An Introduction to Pharmacovigilance, 2nd ed

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In Response

No abstract available

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Preventing Adverse Events in Cataract Surgery: Sub-Tenon’s Block

No abstract available

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Survival Analysis and Interpretation of Time-to-Event Data: The Tortoise and the Hare

Survival analysis, or more generally, time-to-event analysis, refers to a set of methods for analyzing the length of time until the occurrence of a well-defined end point of interest. A unique feature of survival data is that typically not all patients experience the event (eg, death) by the end of the observation period, so the actual survival times for some patients are unknown. This phenomenon, referred to as censoring, must be accounted for in the analysis to allow for valid inferences. Moreover, survival times are usually skewed, limiting the usefulness of analysis methods that assume a normal data distribution. As part of the ongoing series in Anesthesia & Analgesia, this tutorial reviews statistical methods for the appropriate analysis of time-to-event data, including nonparametric and semiparametric methods—specifically the Kaplan-Meier estimator, log-rank test, and Cox proportional hazards model. These methods are by far the most commonly used techniques for such data in medical literature. Illustrative examples from studies published in Anesthesia & Analgesia demonstrate how these techniques are used in practice. Full parametric models and models to deal with special circumstances, such as recurrent events models, competing risks models, and frailty models, are briefly discussed. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Accepted for publication June 8, 2018. Funding: None. The authors declare no conflicts of interest. Reprints will not be available from the authors. Address correspondence to Patrick Schober, MD, PhD, MMedStat, Department of Anesthesiology, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, the Netherlands. Address e-mail to p.schober@vumc.nl. © 2018 International Anesthesia Research Society

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Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study

Abstract

Background

Hypotension after induction of general anesthesia (GAIH) is common in anesthesiology practice and can impact outcomes.

Methods

In this prospective multicenter, cross-sectional, observational study, the hypotension was defined as a decrease in mean arterial pressure of > 30% compared to the first measurement in the operation theatre before general anesthesia (GA) induction. Blood pressure was measured immediately at the time of endotracheal intubation (T_ETI), at five (T₅) and 10 (T₁₀) minutes after. All subjects aged > 18 years undergoing elective non-cardiac surgery under GA were included. The goals were description of GAIH occurrence, the association of GAIH with selected comorbidities, chronic medications, and anesthetics with GAIH, and the type and efficacy of interventions used to correct hypotension.

Results

Data from 661 subjects, whose GA was induced with propofol and sufentanil, were analyzed. In 36.5% of subjects, GAIH was observed at ≥ 1 of the assessed time points. GAIH was present in 2.9% subjects at all time points. The probability of GAIH is raising with age, degree of hypertension at time of arrival to theatre and presence of diabetes. The type of volatile anesthetic was not associated with the occurrence of GAIH. The overall efficiency of interventions to correct hypotension was 94.4%. Bolus fluids were the most often used intervention and was 96.4% effective.

Conclusion

GAIH rate depends on age, degree of blood pressure decompensation prior the surgery, and presence of diabetes mellitus type II.

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Müllerian Agenesis Masquerading as Secondary Amenorrhea

The most common cause of primary amenorrhea is congenital malformation of the Müllerian ducts, including Müllerian agenesis, also known as Mayer–Rokitansky–Küster–Hauser syndrome (MRKH). Most general gynecologists and primary care physicians who see female adolescents will encounter MRKH in their careers. We present the case of an adolescent with MRKH who reported secondary, instead of primary amenorrhea. We discuss the subtleties of diagnosing MRKH, especially when patient history may not always be accurate. Because MRKH had not been included in the differential diagnosis for delayed menses, this patient was initially misdiagnosed. Delayed diagnosis of MRKH may harm patients by delaying assessment of concomitant renal, skeletal, hearing, and cardiac defects, which might otherwise impact the treatment plan.

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Right hepatectomy due to hepatolithiasis caused by endoclip migration after laparoscopic cholecystectomy: a case report

Abstract

Complications related to cholecystectomy occur in <3% of patients. Endoclip migration after laparoscopic cholecystectomy with hepatolithiasis is an extremely rare complication. We report a case of hepatolithiasis secondary to endoclip migration after laparoscopic cholecystectomy treated successfully via right hepatectomy. A 35-year-old female presented with upper abdominal pain, fever and vomiting 9 years after laparoscopic cholecystectomy for chronic calculus cholecystitis. Laboratory investigation revealed gamma-glutamyl transpeptidase of 550 U/L and alkaline phosphatase of 350 U/L. Magnetic resonance cholangiopancreatography revealed a dilated intrahepatic bile duct in segment 6 filled with stones. After preoperative evaluation, a right hepatectomy was performed using the intermittent Pringle maneuver. The postoperative recovery was uneventful and the patient was well after 4 months of follow-up. Although rare, endoclip migration should be considered in patients presenting with intrahepatic lithiasis even many years after laparoscopic cholecystectomy. Liver resection may be necessary in cases of failure of endoscopic extraction.

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Paraestomal hernia with gastric outlet obstruction: a case report and literature review

Abstract

An 69-year-old obese woman was submitted to an abdominoperineal resection (APR) with left side end colostomy to treat a synchronic sigmoid and middle rectum cancer. Six months after APR, she develop a PH with a progressive increase of the size. The patient refused the surgical indication. Thirteen years after APR she presenting with abdominal pain, hematemesis, bilious vomiting and non-functioning of the stoma in the last 2 days. She had a distended and painful abdomen without signs of peritoneal irritation and a large incarcerated PH. CT showed a PH with incarcerated gastric herniation. Endoscopy showed a 4 cm ulcerated lesion in the lesser curvature of the stomach whose posteriorly histopathological study revealed that it was an ischemic ulcer. She was submitted a correction of PH using an onlay polypropylene mesh put around of the previous stoma. The patient has an uneventful recovery and was discharged 3 days later.

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A rare case report of gallbladder carcinosarcoma

Abstract

Introduction:Carcinosarcoma of the gallbladder (CSGB) is a rare clinical condition. To date, only 107 cases of CSGB have been reported worldwide. We present our experience of a late presentation of disseminated CSGB. To this we add a discussion of prognostic factors and treatment options for this rare gallbladder malignancy drawn from CSGB cases reported in the literature. Case report: A 73-year-old female presented to our facility with a poorly differentiated CSGB with widespread liver and peritoneal metastases. Fifteen days from the time of hospital admission, the patient suffered an acute episode of massive haematemesis with clinical signs of perforated viscous. Her cause of death was thought to be a tumour-related duodenal erosion. Discussion: Given the poor prognosis of CSGB, particularly when diagnosed at locally advanced or disseminated stages, we suggest a greater role for laparoscopic tissue diagnosis before considering radical surgical intervention.

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Rapid resolution of severe subcutaneous emphysema with simple percutaneous angiocatheter decompression

Abstract

Subcutaneous emphysema (SE) is often seen as a sequela of chest tube placement, cardiothoracic surgery, trauma, pneumothorax, infection or malignancy. In most cases SE is self-limited and requires no intervention. Rarely, air can rapidly dissect into subcutaneous tissue planes leading to respiratory distress, patient discomfort and airway compromise. This is a case of a 75-year-old woman that developed massive SE and impending respiratory failure with rapid progression of air into her subcutaneous tissue. In an effort to rapidly stabilize the patient we placed multiple percutaneous angiocatheters into the subfascial space with complete resolution in <24 h. This technique was an excellent temporizing measure and found to be superior to previously described techniques involving large open 'blow hole' incisions or large bore drains. Placement of angiocatheter needles for the decompression of subcutaneous air is a well-tolerated, readily accessibility, low cost and simple procedure for the treatment of SE.

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Trans‐mediastinal herniation of pulmonary bulla with paradoxical pneumothorax

Abstract

Trans-mediastinal herniation of a lung bullae is an extremely rare condition. Here we present a case of a 75-year-old patient with a clinical history of chronic obstructive pulmonary disease and emphysema presenting with a right contralateral pneumothorax secondary to a trans-mediastinal herniated lung bullae. Herniation occurred through a mediastinal pleural defect; we call this event a paradoxical pneumothorax. To our knowledge this is the first report in the medical literature. The patient was successfully treated using a VATS approach with a right pleurodesis, a left thoracoscopic trans-mediastinal hernia reduction and bullectomy.

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The Wolf Hidden behind the Clots: Catastrophic Antiphospholipid Antibody Syndrome

Catastrophic antiphospholipid syndrome (CAPS) is a rare but highly fatal clinical syndrome that occurs in up to 1% of patients with antiphospholipid syndrome (APS). The diagnosis of CAPS is often delayed because its presentation with multiple organ thromboses can be confused with other thrombotic microangiopathies and severe sepsis. We report a case of CAPS in a patient with APS and systemic lupus erythematosus (SLE) presenting with thrombotic storm precipitated by trauma, cytomegalovirus (CMV) infection, and noncompliance with anticoagulation therapy. Our case reflects the "two-hit hypothesis" of APS in which the presence of antiphospholipid antibodies (first hit) increases the thrombophilic risk, and thromboses take place in the presence of another thrombophilic condition such as CMV infection in our case. In this case review, we discuss the diagnostic challenges and management of CAPS. In clinical practice, we aim to stress the importance of thorough evaluation and management of precipitating events such as infections in addition to timely diagnosis and treatment of this catastrophic clinical entity.

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