Padua Prediction Score and Hospital Acquired Proximal and Isolated Distal Deep Vein Thrombosis

Padua Prediction Score and Hospital Acquired Proximal and Isolated Distal Deep Vein Thrombosis | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Padua Prediction Score and Hospital Acquired Proximal and Isolated Distal Deep Vein Thrombosis Michelangelo Sartori, Mario Soldati, Mriam Fiocca, Laura Borgese, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4325562/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Hospital acquired deep vein thrombosis (DVT) is an important cause of morbidity and mortality. The purpose of this study was to evaluate the prevalence of lower limb proximal DVT and isolated distal DVT (IDDVT) and the relationship with the Padua Prediction score (PPS) in acutely ill hospitalized medical patients. In a single center cross-sectional study, all inpatients from medical departments with suspected lower-extremity DVT were evaluated with whole-leg ultrasonography during 183 days from 2016 to 2017. Among the 507 inpatients (age 78.0±13.3 y, females 59.2%) from medical departments, 204 (40.2%) had PPS ≥4, but only 54.4% of them underwent pharmacological thrombo-prophylaxis. Whole leg ultrasonography detected 47 proximal DVTs (9.3%) and 65 IDDVTs (12.8%). Proximal DVT prevalence was higher in patients with high PPS vs those with low PPS (12.7% vs. 7.0% p=0.029, respectively), whereas IDDVT prevalence was similar in patients with high and low PPS score (14.7% vs. 11.6% p=0.311, respectively). The area under the receiver operating curve (AUC) for the PPS was 0.62±0.03 for all DVTs, 0.64±0.04 for proximal DVT, 0.58±0.04 for IDDVT. In hospitalized patients, IDDVT has a similar prevalence regardless of PPS risk stratification. Adherence to thrombo-prophylaxis in medical patients was still far from optimal. deep vein thrombosis diagnosis inpatients isolated distal deep vein thrombosis calf deep vein thrombosis Padua Prediction Score Figures Figure 1 Highlights Current guidelines recommend anticoagulant thrombo-prophylaxis with low-molecular-weight heparin for acutely ill hospitalized medical patients based on the Padua Prediction Score (PPS). A single center cross-sectional study was conducted in a University Hospital. Isolated Distal DVT prevalence in patients with low PPS and high PPS was similar, in contrast with the aim of PPS itself. INTRODUCTION Hospital-related venous thromboembolism (VTE) is a major cause of long-term morbidity, functional disability, and mortality [ 1 ]. Recently we showed that isolated distal or calf vein thrombosis (IDDVT) is a frequent finding in hospitalized patients [ 2 ]. Although IDDVT is a more benign condition than proximal DVT, it may extend to proximal veins or may lead to pulmonary embolism (PE) if left untreated [ 3 ]. Past guidelines recommend anticoagulant thrombo-prophylaxis with low-molecular-weight heparin for acutely ill hospitalized medical patients at increased risk of thrombosis [ 4 ] and suggest a risk assessment model based on the Padua Prediction Score (PPS) for baseline low- and high-risk stratification [ 4 ]. In the original study of Barbar et al, patients with PPS score ≥ 4 experienced 30 times more VTE complications as compared with the low-risk group [ 5 ]. However, PPS was empirically created on experts’ opinion and literature reviews and was validated in a population that included patients receiving thrombo-prophylaxis [ 5 ]. In a retrospective analysis of patients enrolled in the PREVENU trial, PPS performance was not superior than the patient’s age alone in VTE risk assessment [ 6 ]. Nevertheless, PPS is applied extensively in medical departments in Emilia Romagna [ 7 ] and its use is encouraged by latest guidelines [ 8 ]. Since no data is available on the PPS ability to accurately identify inpatients at risk of IDDVT, the purpose of this study was to evaluate the prevalence of lower limb DVT in different risk stratification groups based on the PPS in hospitalized patients from medical wards. METHODS Study setting This was an ancillary analysis of an observational cross-sectional study performed in a Tertiary Healthcare Academic Hospital (IRCCS Azienda Ospedaliero-Universitaria di Bologna) from October 2016 to March 2017 sought to describe the prevalence of lower limb DVT in inpatients and the accuracy of the Wells rule for suspected lower limb DVT in hospitalized patients [ 2 ]. The study was approved by the local Ethics Committee. Written informed consent was obtained from all patients. All procedures performed in the present study involving human participants were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Study population In the present sub-analysis, patients from medical/hematology/oncology departments were considered eligible and recruited if symptomatic and referred to the Vascular Emergency Service for suspected acute DVT of the lower limbs. Exclusion criteria consisted of DVT symptoms prior to hospital admission, history of hospitalization for DVT and/or PE, diagnosis of DVT and/or PE in the previous 12 months, age under 18 years, pregnancy or puerperium, surgery, leg fracture or plaster cast within 3 months before admission – although patients with minor trauma involving the symptomatic leg were included. Moreover, we excluded patients that were already receiving anticoagulants such as vitamin K antagonists or direct oral anticoagulants before admission. At admission, the need of pharmacologic thrombo-prophylaxis was assessed by the medical ward clinician. During the subsequent stay, in case of suspected lower extremity DVT, an ultrasound scan (whole leg duplex ultrasonography - DUS) was performed within 24 hours. In the Vascular Emergency Service, patients signed the informed consent and a separate investigator reviewed the clinical files, performed a physical examination of the patient in the supine position, and elicited a personal and family history from each patient, collecting data on as standardized form and calculated PPS. The number of days from admission (day 0) to the time when suspicion of DVT arose were calculated. Next, an other physicians performed and interpreted the DUS. Diagnosis of proximal DVT and IDDVT was based on DUS. Pharmacologic thrombo-prophylaxis was defined as the use of subcutaneous heparin calcium, 5000 U, 2 or 3 times daily, or subcutaneous enoxaparin sodium, 40mg/d, or subcutaneous fondaparinux, 1,5/2,5 mg/d, started at admission and administered daily until whole leg ultrasound. Padua Prediction Score Among the several risk assessment models for VTE in medical inpatients, past guidelines suggested the PPS [ 4 ]. The PPS includes several items. One point was added for each of the following positive findings: a) age ≥ 70 years; b) heart and/or respiratory failure; c) acute myocardial infarction or ischemic stroke; d) acute infection and/or rheumatologic disorder; e) BMI ≥ 30; f) ongoing hormonal treatment; two points were added for recent trauma and/or surgery; three points were added for each of the following positive finding: a) Active cancer; b) previous VTE; c) reduced mobility; d) already known thrombophilic condition. The overall score was obtained by the sum of each item and a final score ≥ 4 was considered indicative of high risk of VTE [ 5 ]. Immobility was defined as bed rest without bathroom privileges (either because of patient’s limitations or on physician’s order) for at least 3 days. The patients enrolled in the present study were considered to have: (i) acute respiratory failure if they were admitted to the medical ward for acute hypoxemia due to lung failure; (ii) acute heart failure if they were admitted to the medical ward for rapid onset or worsening of symptoms and/or signs of heart failure as a first occurrence or because of acute decompensation of chronic heart failure. Whole-leg ultrasonography investigation In our Academic Hospital, hospitalized patients with clinical suspicion of DVT undergo a DUS evaluation within 24 h from the request. In 2016 and 2017, board-certified Vascular Medicine physicians performed DUS of both lower extremities with an EnVisor C HD (Philips Medical System S.p.A, Monza, Italy) using a standardized examination protocol as previously described [ 9 ]. Briefly, patients underwent a comprehensive real-time B-mode and color Doppler compression ultrasonography examination of both legs: first the proximal deep veins, then the calf veins. The veins were scanned in the transverse plane over their entire length: posterior tibial veins, fibular veins, internal and external gastrocnemius veins, and soleal veins. DVT diagnosis was confirmed in case of absence of compression of the vein, combined with the absence of venous flow with distal compression. IDDVT was defined as thrombosis confined to the infra-popliteal veins of the lower limbs (or calf deep vein thrombosis), whereas thrombosis that involved the popliteal vein and/or the above venous system was defined as proximal DVT. The physician interpreting the ultrasound was blinded to the PPS. Statistical analysis Analysis was carried out using the SPSS™software package (version 21; IBM Corp., USA). Relationships between variables were assessed by means of Pearson correlation for continuous variables and chi-square test for categorical variables. Student t-test was used to compare means among groups for normally distributed variables. Receivers operating characteristic (ROC) curves were determined by plotting the sensitivity versus 1- specificity. The area under the ROC-curves (AUC) for the discriminatory accuracy of the PPS was calculated. Categorical variables were expressed as frequency and percentage with 95% CI; continuous variables were expressed as mean ± SD. For the time-to-first-event analysis, cumulative endpoint curves were estimated with the Kaplan–Meier procedure and survival curves were tested by the log-rank test. The significance level was set at < 0.05. Results Characteristics of 507 patients (age 78.0 ± 13.3 y, females 59.2%) enrolled from medical/hematology/oncology departments with suspected lower limb DVT are summarized in Table 1. Among them, the most frequent risk factors for thrombosis were immobility (50.9%), cancer (22.3%), minor trauma involving the symptomatic leg within 1 month (14.4%), and previous VTE (13.8%). Pharmacologic thrombo-prophylaxis was administered to 282 (55.6%) patients. There were 301 (59.4%) patients with PPS < 4 and 204 (40.2%) with PPS ≥ 4, in two patients PPS was not calculated (table 2). The percentage of subjects receiving pharmacological thrombo-prophylaxis was similar in patients with a high and a low PPS (57.2% vs. 54.2%, p = 0.413, respectively). DUS was performed after a mean of 5 days (median 3 days) from hospitalization and detected DVT in 112 patients (22.1%): in 47 patients (9.3%) proximal DVTs were found while in 65 (12.9%) IDDVTs were found. As shown in table 2, the prevalence of all DVTs was 18.6% in low probability group according to PPS stratification and 27.5% in high probability group (p = 0.019). Proximal DVT prevalence was higher in patients with high PPS vs those with low PPS (12.7% vs. 7.1% p = 0.029, respectively), whereas IDDVT prevalence was similar in patients with high and low PPS score (14.7% vs. 11.6% p = 0.311, respectively). Considering the discriminatory accuracy of PPS for all DVTs risk identified on DUS, the area under the receiver operating characteristics curve (AUC) was 0.62 ± 0.03, the AUC for proximal DVT was 0.64 ± 0.04, whereas it was 0.58 ± 0.04 for IDDVT. The Kaplan–Meier curves of probability for DVTs in patients with high PPS vs low PSS according to the time from admission are reported in Fig. 1 and show that patients suspected of DVT with high PSS had a similar risk of DVT than those with low PPS (p = 0.339). Among the 224 patients without pharmacological thrombo-prophylaxis, proximal DVT prevalence (11.6% vs. 8.0% p = 0.361) and IDDVT prevalence (18.6% vs. 11.6% p = 0.145) were similar in patients with a high and a low PPS score. Among the 281 patients receiving pharmacological thrombo-prophylaxis, proximal DVT prevalence was higher in patients with high PPS vs those with low PPS (13.6% vs. 6.1% p = 0.034), whereas IDDVT prevalence was similar in patients with high PPS vs those with low PPS (11.9% vs. 11.7% p = 0.957). Discussion Our data show that hospital-acquired IDDVT is a more frequent finding than proximal DVT and its prevalence in patients with low PPS is similar than in those with high PPS, in contrast with the aim of PPS itself, such as the stratification of VTE risk. Of note, PPS cannot be used to predict and diagnose DVT. It has already been clearly established that hospitalization is one of the major factors for the risk of VTE and hospitalization for acute medical illness is associated with an eightfold increased risk of VTE [ 10 ]. As shown by Heit et al., the overall VTE incidence rate in a cohort of patients who resided in Olmsted County, Minnesota, was of 960.5 per 10,000 person-years in hospitalized patients while it was 100 times less in community residents (7.1 per 10,000 person-years) [ 11 ]. We have already shown that DVT prevalence was 1.1% in our hospital, in line with data from a large population of US medical patients, among whom 2.0% of all patients experienced a DVT during their hospitalization [ 12 ]. In accordance with these data, past and present guidelines recommend anticoagulant thrombo-prophylaxis with low-molecular-weight heparin for acutely ill hospitalized medical patients at increased risk of thrombosis [ 4 , 8 ]. At the time of the study design, the 9th American College of Chest Physicians Evidence-Based Clinical Practice Guidelines suggested PPS for VTE risk [ 4 ]. PPS was validated based on several studies with conflicting results [ 13 ]. Vardi et al. studied VTE risk among 1080 patients hospitalized because of sepsis; they showed that 71.2% of the patients had a positive PPS and this was highly associated with death and may reflect a more general co-morbidity and disease severity index [ 14 ]. The ESTIMATE study, the first study to test the PPS in a multicenter setting, showed that both Geneva Risk Score and PPS were strongly associated with the composite endpoint of symptomatic VTE or VTE-related death [ 15 ]. PPS was compared to the Caprini RAM (risk assessment model) in a Chinese case-control study by Zhou et al; the Caprini score showed greater sensitivity in identifying high risk hospitalized patients (82.3% of high risk patients according to the Caprini RAM had VTE vs 30.1% according to PPS), even if VTE risk associated to highest risk groups determined by both models was similar [ 16 ]. Also Liu et al found the Caprini RAM having a greater sensitivity and positive and negative predictive values than the Padua RAM, although PPS had a higher specificity [ 17 ]. In addition, an Automated Padua Prediction Score (APPS) to auto-calculate a VTE risk score using electronic health record was developed, showing no significant difference in average score and a similar ability in predicting VTE risk [ 18 ]. Among the many available RAMs, in 2018 the “TEVere Score” was developed by Vincentelli et al, based on VTE risk factors with higher statistical significance, and it showed a higher specificity and sensitivity (respectively 43.3 and 87.5, with accuracy 72.1) compared with the PPS [ 19 ]. Of note, a retrospective analysis on patients prospectively enrolled in the PREVENU trial, aimed at comparing the main RAMs (including the Caprini score, IMPROVE and PPS), showed that none of them performed significantly better than advanced age as a single predictor [ 6 ]. Also Wang et al. compared the PPS with nine machine learning methods, since the PPS model is not suitable for the Chinese population because of differences in race and disease spectrum; nevertheless they showed lower sensitivities to that of the PPS [ 20 ]. In our series, we expected a lower prevalence of DVT in the low risk PPS group vs those with PPS ≥ 4, whereas IDDVT prevalence was similar in patients with high and low PPS score and proximal DVT prevalence was only slightly higher in patients with high PPS vs those with low PPS. This evidence is in line with a recent review on risk assessment models for VTE in hospitalised adult patients that found a modest ability of PPS in predicting the risk of VTE [ 13 ]. In the Prevention of Venous Thromboembolism Disease in Emergency Departments (PREVENU) study on 14 660 patients hospitalized for at least 2 days in a medical ward, PPS performance was not superior than an advanced age alone in VTE risk assessment [ 6 ]. Moreover, in a multicenter retrospective cohort study including over 1 million of unselected consecutive hospitalizations across the United States, the PPS demonstrated limited predictive ability with a PPS discriminatory accuracy for VTE risk of 0.59 [ 21 ], in line with our results (discriminatory accuracy of 0.62). Our study shows the prevalence of hospital acquired IDDVT is higher than the prevalence of proximal DVT, in opposition with our findings in outpatients [ 22 ]. Since the prevalence of inpatients DVT is higher than community-acquired DVT, such difference may be at least partially due to an elevated prevalence of isolated distal DVT. Our study suggests that patients in medical wards are at higher risk of IDDVT than outpatients. In fact, the Riete registry showed that IDDVT was more frequently associated to transient risk factors (i.e. recent travel, hospitalization, recent surgery), whereas proximal DVTs were more frequently associated with chronic states [ 23 ]. Patients receiving pharmacological thrombo-prophylaxis had a similar prevalence of DVT than those without thrombo-prophylaxis. This may be due to several reasons: 1) our participants were enrolled because of suspected DVT and this could represent a potential selection bias; 2) we performed DUS within 24h from clinical suspicion and this could have led to an early diagnosis before extension to the proximal veins; 3) we only enrolled patients complaining of symptoms and could have missed asymptomatic thrombosis; 4) the study was not prospective; 5) the use of mechanical prophylaxis in several patients could have reduced DVT prevalence in patients not receiving pharmacological thrombo-prophylaxis. The use of pharmacological thrombo-prophylaxis was similar in patients with a high and a low PPS. This is in line with a recent meta-analysis showing that thrombo-prophylaxis prescriptions were still unsatisfactory among hospitalized medically ill patients in several countries [ 24 ]. Despite guidelines recommendations, adherence to thrombo-prophylaxis remains moderate, with almost 40% of patients at high risk according to PPS that do not receive prophylaxis [ 24 ]. These results further support a call to action for pharmacological thrombo-prophylaxis in medical patients because they are at risk not only for DVT, but also for PE [ 8 ]. The risk assessment models should aim to help clinicians selecting medical inpatients who are at increased risk of VTE and may benefit of prophylaxis. However, no risk assessment model had satisfactory performances in this setting and which risk assessment model is optimal is still uncertain. Even though not all patients may benefit from thrombo-prophylaxis, our data support the use of thrombo-prophylaxis in all medical inpatients without contraindications or high bleeding risk, as recently suggested [ 25 ]. Some limitations of the present study should be acknowledged. No inter-observer variability was assessed for IDDVT diagnosis; we did not follow-up patients with negative whole-leg ultrasonography examination, but several studies have shown that anticoagulant therapy can be safely withheld after negative complete compression ultrasound without further testing [ 22 , 26 ] also in inpatients [ 27 ]. The prevalence of DVT may have been underestimated since we did not evaluate patients with asymptomatic DVT or with symptomatic DVT who were discharged before referral to our service. The study was conducted in a single academic institution and may not be representative of population in different types of hospitals. We must underline that our participants were enrolled because suspected DVT, suggesting a potential selection bias. In summary, IDDVT is a frequent finding in inpatients and its prevalence is not related to PPS, in contrast with the aim of PPS itself. Our study supports that clinical judgment should be integrated with risk assessment models for VTE in medical inpatients. Declarations Funding: None. Compliance with ethical standards Conflict of interest : The author(s) declare that they have no conflict of interest. Statement of human and animal rights : All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent was obtained from all patients. Financial disclosure : none References Dobesh P. P. (2009). Economic burden of venous thromboembolism in hospitalized patients. Pharmacotherapy, 29(8), 943–953. https://doi.org/10.1592/phco.29.8.943 Sartori, M., Gabrielli, F., Favaretto, E., Filippini, M., Migliaccio, L., & Cosmi, B. (2019). 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Age-adjusted D-dimer, clinical pre-test probability-adjusted D-dimer, and whole leg ultrasound in ruling out suspected proximal and calf deep venous thrombosis. American journal of hematology, 98(11), 1772–1779. https://doi.org/10.1002/ajh.27077 Galanaud, J. P., Quenet, S., Rivron-Guillot, K., Quere, I., Sanchez Muñoz-Torrero, J. F., Tolosa, C., Monreal, M., & RIETE INVESTIGATORS (2009). Comparison of the clinical history of symptomatic isolated distal deep-vein thrombosis vs. proximal deep vein thrombosis in 11 086 patients. Journal of thrombosis and haemostasis : JTH, 7(12), 2028–2034. https://doi.org/10.1111/j.1538-7836.2009.03629.x Forgo, G., Micieli, E., Ageno, W., Castellucci, L. A., Cesarman-Maus, G., Ddungu, H., De Paula, E. V., Dumantepe, M., Guillermo Esposito, M. C., Konstantinides, S. V., Kucher, N., McLintock, C., Ní Áinle, F., Spyropoulos, A. C., Urano, T., Hunt, B. J., & Barco, S. (2022). An update on the global use of risk assessment models and thromboprophylaxis in hospitalized patients with medical illnesses from the World Thrombosis Day steering committee: Systematic review and meta-analysis. Journal of thrombosis and haemostasis : JTH, 20(2), 409–421. https://doi.org/10.1111/jth.15607 Davis, S., Goodacre, S., Horner, D., Pandor, A., Holland, M., de Wit, K., Hunt, B. J., & Griffin, X. L. (2024). Effectiveness and cost effectiveness of pharmacological thromboprophylaxis for medical inpatients: decision analysis modelling study. BMJ medicine, 3(1), e000408. https://doi.org/10.1136/bmjmed-2022-000408 Johnson, S. A., Stevens, S. M., Woller, S. C., Lake, E., Donadini, M., Cheng, J., Labarère, J., & Douketis, J. D. (2010). Risk of deep vein thrombosis following a single negative whole-leg compression ultrasound: a systematic review and meta-analysis. JAMA, 303(5), 438–445. https://doi.org/10.1001/jama.2010.43 Sevestre, M. A., Labarère, J., Casez, P., Bressollette, L., Haddouche, M., Pernod, G., Quéré, I., & Bosson, J. L. (2010). Outcomes for inpatients with normal findings on whole-leg ultrasonography: a prospective study. The American journal of medicine, 123(2), 158–165. https://doi.org/10.1016/j.amjmed.2009.05.034 Tables Tables 1 to 3 are available in the Supplementary Files section. Supplementary Files Tables1to3.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4325562","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":296860523,"identity":"03f5b99a-0f4d-45b3-9a80-78645791d2a9","order_by":0,"name":"Michelangelo Sartori","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0003-3466-4676","institution":"IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola","correspondingAuthor":true,"prefix":"","firstName":"Michelangelo","middleName":"","lastName":"Sartori","suffix":""},{"id":296860524,"identity":"e08e0f9a-b1bb-48c5-8c28-a7b6fef09cdb","order_by":1,"name":"Mario Soldati","email":"","orcid":"","institution":"IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola: IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola","correspondingAuthor":false,"prefix":"","firstName":"Mario","middleName":"","lastName":"Soldati","suffix":""},{"id":296860525,"identity":"8c90d81f-4c0a-4c8b-8c84-6746607aaf2d","order_by":2,"name":"Mriam Fiocca","email":"","orcid":"","institution":"IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola: IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola","correspondingAuthor":false,"prefix":"","firstName":"Mriam","middleName":"","lastName":"Fiocca","suffix":""},{"id":296860526,"identity":"5583b6b9-4d94-439a-94c1-f40d1b199921","order_by":3,"name":"Laura Borgese","email":"","orcid":"","institution":"IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola: IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola","correspondingAuthor":false,"prefix":"","firstName":"Laura","middleName":"","lastName":"Borgese","suffix":""},{"id":296860527,"identity":"27c0b36d-e47f-4352-880f-910f8230a00c","order_by":4,"name":"Elisabetta Favaretto","email":"","orcid":"","institution":"IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola","correspondingAuthor":false,"prefix":"","firstName":"Elisabetta","middleName":"","lastName":"Favaretto","suffix":""},{"id":296860528,"identity":"de4544ac-2e9e-4f1b-b294-c8241f49a6b3","order_by":5,"name":"Benilde Cosmi","email":"","orcid":"","institution":"IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola","correspondingAuthor":false,"prefix":"","firstName":"Benilde","middleName":"","lastName":"Cosmi","suffix":""}],"badges":[],"createdAt":"2024-04-25 17:27:00","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4325562/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4325562/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":56043740,"identity":"2bf29709-6ba2-4ad6-8d42-0f8d297c677d","added_by":"auto","created_at":"2024-05-07 20:25:43","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":30958,"visible":true,"origin":"","legend":"\u003cp\u003eEstimated cumulative probability of all DVTs (proximal and IDDVT) in acutely ill medical inpatients suspected of DVT with low PPS (solid line) and in those with high PPS (dotted line) according to the time when whole leg ultrasound was performed (days, day 0 admission to the medical ward). DVT, deep vein thrombosis; IDDVT, isolated distal vein thrombosis; high PPS, Padua Prediction Score \u003cu\u003e\u0026gt;\u003c/u\u003e4; low PPS, Padua Prediction Score \u0026lt;4.\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4325562/v1/e193572863c3fea881d3c719.jpg"},{"id":58001581,"identity":"cc3da2af-1d22-4b47-937d-6ba0d05b368a","added_by":"auto","created_at":"2024-06-09 14:01:24","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":348920,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4325562/v1/f1def0d7-8d62-4097-b964-88855ec7b328.pdf"},{"id":56043741,"identity":"fec11c28-eae6-4eb1-879f-71bf8e163bfa","added_by":"auto","created_at":"2024-05-07 20:25:43","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":15650,"visible":true,"origin":"","legend":"","description":"","filename":"Tables1to3.docx","url":"https://assets-eu.researchsquare.com/files/rs-4325562/v1/bfacc611d33d9a2b16f0350e.docx"}],"financialInterests":"","formattedTitle":"Padua Prediction Score and Hospital Acquired Proximal and Isolated Distal Deep Vein Thrombosis","fulltext":[{"header":"Highlights","content":"\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eCurrent guidelines recommend anticoagulant thrombo-prophylaxis with low-molecular-weight heparin for acutely ill hospitalized medical patients based on the Padua Prediction Score (PPS).\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eA single center cross-sectional study was conducted in a University Hospital.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eIsolated Distal DVT prevalence in patients with low PPS and high PPS was similar, in contrast with the aim of PPS itself.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"INTRODUCTION","content":"\u003cp\u003eHospital-related venous thromboembolism (VTE) is a major cause of long-term morbidity, functional disability, and mortality [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Recently we showed that isolated distal or calf vein thrombosis (IDDVT) is a frequent finding in hospitalized patients [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Although IDDVT is a more benign condition than proximal DVT, it may extend to proximal veins or may lead to pulmonary embolism (PE) if left untreated [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePast guidelines recommend anticoagulant thrombo-prophylaxis with low-molecular-weight heparin for acutely ill hospitalized medical patients at increased risk of thrombosis [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] and suggest a risk assessment model based on the Padua Prediction Score (PPS) for baseline low- and high-risk stratification [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. In the original study of Barbar et al, patients with PPS score\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026ge;\u003c/span\u003e\u0026thinsp;4 experienced 30 times more VTE complications as compared with the low-risk group [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. However, PPS was empirically created on experts\u0026rsquo; opinion and literature reviews and was validated in a population that included patients receiving thrombo-prophylaxis [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. In a retrospective analysis of patients enrolled in the PREVENU trial, PPS performance was not superior than the patient\u0026rsquo;s age alone in VTE risk assessment [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Nevertheless, PPS is applied extensively in medical departments in Emilia Romagna [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] and its use is encouraged by latest guidelines [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSince no data is available on the PPS ability to accurately identify inpatients at risk of IDDVT, the purpose of this study was to evaluate the prevalence of lower limb DVT in different risk stratification groups based on the PPS in hospitalized patients from medical wards.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy setting\u003c/h2\u003e \u003cp\u003eThis was an ancillary analysis of an observational cross-sectional study performed in a Tertiary Healthcare Academic Hospital (IRCCS Azienda Ospedaliero-Universitaria di Bologna) from October 2016 to March 2017 sought to describe the prevalence of lower limb DVT in inpatients and the accuracy of the Wells rule for suspected lower limb DVT in hospitalized patients [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The study was approved by the local Ethics Committee. Written informed consent was obtained from all patients. All procedures performed in the present study involving human participants were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy population\u003c/h2\u003e \u003cp\u003eIn the present sub-analysis, patients from medical/hematology/oncology departments were considered eligible and recruited if symptomatic and referred to the Vascular Emergency Service for suspected acute DVT of the lower limbs. Exclusion criteria consisted of DVT symptoms prior to hospital admission, history of hospitalization for DVT and/or PE, diagnosis of DVT and/or PE in the previous 12 months, age under 18 years, pregnancy or puerperium, surgery, leg fracture or plaster cast within 3 months before admission \u0026ndash; although patients with minor trauma involving the symptomatic leg were included. Moreover, we excluded patients that were already receiving anticoagulants such as vitamin K antagonists or direct oral anticoagulants before admission.\u003c/p\u003e \u003cp\u003eAt admission, the need of pharmacologic thrombo-prophylaxis was assessed by the medical ward clinician. During the subsequent stay, in case of suspected lower extremity DVT, an ultrasound scan (whole leg duplex ultrasonography - DUS) was performed within 24 hours. In the Vascular Emergency Service, patients signed the informed consent and a separate investigator reviewed the clinical files, performed a physical examination of the patient in the supine position, and elicited a personal and family history from each patient, collecting data on as standardized form and calculated PPS. The number of days from admission (day 0) to the time when suspicion of DVT arose were calculated. Next, an other physicians performed and interpreted the DUS. Diagnosis of proximal DVT and IDDVT was based on DUS.\u003c/p\u003e \u003cp\u003ePharmacologic thrombo-prophylaxis was defined as the use of subcutaneous heparin calcium, 5000 U, 2 or 3 times daily, or subcutaneous enoxaparin sodium, 40mg/d, or subcutaneous fondaparinux, 1,5/2,5 mg/d, started at admission and administered daily until whole leg ultrasound.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003ePadua Prediction Score\u003c/h2\u003e \u003cp\u003eAmong the several risk assessment models for VTE in medical inpatients, past guidelines suggested the PPS [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. The PPS includes several items. One point was added for each of the following positive findings: a) age\u0026thinsp;\u0026ge;\u0026thinsp;70 years; b) heart and/or respiratory failure; c) acute myocardial infarction or ischemic stroke; d) acute infection and/or rheumatologic disorder; e) BMI\u0026thinsp;\u0026ge;\u0026thinsp;30; f) ongoing hormonal treatment; two points were added for recent trauma and/or surgery; three points were added for each of the following positive finding: a) Active cancer; b) previous VTE; c) reduced mobility; d) already known thrombophilic condition. The overall score was obtained by the sum of each item and a final score\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026ge;\u003c/span\u003e\u0026thinsp;4 was considered indicative of high risk of VTE [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eImmobility was defined as bed rest without bathroom privileges (either because of patient\u0026rsquo;s limitations or on physician\u0026rsquo;s order) for at least 3 days. The patients enrolled in the present study were considered to have: (i) acute respiratory failure if they were admitted to the medical ward for acute hypoxemia due to lung failure; (ii) acute heart failure if they were admitted to the medical ward for rapid onset or worsening of symptoms and/or signs of heart failure as a first occurrence or because of acute decompensation of chronic heart failure.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eWhole-leg ultrasonography investigation\u003c/h2\u003e \u003cp\u003eIn our Academic Hospital, hospitalized patients with clinical suspicion of DVT undergo a DUS evaluation within 24 h from the request. In 2016 and 2017, board-certified Vascular Medicine physicians performed DUS of both lower extremities with an EnVisor C HD (Philips Medical System S.p.A, Monza, Italy) using a standardized examination protocol as previously described [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Briefly, patients underwent a comprehensive real-time B-mode and color Doppler compression ultrasonography examination of both legs: first the proximal deep veins, then the calf veins. The veins were scanned in the transverse plane over their entire length: posterior tibial veins, fibular veins, internal and external gastrocnemius veins, and soleal veins. DVT diagnosis was confirmed in case of absence of compression of the vein, combined with the absence of venous flow with distal compression. IDDVT was defined as thrombosis confined to the infra-popliteal veins of the lower limbs (or calf deep vein thrombosis), whereas thrombosis that involved the popliteal vein and/or the above venous system was defined as proximal DVT. The physician interpreting the ultrasound was blinded to the PPS.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eAnalysis was carried out using the SPSS\u0026trade;software package (version 21; IBM Corp., USA). Relationships between variables were assessed by means of Pearson correlation for continuous variables and chi-square test for categorical variables. Student t-test was used to compare means among groups for normally distributed variables. Receivers operating characteristic (ROC) curves were determined by plotting the sensitivity versus 1- specificity. The area under the ROC-curves (AUC) for the discriminatory accuracy of the PPS was calculated. Categorical variables were expressed as frequency and percentage with 95% CI; continuous variables were expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD. For the time-to-first-event analysis, cumulative endpoint curves were estimated with the Kaplan\u0026ndash;Meier procedure and survival curves were tested by the log-rank test. The significance level was set at \u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eCharacteristics of 507 patients (age 78.0\u0026thinsp;\u0026plusmn;\u0026thinsp;13.3 y, females 59.2%) enrolled from medical/hematology/oncology departments with suspected lower limb DVT are summarized in Table\u0026nbsp;1. Among them, the most frequent risk factors for thrombosis were immobility (50.9%), cancer (22.3%), minor trauma involving the symptomatic leg within 1 month (14.4%), and previous VTE (13.8%). Pharmacologic thrombo-prophylaxis was administered to 282 (55.6%) patients. There were 301 (59.4%) patients with PPS\u0026thinsp;\u0026lt;\u0026thinsp;4 and 204 (40.2%) with PPS\u0026thinsp;\u0026ge;\u0026thinsp;4, in two patients PPS was not calculated (table 2). The percentage of subjects receiving pharmacological thrombo-prophylaxis was similar in patients with a high and a low PPS (57.2% vs. 54.2%, p\u0026thinsp;=\u0026thinsp;0.413, respectively). DUS was performed after a mean of 5 days (median 3 days) from hospitalization and detected DVT in 112 patients (22.1%): in 47 patients (9.3%) proximal DVTs were found while in 65 (12.9%) IDDVTs were found. As shown in table 2, the prevalence of all DVTs was 18.6% in low probability group according to PPS stratification and 27.5% in high probability group (p\u0026thinsp;=\u0026thinsp;0.019). Proximal DVT prevalence was higher in patients with high PPS vs those with low PPS (12.7% vs. 7.1% p\u0026thinsp;=\u0026thinsp;0.029, respectively), whereas IDDVT prevalence was similar in patients with high and low PPS score (14.7% vs. 11.6% p\u0026thinsp;=\u0026thinsp;0.311, respectively). Considering the discriminatory accuracy of PPS for all DVTs risk identified on DUS, the area under the receiver operating characteristics curve (AUC) was 0.62\u0026thinsp;\u0026plusmn;\u0026thinsp;0.03, the AUC for proximal DVT was 0.64\u0026thinsp;\u0026plusmn;\u0026thinsp;0.04, whereas it was 0.58\u0026thinsp;\u0026plusmn;\u0026thinsp;0.04 for IDDVT.\u003c/p\u003e \u003cp\u003eThe Kaplan\u0026ndash;Meier curves of probability for DVTs in patients with high PPS vs low PSS according to the time from admission are reported in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e and show that patients suspected of DVT with high PSS had a similar risk of DVT than those with low PPS (p\u0026thinsp;=\u0026thinsp;0.339).\u003c/p\u003e \u003cp\u003eAmong the 224 patients without pharmacological thrombo-prophylaxis, proximal DVT prevalence (11.6% vs. 8.0% p\u0026thinsp;=\u0026thinsp;0.361) and IDDVT prevalence (18.6% vs. 11.6% p\u0026thinsp;=\u0026thinsp;0.145) were similar in patients with a high and a low PPS score. Among the 281 patients receiving pharmacological thrombo-prophylaxis, proximal DVT prevalence was higher in patients with high PPS vs those with low PPS (13.6% vs. 6.1% p\u0026thinsp;=\u0026thinsp;0.034), whereas IDDVT prevalence was similar in patients with high PPS vs those with low PPS (11.9% vs. 11.7% p\u0026thinsp;=\u0026thinsp;0.957).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur data show that hospital-acquired IDDVT is a more frequent finding than proximal DVT and its prevalence in patients with low PPS is similar than in those with high PPS, in contrast with the aim of PPS itself, such as the stratification of VTE risk. Of note, PPS cannot be used to predict and diagnose DVT.\u003c/p\u003e \u003cp\u003eIt has already been clearly established that hospitalization is one of the major factors for the risk of VTE and hospitalization for acute medical illness is associated with an eightfold increased risk of VTE [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. As shown by Heit et al., the overall VTE incidence rate in a cohort of patients who resided in Olmsted County, Minnesota, was of 960.5 per 10,000 person-years in hospitalized patients while it was 100 times less in community residents (7.1 per 10,000 person-years) [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. We have already shown that DVT prevalence was 1.1% in our hospital, in line with data from a large population of US medical patients, among whom 2.0% of all patients experienced a DVT during their hospitalization [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. In accordance with these data, past and present guidelines recommend anticoagulant thrombo-prophylaxis with low-molecular-weight heparin for acutely ill hospitalized medical patients at increased risk of thrombosis [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. At the time of the study design, the 9th American College of Chest Physicians Evidence-Based Clinical Practice Guidelines suggested PPS for VTE risk [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. PPS was validated based on several studies with conflicting results [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Vardi et al. studied VTE risk among 1080 patients hospitalized because of sepsis; they showed that 71.2% of the patients had a positive PPS and this was highly associated with death and may reflect a more general co-morbidity and disease severity index [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. The ESTIMATE study, the first study to test the PPS in a multicenter setting, showed that both Geneva Risk Score and PPS were strongly associated with the composite endpoint of symptomatic VTE or VTE-related death [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. PPS was compared to the Caprini RAM (risk assessment model) in a Chinese case-control study by Zhou et al; the Caprini score showed greater sensitivity in identifying high risk hospitalized patients (82.3% of high risk patients according to the Caprini RAM had VTE vs 30.1% according to PPS), even if VTE risk associated to highest risk groups determined by both models was similar [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Also Liu et al found the Caprini RAM having a greater sensitivity and positive and negative predictive values than the Padua RAM, although PPS had a higher specificity [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. In addition, an Automated Padua Prediction Score (APPS) to auto-calculate a VTE risk score using electronic health record was developed, showing no significant difference in average score and a similar ability in predicting VTE risk [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAmong the many available RAMs, in 2018 the \u0026ldquo;TEVere Score\u0026rdquo; was developed by Vincentelli et al, based on VTE risk factors with higher statistical significance, and it showed a higher specificity and sensitivity (respectively 43.3 and 87.5, with accuracy 72.1) compared with the PPS [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Of note, a retrospective analysis on patients prospectively enrolled in the PREVENU trial, aimed at comparing the main RAMs (including the Caprini score, IMPROVE and PPS), showed that none of them performed significantly better than advanced age as a single predictor [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Also Wang et al. compared the PPS with nine machine learning methods, since the PPS model is not suitable for the Chinese population because of differences in race and disease spectrum; nevertheless they showed lower sensitivities to that of the PPS [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. In our series, we expected a lower prevalence of DVT in the low risk PPS group vs those with PPS\u0026thinsp;\u0026ge;\u0026thinsp;4, whereas IDDVT prevalence was similar in patients with high and low PPS score and proximal DVT prevalence was only slightly higher in patients with high PPS vs those with low PPS. This evidence is in line with a recent review on risk assessment models for VTE in hospitalised adult patients that found a modest ability of PPS in predicting the risk of VTE [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. In the Prevention of Venous Thromboembolism Disease in Emergency Departments (PREVENU) study on 14 660 patients hospitalized for at least 2 days in a medical ward, PPS performance was not superior than an advanced age alone in VTE risk assessment [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Moreover, in a multicenter retrospective cohort study including over 1\u0026nbsp;million of unselected consecutive hospitalizations across the United States, the PPS demonstrated limited predictive ability with a PPS discriminatory accuracy for VTE risk of 0.59 [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e], in line with our results (discriminatory accuracy of 0.62).\u003c/p\u003e \u003cp\u003eOur study shows the prevalence of hospital acquired IDDVT is higher than the prevalence of proximal DVT, in opposition with our findings in outpatients [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Since the prevalence of inpatients DVT is higher than community-acquired DVT, such difference may be at least partially due to an elevated prevalence of isolated distal DVT. Our study suggests that patients in medical wards are at higher risk of IDDVT than outpatients. In fact, the Riete registry showed that IDDVT was more frequently associated to transient risk factors (i.e. recent travel, hospitalization, recent surgery), whereas proximal DVTs were more frequently associated with chronic states [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePatients receiving pharmacological thrombo-prophylaxis had a similar prevalence of DVT than those without thrombo-prophylaxis. This may be due to several reasons: 1) our participants were enrolled because of suspected DVT and this could represent a potential selection bias; 2) we performed DUS within 24h from clinical suspicion and this could have led to an early diagnosis before extension to the proximal veins; 3) we only enrolled patients complaining of symptoms and could have missed asymptomatic thrombosis; 4) the study was not prospective; 5) the use of mechanical prophylaxis in several patients could have reduced DVT prevalence in patients not receiving pharmacological thrombo-prophylaxis.\u003c/p\u003e \u003cp\u003eThe use of pharmacological thrombo-prophylaxis was similar in patients with a high and a low PPS. This is in line with a recent meta-analysis showing that thrombo-prophylaxis prescriptions were still unsatisfactory among hospitalized medically ill patients in several countries [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Despite guidelines recommendations, adherence to thrombo-prophylaxis remains moderate, with almost 40% of patients at high risk according to PPS that do not receive prophylaxis [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. These results further support a call to action for pharmacological thrombo-prophylaxis in medical patients because they are at risk not only for DVT, but also for PE [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. The risk assessment models should aim to help clinicians selecting medical inpatients who are at increased risk of VTE and may benefit of prophylaxis. However, no risk assessment model had satisfactory performances in this setting and which risk assessment model is optimal is still uncertain. Even though not all patients may benefit from thrombo-prophylaxis, our data support the use of thrombo-prophylaxis in all medical inpatients without contraindications or high bleeding risk, as recently suggested [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSome limitations of the present study should be acknowledged. No inter-observer variability was assessed for IDDVT diagnosis; we did not follow-up patients with negative whole-leg ultrasonography examination, but several studies have shown that anticoagulant therapy can be safely withheld after negative complete compression ultrasound without further testing [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] also in inpatients [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. The prevalence of DVT may have been underestimated since we did not evaluate patients with asymptomatic DVT or with symptomatic DVT who were discharged before referral to our service. The study was conducted in a single academic institution and may not be representative of population in different types of hospitals. We must underline that our participants were enrolled because suspected DVT, suggesting a potential selection bias.\u003c/p\u003e \u003cp\u003eIn summary, IDDVT is a frequent finding in inpatients and its prevalence is not related to PPS, in contrast with the aim of PPS itself. Our study supports that clinical judgment should be integrated with risk assessment models for VTE in medical inpatients.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e None.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompliance with ethical standards\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest\u003c/strong\u003e: The author(s) declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatement of human and animal rights\u003c/strong\u003e: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWritten informed consent\u003c/strong\u003e was obtained from all patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFinancial disclosure\u003c/strong\u003e: none\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eDobesh P. 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Journal of thrombosis and haemostasis : JTH, 18(6), 1398\u0026ndash;1407. https://doi.org/10.1111/jth.14796\u003c/li\u003e\n\u003cli\u003eDepietri, L., Marietta, M., Scarlini, S., Marcacci, M., Corradini, E., Pietrangelo, A., \u0026amp; Ventura, P. (2018). Clinical impact of application of risk assessment models (Padua Prediction Score and Improve Bleeding Score) on venous thromboembolism, major hemorrhage and health expenditure associated with pharmacologic VTE prophylaxis: a \u0026quot;real life\u0026quot; prospective and retrospective observational study on patients hospitalized in a Single Internal Medicine Unit (the STIME study). Internal and emergency medicine, 13(4), 527\u0026ndash;534. https://doi.org/10.1007/s11739-018-1808-z\u003c/li\u003e\n\u003cli\u003eSch\u0026uuml;nemann, H. J., Cushman, M., Burnett, A. E., Kahn, S. R., Beyer-Westendorf, J., Spencer, F. A., Rezende, S. M., Zakai, N. A., Bauer, K. A., Dentali, F., Lansing, J., Balduzzi, S., Darzi, A., Morgano, G. 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Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis, 17(6), 611\u0026ndash;619. https://doi.org/10.1177/1076029611405035\u003c/li\u003e\n\u003cli\u003ePandor, A., Tonkins, M., Goodacre, S., Sworn, K., Clowes, M., Griffin, X. L., Holland, M., Hunt, B. J., de Wit, K., \u0026amp; Horner, D. (2021). Risk assessment models for venous thromboembolism in hospitalised adult patients: a systematic review. BMJ open, 11(7), e045672. https://doi.org/10.1136/bmjopen-2020-045672\u003c/li\u003e\n\u003cli\u003eVardi, M., Ghanem-Zoubi, N. O., Zidan, R., Yurin, V., \u0026amp; Bitterman, H. (2013). Venous thromboembolism and the utility of the Padua Prediction Score in patients with sepsis admitted to internal medicine departments. Journal of thrombosis and haemostasis : JTH, 11(3), 467\u0026ndash;473. https://doi.org/10.1111/jth.12108\u003c/li\u003e\n\u003cli\u003eNendaz, M., Spirk, D., Kucher, N., Aujesky, D., Hayoz, D., Beer, J. H., Husmann, M., Frauchiger, B., Korte, W., Wuillemin, W. A., J\u0026auml;ger, K., Righini, M., \u0026amp; Bounameaux, H. (2014). Multicentre validation of the Geneva Risk Score for hospitalised medical patients at risk of venous thromboembolism. Explicit ASsessment of Thromboembolic RIsk and Prophylaxis for Medical PATients in SwitzErland (ESTIMATE). Thrombosis and haemostasis, 111(3), 531\u0026ndash;538. https://doi.org/10.1160/TH13-05-0427\u003c/li\u003e\n\u003cli\u003eZhou, H., Wang, L., Wu, X., Tang, Y., Yang, J., Wang, B., Yan, Y., Liang, B., Wang, K., Ou, X., Wang, M., Feng, Y., \u0026amp; Yi, Q. (2014). Validation of a venous thromboembolism risk assessment model in hospitalized chinese patients: a case-control study. Journal of atherosclerosis and thrombosis, 21(3), 261\u0026ndash;272. https://doi.org/10.5551/jat.20891\u003c/li\u003e\n\u003cli\u003eLiu, X., Liu, C., Chen, X., Wu, W., \u0026amp; Lu, G. (2016). Comparison between Caprini and Padua risk assessment models for hospitalized medical patients at risk for venous thromboembolism: a retrospective study. Interactive cardiovascular and thoracic surgery, 23(4), 538\u0026ndash;543. https://doi.org/10.1093/icvts/ivw158\u003c/li\u003e\n\u003cli\u003eElias, P., Khanna, R., Dudley, A., Davies, J., Jacolbia, R., McArthur, K., \u0026amp; Auerbach, A. D. (2017). Automating Venous Thromboembolism Risk Calculation Using Electronic Health Record Data upon Hospital Admission: The Automated Padua Prediction Score. Journal of hospital medicine, 12(4), 231\u0026ndash;237. https://doi.org/10.12788/jhm.2714\u003c/li\u003e\n\u003cli\u003eVincentelli, G. M., Timpone, S., Murdolo, G., Fusco Moffa, I., L\u0026apos;angiocola, P. D., Borgognoni, F., \u0026amp; Monti, M. (2018). A new risk assessment model for the stratification of the thromboembolism risk in medical patients: the TEVere Score. Minerva medica, 109(6), 436\u0026ndash;442. https://doi.org/10.23736/S0026-4806.18.05689-6\u003c/li\u003e\n\u003cli\u003eWang, X., Yang, Y. Q., Liu, S. H., Hong, X. Y., Sun, X. F., \u0026amp; Shi, J. H. (2020). Comparing different venous thromboembolism risk assessment machine learning models in Chinese patients. Journal of evaluation in clinical practice, 26(1), 26\u0026ndash;34. https://doi.org/10.1111/jep.13324\u003c/li\u003e\n\u003cli\u003eHayssen, H., Sahoo, S., Nguyen, P., Mayorga-Carlin, M., Siddiqui, T., Englum, B., Slejko, J. F., Mullins, C. D., Yesha, Y., Sorkin, J. D., \u0026amp; Lal, B. K. (2024). Ability of Caprini and Padua risk-assessment models to predict venous thromboembolism in a nationwide Veterans Affairs study. Journal of vascular surgery. Venous and lymphatic disorders, 12(2), 101693. https://doi.org/10.1016/j.jvsv.2023.101693\u003c/li\u003e\n\u003cli\u003eSartori, M., Borgese, L., Favaretto, E., Lasala, E., Bortolotti, R., \u0026amp; Cosmi, B. (2023). Age-adjusted D-dimer, clinical pre-test probability-adjusted D-dimer, and whole leg ultrasound in ruling out suspected proximal and calf deep venous thrombosis. American journal of hematology, 98(11), 1772\u0026ndash;1779. https://doi.org/10.1002/ajh.27077\u003c/li\u003e\n\u003cli\u003eGalanaud, J. P., Quenet, S., Rivron-Guillot, K., Quere, I., Sanchez Mu\u0026ntilde;oz-Torrero, J. F., Tolosa, C., Monreal, M., \u0026amp; RIETE INVESTIGATORS (2009). Comparison of the clinical history of symptomatic isolated distal deep-vein thrombosis vs. proximal deep vein thrombosis in 11 086 patients. Journal of thrombosis and haemostasis : JTH, 7(12), 2028\u0026ndash;2034. https://doi.org/10.1111/j.1538-7836.2009.03629.x\u003c/li\u003e\n\u003cli\u003eForgo, G., Micieli, E., Ageno, W., Castellucci, L. A., Cesarman-Maus, G., Ddungu, H., De Paula, E. V., Dumantepe, M., Guillermo Esposito, M. C., Konstantinides, S. V., Kucher, N., McLintock, C., N\u0026iacute; \u0026Aacute;inle, F., Spyropoulos, A. C., Urano, T., Hunt, B. J., \u0026amp; Barco, S. (2022). An update on the global use of risk assessment models and thromboprophylaxis in hospitalized patients with medical illnesses from the World Thrombosis Day steering committee: Systematic review and meta-analysis. Journal of thrombosis and haemostasis : JTH, 20(2), 409\u0026ndash;421. https://doi.org/10.1111/jth.15607\u003c/li\u003e\n\u003cli\u003eDavis, S., Goodacre, S., Horner, D., Pandor, A., Holland, M., de Wit, K., Hunt, B. J., \u0026amp; Griffin, X. L. (2024). Effectiveness and cost effectiveness of pharmacological thromboprophylaxis for medical inpatients: decision analysis modelling study. BMJ medicine, 3(1), e000408. https://doi.org/10.1136/bmjmed-2022-000408\u003c/li\u003e\n\u003cli\u003eJohnson, S. A., Stevens, S. M., Woller, S. C., Lake, E., Donadini, M., Cheng, J., Labar\u0026egrave;re, J., \u0026amp; Douketis, J. D. (2010). Risk of deep vein thrombosis following a single negative whole-leg compression ultrasound: a systematic review and meta-analysis. JAMA, 303(5), 438\u0026ndash;445. https://doi.org/10.1001/jama.2010.43\u003c/li\u003e\n\u003cli\u003eSevestre, M. A., Labar\u0026egrave;re, J., Casez, P., Bressollette, L., Haddouche, M., Pernod, G., Qu\u0026eacute;r\u0026eacute;, I., \u0026amp; Bosson, J. L. (2010). Outcomes for inpatients with normal findings on whole-leg ultrasonography: a prospective study. The American journal of medicine, 123(2), 158\u0026ndash;165. https://doi.org/10.1016/j.amjmed.2009.05.034\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 3 are available in the Supplementary Files section.\u003c/p\u003e "}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"deep vein thrombosis, diagnosis, inpatients, isolated distal deep vein thrombosis, calf deep vein thrombosis, Padua Prediction Score","lastPublishedDoi":"10.21203/rs.3.rs-4325562/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4325562/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eHospital acquired deep vein thrombosis (DVT) is an important cause of morbidity and mortality. The purpose of this study was to evaluate the prevalence of lower limb proximal DVT and isolated distal DVT (IDDVT) and the relationship with the Padua Prediction score (PPS) in acutely ill hospitalized medical patients.\u003c/p\u003e\n\u003cp\u003eIn a single center cross-sectional study, all inpatients from medical departments with suspected lower-extremity DVT were evaluated with whole-leg ultrasonography during 183 days from 2016 to 2017. Among the 507 inpatients (age 78.0±13.3 y, females 59.2%) from medical departments, 204 (40.2%) had PPS ≥4, but only 54.4% of them underwent pharmacological thrombo-prophylaxis. Whole leg ultrasonography detected 47 proximal DVTs (9.3%) and 65 IDDVTs (12.8%). Proximal DVT prevalence was higher in patients with high PPS vs those with low PPS (12.7% vs. 7.0% p=0.029, respectively), whereas IDDVT prevalence was similar in patients with high and low PPS score (14.7% vs. 11.6% p=0.311, respectively). The area under the receiver operating curve (AUC) for the PPS was 0.62±0.03 for all DVTs, 0.64±0.04 for proximal DVT, 0.58±0.04 for IDDVT.\u003c/p\u003e\n\u003cp\u003eIn hospitalized patients, IDDVT has a similar prevalence regardless of PPS risk stratification. Adherence to thrombo-prophylaxis in medical patients was still far from optimal.\u003c/p\u003e","manuscriptTitle":"Padua Prediction Score and Hospital Acquired Proximal and Isolated Distal Deep Vein Thrombosis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-05-07 20:25:38","doi":"10.21203/rs.3.rs-4325562/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"561c6ce0-5ef4-46a8-8629-5ca35b69ef67","owner":[],"postedDate":"May 7th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-06-09T13:53:17+00:00","versionOfRecord":[],"versionCreatedAt":"2024-05-07 20:25:38","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4325562","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4325562","identity":"rs-4325562","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}