Israel Medical Association Journal

Abstract

During recent months, the Centers for Disease Control and Prevention (CDC) announced the occurrence of three major biosafety incidents, raising serious concern about biosafety and biosecurity guideline implementation in the most prestigious agencies in the United States: the CDC, the National Institutes of Health (NIH) and the Federal Drug Administration (FDA). These lapses included: a) the mishandling of Bacillus anthracis spores potentially exposing dozens of employees to anthrax; b) the shipment of low pathogenic influenza virus unknowingly cross-contaminated with a highly pathogenic strain; and c) an inventory lapse of hundreds of samples of biological agents, including six vials of variola virus kept in a cold storage room for decades, unnoticed. In this review we present the published data on these events, report the CDC inquiry’s main findings, and discuss the key lessons to be learnt to ensure safer scientific practice in biomedical and microbiological service and research laboratories.

Background: Chronic spontaneous urticaria (CSU) is a common, debilitating disease that is frequently resistant to standard therapy. Omalizumab, anti-immunoglobulin-E humanized monoclonal antibody, was recently shown to be effective in treating resistant CSU.

Objectives: To investigated the treatment of CSU with omalizumab in Israel.

Methods: We conducted a multicenter retrospective analysis of patients with refractory CSU treated with omalizuamb in Israel during 2012–2013. Complete improvement was defined as resolution of symptoms with no need for other medications, or satisfactory when patients’ condition improved but required regular or intermittent doses of antihistamines.

Results: Forty-three patients received omalizumab off-label for refractory CSU. Their mean age was 45 ± 12 years and CSU duration was 4.3 ± 4 years. In this cohort, 98% were unsuccessfully treated with high dose H(1)-antihistamines, 88% with systemic glucocorticoids and 30% with cyclosporine and/or other immune-modulators. Fourteen patients received only one injection of omalizumab, while the other 29 received on average of 4.3 ± 3.2 injections; 30 patients received 150 mg/month and 13 received 300 mg/month. Following omalizumab therapy, disease remitted within weeks in 86% of patients, of whom half achieved complete remission. The latter was associated with usage of high dose omalizumab, 300 mg/month vs. 150 mg/month (P = 0.02) and repeated therapy (i.e., multiple injections vs. a single injection) (P = 0.0005).

Conclusions: Omalizumab is an effective and safe treatment for refractory CSU with rapid onset of action for inducing and maintaining remission. Treating CSU patients mandates an individual approach, because while low dose omalizumab will suffice for some patients others might need higher doses and prolonged therapy. 

Objectives: To investigate the 30 day clinical outcome of the first 300 consecutive patients treated with transfemoral TAVI at the Tel Aviv Medical Center.

Methods: The CoreValve was used in 250 patients and the Edwards-Sapien valve in 50 patients. The mean age of the patients was 83 ± 5.3 years (range 63–98 years) and the mean valve area 0.69 ± 0.18 cm² (range 0.3–0.9 cm²); 62% were women.

Results: The procedural success rate was 100%, and 30 day follow-up was done in all the patients. The average Euro-score for the cohort was 26 ± 13 (range 1.5–67). Total in-hospital mortality and 30 day mortality were both 2.3% (7 patients). Sixty-seven patients (22%) underwent permanent pacemaker implantation after the TAVI procedure, mostly due to new onset of left bundle brunch block and prolonged PR interval or to high degree atrioventricular block. The rate of stroke was 1.7% (5 patients). Forty-one patients (13.7%) had vascular complications, of whom 9 (3%) were defined as major vascular complications (according to the VARC definition).

Conclusions: The 30 day clinical outcome in the first 300 consecutive TAVI patients in our center was favorable, with a mortality rate of 2.3% and low rates of stroke (1.7%) and major vascular complications (3%).

Background: Carbon dioxide is the most widely used gas to establish pneumoperitoneum during laparoscopic surgery. Gastrointestinal trauma may occur during the peritoneal insufflation or during the operative phase itself. Early diagnosis of these injuries is critical.

Objectives: To assess changes in end-tidal carbon dioxide (E_TCO₂) following gastric perforation during pneumoperitoneum in the rat.

Methods: Wistar rats were anesthetized, tracheotomized and mechanically ventilated with fixed minute volume. Each animal underwent a 1 cm abdominal longitudinal incision. A 0.3 x 0.3 cm cross-incision of the stomach was performed in the perforation group but not in the controls (n=10/group), and the abdomen was closed in both groups. After stabilization, CO₂-induced pneumoperitoneum was established at 0, 5, 8 and 12 mmHg for 20 min periods consecutively, each followed by complete pressure relief for 5 minutes.

Results: Ventilatory pressure increased in both groups when pneumoperitoneal pressure ≥ 5 mmHg was applied, but more so in the perforated stomach group (P = 0.003). E_TCO₂ increased in both groups during the experiment, but less so in the perforated group (P = 0.04). It then returned to near baseline values during pressure annulation in all perforated animals but only in the 0 and 5 mmHg periods in the controls.

Conclusions: When subjected to pneumoperitoneum, E_TCO₂ was lower in rats with a perforated stomach than in those with an intact stomach. An abrupt decrease in E_TCO₂ during laparoscopy may signal gastric perforation.
 

The prevalence of food allergy is increasing in both the pediatric and adult populations. While symptom onset is mostly during childhood, there are a considerable number of patients whose symptoms first begin to appear after the age of 18 years. The majority of patients with adult‑onset food allergy have the pollen-plant allergy syndromes. Many of them manifest their allergy after exercise and consuming food to which they are allergic. Eosinophilic esophagitis, an eosinophilic inflammation of the esophagus affecting individuals of all ages, recently emerged as another allergic manifestation, with both immediate and late response to the ingested food. This review provides a condensed update of the current data in the literature on adult-onset allergy.

Suicide is universal within the range of human behaviors and is not necessarily related to psychiatric morbidity, though it is considerably more prevalent among psychiatric patients. Considering the limitations of medical knowledge, psychiatrists cope with an unfounded and almost mythical perception of their ability to predict and prevent suicide. We set out to compose a position paper for the Israel Psychiatric Association (IPA) that clarifies expectations from psychiatrists when treating suicidal patients, focusing on risk assessment and boundaries of responsibility, in the era of defensive medicine. The final draft of the position paper was by consensus. The IPA Position Paper established the first standard of care concerning expectations from psychiatrists in Israel with regard to knowledge-based assessment of suicide risk, elucidation of the therapist's responsibility to the suicidal psychotic patient (defined by law) compared to patients with preserved reality testing, capacity for choice, and responsibility for their actions. Therapists will be judged for professional performance rather than outcomes and wisdom of hindsight. This paper may provide support for psychiatrists who, with clinical professionalism rather than extenuating considerations of defensive medicine, strive to save the lives of suicidal patients.
 

Background: The effect of anti-platelet drugs on surgical blood loss and perioperative complications has not been studied in depth and the management of surgical patients taking anti-platelet medications is controversial.

Objective: To assess the effect of anti-platelet therapy on perioperative blood loss in patients undergoing appendectomy either laparoscopically or via open surgery.

Methods: We reviewed the files of all patients > 40 years old who underwent open or laparoscopic appendectomies from 2007 to 2010. Excluded were patients with short hospitalization and no follow-up of hemoglobin level, patients on warfarin treatment and patients who underwent additional procedures. Estimation of blood loss was based on decrease in hemoglobin level from admission to discharge. Risk factors for blood loss, such as anti-platelet therapy, age, gender, surgical approach, surgical time, surgical findings and complications, were analyzed.

Results: The final cohort included 179 patients (mean age 61 ± 14 years, range 40–93) of whom 65 were males. The mean perioperative hemoglobin decrease was 1.59 ± 1.07 mg/dl (range 0–5 mg/dl). Thirty-nine patients received anti-platelet therapy prior to surgery and 140 did not. No significant differences in decrease of hemoglobin level were found between patients receiving anti-platelet therapy and those who were not (1.73 ± 1.21 vs. 1.55 ± 1.02 mg/dl, P = 0.3). In addition, no difference was found between patients on anti-platelet therapy operated laparoscopically and those operated in an open fashion (1.59 ± 1.18 vs. 2.04 ± 1.28 mg/dl, P = 0.29). Five patients required blood transfusions, two of whom were on anti-platelet therapy. Blood loss was significantly greater in patients with a perforated appendicitis and in those with an operative time of more than one hour.

Conclusions: Anti-platelet therapy does not pose a risk for increased blood loss following emergent appendectomy performed either laparoscopically or in an open fashion.