Open Access

ARTICLE

Procedural Performance and Safety of VACS^® Balloon Catheters in Congenital Heart Interventions

Guido Mandilaras^1,2,*, Anja Tengler¹, Andre Jakob¹, Robert Dalla Pozza¹, Nikolaus A. Haas¹

1 Department of Pediatric Cardiology and Pediatric Intensive Care, University Hospital of Munich, LMU, Munich, Germany
2 Center for Congenital Heart Defects Stuttgart, Department of Pediatric Intensive Care, Pneumology and Allergology, Klinikum Stuttgart, Olgahospital/Women’s Clinic, Stuttgart, Germany

* Corresponding Author: Guido Mandilaras. Email:

Structural and Congenital Heart Disease 2026, 21(4), 3 https://doi.org/10.32604/schd.2026.080384

Received 08 February 2026; Accepted 18 August 2026; Issue published 30 September 2026

Abstract

Background: Balloon catheters are essential tools in congenital cardiac catheterization and are used for therapeutic balloon dilatation, anatomical balloon interrogation, and stent implantation. Clinical performance data for established devices have become increasingly important under the European Medical Device Regulation (MDR). We evaluated the procedural performance and safety of the Osypka VACS^® (Valvuloplasty Catheter System; Osypka AG, Rheinfelden, Germany) II and VACS^® III balloon catheters across a broad spectrum of congenital heart interventions. Methods: This retrospective single-center study reviewed the institutional experience with VACS^® II and VACS^® III balloon catheters over 10 years. Consecutive procedures from predefined indication groups were analyzed descriptively to assess balloon performance across therapeutic and diagnostic applications. The primary endpoint was technical device success, defined as successful positioning, intended balloon inflation according to the procedural objective, and uncomplicated retrieval of the balloon catheter. Device-related complications and indication-specific procedural outcomes were recorded. Results: For the present indication-based analysis, consecutive procedures were sampled as described in the Methods. The predefined criteria for technical device success were fulfilled in all analyzed procedures. Balloon rupture occurred in two of the 25 right ventricular outflow tract dilatation procedures (n = 2/25, 8%), both during high-pressure dilatation of severely calcified postoperative conduits, without vascular injury or retrieval difficulties. Therapeutic balloon dilatation resulted in substantial improvements in indication-specific hemodynamic parameters, while balloon interrogation and stent implantation procedures were successfully completed in all intended cases. Seven patients developed moderate aortic regurgitation following maximal balloon aortic valvuloplasty, representing a recognized procedural complication rather than device malfunction. No procedure-related mortality or serious device-related adverse events were observed. Conclusions: The Osypka VACS^® II and VACS^® III balloon catheters demonstrated reliable procedural performance, broad applicability, and a low rate of device-related complications across diverse congenital heart interventions. These real-world data provide clinical performance evidence supporting the continued use and regulatory evaluation of established balloon catheter systems under the current European MDR framework.

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