New transcatheter aortic valve implantation system found promising
AT THE STS ANNUAL MEETING
In terms of valve performance, all patients had a reduction from baseline in mean aortic gradient at 30 days, which was sustained at 6 months. The proportion of patients having a NYHA class of I or II was just 12% at baseline, but it rose to 78% at 30 days and 82% at 6 months.
Actuarial analyses showed that the 30-day rate of all-cause mortality was 9.9% and the 6-month rate was 16.9%. "This is well in the range of other transapical devices that we have seen before in studies," Dr. Holzhey commented. The respective rates of stroke were 1.8% and 5.5%.
The 30-day rate of new pacemaker receipt was 30.2% and the 6-month rate was 32.4%. Corresponding rates of paravalvular leak were 24% and 13%; all cases were trace or mild.
Dr. Holzhey disclosed no relevant conflicts. Medtronic sponsored the trial and performed data analysis.
