Publications by authors named "Nicoletta Riva"

69 Publications

Diagnostic accuracy of D-dimer in patients at high-risk for splanchnic vein thrombosis: A systematic review and meta-analysis.

Thromb Res 2021 Sep 27;207:102-112. Epub 2021 Sep 27.

Department of Anatomy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta. Electronic address:

Background: D-dimer is included in the diagnostic algorithm for deep vein thrombosis and pulmonary embolism. However, its role in the diagnosis of splanchnic vein thrombosis (SVT) is still controversial. The aim of this study was to evaluate the diagnostic accuracy of D-dimer for SVT.

Methods: We performed a systematic review of the literature with meta-analysis (PROSPERO protocol registration number: CRD42020184300). The electronic databases MEDLINE, EMBASE, and CENTRAL were searched from inception to March 2021 week 4. Studies which evaluated D-dimer accuracy for SVT in any category of patients were selected. The index test was any D-dimer assay; the reference standard was any radiological imaging. The QUADAS-2 checklist was used for the risk of bias assessment. A bivariate random-effects regression model was used to calculate summary estimates of sensitivity and specificity.

Results: 12 studies (with a total of 1298 patients) evaluating the accuracy of D-dimer in patients at high risk of SVT (surgical patients, patients with liver cirrhosis or hepatocellular carcinoma) were included. None of the included studies was at low risk of bias. The weighted mean prevalence of SVT was 33.4% (95% CI, 22.5-45.2%, I = 94.8%). D-dimer accuracy was expressed by sensitivity 96% (95% CI, 72-100%); specificity 25% (95% CI, 5-67%); positive likelihood ratio 1.3 (95% CI, 0.9-1.9); negative likelihood ratio 0.16 (95% CI, 0.03-0.84); area under the ROC curve 0.80 (95% CI, 0.76-0.83).

Conclusions: D-dimer seems to have high sensitivity in the diagnosis of patients at high-risk for SVT. However, there is a strong need for more robust evidence on this topic.
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http://dx.doi.org/10.1016/j.thromres.2021.09.016DOI Listing
September 2021

Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score.

Thromb Haemost 2021 Sep 20. Epub 2021 Sep 20.

Department of Acute Internal Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.

Background:  Bleeding risk is highly relevant for treatment decisions in cancer-associated thrombosis (CAT). Several risk scores exist, but have never been validated in patients with CAT and are not recommended for practice.

Objectives:  To compare methods of estimating clinically relevant (major and clinically relevant nonmajor) bleeding risk in patients with CAT: (1) existing risk scores for bleeding in venous thromboembolism, (2) pragmatic classification based on cancer type, and (3) new prediction model.

Methods:  In a posthoc analysis of the Hokusai VTE Cancer study, a randomized trial comparing edoxaban with dalteparin for treatment of CAT, seven bleeding risk scores were externally validated (ACCP-VTE, HAS-BLED, Hokusai, Kuijer, Martinez, RIETE, and VTE-BLEED). The predictive performance of these scores was compared with a pragmatic classification based on cancer type (gastrointestinal; genitourinary; other) and a newly derived competing risk-adjusted prediction model based on clinical predictors for clinically relevant bleeding within 6 months after CAT diagnosis with nonbleeding-related mortality as the competing event ("CAT-BLEED").

Results:  Data of 1,046 patients (149 events) were analyzed. Predictive performance of existing risk scores was poor to moderate (C-statistics: 0.50-0.57; poor calibration). Internal validation of the pragmatic classification and "CAT-BLEED" showed moderate performance (respective C-statistics: 0.61; 95% confidence interval [CI]: 0.56-0.66, and 0.63; 95% CI 0.58-0.68; good calibration).

Conclusion:  Existing risk scores for bleeding perform poorly after CAT. Pragmatic classification based on cancer type provides marginally better estimates of clinically relevant bleeding risk. Further improvement may be achieved with "CAT-BLEED," but this requires external validation in practice-based settings and with other DOACs and its clinical usefulness is yet to be demonstrated.
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http://dx.doi.org/10.1055/s-0041-1735251DOI Listing
September 2021

Feasibility and efficiency of European guidelines for NAFLD assessment in patients with type 2 diabetes: A prospective study.

Diabetes Res Clin Pract 2021 Jul 1;177:108882. Epub 2021 Jun 1.

Epidemiology Unit, AUSL- IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Aim: We aimed to evaluate the feasibility and efficiency of a guidelines-compliant NAFLD assessment algorithm in patients with newly diagnosed type 2 diabetes (T2D).

Methods: Consecutive patients aged < 75 newly diagnosed with T2D without coexisting liver disease or excessive alcohol consumption were enrolled. Patients were stratified based on liver enzymes, fatty liver index, ultrasound, fibrosis scores and liver stiffness measurement. Referral rates and positive predictive values (PPVs) for histological non-alcoholic steatohepatitis (NASH) and significant fibrosis were evaluated.

Results: Of the 171 enrolled patients (age 59 ± 10.2 years, 42.1% females), 115 (67.3%) were referred to a hepatologist due to abnormal liver enzymes (n = 60) or steatosis plus indeterminate (n = 37) or high NAFLD fibrosis score (n = 18). Liver biopsy was proposed to 30 patients (17.5%), but only 14 accepted, resulting in 12 NASH, one with significant fibrosis. The PPV of hepatological referral was 12/76 (15.8%) for NASH and 1/76 (1.3%) for NASH with significant fibrosis. The PPV of liver biopsy referral was 12/14 (85.7%) for NASH and 1/14 (7.1%) for NASH with significant fibrosis.

Conclusions: By applying a guidelines-compliant algorithm, many patients with T2D were referred for hepatological assessment and liver biopsy. Further studies are necessary to refine non-invasive algorithms.
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http://dx.doi.org/10.1016/j.diabres.2021.108882DOI Listing
July 2021

Treatment of portal vein thrombosis: an updated narrative review.

Minerva Med 2021 Apr 9. Epub 2021 Apr 9.

Department of Medicine and Surgery, University of Insubria, Varese, Italy.

Portal vein thrombosis (PVT) is the most frequent among the splanchnic vein thrombosis, accounting for 90% of cases. More than half of PVT are provoked by liver cirrhosis, solid cancer or myeloproliferative neoplasms. The remaining cases are non-malignant non-cirrhotic PVT and include either unprovoked events or thrombosis secondary to other less common risk factors (e.g. abdominal surgery, intrabdominal inflammations/infections, or hormonal stimuli). Anticoagulant therapy in patients with acute symptomatic PVT should be started early after diagnosis, if no active bleeding, to obtain greater vessel recanalization and reduce the occurrence of portal-hypertension related complications. Gastroesophageal varices do not represent a contraindication to anticoagulant treatment, as long as adequate measures have been undertaken for the prophylaxis of gastroesophageal bleeding. Different treatment options (unfractionated or low molecular weight heparin, vitamin K antagonists and direct oral anticoagulants [DOACs]) can be considered. In this narrative review we will discuss the treatment of PVT in the three most common scenarios (cirrhosis-associated, cancer-associated and non-malignant non-cirrhotic PVT). We will also discuss the role of the DOACs and summarise recent guidelines on this topic.
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http://dx.doi.org/10.23736/S0026-4806.21.07526-1DOI Listing
April 2021

Direct oral anticoagulants for unusual-site venous thromboembolism.

Res Pract Thromb Haemost 2021 Feb 28;5(2):265-277. Epub 2021 Jan 28.

Department of Medicine and Surgery University of Insubria Varese Italy.

Direct oral anticoagulants (DOACs) are currently the preferred oral anticoagulant treatment for most of the patients with deep vein thrombosis of the lower extremities and/or pulmonary embolism. DOACs have several advantages over vitamin K antagonists, such as availability of fixed dosages, fewer drug interactions, faster onset of action, shorter half-life, and lower risk of major and intracranial bleeding. Although the evidence on the use of DOACs in patients with unusual-site venous thromboembolism (VTE) is limited to a few, small randomized controlled trials, these drugs are increasingly used in clinical practice, and several observational cohort studies have been published recently. This narrative review will describe the latest evidence for the use of the DOACs in patients with thrombosis in atypical locations (splanchnic, cerebral, upper extremity, ovarian, and renal vein thrombosis) and will provide some practical advice for their use in patients with unusual-site VTE.
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http://dx.doi.org/10.1002/rth2.12480DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938617PMC
February 2021

High-dose glucocorticoids pulse-therapy for beta-coronaviridae pneumonia: a systematic literature review and case-series of Coronavirus disease-2019.

Clin Exp Rheumatol 2021 Sep-Oct;39(5):1119-1125. Epub 2021 Feb 26.

Rheumatology Unit, IRCCS Arcispedale Santa Maria Nuova, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, and Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy.

Objectives: The results of the RECOVERY trial identified dexamethasone as the first pharmacological therapy that reduces mortality in patients with COVID-19. The aim of this paper is to conduct a systematic literature review on safety and efficacy of pulse glucocorticoid therapy for Severe Acute Respiratory Syndrome (SARS)-CoronaVirus (CoV), Middle East Respiratory Syndrome (MERS)-CoV or SARS-CoV-2 infections and describe a case-series of COVID-19 patients treated with off-label pulse doses of methylprednisolone.

Methods: We performed a systematic literature review on safety and efficacy of pulse therapy for betacoronaviridae infections as described in the protocol registered on PROSPERO (CRD42020190183). All consecutive patients admitted to Arcispedale Santa Maria Nuova di Reggio Emilia or Guastalla Hospital with COVID-19 between March 1st and April 30th, 2020 and treated with methylprednisolone 1 gram/day for at least three days were included in the case series. A retrospective review of available computed tomography (CT) scan and chest x-ray was performed independently by two radiologists blinded to clinical data, and discordances were resolved by consensus.

Results: Twenty papers were included for SARS, but only two were comparative and were included in the primary endpoint analysis. Likewise, eleven papers were included for COVID-19, four of which were comparative and were considered for the primary outcome analysis. Included studies for both SARS and COVID-19 are mostly retrospective and highly heterogeneous, with lethality ranging from 0% to 100% and ICU admission rate ranging from 9% to 100%. Fourteen patients were included in our case series, 7 males and 7 females.

Conclusions: No randomised controlled trial is available yet for corticosteroids pulse-therapy defined as at least ≥500mg/day methylprednisolone in patients with emerging coronavirus pneumonia. Lethality among our cohort is high (4/14), but this finding should be interpreted with caution due to the fact that in our setting pulse-steroids were used in patients not eligible for other treatments because of comorbidities or as rescue therapy. The incidence of steroid-related adverse events seems low in our cohort. The quality of the evidence on glucocorticoid pulse-therapy in SARS, MERS and COVID-19 is poor. Randomised controlled trials are greatly needed.
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September 2021

The effect of DOAC-Stop on several oral and parenteral anticoagulants.

Int J Lab Hematol 2021 08 17;43(4):O171-O175. Epub 2021 Feb 17.

Department of Pathology, Faculty of Medicine and Surgery, University of Malta, Msida, Malta.

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http://dx.doi.org/10.1111/ijlh.13487DOI Listing
August 2021

Anticoagulant Treatment for Splanchnic Vein Thrombosis in Liver Cirrhosis: A Systematic Review and Meta-Analysis.

Thromb Haemost 2021 Jul 1;121(7):867-876. Epub 2021 Feb 1.

Department of Medicine and Surgery, University of Insubria, Varese, Italy.

Background:  Splanchnic vein thrombosis (SVT) is a common complication in patients with liver cirrhosis. The aim of this study was to evaluate the efficacy and safety of anticoagulant therapy for SVT in cirrhotic patients.

Methods:  In this systematic review and meta-analysis, studies reporting on SVT recanalization and progression, recurrent venous thromboembolism (VTE), major bleeding, and overall mortality were searched in MEDLINE, EMBASE, and ClinicalTrial.gov up to December 2019. Pooled proportions and risk ratios (RRs) with corresponding 95% confidence intervals (CIs) were calculated.

Results:  A total of 1,475 patients were included in 26 studies (23 observational and 3 randomized controlled trials). In patients receiving anticoagulant therapy, SVT recanalization occurred in 68% (95% CI, 62-74; 571/842 patients; 22 studies), SVT progression in 6% (95% CI, 4-9; 25/748 patients; 22 studies), recurrent VTE in 10% (95% CI, 4-22; 48/399 patients; 7 studies), major bleeding in 6% (95% CI, 4-10; 58/785 patients; 18 studies), and overall mortality in 9% (95% CI, 6-14; 68/787 patients; 17 studies). Anticoagulant treatment was associated with higher SVT recanalization (RR 3.19; 95% CI, 1.42-7.17), lower thrombosis progression (RR 0.28; 95% CI, 0.15-0.52), major bleeding (RR 0.52; 95% CI, 0.28-0.97), and overall mortality (RR 0.42; 95% CI, 0.24-0.73) compared with no treatment.

Conclusion:  Anticoagulant therapy seems to improve vein recanalization and to reduce SVT progression, major bleeding, and overall mortality in cirrhotic patients with SVT. The incidence of recurrent VTE during anticoagulation remains substantial.
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http://dx.doi.org/10.1055/s-0040-1722192DOI Listing
July 2021

Exciting times for the ISTH early career professionals.

J Thromb Haemost 2020 10;18(10):2437-2438

HITh, UMR_S1176, Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay, Le Kremlin-Bicêtre, France.

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http://dx.doi.org/10.1111/jth.15070DOI Listing
October 2020

Ovarian Vein Thrombosis: A Narrative Review.

Hamostaseologie 2021 Aug 21;41(4):257-266. Epub 2020 Dec 21.

Department of Anatomy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta.

Ovarian vein thrombosis (OVT) is a rare type of venous thromboembolism. The most common risk factors for OVT include pregnancy, oral contraceptives, malignancies, recent surgery, and pelvic infections; however, in 4 to 16% of cases, it can be classified as idiopathic. Most of the available information regards pregnancy-related OVT, which has been reported to complicate 0.01 to 0.18% of pregnancies and to peak around 2 to 6 days after delivery or miscarriage/abortion. The right ovarian vein is more frequently involved (70-80% of cases). Clinical features of OVT include abdominal pain and tenderness, fever, and gastrointestinal symptoms. The most typical finding is the presence of a palpable abdominal mass, although reported in only 46% of cases. OVT can be the cause of puerperal fever in approximately a third of women. Ultrasound Doppler is the first-line imaging, because of its safety, low cost, and wide availability. However, the ovarian veins are difficult to visualize in the presence of bowel meteorism or obesity. Thus, computed tomography or magnetic resonance imaging is often required to confirm the presence and extension of the thrombosis. In oncological patients, OVT is often an incidental finding at abdominal imaging. Mortality related to OVT is nowadays low due to the combination treatment of parenteral broad-spectrum antibiotics (until at least 48 hours after fever resolution) and anticoagulation (low-molecular-weight heparin, vitamin K antagonists, or direct oral anticoagulants). Anticoagulant treatment duration of 3 to 6 months has been recommended for postpartum OVT, while no anticoagulation has been suggested for incidentally detected cancer-associated OVT.
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http://dx.doi.org/10.1055/a-1306-4327DOI Listing
August 2021

Effect of anticoagulants on fibrin clot structure: A comparison between vitamin K antagonists and factor Xa inhibitors.

Res Pract Thromb Haemost 2020 Nov 25;4(8):1269-1281. Epub 2020 Oct 25.

Discovery and Translational Science Department Institute of Cardiovascular and Metabolic Medicine University of Leeds Leeds UK.

Background: Abnormal clot structure has been identified in patients with thrombotic disorders. Anticoagulant therapy offers clear benefits for thrombosis prevention and treatment by reducing blood clot formation and size; nevertheless, there are limited data on the effects of different anticoagulants, where clotting is initiated with different triggers, on clot structure.

Objectives: Our aim was to investigate the effects of vitamin K antagonists and factor Xa inhibitors on clot structure.

Methods: Clots from pooled plasma spiked with rivaroxaban, apixaban, or enoxaparin, as well as plasma from patients on warfarin, were compared to plasma without anticoagulation. The kinetic profile of polymerizing clots was obtained by turbidity, fiber density was determined by confocal microscopy, clot pore size was investigated by permeation, and fiber size was analyzed using scanning electron microscopy. Clotting agonist was either tissue factor or thrombin.

Results: Following clotting with tissue factor, all anticoagulated clots had a significantly increased lag time, with the exception of enoxaparin. Rivaroxaban additionally led to significantly less dense and more permeable clots, with thicker fibers. In contrast, turbidity analysis following initiation with thrombin showed few effects of anticoagulation, with only enoxaparin leading to a prolonged lag time. Enoxaparin clots made with thrombin were less dense and more permeable.

Conclusion: Our results show that anticoagulants modulate clot structure particularly when induced by tissue factor, most likely due to reduction of thrombin generation. We propose that the effects of different anticoagulants could be assessed with a global clot structure measurement such as permeation or turbidity, providing information on clot phenotype.
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http://dx.doi.org/10.1002/rth2.12443DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7695561PMC
November 2020

Clinical history of cancer-associated splanchnic vein thrombosis.

J Thromb Haemost 2021 04 24;19(4):983-991. Epub 2021 Feb 24.

Department of Medicine and Surgery, University of Insubria, Varese, Italy.

Background: Cancer represents a risk factor for splanchnic vein thrombosis (SVT) and usual site venous thromboembolism (VTE).

Objectives: To compare characteristics and outcomes of patients with cancer-associated SVT and usual site VTE.

Patients/methods: Patients with solid cancer and SVT were enrolled in an international, prospective registry between May 2008 and January 2012. The comparison cohort included (1:1 ratio) patients with solid cancer and usual site VTE treated at two thrombosis centers who had a minimum of 12 months follow-up at December 2019 or experienced one of the outcomes within 12 months follow-up. Recurrent VTE, major bleeding, and all-cause mortality were evaluated at 12-month follow-up.

Results: A total of 264 patients (132 in each cohort) were enrolled. Patients with SVT were less likely to have metastatic disease (36.1% vs 72.5%) or receive cancer therapy at thrombosis diagnosis (29.6% vs 64.9%). The most frequent cancer types were hepatobiliary and pancreatic in the SVT cohort and gastrointestinal in the usual site VTE cohort. Fewer patients with SVT received anticoagulation (68.9% vs 99.2%), and treatment duration was shorter (6.0 vs 11.0 months). The cumulative incidence of major bleeding (2.3% vs 4.7%) was nonsignificantly lower in the SVT cohort, whereas recurrent thrombosis (4.7% vs 5.5%) and all-cause mortality (41.7% vs 39.4%) were comparable between the two cohorts.

Conclusions: The risk of recurrent thrombosis and bleeding appears to be similar in cancer patients with SVT and cancer patients with usual site VTE, despite some differences in baseline characteristics and anticoagulant treatment. Further prospective studies are warranted to confirm these findings.
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http://dx.doi.org/10.1111/jth.15214DOI Listing
April 2021

Diagnostic accuracy of inferior vena cava ultrasound for heart failure in patients with acute dyspnoea: a systematic review and meta-analysis.

Emerg Med J 2021 Mar 9;38(3):232-239. Epub 2020 Dec 9.

Medicine and Surgery, University of Insubria, Varese/Como, Italy.

Background: Dyspnoea is the most common sign of heart failure (HF). Patients accessing the ED for HF-related symptoms require fast diagnosis and early treatment. Transthoracic echocardiography has a crucial role in HF diagnosis, but requires qualified staff and adequate time for execution. The measurement of inferior vena cava (IVC) diameter has been recently proposed as a rapid, simple and reliable marker of volume overload. The aim of this systematic review was to assess the accuracy of IVC-ultrasound as a stand-alone test for HF diagnosis in patients presenting to the ED with acute dyspnoea.

Methods: Studies evaluating the diagnostic accuracy of the inferior vena cava collapsibility index (IVC-CIx) for HF diagnosis were systematically searched in the EMBASE and MEDLINE databases (up to January 2018). Quality Assessment of Diagnostic Accuracy Studies 2 tool was used for the quality assessment of the primary studies. A bivariate random-effects regression approach was used for summary estimates of both sensitivity and specificity.

Results: Seven studies, for a total of 591 patients, were included. Three studies were at low-risk of bias. All studies used a proper reference test. Weighted mean prevalence of HF was 49.3% at random-effect model (I index for heterogeneity=74.7%). IVC-CIx bivariate weighted mean sensitivity was 79.1% (95% CI 68.5% to 86.8%) and bivariate weighted mean specificity was 81.8% (95% CI 75.0% to 87.0%).

Conclusions: Our findings suggest that the sensitivity and specificity of IVC-CIx are suboptimal to rule in or rule out HF diagnosis in patients with acute dyspnoea in the ED setting. Therefore, IVC-CIx is not advisable as a stand-alone test, but may be useful when integrated in a specific diagnostic algorithm for the differential diagnosis of acute dyspnoea.
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http://dx.doi.org/10.1136/emermed-2019-208547DOI Listing
March 2021

Anticoagulation in splanchnic and cerebral vein thrombosis: An international vignette-based survey.

Res Pract Thromb Haemost 2020 Oct 11;4(7):1192-1202. Epub 2020 Sep 11.

Department of Medicine and Surgery University of Insubria Varese Italy.

Background: Anticoagulant treatment of splanchnic (SVT) and cerebral vein thrombosis (CVT) can be challenging due to the rarity of these conditions, the concomitantly high thrombotic and bleeding risks, and the available low-quality evidence.

Objectives: To explore the current therapeutic approaches to SVT and CVT, and the rationale behind the anticoagulant treatment choice.

Methods: A cross-sectional survey was conducted (October 2018-April 2019) among members of three thrombosis and hemostasis societies. The survey consisted of four vignette cases: (i) SVT secondary to transient risk factor; (ii) cirrhotic SVT with esophageal varices; (iii) CVT secondary to transient risk factor; and (iv) unprovoked CVT with intracranial hemorrhage.

Results: A total of 397 physicians responded to the survey. There was wide variability in anticoagulant treatment options, starting time, and duration. Vitamin K antagonists were the commonest choice across the four vignette cases (44.2%-63.0%). The direct oral anticoagulants (DOACs) were the second commonest choice in low-bleeding-risk scenarios (27.7% in case 1, 22.9% in case 3), while parenteral anticoagulation alone was the second commonest choice in high-bleeding-risk scenarios (39.9% in case 2, 39.8% in case 4). The most frequent reasons for selecting DOACs were oral route of administration (50.6%), lack of need for laboratory monitoring (48.1%), and favorable safety profile of these drugs (43.4%).

Conclusions: The results of our study showed that, despite being off-label, the DOACs were considered for the treatment of unusual-site venous thromboembolism. The wide variability among different physicians reflected the clinical difficulties and raised the need for more collaborative trials on these disorders.
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http://dx.doi.org/10.1002/rth2.12424DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590282PMC
October 2020

Anticoagulant therapy for splanchnic vein thrombosis: a systematic review and meta-analysis.

Blood 2021 03;137(9):1233-1240

Department of Medicine and Surgery, University of Insubria, Varese, Italy.

Treatment of splanchnic vein thrombosis (SVT) is challenging, and evidence to guide therapeutic decisions remains scarce. The objective of this systematic review and meta-analysis was to determine the efficacy and safety of anticoagulant therapy for SVT. MEDLINE, EMBASE, and clinicaltrials.gov were searched from inception through December 2019, without language restrictions, to include observational studies and randomized controlled trials reporting radiological or clinical outcomes in patients with SVT. Pooled proportions and risk ratios (RRs) with 95% confidence intervals (CIs) were calculated in a random-effects model. Of 4312 records identified by the search, 97 studies including 7969 patients were analyzed. In patients receiving anticoagulation, the rates of SVT recanalization, SVT progression, recurrent venous thromboembolism (VTE), major bleeding, and overall mortality were 58% (95% CI, 51-64), 5% (95% CI, 3-7), 11% (95% CI, 8-15), 9% (95% CI, 7-12), and 11% (95% CI, 9-14), respectively. The corresponding values in patients without anticoagulation were 22% (95% CI, 15-31), 15% (95% CI, 8-27), 14% (95% CI, 9-21), 16% (95% CI, 13-20), and 25% (95% CI, 20-31). Compared with no treatment, anticoagulant therapy obtained higher recanalization (RR, 2.39; 95% CI, 1.66-3.44) and lower thrombosis progression (RR, 0.24; 95% CI, 0.13-0.42), major bleeding (RR, 0.73; 95% CI, 0.58-0.92), and overall mortality (RR, 0.45; 95% CI, 0.33-0.60). These results demonstrate that anticoagulant therapy improves SVT recanalization and reduces the risk of thrombosis progression without increasing major bleeding. The incidence of recurrent VTE remained substantial in patients receiving anticoagulation, as well. Effects were consistent across the different subgroups of patients. This trial was registered on the PROPERO database at (https://www.crd.york.ac.uk/prospero//display_record.php?ID=CRD42019127870) as #CRD42019127870.
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http://dx.doi.org/10.1182/blood.2020006827DOI Listing
March 2021

Anticoagulation control with the point-of-care INR: A retrospective pre-/post-analysis.

Thromb Res 2020 12 1;196:21-24. Epub 2020 Aug 1.

Department of Pathology, Faculty of Medicine and Surgery, University of Malta, Msida, Malta; Coagulation Medicine Laboratory, Department of Pathology, Mater Dei Hospital, Msida, Malta. Electronic address:

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http://dx.doi.org/10.1016/j.thromres.2020.07.050DOI Listing
December 2020

Head, Neck, and Abdominopelvic Septic Thrombophlebitis: Current Evidence and Challenges in Diagnosis and Treatment.

Hamostaseologie 2020 Aug 29;40(3):301-310. Epub 2020 Jul 29.

Department of Pathology and Anatomy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta.

Septic thrombophlebitis (STP) is a complex, cross-disciplinary clinical condition that combines a localized infection with a neighboring venous thrombosis. STP can occur at several possible anatomic sites, such as dural sinuses, jugular vein (Lemierre syndrome), portal vein (pylephlebitis), and pelvic veins. Its high mortality in the preantibiotic era improved considerably with the introduction of modern antibiotics. However, little evidence exists to date to guide its clinical management. The incidence of STP or its risk factors may be increasing, and its mortality may still be considerable. These trends would have far-reaching implications, especially in the setting of increasing resistance to antimicrobial agents. No clinical assessment tools exist to support patient screening or guide treatment in STP. Few interventional studies exist on the efficacy and safety of anticoagulation. Recommendations on its indications, duration, and the agents of choice are mostly based on evidence derived from small observational studies. While all forms of STP pose similar challenges, future research may benefit from the distinction between bacteria-associated, virus-associated, and mycosis-associated thrombophlebitis. Addressing these gaps in evidence would enhance our ability to diagnose this condition and treat patients effectively.
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http://dx.doi.org/10.1055/a-1177-5127DOI Listing
August 2020

Illustrated State-of-the-Art Capsules of the ISTH 2020 Congress.

Res Pract Thromb Haemost 2020 Jul 12;4(5):680-713. Epub 2020 Jul 12.

Department of Cell and Developmental Biology Perelman School of Medicine University of Pennsylvania Philadelphia PA USA.

The 2020 Congress of the International Society of Thrombosis and Haemostasis (ISTH) was held virtually July 12-15, 2019, due to the coronavirus disease 2019 pandemic. The congress convenes annually to discuss clinical and basic topics in hemostasis and thrombosis. Each year, the program includes State of Art (SOA) lectures given by prominent scientists. Presenters are asked to create Illustrated Capsules of their talks, which are concise illustrations with minimal explanatory text. Capsules cover major themes of the presentation, and these undergo formal peer review for inclusion in this article. Owing to the shift to a virtual congress this year, organizers reduced the program size. There were 39 SOA lectures virtually presented, and 29 capsules (9 from talks omitted from the virtual congress) were both submitted and successful in peer review, and are included in this article. Topics include the roles of the hemostatic system in inflammation, infection, immunity, and cancer, platelet function and signaling, platelet function disorders, megakaryocyte biology, hemophilia including gene therapy, phenotype tests in hemostasis, von Willebrand factor, anticoagulant factor V, computational driven discovery, endothelium, clinical and basic aspects of thrombotic microangiopathies, fibrinolysis and thrombolysis, antithrombotics in pediatrics, direct oral anticoagulant management, and thrombosis and hemostasis in pregnancy. Capsule authors invite virtual congress attendees to refer to these capsules during the live presentations and participate on Twitter in discussion. will release 2 tweets from @RPTHJournal during each presentation, using #IllustratedReview, #CoagCapsule and #ISTH2020. Readers are also welcome to utilize capsules for teaching and ongoing education.
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http://dx.doi.org/10.1002/rth2.12368DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7354406PMC
July 2020

Anticoagulant therapy for splanchnic vein thrombosis: ISTH SSC Subcommittee Control of Anticoagulation.

J Thromb Haemost 2020 07;18(7):1562-1568

Department of Medicine and Surgery, University of Insubria, Varese, Italy.

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http://dx.doi.org/10.1111/jth.14836DOI Listing
July 2020

Patients' satisfaction associated with portable coagulometers for warfarin monitoring: a cross-sectional study.

Blood Transfus 2020 09 4;18(5):386-395. Epub 2020 Jun 4.

Department of Pathology, Faculty of Medicine and Surgery, University of Malta, Msida, Malta, Italy.

Background: The use of point-of-care (POC) coagulometers for monitoring patients on vitamin K antagonist (VKA) treatment makes international normalised ratio (INR) results immediately available. The aim of this study was to compare patients' satisfaction with VKA treatment in two settings characterised by distinct ways of monitoring: POC INR versus laboratory INR.

Materials And Methods: We recruited adult patients on long-term warfarin treatment (July 2017-February 2018) from the Anticoagulation Clinics at five district health centres (namely Cospicua, Floriana, Mosta, Qormi, Rabat-POC INR) and at Mater Dei Hospital (Msida - Laboratory INR) in Malta. We administered two psychometric questionnaires: the Duke Anticoagulation Satisfaction Scale (DASS) (range 25-175, lower scores corresponding to higher satisfaction) and the Perception of Anticoagulation Treatment Questionnaire (PACT-Q2) (range 0-100, higher scores corresponding to higher satisfaction).

Results: We analysed 313 questionnaires (POC INR n=159, laboratory INR n=154). In the POC INR cohort, median age was 72 years and 59.1% were males; in the laboratory INR cohort, median age was 70.5 years and 46.1% were males. The POC INR cohort obtained significantly lower overall DASS score (p<0.001) and significantly higher PACT-Q2 scores (p<0.001 for the subscale "convenience"; p=0.039 for the subscale "anticoagulant treatment satisfaction") than the laboratory INR cohort. In multiple regression analysis, the use of POC coagulometers was significantly associated with the overall DASS score (p=0.013) and the PACT-Q2 convenience score (p=0.012).

Discussion: Patients on warfarin treatment were generally satisfied. Patients monitored with the POC INR with a dedicated time slot reported less inconvenience and burdens and better psychological impact than patients monitored with the traditional laboratory INR.
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http://dx.doi.org/10.2450/2020.0005-20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7592158PMC
September 2020

Abdominal Visceral Infarction in 3 Patients with COVID-19.

Emerg Infect Dis 2020 Aug 12;26(8):1926-1928. Epub 2020 May 12.

A high incidence of thrombotic events has been reported in patients with coronavirus disease (COVID-19), which is caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. We report 3 clinical cases of patients in Italy with COVID-19 who developed abdominal viscera infarction, demonstrated by computed tomography.
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http://dx.doi.org/10.3201/eid2608.201161DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392418PMC
August 2020

Cerebral and Splanchnic Vein Thrombosis: Advances, Challenges, and Unanswered Questions.

J Clin Med 2020 Mar 10;9(3). Epub 2020 Mar 10.

Department of Medicine and Surgery, University of Insubria, 21100 Varese, Italy.

Cerebral vein thrombosis (CVT) and splanchnic vein thrombosis (SVT) are two manifestations of venous thromboembolism (VTE) at unusual sites. They have an incidence at least 25-50 times lower than usual site VTE, but represent true clinical challenges. Recent evidence on the epidemiology, risk factors, prognosis, and treatment of CVT and SVT has been published in the last two decades, thus contributing to a better understanding of these diseases. The improvement in imaging techniques and a higher degree of clinical suspicion may have led to the observed increased frequency, whereas a better knowledge of provoking mechanisms could have contributed to reducing the proportion of events classified as unprovoked or idiopathic (13%-21% of CVT, 15%-27% of SVT). Few small randomized clinical trials and a number of observational studies, although hampered by heterogeneous therapeutic approaches, shed light on the safety and effectiveness of anticoagulant therapy in these populations. However, there are still some grey areas that warrant future research. In this narrative review, we discuss recent advances and therapeutic challenges in CVT and SVT.
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http://dx.doi.org/10.3390/jcm9030743DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7141239PMC
March 2020

Validation and psychometric properties of the Maltese version of the Duke Anticoagulation Satisfaction Scale (DASS).

Psychol Res Behav Manag 2019 28;12:741-752. Epub 2019 Aug 28.

Department of Pathology, Faculty of Medicine and Surgery, University of Malta, Msida, Malta.

Purpose: Assessing treatment satisfaction can guide specific interventions to improve anticoagulation adherence and reduce adverse outcomes. We aimed to assess the psychometric properties (reliability and validity) of the Maltese translation of the Duke Anticoagulation Satisfaction Scale (DASS).

Patients And Methods: The DASS explores three dimensions (limitations, hassles/burdens, psychological impact). The translation process included forward and backward translations. Reliability was evaluated through internal consistency and reproducibility. Validity was evaluated through floor/ceiling effect, convergent/discriminant validity, construct validity, and known-group validity.

Results: The Maltese version of the DASS, administered to 174 patients on warfarin for different clinical indications, showed good reliability (Cronbach's alpha 0.87; intraclass correlation coefficient for test-retest 0.73). Floor effect was identified mainly in the limitations and hassles/burdens subscales. Significant positive correlations were found between the DASS total score and its subscales (limitations 0.80, hassles/burdens 0.85, psychological impact 0.68). Female sex, shorter warfarin treatment duration (≤5 years), previous hospitalization and history of bleeding were associated with lower satisfaction.

Conclusion: Psychometric properties of the Maltese DASS were comparable to the original English version. The Maltese version of the DASS is a valid and reliable instrument that can be used by health care professionals to assess the level of satisfaction of Maltese-speaking anticoagulated patients.
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http://dx.doi.org/10.2147/PRBM.S216617DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6717846PMC
August 2019

Splanchnic Vein Thrombosis: Current Perspectives.

Vasc Health Risk Manag 2019 22;15:449-461. Epub 2019 Oct 22.

Department of Medicine and Surgery, University of Insubria, Varese, Italy.

Splanchnic vein thrombosis (SVT) including portal, mesenteric, splenic vein thrombosis and the Budd-Chiari syndrome, is a manifestation of unusual site venous thromboembolism. SVT presents with a lower incidence than deep vein thrombosis of the lower limbs and pulmonary embolism, with portal vein thrombosis and Budd-Chiari syndrome being respectively the most and the least common presentations of SVT. SVT is classified as provoked if secondary to a local or systemic risk factor, or unprovoked if the causative trigger cannot be identified. Diagnostic evaluation is often affected by the lack of specificity of clinical manifestations: the presence of one or more risk factors in a patient with a high clinical suspicion may suggest the execution of diagnostic tests. Doppler ultrasonography represents the first line diagnostic tool because of its accuracy and wide availability. Further investigations, such as computed tomography and magnetic resonance angiography, should be executed in case of suspected thrombosis of the mesenteric veins, suspicion of SVT-related complications, or to complete information after Doppler ultrasonography. Once SVT diagnosis is established, a careful patient evaluation should be performed in order to assess the risks and benefits of the anticoagulant therapy and to drive the optimal treatment intensity. Due to the low quality and large heterogeneity of published data, guidance documents and expert opinion could direct therapeutic decision, suggesting which patients to treat, which anticoagulant to use and the duration of treatment.
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http://dx.doi.org/10.2147/VHRM.S197732DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6815215PMC
December 2019

Thymus Imaging Detection and Size Is Inversely Associated With Metabolic Syndrome and Frailty in People With HIV.

Open Forum Infect Dis 2019 Oct 4;6(10):ofz435. Epub 2019 Oct 4.

Modena HIV Metabolic Clinic, Infectious Diseases Unit, University of Modena and Reggio Emilia, Italy.

Background: People with HIV (PWH) may experience accentuating aging in relation to immuno-activation. Little is known regarding thymus (THY) involution in this process. We sought to investigate the relationship between THY imaging detection/size and clinically relevant aging outcomes such as metabolic syndrome (MetS), multimorbidity (MM), and frailty in PWH.

Methods: This was a cross-sectional observational study including 665 HIV patients (81% males; median age, 53 years) attending Modena HIV Metabolic Clinic from 2014 to 2017. They underwent thoracic computed tomography scan as part of the medical assessment for cardiovascular disease, in which THY detection and size were reported using a semiquantitative score. Outcome measures were MetS, MM, and frailty.

Results: THY was detected in 27.0% of subjects; 71.1% showed THY size of grade 1-2, and 28.9% exhibited grade ≥3. Covariates that inversely correlated with THY detection were age, male gender, body mass index (BMI), and HIV duration. Covariates that inversely correlated with MetS were age, HIV duration, BMI, and THY grade 1-2. Covariates that inversely correlated with MM were age, HIV duration, and CD4 nadir. Covariates that inversely correlated with frailty were age, HIV duration, CD4 nadir, BMI, and THY detection.

Conclusions: THY is inversely associated with MetS and frailty in PWH.
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http://dx.doi.org/10.1093/ofid/ofz435DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6809752PMC
October 2019

Data extraction methods: an analysis of internal reporting discrepancies in single manuscripts and practical advice.

J Clin Epidemiol 2020 01 18;117:158-164. Epub 2019 Sep 18.

Witten/Herdecke University, School of Medicine, Cologne, Germany.

Background: Data extraction from reports about experimental or observational studies is a crucial methodological step informing evidence syntheses, such as systematic reviews (SRs) and overviews of SRs. Reporting discrepancies were defined as pairs of statements that could not both be true. Authors of SRs and overviews of SRs can encounter reporting discrepancies among multiple sources when extracting data-a manuscript and a conference abstract, and a manuscript and a clinical trial registry. However, these discrepancies can also be found within a single manuscript published in a scientific journal.

Objectives: Hereby, we describe examples of internal reporting discrepancies that can be found in a single source, with the aim of raising awareness among authors of SRs and overviews of SRs about such potential methodological issues.

Conclusions: Authors of SRs and overviews of SRs should check whether the same information is reported in multiple places within a study and compare that information. Independent data extraction by two reviewers increases the chance of finding discrepancies, if they exist. We provide advice on how to deal with different types of discordances and how to report such discordances when conducting SRs and overviews of SRs.
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http://dx.doi.org/10.1016/j.jclinepi.2019.09.003DOI Listing
January 2020

Reliability and validity of the Maltese version of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q).

Patient Prefer Adherence 2019 19;13:969-979. Epub 2019 Jun 19.

Department of Pathology, Faculty of Medicine and Surgery, University of Malta, Msida, Malta.

Anticoagulant therapy has an impact on the health-related quality of life, as it is a chronic treatment for most clinical indications and also requires some lifestyle changes. Since there was no validated questionnaire available in the Maltese language, the aim of our study was to translate and validate the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2). The PACT-Q2 explores two dimensions (convenience and anticoagulant treatment satisfaction). Forward and backward translations were performed. The Maltese version of the PACT-Q2 was administered to 174 patients on warfarin treatment enrolled from different anticoagulation clinics in Malta. Reliability was assessed through internal consistency (Cronbach's alpha) and test-retest (intraclass correlation coefficient [ICC]). Validity was assessed through floor/ceiling effect, factor analysis (root mean square error of approximation [RMSEA], standardized root mean squared residual [SRMR], goodness-of-fit index [GFI], adjusted goodness-of-fit index [AGFI], comparative fit index [CFI]), subscales correlation and known-group validity. Reliability was very good for the convenience subscale (Cronbach's alpha 0.86, ICC 0.87), but less good for the satisfaction subscale (Cronbach's alpha 0.62, ICC 0.40). Floor effect was 0%; ceiling effect was low (6.3% convenience, 1.2% satisfaction). Fit parameters were close to acceptable cut-offs (RMSEA =0.09, SRMR =0.10, GFI =0.82, AGFI =0.78, CFI =0.79). There was no correlation between the two subscales (r=0.01, =0.83). Patients with history of bleeding showed lower convenience (r=-0.16, =0.08) and lower satisfaction (r=-0.21, =0.01). Our results support the finding that the Maltese translation of the PACT-Q2 is a valid and reliable instrument.
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http://dx.doi.org/10.2147/PPA.S207498DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593733PMC
June 2019

Portal Vein Thrombosis in Decompensated Cirrhosis: Rationale for Treatment.

Clin Transl Gastroenterol 2019 04;10(4):e00026

Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.

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http://dx.doi.org/10.14309/ctg.0000000000000026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6602787PMC
April 2019

Determinants of the Quality of Warfarin Control after Venous Thromboembolism and Validation of the SAMe-TT2-R2 Score: An Analysis of Hokusai-VTE.

Thromb Haemost 2019 Apr 7;119(4):675-684. Epub 2019 Feb 7.

Thrombosis Research Unit, Division of Hematology, Department of Medicine I, University Hospital "Carl Gustav Carus," Dresden, Germany.

Background:  Time in therapeutic range (TTR) measures the quality of vitamin K antagonist (VKA) anticoagulation. In patients with atrial fibrillation, the dichotomized SAMe-TT2-R2 score (≥2 vs. < 2 points) can predict if adequate TTR is unlikely to be achieved.

Aims:  We validated the SAMe-TT2-R2 score in patients with venous thromboembolism (VTE) randomized to the warfarin arm of the Hokusai-VTE trial.

Patients And Methods:  A total of 3,874 patients were included in the primary analysis (day 31-180 from randomization). The efficacy and safety outcomes were symptomatic recurrent VTE and major or clinically relevant non-major bleeding.

Results:  The rates of recurrent VTE and bleeding events were higher in patients with a TTR below the median (< 66% vs. ≥66%) resulting in an absolute risk difference (ARD) of +0.5% (95% confidence interval: 0%, +1.1%) and +2.2% (0.9%, +3.5%), respectively. Patients with high SAMe-TT2-R2 score were 76% of total and had lower median TTR (64.7% vs. 70.7%). The SAMe-TT2-R2 score exhibited low negative (0.59) and positive (0.52) predictive value (TTR threshold 66%), and poor discrimination (c-statistic, 0.58). ARD between patients with high and low score was 0% (-0.6%, +0.7%) for recurrence and +1.3% (-0.1%, +2.7%) for bleeding. Results were confirmed in sensitivity analyses focusing on the whole study period (day 1-365).

Conclusion:  In VTE patients, the SAMe-TT2-R2 score showed unsatisfactory discrimination and predictive value for individual TTR and did not correlate well with clinical outcomes. The choice of starting a patient on VKA cannot be based on this parameter and its routine use after VTE may not translate into clinical usefulness.
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http://dx.doi.org/10.1055/s-0039-1678546DOI Listing
April 2019
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