“You can get hemostasis much more effectively and reliably,” and patients can return home faster, senior author says.
Despite a lack US Food and Drug Administration (FDA) approval for pediatric use, the MynxGrip arterial closure device (Cardinal Health) seems to be a safe and effective option for vascular closure following interventional neuroendovascular procedures in children, according to an institutional review published online March 6, 2018, in the Journal of NeuroInterventional Surgery.
In an interview with Neurovascular Exchange, senior author Ali Shaibani, MD (Ann and Robert H. Lurie Children’s Hospital, Chicago, IL), said that as pediatric patients undergo an increasing number of complex neurointerventions, often with antiplatelet or anticoagulant therapy, vascular closure devices can be very helpful.
“You can get hemostasis much more effectively and reliably,” he said, “especially if you’re trying to continue the anticoagulation or the antithrombotics. . . . The other advantage to using a closure device is getting the patients mobilized and home earlier. Six hours of bed rest for a child is somewhat difficult, especially the younger ones, who have a hard time holding still.” Of course, less hospital time also translates to theoretical cost savings, he added.
Unfortunately, the market is too small to make the seeking of FDA approval in the pediatric setting financially worthwhile for most manufacturers of vascular closure devices.
Shaibani along with lead author Tahaamin Shokuhfar, MD (Ann and Robert H. Lurie Children’s Hospital), and colleagues conducted a retrospective review of all 53 pediatric patients who underwent diagnostic or interventional neuroendovascular procedures at their institution using the MynxGrip between October 2013 and November 2016. In total, 83 MynxGrip devices were deployed in 23 boys and 30 girls, whose mean age was 14 years.
Use of the MynxGrip was predicated by an adequate depth of subcutaneous tissue and common femoral artery (CFA) diameter. Patients remained on supine bedrest for 2 hours after diagnostic procedures and for 3 hours after therapeutic procedures. Nearly half of the procedures (46%) were for diagnostic angiography. The right-side CFA was the main point of access for most procedures, and its mean diameter was 6.24 mm, with a range of 4.0 mm to 8.5 mm.
There was only 1 recorded case of device failure, and this occurred without any sequelae. The device was extracted, and hemostasis was achieved by manual compression with the placement of a Safeguard compression device. There were no other immediate or delayed major complications.
Shaibani said he prefers to use the MynxGrip in pediatric patients because most other vascular closure devices “leave something inside the artery as well as outside the artery.” MynxGrip and Vascade (Cardiva Medical) “do not leave anything inside the lumina of the artery,” he continued, adding, “I’m more comfortable with a device that is not leaving a piece of itself inside the artery, which could theoretically have a higher chance of causing a downstream complication.”
The major limiting factor to use of MynxGrip in pediatrics is that the minimum diameter of the vessel must be at least 4 mm to accommodate the balloon at the end of the device, he said. Ideally, patients will also have some “cushion” of subcutaneous tissue under the skin, but Shaibani and his team have managed to use the device in very thin patients.
“We use ultrasound guidance in all the kids, and we start our skin access point at least an inch below our puncture point,” he explained. “That gives us a very long horizontal subcutaneous track. This allows us to use the device even in kids who, when we first started using the device [we thought we] could not use it because they were too skinny.” Using this technique, he has successfully employed the device in children as young as 5.
While failure rate with the MynxGrip is low, Shaibani still recommends, like with other vascular closure devices, ensuring the puncture is over bone so that the area is compressible should the device fail.
Source:
Shokuhfar T, Hurley MC, Al-Smadi A, et al. MynxGrip vascular closure device use in pediatric neurointerventional procedures. J Neurosurg Pediatr. 2018;Epub ahead of print.
Disclosures:
Shaibani reports no relevant conflicts of interest.