Endoluminal aortic shunting for distal perfusion during thoracic aortal cross-clamping in a pig model.

PURPOSE OF THE STUDY: To investigate the haemodynamic properties of a direct endovascular aortic shunt to maintain distal aortic perfusion as an alternative of a distal shunt (left-left-, Gott shunt) in thoracic aortic aneurysm repair. METHODS: A shunt was developed and tested in an in vitro model which should be capable of transporting a flow of 3-4 L/min with a decrease in blood pressure < 20 mmHg. Thereupon the shunt was tested in an in vivo experiment in six pigs to assess the possibility of its use with normal distal blood pressure. The shunt was inserted in the thoracic aorta and stayed in place for 1.5 h. Parameters were measured at six time intervals to assess organ perfusion, -function, cardiac output, proximal- and distal blood pressure and aortic- and shunt flow. PRINCIPLE FINDINGS: The mean blood flow through the shunt was 2.5 L/min. The difference of the mean blood pressure over the shunt was on average 14.20 mmHg. Parameters for coagulation disturbance and organ ischaemia were tested. The decrease in mean thrombocyte count was 299-158 (p<0.02). The venous lactate and the venous mesenteric lactate as parameters for intestinal ischemia did not increase significantly. No significant changes occurred in angiotensin II levels. Pulsatile flow was maintained but significantly suppressed (60%) distal from the shunt. The clamp time needed to insert the shunt and the venous mesenteric lactate, as well as the venous lactate, showed high correlation, r(s) = 0.9 (p<0.05) and r(s) = 0.94 (p<0.01). This also accounted for the 2nd clamp time, both r(s) = 0.95 (p<0.05). CONCLUSION: The shunt is capable of transporting a blood flow of 2-4 L/min with an acceptable decrease in distal blood pressure. However, the time, needed to insert the shunt, was significantly associated with parameters of organ ischaemia.

Experiences with a new security standard for healthcare information systems.

This article describes the results of the implementation and demonstration of the Standard CEN ENV 12924 (Security Categorisation and Protection of Health Care Information Systems), that was performed as part of the ISIS/MEDSEC project of the EU. The categorisation scheme given in the standard was followed through for almost all information systems or sub-systems in the Leiden University Medical Centre. The status of the security measures was evaluated for ten systems; further implementation plans were then drawn up for these systems, and partly effectuated. Findings are reported, both on the present security level, and on the applicability of the standard (which in general was found to be very positive). In the course of this work, use was made of a database support tool, developed in an earlier EU project (SEISMED).