Luis F. Bonilla

Minimizing aortic manipulation during OPCAB using the symmetry aortic connector system for proximal vein graft anastomoses.

BACKGROUND Since minimal invasive techniques have become increasingly common in coronary artery bypass grafting (CABG), there has been renewed interest in facilitated mechanical anastomoses devices that might have the potential of replacing the standard suturing techniques in vascular anastomoses. We report our initial experience with the successful creation of mechanical proximal vein graft anastomoses in off-pump coronary artery bypass operations. METHODS From August to December 2000, we investigated the first 20 consecutive patients who underwent CABG on the beating heart without extracorporeal circulation and who received at least one mechanical proximal vein graft anastomosis with the St. Jude Medical Symmetry aortic connector system without side-clamping of the aorta. We evaluated the different components of the system, the feasibility of such anastomoses, and the intraoperative flow measurements of the grafts using transit time methods. RESULTS A total of 32 proximal vein graft anastomoses were performed with the aortic connector system. Hemostasis was instantaneous in all cases except one, in which the connector was removed and the anastomosis was hand-sewn without complications. All other vein grafts were patent at the end of the procedure; intraoperative flow measurements were 39 +/- 25 mL/min for single vein grafts (n = 20) and 69 +/- 25 mL/min for sequential grafts (n = 11). CONCLUSIONS The St. Jude Medical Symmetry aortic connector system is a user-friendly, effective, quick, and reliable device for sutureless proximal vein graft anastomosis in CABG. This system allows the construction of uniform and geometrically perfect anastomoses and does not require aortic side-biting. This technology is attractive for all CABG procedures because aortic manipulation is reduced. In off-pump surgical procedures the connector system allows aortic manipulation to be minimized, potentially reducing embolization from aortic wall debris.

Sutureless mechanical anastomosis of a saphenous vein graft to a coronary artery with a new connector device

Construction of vascular anastomoses by manual suturing is a highly skilled and time-consuming procedure. The St Jude Medical Anastomotic Technology Group has developed a sutureless mechanical anastomosis device, which, when tested in animals, produced anastomoses in less than 3 min and with little training. Here we present the results of the first clinical saphenous-vein to coronary-artery anastomosis by means of this device.

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.

Prospective Evaluation of the St. Jude Medical Aortic Connector for Aortic-to-Autologous Vessel Graft Anastomoses.

Background Evolving technologies of proximal anastomosis devices meet the endeavor of surgeons to minimize manipulation of the ascending aorta during surgical myocardial revascularization. The objective of this study was to compare the patency rate of the saphenous vein coronary bypass grafts in which the proximal anastomoses were performed with automatic connector devices to the suture technique. Methods From September 2002 through July 2003, 86 patients underwent coronary artery bypass grafting with at least 1 vein graft anastomosed to the ascending aorta with the Symmetry G2 connector. Six-month clinical and angiographic follow-up, including Core-Lab quantitative coronary angiography (QCA) and corrected TIMI frame count (CTFC), was performed. Results Eighty patients had at least 1 connector successfully implanted. Freedom from MACE (cardiac mortality myocardial infarction and target vessel reintervention) was 72/80 (90%). Six patients underwent a target vessel reintervention on the connector grafts. Six-month (mean 193 ± 36 days) angiography patency rates for the connector grafts were 72/81 (88.89%), 37/40 (92.5%) in sutured grafts, and 60/62 (96.8%) in arterial grafts. By QCA, 64/65 (98.5%) patent connector-grafts were free from more than 50% stenosis (1 connector-graft with a 51% stenosis). CTFC showed 65/65 (100%) patent connector-grafts with nonrestrictive flow. Conclusions Saphenous vein grafts anastomosed to the aorta with the Symmetry G2 connector have early and midterm patency rates comparable to the conventional sutured anastomoses. These results support the efficiency of the second generation of symmetry aortic connectors.