Clinical Evaluation of the eSVS Mesh

Abstract

In coronary artery bypass graft surgery, saphenous vein graft (SVG) patency is much lower than that of the internal mammary artery (IMA). To address this problem, an external support device, the eSVS Mesh was developed. A prospective randomized First-in-Man feasibility trial was conducted in 90 patients after institutional ethics committee approval at seven international centers. The left IMA was used to bypass the anterior descending artery. A mesh-supported (treated) saphenous vein was randomized to either the right or the circumflex coronary system, and an unsupported (control) vein was grafted to the opposing territory. Device diameters available for use were 3.0, 3.5, 4.0, and 4.5 mm. Primary end-points were 30 day adverse cardiac and cerebral events and angiographic patency at 9-12 months. Eighty-five of 90 patients returned for 30 day clinical follow-up (94%). Five patients refused to return, but by telephone contacts were asymptomatic. There was one late noncardiac death and 73 patients returned for angiography (82%), thus 12 additional patients were lost to follow-up at 1 year. Overall patency rate was 49% for the treated versus 81% for controls (p < 0.001). Subset analysis revealed significantly lower patency at one center and with use of the 3.0 mm device (p < 0.05). Removing these data, patency was 72% vs. 81% (p = NS). Sternal wound infection was higher than expected at 5.0%, but this was center specific. The eSVS Mesh is safe, but at up to 1 year, patency is equivalent to untreated vein grafts after removal of outlying data. This study provides insight into operative events and parameters that may optimize outcomes and point to potential improvements in the external SVG support device. Furthermore, longer term studies are pending.

Perivascular medical devices and drug delivery systems: Making the right choices

“…A non-constrictive Dacron ® sheath reinforced with PTFE ribs failed to improve patency due to frequent thrombosis, likely because of stent rigidity or oversizing, resulting in kinking [45]. To date, the most successful effort for improving vein graft patency is eSVS ® (Kips Bay Medical Inc.), consisting of a flexible kink-resistant nitinol mesh that received marketing authorization for patients undergoing coronary artery bypass grafting, which was consistently reported as safe [46]. However, enthusiasm was moderated as the outcomes of studies on graft patency following coronary bypass were contradictory.…”

“…However, enthusiasm was moderated as the outcomes of studies on graft patency following coronary bypass were contradictory. While some showed a patency up to 100 % [47,48], others demonstrated that the patency rate of mesh-supported grafts ranged from 28 to 49 % after 9-12 months [14,46,49]. It was suggested that trials had confusing confounding variables other than the evaluation of the mesh that could impact results.…”

Biomaterial‐Based Approaches to Address Vein Graft and Hemodialysis Access Failures

“…Although there is some promise with ongoing clinical trials utilizing a braided Phynox mesh (Fluent, Vascular Graft Solutions) to support vein grafts in CABG and a Nitinol mesh to support fistulas for hemodialysis patients (VasQ, Laminate Medical), a recent clinical trial reinforcing vein grafts in CABG with a Nitinol mesh (eSVS Mesh, Kips Bay Medical) was terminated due to lower patency rates. It is possible that this also may have been due in part to tissue buckling or kinking …”

Mid- and Long-Term Outcomes of Total Arterial Myocardial Revascularization in Patients Aged 70 Years and Older: A Single-Center Experience

“…[2][3][4] The long-term efficacy of arterial revascularization especially of the left internal thoracic artery (LITA) on the left anterior descending (LAD) has been proven in many stu-dies. 5,6 Although the harvesting of venous graft material was felt to be easier and several items were developed to improve the quality of the veins, 7 venous grafts often show occlusion rates of 5 to 10% per year. 8 Therefore, long-term durability is often comparably bad.…”