Coronary Anastomotic Device Research Articles

Sutureless versus Hand-Sewn Coronary Anastomoses: A Systematic Review and Meta-Analysis.

Background: Sutureless coronary anastomotic devices are intended to facilitate minimally invasive coronary artery bypass grafting (MICS-CABG) by easing and eventually standardizing the anastomotic technique. Within this systematic review and meta-analysis, we aim to determine patency and to evaluate safety outcomes for the sutureless anastomoses. Methods: CENTRAL, MEDLINE, and EMBASE were searched from database start till August 2021 in a predefined search strategy combining the key concepts: ‘coronary artery bypass grafting’, ‘sutureless coronary anastomoses’, and ‘hand-sewn coronary anastomoses’ by the Boolean operation ‘AND’. Study characteristics, patient demographics, interventional details, and all available outcome data were extracted. A meta-analysis was performed on patency at longest follow-up. Safety outcomes were presented. Results: A total of eleven trials towards six sutureless anastomotic devices were included, comprising 3724 patients (490 sutureless and 3234 hand-sewn). There was no significant difference in patency at a mean follow-up duration of 546.3 (range 1.5–2691) days, with a risk ratio of 0.77 (95% CI 0.55–1.06). MACE was reported in 4.5% sutureless and 3.9% hand-sewn patients, including all-cause mortality (resp. 1.3 vs. 1.9%), myocardial infarction (resp. 1.6 vs. 1.7%), and coronary revascularization (resp. 1.8 vs. 0.5%). Incomplete hemostasis occurred in 24.8% of the sutureless anastomoses. Intra-operative device failure forced conversion to hand-sewn or redo-anastomosis in 5.8% of the sutureless cases. Conclusion: Based on the systematic review and meta-analysis including six devices, we conclude that sutureless coronary anastomotic devices appear safe and effective when used by well-trained and dedicated surgical teams.

A different technique for sutureless coronary bypass grafting.

IntroductionMany coronary anastomotic devices have been designed to replace manual stitching in coronary surgery; however, interestingly, none of them became widespread. Our aim was to work out an easy and fast endoluminal vessel-to-vessel stent bridge distal anastomotic technique.Materials and methodsTen coronary arteries of eight fresh human hearts were used in this study. The anastomosis was performed with the implantation of a graft vessel into the lumen of the coronary artery by performing stent fixation. The technique is described and photo documented in detail. The durability and the conductibility of the anastomosis were examined with intraluminal endoscopy, functional streaming test, and a coloring of the vessels.ResultsThe anastomosis had great results in all cases. Obstruction, dissection, or dislocation of the vessels was not observable.ConclusionsThis study confirmed the ex-vivo feasibility of the described technique. This method can be an easy, fast, and reliable method applied in the endoscopic distal coronary artery anastomosis surgery. The development of stents adapted to this method and the in-vivo testing of this technique are necessary for the future.

The C-Port Distal Coronary Anastomotic Device is Comparable with a Hand-Sewn Anastomosis

The C-Port Distal Coronary Anastomotic Device is Comparable with a Hand-Sewn Anastomosis

Abstract 15504: A New Coronary Anastomotic Connector in a Preclinical Safety Study

Introduction: A facilitated construction of a distal coronary anastomosis is the key towards less invasive coronary bypass surgery, ideally in an endoscopic hybrid approach. This study evaluates a new laser-assisted, zero ischemia coronary anastomotic connector in comparison to the hand-sutured anastomotic technique, in a long-term follow-up porcine off-pump bypass model. The initial results of this preclinical comparative safety study are presented. Hypothesis: We assessed the hypothesis that the coronary connector is not inferior to the hand-sutured technique, in terms of patency, healing, and hemodynamic function. Methods: In 22 pigs (3 months follow-up, n=10; 6 months follow-up, n=12), the so-called Trinity Clip connector facilitated a LITA-to-LAD anastomosis, and in 14 pigs (3 months follow-up, n=6; 6 months follow-up, n=8) the anastomosis was hand-sutured. All anastomoses (n=36) were evaluated intraoperatively by means of graft flow measurements and at follow-up by angiography and histology. Results: After construction, complete hemostasis was obtained in 95% (21/22) of the connector facilitated anastomoses and in 86% (12/14) of the hand-sutured. Both groups had a mean coronary outer diameter of 1.8 ± 0.1 mm. The mean peak hyperemic flow response (peak [following 30-second graft occlusion]/base flow) was 4.1 ± 1.0 in the connector group versus 4.2 ± 1.1 in the hand-sutured group. The patency in both groups was 100% (connector group: at 6 months [n=3/3] and 3 months [n=5/5]; hand-sutured group: at 6 months [n=1/1] and 3 months [n=4/4]). Conclusions: The initial data of this preclinical study demonstrates similar anastomosis success rate in both groups. The connector is easy-to-use and seems to be safe and reliable in the long-term porcine off-pump bypass model. Complete data on the long-term will be expected soon and the resulting histological and angiographic data will further elucidate the future relevance of this new coronary anastomotic device. In conclusion, albeit the preliminary study status, the connector has potential to facilitate minimally invasive or endoscopic CABG.

A procedure to simulate coronary artery bypass graft surgery

In coronary artery bypass graft (CABG) surgery the involved tissues are overstretched, which may lead to intimal hyperplasia and graft failure. We propose a computational methodology for the simulation of traditional CABG surgery, and analyze the effect of two clinically relevant parameters on the artery and graft responses, i.e., incision length and insertion angle for a given graft diameter. The computational structural analyses are based on actual three-dimensional vessel dimensions of a human coronary artery and a human saphenous vein. The analyses consider the structure of the end-to-side anastomosis, the residual stresses and the typical anisotropic and nonlinear vessel behaviors. The coronary artery is modeled as a three-layer thick-walled tube. The finite element method is employed to predict deformation and stress distribution at various stages of CABG surgery. Small variations of the arterial incision have relatively big effects on the size of the arterial opening, which depends solely on the residual stress state. The incision length has a critical influence on the graft shape and the stress in the graft wall. Stresses at the heel region are higher than those at the toe region. The changes in the mechanical environment are severe along all transitions between the venous tissue and the host artery. Particular stress concentrations occur at the incision ends. The proposed computational methodology may be useful in designing a coronary anastomotic device for reducing surgical trauma. It may improve the quantitative knowledge of vessel diseases and serve as a tool for virtual planning of vascular surgery.

Coronary Artery Bypass with the Use of a Magnetic Distal Anastomotic Device: Surgical Technique and Preliminary Experience

At present there is little reported experience in the application of new technology in the performance of distal coronary anastomoses in the clinical setting. The aim of our study was to evaluate the feasibility of using the Ventrica magnetic vascular positioner (MVP) device for left internal thoracic artery (LITA)-to-left anterior descending (LAD) coronary anastomosis. We present our preliminary experience of the first 14 coronary artery cases performed in the United Kingdom from April 2003 to December 2003. The selection criteria, surgical technique, clinical outcome, advantages or disadvantages, and future implications are all discussed. The device was used in 12 patients for LITA-to-LAD anastomosis and in 2 patients for the proximal anastomosis of a radial artery Y-graft from the LITA to the circumflex territories. The first 3 patients underwent coronary artery bypass graft with the use of cardiopulmonary bypass, and the remaining 9 underwent surgery performed using an off-pump coronary artery bypass technique. No mortality or device-related events were observed in these patients. The anastomosis time in our series was 5.6 +/- 1.99 minutes, and the blood loss was 914 +/- 234 mL. The mean length of stay was 5.8 +/- 1.16 days. The MVP system is a novel distal coronary anastomotic device that is quick, simple, and effective, producing consistently reliable coronary anastomoses in a wide variety of coronary bypass procedures. Early results are encouraging, and further studies are required in order to evaluate long-term efficacy of this system in the rapidly changing world of coronary revascularization.

Coronary anastomotic devices: blood-exposed non-intimal surface and coronary wall stress

Objective This study compares the area of blood-exposed non-intimal surface in device-constructed anastomoses with the conventionally sutured anastomosis and examines the technical feasibility of 0 blood-exposed non-intimal surface anastomosis configurations. Methods In the device-constructed anastomosis, blood-exposed non-intimal surface was estimated in all anastomosis configurations identified in truly new (ie, nonduplicate and nonrelated) patent applications and in anastomotic devices recently introduced by several institutions. In the sutured anastomosis, blood-exposed non-intimal surface area was estimated by analysis of previously investigated anastomoses. In 0 blood-exposed non-intimal surface anastomosis configurations, finite element modeling was used to calculate coronary wall stress. Results By the end of 2001, 57 truly new applications for the distal coronary anastomosis had been published, categorized in 11 types of anastomosis configurations. The tissue blood-exposed non-intimal surface area (ie, non-intimal tissue surface area) ranged from 0 to 6 mm 2. Approximate total blood-exposed non-intimal surface areas (ie, sum of tissue blood-exposed non-intimal surface and foreign body surface area) in recent devices are 80 mm 2 (GraftConnector, Jomed, Helsingborg, Sweden); 33 mm 2 (Magnetic Vascular Positioner rings, Ventrica, Inc, Fremont, Calif); 4.3 mm 2 (distal connector of St Jude Medical, Inc, St Paul, Minn); and 0.3 mm 2 (Crinoline frame, University Medical Center Utrecht/Delft University of Technology, The Netherlands). The sutured anastomoses, in contrast, contained approximately 1.3 mm 2 blood-exposed non-intimal surface area. The mean peak porcine coronary wall stress in 0 blood-exposed non-intimal surface anastomosis configurations with greater than 90° arteriotomy edge eversion ranges from 0.4 to 0.8 N/mm 2 compared with the mean porcine coronary tear stress of 0.8 N/mm 2. Conclusions In recently introduced devices for clinical use, the total blood-exposed non-intimal surface area ranges from 4.3 to 80 mm 2 compared with 1.3 mm 2 in sutured anastomoses. The blood-exposed non-intimal surface area depends on anastomotic orifice size, wall thickness, and bonding components’ location and size. Deforming the coronary wall to most of the 0 blood-exposed non-intimal surface anastomosis configurations leads to dangerously high stress concentrations in the coronary arteriotomy corners. 28

An automatic sutureless coronary anastomotic device: initial results of an animal study.

The efficacy and long-term patency of a new distal anastomotic device (DAD) for the creation of rapid, sutureless end-to-side venous or arterial coronary artery bypass graft anastomoses were tested in a sheep model. The DAD was used on the beating hearts of 34 sheep to create 20 anastomoses between saphenous veins (n = 9) or internal mammary arteries (n = 11) and various coronary arteries. Fourteen conventional hand-sutured anastomoses (7 veins; 7 internal mammary arteries) served as controls. The sheep were sacrificed 1 day, 1 week, and 1, 3, and 6 months after surgery. The immediate patencies of all anastomoses were proven by the rates and pattern of flow. There were no significant differences between the DAD and suture anastomosis groups in presacrifice pulsatility index and occlusion rate. The histomorphometric studies showed complete intimal bridging over the DAD with no significant differences between DAD and suture anastomoses with respect to tissue response, mural injury, inflammation, and adventitial fibrosis. The DAD enables the creation of rapid, efficient, and sutureless venous or arterial coronary anastomoses. The long-term results of histomorphometric studies show that the results with the DAD are comparable with those of conventional hand-sutured anastomoses.

Coronary anastomotic devices: theory and patented ideas on micromechanical fastening.

Coronary anastomotic devices are being designed to reduce the laborious, complex suturing approach to endoscopic coronary surgery. An anastomotic device should be safe and reliable, it should allow full view of the vessel parts to be bonded, it must provide a simple and rapid deployment, and should be hemodynamically adequate. Three anastomotic device categories found in the (patent) literature are discussed that use micromechanical fastening techniques. First, devices using individual bonding elements; second, devices using bonding elements anchored to extra-luminal frames; third, devices using an internal frame, often a stent-like structure. Anastomotic devices described in the (patent) literature to date fail to meet all requirements for endoscopic coronary application.

Assessment of patented coronary end-to-side anastomotic devices using micromechanical bonding

Background. Despite multiple patented ideas for vascular end-to-side anastomotic devices, and the growing need for them in minimally invasive coronary bypass procedures, no device has been evaluated clinically yet. This study assessed patents of micromechanical end-to-side anastomotic devices with respect to application in coronary artery bypass grafting. Methods. Patents were categorized with respect to their micromechanical bonding principle. Calculated values for the wall strain during the construction of an anastomosis were compared with the allowable strain for human coronary arteries. Results. From 51 patents describing vascular anastomotic devices, 11 ideas, categorized into four groups (staples, clips, mounting systems, and intraluminal stent structures), are serious candidates for coronary end-to-side anastomoses. Most ideas use an anvil for proper application of the bonding elements. For small (1.5 mm) coronary arteries, the calculated wall strain was 0.87, exceeding the breaking strain (0.45) in 60- to 79-year-old patients. Conclusions. In a coronary anastomotic device, the concept of using an anvil for the application of micromechanical bonding elements is not attractive, because excessive wall strain is likely to occur.