Clinical impact of defibrillation testing in a real-world S-ICD population: Data from the ELISIR registry.

BACKGROUND: Current guidelines recommend defibrillation testing (DT) performance in patients with a subcutaneous implantable cardioverter defibrillator (S-ICD), theoretically to reduce the amount of ineffective shocks. DT, however, has been proven unnecessary in transvenous ICD and real-world data show a growing trend in avoidance of DT after S-ICD implantation. METHODS: All patients undergoing S-ICD implant at nine associated Italian centers joining in the ELISIR registry (ClinicalTrials.gov Identifier: NCT04373876) were enrolled and classified upon DT performance. Long-term follow-up events were recorded and compared to report the long-term efficacy and safety of S-ICD implantations without DT in a real-world setting. RESULTS: A total of 420 patients (54.0 ± 15.5 years, 80.0% male) were enrolled in the study. A DT was performed in 254 (60.5%) patients (DT+ group), while in 166 (39.5%) was avoided (DT- group). Over a median follow-up of 19 (11-31) months, a very low rate (0.7%) of ineffective shocks was observed, and no significant differences in the primary combined arrhythmic outcome were observed between the two groups (p = .656). At regression analysis, the only clinical predictor associated with the primary combined outcome was S-ICD placement for primary prevention (odds ratio: 0.42; p = .013); DT performance instead was not associated with a reduction in primary outcome (p = .375). CONCLUSION: Implanting an S-ICD without DT does not appear to impact the safety of defibrillation therapy and overall patients' survival.

Clinical role of filgrastim in the management of patients at risk of prolonged severe neutropenia: An evidence-based review.

BACKGROUND: Patients undergoing chemotherapy are at risk of toxicity, especially of haematological origin. Granulocyte depletion, although often underestimated, can lead to the occurrence of an event defined as febrile neutropenia (FN). Neutropenic fever syndromes are dangerous because they cause major complications in around 25%-30% of patients and have a mortality rate of up to 11%. Treatment for FN was limited to antibiotics and supportive therapies until filgrastim was approved for use in the 1990s. OBJECTIVES: The present systematic review focuses on the efficacy and safety of this haematopoietic growth factor. DATA SOURCES AND METHODS: For this review, a systematic literature search of electronic databases and references from recent reviews up to December 2018 was carried out to identify clinical trials, observational studies and case reports evaluating filgrastim efficacy and safety. English language was defined as a restriction. Published randomised controlled trials (RCTs), case reports and reviews analysing the effects of filgrastim on severe neutropenia and its limits were considered. Four review authors independently selected the studies, assessed the risk of bias and extracted study data. RESULTS: As reported in ASCO guidelines, the efficacy of filgrastim with respect to placebo or no treatment in RCTs is based on its prevention of FN. A recent meta-analysis analysed nine RCTs with 2197 patients, revealing a reduction in the incidence of FN with filgrastim (risk ratio [RR] 0.63, 95% CI 0.53-0.75). These findings were further confirmed in two observational studies. Bone pain is the most commonly reported adverse event with filgrastim, while other toxicities are associated with filgrastim efficacy and with an increased neutrophil count. KEY FINDINGS: In conclusion, our findings attest to the previous results on the efficacy and safety of filgrastim.