9 research outputs found
Acute idiopathic heart failure following laparoscopic myotomy for achalasia of the esophagus
Background: Stress-induced cardiomyopathy, also known as takotsubo cardiomyopathy, is not fully understood. It is thought to occur in patients who have signs and symptoms consistent with acute myocardial infarction but display no obstructive coronary lesions during heart catheterization. Characteristics include transient left ventricular dysfunction, wall motion abnormalities on echocardiogram, new electrocardiographic ST-segment changes, and the occurrence of a precipitating stressor. Case Report: We present a patient who underwent Heller myotomy and suffered acute heart failure in the immediate postoperative period. Left heart catheterization revealed clean coronary arteries, and the patient fully recovered days later. While difficult to fully exclude drug-related causes, we believe this case to be consistent with takotsubo cardiomyopathy. Conclusion: This unusual postoperative complication following uneventful laparoscopic surgery should be kept in mind when unsuspected cardiovascular compromise is seen in the early perioperative recovery period. In addition to the rare occurrence of acute coronary ischemia syndromes and possible perioperative pulmonary embolic events, cardiovascular decompensation related to acute stress syndromes or idiopathic pharmacologic responses must be considered. Even patients who seem most healthy can have complications that warrant immediate attention and treatment
Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection
BACKGROUND Clostridium difficile is the most common cause of infectious diarrhea in hospitalized patients. Recurrences are common after antibiotic therapy. Actoxumab and bezlotoxumab are human monoclonal antibodies against C. difficile toxins A and B, respectively. METHODS We conducted two double-blind, randomized, placebo-controlled, phase 3 trials, MODIFY I and MODIFY II, involving 2655 adults receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection. Participants received an infusion of bezlotoxumab (10 mg per kilogram of body weight), actoxumab plus bezlotoxumab (10 mg per kilogram each), or placebo; actoxumab alone (10 mg per kilogram) was given in MODIFY I but discontinued after a planned interim analysis. The primary end point was recurrent infection (new episode after initial clinical cure) within 12 weeks after infusion in the modified intention-to-treat population. RESULTS In both trials, the rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% [67 of 386] vs. 28% [109 of 395]; adjusted difference, â10.1 percentage points; 95% confidence interval [CI], â15.9 to â4.3; P<0.001; MODIFY II: 16% [62 of 395] vs. 26% [97 of 378]; adjusted difference, â9.9 percentage points; 95% CI, â15.5 to â4.3; P<0.001) and was significantly lower with actoxumab plus bezlotoxumab than with placebo (MODIFY I: 16% [61 of 383] vs. 28% [109 of 395]; adjusted difference, â11.6 percentage points; 95% CI, â17.4 to â5.9; P<0.001; MODIFY II: 15% [58 of 390] vs. 26% [97 of 378]; adjusted difference, â10.7 percentage points; 95% CI, â16.4 to â5.1; P<0.001). In prespecified subgroup analyses (combined data set), rates of recurrent infection were lower in both groups that received bezlotoxumab than in the placebo group in subpopulations at high risk for recurrent infection or for an adverse outcome. The rates of initial clinical cure were 80% with bezlotoxumab alone, 73% with actoxumab plus bezlotoxumab, and 80% with placebo; the rates of sustained cure (initial clinical cure without recurrent infection in 12 weeks) were 64%, 58%, and 54%, respectively. The rates of adverse events were similar among these groups; the most common events were diarrhea and nausea. CONCLUSIONS Among participants receiving antibiotic treatment for primary or recurrent C. difficile infection, bezlotoxumab was associated with a substantially lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo. The addition of actoxumab did not improve efficacy. (Funded by Merck; MODIFY I and MODIFY II ClinicalTrials.gov numbers, NCT01241552 and NCT01513239.
International Consensus Statement on Rhinology and Allergy: Rhinosinusitis
Background: The 5 years since the publication of the first International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICARâRS) has witnessed foundational progress in our understanding and treatment of rhinologic disease. These advances are reflected within the more than 40 new topics covered within the ICARâRSâ2021 as well as updates to the original 140 topics. This executive summary consolidates the evidenceâbased findings of the document. Methods: ICARâRS presents over 180 topics in the forms of evidenceâbased reviews with recommendations (EBRRs), evidenceâbased reviews, and literature reviews. The highest grade structured recommendations of the EBRR sections are summarized in this executive summary. Results: ICARâRSâ2021 covers 22 topics regarding the medical management of RS, which are grade A/B and are presented in the executive summary. Additionally, 4 topics regarding the surgical management of RS are grade A/B and are presented in the executive summary. Finally, a comprehensive evidenceâbased management algorithm is provided. Conclusion: This ICARâRSâ2021 executive summary provides a compilation of the evidenceâbased recommendations for medical and surgical treatment of the most common forms of RS