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1.
Braz. j. biol ; 83: e246040, 2023. tab, graf
Artigo em Inglês | LILACS-Express | LILACS, VETINDEX | ID: biblio-1285610

RESUMO

Abstract Autosomal recessive primary microcephaly (MCPH) is a neurodevelopmental disorder characterized by a congenitally reduced head circumference (-3 to -5 SD) and non-progressive intellectual disability. The objective of the study was to evaluate pathogenic mutations in the ASPM gene to understand etiology and molecular mechanism of primary microcephaly. Blood samples were collected from various families across different remote areas of Pakistan from February 2017 to May 2019 who were identified to be affected with primary microcephaly. DNA extraction was performed using the salting-out method; the quality and quantity of DNA were evaluated using spectrophotometry and 1% agarose gel electrophoresis, respectively in University of the Punjab. Mutation analysis was performed by whole exome sequencing from the Cologne Center for Genomics, University of Cologne. Sanger sequencing was done in University of the Punjab to confirm the pathogenic nature of mutation. A novel 4-bp deletion mutation c.3877_3880delGAGA was detected in exon 17 of the ASPM gene in two primary microcephaly affected families (A and B), which resulted in a frame shift mutation in the gene followed by truncated protein synthesis (p.Glu1293Lysfs*10), as well as the loss of the calmodulin-binding IQ domain and the Armadillo-like domain in the ASPM protein. Using the in-silico tools Mutation Taster, PROVEAN, and PolyPhen, the pathogenic effect of this novel mutation was tested; it was predicted to be "disease causing," with high pathogenicity scores. One previously reported mutation in exon 24 (c.9730C>T) of the ASPM gene resulting in protein truncation (p.Arg3244*) was also observed in family C. Mutations in the ASPM gene are the most common cause of MCPH in most cases. Therefore, enrolling additional affected families from remote areas of Pakistan would help in identifying or mapping novel mutations in the ASPM gene of primary microcephaly.


Resumo Microcefalia primária autossômica recessiva (MCPH) é um distúrbio do neurodesenvolvimento caracterizado por uma redução congênita do perímetro cefálico (-3 a -5 DP) e deficiência intelectual não progressiva. O objetivo do estudo foi avaliar mutações patogênicas no gene ASPM a fim de compreender a etiologia e o mecanismo molecular da microcefalia primária. Amostras de sangue foram coletadas de várias famílias em diferentes áreas remotas do Paquistão de fevereiro de 2017 a maio de 2019, que foram identificadas como afetadas com microcefalia primária. A extração do DNA foi realizada pelo método salting-out; a qualidade e a quantidade de DNA foram avaliadas por espectrofotometria e eletroforese em gel de agarose a 1%, respectivamente, na Universidade de Punjab. A análise de mutação foi realizada por sequenciamento completo do exoma do Cologne Center for Genomics, University of Cologne. O sequenciamento de Sanger foi feito na Universidade do Punjab para confirmar a natureza patogênica da mutação. Uma nova mutação de deleção de 4 bp c.3877_3880delGAGA foi detectada no exon 17 do gene ASPM em duas famílias afetadas por microcefalia primária (A e B), que resultou em uma mutação de frame shift no gene seguida por síntese de proteína truncada (pGlu1293Lysfs * 10), bem como a perda do domínio IQ de ligação à calmodulina e o domínio do tipo Armadillo na proteína ASPM. Usando as ferramentas in-silico Mutation Taster, PROVEAN e PolyPhen, o efeito patogênico dessa nova mutação foi testado; foi previsto ser "causador de doenças", com altos escores de patogenicidade. Uma mutação relatada anteriormente no exon 24 (c.9730C > T) do gene ASPM, resultando em truncamento de proteína (p.Arg3244 *) também foi observada na família C. Mutações no gene ASPM são a causa mais comum de MCPH na maioria dos casos . Portanto, a inscrição de famílias afetadas adicionais de áreas remotas do Paquistão ajudaria a identificar ou mapear novas mutações no gene ASPM da microcefalia primária.

2.
Braz J Biol ; 83: e246040, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34378666

RESUMO

Autosomal recessive primary microcephaly (MCPH) is a neurodevelopmental disorder characterized by a congenitally reduced head circumference (-3 to -5 SD) and non-progressive intellectual disability. The objective of the study was to evaluate pathogenic mutations in the ASPM gene to understand etiology and molecular mechanism of primary microcephaly. Blood samples were collected from various families across different remote areas of Pakistan from February 2017 to May 2019 who were identified to be affected with primary microcephaly. DNA extraction was performed using the salting-out method; the quality and quantity of DNA were evaluated using spectrophotometry and 1% agarose gel electrophoresis, respectively in University of the Punjab. Mutation analysis was performed by whole exome sequencing from the Cologne Center for Genomics, University of Cologne. Sanger sequencing was done in University of the Punjab to confirm the pathogenic nature of mutation. A novel 4-bp deletion mutation c.3877_3880delGAGA was detected in exon 17 of the ASPM gene in two primary microcephaly affected families (A and B), which resulted in a frame shift mutation in the gene followed by truncated protein synthesis (p.Glu1293Lysfs*10), as well as the loss of the calmodulin-binding IQ domain and the Armadillo-like domain in the ASPM protein. Using the in-silico tools Mutation Taster, PROVEAN, and PolyPhen, the pathogenic effect of this novel mutation was tested; it was predicted to be "disease causing," with high pathogenicity scores. One previously reported mutation in exon 24 (c.9730C>T) of the ASPM gene resulting in protein truncation (p.Arg3244*) was also observed in family C. Mutations in the ASPM gene are the most common cause of MCPH in most cases. Therefore, enrolling additional affected families from remote areas of Pakistan would help in identifying or mapping novel mutations in the ASPM gene of primary microcephaly.


Assuntos
Microcefalia , Proteínas do Tecido Nervoso , Consanguinidade , Humanos , Microcefalia/genética , Mutação/genética , Proteínas do Tecido Nervoso/genética , Paquistão
3.
Eur J Vasc Endovasc Surg ; 62(2): 276-283, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34053840

RESUMO

OBJECTIVE: The impact of stent design on venous patency is not well studied. The purpose of this study was to investigate the effect of stent material burden on endothelial coverage of stented venous segments, which may contribute to vessel healing and patency. METHODS: Segmented self expanding bare nitinol stents (18 × 50 mm) comprising 5 mm long attached metallic rings separated by 2, 5, or 8 mm gaps were implanted in the inferior vena cava (IVC) of 10 sheep. These stents were designed and manufactured for the purposes of this study. At six, 12, and 24 weeks after implantation the animals were euthanised and the stented vessels harvested for histomorphometric analysis. Three sections from the metallic part as well as the gaps between the struts were reviewed for quantification of endothelialisation after six, 12, and 24 weeks. The intimal thickness over and between the stent struts was measured. The endothelialisation score (graded from 1 for complete luminal endothelialisation to 5 for absence of endothelial cells) was determined. RESULTS: All stents were successfully deployed and all 10 sheep survived until the time of harvesting. Macroscopic inspection after 24 weeks showed only partial endothelialisation over stents with 2 mm and 5 mm skipped segments, whereas the stents with 8 mm skipped segments were totally incorporated into the vein wall. After 24 weeks, the mean (SD) neointimal thicknesses over stent struts with 2 mm, 5 mm, and 8 mm skipped segments were 254.0 (51.6), 182.2 (98.1), and 194.6 (101.1) µm, respectively. Comparison of endothelialisation scores of stents over time showed statistically significantly better endothelialisation over stents with 8 mm gaps after 12 and 24 weeks. CONCLUSION: Stent designs providing structural support to veins with larger gaps between the scaffold material appear to lead to faster and more complete endothelialisation as well as a thinner intimal layer.


Assuntos
Endotélio/fisiopatologia , Neointima/patologia , Desenho de Prótese , Stents , Ligas , Animais , Microscopia Eletrônica de Varredura , Distribuição Aleatória , Ovinos , Veia Cava Inferior
4.
Artigo em Inglês | MEDLINE | ID: mdl-33894343

RESUMO

OBJECTIVE: Deep vein thrombosis (DVT) is a common condition with a high risk of post-thrombotic morbidity, especially in patients with a proximal thrombus. Successful iliofemoral clot removal has been shown to decrease the severity of post-thrombotic syndrome. It is assumed that earlier thrombus lysis is associated with a better outcome. Generally, the earlier IFDVT is confirmed, the earlier thrombus lysis could be performed. d-Dimer levels and Wells score are currently used to assess the preduplex probability for DVT; however, some studies indicate that the d-dimer value varies depending on the thrombus extent and localization. Using d-dimer and other risk factors might facilitate development of a model selecting those with an increased risk of IFDVT that might benefit from early referral for additional analysis and adjunctive iliofemoral thrombectomy. METHODS: All consecutive adult patients from a retrospective cohort of STAR diagnostic center (primary care) in Rotterdam suspected of having DVT between September 2004 and August 2016 were assessed for this retrospective study. The diagnostic workup for DVT including Wells score and d-dimer were performed as well as complete duplex ultrasound examination. Patients with objective evidence of DVT were categorized according to thrombus localization using the Lower Extremity Thrombolysis classification. Logistic regression analysis was done for a model predicting IFDVT. The cut-off value of the model was determined using a receiver operating characteristic curve. RESULTS: A total of 3381 patients were eligible for study recruitment, of whom 489 (14.5%) had confirmed DVT. We developed a multivariate model (sensitivity of 77% and specificity of 82%; area under the curve, 0.90; 0.86-0.93) based on d-dimer, Wells score, age, and anticoagulation use, which is able to distinguish IFDVT patients from all patients suspected of DVT. CONCLUSIONS: This multivariate model adequately distinguishes IFDVT among all suspected DVT patients. Practically, this model could give each patient a preduplex risk score, which could be used to prioritize suspected IFDVT patients for an immediate imaging test to confirm or exclude IFDVT. Further validation studies are needed to confirm potential of this prediction model for IFDVT.

5.
J Vasc Interv Radiol ; 32(3): 453-458, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33454181

RESUMO

PURPOSE: To evaluate the feasibility of a new optical device that measures peripheral blood flow as a diagnostic and monitoring tool for patients with peripheral artery disease (PAD). MATERIALS AND METHODS: In this prospective study, 167 limbs of 90 patients (mean age, 76 y; 53% men) with suspected PAD were evaluated with the FlowMet device, which uses a new type of dynamic light-scattering technology to assess blood flow in real time. Measurements of magnitude and phasicity of blood flow were combined into a single-value flow-waveform score and compared vs ankle-brachial index (ABI), toe-brachial index (TBI), and clinical presentation of patients per Rutherford category (RC). Receiver operating characteristic curves were constructed to predict RC. Area under the curve (AUC), sensitivity, and specificity were compared among flow-waveform score, ABI, and TBI. RESULTS: Qualitatively, the FlowMet waveforms were analogous to Doppler velocity measurements, and degradation of waveform phasicity and amplitude were observed with increasing PAD severity. Quantitatively, the flow, waveform, and composite flow-waveform scores decreased significantly with decreasing TBI. In predicting RC ≥ 4, the flow-waveform score (AUC = 0.83) showed a linear decrease with worsening patient symptoms and power comparable to that of TBI (AUC = 0.82) and better than that of ABI (AUC = 0.71). Optimal sensitivity and specificity pairs were found to be 56%/83%, 72%/81%, and 89%/74% for ABI, TBI, and flow-waveform score, respectively. CONCLUSIONS: The technology tested in this pilot study showed a high predictive value for diagnosis of critical limb ischemia. The device showed promise as a diagnostic tool capable of providing clinical feedback in real time.


Assuntos
Técnicas de Diagnóstico Cardiovascular/instrumentação , Isquemia/diagnóstico , Doença Arterial Periférica/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Índice Tornozelo-Braço , Velocidade do Fluxo Sanguíneo , Estado Terminal , Estudos Transversais , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Isquemia/fisiopatologia , Luz , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/fisiopatologia , Projetos Piloto , Valor Preditivo dos Testes , Estudos Prospectivos , Fluxo Sanguíneo Regional , Reprodutibilidade dos Testes , Espalhamento de Radiação , Índice de Gravidade de Doença
6.
J Vasc Access ; 22(1): 141-146, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32597356

RESUMO

PURPOSE: Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The Surfacer System to Facilitate Access in Venous Occlusions Study was an Food and Drug Administration-approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction. METHODS: Thirty patients were enrolled in this prospective, multicenter, single-arm study between December 2017 and May 2019. Device performance and adverse events were collected peri-procedurally and at discharge. Enrollment included 15 female and 15 male subjects with a mean age of 55.5 ± 12.9 (range: 30-79) years. Twenty-eight patients (93.3%) required central venous access for hemodialysis access. Locations of thoracic central venous obstruction were graded from 1 to 4 based on severity and extension of venous occlusions. Seven patients (23.3%) had type 1, 6 (20.0%) type 2, 16 (53.3%) type 3, and 1 (3.3%) type 4 obstruction. RESULTS: Successful central venous catheter placement was achieved in 27 of 30 patients (90.0%). The procedure was discontinued in three (10.0%) due to tortuous anatomy discovered intraprocedurally. All 27 patients with successful CVC placement achieved adequate catheter patency and tip positioning with a mean overall procedural time and time to achieve central venous access with the Surfacer System being 44.1 ± 30.6 and 19.1 ± 25.1 min, respectively. There were no device-related adverse events or catheter malposition. CONCLUSION: The results of the SAVEUS Study confirm the safety and efficacy of the Surfacer System and the Inside-Out procedure when used for the placement of right-sided central venous access in patients with thoracic central venous obstruction.


Assuntos
Cateterismo Venoso Central/instrumentação , Cateteres de Demora , Cateteres Venosos Centrais , Tórax/irrigação sanguínea , Doenças Vasculares , Veias , Adulto , Idoso , Cateterismo Venoso Central/efeitos adversos , Constrição Patológica , Aprovação de Equipamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Diálise Renal , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration , Doenças Vasculares/diagnóstico por imagem , Doenças Vasculares/etiologia , Veias/diagnóstico por imagem
7.
Vasa ; 50(1): 59-67, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32449481

RESUMO

Background: This study sought to compare effectiveness and safety of percutaneous mechanical thrombectomy (PMT) and thrombolysis alone (THR) in patients with acute or subacute iliofemoral deep vein thrombosis (IfDVT). Patients and methods: Observational and randomized trials, published between January 2001 to February 2019 were identified by searching MEDLINE. Studies on deep venous thrombosis (DVT) treated with either THR or PMT adjunctive to conventional anticoagulation and compressive intervention were included. Meta-analysis of proportions was conducted to assess effectiveness outcomes of successful lysis and primary patency, post-thrombotic syndrome (PTS), valvular reflux, recurrent DVT, as well as safety outcomes of major bleeding, hematuria, and pulmonary embolism. Results: Of 77 identified records, 17 studies including 1417 patients were eligible. Pooled proportion of successful lysis was similar between groups (THR: 95 % [I2 = 68.4 %], PMT 96 %, [I2 = 0 %]; Qbet [Cochran's Q between groups] 0.3, p = 0.61). However, pooled proportion of 6-month primary patency was lower after THR than after PMT (68 % [I2 = 15.6 %] versus 94 %; Qbet 26.4, p < 0.001). Considerable heterogeneity within groups did not allow for between-group comparison of PTS and recurrent DVT. Major bleeding was more frequent after THR than after PMT (6.0 % [I2 = 0 %] versus 1.0 % [I2 = 0 %]; Qbet 12.3, p < 0.001). Incidence of hematuria was lower after THR as compared to PMT (2 % [I2 = 56 %] versus 91.3 % [I2 = 91.7 %]; Qbet 714, p < 0.001). Incidences of valvular reflux and pulmonary embolism were similar across groups (THR: 61 % versus PMT: 53 %; Qbet 0.7, p = 0.39 and THR: 2 % versus PMT: 1 %; Qbet 1.1, p = 0.30, respectively). Conclusions: In patients with iliofemoral DVT, percutaneous mechanical thrombectomy was associated with a higher cumulative 6-month primary patency and a lower incidence of major bleeding compared to thrombolysis alone. Risk of hemolysis from mechanical thrombectomy needs further consideration.


Assuntos
Veia Ilíaca/cirurgia , Trombólise Mecânica , Trombectomia/efeitos adversos , Terapia Trombolítica/efeitos adversos , Trombose Venosa/terapia , Humanos , Veia Ilíaca/diagnóstico por imagem , Síndrome Pós-Trombótica/etiologia , Estudos Retrospectivos , Resultado do Tratamento
8.
Innovations (Phila) ; 16(1): 26-33, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33124923

RESUMO

Preoperative image-guided localization of lung nodules is necessary for successful intraoperative localization and resection. However, current localization techniques carry significant intraoperative disadvantages for surgeons. Articles were selected through multiple search engines using key search terms and reviewed to compare results, outcomes, advantages, limitations, and complications of various localization methods. Current methods utilize microcoils, hookwires, contrast media, dyes, cyanoacrylate, radiotracers, or fluorescence tracers, which are associated with many intraoperative disadvantages even when paired with other imaging modalities including computed tomography and bronchoscopy techniques. Novel technologies including robotic bronchoscopy, 4-hook anchor, SPiN Thoracic Navigation System, superDimension, Ion Endoluminal System, and the SCOUT system are reviewed including their advantages, which may change the future direction of minimal thoracoscopic surgery with potential to improve intraoperative accuracy and efficiency.

9.
J Vasc Interv Radiol ; 31(12): 2060-2065, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33153863

RESUMO

PURPOSE: To report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions. MATERIALS AND METHODS: A retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18-68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Iliocaval confluence was treated by deploying a nitinol stent in inferior vena cava (IVC) and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was assessed by duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter. RESULTS: Recanalization and stent reconstruction was technically successful in 47 (98%) patients. The sinus-XL venous stent was used to treat IVC (95 [100%]). Common iliac and external iliac veins were treated with sinus-Venous and VENOVO stents (80 [83%] and 16 [17%] limbs, respectively). External iliac and common femoral veins were treated with sinus-Venous and VENOVO stents (83 [92%] and 7 [18%] limbs, respectively). Early thrombosis (< 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74%, 83%, and 97%. CONCLUSIONS: Findings of this study suggest that leaving a skipped lesion at the level of iliocaval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of iliocaval confluence.


Assuntos
Procedimentos Endovasculares/instrumentação , Veia Ilíaca , Stents Metálicos Autoexpansíveis , Doenças Vasculares/terapia , Veia Cava Inferior , Adolescente , Adulto , Idoso , Ligas , Doença Crônica , Constrição Patológica , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Veia Ilíaca/diagnóstico por imagem , Veia Ilíaca/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Doenças Vasculares/diagnóstico por imagem , Doenças Vasculares/fisiopatologia , Grau de Desobstrução Vascular , Veia Cava Inferior/diagnóstico por imagem , Veia Cava Inferior/fisiopatologia , Adulto Jovem
10.
Expert Rev Med Devices ; 17(9): 937-944, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32941079

RESUMO

INTRODUCTION: The development of thoracic central venous obstruction (TCVO) leads to narrowing of the vessel lumen which impacts blood flow and the placement of central venous access. The most common cause of TCVO is central venous catheters (CVCs) which can induce intravascular scarring or endoluminal obstruction via thrombus formation. AREAS COVERED: The Surfacer® System is used to obtain central venous access (CVA) in patients with TCVO by facilitating catheter insertion via the novel Inside-Out® approach. This review summarizes the results of clinical studies to date with the Surfacer System, focusing on how the procedure is performed, clinical efficacy and safety of the device and patient populations where the device offers substantial clinical benefit. EXPERT OPINION: The Surfacer System offers a safe and effective approach to reliably preserve and restore critical upper body vascular access sites. For dialysis patients, the device offers an alternative which avoids placement of dialysis catheters in veins which may impact the ability to achieve maturation of hemodialysis vascular access or in locations which have an increased risk of insertion-related complications or are associated with higher morbidity.


Assuntos
Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/instrumentação , Cateteres Venosos Centrais/efeitos adversos , Trombose/etiologia , Veias/cirurgia , Ensaios Clínicos como Assunto , Humanos , Resultado do Tratamento
11.
J Vasc Interv Radiol ; 31(10): 1517-1528.e2, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32948386

RESUMO

PURPOSE: To evaluate relationships between immediate venographic results and clinical outcomes of pharmacomechanical catheter-directed thrombolysis (PCDT). MATERIALS AND METHODS: Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multicenter randomized trial were reviewed. Quantitative thrombus resolution was assessed by independent readers using a modified Marder scale. The physician operators recorded their visual assessments of thrombus regression and venous flow. These immediate post-procedure results were correlated with patient outcomes at 1, 12, and 24 months. RESULTS: PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments). At procedure end, spontaneous venous flow was present in 99% of iliofemoral venous segments and in 89% of femoral-popliteal venous segments. For the overall proximal DVT population, and for the femoral-popliteal DVT subgroup, post-PCDT thrombus volume did not correlate with 1-month or 24-month outcomes. For the iliofemoral DVT subgroup, over 1 and 24 months, symptom severity scores were higher (worse), and venous disease-specific quality of life (QOL) scores were lower (worse) in patients with greater post-PCDT thrombus volume, with the difference reaching statistical significance for the 24-month Villalta post-thrombotic syndrome (PTS) severity score (P = .0098). Post-PCDT thrombus volume did not correlate with 12-month valvular reflux. CONCLUSIONS: PCDT successfully removes thrombus in acute proximal DVT. However, the residual thrombus burden at procedure end does not correlate with the occurrence of PTS during the subsequent 24 months. In iliofemoral DVT, lower residual thrombus burden correlates with reduced PTS severity and possibly also with improved venous QOL and fewer early symptoms.


Assuntos
Veia Femoral , Fibrinolíticos/administração & dosagem , Veia Ilíaca , Veia Poplítea , Terapia Trombolítica , Ativador de Plasminogênio Tecidual/administração & dosagem , Trombose Venosa/terapia , Adolescente , Adulto , Idoso , Feminino , Veia Femoral/diagnóstico por imagem , Fibrinolíticos/efeitos adversos , Humanos , Veia Ilíaca/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Flebografia , Veia Poplítea/diagnóstico por imagem , Síndrome Pós-Trombótica/etiologia , Terapia Trombolítica/efeitos adversos , Fatores de Tempo , Ativador de Plasminogênio Tecidual/efeitos adversos , Resultado do Tratamento , Estados Unidos , Trombose Venosa/complicações , Trombose Venosa/diagnóstico por imagem , Adulto Jovem
12.
J Vasc Interv Radiol ; 31(9): 1410-1418.e10, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32868016

RESUMO

PURPOSE: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). RESULTS: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. CONCLUSIONS: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Artéria Femoral , Disparidades nos Níveis de Saúde , Doença Arterial Periférica/terapia , Artéria Poplítea , Dispositivos de Acesso Vascular , Fatores Etários , Idoso , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Progressão da Doença , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Fatores de Risco , Fatores Sexuais , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
13.
J Vasc Surg Venous Lymphat Disord ; 8(1): 8-23.e18, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31843251

RESUMO

BACKGROUND: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT. METHODS: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups. RESULTS: Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups. CONCLUSIONS: Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.


Assuntos
Veia Femoral , Fibrinolíticos/administração & dosagem , Veia Ilíaca , Trombólise Mecânica , Qualidade de Vida , Terapia Trombolítica , Trombose Venosa/terapia , Adulto , Feminino , Veia Femoral/fisiopatologia , Fibrinolíticos/efeitos adversos , Humanos , Veia Ilíaca/fisiopatologia , Masculino , Trombólise Mecânica/efeitos adversos , Pessoa de Meia-Idade , Inquéritos e Questionários , Terapia Trombolítica/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Trombose Venosa/diagnóstico , Trombose Venosa/fisiopatologia
14.
Circ Cardiovasc Interv ; 12(12): e008268, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31833414

RESUMO

BACKGROUND: Chronic venous insufficiency is characterized by inadequate venous return from the lower extremities, which may arise from intravenous obstruction after deep vein thrombosis or from extrinsic venous compression. The purpose of this study was to determine the safety and effectiveness of a dedicated endovenous stent for symptomatic iliofemoral venous obstruction. METHODS: The VIRTUS trial (VIRTUS Safety and Efficacy of the Veniti Vici Venous Stent System [Veniti, Inc] When Used to Treat Clinically Significant Chronic Non-Malignant Obstruction of the Iliofemoral Venous Segment) was a prospective, international, single-arm, pivotal study of endovenous stent placement in patients with symptomatic iliofemoral venous obstruction. Patients included those with ≥50% obstruction on venography and Clinical, Etiology, Anatomic, Pathophysiology clinical classification ≥3, or at least moderate leg pain with a Venous Clinical Severity Score of 2 or greater. All patients were treated with a self-expanding nitinol stent developed for dedicated use in the venous system (Vici Venous Stent System, Veniti, Inc/Boston Scientific, Marlborough, MA). Patients returned for clinical and imaging follow-up visits at 1 month, 6 months, and 1 year. The primary safety outcome was freedom from major adverse events at 30 days. The primary effectiveness outcome was venographic primary patency at 1-year. Adverse events were adjudicated by a Clinical Events Committee, and all imaging including venograms, intravascular ultrasound, and Doppler examinations were assessed by respective core laboratories. RESULTS: Between March 2015 and November 2016, 170 patients (127 chronic post-thrombotic, mean age 54 years, 56.4% female) at 22 sites underwent endovenous stent placement. Mean diameter stenosis was 78%, with 31.2% total occlusions. Mean lesion length was 111.3 mm, range 10 to 260 mm (mean 125.3 mm for post-thrombotic patients and 70.2 mm for nonthrombotic patients). Freedom from a major adverse event through 30 days was 98.8%. The 1-year primary patency rate for the entire group was 84.0%. Venographic patency rates for the nonthrombotic and chronic post-thrombotic groups were 96.2% and 79.8%, respectively. At 12 months, 64% (85/132) of patients demonstrated at least a 3-point reduction in Venous Clinical Severity Score. CONCLUSIONS: Twelve-month safety and effectiveness were demonstrated with the use of a dedicated venous stent to treat symptomatic iliofemoral venous obstructions, with reductions in clinical symptoms and improvements in quality of life, through 1-year follow-up. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02112877.


Assuntos
Procedimentos Endovasculares/instrumentação , Veia Femoral , Veia Ilíaca , Stents , Insuficiência Venosa/terapia , Adulto , Idoso , Doença Crônica , Procedimentos Endovasculares/efeitos adversos , Europa (Continente) , Feminino , Veia Femoral/diagnóstico por imagem , Veia Femoral/fisiopatologia , Humanos , Veia Ilíaca/diagnóstico por imagem , Veia Ilíaca/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução Vascular , Insuficiência Venosa/diagnóstico por imagem , Insuficiência Venosa/fisiopatologia
15.
Circulation ; 140(14): 1145-1155, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31567024

RESUMO

BACKGROUND: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients. METHODS: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry). All serious adverse events including deaths were adjudicated by a blinded, third-party, independent Clinical Events Committee. Kaplan-Meier estimates in the RCTs were compared with restricted mean survival time. Predictors of death were assessed with hazard ratios (HRs) and Cox proportional hazards modeling. RESULTS: Baseline characteristics were similar in the patients treated with DCB and PTA in the pooled RCT analysis, with the exception that the DCB cohort was younger (67.4±9.7 versus 69.4±9.4 years, P=0.02), smoked more frequently (86.6% versus 78.8%, P=0.02), and were less often treated for recurrent lesions (8.8% versus 14.7%, P=0.04). In the RCTs, patients treated with DCB had all-cause mortality rates that were not different from those of patients treated with PTA (Kaplan-Meier estimates 1.8±0.7% versus 1.3±0.9%, 6.5±1.2% versus 5.9±1.9%, and 9.3±1.5% versus 9.9±2.4% at 1, 2, and 3 years, respectively, P=0.86). All-cause mortality rates were similar in a 1906-patient pooled nonrandomized DCB data set (Kaplan-Meier estimates of 2.1%, 4.9%, and 7.0% at 1, 2, and 3 years, respectively). Clinical Events Committee-adjudicated causes of death were balanced between the DCB and PTA cohorts. Multivariable Cox modeling identified age (HR, 1.06; 95% CI, 1.04-1.08; P<0.001), diabetes mellitus (HR, 1.42; 95% CI, 1.01-2.00; P=0.04), congestive heart failure (HR, 1.88; 95% CI, 1.12-3.16; P=0.02), and renal insufficiency (HR, 2.00; 95% CI, 1.33-3.01; P<0.001) as predictors of mortality. Paclitaxel exposure was unrelated to mortality (HR, 1.04; 95% CI, 0.98-1.10; P=0.23). CONCLUSIONS: The mortality rates for patients treated with the DCB and uncoated PTA were indistinguishable over 3-year follow-up. Additional patient-level, adequately powered meta-analyses with larger RCT data sets will be needed to confirm the generalizability of these findings. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT02110524, NCT01858363, NCT01858428, NCT03421561, NCT01912937, NCT01927068, and NCT02769273.


Assuntos
Stents Farmacológicos/efeitos adversos , Paclitaxel/química , Doença Arterial Periférica/tratamento farmacológico , Idoso , Angioplastia/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Paclitaxel/uso terapêutico , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/terapia , Modelos de Riscos Proporcionais , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
J Vasc Surg ; 70(4): 1177-1191.e9, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31543165

RESUMO

OBJECTIVE: Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA. METHODS: The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders. RESULTS: At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA. CONCLUSIONS: In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença Arterial Periférica/terapia , Ultrassonografia Doppler Dupla , Dispositivos de Acesso Vascular , Idoso , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Valor Preditivo dos Testes , Pontuação de Propensão , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
17.
J Agric Food Chem ; 67(29): 8096-8106, 2019 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-31260296

RESUMO

Field experiments were conducted on wheat to study the effects of foliar-applied iodine(I) alone, Zn (zinc) alone, and a micronutrient cocktail solution containing I, Zn, Se (selenium), and Fe (iron) on grain yield and grain concentrations of micronutrients. Plants were grown over 2 years in China, India, Mexico, Pakistan, South Africa, and Turkey. Grain-Zn was increased from 28.6 mg kg-1 to 46.0 mg-1 kg with Zn-spray and 47.1 mg-1 kg with micronutrient cocktail spray. Foliar-applied I and micronutrient cocktail increased grain I from 24 µg kg-1 to 361 µg kg-1 and 249 µg kg-1, respectively. Micronutrient cocktail also increased grain-Se from 90 µg kg-1 to 338 µg kg-1 in all countries. Average increase in grain-Fe by micronutrient cocktail solution was about 12%. The results obtained demonstrated that foliar application of a cocktail micronutrient solution represents an effective strategy to biofortify wheat simultaneously with Zn, I, Se and partly with Fe without yield trade-off in wheat.


Assuntos
Biofortificação/métodos , Produção Agrícola/métodos , Iodo/metabolismo , Ferro/metabolismo , Selênio/metabolismo , Triticum/metabolismo , Zinco/metabolismo , China , Fertilizantes/análise , Índia , Iodo/análise , Ferro/análise , México , Micronutrientes/análise , Micronutrientes/metabolismo , Paquistão , Folhas de Planta/química , Folhas de Planta/metabolismo , Sementes/química , Sementes/crescimento & desenvolvimento , Sementes/metabolismo , Selênio/análise , África do Sul , Triticum/química , Triticum/crescimento & desenvolvimento , Turquia , Zinco/análise
18.
Vasc Med ; 24(5): 442-451, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31354089

RESUMO

Few studies have documented relationships between endovascular therapy, duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial randomized 692 patients with acute proximal deep vein thrombosis (DVT) to receive anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT). Compression DUS was obtained at baseline, 1 month and 12 months. Reflux DUS was obtained at 12 months in a subset of 126 patients. Clinical outcomes were collected over 24 months. At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, p < 0.0001), femoral vein (51% vs 70%, p < 0.0001), and popliteal vein (61% vs 74%, p < 0.0001). At 12 months, in the ultrasound substudy, valvular reflux prevalence was similar between groups (85% vs 91%, p = 0.35). CFV non-compressibility at 1 month was associated with higher rates of any PTS (61% vs 46%, p < 0.001), a higher incidence of moderate-or-severe PTS (30% vs 19%, p = 0.003), and worse QOL (difference 8.2 VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study on Quality of Life) points; p = 0.004) at 24 months. Valvular reflux at 12 months was associated with moderate-or-severe PTS at 24 months (30% vs 0%, p = 0.01). In summary, PCDT results in less residual thrombus but does not reduce venous valvular reflux. CFV non-compressibility at 1 month is associated with more PTS, more severe PTS, and worse QOL at 24 months. Valvular reflux may predispose to moderate-or-severe PTS. ClinicalTrials.gov Identifier NCT00790335.


Assuntos
Cateterismo Periférico , Fibrinolíticos/administração & dosagem , Terapia Trombolítica , Ultrassonografia Doppler Dupla , Trombose Venosa/terapia , Administração Intravenosa , Adulto , Cateterismo Periférico/efeitos adversos , Feminino , Fibrinolíticos/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , América do Norte , Síndrome Pós-Trombótica/diagnóstico por imagem , Síndrome Pós-Trombótica/etiologia , Síndrome Pós-Trombótica/fisiopatologia , Valor Preditivo dos Testes , Qualidade de Vida , Fatores de Risco , Índice de Gravidade de Doença , Terapia Trombolítica/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/fisiopatologia
19.
Surg Innov ; 26(4): 469-472, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31027475

RESUMO

Background. Current techniques for localization and resection of lung nodules carry many intraoperative challenges for surgeons. This article proposes a new localization method for diagnosis and treatment of pulmonary nodules, which provides a navigational system for more accurate lung resection. Methods. We report the case of a 77-year-old female with a pulmonary nodule of the right lower lobe. A nonradioactive localization technology, known as SAVI SCOUT (Cianna Medical Inc, Aliso Viejo, CA), was placed by interventional radiology under computed tomography guidance preoperatively. Using the SCOUT Wire-Free Radar Localization System, the pulmonary nodule was robotically localized and resected. SCOUT removal was confirmed using the Trident Specimen Radiology System. The efficacy of this procedure was evaluated in terms of ease of use and procedure time by interventional radiology, surgical resection accuracy, diagnostic accuracy, simplicity, and ease to implement this technology in an existing hospital. Results. The SCOUT system allowed for the first reported case of successful SCOUT placement in lung tissue, targeted the pulmonary nodule intraoperatively, and facilitated accurate lung resection. Conclusions. The SCOUT system shows promising advancements in the ability to eliminate many challenges currently seen with lung nodule localization and resection.


Assuntos
Neoplasias Pulmonares/cirurgia , Radiografia Intervencionista/instrumentação , Procedimentos Cirúrgicos Robóticos , Nódulo Pulmonar Solitário/cirurgia , Tomografia Computadorizada por Raios X , Idoso , Feminino , Humanos , Biópsia Guiada por Imagem , Neoplasias Pulmonares/diagnóstico por imagem , Tomografia por Emissão de Pósitrons , Nódulo Pulmonar Solitário/diagnóstico por imagem
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