Edwards Lifesciences’ redesigned non-invasive heart valve replacement system – Sapien XT – showed good performance and was associated with fewer complications compared to the original Sapien, clinical trial researchers explained at the American College of Cardiology’s (ACC) 62nd Annual Scientific Session in San Francisco, on Saturday.



The PARTNER II Trialthe lower-profile Sapien XT valve was associated with fewer vascular events



In this video, the Sapien XT is implanted by threading a catheter via the upper leg (transfemorally)






“We are very pleased to see improved outcomes in both the SAPIEN and SAPIEN XT patients, as compared to results from earlier trials. The SAPIEN XT valve was designed to reduce complications of the TAVR procedure, and we believe this has been demonstrated by today’s results. Edwards is proud to lead the advancement of cutting-edge innovations for these high-risk patients, supported by rigorous clinical evidence.”

  • 284 received the Sapien XT valve
  • 276 received the Sapien valve
stroke

  • After one year, 22.5% of the Sapien XT patients had died, compared to 23.7% in the Sapien group (the patients’ mean age was 84 years).
  • 5.9% of those in the Sapien XT group suffered a stroke within 12 months, compared to 5.7% in the Sapien group
  • There were 40% fewer vascular complications in the Sapien XT group, compared to those in the Sapien group
  • Within 30 days, the death rate (for any cause) in the Sapien XT group was 3.5%, compared to 5.1% in the other group (a difference, but not a statistically significant one)
Dr. Leon described the Sapien XT’s 30-day mortality as “about the lowest I have ever seen in TAVR and it happens to be in the sickest of the sick patients, so even though it’s not statistically significant, directionally it’s encouraging.”



the FDA (Food and Drug Administration) approved the Sapien valve for patients who are unable to undergo traditional open-heart surgery

  • Leaky (aortic insufficiency/regurgitation)
  • Partially blocked (aortic stenosis)
  • Open-heart surgery
  • Minimally invasive cardiac surgery
  • Transcatheter aortic valve replacement (TAVR)
Diagram of the human heart (cropped)
Opened heart seen from the front. The aortic valve separates the left ventricle from the aorta

Transcatheter Aortic Valve Replacement (TAVR)Percutaneous Aortic Valve Replacement (PAVR)Transcatheter Aortic Valve Implantation (TAVI)
  • via the upper leg (transfemoral)
  • via the wall of the heart (transapical)
  • coming in beneath the collar bone (subclavian)
  • through a minimally invasive incision into the aorta (direct aortic)