A novel Laser Navigation System reduces radiation exposure and improves accuracy and workflow of CT-guided spinal interventions: a prospective, randomized, controlled, clinical trial in comparison to conventional freehand puncture.

PURPOSE: Phantom model evaluation and prospective randomized clinical trial to assess the clinical feasibility and benefit of using a novel Laser Navigation System (LNS) in CT-guided epidural and perineural injections in comparison to the conventional freehand procedure. METHODS: The LNS guided puncture technique was compared to the standard CT-guided freehand treatment using a phantom model and a randomized clinical trial. Spinal injections were administered by an experienced interventional team to evaluate needle placement accuracy, treatment time and radiation exposure. RESULTS: In the LNS group of the phantom model study, the needle entrance point accuracy of 0.5mm (freehand 3.1mm), needle target point accuracy of 2.0mm (freehand 3.5mm), number of control CT slices of 1.4 (freehand 2.7) and needle placement time of 5min 4s (freehand: 9min 18s) showed significant improvements compared to freehand in 60 punctures. In the clinical trial the LNS group achieved needle entrance point accuracy of 1.3mm (freehand 4.6mm), needle angulation accuracy of 0.4° (freehand 2.3°), number of control CT slices of 1.1 (freehand 1.8) and needle placement time of 6min 54s (freehand 9min 00s), showing significant improvements compared to freehand in a total of 58 CT-guided interventions. CONCLUSION: The LNS group showed significantly improved results in both study designs. Both the phantom model evaluation and the clinical trial of spinal injections showed feasibility and efficacy of using the novel LNS. Even an experienced interventional team worked with it more precise, faster and with reduced radiation exposure.

Open randomized phase II trial of an extracorporeal endotoxin adsorber in suspected Gram-negative sepsis.

OBJECTIVE: An initial phase II trial to investigate the safety and therapeutic effect of the endotoxin adsorber system EN 500 in septic patients suffering from presumed Gram-negative infection. DESIGN: Open, controlled, prospective, randomized, multiple-center, parallel-group clinical trial. SETTING: Intensive care units of 31 university-affiliated and community hospitals in Europe. PATIENTS: One hundred forty-five patients with a clinical diagnosis of severe sepsis or septic shock due to suspected Gram-negative infection. INTERVENTIONS: Patients were randomized to receive either standard therapy alone for sepsis (n = 76) or standard therapy plus extracorporeal endotoxin adsorption (n = 67) daily for the first 4 days following study entry. MEASUREMENTS AND MAIN RESULTS: The primary end point was the proportion of responders (defined as a decrease in Acute Physiology and Chronic Health Evaluation II score by > or =4 points from study entry to day 4). Secondary outcomes were the Sequential Organ Failure Assessment score and its components, length of intensive care unit stay, survival rate, and safety of the adsorber treatment. Patient characteristics at entry were well balanced between the two treatment groups, except for a higher Sequential Organ Failure Assessment score in the adsorber group. On all-subjects-treated analysis, 65% of the adsorber group were responders vs. 57% for the standard (p =.389). A planned interim analysis restricted further enrollment to patients with peritonitis, in whom a slightly higher proportion of responders was observed with the adsorber treatment (69%) vs. standard treatment (54%, p =.159). There were no differences in survival, but adsorption treatment in peritonitis patients was associated with trends toward a reduction in length of intensive care unit stay and a more rapid decline in plasma endotoxin concentrations. There was a significantly greater reduction in platelet count with the adsorber; however, this did not require extra treatment. CONCLUSIONS: The endotoxin adsorber system did not result in a significantly improved primary end point in patients with presumed Gram-negative sepsis. In patients with peritonitis, the adsorber treatment likewise did not result in significantly improved Acute Physiology and Chronic Health Evaluation II scores. There were no clinically important side effects. These results provide encouragement for further study of adsorber treatment in patients with high likelihood of Gram-negative sepsis (e.g., peritonitis).

A new endotoxin adsorption device in Gram-negative sepsis: use of immobilized albumin with the MATISSE adsorber.

MATISSE is a new endotoxin (ET) adsorption system. It comprises the FRESENIUS hemoadsorption machine 4008 ADS to maintain the extracorporeal circuits and disposables including the MATISSE-adsorber based on macroporous beads immobilized with human serum albumin. In vivo and in vitro experiments with this new compound had shown favourable ET elimination properties. In a first study 19 healthy volunteers were included for the safety and tolerability of the endotoxin adsorber system. One single veno-venous hemoperfusion with this system was performed. Apheresis treatment with the human albumin immobilized adsorber seems to be safe and well tolerable in healthy volunteers. A slight decrease in platelet count as well as insulin level was observed. No serious adverse events were mentioned. Similar findings were made in an open uncontrolled trial in six patients with suspected Gram-negative sepsis. Here endotoxin adsorption seems to be safe and well tolerated without adsorber related major adverse events. In the last clinical trial including 145 patients mainly peritonitis patients (104), again no safety concerns were found during the apheresis. Trends in improvement of morbidity and organ dysfunction were found as well as efficient LPS removal in peritonitis patients. LPS whole blood immunoadsorption is a promising new method. No relevant side effects were observed so far. A large controlled study to prove clinical efficacy in patients with severe sepsis and confirmed endotoxemia (e.g. peritonitis) should be necessary.