First, we're going to start with Dr. Vaughn presenting about shunt infections in Sub-Saharan Africa. All right, I'm Carrie Vaughn. Thank you very much for the Delmo NS for having me and letting me present our work on behalf of our co-authors. And thank you to the audience for staying to the end of the conference on Wednesday. We have no disclosures. I'm going to be talking about hydrocephalus, which obviously we're all very well acquainted with, but one of the most common neurosurgical conditions worldwide and one of the ones where we can really make the most difference around the world, along with things like trauma. And it's globally recognized by the global surgery community as an area where we can make a high impact. We see a lot of hydrocephalus, obviously, in our center in Uganda. Ends up being quite a different population, what we see for hydrocephalus in high-income countries like the U.S., for example. We often use a standard shunt when we treat these patients at our hospital when they've, for example, failed an ETV. And we see a historical infection rate usually anywhere between 9 to 14%. And again, these are just with standard shunts. There are antibiotic impregnated shunts, obviously, on the market, which are quite a bit more expensive, about 10 times as expensive as the shunt we typically use at our center. But are potentially have cost-saving implications and may come with a lower risk of infection based on some conflicting studies from high-income countries. It's very important to note that most of these studies have been done in high-income countries, again, with a very different hydrocephalus population than what we see. And there's really not any data from low and middle-income countries on these antibiotic impregnated shunts. The other important fact about these is that the efficacy of the antibiotics in the impregnated catheters drops off in vitro after about two months. There's no clear link to delayed infections with these catheters, but there is the potential for risk there. We developed a randomized controlled trial to look at the standard versus the antibiotic impregnated shunts in our population, just based on the conflicting data, again, from high-income countries, and retrospectively in our own cohort onsite in Uganda as well. We looked at any patient that was less than 16 years old, had hydrocephalus, that had never been treated with a shunt, and obviously did not have any active infection at the time of screening. In terms of primary outcomes, our focus was really on infection, as based on both clinical and lab markers from CSF sampling at the time of admission. And our secondary outcomes were malfunction, mortality, and shunt reoperation. This was all in a setting of six months postoperative follow-up. We screened about 1,500 patients over the course of three years for enrollment in the study, and ended up enrolling 248, meaning 124 in each arm for standard and antibiotic impregnated shunts. We, all the patients were randomized at the time of surgery, and all caretakers were blinded except for the surgeon who was actually implanting the shunt. And both groups ended up having standard postoperative care at their center, including IV antibiotics postoperatively for both groups, and then follow-up for six months. If the patients and families failed to show up for follow-up, we had a social work team reach out to them to see what was going on, and see if we could help bring them in, in order to see how the child was doing. In terms of our two cohorts, we found that there was no difference for age, gender, etiology of hydrocephalus, and even loss to follow-up. So we had minimal loss to follow-up in both groups, and again, no significant difference. For the etiology of hydrocephalus, as I mentioned, most of our children that we see in Uganda have hydrocephalus linked to typically neonatal febrile infections of unclear etiology. It may be meningitis, but can also be from a lot of different organ system sources. And that ended up being most of our population, as we see with just overall admissions at our center. Eighty-one percent for the control arm, and 72 percent for the experimental arm. And again, post-infectious hydrocephalus, we see clinically has quite a different course from the standard, or the more common congenital, or post-hemorrhagic hydrocephalus that we would expect in the U.S. and other high-income countries. Looking at our primary and secondary outcomes, we found no significant difference in terms of shunt infection, malfunction, mortality, or re-operation across the two groups. And this held true at six-month follow-up, as well as beyond that when we continued to follow these children after the official end of the trial. Looking at Kaplan-Mein survival curves for these, we see that shunt-free, or infection-free survival, was the same for both cohorts, again, up until the official end of the trial at six months on the left side of the screen, as well as beyond six months on the right side of the screen. Even accounting for censoring events, which you can see at the very bottom of the graphs. This was also true for the secondary outcome, again, of malfunction, death, or re-operation, both within the six-month window on the left side, and then beyond the six-month window on the right side. Again, censoring did not affect our results in this case. This is incredibly important for a lot of different contexts, because hydrocephalus is not a uniform disease. And the results that have been found previously in high-income countries looking at these antibiotic-impregnated shunts may not hold true everywhere else around the world. Obviously, as I mentioned, the main reason that we believe this is true is because of the difference in etiology in hydrocephalus. More work needs to be done to look into this. But with the lack of difference between primary and secondary outcomes in our two groups, meaning standard shunt and antibiotic-impregnated shunts, we don't believe that the additional cost of this antibiotic-impregnated shunt up front is worth the economic investment, you know, given that postoperatively the families may not see any difference in the rate of infection or other complications. So the families tend to incur this cost up front of the implant for most centers around the world. There's very few countries that have insurance systems. And even in government hospitals in lower-income countries, the cost of implants, again, is often incurred by the families. So the lack of difference in infections and other complications to us suggests that it's not necessarily a feasible alternative. We think the standard shunt performs just as well. Obviously, there were a lot of people involved in this project. First and foremost, I'd like to thank my mentor, Dr. Worf, for all of his work on this, and the entire team at CURE Uganda, who has been instrumental in designing and helping to continue this study, and the AANS for having me present this work here. Thank you.

shunt infections

Sub-Saharan Africa

standard shunts

antibiotic-impregnated shunts

hydrocephalus