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1.
Thromb Res ; 235: 79-87, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38308882

RESUMEN

INTRODUCTION: Cancer-related pulmonary embolism (PE) is associated with poor prognosis. Some decision rules identifying patients eligible for home treatment categorize cancer patients at high risk of complications, precluding home treatment. We sought to assess the effectiveness and the safety of outpatient management of patients with low-risk cancer-associated PE. METHODS: In the HOME-PE trial, hemodynamically stable patients with symptomatic PE were randomized to either triaging with Hestia criteria or sPESI score. We analyzed 3 groups of low-risk PE patients: 47 with active cancer treated at home (group 1), 691 without active cancer treated at home (group 2), and 33 with active cancer as the only sPESI criterion qualifying them for hospitalization (group 3). The main outcome was the composite of recurrent venous thromboembolism, major bleeding, and all-cause death within 30 days after randomization. RESULTS: Patients treated at home had composite outcome rates of 4.3 % (2/47) for those with cancer vs. 1.0 % (7/691) for those without (odds ratio (OR) 4.98, 95%CI 1.15-21.49). Patients with cancer had rates of complications of 4.3 % when treated at home vs. 3.0 % (1/33) when hospitalized (OR 1.19, 95%CI 0.15-9.47). In multivariable analysis, active cancer was associated with an increased risk of complications for patients treated at home (OR 7.95; 95%CI 1.48-42.82). For patients with active cancer, home treatment was not associated with the primary outcome (OR 1.19, 95%CI 0.15-9.74). CONCLUSIONS: Among patients treated at home, active cancer was a risk factor for complications, but among patients with active cancer, home treatment was not associated with adverse outcomes.


Asunto(s)
Neoplasias , Embolia Pulmonar , Humanos , Pacientes Ambulatorios , Embolia Pulmonar/complicaciones , Embolia Pulmonar/terapia , Atención Ambulatoria , Factores de Riesgo , Neoplasias/complicaciones , Neoplasias/terapia
2.
Biomedicines ; 11(12)2023 Nov 29.
Artículo en Inglés | MEDLINE | ID: mdl-38137399

RESUMEN

N-butyl cyanoacrylate (NBCA) is a lipophilic, permanent embolic glue that must be opacified for fluoroscopic guidance. Empirically, lipophilic Lipiodol Ultra Fluid® (LUF) has been added to produce a single-phase physically stable mixture. Varying the dilution ratio allows control of glue polymerization kinetics. LUF is far more costly than water-soluble iodinated contrast agents (ICAs). Our purpose was to evaluate whether a water-soluble nonionic iso-osmolar ICA could be used instead. We embolized both renal arteries of six swine using 1:3 NBCA-LUF or NBCA-iodixanol in 1:1, 1:3, and 1:7 ratios. We used both micro-computed tomography to assess the distality of glue penetration and indexed cast ratio and histology to assess distality, arterial obliteration, vessel-wall damage, and renal-parenchyma necrosis. Glue-LUF produced significantly greater indexed cast ratio and renal-artery ROI values and a significantly shorter cast-to-capsule distance. The injected volume was significantly greater with 1:7 iodixanol than with the other mixtures. No significant differences were found for histological evidence of artery obliteration, vessel-wall damage, or renal-parenchyma necrosis. This is the first study dealing with ICA alone as a contrast agent for cyanoacrylate embolization, compared to LUF. More research is needed to determine whether water-soluble nonionic iodinated agents can be used for human NBCA embolization given the good safety profile, availability, and low cost of ICA.

3.
Biomedicines ; 11(8)2023 Aug 02.
Artículo en Inglés | MEDLINE | ID: mdl-37626671

RESUMEN

The Micro Vascular Plug® (MVP, Medtronic) is a mechanical embolic agent available in small sizes that allows for distal embolisation. The objective of this retrospective observational single-centre study was to assess MVP embolisation procedures performed at a university hospital. The 33 patients who underwent MVP embolisation in 2021 were included (mean age, 64; 24 males and 9 females). The primary endpoint was technical success, which was defined as a full first-attempt occlusion with one or more MVPs, as documented on the end-of-procedure angiogram. In all patients, 51 MVPs were used overall, with other embolic agents in 23 of the 33 cases (usually coils and/or glue); 22 of the 33 procedures were emergent for bleeding and 11 were planned for other indications. Of the three technical failures, two were due to an angled target artery configuration precluding microcatheterisation and one to failure of the device to release from its wire. The technical success rate was thus 90.9%. No patient experienced MVP migration or other major complications. Five patients had recurrent clinical symptoms; in four cases, the cause was collateral development, and in one case, the cause was incomplete initial embolisation. No instances of recanalisation were documented during the short follow-up of 12 months, for a 100% secondary clinical success rate. At our tertiary-level centre, the MVP was both effective and safe for peripheral applications. Interventional radiologists should be conversant with the techniques and indications of MVP embolisation.

4.
Cancers (Basel) ; 15(15)2023 Jul 31.
Artículo en Inglés | MEDLINE | ID: mdl-37568708

RESUMEN

Cancer-associated thrombosis (CAT) is a common complication during cancer, with complex management due to an increased risk of both recurrence and bleeding. Bevacizumab is an effective anti-angiogenic treatment but increases the risk of bleeding and potentially the risk of venous thromboembolism (VTE). The aim of this study was to evaluate the efficacy and safety of anticoagulant therapy in patients with CAT receiving bevacizumab, according to the continuation or discontinuation of bevacizumab. In a retrospective multicenter study, patients receiving anticoagulant for CAT occurring under bevacizumab therapy were included. The primary endpoint combined recurrent VTE and/or major or clinically relevant non-major bleeding. Among the 162 patients included, bevacizumab was discontinued in 70 (43.2%) patients and continued in 92 (56.8%) patients. After a median follow-up of 318 days, 21 (30.0%) patients in the discontinuation group experienced VTE recurrence or major or clinically relevant non-major bleeding, compared to 27 (29.3%) in the continuation group. The analysis of survival following the first event showed no significant difference between the groups in uni- or multivariate analysis (p = 0.19). The primary endpoint was not influenced by the duration of bevacizumab exposure. These results suggest that the efficacy and safety of anticoagulant therapy in patients with CAT receiving bevacizumab is not modified regardless of whether bevacizumab is continued or discontinued.

5.
Biomedicines ; 11(7)2023 Jul 07.
Artículo en Inglés | MEDLINE | ID: mdl-37509574

RESUMEN

The primary objective was to evaluate the clinical success rate after endovascular embolization of iatrogenic vascular lesions caused during partial nephrectomy. The secondary objective was to evaluate the technical success and to assess potential effects on renal function. We retrospectively included consecutive patients from our center who underwent selective embolization to treat iatrogenic renal arterial lesions induced during partial nephrectomy between June 2010 and June 2020. The technical and clinical success rates and renal outcomes were collected. We identified 25 patients with 47 pseudoaneurysms and nine arteriovenous fistulas. Among them, eight were treated by coils only, eight by liquid embolization agents only, and nine by both. The technical success rate was 96% after the first attempt and 100% after the second attempt. The median follow-up was 27.1 ± 24.3 months. Clinical success, defined as no need for further hemostatic surgery during follow-up, was also obtained in 96% and 100% of patients with one and two attempts, respectively. Renal function estimated by the modification of diet in renal disease equation did not change significantly despite a mean 13.8% ± 15.1% decrease in kidney functional volume estimated by angiography. No complications were attributable to the endovascular treatment. No significant difference was found across embolization agents; however, the subgroup sizes were small. Endovascular embolization is safe and effective for treating iatrogenic arterial lesions after partial nephrectomy: success rates are high, complications are infrequent, and renal function is maintained. Recommendations by interventional radiology societies are needed to standardize this treatment.

6.
Diagnostics (Basel) ; 13(14)2023 Jul 08.
Artículo en Inglés | MEDLINE | ID: mdl-37510057

RESUMEN

Endovenous thermal methods are superseding surgical stripping for treating chronic superficial venous disease but require tumescent anesthesia and can cause heat-related nerve injuries. Endovenous cyanoacrylate ablation is a more recent technique that does not share these drawbacks. A retrospective observational study of consecutive adults managed with endovenous cyanoacrylate was conducted in 2018-2021 at a single university center. The follow-up was 18 months. We identified factors associated with target vein closure at 18 months and measured changes in quality of life using the generic 36-item Short-Form (SF-36) tool and the venous disease-specific VEINES-QOL/Sym questionnaire. Adverse events were collected. In the 55 study patients with 67 treated veins, the closure rate at 18 months was 94% (95% CI, 85-98%). Target vein diameter ≥9.5 mm had 81% sensitivity and 75% specificity for predicting recanalization. Quality-of-life scores improved significantly (p < 0.001 for both surveys). The only adverse event was a type IV allergic reaction to cyanoacrylate that was resolved with corticosteroid and histamine-antagonist therapy. Endovenous cyanoacrylate ablation was highly effective and is safe in experienced hands. Studies are warranted to determine whether changes in the protocol increase the closure rate in patients with target veins ≥9.5 mm in diameter.

7.
Diagnostics (Basel) ; 13(14)2023 Jul 13.
Artículo en Inglés | MEDLINE | ID: mdl-37510101

RESUMEN

Excellent outcomes of angioplasty/stenting for the post-thrombotic syndrome (PTS) have been reported, notably regarding objective criteria in the vast French SFICV cohort. Differences may exist between patient-reported and objective outcomes. We investigated this possibility by using validated scales because significative correlations are discordant in the literature between patency and patient-reported characteristics. Patient-reported outcomes seem to be a more consistent tool than radiologic patency for the diagnosis and follow-up of patients displaying PTS. We retrospectively reviewed the Villalta scale and 20-item ChronIc Venous dIsease quality-of-life Questionnaire (CIVIQ-20) scores recorded after endovascular stenting for PTS at 14 centres in France in 2009-2019. We also collected patency rates, pre-operative post-thrombotic lesion severity, and the extent of stenting. We performed multivariate analyses to identify factors independently associated with improvements in each of the two scores. The 539 patients, including 324 women and 235 men, had a mean age of 44.7 years. The mean Villalta scale improvement was 7.0 ± 4.7 (p < 0.0001) and correlated with the thrombosis sequelae grade and time from thrombosis to stenting. The CIVIQ-20 score was available for 298 patients; the mean improvement was 19.2 ± 14.8 (p < 0.0001) and correlated with bilateral stenting, single thrombosis recurrence, and single stented segment. The objective gains demonstrated in earlier work after stenting were accompanied by patient-reported improvements. The factors associated with these improvements differed between the Villalta scale and the CIVIQ-20 score. These results proved that clinical follow-up with validated scores is gainful in patients treated for PTS thanks to a mini-invasive procedure.

8.
J Clin Med ; 12(14)2023 Jul 14.
Artículo en Inglés | MEDLINE | ID: mdl-37510806

RESUMEN

Transarterial embolization (TAE) for high-flow pancreaticoduodenal artery (PDA) aneurysms in patients with celiac-trunk stenosis by the median arcuate ligament (MAL) has been found effective both after rupturing and to prevent rupture. The objective was to describe the TAE techniques used and their effectiveness in excluding PDA aneurysms due to MAL syndrome. This single-center retrospective study done at the Dijon-Bourgogne University Hospital included all patients treated by TAE in 2010-2022 for ruptured or unruptured high-flow PDA aneurysms caused by MAL syndrome. We identified 14 patients (7 women and 7 men; mean age, 64 years). Packing and trapping techniques were used alone or together. Occlusion was with microcoils, co-polymer, or cyanoacrylate glue, used separately or combined. Technical success was achieved in 13 (93%) patients. Clinical success was achieved in 12 (86%) patients. One major and two minor complications were recorded within the first 30 days. No complications occurred after 30 days. Follow-up ranged from 1 to 84 months. No cases of aneurysm recanalization have been recorded to date. TAE had high technical and clinical success rates in our patients with unruptured or ruptured PDA aneurysms due to MAL syndrome.

9.
Thromb Res ; 227: 25-33, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37209588

RESUMEN

INTRODUCTION: We prospectively investigated whether home treatment of pulmonary embolism (PE), is as effective and safe as the recommended early discharge management in terms of outcomes at 3 months. METHODS: We performed a post hoc analysis of prospectively and consecutively recorded data in acute PE patients from a tertiary care facility between January 2012 and November 2021. Home treatment was defined as discharge to home directly from the emergency department (ED) after <24 h stay. Early discharge was defined as in-hospital stay of ≥24 h and ≤48 h. Primary efficacy and safety outcomes were a composite of PE-related death or recurrent venous thrombo-embolism, and major bleeding, respectively. Outcomes between groups were compared using penalized multivariable models. RESULTS: In total, 181 patients (30.6 %) were included in the home treatment group and 463 (69.4 %) patients in the early discharge group. Median duration of ED stay was 8.1 h (IQR, 3.6-10.2 h) in the home treatment group, and median length of hospital stay was 36.4 h (IQR, 28.7-40.2) in the early discharge group. The adjusted rate of the primary efficacy outcome was 1.90 % (95 % CI, 0.16-15.2) vs 2.05 % (95 % CI, 0.24-10.1) for home treatment vs early discharge (hazard ratio (HR) 0.86 (95 % CI, 0.27-2.74). The adjusted rates of the primary safety outcome did not differ between groups at 3 months. CONCLUSIONS: In a non-randomized cohort of selected acute PE patients, home treatment provided comparable rates of adverse VTE and bleeding events to the recommended early discharge management, and appears to have similar clinical outcomes at 3 months.


Asunto(s)
Alta del Paciente , Embolia Pulmonar , Humanos , Pacientes Ambulatorios , Embolia Pulmonar/tratamiento farmacológico , Estudios de Cohortes , Tiempo de Internación , Hemorragia
10.
Rheumatology (Oxford) ; 62(4): 1568-1575, 2023 04 03.
Artículo en Inglés | MEDLINE | ID: mdl-35866984

RESUMEN

OBJECTIVES: To investigate the performance of cranial PET/CT for the diagnosis of GCA. METHODS: All patients with a suspected diagnosis of GCA were prospectively enrolled in this study and had a digital PET/CT with evaluation of cranial arteries if they had not started glucocorticoids >72 h previously. The diagnosis of GCA was retained after at least 6 months of follow-up if no other diagnosis was considered by the clinician and the patient went into remission after at least 6 consecutive months of treatment. Cranial PET/CT was considered positive if at least one arterial segment showed hypermetabolism similar to or greater than liver uptake. RESULTS: For cranial PET/CT, sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) were 73.3%, 97.2%, 91.7% and 89.7%, respectively. For extracranial PET/CT, diagnostic performance was lower (Se = 66.7%, Sp = 80.6%, PPV = 58.8%, NPV = 85.3%). The combination of cranial and extracranial PET/CT improved overall sensitivity (Se = 80%) and NPV (NPV = 90.3%) while decreasing overall specificity (Sp = 77.8%) and PPV (PPV = 60%). CONCLUSION: Cranial PET/CT can be easily combined with extracranial PET/CT with a limited increase in examination time. Combined cranial and extracranial PET/CT showed very high diagnostic accuracy for the diagnosis of GCA. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT05246540.


Asunto(s)
Arteritis de Células Gigantes , Humanos , Arterias , Fluorodesoxiglucosa F18 , Arteritis de Células Gigantes/diagnóstico por imagen , Tomografía Computarizada por Tomografía de Emisión de Positrones , Valor Predictivo de las Pruebas , Arterias Temporales
11.
Biomedicines ; 10(10)2022 Oct 19.
Artículo en Inglés | MEDLINE | ID: mdl-36289887

RESUMEN

Although introduced decades ago, few cyanoacrylate glues have been approved for endovascular use, despite evidence of their usefulness, notably for complex procedures suchas hemostatic embolization. Indications include massive bleeding requiring emergent hemostasis and prevention of severe bleeding during scheduled surgery to remove a hypervascular tumor. Adding radiopaque Lipiodol Ultra Fluid® (LUF) modulates glue polymerization and allows fluoroscopic guidance, but few comparative in vivo studies have assessed the impact of the resulting change in glue concentration or of other factors such as target-vessel blood flow. In a rabbit model, we used ex vivo X-ray microtomography to assess the results of in vivo renal-artery embolization by various mixtures of N-butyl cyanoacrylate (NBCA), metacryloxysulfolane, and LUF. Overall, penetration to the superficial interlobular arteries was achieved in about two-thirds of cases and into the capillaries in nearly half the cases, while cast fragmentation was seen in slightly more than half the cases. Greater NBCA dilution and the blocked-blood-flow technique were independently associated with greater distality of penetration. Blocked-blood-flow injection was independently associated with absence of fragmentation, capillary penetration, a shorter cast-to-capsule distance, and higher cast attenuation. A larger mixture volume was independently associated with higher indexed cast ratio and deeper penetration. Finally, microtomography is an adapted tool to assess ex vivo distribution of glue cast.

12.
Res Pract Thromb Haemost ; 6(5): e12748, 2022 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35992565

RESUMEN

Background: Postthrombotic syndrome (PTS) is a long-term complication after deep vein thrombosis (DVT) and can affect quality of life (QoL). Pathogenesis is not fully understood but inadequate anticoagulant therapy with vitamin K antagonists is a known risk factor for the development of PTS. Objectives: To compare the prevalence of PTS after acute DVT and the long-term QoL following DVT between patients treated with edoxaban or warfarin. Methods: We performed a long-term follow-up study in a subset of patients with DVT who participated in the Hokusai-VTE trial between 2010 and 2012 (NCT00986154). Primary outcome was the prevalence of PTS, defined by the Villalta score. The secondary outcome was QoL, assessed by validated disease-specific (VEINES-QOL) and generic health-related (SF-36) questionnaires. Results: Between 2017 and 2020, 316 patients were enrolled in 26 centers in eight countries, of which 168 (53%) patients had been assigned to edoxaban and 148 (47%) to warfarin during the Hokusai-VTE trial. Clinical, demographic, and thrombus-specific characteristics were comparable for both groups. Mean (SD) time since randomization in the Hokusai-VTE trial was 7.0 (1.0) years. PTS was diagnosed in 85 (51%) patients treated with edoxaban and 62 (42%) patients treated with warfarin (adjusted odds ratio 1.6, 95% CI 1.0-2.6). Mean differences in QoL scores between treatment groups were not clinically relevant. Conclusion: Contrary to our hypothesis, the prevalence of PTS tended to be higher in patients treated with edoxaban compared with warfarin. No differences in QoL were observed. Further research is warranted to unravel the role of anticoagulant therapy on development of PTS.

13.
J Am Heart Assoc ; 11(13): e024425, 2022 07 05.
Artículo en Inglés | MEDLINE | ID: mdl-35730608

RESUMEN

Background Pulmonary embolism (PE) has a long-term risk of adverse events, which can be prevented by extended anticoagulation. We compared clinical characteristics and outcomes between patients treated with 2-year extended anticoagulation and those who were not, in a population who had completed an initial phase of 3 to 6 months of anticoagulant therapy after acute PE. Methods and Results Observational cohort analysis of patients with PE who survived an initial phase of 3 to 6 months anticoagulation. Primary efficacy outcome was all-cause death or recurrent venous thromboembolism. Primary safety outcome was major bleeding. In total, 858 (71.5%) patients were treated with and 341 (28.5%) were treated without extended anticoagulant therapy during the active study period. Age <65 years, intermediate-high or high-risk index PE, normal platelet count, and the absence of concomitant antiplatelet treatment were independently associated with the prescription of extended anticoagulation. The mean duration of the active phase was 2.1±0.3 years. The adjusted rate of the primary efficacy outcome was 2.1% in the extended group and 7.7% in the nonextended group (P<0.001) for patients treated with extended anticoagulant therapy. Rate of bleeding were similar between the extended anticoagulant group and the nonextended group. Conclusions Extended oral anticoagulation over 2 and a half years after index PE seems to provide a net clinical benefit compared with no anticoagulation in patients with PE selected to receive extended anticoagulation. Randomized clinical trials are warranted to explore the potential benefit of extended anticoagulation in patients with PE, especially those with transient provoking factors but residual risk.


Asunto(s)
Embolia Pulmonar , Tromboembolia Venosa , Anciano , Anticoagulantes/efectos adversos , Estudios de Cohortes , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Embolia Pulmonar/epidemiología , Recurrencia , Tromboembolia Venosa/inducido químicamente , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/epidemiología
14.
Thromb Haemost ; 122(1): 151-157, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-33878800

RESUMEN

INTRODUCTION: Recurrent venous thromboembolism (VTE) despite curative anticoagulation is frequent in patients with cancer. Identifying patients with a high risk of recurrence could have therapeutic implications. A prospective study was designed to validate the Ottawa risk score of recurrent VTE in cancer patients. METHODS: In a prospective multicenter observational cohort, adult cancer patients with a recent diagnosis of symptomatic or incidental lower limb deep vein thrombosis or pulmonary embolism (PE) were treated with tinzaparin for 6 months. The primary endpoint was the recurrence of symptomatic or asymptomatic VTE within the first 6 months of treatment. All clinical events were centrally reviewed and adjudicated. Time-to-event outcomes were estimated by the Kalbfleisch and Prentice method to take into account the competing risk of death. A C-statistic value of > 0.70 was needed to validate the Ottawa score. RESULTS: A total of 409 patients were included and analyzed on an intention-to-treat basis. Median age was 68 years, 60.4% of patients had PE, and VTE was symptomatic in 271 patients (66.3%). The main primary sites were lung (31.3%), lower digestive tract (14.4%), and breast (13.9%) cancers. The Ottawa score was high (≥ 1) in 58% of patients. The 6-month cumulative incidence of recurrent VTE was 7.3% (95% confidence interval [CI]: 4.9-11.1) overall, and 5.0% (95% CI: 2.3-10.8) versus 9.1% (95%CI: 6.1-13.6) in the Ottawa low versus high risk groups, respectively. The C-statistic value was 0.60 (95% CI: 0.55-0.65). CONCLUSION: In this prospective cohort of patients with cancer receiving tinzaparin for VTE, the Ottawa score failed to accurately predict recurrent VTE.


Asunto(s)
Neoplasias/complicaciones , Medición de Riesgo/normas , Tromboembolia Venosa/diagnóstico , Adulto , Anciano , Anticoagulantes/farmacología , Anticoagulantes/uso terapéutico , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/epidemiología , Estudios Prospectivos , Medición de Riesgo/métodos , Medición de Riesgo/estadística & datos numéricos , Tinzaparina/farmacología , Tinzaparina/uso terapéutico , Tromboembolia Venosa/epidemiología
15.
Chest ; 161(3): 781-790, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-34627853

RESUMEN

BACKGROUND: Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated VTE. RESEARCH QUESTION: Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE? STUDY DESIGN AND METHODS: In a randomized open-label noninferiority trial, patients with active cancer who had proximal DVT, pulmonary embolism (PE), or both were assigned randomly to therapeutic doses of rivaroxaban or dalteparin for 3 months. The primary outcome was the cumulative incidence of recurrent VTE, a composite of symptomatic or incidental DVT or PE, and worsening of pulmonary vascular or venous obstruction at 3 months. RESULTS: Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, and 115 patients (76.2%) had metastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (both the intention-to-treat and per-protocol populations: cumulative incidence, 6.4% vs 10.1%; subdistribution hazard ratio [SHR], 0.75; 95% CI, 0.21-2.66). Major bleeding occurred in 1 and 3 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 1.4% vs 3.7%; SHR, 0.36; 95% CI, 0.04-3.43). Major or clinically relevant nonmajor bleeding occurred in 9 and 8 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 12.2% vs 9.8%; SHR, 1.27; 95% CI, 0.49-3.26). Overall, 19 patients (25.7%) and 20 patients (23.8%) died in the rivaroxaban and dalteparin groups, respectively (hazard ratio, 1.05; 95% CI, 0.56-1.97). INTERPRETATION: In this trial comparing rivaroxaban and dalteparin in the treatment of cancer-associated VTE, the number of patients was insufficient to reach the predefined criteria for noninferiority, but efficacy and safety results were consistent with those previously reported with DOACs. An updated meta-analysis of randomized trials comparing DOACs with low-molecular-weight heparin in patients with cancer-associated VTE is provided. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02746185; URL: www. CLINICALTRIALS: gov.


Asunto(s)
Dalteparina , Neoplasias , Rivaroxabán , Tromboembolia Venosa , Anciano , Anticoagulantes/efectos adversos , Dalteparina/efectos adversos , Hemorragia/inducido químicamente , Heparina de Bajo-Peso-Molecular/uso terapéutico , Humanos , Neoplasias/complicaciones , Embolia Pulmonar/tratamiento farmacológico , Embolia Pulmonar/etiología , Rivaroxabán/efectos adversos , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/etiología
16.
J Clin Med ; 10(21)2021 Oct 27.
Artículo en Inglés | MEDLINE | ID: mdl-34768506

RESUMEN

The study's purpose was to assess the safety, feasibility and efficiency of selective arterial embolization (SAE) using N-butyl cyanoacrylate (NBCA) glue before percutaneous cryoablation (PCA) of renal malignancies in patients whose tumor characteristics and/or comorbidities resulted in an unacceptable risk of bleeding. In this single-center retrospective study of 19 consecutive high-risk patients (median age, 74 years) with renal malignancies managed in 2017-2020 by SAE with NBCA followed by PCA, data about patients, tumor and procedures characteristics, complications, renal function and hemoglobin concentration before and after treatment, as well as recurrence were collected. Charlson comorbidity index was ≥4 in 89.5% of patients. Ten patients were treated by antiplatelet and/or anticoagulant therapy. Median tumor largest diameter was 3.75 cm (range, 1-6.5 cm) and R.E.N.A.L. nephrometry score was ≥7 in 80%, indicating substantial tumor complexity. No major complications were recorded and minor complications occurred in 7 patients. No residual tumor was found at 6-week imaging follow-up in 18/19 patients. Tumor recurrence was visible in 1/16 patients at 6-month imaging follow-up. No significant difference was found for renal function after treatment (p = 0.07), whereas significant decrease in hemoglobin concentration was noted (p = 0.00004), although it was relevant for only one patient who required only blood transfusion and no further intervention. SAE prior to PCA is safe and effective for managing renal malignancies in high-risk patients.

17.
Biomedicines ; 9(10)2021 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-34680539

RESUMEN

Surgical treatment or varicocele embolization (VE) with sclerosing or mechanical embolic agents have been shown to improve the semen parameters of infertile men. The aim of this study was to evaluate the impact of VE using N-butyl cyanoacrylate (NBCA) glue on semen parameters in infertile men. From January 2014 to June 2018, infertile adult patients with stage 3 varicocele and an initial semen analysis showing at least one abnormal semen parameter, and who were successfully embolized with NBCA Glubran®2 glue, were retrospectively recruited. The availability of a second semen analysis after VE was mandatory for patient inclusion. The primary endpoint was the change in total sperm number (TSN) after VE. The other parameters of interest were progressive and total sperm motilities (Smot) at 1 h (H1), sperm vitality (SV) and morphology (SMor). One hundred and two patients were included. Eight patients presented null TSN before and after VE. Among the remaining 94 patients, a significant improvement in the median TSN after VE was shown (31.79 × 106/ejaculate [IQR: 11.10-127.40 × 106/ejaculate] versus 62.24 × 106/ejaculate [IQR: 17.90-201.60 × 106/ejaculate], p = 0.0295). Significant improvement in TSN was found for the 60 oligo- or azoospermic patients (p = 0.0007), whereas no significant change was found for the 42 patients with normal initial TSN (p = 0.49). Other parameters, such as progressive and total SMot, SV and SMor, also significantly improved after VE (p = 0.0003, 0.0013, 0.0356 and 0.007, respectively). The use of NBCA glue as an embolic agent for VE in infertile men with stage 3 varicocele significantly improves the semen parameters.

18.
J Clin Med ; 10(19)2021 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-34640339

RESUMEN

Endovascular embolization agents are particles and fluids that can be released into the bloodstream through a catheter to mechanically and/or biologically occlude a target vessel, either temporarily or permanently. Vascular embolization agents are available as solids, liquids, and suspensions. Although liquid adhesives (glues) have been used as embolic agents for decades, experience with them for peripheral applications is generally limited. Cyanoacrylates are the main liquid adhesives used for endovascular interventions and have a major role in managing vascular abnormalities, bleeding, and many vascular diseases. They can only be injected as a mixture with ethiodized oil, which provides radiopacity and modulates the polymerization rate. This review describes the characteristics, properties, mechanisms of action, modalities of use, and indications of the cyanoacrylate-Lipiodol® combination for peripheral embolization.

19.
J Clin Med ; 10(18)2021 Sep 08.
Artículo en Inglés | MEDLINE | ID: mdl-34575172

RESUMEN

Selective arterial embolization (SAE) for renal angiomyolipoma (rAML) is effective to treat or prevent bleeding. We report our experience using a cyanoacrylate-Lipiodol mixture. We performed a single-center retrospective review of all rAMLs embolized with cyanoacrylate glue between July 2014 and June 2020. Demographics, tuberous sclerosis complex (TSC) status, clinical presentation, angiography features, and follow-up data were recorded. Pre- and post-procedure rAML sizes and volumes were estimated from computed tomography (CT) or magnetic resonance imaging (MRI) studies. Kidney function was assessed before and after the procedure. We identified 24 patients (22 females and 2 males, mean age 51 years) treated for 27 AMLs, either prophylactically (n = 20) or as an emergency (n = 4). Technical success was achieved for 25/27 AMLs; two patients, each with a single AML, required nephrectomy and repeated embolization, respectively. Major complications occurred in three patients and minor complications such as postembolization syndrome in 15 patients. AML volume reduction after embolization was 55.1% after a mean follow-up of 15 months (range, 1-72 months). Factors associated with greater volume reduction were a smaller percentage of fat (p = 0.001), larger initial rAML volume (p = 0.014), and longer follow-up (p = 0.0001). The mean creatinine level did not change after SAE. Embolization of rAMLs with a mixture of cyanoacrylate and Lipiodol is feasible, safe, and effective in significantly decreasing tumor volume.

20.
Eur Heart J ; 42(33): 3146-3157, 2021 08 31.
Artículo en Inglés | MEDLINE | ID: mdl-34363386

RESUMEN

AIMS: The aim of this study is to compare the Hestia rule vs. the simplified Pulmonary Embolism Severity Index (sPESI) for triaging patients with acute pulmonary embolism (PE) for home treatment. METHODS AND RESULTS: Normotensive patients with PE of 26 hospitals from France, Belgium, the Netherlands, and Switzerland were randomized to either triaging with Hestia or sPESI. They were designated for home treatment if the triaging tool was negative and if the physician-in-charge, taking into account the patient's opinion, did not consider that hospitalization was required. The main outcomes were the 30-day composite of recurrent venous thrombo-embolism, major bleeding or all-cause death (non-inferiority analysis with 2.5% absolute risk difference as margin), and the rate of patients discharged home within 24 h after randomization (NCT02811237). From January 2017 through July 2019, 1975 patients were included. In the per-protocol population, the primary outcome occurred in 3.82% (34/891) in the Hestia arm and 3.57% (32/896) in the sPESI arm (P = 0.004 for non-inferiority). In the intention-to-treat population, 38.4% of the Hestia patients (378/984) were treated at home vs. 36.6% (361/986) of the sPESI patients (P = 0.41 for superiority), with a 30-day composite outcome rate of 1.33% (5/375) and 1.11% (4/359), respectively. No recurrent or fatal PE occurred in either home treatment arm. CONCLUSIONS: For triaging PE patients, the strategy based on the Hestia rule and the strategy based on sPESI had similar safety and effectiveness. With either tool complemented by the overruling of the physician-in-charge, more than a third of patients were treated at home with a low incidence of complications.


Asunto(s)
Embolia Pulmonar , Enfermedad Aguda , Humanos , Alta del Paciente , Pronóstico , Embolia Pulmonar/tratamiento farmacológico , Medición de Riesgo , Índice de Severidad de la Enfermedad
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