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1.
J Vasc Surg Venous Lymphat Disord ; 12(5): 101866, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38447877

RESUMO

OBJECTIVE: Interventional treatments for acute iliofemoral deep vein thrombosis (DVT) remain controversial after publication of the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) study. Interventions have been shown to reduce post-thrombotic syndrome severity and improve quality of life in DVT patients, but have been accompanied by risk of major bleeding from thrombolytics. We describe thrombus removal using a novel combined basket-rotational thrombectomy device that minimizes the need for thrombolytics or repeat procedures. METHODS: The aim of this prospective, nonrandomized, multicenter, first-in-human study of 19 patients with acute iliofemoral DVT was to evaluate the safety and performance of the Pounce venous thrombectomy system ≤12 months after treatment. The primary performance end point was defined as procedural success through achievement of Society of Interventional Radiology (SIR) grade II lysis in treated vessels with freedom from procedural adverse events. Secondary end points included venous disease severity assessments using the Villalta scale and the Venous Clinical Severity Score, patient quality-of-life measurement using the Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire, and calf circumference measurements taken at baseline, 24 hours, and 1 month. RESULTS: The primary end point of complete or near-complete thrombus removal (Society of Interventional Radiology grade II or III) was achieved in all patients. All study device-related safety end points were met, with no major bleeding or device-related adverse events. Of the 19 patients treated, 16 (84.2%) did not receive thrombolytics during the procedure. Post-thrombotic syndrome (Villalta scale >4) was identified in 17 of 19 patients (89.5%) at baseline, 4 of 13 patients (30.8%) available for follow-up at 6 months, and 2 of 11 patients (18.2%) at 12 months. The median Venous Clinical Severity Score decreased (P < .001) from 8.5 (interquartile range [IQR], 7-10) at baseline to 4 (IQR, 2-4) at 1 month after the procedure and was similar at 6 months (2; IQR, 2-5) and 12 months (2; IQR, 1.5-3) after the procedure. The median Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire score improved (P < .001) by 39 from baseline (57; IQR, 53.5-74) to 1 month (96; IQR, 86-101) after the procedure, and remained high at 6 months (99; IQR, 75-103) and 12 months (98; IQR, 94.5-100). The median calf circumference decreased (P = .089) from 39 cm (IQR, 35-47.8 cm) at baseline to 36 cm (IQR, 32.5-40.5 cm) at 24 hours after the procedure and was 34.5 cm (IQR, 33.2-38.5 cm) at 1 month. CONCLUSIONS: The Pounce device is safe and effective for removal the of thrombus in patients with acute iliofemoral DVT. Initial results demonstrate improvements in venous disease severity and patient quality of life.


Assuntos
Veia Femoral , Veia Ilíaca , Qualidade de Vida , Trombectomia , Trombose Venosa , Humanos , Feminino , Trombose Venosa/terapia , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/fisiopatologia , Masculino , Estudos Prospectivos , Pessoa de Meia-Idade , Veia Femoral/diagnóstico por imagem , Veia Femoral/cirurgia , Veia Femoral/fisiopatologia , Veia Ilíaca/diagnóstico por imagem , Veia Ilíaca/fisiopatologia , Veia Ilíaca/cirurgia , Idoso , Resultado do Tratamento , Trombectomia/instrumentação , Trombectomia/efeitos adversos , Adulto , Fatores de Tempo , Desenho de Equipamento , Índice de Gravidade de Doença , Síndrome Pós-Trombótica/terapia , Síndrome Pós-Trombótica/diagnóstico por imagem , Síndrome Pós-Trombótica/fisiopatologia
2.
Eur Heart J Cardiovasc Pharmacother ; 6(4): 222-230, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-31876907

RESUMO

AIMS: To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. METHODS AND RESULTS: This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21-3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm. CONCLUSION: In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected. CLINICAL TRIAL REGISTRATION UNIQUE IDENTIFIER: NCT01813435.


Assuntos
Doença da Artéria Coronariana/terapia , Dispneia/epidemiologia , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Ticagrelor/administração & dosagem , Idoso , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Esquema de Medicação , Terapia Antiplaquetária Dupla , Dispneia/induzido quimicamente , Dispneia/diagnóstico , Dispneia/mortalidade , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Medição de Risco , Fatores de Risco , Ticagrelor/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
3.
J Endovasc Ther ; 13(5): 693-6, 2006 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-17042655

RESUMO

PURPOSE: To report a rare case of dissecting thoracic aortic aneurysm in a young patient with Turner syndrome owing to complete or partial monosomy of the X chromosome. CASE REPORT: A 22-year-old patient with Turner syndrome presented with a 2-month history of voice loss and dysphagia. Multislice computed tomography (MSCT) disclosed a large (53x75-mm) aneurysm with focal dissection affecting the distal part of the aortic arch and the proximal descending aorta, partially involving the left subclavian artery. A TAG endoprosthesis was implanted without complications. MSCT scans at 3 and 6 months after the procedure showed good position and patency of the stent-graft, with total exclusion and shrinkage of the aneurysm. After 1 year of follow-up, she is doing well, without voice disturbances or dysphagia. CONCLUSION: Although cardiovascular malformations are common in patients with Turner syndrome, dissecting thoracic aortic aneurysm is unusual. Stent-graft repair would appear to be feasible in this situation, but long-term implantation in young patients has not been explored.


Assuntos
Aneurisma da Aorta Torácica/cirurgia , Dissecção Aórtica/cirurgia , Implante de Prótese Vascular , Síndrome de Turner/complicações , Adulto , Dissecção Aórtica/diagnóstico por imagem , Dissecção Aórtica/etiologia , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/etiologia , Feminino , Humanos , Stents , Artéria Subclávia/cirurgia , Tomografia Computadorizada por Raios X , Síndrome de Turner/diagnóstico por imagem , Grau de Desobstrução Vascular
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