Paul J. Hindrichs

An experimental model of saphenous vein-to-coronary artery anastomosis with the St. Jude Medical stainless steel connector.

BACKGROUND A new stainless steel anastomosis device developed by St. Jude Medical Cardiovascular Group was studied in a canine model. METHODS In 12 dogs, coronary saphenous vein grafts were made to the left anterior descending coronary artery and to the circumflex coronary artery; one anastomosis was completed with the St. Jude Medical stainless steel connector device, and the other with conventional suturing. A 30-day coronary angiogram was performed in surviving animals, and, after sacrifice, anastomoses were measured, examined grossly, and submitted for histologic study. RESULTS All 12 animals survived the procedure, and 9 survived to sacrifice at 30 days. Comparing the connector grafts and sutured grafts, no significant differences were found between vessel diameters, intraoperative graft flows, graft patency, and histology. The average loading time for the connector was 8.5 minutes (range 4 to 16 minutes). Mean time for the 12 connector anastomoses was 3 minutes (range 2 to 5 minutes) compared with 8.4 minutes for suture (range 4 to 13 minutes). CONCLUSIONS The side-to-side stainless steel connector anastomotic device produces a secure anastomosis with minimal variability; compared with suture methods, it is expeditious and has comparable 30-day histology and angiographic results. It promises to be an important addition to the surgical armamentarium for the treatment of coronary artery disease.

Two generations of the St. Jude Medical ATG coronary connector systems for coronary artery anastomoses in coronary artery bypass grafting

BACKGROUND In the past, coronary anastomoses have been performed using running and, occasionally, interrupted non-resorbable sutures. Recently, special interest has developed in mechanical anastomotic devices to facilitate minimal invasive techniques or limited access surgery. The experience with two series of patients undergoing coronary artery bypass grafting (CABG) using the St. Jude Medical ATG coronary connector systems (investigational stainless steel device, not yet commercially available) for vein-to-coronary artery anastomoses is reported here. METHODS Between November 2000 and April 2002, we evaluated two generations of distal coronary connector systems in 19 patients who were scheduled for multivessel CABG. One vein graft-to-coronary artery anastomosis per patient was performed with a stainless steel mechanical connector, in an ongoing investigational study. Although these two generations of the St. Jude Medical ATG coronary connectors have the same underlying construction, somewhat cumbersome loading of the first-generation system led to simplification of the second-generation system, which is currently evaluated. RESULTS With the first generation of distal connector, hemostasis was instantaneous in all cases, and all anastomoses were patent at the end of the procedure. However, retrograde flow to the native coronary artery was restricted in 1 patient. The connector was removed, and the anastomosis was performed with a running suture at the same site. Three-month angiography or magnetic resonance imaging angiography was available in 11 patients with 10 patent connector grafts. With the second-generation connectors one of five had to be removed because of leakage, and the anastomosis could be sutured at the same site. The other four connector anastomoses were patent and hemostatic at the end of the procedure. CONCLUSIONS The St. Jude Medical ATG coronary connector system is an effective device for sutureless vein graft to coronary artery anastomoses in CABG. The second-generation system presents a further development eliminating some drawbacks of the first generation such as cumbersome, time-consuming loading as well as suitability for smaller coronary arteries. These connectors allow construction of geometrically round anastomoses and theoretically may also be suitable for sequential anastomoses. After tremendous research and development efforts, an optimized mechanical connection system for small vessel anastomoses has been introduced into clinical investigation. This represents a major step in the era of sutureless vascular connections in cardiac surgery.