“I have tried several devices in the last 10 or 20 years, but I think this is absolutely different—this is the first time that we have treated non-vascular problems [using an] endovascular solution,” Pedro Lylyk (Clinica Sagrada Familia, Buenos Aires, Argentina) told attendees at the Society of NeuroInterventional Surgery’s 18th annual meeting (SNIS; 26–29 July 2021, Colorado Springs, USA and virtual), documenting first-in-human experience with the eShunt system (CereVasc)—an investigational device for the treatment of communicating hydrocephalus (CH).
Lylyk is the principal investigator in the ETCHES I (Endovascular treatment of communicating hydrocephalus with the eShunt system) assessing the use of the device, which is implanted through a leg vein using X-ray guidance. eShunt is described as the first minimally invasive treatment for CH—the abnormal build-up of fluid in the brain.
The current standard of care for CH is the ventriculo-peritoneal (VP) shunt, Lylyk told SNIS attendees during the late-breaking abstract session in which he presented the results of the first-in-human case. VP shunts have been shown to have high complication and failure rates, Lylyk added, with reports describing that >40% of VP shunts fail within the first two years of implantation.
Therefore, Lylyk and colleagues believed that, using modern fluoroscopic imaging and 3D vascular visualisation, a less invasive option may be viable. eShunt is designed to eliminate the need for a craniotomy or surgical opening into the skull, passage of a catheter through white matter of the brain, or subcutaneous tunnelling across the chest and abdomen for placement of a long outflow catheter into a second surgical incision in the abdomen.
The shunt consists of a subarachnoid space (SAS) anchor, a shunt body of 35mm in length, and a slit proximal valve, Lylyk described in his presentation, noting that the delivery system is comprised of two components: one distal, that stays at the cavernous sinus; and one proximal, which is a 4 French penetrating catheter with a 20G needle, protected by a retractable needle guard.
Describing the case, Lylyk told SNIS attendees that the patient, an 84-year-old female, was referred five days after subarachnoid haemorrhage (SAH) and developed neurological deterioration after a further five days. CH was detected on computed tomography (CT), prompting the implantation of the eShunt. The patient died 59 days after occurrence of the SAH after developing sepsis secondary to a respiratory infection progressing to renal failure, but Lylyk described early experience with the device as encouraging.
“We achieved the early communication between the CSF [cerebrospinal fluid] and the blood,” Lylyk told NeuroNews in an interview following his SNIS presentation, in which he discussed the procedure. “We dropped the pressure inside the brain [which returned] within the next 36 hours up to normal, so that was a big achievement. The patient had improved ICP [increased intracranial pressure] of the brain, so that was the first achievement.”
However, Lylyk also commented that the proof of the concept also potentially opens the door for its wider usage. “This is a fantastic new solution for [treating] non-vascular problems by endovascular means,” Lylyk said. “This is the first case in which we achieved the percutaneous endovascular transluminal access to the central nervous system and that may have nice implications for an access platform.
“We can deliver gene therapy, brain stem cells, or do endovascular surgery that way. Also, we achieved the first transdural venous to cisternal punctures safely, without any haemorrhage inside the brain,” he noted. “I think we have proved the concept that we can join the CP [cerebellopontine] angle, the cistern of the CP angle, with the IPS [Inferior petrosal sinus] with rapid and sustained decreases of ICP.”
Lylyk added that he is “very excited” about the potential of the device. “I think this is a new avenue for us for the endovascular treatment of many other diseases. It is just the first step, but I think it is a big step,” he told NeuroNews.