Catheter or surgery?
Clinical study on heart valve replacement begins.
In principle, there are two ways to do this: the patient's thorax is opened surgically and an artificial valve is implanted; or a new valve is advanced through a femoral artery up to the heart using a catheter.
Only since the first successful minimally invasive transcatheter aortic valve implantation (TAVI) in 2002 could these patients be treated.
For some time now, however, there has been a paradigm change: more and more physicians are also treating younger and healthier patients with TAVI, even though there are no long-term clinical observations in these patients.
The DEDICATE study (DZHK6) is now comparing the surgical therapy procedure to the catheter-supported TAVI method in patients with medium to low surgical risk (STS score of 3 to 6) in order to achieve a higher procedural safety.
Only patients who are eligible for both methods may participate in the study.
Two treatment methods are being compared In comparison to other studies, DEDICATE is distinctive in another way: for the first time, not only TAVI valves of one manufacturer will be compared to the surgical procedure, but the physician can choose the valve according to accuracy of fit and size from various models and manufacturers. "Therefore, we are not comparing one valve model to the surgical method, but one treatment method to another", says the study's principal investigator, Prof. Stefan Blankenberg, cardiologist at the University Medical Center Hamburg-Eppendorf.
Prof. Blankenberg also hopes that the study's outcomes will provide the chance for more objectivity and procedural safety for patients, physicians and health insurance companies.