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International Society For Minimally Invasive Cardiothoracic Surgery

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A Novel Versatile, Easy-to-use Coronary Bypass Connector Designed For Reliable Anastomoses Under Limited Access Conditions
Monica Gianoli1, Paul T.W. Suyker2, Matthijs Wassink1, Jeroen van den Berg1, Froukje E. Euwe1, Jesse M. Bosma1, Leonard J. Schelven1, Paul F. Gründeman1, Willem J.L. Suyker1.
1UMCU, Utrecht, Netherlands, 2iiTech BV, Amsterdam, Netherlands.

BACKGROUND: Routine coronary artery bypass grafting (CABG) is still largely performed through a full sternotomy, burdening patients with major surgical trauma and a prolonged recovery period. The challenge of reliable anastomosis construction through limited surgical access remains the main obstacle to move towards minimally invasive approaches. An automated coronary bypass connector could overcome this impediment but has proven to be difficult to realize. In order to meet this long-standing challenge, our team set out to develop a promising coronary bypass connector suitable for beating-heart endoscopic CABG. METHODS: We reviewed published coronary connector studies along three major usability criteria: patency, device versatility (suitable vessel diameter and wall quality range) and ease-of-use (device deployment). Outcomes were related to device characteristics where three major failures modes were identified. Early thrombosis, geometrical flaws like graft kinking and stenotic intimal hyperplasia. The most likely causes were respectively: a large blood exposed non-intimal surface (BENIS), unfavorable graft angle geometry inherent to connector designs, and tissue trauma. The insights gained by this analysis combined with our S2 connector expertise were included in the design criteria for our new connector. Once realized, the device was tested for the major usability criteria in laboratory using porcine and human ex vivo tissue. RESULTS: Based on our previously developed and animal validated S2 micro-stapling technology, we devised a novel coronary bypass connector having a very small BENIS and inflicting only minimal tissue trauma. Versatility was optimized by adopting a side-to-side anastomosis configuration, allowing jump grafts, Y-grafts as well as end-to-side geometry conversion, also under limited access conditions. Finetuned staple parameters allowed the use of both internal mammary as well as saphenous vein conduits. Ease-of-use was maximized by a stepwise, fully visually checkable deployment procedure. Laboratory tests showed excellent device efficacy in terms of consistently creating precise and widely patent anastomoses and freedom of leakage against high burst pressures in both porcine and human tissue. CONCLUSIONS: By fulfilling key usability criteria concerning anastomosis geometry, device versatility and ease-of-use in ex vivo experiments, our novel anastomotic connector holds promise for enabling reliable minimally invasive endoscopic CABG.

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