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Ann Thorac Surg 1997;63:988-992
© 1997 The Society of Thoracic Surgeons


Original Article: Cardiovascular

Safe and Effective Method of Stabilization for Coronary Artery Bypass Grafting on the Beating Heart

Hani Shennib, MD, Allan G. L. Lee, MSc, Jodi Akin, MS

Department of Cardiothoracic Surgery, McGill University, Montreal, Quebec, Canada

Accepted for publication October 22, 1996.


    Abstract
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background. There is an emerging interest in performing coronary artery bypass grafting on the beating heart. This study examines the efficacy and safety of two types of coronary artery stabilizers developed to perform coronary artery bypass grafting on the beating heart.

Methods. Four dogs underwent left internal mammary artery to left anterior descending artery anastomosis using a retractor-fixed stabilizer. Measurements of hemodynamic indices and range of motion of the targeted arteriotomy were done before and after application of the stabilizers. Patency of the anastomosis was evaluated by angiography. To clinically validate the safety of this stabilizer, we collected data on 150 patients from centers that had access to the retractor-fixed stabilizer.

Results. All animals survived the procedure with no ischemic changes or hemodynamic alterations. A significant reduction in range of motion (mm) of the left anterior descending coronary artery was achieved after application of the stabilizers. Angiographic studies showed good anastomotic patency. Histologic examination showed no myocardial injury. Patient data revealed successful completion of the anastomosis, with conversion to sternotomy or cardiopulmonary bypass in 1 patient each. Intraoperative and postoperative myocardial infarctions occurred in 1 patient each, with one in-hospital death.

Conclusions. Significant stabilization of targeted coronary arteries allowing the performance of safe and reliable anastomosis on a beating heart can be achieved using the stabilizer.


    Introduction
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
See also page 980.

Currently, the majority of coronary artery bypass grafting (CABG) operations are performed with cardiopulmonary bypass (CPB). Using CPB for CABG operations allows performance of coronary artery anastomosis in a steady, bloodless field with myocardial protection, yielding an excellent patency rate on long-term follow-up [1]. Nevertheless, CPB is associated with several adverse effects, such as bleeding, neurologic complications, tissue edema, myocardial injury, and potential failure to wean the patient off the pump [14]. Many of these complications can be attributed to mechanical and immunologic alterations of blood components [1, 57]. In addition, the use of an aortic cross-clamp to exclude the heart may add to the risk of myocardial, aortic, and neurologic complications [8]. More recently, serious persistent cognitive defects have been noted to develop in patients subjected to CPB regardless of the duration of CPB [9].

As such, there has been a revival of interest in performing CABG without using CPB or aortic occlusion on a beating heart [1 ,7, 1018]. Hence, establishing simple and safe surgical techniques that provide a steady and bloodless coronary anastomotic field is essential for successful CABG on a beating heart.

In this study, we evaluated the efficacy (stability of the coronary artery and patency of the anastomosis) and safety (effect on hemodynamic measurements and myocardial tissue injury) of two novel types of coronary artery stabilizers, a retractor-fixed and a hand-held stabilizer (CardioThoracic Systems, Inc, Cupertino, CA), in facilitating the performance of a left internal mammary artery-to-left anterior descending coronary artery (LIMA-to-LAD) anastomosis on a beating canine heart. In addition, preliminary operative data from several European and North American centers were collected on 150 patients who underwent CABG on a beating heart using the retractor-fixed stabilizer.


    Material and Methods
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Experimental Design
Two types of stabilizers, hand-held and retractor-fixed, were evaluated in this study (Figs 1A, 1BGoGo).



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Fig 1. . The two types of coronary artery stabilizers: (A) hand-held, (B) retractor-fixed (CardioThoracic Systems, Inc, Cupertino, CA).

 
Four unconditioned mongrel dogs (25 to 30 kg) were anesthetized with pentobarbital (30 mg/kg) and maintained on 1% halothane. The animals were mechanically ventilated on 100% oxygen with a flow rate of 0.5 L/s. Neuromuscular blockers were not used in this study. The animals were then prepared for hemodynamic monitoring. The heart rate was measured with a continuous electrocardiographic monitor (model 90903A; SpaceLabs Inc, Redmond, WA). Invasive arterial blood pressure was measured with femoral artery cannulation, while the pulmonary artery pressure was measured with a Swan-Ganz catheter positioned in the pulmonary artery. Cardiac output was also measured with a Swan-Ganz catheter using thermal dilution techniques. Arterial oxygen saturation was measured with a sensor probe (Pulse-Oxymeter; Criticare Systems Inc, Redmond, WA) fixed on the tongue.

A small left anterior thoracotomy (8 cm) was then performed at the fifth intercostal space, followed by complete mobilization of the LIMA under direct vision. The pericardium opposite the LAD was incised and suspended to the chest wall with 3-0 sutures. At this point, baseline hemodynamic indices and coronary artery range of motion were measured three consecutive times. Range of LAD motion (mm) was measured with a high-resolution laser displacement sensor (model LB-1000; Keyence Corp, Woodcliff Lake, NJ). The laser sensor was calibrated before each session. After identification of the arteriotomy point on the LAD, the laser emitter and sensor were positioned above the coronary artery with the laser beam targeted over the center of the planned incision site on the LAD. Range of motion (mm) was defined as the difference in the maximum and minimum displacement of the LAD over a 10-second interval.

After baseline measurements, the effects of both types of coronary artery stabilizers on LAD range of motion and hemodynamic function were evaluated before and after the application of each stabilizer three consecutive times (Fig 2Go).



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Fig 2. . The retractor-fixed stabilizer positioned intraoperatively with the left anterior descending coronary artery (LAD) running between the two feet of the stabilizer. Note the infrared laser beam fixed on the arteriotomy point of the LAD. A laser sensor (not shown) is positioned directly above to calculate the LAD range of motion.

 
After completion of measurements, two occlusive sutures were applied proximally and distally around the coronary artery, the LIMA was incised to a proper length, and LIMA-to-LAD anastomosis was performed with 7-0 Prolene (Ethicon, Somerville, NJ) sutures. After ascertaining adequate hemostasis and hemodynamic stability, we terminated the experiments by sacrificing the animals with a bolus intravenous injection of potassium chloride (30 mL, 20 mEq). The heart together with a length of the anastomosed LIMA was then resected. A catheter was inserted at the proximal end of the LIMA, and an angiogram was performed immediately to evaluate the adequacy of the anastomosis. Biopsy samples of the heart underlying and adjacent to the anastomosis and the site of application of the stabilizers were obtained, fixed in 4% paraformaldehyde, embedded in paraffin, and stained conventionally with hematoxylin and eosin to evaluate potential injury to the coronary artery anastomosis, epicardium, and myocardium.

Animal Care
All animals were given humane care in compliance with the Animal Care Committee regulations of the Montreal General Hospital and McGill University, as well as with the "Principles of Laboratory Animal Care" formulated by the National Society for Medical Research and the "Guide for the Care and Use of Laboratory Animals" prepared by the National Academy of Sciences and published by the National Institutes of Health (NIH publication 85-23, revised 1985).

Clinical Data
Data forms requesting intraoperative and postoperative in-hospital information on patients undergoing CABG on the beating heart using the stabilizer were collected and analyzed retrospectively. Data included patient demographics, prior revascularization procedures, type of grafts used, and coronary arteries grafted. Intraoperative complications including conversion to sternotomy, the need to use CPB, intraoperative arrhythmias, and myocardial infarction were noted. In-hospital and 30-day morbidity and mortality were also recorded.

Statistical Analysis
Statistical analysis of the data was performed using factorial analysis of variance with a commercially available software package (Statview 4.0, Abacus Concepts, Berkeley, CA) on a Macintosh personal computer. All hemodynamic and range of motion measurements are presented as mean ± standard error of the mean.


    Results
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Experimental Results
All animals survived the procedure and maintained excellent hemodynamic measurements. Application of both stabilizers had no adverse effects on heart rate, arterial blood pressure, pulmonary artery pressure, cardiac output, or arterial oxygen saturation (Table 1Go).


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Table 1. . Hemodynamic Measurements and Range of Motion of the Left Anterior Descending Coronary Artery With and Without Application of the Coronary Artery Stabilizers
 
Increased stability of the coronary artery was achieved with both types of stabilizers. The hand-held stabilizer significantly reduced LAD motion (mm) from 5.3 ± 0.6 to 1.7 ± 0.2 (p = 0.009). The retractor-fixed stabilizer similarly reduced LAD motion (mm) from 5.0 ± 0.5 to 1.5 ± 0.1 (p = 0.006). Using the retractor-fixed stabilizer, two independent cardiac surgeons judged the performance of the LIMA to LAD anastomosis as not different in its facility from that performed with the heart arrested. There was no evidence of hemorrhage and no other technical abnormalities necessitating repair or redoing of the anastomosis.

Angiographic examination of the anastomosis revealed good patency (Fig 3Go). Histologic examination demonstrated normal anastomotic arteries and myocardial tissue at the site of and adjacent to stabilizer application.



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Fig 3. . Angiogram of the left internal mammary artery-to-left anterior descending coronary artery anastomosis from an extracted heart, showing good lumen patency.

 
Clinical Data
Clinical data were available on 150 patients subjected to CABG on the beating heart using the retractor-fixed stabilizer. There were 118 men and 32 women, with age ranging from 38 to 87 years. Thirty-nine patients had previous catheter intervention angioplasty with or without stenting (26%). Another 7 patients (4.6%) had previous CABG. Most patients (144) had LIMA-to-LAD bypass. Eight patients received LIMA to diagonal bypass, 3 had right internal mammary artery to right coronary artery bypass, 3 had a saphenous vein graft to the LAD, 2 had right internal mammary artery-to-LAD bypass, and 1 had gastroepiploic to right coronary artery bypass. Single grafts were performed in 140 patients and multiple grafts in 10.

Conversion to sternotomy was needed in 1 patient (0.6%). Another patient required emergent installation of CPB (0.6%). Two patients had perioperative arrhythmias (1.3%), and 1 patient had intraoperative bleeding (0.6%). There were no perioperative deaths, and the incidence of perioperative acute myocardial infarction was 0.6% (1 patient). One patient had a postoperative acute myocardial infarction that was not in the region of the anastomosis. The 30-day and in-hospital mortality was 0.6%. Because these data were collected from a variety of North American and European centers, hospital stay was widely different from one center to another.


    Comment
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Current methods of CABG are generally safe and efficient, although several complications and disadvantages continue to arise with the use of CPB and cardiac arrest. Most important of these are the added risk of hemorrhage, inadequate cardiac preservation leading to myocardial ischemia or infarction, and neurologic events including cognitive dysfunction. The latter has recently been recognized as an important and common complication regardless of the duration of CPB. The need to address these concerns as well as the desire to minimize other potential risks (ie, sternal wound infection, dehiscence, and pain) stimulated interest in developing less invasive open heart surgical techniques.

The recent success of minimally invasive surgical interventions in abdominal and thoracic surgery [19] led to a surge of interest in performing CABG through a small anterior thoracotomy on a beating heart without CPB. Many centers have reported excellent results in performing off-pump CABG in select subgroups of patients with stenotic, well-collateralized LAD or right coronary artery lesions [1, 7]. In one of the largest clinical reports on myocardial revascularization without extracorporeal circulation (700 patients), Benetti and associates [10] reported a morbidity and mortality rate of 4% and 1%, respectively, with a 90% probability of survival at 7 years. Pfister and colleagues [1] previously compared the results of mortality and morbidity in 220 patients undergoing CABG without CPB with a matched number of on-pump controls. No statistically significant difference in mortality was observed in all subgroups of patients undergoing CABG with or without CPB. However, requirements for postoperative blood transfusions and low cardiac output syndrome occurred significantly less frequently in off-pump patients. In their clinical series, patients with severely impaired left ventricles and the elderly particularly benefited from off-pump techniques. As well, the elimination of personnel and material expenses associated with extracorporeal pump operation, lower morbidity rates, quicker patient recovery, and fewer hospital days in off-pump CABG patients have resulted in substantial cost savings in several centers [20, 21].

Despite the potential advantages of performing off-pump CABG on a beating heart, several limitations persist that hamper its greater use. Most notable is the technical challenge of performing coronary anastomosis on a moving targeted coronary artery. Current surgical techniques used to stabilize the coronary artery for the purpose of anastomosis on a beating heart include application of epicardial sutures, finger stabilization, or pharmacologic slowing of the heart rate, such as with administration of ß- or calcium-blockers. The inconsistency of each of these methods is a major drawback and a limitation to its wide applicability.

We have developed two simple and reliable coronary artery stabilizers that allow the performance of LIMA anastomosis to a well-stabilized arteriotomy point on the LAD. Both types of stabilizers significantly reduced targeted LAD motion and allowed easy performance of a LIMA to LAD anastomosis. No untoward effects on any of the measured hemodynamic indices were noted during the application of either type of stabilizer. Despite the small caliber of canine coronary arteries, the anastomosis was shown to be done properly by angiographic evaluation. Furthermore, the lack of any histologic evidence of injury to the epicardium and myocardium directly beneath or adjacent to the position of the stabilizer is reassuring and may indicate a potential advantage over other stabilization techniques such as epicardial traction sutures or suction, which may tear the epicardium or bruise the tissue.

Preliminary data on 150 patients subjected to CABG on the beating heart revealed successful completion of the anastomosis, with the need to convert to a sternotomy incision in only 1 patient and the emergent utilization of CPB in another. This and the low incidence of complications confirm the safety and efficacy of the retractor-fixed stabilizer. The adequacy of the anastomosis, however, should be determined by angiographic studies on appropriate follow-up. This and other information would clearly be the subject of another report.

In conclusion, significant improvement in stabilization of the coronary artery can be achieved with both types of stabilizers. Using the retractor-fixed stabilizer allows performance of a reliable LIMA-to-LAD anastomosis with ease and with no untoward effects on the heart or cardiovascular hemodynamic indices. The retractor-fixed stabilizer continues to be evaluated clinically, with increasing numbers of patients undergoing a variety of anastomoses on the beating heart. We believe that this instrument provides excellent stabilization of targeted coronary artery segments and facilitates the anastomosis.


    Acknowledgments
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
This work was funded in part by a grant from the Canadian Heart and Stroke Foundation. Stabilizer equipment tested was provided by CardioThoracic Systems, Inc, Cupertino, California. We acknowledge the following individuals and institutions for contributing to the Registry: Federico J. Benetti, Benetti Foundation, Argentina; Joachim Cremer and Axel Haverich, Medizinische Hochschule Hannover, Hannover, Germany; Marco Zenati, University of Pittsburgh, Pittsburgh, PA; Paul A. Spence, University of Louisville, Louisville, Kentucky; Valavanur A. Subramanian, Lennox Hill Hospital, New York, New York; Paul J. Corso and Albert J. Pfister, Washington Hospital Center, Washington, DC; Jan G. Granjean and Piet W. Boonstra, University Hospital Groningen, Groningen, the Netherlands; and Antonio M. Calafiore, University of Chieti, Chieti, Italy.


    Footnotes
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Address reprint requests to Dr Shennib, The Montreal General Hospital, 1650 Cedar Ave, Suite L9-120, Montreal, Que, H3G 1A4, Canada.

Doctor Shennib is a clinical advisor with CardioThoracic Systems, Inc. Jodi Akin is a manager of clinical affairs with CardioThoracic Systems, Inc.


    References
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Pfister AJ, Zaki MS, Garcia JM, et al. Coronary artery bypass without cardiopulmonary bypass. Ann Thorac Surg 1992;54:1085–92.[Abstract]
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  3. Mills SA. Cerebral injury and cardiac operations. Ann Thorac Surg 1993;56:S86–91.
  4. Jain U, Sullivan HJ, Pifarre R, et al. Graft atheroembolism as the probable cause of failure to wean from cardiopulmonary bypass. J Cardiothorac Anesth 1990;4:476–80.[Medline]
  5. Farah B, Vuillemenot A, Lecompte T, et al. Myocardial neutrophil sequestration and activation related to the reperfusion of human heart during coronary artery surgery. Cardiovasc Res 1994;28:1226–30.[Abstract/Free Full Text]
  6. Woodman RC, Harker LA. Bleeding complication associated with cardiopulmonary bypass. Blood 1990;76:1680–97.[Abstract/Free Full Text]
  7. Moshkovitz Y, Mohr R. Coronary artery bypass without cardiopulmonary bypass-the pros and the cons. Isr J Med Sci 1993;29:716–20.[Medline]
  8. Dubost A, DeGevigney G, Zanbartas C, et al. Myocardial infarction after coronary bypass surgery. Associated factors and prognosis. Arch Mal Coeur Vaiss 1990;83:947–52.[Medline]
  9. Benedict RH. Cognitive function after open-heart surgery: are postoperative neuropsychological deficits caused by cardiopulmonary bypass? Neuropsychol Rev 1994;4:223–55.[Medline]
  10. Benetti FJ, Naselli G, Wood M, Geffner L. Direct myocardial revascularization without extracorporeal circulation. Experience in 700 patients. Chest 1991;100:312–5.[Abstract/Free Full Text]
  11. Benetti FJ. Direct coronary artery surgery with saphenous vein bypass without either cardiopulmonary bypass or cardiac arrest. J Cardiovasc Surg 1985;26:217–22.[Medline]
  12. Yamanaka J, Takeuchi Y, Gomi A, Torii S, Koyanagi T, Yashima M. Coronary artery bypass grafting without cardiopulmonary bypass in patients with LV dysfunction (EF < or = 30%)-a report of 3 cases. J Jpn Assoc Thorac Surg 1995;43:1069–72.
  13. Tashiro T, Todo K, Haruta Y, Yasunaga H, Nagata M, Nakamura M. Coronary artery bypass grafting without cardiopulmonary bypass. J Jpn Assoc Thorac Surg 1993;41:598–602.
  14. Yamamura M, Aoki K, Takanashi S, Tadokoro M, Furuta S, Kashiwagi H. A case of coronary artery bypass grafting without cardiopulmonary bypass in a patient of both coronary ostial stenosis due to Takayasu's arteritis. J Jpn Assoc Thorac Surg 1994;42:961–5.
  15. Kigawa I, Marat SH, Fujita S, et al. Reoperative coronary revascularization without cardiopulmonary bypass. Jpn J Thorac Surg 1994;47:979–82.
  16. Ankeney JL. To use or not to use the pump oxygenator in coronary bypass operations. Ann Thorac Surg 1975;19:108–9.[Medline]
  17. Trapp WG, Bisarya R. Placement of coronary artery bypass graft without pump oxygenator. Ann Thorac Surg 1975;19:1–9.[Medline]
  18. Kluge TH, Kerth WJ, Gerbode F. Aorto-coronary bypass in experimental animals without the use of extracorporeal circulation. Scand J Thorac Cardiovasc Surg 1972;6:257–61.[Medline]
  19. Goh P, Tekant Y, Krishnan SM. Future developments in high technology abdominal surgery: ultrasound, stereo imaging, robotics. Baillieres Clin Gastroenterol 1993;7:961–87.[Medline]
  20. Benetti FJ. Coronary artery bypass without extracorporeal circulation versus percutaneous transluminal coronary angioplasty: comparison of costs. J Thorac Cardiovasc Surg 1991;102:802–3.
  21. Buffolo E, de Andrade JCS, Nelson J, et al. Coronary artery grafting without cardiopulmonary bypass. Ann Thorac Surg 1996;61:63–6.[Abstract/Free Full Text]

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H. Shennib, M. J. Mack, and A. G. L. Lee
A Survey on Minimally Invasive Coronary Artery Bypass Grafting
Ann. Thorac. Surg., July 1, 1997; 64(1): 110 - 114.
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