This advertorial is sponsored by Sim&Cure.
Following the introduction of Sim&Size v2.1 (Sim&Cure)—the latest advancement in the use of simulation software to support the planning of neurointerventional procedures—early adopter Christian Ferreira (Northwell Health, New York, USA) speaks to NeuroNews to discuss the benefits held by these technologies and their likely role in the future of intracranial aneurysm treatments.
“Healthcare gets better when we have protocols and standardised treatments,” says cerebrovascular neurosurgeon Ferreira. “The fact that we can help the operator to [model how devices will deform during a procedure] is likely to make life easier for everyone—especially the residents and fellows who don’t have as much experience as a mid-career endovascular surgeon. And, if I was a patient, I would prefer to have my aneurysm treatment simulated before any procedure. Wouldn’t you?”
Given the growing body of evidence evaluating simulation software in endovascular aneurysm care, and the growing number of global centres that have integrated these technologies into their practice, the question posed by Ferreira appears to be a very reasonable one. Last year, he and his colleagues contributed to the aforementioned body of evidence, publishing a meta-analysis intended to synthesise existing data on virtual simulation software in the neurointerventional space.
“We wanted to look at what has already been published on these softwares, because we don’t have a major clinical trial attempting to compare cases using these different softwares versus cases without software planning,” Ferreira explains. “Our thinking was to describe what we have so far in terms of data and add that information together to see if the softwares really make a difference.”
The analysis—published in Interventional Neuroradiology—looked specifically at the selection and sizing of flow diverters, pulling together 10 studies comprising a total of 658 intracranial aneurysms. The researchers found that simulation software demonstrated a high level of accuracy, with no statistically significant discrepancy between simulated and postoperative device lengths (mean difference, 1.7mm), while other key results showed no significant difference between physician-selected and software-selected device diameters (mean difference, 0.04mm). Beyond these findings, the meta-analysis demonstrated the clinical efficacy of simulation softwares, reporting a 96% success rate for software-guided deployment alongside a minimal complication rate of 4%.
“Our paper also showed that most of the physicians were choosing a device that was too long, unnecessarily—probably because they feel safer doing so—and we [demonstrated that you can potentially] opt for a shorter device if you go with the simulation,” Ferreira notes, alluding to the mean overestimation of 2.11mm seen with physician-chosen device lengths compared to those generated by the simulation softwares.
Benefits in procedural planning
Ferreira’s explanation for this is based on the fact that operators will typically default to selecting excessive device lengths when choosing a flow-diverting stent, believing that the safest approach is to ensure the aneurysm neck is fully covered—even if this means deploying a longer-than-necessary device.
“When using flow diverters in smaller aneurysms with, for example, a 7mm neck, they might decide to use a device that is 14mm or even 20mm long, so that they have some extra length to play with,” he continues. “The problem is that you may be covering some other [unrelated] branches or areas that you don’t need to cover to treat the aneurysm, which could increase the chances of complications.”
While historical focus has remained on sizing accuracy, there is a growing recognition among operators that precision is merely the foundation, and priorities are shifting towards identifying the optimal treatment strategy rather than simply an effective one. By modelling device-specific mechanics, physicians can better balance effectiveness with safety—improving understanding of how a device may conform to a patient’s unique anatomy to help minimise potential complications.
This is where the simulations generated by Sim&Size can, in Ferreira’s view, have a tangible impact on endovascular aneurysm treatments, making these procedures more predictable and ultimately safer by enabling the deployed state of a number of different devices and techniques to be comprehensively modelled beforehand—whether that means brainstorming strategies in the office before the procedure or developing a strategy in the operating room on the day of the procedure.
“You always want to [model] how the device is going to [deform],” he says. “When you plan the treatment of an aneurysm, you have a picture in your mind of exactly how you want the device to be deployed inside the patient. Running a simulation and getting an idea of the device deformation before you start the procedure—even if you don’t have a lot of experience with that device—makes your life much easier, because you can quickly and easily simulate the deployed states of new devices and devices from different companies [without impacting your patient]. The software doesn’t replace your expertise; it enhances it, and helps you transfer what you want to do into the real world.”
Ferreira goes on to state that, in addition to giving him a greater degree of confidence prior to the procedure, these simulations can facilitate more informed discussions between every individual involved in a patient’s treatment as well as serving as an educational tool for less experienced members of the neurointerventional team.
Expanding possibilities
The simulation capabilities of Sim&Size—a software as a medical device intended solely for healthcare providers—span the full gamut of endovascular aneurysm therapies, from regular stents and embolisation coils to intrasaccular devices and flow diverters. For Ferreira, being able to run simulations involving the latest and most advanced products on the market is critical, as “the field is moving very quickly, and we need to stay updated with all of these innovations”—and the availability of such a wide array of devices means physicians can even simulate deployments of products they do not have in stock at the time.
“The software doesn’t replace your expertise; it enhances it, and helps you transfer what you want to do into the real world”
“That’s another good thing about having the simulation software in the office setting, not just in the operating room. When you’re seeing outpatients, and you’re going to do an elective, unruptured aneurysm case, you can run simulations before you bring the patient in for the procedure. Then, you can call a representative from the company and tell them the specific device you’re going to need,” Ferreira adds.
To account for potential anatomical variations or changes in vessel morphology that can occur between early planning and the actual intervention, a final simulation using Sim&Size should always be performed on the day of the procedure. This ensures the strategy is based on the most recent imaging data and allows the physician to confirm the final device selection against the patient’s current anatomy.
Based on his early experiences with the recently introduced Sim&Size v2.1, Ferreira reports that the software features a more streamlined clinical workflow. Specifically, a reduction in the number of steps required to execute multiple simulations with different device types in the same case has made the platform’s usage more efficient and straightforward, allowing for faster comparisons during the planning phase.
In addition to simulations providing increasingly sophisticated representations of how a device is likely to deform inside the patient’s vasculature, another key detail Ferreira points to within Sim&Size’s latest update is a greater emphasis on advanced device-specific metrics. The platform provides biomarkers already documented in clinical literature as correlating with occlusion, such as volume embolisation ratio (VER) in coiling, alongside device-aneurysm volume (DAV) ratio and compression in intrasaccular therapies. Taking this a step further, Sim&Size also incorporates a proprietary metric created by Sim&Cure—specifically, the Spruce Index, which has been retrospectively correlated with aneurysm occlusion status. Finally, for flow diversion, metrics like relative sizing and pore density hold the potential to transform subjective visual assessments into measurable data, allowing the industry to explore their future role as predictive biomarkers.
Ferreira goes on to posit that the objective, data-driven insights provided by the software serve as a “really good starting point”, allowing him to use simulations as a comparator against his initial procedural strategy, quipping that “it’s almost like a second opinion from a different doctor”. It is also important to note, however, that the information provided by the software is not intended to in any way eliminate, replace or substitute for—in whole or in part—the healthcare provider’s judgment and analysis of the patient’s condition.
“The performance of the software has improved as well—the time it takes to run a simulation is even faster now, and the simulations are more detailed,” Ferreira adds.
Will simulation become normality?
With the exception of certain urgent cases involving ruptured aneurysms—in which even a small amount of extra time and additional pre-emptive planning is harder to justify—Ferreira is now utilising Sim&Size for the majority of the aneurysms he treats. And, as this technology becomes more seamlessly integrated within current angio systems, and communal experience and familiarity grows, he anticipates that virtual simulations will essentially become another standard part of every elective aneurysm procedure.
“I think there will still be a lot of resistance for a couple of years and we’re going to need more robust data,” he comments. “We will need a trial randomising patients to simulation versus no simulation to really prove its clinical benefit, because most of the studies we have are retrospective.”
To answer this call for higher-level evidence, initiatives for prospective, randomised evaluations are already beginning to take shape within the neurointerventional community.
“I think that—eventually—everyone will be using these softwares on a daily basis,” Ferreira says, noting that another future goal is for these tools to become native to the angio suite.
Sim&Cure is already leading these efforts through active partnerships with major imaging providers like Siemens and Philips. By enabling seamless simulation overlays today, the company hopes these partnerships will actively evolve towards even deeper angio-suite integration, including future tableside controls.
While there are a variety of reasons why some physicians may remain reluctant to embrace technologies like Sim&Size, history shows that these people are likely to “fall behind” their peers, according to Ferreira.
“It can be really hard to change the way you do something that you are familiar with—especially in elective aneurysm treatments, because the complication rate is so low and people underestimate the fact that you can still make improvements,” he concludes. “It’s the same concept that we saw several years ago with the 3D angiogram. Many people were just relying on 2D angiograms for everything and, when the 3D angiogram came along, everybody said it took too long and it was too complicated—but, now, we all use it every day! I think the simulation software is going to be the same. It is a must-try technology.”
