Cardiology, Tavi more effective than surgery even in intermediate-risk patients
The findings emerge from an analysis of data from the PARTNER II study, published in April in the New England Journal of Medicine, presented at the “TAVI Today” symposium in Milan, Italy
TAVI, the procedure to replace, in cases of aortic stenosis, the degenerated aortic valve by transcatheter, from the groin or through the tip of the heart, without resorting to open heart surgery, will no longer be reserved only for inoperable patients or those with too high an operative risk. This was determined in recent weeks by the granting, on the basis of data from scientific studies, of the CE mark to the SAPIEN 3 valve from Edwards Lifesciences, for indication for use also in patients at so-called intermediate risk, for whom it would be possible to intervene with both approaches.
Transcatheter implantation of the SAPIEN 3 valve, in patients with severe and symptomatic intermediate-risk aortic stenosis, halves compared with cardiac surgery – from 16.6 percent to 8.4 percent – the combined endpoint of mortality and risk of a disabling stroke. It also reduces all-cause mortality (TAVI: 7.4%; surgery: 13.3%) and the occurrence of stroke (TAVI: 4.6%; surgery: 8.2%). Data come from follow-up analyses of the PARTNER II study, published last spring in the New England Journal of Medicine and Lancet1.
The findings were presented today at the “TAVI Today” symposium, organized in Milan by Edwards Lifesciences. “This is very significant for the quality and innovation of care offered in Italy, as well as for patients with aortic stenosis. The extension of the indication to the intermediate-risk patient will make it possible to guarantee effective and safe treatment for a greater number of people suffering from this serious disease; this will ensure increasingly appropriate and less invasive treatment, allowing a very rapid functional recovery with the prompt resumption of normal daily activities for our patients,” commented Giuseppe Musumeci, President GISE-Italian Society of Interventional Cardiology.
Edwards Lifesciences, based in Irvine, California, is a world leader in the treatment of structural heart valve disease, surgical monitoring and intensive care. Dedicated to developing innovative solutions for patient care, collaborates with the medical and scientific community to save lives and improve quality of life.