Abstract
Hallux valgus surgery (HVS) is one of the most common orthopedic procedures, often occurring in older adults. Guidelines provide inconsistent recommendations about venous thromboembolism (VTE) prophylaxis after HVS and data are scarce regarding VTE presentation and outcomes in this population. We reported the clinical characteristics and outcomes of VTE following HVS among patients enrolled in Registro Informatizado Enfermedad TromboEmbolica (RIETE), a prospective multicenter VTE registry. We compared the findings with those of other patients in RIETE. Consecutive patients with VTE post HVS were included in the study. Baseline characteristics, administration of VTE prophylaxis prior to diagnosis, presenting symptoms and signs, risk factors for VTE, and 90-day outcomes including recurrent VTE, major bleeding and death were determined. A total of 54 patients with VTE post HVS were identified in RIETE [median age: 64 (interquartile range 56–71) years; 85.2% female] and were compared with 74,111 VTE patients who had not undergone HVS. Among those with VTE post HVS, 63.0% had received VTE prophylaxis, in contrast to 35.6% in the rest of the RIETE cohort. Simplified Pulmonary Embolism Severity Index was zero in 66.7% of the patients with pulmonary embolism post HVS and 33.3% of other RIETE patients (P = 0.011). Compared with other VTE patients, use of estrogens was higher in HVS group (13.0% vs 5.4%, P = 0.01). All patients with VTE post HVS (100%) and most of other VTE patients (99.6%) were treated with anticoagulation, most commonly with low-molecular weight heparins. In contrast to the rest of the patients in RIETE, the absolute number of all fatal and non-fatal outcomes at 90 days was zero in the post HVS group (i.e. no deaths, no recurrence of VTE, and no major bleeding). In a large registry of patients with VTE, all patients with VTE post HVS underwent anticoagulation. These patients had much better outcomes than the rest of VTE patients, with no deaths, recurrences or major bleeding events at 90-day follow-up.
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Acknowledgements
We express our gratitude to Sanofi Spain for supporting this Registry with an unrestricted educational grant. We also express our gratitude to Bayer Pharma AG for supporting this Registry. Bayer Pharma AG’s support was limited to the part of RIETE outside Spain, which accounts for a 25.28% of the total patients included in the RIETE Registry. We also thank the RIETE Registry Coordinating Center, S&H Medical Science Service, for their quality control data, logistic and administrative support and Prof.
Funding
RIETE registry is supported by research grants from Sanofi Spain and Bayer Pharma AG. The funders have no access to the database nor had any role in the design of the current study. They did not have access to the prepared manuscript, and did not have a role in the decision to submit the manuscript.
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Dr. Behnood Bikdeli was supported by the National Heart, Lung, and. Blood Institute, National Institutes of Health, through Grant Number T32 HL007854. The content is the responsibility of the authors and does not necessarily represent the views of the NIH. Dr. Bikdeli reports that he has been a consulting expert (on behalf of the plaintiff) for litigation related to a specific type of IVC filters. Dr Ido Weinberg is on the scientific advisory board for Novate Medical and a non-compensated advisor for BTG. The current study is the idea of the investigators and has not been prepared at the request of a third party. Other authors have no conflict of interest to disclose.
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Appendix
Appendix
Coordinator of the RIETE Registry: Manuel Monreal.
RIETE Steering Committee Members: Paolo Prandoni, Benjamin Brenner and Dominique Farge-Bancel.
RIETE National Coordinators: Raquel Barba (Spain), Pierpaolo Di Micco (Italy), Laurent Bertoletti (France), Sebastian Schellong (Germany), Inna Tzoran (Israel), Abilio Reis (Portugal), Marijan Bosevski (R. Macedonia), Henri Bounameaux (Switzerland), Radovan Malý (Czech Republic), Peter Verhamme (Belgium), Joseph A. Caprini (USA), Hanh My Bui (Vietnam).
RIETE Registry Coordinating Center: S & H Medical Science Service. Members of the RIETE Group.
SPAIN: Adarraga MD, Agud M, Aibar MA, Amado C, Arcelus JI, Ballaz A, Barba R, Barbagelata C, Barrón M, Barrón-Andrés B, Blanco-Molina A, Camon AM, Cañas I, Carrasco C, Castro J, de Ancos C, del Toro J, Demelo P, Díaz-Pedroche C, Díaz-Peromingo JA, Encabo M, Falgá C, Farfán AI, Fernández de Roitegui K, Fernández-Capitán C, Fernández-Criado MC, Fidalgo MA, Flores K, Font C, Font L, Furest I, Galián JD, García MA, García-Bragado F, García-Morillo M, García-Raso A, Gavín O, Gayol MC, Gil-Díaz A, Gómez V, Gómez-Cuervo C, González-Martínez J, Grau E, Gutiérrez J, Hernández-Blasco LM, Hermosa-Los Arcos MJ, Iglesias M, Jara-Palomares L, Jaras MJ, Jiménez D, Jiménez R, Joya MD, Jou I, Lima J, Llamas P, Lobo JL, López-Jiménez L, López-Miguel P, López-Núñez JJ, López-Reyes R, López-Sáez JB, Lorente MA, Lorenzo A, Loring M, Lumbierres M, Madridano O, Maestre A, Marchena PJ, Martín del Pozo M, Martínez-García MA, Mella C, Mellado M, Monreal M, Morales MV, Nieto ML, Nieto JA, Núñez MJ, Olivares MC, Otalora S, Otero R, Panadero-Macía M, Pedrajas JM, Pellejero G, Pérez-Ductor C, Pérez-Jacoiste A, Pérez-Rus G, Peris ML, Porras JA, Rivas A, Rodríguez-Cobo A, Rodríguez-Hernández A, Rubio CM, Ruiz-Ruiz J, Ruiz-Sada P, Sahuquillo JC, Sala-Sainz MC, Salazar V, Salgueiro G, Sampériz A, Sánchez-Muñoz-Torrero JF, Sancho T, Soler S, Suriñach JM, Tolosa C, Torres MI, Uresandi F, Valle R, Vela JR, Vidal G, Villares P, ARGENTINA: Gutiérrez P, Vázquez FJ, Vilaseca A, BELGIUM: Vanassche T, Vandenbriele C, Verhamme P, BRAZIL: Yoo HHB, CZECH REPUBLIC: Hirmerova J, Malý R, ECUADOR: Salgado E, FRANCE: Benzidia I, Bertoletti L, Bura-Riviere A, Debourdeau P, Farge-Bancel D, Helfer H, Hij A, Mahé I, Moustafa F, GERMANY: Schellong S, ISRAEL: Braester A, Brenner B, Tzoran I, IRAN: Sharif-Kashani B, ITALY: Barillari G, Bilora F, Bortoluzzi C, Brandolin B, Ciammaichella M, Dentali F, Di Micco P, Folath M, Imbalzano E, Landolfi R, Maida R, Mastroiacovo D, Pace F, Pallotti G, Pesavento R, Prandoni P, Quintavalla R, Rocci A, Siniscalchi C, Tufano A, Visonà A, Zalunardo B, LATVIA: Gibietis V, Kigitovica D, Skride A, REPUBLIC OF MACEDONIA: Bosevski M, SWITZERLAND: Bounameaux H, Mazzolai L, USA: Bikdeli B, Caprini J, VIETNAM: Bui HM. Salvador Ortiz, Universidad Autónoma Madrid and Silvia Galindo, both Statistical Advisors in S&H Medical Science Service for the statistical analysis of the data presented in this paper.
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Bikdeli, B., Visvanathan, R., Weinberg, I. et al. Clinical characteristics and outcomes of venous thromboembolic events after hallux valgus surgery: insights from the RIETE registry. J Thromb Thrombolysis 49, 651–658 (2020). https://doi.org/10.1007/s11239-019-02025-2
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DOI: https://doi.org/10.1007/s11239-019-02025-2