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Ann Thorac Surg 1999;67:99-104
© 1999 The Society of Thoracic Surgeons
a Linköping Heart Center, University Hospital, Linköping, Sweden
Accepted for publication July 1, 1998.
Address reprint requests to Dr Lönn, Linköping Heart Center, University Hospital, 581 85 Linköping, Sweden
| Abstract |
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Method. Thirty-two patients were prospectively randomized. The study group was operated on using an axial blood flow pump (Hemopump; HP) as circulatory support. Operations were performed on the beating heart. The control group was operated on using CPB, aortic cross-clamping, and cardioplegic arrest.
Results. All patients went through the procedure without major complications, and were discharged from the hospital. No statistical differences were observed between the groups for time on support (HP, 60.5 minutes; CPB, 70.5 minutes) or total operating time (HP, 178 minutes; CPB, 162 minutes). The number of grafts was greater in the CPB group (HP, 1.8; range, 1 to 3; CPB, 2.5; range, 1 to 4; p = 0.03). Statistical differences were found for intraoperative bleeding (HP mean, 312 mL; CPB mean, 582 mL; p = 0.0003) and myocardial trauma as measured by postoperative troponin-T values (HP, 0.23 µg/L; CPB, 1.17 µg/L; p = 0.004).
Conclusions. Hemopump-supported coronary artery bypass graft operation has been shown to be a safe and feasible procedure with the potential benefits of reduced operative bleeding and myocardial damage without prolonging intraoperative support or total operating time.
| Introduction |
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Beating heart CABG has been reported earlier by Buffolo and coworkers [3], Benetti and associates [4], and Pfister and colleagues [5] as an alternative to the gold standard, ie, use of CPB, aortic cross-clamping, and cardioplegic arrest. This procedure is technically more demanding and concerns have been raised about the long-term results. Since the introduction of minimally invasive direct coronary artery bypass grafting (MIDCAB), this approach has become a widespread technique [6]. The most common procedure has been left internal mammary artery grafting to the left anterior descending coronary artery on the beating heart, through a limited anterior thoracotomy [7]. Long-term results of MIDCAB are not yet available.
Ventricular assist devices have been successfully used to support patients during CABG [8]. These techniques avoid the risk of CPB and an artificial oxygenator because the patients own lungs are functioning. Sweeney and Frazier [9] reported good results when using ventricular assist device-supported CABG in high-risk patients. They used the ß-blocking agent esmolol as an adjunct to make the heart flaccid. The technique using both left- and right-sided assist with Bio-Medicus pumps is, however, cumbersome with the risk for device-related complications. In a few cases Sweeney and Frazier used an intracorporeal axial blood flow pump for left ventricular support with encouraging results [9]. This method may become an alternative to the MIDCAB procedure as it provides the surgeon with an approach by which he can reach more than one vessel, while avoiding the negative effects of CPB. It can also provide a less dramatic way of using the MIDCAB approach, operating on the beating heart but with the convenience of a sternotomy, giving better control over the surgical field. We recently reported our experience with this approach in an animal model followed by a pilot study in humans [10, 11].
This report describes a prospective randomized study comparing Hemopump (HP)-supported CABG operations on the beating heart with the gold standard.
| Material and methods |
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Thirty-two patients with stable angina scheduled for CABG were selected for this study. Previous experience has shown us that there may be problems reaching the middle branches of the circumflex artery when using the HP technique; patients needing a graft to this area were therefore excluded. The patients were prospectively randomized into two groups. The patients in the control group were operated on using CPB and aortic cross-clamping with cold ischemic arrest. Those in the study group were operated on with an "empty-beating" heart by means of the Hemopump (Medtronic Inc., Grand Rapids, MI) support. Both groups were treated according to our routines for preoperative and postoperative care. Demographic data are shown in Table 1. The patients were mechanically ventilated with a mixture of oxygen and air (Servo 900 D, Siemens-Elema, Stockholm, Sweden) and anesthetized as for open heart surgery, ie, fentanyl, isoflurane, and benzodiazepine. A Swan-Ganz catheter was placed (Baxter Healthcare, Irvine, CA) before anesthesia allowing hemodynamic monitoring as well as real-time measurements of mixed venous oxygen saturation. Muscle relaxation was achieved with pancuronium. A midline sternotomy was performed, and the pericardium was opened to visualize the areas of intervention.
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The esmolol infusion was titrated up to a dose at which the surgeon felt the heart was flaccid enough to perform bypass procedures without difficulty. Before each increase in infusion rate an additional bolus dose of 0.5 mg · kg-1 of esmolol was given. Proximal and distal to the site of anastomosis on the coronary artery, special air-cushioned vessel loops (Retract-o-tape, Quest Medical Inc., Allen, TX) were placed to prevent bleeding. In both groups the anastomoses were carried out with a running 6-0 or 7-0 Prolene (Ethicon, Somerville, NJ) suture.
The hemodynamic response was measured before anesthesia, after induction of anesthesia, at a steady-state level with maximal esmolol effect during the operation, after removal of the HP, on arrival at ICU, 6 hours postoperatively, and at discharge from the ICU. Hemodynamic data were recorded in 12 of 16 patients (Fig 3). The esmolol infusion was stopped just before completion of the bypass operation, and at least 15 minutes of reperfusion was maintained with the HP at full speed before weaning the patient off circulatory support. After weaning, the HP was withdrawn into the graft and a sidebiter was placed just proximal to the insertion site, the graft was removed, and the arteriotomy was sutured with two layers of running 4-0 Prolene.
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In both groups blood chemistry data were obtained the day before the operation and the morning after the operation at the ICU, except for plasma-free hemoglobin and troponin-T, which were only measured postoperatively. To determine heart muscle damage the enzymes aspartate aminotransferase was measured together with troponin-T. Renal function was assessed by means of serum creatinine, and platelet consumption was assumed to be the difference between preoperative and postoperative counts.
Statistics
Descriptive statistics were used to summarize the data in terms of mean, median, and range. Unpaired Students t test was used to detect differences between the groups.
| Results |
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In the CPB group there were 4 patients with complications. One patient experienced reversible neurologic symptoms involving the left arm. One patient had to be reoperated on because of postoperative bleeding. One patient had respiratory insufficiency requiring prolonged ventilator treatment (3 days), and one patient had respiratory insufficiency together with sternal wound infection and was transferred to the referring hospital for rehabilitation on the 12th postoperative day.
Intraoperative data are shown in Table 2. Statistically, there were more grafts placed in the CPB group than in the HP group (2.5, range, 1 to 4 versus 1.8, range, 1 to 3; p = 0.03). Time on cardiac support or total operating time did not differ between the groups. Heparin doses and activated clotting times differed because of the different need for heparinization between the two methods. Intraoperative bleeding was statistically different between the groups (HP group mean, 312 mL; range, 150 to 500 mL; CPB group mean, 582 mL; range, 350 to 1150 mL; p = 0.0003). Total fluid balance, including all fluids given or lost (crystalloids, colloids, urine output, evaporation), did not differ between the groups. The average aortic cross-clamp time in the CPB group was 34.1 minutes (range, 15 to 75 minutes).
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| Comment |
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Hemodynamic conditions were stable throughout the operation in our patients in the HP group, and there were no signs of ischemia on the electrocardiogram. The HP was easily inserted into the left ventricle through the graft sutured to the ascending aorta. When the HP was in the correct position it effectively unloaded the left ventricle as has been reported previously [12, 13]. A concomitant reduction in wall tension should decrease the oxygen demand and increase perfusion of the subendocardial tissue [14], which is beneficial for impaired left ventricles with high filling pressures. An increase in myocardial perfusion pressure and decrease in myocardial oxygen consumption during HP treatment of experimental cardiogenic shock has been reported [15]. In our patients, the decompressed heart was manipulated and supported with bolsters of laparotomy pads without signs of ischemia or circulatory instability. Arrhythmias were temporary provoked by these maneuvers, probably because of changes in HP position. The HP was withdrawn within 15 minutes of completion of the operation in all patients. Should there have been any heart failure or signs of ischemia we could easily have continued with the HP support in the ICU as a left ventricular assist device.
Titration of the short-acting ß-blocker esmolol was very carefully done, as we previously have experienced adverse effects with severe circulatory failure when we used high doses in animals [10]. Careful monitoring of right ventricular function is essential when using this approach, especially in the beginning of ones learning curve. A right ventricular assist backup may be a good idea, especially in patients with severely impaired heart function. Administration of esmolol did not significantly decrease heart rate but the overall contractility of the heart was reduced. When the infusion rate was optimally titrated, CABG operation could be performed with the same technique and precision as during conventional operation. We had no device-related complications.
One benefit of HP-supported CABG as shown in this study is the reduction in intraoperative bleeding, which is most likely dependent on the lower doses of heparin in the HP group. Massive bleeding from the aorta is a threat that cannot be coped with as effectively when using CPB. Some form of blood-preserving system for intraoperative and postoperative autotransfusion is essential if we are to fully exploit the potential of HP-supported CABG. Two patients in the HP group received blood transfusions. One patient was an older woman with anemia before her operation. She received one unit of erythrocytes. An additional patient received one unit of blood postoperatively, for reasons that are unclear. In the CPB group 19 units of blood or blood products were given to 4 patients; 13 of these were given to the patient who had to be reoperated on because of bleeding in the early postoperative period. Even if there is a need for transfusion in 25% to 75% of patients when CPB is used, a simple but strict protocol can reduce this to less than 5% [16].
Avoidance of full heparinization is an advantage with HP-supported CABG. Similar results can probably be achieved using heparin-coated CPB systems [17]. Temporary occlusion of the coronary vessels has not caused problems in previous series of CABG without CPB [35]. Occlusion of the coronary arteries is usually well tolerated during percutaneous transluminal coronary angioplasty without any cardiac decompression. The absence of ST-segment changes during HP-supported CABG might be explained by the combined use of ventricular unloading and high doses of ß-blocker, creating a global left ventricular preconditioning.
Coronary artery bypass grafting supported by HP may be an alternative way of handling patients with ongoing ischemia or with poor ventricular function. Besides providing good myocardial protection, an effective ventricular assist device is already in place if needed. In compromised hearts, improved patient outcome may be possible because intervention is early and the heart is maintained in an unloaded state postoperatively. There are also data indicating a reduction of the size of an acute infarction when mechanical ventricular decompression is applied [18].
In both groups we followed our standard clinical protocol regarding anesthesia and postoperative follow-up. We did not therefore expect any differences for time on ventilator and time in hospital for these patients. Should our anesthesia protocol be modified using short-acting substances the patients could probably be extubated in the operating room or very soon after. A critical factor is the preservation of normothermia. A significant number of these patients would probably be sent home on the third or fourth postoperative day if included in a fast-track protocol, but because we have followed our routine protocol for all patients this was not evaluated. We hope to change that situation in future trials. The reason for the significant difference in the number of grafts placed in these groups is unclear; all patients received bypass grafts to the intended vessels based on preoperative angiograms.
The most suitable candidates for this procedure are presumably patients with impaired left ventricular function or acute ongoing ischemia, as myocardial ischemia is reduced using this technique and if the heart should fail, left ventricular assist device is already in place.
In this study, HP-supported CABG was shown to be a safe and feasible method compared with the gold standard. Potential benefits included less intraoperative bleeding and less ischemia of the heart muscle. The procedure takes no longer to perform, and time of cardiac support during the operation does not differ. No device-related complications were seen. Esmolol was an important adjuvant facilitating precise surgical procedures. It should be pointed out that the results from this study only apply narrowly to the short-term postoperative period, and the real test of this method can only be done in large long-term studies.
| References |
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, Abdelnoor M., Øystese R. Conventional blood conservation techniques in 500 consecutive coronary artery bypass operations. Ann Thorac Surg 1991;52:500-505.[Abstract]
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