Husam H Balkhy, Nirav C Patel1, Mahesh Ramshandani2, Hiroto Kitahara, Valavunar A Subramanian1, Nicholas V Augelli3, Gareth Tobler4, Tung H Cai5. 1. Department of Cardiac Surgery, Lenox Hill Hospital, New York, NY USA. 2. Department of Cardiothoracic Surgery, Houston Methodist Hospital, Houston, TX USA. 3. Department of Cardiac Surgery, ThedaCare Regional Medical Center, Appleton, WI USA. 4. Department of Cardiothoracic Surgery, John L. McClellan Veterans Administration Medical Center, Little Rock, AR USA. 5. Department of Cardiothoracic Surgery, CRSTI Heart Hospital, Plano, TX USA.
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.
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.
Authors: Marieke Hoogewerf; Jeroen Schuurkamp; Johannes C Kelder; Stephan Jacobs; Pieter A Doevendans Journal: J Clin Med Date: 2022-01-29 Impact factor: 4.241
Authors: Karel M Van Praet; Markus Kofler; Timo Z Nazari Shafti; Alaa Abd El Al; Antonia van Kampen; Andrea Amabile; Gianluca Torregrossa; Jörg Kempfert; Volkmar Falk; Husam H Balkhy; Stephan Jacobs Journal: Interv Cardiol Date: 2021-05-19