There is little information about the use of bioresorbable vascular devices in patients with a reference diameter ≥4mm, long, bifurcation, calcified or unstable lesions. The BVS-Expand registry is a single-center study that evaluates the safety and efficacy of this device in past populations (real world).The primary endpoint was the occurrence of MACE (cardiac death, myocardial infarction, emergency surgery, or target lesion revascularization) at 12-months follow-up.
Between September 2012 and April 2013, 174 patients were treated with this device, of which 132 had lesions that are considered complex and outside the protocols for the use of the platform. 30% of patients had multi-vessel disease, 25% had bifurcated lesions, 8% had total occlusions, and 35% had an overlap of the device (mean lesion length: 20.3mm). The success rate of the device implantation was 96%, with a low occurrence of MACE (1%).
Conclusion: This is the first study to demonstrate the safety and efficacy of the implantation of bioresorbable platforms in patients with complex lesions. In the 30-day follow-up, there was only one reported event. Due to the navigability of the device and the type of lesion, we need a longer period for the procedure, the use of guides with better support and a good pre-dilatation.
Robert-Jan van Geuns, MD.
2013-05-22
Original title: Bioresorbable vascular scaffold EXPAND: first results of wide clinicalapplications
