New Technology to Simplify Coronary Artery Anastomosis through Small Thoracotomy Access
Eric Ndikumana1, Kyle Purrman2, Hossein Amirjamshidi1, Jude Sauer2, Peter Knight1
1Cardiac Surgery, University of Rochester Medical Center, Rochester, New York, United States, 2LSI Solutions, Victor, New York, United States
Objective Avoiding sternotomy and rib transection during coronary artery bypass surgery is a potentially beneficial approach to cardiac revascularization that remains underutilized due in part to its technical complexity; purpose-built technology and simplified techniques may reduce this barrier to adoption. Recent progress toward developing a novel technologic platform to enable smooth, gentle, and reliable coronary anastomoses through tiny thoracotomies merits further clinical evaluation.
Methods To simplify the construction of running end-to-side or side-to-side coronary anastomoses, a novel custom adjustable pedestal includes a soft plastic member, which atraumatically holds an appropriately positioned internal thoracic artery (ITA) within a small thoracotomy. The pedestal also includes a latch feature to temporarily integrate the anastomotic sutures as stay sutures. Thoracotomy size and location, plus bypass suturing method, are determined by the surgeonís preference. To obviate traditional hand-tying of 6-0, 7-0, or 8-0 polypropylene suture through a remote access site, a titanium fastener deployment device with a 3 mm shaft was developed and recently received FDA 510(k) clearance for clinical use in the United States. After anastomotic suturing is completed, the suture tails are placed through a wire snare at the patient end of the device shaft and pulled through a titanium fastener preloaded in the device shaft. The device tip is slid to the closure site. A single squeeze of its lever crimps the titanium fastener and trims suture tails. Cadaver and ex vivo and in vivo porcine models were used to evaluate the feasibility of this technology.
Results This technology was used to successfully perform coronary artery bypass on more than 50 explanted pig hearts and in situ porcine carcass models. Of the past 50 anastomoses, 48 (96%) demonstrated patency and no leaks. In vivo porcine wound closures secured with titanium fasteners demonstrated excellent results. Seven titanium fasteners have also been successfully placed in two patients undergoing open coronary artery bypass surgery.
Conclusions Patients with ischemic heart disease will benefit from safe and reliable bone-sparing techniques for surgical coronary revascularization. The evaluated technology and techniques offer potentially simplified, less traumatic revascularization options. Initial preclinical and clinical results encourage further exploration.
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