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Ann Thorac Surg 1996;62:435-440
© 1996 The Society of Thoracic Surgeons
Departments of Cardiothoracic Surgery, Anesthesia, Surgery, and Pathology, Stanford University School of Medicine, Stanford, and Veterans Affairs Health Care System, Palo Alto, California
| Abstract |
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Methods. Twenty-three dogs underwent acute studies and 4 dogs underwent survival studies. The left internal mammary artery was taken down using a thoracoscope. Cardiopulmonary bypass was conducted via femoral cannulas and using an endovascular balloon catheter for ascending aortic occlusion, root venting, and delivery of antegrade blood cardioplegia. Pulmonary artery venting was achieved with a jugular vein catheter. An internal mammary artery-to-coronary artery anastomosis was performed using a microscope through a 10 mm port.
Results. All animals were weaned from cardiopulmonary bypass in sinus rhythm without inotropes. Cardiopulmonary bypass duration was 104 ± 28 minutes and aortic clamp duration was 61 ± 22 minutes. Cardiac output and pulmonary artery occlusion pressure were unchanged. The internal mammary artery was anastomosed to the left anterior descending artery (25) or the first diagonal (2) with patency shown in 25 of 27. One dog in the survival study had a very short internal mammary artery pedicle under tension and was euthanized for excessive postoperative hemorrhage. Three weeks postoperatively the remaining dogs had angiographically patent anastomoses, normal transthoracic echocardiograms, and histologically normal healing and patent grafts.
Conclusions. Endovascular cardiopulmonary bypass using a balloon catheter is effective in arresting and protecting the heart to allow thoracoscopic internal mammary artery-to-coronary artery anastomosis.
| Introduction |
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Minimally invasive surgical techniques for the management of diseases of the chest have been in use for more than 75 years [1]. With the advent of high-resolution video equipment and superior instrumentation there has been an explosion in the applications of minimal access laparoscopic and thoracoscopic surgery. The last decade has been revolutionary, as surgeons have developed new approaches to minimize patient discomfort, shorten hospital stays and rehabilitation periods, and reduce health care costs. Because of the inability to apply standard myocardial preservation and cardiopulmonary bypass methods to patients in a minimal-access fashion, the invasive nature of coronary artery bypass grafting has been relatively unchanged during the development of this exciting new technology.
The use of the left internal mammary artery (LIMA) as a graft to the left anterior descending artery (LAD) in a direct manner was initiated by Kolesov [2] by way of a fifth intercostal space thoracotomy with the anastomosis performed on a beating heart. The pioneering work of Favaloro [4], Loop and associates [3], and Kolesov led to the rapid refinement of coronary artery grafting using the LIMA as the optimal conduit. The ability to provide excellent cardiopulmonary bypass and myocardial preservation, combined with significant advances in surgical technique, has allowed dramatic improvements in coronary artery surgical morbidity and mortality as well as outstanding long-term patency when the internal mammary artery is used [5].
If modern techniques of cardiopulmonary bypass and myocardial preservation could be applied to patients without the need to open the chest, the optimal solution to minimal access coronary artery grafting might be realized. This method would entail femoral venous-arterial cardiopulmonary bypass with an endoaortic occlusion balloon in the ascending aorta. This catheter-based system would have the ability to deliver cardioplegia and effectively vent the arrested heart [68]. With this basic platform of closed-chest myocardial protection, and many of the techniques and devices similar to those developed for minimal access surgery over the past 10 years, the ability to perform precise coronary artery bypass grafting with minimal access seemed feasible.
This study was aimed at evaluating a minimally invasive approach, termed "port-access" coronary artery bypass grafting, in the canine model using cardiopulmonary bypass and cardioplegic arrest of the heart.
| Material and Methods |
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A stereoscopic optical probe (stereovision probe; Heartport, Redwood City, CA) was coupled to the operating microscope (OPMI-MDU; Zeiss, Thornwood, NY) and a visual check made. Three 10-mm left lateral chest ports were placed and an articulated thoracoscope (Distalvu 360; Welch-Allyn, Skaneatales, NY) was inserted to confirm the left lung was collapsed. The LIMA was dissected from the first rib to its bifurcation. A port-access electrocautery device and port-access small clip appliers (Heartport) were used to accomplish the dissection. The animal was then systemically heparinized (300 U/kg). A bulldog clamp (Heartport) was placed thoracoscopically on the proximal pedicle, a large clip was applied across the most distal part of the pedicle, and the LIMA was transected. The distal end of the pedicle was exteriorized through a lateral chest port, flow was checked, and the end was prepared for anastomosis.
The right femoral vein and artery were exposed and cannulated with 17F and 14F cannulas (DLP, Grand Rapids MI), respectively. The tip of the venous drainage catheter was placed under fluoroscopic guidance in the superior vena cava. The thermodilution catheter was exchanged for a 9.5F endovascular pulmonary artery vent catheter (endopulmonary vent; Heartport). The single-lumen endopulmonary vent was passed into the main pulmonary artery by advancing it over a 110-cm 5F balloon-tipped double-lumen catheter (Arrow) under fluoroscopic or with pressure transducer guidance. A 12F three-lumen balloon-tipped catheter (endoaortic clamp; Heartport) was introduced through the left femoral artery, and the tip was positioned in the ascending aorta under fluoroscopy (Fig 1
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The stereovision probe was positioned in the central 10-mm anterior port, and the LAD was identified. A 4- to 5-millimeter arteriotomy was made, and the LIMA to-LAD-anastomosis was created with a single running continuous suture (7/0 Ultex; W. L. Gore & Assoc, Flagstaff, AZ) (Fig 3
). All sutures were double armed and 10 cm in length. Sutures were knotted using an endoscopic instrument tie. Patency was checked by delivering antegrade cardioplegia and observing brisk retrograde filling of the LIMA. Hemostasis was checked similarly by temporarily removing the internal mammary artery clamp. Another injection of contrast material was delivered to the aortic root to check the position of the endoaortic clamp before the balloon was deflated. External defibrillation was performed if necessary and ventilation initiated once the animal was in a stable sinus rhythm. The animal was rewarmed to 37°C and weaned from bypass, and all cannulas were removed. The thermodilution catheter was reinserted, intravascular volume was given to achieve a pulmonary artery occlusion pressure similar to the preoperative baseline value, and cardiac output was measured. The acute study animals were sacrificed immediately postoperatively. Gross examination was performed via a left thoracotomy, with particular note made of the myocardium, aortopulmonary valves, ascending aorta, and the alignment of the mammary pedicle. The pedicle was transected and an angiogram done to check vessel patency.
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Statistical analysis was performed using paired t test with p less than 0.05 considered significant.
| Results |
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The anastomosis was made to the correct target coronary vessel in 25 of 27 studies. In an early study a graft was made to the first diagonal branch, which was mistaken for the LAD, and in one of the survival studies a very short pedicle was attached to a large ramus branch in its proximal segment. Graft hemostasis and patency were shown acutely in 25 of 27 studies. All grafts were assessed intraoperatively by observation and considered patent. In one acute study, a postoperative angiogram showed incomplete patency; at postmortem examination a suture had caught the back wall. In a survival study, one anastomosis was under considerable tension due to a very short LIMA pedicle and required tacking sutures. It was shown to be patent during an intraoperative LIMA angiogram. At 4 hours postoperatively the chest tube output suddenly increased, and a gas tension analysis was consistent with arterial blood. The dog was reheparinized and euthanized, and a postmortem was performed. The pedicle was attached but under considerable tension, and a partial anastomotic dehiscence was noted at the heel.
All dogs were successfully maintained on cardiopulmonary bypass for 104 ± 28 minutes (mean ± standard deviation). Kinetic assisted venous drainage maintained the venous line pressure of -40 to -80 mm Hg during bypass. Endopulmonary vent flows typically remained less than 10 mL/min during this time, with excellent cardiac decompression. The mean cardiac arrest time was 61 ± 22 minutes.
In 19 of 27 studies, the endoaortic clamp position was checked with fluoroscopy before deflation. Migration toward the aortic valve was noted in 3 of 19 studies. On these 3 occasions, there was no evidence of loss of aortic occlusion (equalization of aortic root and carotid artery pressures, early myocardial rewarming, or early return of cardiac activity). Contrast injection into the root confirmed complete aortic occlusion. There was no clinical, radiographic, or postmortem evidence of aortic regurgitation or aortic valve damage that balloon migration might have caused. In the remaining 8 studies no predeflation aortic root contrast injection was performed; however, there was no clinical evidence to suggest balloon migration during the period of inflation.
After endoaortic clamp deflation and resuscitation to sinus rhythm, all dogs were successfully weaned from cardiopulmonary bypass. Preoperative and postoperative cardiac output measurements were obtained in 19 studies. The mean preoperative cardiac output was 2.9 ± 0.8 L/min with a pulmonary artery occlusion pressure of 6 ± 3 mm Hg, and the postoperative values were not significantly different at 3.2 ± 0.6 L/min and 7 ± 2 mm Hg, respectively.
In the 3 surviving dogs, postoperative recovery was uneventful and all were moving about and drinking within 4 hours of the operation. Average total postoperative chest drainage was 300 mL (range, 50 to 760 mL). One dog required a transfusion of 1 unit of whole blood on the first postoperative day for symptoms of anemia, with a hematocrit of 28%. Transthoracic echocardiography demonstrated normal left and right ventricular function, no aortic incompetence, and a normal-appearing ascending aorta in the 3 surviving dogs. One dog had an infected neck wound, and another dog was noted to have a small abscess associated with one of the port sites. These infections healed without complication. Angiography performed 3 weeks postoperatively revealed that the LIMA and anastomosis were fully patent and without stenosis in all cases (Fig 4
). All studies demonstrated excellent run-off into the LAD. At postmortem examination, adhesions were noted in the left chest, but not involving the anterior mediastinum. The LIMA pedicle was well aligned, and the myocardium, aorta, pulmonary artery, bowel, and kidneys were grossly and histologically normal in all dogs. One dog had evidence of a pericarditis but no ischemia or infarction. Histologic sections of the anastomoses demonstrated normal healing.
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| Comment |
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One of the most important coronary artery differences is size discrepancy, with the canine coronary artery being approximately one half to one third the size of the typically grafted human coronary artery. In spite of the significant caliber difference between human and canine internal mammary and coronary artery sizes, the patency rate was quite acceptable. The absence of coronary artery disease prevents accurate assessment of the therapeutic benefits of direct coronary artery revascularization, although the technical adequacy was confirmed angiographically and pathologically. In addition, with the absence of coronary artery disease, the distribution of the antegrade cardioplegia would be expected to be more thorough than in a patient with severe obstructive coronary artery lesions. There is very high noncoronary collateral flow in dogs, but with relatively low systemic temperatures this limitation was not a significant problem.
The myocardial protection achieved was studied only by obtaining clinically relevant measures of cardiac output with similar left ventricular filling pressures. These results suggested excellent myocardial protection. Schwartz and associates [8] have studied in detail the myocardial protection achieved with the endovascular cardiopulmonary bypass system as compared with the standard open chest myocardial protection scheme, with no significant differences. Finally, the very small femoral vessels of the dog required bilateral femoral artery manipulation for the arterial inflow cannula and insertion of the endoaortic clamp. In the human we anticipate single femoral artery access to accomplish both functions.
This minimal-access approach to performing coronary artery bypass grafting should be evaluated and compared with all presently available strategies for direct coronary artery revascularization. These include standard open chest coronary artery bypass grafting with cardiopulmonary bypass and cardioplegia [13], open chest coronary artery bypass grafting on a beating heart without cardiopulmonary bypass [14, 15], minimal-access coronary artery bypass grafting without cardiopulmonary bypass [1618], and catheter-based interventions including percutaneous transluminal coronary angioplasty, coronary atherectomy, and intracoronary stent placement [1921].
Undoubtedly, the gold standard for direct coronary artery revascularization remains open chest coronary artery grafting with cardiopulmonary bypass and cardioplegic arrest. This has become an extremely safe, reproducible, and long-term solution to symptomatic coronary artery disease. The use of the internal mammary artery as the conduit of choice has provided excellent durability to this revascularization strategy, with patency rates of 90% at 20 years [5]. This approach is used in the overwhelming majority of coronary artery bypass operations. There is a role for coronary artery bypass grafting through an open chest without cardiopulmonary bypass in patients who are deemed to be at unacceptable risk for cardiopulmonary bypass or who need single-vessel revascularization and are amenable to this technique. Yet it is limited by the difficulty of access to multiple vessels and the demanding technical nature of performing precise internal mammary artery-to-coronary artery anastomoses on a beating heart. This approach was first used more than 30 years ago by Koselov [2] by way of a left thoracotomy and laid the essential groundwork for the development of internal mammary artery bypass grafting. Some surgeons have been reevaluating this approach through a limited anterior thoracotomy and performing direct anastomoses on a beating heart, much the way Koselov described, with operative mortality rates of 1% to 3.2%; perioperative myocardial infarction, 1% to 2.7%; cerebrovascular accident, 0.1% to 0.4%; mediastinitis, 1.4% to 2%; early return of angina, 7.7%; and internal mammary graft patency of 87.5% at 1 month [14, 15]. This technique is also limited by the accessibility of only the LAD or proximal right coronary artery, and again is restricted by the difficulty of performing a precise anastomosis on a beating heart, although pharmacologically induced bradycardia may facilitate this technique. This approach is mostly limited to highly selected patients in need of single-vessel grafting.
The use of percutaneous methods for coronary artery revascularization has rapidly expanded over the last decade. Balloon angioplasty remains the most frequent and versatile method, but the addition of coronary atherectomy and intracoronary stent placement has increased the number of patients eligible for treatment with this strategy. These advances in interventional cardiology have resulted in decreased patient discomfort, hospital stay, and short-term cost. The disadvantages of these percutaneous techniques include reduction in long-term durability, increased rate of recurrent angina, and the need for subsequent costly procedures [22]. The optimal therapy for occlusive coronary artery disease has not yet been defined. The feasibility of a minimally invasive method for performing coronary artery grafting with the LIMA has been demonstrated in the present study. This method seems to provide the benefits of the standard surgical approach, with access to an optimally protected, decompressed, immobile heart and the patient on effective cardiopulmonary support. The lack of a major thoracotomy may allow decreased patient discomfort, hospital stay, overall recovery time, and cost, yet provide the benefit of complete revascularization similar to standard open chest coronary artery bypass grafting. Clinical investigation will be necessary to elucidate the importance of median sternotomy, cardiopulmonary bypass, and myocardial protection methods on patient recovery and morbidity.
This feasibility study demonstrates advances in four very important areas that have been obstacles to performing safe and effective minimally invasive coronary artery bypass grafting. First, femoral venous and femoral arterial bypass with kinetic augmentation of venous drainage provides excellent cardiopulmonary support in the closed chest model. Second, occlusion of the ascending aorta, delivery of antegrade blood cardioplegia, and venting have allowed excellent myocardial protection as well as a still and bloodless field to perform precise internal mammary artery-to-coronary artery anastomoses. Third, the modified operating microscope provides high-resolution stereoscopic visualization [23]. Finally, surgical instruments and methods based on conventional surgical technique, including cautery, suturing, and knot tying, can be adapted to this minimally invasive approach. One might expect that the time required to perform this operation would diminish with increased surgical experience with these methods.
With the development of these technologies an effective minimally invasive method for durable treatment of coronary artery disease could be possible. Further, these methods may be readily extended to multivessel coronary artery bypass operations. A clinical trial is presently underway to refine the method of port-access coronary artery bypass grafting and to understand the risks and benefits of this new method.
| Acknowledgments |
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| Footnotes |
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Address reprint requests to Dr Siegel, Stanford University Medical Center, 300 Pasteur Dr, Stanford, CA 94305-5117.
| References |
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