Five Years and 1600 Patients: Study Aims to Inform TAVI vs Surgery Decision May 12, 2017

A new study aims to establish whether transcatheter or surgical aortic valve replacement is best in comparative populations.

Background

We’ve written a lot of words on the technological changes that have occurred in aortic valve replacement over the past ten years. Transcatheter (TAVI) techniques are clearly of-the-minute and have seen tremendous uptake, but in the eyes of some practitioners and healthcare providers remain an option only for patients at too high a risk for conventional surgery. This is because of their significantly greater cost (double) compared with conventional valve replacement surgery and the fact that even these state-of-the-art techniques are not risk-free.

So should TAVI be reserved for high surgical risk patients? After all, an increasing number of physicians are now treating younger and healthier patients with TAVI.

Now a clinical study of the German Centre for Cardiovascular Research (DZHK) shall investigate for the first time which of the two methods is better for patients with medium to low surgical risk. This significant body of work should prove highly informative for physicians, patients and health insurance companies and provide guidance for reimbursement recommendations. As such, it’s long overdue.

The study will comprise 1,600 patients and costs 4.5 million euros. It is not an industry initiated trial, so the valves of all established manufacturers will be used. Tagged DEDICATE (DZHK6) the study will compare 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. They will be assigned randomly to two groups and their survival rate will be determined over five years. Previous studies have thus far covered considerably shorter periods.

The ultimate goal is to gain a better understanding of the objectivity and procedural safety for patients, physicians and health insurance companies.

Investigator comments

Principal investigator, Prof. Stefan Blankenberg, cardiologist at the University Medical Center Hamburg-Eppendorf stated; “We are not comparing one valve model to the surgical method, but one treatment method to another.”

Prof. Jochen Cremer of UKSH, Campus Kiel, who represents the surgical branch said; “Heart surgeons and cardiologists have planned the study together. Together we want to determine the best treatment for our patients.”

Source:  Deutsches Zentrum für Herz-Kreislauf-forschung


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