CoreValve System (Medtronic) success in Continued Access Study

The CoreValve Continued Access study results of the Core Valve System, were presented at a late-breaking clinical trial session of the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference. The CoreValve System, met its primary endpoint in patients who were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery, with a rate of death or major stroke at one year of 25.5 percent. This result is highly significant (p<0.0001) as it was 40.7 percent lower in patients treated with the corevalve system than was expected with standard therapy a pre-specified performance goal of 43.0 percent.>

The rate of stroke - one of the complications most concerning to physicians and patients because it increases mortality and affects quality of life - is among the lowest reported. At one month, the major stroke rate was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. In addition, in more than 800 extreme risk patients enrolled in the CoreValve Continued Access Study, CoreValve patients experienced an even lower rate of major stroke (1.8 percent at one month). The study also found significant and sustained functional and quality-of-life improvements, with the heart failure symptoms of most patients (90.0 percent) improving at least one class at one year (as measured by NYHA Class), and quality-of-life scores improving 27.4 points at one year (as measured by the KCCQ 100-point scale, in which a 20-point change is considered highly significant). Major vascular complication rates were low: 8.3 percent at one month and 8.5 percent at one year. Consistent with previous studies on self-expanding technology, the permanent pacemaker rate was 22.2 percent at one month and, importantly, pacemaker implants were not associated with mortality for these patients.

In the recent past, these patients had no good treatment option and a 50 percent chance of death at one year.