Prospective Evaluation of the St. Jude Medical Aortic Connector for Aortic-to-Autologous Vessel Graft Anastomoses.
ABSTRACT : 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.
: 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.
: 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.
: 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.
- SourceAvailable from: Paolo Vanelli[show abstract] [hide abstract]
ABSTRACT: Until now technologic evolution in coronary bypass surgery has focused on extracorporeal circulation, on operation without extracorporeal circulation, and on the exposure of the operative site. Recently a one-shot anastomotic device for the proximal anastomosis in coronary surgery was developed. We investigated whether the use of the aortic connector system (ACS) could facilitate the creation of aortosaphenous vein graft anastomoses in myocardial revascularization. From November 2000, 40 ACS devices were used in 36 consecutive patients (mean age 70.7 +/- 8.9 years); 12 patients (33.3%) underwent surgery on pump and 24 patients (66.6%) off pump; 50 distal anastomoses were performed. In all cases the connection with the ascending aorta was created before the distal anastomoses because of the necessity to slide the saphenous vein graft (SVG) over the vein transfer sheath. Intraoperative graft function was tested measuring blood flow by Doppler analysis. Postoperative evaluation of the anastomotic patency was carried out by early angiography in 34 patients (94.7%) but was excluded in 5 patients (5.3%) with extensive extracardiac vascular occlusive disease. Of 38 AC (95%) evaluated, 36 (94.7%) functioned properly. The end-to-side proximal anastomosis without aortic clamping is instantaneous, the quality of anastomoses was highly rated, no additional stitches were required, and all coronary arteries could be reached. Intraoperative quantity flow was measured by Doppler analysis and all but one showed good flow. Early postoperative angiography demonstrated good patency of the grafts in all cases but 2 (5.3%). At 1-year follow-up, 1 patient died of stroke; all other patients remained free of symptoms and no reoperation was required. The use of ACS makes end-to-side anastomosis rapid, effective, and reproducible while eliminating aortic cross clamping; it opens a new era in beating or nonbeating coronary surgery. Long-term results are mandatory to confirm our favorable preliminary results.The Annals of Thoracic Surgery 01/2003; 74(6):2101-5. · 3.45 Impact Factor
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ABSTRACT: Although 30 day risk-adjusted operative mortality (ROM) has been used for quality assessment, it is not sufficient to describe the outcomes after coronary artery bypass grafting (CABG) surgery. Risk-adjusted major morbidity may differentially impact quality of care (as complications occur more frequently than death) and enhance a surgical team's ability to assess their quality. This study identified the preoperative risk factors associated with several complications and a composite outcome (the presence of any major morbidity or 30-day operative mortality or both). For CABG procedures, the 1997 to 1999 Society of Thoracic Surgeons (STS) National Adult Cardiac Surgery Database was used to develop ROM and risk-adjusted morbidity (ROMB) models. Risk factors were selected using standard STS univariate screening and multivariate logistic regression approaches. Risk model performance was assessed. Across STS participating sites, the association of observed-to-expected (O/E) ratios for ROM and ROMB was evaluated. The 30-day operative death and major complication rates for STS CABG procedures were 3.05% and 13.40%, respectively (503,478 CABG procedures), including stroke (1.63%), renal failure (3.53%), reoperation (5.17%), prolonged ventilation (5.96%), and sternal infection (0.63%). Risk models were developed (c-indexes for stroke [0.72], renal failure [0.76], reoperation [0.64], prolonged ventilation [0.75], sternal infection [0.66], and the composite endpoint [0.71]). Only a slight correlation was found, however, between ROMB and ROM indicators. Used in combination, ROMB and ROM may provide the surgical team with additional information to evaluate the quality of their care as well as valuable insights to allow them to focus on areas for improvement.The Annals of Thoracic Surgery 07/2003; 75(6):1856-64; discussion 1864-5. · 3.45 Impact Factor
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ABSTRACT: The Symmetry Bypass System Aortic Connector (St Jude Medical, Inc) is a novel device for the construction of sutureless proximal anastomoses. The connector allows attachment of saphenous vein grafts to the aorta without requiring aortic clamping. We report our initial clinical experience with this device. In a 2-month period from May to July 2001, a total of 139 consecutive proximal anastomoses were performed in 67 patients using the connector. All procedures were performed on a beating heart without cardiopulmonary bypass or any aortic clamping. Intraoperative variables and postoperative results were prospectively collected and retrospectively analyzed. Of 139 consecutive proximal anastomoses 138 (99.3%) were successfully completed with the device. One anastomosis required suture revision because of misdeployment. Six anastomoses (4.3%) required an additional suture for leak. Predeployment problems included connector loading/preparation malfunction in 10 grafts (7.2%), five because of human error and five technical failure. There was no operative mortality, perioperative myocardial infarction, or stroke. Vessels bypassed included the circumflex system (n = 59), right coronary artery and branches (n = 48), diagonal branch (n = 26), and left anterior descending coronary artery (n = 6). At a mean follow-up of 7 months, survival was 94.1% and survival free of major adverse cardiac and cerebrovascular events (MACCE) was 88.1%. Initial clinical experience with a sutureless proximal saphenous vein graft to aorta anastomosis performed with a mechanical connector demonstrates safety, reliability, and ease of use. Surmounting a brief learning curve improves the subtleties of device loading and deployment. Further benefits will be determined in an ongoing randomized study.The Annals of Thoracic Surgery 07/2003; 75(6):1866-70; discussion 1870-1. · 3.45 Impact Factor