Use of Impella CP Device in Off-Pump Coronary Artery Bypass Graft Surgery.

Off-pump coronary artery bypass grafting (OPCABG) may be performed on patients with high surgical risk who are poor candidates for traditional mechanical circulatory support. Hemodynamic support with micro-axial mechanical circulatory devices has been performed with limited but promising results.We report a case of a 66-year-old male with multiple comorbidities and low cardiac output undergoing OPCABG. Impella CP device was deployed for "in-pump" support during surgical coronary revascularization resulting in intraoperative stability and uncomplicated post-operative recovery.Previous reports have described the use of the Impella Recover LP 5.0 device for use during OPCABG. We describe the successful and safe perioperative use of the Impella CP device. Despite lower flow rates, adequate support was achieved and the transfemoral cannulation and smaller outer diameter than the Impella 5.0 device may decrease the risk of complications and expedite recovery. Further research will be necessary to determine the optimal perioperative hemodynamic support strategy to offer hemodynamically unstable, high, and prohibitive risk patients.

Endotracheal bioimpedance cardiography improves immediate postoperative outcome: a case-control study in off-pump coronary surgery.

The feasibility and clinical utility of the endotracheal cardiac output monitor (ECOM) to optimize intraoperative hemodynamics and improve short-term outcome in off-pump coronary artery bypass grafting (OPCAB) is unknown. We aimed to compare ECOM with a standard of care in that specific surgical setting. Twenty consecutive adult ECOM-monitored patients undergoing OPCAB were prospectively included (ECOM group) and retrospectively compared to 42 patients scheduled for similar surgery without ECOM monitoring (Control group). The primary endpoint was the global rate of postoperative admission to the intensive care unit (ICU). Secondary endpoints were the time to extubation, the length of stay in ICU and in hospital, the postoperative levels of lactate and troponin and the feasibility of ECOM. The rate of postoperative admission to the ICU was 38/42 (90%) in the Control group versus 11/20 (55%) in the ECOM group, P = 0.008. None unexpected admission for hemodynamic instability was observed in the ECOM group. The time to extubation, the length of stay in ICU, and both troponin level at admission and lactate level at H6 were all significantly decreased in the ECOM group. On a scale ranging from 0 to 5, convenience and satisfaction regarding ECOM were 4.30 ± 1.17 and 3.45 ± 0.68, respectively. The systematic use of ECOM is associated with a significant reduction in the rate of admission to the ICU and an improvement in immediate outcome in OPCAB.

Clampless versus clamped coronary bypass grafting: does it make a difference?

PURPOSE OF REVIEW: The techniques of coronary artery bypass grafting (CABG) have evolved remarkably over the last two decades since the introduction of off-pump coronary artery bypass (OPCAB). This article focuses on the clinical outcomes of 'clampless' CABG strategies, that include OPCAB with a partial clamp, OPCAB with a proximal suture device, and aorta no-touch OPCAB. RECENT FINDINGS: Observational studies have shown the superiority of OPCAB for preventing strokes and pulmonary complications. Conversely, recent large-scale randomized controlled trials (RCTs) have been unable to demonstrate the benefits of OPCAB. Because of these differing results across numerous studies, the debate about the overall superiority of OPCAB versus on-pump CABG remains controversial. However, the literature regarding the OPCAB technique with minimized manipulation of the aorta suggests this has likely benefits, especially for high-risk patients. SUMMARY: Previous large RCTs did not focus on specific approaches of OPCAB or the importance of the experience of surgeons and institutions, and so further studies are needed. Observational studies and meta-analyses have indicated that improved outcomes can be achieved by applying specific OPCAB approaches according to each patient's characteristics.

Minimally invasive direct coronary artery bypass grafting with an improved rib spreader and a new-shaped cardiac stabilizer: results of 200 consecutive cases in a single institution.

BACKGROUND: Performing minimally invasive direct coronary artery bypass (MIDCAB) grafting via small chest incisions on a beating heart is challenging. We report our experiences of MIDCAB with the utilization of both an improved rib spreader to harvest the left internal mammary artery (LIMA) and a new-shaped cardiac stabilizer to facilitate LIMA-left anterior descending (LAD) coronary anastomosis. METHODS: Between May 2012 and June 2104, a total of 200 patients who were consecutively operated on in this period were enrolled in this study. Data reported included demographic information, preoperative clinical and cardiac status, LIMA harvest time, postoperative in-hospital outcomes, and 30-day mortality. RESULTS: The average LIMA harvest time was 43 min. The mean age was 62.59 ± 10.19 years, and 45 of the 200 were females. The 30-day mortality was 0.5% (one patient) due to perioperative myocardial infarction. Duration of mechanical ventilation and length of stay in intensive care unit was 9.27 ± 7.65 and 24.27 ± 17.85 h, respectively. The unit of packed RBC transfusion was 0.79 ± 1.58. Postoperative atrial fibrillation was observed in 14 (7%) patients. There was no postoperative stroke, renal failure, or incision complication. CONCLUSION: Performing MIDCAB with the improved retractor and stabilizer utilized in this study showed favorable outcomes in terms of harvesting the LIMA, postoperative morbidities, and 30-day mortality.

Partially anaortic clampless off-pump coronary artery bypass prevents neurologic injury compared to on-pump coronary surgery: a propensity score-matched study on 286 patients.

Anaortic coronary artery bypass proved to prevent early neurologic injury compared to on-pump CABG. The Cardica PAS-Port(®) is a fully automated device that might be able to perform proximal aorto-venous anastomoses without an increased embolic risk. We evaluated early post-operative neurologic outcome in a matched population following clampless OPCAB (CCAB: either "all-arterial" or with automatically anastomosed venous grafts) or on-pump CABG. 366 consecutive patients were submitted to isolated coronary bypass by a single surgeon experienced in both off and on-pump procedures between January 2009 and December 2013. Of these patients, 223 underwent a clampless off-pump revascularization. After propensity score matching, 143 pairs were selected, who received either off-pump or on-pump surgery. In the off-pump group, CCAB was performed with an all-arterial approach (n = 33) or with automated proximal anastomosis of the venous graft(s) by means of the Cardica PAS-Port(®) connector (n = 110). Neurologic injury was defined as non-reversible (NRNI: lethal coma or stroke) or reversible (RNI: TIA or delirium). Operative mortality was 2.4 % (CCAB 1.4 %; CABG 3.5 %; p = 0.14). The global rate of early neurologic injury was 5.6 % (CCAB 2.1 vs. CABG 9.1 %; p = 0.006). Incidence was 1.4 % for NRNI (CCAB 0 vs. CABG 2.8 %; p = 0.04) and 4.2 % for RNI (CCAB 2.1 vs. CABG 6.3 %; p = 0.06). No differences were found among other major perioperative outcomes. CCAB prevents both early post-operative RNI and NRNI. This result can be achieved with a totally anaortic strategy and also with the aid of a fully automated device for proximal aorto-venous anastomoses.

[New Intracoronary Shunt Cannula in Off-pump Coronary Artery Bypass Grafting].

In off-pump coronary artery bypass grafting(OPCAB), a bloodless operative field has great influence on the quality of anastomosis. In addition, maintenance of distal coronary flow during anastomosis stabilizes hemodynamics. We introduced a new intracoronary shunt cannula, Mini Shunt Pro (MSP). MSP adopts the step-tip, which allows easy insertion and reduces the risk of intimal injury. The distal and proximal sides of the tips of MSP are 0.25 mm different in diameter, which improves its fitness to the coronary artery and enhances a bloodless operative field. This new shunt cannula is considered to be safe and useful for high-quality anastomosis in OPCAB.

Probe endarterectomy on the beating heart for severe coronary artery disease.

Although coronary endarterectomy is a challenging procedure, its implementation might be mandatory in some cases with diffuse atherosclerotic coronary artery disease. The traditional techniques such as open, semi-closed, eversion, orificial and extraction endarterectomies have been well defined in vascular surgery, however, due to the small size of the coronary arteries, their implementation is not always possible in surgical cardiac revascularization. In this report, we describe a simple method which combines the open and closed techniques of coronary endarterectomy, in which we use the coronary probes at different sizes in order to extract and release the atheromatous plaques from coronary arteries. This technique facilitates the removal of the plaques with easy handling of the coronary probes.

[Clinical Experience of Beating Heart Atrial Septostomy Using a Device for Coronary Artery Anastomosis Site Creator].

BACKGROUND: Intra-atrial communication was mandatory for several congenital cardiac diseases, such as pulmonary atresia with intact ventricular septum (PA/IVS), and either sided aortoventricular valve atresia. We assessed whether the new methods of atrial septal defect(ASD)creation was effective. METHODS: We experienced 4 cases of the surgical atrial septostomy performed under on-pump beating. We used a new device, a circular punch out defect creator. RESULTS: All cases were alive. The mean ASD diameter was enlarged from 4.37 mm to 5.55 mm and the mean ASD shunt flow was significantly decreased from 1.47 m/s to 1.11 m/s. CONCLUSIONS: We performed the surgical atrial septostomy using an aortic puncher under beating heart effectively and safely.

[How to use assist devices effectively in off-pump coronary artery bypass surgery].

Off-pump coronary artery bypass is a technically demanding procedure, which is, however, widely performed in Japan. In this paper, most widely used assist devices such as tissue stabilizers, heart positioners, intraluminal coronary artery shunts and proximal anastomosis assist devices are introduced along with tips of usage.

Long-term clinical outcome of the symmetry aortic connector system in off-pump coronary artery bypass grafting.

BACKGROUND: Several short-term and midterm follow-up studies of the Symmetry aortic connector system showed controversial results. The objective of the present study was assessing the long-term clinical outcome of patients operated with the Symmetry device and to compare the results with hand-sewn control patients. METHODS: A retrospective case-control study of 156 (46 cases, 110 controls) consecutive patients, that underwent off-pump coronary revascularization, between January 2001 and December 2004, was conducted. Study endpoints were all-cause mortality, coronary reintervention and postoperative stroke. RESULTS: There was no difference in survival between cases and controls (89.1 vs. 82.4%, p = 0.27) after 8 years of follow-up. No significant difference could be detected between cases and controls with respect to overall long-term coronary reintervention free survival (82.6 vs. 88.9%, p = 0.41) and freedom from coronary reintervention due to proximal vein graft failure (91.3 vs. 96.3%, p = 0.24). The use of Symmetry device could not be identified as independent risk-factor of coronary reintervention due to proximal vein graft failure (p = 0.25). Furthermore, postoperative stroke rates were comparable between cases and controls (0.0 vs. 0.9%, p = 1.00). CONCLUSION: This study suggests that the use of the Symmetry Bypass Connector was not associated with adverse outcome in terms of overall survival, long-term coronary reintervention free survival, freedom from reintervention due to proximal vein graft failure and postoperative stroke.

Near infrared fluorescence imaging with ICG in TECAB surgery using the da Vinci Si surgical system in a canine model.

BACKGROUND: This study assessed the clinical utility of near-infrared fluorescence imaging using indocyanine green in off-pump beating heart total endoscopic and robotic-assisted coronary artery bypass using the fluorescence imaging system for the da Vinci Si on a canine model for vessel identification, graft patency, and correlation of graft patency with ultrasound transit-time flow measurement probe. METHODS: Beating heart total endoscopic robotic-assisted coronary artery bypass was performed on eight canine using indocyanine green and fluorescence imaging to identify the internal mammary artery prior to harvesting, the coronary vessel anatomy, and the patency of the beating heart total endoscopic coronary artery bypass anastomosis. Three to four injections of indocyanine green with a dose of 1.25 mg to 2.5 mg were administered per animal. Transit-time flow was measured in each of the dogs. RESULTS: High definition 3D images were obtained. The camera working distance, indocyanine green dosage, internal mammary artery visualization, coronary artery visualization, patency by indocyanine green injection, and patency by transit-time flow were recorded. Six cases were completed successfully, and all demonstrated correlation between indocyanine green measurements of flow, and the transit-time flow measurement. CONCLUSION: Use of near-infrared fluorescence with indocyanine green was feasible in our study, and would be of great benefit during total endoscopic robotic-assisted coronary artery bypass using the fluorescence imaging-capable da Vinci Si system to help identify the internal mammary artery, delineate the coronary anatomy, and also determine patency of the anastomoses. This procedure correlated well with transit-time flow measurement.

[Comparison of sternotomy off-pump coronary artery bypass and minimally invasive technique for isolated single vessel grafting].

OBJECTIVE: To compare the outcomes of minimally invasive coronary artery bypass grafting operation performed via a small thoracotomy versus da Vinci S system (Endo-A-CAB) with sternotomy off-pump coronary artery bypass grafting (OPCAB) for single vessel lesion. METHODS: From April 2000 to August 2011, a total of 194 patients with single coronary artery stenosis accepted CABG on beating heart were divided into 2 groups by different surgical approaches. Group A (n = 99) received sternotomy OPCAB while Group B (n = 95) underwent Endo-A-CAB. All patients had a history of unstable angina and coronary arteriography showed severe stenosis in left anterior descending artery (LAD). The procedure performed in Group B included robotic internal mammary artery (IMA) harvesting and single manual anastomosis to LAD and/or diagonal branch through small incision thoracotomy. IMA flow was evaluated by the Doppler flow meter after the completion of anastomosis. Grafting patency was evaluated postoperatively by computed tomography angiography (CTA) or angiography. RESULTS: The ventilation time and postoperative drainage volume in Group B were less than those in Group A ((5.1 ± 2.1) vs (10.1 ± 5.8) h, P = 0.03; (411 ± 295) vs (605 ± 244) ml, P = 0.000). No significant difference existed in blood flow, mortality and postoperative complication morbidity between two groups. All symptoms of angina disappeared. CONCLUSION: As a new advanced modality of revascularization, in comparison with OPCAB, Endo-A-CAB procedure is a less invasive and safer method of coronary artery bypass grafting for single vessel lesion.

[Specific features of the technique of performing coronary bypass operations on the beating heart].

The article presents a technique of performing coronary bypass operations on the beating heart used by the authors in 847 patients which is based on high thoracic epidural anesthesia, primary formation of proximal anastomoses of the aorto-coronary bypasses and specified succession of the formation of distal, stabilization of the local part of the heart in the field of placing distal anastomosis and access to the lateral and posterior surface of the heart with vacuum stabilizers, using blower-humidifier and intracoronary shunts.

Endoscope system with plasma flushing and coaxial round jet nozzle for off-pump cardiac surgery.

BACKGROUND: To develop a new endoscope for performing simple surgical tasks inside the blood-filled cardiac atrium/chamber, that is, "off-pump" cardiac surgeries. METHODS: We developed the endoscope system with plasma flushing and coaxial round jet nozzle. The "plasma flushing" system was invented to observe the interior of the blood-filled heart by displacing blood cells in front of the endoscope tip. However, some areas could not be observed with simple flushing of the liquid because the flushed liquid mixed with blood. Further, a large amount of liquid had to be flushed, which posed a risk of cardiac damage caused by excess volume. Therefore, to safely capture high-resolution images of the interior of the heart, an endoscope with a coaxial round jet nozzle through which plasma is flushed has been developed. And to reduce the volume of flushed liquid, the synchronization system of heartbeat and the endoscope system with plasma flushing has been developed. RESULTS: We conducted an in vivo experiment to determine whether we could observe intracardiac tissues in swine without the use of a heart-lung machine. As a result, we successfully observed intracardiac tissues without using a heart-lung machine. By using a coaxial nozzle, we could even observe the tricuspid valve. Moreover, we were able to save up to 30% of the flushed liquid by replacing the original system with a synchronization system. And we evaluated the performance of the endoscope with the coaxial round jet nozzle by conducting fluid analysis and an in vitro experiment. CONCLUSION: We successfully observed intracardiac tissues without using a heart-lung machine. By using a coaxial nozzle, we could even observe the tricuspid valve. And by replacing an original system to a synchronization system, we were able to save up to 30% of the flushed liquid. As a follow-up study, we plan to create a surgical flexible device for valve disease that can grasp, staple, and repair cardiac valves by endoscopic visualization.

A haemodynamic study during OPCAB surgery using a new multi-suction cardiac positioner.

BACKGROUND: Displacement of the heart is necessary to expose the target vessel for distal anastomosis to achieve successful multivessel off-pump coronary artery bypass (OPCAB) grafting. In addition to complete revascularisation of the heart, a main challenge during the operation is to maintain haemodynamic stability during this procedure. A new heart positioner (Tentacles) was tested. METHODS: In a prospective clinical study we used the Tentacles device in 50 patients scheduled for multivessel OPCAB procedures and investigated the haemodynamic effects during displacement of the heart and while performing the anastomoses to the anterior, lateral and posterior wall. The following haemodynamic parameters were investigated: mean arterial blood pressure (MAP), cardiac index (CI) and stroke volume index (SVI). The incidence of myocardial ischaemia was monitored by transoesophageal echocardiography (TEE) and by ST-segment analysis in the electrocardiogram (ECG). RESULT: The Tentacles device permitted rapid, secure and excellent exposure of the lateral and posterior wall of the heart. During exposure of the anterior wall there was a small decrease in MAP (77 ± 10 vs.71 ± 9 mmHg, P = 0.02) in combination with an increase in the CI (3.0 ± 0.7 l vs. 3.1 ± 0.8 l/min/m2, P = 0.03). When the lateral and posterior walls of the heart were exposed, the SVI decreased significantly (36 ± 11 and 38 ± 8 mL/m2, P < 0.01 and P = 0.04, respectively) compared to baseline (44 ± 11 mL/m2) while CI and MAP remained stable. The amount of norepinephrine administered during displacement of the heart was significantly higher in all three positions (0.05 ± 0.05, 0.06 ± 0.05 and 0.04 ± 0.03 µg/kg/min, P < 0.01) compared to the physiological position (0.02 ± 0.02 µg/kg/min). Sinus rhythm was maintained throughout the operation. Neither significant changes of the ST-segment in the ECG nor incidences of wall motion abnormality in TEE were observed. Six hours postoperatively the troponin I concentration was 11.7 ± 4.3 ng/mL. CONCLUSION: The Tentacles device provided excellent access in multivessel OPCAB surgery. Haemodynamic stability was maintained in all patients; however additional catecholamine support was used when the heart was displaced. This was the case when carrying out an anastomosis on the anterior, lateral, or posterior wall.

Avoidance of aortic side-clamping for proximal bypass anastomoses: better short-term outcome?

OBJECTIVES: The benefit of off-pump coronary artery bypass (OPCAB) surgery may be reduced by strokes caused by microemboli produced after aortic side-clamping for proximal bypass anastomoses. The Heartstring device allows constructing proximal bypass anastomoses without side-clamping of the aorta. METHODS: This retrospective study describes 260 consecutive patients who underwent OPCAB surgery; 442 proximal anastomoses were performed with the Heartstring device in this series. Ten percent of the patients were randomly sampled before discharge to undergo a coronary angiogram for assessment of graft patency. RESULTS: Intraoperative Doppler measurements confirmed regular bypass function. Early mortality occurred in 4 patients (1.5%), and stroke occurred in 2 patients (0.8%). Device-related bleeding was negligible, and there were no cases of aortic dissection. Perioperative ischemia occurred in 8 patients (3.1%). Predischarge coronary angiography evaluations in 25 of the patients (of 260) showed that all 42 Heartstring-assisted anastomoses (of 442) were patent. CONCLUSIONS: Clampless performance of proximal bypass anastomoses combined with OPCAB is associated with a very low incidence of stroke complications. Short-term follow-up has shown excellent results regarding bypass patency and other adverse events. Prospective randomized trials are required to confirm the advantage of this technique.

Does on-pump normothermic beating-heart valve surgery with low tidal volume ventilation protect the lungs?

BACKGROUND: Postoperative pulmonary dysfunction following cardiopulmonary bypass (CPB) usually develops secondary to the inflammatory process with contact activation, hypothermia, operative trauma, general anesthesia, atelectasis, pain, and pulmonary ischemia/reperfusion due to cross-clamping. The aim of the present study was to evaluate the effects of an on-pump, normothermic, and beating-heart technique and of low-volume ventilation on lung injury. METHODS: We compared the results for 20 patients who underwent operations with an on-pump, normothermic, and beating-heart technique of mitral valve surgery with low-volume ventilation (group 1) with the results for 23 patients who underwent their operations with an on-pump, hypothermic cardiac-arrest technique (group 2). In both groups, blood samples were collected from the right superior pulmonary vein, and inflammation and oxidative stress markers (malondialdehyde, lactic acid, platelet-activating factor, and myeloperoxidase) were studied. RESULTS: Malondialdehyde, myeloperoxidase, and lactate values were significantly lower in group 1 than in group 2 just before the termination of CPB (P < .05). We observed no differences between the 2 groups with regard to values for platelet-activating factor. CONCLUSIONS: Inflammation and oxidative stress markers were lower in the group of patients who underwent beating-heart valve surgery with low-volume ventilation. These results reflect less of an ischemic insult and lower inflammation compared with the results for the patients who underwent conventional operations.

Miniaturized extracorporeal circulation vs. off-pump coronary artery bypass grafting: what the evidence shows?

Recognition of the potentially deleterious effects of esxtracorporeal circulation led to off-pump coronary artery surgery (OPCAB) experiencing a surge in popularity in the initial decade after its conception. However, OPCAB has its own limitations and technical difficulties, such as coronary access, increased left ventricular size and reduced function, which may lead to the potential for suboptimal revascularization. As an alternative technique, miniaturized extracorporeal circulation (mECC) may provide a more controlled operative field in which the heart may be manipulated whilst minimizing the inflammatory, coagulopathic and haemodilutional effects of cardiopulmonary bypass. In this review, we outline the proposed benefits of the mECC system, discuss the pitfalls associated with mECC, and directly compare mECC to 'off-pump' coronary surgery for a variety of clinical and non-clinical outcomes.

[Robotically assisted coronary artery bypass grafting on beating heart].

OBJECTIVES: To analyze the safety and efficiency of robotically assisted coronary artery bypass grafting (RACABG) on beating heart using da Vinci S system. METHODS: From January 2007 to March 2011, 105 patients underwent RACABG on beating heart through minithoracotomy. There were 77 male and 28 female patients, aged from 33 to 77 years with a mean of (59 ± 10) years. After establishment of single left lung ventilation, the 3 trocars of da Vinci system were inserted into the left hemithorax, and robotic system was used to harvest the left internal mammary artery (LIMA) and/or right internal mammary artery (RIMA) from the subclavian vein to the internal mammary artery (IMA) bifurcation with skeletonized technique. After positioning the stabilizer, the LIMA was anastomosed manually to the left anterior descending or diagonal branch sequentially on beating heart through left minithoracotomy. The graft flow was evaluated by the Doppler flow meter after anastomosis was completed, and the graft patency was also evaluated by CT angiography or arteriography after surgery. RESULTS: All patients had successful RACABG on the beating heart, and the mean graft flow was (21 ± 13) ml/min. One patient suffered from cardiac arrest after the first postoperative day, but he recovered soon and CT angiography showed that graft was patent. One patient with preoperative stroke had postoperative pulmonary infection, and was discharged after treatment. After 4 to 5 days, 4 patients received stent placement in right coronary artery or circumflex coronary in distinct hybrid session. There were no deaths or stroke or reintervention. All patients were discharged without complications and followed up. CTA or angiography revealed patent grafts in all patients, and the mean time of follow-up was (30 ± 12) months. CONCLUSIONS: Robotically assisted coronary artery bypass grafting on beating heart can be performed safely using da Vinci S system. It is a new advanced approach of revascularization not only for patients with single vessel but with multi-vessel lesions as well.

Device Use for Proximal Anastomosis on Ascending Aorta in Off-Pump Coronary Artery Bypass Grafting.

BACKGROUND: We recently reported early postoperative results comparing the use of an anastomosis-assist device with a side-biting clamp for ascending aorta during coronary artery bypass grafting (CABG). Transient neurological complications occurred less often with the device. Here, we evaluated the perioperative safety of the device compared with the aorta no-touch technique (no-touch). METHODS: We evaluated patients listed in the Japan Adult Cardiovascular Surgery Database who received isolated off-pump CABG with either the device or the no-touch approach from 2014 to 2016. We performed a one-to-one matched analysis based on a propensity score modeled from patient demographics, comorbidities, cardiac conditions, and procedural characteristics. We compared early outcomes in both groups using Pearson's chi-square or Wilcoxon rank sum test as appropriate; P less than .05 was statistically significant. RESULTS: Among 9546 device and 6890 no-touch patients, we found 5012 patient matches for each group. The device operation time was significantly longer (293 versus 281 minutes; P < .001) and homologous transfusion was significantly greater (56.9% versus 51.0%; P < .001) than with no-touch. Thirty-day operative mortality (1.5% versus 1.7%; P = .34), morbidity and mortality (6.8% versus 7.5%; P = .17), and stroke (0.9% versus 1.1%; P = .36) were similar in both groups. New-onset atrial fibrillation (11.9% versus 10.3%; P = .01) occurred significantly more often with the device. Newly initiated dialysis (1.4% versus 1.9%; P = .051) was more frequent with no-touch whereas reoperation for graft occlusion was more frequent with the device (1.0% versus 0.6%; P = .06) but was not significant for either outcome. CONCLUSIONS: The clinical safety of use of the device in CABG was comparable to no-touch for mortality and morbidity. Hemostasis may be a key issue for accomplishing higher-level quality control when devices are used in proximal anastomosis of CABG.