Humoral immunogenicity of COVID-19 vaccines in patients with inflammatory rheumatic diseases under treatment with Rituximab: a case-control study (COVID-19VacRTX).

OBJECTIVES: Patients with inflammatory rheumatic diseases (IRDs) treated with the anti-CD20 mAb rituximab (RTX) have been identified as high-risk for severe COVID-19 outcomes. Additionally, there is increased risk due to reduced humoral immune response, induced by therapeutic B cell depletion. This study sought to quantify humoral response after vaccination against SARS-CoV-2 in patients with IRD treated with RTX. It also sought to elucidate the influence of the time frame between the last RTX dose and the first vaccination, or the status of B cell depletion on antibody titre. METHODS: In this case-control study, patients with IRDs previously treated with RTX were examined for humoral immune response after completing the first series of vaccinations with approved vaccines [BNT162b2 (Biontech/Pfizer), RNA-1273 (Moderna), AZD1222 (AstraZeneca/Oxford), Ad26.COV2.S (Janssen/Johnson & Johnson)]. Antibody levels were quantified using the Euroimmun Anti-SARS-CoV-2 QuantiVac ELISA (EI-S1-IgG-quant). Blood samples were taken just before the next infusion with RTX after the vaccination. The interval between the last RTX infusion and the first vaccination against SARS-CoV-2 and other possible factors influencing the antibody levels were evaluated. RESULTS: A total of 102 patients were included. Of these, 65 (64%) showed a negative antibody level (<24 IU (international unit)/ml) after the vaccination. The comparative univariate analysis of the antibody levels achieved a significant result (P = 0.0008) for the time between the last RTX infusion and first vaccination against SARS-CoV-2. No CD19+ peripheral B-cells could be detected in 73 of the patients (72%). CONCLUSION: The study confirms the negative impact of RTX on antibody level after vaccination against SARS-CoV-2. A clear relationship exists between the antibody titre and the interval between the last RTX infusion and the first vaccination, the number of peripheral B-cells, and immunoglobulin quantity. Improved understanding of the effect of these parameters can help guide synchronization of vaccination in relation to the RTX therapy regimen.

Donor-Site Morbidity after Fibula Transplantation in Head and Neck Tumor Patients: A Split-Leg Retrospective Study with Focus on Leg Stability and Quality of Life.

The free fibula flap has been one of the most important microvascular grafts for orofacial reconstruction for more than 30 years. The complication rates at the donor-site reported in literature are considered to be low, but the published data vary greatly in some cases. In particular, restrictions in the stability and balance of the involved leg and their effects on the quality of life have been described very inconsistently to date. Therefore, this study mainly focuses on the stability and balance of the affected leg in a split-leg design. Between December 2014 and January 2018, out of 119 subjects who underwent mainly jaw ablative tumor surgery and reconstruction using a fibula flap, 68 subjects were examined for donor site morbidity. Besides reporting general types of complications, two specific test procedures were used. The Star Excursion Balance Test (SEBT) as a practical test for ankle function and the Foot and Ankle Disability Index (FADI) as a questionnaire in order to assess quality of life, depending on the lower leg function. SEBT revealed an average of 55.3 cm with the operated leg as the supporting leg, which corresponds to 95.5% of 57.9 cm achieved with the healthy leg as the supporting leg. An average FADI score of 89.4% was recorded. SEBT and FADI seem to be suitable methods of examination for subjects post fibular transplantation and pointed out minimal limitations of the involved legs in comparison to the unaffected legs. These limitations were clinically not relevant and they had minor influence on the subjects' quality of life and their daily activities.

International survey on the perioperative management of pulmonary endarterectomy: the perfusion perspective.

INTRODUCTION: Pulmonary endarterectomy (PEA) is the most effective treatment available for chronic thromboembolic pulmonary hypertension (CTEPH). Patient selection, surgical technique and perioperative management have improved patient outcomes, which are traditionally linked to surgical and center experience. However, optimal perfusion care has not been well defined. The goal of the international survey was to better characterize the contemporary perfusion management of PEA and highlight similarities and controversies. METHOD: The combined caseload of 15 participating centers was 5,066 cases. Topics queried included materials and types of cardiopulmonary bypass (CPB) equipment, choice of prime, fluid management, deep hypothermia strategy, temperature management, treatment of acid-base abnormalities and intraoperative hematocrit as well as anticoagulation management for heparin-induced thrombocytopenia. CONCLUSION: Our assessment could provide a base for further advancement and may help design future studies to elucidate the impact of perfusion in this challenging field.

Usefulness of N-acetylcysteine or ascorbic acid versus placebo to prevent contrast-induced acute kidney injury in patients undergoing elective cardiac catheterization: a single-center, prospective, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) is a serious complication of procedures requiring contrast media associated with rising costs, prolonged hospitalization, and increased mortality. The aim of this study was to assess whether prophylactic administration of standard dosages of intravenous N-acetylcysteine or ascorbic acid reduce the incidence of CI-AKI in patients with chronic renal insufficiency undergoing elective cardiac catheterization. METHODS: In a single-center, prospective, randomized, double-blind, placebo-controlled trial, the preventive effects of N-acetylcysteine and ascorbic acid were evaluated in 520 patients with chronically impaired renal function (serum creatinine ≥1.3 mg/dL) undergoing elective cardiac catheterization. The study drugs (600 mg N-acetylcysteine, 500 mg ascorbic acid, placebo) were administered intravenously twice (at 24 hours and 1 hour before the procedure). Serum creatinine, estimated glomerular filtration rate (eGFR) and serum urea were assessed at baseline and at 24 hours and 72 hours after contrast media exposure. CI-AKI was defined as a postangiographical increase in serum creatinine ≥0.5 mg/dL. Results. The incidence of CI-AKI was 27.6% in the N-acetylcysteine group (P=.20 vs placebo group) and in 24.5% in the ascorbic acid group (P=.11 vs placebo group). CI-AKI occurred in 32.1% of the placebo group. CONCLUSIONS: Standard doses of N-acetylcysteine and ascorbic acid did not prevent CI-AKI in patients at high risk undergoing cardiac catheterization with non-ionic, low-osmolality contrast agent.

Coronary stenting before coronary artery bypass graft surgery in diabetic patients does not increase the perioperative risk of surgery.

OBJECTIVE: A negative relationship between coronary stenting before coronary artery bypass graft (CABG) surgery and the perioperative mortality and morbidity has been shown in diabetic patients. We tried to assess this relationship in a 2-institution database. METHODS: In the years 2005 and 2006, 1125 of 3311 patients undergoing CABG surgery had diabetes mellitus (33.9%), and 185 (16.4%) of the diabetic patients had at least 1 previous stent. There was no evidence of any clinically significant difference in the preoperative and intraoperative parameters between diabetics with or without previous stents. RESULTS: Thirty-day mortality (no-stent group, 3.86%; stent group, 1.62%) and postoperative major adverse cardiovascular and cerebrovascular events (MACCEs; mortality, stroke, myocardial infarction, renal failure) (no-stent group, 12.2%; stent group, 5.9%) occurred more often in diabetic patients without coronary stents. Logistic regression for 30-day mortality using possible confounders including preoperative stent showed a significant positive effect of preoperative coronary stenting (OR, 0.157; 95% CI limits, 0.033-0.737). Taking percutaneous coronary intervention out of the calculation model, this positive effect was no longer significant (OR, 0.344; CI, 0.091-1.298). Logistic regression for perioperative MACCE, with as well as without percutaneous coronary intervention as a confounder, also showed a significant positive effect of preoperative coronary stenting (OR, 0.231; 95% CI, 0.091-0.590). CONCLUSIONS: Coronary stenting before CAGB in diabetic patients does not predispose to a higher perioperative risk regarding mortality and morbidity after CABG surgery.

Anemia before coronary artery bypass surgery as additional risk factor increases the perioperative risk.

BACKGROUND: A negative relationship between anemia before coronary artery bypass graft (CABG) surgery and the perioperative mortality has been shown. We tried to clarify whether anemia only expresses an increased perioperative risk or is a risk factor per se in a two-institution database. METHODS: In the years 2005 and 2006, 185 of 3,311 patients undergoing isolated first-time CABG surgery had anemia defined as hematocrit less than 33% or Hb≤11 g/dL. Preoperative and postoperative data of patients having anemia and patients having normal hematocrit were compared using χ2-tests or Fisher's exact tests regarding structural group differences. To determine factors influencing perioperative mortality, methods of logistic regression were used. RESULTS: The 30-day mortality of anemic patients (12.9%) was significantly higher (p<0.001) than the mortality of nonanemic patients (2.2%). Patients having anemia, though, had a worse risk profile before surgery: high European System for Cardiac Operative Risk Evaluation values (median, 7 in anemic patients versus 4 in nonanemic patients), acute myocardial infarction (9.7% in anemic versus 2% in nonanemic patients), diabetes mellitus (45.4% in anemic versus 33.3% in nonanemic patients), and cardiogenic shock (5.4% in anemic versus 0.8% in nonanemic patients) were significantly more frequent in the anemic group. However, taking these risks in account, the logistic regression revealed preoperative anemia still to be a mortality-increasing factor in patients undergoing CABG surgery (odds ratio 3.727, confidence interval: 2.196 to 6.324). Furthermore, anemia was a risk factor for perioperative morbidity (major adverse cardiovascular events) after CABG surgery (odds ratio 2.199, confidence interval: 1.423 to 3.397). CONCLUSIONS: In our patient group undergoing CABG surgery, preoperative anemia increased the mortality risk by 3.4, even when taking the higher perioperative risk of anemic patients into consideration.

Sperm function and assisted reproduction technology.

The evaluation of different functional sperm parameters has become a tool in andrological diagnosis. These assays determine the sperm's capability to fertilize an oocyte. It also appears that sperm functions and semen parameters are interrelated and interdependent. Therefore, the question arose whether a given laboratory test or a battery of tests can predict the outcome in in vitro fertilization (IVF). One-hundred and sixty-one patients who underwent an IVF treatment were selected from a database of 4178 patients who had been examined for male infertility 3 months before or after IVF. Sperm concentration, motility, acrosin activity, acrosome reaction, sperm morphology, maternal age, number of transferred embryos, embryo score, fertilization rate and pregnancy rate were determined. In addition, logistic regression models to describe fertilization rate and pregnancy were developed. All the parameters in the models were dichotomized and intra- and interindividual variability of the parameters were assessed. Although the sperm parameters showed good correlations with IVF when correlated separately, the only essential parameter in the multivariate model was morphology. The enormous intra- and interindividual variability of the values was striking. In conclusion, our data indicate that the andrological status at the end of the respective treatment does not necessarily represent the status at the time of IVF. Despite a relatively low correlation coefficient in the logistic regression model, it appears that among the parameters tested, the most reliable parameter to predict fertilization is normal sperm morphology. (Reprod Med Biol 2005; 4: 7-30).