Esmeralda Filippucci

Risk of recurrent cerebrovascular events in patients with cryptogenic stroke or transient ischemic attack and patent foramen ovale: The FORI (Foramen Ovale Registro Italiano) study

Background: The optimal management of patients with cryptogenic ischemic stroke found to have a patent foramen ovale (PFO) at diagnostic workup remains unclear. The aims of this observational multicenter study were to evaluate: (1) the risk of recurrent cerebrovascular events in patients with cryptogenic minor ischemic stroke or transient ischemic attack (TIA) and PFO who either underwent percutaneous PFO closure or received only medical treatment, and (2) the risk factors associated with recurrent events. Methods: Consecutive patients (aged 55 years or less) with first-ever cryptogenic minor ischemic stroke or TIA and PFO were recruited in 13 Italian hospitals between January 2006 and September 2007 and followed up for 2 years. Results: 238 patients were included in the study (mean age 42.2 ± 10.0 years; 118 males); 117 patients (49.2%) received only antithrombotic therapy while 121 patients underwent percutaneous PFO closure (50.8%). Stroke as the qualifying event was more common in the medical treatment group (p = 0.01). The presence of atrial septal aneurysm and evidence of 20 bubbles or more on transcranial Doppler were more common in the PFO closure group (p = 0.002 and 0.02). Eight patients (6.6%) experienced a nonfatal complication during PFO closure. At the 2-year follow-up, 17 recurrent events (TIA or stroke; 3.6% per year) were observed; 7 of these events (2.9% per year) occurred in the percutaneous PFO closure group and 10 events (4.2% per year) in the medical treatment group. The rate of recurrent stroke was 0.4% per year in patients who underwent percutaneous closure (1 event) and 3.4% per year in patients who received medical treatment (8 events). On multivariate analysis, percutaneous closure was not protective in preventing recurrent TIA or stroke (OR = 0.1, 95% CI = 0.02–1.5, p = 0.1), while it was barely protective in preventing recurrent stroke (OR = 0.1, 95% CI = 0.0–1.0, p = 0.053). Conclusions: The results of this observational, nonrandomized study suggest that PFO closure might be superior to medical therapy for the prevention of recurrent stroke. Periprocedural complications were the trade-off for this clinical benefit. Controlled randomized clinical trials comparing percutaneous closure with medical management are required.

Parnaparin versus aspirin in the treatment of retinal vein occlusion. A randomized, double blind, controlled study

INTRODUCTIONnRetinal vein occlusion (RVO) is a common cause of unilateral visual loss. Evidence based treatment recommendations for patients with RVO cannot be made because of the lack of adequate clinical trials. To compare the efficacy and safety of aspirin and of a low molecular weight heparin, parnaparin, in the treatment of RVO.nnnMATERIALS AND METHODSnIn a multicenter, randomized, double blind, controlled trial eligible patients with a delay between symptoms onset and objective diagnosis of less than 15 days were randomized to aspirin 100 mg/day for 3 months or to a fixed daily dose of parnaparin, 12.800 IU for 7 days followed by 6.400 IU for a total of 3 months. Primary end-point of the study was the incidence of functional worsening of the eye with RVO at 6 months, as assessed by fluorescein angiography, visual acuity, and visual field. Study end-points were adjudicated by an independent committee.nnnRESULTSnSixty-seven patients were enrolled in the study and 58 of them (28 treated with parnaparin, 30 with aspirin) were evaluable for the analysis. Baseline characteristics were well balanced between groups. Functional worsening was adjudicated in 20.7% of patients treated with parnaparin and in 59.4% of patients treated with ASA (p=0.002). Recurrent RVO was diagnosed in 3 patients, all treated with ASA (p=n.s.). Bleeding rates were similar between the two groups.nnnCONCLUSIONSnParnaparin appears to be more effective than aspirin in preventing functional worsening in patients with RVO. The results of this study need to be confirmed in a larger clinical trial.

Incidence and risk factors for venous thromboembolism after laparoscopic surgery for colorectal cancer

Background Limited data are currently available concerning the risk for venous thromboembolism (VTE) after laparoscopic surgery for cancer. Methods Consecutive patients who had laparoscopic surgery for colorectal cancer were included in a prospective multicenter study. Compression ultrasonography of the lower limbs was performed at 8+/-2 days after surgery. The primary study outcome was symptomatic objectively confirmed or ultrasonography-detected VTE at day 8+/-2 after surgery. Results 305 patients were included in the study, mean age 67+/-11 years, 54% males. All included patients received prophylaxis with low molecular weight heparin from the day of surgery to the day of ultrasonography. VTE was diagnosed in 54 patients (17.7%), in all of them as deep vein thrombosis of the lower limbs. Obesity and age ≥70 years were independent predictors for VTE at day 8+/-2. Conclusions The risk of VTE after laparoscopic surgery for colorectal cancer is substantial despite antithrombotic prophylaxis and is more common in obese and old patients.

Prophylaxis of venous thromboembolism with low molecular weight heparin in bariatric surgery: a prospective, randomised pilot study evaluating two doses of parnaparin (BAFLUX Study).

BackgroundThe optimal dose of low molecular weight heparin (LMWH) to prevent venous thromboembolism (VTE) after bariatric surgery remains controversial. The aim of this multicentre, open-label, pilot study was to evaluate the efficacy and safety of two different doses of the LMWH parnaparin administered to patients undergoing bariatric surgery.MethodsPatients were randomised to receive 4,250xa0IU/day (group A) or 6,400xa0IU/day (group B) of parnaparin s.c. for 7–11xa0days. Bilateral colour Doppler ultrasound of the lower limb was performed before surgery and at the end of the treatment period. The primary efficacy outcome was a composite of asymptomatic and symptomatic deep vein thrombosis, symptomatic pulmonary embolism and death from any cause during treatment. The primary safety endpoint was major and clinically relevant non-major bleeding.ResultsA total of 258 patients underwent randomization; 8 subjects were excluded following the safety analysis. One hundred thirty-one patients [106 females; mean age, 40.3xa0years (standard deviation (SD) ±9.6); mean body mass index (BMI), 44.6xa0kg/m2 (SD ±5.4)] were assigned to group A and 119 patients [93 females; mean age, 41.5xa0years (SD ±9.9); mean BMI, 44.2xa0kg/m2 (SD ±5.4)] were assigned to group B. The rate of the primary efficacy outcome was 1.5xa0% (two cases; 95xa0% confidence interval (CI), 0.2–6.0xa0%) in group A as compared with 0.8xa0% (one case; 95xa0% CI, 0.4–5.3xa0%) in group B (pu2009=u2009ns). The composite incidence of major bleeding and clinically relevant non-major bleeding was 6.1xa0% (eight cases; 95xa0% CI, 2.9–12.1xa0%) in group A and 5.0xa0% (six cases; 95xa0% CI, 2.1–11.1xa0%) in group B (pu2009=u2009ns).ConclusionsA parnaparin dose of 4,250xa0IU/day seems suitable for VTE prevention in patients undergoing bariatric surgery.

Vitamin K and non-vitamin K antagonist oral anticoagulants for non-valvular atrial fibrillation in real-life.

BACKGROUNDnCurrent guidelines recommend vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in patients with non-valvular atrial fibrillation (AF).nnnMETHODSnWe compared the clinical features of consecutive in- and out-patients with non-valvular AF newly-treated with NOACs or on treatment with VKAs.nnnRESULTSnOverall, 1314 patients newly-treated with NOACs and 1024 on treatment with VKAs were included in the study. The mean CHA2DS2-VASc score was 4.3±1.5 and 4.0±1.5 and the mean HAS-BLED score was 2.8±1.2 and 2.2±1.1 in the two groups, respectively (both p<0.001). Hypertension, previous stroke, female gender, vascular diseases and previous bleeding were more prevalent in NOACs patients. Renal failure, age ≥75years and congestive heart failure were more prevalent in VKAs patients. Among NOACs patients, 438 were given dabigatran, 463 rivaroxaban and 413 apixaban (33%, 35% and 31%, respectively). The mean CHA2DS2-VASc and HAS-BLED scores were higher in rivaroxaban or apixaban patients compared with dabigatran (both p<0.001) and VKAs patients (both p<0.001). A lower mean age was observed in patients newly-treated with dabigatran. Patients newly-treated with reduced doses of NOACs (599 patients, 45.5%) had a higher CHA2DS2-VASc (4.8±1.4 vs. 3.9±1.5 vs. 4.0±1.5) and HAS-BLED (2.9±1.1 vs. 2.8±1.2 vs. 2.2±1.1) scores compared with those treated with regular doses of NOACs or VKAs.nnnCONCLUSIONnPatients given rivaroxaban and apixaban in clinical practice have a higher thrombotic and hemorrhagic risk in comparison with patients given dabigatran or VKAs. A considerable proportion of patients receive reduced doses of NOACs.

Holter monitoring to detect silent atrial fibrillation in high-risk subjects: the Perugia General Practitioner Study

Atrial fibrillation (AF) is diagnosed for the first time in about 5xa0% of patients admitted for acute ischemic stroke. Advanced aged and arterial hypertension are risk factors for AF. We evaluated the prevalence of silent AF in subjects with advanced age and systemic arterial hypertension. Subjects of both gender, aged 65xa0years or more with systemic arterial hypertension were randomly identified from the patient lists of the participating general practitioners in the Perugia area, in Italy. Study subjects underwent baseline 12-lead ECG and, if this did not show AF, 48-h Holter monitoring was performed. AF was known and confirmed by 12-lead ECG in 4 out of the 308 evaluated subjects (1.3xa0%). Baseline 12-lead ECG showed no cases of silent AF. Holter monitoring was performed in 300 subjects, mean age 70xa0±xa04. Twenty-six recordings were not evaluable for the presence of artifacts; therefore, 274 subjects were included in the analysis. Holter monitoring showed AF in 27 out of 274 subjects (10xa0%; 95xa0% confidence interval 6.4–13.5xa0%); AF was longer than 30xa0s in four of the subjects. In 56 additional subjects, Holter monitoring revealed excessive supraventricular ectopic activity (20xa0%; 95xa0% confidence interval 15.3–24.7xa0%). Holter monitoring was able to detect silent AF in about 10xa0% of subjects aged 65 or above with systemic arterial hypertension. The risk of stroke associated with screened silent AF should be carefully evaluated.

Giant sigmoid diverticulum: a rare cause of common gastrointestinal symptoms

A 75-year-old woman was admitted to the emergency department (ED) with a history of vague abdominal pain associated with meteorism, nausea and occasional vomiting. Over the 6–7 months prior to admission, the symptoms had been characterized by periods of exacerbation, alternating with spontaneous remission. During this period, the patient had been periodically treated with a symptomatic pharmacological approach, with consequent alleviation of the symptoms. Before hospitalization, no laboratory tests, radiological screening or colonoscopic surveillance had been carried out. When the patient came to our unit, she presented the abdominal symptoms described above with stable vital signs and was afebrile. On physical examination, the abdomen was mildly tender to palpation in the middle and lower quadrants with no signs of peritonitis. No abdominal mass was felt during abdominal palpation. A digital rectal examination gave no clues, while laboratory tests yielded a positive result for occult blood in the faeces. Laboratory tests also revealed a white blood cell count of 18.3 9 10/lL (normal value: 4.5–10.8 9 10/lL) with a mild increase in the neutrophil cells and an iron deficiency anaemia. A plain abdominal X-ray study demonstrated a large, rounded, radiolucent formation (12 cm 9 22 cm) in the middle and lower abdomen, with no signs of obstruction (Fig. 1a, b). The subsequent unenhanced CT scan presented an image of an air-filled structure with thin regular walls and a narrow neck, opening into the sigmoid colon. The inner part of this structure contained a small quantity of fluid. The presence of this formation was confirmed by 2D MPRs in the sagittal and coronal plane (Fig. 2a, b). The mass was diagnosed as a giant sigmoid diverticulum (GSD). Multiple other diverticula were present in the descending colon. The patient underwent sigmoid resection with primary anastomosis, without further complications.

PO-40 - Real-life use of non-vitamin k antagonist oral anticoagulants in patients with cancer associated venous thromboembolism: data from a prospective cohort.

INTRODUCTIONnCancer associated thrombosis (CAT) has an increased risk of recurrent venous thromboembolism (VTE). Type, stage of cancer and chemotherapy (CHT) influence thromboembolic risk. The use of novel oral anticoagulants (NOACs) is controversial in patients with CAT.nnnAIMnThe aim of this study is to assess mortality, recurrent VTE and bleeding complications in patients with CAT and in patients without cancer receiving NOACs.nnnMATERIALS AND METHODSnConsecutive patients with acute objectively confirmed VTE receiving NOACs within 1 month from diagnosis are included from September 2013 in an ongoing prospective cohort study. Characteristics of patients and outcome are reported according to the presence of CAT. Chi-squared test and Student t-test are used.nnnRESULTSnAs for November 10(th) 2015, 472 patients were included in the study: 78 with CAT (16.5%). Lung, breast, gastrointestinal and genitourinary cancer was observed in 16%, 24%, 20% and 24% of patients with CAT, respectively. 31 patients with CAT (40%) were on CHT or radiotherapy (RT). 10 patients with CAT (13%) had at least an additional risk factor for VTE (4 had a CVC related thrombosis) and 34 (43.5%) were inpatients. Baseline characteristics of patients with and without CAT are reported in the Table. Pulmonary embolism was index VTE in 152 patients: 24.4% of patients with CAT and in 33.8% of those without cancer (p=0.10). DVT only was present in 320 patients and 78 had both DVT and PE. Among NOACs patients, 312 (66%) received initial loading dose: 61% of those with CAT and 67% without. 53 (11%) received reduced maintenance doses (10% with CAT, 11% without). As for nowadays, 272 patients had at least 3 months of follow-up, the mean follow-up being 8.6 months. 20 patients died (7.3%): 17 were cancer related deaths. Non cancer related death occurred in 1 patient with CAT (2%) and in 2 patients without (0.9%). No fatal bleedings or fatal VTE recurrences occurred. Patients recruitment and follow-up is currently ongoing aimed at assessing mortality, recurrent VTE and bleeding complications. Updated results on clinical outcomes will be presented at the congress.nnnCONCLUSIONSnPatients with CAT receiving NOACs are treated as patients without CAT in terms of use of loading doses and maintenance treatment. Upper arm thrombosis is more frequently involved in CAT patients and proximal lower vein in patients without CAT. Non cancer related mortality was higher in CAT patients but no fatal recurrences or fatal bleedings were observed so far.