Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial.

About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.

Acute abdomen: a rare presentation of group a streptococcal infection.

In this case report we describe a 38-year old female patient admitted to the emergency department with acute abdomen and sepsis. Broad-spectrum antibiotics were started. Abdominal imaging was inconclusive, exploratory laparoscopy showed four-quadrant peritonitis. No provoking factor could be withheld. Due to clinical deterioration the patient was transferred to the intensive care unit. Blood cultures showed the presence of group A streptococcus, and clindamycin was associated. She recovered, and could be discharged after several days. Peritonitis caused by group A Streptococcus pyogenes is rare in healthy individuals, and occurs mostly in middle-aged women. There is no consensus regarding surgical treatment but surgical exploration is often necessary to exclude secondary peritonitis. Treatment with broad-spectrum antibiotics and supportive measurements remain the cornerstone in patient management. Association of clindamycin has been shown to reduce mortality. There is inconclusive evidence to support Intravenous polyspecific immunoglobulin G (IVIG) therapy in streptococcal toxic shock syndrome.

A comparative study of patient satisfaction about anesthesia with dexmedetomidine for ambulatory dental surgery.

OBJECTIVE: Intranasal administration of dexmedetomidine for monitored anesthesia care (MAC) appears to be an effective, safe, and appropriate alternative to general anesthesia (GA) for ambulatory dental surgery. Based on the available evidence we evaluated a new MAC protocol with intranasal dexmedetomidine as the primary choice. To assess a difference in patient satisfaction and anesthesia-related discomfort between GA and MAC in ambulatory dental surgery, a study was conducted among patients undergoing various dental procedures. Patient satisfaction and anesthesia-related discomfort were assessed on the first postoperative day using the Bauer patient satisfaction questionnaire. RESULTS: Although the differences were small, patients in the MAC group were overall more satisfied with the general care compared to the GA group (p < 0.02). Patients in the MAC group reported more postoperative drowsiness compared to the GA group (p < 0.05), but less postoperative hoarseness and sore throat (p = 0.005 and p < 0.001, respectively). Moreover, postoperative thirst was more common in the GA group (p = 0.002). In conclusion, the differences in patient satisfaction and anesthesia-related discomfort between GA and MAC in this implementation study were small but appeared to favor MAC with intranasal dexmedetomidine over GA as anesthesia method during dental ambulatory surgery.

Population-wide persistent hemostatic changes after vaccination with ChAdOx1-S.

Various vaccines were developed to reduce the spread of the Severe Acute Respiratory Syndrome Cov-2 (SARS-CoV-2) virus. Quickly after the start of vaccination, reports emerged that anti-SARS-CoV-2 vaccines, including ChAdOx1-S, could be associated with an increased risk of thrombosis. We investigated the hemostatic changes after ChAdOx1-S vaccination in 631 health care workers. Blood samples were collected 32 days on average after the second ChAdOx1-S vaccination, to evaluate hemostatic markers such as D-dimer, fibrinogen, α2-macroglobulin, FVIII and thrombin generation. Endothelial function was assessed by measuring Von Willebrand Factor (VWF) and active VWF. IL-6 and IL-10 were measured to study the activation of the immune system. Additionally, SARS-CoV-2 anti-nucleoside and anti-spike protein antibody titers were determined. Prothrombin and fibrinogen levels were significantly reduced after vaccination (-7.5% and -16.9%, p < 0.0001). Significantly more vaccinated subjects were outside the normal range compared to controls for prothrombin (42.1% vs. 26.4%, p = 0.026) and antithrombin (23.9% vs. 3.6%, p = 0.0010). Thrombin generation indicated a more procoagulant profile, characterized by a significantly shortened lag time (-11.3%, p < 0.0001) and time-to-peak (-13.0% and p < 0.0001) and an increased peak height (32.6%, p = 0.0015) in vaccinated subjects compared to unvaccinated controls. Increased VWF (+39.5%, p < 0.0001) and active VWF levels (+24.1 %, p < 0.0001) pointed toward endothelial activation, and IL-10 levels were significantly increased (9.29 pg/mL vs. 2.43 pg/mL, p = 0.032). The persistent increase of IL-10 indicates that the immune system remains active after ChAdOx1-S vaccination. This could trigger a pathophysiological mechanism causing an increased thrombin generation profile and vascular endothelial activation, which could subsequently result in and increased risk of thrombotic events.

Vascular activation is a strong predictor of mortality in coronavirus disease 2019 patients on the ICU.

Respiratory failure in coronavirus disease 2019 (COVID-19) patients is one of the most frequent causes for referral to the ICU. A significant percentage of these patients does not survive the infection due to thromboembolic complications. Furthermore, the vascular system seems also to be involved in the pathogenesis. To investigate the role of hemostasis and endothelium on the outcome of COVID-19 patients admitted to the ICU. Blood was drawn from 16 ICU COVID-19 patients for hemostatic analysis. Patients were followed-up till discharge (n = 11) or death (n = 5). Parameters related to both coagulation and fibrinolysis, though disturbed, were not associated with mortality. Contrarily, activated Von Willebrand factor was increased and ADAMTS13 levels were decreased by two-fold in nonsurvivors compared with survivors. Our data established the involvement of the Von Willebrand factor-ADAMTS13 axis in the COVID-19 pathogenesis, thereby demonstrating that these plasma proteins seem to be strong predictors for ICU mortality.

General Anesthesia Versus Monitored Anesthesia Care for Transfemoral Transcatheter Aortic Valve Implantation: A Retrospective Study in a Single Belgian Referral Center.

OBJECTIVE: The objective of this study was to compare the effect of general anesthesia (GA) versus monitored anesthesia care (MAC) on post-interventional outcomes in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). DESIGN: Retrospective before-after study using a quasi-experimental design. SETTING: University Hospitals Leuven, a single Belgian referral center. PARTICIPANTS: Patients undergoing transfemoral TAVI from March 1, 2014, to December 31, 2017, were included. INTERVENTIONS: GA was switched to MAC at the authors' institution for transfemoral TAVI in April 2016, and outcomes of patients who received GA were compared with those who received MAC. MEASUREMENTS AND MAIN RESULTS: The primary outcomes were length of stay in the intensive care unit and hospital. Secondary outcomes included standardized endpoints for TAVI trials as suggested by the Valve Academic Research Consortium, the incidence of vasopressor use, maximum dose of vasopressors, procedural time, and total anesthesia time. In the period studied, 178 patients underwent transfemoral TAVI (GA: n = 85; MAC: n = 93). Implementation of MAC was associated with a significant reduction in total length of hospital stay (7.6 [6.05-9.15] v 5.48 [4.58-6.38] d; p = 0.02); vasopressor requirements; and procedural and total anesthesia time. Length of intensive care unit stay and Valve Academic Research Consortium endpoints were not significantly different. CONCLUSIONS: In the authors' institution, implementation of MAC for patients undergoing transfemoral TAVI resulted in a significant reduction of hospital length of stay and increased operating room efficiency. Results could be confounded by increasing operator experience and improved implantation techniques.