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DOI: 10.1055/s-2005-862141
VSTENT™ – A new alternative for common coronary arterial revascularizing techniques
Objectives: The VSTENT™ Myocardial Implant has been proposed as an alternative means of achieving coronary revascularization connecting the left ventricle directly to the coronary artery. Preclinical acute and chronic animal data prove device patency and sufficient blood flow coronary reserve. To date 28 have been implanted world-wide.
Material and Methods: From June 03 until September 03 eight patients (mean age (y): 59.5±7.9; mean EF (%): 58.1±7.4) have been enrolled in the European multicenter study at our institution for adjunct treatment to CABG surgery (Advantage Study). This specially designed stent-like device was surgically implanted between the coronary artery and the left ventricular cavity to create a blood flow conduit distal to an arterial occlusion or high grade stenosis. In five patients the device was implanted in a diagonal (n=2), intermediate (n=2) or obtuse marginal branch (n=1). After implantation, flow and position of the VSTENT™ were controlled using epicardial echo.
Results: All patients recovered well from surgery and were free of symptoms of angina after the operation. In one patient occlusion of the VSTENT™ was demonstrated after three months at coronary angiography follow up. Two stents were showed to be occluded and two stents were stenosed after 6 months. In all patients the target vessel was revascularized with conventional intracoronary stents without complications.
Conclusions: Implantation of the device has been safe, 6 months patency data of the VSTENT™ showed however significant in-stent stenosis and occlusion due to intimal hyperplasia at the vessel junction. Strategies for improvement of long-term patency should incorporate drug eluting stent technology and technical modifications to improve flow conditions.