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1. Spinal Cord Stimulation for Intractable Visceral Pain Originating from the Pelvic and Abdominal Region: A Narrative Review on a Possible New Indication for Patients with Therapy-Resistant Pain

Author

Bieze M, van Haaps AP, Kapural L, Li S, Ferguson K, de Vries R, Schatman ME, Mijatovic V, and Kallewaard JW

Subjects
neuromodulation, scs, spinal cord stimulation, visceral pain, chronic pelvic pain, chronic pain, Medicine (General), R5-920
Abstract

Matthanja Bieze,1,2,* Annelotte Pauline van Haaps,3,4,* Leonardo Kapural,5 Sean Li,6 Kris Ferguson,7 Ralph de Vries,8 Michael E Schatman,9,10 Velja Mijatovic,3,4 Jan Willem Kallewaard1,11 1Department of Anesthesiology and Pain Management, Amsterdam UMC Location University of Amsterdam, Amsterdam, the Netherlands; 2Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada; 3Department of Reproductive Medicine, Amsterdam University Medical Center location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; 4Amsterdam Reproduction and Development, Amsterdam University Medical Centers, Amsterdam, the Netherlands; 5Carolina’s Pain Institute and Center for Clinical Research, Winston Salem, North Carolina, USA; 6National Spine and Pain Centers, Shrewsbury, New Jersey, USA; 7Aspirus Langlade Hospital Pain Clinic, Antigo, Wisconsin, USA; 8Medical Library, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; 9Department of Anesthesiology, Perioperative Care & Pain Medicine, NYU Grossman School of Medicine, New York, New York, USA; 10Department of Population Health – Division of Medical Ethics, NYU Grossman School of Medicine, New York, New York, USA; 11Department of Anesthesiology and Pain Management, Rijnstate Ziekenhuis, Arnhem, the Netherlands*These authors contributed equally to this workCorrespondence: Jan Willem Kallewaard, Department of Anaesthesiology and Pain Management, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands, Email j.w.kallewaard@amsterdamumc.nlAim: Visceral pain, characterized by pain that is diffuse and challenging to localize, occurs frequently and is difficult to treat. In cases where the pain becomes intractable despite optimal medical management, it can affect patients’ Quality of Life (QoL). Spinal Cord Stimulation (SCS) has emerged as a potential solution for intractable visceral pain.Purpose: In this narrative review, we collected all evidence regarding the efficacy of SCS for visceral pain across various underlying conditions.Methods: A comprehensive literature search was conducted in PubMed, Embase, and Web of Science in which articles published from October 1st, 1963 up to March 7th, 2023 were identified.Results: Seventy articles were included in this review of which most were retrospective cohort studies, case series and case reports. The studies, often with a small number of participants, reported on SCS for chronic pancreatitis, anorectal pain and bowel disorders, gynaecological diagnoses, visceral pelvic pain, urological disorders and finally general visceral pain. They found positive effects on pain and/or symptom relief, opioid consumption, anxiety and depression and QoL. Complications occurred frequently but were often minor and reversible.Conclusion: Better screening and selection criteria need to be established to optimally evaluate eligible patients who might benefit from SCS. A positive outcome of a sympathetic nerve block appears to be a potential indicator of SCS effectiveness. Additionally, women receiving SCS for endometriosis had a better outcome compared to other indications. Finally, SCS could also relief functional symptoms such as voiding problems and gastroparesis. Complications could often be resolved with revision surgery. Since SCS is expensive and not always covered by standard health insurance, the incorporation of cost-analyses is recommended. In order to establish a comprehensive treatment plan, including selection criteria for SCS, rigorous prospective, possibly randomized and controlled studies that are diagnosis-oriented, with substantial follow-up and adequate sample sizes, are needed.Keywords: neuromodulation, SCS, spinal cord stimulation, visceral pain, chronic pelvic pain, chronic pain

Published
2024

6. Diet associations in endometriosis: a critical narrative assessment with special reference to gluten

Author

Fred Brouns, Annelotte Van Haaps, Daniel Keszthelyi, Koen Venema, Marlies Bongers, Jacques Maas, and Velja Mijatovic

Subjects
endometriosis, diet associations, diet recommendations, omega-3, red meat, gluten-free, Nutrition. Foods and food supply, TX341-641
Abstract

Endometriosis is characterized by the presence of endometrium-like tissue outside the uterus. The etiology remains largely unknown. Despite adequate treatment, patients can still experience symptoms or side effects resulting in therapy incompliance and in self-management strategies such as dietary measures is increasing. A gluten free diet is thought to be contributory in reducing endometriosis-related pain, thereby optimizing quality of life. However, data is conflicting and currently provides no evidence for causality. This narrative review aims to put the effect of dietary self-management strategies on endometriosis in a balanced perspective, especially the effect of gluten and a gluten free diet. Several studies have found a strong overlap in symptoms, metabolic and immune responses associated with endometriosis and those associated with celiac disease, ulcerative colitis, Crohn’s disease, irritable bowel syndrome and non-celiac wheat sensitivity. However, it remains unclear whether these diseases and/or disorders are causal to an increased risk of endometriosis. Some studies have found a positive effect on the risk of endometriosis, endometriosis-related symptoms and quality of life (QoL) when women either avoided certain nutrients or foods, or applied a specific nutrient supplementation. This includes the avoidance of red meat, an increasing intake of foods rich in anti-oxidants, omega-3, micronutrients and dietary fibers (e.g., fruit, vegetables) and the appliance of a gluten free diet. However, data from the available studies were generally graded of low quality and it was noted that placebo and/or nocebo effects influenced the reported positive effects. In addition, such effects were no longer seen when adjusting for confounders such as overweight, when a translation was made from in vitro to in vivo, or when the nutrients were not supplemented as isolated sources but as part of a mixed daily diet. Finally, some studies showed that long-term adherence to a gluten free diet is often associated with an impaired diet quality and nutrient intake, leading to negative health outcomes and reduced QoL. Concluding, scientific evidence on the efficacy of dietary interventions on well-defined clinical endpoints of endometriosis is lacking and recommending a gluten free diet to women solely diagnosed with endometriosis should therefore not be advised.

Published
2023
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7. Lupus anticoagulant associates with thrombosis in patients with COVID‐19 admitted to intensive care units: A retrospective cohort study

Author

Noordermeer, Tessa, Schutgens, Roger E.G., Visser, Chantal, Rademaker, Emma, de Maat, Moniek P.M., Jansen, A.J. Gerard, Limper, Maarten, Cremer, Olaf L., Kruip, Marieke J.H.A., Endeman, Henrik, Maas, Coen, de Laat, Bas, Urbanus, Rolf T., van de Beek, D., Brouwer, M.C., de Bruin, S., Coppens, M., van Es, N., van Haaps, T.F., Juffermans, N.P., Muller, M.C.A., Vlaar, A.P.J., Hertogh, C.M.P.M., Heunks, L.M.A., Hugtenburg, J.G., van Kooten, J., Nossent, E.J., Smulders, Y., Tuinman, P.R., Vonk Noordegraaf, A., Grootenboers, M.J.J.H., van Guldener, C., Kant, M., Lansbergen, A., Faber, J., Hajer, G., Stemerdink, A., van den Akker, J., Bierings, R., Endeman, H., Goeijenbier, M., Hunfeld, N.G.M., van Gorp, E.C.M., Gommers, D.A.M.P.J., Koopmans, M.P.G., Kruip, M.J.H.A., Kuiken, T., Langerak, T., Leebeek, Lauw, M.N., de Maat, M.P.M., Noack, D., Paats, M.S., Raadsen, M.P., Rockx, B., Rokx, C., Schurink, C.A.M., Tong‐Minh, K., van den Toorn, L., den Uil, C.A., Visser, C., Boutkourt, F., Roest, T., Douma, R.A., de Haan, L.R., ten Wolde, M., Bemelmans, R.H.H., Festen, B., Stads, S., de Jager, C.P.C., Simons, K.S., Antoni, M.L., Bos, M.H., Burggraaf, J.L.I., Cannegieter, S.C., Eikenboom, H.C.J., den Exter, P.L., Geelhoed, J.J.M., Huisman, M.V., de Jonge, E., Kaptein, F.H.J., Klok, F.A., Kroft, L.J.M., Lijfering, W.M., Nab, L., Ninaber, M.K., Putter, H., Ramai, S.R.S., da Rocha Rondon, A.M., Roukens, A.H.E., Stals, M.A.M., Versteeg, H.H., Vliegen, H.W., van Vlijmen, B.J.M., van de Berg, T., Bruggemann, R., van Bussel, B.C.T., ten Cate, H., ten Cate‐Hoek, A., Hackeng, T.M., Henskens, ir.Y., Hulshof, A., Mulder, M., Olie, R.H., Schurgers, L., Spaetgens, B., Spronk, H., Winckers, K., Nieuwenhuizen, L., Franken, B., Schrover, I.M., de Waal, E.G.M., Beishuizen, A., Cornet, A., Krabbe, J., Kramers, K., Leentjens, J., de Mast, Q., Middeldorp, S., Brouwer, R.E., Ellerbroek, J.L.J., Tijmensen, J., Hovens, M.M C., Oostdijk, E.A.N., Westerhof, B.D., Faber, L.M., van den Biggelaar, M., Meijers, J.C.M., Voorberg, J., Kevenaar, M.E., Soei, Y.L., Wils, E.J., Croles, F.N., de Laat, B., Kamphuisen, P.W., Vink, R., Lisman, T., Meijer, K., van Tichelaar, Y.I.G., Cremer, O.L., Geersing, G., Kaasjager, H.A.H., Kusadasi, N., Huisman, A., Maas, C., Nijkeuter, M., Schutgens, R.E.G., Creveldkliniek, Van, Urbanus, R.T., Westerink, J., Faber, H.J., Koster, S.C.E., van Montfort, P., and van Twist, D.J.L.

Published
2022
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9. Evaluation of the Khorana, PROTECHT, and 5‐SNP scores for prediction of venous thromboembolism in patients with cancer

Author

Guman, Noori A.M., van Geffen, Roos J., Mulder, Frits I., van Haaps, Thijs F., Hovsepjan, Vahram, Labots, Mariette, Cirkel, Geert A., de Vos, Filip Y.F.L., Ten Tije, Albert J., Beerepoot, Laurens V., Tjan‐Heijnen, Vivianne C.G., van Laarhoven, Hanneke W.M., Hamberg, Paul, Vulink, Annelie J.E., Los, Maartje, Zwinderman, Aeilko H., Ferwerda, Bart, Lolkema, Martijn P.J.K., Steeghs, Neeltje, Büller, Harry R., Kamphuisen, Pieter W., and van Es, Nick

Published
2021
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12. The effect of current antithrombotic therapy on mortality in nursing home residents with COVID-19: a multicentre retrospective cohort study

Author

Boutkourt, Firdaouss, primary, van Haaps, Thijs, additional, Brüggemann, Reneé, additional, Bhoelan, Soerajja, additional, ten Cate, Hugo, additional, Kruip, Marieke J H A, additional, Spaetgens, Bart, additional, van Es, Nick, additional, Roest, Tineke, additional, Joling, Karlijn J, additional, Meijer, Karina, additional, and Hugtenburg, Jacqueline, additional

Published
2024
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13. The Incidence of Pulmonary Embolism in Hospitalized Non-ICU Patients with COVID-19 during the First Wave: A Multicenter Retrospective Cohort Study in the Netherlands

Author

Maas, Arno F.G., primary, Wyers, Caroline, additional, Dielis, Arne, additional, Barten, Dennis G., additional, van Kampen, Vivian E.M., additional, van der Krieken, Thomas E., additional, de Kruif, Martijn, additional, Simsek, Suat, additional, Spaetgens, Bart, additional, van Haaps, Thijs, additional, Appelman, Brent, additional, Gritters, Niels C., additional, Doornbos, Stefan, additional, Moeniralam, Hazra S., additional, Noordzij, Peter G., additional, Reidinga, Auke, additional, Douma, Renée A., additional, Nossent, Esther J., additional, Beudel, Martijn, additional, Elbers, Paul, additional, Middeldorp, Saskia, additional, van Es, Nick, additional, van den Bergh, Joop P.W., additional, and van Osch, Frits H.M., additional

Published
2024
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14. The effect of current antithrombotic therapy on mortality in nursing home residents with COVID-19:a multicentre retrospective cohort study

Author

Boutkourt, Firdaouss, van Haaps, Thijs, Brüggemann, Reneé, Bhoelan, Soerajja, ten Cate, Hugo, Kruip, Marieke J.H.A., Spaetgens, Bart, van Es, Nick, Roest, Tineke, Joling, Karlijn J., Meijer, Karina, Hugtenburg, Jacqueline, Boutkourt, Firdaouss, van Haaps, Thijs, Brüggemann, Reneé, Bhoelan, Soerajja, ten Cate, Hugo, Kruip, Marieke J.H.A., Spaetgens, Bart, van Es, Nick, Roest, Tineke, Joling, Karlijn J., Meijer, Karina, and Hugtenburg, Jacqueline

Abstract

Background: The first wave of COVID led to an alarmingly high mortality rate among nursing home residents (NHRs). In hospitalised patients, the use of anticoagulants may be associated with a favourable prognosis. However, it is unknown whether the use of antithrombotic medication also protected NHRs from COVID-19-related mortality. Objectives: To investigate the effect of current antithrombotic therapy in NHRs with COVID-19 on 30-day all-cause mortality during the first COVID-19 wave. Methods: We performed a retrospective cohort study linking electronic health records and pharmacy data in NHRs with COVID-19. A propensity score was used to match NHRs with current use of therapeutic dose anticoagulants to NHRs not using anticoagulant medication. The primary outcome was 30-day all-cause mortality, which was evaluated using a logistic regression model. In a secondary analysis, multivariable logistic regression was performed in the complete study group to compare NHRs with current use of therapeutic dose anticoagulants and those with current use of antiplatelet therapy to those without such medication. Results: We included 3521 NHRs with COVID-19 based on a positive RT-PCR for SARS-CoV-2 or with a well-defined clinical suspicion of COVID-19. In the matched propensity score analysis, NHRs with current use of therapeutic dose anticoagulants had a significantly lower all-cause mortality (OR = 0.73; 95% CI: 0.58–0.92) compared to NHRs who did not use therapeutic anticoagulants. In the secondary analysis, current use of therapeutic dose anticoagulants (OR: 0.62; 95% CI: 0.48–0.82) and current use of antiplatelet therapy (OR 0.80; 95% CI: 0.64–0.99) were both associated with decreased mortality. Conclusions: During the first COVID-19 wave, therapeutic anticoagulation and antiplatelet use were associated with a reduced risk of all-cause mortality in NHRs. Whether these potentially protective effects are maintained in vaccinated patients or patients with other COVID-19 varian

Published
2024

15. Spinal Cord Stimulation for Intractable Visceral Pain Originating from the Pelvic and Abdominal Region: A Narrative Review on a Possible New Indication for Patients with Therapy-Resistant Pain

Author

Bieze,Matthanja, van Haaps,Annelotte, Kapural,Leonardo, Li,Sean, Ferguson,Kris, de Vries,Ralph, Schatman,Michael, Mijatovic,Velja, Kallewaard,Jan Willem, Bieze,Matthanja, van Haaps,Annelotte, Kapural,Leonardo, Li,Sean, Ferguson,Kris, de Vries,Ralph, Schatman,Michael, Mijatovic,Velja, and Kallewaard,Jan Willem

Abstract

Matthanja Bieze,1,2,* Annelotte Pauline van Haaps,3,4,* Leonardo Kapural,5 Sean Li,6 Kris Ferguson,7 Ralph de Vries,8 Michael E Schatman,9,10 Velja Mijatovic,3,4 Jan Willem Kallewaard1,11 1Department of Anesthesiology and Pain Management, Amsterdam UMC Location University of Amsterdam, Amsterdam, the Netherlands; 2Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada; 3Department of Reproductive Medicine, Amsterdam University Medical Center location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; 4Amsterdam Reproduction and Development, Amsterdam University Medical Centers, Amsterdam, the Netherlands; 5Carolina’s Pain Institute and Center for Clinical Research, Winston Salem, North Carolina, USA; 6National Spine and Pain Centers, Shrewsbury, New Jersey, USA; 7Aspirus Langlade Hospital Pain Clinic, Antigo, Wisconsin, USA; 8Medical Library, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; 9Department of Anesthesiology, Perioperative Care & Pain Medicine, NYU Grossman School of Medicine, New York, New York, USA; 10Department of Population Health – Division of Medical Ethics, NYU Grossman School of Medicine, New York, New York, USA; 11Department of Anesthesiology and Pain Management, Rijnstate Ziekenhuis, Arnhem, the Netherlands*These authors contributed equally to this workCorrespondence: Jan Willem Kallewaard, Department of Anaesthesiology and Pain Management, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands, Email j.w.kallewaard@amsterdamumc.nlAim: Visceral pain, characterized by pain that is diffuse and challenging to localize, occurs frequently and is difficult to treat. In cases where the pain becomes intractable despite optimal medical management, it can affect patients’ Quality of Life (QoL). Spinal Cord Stimulation (SCS) has emerged as a potential solution for intractable visceral pain.Purpose: In t

Published
2024

20. A better quality of life could be achieved by applying the endometriosis diet: a cross-sectional study in Dutch endometriosis patients

Author

van Haaps, AP, Mijatovic, V, Schreurs, AMF, Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), and ACS - Atherosclerosis & ischemic syndromes

Abstract

Research questionDoes the endometriosis diet positively affect quality of life (QoL) in women diagnosed with endometriosis?DesignA cross-sectional study was performed, recruiting women using the website and online peer platforms from the Dutch Endometriosis Society. In total, 211 women with a self-reported diagnosis of endometriosis were included in the study. They completed a questionnaire on the six QoL domains based on the conversation tool ‘My Positive Health’. Women who adhered to the endometriosis diet were compared with women who did not. A distinction was made between strict (score ≥8 on a scale of 0–10) and less strict adherence to the diet.ResultsA significantly higher score was seen in all six QoL domains in women who adhered to the endometriosis diet (n = 90) compared with women who did not (n = 121) (range P < 0.001 to P = 0.043). Furthermore, women with strict adherence (n = 48) compared to less strict adherence (n = 42) reported significantly higher scores in all six QoL domains (range P = 0.005 to 0.05). Women diagnosed with endometriosis more than 10 years ago (n = 13) adhered to the endometriosis diet significantly less often than women that were diagnosed more recently (n = 163; range P = 0.005 to 0.046).ConclusionThe endometriosis diet was associated with a better QoL in Dutch women with endometriosis. Strict adherence showed higher QoL scores compared with less strict adherence. Therefore, more research is needed to clarify the mechanism of this beneficial effect and to identify facilitators and barriers to dietary adjustments in patients with endometriosis.

Published
2022

21. Interrater agreement of two scales on the severity of anticoagulant-related major bleeding in patients with venous thromboembolism

Author

Noori A.M. Guman, Thijs F. van Haaps, Nick van Es, Mariska M.G. Leeflang, Victor E.A. Gerdes, Saskia Middeldorp, Harry R. Büller, Noémie Kraaijpoel, Internal medicine, Graduate School, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, Amsterdam Cardiovascular Sciences, Epidemiology and Data Science, APH - Methodology, Amsterdam Reproduction & Development (AR&D), APH - Personalized Medicine, and ACS - Diabetes & metabolism

Subjects
Reproducibility of results, Observer variation, Severity of illness index, Risk Factors, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Anticoagulants, Humans, Hemorrhage, Hematology, Venous Thromboembolism
Abstract

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Published
2022
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22. Low-Molecular-Weight Heparin Versus Standard Pregnancy Care for Women with Recurrent Miscarriage and Inherited Thrombophilia (ALIFE2): An Open-Label, Phase III Randomized Controlled Trial

Author

Quenby, Siobhan, primary, Booth, Katie, additional, Hiller, Louise, additional, Coomarasamy, Arri, additional, Hamulyák, Eva, additional, Scheres, Luuk, additional, de Jong, Paulien G., additional, van Haaps, Thijs, additional, Ewington, Lauren J., additional, Tewary, Shreeya, additional, Goddijn, Mariëtte, additional, and Middeldorp, Saskia, additional

Published
2022
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24. Incidence of venous thromboembolism in hospitalized patients with COVID‐19

Author

Marcella C.A. Müller, Ruud S. Kootte, Alexander P.J. Vlaar, Jarom Heijmans, Nick van Es, Peter I. Bonta, Ludo F. M. Beenen, Merijn Foppen, Michiel Coppens, Thijs F. van Haaps, Loek P. Smits, Saskia Middeldorp, Catherine C. S. Bouman, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, ARD - Amsterdam Reproduction and Development, Intensive Care Medicine, Graduate School, Radiology and Nuclear Medicine, ACS - Microcirculation, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, ANS - Neurovascular Disorders, ACS - Atherosclerosis & ischemic syndromes, ACS - Diabetes & metabolism, AGEM - Endocrinology, metabolism and nutrition, General Internal Medicine, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, AMS - Amsterdam Movement Sciences, AMS - Restoration & Development, and Pulmonology

Subjects
Male, pulmonary embolism, critically ill, 030204 cardiovascular system & hematology, law.invention, 0302 clinical medicine, Risk Factors, law, Thrombophilia, Cumulative incidence, low-molecular-weight heparin, Netherlands, Incidence, Incidence (epidemiology), Venous Thromboembolism, Hematology, Middle Aged, Thrombosis, Intensive care unit, Pulmonary embolism, Intensive Care Units, Venous thrombosis, low‐molecular‐weight heparin, Female, Original Article, venous thrombosis, Coronavirus Infections, Cohort study, Catheterization, Central Venous, medicine.medical_specialty, medicine.drug_class, Pneumonia, Viral, Low molecular weight heparin, Fibrin Fibrinogen Degradation Products, general_medical_research, 03 medical and health sciences, Betacoronavirus, COVID‐19, Internal medicine, Patients' Rooms, medicine, Humans, cardiovascular diseases, Pandemics, Aged, Retrospective Studies, SARS-CoV-2, business.industry, Anticoagulants, COVID-19, Retrospective cohort study, Original Articles, Thrombophlebitis, medicine.disease, equipment and supplies, THROMBOSIS, business, Venous thromboembolism, Biomarkers
Abstract

Background Coronavirus disease 2019 (COVID-19) can lead to systemic coagulation activation and thrombotic complications. Objectives To investigate the incidence of objectively confirmed venous thromboembolism (VTE) in hospitalized patients with COVID-19. Methods Single-center cohort study of 198 hospitalized patients with COVID-19. Results Seventy-five patients (38%) were admitted to the intensive care unit (ICU). At time of data collection, 16 (8%) were still hospitalized and 19% had died. During a median follow-up of 7 days (IQR, 3-13), 39 patients (20%) were diagnosed with VTE of whom 25 (13%) had symptomatic VTE, despite routine thrombosis prophylaxis. The cumulative incidences of VTE at 7, 14 and 21 days were 16% (95% CI, 10-22), 33% (95% CI, 23-43) and 42% (95% CI 30-54) respectively. For symptomatic VTE, these were 10% (95% CI, 5.8-16), 21% (95% CI, 14-30) and 25% (95% CI 16-36). VTE appeared to be associated with death (adjusted HR, 2.4; 95% CI, 1.02-5.5). The cumulative incidence of VTE was higher in the ICU (26% (95% CI, 17-37), 47% (95% CI, 34-58), and 59% (95% CI, 42-72) at 7, 14 and 21 days) than on the wards (any VTE and symptomatic VTE 5.8% (95% CI, 1.4-15), 9.2% (95% CI, 2.6-21), and 9.2% (2.6-21) at 7, 14, and 21 days). Conclusions The observed risk for VTE in COVID-19 is high, particularly in ICU patients, which should lead to a high level of clinical suspicion and low threshold for diagnostic imaging for DVT or PE. Future research should focus on optimal diagnostic and prophylactic strategies to prevent VTE and potentially improve survival.

Published
2020

26. Low-Molecular-Weight Heparin Versus Standard Pregnancy Care for Women with Recurrent Miscarriage and Inherited Thrombophilia (ALIFE2): An Open-Label, Phase III Randomized Controlled Trial

Author

Siobhan Quenby, Katie Booth, Louise Hiller, Arri Coomarasamy, Eva Hamulyák, Luuk Scheres, Paulien G. de Jong, Thijs van Haaps, Lauren J. Ewington, Shreeya Tewary, Mariëtte Goddijn, and Saskia Middeldorp

Subjects
Immunology, Cell Biology, Hematology, Biochemistry
Published
2022
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27. Pre-admission anticoagulant therapy and mortality in hospitalized COVID-19 patients: A retrospective cohort study

Author

van Haaps, Thijs F., Collard, Didier, van Osch, Frits H.M., Middeldorp, Saskia, Coppens, Michiel, de Kruif, Martijn D., Vlot, Eline A., Douma, Renée A., ten Cate, Hugo, Juffermans, Nicole P., Gritters, Niels, Vlaar, Alexander P., Reidinga, Auke C., Heuvelmans, Marjolein A., Oudkerk, Matthijs, Büller, Harry R., van den Bergh, Joop P.W., Maas, Arno, Ten Wolde, Marije, Simsek, Suat, Beudel, Martijn, and van Es, Nick

Published
2021
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28. Pre-admission anticoagulant therapy and mortality in hospitalized COVID-19 patients: A retrospective cohort study

Author

Auke C Reidinga, Suat Simsek, Frits H.M. van Osch, Harry R. Büller, Nicole P. Juffermans, Saskia Middeldorp, Niels Gritters, Didier Collard, Matthijs Oudkerk, Marjolein A Heuvelmans, Hugo ten Cate, Renée A. Douma, Eline A Vlot, Thijs F. van Haaps, Nick van Es, Alexander P.J. Vlaar, Arno Maas, Marije ten Wolde, Michiel Coppens, Martijn Beudel, Martijn D. de Kruif, Joop P. W. van den Bergh, Graduate School, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, Amsterdam Reproduction & Development (AR&D), Intensive Care Medicine, ACS - Microcirculation, Neurology, Amsterdam Neuroscience - Neurodegeneration, ACS - Atherosclerosis & ischemic syndromes, Epidemiologie, RS: NUTRIM - R3 - Respiratory & Age-related Health, Interne Geneeskunde, MUMC+: HVC Pieken Trombose (9), MUMC+: MA Alg Interne Geneeskunde (9), MUMC+: HVC Trombosezorg (8), and RS: Carim - B04 Clinical thrombosis and Haemostasis

Subjects
2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Letter to the Editors-in-Chief, COVID-19, Anticoagulants, Retrospective cohort study, Thrombosis, Hematology, medicine.disease, Anticoagulant therapy, Internal medicine, medicine, Humans, Original Article, Hospital Mortality, Mortality, business, Retrospective Studies
Abstract

Background Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. Methods In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support–free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of −1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. Results The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support–free days was 1 (interquartile range, −1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, −1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio

Published
2021

29. Characteristics and Outcomes of Patients With Cerebral Venous Sinus Thrombosis in SARS-CoV-2 Vaccine-Induced Immune Thrombotic Thrombocytopenia

Author

van Kammen, MS, de Sousa, DA, Poli, S, Cordonnier, C, Heldner, MR, van de Munckhof, A, Krzywicka, K, van Haaps, T, Ciccone, A, Middeldorp, S, Levi, MM, Hovinga, JAK, Silvis, S, Hiltunen, S, Mansour, M, Arauz, A, Barboza, MA, Field, TS, Tsivgoulis, G, Nagel, S, Lindgren, E, Tatlisumak, T, Jood, K, Putaala, J, Ferro, JM, Arnold, M, Coutinho, JM, Guisado-Alonso D., and Cerebral Venous Sinus Thrombosis T

Abstract

Importance Thrombosis with thrombocytopenia syndrome (TTS) has been reported after vaccination with the SARS-CoV-2 vaccines ChAdOx1 nCov-19 (Oxford-AstraZeneca) and Ad26.COV2.S (Janssen/Johnson & Johnson). Objective To describe the clinical characteristics and outcome of patients with cerebral venous sinus thrombosis (CVST) after SARS-CoV-2 vaccination with and without TTS. Design, Setting, and Participants This cohort study used data from an international registry of consecutive patients with CVST within 28 days of SARS-CoV-2 vaccination included between March 29 and June 18, 2021, from 81 hospitals in 19 countries. For reference, data from patients with CVST between 2015 and 2018 were derived from an existing international registry. Clinical characteristics and mortality rate were described for adults with (1) CVST in the setting of SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia, (2) CVST after SARS-CoV-2 vaccination not fulling criteria for TTS, and (3) CVST unrelated to SARS-CoV-2 vaccination. Exposures Patients were classified as having TTS if they had new-onset thrombocytopenia without recent exposure to heparin, in accordance with the Brighton Collaboration interim criteria. Main Outcomes and Measures Clinical characteristics and mortality rate. Results Of 116 patients with postvaccination CVST, 78 (67.2%) had TTS, of whom 76 had been vaccinated with ChAdOx1 nCov-19; 38 (32.8%) had no indication of TTS. The control group included 207 patients with CVST before the COVID-19 pandemic. A total of 63 of 78 (81%), 30 of 38 (79%), and 145 of 207 (70.0%) patients, respectively, were female, and the mean (SD) age was 45 (14), 55 (20), and 42 (16) years, respectively. Concomitant thromboembolism occurred in 25 of 70 patients (36%) in the TTS group, 2 of 35 (6%) in the no TTS group, and 10 of 206 (4.9%) in the control group, and in-hospital mortality rates were 47% (36 of 76; 95% CI, 37-58), 5% (2 of 37; 95% CI, 1-18), and 3.9% (8 of 207; 95% CI, 2.0-7.4), respectively. The mortality rate was 61% (14 of 23) among patients in the TTS group diagnosed before the condition garnered attention in the scientific community and 42% (22 of 53) among patients diagnosed later. Conclusions and Relevance In this cohort study of patients with CVST, a distinct clinical profile and high mortality rate was observed in patients meeting criteria for TTS after SARS-CoV-2 vaccination. Question What are the clinical characteristics and outcomes of patients with cerebral venous sinus thrombosis with thrombocytopenia syndrome after SARS-CoV-2 vaccination? Findings In this cohort study of 116 patients with cerebral venous sinus thrombosis after SARS-CoV-2 vaccination, 78 (67.2%) had thrombosis with thrombocytopenia syndrome. Patients with thrombosis with thrombocytopenia syndrome were frequently comatose at presentation (24%) and often had intracerebral hemorrhage (68%) and concomitant thromboembolism (36%), and 47% died during hospitalization. Meaning Patients with cerebral venous sinus thrombosis after SARS-CoV-2 vaccination who met criteria for thrombosis with thrombocytopenia syndrome had a distinct clinical profile and high mortality rate. This cohort study describes the clinical characteristics and outcome of patients with cerebral venous sinus thrombosis after SARS-CoV-2 vaccination with and without thrombosis with thrombocytopenia syndrome.

Published
2021

30. Characteristics and Outcomes of Patients With Cerebral Venous Sinus Thrombosis in SARS-CoV-2 Vaccine-Induced Immune Thrombotic Thrombocytopenia

Author

Gregory Polkinghorne, Jean-François Payen, Fabrice Vuillier, Katarina Jood, Simon Nagel, Suzanne Silvis, Hans D. Katzberg, Aarti Sharma, Anemon Puthuppallil Philip, Caroline Vayne, Pankaj Sharma, Marcel Levi, Sini Hiltunen, Mayte Sánchez van Kammen, Monica Bandettini di Poggio, Erik Lindgren, Moritz J Scholz, Roberto Acampora, Felix J. Bode, Shyam S Sharma, Jim Burrow, Miguel Miranda, Alfonso Ciccone, Guillaume Franchineau, Ana Paiva Nunes, Yildiz Arslan, Christian Pfrepper, Vanessa Dizonno, Frank Maier, Emmanuel De Maistre, Domenico S Zimatore, Ahmed Elkady, Giovanni Frisullo, Fabrizio Giammello, Laurent Puy, Albrecht Günther, Dominik Michalski, Clement Tracol, Marta Carvalho, Irem Baharoglu, Jukka Putaala, José M. Ferro, Olivier Huet, Matthias Wittstock, Florindo d'Onofrio, Sophie Susen, Ronen R. Leker, Brian Buck, Jaskiran Brar, Katia Garambois, Barbara Casolla, Lukas Kellermair, Robert Kahnis, Avinash Aujayeb, Lucia Lebrato Hernandez, Catherine Legault, Simerpreet Bal, Mar Morin Martin, David Bougon, Anita van de Munckhof, Ricardo Vieira, Julian Zimmerman, Turgut Tatlisumak, Audrey Tawa, Hakan Cangür, Cristina Soriano, Georgios Tsivgoulis, Alberto Negro, Annerose Mengel, Jonathan M. Coutinho, Saskia Middeldorp, Dylan Blacquiere, Emmanuel Carrera, Antonio Arauz, Sean Murphy, Elias Johansson, Silvia Schönenberger, Judith Schouten, Thomas Gattringer, Sven Poli, François Cotton, Miguel A Barboza, Thomas Geeraerts, Nicolas Raposo, Nyika D. Kruyt, Mirjam Rachel Heldner, Shelagh B. Coutts, Timothy Kleinig, Elisa Cuadrado-Godia, Katarzyna Krzywicka, Mona Skjelland, Daniel Guisado-Alonso, Charlotte Cordonnier, Andreas Tiede, Marie-Cécile Dubois, Maria Cotelli, Diana Aguiar de Sousa, Maryam Mansour, Katharina Althaus, Peggy Reiner, Carlos Garcia-Esperon, Marcel Arnold, Thomas Cox, Laurent Derex, Thalia S. Field, Thijs F. van Haaps, Carla Zanferrari, Paolo Candelaresi, François Caparros, Åslög Hellström Vogel, Lisa Humbertjean, Francesco Grillo, A. Medina, Giosue Gulli, Marco Petruzzellis, Rolf Kern, Igor Sibon, João Fernandes, Fabrice Bonneville, Johanna A. Kremer Hovinga, Alexander Gutschalk, Alina Buture, Thorsten Bartsch, Graduate School, Neurology, Amsterdam Neuroscience - Neurovascular Disorders, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, Amsterdam Reproduction & Development, ACS - Atherosclerosis & ischemic syndromes, ANS - Neurovascular Disorders, and ARD - Amsterdam Reproduction and Development

Subjects
Male, Pediatrics, Outcome Assessment, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], 030204 cardiovascular system & hematology, Sinus Thrombosis, Sinus Thrombosis, Intracranial/blood, Cohort Studies, Sinus Thrombosis, Intracranial, Venous Thromboembolism/blood, 0302 clinical medicine, Outcome Assessment, Health Care, Hospital Mortality, Registries, Original Investigation, Mortality rate, Syndrome, Venous Thromboembolism, Heparin, Middle Aged, Thrombosis, 3. Good health, Vaccination, Female, Thrombocytopenia/blood, Cohort study, medicine.drug, Adult, medicine.medical_specialty, COVID-19 Vaccines, Drug-Related Side Effects and Adverse Reactions, Young Adult, 03 medical and health sciences, Sex Factors, ChAdOx1 nCoV-19, medicine, Intracranial/blood, Humans, Thrombus, Cerebral venous sinus thrombosis, BNT162 Vaccine, Aged, Ad26COVS1, business.industry, medicine.disease, Intracranial, Thrombocytopenia, Health Care, Drug-Related Side Effects and Adverse Reactions/mortality, Concomitant, Neurology (clinical), business, 030217 neurology & neurosurgery, COVID-19 Vaccines/adverse effects
Abstract

Contains fulltext : 245661.pdf (Publisher’s version ) (Closed access) IMPORTANCE: Thrombosis with thrombocytopenia syndrome (TTS) has been reported after vaccination with the SARS-CoV-2 vaccines ChAdOx1 nCov-19 (Oxford-AstraZeneca) and Ad26.COV2.S (Janssen/Johnson & Johnson). OBJECTIVE: To describe the clinical characteristics and outcome of patients with cerebral venous sinus thrombosis (CVST) after SARS-CoV-2 vaccination with and without TTS. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from an international registry of consecutive patients with CVST within 28 days of SARS-CoV-2 vaccination included between March 29 and June 18, 2021, from 81 hospitals in 19 countries. For reference, data from patients with CVST between 2015 and 2018 were derived from an existing international registry. Clinical characteristics and mortality rate were described for adults with (1) CVST in the setting of SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia, (2) CVST after SARS-CoV-2 vaccination not fulling criteria for TTS, and (3) CVST unrelated to SARS-CoV-2 vaccination. EXPOSURES: Patients were classified as having TTS if they had new-onset thrombocytopenia without recent exposure to heparin, in accordance with the Brighton Collaboration interim criteria. MAIN OUTCOMES AND MEASURES: Clinical characteristics and mortality rate. RESULTS: Of 116 patients with postvaccination CVST, 78 (67.2%) had TTS, of whom 76 had been vaccinated with ChAdOx1 nCov-19; 38 (32.8%) had no indication of TTS. The control group included 207 patients with CVST before the COVID-19 pandemic. A total of 63 of 78 (81%), 30 of 38 (79%), and 145 of 207 (70.0%) patients, respectively, were female, and the mean (SD) age was 45 (14), 55 (20), and 42 (16) years, respectively. Concomitant thromboembolism occurred in 25 of 70 patients (36%) in the TTS group, 2 of 35 (6%) in the no TTS group, and 10 of 206 (4.9%) in the control group, and in-hospital mortality rates were 47% (36 of 76; 95% CI, 37-58), 5% (2 of 37; 95% CI, 1-18), and 3.9% (8 of 207; 95% CI, 2.0-7.4), respectively. The mortality rate was 61% (14 of 23) among patients in the TTS group diagnosed before the condition garnered attention in the scientific community and 42% (22 of 53) among patients diagnosed later. CONCLUSIONS AND RELEVANCE: In this cohort study of patients with CVST, a distinct clinical profile and high mortality rate was observed in patients meeting criteria for TTS after SARS-CoV-2 vaccination.

Published
2021

31. Characteristics and Outcomes of Patients With Cerebral Venous Sinus Thrombosis in SARS-CoV-2 Vaccine-Induced Immune Thrombotic Thrombocytopenia

Author

Sánchez van Kammen, Mayte, Aguiar de Sousa, Diana, Poli, Sven, Cordonnier, Charlotte, Heldner, Mirjam R., van de Munckhof, Anita, Krzywicka, Katarzyna, van Haaps, Thijs, Ciccone, Alfonso, Middeldorp, Saskia, Levi, Marcel M, Kremer Hovinga, Johanna A., Silvis, Suzanne, Hiltunen, Sini, Mansour, Maryam, Arauz, Antonio, Barboza, Miguel A, Field, Thalia S, Tsivgoulis, Georgios, Nagel, Simon, Lindgren, Erik, Tatlisumak, Turgut, Jood, Katarina, Putaala, Jukka, Ferro, Jose M, Arnold, Marcel, and Coutinho, Jonathan M

Subjects
610 Medicine & health
Abstract

Importance Thrombosis with thrombocytopenia syndrome (TTS) has been reported after vaccination with the SARS-CoV-2 vaccines ChAdOx1 nCov-19 (Oxford-AstraZeneca) and Ad26.COV2.S (Janssen/Johnson & Johnson). Objective To describe the clinical characteristics and outcome of patients with cerebral venous sinus thrombosis (CVST) after SARS-CoV-2 vaccination with and without TTS. Design, Setting, and Participants This cohort study used data from an international registry of consecutive patients with CVST within 28 days of SARS-CoV-2 vaccination included between March 29 and June 18, 2021, from 81 hospitals in 19 countries. For reference, data from patients with CVST between 2015 and 2018 were derived from an existing international registry. Clinical characteristics and mortality rate were described for adults with (1) CVST in the setting of SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia, (2) CVST after SARS-CoV-2 vaccination not fulling criteria for TTS, and (3) CVST unrelated to SARS-CoV-2 vaccination. Exposures Patients were classified as having TTS if they had new-onset thrombocytopenia without recent exposure to heparin, in accordance with the Brighton Collaboration interim criteria. Main Outcomes and Measures Clinical characteristics and mortality rate. Results Of 116 patients with postvaccination CVST, 78 (67.2%) had TTS, of whom 76 had been vaccinated with ChAdOx1 nCov-19; 38 (32.8%) had no indication of TTS. The control group included 207 patients with CVST before the COVID-19 pandemic. A total of 63 of 78 (81%), 30 of 38 (79%), and 145 of 207 (70.0%) patients, respectively, were female, and the mean (SD) age was 45 (14), 55 (20), and 42 (16) years, respectively. Concomitant thromboembolism occurred in 25 of 70 patients (36%) in the TTS group, 2 of 35 (6%) in the no TTS group, and 10 of 206 (4.9%) in the control group, and in-hospital mortality rates were 47% (36 of 76; 95% CI, 37-58), 5% (2 of 37; 95% CI, 1-18), and 3.9% (8 of 207; 95% CI, 2.0-7.4), respectively. The mortality rate was 61% (14 of 23) among patients in the TTS group diagnosed before the condition garnered attention in the scientific community and 42% (22 of 53) among patients diagnosed later. Conclusions and Relevance In this cohort study of patients with CVST, a distinct clinical profile and high mortality rate was observed in patients meeting criteria for TTS after SARS-CoV-2 vaccination.

Published
2021
Full Text
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32. Characteristics and Outcomes of Patients With Cerebral Venous Sinus Thrombosis in SARS-CoV-2 Vaccine-Induced Immune Thrombotic Thrombocytopenia

Author

van Kammen, Mayte Sanchez de Sousa, Diana Aguiar Poli, Sven and Cordonnier, Charlotte Heldner, Mirjam R. van de Munckhof, Anita and Krzywicka, Katarzyna van Haaps, Thijs Ciccone, Alfonso and Middeldorp, Saskia Levi, Marcel M. Hovinga, Johanna A. Kremer and Silvis, Suzanne Hiltunen, Sini Mansour, Maryam Arauz, Antonio Barboza, Miguel A. Field, Thalia S. Tsivgoulis, Georgios Nagel, Simon Lindgren, Erik Tatlisumak, Turgut and Jood, Katarina Putaala, Jukka Ferro, Jose M. Arnold, Marcel and Coutinho, Jonathan M. Cerebral Venous Sinus Thrombosis T

Abstract

Importance Thrombosis with thrombocytopenia syndrome (TTS) has been reported after vaccination with the SARS-CoV-2 vaccines ChAdOx1 nCov-19 (Oxford-AstraZeneca) and Ad26.COV2.S (Janssen/Johnson & Johnson). Objective To describe the clinical characteristics and outcome of patients with cerebral venous sinus thrombosis (CVST) after SARS-CoV-2 vaccination with and without TTS. Design, Setting, and Participants This cohort study used data from an international registry of consecutive patients with CVST within 28 days of SARS-CoV-2 vaccination included between March 29 and June 18, 2021, from 81 hospitals in 19 countries. For reference, data from patients with CVST between 2015 and 2018 were derived from an existing international registry. Clinical characteristics and mortality rate were described for adults with (1) CVST in the setting of SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia, (2) CVST after SARS-CoV-2 vaccination not fulling criteria for TTS, and (3) CVST unrelated to SARS-CoV-2 vaccination. Exposures Patients were classified as having TTS if they had new-onset thrombocytopenia without recent exposure to heparin, in accordance with the Brighton Collaboration interim criteria. Main Outcomes and Measures Clinical characteristics and mortality rate. Results Of 116 patients with postvaccination CVST, 78 (67.2%) had TTS, of whom 76 had been vaccinated with ChAdOx1 nCov-19; 38 (32.8%) had no indication of TTS. The control group included 207 patients with CVST before the COVID-19 pandemic. A total of 63 of 78 (81%), 30 of 38 (79%), and 145 of 207 (70.0%) patients, respectively, were female, and the mean (SD) age was 45 (14), 55 (20), and 42 (16) years, respectively. Concomitant thromboembolism occurred in 25 of 70 patients (36%) in the TTS group, 2 of 35 (6%) in the no TTS group, and 10 of 206 (4.9%) in the control group, and in-hospital mortality rates were 47% (36 of 76; 95% CI, 37-58), 5% (2 of 37; 95% CI, 1-18), and 3.9% (8 of 207; 95% CI, 2.0-7.4), respectively. The mortality rate was 61% (14 of 23) among patients in the TTS group diagnosed before the condition garnered attention in the scientific community and 42% (22 of 53) among patients diagnosed later. Conclusions and Relevance In this cohort study of patients with CVST, a distinct clinical profile and high mortality rate was observed in patients meeting criteria for TTS after SARS-CoV-2 vaccination. Question What are the clinical characteristics and outcomes of patients with cerebral venous sinus thrombosis with thrombocytopenia syndrome after SARS-CoV-2 vaccination? Findings In this cohort study of 116 patients with cerebral venous sinus thrombosis after SARS-CoV-2 vaccination, 78 (67.2%) had thrombosis with thrombocytopenia syndrome. Patients with thrombosis with thrombocytopenia syndrome were frequently comatose at presentation (24%) and often had intracerebral hemorrhage (68%) and concomitant thromboembolism (36%), and 47% died during hospitalization. Meaning Patients with cerebral venous sinus thrombosis after SARS-CoV-2 vaccination who met criteria for thrombosis with thrombocytopenia syndrome had a distinct clinical profile and high mortality rate. This cohort study describes the clinical characteristics and outcome of patients with cerebral venous sinus thrombosis after SARS-CoV-2 vaccination with and without thrombosis with thrombocytopenia syndrome.

Published
2021

33. Post‐SARS‐CoV‐2‐vaccination cerebral venous sinus thrombosis: an analysis of cases notified to the European Medicines Agency

Author

Krzywicka, Katarzyna, primary, Heldner, Mirjam R., additional, Sánchez van Kammen, Mayte, additional, van Haaps, Thijs, additional, Hiltunen, Sini, additional, Silvis, Suzanne M., additional, Levi, Marcel, additional, Kremer Hovinga, Johanna A., additional, Jood, Katarina, additional, Lindgren, Erik, additional, Tatlisumak, Turgut, additional, Putaala, Jukka, additional, Aguiar de Sousa, Diana, additional, Middeldorp, Saskia, additional, Arnold, Marcel, additional, Coutinho, Jonathan M., additional, and Ferro, José M., additional

Published
2021
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35. COVID-19-associated coagulopathy and antithrombotic agents—lessons after 1 year

Author

Poli Van Creveldkliniek Medisch, Circulatory Health, Infection & Immunity, Leentjens, Jenneke, van Haaps, Thijs F., Wessels, Pieter F., Schutgens, Roger E.G., Middeldorp, Saskia, Poli Van Creveldkliniek Medisch, Circulatory Health, Infection & Immunity, Leentjens, Jenneke, van Haaps, Thijs F., Wessels, Pieter F., Schutgens, Roger E.G., and Middeldorp, Saskia

Published
2021

36. Evaluation of the Khorana, PROTECHT, and 5-SNP scores for prediction of venous thromboembolism in patients with cancer

Author

MS Medische Oncologie, Cancer, Guman, Noori A M, van Geffen, Roos J, Mulder, Frits I, van Haaps, Thijs F, Hovsepjan, Vahram, Labots, Mariette, Cirkel, Geert A, de Vos, Filip Y F L, Ten Tije, Albert J, Beerepoot, Laurens V, Tjan-Heijnen, Vivianne C G, van Laarhoven, Hanneke W M, Hamberg, Paul, Vulink, Annelie J E, Los, Maartje, Zwinderman, Aeilko H, Ferwerda, Bart, Lolkema, Martijn P J K, Steeghs, Neeltje, Büller, Harry R, Kamphuisen, Pieter W, van Es, Nick, MS Medische Oncologie, Cancer, Guman, Noori A M, van Geffen, Roos J, Mulder, Frits I, van Haaps, Thijs F, Hovsepjan, Vahram, Labots, Mariette, Cirkel, Geert A, de Vos, Filip Y F L, Ten Tije, Albert J, Beerepoot, Laurens V, Tjan-Heijnen, Vivianne C G, van Laarhoven, Hanneke W M, Hamberg, Paul, Vulink, Annelie J E, Los, Maartje, Zwinderman, Aeilko H, Ferwerda, Bart, Lolkema, Martijn P J K, Steeghs, Neeltje, Büller, Harry R, Kamphuisen, Pieter W, and van Es, Nick

Published
2021

37. ANDEXANET ALFA FOR ACUTE BLEEDING DURING TREATMENT WITH ENOXAPARIN

Author

van Haaps, Thijs F., primary, Benz, Alexander P., additional, Xu, Lizhen, additional, Coppens, Michiel, additional, Eikelboom, John W., additional, Milling, Truman J., additional, Crowther, Mark, additional, Beyer-Westendorf, Jan, additional, Cohen, Alexander T., additional, Yue, Patrick, additional, Conley, Pamela B., additional, Lu, Genmin, additional, Connolly, Stuart J., additional, and Middeldorp, Saskia, additional

Published
2021
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39. Incidence of Venous Thromboembolism in Hospitalized Patients with COVID-19

Author

Middeldorp, Saskia, primary, Coppens, Michiel, additional, van Haaps, Thijs F., additional, Foppen, Merijn, additional, Vlaar, Alexander P., additional, Muller, Marcella C.A., additional, Bouman, Catherine C.S., additional, Beenen, Ludo F.M., additional, Kootte, Ruud S., additional, Heijmans, Jarom, additional, Smits, Loek P., additional, Bonta, Peter I., additional, and van Es, Nick, additional

Published
2020
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40. ANDEXANET ALFA FOR ACUTE BLEEDING DURING TREATMENT WITH ENOXAPARIN

Author

Alexander P. Benz, Michiel Coppens, Lizhen Xu, Pamela B. Conley, Alexander T. Cohen, Thijs F. van Haaps, Genmin Lu, Patrick Yue, Saskia Middeldorp, Mark Crowther, Stuart J. Connolly, Jan Beyer-Westendorf, Truman J. Milling, and John W. Eikelboom

Subjects
medicine.medical_specialty, business.industry, medicine, Acute bleeding, Cardiology and Cardiovascular Medicine, business, Surgery, Andexanet alfa, medicine.drug
Published
2021
Full Text
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41. Post-SARS-CoV-2-vaccination Cerebral Venous Sinus Thrombosis: an analysis of cases notified to the European Medicines Agency

Author

Krzywicka, Katarzyna, Heldner, Mirjam R., Sánchez van Kammen, Mayte, van Haaps, Thijs, Hiltunen, Sini, Silvis, Suzanne M, Levi, Marcel, Kremer Hovinga, Johanna A., Jood, Katarina, Lindgren, Erik, Tatlisumak, Turgut, Putaala, Jukka, Aguiar de Sousa, Diana, Middeldorp, Saskia, Arnold, Marcel, Coutinho, Jonathan M, and Ferro, José M

Subjects
610 Medicine & health, 360 Social problems & social services, 3. Good health
Abstract

BACKGROUND Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARS-CoV-2. We report clinical characteristics of 213 post-vaccination CVST cases notified to the European Medicines Agency (EMA). METHODS Data on Adverse Drug Reactions after SARS-CoV-2 vaccination notified until 8 April 2021 under the Medical Dictionary for Regulatory Activities Term 'Central nervous system vascular disorders' were obtained from the EudraVigilance database. We compared post-vaccination CVST to 100 European patients with CVST from before the COVID-19 pandemic derived from the International CVST Consortium. RESULTS We identified 213 CVST cases: 187 after AstraZeneca/Oxford (ChAdOx1 nCov-19), vaccination and 26 after a mRNA vaccine (25 Pfizer/BioNTech, BNT162b2 and 1 Moderna, mRNA-1273). Thrombocytopenia was reported in 107/187 CVST cases (57%, 95%CI 50-64%) in the ChAdOx1 nCov-19 group, in none in the mRNA vaccine group (0%, 95%CI 0-13%), and in 7/100 (7%, 95%CI 3-14%) in the pre-COVID-19 group. In the ChAdOx1 nCov-19 group, there were 39 (21%) reported COVID-19 PCR tests performed within 30 days of CVST symptom onset, and all were negative. Of the 117 patients with a reported outcome in the ChAdOx1 nCov-19 group, 44 (38%, 95%CI 29-47%) had died, compared to 2/10 (20%, 95%CI 6-51%) in the mRNA vaccine group and 3/100 (3%, 95%CI 1-8%) in the pre-COVID-19 group. Mortality among patients with thrombocytopenia in the ChAdOx1 nCov-19 group was 49% (95%CI 39-60%). CONCLUSIONS CVST occurring after ChAdOx1 nCov-19 vaccination has a clinical profile distinct from CVST unrelated to vaccination. Only CVST after ChAdOx1 nCov-19 was associated with thrombocytopenia.

42. POST-SARS-COV-2-VACCINATION CEREBRAL VENOUS SINUS THROMBOSIS: AN ANALYSIS OF CASES NOTIFIED TO THE EUROPEAN MEDICINES AGENCY

Author

Suzanne Silvis, Erik Lindgren, Mayte Sánchez van Kammen, Katarzyna Krzywicka, Sini Hiltunen, Marcel Arnold, José M. Ferro, Jukka Putaala, Turgut Tatlisumak, Mirjam Rachel Heldner, Saskia Middeldorp, Jonathan M. Coutinho, Marcel Levi, Johanna A. Kremer Hovinga, Diana Aguiar de Sousa, Thijs F. van Haaps, Katarina Jood, Graduate School, Neurology, ANS - Neurovascular Disorders, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, ACS - Atherosclerosis & ischemic syndromes, HUS Neurocenter, University of Helsinki, Neurologian yksikkö, and Department of Neurosciences

Subjects
2019-20 coronavirus outbreak, medicine.medical_specialty, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), MedDRA, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], 610 Medicine & health, thrombocytopenia, 030204 cardiovascular system & hematology, 3124 Neurology and psychiatry, 03 medical and health sciences, Sinus Thrombosis, Intracranial, 0302 clinical medicine, 360 Social problems & social services, EMA, Internal medicine, ChAdOx1 nCoV-19, medicine, Humans, Symptom onset, Drug reaction, Cerebral venous sinus thrombosis, Pandemics, BNT162 Vaccine, business.industry, SARS-CoV-2, Vaccination, 3112 Neurosciences, COVID-19, medicine.disease, CVST, 3. Good health, Neurology, Neurology (clinical), business, COVID-19 vaccine, 030217 neurology & neurosurgery
Abstract

Contains fulltext : 245709.pdf (Publisher’s version ) (Open Access) BACKGROUND AND PURPOSE: Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARS-CoV-2. The clinical characteristics of 213 post-vaccination CVST cases notified to the European Medicines Agency are reported. METHODS: Data on adverse drug reactions after SARS-CoV-2 vaccination notified until 8 April 2021 under the Medical Dictionary for Regulatory Activities Term 'Central nervous system vascular disorders' were obtained from the EudraVigilance database. Post-vaccination CVST was compared with 100 European patients with CVST from before the COVID-19 pandemic derived from the International CVST Consortium. RESULTS: In all, 213 CVST cases were identified: 187 after AstraZeneca/Oxford (ChAdOx1 nCov-19) vaccination and 26 after a messenger RNA (mRNA) vaccination (25 with Pfizer/BioNTech, BNT162b2, and one with Moderna, mRNA-1273). Thrombocytopenia was reported in 107/187 CVST cases (57%, 95% confidence interval [CI] 50%-64%) in the ChAdOx1 nCov-19 group, in none in the mRNA vaccine group (0%, 95% CI 0%-13%) and in 7/100 (7%, 95% CI 3%-14%) in the pre-COVID-19 group. In the ChAdOx1 nCov-19 group, 39 (21%) reported COVID-19 polymerase chain reaction tests were performed within 30 days of CVST symptom onset, and all were negative. Of the 117 patients with a reported outcome in the ChAdOx1 nCov-19 group, 44 (38%, 95% CI 29%-47%) had died, compared to 2/10 (20%, 95% CI 6%-51%) in the mRNA vaccine group and 3/100 (3%, 95% CI 1%-8%) in the pre-COVID-19 group. Mortality amongst patients with thrombocytopenia in the ChAdOx1 nCov-19 group was 49% (95% CI 39%-60%). CONCLUSIONS: Cerebral venous sinus thrombosis occurring after ChAdOx1 nCov-19 vaccination has a clinical profile distinct from CVST unrelated to vaccination. Only CVST after ChAdOx1 nCov-19 vaccination was associated with thrombocytopenia.

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43. The effect of dietary interventions on pain and quality of life in women diagnosed with endometriosis: a prospective study with control group.

Author

van Haaps AP, Wijbers JV, Schreurs AMF, Vlek S, Tuynman J, De Bie B, de Vogel AL, van Wely M, and Mijatovic V

Subjects
Humans, Female, Prospective Studies, Quality of Life, Control Groups, Pilot Projects, Pelvic Pain therapy, Pelvic Pain complications, Endometriosis complications
Abstract

Study Question: What is the influence of dietary interventions, namely the low fermentable oligo-, di-, mono-saccharides, and polyols (Low FODMAP) diet and endometriosis diet, on endometriosis-related pain and quality of life (QoL) compared to a control group?, Summary Answer: After adhering to a dietary intervention for 6 months, women with endometriosis reported less pain and an improved QoL compared to baseline whereas, compared to the control group, they reported less bloating and a better QoL in 3 of 11 domains., What Is Known Already: Standard endometriosis treatment can be insufficient or may be accompanied by unacceptable side effects. This has resulted in an increasing interest in self-management strategies, including the appliance of the Low FODMAP diet and the endometriosis diet (an experience-based avoidance diet, developed by women with endometriosis). The Low FODMAP diet has previously been found effective in reducing endometriosis-related pain symptoms, whereas only limited studies are available on the efficacy of the endometriosis diet. A survey study recently found the endometriosis diet effective in improving QoL but currently no guidelines on use of the diet exist., Study Design, Size, Duration: A prospective one-center pilot study was performed between April 2021 and December 2022. Participants could choose between adherence to a diet-the Low FODMAP diet or endometriosis diet-or no diet (control group). Women adhering to a diet received extensive guidance from a dietician in training. The follow-up period was 6 months for all three groups. For all outcomes, women adhering to the diets were compared to their baseline situation and to the control group., Participants/materials, Setting, Methods: We included women diagnosed with endometriosis (surgically and/or by radiologic imaging) who reported pain scores ≥3 cm on the visual analogue score (0-10 cm) for dysmenorrhea, deep dyspareunia, and/or chronic pelvic pain. The primary endpoint focused on pain reduction for all pain symptoms, including dysuria, bloating, and tiredness. Secondary endpoints, assessed via questionnaires, focused on QoL, gastro-intestinal health, and diet adherence., Main Results and the Role of Chance: A total of 62 participants were included in the low FODMAP diet (n = 22), endometriosis diet (n = 21), and control group (n = 19). Compared to their baseline pain scores, participants adhering to a diet reported less pain in four of six symptoms (range P < 0.001 to P = 0.012) and better scores in 6 of 11 QoL domains (range P < 0.001 to P = 0.023) after 6 months. Compared to the control group, analyzed longitudinally over the 6-month follow-up period, participants applying a diet reported significant less bloating (P = 0.049), and better scores in 3 of 11 QoL domains (range P = 0.002 to P = 0.035)., Limitations, Reasons for Caution: No sample size was calculated since efficacy data were lacking in the literature. In order to optimize dietary adherence, randomization was not applied, possibly resulting in selection bias., Wider Implications of the Findings: Our study suggests that women could benefit from adherence to a dietary intervention, since we found lower pain scores and better QoL after 6 months. However, caution is implied since this is a pilot study, no sample size was calculated, and data on long-term effects (>6 months) are lacking. The results of this pilot study underline the importance of further research and the drawing up of guidelines., Study Funding/competing Interest(s): A.v.H. reports receiving a travel grant from Merck outside the scope of this study. J.W., S.V., J.T., and B.D.B. have no conflicts of interest to report. A.d.V. reports having received KP-register points for internship guidance of J.W., performing paid consultations with endometriosis patients outside the study and receiving reimbursements for educational lectures at the local hospital (Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands). A.S. reports having received expenses for travel and hotel costs as an invited speaker from ESHRE. This was outside the scope of this study. M.v.W. reports that she is a Co-Ed of Cochrane Gynecology and Fertility. V.M. reports receiving travel and speaker's fees from Guerbet and research grants from Guerbet, Merck and Ferring. The department of reproductive medicine (V.M.) of the Amsterdam UMC, location VUmc, has received several research and educational grants from Guerbet, Merck and Ferring not related to the submitted work., Trial Registration Number: N/A., (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2023
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