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1.
Cardiovasc Intervent Radiol ; 42(10): 1405-1412, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31062066

RESUMO

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.


Assuntos
Embolização Terapêutica/métodos , Sintomas do Trato Urinário Inferior/complicações , Sintomas do Trato Urinário Inferior/terapia , Cuidados Paliativos/métodos , Neoplasias da Próstata/complicações , Retenção Urinária/terapia , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Retenção Urinária/complicações
2.
Eur Radiol ; 29(1): 287-298, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29948079

RESUMO

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.


Assuntos
Embolização Terapêutica/métodos , Próstata/irrigação sanguínea , Hiperplasia Prostática/terapia , Artérias , Tomografia Computadorizada de Feixe Cônico , Humanos , Masculino , Próstata/diagnóstico por imagem , Hiperplasia Prostática/diagnóstico , Resultado do Tratamento
3.
Transfus Med ; 28(5): 386-391, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29781549

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal , Ruptura Aórtica , Transfusão de Plaquetas , Procedimentos Cirúrgicos Vasculares , Idoso , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Abdominal/terapia , Ruptura Aórtica/mortalidade , Ruptura Aórtica/terapia , Feminino , Seguimentos , Humanos , Masculino , Complicações Pós-Operatórias , Estudos Prospectivos , Procedimentos Cirúrgicos Vasculares/mortalidade
4.
Eur J Vasc Endovasc Surg ; 54(4): 439-445, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28765014

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal/diagnóstico por imagem , Imageamento Tridimensional , Ultrassonografia , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/cirurgia , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Estudos Prospectivos , Conduta Expectante
5.
Transfus Med ; 27(4): 268-274, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28661030

RESUMO

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.


Assuntos
Preservação de Sangue/efeitos adversos , Angiografia Coronária/mortalidade , Transfusão de Eritrócitos/mortalidade , Eritrócitos , Idoso , Idoso de 80 Anos ou mais , Dinamarca , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Fatores de Tempo
6.
Eur J Vasc Endovasc Surg ; 54(1): 34-41, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28549712

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/normas , Competência Clínica/normas , Técnica Delphi , Procedimentos Endovasculares/normas , Avaliação de Processos em Cuidados de Saúde/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Adulto , Idoso , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Consenso , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Stents , Análise e Desempenho de Tarefas , Resultado do Tratamento
7.
Eur J Vasc Endovasc Surg ; 53(6): 844-852, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28442183

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Competência Clínica , Tomada de Decisão Clínica , Técnicas de Apoio para a Decisão , Procedimentos Endovasculares/instrumentação , Desenho de Prótese , Stents , Adulto , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/métodos , Angiografia por Tomografia Computadorizada , Humanos , Pessoa de Meia-Idade , Seleção de Pacientes , Valor Preditivo dos Testes , Interpretação de Imagem Radiográfica Assistida por Computador , Reprodutibilidade dos Testes
8.
Acta Neurol Scand ; 135(1): 17-24, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27558404

RESUMO

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.


Assuntos
Imageamento por Ressonância Magnética/métodos , Esclerose Múltipla/diagnóstico por imagem , Guias de Prática Clínica como Assunto , Humanos , Imageamento por Ressonância Magnética/normas , Neurologia/organização & administração , Sociedades Médicas , Suécia
9.
Eur J Vasc Endovasc Surg ; 52(6): 729-734, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27760698

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aortografia/métodos , Implante de Prótese Vascular , Angiografia por Tomografia Computadorizada , Meios de Contraste/administração & dosagem , Endoleak/diagnóstico por imagem , Procedimentos Endovasculares , Fosfolipídeos/administração & dosagem , Hexafluoreto de Enxofre/administração & dosagem , Ultrassonografia Doppler Dupla/métodos , Idoso , Idoso de 80 Anos ou mais , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Estudos Transversais , Erros de Diagnóstico , Endoleak/etiologia , Endoleak/terapia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Masculino , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Estudos Retrospectivos , Stents , Fatores de Tempo , Resultado do Tratamento
10.
Perspect Med Educ ; 5(1): 3-4, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26797929
11.
Scand J Surg ; 105(1): 42-8, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25663149

RESUMO

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.


Assuntos
Amputação Cirúrgica/estatística & dados numéricos , Angioplastia/métodos , Isquemia/cirurgia , Perna (Membro)/irrigação sanguínea , Salvamento de Membro/métodos , Doença Arterial Periférica/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Isquemia/etiologia , Estimativa de Kaplan-Meier , Perna (Membro)/cirurgia , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/complicações , Estudos Retrospectivos , Resultado do Tratamento
12.
Eur J Vasc Endovasc Surg ; 49(3): 289-96, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25662155

RESUMO

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.


Assuntos
Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Imageamento Tridimensional , Aortografia/métodos , Doenças Assintomáticas , Dinamarca , Feminino , Humanos , Interpretação de Imagem Assistida por Computador , Masculino , Variações Dependentes do Observador , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Reprodutibilidade dos Testes , Tomografia Computadorizada por Raios X , Ultrassonografia
13.
Eur J Vasc Endovasc Surg ; 49(2): 166-73, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25549577

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Cateterismo Periférico , Procedimentos Endovasculares , Fasciotomia , Artéria Femoral/cirurgia , Técnicas de Sutura/instrumentação , Dispositivos de Oclusão Vascular , Idoso , Idoso de 80 Anos ou mais , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/economia , Competência Clínica , Redução de Custos , Análise Custo-Benefício , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/economia , Desenho de Equipamento , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Duração da Cirurgia , Punções , Técnicas de Sutura/economia , Suécia , Fatores de Tempo , Resultado do Tratamento , Dispositivos de Oclusão Vascular/economia
15.
Eur J Vasc Endovasc Surg ; 48(3): 285-91, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24962744

RESUMO

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.


Assuntos
Dissecção Aórtica/cirurgia , Implante de Prótese Vascular/métodos , Procedimentos Endovasculares/métodos , Doença Aguda , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Stents , Resultado do Tratamento
16.
Eur J Vasc Endovasc Surg ; 48(5): 527-33, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24878235

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Prótese Vascular/efeitos adversos , Oclusão de Enxerto Vascular/epidemiologia , Artéria Ilíaca/cirurgia , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Aortografia/métodos , Feminino , Oclusão de Enxerto Vascular/etiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Período Pré-Operatório , Estudos Retrospectivos , Medição de Risco , Stents , Resultado do Tratamento
18.
Eur J Vasc Endovasc Surg ; 46(5): 525-32, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24091092

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Interpretação de Imagem Assistida por Computador , Imageamento Tridimensional , Ultrassonografia de Intervenção , Idoso , Idoso de 80 Anos ou mais , Aortografia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Valor Preditivo dos Testes , Estudos Prospectivos , Reprodutibilidade dos Testes , Tomografia Computadorizada por Raios X , Resultado do Tratamento
19.
Eur J Vasc Endovasc Surg ; 46(1): 57-64, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23683392

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Idoso , Estudos de Coortes , Dinamarca , Procedimentos Cirúrgicos Eletivos , Procedimentos Endovasculares , Feminino , Humanos , Masculino , Estudos Retrospectivos , Procedimentos Cirúrgicos Vasculares
20.
Eur J Vasc Endovasc Surg ; 45(5): 450-5; discussin 456, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23433497

RESUMO

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.


Assuntos
Aneurisma Aórtico/diagnóstico por imagem , Aneurisma Aórtico/cirurgia , Procedimentos Endovasculares , Imageamento Tridimensional , Ultrassonografia de Intervenção , Idoso , Aneurisma Aórtico/patologia , Feminino , Humanos , Masculino , Tamanho do Órgão , Estudos Prospectivos , Reprodutibilidade dos Testes
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