Clinical background

As literature stands, the prevalence of congenital heart defects with clinically relevant shunts ranges from two to twelve cases per thousand of live births with a steadily rising tendency. The number of serious developed regurgitation defects has also risen, mainly due to the successful treatment of ischemic and degenerative defects. In both cases, but especially in congenital malformations, this is a serious medical, social and economic problem. Accurate hemodynamic diagnosis of heart defects will assist in the selection and timing of optimal therapy for the patient (here specifically direct quantification of intra-cardiac shunts and cardiac regurgitation), At present, there is no technology able to precisely quantify just the above-mentioned parameters. Basic thermodilution is a known method, however, with limitation of usability for quantification of minute output only. Other key parameters are currently not capturable. Innova Medical's together with prof. Jiri Endrys, the inventor of the method has developed an innovative thermodilution system capable to capture all three parameters – not only minute output but also shunts quantification and to some extent regurgitation measurements.

Thermodilution device description

The thermodilution device consists of a special thermodilution catheter, a communication unit and a SW application, creating a complete diagnostic system usable for specialized cardiovascular departments. Thanks to the unique design of the tip of thermocouple catheter, the temperature of the injected medium (physiological saline) can be sensed intracardially always in the middle of the main flow. Based on the detected values, key diagnostic parameters can be determined. Based on exact hemodynamic parameters, the most effective heart defects treatment can be chosen (such as cardiac surgery or cardiovascular intervention- occluders). At present, a similarly simple and accurate diagnostic method does not exist. In contrast to other methods, it is not necessary for the patient to take blood samples or apply dye to the bloodstream. The system is totally atraumatic and the risk of its use and complications does not exceed the usual interventional procedures.

The system has been tested for clinical application for classical and also unclear and atypical defects of the circulatory system. It has been used for example:

Rupture of Sinus Valsava aneurysm

Partial anomalous pulmonary venous return

Scimitar syndrome

Coronary artery fistule to right ventricle

ASD – atrial septal defect

VSD – ventricular Septal Defect

PFO – patent foramen ovale

PDA – persistent ductus arteriosus

Fallot Tetralogy