Explore the vast range of titles available.

BackgroundAtrial High-Rate Episodes (AHRE), as detected by implantable cardiac devices, increase stroke risk. Remote monitoring (RM) provides physicians with timely notification of such episodes through automatic downloads from home. The AHRE burden required to increase thromboembolic risk is unclear albeit the European Society of Cardiology (ESC) AF guidelines recommend initiating oral anticoagulation (OAC) in patients with at least a single episode of long duration (≥ 1 hour) and an overall ‘high’ daily burden of AHRE (total duration of all episodes), having considered the CHA2DS-VAS2C score. Moreover, device manufacturers are inconsistent with their nominal AHRE notification settings.AimIn light of the ESC AF guidelines (2020), this study reviewed the current practise of RM for AHRE detection to determine OAC in patients with AHRE and CHA2DS-Vas2c ≥ 2 (Male) or 3 (Female).MethodsWe retrospectively collected data from 50 patients with RM devices at a district hospital in the UK. Patients were selected to allow comparison between the 4 different manufacturers (Abbott, Biotronik, Boston Scientific, and Medtronic) used at the centre (figure 1). The latest AHRE notification alert settings and clinical data were obtained from electronic patient records. Table 1 shows the nominal settings.ResultsOf the 50 patients, 50% had dual chamber pacemaker (figure 2), mean age 74 (SD ± 9) years, 38 patients (76%) had no documented history of atrial fibrillation at device implantation: 37 of them had an elevated CHA2DS-Vas2c score or previous TIA/stroke. Of these 37 patients, 33 patients had nominal RM settings with 8 of these patients later anticoagulated for AF; 4 patients had AHRE burden settings reduced to 1 hour, with one of these patients later anticoagulated for AF. DiscussionAbbott can alert for single, prolonged AHRE episodes in accordance with ESC guidance. However, episode detection is nominally set at 3 hours. AHRE burden can be determined by all manufacturers and may be used solely (without supporting guidance) in the absence of single episode alerts, pending robust trial data to conclusively alter the current OAC recomendation. Also, it is apparent that RM nominal settings are not actively altered by device implanting physicians but this may change as a result of the recently revised ESC AF guidance.In our cohort, 37 patients without a history of AF at device implantation were at significant risk of thromboembolism in the event of developing AF. It is possible that the 9 patients on OAC may have initiated OAC sooner if significant AHRE been detected earlier. Similarly, limitations of AHRE detection and a failure by physicians to alter RM nominal settings potentially limited identification of other patients suitable for OAC.Abstract 102 Figure 1Abstract 102 Figure 2Abstract 102 Table 1RM nominal settings for AHRE alerts between different device manufacturers Single Episode (On/Off) Single Episode Duration Daily Burden (On/Off) Daily Burden Duration AbbottOn3hrOn6 hrBiotronikN/AN/AOn6 hrBoston ScientificN/AN/AOn0 hrMedtronicN/AN/AOff6 hrsConclusionsGuideline-directed AHRE detection settings are under-utilised even though most patients with implantable cardiac devices are at potentially high risk of developing thromboembolic events.Conflict of InterestNone

In a randomized trial, oral apixaban was noninferior to a low-molecular-weight heparin, dalteparin, in preventing recurrent venous thromboembolism at 6 months in patients with cancer. The use of apixaban was not associated with a higher risk of major bleeding than dalteparin, even in patients with gastrointestinal cancer.

In a trial in patients with pelvic or acetabular fractures or extremity fractures that were treated operatively, aspirin thromboprophylaxis was noninferior to low-molecular-weight heparin in preventing death at 90 days.

In a randomized trial, 1050 patients with cancer who had acute venous thromboembolism were assigned to receive either dalteparin or edoxaban for 6 to 12 months. Edoxaban was noninferior to dalteparin with respect to the outcome of recurrent venous thromboembolism or major bleeding.

In patients with provoked venous thromboembolism and ongoing risk factors, extended treatment with low-dose apixaban for 12 months resulted in a lower risk of recurrent VTE than placebo, with a low risk of major bleeding.

Pregnancy-related venous thromboembolism is a leading cause of maternal morbidity and mortality, and thromboprophylaxis is indicated in pregnant and post-partum women with a history of venous thromboembolism. The optimal dose of low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy and the post-partum period is uncertain. In this open-label, randomised, controlled trial (Highlow), pregnant women with a history of venous thromboembolism were recruited from 70 hospitals in nine countries (the Netherlands, France, Ireland, Belgium, Norway, Denmark, Canada, the USA, and Russia). Women were eligible if they were aged 18 years or older with a history of objectively confirmed venous thromboembolism, and with a gestational age of 14 weeks or less. Eligible women were randomly assigned (1:1), before 14 weeks of gestational age, using a web-based system and permuted block randomisation (block size of six), stratified by centre, to either weight-adjusted intermediate-dose or fixed low-dose low-molecular-weight heparin subcutaneously once daily until 6 weeks post partum. The primary efficacy outcome was objectively confirmed venous thromboembolism (ie, deep-vein thrombosis, pulmonary embolism, or unusual site venous thrombosis), as determined by an independent central adjudication committee, in the intention-to-treat (ITT) population (ie, all women randomly assigned to treatment). The primary safety outcome was major bleeding which included antepartum, early post-partum (within 24 h after delivery), and late post-partum major bleeding (24 h or longer after delivery until 6 weeks post partum), assessed in all women who received at least one dose of assigned treatment and had a known end of treatment date. This study is registered with ClinicalTrials.gov, NCT01828697, and is now complete. Between April 24, 2013, and Oct 31, 2020, 1339 pregnant women were screened for eligibility, of whom 1110 were randomly assigned to weight-adjusted intermediate-dose (n=555) or fixed low-dose (n=555) low-molecular-weight heparin (ITT population). Venous thromboembolism occurred in 11 (2%) of 555 women in the weight-adjusted intermediate-dose group and in 16 (3%) of 555 in the fixed low-dose group (relative risk [RR] 0·69 [95% CI 0·32–1·47]; p=0·33). Venous thromboembolism occurred antepartum in five (1%) women in the intermediate-dose group and in five (1%) women in the low-dose group, and post partum in six (1%) women and 11 (2%) women. On-treatment major bleeding in the safety population (N=1045) occurred in 23 (4%) of 520 women in the intermediate-dose group and in 20 (4%) of 525 in the low-dose group (RR 1·16 [95% CI 0·65–2·09]). In women with a history of venous thromboembolism, weight-adjusted intermediate-dose low-molecular-weight heparin during the combined antepartum and post-partum periods was not associated with a lower risk of recurrence than fixed low-dose low-molecular-weight heparin. These results indicate that low-dose low-molecular-weight heparin for thromboprophylaxis during pregnancy is the appropriate dose for the prevention of pregnancy-related recurrent venous thromboembolism. French Ministry of Health, Health Research Board Ireland, GSK/Aspen, and Pfizer.

Patients discharged from the hospital carry an increased risk of venous thromboembolism after discharge. A randomized trial of rivaroxaban for 6 weeks after hospital discharge had no significant effect on the risk of venous thromboembolism as compared with placebo.

AbstractObjectiveTo assess the effect of statin treatment versus placebo on clinical outcomes in patients with covid-19 admitted to the intensive care unit (ICU).DesignINSPIRATION/INSPIRATION-S was a multicenter, randomized controlled trial with a 2×2 factorial design. Results for the anticoagulation randomization have been reported previously. Results for the double blind randomization to atorvastatin versus placebo are reported here.Setting11 hospitals in Iran.ParticipantsAdults aged ≥18 years with covid-19 admitted to the ICU.InterventionAtorvastatin 20 mg orally once daily versus placebo, to be continued for 30 days from randomization irrespective of hospital discharge status.Main outcome measuresThe primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or all cause mortality within 30 days from randomization. Prespecified safety outcomes included increase in liver enzyme levels more than three times the upper limit of normal and clinically diagnosed myopathy. A clinical events committee blinded to treatment assignment adjudicated the efficacy and safety outcomes.ResultsOf 605 patients randomized between 29 July 2020 and 4 April 2021 for statin randomization in the INSPIRATION-S trial, 343 were co-randomized to intermediate dose versus standard dose prophylactic anticoagulation with heparin based regimens, whereas 262 were randomized after completion of the anticoagulation study. 587 of the 605 participants were included in the primary analysis of INSPIRATION-S, reported here: 290 were assigned to atorvastatin and 297 to placebo (median age 57 years (interquartile range 45-68 years); 256 (44%) women). The primary outcome occurred in 95 (33%) patients assigned to atorvastatin and 108 (36%) assigned to placebo (odds ratio 0.84, 95% confidence interval 0.58 to 1.21). Death occurred in 90 (31%) patients in the atorvastatin group and 103 (35%) in the placebo group (odds ratio 0.84, 95% confidence interval 0.58 to 1.22). Rates for venous thromboembolism were 2% (n=6) in the atorvastatin group and 3% (n=9) in the placebo group (odds ratio 0.71, 95% confidence interval 0.24 to 2.06). Myopathy was not clinically diagnosed in either group. Liver enzyme levels were increased in five (2%) patients assigned to atorvastatin and six (2%) assigned to placebo (odds ratio 0.85, 95% confidence interval 0.25 to 2.81).ConclusionsIn adults with covid-19 admitted to the ICU, atorvastatin was not associated with a significant reduction in the composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or all cause mortality compared with placebo. Treatment was, however, found to be safe. As the overall event rates were lower than expected, a clinically important treatment effect cannot be excluded.Trial registrationClinicalTrials.gov NCT04486508.