Related Experiment Video
Updated: May 20, 2026

Neuronavigation and Laparoscopy Guided Ventriculoperitoneal Shunt Insertion for the Treatment of Hydrocephalus
Published on: October 14, 2022
Ventriculo-atrial shunt and European regulations: a delicate balance
Luca Massimi1,2, Marco Obersnel3, Paolo Frassanito3
1Department of Pediatric Neurosurgery, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy - luca.massimi@policlinicogemelli.it.
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.
Related Concept Videos
Mitral Regurgitation III: Medical Management
Regulation of Stroke Volume
Preload refers to the degree of stretch on the heart before it contracts. It's analogous to the stretching of a rubber band; the more it's stretched, the more forcefully it snaps back. This concept is encapsulated in the Frank-Starling law of the...
Mitral Regurgitation I: Introduction
Aortic Regurgitation III: Medical Management
Aortic Regurgitation I: Introduction
Mitral Stenosis III: Medical Management

