The first generation of the Edwards valve was stainless steel and bovine pericardium with a profile of 22 to 24 Fr for transfemoral access and up to 33 Fr to apical access. From 2010 it became cobalt chromium bovine pericardium with a higher profile, (18-19 Fr for transfemoral and 24-26 Fr for transapical). 2,688 patients who received the valve were included in 93 centers throughout 17 countries and were followed for one year. There was a mortality rate of 2.3%, a stroke rate of 2.2%, ring rupture 0.4% and cardiac tamponade 0.9%. The need for a permanent pacemaker was 5.7% and vascular complications occurred in 11%.

Conclusion: The results with the Edwards Sapien XP valve after one year follow-up suggest a large effect in terms of symptom relief and improved quality of life with a low rate of mortality and stroke.

Stephan Windecker
2013-05-21

Original title:One-Year outcomes from the SOURCE XT post approval study.