Initial Experience with the Enclose Proximal Aortic Anastomosis Device during Off-Pump Coronary Artery Bypass: An Alternative to Aortic Side Clamping
Background. The utilization of off-pump coronary artery bypass surgery (OPCAB) has resulted in the development of new technology to facilitate the creation of aorto-coronary graft anastomoses. Proximal aortic devices (PADs) enable the construction of a proximal aortic anastomosis without the use of a side-biting aortic clamp, thus reducing the risk of neurologic injury from particulate embolization.
Methods. One hundred ninety-seven patients underwent OPCAB at our institution between January 2003 and December 2004. Sixty (30.5%) patients had proximal aorto-coronary graft anastomoses constructed with the Novare Enclose PAD. The remaining 137 (69.5%) patients had graft construction with a standard aortic side-clamp technique. We compared the outcomes of these 2 cohorts to evaluate the safety and efficacy of the Novare Enclose PAD.
Results. One hundred seven proximal anastomoses were constructed in the PAD group, and 199 proximal were constructed in the side-clamp group. Three patients (1.5%), all in the side-clamp group, sustained permanent neurologic deficits after OPCAB. There were 2 cases of device malfunctions. There were no anastomotic thromboses, no reoperations for anastomotic hemorrhage, and no patients required anastomotic revision. Of the 197 patients in the series, there were 4 deaths, 2 in each group, resulting in an overall mortality rate of 2%.
Conclusion. The Novare Enclose PAD is a safe device that facilitates suture construction of proximal aorto-coronary graft anastomosis. In a select group of patients, the use of this device may reduce the risk of neurologic injury when compared to the application of an aortic side-biting clamp for coronary bypass surgery.
Akpinar B, Guden M, Sagbas E, Sanisoglu I, Ergenoglu MU, Turkoglu C. 2005. Clinical experience with the Novare Enclose II manual proximal anastomotic device during off-pump coronary artery surgery. Eur J Cardiothorac Surg27:1070-3.nEdwards FH, Ferguson TB. 2004. The Society of Thoracic Surgeons Practice Guidelines. Ann Thorac Surg77:1140-1.nShennib H. 2001. Enter the era of facilitated anastomotic devices for coronary bypass surgery. J Thorac Cardiovase Surg121:833-4.nAranki SF, Shekar PS, Ehsan A, Byrne-Taft M, Couper GS. 2005. Evaluation of the Enclose proximal anastomosis device in coronary artery bypass grafting. Ann Thorac Surg80:1091-5.nBarbut D, Hinton RB, Szatrowski TP, et al. 1994. Cerebral emboli detected during bypass surgery are associated with clamp removal. Stroke25:2398-402.nBarzilai B, Marshall WG Jr, Saffitz JE, Kouchoukos N. 1989. Avoidance of embolic complications by ultrasonic characterization of the ascending aorta. Circulation80:1275-9.nBlauth CI, Cosgrove DM, Webb BW, et al. 1992. Atheroembolism from the ascending aorta. An emerging problem in cardiac surgery. J Thorac Cardiovasc Surg103:1104-11; discussion 1111-2.nCarrel TP, Eckstein FS, Englberger L, Berdat PA, Schmidli J. 2004. Clinical experience with devices for facilitated anastomoses in coronary artery bypass surgery. Ann Thorac Surg77:1110-20.nChavanon O, Carrier M, Cartier R, et al. 2001. Increased incidence of acute ascending aortic dissection with off-pump aortocoronary bypass surgery? Ann Thorac Surg71:117-21.nEckstein FS, Bonilla LF, Englberger L., et al. 2001. Minimizing aortic manipulation during OPCAB using the symmetry aortic connector system for proximal vein graft anastomoses. Ann Thorac Surg72:8995-8.nLahtinen J, Biancari F, Mosorin M, et al. 2004. Fatal complications after use of the Symmetry Aortic Connector in coronary artery bypass surgery. Ann Thorac Surg77:1817-9.nLev-Ran O, Braunstein R, Sharony R, et al. 2005. No-touch aorta off-pump coronary surgery: the effect on stroke. J Thorac Cardiovae Surg129:307-13.n
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