Six-Month Angiographic Evaluation of Beating-Heart Coronary Arterial Graft Interrupted Anastomoses Using the Coalescent U-CLIP Anastomotic Device: A Prospective Clinical Study

(#2002-77117 ... September 23, 2002)

Michael P. Caskey, MD,¹ Merick S. Kirshner, MD,¹ Edwin L. Alderman, MD,² Sonna Lea Hunsley, RN, BS,¹ Michael A. Daniel, MS, MBA³

¹St. Joseph's Hospital, Phoenix, Arizona;
²Stanford University Medical Center, Palo Alto, California;
³Daniel and Daniel Consulting, Orinda, California, USA

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ABSTRACT

Background: Interrupted suture technique avoids the "purse string" and puckering effects frequently seen with continuous suture techniques and should represent the standard of care in the creation of high-quality vascular anastomoses. This clinical study evaluated the safety and effectiveness of a self-closing surgical clip (Coalescent Surgical U-CLIP Anastomotic Device [U-CLIP]) designed to facilitate this interrupted technique. Left internal mammary artery (LIMA) to left anterior descending (LAD) coronary bypass grafting was studied.

Methods: Eighteen patients meeting inclusion criteria were enrolled (October 2000 through September 2001) into this prospective study. Anastomoses were performed using a beating-heart median sternotomy procedure (off-pump coronary artery bypass) in 17 cases (94%) and a minimally invasive beating-heart procedure (minimally invasive direct coronary artery bypass [MIDCAB]) in one case (6%). Sixmonth follow-up was completed on 18 patients (100%), with angiograms performed on 17 patients (94%) at a mean of 179 days (range, 168-191 days). Qualitative and quantitative angiographic assessment was performed by an independent core laboratory.

Results: The U-CLIP was used for 18 LIMA-to-LAD interrupted anastomoses without the requirement for knot tying or suture management and with no device-related morbidity or mortality. Mean LIMA-to-LAD anastomosis time was 8.6 minutes (range, 5-14 minutes). All anastomoses were FitzGibbon grade A at 6 months postprocedure. Quantitative analysis showed mean luminal diameters proximal to the anastomosis of 2.32 mm, at the anastomosis of 2.25 mm, and immediately distal to anastomosis of 1.99 mm. The average ratio of anastomosis to LAD diameter was 1.17 (range, 0.93- 1.93). Anastomotic stenosis as a percentage of average LIMA/LAD diameter was a negative 4.2%, comparing favorably with the 23% to 24% reported in the POEM (Patency, Outcomes, Economics of MIDCAB) study. Conclusions: The interrupted technique, facilitated by a self-closing anastomotic clip, yielded 6-month follow-up and angiographic results that compared favorably with results of other published studies.

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