Cost analysis of pulmonary lobectomy procedure: comparison of stapler versus precision dissection and sealant

Objective: We aimed to evaluate the direct costs of pulmonary lobectomy hospitalization, comparing surgical techniques for the division of interlobar fissures: stapler (ST) versus electrocautery and hemostatic sealant patch (ES).Methods: The cost comparison analysis was based on the clinical pathway and drawn up by collecting the information available from the Thoracic Surgery Division medical team at Mantova Hospital. Direct resource consumption was derived from a previous randomized controlled trial including 40 patients. Use and maintenance of technology, equipment and operating room; administrative plus general costs; and 30-day use of postsurgery hospital resources were considered. The analysis was conducted from the hospital perspective.Results: On the average, a patient submitted to pulmonary lobectomy costs (sic)9,744.29. This sum could vary from (sic)9,027 (using ES) to (sic)10,460 (using ST). The overall lower incidence (50% vs 95%, P=0.0001) and duration of air leakage (1.7 days vs 4.5 days, P=0.0001) in the ES group significantly affects the mean time of hospital stay (11.0 days vs 14.3 days) and costs. Cost saving in the ES group was also driven by the lower incidence of complications. The main key cost driver was staff employment (42%), then consumables (34%) and operating room costs (12%).Conclusion: There is an overall saving of around (sic)1,432.90 when using ES patch for each pulmonary lobectomy. Among patients undergoing this surgical procedure, ES can significantly reduce air leakage incidence and duration, as well as decrease hospitalization rates. However, further multicenter research should be developed considering different clinical and managerial settings

Cost analysis of pulmonary lobectomy procedure: comparison of stapler versus precision dissection and sealant

Objective: We aimed to evaluate the direct costs of pulmonary lobectomy hospitalization, comparing surgical techniques for the division of interlobar fissures: stapler (ST) versus electrocautery and hemostatic sealant patch (ES).Methods: The cost comparison analysis was based on the clinical pathway and drawn up by collecting the information available from the Thoracic Surgery Division medical team at Mantova Hospital. Direct resource consumption was derived from a previous randomized controlled trial including 40 patients. Use and maintenance of technology, equipment and operating room; administrative plus general costs; and 30-day use of postsurgery hospital resources were considered. The analysis was conducted from the hospital perspective.Results: On the average, a patient submitted to pulmonary lobectomy costs (sic)9,744.29. This sum could vary from (sic)9,027 (using ES) to (sic)10,460 (using ST). The overall lower incidence (50% vs 95%, P=0.0001) and duration of air leakage (1.7 days vs 4.5 days, P=0.0001) in the ES group significantly affects the mean time of hospital stay (11.0 days vs 14.3 days) and costs. Cost saving in the ES group was also driven by the lower incidence of complications. The main key cost driver was staff employment (42%), then consumables (34%) and operating room costs (12%).Conclusion: There is an overall saving of around (sic)1,432.90 when using ES patch for each pulmonary lobectomy. Among patients undergoing this surgical procedure, ES can significantly reduce air leakage incidence and duration, as well as decrease hospitalization rates. However, further multicenter research should be developed considering different clinical and managerial settings

Efficacy and safety of QGE031, a novel anti-IgE antibody, in atopic subjects

Background: Omalizumab has a mid-range affinity for IgE, and the clinical effects of deeper IgE suppression are largely unknown. Objective: To explore the safety, pharmacokinetics and pharmacodynamics of QGE031, a novel high-affinity anti-IgE antibody. Methods: Preclinical assessments and two randomized, placebo-controlled, double-blind clinical trials were conducted in atopic subjects. The first trial administered QGE031 (0.1-10 mg/kg) or placebo intravenously, while the second trial administered QGE031 (0.2- 4 mg/kg) or placebo subcutaneously. Both trials included an open-label omalizumab arm. Results: Sixty of seventy-three (82%) and 96/110 (87%) subjects completed the intravenous and subcutaneous studies, respectively. Exposure to QGE031 and its half-life were dependent on the dose of QGE031 and serum IgE level. QGE031 had a biexponential pharmacokinetic profile after intravenous administration and a terminal half-life of approximately 20 days (subcutaneous study; range, 13-26 days). QGE031 demonstrated dose- and time-dependent suppression of free IgE, basophil FcεRI and basophil surface IgE superior in extent (free IgE and surface IgE) and duration to omalizumab. At Day 85, six weeks after the last dose, skin-prick wheal responses to allergen were suppressed by >95% and 41% in subjects treated subcutaneously with QGE031 (2 mg/kg) or omalizumab, respectively (P < .001). Urticaria was observed in QGE031- and placebo-treated subjects and was accompanied by systemic symptoms in one subject treated with 10 mg/kg intravenous QGE031. There were no serious adverse events. Conclusion and clinical relevance: These are the first clinical data obtained with QGE031, a novel anti-IgE monoclonal antibody; they demonstrate that increased suppression of free IgE compared with omalizumab translated to superior reduction of pharmacodynamic endpoints in atopic subjects, including those with high levels of IgE. QGE031 may therefore benefit patients unable to receive, or not optimally treated with, omalizumab

Pleurodesis with Thulium Cyber Laser versus talc poudrage: a comparative experimental study

none12noSclerosing fluids to achieve pleurodesis could be hardly replaced for bed-side procedures, but other devices may be successfully applied during thoracoscopy. Thulium Cyber Laser was experimented for this purpose and compared to talc poudrage. Twenty pigs underwent operative videothoracoscopy (VATS). Ten models were subjected to double-port VATS and parietal pleura photoevaporation using Thulium Cyber Laser™ (TCL) 150 W 2010 nm on the posterior third of three ribs; the pleural surface was homogeneously treated inside the target perimeter. The remaining ten pigs underwent uniportal thoracoscopy; talc poudrage was performed using the current clinical practice dosage (1 g/18 kg) with accurate talc powder spread over the whole pleural surface. All models were followed up for 60 days. Pleurodesis firmness was graded on a three-tier scale (none-moderate-firm) and site-matching topographical expectancy was evaluated. TCL produced pleurodesis in all models: 7/10 were firm and 3/10 moderate. Talc poudrage pleurodesis was firm in 4/10 and moderate in 6/10. Pleural adhesions were found exclusively in the treated area after laser treatment, while talc created a wide spectrum of effects, most commonly anarchic jagged adhesions obliterating less than 50 % of the pleural cavity (7/10), mostly declivous. The pathologist found more aggressive inflammation (sometimes severe) in the talc group. Expected localized pleurodesis was always registered in laser group (10/10), while talc poudrage was found poorly effective if consistent pleurodesis is expected in an apico-dorsal position (2/10). Laser pleurodesis appears more homogeneous, qualitatively not inferior, and topographically more predictable than talc pleurodesis. Parietal photoevaporation seems effective and the localized pleurodesis is reproducible.mixedDroghetti, Andrea; Vannucci, Jacopo; Bufalari, Antonello; Bellezza, Guido; De Monte, Valentina; Marulli, Giuseppe; Bottoli, Maria Caterina; Giovanardi, Michele; Daddi, Niccolo'; De Angelis, Verena; Moriconi, Franco; Puma, FrancescoDroghetti, Andrea; Vannucci, Jacopo; Bufalari, Antonello; Bellezza, Guido; De Monte, Valentina; Marulli, Giuseppe; Bottoli, Maria Caterina; Giovanardi, Michele; Daddi, Niccolo'; De Angelis, Verena; Moriconi, Franco; Puma, Francesc

Prophylaxis of postoperative endophthalmitis following cataract surgery: Results of the ESCRS multicenter study and identification of risk factors

Purpose: To identify risk factors and describe the effects of antibiotic prophylaxis on the incidence of postoperative endophthalmitis after cataract surgery based on analysis of the findings of the European Society of Cataract & Refractive Surgeons (ESCRS) multicenter study. Setting: Twenty-four ophthalmology units in Austria, Belgium, Germany, Italy, Poland, Portugal, Spain, Turkey, and the United Kingdom. Methods: A prospective randomized partially masked multicenter cataract surgery study recruited 16 603 patients. The study was based on a 2 × 2 factorial design, with intracameral cefuroxime and topical perioperative levofloxacin factors resulting in 4 treatment groups. The comparison of case and non-case data was performed using multivariable logistic regression analyses. Odds ratios (ORs) associated with treatment effects and other risk factors were estimated. Results: Twenty-nine patients presented with endophthalmitis, of whom 20 were classified as having proven infective endophthalmitis. The absence of an intracameral cefuroxime prophylactic regimen at 1 mg in 0.1 mL normal saline was associated with a 4.92-fold increase (95% confidence interval [CI], 1.87-12.9) in the risk for total postoperative endophthalmitis. In addition, the use of clear corneal incisions (CCIs) compared to scleral tunnels was associated with a 5.88-fold increase (95% CI, 1.34-25.9) in risk and the use of silicone intraocular lens (IOL) optic material compared to acrylic with a 3.13-fold increase (95% CI, 1.47-6.67). The presence of surgical complications increased the risk for total endophthalmitis 4.95-fold (95% CI, 1.68-14.6), and more experienced surgeons were more likely to be associated with endophthalmitis cases. When considering only proven infective endophthalmitis cases, the absence of cefuroxime and the use of silicone IOL optic material were significantly associated with an increased risk, and there was evidence that men were more predisposed to infection (OR, 2.70; 95% CI, 1.07-6.8). Conclusions: Use of intracameral cefuroxime at the end of surgery reduced the occurrence of postoperative endophthalmitis. Additional risk factors associated with endophthalmitis after cataract surgery included CCIs and the use of silicone IOLs. © 2007 ASCRS and ESCRS

Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

BackgroundTocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients.MethodsA multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival.ResultsIn the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6-24.0, P=0.52) and 22.4% (97.5% CI: 17.2-28.3, P&lt;0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline.ConclusionsTocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline.Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092)

Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

BackgroundTocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients.MethodsA multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival.ResultsIn the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6-24.0, P=0.52) and 22.4% (97.5% CI: 17.2-28.3, P<0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline.ConclusionsTocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline.Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092)