Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

Background: Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. Methods: We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124. Findings: Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82–1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98). Interpretation: We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Prosthetic Aortic Valve Endocarditis Creeping Into the Paravalvular Space.

Prosthetic valve endocarditis is a devastating infection with a challenging diagnosis and management. Despite advances in its diagnostic modalities, medical, and surgical interventions, prosthetic valve endocarditis still carries high morbidity and mortality rates. Here, we report a case of prosthetic aortic valve endocarditis that progressed to involve the paravalvular space and the importance of multimodality cardiac imaging in the early detection of paravalvular complications

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Impella RP Use in Refractory Cardiogenic Shock in a Patient Presenting With Acute Right Coronary Artery Occlusion: A Case Report

It is common for patients with inferior myocardial infarction to experience right ventricular infarction, occurring in half of the patients with inferior myocardial infarction. Right ventricular failure due to acute right myocardial infarction is often associated with a worse prognosis. In this case, we report a patient with acute chest pain due to acute right coronary artery occlusion status post placement of multiple stents in the right coronary artery. Unfortunately, he developed refractory cardiogenic shock requiring biventricular assist device placement

Urgent Transcatheter Mitral Valve-in-Valve Replacement With Venoarterial Extracorporeal Membrane Oxygenation Support: Case Report and Review of the Literature

Critical mitral valve stenosis due to a failed bioprosthetic valve is associated with significant morbidity and mortality, with the transcatheter Valve-in-Valve (ViV) approach becoming a popular treatment option. We present a case of cardiogenic shock secondary to a stenotic mitral bio-prosthetic valve. The Heart team was consulted; the patient was a high-risk surgical candidate for valve replacement. He required venoarterial extracorporeal membrane oxygenation as a bridge to definitive therapy. The patient underwent a successful urgent transcatheter mitral ViV procedure with a trans-septal approach. Follow-up echocardiography showed significant improvement in mitral valve dynamics. Recently emerging transcatheter approaches for mitral ViV implantation after balloon valvuloplasty into a failed mitral valve prosthesis are technically feasible in high-risk patient populations and should be considered over re-operative mitral valve surgery

The coagulation changes associated with acute variceal bleeding in patients with HCV-induced cirrhosis as assessed by rotational thromboelastometry

Abstract Background and objectives Alterations of hemostasis in patients with decompensated cirrhosis are complex. Accordingly, standard coagulation tests are not feasible to evaluate bleeding risk in these patients. The aim of this study was to assess the coagulation kinetics in cirrhotic patients with variceal bleeding using rotational thromboelastometry (ROTEM). ROTEM including EXTEM, INTEM, and FIBTEM which represent extrinsic, intrinsic pathways, and fibrinogen activity, respectively, was measured in 60 cirrhotic patients with variceal bleeding who were compared to 60 patients with stable cirrhosis. APTEM was optionally performed to evaluate fibrinolysis. Results Overall, cirrhosis patients displayed features of hypofibrinolysis, whereas the state of hypocoagulability was significantly higher in cirrhotic patients with variceal bleeding (61.7% versus 30%, p = 0.001). Values of clot formation time (CFT) by EXTEM and INTEM correlated positively with those of model for end-stage liver disease score (r = 0.529, p = 0.001, and r = 0.595, p < 0.001, respectively). Furthermore, in a multivariate analysis, values of CFT in both assays were significantly associated with increased risk of 1.9 (95% CI = 1.04–2.45, p = 0.02) and of 1.78 (95% CI = 1.02–2.14, p = 0.01), respectively, for occurrence of variceal bleeding. Conclusion Cirrhotic patients with variceal bleeding frequently showed a hypocoagulable state that is triggered by thrombocytopenia and/or hypofibrinogenemia. CFT by EXTEM and INTEM seemed to be an extra marker for disease severity and prognosis in cirrhosis patients, in addition to its valuable role in prediction of variceal bleeding in these patients. However, large multicenter studies have yet been required