GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique

Abstract

Background: Freehand ventricular catheter placement may represent limited accuracy for the surgeon's intent to achieve primary optimal catheter position.

Objective: To investigate the accuracy of a ventricular catheter guide assisted by a simple mobile health application (mhealth app) in a multicenter, randomized, controlled, simple blinded study (GAVCA study).

Methods: In total, 139 eligible patients were enrolled in 9 centers. Catheter placement was evaluated by 3 different components: number of ventricular cannulation attempts, a grading scale, and the anatomical position of the catheter tip. The primary endpoint was the rate of primary cannulation of grade I catheter position in the ipsilateral ventricle. The secondary endpoints were rate of intraventricular position of the catheter's perforations, early ventricular catheter failure, and complications.

Results: The primary endpoint was reached in 70% of the guided group vs 56.5% (freehand group; odds ratio 1.79, 95% confidence interval 0.89-3.61). The primary successful puncture rate was 100% vs 91.3% (P = .012). Catheter perforations were located completely inside the ventricle in 81.4% (guided group) and 65.2% (freehand group; odds ratio 2.34, 95% confidence interval 1.07-5.1). No differences occurred in early ventricular catheter failure, complication rate, duration of surgery, or hospital stay.

Conclusion: The guided ventricular catheter application proved to be a safe and simple method. The primary endpoint revealed a nonsignificant improvement of optimal catheter placement among the groups. Long-term follow-up is necessary in order to evaluate differences in catheter survival among shunted patients.

Figures

Figure 1.

Flow chart of patient population enrolled in the GAVCA study.

Figure 2.

Quality of catheter position was evaluated in different factors. The factors 1 to 3 refer to the primary endpoint analysis combining first, the amount of puncture attempts, second, grading of catheter tip location in relation to paraventricular tissue, and third, anatomical position of the catheter tip. The primary endpoint was defined as an optimal catheter position at first puncture attempt, grade I and ipsilateral ventricle (upper green box). In addition, the incorrect catheter position was defined as ≥2 puncture attempts, grade II and IV, and nonipsilateral catheter position (upper red box). A, Grading scale (for distal 2 cm of catheter): grade I: catheter position without contact of more than 0.5 cm to the ventricular wall; grade II: contact of more than 0.5 cm to the ventricular wall or the choroid plexus; grade III: only partially intraventricular position of the catheter tip (less than 1.5 cm intraventricular); grade IV: extraventricular position of the catheter (less than 0.5 cm intraventricular). B, Anatomical catheter position with the catheter tip position located in the ipsilateral, contralateral, third ventricle, or in the tissue. C, As a secondary endpoint, the rate of complete intraventricular position of the perforated part of the catheter tip was defined. Aside from the complete extraventricular position of the catheter tip, different possible scenarios for perforations being in contact with adjacent brain tissue. That represents either the catheter is positioned too short, too long, has perforated the septum or not is inside the ventricles (iv, intraventricular).

Figure 3.

The surgical instrument used as a ventricular catheter guide (right) and a screenshot of the mobile health application (left) with the measured parameters for correct catheter placement.

Figure 4.

Range of ventricular width for including the patients for this study was FOHR  0.05. The range of ventricular width is shown on representative MRIs with an FOHR of 0.47 (right) in the upper range and FOHWR 0.09 (left) in the lower range.

Figure 5.

A, Rate distribution for the quality of ventricular catheter position in postoperative imaging. The optimal catheter position defined as primary, grade I in the ipsilateral ventricle (light green) reached a rate of 70% in the guided group compared to 56.5% in the freehand group (ITT: P = .099; PP: P = .137; AT: P = .045), while an incorrect catheter position (nonprimary, grade II and IV, nonipsilateral, red) could be avoided significantly more often in the guided group (10% vs 31.9%; P = .001). Intermediate catheter position (primary, grade II, ipsilateral; dark green) revealed 20% in the guided and 11.6% in the freehand group. B, The rate of complete intraventricular positioning of the catheter perforations was significantly higher in the guided group (81.4% vs 65.2% in the freehand group; P = .031).