Multicenter Assessment of Grafts in Coronaries

Abstract

Objective

The commercially available C-Port distal anastomotic device (Food and Drug Administration cleared in 2007) is an automated miniature vascular stapler that performs the coronary anastomosis. This prospective multicenter registry sought to evaluate midterm patency using this device compared with hand-sewn grafts.

Methods

Patients receiving at least one C-Port anastomosis during coronary artery bypass grafting surgery were enrolled at eight sites. Of the 117 patients enrolled, 78 patients (67%) with 104 C-Port vein grafts completed the study to patency assessment via computed tomography angiography. Clinical follow-up and index graft patency (Gated 64-slice computed tomography scan) were performed at least 12 months postoperatively. The primary efficacy endpoint was patency compared with the peer-reviewed results from the PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) trial.

Results

The patient population was consistent with the PREVENT IV placebo cohort. The mortality at 12 months was 0.85% (1/117). The major cardiac morbidity rate was 3.4% (4/117). The C-Port vein graft occlusion rate was 16.3% (17/104) compared with 26.6% (597/2242) in the PREVENT IV trial (P = 0.011). Within this study, C-Port graft occlusion rates were not significantly different from the hand-sewn grafts (P = 0.821).

Conclusions

The C-Port device is safe and effective in creating the distal anastomosis with equivalent patency rates to hand-sewn grafts at 12 months. When compared with hand-sewn anastomoses from a recent large prospective trial, the C-Port device demonstrated a statistically significant reduction in midterm graft occlusion. Further studies are required to evaluate its effect in less invasive coronary surgery.