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1.
Trials ; 25(1): 574, 2024 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-39223593

RESUMO

BACKGROUND: One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH. METHODS: This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients. DISCUSSION: In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .


Assuntos
Embolização Terapêutica , Estudos de Equivalência como Asunto , Sintomas do Trato Urinário Inferior , Próstata , Hiperplasia Prostática , Humanos , Masculino , Hiperplasia Prostática/complicações , Hiperplasia Prostática/terapia , Embolização Terapêutica/métodos , Embolização Terapêutica/efeitos adversos , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/terapia , Sintomas do Trato Urinário Inferior/diagnóstico , Resultado do Tratamento , Próstata/irrigação sanguínea , Fatores de Tempo , Micro-Ondas/uso terapêutico , Micro-Ondas/efeitos adversos , Ressecção Transuretral da Próstata , Índice de Gravidade de Doença , Hipertermia Induzida/métodos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto , Idoso
2.
Cardiovasc Intervent Radiol ; 47(5): 632-639, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38233575

RESUMO

PURPOSE: To evaluate the efficacy of a single perioperative dose of dexamethasone in reducing postembolization syndrome following prostatic artery embolization. MATERIALS AND METHODS: We conducted a single-center double-blind randomized controlled trial from March 2021 to May 2022 (NCT04588857). Participants were randomized to receive either i.v. 24 mg dexamethasone or saline. The primary outcome measures were temperature, pain, and quality of life in the first 5 days following prostatic artery embolization. Sample size of 60 patients was needed for the assessment of primary outcomes. Participants were followed for 6 months and assessed for a variety of secondary outcome measures including inflammatory markers and lower urinary tract symptoms severity. RESULTS: Due to lack of clinical effect and mild symptoms in the control group, the trial was terminated early. 31 participants (16 dexamethasone vs. 15 control) were enrolled and analyzed. A difference in mean temperature was observed on day 1 (37.23 ± 0.64 °C control vs 36.74 ± 0.41 °C dexamethasone, p = 0.02, 95% CI 0.09-0.89). Difference in pain (score out of 10) was seen only on day 5 (1.48 ± 1.2 control vs. 2.9 ± 2.24 dexamethasone, p = 0.04, 95% CI - 2.78-- 0.04). A difference in C-reactive protein values was observed on day 2 (108 [54-161] mg/l control vs 10 [5-33] mg/l dexamethasone, p < 0.01). No significant differences in other outcomes were observed. No side effects were recorded. CONCLUSIONS: Twenty-four milligrams of dexamethasone bolus is safe but does not reduce postembolization syndrome following prostatic artery embolization.


Assuntos
Dexametasona , Embolização Terapêutica , Próstata , Humanos , Masculino , Método Duplo-Cego , Embolização Terapêutica/métodos , Dexametasona/administração & dosagem , Dexametasona/uso terapêutico , Próstata/irrigação sanguínea , Idoso , Pessoa de Meia-Idade , Síndrome , Resultado do Tratamento , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/terapia , Sintomas do Trato Urinário Inferior/tratamento farmacológico , Qualidade de Vida , Hiperplasia Prostática/terapia , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/uso terapêutico
3.
Abdom Radiol (NY) ; 49(1): 312-319, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37978076

RESUMO

PURPOSE: To evaluate the diagnostic capabilities of a supplementary color ramped iodine density map compared to virtual monoenergetic images (VMIs) at 74 keV in the diagnosis of acute bowel ischemia (ABI). METHODS: Data for this study were prospectively gathered and retrospectively evaluated. Patients referred to the Department of Diagnostic Radiology between October 2020 and August 2022 on the suspicion of ABI and underwent surgery < 12 h following fast kV-switching venous phase abdominal dual-energy CT (DECT) were consecutively included. Images were evaluated by two board-certified radiologists and two radiology residents. First round included only 74 keV VMIs resembling conventional 120 kVp images, and the second round included a supplementary iodine density map. Readers were asked to register presence of ABI as well as their confidence in their diagnosis based on a 5-point Likert scale. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for each observer with the surgical findings as the gold-standard. McNemar's and Wilcoxon signed-rank test were used to compare registrations and diagnostic confidence across assessment rounds. RESULTS: A total of 29 patients resulting in 31 DECT scans were included. Fourteen cases of ischemic/necrotic bowel were reported following surgery. Sensitivity and NPV were decreased with the use of supplementary iodine map images compared to 120 kVp-like images without supplementary iodine map images for three of four observers (round 1 range: 71.4-92.9% and 78.0-94.8%; round 2 range: 57.1-78.6% and 70.1-83.3%, respectively), while specificity and PPV were increased for three of four observers (round 1 range: 64.7-94.1% and 67.4-93.1%; round 2 range: 88.2-94.1% and 73.8-91.1%, respectively). However, no significant difference in ABI diagnosis or diagnostic confidence was found (p-value range: 0.07-1.00 and 0.23-0.58, respectively). CONCLUSION: No significant difference for the diagnosis of ABI was found using supplementary iodine mapping. Our study may suggest a trend of increased specificity and decreased sensitivity, hence, the use of supplementary iodine mapping should be carefully considered.


Assuntos
Iodo , Isquemia Mesentérica , Humanos , Tomografia Computadorizada por Raios X/métodos , Estudos Retrospectivos , Valor Preditivo dos Testes , Isquemia , Meios de Contraste
4.
J Nephrol ; 36(7): 1991-1999, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37466817

RESUMO

INTRODUCTION: Calcific uremic arteriolopathy is a life-threatening cutaneous condition in patients with chronic kidney disease. Often, clinical diagnosis is accompanied by histopathologic evaluations demonstrating vascular calcium deposits. We aimed to investigate the presence of cutaneous calcifications in non-lesional tissue in patients with chronic kidney disease, and the relation to systemic vascular calcification. METHODS: We investigated the presence of cutaneous vascular calcifications in non-lesional skin biopsies from patients with current or previous calcific uremic arteriolopathy and patients with different stages of chronic kidney disease without calcific uremic arteriolopathy, and explored their association with vascular calcification in other vascular beds. Systemic vascular calcification was examined by mammography and lumbar X-ray. RESULTS: Thirty-nine adults were enrolled (current or previous calcific uremic arteriolopathy, n = 9; end-stage chronic kidney disease, n = 12; chronic kidney disease stage 3b-4, n = 12; healthy controls, n = 6). All calcific uremic arteriolopathy patients had end-stage kidney disease. Cutaneous vascular calcifications were not present in any of the non-lesional skin punch biopsies. Breast arterial calcification was demonstrated in patients with calcific uremic arteriolopathy (75%) and chronic kidney disease (end-stage 67% and stage 3b-4 25%, respectively), but in none of the controls. All chronic kidney disease patients had systemic calcification on lumbar X-ray (median score 21, 22, and 15 in patients with calcific uremic arteriolopathy, end-stage kidney disease and chronic kidney disease stage 3b-4). The serum calcification propensity was significantly different between groups. DISCUSSION: Despite a high burden of systemic vascular calcification, cutaneous calcium deposits in non-lesional tissue could not be demonstrated histopathologically in patients with chronic kidney disease (with or without current or previous calcific uremic arteriolopathy). Further studies to determine whether these findings are representative or attributed to other factors are warranted.


Assuntos
Calcinose Cutânea , Calciofilaxia , Falência Renal Crônica , Calcificação Vascular , Adulto , Humanos , Estudos Transversais , Cálcio , Calciofilaxia/etiologia , Calciofilaxia/complicações , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/complicações , Falência Renal Crônica/complicações
5.
Injury ; 54(5): 1321-1329, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-36907823

RESUMO

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging and potentially life-saving procedure, necessitating qualified operators in an increasing number of centres. The procedure shares technical elements with other vascular access procedures using the Seldinger technique, which is mastered by doctors not only in endovascular specialties but also in trauma surgery, emergency medicine, and anaesthesiology. We hypothesised that doctors mastering the Seldinger technique (experienced anaesthesiologist) would learn the technical aspects of REBOA with limited training and remain technically superior to doctors unfamiliar with the Seldinger technique (novice residents) given similar training. METHODS: This was a prospective trial of an educational intervention. Three groups of doctors were enroled: novice residents, experienced anaesthesiologists, and endovascular experts. The novices and the anaesthesiologists completed 2.5 h of simulation-based REBOA training. Their skills were tested before and 8-12 weeks after training using a standardised simulated scenario. The endovascular experts, constituting a reference group, were equivalently tested. All performances were video recorded and rated by three blinded experts using a validated assessment tool for REBOA (REBOA-RATE). Performances were compared between groups and with a previously published pass/fail cutoff. RESULTS: Sixteen novices, 13 board-certified specialists in anaesthesiology, and 13 endovascular experts participated. Before training, the anaesthesiologists outperformed the novices by 30 percentage points of the maximum REBOA-RATE score (56% (SD 14.0) vs 26% (SD 17%), p<0.01). After training, there was no difference in skills between the two groups (78% (SD 11%) vs 78 (SD 14%), p = 0.93). Neither group reached the endovascular experts' skill level (89% (SD 7%), p<0.05). CONCLUSION: For doctors mastering the Seldinger technique, there was an initial inter-procedural transfer of skills advantage when performing REBOA. However, after identical simulation-based training, novices performed equally well to anaesthesiologists, indicating that vascular access experience is not a prerequisite to learning the technical aspects of REBOA. Both groups would need more training to reach technical proficiency.


Assuntos
Oclusão com Balão , Procedimentos Endovasculares , Choque Hemorrágico , Humanos , Estudos Prospectivos , Hemorragia/terapia , Procedimentos Endovasculares/métodos , Aorta/cirurgia , Oclusão com Balão/métodos , Ressuscitação/métodos , Catéteres
6.
Ann Vasc Surg ; 89: 302-311, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36334895

RESUMO

BACKGROUND: To explore whether simulation-based endovascular training with focus on radiation safety could improve correct behavior without jeopardizing the learning of procedural skills. METHODS: Twenty-four residents without previous endovascular experience completed 10 clinical scenarios on a virtual-reality endovascular simulator with software for peripheral endovascular interventions. Participants were randomized to receive feedback (n = 12) or not (n = 12) on radiation protection (RP) performance after each case. Expert assessments were done at the first, second, fourth, seventh, and 10th case on RP and endovascular skills (ES). Automatic simulator metrics on procedure time, contrast dose, handling errors, and estimated radiation exposure to patient and operator were registered. Outcome metrics were analyzed by two-way mixed analysis of variance pairwise comparisons with independent t-tests. Correlations were explored using Pearson's r for internal consistency reliability. RESULTS: The RP performance was similar in both groups at their first attempt (P = 0.61), but the feedback group significantly outperformed the control group over time (P < 0.001 for all comparisons). The feedback group was however slower to learn the ES at start (P = 0.047 at second performance), but after 7 attempts no difference was shown (P = 0.59). The feedback group used more time (19.5 vs. 15.3 min; P = 0.007) but less contrast (60 vs. 100 mL; P < 0.001). The number of errors was the same in both groups, but all metrics regarding radiation exposure favored the feedback group (P-values from 0.001 to 0.008). CONCLUSIONS: Simulation-based training (SBT) is effective to acquire basic endovascular intervention skills and concurrently learn RP behavior when feedback on radiation culture is provided.


Assuntos
Proteção Radiológica , Treinamento por Simulação , Humanos , Reprodutibilidade dos Testes , Análise e Desempenho de Tarefas , Resultado do Tratamento , Competência Clínica , Simulação por Computador
7.
BJUI Compass ; 3(1): 86-92, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35475158

RESUMO

Objectives: To study safety and efficacy of selective endovascular trans-arterial embolization (TAE) of renal angiomyolipoma (AML) in a 10-year period at a regional tertiary referral center in Denmark. Patients and methods: All 56 patients who underwent TAE of renal AML at Departments of Urology and Radiology, Copenhagen University Hospital - Rigshospitalet, Denmark, from 2009 to 2020 were included. Seven without preoperative and postoperative imaging were excluded, leaving 49 patients for analysis. From national electronic medical records, we retrieved patient characteristics, surgical data, and follow-up data. Tumor size at the time of embolization and during follow-up was compared using Student's paired t test. Estimated glomerular filtration rate (eGFR) pre- and post-embolization were compared using Wilcoxon rank sum test. Results: We included 49 patients of whom 4 had two tumors treated in the same TAE procedure. Median age was 50 years (interquartile range [IQR]: [29-67 years]), and the median follow-up time was 4.6 years [IQR: 3.0-6.7 years]. Post-embolization syndrome (PES) was experienced in 27 patients, and non-PES in 5 patients. Median length of hospital stay was 0 days [IQR, 0-1]. Postoperative Everolimus immunosuppressive treatment was offered to seven patients. Median tumor size was 6.0 cm [IQR: 4.6-7.9 cm] and was significantly reduced to 3.7 cm [IQR: 2.5-5.2 cm] after treatment (p < 0.001). Kidney function was not affected by TAE. Three deaths, not related to AML, were noted during follow-up. Conclusion: Embolization of AML was in this cohort effective to significantly reduce tumor size without serious adverse events and loss of renal function. TAE is a safe and efficacious treatment and the preferred minimally invasive treatment option of AML.

8.
Eur Radiol ; 32(4): 2404-2413, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34786614

RESUMO

OBJECTIVES: To evaluate the effects of center experience and a variety of patient- and procedure-related factors on patient radiation exposure during prostatic artery embolization (PAE) in three Scandinavian centers with different PAE protocols and levels of experience. Understanding factors that influence radiation exposure is crucial in effective patient selection and procedural planning. METHODS: Data were collected retrospectively for 352 consecutive PAE procedures from January 2015 to June 2020 at the three centers. Dose area product (DAP (Gy·cm2)) was selected as the primary outcome measure of radiation exposure. Multiple patient- and procedure-related explanatory variables were collected and correlated with the outcome variable. A multiple linear regression model was built to determine significant predictors of increased or decreased radiation exposure as reflected by DAP. RESULTS: There was considerable variation in DAP between the centers. Intended unilateral PAE (p = 0.03) and each 10 additional patients treated (p = 0.02) were significant predictors of decreased DAP. Conversely, increased patient body mass index (BMI, p < 0.001), fluoroscopy time (p < 0.001), and number of digital subtraction angiography (DSA) acquisitions (p < 0.001) were significant predictors of increased DAP. CONCLUSIONS: To minimize patient radiation exposure during PAE radiologists may, in collaboration with clinicians, consider unilateral embolization, pre-interventional CTA for procedure planning, using predominantly anteroposterior (AP) projections, and limiting the use of cone-beam CT (CBCT) and fluoroscopy. KEY POINTS: • Growing center experience and intended unilateral embolization decrease patient radiation exposure during prostatic artery embolization. • Patient BMI, fluoroscopy time, and number of DSA acquisitions are associated with increased DAP during procedures. • Large variation in radiation exposure between the centers may reflect the use of CTA before and CBCT during the procedure.


Assuntos
Embolização Terapêutica , Hiperplasia Prostática , Exposição à Radiação , Angiografia Digital/métodos , Artérias/diagnóstico por imagem , Embolização Terapêutica/métodos , Fluoroscopia , Humanos , Masculino , Próstata/irrigação sanguínea , Próstata/diagnóstico por imagem , Hiperplasia Prostática/diagnóstico por imagem , Hiperplasia Prostática/terapia , Doses de Radiação , Estudos Retrospectivos
9.
BMJ Open ; 11(11): e047878, 2021 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-34725072

RESUMO

INTRODUCTION: Postembolisation syndrome (PES) is the most common side effect of vascular embolisation of solid organs. Although prophylactic corticosteroids are known to reduce the incidence and severity of PES, no trials investigating their efficacy have been conducted in men undergoing prostatic artery embolisation (PAE). We postulate that steroids can have a similar effect in reducing PES after PAE. This paper describes the rationale and detailed protocol for a randomised controlled trial evaluating the efficacy of dexamethasone (DEXA) in reducing PES after PAE. METHODS AND ANALYSIS: In this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 60 individuals undergoing PAE for benign prostatic hyperplasia. Participants will be randomised to receive IV DEXA (24 mg) or placebo (saline). The primary outcomes will be postprocedural fever, pain and quality of life. The secondary outcomes will include postprocedural nausea, postprocedural medicine usage, laboratory parameters (C reactive protein, prostate-specific antigen) and early PAE results. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Danish Committee on Health Research Ethics in the Capital Region (H-20025910). The results from this trial will be disseminated through publication in peer-reviewed journals and national and international presentations. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov identifier: NCT04588857; EudraCT number: 2020-000915-53.


Assuntos
Hiperplasia Prostática , Artérias , Dexametasona/uso terapêutico , Método Duplo-Cego , Humanos , Masculino , Próstata , Hiperplasia Prostática/terapia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
10.
J Trauma Acute Care Surg ; 91(2): 310-317, 2021 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-34259442

RESUMO

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emergency procedure that is potentially lifesaving in major noncompressible torso hemorrhage. It may also improve outcome in nontraumatic cardiac arrest. However, the procedure can be technically challenging and requires the immediate presence of a qualified operator. Thus, evidence-based training and assessment of operator skills are essential for successful implementation and patient safety. A prerequisite for this is a valid and reliable assessment tool specific for the procedure. The aim of this study was to develop a tool for assessing procedural competence in REBOA based on best-available knowledge from international experts in the field. METHODS: We invited international REBOA experts from multiple specialties to participate in an anonymous three-round iterative Delphi study to reach consensus on the design and content of an assessment tool. In round 1, participants suggested items to be included. In rounds 2 and 3, the relevance of each suggested item was evaluated by all participants to reach consensus. Interround data processing was done systematically by a steering group. RESULTS: Forty panelists representing both clinical and educational expertise in REBOA from 16 countries (in Europe, Asia, and North and South America) and seven different specialties participated in the study. After 3 Delphi rounds and 532 initial item suggestions, the panelists reached consensus on a 10-item assessment tool with behaviorally anchored rating scales. It includes assessment of teamwork, procedure time, selection and preparation of equipment, puncture technique, guidewire handling, sheath handling, placement of REBOA catheter, occlusion, and evaluation. CONCLUSION: We present the REBOA-RATE assessment tool developed systematically by international experts in the field to optimize content validity. Following further studies of its validity and reliability, this tool represents an important next step in evidence-based training programs in REBOA, for example, using mastery learning. LEVEL OF EVIDENCE: Therapeutic, level V.


Assuntos
Aorta/cirurgia , Oclusão com Balão/métodos , Hemorragia/terapia , Ressuscitação/métodos , Competência Clínica , Consenso , Técnica Delphi , Emergências , Procedimentos Endovasculares/métodos , Hemorragia/prevenção & controle , Humanos , Internacionalidade , Treinamento por Simulação , Tronco
11.
J Trauma Acute Care Surg ; 91(4): 663-671, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34225347

RESUMO

BACKGROUND: Valid and reliable assessment of skills is essential for improved and evidence-based training concepts. In a recent study, we presented a novel tool to assess procedural skills in resuscitative endovascular balloon occlusion of the aorta (REBOA), REBOA-RATE, based on international expert consensus. Although expert consensus is a strong foundation, the performance of REBOA-RATE has not been explored. The study aimed to examine the reliability and validity of REBOA-RATE. METHODS: This was an experimental simulation-based study. We enrolled doctors with three levels of expertise to perform two REBOA procedures in a simulated scenario of out-of-hospital cardiac arrest. Procedures were video-recorded, and videos were blinded and randomized. Three clinical experts independently rated all procedures using REBOA-RATE. Data were analyzed using Messick's framework for validity evidence, including generalizability analysis of reliability and determination of a pass/fail standard. RESULTS: Forty-two doctors were enrolled: 16 novices, 13 anesthesiologists, and 13 endovascular experts. They all performed two procedures, yielding 84 procedures and 252 ratings. The REBOA-RATE assessment tool showed high internal consistency (Cronbach's α = 0.95) and excellent interrater reliability (intraclass correlation coefficient, 0.97). Assessment using one rater and three procedures could ensure overall reliability suitable for high-stakes testing (G-coefficient >0.80). Mean scores (SD) for the three groups in the second procedure were as follows: novices, 32% (24%); anesthesiologists, 55% (29%); endovascular experts, 93% (4%) (p < 0.001). The pass/fail standard was set at 81%, which all experts but no novices passed. CONCLUSION: Data strongly support the reliability and validity of REBOA-RATE, which successfully discriminated between all experience levels. The REBOA-RATE assessment tool requires minimal instruction, and one rater is sufficient for reliable assessment. Together, these are strong arguments for the use of REBOA-RATE to assess REBOA skills, allowing for competency-based training and certification concepts. LEVEL OF EVIDENCE: Diagnostic test, no or poor gold standard, level V.


Assuntos
Oclusão com Balão/normas , Competência Clínica/normas , Procedimentos Endovasculares/educação , Parada Cardíaca Extra-Hospitalar/terapia , Ressuscitação/educação , Aorta/cirurgia , Procedimentos Endovasculares/métodos , Procedimentos Endovasculares/normas , Humanos , Masculino , Manequins , Reprodutibilidade dos Testes , Ressuscitação/métodos , Ressuscitação/normas , Treinamento por Simulação/métodos
12.
Eur J Vasc Endovasc Surg ; 61(4): 603-611, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33589326

RESUMO

OBJECTIVE: Endovascular treatment of chronic mesenteric ischaemia (CMI) is linked to low early morbidity and mortality but a higher risk of recurrence than open repair. Mid and long term outcomes after endovascular treatment remain to be proven in larger series. The aim of this study was to assess short and mid term outcome after first line endovascular revascularisation of CMI and acute on chronic mesenteric ischaemia (AoCMI). METHODS: This was a prospective population and registry based cohort study supplemented by a retrospective review of medical records and imaging files. A national cohort was created based on data extracted from the Danish National Registry for Vascular Surgery (Karbase) for all patients treated endovascularly for CMI or AoCMI between 2011 and 2015 in Denmark. Survival data, bowel resection, complications, re-intervention rate, and improvement of clinical symptoms were analysed, as were potential risk factors. RESULTS: In total, 245 patients had an endovascular intervention for CMI (n = 178; 72.6%) and AoCMI (n = 67; 27.3%). One and three year survival estimates were 85% (95% confidence interval [CI] 79 - 90) and 74% (95% CI 67 - 80) in the CMI-group, and 67% (95% CI 54 - 77) and 54% (95% CI 41 - 65) in the AoCMI group. The hazard ratio for death was 1.89 (95% CI 1.23 - 2.9) for AoCMI, relative to patients with CMI. Superior mesenteric artery (SMA) stenosis, rather then occlusion, significantly increased the success of SMA recanalisation: OR 19.4 (95% CI 6.2 - 61.4) and 9.3 (95% CI 1.6 - 53.6) in the CMI and AoCMI groups, respectively. The proportion of patients reporting clinical improvement was 71% (n = 127) in the CMI group and 59% (n = 39) in the AoCMI group. Five patients (3%) in the CMI and 30 (45%) in the AoCMI groups underwent bowel resection (p < .001), and the overall length of hospital stay (LoS) was a median of two days (interquartile range [IQR] 1 - 3 days) in the CMI group and seven days (IQR 3 - 23 days) in the AoCMI group. Within the first year, re-intervention was performed in 14 patients (5.7%). CONCLUSION: First line endovascular treatment of CMI carries a three year mortality rate of 25%, and low risk of re-occurrence of symptomatic ischaemia. Relative to CMI, patients suffering AoCMI have significantly higher morbidity and mortality, more bowel resections, and longer LoS.


Assuntos
Angioplastia , Isquemia Mesentérica/terapia , Oclusão Vascular Mesentérica/terapia , Idoso , Angioplastia/efeitos adversos , Angioplastia/instrumentação , Angioplastia/mortalidade , Doença Crônica , Dinamarca , Feminino , Humanos , Masculino , Isquemia Mesentérica/diagnóstico por imagem , Isquemia Mesentérica/mortalidade , Isquemia Mesentérica/fisiopatologia , Oclusão Vascular Mesentérica/diagnóstico por imagem , Oclusão Vascular Mesentérica/mortalidade , Oclusão Vascular Mesentérica/fisiopatologia , Estudos Prospectivos , Recidiva , Sistema de Registros , Retratamento , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento
13.
Diagnostics (Basel) ; 11(1)2021 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-33401743

RESUMO

Solitary fibrous tumors (SFTs) are mesenchymal, fibroblastic tumors with mostly favorable, but still unpredictable prognosis. Their rarity and occurrence at a variety of locations coupled with variable histological appearance make the diagnosis a challenge. This can be resolved by histological and immunohistochemical analysis on the histologic material eventually coupled with demonstration of NAB2-STAT6 gene fusion by next generation sequencing (NGS) analysis. Tumor removal with clear surgical margins is sufficient for complete cure in most cases. Percutaneous transcatheter embolization in well-vascularized lesions may minimize the risk of bleeding during subsequent removal. In this article we present a rare case of SFT arising from the external auditory canal and treated with preoperative endovascular arterial embolization. A literature review with focus on diagnostics and treatment of this entity in the head and neck region is following.

14.
Diagnostics (Basel) ; 10(11)2020 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-33105888

RESUMO

In vivo monitoring of the microvasculature is relevant since diseases such as diabetes, ischemia, or cancer cause microvascular impairment. Super-resolution ultrasound imaging allows in vivo examination of the microvasculature by detecting and tracking sparsely distributed intravascular microbubbles over a minute-long period. The ability to create detailed images of the renal vasculature of Sprague-Dawley rats using a modified clinical ultrasound platform was investigated in this study. Additionally, we hypothesized that early ischemic damage to the renal microcirculation could be visualized. After a baseline scan of the exposed kidney, 10 rats underwent clamping of the renal vein (n = 5) or artery (n = 5) for 45 min. The kidneys were rescanned at the onset of clamp release and after 60 min of reperfusion. Using a processing pipeline for tissue motion compensation and microbubble tracking, super-resolution images with a very high level of detail were constructed. Image filtration allowed further characterization of the vasculature by isolating specific vessels such as the ascending vasa recta with a 15-20 µm diameter. Using the super-resolution images alone, it was only possible for six assessors to consistently distinguish the healthy renal microvasculature from the microvasculature at the onset of vein clamp release. Future studies will aim at attaining quantitative estimations of alterations in the renal microvascular blood flow using super-resolution ultrasound imaging.

15.
Diagnostics (Basel) ; 10(10)2020 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-33066281

RESUMO

Dual-energy computed tomography (DECT) can estimate tissue vascularity and perfusion via iodine quantification. The aim of this systematic review was to outline current and emerging clinical applications of iodine quantification within the gastrointestinal tract using DECT. The search was conducted with three databases: EMBASE, Pubmed and The Cochrane Library. This identified 449 studies after duplicate removal. From a total of 570 selected studies, 30 studies were enrolled for the systematic review. The studies were categorized into four main topics: gastric tumors (12 studies), colorectal tumors (8 studies), Crohn's disease (4 studies) and miscellaneous applications (6 studies). Findings included a significant difference in iodine concentration (IC) measurements in perigastric fat between T1-3 vs. T4 stage gastric cancer, poorly and well differentiated gastric and colorectal cancer, responders vs. non-responders following chemo- or chemoradiotherapy treatment among cancer patients, and a positive correlation between IC and Crohn's disease activity. In conclusion, iodine quantification with DECT may be used preoperatively in cancer imaging as well as for monitoring treatment response. Future studies are warranted to evaluate the capabilities and limitations of DECT in splanchnic flow.

16.
Diagnostics (Basel) ; 10(5)2020 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-32429192

RESUMO

Prostate artery embolization (PAE) is an emerging therapy for benign prostatic hyperplasia (BPH). Optimal patient selection is an important step when introducing new treatments and several characteristics associated with a good clinical outcome has previously been proposed. However, no prognostic tool is yet available for PAE. Computed tomography perfusion is an imaging technique that provides hemodynamic parameters making it possible to estimate the prostatic blood flow (PBF). This study investigated the relationship between PBF and the response to PAE. A post hoc analysis including prostate-specific antigen (PSA) measurements before and 24-h after embolization from two prospective studies on sixteen patients undergoing PAE with BPH or prostate cancer were performed. The primary outcome was the correlation between baseline PBF and the change in PSA as a surrogate measure of treatment response. Prostate volume strongly correlated with treatment response and the response was greater with incremental amounts of injected embolic material. PBF was not associated with elevation in PSA and added no information that could guide patient selection.

17.
Ann Vasc Surg ; 67: 437-447, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32234573

RESUMO

BACKGROUND: The objective of the study was to compare bypass surgery and endovascular revascularization of the femoropopliteal segment in patients with peripheral arterial disease and critical limb-threatening ischemia (CLTI). METHODS: This is a single-center study including patients undergoing first-time lower extremity intervention with peripheral bypass surgery or percutaneous transluminal angioplasty with or without stenting (PTA/S) of the femoropopliteal segment because of CLTI from 2011 to 2015. Based on prospective entered data from the Danish Vascular Registry, the primary end points were amputation-free survival, overall mortality, and reinterventions. RESULTS: A total of 679 patients with CLTI were included of which 35% (n = 239) were treated with PTA/S, 54% (n = 363) with vein bypass, and 11% (n = 77) with synthetic bypass. After 3 years, amputation-free survival was significantly better with a vein bypass (41.8% [95% CI: 35-48.4]) than both PTA/S (29.7% (95% CI: 22.7-37)) and synthetic bypass (31.7% [95% CI: 19-45.1]). Overall, the endovascular-treated patients faced more than 50% increased risk of major amputation or death than that of a vein bypass, after adjusting for comorbidity and Trans-Atlantic Inter-Society Consensus (TASC) classification (HR: 1.56 [95% CI: 1.21-2.05]). As expected, postoperative complications, length of hospital stay, and reinterventions were more frequent in the bypass groups. CONCLUSIONS: In this nonrandomized study, autologous vein bypass was superior to both PTA/S and synthetic bypass in regard to amputation-free survival and overall mortality. Despite the increased frequency of surgical complications, a vein bypass appears justified in both shorter (TASC B-C) and longer (TASC D) femoropopliteal lesions.


Assuntos
Angioplastia , Implante de Prótese Vascular , Artéria Femoral/cirurgia , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea/cirurgia , Veia Safena/transplante , Idoso , Amputação Cirúrgica , Angioplastia/efeitos adversos , Angioplastia/instrumentação , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Doença Crônica , Estado Terminal , Dinamarca , Procedimentos Endovasculares/efeitos adversos , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/cirurgia , Sistema de Registros , Reoperação , Estudos Retrospectivos , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento
18.
Injury ; 51(2): 147-156, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31810637

RESUMO

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a potentially life-saving but high-risk emergency procedure in patients with haemorrhagic shock. Lack of physicians with competence in the procedure is a barrier to implementation of REBOA. It is currently unclear how training and assessment of competence should be done. OBJECTIVES: To report and evaluate research in training and assessment of competence in REBOA and femoral arterial access with the aim to investigate the effect of simulation-based training in the procedure and to provide suggestions for the future design of training programs and assessment tools. METHODS: Following PRISMA guidelines, PubMed, Embase, and Cochrane Library databases were searched for studies on training or assessment of competence in REBOA and femoral arterial access. Bias assessment was done using the Medical Education Research Study Quality Instrument. Evidence level was assessed using GRADE. RESULTS: Sixteen studies were included, six of them published as abstracts. Full-text studies included 189 trainees ranging in experience level from military medics to surgical specialists. Outcome measures were heterogenous; the most used were rater checklists, knowledge testing, and procedure time. All studies confirmed an effect of training of REBOA on procedural competence in a simulation setting but had a high degree of bias. No study developed or used an assessment tool supported by validity evidence and no study investigated mid and long-term outcomes. CONCLUSION: Simulation-based training of REBOA improves skills, however, the evidence level is very low and data cannot answer important questions on effect size, skill transfer and retention, and optimal course design. To advance research and training programmes, an assessment tool supported by validity evidence with broad applicability is needed.


Assuntos
Aorta/cirurgia , Oclusão com Balão/métodos , Ressuscitação/educação , Choque Hemorrágico/terapia , Oclusão com Balão/estatística & dados numéricos , Competência Clínica/estatística & dados numéricos , Procedimentos Endovasculares/métodos , Artéria Femoral/cirurgia , Humanos , Conhecimento , Saúde Militar/educação , Duração da Cirurgia , Choque Hemorrágico/prevenção & controle , Treinamento por Simulação/métodos
19.
Eur J Vasc Endovasc Surg ; 58(3): 350-356, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31296459

RESUMO

OBJECTIVES: Arterial access closure after endovascular aneurysm repair (EVAR) can be achieved using three different approaches: percutaneous closure devices, surgical exposure and direct suture ("cutdown"), and the less invasive fascial closure technique. The aim of this study was to report on the intra-operative, in hospital, and three month outcome of fascial closure and cutdown, and to determine risk factors for failure. METHODS: The primary outcome was assessed in 439 groins in 225 elective EVAR patients recruited consecutively and prospectively from February 1, 2011 to August 31, 2014. During the study period, fascial closure and cutdown were first and second line closing techniques. Compared with fascial closure, procedures completed with cutdown had lower BMI, thinner subcutaneous tissue of the groin and more complex femoral anatomy. Computed tomographic angiography (CTA) and duplex ultrasound (DUS) of the groin were performed pre-operatively and three months after EVAR. Retrospective review of medical records and CTA were used to determine intra-operative and in hospital outcome, and risk factors for failure. RESULTS: In total, 64%, 33%, and 3% were completed with fascial closure, cutdown, and closure device, respectively. Intra-operative, in hospital, and three month technical success rates of fascial closure vs. cutdown were 91% (283/310 groins) vs. 99% (114/115 groins), 89% (277/310 groins) vs. 99% (114/115 groins), and 89% (275/310 groins) vs. 99% (114/115 groins) (p < .001). Wound complications within three months were infrequent for both methods. No risk factor was significantly associated with failure after fascial closure. CONCLUSION: This study shows that cutdown is superior to fascial closure for femoral artery access after elective EVAR. In acute EVAR, however, fascial closure is still considered to be a good and fast method, and it has been kept in the present authors' armamentarium for this indication.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Procedimentos Cirúrgicos Eletivos/métodos , Procedimentos Endovasculares/métodos , Fascia Lata/cirurgia , Técnicas de Sutura , Dispositivos de Acesso Vascular , Idoso , Aneurisma da Aorta Abdominal/diagnóstico , Implante de Prótese Vascular , Angiografia por Tomografia Computadorizada , Feminino , Artéria Femoral , Seguimentos , Virilha/cirurgia , Humanos , Masculino , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla
20.
Diagnostics (Basel) ; 9(2)2019 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-31027211

RESUMO

Nearly one in three men develop lower urinary tract symptoms (LUTS) and 10% clinically progress despite medication. Transurethral resection of the prostate (TURP) is the reference standard for symptoms refractory to medical treatment. However, some patients cannot tolerate TURP for medical (e.g., comorbidity) or technical (e.g., large prostate) reasons. This study estimated the safety and effect of prostate artery embolization (PAE) in men unfit for surgery. A prospective, single-centre trial including men with LUTS or urinary retention secondary to benign prostatic hyperplasia (BPH) who were unfit for surgery. The primary objective was to treat urinary retention and LUTS. Outcome measures included International Prostate Symptom Score (IPSS), quality of life (IPSS-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. A p-value < 0.05 was considered statistically significant. Eleven consecutive patients with a mean age of 75.2 (SD ± 8.2) underwent PAE. Catheter removal was successful in 60%. IPSS-QoL improved 4.5 points (95% CI: -5.6; -3.4), and PV was reduced by 26.2 cm3 (95% CI: -50.9; -2.3). None of the remaining outcomes changed. No major complications occurred. PAE was effective and safe for LUTS and urinary retention associated with BPH in men unfit for surgery.

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