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2.
Trials ; 24(1): 594, 2023 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-37717001

RESUMO

INTRODUCTION: Pulmonary segmentectomy, when combined with hilar and mediastinal lymphadenectomy, is currently considered the gold standard treatment for early-stage lung tumors (NSCLC) smaller than 2 cm in diameter. The preoperative planning for segmentectomies usually includes a contrast-enhanced CT with 2D reconstructions (axial, coronary, and sagittal). Recent technological advances allow 3D (volume rendering) reconstructions of preoperative CT scans, intended to improve the surgeon's understanding of the segmental anatomy. The study aims to investigate the added value of 3D reconstruction in enhancing the surgeon's understanding of anatomical structures, thus facilitating surgical planning and improving oncological outcomes. METHODS AND ANALYSIS: This is a prospective, randomized, controlled study. Patients will be randomized into two groups: 1. Group 2D: the preoperative workup for these patients will consist of a contrast-enhanced chest CT with two-dimensional (2D) reconstructions (axial, coronary, and sagittal); 2. Group 3D: the preoperative workup for these patients will consist of a contrast-enhanced chest CT with two-dimensional (2D) reconstructions (axial, coronary, and sagittal) and a 3D reconstruction (volume rendering) of the same chest CT employing dedicated software. The primary endpoints will be negative margin (R0) resection rate, resection margin (staple line-to-tumor distance), and thoracotomy conversions. We will use Fisher's exact test for binary outcomes and Mann-Whitney U test for continuous outcomes. For subgroup analyses, we will use regression. Multivariable analyses will be based on logistic regression for binary outcomes and linear regression for continuous outcomes. ETHICS AND DISSEMINATION: The protocol and the model informed consent forms have been reviewed and approved by the ethics committee (N.: 1-2023) concerning scientific content and compliance with applicable research and human subject regulations. A Subcommittee on Publications was established to review all publications and report its recommendations to the steering committee. The anonymized participant-level dataset and statistical code for generating the results will not be publicly available. TRIAL REGISTRATION: The protocol was registered at ClinicalTrials.gov (ID: NCT05716815; Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy - Full-Text View - ClinicalTrials.gov). Jan 19, 2023.


Assuntos
Imageamento Tridimensional , Neoplasias Pulmonares , Humanos , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/cirurgia , Margens de Excisão , Mastectomia Segmentar , Pneumonectomia , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
3.
Eur J Cardiothorac Surg ; 62(3)2022 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-35373816

RESUMO

OBJECTIVES: This study reports the results of an international expert consensus process evaluating the assessment of intraoperative air leaks (IAL) and treatment of postoperative prolonged air leaks (PAL) utilizing a Delphi process, with the aim of helping standardization and improving practice. METHODS: A panel of 45 questions was developed and submitted to an international working group of experts in minimally invasive lung cancer surgery. Modified Delphi methodology was used to review responses, including 3 rounds of voting. The consensus was defined a priori as >50% agreement among the experts. Clinical practice standards were graded as recommended or highly recommended if 50-74% or >75% of the experts reached an agreement, respectively. RESULTS: A total of 32 experts from 18 countries completed the questionnaires in all 3 rounds. Respondents agreed that PAL are defined as >5 days and that current risk models are rarely used. The consensus was reached in 33/45 issues (73.3%). IAL were classified as mild (<100 ml/min; 81%), moderate (100-400 ml/min; 71%) and severe (>400 ml/min; 74%). If mild IAL are detected, 68% do not treat; if moderate, consensus was not; if severe, 90% favoured treatment. CONCLUSIONS: This expert consensus working group reached an agreement on the majority of issues regarding the detection and management of IAL and PAL. In the absence of prospective, randomized evidence supporting most of these clinical decisions, this document may serve as a guideline to reduce practice variation.


Assuntos
Pneumonectomia , Consenso , Técnica Delphi , Humanos , Pneumonectomia/efeitos adversos , Estudos Prospectivos , Inquéritos e Questionários
4.
Ann Vasc Surg ; 75: 397-405, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33556526

RESUMO

BACKGROUND: Durability of low-profile branched aortic stent-grafts (LPSG) in the treatment of patients with thoracoabdominal aortic aneurysms (TAAA) remains unclear. Objective of this study is to compare the outcomes of LPSG with standard profile branched aortic stent-grafts (SPSG). METHODS: Between January 2016 and January 2020, 225 consecutive patients with TAAA were treated by branched endovascular aortic repair (BEVAR). Twenty-four patients who were treated with a LPSG were compared to 24 patients who received SPSG as a control group. Control patients were selected according to aneurysm size (maximum aneurysm diameter) and extension (Crawford classification) as well as availability of adequate preoperative and postoperative CT-angiograms at 24 months. The primary endpoint was ongoing clinical success defined as successful implantation and freedom from aneurysm- or procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion or rupture and conversion. Secondary endpoints were radiological changes of the branched endograft (migration, shortening, scoliosis, lordosis, and fracture). RESULTS: After a median follow-up of 22.6 (LPSG) and 26.2 months (SPSG), no significant difference was found in terms of technical success (100% in both groups), late mortality (4.2% vs 0%), aneurysm diameter increase (4.2% in both groups) and reinterventions (25% vs 37.5%). Infection, thrombosis, aneurysm expansion or rupture and conversion were not observed. Radiological analysis of aortic graft remodeling showed no fracture and no significant migration, shortening, scoliosis and lordosis of the LPSG (6.1 mm, 7.5 mm, 12.8° and 6.1°) compared to SPSG (3.9 mm, 5.1 mm, 7.9° and 5.6°) after 2 years. CONCLUSION: The clinical and radiological findings of the present study showed no increased mortality and complications for the matched patients who underwent treatment with low-profile vs standard-profile BEVAR. This study provides preliminary evidence of safety and efficacy of low-profile branched endografts in patients with demanding iliac access vessels.


Assuntos
Aneurisma da Aorta Torácica/cirurgia , Aortografia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Angiografia por Tomografia Computadorizada , Procedimentos Endovasculares/instrumentação , Stents , Idoso , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico por imagem , Valor Preditivo dos Testes , Desenho de Prótese , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
5.
J Endovasc Ther ; 27(6): 902-909, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32813593

RESUMO

PURPOSE: To analyze the overall performance of flexible nitinol stents used to line chimney grafts (CGs) during chimney endovascular aneurysm repair (chEVAR) of pararenal pathologies. MATERIALS AND METHODS: A retrospective review was conducted of all 116 elective patients (mean age 74.3±7.2 years; 103 men) who underwent chEVAR with balloon-expandable Advanta V12/iCAST CGs in combination with the Endurant stent-graft between January 2009 and December 2017 at a single center. CG lining with a nitinol stent was electively performed in 43 target vessels of 32 patients. The Kaplan-Meier method was used to estimate the primary outcomes of CG patency and freedom from reintervention (FFR) at the patient level and according to the use of a stent to line the CG. Estimates are reported with the 95% confidence interval (CI). Adjusted odds ratios (ORs) were calculated to identify any confounding effect between the presence/absence of a stent lining or according to the number of CGs. RESULTS: The mean radiological follow-up was 27.3 months (range 22.1-32.6). During this time, 8 CGs (4.7%) became occluded, 6 of them were lined with stents. Restoration of patency was possible in 3 of the 4 occluded stents that were associated with symptoms. First-year primary patency estimates were 96.9% (95% CI 92.5% to 100%) for the unlined group vs 77.1% (95% CI 58% to 95.3%; p=0.001) for the lined group, while FFR was 87.6% (95% CI 79.9% to 95.2%) vs 83.4% (95% CI 68.1% to 98.6%; p=0.82), respectively. Lining represented an independent risk factor for CG occlusion (OR 9.9, p=0.006). CONCLUSION: CG lining performed mainly in angulated renal arteries during chEVAR was significantly associated with CG occlusion. These findings highlight the importance of not having the distal part of the CG impinge on the angulated segment of the target vessel.


Assuntos
Aneurisma , Implante de Prótese Vascular , Procedimentos Endovasculares , Artéria Renal , Stents , Idoso , Idoso de 80 Anos ou mais , Ligas , Aneurisma/diagnóstico por imagem , Aneurisma/cirurgia , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Masculino , Desenho de Prótese , Artéria Renal/diagnóstico por imagem , Artéria Renal/cirurgia , Estudos Retrospectivos , Fatores de Risco , Aço Inoxidável , Resultado do Tratamento
6.
Vascular ; 27(1): 3-7, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30282531

RESUMO

OBJECTIVES: To evaluate the use of chimney grafts in the treatment of para-anastomotic aneurysms after previous abdominal aortic aneurysms open repair with short neck. METHODS: A retrospective analysis of prospectively collected data of consecutive patients who underwent endovascular repair for proximal aortic para-anastomotic aneurysms following previous open repair for infrarenal abdominal aortic aneurysms was performed. All included patients had a short infrarenal aortic neck (<10 mm) excluding standard endovascular aortic repair. Five patients were symptomatic at the admission needed urgent treatment. RESULTS: Twelve patients with para-anastomotic aneurysms underwent placement of chimney grafts. The median time between the original operations to redo endovascular procedure was 11 years (interquartile range, 9.5 years). The mean infrarenal length was 4.3 mm (1-9 mm). A total of 28 chimneys grafts were deployed for the 12 patients. The technical success rate was 91.7%. At a median radiologic follow-up of 16 months (2.0-29.4, 95% confidence interval), one patient died, while two late endoleaks and two reinterventions at one and three years for type Ia endoleak were performed by proximal extension and triple chimney graft placement. CONCLUSION: The results of the present study show that ch-endovascular aortic repair is a safe technique for patients who suffered from proximal para-anastomotic aneurysms and having short neck unsuitable for standard endovascular repair. Longer follow up warranted to evaluate the durability of ch-endovascular aortic repair for this specific indication.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/métodos , Procedimentos Endovasculares/métodos , Complicações Pós-Operatórias/cirurgia , Idoso , Idoso de 80 Anos ou mais , Anastomose Cirúrgica , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Aortografia/métodos , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/mortalidade , Angiografia por Tomografia Computadorizada , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Estudos Retrospectivos , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento
7.
Ann Vasc Surg ; 47: 260-265, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28943486

RESUMO

BACKGROUND: We sought to evaluate the midterm results of parallel-graft-endovascular aneurysm repair (pg-EVAR) for complex aortic anatomy in high-risk candidates for open surgical repair of abdominal aortic aneurism (AAA). METHODS: Clinical and radiographic information on 35 patients treated by pg-EVAR between March 2010 and December 2015 was retrospectively reviewed and analyzed. All patients presented with symptomatic aneurysms and were treated within 3 days of clinical presentation. Primary end points included primary chimney graft patency, overall survival, and freedom from all reintervention. RESULTS: Overall, 55 chimney grafts were placed into 47 renal arteries and 8 superior mesenteric arteries in 35 patients. An endurant stent graft was used as the main body component in all cases. At 36 months, primary chimney graft patency was 88%, overall survival of patients was 71%, and the rate of freedom from all reintervention was 78%. CONCLUSIONS: Considering our midterm results, pg-EVAR seems to be a safe and effective treatment for patients with complex anatomies and at poor risk for open repair.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/fisiopatologia , Aortografia/métodos , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Angiografia por Tomografia Computadorizada , Intervalo Livre de Doença , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Itália , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/terapia , Desenho de Prótese , Retratamento , Estudos Retrospectivos , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
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