Abstract and Introduction
Abstract
The everolimus-eluting XIENCE side-branch access (SBA) stent has been the focus of numerous recent publications. Most of the information available on this device comes from the preclinical studies performed in ovine models as well as perfused synthetic heart models. It has now become available in Europe as part of a limited test launch.
Delivered via a low-profile, dual-lumen, single-tip catheter, a single inflation device deploys the stent in the main branch and expands a portal opening into the ostium of the side branch to allow for scaffolding and entry into the side branch. This case report describes the first-in-man experience with this novel device.
Introduction
The everolimus-eluting XIENCE side-branch access stent (XIENCE SBA; Abbott Vascular) has been the focus of numerous preclinical studies. Delivered via a low-profile, dual-lumen, single-tip catheter, a single inflation device deploys the stent in the main branch (MB) and expands a portal into the ostium of the side branch (SB).
The earliest studies were carried out in bench-top perfused synthetic heart models. The encouraging results in synthetic heart model studies prompted evaluation of the XIENCE SBA stent in large-animal, ovine, beating heart models. There have been several recent published reports summarizing these preclinical data. Using widely available workhorse stents as a comparison device, implantation of XIENCE SBA in experimental coronary vessels with complex, branching geometry has been associated with a relative reduction is contrast usage, shorter fluoroscopy times, and fewer episodes of guidewire entanglement, more commonly referred to as 'wire-wrap.' Total procedure time with the XIENCE SBA stent was either comparable to or shorter than with the standard stent. Novel imaging modalities, such as high-intensity 2-dimensional Faxitron radiographic imaging, have shown that the XIENCE SBA favorably conforms to the vessel carina and provides adequate SB access in these experimental models.
Following recent CE marking, the XIENCE SBA is now available in selected European centers as part of a "first-in-man" experience. While this represents a limited device launch in Europe at selected centers, initial human experience includes the XIENCE SBA used in a number of different bifurcation treatment strategies; provisional SB stenting and upfront 2-stent techniques (for more complex parent and daughter vessel disease) are two of the more common clinical scenarios for which this device has been implanted. In addition, a number of operators have used this device simply as a means of "SB preservation" in Medina class 1,1,0 and 0,1,0 coronary anatomy. As such, this confers operator versatility, allowing for modification of the treatment algorithm as needed. The aim of this first-in-man limited European program is to build a database of practical, clinically meaningful device experience. In this article, we report the results of several recently completed cases in which the XIENCE SBA was used in a variety of anatomic subsets.