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

Diegeler, Anno; Šetina, Marek; Antona, Carlo; Lakew, Fitsum; Mokráček, Aleš; Scrofani, Roberto; Eckstein, Friedrich S.; Gibson, Michael; Bonilla, Luis F.; Carrel, Thierry

doi:10.1097/01.imi.0000190492.41439.8c

Cited by 3 publications

(2 citation statements)

References 13 publications

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“…8 Diegeler and associates reported a prospective evaluation of St. Jude Medical's second-generation aortic connector (Symmetry G2) and found early and midterm patency rates comparable to conventional sutured anastomoses at 6 month follow-up angiography. 9 At the March 18 th 2004 meeting of the FDA's Circulatory System Devices Panel, a total of 213 adverse event reports related to the Symmetry aortic anastomotic device were retrieved from the FDA's Medical Device Reporting System (MDR) database. There were 23 reports of death, 185 reports of injury, and 5 reports of malfunction.…”

Section: Discussionmentioning

confidence: 99%

Patency Outcomes of Aortic Connectors

Zenati

Sonel

Hattler

et al. 2006

Innovations�(Phila)

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Objective Controlled outcome analysis of mechanical aortic connectors for proximal saphenous vein bypass graft anastomosis is lacking. We report the clinical and angiographic outcome of patients receiving the Symmetry aortic connector (St. Jude Medical, Inc St. Paul, MN, US) within a multicenter, prospective, randomized study. Methods Twenty-five patients at 3 study sites received aortic connectors at the time of coronary artery bypass surgery. Protocol-defined angiographic follow-up was completed in 19 of 25 patients (76%) at time-points up to 14 months postoperatively; 32 connector anastomoses were evaluated in these 19 patients. Beating heart surgery was performed in 17 patients, and 2 were performed with cardiopulmonary bypass. Age was 69.7 ± 8.1 year; all patients were males. Results The connector anastomosis patency rate was 15.6% (5/32). There were no deaths during the follow-up period. Four patients (21%) suffered myocardial infarction and 2 additional patients (10.5%) required percutaneous coronary interventions; one of who required 3 percutaneous coronary interventions, the other received one percutaneous coronary intervention. Conclusions In this nonrandomized cohort of patients, occlusion rate with Symmetry connectors was significantly greater than anticipated. Patients who have received these connectors during coronary artery bypass surgery may require closer follow-up and evaluation. While the manufacturer has stopped producing this device, there has been no recall of the product, clinical support remains ongoing, and next generation connectors have now been marketed. Consideration should be given to discontinuation of the clinical use of Symmetry connectors.

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Section: Discussionmentioning

confidence: 99%

Patency Outcomes of Aortic Connectors

Zenati

Sonel

Hattler

et al. 2006

Innovations�(Phila)

View full text Add to dashboard Cite

show abstract

“…Although clinical practice inclined to reject the use of these devices, other studies reported a positive experience with advanced devices; Diegeler et al compared the patency rate of the saphenous vein coronary bypass grafts in which the proximal anastomoses were performed with second-generation automatic connector devices to the suture technique 7. This was examined in 86 patients who underwent CABG with at least one vein graft anastomosed to the ascending aorta with the Symmetry G2 connector.…”

Section: Proximal Anastomosis Devicementioning

confidence: 99%