Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial.

BACKGROUND: Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. METHODS: In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. FINDINGS: Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55-0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55-1·53; p=0·76). INTERPRETATION: Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication [corrected]. FUNDING: Boehringer Ingelheim and Canadian Institutes of Health Research.

Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial.

BACKGROUND: The relative contributions of intraoperative and postoperative hypotension to perioperative morbidity remain unclear. We determined the association between hypotension and a composite of 30-day myocardial infarction and death over three periods: (1) intraoperative, (2) remaining day of surgery, and (3) during the initial four postoperative days. METHODS: This was a substudy of POISE-2, a 10,010-patient factorial-randomized trial of aspirin and clonidine for prevention of myocardial infarction. Clinically important hypotension was defined as systolic blood pressure less than 90 mmHg requiring treatment. Minutes of hypotension was the exposure variable intraoperatively and for the remaining day of surgery, whereas hypotension status was treated as binary variable for postoperative days 1 to 4. We estimated the average relative effect of hypotension across components of the composite using a distinct effect generalized estimating model, adjusting for hypotension during earlier periods. RESULTS: Among 9,765 patients, 42% experienced hypotension, 590 (6.0%) had an infarction, and 116 (1.2%) died within 30 days of surgery. Intraoperatively, the estimated average relative effect across myocardial infarction and mortality was 1.08 (98.3% CI, 1.03, 1.12; P < 0.001) per 10-min increase in hypotension duration. For the remaining day of surgery, the odds ratio was 1.03 (98.3% CI, 1.01, 1.05; P < 0.001) per 10-min increase in hypotension duration. The average relative effect odds ratio was 2.83 (98.3% CI, 1.26, 6.35; P = 0.002) in patients with hypotension during the subsequent four days of hospitalization. CONCLUSIONS: Clinically important hypotension-a potentially modifiable exposure-was significantly associated with a composite of myocardial infarction and death during each of three perioperative periods, even after adjustment for previous hypotension.

Retraction: Lipoma Growing on the Back for 26 Years: A Bizarre Case Report.

[This retracts the article DOI: 10.7759/cureus.56999.].

Lipoma Growing on the Back for 26 Years: A Bizarre Case Report.

Lipoma is one of the most typical and benign tumors. They are typically regarded as a mass that is painless, asymptomatic, and slow-growing. It is composed of fat cells of the adult type. It can occur anywhere in the body and is often called a "universal" or ubiquitous tumor. They can develop in any region containing adipose tissue, with a higher prevalence in the subcutaneous tissue of the trunk and the nape of the neck and the limbs and occasionally in other locations, including the hand. There are three main varieties: encapsulated, diffuse, and multiple lipomas. A few lipomas may contain other tissues: fibrolipoma, neurolemma, and myelolipoma. Lipoma, when present for a long time, may undergo certain changes. This is particularly true in cases of lipoma under subcutaneous tissues of the thigh, buttock, or retroperitoneal lipoma. Such changes can be malignant, sarcomatous, calcification, or saponification. Clinically, a lipoma can occur in different anatomical situations; according to this, a lipoma can be classified into subcutaneous type, subfascial type, intramuscular type, subserous type, submucous type, intra-articular type, or it can be intraglandular. Lipomas, the most prevalent benign mesenchymal tumors, consist of mature lipocytes. Typically, lipomas are small, weighing only a few grams, with a maximum diameter usually under 2 cm. The term "giant" is applied when a lipoma reaches a diameter of at least 10 cm or weighs a minimum of 1,000 g. Due to their substantial size, giant lipomas can lead to functional limitations, such as lymphedema, pain syndromes, or nerve compression. Given the unique nature of this condition, characterized by the considerable size of the lesion and the challenges in both diagnosis and treatment, we present a case involving a 45-year-old woman with a giant lipoma in the suprascapular region.

The Miraculous Diagnostic Role of Indocyanine Green in a Diabetic Foot Ulcer: A Rare Case Report.

Diabetes is a chronic metabolic disorder characterized by elevated levels of glucose in the blood. This causes small nerve polyneuropathy resulting in diabetic foot ulcers. A diabetic foot ulcer is an open sore or wound that develops as a result of chronic diabetes. Indocyanine green angiography (ICGA) near-infrared (NIR) can provide real-time visualization of blood flow within the microvasculature of the underlying organ. Here, we discuss a 63-year-old patient who came with a diabetic foot ulcer over his right great toe. His blood glucose level was 208 mg/dl. He drinks alcohol occasionally and smokes regularly. The tissue perfusion of his right foot was checked using the indocyanine green dye, after which orthopedic surgeons were consulted, and the gangrenous part was amputated.

The Wonder Dye: Uses and Implications of Indigocyanine Green in Various Surgeries.

Indigocyanine green (ICG) is a fluorophore dye that has been extensively used in recent modern times for bioimaging in numerous surgeries to aid in easier identification of occult and often tricky-to-find anatomical structures. Surgery becomes complex and challenging due to multiple anatomical anomalies, pathological fibrosis, obesity, or previous surgeries. To overcome these obstacles in surgery, the surgeon yearns to know the structures present beyond their white light vision so that while dissecting the organ, they can avoid injuring the critical systems in the vicinity of dissection. Near-infrared (NIR) imaging aids in visualising the tissues at depth/in the area of dissection, thereby preventing any possible surgical catastrophes due to them inadvertently damaging surrounding vital structures. Various advantages in surgeries like gastric sleeve surgery, lymph node and tumour detection, localisation of ureters and biliary tracts, and intraoperative tissue perfusion of flaps have been described in this study. This review article aims to compile a short list of utilities of ICG with NIR imaging in various surgical interventions. The merits and demerits of this imaging technique have been noted. The study points out the uses of ICG fluorescence imaging under different surgical fronts. This review article concludes by comparing the results of studies performed by various authors. Results have been compared to conventional surgical modalities.

Limy Bile Syndrome: A Report of a Rare Case.

Milk of Calcium Bile or Limy Bile Syndrome (LBS) is a sporadic and infrequent complication of cholecystitis in which the gallbladder is filled with radio-opaque, abnormal bile secretion. A 40-year-old female came to a tertiary care hospital with symptoms of recurrent pain upper abdomen for two years. On examination, the patient had mild jaundice and mild tenderness at Murphy's point exacerbated on deep inspiration. Laboratory investigations suggested raised levels of bilirubin and hepatic enzymes. Upper GI endoscopy revealed a normal GI tract. A hepatobiliary iminodiacetic acid-cholecystokinin (HIDA-CCK) scan suggested a gallbladder ejection fraction of 5%. Cholecystectomy was done the next day. Infrared imaging under Indocyanine green (ICG) dye revealed a completely dark gallbladder. The patient was asked to take ursodeoxycholic acid preparation post-operatively for four weeks. This case of LBS was discharged on the third postoperative day. She was asked to regularly follow up with the surgeons. LBS is a rare patho-clinical entity with a need for standardized diagnostic and treatment regimen. Further case reporting and studies are required to understand the disease in more depth.