asunto(s)
Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Imagenología Tridimensional , Aortografía/métodos , Enfermedades Asintomáticas , Dinamarca , Femenino , Humanos , Interpretación de Imagen Asistida por Computador , Masculino , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Reproducibilidad de los Resultados , Tomografía Computarizada por Rayos X , Ultrasonografía
13.
Eur J Vasc Endovasc Surg ; 49(2): 166-73, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25549577

RESUMEN

OBJECTIVES: The aim was to investigate whether the fascia suture technique (FST) can reduce access closure time and procedural costs compared with the Prostar technique (Prostar) in patients undergoing endovascular aortic repair and to evaluate the short- and mid-term outcomes of both techniques. METHODS: In this two center trial, 100 patients were randomized to access closure by either FST or Prostar between June 2006 and December 2009. The primary endpoint was access closure time. Secondary outcome measures included access related costs and evaluation of the short- and mid-term complications. Evaluation was performed peri- and post-operatively, at discharge, at 30 days and at 6 months follow up. RESULTS: The median access closure time was 12.4 minutes for FST and 19.9 minutes for Prostar (p < .001). Prostar required a 54% greater procedure time than FST, mean ratio 1.54 (95% CI 1.25-1.90, p < .001) according to regression analysis. Adjusted for operator experience the mean ratio was 1.30 (95% CI 1.09-1.55, p = .005) and for patient body mass index 1.59 (95% CI 1.28-1.96, p < .001). The technical failure rate for operators at proficiency level was 5% (2/40) compared with 28% (17/59) for those at the basic level (p = .003). The proficiency level group had a technical failure rate of 4% (1/26) for FST and 7% (1/14) for Prostar, p = 1.00, while corresponding rates for the basic level group were 27% (6/22) for FST and 30% (11/37) for Prostar (p = .84). There was a significant difference in cost in favor of FST, with a median difference of €800 (95% CI 710-927, p < .001). CONCLUSIONS: In aortic endovascular repair FST is a faster and cheaper technique than the Prostar technique.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Cateterismo Periférico , Procedimientos Endovasculares , Fasciotomía , Arteria Femoral/cirugía , Técnicas de Sutura/instrumentación , Dispositivos de Cierre Vascular , Anciano , Anciano de 80 o más Años , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/economía , Competencia Clínica , Ahorro de Costo , Análisis Costo-Beneficio , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/economía , Diseño de Equipo , Femenino , Costos de la Atención en Salud , Humanos , Masculino , Tempo Operativo , Punciones , Técnicas de Sutura/economía , Suecia , Factores de Tiempo , Resultado del Tratamiento , Dispositivos de Cierre Vascular/economía
15.
Eur J Vasc Endovasc Surg ; 48(3): 285-91, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24962744

RESUMEN

OBJECTIVES: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. METHODS: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. RESULTS: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT+TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT+TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT+TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). CONCLUSIONS: Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed.


Asunto(s)
Disección Aórtica/cirugía , Implantación de Prótesis Vascular/métodos , Procedimientos Endovasculares/métodos , Enfermedad Aguda , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Stents , Resultado del Tratamiento
16.
Eur J Vasc Endovasc Surg ; 48(5): 527-33, 2014 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-24878235

RESUMEN

OBJECTIVE: To assess the incidence and outcome of graft limb occlusions after endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) in a high volume single centre. To quantify iliac artery tortuosity in patients with AAA and correlate this with limb occlusion. DESIGN: Data were collected consecutively and prospectively, and analyzed retrospectively. MATERIALS: Patients treated with Zenith bifurcated stent grafts from January 2000 to December 2010 at a tertiary referral vascular unit were analyzed. Routine regular office follow-up with computed tomography angiography (CTA) and, subsequently, duplex ultrasound imaging was performed. Patients with limb occlusions were identified. For each index patient, two controls were obtained, one immediately preceding and one following the index patient in the consecutive cohort of EVAR patients. METHODS: Demographics and CTA data on limb graft occlusions were recorded and compared with a defined control group. Three different indices were used to describe the tortuosity of the iliac vessels based on preoperative CTA: pelvic artery index of tortuosity (PAI), common iliac artery index of tortuosity (CAI), and a visual description of vessel tortuosity - the double iliac sign (DIS). Demographic data and indices were correlated for later occurring limb occlusion. RESULTS: 504 patients underwent EVAR and 18 patients experienced graft limb occlusion during a median follow-up of 28 months (range 0-133). Primary graft patency was 97% at 1 year and 96% at 3 years. Logistic regression showed that iliac artery tortuosity (DIS) (p = .001) and body mass index (p = .007) had a significant impact on graft patency. CONCLUSION: A tortuous vessel on the preoperative CTA is associated with an increased risk of limb occlusion after EVAR. Adjunctive stenting of iliac segments deemed at risk is suggested, which is achieved without compromise of the aneurysm repair.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Prótesis Vascular/efectos adversos , Oclusión de Injerto Vascular/epidemiología , Arteria Ilíaca/cirugía , Procedimientos Quirúrgicos Vasculares/efectos adversos , Anciano , Anciano de 80 o más Años , Aortografía/métodos , Femenino , Oclusión de Injerto Vascular/etiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Periodo Preoperatorio , Estudios Retrospectivos , Medición de Riesgo , Stents , Resultado del Tratamiento
18.
Eur J Vasc Endovasc Surg ; 46(5): 525-32, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-24091092

RESUMEN

OBJECTIVES: Discrepancy between maximum diameters obtained with two-dimensional ultrasound and computed tomography (CT) after endovascular aneurysm repair (EVAR) is well known. The maximal diameter is ideally measured perpendicular to the centerline, a methodology so far only feasible with three-dimensional (3D) CT and magnetic resonance angiography (MRA). We aimed to investigate the agreement between 3D ultrasound and 3D CT and to determine reproducibility measures. METHODS: Prospective study comparing 3D ultrasound with 3D CT in 124 consecutive patients seen 3 or 12 month after EVAR. RESULTS: Replacing 2D with 3D ultrasound, the mean difference was improved from 6.0 mm to -1.3 mm (p < .001), and the range of variability was reduced from 9.4 mm to 6.6 mm (p = .009) using 3D CT as the gold standard. The mean difference between 3D ultrasound and 3D CT maximum diameter of the residual sac was -1.3 mm with upper and lower limits of agreement of 5.2 mm and -7.9 mm, respectively. Reproducibility measures of 3D ultrasound were ± 4 mm. CONCLUSION: 3D ultrasound correlate significantly better to 3D CT than the currently used 2D ultrasound method when assessing maximum diameter of the residual sac after EVAR, and reproducibility measures were within clinical acceptable values.


Asunto(s)
Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Interpretación de Imagen Asistida por Computador , Imagenología Tridimensional , Ultrasonografía Intervencional , Anciano , Anciano de 80 o más Años , Aortografía/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Estudios Prospectivos , Reproducibilidad de los Resultados , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
19.
Eur J Vasc Endovasc Surg ; 46(1): 57-64, 2013 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-23683392

RESUMEN

OBJECTIVE: To assess outcomes after treatment for asymptomatic abdominal aortic aneurysm (AAA) in Denmark in a period when both open surgery (OR) and endoluminal repair (EVAR) have been routine procedures. METHODS: We performed a retrospective nationwide cohort study of patients treated for asymptomatic AAA between 2007 and 2010. Data on demographics, procedural data, perioperative complications, length of stay (LOS), 30-day reinterventions and readmissions, late aneurysm and procedure-related complications and mortality were obtained from the Danish Vascular Registry and the Danish National Patient Register. RESULTS: 525 EVAR and 1176 OR for asymptomatic AAA were identified. LOS was shorter after EVAR than OR (4 vs. 7 days, p < .001). During primary hospitalization procedure-related complications (12% vs. 6%) and general complications (21% vs. 8%) were more common after OR than EVAR (p < 0.001). The 30-day reintervention rate was higher for OR than EVAR (18% vs. 6%, p < 0.001), but there was no difference in readmissions within 30 days. During follow-up (mean 29 ± 15 months) aneurysm-related complications after EVAR were outweighed by procedure-related complications after OR. CONCLUSION: Elective AAA repair in Denmark is overall comparable with international results and both perioperative and late outcomes after EVAR of elective AAA are better than the results after OR.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Anciano , Estudios de Cohortes , Dinamarca , Procedimientos Quirúrgicos Electivos , Procedimientos Endovasculares , Femenino , Humanos , Masculino , Estudios Retrospectivos , Procedimientos Quirúrgicos Vasculares
20.
Eur J Vasc Endovasc Surg ; 45(5): 450-5; discussin 456, 2013 May.
Artículo en Inglés | MEDLINE | ID: mdl-23433497

RESUMEN

OBJECTIVES: Volume estimation is more sensitive than diameter measurement for detection of aneurysm growth after endovascular aneurysm repair (EVAR), but this has only been confirmed on three-dimensional, reconstructed computer tomography (3-D CT). The potential of 3-D ultrasound (3-D US) for volume estimation in EVAR surveillance is unknown. DESIGN: Prospective validation study comparing 3-D US with 3-D CT, using 3-D CT as the gold standard. MATERIALS AND METHODS: From August 2011 to March 2012, 93 consecutive EVAR patients were enrolled and examined with both 3-D US and CT angiography (CTA). Image data were analysed in a mutual blinded setup using a 3-D interactive segmentation technique. RESULTS: The technical success rate of 3D-US was 98% (91/93). In 91 EVAR patients (F/M; 10/81) eligible for further analysis, the mean maximum volume (SD) was 126 (58) ml using 3-D US and 128 (58) ml using 3-D CT. The mean difference was 1 ml (0.4%) and the limits of agreement were -14 to 16 ml (-11; 12%). CONCLUSION: Volume estimation of the aortic sac after EVAR using 3-D US is a feasible and accurate method using 3-D CT as the gold standard.


Asunto(s)
Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/cirugía , Procedimientos Endovasculares , Imagenología Tridimensional , Ultrasonografía Intervencional , Anciano , Aneurisma de la Aorta/patología , Femenino , Humanos , Masculino , Tamaño de los Órganos , Estudios Prospectivos , Reproducibilidad de los Resultados
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