The CoreValve ADVANCE II Trial is a research study of the best practices to implement this device. Those practices included a careful assessment using scan to choose the right valve size, control the depth of the implant to 6 mm or less in relation to the valve annulus and adherence to international standards for pacemaker implantation. The primary end point was the need to implant a permanent pacemaker at one month.
This work showed that implantation of the CoreValve accomplished according to the best recommendations result in a low rate of complications and with a need for permanent pacemaker of 13.3% without episodes of complete AV block or late sudden death. 42% of left bundle branch block and first-degree, resolved spontaneously within 30 days. The need for pacemaker was significantly associated with low implantation of the prosthesis. At six months, all-cause mortality was 9.2%, Stroke 2.6% and need for permanent pacemaker 25.7%.
Conclusion
This study showed low rates of mortality, stroke and need for pacemaker when the CoreValve prosthesis is implanted according to recommendations.
Georg Nickenig
2015-05-20
Original title: 6-month performance of a self-expanding valve in a study of best implantation practices – ADVANCE II CoreValve Trial.
