Biodisk: a new device for closure of patent foramen ovale: a feasibility study in swine.

PURPOSE: To evaluate the feasibility, effectiveness, and safety of a porcine small intestinal submucosa (SIS)-covered Biodisk (BD) for the closure of patent foramen ovale (PFO) in swine. METHODS: Twelve piglets (9-30 kg) with PFO ranging in size from 6 to 12 mm were used for the in vivo testing. The BD device consisted of two basic nitinol wire components covered with platinum coil, a flexible SIS-covered ring, and an anchor. The BD was advanced through an 8-Fr sheath from the femoral vein. Nine acute animals were used to test the BD for deployment, stability, immediate shunt closure, and device repositioning before or after its detachment. To assess retrievability, four devices were deployed and intentionally embolized into the RA (n = 2) and LA (n = 2). The effectiveness of the device was evaluated by angiocardiography. EKG was recorded before and after PFO closure for 3 hr. From the 12 animals, nine were acute and three were followed; one for 6 weeks, one for 12 weeks, and one for 16 weeks. RESULTS: Successful device implantation was achieved in all animals with no shunting of contrast media observed during follow-up in. One animal needed to have device repositioned for complete PFO occlusion because of suboptimal placement at the first attempt. The device was easily placed and retrieved before detachment in all nine animals in the acute study. None of the BDs spontaneously embolized during release or on follow-up. EKG did not demonstrate arrhythmias during or after treatment. Four intentionally embolized BDs were easily retrieved with an Amplatz goose neck snare. Macroscopic and histologic evaluation of the three long-term animals showed that devices were well incorporated in the atrial septum with complete shunt closure. The SIS showed progressive remodeling with the host cells. There was also progressive endothelization of the BD device. CONCLUSION: The BD device deployment is feasible, safe, and effective. Long-term studies are needed to evaluate its long-term effectiveness.

Lipopolysaccharide-binding protein, lipopolysaccharide, and soluble CD14 in sepsis of critically ill neonates and children.

OBJECTIVE: To compare the diagnostic accuracy of lipopolysaccharide-binding protein (LBP) for sepsis in critically ill neonates and children with the two markers participating in the same inflammatory pathway, lipopolysaccharide and soluble CD14. DESIGN AND SETTING: Prospective, observational study in a multidisciplinary neonatal and pediatric intensive care unit. PATIENTS: 47 critically ill neonates and 49 critically ill children with systemic inflammatory response syndrome (SIRS) and suspected sepsis, classified into two groups: those with and those without sepsis. INTERVENTIONS: Serum LBP, lipopolysaccharide, soluble CD14, C-reactive protein, and procalcitonin were measured on 2 consecutive days. The area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and predictive values were evaluated. RESULTS: AUC for LBP on the first day of suspected infection was 0.97 in neonates aged under 48 h, 0.93 in neonates over 48 h and 0.82 in children. AUCs for lipopolysaccharide and soluble CD14 were 0.77 and 0.74 in neonates under 48 h, 0.53 and 0.76 in neonates over 48 h, and 0.72 and 0.53 in children. AUCs for procalcitonin and C-reactive protein were 0.65 and 0.89 in neonates under 48 h, 0.65 and 0.91 in neonates over 48 h, and 0.76 and 0.69 in children. CONCLUSIONS: In critically ill neonates and children LBP concentration on the first day of suspected sepsis is a better marker of sepsis than lipopolysaccharide, soluble CD14, procalcitonin, and in neonates younger than 48 h and children, also a better marker than C-reactive protein. Lipopolysaccharide and soluble CD14 are not suitable markers for the differentiation of infectious and noninfectious SIRS.

Lipopolysaccharide-binding protein in critically ill neonates and children with suspected infection: comparison with procalcitonin, interleukin-6, and C-reactive protein.

OBJECTIVE: To evaluate markers of infection in critically ill neonates and children, comparing lipopolysaccharide-binding protein (LBP) with procalcitonin (PCT), interleukin-6 (IL-6), and C-reactive protein (CRP). DESIGN AND SETTING: Prospective, observational study in the level III multidisciplinary neonatal and pediatric intensive care unit. PATIENTS: Sixty patients with systemic inflammatory response syndrome (SIRS) and suspected infection classified into two groups: SIRS/sepsis ( n=33) and SIRS/no sepsis ( n=27). We included 29 neonates aged less than 48 h (neonates <48 h), 12 neonates older than 48 h (neonates >48 h), and 19 children. Median disease severity was high in neonates aged under 48 h and moderate in neonates aged over 48 h and children. INTERVENTIONS: Serum LBP, PCT, IL-6, and CRP were measured on two consecutive days. Area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, and predictive values were evaluated. RESULTS: Serum LBP was higher in patients with SIRS/sepsis than in patients with SIRS/no sepsis. AUC for LBP on the first day of suspected infection was 0.89 in the younger neonates, 0.93 in the older neonates, and 0.91 in children. CONCLUSIONS: In critically ill neonates aged under 48 h LBP on the first day of suspected infection is a better marker of sepsis than IL-6 and PCT, and is similar to CRP. In critically ill neonates aged over 48 h and children LBP is a better marker than IL-6 and CRP, and is similar to PCT.

Lipopolysaccharide-binding protein as marker of fetal inflammatory response syndrome after preterm premature rupture of membranes.

BACKGROUND: Intra-amniotic inflammation with preterm premature rupture of membranes (PPROM) is a risk factor for fetal inflammatory response syndrome (FIRS) and adverse neonatal outcome. OBJECTIVES: To evaluate the diagnostic accuracy of lipopolysaccharide-binding protein (LBP) for detecting FIRS in preterm neonates born after PPROM. METHODS: This was a prospective study in the level III neonatal intensive care unit (42 neonates; 23 + 6 to 31 + 6 weeks' gestation) of mothers with PPROM. Umbilical cord blood concentrations of LBP, C-reactive protein (CRP), interleukin (IL)-6 and white blood cell count with differential were measured at delivery and 24 h after birth. Neonates were classified into FIRS (n = 22) and no FIRS (n = 20) groups according to clinical criteria and IL-6 level (≥17.5 pg/ml). Histological examination of the placenta and umbilical cord was performed. Neurological examination at 12 months' corrected age was performed. RESULTS: Umbilical cord blood concentration of LBP was significantly higher in the FIRS group than in the no FIRS group at delivery (median 21.6 mg/l vs. median 2.3 mg/l; p < 0.0001) and 24 h after birth (median 17.2 mg/l vs. median 20.0 mg/l; p < 0.001). The area under the ROC curve for FIRS at delivery was 0.98 (95% CI 0.88-1.0) for LBP, 0.92 (95% CI 0.80-0.99) for CRP and 0.82 (95% CI 0.64-0.94) for immature to total neutrophil ratio. Similar results were obtained if FIRS was defined by funisitis. Umbilical cord blood concentration of LBP at delivery was significantly higher in neonates with abnormal neurological exam at 12 months than in those with normal exam (median 19.5 mg/l vs. median 3.75 mg/l; p < 0.015). CONCLUSIONS: In preterm neonates born to asymptomatic women with PPROM, LBP in cord blood at delivery is an excellent diagnostic biomarker of FIRS/funisitis with prognostic potential.

Neutrophil and monocyte CD64 indexes, lipopolysaccharide-binding protein, procalcitonin and C-reactive protein in sepsis of critically ill neonates and children.

OBJECTIVE: To compare the diagnostic accuracy of neutrophil and monocyte CD64 indexes (CD64in and CD64im) for sepsis in critically ill neonates and children with that of lipopolysaccharide-binding protein (LBP), procalcitonin (PCT) and C-reactive protein (CRP). DESIGN AND SETTING: Prospective, observational study in a level III multidisciplinary neonatal and pediatric intensive care unit (ICU). PATIENTS: Forty-six neonates and 36 children with systemic inflammatory response syndrome (SIRS) and suspected infection, classified into two groups: those with bacterial sepsis (microbiologically proven or clinical sepsis) and those without bacterial sepsis (infection not supported by subsequent clinical course, laboratory data and microbiological tests). INTERVENTIONS AND MEASUREMENTS: Flow cytometric CD64in and CD64im, serum LBP, PCT and CRP measurement on 2 consecutive days from admission to the ICU. RESULTS: There were 17 cases of bacterial sepsis in neonates and 24 cases of bacterial sepsis in children. All neonates and the majority of children were mechanically ventilated, and more than two-thirds of neonates with sepsis and one-third of children with sepsis needed inotropic/vasopressor drugs. The highest diagnostic accuracy for sepsis on the 1st day of suspected sepsis was achieved by LBP in neonates (0.86) and by CD64in in children (0.88) and 24 h later by CD64in in neonates (0.96) and children (0.98). CONCLUSIONS: Neutrophil CD64 index (CD64in) is the best individual marker for bacterial sepsis in children, while in neonates the highest diagnostic accuracy at the time of suspected sepsis was achieved by LBP and 24 h later by CD64in.