Ventriculo-atrial shunt and European regulations: a delicate balance.

Background: European regulations on medical devices have been introduced to improve medical standards. However, these changes are leading to the transient lack of medical tools with possible disadvantages. Herein, the problem is addressed for the first time in neurosurgery with regards to ventriculo-atrial shunt (VAS).

Methods: Children undergoing VAS in the 2020-2022 period at a single Institution were enrolled. Patients receiving VAS with Pudenz cardiac catheter (distal slit "valves") were assigned to group A (2020-2021) while those with VAS harboring proximal adjustable valve to group B (2021-2022, Pudenz no more available). The complications leading to shunt malfunction within 2 years from VAS were analyzed.

Results: Twenty-four children belonged to group A (M/F ratio: 2.4; mean age: 42.5 months) and 18 to group B (MF/ratio: 1.8, mean age: 48.1 months). Statistically significant differences were found about: 1) patients needing shunt revision: 7 cases (29%) in group A vs. 11 cases (61%) in group B; 2) number of shunt revisions: 8 in group A vs. 16 in group B; 3) number of children with mechanical complications: 2 (8.3%) in group A vs. 7 (39%) in group B; 4) number of mechanical complications: 2 (group A) vs. 9 (group B). No differences in other complications or placement-to-revision time were detected.

Conclusions: The lack of simple surgical tools (Pudenz catheter) may make VAS more prone to mechanical complications. Prospective and multicenter trials are needed to produce scientific evidence. In the meantime, a multidisciplinary discussion on the European regulation (including Doctors and Manufacturers) is welcome.