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4. Quantitative 3D analysis of tissue damage in a rat model of microembolization

Author

Majoie, Charles, Marquering, Henk, van Bavel, Ed, Hoekstra, Alfons, Dippel, Diederik, Lingsma, Hester, van der Lugt, Aad, Samuels, Noor, Boodt, Nikki, Roos, Yvo, De Meyer, Simon F, Staessens, Senna, Vandelanotte, Sarah, Konduri, Praneeta, Terreros, Nerea Arrarte, Chopard, Bastien, Raynaud, Franck, Petkantchin, Remy, Panteleev, Mikhail, Shibeko, Alexey, Boudjeltia, Karim Zouaoui, Blanc-Guillemaud, Vanessa, Migliavacca, Francesco, Dubini, Gabriele, Luraghi, Giulia, Matas, Jose Felix Rodriguez, Bridio, Sara, Mc Garry, Patrick, Gilvarry, Michael, McCarthy, Ray, Moerman, Kevin, Fereidoonnezhad, Behrooz, Dwivedi, Anushree, Duffy, Sharon, Payne, Stephen, Jozsa, Tamas, Georgakopoulou, Sissy, Padmos, Raymond, Azizi, Victor, Miller, Claire, van der Kolk, Max, Georgakopoulou, Theodosia, van der Wijk, Anne-Eva, Bakker, Erik N.T.P., and vanBavel, Ed

Published
2021
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6. Correction to: VEIN STEP: A Prospective, Observational, International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease

Author

Mezalek, Zoubida Tazi, primary, Feodor, Toni, additional, Chernukha, Larisa, additional, Chen, Zhong, additional, Rueda, Ana, additional, Sánchez, Ignacio Escotto, additional, Ochoa, Alejandro José González, additional, Chirol, Joanna, additional, Blanc-Guillemaud, Vanessa, additional, Lohier-Durel, Caroline, additional, and Ulloa, Jorge Hernando, additional

Published
2023
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8. A simplified mesoscale 3D model for characterizing fibrinolysis under flow conditions

Author

Petkantchin, Rémy, Rousseau, Alexandre, Eker, Omer, Zouaoui Boudjeltia, Karim, Raynaud, Franck, Chopard, Bastien, Majoie, Charles, van Bavel, Ed, Marquering, Henk, Arrarte-Terreros, Nerea, Konduri, Praneeta, Georgakopoulou, Sissy, Roos, Yvo, Hoekstra, Alfons, Padmos, Raymond, Azizi, Victor, Miller, Claire, van der Kolk, Max, van der Lugt, Aad, Dippel, Diederik W.J., Lingsma, Hester L., Boodt, Nikki, Samuels, Noor, Payne, Stephen, Jozsa, Tamas, El-Bouri, Wahbi K., Gilvarry, Michael, McCarthy, Ray, Duffy, Sharon, Dwivedi, Anushree, Fereidoonnezhad, Behrooz, Moerman, Kevin, McGarry, Patrick, Staessens, Senna, de Meyer, Simon, Vandelanotte, Sarah, Migliavacca, Francesco, Dubini, Gabriele, Luraghi, Giulia, Rodriguez Matas, Jose Felix, Bridio, Sara, Blanc-Guillemaud, Vanessa, Panteleev, Mikhail, Shibeko, Alexey, Petkantchin, Rémy, Rousseau, Alexandre, Eker, Omer, Zouaoui Boudjeltia, Karim, Raynaud, Franck, Chopard, Bastien, Majoie, Charles, van Bavel, Ed, Marquering, Henk, Arrarte-Terreros, Nerea, Konduri, Praneeta, Georgakopoulou, Sissy, Roos, Yvo, Hoekstra, Alfons, Padmos, Raymond, Azizi, Victor, Miller, Claire, van der Kolk, Max, van der Lugt, Aad, Dippel, Diederik W.J., Lingsma, Hester L., Boodt, Nikki, Samuels, Noor, Payne, Stephen, Jozsa, Tamas, El-Bouri, Wahbi K., Gilvarry, Michael, McCarthy, Ray, Duffy, Sharon, Dwivedi, Anushree, Fereidoonnezhad, Behrooz, Moerman, Kevin, McGarry, Patrick, Staessens, Senna, de Meyer, Simon, Vandelanotte, Sarah, Migliavacca, Francesco, Dubini, Gabriele, Luraghi, Giulia, Rodriguez Matas, Jose Felix, Bridio, Sara, Blanc-Guillemaud, Vanessa, Panteleev, Mikhail, and Shibeko, Alexey

Abstract

One of the routine clinical treatments to eliminate ischemic stroke thrombi is injecting a biochemical product into the patient’s bloodstream, which breaks down the thrombi’s fibrin fibers: intravenous or intravascular thrombolysis. However, this procedure is not without risk for the patient; the worst circumstances can cause a brain hemorrhage or embolism that can be fatal. Improvement in patient management drastically reduced these risks, and patients who benefited from thrombolysis soon after the onset of the stroke have a significantly better 3-month prognosis, but treatment success is highly variable. The causes of this variability remain unclear, and it is likely that some fundamental aspects still require thorough investigations. For that reason, we conducted in vitro flow-driven fibrinolysis experiments to study pure fibrin thrombi breakdown in controlled conditions and observed that the lysis front evolved non-linearly in time. To understand these results, we developed an analytical 1D lysis model in which the thrombus is considered a porous medium. The lytic cascade is reduced to a second-order reaction involving fibrin and a surrogate pro-fibrinolytic agent. The model was able to reproduce the observed lysis evolution under the assumptions of constant fluid velocity and lysis occurring only at the front. For adding complexity, such as clot heterogeneity or complex flow conditions, we propose a 3-dimensional mesoscopic numerical model of blood flow and fibrinolysis, which validates the analytical model’s results. Such a numerical model could help us better understand the spatial evolution of the thrombi breakdown, extract the most relevant physiological parameters to lysis efficiency, and possibly explain the failure of the clinical treatment. These findings suggest that even though real-world fibrinolysis is a complex biological process, a simplified model can recover the main features of lysis evolution.

Published
2023

9. Sex Differences in the Generalizability of Randomized Clinical Trials in Heart Failure with Reduced Ejection Fraction

Author

Schroeder, Megan, primary, Lim, Yvonne Mei Fong, additional, Savarese, Gianluigi, additional, Suzart‐Woischnik, Kiliana, additional, Baudier, Claire, additional, Dyszynski, Tomasz, additional, Vaartjes, Ilonca, additional, Eijkemans, Marinus JC, additional, Uijl, Alicia, additional, Herrera, Ronald, additional, Vradi, Eleni, additional, Brugts, Jasper J., additional, Rocca, Hans‐Peter Brunner‐La, additional, Blanc‐Guillemaud, Vanessa, additional, Waechter, Sandra, additional, Couvelard, Fabrice, additional, Tyl, Benoit, additional, Fatoba, Samuel, additional, Hoes, Arno W, additional, Lund, Lars H, additional, Gerlinger, Christoph, additional, Asselbergs, Folkert W, additional, Grobbee, Diederick E, additional, Cronin, Maureen, additional, and Koudstaal, Stefan, additional

Published
2023
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11. Generalizability of randomized controlled trials in heart failure with reduced ejection fraction

Author

Cardiovasculaire Epi Team 7B, Cardiovasculaire Epi Team 5, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Biostatistiek Onderzoek, Child Health, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Onderzoek Precision medicine, Directie Raad van Bestuur, Team Medisch, Global Health, Regenerative Medicine and Stem Cells, Lim, Yvonne Mei Fong, Molnar, Megan, Vaartjes, Ilonca, Savarese, Gianluigi, Eijkemans, Marinus J C, Uijl, Alicia, Vradi, Eleni, Suzart-Woischnik, Kiliana, Brugts, Jasper J, Brunner-La Rocca, Hans-Peter, Blanc-Guillemaud, Vanessa, Couvelard, Fabrice, Baudier, Claire, Dyszynski, Tomasz, Waechter, Sandra, Lund, Lars H, Hoes, Arno W, Tyl, Benoit, Asselbergs, Folkert W, Gerlinger, Christoph, Grobbee, Diederick E, Cronin, Maureen, Koudstaal, Stefan, Cardiovasculaire Epi Team 7B, Cardiovasculaire Epi Team 5, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Biostatistiek Onderzoek, Child Health, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Onderzoek Precision medicine, Directie Raad van Bestuur, Team Medisch, Global Health, Regenerative Medicine and Stem Cells, Lim, Yvonne Mei Fong, Molnar, Megan, Vaartjes, Ilonca, Savarese, Gianluigi, Eijkemans, Marinus J C, Uijl, Alicia, Vradi, Eleni, Suzart-Woischnik, Kiliana, Brugts, Jasper J, Brunner-La Rocca, Hans-Peter, Blanc-Guillemaud, Vanessa, Couvelard, Fabrice, Baudier, Claire, Dyszynski, Tomasz, Waechter, Sandra, Lund, Lars H, Hoes, Arno W, Tyl, Benoit, Asselbergs, Folkert W, Gerlinger, Christoph, Grobbee, Diederick E, Cronin, Maureen, and Koudstaal, Stefan

Published
2022

12. Generalizability of randomized controlled trials in heart failure with reduced ejection fraction

Author

Lim, Yvonne Mei Fong, Molnar, Megan, Vaartjes, Ilonca, Savarese, Gianluigi, Eijkemans, Marinus J.C., Uijl, Alicia, Vradi, Eleni, Suzart-Woischnik, Kiliana, Brugts, Jasper J., Brunner-La Rocca, Hans Peter, Blanc-Guillemaud, Vanessa, Couvelard, Fabrice, Baudier, Claire, Dyszynski, Tomasz, Waechter, Sandra, Lund, Lars H., Hoes, Arno W., Tyl, Benoit, Asselbergs, Folkert W., Gerlinger, Christoph, Grobbee, Diederick E., Cronin, Maureen, Koudstaal, Stefan, Lim, Yvonne Mei Fong, Molnar, Megan, Vaartjes, Ilonca, Savarese, Gianluigi, Eijkemans, Marinus J.C., Uijl, Alicia, Vradi, Eleni, Suzart-Woischnik, Kiliana, Brugts, Jasper J., Brunner-La Rocca, Hans Peter, Blanc-Guillemaud, Vanessa, Couvelard, Fabrice, Baudier, Claire, Dyszynski, Tomasz, Waechter, Sandra, Lund, Lars H., Hoes, Arno W., Tyl, Benoit, Asselbergs, Folkert W., Gerlinger, Christoph, Grobbee, Diederick E., Cronin, Maureen, and Koudstaal, Stefan

Abstract

BACKGROUND: Heart failure (HF) trials have stringent inclusion and exclusion criteria, but limited data exist regarding generalizability of trials. We compared patient characteristics and outcomes between patients with HF and reduced ejection fraction (HFrEF) in trials and observational registries. METHODS AND RESULTS: Individual patient data for 16 922 patients from five randomized clinical trials and 46 914 patients from two HF registries were included. The registry patients were categorized into trial-eligible and non-eligible groups using the most commonly used inclusion and exclusion criteria. A total of 26 104 (56%) registry patients fulfilled the eligibility criteria. Unadjusted all-cause mortality rates at 1 year were lowest in the trial population (7%), followed by trial-eligible patients (12%) and trial-non-eligible registry patients (26%). After adjustment for age and sex, all-cause mortality rates were similar between trial participants and trial-eligible registry patients [standardized mortality ratio (SMR) 0.97; 95% confidence interval (CI) 0.92-1.03] but cardiovascular mortality was higher in trial participants (SMR 1.19; 1.12-1.27). After full case-mix adjustment, the SMR for cardiovascular mortality remained higher in the trials at 1.28 (1.20-1.37) compared to RCT-eligible registry patients. CONCLUSION: In contemporary HF registries, over half of HFrEF patients would have been eligible for trial enrolment. Crude clinical event rates were lower in the trials, but, after adjustment for case-mix, trial participants had similar rates of survival as registries. Despite this, they had about 30% higher cardiovascular mortality rates. Age and sex were the main drivers of differences in clinical outcomes between HF trials and observational HF registries.

Published
2022

14. Quantitative 3D analysis of tissue damage in a rat model of microembolization

Author

Georgakopoulou, Theodosia, primary, van der Wijk, Anne-Eva, additional, Bakker, Erik N.T.P., additional, vanBavel, Ed, additional, Majoie, Charles, additional, Marquering, Henk, additional, van Bavel, Ed, additional, Hoekstra, Alfons, additional, Dippel, Diederik, additional, Lingsma, Hester, additional, van der Lugt, Aad, additional, Samuels, Noor, additional, Boodt, Nikki, additional, Roos, Yvo, additional, De Meyer, Simon F, additional, Staessens, Senna, additional, Vandelanotte, Sarah, additional, Konduri, Praneeta, additional, Terreros, Nerea Arrarte, additional, Chopard, Bastien, additional, Raynaud, Franck, additional, Petkantchin, Remy, additional, Panteleev, Mikhail, additional, Shibeko, Alexey, additional, Boudjeltia, Karim Zouaoui, additional, Blanc-Guillemaud, Vanessa, additional, Migliavacca, Francesco, additional, Dubini, Gabriele, additional, Luraghi, Giulia, additional, Matas, Jose Felix Rodriguez, additional, Bridio, Sara, additional, Mc Garry, Patrick, additional, Gilvarry, Michael, additional, McCarthy, Ray, additional, Moerman, Kevin, additional, Fereidoonnezhad, Behrooz, additional, Dwivedi, Anushree, additional, Duffy, Sharon, additional, Payne, Stephen, additional, Jozsa, Tamas, additional, Georgakopoulou, Sissy, additional, Padmos, Raymond, additional, Azizi, Victor, additional, Miller, Claire, additional, and van der Kolk, Max, additional

Published
2021
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15. Generalizability of randomized controlled trials in heart failure with reduced ejection fraction

Author

Lim, Yvonne Mei Fong, primary, Molnar, Megan, additional, Vaartjes, Ilonca, additional, Savarese, Gianluigi, additional, Eijkemans, Marinus J C, additional, Uijl, Alicia, additional, Vradi, Eleni, additional, Suzart-Woischnik, Kiliana, additional, Brugts, Jasper J, additional, Brunner-La Rocca, Hans-Peter, additional, Blanc-Guillemaud, Vanessa, additional, Couvelard, Fabrice, additional, Baudier, Claire, additional, Dyszynski, Tomasz, additional, Waechter, Sandra, additional, Lund, Lars H, additional, Hoes, Arno W, additional, Tyl, Benoit, additional, Asselbergs, Folkert W, additional, Gerlinger, Christoph, additional, Grobbee, Diederick E, additional, Cronin, Maureen, additional, and Koudstaal, Stefan, additional

Published
2021
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20. Terutroban, a Thromboxane/Prostaglandin Endoperoxide Receptor Antagonist, Increases Survival in Stroke-Prone Rats by Preventing Systemic Inflammation and Endothelial Dysfunction: Comparison with Aspirin and Rosuvastatin

Author

Gelosa, Paolo, primary, Ballerio, Rossana, additional, Banfi, Cristina, additional, Nobili, Elena, additional, Gianella, Anita, additional, Pignieri, Alice, additional, Brioschi, Maura, additional, Guerrini, Uliano, additional, Castiglioni, Laura, additional, Blanc-Guillemaud, Vanessa, additional, Lerond, Laurence, additional, Tremoli, Elena, additional, and Sironi, Luigi, additional

Published
2010
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21. An international observational study assessing conservative management in hemorrhoidal disease: results of CHORALIS (aCute HemORrhoidal disease evALuation International Study).

Author

Godeberge P, Csiki Z, Zakharash M, Opot EN, Shelygin YA, Nguyen TT, Amir A, Konaté I, Momoh M, Chirol J, Blanc-Guillemaud V, and Donglin R

Subjects
Humans, Female, Male, Adult, Prospective Studies, Middle Aged, Pain Measurement methods, Treatment Outcome, Surveys and Questionnaires, Hemorrhoids therapy, Conservative Treatment methods, Quality of Life
Abstract

Aim: Real-world evidence on the management of hemorrhoidal disease (HD) is limited. This international study collected clinical practice data on the effectiveness of conservative treatments for acute HD on symptoms and quality of life (QoL), providing perspectives of treatment modalities from different continents. Patients & methods: The 4-week observational prospective CHORALIS study involved adult outpatients consulting for spontaneous complaints of hemorrhoids (graded using Goligher classification) and prescribed conservative treatments according to usual clinical practice. Assessments were: anal pain/discomfort (visual analog scale [VAS]), other signs/symptoms (patient questionnaire), Patient Global Impression of Change (PGI-C) questionnaire and disease-specific QoL (HEMO-FISS-QoL questionnaire). Results: Of 3592 participants, 3505 were analyzed (58.4% male; age 40.5 ± 13.7 years; history of HD in 48.4%; 72.1% Goligher grade I and II). Pain and discomfort were the most common symptoms. Most treatments were venoactive drugs (VADs; 90.9%), particularly micronized purified flavonoid fraction (MPFF; 73.7%) and diosmin (14.6%). All VAD-based therapies improved signs/symptoms (number/intensity/frequency of pain, discomfort, bleeding, swelling, itching and soiling) and QoL. MPFF was associated with a significantly greater proportion of patients with no symptoms (48.8 vs diosmin 34.4%, p < 0.001), pain disappearance (69.7 vs diosmin 52.8%, p < 0.001), treatment impact at 1 week rated on PGI-C as 'very much better' (30.5 vs diosmin 17.9%, p < 0.001) and shorter times to improvement (mean ± SD 3.9 ± 1.5 days vs diosmin 4.2 ± 1.7 days). Conclusion: In this prospective real-world study of patients with acute HD, conservative therapies consisting mainly of VADs, including MPFF, improved the clinical signs and symptoms of disease, as well as QoL. This study evidence supports clinical advantages associated with VADs, mostly MPFF, for effectively managing acute HD.

Published
2024
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22. Generalizability of randomized controlled trials in heart failure with reduced ejection fraction.

Author

Lim YMF, Molnar M, Vaartjes I, Savarese G, Eijkemans MJC, Uijl A, Vradi E, Suzart-Woischnik K, Brugts JJ, Brunner-La Rocca HP, Blanc-Guillemaud V, Couvelard F, Baudier C, Dyszynski T, Waechter S, Lund LH, Hoes AW, Tyl B, Asselbergs FW, Gerlinger C, Grobbee DE, Cronin M, and Koudstaal S

Subjects
Humans, Stroke Volume, Randomized Controlled Trials as Topic, Registries, Heart Failure
Abstract

Background: Heart failure (HF) trials have stringent inclusion and exclusion criteria, but limited data exist regarding generalizability of trials. We compared patient characteristics and outcomes between patients with HF and reduced ejection fraction (HFrEF) in trials and observational registries., Methods and Results: Individual patient data for 16 922 patients from five randomized clinical trials and 46 914 patients from two HF registries were included. The registry patients were categorized into trial-eligible and non-eligible groups using the most commonly used inclusion and exclusion criteria. A total of 26 104 (56%) registry patients fulfilled the eligibility criteria. Unadjusted all-cause mortality rates at 1 year were lowest in the trial population (7%), followed by trial-eligible patients (12%) and trial-non-eligible registry patients (26%). After adjustment for age and sex, all-cause mortality rates were similar between trial participants and trial-eligible registry patients [standardized mortality ratio (SMR) 0.97; 95% confidence interval (CI) 0.92-1.03] but cardiovascular mortality was higher in trial participants (SMR 1.19; 1.12-1.27). After full case-mix adjustment, the SMR for cardiovascular mortality remained higher in the trials at 1.28 (1.20-1.37) compared to RCT-eligible registry patients., Conclusion: In contemporary HF registries, over half of HFrEF patients would have been eligible for trial enrolment. Crude clinical event rates were lower in the trials, but, after adjustment for case-mix, trial participants had similar rates of survival as registries. Despite this, they had about 30% higher cardiovascular mortality rates. Age and sex were the main drivers of differences in clinical outcomes between HF trials and observational HF registries., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Published
2022
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