TCT 2016: Sapien valve is durable up to 5 years in patients with severe aortic stenosis

Patients with severe aortic stenosis who underwent transcatheter aortic valve replacement (TAVR) with the Sapien first generation device had positive hemodynamics up to five years following implant, according to an analysis of a randomized trial.

Lead researcher Pamela S. Douglas, MD, presented the findings Nov. 1 in a late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, D.C.

Edwards Lifesciences, which manufactures the Sapien valves, funded the trial. Douglas received a research grant from Edwards Lifesciences.

For this analysis, the researchers evaluated 2,404 patients from the PARTNER 1A and 1B trials who underwent successful TAVRs with the Sapien valve and had serial post-implant echocardiography data. The FDA approved the first generation Sapien valve in November 2011 for treating inoperable patients. In October 2012, the FDA approved the valve for high-risk aortic stenosis patients.

The mean age was 84.5 years old, and 48 percent of patients were females. In addition, 95 percent of patients had New York Heart Association class 3 or 4 heart failure and 92 percent had obstructive coronary artery disease.

During the follow-up period, the researchers assessed 10,560 echocardiograms and hemodynamics at seven days, 30 days, six months, one year, two years, three years, four years and five years post-implant. Based on a nonlinear, mixed effects model, they found that there were early favorable changes immediately after TAVR and mid-term stability up to five years.

Douglas said during a news conference that death or reintervention was associated with lower mean aortic valve gradient, ejection fraction and stroke volume index up to three years and had no relationship to dimensionless valve index. At five years, 39 percent of patients survived without reintervention.

“The five-year data from the largest, core-lab based study of TAVR to date showed stable [aortic valve] mean gradients over the mid-term, with no suggestion of late structural deterioration,” Douglas said in a news release. “Similarly, severely abnormal hemodynamics in individual patients which might be suggestive of valve thrombosis or stenosis were rare. Together, the results suggest that the low five-year survival observed in this cohort is not due to adverse hemodynamics.”